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AstraZeneca -- >>> AstraZeneca is an international drugmaker that doesn't get much attention from U.S.-based investors. That's because its dividend payouts are a little unusual.
https://www.fool.com/investing/2024/09/19/2-unstoppable-sp-500-stocks-that-keep-beating-the/
Instead of four equal quarterly distributions, AstraZeneca insists on two payments per year, with a greater portion announced alongside fourth-quarter results and payable in March. In July, the company raised its first interim distribution by 7.5% to $0.50 per American depository receipt (ADR).
At recent prices, the stock offers a 1.9% dividend yield. That isn't particularly tempting now, but the distribution could grow at the same pace as the company's bottom line. AstraZeneca generated $7 billion in free cash flow over the past year and only needed 64% of this sum to meet its dividend commitment.
AstraZeneca has multiple growth drivers that could push up profits and its dividend payout in the years ahead. In the first half of 2024, sales of Farxiga -- a treatment for diabetes, heart failure, and chronic kidney disease -- surged 35% year over year to $3.8 billion. Sales of Calquence, a blood cancer drug, surged 27% to $1.5 billion, and Ultomiris, a rare disease drug, shot 32% higher to $1.8 billion.
Free cash flow has surged since 2020 and could continue rising, thanks to an extremely successful product line. In the first half of 2024, AstraZeneca reported sales that grew more than 10% year over year for 21 different drugs.
With heaps of growth drivers to push earnings higher and a lack of significant patent cliffs to offset, AstraZeneca expects earnings to grow by a percentage in the middle teens this year. Adding some shares to a diversified portfolio now looks like a smart move.
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AbbVie -- >>> AbbVie raised its dividend payout by a stunning 270% over the past 10 years but isn't trading like a stock that rapidly raises its quarterly payout. At recent prices, it offers a 3.2% yield.
https://www.fool.com/investing/2024/09/19/2-unstoppable-sp-500-stocks-that-keep-beating-the/
Shares of AbbVie have been under pressure because its former lead drug Humira lost patent-protected market exclusivity in the U.S. in 2023. In the first half of 2024, Humira sales decreased 33% year over year to $5.1 billion.
Declining Humira sales are a challenge, but AbbVie has done a pretty good job reinvesting the profits it produced. In 2019, the company launched Skyrizi for psoriasis and Rinvoq for arthritis, and these two drugs are offsetting Humira losses on their own.
Combined sales of the pair reached $7.3 billion in the first half of 2024 and are a long way from being finished. In February, management told investors it expects Rinvoq and Skyrizi to generate more than $27 billion in combined annual sales by 2027.
Investors will be glad to learn that Rinvoq and Skyrizi aren't the only blockbuster drugs that AbbVie's launched in recent years. For example, its oral treatments for migraine headaches, Ubrelvy and Qulipta, are expected to produce more than $3 billion in combined annual sales at their peaks.
AbbVie shares have been trading for around 17.9x the midpoint of management's earnings expectations for 2024. That's a historically high multiple for this company, but pressure from Humira's competition is already beginning to subside. With plenty of growth drivers to push earnings higher, investors who buy at recent prices have a great chance to come out miles ahead over the long run.
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Johnson & Johnson ->>> J&J unit files for bankruptcy to advance $10 billion talc settlement
Reuters
September 20, 2024
By Dietrich Knauth
https://finance.yahoo.com/news/j-j-subsidiary-files-bankruptcy-193903276.html
(Reuters) - A Johnson & Johnson subsidiary filed for bankruptcy for a third time on Friday as the healthcare giant seeks to advance an approximately $10 billion proposed settlement that would end tens of thousands of lawsuits alleging that the company's baby powder and other talc products caused cancer.
J&J faces lawsuits from more than 62,000 claimants who alleged that its baby powder and other talc products were contaminated with asbestos and caused ovarian and other cancers. To stop those lawsuits, J&J subsidiary Red River Talc filed for bankruptcy protection in a federal bankruptcy court in Houston.
The company has denied the allegations and has called its products safe.
Erik Haas, J&J's worldwide vice president of litigation, said on Friday that the settlement is "fair and equitable to all parties" and that 83% of current talc claimants voted for it.
The settlement proposal has divided attorneys who represent cancer victims. Opponents of the deal said they will quickly ask the court to dismiss the bankruptcy or transfer it to New Jersey, where courts have twice rebuffed J&J's attempts to end the litigation in a so-called "Texas two-step" bankruptcy.
Andy Birchfield, an attorney opposed to the deal, said that J&J is gaming the bankruptcy system in an attempt to underpay tens of thousands of cancer victims.
"We view this so-called vote as another fraudulent effort by J&J to manipulate the bankruptcy process and minimize the legitimate claims of ovarian cancer victims," Birchfield said.
Other attorneys spoke in support of the deal, including Allen Smith, a lawyer who had previously represented 11,000 claimants in partnership with Birchfield's law firm.
Smith said the settlement offer "finally provides my clients reasonable and fair compensation. It's now time to go to work and get them compensated as soon as possible."
The "two-step" maneuver employed by J&J involves offloading liabilities onto a newly created subsidiary that then declares Chapter 11, a type of bankruptcy that involves a reorganization of assets and debts under court supervision. The goal is to use the proceeding to force all plaintiffs into one settlement, without requiring J&J itself to file for bankruptcy.
Bankruptcy judges can enforce global settlements that permanently halt all related lawsuits and forbid new ones.
Outside of bankruptcy, any settlement J&J reached with some claimants would still leave holdouts or future plaintiffs with the right to sue - and leave the company exposed to potential multibillion-dollar verdicts that encouraged it to use a two-step in the first place.
To improve its chances in a third bankruptcy effort, J&J asked plaintiffs to vote on its proposed deal ahead of time to ensure that it has enough support for its plan to succeed. J&J needed more than 75% to back the plan for a bankruptcy judge to impose the deal on all plaintiffs.
GYNECOLOGICAL CANCER CLAIMS
J&J's third attempt at a bankruptcy settlement also differs from its previous efforts in part because it focuses only on ovarian and other gynecological cancer claims, building on J&J's previous settlements with state attorneys general and people who had sued after developing mesothelioma, a rare form of cancer linked to asbestos exposure.
J&J's proposed settlement would pay talc claimants about $10 billion over 25 years. The present value of the settlement is roughly $8 billion after J&J recently agreed to kick in an additional $1.1 billion to the settlement fund and pay $650 million in legal fees to attorneys that had previously opposed the settlement offer.
The company has been engaged in a bitter fight with lawyers opposing its third attempt to settle the litigation in bankruptcy.
J&J's bankruptcy strategy still faces legal hurdles. These include a June U.S. Supreme Court decision involving Purdue Pharma's bankruptcy, court orders dismissing its previous efforts and proposed federal legislation aimed at preventing financially healthy companies like J&J from benefiting from bankruptcy protection.
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>>> Doctors ‘truly amazed’ by man’s recovery after world-first whole-eye transplant
by Nilima Marshall
PA Science Reporter
September 9, 2024
https://www.yahoo.com/news/doctors-truly-amazed-man-recovery-150000838.html
Surgeons who performed the world’s first whole eye transplant on an army veteran said they have been “truly amazed” by his remarkable recovery.
Aaron James, 47, from Arkansas in the US, lost his left eye and most of his face after an electrical cable touched the left side three years ago.
In May 2023, he underwent 21 hours of surgery involving more than 140 healthcare professionals to replace his face – which included getting a new eye.
Now more than a year later, his donor eye continues to maintain normal pressure and blood flow – despite surgeries on animals showing a different outcome where the eye often shrank significantly, the doctors said.
Eduardo D Rodriguez, chair of the Hansjorg Wyss Department of Plastic Surgery at NYU Langone Health in the US, said: “We are truly amazed by Aaron’s recovery, with no episodes of rejection.”
Tests also show that that rods and cones, the light-sensitive nerve cells in the eye, survived the transplant.
Doctors say this raises hope that one day, whole-eye transplants could be performed to restore sight – despite Mr James still yet to regain his vision in his left eye.
Dr Daniel J Ceradini, director of research and associate professor in the Hansjorg Wyss Department of Plastic Surgery, said: “The whole thing has been a monumental achievement, considering how Aaron has done post operatively and how good he functions and looks.”
He said scans suggest the brain may be responding to the light through the donor eye but added that these findings, published in the journal Jama, “are very preliminary and would need to be studied over time”.
Mr James, who served in the Army National Guard for 10 years, said that being able to smell, taste and eat solid food – particularly pizza – after surviving on purees for two years was a “shining moment”.
He added: “I knew getting back to normal would be (on track) if I could eat pizza.
“The very first thing that I can remember when I woke up from surgery is being able to smell, because before that, I didn’t have a nose, so I couldn’t smell, and that also meant I could not taste anything.
“The only way I could eat was through a straw because by mouth was locked – I couldn’t open or close my mouth.”
Mr James, who also lost his left arm in the accident and now wears a prosthetic, said that since surgery, he is now “pretty much back to being a normal guy, doing normal things”.
Meagan James, 39, his wife of more than 20 years, said her emotional moment was when she kissed her husband on the lips for the first time in two years.
She said: “Just to have that back was pretty special.”
Prof Ceradini said the team will continue to do more work to understand how to restore sight to the eye.
He said one of the steps could involve helping the optic nerve – which send visual messages to the brain to help a person see – regrow.
Despite not being able to see with his left eye, Mr James said he “felt honoured to be patient zero”.
He said: “This has been the most transformative year of my life.
“I’ve been given the gift of a second chance, and I don’t take a single moment for granted.
“I’ve gained my quality of life back, and I know this is a step forward in the path to help future patients.”
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>>> LeMaitre Vascular, Inc. (LMAT) develops, manufactures, and markets medical devices and implants used in the field of vascular surgery worldwide.
It offers human cadaver tissue cryopreservation services; angioscope, a fiberoptic catheter used for viewing the lumen of a blood vessel; embolectomy catheters to remove blood clots from arteries; thrombectomy catheters for removing thrombi in the venous system; occlusion catheters that temporarily occlude the blood flow; and perfusion catheters to perfuse the blood and other fluids into the vasculature.
The company also provides artegraft biologic graft, a bovine carotid artery used for dialysis access; XenoSure biologic patches, used for closure of vessels after surgical intervention; VascuCel and CardioCel biologic patches, used in vessel repair, heart repair and reconstruction, and neonatal repairs; cardiovascular patches; carotid shunts that temporarily shunt the blood to the brain during the removal of plaque in a carotid endarterectomy surgery; biosynthetic vascular graft indicated for lower extremity bypass and dialysis access; and vascular grafts used to bypass or replace diseased arteries.
In addition, it offers radiopaque tape, a medical-grade tape applied to the skin that enables surgeons and interventionalists to cross-refer between the inside and the outside of a patient's body and allows them to locate tributaries or lesions beneath the skin. Further, the company provides valvulotomes, which cut or disrupt valves in the saphenous vein to function as an artery to carry blood past diseased arteries to the lower leg or the foot; and closure systems to attach vessels to one another with titanium clips instead of sutures.
It markets its products through a direct sales force and distributors. The company was formerly known as Vascutech, Inc. and changed its name to LeMaitre Vascular, Inc. in April 2001. LeMaitre Vascular, Inc. was incorporated in 1983 and is headquartered in Burlington, Massachusetts.
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https://finance.yahoo.com/quote/LMAT/profile/
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>>> Pfizer, joining Lilly, enters the direct-to-consumer market with a telehealth and prescription platform
Yahoo Finance
by Anjalee Khemlani
Aug 27, 2024
https://finance.yahoo.com/news/pfizer-joining-lilly-enters-the-direct-to-consumer-market-with-a-telehealth-and-prescription-platform-120250691.html
On Tuesday, Pfizer (PFE) said it will enter the direct-to-consumer business, following the lead of a Big Pharma rival, Eli Lilly (LLY), which launched a similar plan in January.
The new website and patient platform, called PfizerForAll, aims to help patients more quickly access migraine treatments as well as vaccines and treatments for respiratory viruses like COVID-19 and the flu. While these are all products of Pfizer, the company contends that patients will not be forced to choose a Pfizer drug. That decision, they say, will remain in the hands of clinicians.
Pfizer chief US commercial officer Aamir Malik told Yahoo Finance the company is hoping to make access to medicines easier. "Navigating our healthcare system is time-consuming. It's complicated. It's overwhelming. And the last thing that anybody needs when they're trying to get the care that they need for themselves or a loved one is to have to navigate that complex, painful, difficult system," Malik said.
Malik and others point out that patients often have to search for doctors who can write the prescriptions they need quickly — or even find a doctor who will see them in a timely manner, Malik said.
Adding to the complexity is the insurance process, which involves various coverage hurdles, such as pre-authorization requests and the hunt for a pharmacy that can dispense the drug at a lower co-pay cost.
But Pfizer's goal isn't to eradicate that complex system. Instead, Malik emphasized that the new portal will simply serve as an additional avenue for patients to get the drugs they are already familiar with, and also introduce new patients to the drugs. (It won't be able to help with drug shortages, as that issue rests with drug manufacturers.)
In addition, the site will have a customer helpline for patients if they run into any of the usual hurdles. That includes contacting the insurer to remove any access barriers or guiding the patients on how to contact the insurers themselves if needed.
How it works
Pfizer will use social media ads to find patients and funnel them to the new portal. The entry point will be whatever health problem the patient is trying to resolve, such as addressing migraine pain. That will lead to a specific landing page, which will offer a telehealth visit through a third-party vendor, UpScript, for $35 or an in-person visit with the booking portal Zocdoc.
At that point, the patient is outside of the Pfizer portal and has a visit with a clinician who can prescribe an appropriate drug. This could be a Pfizer drug — or not, Malik said.
There is no revenue sharing from the clinical visits or the prescriptions, which means that clinicians aren't getting paid or sharing in profits of the sales if they prescribe a Pfizer drug.
Patients can then get the drug mailed or pick it up at their regular pharmacy. In the case of vaccines, Pfizer will help book appointments at major retail pharmacies CVS (CVS) or Walgreens (WBA), which have more than 17,000 locations combined across the country — and more pharmacies anticipated in the future. Under respiratory care, Pfizer will also offer access to at-home tests through Instacart (CART) the same day or via two-day shipping from Amazon (AMZN).
Pfizer said that the company doesn't see this as a profit-focused business. "We're not building this as a standalone business with a revenue and a profit objective to it," Malik told Yahoo Finance. "We're not holding revenue targets to PfizerForAll." Instead, the company will measure success on how popular the site is.
The market
Eli Lilly launched its site, LillyDirect, earlier this year to help patients with diabetes, obesity, and migraines.
Lilly CEO David Ricks noted that the telehealth solution helps obesity patients the most — especially those hunting for its blockbuster drug, Zepbound. He told Yahoo Finance in January that "patients report doctor shopping" for someone who will write their prescription. That's why the site, in addition to offering telehealth, can also help find an obesity specialist by zip code.
LillyDirect is similar to PfizerForAll in that it relies on replicating the traditional pathway to get a prescription. But the clinicians are different. Whereas Pfizer is using one platform for telehealth and ZocDoc for doctor's visits, Lilly is using three different telehealth platforms.
For diabetes and obesity, Lilly is using 9amHealth, which accepts a limited number of insurance plans only in Texas and California. It is unclear if patients in other states have access. Lilly is also using FormHealth for obesity, which accepts most major insurers and Medicare. For migraine treatments, the company partnered with Cove, which accepts insurers and has a $30 copay or costs $99 for a visit without insurance.
Compare that to the $35 flat fee through Pfizer for UpScript.
In the eight months since its launch, it is unclear how well LillyDirect is doing. Lilly declined to provide Yahoo Finance with updates on traffic to the site.
In a first quarter earnings call in April, Lilly USA Diabetes and Obesity president Patrik Jonsson said that the site was "gaining traction by weeks." But in response to a question about tracking prescriptions for GLP-1 weight loss drug Zepbound, Jonsson said, "It's relatively low volume that goes through LillyDirect."
But new patients, who are filling prescriptions for the drug for the first time in their lives through the site, was slightly higher, he said. No specific numbers were provided.
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>>> Ozempic Could Have a Terrible Side Effect. Is Novo Nordisk in Trouble?
by Prosper Junior Bakiny
Motley Fool
Aug 27, 2024
https://finance.yahoo.com/news/ozempic-could-terrible-side-effect-100000193.html
The diabetes medicine Ozempic has been a veritable cash cow for Novo Nordisk (NYSE: NVO). The company's revenue, earnings, and stock price have been on a tear in recent years -- and no single drug has contributed more to its performance than Ozempic.
However, various potential headwinds have popped up that could disrupt Ozempic's progress. One of them is competition. Novo Nordisk's longtime foe in the diabetes market, Eli Lilly, developed Mounjaro, a diabetes medicine whose sales are growing incredibly fast.
Elsewhere, the side effects of Novo Nordisk's crown jewel have come under increased scrutiny, and a recent study suggests that Ozempic could have a dangerous safety issue. Let's look at what it could mean for Novo Nordisk.
Could Ozempic cause suicidal thoughts?
One of Ozempic's side effects that has generated quite a bit of attention is muscle loss. However, an even more dangerous potential drawback that some researchers have warned about is the possibility that Ozempic could increase suicidal thoughts.
A recent study claims to shed more light on this topic. The study looked at two medicines in the GLP-1 receptor agonist class, to which semaglutide, the active ingredient in Ozempic, belongs. The other GLP-1 medicine featured was liraglutide, the generic name for Victoza and Saxenda, which treat diabetes and obesity, respectively.
Liraglutide was another one of Novo Nordisk's discoveries. Through a database from the World Health Organization that tracks suspected adverse reactions from medicines and vaccines, the researchers found that Ozempic was associated with a higher rate of reported suicidal thoughts compared to other drugs. Liraglutide did not seem to be linked with higher rates of suicidal thoughts.
What should investors make of these findings? Should you sell the healthcare stock?
No reason to hit the panic button
Regulatory authorities are already aware of the potential association between Ozempic -- or at least its active ingredient, semaglutide -- and suicidal thoughts. Wegovy, an obesity medicine that shares this same active ingredient, has a warning for precisely that in the U.S.
Researchers sometimes learn even more about a therapy and its side effects after years of use in real-life settings. If studies establish a robust causal link between Ozempic or Wegovy and suicidal thoughts, that could cause regulators to take action. Perhaps they would add additional warnings or, in the worst-case scenario, take the medicine off the market. Either way, it would mean lower (or nonexistent) sales for Novo Nordisk's biggest growth driver, dragging down its revenue, earnings, and stock price.
But there's no reason to think this study will lead to that morbid scenario. Other studies have reached different conclusions. One published in Nature Medicine, one of the world's most prestigious science journals, found that semaglutide had a lower risk of producing suicidal thoughts than other non-GLP-1 anti-obesity medicines in real-life settings. This study, unlike the previous one, compared patients based on factors that can influence suicidal behavior, including sex, socioeconomic status, ethnicity, and mental health.
It would take a lot to reverse these findings. So, for now, investors can continue focusing on how Novo Nordisk is performing. And on that front, there aren't too many complaints.
Financial results continue to be strong. In the first half of the year, the company's net sales grew by 24% year over year to 133.4 billion Danish kroner ($19.8 billion). Ozempic's sales increased 36% year over year, while Wegovy's jumped 74%. Notably, Novo Nordisk continues to lead the GLP-1 market -- its share was 56% as of May, compared to 54% a year before.
Ozempic could win several label expansions, including in the exciting area of nonalcoholic steatohepatitis, where it's being investigated in a phase 3 study. Novo Nordisk has many more promising candidates. CagriSema, a next-gen GLP-1 drug, could be yet another multibillion-dollar medicine. The drugmaker is also looking to diversify, with several programs across a range of therapeutic areas.
Though various challenges to Ozempic will continue to appear, the recent study doesn't pose too much of a problem for the medicine and its maker. Novo Nordisk should continue delivering strong financial results and stock-market performance for the foreseeable future. I believe the stock is still worth buying.
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>>> Tiny shards of plastic are increasingly infiltrating our brains, study says
by Sandee LaMotte
CNN
August 23, 2024
https://www.yahoo.com/news/microplastics-found-human-brains-130318087.html
Human brain samples collected at autopsy in early 2024 contained more tiny shards of plastic than samples collected eight years prior, according to a preprint posted online in May. A preprint is a study which has not yet been peer-reviewed and published in a journal.
“The concentrations we saw in the brain tissue of normal individuals, who had an average age of around 45 or 50 years old, were 4,800 micrograms per gram, or 0.5% by weight,” said lead study author Matthew Campen, a regents’ professor of pharmaceutical sciences at the University of New Mexico in Albuquerque.
“Compared to autopsy brain samples from 2016, that’s about 50% higher,” Campen said. “That would mean that our brains today are 99.5% brain and the rest is plastic.”
That increase, however, only shows exposure and does not provide information about brain damage, said Phoebe Stapleton, an associate professor of pharmacology and toxicology at Rutgers University in Piscataway, New Jersey, who was not involved in the preprint.
“It is unclear if, in life, these particles are fluid, entering and leaving the brain, or if they collect in neurological tissues and promote disease,” she said in an email. “Further research is needed to understand how the particles may be interacting with the cells and if this has a toxicological consequence.”
The brain samples contained 7% to 30% more tiny shards of plastic than samples from the cadavers’ kidneys and liver, according to the preprint.
“Studies have found these plastics in the human heart, the great blood vessels, the lungs, the liver, the testes, the gastrointestinal tract and the placenta,” said pediatrician and biology professor Dr. Philip Landrigan, director of the Program for Global Public Health and the Common Good and the Global Observatory on Planetary Health at Boston College.
“It’s important not to scare the hell out of people, because the science in this space is still evolving, and nobody in the year 2024 is going to live without plastic,” said Landrigan, who was not involved with the preprint.
“I say to people, ‘Listen, there are some plastics that you can’t escape. You’re not going to get a cell phone or a computer that doesn’t contain plastic.’ But do try to minimize your exposure to the plastic that you can avoid, such as plastic bags and bottles.”
CNN reached out to the American Chemistry Council, an industry association, but did not hear back before publication.
Nanoplastics ‘hijack’ their way into the brain
For the study, researchers examined brain, kidney and liver tissues from 92 people who underwent a forensic autopsy to verify cause of death in both 2016 and 2024. Brain tissue samples were gathered from the frontal cortex, the area of the brain associated with thinking and reasoning, and which is most affected by frontotemporal dementia (FTD) and later stages of Alzheimer’s disease.
“Based on our observations, we think the brain is pulling in the very smallest nanostructures, like 100 to 200 nanometers in length, whereas some of the larger particles that are a micrometer to five micrometers go into the liver and kidneys,” Campen said.
Microplastics are fragments that can range from less than 0.2 inch (5 millimeters) or about the size of a pencil eraser, to 1 nanometer. A strand of human hair is about 80,000 nanometers wide, according to the US Environmental Protection Agency. Anything smaller is a nanoplastic that must be measured in billionths of a meter.
Nanoplastics are the most worrisome plastics for human health, experts say, because the minuscule pieces can take up residence inside individual cells.
“Somehow these nanoplastics hijack their way through the body and get to the brain, crossing the blood-brain barrier,” Campen said. “Plastics love fats, or lipids, so one theory is that plastics are hijacking their way with the fats we eat which are then delivered to the organs that really like lipids — the brain is top among those.”
The human brain is about 60% fat by weight, far more than any other organ. Essential fatty acids, such as omega 3s, are key to the strength and performance of the brain’s cells. Since the human body can’t produce essential fatty acids on its own, they must come from food or supplements.
Diet is the main route of exposure for micro- and nanoplastics, said Landrigan, who is the lead author of a March 2023 report from the Minderoo – Monaco Commission on Plastics and Human Health, a global consortium of scientists, health-care workers and policy analysts charged with following plastics from creation to final product.
In that report, the consortium determined plastics are associated with harms to human health at every single stage of the plastic lifecycle.
“Some microplastics are also airborne,” Landrigan said. “For example, when people are driving down the highway and their tires are abrading on the surface of the highway, a certain amount of microplastic particles are thrown into the air.
“If you live near the coast, some of the microplastic particles that are in the ocean get kicked into the air through wave action,” he said. “So ingestion is probably the dominant route, but inhalation is also an important route.”
Plastics with ties to cancer
Polyethylene, which is used in plastic bags, films and bottles and is not biodegradable, was the predominant type of plastic found in tissue samples. It was found in greater quantities in the brain than in the liver or kidney, according to the preprint.
Polyethylene was also the predominant type of polymer found in human and dog testicles, according to an August 2024 study by Campen and his team.
The production of various forms of polyethylene, such as polyethylene terephthalate (PET) plastics, are the biggest contributor to the release of the solvent 1,4-dioxane into the environment, according to industry data collected by Defend our Health, an environmental advocacy group.
The US National Toxicity Program and the International Agency for Research on Cancer considers 1,4-dioxane to be possibly carcinogenic to humans. In 2023, the EPA released a draft report saying that the solvent poses an “unreasonable risk of injury to health” for plastics workers and community residents whose drinking water has been polluted by discharges from PET plastics factories.
“The biggest question is, ‘OK, what are these particles doing to us?’ Honestly there’s a lot we still don’t know,” Landrigan said. “What we do know with real certainty is that these microplastic particles are like Trojan horses — they carry with them all the thousands of chemicals that are in plastics and some are very bad actors.”
By invading individual cells and tissues in major organs, nanoplastics can potentially interrupt cellular processes and deposit endocrine-disrupting chemicals such as bisphenols, phthalates, flame retardants, heavy metals and per- and polyfluorinated substances, or PFAS.
Endocrine disruptors interfere with the human reproductive system, leading to genital and reproductive malformations as well as female infertility and a decline in sperm count, according to the Endocrine Society.
“We have some pretty good indications that microplastics and nanoplastics cause harm, even though we are a long way from knowing the full extent of that harm,” Landrigan said. “I would say we have enough information here that we need to start taking protective action.”
Learn to use less plastic
There are many steps individuals can take to reduce their exposure to plastics and their plastic footprint, experts say.
“It’s hard to avoid foods wrapped in plastic film but be sure to take the food out of the plastic wrapping before you cook it or put it in the microwave,” Landrigan said. “When you heat plastic, that accelerates the movement of the microplastics out of the wrapping into the food.
Invest in a zippered fabric bag and ask the dry cleaner to return your clothes in that instead of those thin sheets of plastic, suggested the Natural Resources Defense Council, an environmental advocacy group. Bring a travel mug to the local coffee store for takeout and silverware to the office to cut back on plastic cups and utensils.
“Don’t use plastic bags when you go shopping. Use a cloth bag or a paper bag or a recycle bag. Try to avoid plastic water bottles, if you can possibly do so,” Landrigan said.
A March 2024 study found 1 liter of bottled water — the equivalent of two standard-size bottled waters typically purchased by consumers — contained an average of 240,000 plastic particles from seven types of plastics. Some 90% of those were nanoplastics.
“Use a metal or glass drinking cup instead of a plastic cup. Store your food in glass containers instead of in plastic ones,” Landrigan said. “Work in your local community to ban plastic bags, as many communities around the United States have now done. There is a lot you can do.”
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Re-post - >>> Gadolinium-based Contrast Agent Accumulates in the Brain Even in Subjects without Severe Renal Dysfunction: Evaluation of Autopsy Brain Specimens with Inductively Coupled Plasma Mass Spectroscopy
https://pubs.rsna.org/doi/10.1148/radiol.2015142690
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174981213
Original Research
Neuroradiology
Tomonori Kanda , Toshio Fukusato, Megumi Matsuda, Keiko Toyoda, Hiroshi Oba, Jun’ichi Kotoku, Takahiro Haruyama, Kazuhiro Kitajima, Shigeru Furui
Author Affiliations
Published Online:May 5 2015https://doi.org/10.1148/radiol.2015142690
Abstract
Even in subjects without severe renal dysfunction, gadolinium-based contrast agent administration causes gadolinium accumulation in the brain, especially in the dentate nucleus and globus pallidus.
Purpose
To use inductively coupled plasma mass spectroscopy (ICP-MS) to evaluate gadolinium accumulation in brain tissues, including the dentate nucleus (DN) and globus pallidus (GP), in subjects who received a gadolinium-based contrast agent (GBCA).
Materials and Methods
Institutional review board approval was obtained for this study. Written informed consent for postmortem investigation was obtained either from the subject prior to his or her death or afterward from the subject’s relatives. Brain tissues obtained at autopsy in five subjects who received a linear GBCA (GBCA group) and five subjects with no history of GBCA administration (non-GBCA group) were examined with ICP-MS. Formalin-fixed DN tissue, the inner segment of the GP, cerebellar white matter, the frontal lobe cortex, and frontal lobe white matter were obtained, and their gadolinium concentrations were measured. None of the subjects had received a diagnosis of severely compromised renal function (estimated glomerular filtration rate <45 mL/min/1.73 m2) or acute renal failure. Fisher permutation test was used to compare gadolinium concentrations between the two groups and among brain regions.
Results
Gadolinium was detected in all specimens in the GBCA agent group (mean, 0.25 µg per gram of brain tissue ± 0.44 [standard deviation]), with significantly higher concentrations in each region (P = .004 vs the non-GBCA group for all regions). In the GBCA group, the DN and GP showed significantly higher gadolinium concentrations (mean, 0.44 µg/g ± 0.63) than other regions (0.12 µg/g ± 0.16) (P = .029).
Conclusion
Even in subjects without severe renal dysfunction, GBCA administration causes gadolinium accumulation in the brain, especially in the DN and GP.
© RSNA, 2015
Article History
Received November 20, 2014; revision requested January 5, 2015; revision received February 8; accepted March 2; final version accepted March 24.
Published online: May 05 2015
Published in print: July 2015
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Re-post - Gadolinium - >>> UNM Doctor Researches Toxic Side Effects of Rare Earth Metal Used in MRI Studies
https://hsc.unm.edu/news/2022/02/doctor-researches-toxic-side-effects-rare-earth-metals-mri.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174981201
Brent Wagner, MDPhysicians who schedule magnetic resonance imaging (MRI) studies for their patients often specify the use of a gadolinium-based contrast agent – a chemical solution injected into the bloodstream that makes for better quality images.
Gadolinium is a rare earth metal that aligns with an MRI’s powerful magnetic field, but it is also toxic, so in its injectable form the metal is bound to chelating molecules to block its dangerous effects. Most of these molecules are then filtered through the kidneys and eliminated.
But there is growing evidence that tiny particles of gadolinium remain in the body – including the brain – causing serious side effects in some people, says kidney researcher Brent Wagner, MD, an associate professor in The University of New Mexico Department of Internal Medicine.
“We’ve come to the conclusion if a living organism gets this stuff there’s a chance that these weird particles can form, and my suspicion is this is what triggers this reaction,” says Wagner, who also serves as a staff physician at the Raymond G. Murphy Veterans Affairs Medical Center in Albuquerque. “It’s probably distributing everywhere in the body once someone gets it.”
Reports first started emerging about 15 years ago that some patients who had received the gadolinium contrast agent were experiencing a painful, debilitating skin condition called systemic fibrosis, which causes skin thickening and tightening in the joints and extremities, as well as internal organ damage.
At first, it was assumed that the reaction only occurred in patients with pre-existing kidney disease, but it later became clear that it also occurs in people with healthy kidneys, Wagner says.
“The kidneys themselves are not the problem,” he says. “There is long-term retention of gadolinium – a known toxic metal – regardless of the brand and irrespective of kidney function. There are thousands of members of social media groups focused on the chronic adverse effects of gadolinium-based contrast agents.”
Now, Wagner leads a team of researchers exploring how gadolinium triggers the systemic reaction in some patients.
It has been theorized that the majority of the skin thickening was due to circulating, bone marrow-derived white blood cells called fibrocytes, Wagner says, adding that the gadolinium appears to produce an inflammatory response that triggers the buildup of fibrocytes in skin tissue.
“My laboratory was the first to prove this experimentally,” he says. “Furthermore, we were the first to demonstrate that bone marrow possesses a ‘memory’ of gadolinium exposure – gadolinium-induced fibrosis is enhanced in those who have had a prior administration of magnetic resonance imaging contrast.”
Much of Wagner’s research to date has been conducted in animal models or using donated tissue. Now, he is recruiting patients for a pilot study in humans through the UNM Clinical & Translational Science Center in hopes of identifying potential treatments.
While many participants have had just one dose of the contrast agent, gadolinium is still detectable in their blood, urine, fingernails and scalp hair without causing symptoms. Wagner stresses that “most people just tolerate it very, very well. If we know why that it is, maybe we have a shot at helping the people who do have symptoms.”
While gadolinium-based contrast agents often play an important role in helping physicians diagnose disease, Wagner believes they should be used with caution and consideration of whether the risks outweigh the potential benefits.
“I don’t know if there’s a true gadolinium deposition disease or not, but I do want to take the patient’s perspective,” he says. “It’s an alien heavy metal that stays in your body.”
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>>> Brain pacemaker could help treat symptoms related to Parkinson’s Disease
WPRI Providence
August 20, 2024
https://www.yahoo.com/news/brain-pacemaker-could-help-treat-205200432.html
A self-adjusting brain pacemaker could help treat symptoms related to Parkinson’s Disease, according to a new study by the National Institutes of Health. The implanted device, regulated by the body’s brain activity, could provide continual and improved treatment for symptoms.
A brain implant can help people with Parkinson’s disease deal with movement problems during the day and insomnia at night, new research suggests.
The study found that the device, which is controlled by brain activity, could provide personalised continual and improved treatment for the symptoms in some people with the condition.
When the implant detects changes in symptoms from brain activity, it releases pulses of electricity.
The treatment works with medications that Parkinson’s patients take to manage their symptoms, giving less stimulation when the drug is active, and more stimulation as the drug wears off, to prevent stiffness.
Megan Frankowski, programme director for the USA’s National Institutes of Health’s Brain Initiative, which helped fund this project, said: “This study marks a big step forward towards developing a DBS (deep brain stimulation) system that adapts to what the individual patient needs at a given time.”
Professor Philip Starr, from the University of California, San Francisco, said: “This is the future of deep brain stimulation for Parkinson’s disease.”
DBS involves implanting electrodes into the brain at specific locations.
These wires then deliver electrical signals that can help mitigate the symptoms of brain disorders such as Parkinson’s.
Conventional DBS provides a constant level of stimulation and can also lead to unwanted side effects, because the brain does not always need the same strength of treatment.
But the new treatment, adaptive DBS (aDBS) uses data taken directly from someone’s brain and uses artificial intelligence to adjust the level of stimulation in real time as the person’s needs change over time.
In the study, published in Nature Medicine, four people already on regular DBS were asked which symptom bothered them the most despite treatment, before being given the new treatment.
Researchers found that aDBS improved each person most problematic symptom by roughly 50% compared to conventional DBS.
This project is a continuation of several years of work led by Prof Starr, and colleagues at the University of California, San Francisco (UCSF).
In 2018 they reported the development of an adaptive DBS system, referred to as a “closed loop” system, that adjusted based on feedback from the brain itself.
In 2021, they described their ability to record brain activity in people as they went about their daily lives.
Here, those two findings were combined to use brain activity recorded during normal life activities to drive the aDBS system.
UCSF researchers led by Simon Little, conducted a separate trial to look at Parkinson’s related insomnia, that included four patients with Parkinson’s and one patient with dystonia, a related movement disorder.
In their paper published in Nature Communications, the researchers found that the device could recognise brain activity associated with various states of sleep.
They also found that it could recognise other patterns that indicate a person is likely to wake up in the middle of the night.
Researchers say there is still some way to go before this therapy can be more widely available.
The initial set-up of the device requires considerable input from highly trained clinicians, but the experts envision a future where most of the work would be managed by the device itself.
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>>> UFP Technologies Acquires Marble Medical
UFP Technologies, Inc.
Jul 16, 2024
https://finance.yahoo.com/news/ufp-technologies-acquires-marble-medical-200500449.html
NEWBURYPORT, Mass., July 16, 2024 (GLOBE NEWSWIRE) -- UFP Technologies, Inc. (Nasdaq: UFPT), a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products, today announced the acquisition of Marble Medical. Founded in 1988 and headquartered in Tallahassee, FL, Marble Medical develops and manufactures adhesive based medical components and single-use devices.
“Adding Marble Medical’s adhesives expertise is a great complement to our surgical robot drapes and stick to skin device platforms,” said R. Jeffrey Bailly, chairman and CEO of UFP Technologies. “Marble Medical is a 3M Preferred Converter, and along with their precision die cutting capabilities, gives our clients access to a broader range of innovative solutions incorporating highly specialized adhesive technologies.”
“In addition, Marble Medical is a longstanding partner to our DAS Medical operation, making them an excellent overall fit into our MedTech business,” continued Bailly. “This acquisition aligns with our strategic focus and provides valuable technologies in multiple key markets to bring more value to our client base. This expanded range of materials and capabilities will also allow us to vertically integrate in many existing application areas.
Joe Audie, Marble Medical’s president, stated, “We are excited to join the UFP family and be part of such a fast growing and dynamic company. UFP’s customer base, engineering skills, vast resources, and global manufacturing footprint is expected to help Marble accelerate growth by leveraging our biocompatible adhesives expertise in adjacent areas such as diagnostic patches, wound care, and other stick to skin applications.”
About UFP Technologies, Inc.
UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.
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>>> Scientists Found Heavy Metals Like Lead In Many Chocolate Bars. Should Consumers Be Worried?
Forbes
by Robert Hart
7-31-24
https://www.msn.com/en-us/health/nutrition/scientists-found-heavy-metals-like-lead-in-many-chocolate-bars-should-consumers-be-worried/ar-BB1qYHlw?ocid=BingNewsSerp
Many dark chocolate and cocoa products sold across the country contain levels of toxic heavy metals that exceed food safety guidelines, according to new research published Wednesday—and while the food industry and researchers involved said the findings should not stop people from eating chocolate, experts said it warrants further scrutiny.
Key Facts
Researchers from George Washington University and ConsumerLab, a company that tests foods and supplements, examined the amount of lead, cadmium and arsenic in more than 70 dark chocolate and cocoa products purchased from retailers including Amazon, GNC and Whole Foods Market over 8 years.
Their results, published in the peer reviewed journal Frontiers of Nutrition, revealed 43% of products exceeded acceptable levels of lead per serving and 35% exceeded acceptable levels of cadmium, according to California’s stringent food guidelines.
The state’s guidelines are often used by researchers as a conservative safety benchmark when investigating heavy metal contamination in foods, as the Food and Drug Administration does not set limits for toxins including cadmium and arsenic and for others like lead may only do so for specific products like candy or baby food.
None of the products tested exceeded California’s maximum level for arsenic and almost all products—70 out of 72, or 97%—had levels of lead that fell below FDA limits for the metal.
The researchers said the heavy metals found in the chocolate are unlikely to “pose any appreciable risk” when consumed as a single serving but could be “potentially problematic” if multiple servings are consumed or they are eaten with other products that may contain heavy metals such as teas or spices.
The study is the latest research to suggest some popular chocolate brands contain heavy metals, including studies by Consumer Reports.
In an emailed statement, the National Confectioners Association told Forbes “chocolate and cocoa are safe to eat and can be enjoyed as treats as they have been for centuries,” adding that “food safety and product quality remain” the organization’s “highest priorities.”
What Brands Of Chocolate Contain Heavy Metals?
It’s not clear what brands of dark chocolate and cocoa products had what levels of heavy metals in the study as the researchers intentionally left the information out of the study. The products tested are likely to be well known to consumers, however, and the researchers said their aim was to assess heavy metal contamination in “the most popular cocoa-containing consumer products each year for several years to assess trends,” using consumer surveys to assess popularity.
Should I Stop Eating Chocolate?
In short, no. According to the researchers, the amount of heavy metals found in the chocolate studied is unlikely to be “biologically significant” on its own, especially as most people are likely to consume the products relatively infrequently and in small amounts. The findings do suggest a need for better food standards and guidelines when it comes to heavy metal contamination, they said. “Enhanced surveillance may be warranted,” as well, the researchers added, particularly given the presence of outliers in the study with particularly high levels of contamination. Further research into the potential impact of multiple streams of food contamination should also be conducted, the researchers said, as it’s possible there may be “additive exposure” that is problematic from multiple food sources.
Can I Avoid Heavy Metal Exposure In Food?
Also no. “You actually cannot avoid exposure to heavy metals in the diet,” Leigh Frame, the study’s lead author and director of integrative medicine at George Washington University School of Medicine and Health Sciences, told NBC News. Heavy metals can naturally enter foods from soil and water in the growing process or at various points during packaging, drying, processing and transportation. Cocoa, rice, cereals, potatoes and tobacco can take up cadmium from the soil, for example, and lead can be introduced in the production of cocoa products. Small levels are not always dangerous and can be excreted from the body such as through sweat and urine but high levels can become concentrated in the body where they can cause damage. Cadmium is a carcinogen at high levels—it can cause cancer—and can damage most of the body’s systems, including the lungs, bones and kidneys. The CDC says there are no safe levels of lead in the blood for children and the metal can interfere with the developing brain and damage the nervous system. However, “it’s really not about avoiding them; it’s about making sure you’re not getting too much,” Frame said. Eating a diverse diet is one way of avoiding exposure, as is limiting consumption of products known to contain relatively high levels. Frame added that “better quality control practices during harvesting and manufacturing may help eliminate the problem” too, as well as better surveillance.
Surprising Fact
Organic products were more likely to have higher levels of cadmium and lead, the researchers found. “More striking, the number of trade certifications (e.g., Non-GMO, Fairtrade) did not significantly alter the levels of heavy metals found among products surveyed,” the researchers wrote.
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>>> Merck Falls as HPV Vaccine Miss Overshadows Profit, Sales Beat
by Damian Garde
Jul 30, 2024
https://finance.yahoo.com/news/merck-falls-hpv-vaccine-miss-143523851.html
(Bloomberg) -- Merck & Co.’s shares fell the most in three years as light sales of its Gardasil HPV vaccine in China dimmed quarterly profit and sales that beat Wall Street estimates.
The drugmaker also lowered its 2024 profit outlook on acquisition costs. The stock dropped as much as 7.7% in New York, its biggest loss since November 2021. It had risen 17% this year through Monday’s close, outperforming most of its US pharmaceutical peers and the S&P 500 Index.
Merck has spent billions to find new sources of growth as Keytruda, approved for many types of cancer, will face pricing pressure later this decade. Last year, the company spent nearly $11 billion on Prometheus Biosciences Inc., maker of treatments for autoimmune disorders, and signed a deal with Daiichi Sankyo Co. worth as much as $22 billion to collaborate on novel cancer medicines.
Gardasil, a widely used vaccine to prevent the cancer-linked human papillomavirus, is a key product for Merck’s future. The company said sales of the shot in China could fall below expectations this year due to an issue with a third-party distributor.
The company saw a “surprising” decrease of Gardasil shipments to China, Chief Executive Officer Rob Davis said on a conference call with analysts, and if the trend continues, Merck will likely ship fewer doses of the vaccine than it had previously forecast.
Slowing sales in one of the most populous countries in the world could call into question the more optimistic long-term consensus sales targets, John Murphy, a Bloomberg Intelligence analyst, said in an email.
Merck increased its full-year revenue forecast by $200 million at the median, to between $63.4 billion and $64.4 billion. Its next big product is expected to come in the form of Winrevair, a treatment for a rare lung disease that was approved in March. The drug, acquired in Merck’s $11 billion buyout of Acceleron Pharma Inc. in 2021, brought in $70 million in its first full quarter on the US market, exceeding analysts’ estimates.
Adjusted earnings were $2.28 a share in the second quarter, the company said in a statement Tuesday, outpacing analysts’ average estimate by 11 cents. Revenue also beat estimates, as sales of Keytruda increased 16% to $7.3 billion.
“Another quarter of the same story,” BMO analyst Evan Seigerman wrote in a note. “Merck commercial outperformance remains steady as Winrevair launch exceeds even the highest expectations.”
Profit for the year will be $7.94 to $8.04 a share, Merck said, reduced by about 60 cents per share to reflect one-time charges related to the acquisitions of the biotech firm EyeBio and the aquatic business of Elanco Animal Health Inc.
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Valley Fever - >>> Mom raises critical warning to parents after son contracts serious disease spreading across state: 'It ravaged his body'
Yahoo Finance
by Jeremiah Budin
July 22, 2024
https://news.yahoo.com/news/mom-raises-critical-warning-parents-011500429.html
In Arizona, cases of valley fever — a disease spread by a fungus that lives in the dirt — have more than doubled in the past year, 12News reported. The spike in cases may be related to conditions brought about by the ongoing overheating of our planet, officials said.
What's happening?
Valley fever is a lung infection that causes symptoms similar to those that come with pneumonia. These symptoms include fatigue, cough, fever, headache, shortness of breath, night sweats, muscle aches, and rash, according to the Centers for Disease Control and Prevention.
Though more than 60% of people who are infected with valley fever do not get sick from it, in some cases the infection is severe enough that patients require hospitalization.
Complicating things is the fact that valley fever presents similarly to many other respiratory infections, making it difficult for doctors to diagnose.
One Gilbert, Arizona, mom is trying to raise awareness of the disease after her teenage son was infected. "It was devastating; it ravaged his body," she said. "He went from being a high school basketball recruit to not being able to get out of bed and walk to the kitchen without labored breathing."
Why is this rise in valley fever cases important?
According to Dr. Wassim Ballan, the division chief of infectious diseases at Phoenix Children's, it is difficult to say whether the rise in cases is because of Arizona's expanding population or hotter and drier weather conditions in the state. June 2024 just tied June 2021 as the hottest month in state history.
If the spike were related to changing climate conditions, however, that would be consistent with many diseases — particularly those spread by mosquitoes and other insects, such as malaria and dengue fever, which have expanded their ranges as the planet continues to overheat.
What's being done about valley fever?
Valley fever is impossible to fully avoid, as it can enter your body if you simply breathe in dust. However, there is a higher risk of contracting it in especially dusty outdoor settings, such as construction sites.
Officials are urging Arizona (and California) residents to be aware of the disease and its dangers.
"I'm not saying every kid or every patient who has a fever and some respiratory illness needs to automatically be tested for valley fever, but that should be in mind especially if they're not getting better," Ballan told 12News.
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>>> Here's Why Danaher Stock Surged Today
by Lee Samaha
Motley Fool
Jul 23, 2024
https://finance.yahoo.com/news/heres-why-danaher-stock-surged-155045315.html
Danaher's (NYSE: DHR) core revenue decline of 3.5% in the second quarter might not seem like anything to write home about. Still, as ever in investing, it's about context, and the company's earnings report shows that it's set to return to its long-term growth track.
The good news encouraged investors to bid the stock up by more than 7% in trading before 10 a.m. ET today.
Danaher beats guidance
As you might expect from a biotechnology, life sciences, and diagnostics company, Danaher's core revenue and earnings have bounced around in recent years due to the pandemic. Not only did Danaher manufacture PCR tests used to detect COVID-19, but it also sold life sciences equipment used to research vaccines.
The retraction from the massive boost in demand caused by the pandemic creates near-term challenges for Danaher. Therefore, management still expects this to be a year of low single-digit core revenue declines, but the evidence from the second-quarter earnings suggests that investors might have to revise their expectations at some point.
Going into the second-quarter earnings, management's guidance called for a year-over-year core revenue decline in the mid-single-digit range (implying 4%-6%) with an adjusted operating profit margin of 26%. However, the second-quarter core revenue declined by just 3.5%, and the adjusted operating profit margin came in at 27.3%.
Better-than-expected revenue and margin performance led to earnings per share of $1.72 in the quarter, compared to the analyst consensus of $1.57.
Where next for Danaher stock?
Management continues to expect a core revenue decline in the low single digits for the third quarter and the full year, but it's hard not to think it's being conservative.
CEO Rainer Blair cited positive momentum in its bioprocessing business and market share gains in its molecular diagnostic testing business, Cepheid. If Danaher can sustain those improvements, the company can return to the high-single-digit growth rates Wall Street analysts expect in 2025 and 2026.
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>>> Johnson & Johnson - Another quality business with a long track record of regularly hiking its dividends is healthcare staple Johnson & Johnson (NYSE: JNJ).
https://finance.yahoo.com/news/2-magnificent-p-500-dividend-082500784.html
J&J's stock price is down 19% from its early 2022 high. Part of that dip can be attributed to concerns regarding legal liabilities related to lawsuits involving its talc products. J&J is making efforts to resolve this (hopefully) short-term headwind. The dip can also partly be attributed to concerns about J&J's growth outlook for the next few years, when it will lose patent exclusivity on some of its pharmaceutical products, opening the door for other companies to make generic versions, which will put a drag on sales. But Wall Street is undervaluing the company's track record for developing new pharmaceuticals that can pick up the slack and drive further growth.
Johnson & Johnson has a long history of innovation. It has steadily increased its research and development budget for years, spending over $15 billion on it last year alone. The company is constantly investing in its pipeline of new treatments and technologies that will keep the company growing, as it has for over a century. In fact, products that were introduced within the last five years made up a quarter of J&J's total revenue last year.
It's a quality business in large part due to management's history of achieving high returns on capital. In addition to its product pipeline, management is always looking for opportunities to make strategic acquisitions that expand its capabilities in high-growth areas of healthcare, including its medical technology segment. It just completed its acquisition of Shockwave Medical, extending its presence in the high-growth market for cardiovascular intervention devices.
Johnson & Johnson's profitable business has funded a growing dividend for over 60 years. It recently raised the quarterly payment by $0.05 per share, bringing its forward dividend yield at the current share price to 3.32%.
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Medpace, Icon PLC - >>> Ranking the top ten clinical research organisations in the world
GlobalData
by Allie Nawrat
Jun 18, 2024
https://finance.yahoo.com/news/ranking-top-ten-clinical-research-101307245.html
Top Ten Clinical Research Organisations
Clinical research organisations support pharmaceutical companies during the research and development (R&D) phase by providing a way for some of the necessary stages in the clinical trial process to be outsourced.
Clinical research organisations play a central role in the pharma industry’s R&D efforts, as reflected in the size of the pharma outsourcing market, which reached a value of $36.7bn in 2017. Grand View Research has projected that he market’s value will top $51bn by 2024.
The continuing growth of the clinical research market and the number of related organisations begs the question, what are the largest global clinical research organisations?
Igea Hub, a pharmaceutical blog created by Novartis Oncology’s global medical director Luca Dezzani, has listed the top ten clinical research organisations worldwide for 2018. The list contains a mixture of publicly listed and privately held organisations, and only two of the top ten are not based in the US; ICON is based in Ireland and Wuxi Apptec is Chinese.
The ranking is based on a system that tracks revenue based on the company’s financial reports, annual revenue growth between 2016 and 2017, net income, expenses ratios, revenue per employee and scope of service portfolio. Each of these components is weighted, with revenue being the most important and composing 70% of the score, and the final ranking aims to represent the financial health, competitive advantage and activity status of the clinical research organisations listed.
Igea Hub’s top ten list is consistent with others compiled by pharma industry publications and websites, such as Pharma IQ.
Top ten clinical research organisations in 2017
Laboratory Corporation of America Holdings
Laboratory Corporation of America was ranked at number one in Igea Hub's list of the top ten clinical research organisations with $10.44bn in revenue in 2017, of which 12.14% was income. The company has 31 units in its service portfolio.
Laboratory Corporation of America is composed of two business segments: LabCorp Diagnostics and Covance Drug Development. Covance is the portion that focuses on clinical research; it provides services to help with drug development throughout the clinical research process from early-stage research to post-regulatory approval. Covance claims to have worked on all of the 50 best-selling drugs on the market using its range of clinical and commercialisation services.
One recent example of Covance’s work in the clinical research space is working with the Chinese Food and Drug Administration (CFDA) on behalf of an Indian pharma company developing a new combination therapy for complicated Urinary Tract Infection (cUTI). Covance’s role included creating a regulatory strategy and facilitating interactions between the CFDA and the pharma company.
IQVIA
US-based, publicly listed IQVIA was created out of a merger between Quintiles and IMS Health in 2016. Its revenues for 2017 totalled $9.74bn with 13.44% representing income and it has 92 units in its service portfolio. Under the name Quintiles IMS, IQVIA was ranked number one in Igea Hub’s 2017 list of the top ten clinical research organisations, while LabCorp was ranked second.
These figures are consistent with the second quarter (Q2) 2018 results IQVIA reported in July; $2.567bn in revenue, an increase of 9% or 7.7% at constant currency.
IQVIA focuses on leveraging its IQVIA Core platform to help pharma companies and other medical bodies to innovate and maximise opportunities. In addition to clinical development, the company has also developed analytics and technology solutions to help the medical industry to commercialise products and better engage with customers.
Syneos Health
Created through the merger of INC Research and inVentiv Health, Syneos Heath is also based in the US and provides biopharmaceutical services in three areas: clinical development, commercialisation and consulting.
Syneos Health’s revenue for 2017 was $2.67bn with 91.1% spent on expenses and 42 services in its portfolio. The company’s revenue appears to be increasing in 2018 with $2.13bn for the first half of the year.
Within its clinical development segment, in addition to providing support to companies throughout each phase of the clinical research process, Syneos is also a functional service provider covering areas, including biostatistics, pharmacovigilance and patient recruitment.
Parexel International Corporation
Ranked at number four on Igea Hub’s list with a 2017 revenue of $2.44bn, Paraxel International is headquartered in Massachusetts, US and has been privately owned by Pamplona Capital Management since 2017. It partners with drug manufacturers and medical device companies throughout the product development and commercialisation process. 95% of its revenues in 2017 were dedicated to expenditure and its service portfolio has 79 units.
Parexel has fallen one place from its ranking from 2017 with revenues of $2.43bn for 2016 and 79 units in the portfolio.
The company initially focused on supporting German and Japanese pharmaceutical firms, but has expanded and now has clients in more than 100 countries worldwide.
Parexel partnered with data-focused marketing technology company Datavant earlier in September this year. The aim of the partnership is to enhance its clinical study design and capacity by allowing the linking of healthcare data from different sources.
PRA Health Sciences (acquired by Icon PLC in 2021)
US-based PRA Health Sciences was acquired by Kohlberg Kravis Roberts and made public in 2014. Its 2017 revenue was $2.26bn, a 24.73% increase from 2016, which earned it a rise of one place in Igea Hub’s ranking.
Revenue growth seems to be continuing with the company reporting $722.8m in Q2 2018, which represents 34.2% growth on a constant currency basis from Q2 2017.
The company primarily focuses on offering operational and therapeutic expertise to its clients through integrated systems, as well as supplying local expertise in specific regions via its 80 global offices. PRA works in both early and late-stage clinical trial processes, as well as the fields of consultancy, technology, strategy and bio-analytics.
Pharmaceutical Product Development (bought by Thermo Fisher in 2021)
Privately-held, North Carolina-based Pharmaceutical Product Development (PPD) had $1.90bn in revenue for 2017 and a service portfolio of 44 units.
The company focuses on three areas: drug development, laboratory and lifecycle management services. It has clients in a range of areas in addition to pharmaceutical companies, including medical device manufacturers, academic organisations and government groups.
In June this year, PPD launched a new patient enrolment model called PatientAdvantage, which it claims reduces the time and cost of conducting clinical trials by conducting data-driven research to identify eligible patients.
The PatientAdvantage system has been employed in three Phase III studies conducted for The Medicines Company, which were part of the ORION project.
Charles River Laboratories
Ranked seventh is Charles River Laboratories, a 71-year-old publicly-listed, US company, which claims to have worked on 80% of the drugs approved by the FDA in 2017. Its revenue for 2017 totalled $1.86bn, representing a 10.47% increase on 2016.
Charles River was ranked first in Igea Hub’s 2016 list, falling to ninth in 2017.
The company’s capabilities span the entire drug R&D process from basic research to pre-clinical testing to manufacturing and commercialisation within two major services: Good Laboratory Practice (GLP) and non-GLP. Charles River recently purchased Thermo Scientific’s Lab Vision Autostainer 720 to enhance its immunohistochemistry automation capacities, thus reducing the time it takes to run slides and the risk of batch variation.
Icon PLC
Falling one rank from 2017 to number eight is Icon plc. It is based in Ireland and generated $1.76bn in revenue in 2017, compared to $1.67bn in 2016, which represents an increase of approximately 5%.
The company’s revenue growth continues into 2018; it reported a10% year-on-year revenue increase of $473.9m in Q2.
Icon offers a range of consulting, development and commercialisation services in 37 countries, but it has a specific focus on the Asia-Pacific and Latin America regions. It has established many partnerships with pharmaceutical industry companies and healthcare organisations; a recent example is electronic health record company Practice Fusion to improve Icon’s use of patient data during the clinical trial process.
WuXi Apptec
Chinese privately firm WuXi Apptec focuses on reducing the discovery and development time for pharmaceutical and medical device products.
The company recorded a revenue of $1.01bn in 2017, and dropped one place from the 2017 ranking; in 2016 its revenue was estimated to be $919.9m. It had a service portfolio of five in both 2016 and 2017.
WuXi’s portfolio includes small molecules, biologics, cell and gene therapy and genomics and it provides support to biotechnology and pharmaceutical companies throughout the R&D process and into the commercialisation phase.
Earlier in September this year, WuXi’s partner, Shanghai-based Hutchison MediPharma, received approval for Elunate for metastatic colorectal cancer in China. WuXi’s STA subsiary supported the market launch of this drug through process optimisation and validation of Elunate’s active ingredient, as well as aiding with the regulatory submission process.
Medpace Holdings
US-based, publicly listed Medpace Holdings was ranked tenth in Igea Hub’s list of the top ten clinical research organisations in the world with a total 2017 revenue of $436m.
Medpace was not listed on the 2017 list, but is growing quickly with its share value rising more than 34% in the past quarter and 86% in the past year.
The company offers full-service clinical trial outsourcing through its medical, regulatory and operational teams.
"Ranking the top ten clinical research organisations in the world" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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MRI - Gadolinium - >>> The onset of rare earth metallosis begins with renal gadolinium-rich nanoparticles from magnetic resonance imaging contrast agent exposure
https://pubmed.ncbi.nlm.nih.gov/36739294/
Sci Rep
. 2023 Feb 4;13(1):2025. doi: 10.1038/s41598-023-28666-1.
Joshua DeAguero 1 2 3, Tamara Howard 4, Donna Kusewitt 4, Adrian Brearley 5, Abdul-Mehdi Ali 5, James H Degnan 6, Stephen Jett 7, John Watt 8, G Patricia Escobar 9 4 10, Karol Dokladny 9 4 10, Brent Wagner 11 12 13
Affiliations expand
PMID: 36739294 PMCID: PMC9899216 DOI: 10.1038/s41598-023-28666-1
Abstract
The leitmotifs of magnetic resonance imaging (MRI) contrast agent-induced complications range from acute kidney injury, symptoms associated with gadolinium exposure (SAGE)/gadolinium deposition disease, potentially fatal gadolinium encephalopathy, and irreversible systemic fibrosis. Gadolinium is the active ingredient of these contrast agents, a non-physiologic lanthanide metal. The mechanisms of MRI contrast agent-induced diseases are unknown. Mice were treated with a MRI contrast agent. Human kidney tissues from contrast-naïve and MRI contrast agent-treated patients were obtained and analyzed. Kidneys (human and mouse) were assessed with transmission electron microscopy and scanning transmission electron microscopy with X-ray energy-dispersive spectroscopy. MRI contrast agent treatment resulted in unilamellar vesicles and mitochondriopathy in renal epithelium. Electron-dense intracellular precipitates and the outer rim of lipid droplets were rich in gadolinium and phosphorus. We conclude that MRI contrast agents are not physiologically inert. The long-term safety of these synthetic metal-ligand complexes, especially with repeated use, should be studied further.
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>>> Top dividend stock No. 2: Eli Lilly
https://finance.yahoo.com/news/want-decades-passive-income-2-113700915.html
For more than 140 years, Eli Lilly (NYSE: LLY) has used cutting-edge science to help people live better. The healthcare leader's history is chock-full of medical breakthroughs, but its latest discovery could be the most impactful and profitable one yet.
Almost 70% of American adults are obese or overweight, which can lead to life-threatening illnesses like diabetes, heart disease, and strokes. Fortunately, Eli Lilly has developed a game-changing drug that makes it easier for people to lose weight.
Zepbound, the pharmaceutical pioneer's weight-management treatment for adults, activates hormone receptors that reduce appetite. Participants in a 72-week clinical trial who received the highest dose of the drug lost 48 pounds on average.
When combined with diet and exercise, Zepbound also helped these people improve their cholesterol and blood pressure profiles. And tirzepatide, the active ingredient in Zepbound, can make it easier for adults with type 2 diabetes to control their blood sugar levels. Better still, recent studies suggest that tirzepatide could have positive effects for people with liver disease and sleep apnea.
Due to tirzepatide's many potential health benefits, CEO Dave Ricks believes it will be the most important medicine of his 28-year career. Wall Street seems to agree. Investment bank Goldman Sachs expects Eli Lilly to be a leader in an anti-obesity drug market that will soar to $130 billion by the end of the decade. The company's profits, in turn, are projected to increase by more than 60% annually over the next five years.
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>>> Damage to synapses caused by Alzheimer’s disease reversed
A novel treatment has been proven to effectively treat cognitive decline in mice with Alzheimer’s disease.
OIST - Okinawa Institute of Science and Technology
June 20, 2024
https://www.oist.jp/news-center/news/2024/6/20/damage-synapses-caused-alzheimers-disease-reversed
Alzheimer’s disease is a progressive, neurodegenerative disorder that is the leading cause of dementia, which involves cognitive decline, memory loss, and ultimately the inability to perform daily tasks. It affects an estimated 55 million people globally, and in Japan alone, an estimated 4.4 million people are living with dementia, a number that is expected to climb to 6.5 million in 2060 according to government data.
Curing or delaying the debilitating symptoms of Alzheimer’s is extraordinarily difficult due to the elusive nature of the disease. The exact cause is unknown, and likely involves multiple factors from genetics to lifestyle, and due to the progressive nature of the condition, it is often too late to treat effectively once the symptoms begin to impact daily life.
However, a team of researchers from the former Cellular and Molecular Synaptic Function Unit at the Okinawa Institute of Science and Technology (OIST), led by Professor Emeritus Tomoyuki Takahashi, has now made headway into finding a viable treatment of those symptoms, putting us on the path to rescuing brain functions before they are irreversibly damaged by Alzheimer’s disease. Their findings have recently been published in Brain Research. “We successfully reversed the symptoms of Alzheimer’s disease in mice,” explains Dr. Chia-Jung Chang, first author of the study and presently a member of the Neural Computation Unit at OIST. “We achieved this with a small, synthetic peptide, PHDP5, that can easily cross the blood-brain barrier to directly target the memory center in the brain.”
Saving dynamin
A central factor in Alzheimer’s disease is the health of brain synapses. Synapses are the junctions between neurons in the brain, where information is conveyed from one neuron to the next through chemical neurotransmitters encased in synaptic vesicles. These vesicles have to be constantly recycled to secure a steady supply, and an essential step in the vesicle recycling process is the membrane retrieval (endocytosis) by the protein dynamin, which ‘cuts off’ the vesicle from the cell membrane. Dynamin is available throughout the neurons, either freely or bound to the microtubules that make up the cytoskeleton of cells.
Vesicle recycling in the presynaptic terminal at one end of a neuron, showing the role of dynamin during the last step of endocytosis (membrane retrieval), where the protein cuts off the vesicle from the cell membrane. The vesicle is then filled with neurotransmitters and transported back to the release site of cell membrane, where the neurotransmitters are released, and the vesicle is recycled.
The key antagonist here is the protein tau, which in normal circumstances is involved in stabilizing the microtubules. However, in the early stage of Alzheimer’s, tau begins to disassociate from microtubules. Being freely available, tau over-assembles new microtubules, effectively vacuuming dynamin from cell, making it unavailable for the last step of endocytosis. As Alzheimer’s progresses, the accumulated tau aggregates into neurofibrillary tangles, which are the hallmark of the disease – by the time these tangles show up on brain scans, it is often too late to treat the disease.
The OIST researchers focused specifically on the dynamin-microtubule interaction, and they have previously proven the positive effects of inhibiting this interaction in vitro using the synthetic peptide PHDP5. Dr. Zacharie Taoufiq, presently in the Synapse Biology Unit at OIST and second author of the paper, explains: "By preventing the interaction between dynamin and microtubules, PHDP5 ensures that dynamin is available for vesicle endocytosis during recycling, which can restore the lost communication between neurons inside the synapses at an early stage.”
Using transgenic mice, the researchers have now shown the same restorative effect in vivo. "We were thrilled to see that PHDP5 significantly rescued learning and memory deficits in the mice,” says Dr. Chang. “This success highlights the potential of targeting the dynamin-microtubule interaction as a therapeutic strategy for Alzheimer's disease."
Some of the main findings from the Alzheimer's paper.
Some of the main findings from the paper. SPHDP5 is a scrambled peptide that has no therapeutic effect, used as a control. A) shows the experimental setup with a Morris Water Maze, whereby a mouse is put in a water bath and trained to find a hidden platform using visual cues. B) are representative illustrations of the swimming paths of the mice towards the hidden platform (dashed white line). C) shows the effect of the intranasal administration of PHDP5 over time – notice how the curves for healthy mice (dashed black line) and transgenic mice treated with PHDP5 (grey line with triangles) are very similar. Credit: Chang et al.
Because PHDP5 inhibits dynamin-microtubule interactions generally, the researchers modified the peptide to include a cell-penetrating peptide, which allows the treatment to be administered through the nasal cavity where the blood-brain barrier is not fully developed, and which is close to the memory center of the brain, the hippocampus. In this way, the peptide would be delivered to the hippocampus at a higher concentration than through other methods of administration, while also minimizing potential side effects elsewhere in the body.
From molecules and mazes to viable treatments
Provided the synapses are treated with PHDP5 at a relatively early stage, the damage caused by the rampant dynamin-microtubule interaction can be reversed to the point that the treated transgenic mice have learning and memory abilities on par with healthy mice. While the peptide cannot cure Alzheimer’s, the inhibition of the dynamin-microtubule interaction delays cognitive decline significantly, to the point where it may not affect healthy people within a normal lifespan.
Emboldened by these results, the research team, now headed by Dr. Taoufiq and composed of specialists from different units across OIST, is continuing their work on the treatment. Dr. Taoufiq, based in the Synapse Biology Unit, is working to improve the peptide itself and the ways in which it functions in vivo. “We want to increase the amount of PHDP5 in the brain to achieve better effects, while minimizing side effects,” as he puts it. Meanwhile, Dr. Chang, based in the Neural Computation Unit, is working to introduce AI in the pursuit of additional and more robust data: “We’re using the different areas of expertise within OIST to improve our research.”
At the same time, the team is working with the OIST Innovation division to move the peptide through the production pipeline. “We want to involve pharmaceutical companies going forward,” explains Dr. Taoufiq. “They have the necessary expertise in pharmacology and the capacity for human trials to turn our peptide into a viable treatment.”
While the journey from research to drug is infamously long, taking an average of 20 years from paper to prescription, the researchers remain highly enthusiastic. As Dr. Chang says, “the coronavirus vaccine showed us that treatments can be rapidly developed, without sacrificing scientific rigor or safety. We don’t expect this to go as quickly, but we know that governments – especially in Japan – want to address Alzheimer’s disease, which is affecting so many people. And now, we have learned that it is possible to effectively reverse cognitive decline if treated at an early stage.”
Comment from OIST Professor Emeritus Tomoyuki Takahashi
While he is now retired from OIST, Prof. Takahashi started the project and ran it until the unit’s closure. “In this study, together with the previous one, we have clarified the pathological significance of dynamin-microtubule (MT) interaction in Alzheimer’s disease (AD), by which synaptic functions are significantly impaired. The dynamin-MT inhibitor PHDP5 rescues synaptic dysfunctions caused by tau accumulation in brain slices and can reverse learning and memory deficits to normal levels in transgenic AD mice models. This in vivo effect is robust since it is reproducible in double-blind tests and consistent in two types of model mice. Clearly, the next crucial step is to submit PHDP5 to the Phase 1-4 tests of AD therapeutic trials, which would be best performed by pharmaceutical companies. We strongly hope that our peptide could go through the tests and reach AD patients without much delay and rescue their cognitive symptoms, which is the primary concern of patients and their families.”
Note
The study began in the Cellular and Molecular Synaptic Function Unit, which was closed in March 2024. Professor Tomoyuki Takahashi designed and directed the whole project and wrote the text of the paper, while group leader Dr. Tetsuya Hori, currently in the Synapse Biology Unit together with Dr. Zacharie Taoufiq, arranged the experimental setups, the animals, and organized collaborations. Dr. Chia-Jung Chang conducted behavioral experiments and Dr. Taoufiq designed and modified the peptides.
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Xena, >> how can the S.O.C. have a black box warning <<
The pharma company spent billions to get the drug to market, so they will do almost anything to keep it on the market, public be damned. As in other industries, the regulators are largely in the pocket of the industry they are supposed to be regulating, ie - 'regulatory capture'. Money talks, and in pharma there is a revolving door between the industry and the FDA / regulatory body. It's crooked, just like most everything else in our world -
>>> Regulatory capture
https://en.wikipedia.org/wiki/Regulatory_capture
In politics, regulatory capture (also called agency capture) is a form of corruption of authority that occurs when a political entity, policymaker, or regulator is co-opted to serve the commercial, ideological, or political interests of a minor constituency, such as a particular geographic area, industry, profession, or ideological group.[1][2]
When regulatory capture occurs, a special interest is prioritized over the general interests of the public, leading to a net loss for society. The theory of client politics is related to that of rent-seeking and political failure; client politics "occurs when most or all of the benefits of a program go to some single, reasonably small interest (e.g., industry, profession, or locality) but most or all of the costs will be borne by a large number of people (for example, all taxpayers)".[3]
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How on earth can the S.O.C. have a black box warning?
???????
Xena, MDs are also locked into the 'standard of care' strait jacket, and if you venture away from it you can be sued. If the standard of care is pill X, then that's the treatment.
It's all big business these days --> Big Pharma, Big Agro, Big Finance, etc. Billions of dollars, that's the bottom line. At higher levels there is also a depopulation agenda.
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>>> The Gut Microbiome: Unleashing the Doctor Within
Dexter Shurney, MD, MBA, MPH
Am J Lifestyle Med. 2019 May-Jun; 13(3): 265–268.
PMCID: PMC6506970
PMID: 31105489
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506970/#:~:text=Not%20surprisingly%2C%20it%20was%20Hippocrates,that%20reside%20in%20the%20gut.
Wisdom From the Past
Hippocrates said,
Everyone has a doctor in him or her; we just have to help it in its work. The natural healing force within each of us is the greatest force in getting well. Our food should be our medicine. Our medicine should be our food.
As we continue to embark on the transformation of health care, it will be increasingly important to educate and empower our patients about their body’s amazing ability to heal itself. While this is not always an easy task, new research continues to provide us, as lifestyle medicine practitioners, with new ways to deliver our message. Perhaps no research is quite as exciting for lifestyle medicine as that of the human gut microbiome and its incredible and undeniable impact on human health.
Not surprisingly, it was Hippocrates who also coined the phrase, “All diseases begin in the gut.” While 2000 years of time and research has demonstrated that not all diseases originate in the gut, an increasing number of conditions are linked to the complex ecosystem of microbes that reside in the gut. The most promising part? We have the unique ability to manipulate this ecosystem, and health outcomes, through practical methods, many of which just so happen to be the pillars of lifestyle medicine.
The Human Microbiome
The human gastrointestinal (GI) tract is the complex plumbing system within; it is our first line of defense and our largest interface between the outside world. It is the microbial ecosystem, referred to as the gut microbiome, that is partially responsible for maintaining human health and is also associated with various diseases.
‘It is the microbial ecosystem, referred to as the gut microbiome, that is partially responsible for maintaining human health and is also associated with various diseases.’
Trillions of microorganisms survive in our intestines that have protective, structural, and metabolic roles. Metabolically, the gut microbiota functions to produce vitamins and synthesize amino acids. It is also involved in bile acid biotransformation and the fermentation of nondigestible substrates into short-chain fatty acids, which further stimulates the absorption of salts and water. The microbiome ensures protection from pathogenic colonization by competing for attachment sites and nutrients as well as through its ability to produce and secrete antimicrobials. In addition, healthy gut microbiota are essential for the development and homeostasis of the immune system. Structurally, certain bacteria in the microbiome have been shown to strengthen the mucus layer of the intestinal wall, which works as an obstacle to the uptake of proinflammatory molecules and antigens. Other bacteria are involved with strengthening the tight junctions of intestinal cell wall, which is partially responsible for keeping pathogens from entering the bloodstream.1
Dysbiosis is a term used to refer to a microbiota community associated with a diseased state that can be differentiated from the microbiota community associated with a healthy control state. Many factors can alter the ecosystem of the GI tract including antibiotics, psychological and physical stress, radiation, altered peristalsis, and dietary changes.2 The exact relationship between dysbiosis and various disease pathogenesis is somewhat uncertain mainly due to the lack of definitive research in this area. It does appear clear that there is a bidirectional relationship between human gut dysbiosis and disease, especially diseases of inflammation. Not only does dysbiosis of the gut microbiome lead to certain diseases, certain diseases also alter the gut microbiome. Recent findings have illustrated a role of microbiota dysbiosis in cardiovascular disease, irritable bowel disease, Clostridium difficile infection, and inflammatory bowel disease,1 as well as rheumatoid arthritis,3 colorectal cancer,4 obesity,5 and diabetes.6...
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Sounds like a cultural epidemic of self infantilization to me.,,,
Xena, >> physicians <<
Numerous reasons why they are largely clueless about what they are prescribing --> they are so busy, and figure the FDA wouldn't allow a drug on the market if it wasn't 'safe + effective'. MDs are indoctrinated in school to just write prescriptions for everything. Med school curriculum is designed by Big Pharma. Prevention? It's not in their vocabulary. A young doc I met said they had one lecture on nutrition in his entire time in med school. These guys are clueless.
It's sad - the US spends far more than any other country on healthcare, but we have the worst health by far. A huge problem is our devastated intestinal microbiome, due to the glyphosate / Roundup in almost all foods. Glyphosate was originally patented as an antibiotic, and it kills the healthy gut bacteria that we need for good health. This leads to leaky gut and chronic autoimmunity (see Dr. Steve Gundry's research). But some of the GI docs are finally catching on to the microbiome being key to all health. As Hippocrates said - "All disease begins in the gut'.
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Yes, I've seen this or similar .....
But WTF gives my physician the right to prescribe without testing...
ESPECIALLY..
When I told the creep I had previous issues ????
Xena, It looks like this is the likely mechanism for Cipro's neuro-psych side effects (see below and link). Not everyone gets the severe neuro-psych effects from Cipro, but only if you have the genetic anomaly involving your Cytochrome P-450 gene. Without the anomaly, there's no severe neuro-psych side effects. I'll search for info on the other Cipro side effects (tendon rupturing, etc), which likely have a totally different mechanism. Not sure what side effects you experienced from Cipro, but extensive scouring of the web for info may be the only way to figure it out.
Btw, Cytochrome P-450 is also the mechanism for anti-viral Paxlovid's horrendous side effects. Cytochrome P-450 is needed to break down many prescription meds, so when Paxlovid blocks its activity, the meds build up to ultra high levels. My sister took Paxlovid for Covid and it took months to get her meds stabilized again. The doctor who gave her the Paxlovid had no idea about its horrendous side effects, but Paxlovid was rushed into service against Covid (since the 'vaccines' weren't doing diddly).
>>> We did a series where we got blood samples from 25 people with neuropsychiatric illness, with quinolones, and 55 percent had a genetic abnormality to cytochrome P450 gene, which led them to mis-metabolize, under-metabolize the drug, which means the reason why it’s causing these psychiatric effects is many people have a genetic defect that leads them to poorly metabolize the drug and leads to tremendously large CNS-brain accumulation of drug. <<<
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174608507
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Excerpt - >>> DR. BENNETT: One of the most important things about a drug side effect (potentially ?) is an animal model, and my thinking is that deep in the woodwork at Johnson & Johnson and at Bayer their animal model data exists and it says that when you gave mice this drug, they produced long-term and short-term neuropsychiatric illness, because you would not get a drug to market without animal testing. And what we did in 2014 and 2012 and ’13 is with Dr. Raja Fayad. We gave mice increasing doses of Cipro, which apparently – in the laboratory setting, and we generated the exact same side effects we talk about now, in the mice, which is a really clearly convincing argument that the mice are – that this is a toxic drug, and why – the basic path of physiology is – and we identified it in a second set of series that my son led, who is now at Oxford in pharmacology. We did a series where we got blood samples from 25 people with neuropsychiatric illness, with quinolones, and 55 percent had a genetic abnormality to cytochrome P450 gene, which led them to mis-metabolize, under-metabolize the drug, which means the reason why it’s causing these psychiatric effects is many people have a genetic defect that leads them to poorly metabolize the drug and leads to tremendously large CNS-brain accumulation of drug. And then when Raja did the work with the mice to generate the exact same symptomatology, he called me up on a Monday and he says Charlie, I have it, I’ve nailed it, it is “this.” I went to see the mice and they were depressed, they couldn’t – (inaudible) – they couldn’t go through a maze, and as increasing dosages we had neuro-psychiatrically damaged mice from Cipro. That was on a Monday. Thursday I got an email at the University of South Carolina where I worked, and there had been a murder on campus and Raja was dead with the papers – with his dead body lying over his research. And his wife and he had had a fight and she shot him eight times and killed herself. So I was able to get his research and it was published – that was completed three days before his untimely murder. <<<
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>>> Bitter Pills: Inside the Hazardous World of Legal Drugs Paperback – May 4, 1999
by Stephen Fried (Author)
We take our medicines on faith. We assume our doctors are well-informed, our drug companies scrupulous, our FDA diligent—and our medications safe. All too often we're wrong. Just how wrong is documented in this critically acclaimed portrait of the international pharmaceutical industry by one of our most highly respected investigative journalists.
According to the Journal of the American Medical Association (JAMA), adverse drug reactions are the fourth leading cause of death in America. Reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined.
Stephen Fried's wife took a pill for a minor infection—and ended up in the emergency room. Some drug reactions go away in a few hours or days. Diane's did not. This emotionally wrenching experience launched Fried into a five-year examination of the entire pharmaceutical industry, the most profitable legal business in the world. Rigorously documented, Bitter Pills is a full-scale portrait of pill making and pill taking in America today, presented through the powerful human drama of doctors, patients, drug companies, the FDA, and government regulators as they war for control of our medicine cabinet
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https://www.amazon.com/Bitter-Pills-Inside-Hazardous-World/dp/055337852X
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Cipro -- Fluoroquinolone associated disability -
>>> “The Cost of Being a David,” a conversation with Dr. Charles Bennett
https://www.knowrisks.org/episode6
On this episode Dr. Charles Bennett joins Heather and Lee to discuss the forthcoming book, Taking On Big Pharma: Dr. Bennett’s Battle; black box warnings; citizens petitions; and his recent journal article, “Davids versus Goliaths,” where he talks about his story and that of 26 others and how they were retaliated against for reporting on drug safety, effectiveness, and data integrity concerns.
LEE: Awareness is power.
HEATHER: And it can save your life.
LEE: Welcome to our podcast, “Know Risks.”
HEATHER: I’m Heather.
LEE: And I’m Lee. We’re two moms, a lawyer and a nurse, who were brought together by a misfortune. Both our children were harmed by adverse drug reactions.
HEATHER: The purpose of this podcast is to educate people on the risk of any health treatments you put in or on your body.
LEE: We feel if we’d been properly informed and been our own experts, our children would not have been harmed.
HEATHER: In today’s world, with medicines being incentivized for profits, you need to educate yourself. Know the risk of health treatments and it can protect yourself and your loved ones from being harmed.
LEE: Thank you for joining us today on our episode, “The Cost of Being a David.” We are honored to have Dr. Charles Bennett with us to discuss his new book, Taking On Big Pharma, black box warnings, citizens petitions, and his publication, “Davids versus Goliaths,” where he talks about his story and that of 26 others and how they were retaliated against for reporting on drug safety, effectiveness, and data integrity concerns.
Here is Heather to tell us a little bit more about Dr. Charles Bennett.
HEATHER: Thanks, Lee.
View fullsize
Dr. Charles Bennett, M.D., Ph.D., MPP
Charles L Bennett M.D., Ph.D., MPP, is the Frank P. and Josie M. Fletcher Chair, and the SmartState Chair and Director of the SmartState Center for Medication Safety and Efficacy at the University of South Carolina. Dr. Bennett was the first physician to hold the A.C. Buehler Chair of Economics and Medicine at the Northwestern University Kellogg School of Management and the Feinberg School of Medicine. He has led seven R01-funded research grants on pharmaceutical safety, with the initial decade funding the Research on Adverse Drug Events and Reports — also known as RADAR — at Northwestern University, and for the past six years, the R01 funding has supported the Southern Network on Adverse Reactions — also known as SONAR — at the University of South Carolina. The SONAR project includes active collaboration with clinicians and researchers throughout the United States, Europe, Canada, and Asia.
Dr. Bennett is an academic hematologist/oncologist who has been the principal investigator for over $15 million dollars in peer-reviewed grant support from the NIH, the American Cancer Society, and the Pfizer Foundation. Dr. Bennett is a Phi Beta Kappa and High Honors graduate of Swarthmore College (in 1977), a 1981 graduate of the University of Pennsylvania School of Medicine, and a 1989 recipient of a Ph.D. and Masters in Public Policy from the RAND Graduate School in Santa Monica, for which he received honors in social science research. He has published over 450 articles in peer-reviewed medical journals, including first-authored papers in the NEJM, JAMA, Lancet, Blood, and Journal of Clinical Oncology, and Lancet Oncology.
Dr. Bennett is currently the principal investigator of the American Cancer Society Institutional Research Grant at the University of South Carolina, which is now in its seventh year of funding. His current paper, “Davids and Goliaths: Scientists versus Pharma,” is published in The Journal of Scientific Practice and Integrity. He also has a book, Taking On Big Pharma: Dr. Charles Bennett's Battle, which will be out in January 2023. Dr. Bennett will touch on both of these most recent publications in our interview today.
LEE: Thank you so much. We are just honored to have you here with us today, Dr. Bennett. I know that you’ve had lots of contact with Heather but, for me, I’m just so pleased to finally put a face to the name, a name that helped me so much through my journey with my daughter, Charlie. The work that you have done on fluroquinolones has just been hugely instrumental in helping to get the black box warnings on that medication, that medication that just has such horrific side effects. And I know that as a community, survivors, fluoroquinolone survivors and loved ones of people harmed by fluoroquinolones, we almost consider you saint-like for the work that you’ve done and we just so greatly appreciate it.
I think it might be nice today if we could perhaps talk about these black box warnings. I know the fluoroquinolones have had several of them added over a period of years. And perhaps you could just walk us through that process, like what’s involved in trying to get those black box warning attached to these medications.
DR. BENNETT: Just to be clear, we tracked black box warnings, safety advisories, communications, side effects, adverse events. They have seven different sections on the label. And as Heather knows, very intimately, when you get to a package label, which is often attached to the product that you give to the pharmacy, you should set aside a couple days worth of reading time because the labels are – I’ve been up to places where they do product review for quality up in New York and Underwriters Laboratory and what they did was they printed one of the labels out in a font that you could actually see and the label went for 42 feet.
HEATHER: Oh, my gosh.
DR. BENNETT: Nobody could read it. And so, as you can imagine, the labels are primarily for lawyer protection. Heather, maybe you’ll agree with me –
HEATHER: Yes.
DR. BENNETT: – because Heather’s clearly a lawyer. And then they claim that it provides some insight into side effects of a drug and you would need to have a whole day worth of reading to do it. We have on the labels what used to be called black box warnings. The FDA, in their infinite wisdom, thought the color black was too sinister so they made them box warnings now; they took away the black box warnings because black box warnings – you could almost imagine somebody might want to read it. But a box warning, you can really get past and say there’s nothing different because the color’s not different. Box warning, by definition, to the FDA, is there’s no regulatory requirement of what gets you to a black box warning, so it’s sort of like they say at the Supreme Court, you know it when you get there, and there’s no – say if you have X, Y, Z, A, B, and C you’re in a black box. No such thing X, Y, and Z, A, B, C. The box warning is the hope that the patient who gets the label might read at least the box warning, which should have three to four major concerns, and that’s it. And that way they don’t have to read 57 pages in the warning and the four major concerns in the black box warning. So that’s what we’ve done over time. And in 2006 the box warning, black box at that time, was for Achilles’ tendon rupture, and I’ve known several people who have taken one or two doses of the quinolone – Cipro, Levaquin – and they end up with a bilateral or unilateral Achilles’ tendon rupture. Also shoulder rupture. You can rupture any tendon in the body. My lawyer came from his biopsy of his prostate where he got a dose of Cipro they said would be good to protect against infection, and then the parking lot at the place where he got it his biopsy, he fell down because both Achilles’ tendons ruptured about an hour after he took the biopsy.
Those black box warnings, 2006, weren’t easy to get black box. Ralph Nader’s group, which Sidney Wolfe led, helped petition and they were not – they being Johnson & Johnson and Cipro. FDA supported Johnson & Johnson/Cipro – (inaudible) – no black box. In the meantime, I had tried a clever idea that I had never thought about except for Richard Blumenthal, currently Senator Blumenthal of Connecticut. Then-attorney general of Connecticut said to me he liked one of my concerns on a different drug and wanted a black box warning on it and so he and I collaboratively – first collaborative black box warning from an attorney general. He was Connecticut attorney general at the time – on it, and we got a year later – one year later we got the first ever black box warning collaboratively from an attorney general and a public citizen, myself. And Sidney Wolfe read about that and he replicated that and attorney general of Illinois, Lisa Madigan, joined him and they got a black box warning for Cipro and Levaquin for Achilles’ tendon rupture. It did not come easy because they had to file a lawsuit in court – (inaudible). Besides the petition you had to do lawsuit in court. There have actually been only six citizen petitions ever accepted, in part or in total, by citizens. Citizen petitions, just to let you understand, are really misnamed because they’re meant to be competitive drug company petitions and they’re primarily there to make sure that competitors do not market the drug, and 95 to 98 percent of all citizen petitions are written by drug companies trying to prevent another drug company from competing against them. It’s very rare.
HEATHER: Wait, so the drug companies – just to understand this because this is just fascinating to me – so the drug companies are doing citizens petitions against competitor drugs?
DR. BENNETT: Right. And it would be primarily a generic drug and a branded drug. The branded drug will say the generic drug is not up to quality; it should not be allowed on the market, and regulation is generic drug companies being brought against by the brand. The courts have six months to adjudicate so it puts a six-month halt on a generic company from manufacturing and competing. So these become a huge game and a way to slow down your competitors. On the other hand, a poor citizen like me trying to write a citizen petition, they have no – there’s no law there. Only six of us have done it besides Ralph Nader, and two of the six that have ever been accepted, two of the six that have been submitted by people other than Ralph Nader are Sidney Wolfe. Two of the six are by me. And they both were partially accepted. I’ve had two rejections. But I have the most citizen petitions in the country that are partially accepted.
HEATHER: Excellent. And I know I was with you – I believe that was in 2016 for the citizens petition that you submitted in regard to the fluoroquinolone-associated disability. And just to back up, for some our listeners who are maybe just joining in, I know a lot of our listeners will see Dr. Bennet’s name and they know quite a bit about fluoroquinolones, either from being damaged by them or having a loved one hurt by them, but in this particular citizens petition, was that – that was one of the ones you’re referring to that was – resulted in a black box warning for the associated disability?
DR. BENNETT: So to bring things clearer, Linda Martin, who’s very active with me and Heather, has worked with me hand in hand on citizens petitions and we felt filing a petition just like a piece of paper over the transom would be unlikely to be successful and needed some more oomph. So Linda and I and Terry Aston, we flew in 2014 to Washington, D.C., to the Rayburn Building and we met with 19 senators, policymakers about a petition that we wanted to write in 2014, which we wanted them to include issues related to fluoroquinolone-associated disability, long-term neuropsychiatric disability. We had 19 senators; 18 of them kicked us out of the office with the boot. And one of them had – the aide to Patty Murray, he was very subtle, called Terry at home many nights after that saying that he was talking to Senator Patty Murray, liked our petition, was unlike the others, and lo and behold, in 2015, we had an FDA Advisory Committee meeting, which Heather attended, and the advisory committee meeting talked about fluoroquinolones. It had came as a shock to us – maybe not to Heather; maybe you were able to lobby for it, but we had no idea they were going to have that. But when we went to citizen petition review in 2015, November 5th at the FDA, there were many patients, many family members. There was an armed guard. There was a rope line. There was CNN, Wall Street Journal, New York Times, there were a bunch of lawyers, there were a bunch of investment bankers looking to see which way the stock went, and then – (inaudible) – was the fact that 21 advisers of the FDA and on two sides people in suits on the left side with the suits I can’t afford to buy; those are called – businesspeople at Johnson & Johnson and Bayer, and then on the right side was the FDA people, and at that meeting they discussed fluoroquinolone-associated disability and one FDA employee, Debra Boxwell, said that she had read through notes of people like Heather’s son and others; she had read about 80 of them; she felt that despite it not being statistically significant – which maybe David Healy might have addressed in his podcast – that she had never seen such visceral and such real pain at these narratives, which were never before used by the FDA to define an adverse event were in fact for her definitive. She called it FQAD. We left the meeting with a 21-1, 18-2 and 19-1 approval that all three uses – uses would be sinusitis, COPD, and also UTI – that quinolones should go first-line drug to last-line drug. We left that meeting with The Wall Street Journal supporting us, and as you can imagine, the next day nothing happened. It was an advisory committee meeting. They decided to disregard our advice – 19-2, 18-1, 20-1. Nothing happened. A year later, Johnson & Johnson and Cipro said that they had reconsidered their thinking and these drugs were now last-line drugs in 2016. 2018, I get a letter in my office in a brown envelope, no FedEx, no nothing. I open it up; it’s from FDA, at that time Janet Woodcock, the interim director of the FDA, and she said she thought that the suggestions that I made in 2014 she could live with for half of them, and the black box warning became a reality in 2018. So to remind you of the timeline, it was not a year; it’s four years – (inaudible).
LEE: That’s just terrible when you – well, Heather and I both know how many people’s lives have been affected by this category of medications and to just know how much effort and convincing it takes, and then the time, so in that time, how many other people have been harmed? And then you brought up – and Dr. Healy did touch on – that it’s only a very small percentage – I think it’s 1 percent of the people that actually the adverse drug reactions get reported. Is that right?
DR. BENNETT: We published in different journals that we could empirically document only 1 percent get reported because we had a way of getting two sources of documents – what was reported and, secondly, what was reported in clinical trials, and we showed only 1 percent were ever reported. In 2019, after we were frustrated that the black box warning did not actually have the effect of actually warning anybody about the side effect, I filed my third citizens petition related to the quinolones and this time I asked if there could be a signature required by patients and doctors before they received the drug, going through the side effects that people like you, both of you, who have experienced these side effects would know about them in real time because you’d signed a consent form and your doctor signed the consent form and the pharmacy signed the consent form, which is not unusual – it’s severe but not unusual; it’s done for retinal gas. It is done for acne drugs. I mean, you can’t imagine. They also do it for drugs they use for anemia, for cancer patients. And we’re just asking to have some really strong way to make sure that you don’t bypass something that might come back to really affect lives, your daughter and her son.
LEE: Yeah, I think what that – well, what you’re asking for is really documentation of informed consent.
DR. BENNETT: Exactly. And if you don’t document it, don’t get the drug. And we got a letter, a terse letter back in six months from the FDA saying this will never happen in my lifetime.
LEE: Wow.
HEATHER: Now, can we – yeah, I’m just still kind of – I just want to go back for a second because you said it was two – the black box warning label for the FQAD actually was done because the two pharmaceutical makers, Johnson & Johnson being one of them, two years later they decided that was important? What would have been the motivation behind that in 2018?
DR. BENNETT: I think what happened (beyond ?) that is to have an advisory committee meet, make a recommendation, and nothing happened, it must mean there must be ongoing, behind-the-scenes conversations between the FDA and the company, and finally they convinced them that this is the right thing to do. So there’s no real event. But I will say, it was interesting that we found in 2015, you had in 2014 – the meeting was held in 2015. And the other important event was in 2018; the European Medical Association asked me and asked others and they flew patients in from 27 European Union countries and each of them talked about their own personal experience with fluoroquinolone-associated disability. Now, the FDA and every country in the world has refused to call it fluoroquinolone-associated disability. The term that they’ve used is called long-term disability or long-term neuropsychiatric disability. They do not call it fluoroquinolone-associated disability because I don’t think they want another name to be used in the ICD-10 nomenclature and the name would require possibly (meaning ?) that there will be money. Fluoroquinolone-associated disability might mean that there should be a claim for disability –
HEATHER: Correct.
DR. BENNETT: – from the government and you would be entitled to some disability payments. So they have purposely not gone with it. But the Europeans voted 28-0 – 27 now because of Brexit – that what we had found in the U.S. was exactly correct and they also moved it from first-line to last-line in Europe, and that also may have been somewhat of a trigger for the change because the Europeans were moving on it. Japan followed, Australia followed, New Zealand followed, and Canada followed. Those four countries I just mentioned at the end did not change placement of the quinolones from first-line to third-line; they just made an announcement that these drugs to them were too important to move around and that people could occasionally – and they wrote rarely – have permanent neuropsychiatric damage. They were uniquely different from the 28/27 European Union and the U.S. in terms of that. The Japanese, for instance, said that they only saw it with Levaquin in only one or two cases so they really wouldn’t even put much on their label about it, and only on Levaquin and not all quinolones.
LEE: But one would think potentially that the motivation of Johnson & Johnson to want to help change the labeling could be the – were they under a lot of legal, like, lawsuits as well?
DR. BENNETT: Lawsuits do not work in this case because the Supreme Court has, in its infinite wisdom, ruled in the Atkins case in 2013 that if a drug is generic the manufacturer cannot be sued for anything, and so if you take generic Levaquin or generic Cipro and had a terrible outcome like Heather’s son or your daughter being ill, none of that can be sued by anybody. So the reason – put on a label is not because of anything related to lawsuits; it is about just trying to get the label to be complete.
LEE: Well, yeah, and subsequently prevent people from being harmed because it’s, you know, the health care professionals should be aware –
DR. BENNETT: I think that in the perfect world they’d be aware. The reason why I filed the last petition is because I don’t think they are aware and that’s why I asked for the consent form. I don’t think – and I have many, many friends who tell me routinely, I’ve used Cipro and Levaquin for at least three decades. Now, don’t forget these drugs came to market in 1986 and the only one who started raising concern besides concerned patients and family members was me in 2011 and (Jay Cohen?) who died in 2011. And so this concern lasted 11 and 14, 25 years before some initial concern happens, and after 25 years the label gets changed, in 2018 with the black box warning, which is 14, 18 – 32 years after these drugs hit the market.
HEATHER: Yeah, and, I mean, we know how many people were harmed. I believe – who was the journalist – I think that was in the late ’90s – Stephen Fried, who wrote Bitter Pills. I mean, that was almost identical situation what happened to his wife, although she survived, and my son. You know, having the neuropsychiatric issues, being diagnosed with bipolar, landing in the mental health system. So, I mean, essentially, it just sounds like, to me, that for the industry, anyways, and for our regulatory agencies, it’s just not really about patient safety but more about navigating a system to kind of slow down any type of negativity associated with the drug. In the meantime, the pharmaceutical industry is just reaping the profits from it. I mean, is that kind of what’s happening here?
DR. BENNETT: I don’t think so, actually.
HEATHER: No?
DR. BENNETT: I think what’s happened since Stephen Fried’s case, his wife was very sick and mentally ill for a year, and he wrote a long book, as you – (inaudible) – Bitter Pills. Now if you talk to Stephen Fried, he hardly brings it up in a conversation.
HEATHER: Really?
DR. BENNETT: Yes. So Heather, you know – and you, Lee – you’re committed, long-time, lifetime advocates. You’ll be there. Stephen Fried, you call him up, he’s writing a different book now. He’s moved on in his life. His wife is a little better, a lot better, and this is all a bump in the road that he hardly remembers.
Now, I would like to say that, make it clear that this is not a rare side effect.
HEATHER: Exactly.
DR. BENNETT: People blow us off all the time and say it’s a rare side effect. And the reason why they do that is because a side effect that causes a heart attack or Achilles’ tendon rupture, it’s easy to see and feel. Tendon goes out, you get tendon repair; your heart attack goes out, you go to the hospital. But when you get a brain attack or brain injury, then they talk to you about drinking too much, having poor sex life, not accommodating, and millions of things, and it does not include – and this is why – that’s why almost the majority of these actual events occur in isolation. You’ll go see at least 10 doctors who would tell you that everything that has happened is in your mind, it can’t be this drug that’s been on the market since 1986 or we would have heard more about it. And it’s true.
HEATHER: Yeah, exactly. And, you know, to kind of go along with that, I mean, in my son’s case, you had a patient who was telling his doctors, even though he was experiencing these neuropsychiatric issues, that this is from this drug, this is from this – he’s, you know, connecting it, and again, none of the many, many doctors, you know, wanted to give any validity to that. And I think that that’s kind of a good lead-in because the system really has a way of shutting down these type of complaints from patients or giving them the attention that they need. And I know you have an article that will be published soon in The Journal of Scientific Practice and Integrity that kind of deals with – we talked a little bit about the low number of reports, such as FAERS reports, the FDA Adverse Event Reporting System, from doctors and also from patients. You can’t really, you know, criticize a patient for not knowing to report because it’s hard to know that information and if you’re scared and you’re having a bad reaction to a drug, especially one that might affect your perception and your ability to function and your mind, more likely than not, that’s not going to happen. And we don’t have a lot of doctors reporting either for exactly the issues that you just discussed, Dr. Bennett. But I kind of want to go back because I know Dr. Healy, I know you have been a victim of this, and it’s just this total maligning of anyone especially in the medical field or scientists who come out and speak about – you know, advocate for the patients or try to warn about potential effects of drugs. I just was wondering if you could talk a little bit about that.
DR. BENNETT: One of the most important things about a drug side effect (potentially ?) is an animal model, and my thinking is that deep in the woodwork at Johnson & Johnson and at Bayer their animal model data exists and it says that when you gave mice this drug, they produced long-term and short-term neuropsychiatric illness, because you would not get a drug to market without animal testing. And what we did in 2014 and 2012 and ’13 is with Dr. Raja Fayad. We gave mice increasing doses of Cipro, which apparently – in the laboratory setting, and we generated the exact same side effects we talk about now, in the mice, which is a really clearly convincing argument that the mice are – that this is a toxic drug, and why – the basic path of physiology is – and we identified it in a second set of series that my son led, who is now at Oxford in pharmacology. We did a series where we got blood samples from 25 people with neuropsychiatric illness, with quinolones, and 55 percent had a genetic abnormality to cytochrome P450 gene, which led them to mis-metabolize, under-metabolize the drug, which means the reason why it’s causing these psychiatric effects is many people have a genetic defect that leads them to poorly metabolize the drug and leads to tremendously large CNS-brain accumulation of drug. And then when Raja did the work with the mice to generate the exact same symptomatology, he called me up on a Monday and he says Charlie, I have it, I’ve nailed it, it is “this.” I went to see the mice and they were depressed, they couldn’t – (inaudible) – they couldn’t go through a maze, and as increasing dosages we had neuro-psychiatrically damaged mice from Cipro. That was on a Monday. Thursday I got an email at the University of South Carolina where I worked, and there had been a murder on campus and Raja was dead with the papers – with his dead body lying over his research. And his wife and he had had a fight and she shot him eight times and killed herself. So I was able to get his research and it was published – that was completed three days before his untimely murder.
HEATHER: Oh, my goodness.
DR. BENNETT: And so I call the work that I do Raja’s legacy –
HEATHER: Yes.
DR. BENNETT: – because he had just gotten tenure as an academic, and this was the first tenured project. He had just received tenure at 42 and then he was dead. And so I felt – the work that he would have continued to do with me on the Cipro, we would have just continued to find more and more, but because of his untimely murder, we had to shorten it. And then the – (I guess ?) the other effects that I said – besides Raja, my son’s findings on the genetics were stark, startling. We filed a provisional patent on that genetic test, and with some additional help we hope some day to market that test so before you take Cipro or Levaquin you take the gene test and if your genes aren’t going to metabolize the drug, they’re going to end up with a CNS (blast ?). Don’t take the drug.
LEE: Well, we’re not researchers but just through the journey with my daughter, you know, we’ve connected with thousands and thousands of people that have been harmed, and there is a commonality in that a lot of them seem to have what they call this – where they don’t methylate or they don’t detox. But the research that you’re saying, which, you know, is not, whatever, published or – but do you feel that it’s specific to the fluoroquinolones or that’s already sort of a harmful enough drug that that’s one of the ones that makes it worse? Would other medications be a factor with this genetic –
DR. BENNETT: There are – (inaudible) – drugs that have cytochrome P450 metabolic issues and this is just one of many.
LEE: OK.
DR. BENNETT: But what it accounts for is the fact that this side effect is undoubtedly not rare. The cytochrome P450, out of 25 people we tested, or 54, we had 55 percent with the genetic – (inaudible). So the reason why people are not being protected is not because this is rare but because doctors won’t listen to it and won’t report it and won’t say anything about it and won’t count this. So we 100 percent believe this is a fairly common side effect, and if you walk around the world and talk to people you meet socially on the plane or at a restaurant or anywhere else, they say, this happened to me, happened to my aunt, my grandma, my mother, my brother.
LEE: I agree and I think, too, that part of the problem is – well, the doctors aren’t aware of the warnings, they don’t listen to you when you complain because one of the things that I heard – we must have seen over 12 different doctors. They thought well, the drug’s out of the system so it wouldn’t keep causing harm. It is a little bit of a delay and these symptoms can keep developing. And then it’s given – a lot of the time, people are elderly, so if you have – you know, they just categorize you, oh, you’re, you know, feeling depressed; you know, they’re associating it with age a lot of the time or just –
DR. BENNETT: But as you know, from your own personal experience with your daughter, and Heather knows from prior experience with her son, there’s nothing about this that is protected by age.
LEE: No.
DR. BENNETT: Young people – at the FDA meeting, Heather, that you were at, the 17-year-old girl from Seattle, Washington, came in a wheelchair; she’d found her way to Harvard before she took this drug for a bladder infection and she wasn’t going to Harvard. She was going down a wheelchair to the FDA.
LEE: Yeah. And I think that’s why we were – our cases were successful in that we had – like, they told me, my daughter was a high-level athlete in perfect health and then within 10, you know, 10 days, she could barely move her arms, like, and had all these issues, which I didn’t even realize the anxiety and all those other things were actually related until afterwards when those warnings came out, thanks to you. I didn’t even connect those ones, but it was because she was so young and healthy that it was like textbook, almost.
DR. BENNETT: I’d like – you mentioned in your preamble in that conversation that Heather and you were successful for a reason. Could you define to me and to the audience what you mean by successful?
HEATHER: Well, that’s interesting – (laughs) – because what’s successful, you know, you think you’re – when something like this happens to you in your family, your first inclination is to try to, you know, get the word out. First of all, you’re – in my case, I’m mourning the loss of a child and also not wanting this to happen to someone else. In terms of success, I would term success in this in having broad knowledge amongst patients of the dangers of these drugs, which, you know, signed informed consent? Yes. That’s extremely important. In terms of court cases, I think Lee and I can both attest: It’s a long process and you think in doing so you’re trying to achieve some type of acknowledgment for the wrong that’s been done either by a doctor or by the pharmaceutical industry, but the result of those, if it’s with the pharmaceutical industry, is going to be a settlement with a nondisclosure, or a gag order, so the goal of talking about it’s not really going to happen. And even in a basic law case, it’s just not – the courts aren’t suited to make the type of broad change that’s needed in this. So when you speak about success, it’s just – it becomes very frustrating as you start to move forward down these different paths of what you think are your recourse for the type of damage that’s done to people, you know, only to find out that the impact of what you’re doing is very small. And I think that’s what you’re getting at, Dr. Bennett. Is that correct?
LEE: I think so too. I’d just add to that before he answers is that that’s a really great – that made me think, just right on the spot, I actually don’t think that we were successful and I think that’s one of the reasons for our podcast is that our individual kids’ cases were not about trying to get financial compensation. You could put no money on – I’d give up everything I had to go backwards in time and not have that happen, and I know Heather would give probably 10 times that. So we got acknowledgment, which you seem to want after being told over and over and over that this is in your head, that this isn’t happening. So that I felt successful in. But in getting a broad audience reached, we’re hoping to do more with the podcast. But obviously the work that you’ve done trying to get some labeling, and hopefully that there will be this one where they have to actually sign, that’s going to make way more of a difference because it’s going to reach way more people.
DR. BENNETT: Well, my citizens petition is out there in the web and anybody who wants to sign on to it, you just sign on to it through the website and people put a note supporting it. You can talk to – Heather knows some political people in her neighborhood. You can chat those people up and try to get – (inaudible) – the more political agenda you have, the more political influence you have, the more likely it is to happen. Bart Stupak, who used to be a congressman from Michigan, his son died of Accutane-induced suicide. He put the black box warning and the patient consent on Accutane. He’d be all over trying to get this for a similar story.
I will make a mention to this and I haven’t given you my journey in full. I have two pieces – three pieces of information to provide you. Besides the article coming out, my – a biography of me has been accepted and will be published – distributed by Simon & Schuster.
HEATHER: Oh, congratulations.
DR. BENNETT: And so a lawyer who went to Harvard Law School, taught at Yale and Stanford, University of Chicago, University of Texas, 93 years old, has spent six years detailing my journey with the Cipro and Levaquin, and they also added another journey that we did on Epo, a drug that’s used for anemia made by the largest biotech company. When Epo came up, in 2006, the result was the University of Northwestern, where I worked for 24 years as a stellar researcher with the most grants, resulted in them saying that I stole my research, I stole my money, I created no new research, and they took all my grants and gave them to people that did not do the research. They took my academic position away and I have been unable to return to a (pharmacy ?) medical school for 13 – since 2008. It’s now 15 years that I’m unable to get a job at a medical school, which I’ve applied for almost every year and sometimes twice, three times a year. And the important thing about that is they have a note on the internet you can read yourself, by Mort Schapiro at Northwestern, saying that, in his opinion, as the president of the university and the provost, dean of the medical school, Charlie Bennett is an unfit researcher and has developed and has propagated research that is not replicable and stolen money in the meanwhile. And that letter, which is on the internet today, this minute, is still there and I’ve never had a meeting in my life with Schapiro or Linzer or the dean, Neilson, in my life. But they did say – and I heard this from somebody else – is that somebody who knew the inside of the case was told by the university if he could sign a sheet that said that I was all those things the university could blame all their troubles on their mismanagement of my grants on me and I would pay the university’s $2.9 million fine. The end is they were able to give me a $475,000 fine on my “mismanagement,” quote/unquote, of grants, which I don’t manage because I’m a researcher, not a grant administrator, and I paid the $475,000, which required me to sell my house, empty out my retirement accounts, and as part of that – shortly after that, two, three years later, they took away all my research grants, gave them away to people who don’t know how to do the research. Research became pro-pharma. They took it from anti-pharma pharma oversight to a pharma booster, and that research then dissolved, and then they tried to take my medical license away and said that I could not practice medicine, (collected ?) $50,000 (to get ?) the license away. And the university just last week had Sidley Austin, a rather large law firm – said that while the note about me is not – is meant to be harmful that unless they can find a fault in it, it’s a lie, it needs to stay up there for the rest of the life of the world and no reason to take it out because history is history. And they make a point in the letter that no employee at Northwestern currently – when they wrote the letter in 2013 – had ever mismanaged my grants. Well, I left in 2010 and the woman that mismanaged my grants in 2009 was fined, criminal fine, sentenced to jail, quit her job for cause, and paid a penalty, and the reason why in 2013 she wasn’t considered a current employee four years after I left is because she wasn’t a current employee; they fired her four years ago. And so it shows you, at the end of the day, they would not – and they will not – this letter is used by every medical center that I’ve applied to, by their lawyers, for reason not to allow me to work as an oncologist in the medical school where I have spent 14 years of training and 20 years of research to do my work.
The only good side, the silver lining of that, is because of that effort I moved to South Carolina with a brand new slate because I lost all my research. I went to an FDA meeting in 2011. At that meeting I met (John ?) Bradee (ph) who has a very severe case of quinolone-associated neuropsychiatric damage, and it was because I met him at that meeting, shook his hand, listened to him, that I spent the next 10 years of my life on Cipro- and Levaquin-associated disability.
LEE: It’s a hard journey and tragic, but, I mean, us quinolone-affected –
HEATHER: We’re grateful. (Laughs.)
LEE: We’re grateful, not that that’s any consolation for what you had to go through.
DR. BENNETT: And we’re not done. As Heather knows, I’ve filed a whistleblower lawsuit personally against Johnson & Johnson and Bayer, saying what they’ve done is not (disseminate ?) the safety issues, and we’ve gone – we’re in the public domain now. It’s in the public domain; you can just google it. But we’re in a very positive stream of decisions. Judge Salas, who’s the judge in New Jersey whose son was shot by the FedEx driver and then her husband was shot by the FedEx driver but not killed, son was killed, and she is our judge – (federal ?) court – and we are publicly out there, and if the decisions continue to go our way, it will be a $2 billion payment from Johnson & Johnson related to the the side effect.
LEE: So we’re going put some of – just for our listeners, we’re going to have – you mentioned at the FDA there’s somewhere that they can go to – can you just –
DR. BENNETT: They can do it on the FDA website. There’s a citizen petition website where you can sign up. But they should also – and Heather knows this – they can talk to their local political people. And they can read my citizens petition; it’s also on the website. And I’ve had two congressmen from St. Louis, Missouri, both Republicans, in this case, support me, and the more political support we can get for those petitions to require the consent, the more likely they will actually be enacted. So you go to the website, you can sign your name up and say you agree with the petition, but you can really talk to your congressman and say it’s – I have a personal reason why this must be so; it’s my son and my daughter that I believe in personally, are important to me, as you know – Heather with a lost son and you, Lee, with a damaged daughter. There’s a reason to be there. And your congressman is only meant to help you and that’s why I think going through congressmen would be something terrifically important.
HEATHER: And this whole – like, the retaliation that was taken against you, Dr. Bennett – I mean, I briefly mentioned an article that will soon be published by you; it will be published by the time we air this podcast – but this is common. I mean, this is just common for –
DR. BENNETT: No, let me clarify this.
HEATHER: Yeah.
DR. BENNETT: No, I’m not saying it’s common.
HEATHER: No?
DR. BENNETT: I want to talk to you about icebergs. Some people ask me if this is the tip of the iceberg. What do you think? Is this the tip of the iceberg? Heather, what do you think?
HEATHER: A very small tip, I would say. (Laughs.)
DR. BENNETT: OK, I’m going to tell you this is the iceberg.
HEATHER: This is the iceberg?
DR. BENNETT: This is the iceberg. And why do I mean that? In my paper, we have 26 Davids and Goliaths. The paper’s called Davids and Goliaths. If you look on Google under Davids and Goliaths, you’ll see a total of zero articles called Davids and Goliaths. You’ll see a thousand called David and Goliath, because Erin Brockovich, she’s a David, the guy from the Insider was a David. People are Davids. Like David Healy is a David. The 26 Davids are never in one paper. Everybody fights a very lonesome fight where they get slaughtered by the company and by the university and, in my case, the Department of Justice on top of it.
HEATHER: Yeah, unbelievable.
DR. BENNETT: You know, to fight the university was hard, but I could get through it. To fight the drug company was hard but I realized I would get through it. The Department of Justice Assistant U.S. Attorney Kurt Lindland said to me in 2013, he goes, Charlie, let me just tell you the three most evil people in Chicago ever: those are Rob Blagojevich, the governor who was in jail; Scooter Libby, who worked for Ronald Reagan, was in jail; and Charlie Bennett. And he said, I will do everything in my power to make sure all three of those people go to jail. Can you imagine that? And then he wrote, he said, you know, I’m going to write a press release about you, it’s going to cost you your job, and I don’t have to be accurate; nobody vets my press releases. And so he wrote one parallel to the Northwestern one where he talked about nobody at the university was involved because the woman who was involved had been fired because she was in jail. Surely she was not employed by Northwestern when she was in jail. And he said I can say anything I want and I will have your career in three months’ time and you’ll be broke and I can take your family’s incomes too, so there’ll be nothing left for you. He said, you will learn what it’s like to work for Starbucks.
LEE: Wow. Oh, my god.
DR. BENNETT: Can you imagine getting that from the Department of Justice?
LEE: No.
DR. BENNETT: When all you’re doing is research. As my old boss said, I’ve saved more lives in American medicine than anybody ever in the history of the United States. People can save lives by generating new drugs. (Inaudible.) The amount of lives I’ve saved on safety is at least millions of lives, and more than anybody would do on 50 drugs like Cipro and Levaquin. As my mother said to me before she died three years ago, she said, they will kill you, but when they do kill you, you won’t know who did it. So the 26 Davids in my paper, the reason why I say, Heather, it’s not the tip of the iceberg, of the 26 people – and I personally interviewed almost all of them, went all over the country and the world to visit with them; I sat down with them; we had lunch. Many of them had hidden these stories inside their bodies, inside their heart, inside their heads for decades because the pain of losing their job and the fight they had was so real that they never wanted to talk about it again. And I’m coming in there bringing it up again and everyone I have in my paper on Davids and Goliaths is named. The 26 Davids are named in my paper. And more than that, I have a quote from each of them in their own words that have been published in Senate hearings, FDA hearings, New York Times, “60 Minutes,” in their own words about the pain that they went through. So I didn’t ask them to tell me something. I just looked through this published literature for the words that they’ve used to describe their own personal experiences. So when I cited the paper, I said, you want to find the words? I give you the actual page number of the Senate testimony. Let me give you an example of one piece of words. Tyrone Hayes, who’s been in the New Yorker magazine, had a very tremendous negative experience at UC Berkeley. Graduated from Harvard undergrad, Berkeley Ph.D., chairman of the department. His department is on animal biology. And he found that when you gave frogs a pesticide, the male frogs became feminized, much to the disappointment of Monsanto – Syngenta at that time. And they – as he presented his talk – (inaudible) – at a lecture, Syngenta vice president said Tyrone, we knew – Tyrone’s an African-American chap, about 5’3”, his wife’s Korean or Asian – guy said to Tyrone, he says, you’re going to give a very important talk and you should say what you believe. He says, I just want you to know that we’re not above murdering people; we’re not above raping your wife; we’re not above lynching your kids. And Tyrone said to the guy, his name is in the book, my book, he said to him, that is the most disgusting thing I’ve ever heard in my life but fortunately I have my tape recorder on. And he has that on and he’s presented that around the world and he has that tape – that’s a real tape. (Inaudible) – to do that. Tyrone – they have an internet site called Tyrone Hayes, which is owned by Syngenta, calls him a pedophile, and when you go look up at Google “Tyrone Hayes,” you find the most mean things about Tyrone Hayes that the drug companies populated with inaccuracies, terrible things about Tyrone. A hundred counties sued Syngenta for the water was poisoned and hundred counties were fined or settled for $100 million the amount of money it takes to clean that water up and the damage it’s doing to the kids in those neighborhoods. That’s just one of the other 26 of me. Every story is as powerful as that.
We monetize – what does these 26 stories mean? The 26 stories – here’s the thing we found. This is even worse besides the stories. All those companies, they were eventually asked to pay criminal fines or settle civil lawsuits. The total amount of money involved in those lawsuits was $27 billion so that’s why I say it’s not the tip of the iceberg because if it were – the tip of the iceberg is 1 percent. That would mean that would be $2.7 trillion involved in this kind of work, which would be far more than COVID. We wouldn’t even talk about COVID today if this were $2.7 trillion. We showed a million lives lost from these drugs from the harm that they did, either very severely damaged or dead. We also showed 13 of the companies that we evaluated of the 26 – 27 companies evaluated, 26 people – 13 of them, when they were identified by the Davids as submitting fraudulent data to the FDA for approval, 13 of them submitted fraudulent data to the FDA for approval and the Davids in our stories pointed that out. When they pointed it out, the Davids lost their jobs and the FDA data went through and the drugs got approved. So the answer to what happened there is the messenger lost their jobs. The people who were actual culprits got these drugs through the FDA and sold – total sales of these drugs are trillions of dollars we’re talking about here. And we asked in the paper, in the conclusion, that the just answer for this work should be not destroy 26 people like me who have been unable to work for several decades, and I’ve gone through the best medical school, college, graduate school, Ph.D. programs in the country and I’ve been sidelined except for the quinolones for the last 15 years and I don’t see patients for the last two years. And I went to – I didn’t go to average schools; I went to Penn, I went to – I work at Johns Hopkins now, I went to UCLA, I went to University of Chicago, I went to Duke University, Northwestern University. We’re talking about schools – Swarthmore College – that you could never imagine anybody getting into all five or six of those schools ever in their lifetime, and to have that kind of training and that kind of education not being put to use –
LEE: It’s a tragedy.
DR. BENNETT: It’s a crime.
HEATHER: It’s criminal. It’s criminal. There should be charges against all of them. And, I mean, just the 26 – how many – I mean, scientists, doctors like you are few and far between of what we’re seeing now. We see that more than ever now with this recent pandemic is most are just going to go along with the program; they’re not going to speak up. And how many lives are lost there?
DR. BENNETT: You wouldn’t want to lose your job, your career, your reputation, your friends. How many of my friends have deserted me? I can’t even go see 99 percent of my friends. The job getting pushed away from me, losing my house, my retirement plan. Every time my son goes to school, when he was in high school, looks up the internet; all they have is a Department of Justice press release about me. He said, dad, I didn’t know you were a criminal.
HEATHER: Amazing. Well, if it’s any consolation, you know, the result of the system that silences those who have integrity and have a commitment to science and speaking out, I mean, this system – there’s so much blood on its hands. I am not the only one – I lost a child. I mean, my son should be here today, but for, you know, the refusal to speak out on behalf of a whole lot of people – certainly not you, Dr. Bennett. But it’s just – it’s horrific what you have to go through for doing what is the right thing, what is the human thing. I mean, the result of this system is families like mine, you know? A bright young man who lost his life over this, you know, for profits. So it seems to me at the very core of this is they just want to preserve the income and the money, and paying off a few people is probably just chump change for a lot of, you know, those in the industry. But it’s just so difficult to wrap your head around such an unconscionable system. I mean, just the violence of the health care system and medicine system itself – it’s – you know, I commend you and I know Lee does too, but it’s just so sickening to hear this.
DR. BENNETT: You know, the point is there is no way forward for somebody to follow behind me. I can’t, in good faith, tell my son, I hope you save as many lives as I did and I hope you don’t mind being put out of work before you ever complete your life mission and I hope you don’t mind losing all your friends and your house, part of your medical license and all your grants and everything you worked for. If you’re willing to give all that up to save people’s lives, then go at it. There’s nobody in their right mind who will follow behind me.
HEATHER: I pray there are people who will. (Laughs.) I pray there are.
LEE: If we lose all the Davids because of the way that they’re treated and destroying your life, just to speak up and do the right thing, then where does that leave all of the public and the safety? Like, it’s a really, really scary thing to think about.
DR. BENNETT: That’s why my current lawsuit is important and it has to be won. If that lawsuit is won, Johnson & Johnson will pay $2 billion. And that would provide an opportunity for young Davids to see a path forward.
LEE: Yes.
DR. BENNETT: I’ll be the first ever in the history of the United States to take my research, which started in 2011, file it as a false claims lawsuit with the government. I’ve been certified by the court as the finder and relater, the person with unique non-public information, so other people who can do research, who want to do research do what I do which is I file my work, I do citizens petitions, I filed the Qui Tam lawsuits, and that is a whole package of things that are nontraditional. Nobody files – (inaudible). I did. Nobody files a whistleblower lawsuit. I did. I’ve been certified that way. In a year and half or two, before the next presidential election, it is our goal and our hope that that money would come forward and then people who want to do the right thing may have spent a lot of years suffering, but at the end of the day, $300 million, $600 million comes back to us, there will at least be some financial gain for the work that’s happened. The book is very important for my effort as well. I hope it’s called Resilience, because that’s what it is. We have been talking with Hollywood producers. Al Ruddy, who just did the movie – 50-year anniversary of “The Godfather,” which he and Francis Ford Coppola got the Academy Award for, has done a 10-part series on how he made “The Godfather.” He’s 93 as well and he wants to co-produce my movie about this work. We have a singer, Carol Connors, who got the Academy – not the Academy Award – she wrote the song for “Rocky,” “Up and Away” (sic/”Gonna Fly Now”). She did not get the Academy Award because Barbra Streisand won the award that year for “The Way We Were,” 1977, the year that Elvis Presley died. But that song is by far the most downloaded song on any song ever from a movie, and she’s agreed, in person when I’ve seen her, to make my movie. So we feel that between the book, the movie, the court case, citizens petition, some of the work that you’ll follow on, people like that, this will be an enterprise. If you all take a chance to look at on Hulu TV, there’s a TV show called “The Resident” you may or may not have seen. It’s “The Resident.” On Hulu you can buy it for a buck or two bucks. It’s made by Amy Holden Jones, who’s a partner of Martin Scorsese. It’s been on Fox for seven years, but Season 3, Episode 7 is called “Woman Down,” Season 3, Episode 10 is called “The Whistleblower,” and both episodes are about my work, so we’ve been able to get it into Fox TV, we hope the movie, the book. So I – as Heather knows, you can’t just take one avenue; you’ve got to take multiple avenues and you have to be persistent. I don’t sleep ever. This is something I believe in day or night – and night. Tim Robbins is going to play me, just to let you know, 6 foot 2 –
LEE: Oh, wow.
HEATHER: (Laughs.) Oh, gosh, that would be just spectacular.
DR. BENNETT: His hair is a little bit neater than my hair.
HEATHER: (Laughs.) That would be spectacular.
I am just – Dr. Bennett, you’re so impressive. And no, I know that you’ve had to go through quite a bit over the past decade, longer than that. But it’s people like you who give us the energy to push forward in doing the small parts that we are and trying to address these issues.
LEE: You have been instrumental. Our children were harmed. Heather did lose her son but my daughter is here today because of those warnings, because if I did not have those black box warnings and just the information and the petitions that you guys did at the FDA, I would have no credibility and I would not – her symptoms, everything – we would have been down a completely different path.
DR. BENNETT: Let me say this: I got a call from a husband from Tampa maybe five months ago. His wife, she had no prior medical, psychiatric history. She had, like, a sinus infection or a pulmonary infection. Her internist gave her Cipro; she took the first dose and she felt foggy. She looked at the package insert; it says on page one it can cause CNS toxicity. She wondered to herself, what does CNS toxicity mean? He says, if you want to learn about it, go to page 42 of the 72-page – I think, Heather, you’ve already done it – going deeper on this. And then it says, some people have committed suicide after one or two doses. She took a screenshot of those statements and sent it to her doctor, her internist. He told her not to worry because it’s overblown. She tied herself to a chair in a swimming pool area in Tampa, she moved the chair into the swimming pool; when her husband came home from the store she was under water and she was dead.
HEATHER: Yep.
DR. BENNETT: And that’s only one dose.
HEATHER: And no history, no mental health history –
DR. BENNETT: No history.
HEATHER: – no history of depression.
DR. BENNETT: As with Heather’s son, they’re not talking about immediate – that’s only like this.
HEATHER: No.
DR. BENNETT: People can get psychiatrically damaged over months and then they throw you on a bunch of different psychiatric medications which can only damage you even more –
HEATHER: Yes.
DR. BENNETT: – and then months later the person can be dead. So we’re not talking about just immediate death.
HEATHER: It was a very slow walk with Shea. He knew – he connected the dots but it was a slow walk. And, you know, ironically he was put on more drugs by Johnson & Johnson, more drugs that are similarly as dangerous, Risperdal, which resulted in numerous lawsuits. It’s just this slow unraveling in a perfect storm of destructive treatments when you’re already experiencing a toxic reaction to another drug.
So this has just been a wonderful interview, Dr. Bennett. I appreciate you so much. I want to highlight this article again, and we’ll have it – a link to it on our website. It’s “Davids and Goliaths: Scientists vs. Pharma.” It’s going to be in The Journal of Scientific Practice and Integrity. Just so appreciative. We’ll get that petition going for you, most definitely, for all that you’ve done for all of us and all the victims out there. We surely want to support you and let you know we appreciate you, and your work has been lifesaving for many people, and life-changing for others. I know for me I can’t bring my son back. The result of this system and the result of the incentivizing treatments and prioritizing profits, you know, results in death. That is the result.
DR. BENNETT: Instead of destroying the messenger, we want the corporate executives who do this fraudulent work to end up in jail.
HEATHER: To be accountable. Yeah.
DR. BENNETT: To end up in jail. That’s simple.
HEATHER: Yeah, that’s where they belong.
DR. BENNETT: And they will stop that as a company and as a system and as an industry once five or 10 of these corporates find themselves in a one- or two- or three-year vacation.
HEATHER: Hopefully longer than that. (Laughs.) Hopefully longer than that.
LEE: Well, thank you again. We hope you’ll join us on another episode, and as Heather mentioned, we will post all your links and we’ll also have your information on our website.
DR. BENNETT: Again, I appreciate so much support that you all have given me for the last 10, 12 years that I’ve been doing this journey. But I will say that Linda and I and a couple others, one from Britain, a woman in the U.S., and a student, we have collaborated on an update on the Cipro- and Levaquin-associated toxicities which will be published in eClinicalMedicine, which is a Lancet journal, as soon as they go through the last round of reviews, which it seems to me that they’ll take, and then a copy edit, so we’ll have a very informative paper. That paper reviews how the various toxicities from fluoroquinolones have been reviewed and analyzed in six different geographic regions – the U.S., Canada, Australia, Japan, New Zealand, and I forgot one in there. But the thing that’s amazing – that U.S. – oh, Great Britain; it’s separate because it’s no longer part of the EU – the U.S. and the EU and now Great Britain have made strongly definitive statements, these drugs are not first-line therapies. The other three regions – Australia, Japan, and New Zealand – do not make similar concerns. And the more recent side effects that have been known is aortic aneurysms, aortic valve rupture. And again, there’s not complete agreement on this but there’s been a “dear doctor” letter sent out in Europe; in the U.S., no “dear doctor” letter. We want to harmonize these safety messages for the entire world, not just the U.S., and that’s what we want to harmonize. People shouldn’t have to read six different labels and get six different opinions, especially on this, and particularly on this worldwide, terrible and life-threatening and life-ending side effect.
HEATHER: Well, thank you so much. Just really appreciate you, and know that the work you’ve done has just impacted us and our lives and we thank you.
DR. BENNETT: My pleasure.
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Xena, You are 100% right to be suspicious of the medical establishment, Big Pharma and the FDA, who increasingly act like gangsters.
Concerning your post on the AVXL board (links below), they called that incident a 'murder-suicide', but who commits suicide by shooting themself in the abdomen? Looks more like a contract hit by the Big Pharma mafioso -
>>> Rx warning Possible side effects from some antibiotics
https://muschealth.org/patients-visitors/news/2015/04/07/rx-warning-possible-side-effects-from-some-antibiotics
When Raja Fayad, M.D., was murdered on the campus of the University of South Carolina this past February, he was working on something big, something Charles Bennett, M.D., Ph.D., hopes will be his legacy.
Bennett is endowed chair in medication safety and efficacy at the South Carolina College of Pharmacy, a partnership between USC and MUSC. Bennett also runs one of the largest and most successful pharmaceutical watchdog groups in the country, the Southern Network on Adverse Reactions—SONAR...
...Before Fayad was killed, he was engaged in documenting these side effects in a clinical setting, adding empirical evidence to a surfeit of anecdotal accounts. Fayad’s paper, submitted last summer, has been under review for eight months. This is an unusually long time, Bennett said, saying it amounted to a “pocket veto.” Since Fayad is no longer able to fight for his work, Bennett is stepping in. <<<
>>> Coroner: USC professor, woman in murder-suicide previously married
https://www.wyff4.com/article/coroner-usc-professor-woman-in-murder-suicide-previously-married/7012813
Dr. Raja Fayad, ex-wife, Sunghee Kwon, die in shooting
Watts said Fayad died from complications of multiple gunshot wounds to the upper body.
Watts said the woman, Sunghee Kwon, 46, died from a gunshot wound to the abdomen.
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>>> ISS astronauts exposed to mutant superbugs that evolved in space
Independent
by Vishwam Sankaran
June 11, 2024
https://news.yahoo.com/news/iss-astronauts-exposed-mutant-superbugs-044145512.html
ISS astronauts exposed to mutant superbugs that evolved in space
Scientists have discovered a superbug notorious for being resistant to drugs in samples isolated from the International Space Station, sparking concerns for astronaut health.
They found 13 strains of the bacterium Enterobacter bugandensis which is known to be multidrug resistant.
The findings suggest these bacterial strains mutated under the stress of the space environment and became genetically distinct from their Earth counterparts.
On Earth, Enterobacter bugandensis is mainly found in clinical specimens, including from the human gut.
It’s usually a harmless bacterium inhabiting the gut but can act as an opportunistic pathogen, co-infecting people with compromised immunity.
The bacterium is also known to transfer its genome or obtain DNA from other organisms.
This means it possesses harmful traits that can lead to a “plethora of infections”, researchers said.
The superbug can persist on the ISS for long periods, co-existing with multiple other microorganisms.
Scientists said that the closed human environment of the ISS offers a unique extreme environment with microgravity, radiation and elevated carbon dioxide levels that force such microbes to adapt in order to thrive.
In a study published in the journal Microbiome, researchers found that the bacterium from the ISS sample developed a method to evade the action of many different types of antibiotics.
This is usually seen in pathogens recognised for their formidable resistance to antimicrobial treatments on Earth.
Over a two-year study period, scientists isolated 13 different strains of multidrug-resistant Enterobacter bugandensis from various locations within the ISS.
“The singular nature of the stresses of the space environment, distinct from any on Earth, could be driving these genomic adaptations,” researchers noted.
Scientists also mapped the prevalence and distribution of the bacterium across the ISS over time.
The findings shed light on the factors that could contribute to the dominance and succession of Enterobacter bugandensis in the space station.
By assessing such microbes, they said better preventive measures can be developed to protect the health of astronauts.
The findings underscore the need for “robust preventive measures” to ensure the health and safety of astronauts by mitigating risks associated with potential pathogenic threats, scientists said.
The findings also have implications for safety measures in terrestrial settings such as hospital ICUs and surgical theatres, they added.
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Re-post - Gadolinium toxicity from MRI scans -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174585381
>>> One of the biggest radiological concerns in recent years is the safety of GBCAs used in magnetic resonance imaging (MRI). As a study showed that gadolinium deposited in the brain and remained there, radiologists began to question the safety of gadolinium 2 . Results showed that the high signal intensity in patients’ brains is correlated with the number of GBCAs administrated. The new findings have sparked a major debate in radiology about the safety of these agents. For all GBCAs of MRI, the Food and Drug Administration (FDA) mandates a new class warning and additional safety precautions in terms of gadolinium staying in the patients’ bodies, including the brain, for months to years after taking these medications 3 .
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9574993
But there is growing evidence that tiny particles of gadolinium remain in the body – including the brain – causing serious side effects in some people, says kidney researcher Brent Wagner, MD, an associate professor in The University of New Mexico Department of Internal Medicine.
“We’ve come to the conclusion if a living organism gets this stuff there’s a chance that these weird particles can form, and my suspicion is this is what triggers this reaction,” says Wagner, who also serves as a staff physician at the Raymond G. Murphy Veterans Affairs Medical Center in Albuquerque. “It’s probably distributing everywhere in the body once someone gets it.”
Reports first started emerging about 15 years ago that some patients who had received the gadolinium contrast agent were experiencing a painful, debilitating skin condition called systemic fibrosis, which causes skin thickening and tightening in the joints and extremities, as well as internal organ damage.
At first, it was assumed that the reaction only occurred in patients with pre-existing kidney disease, but it later became clear that it also occurs in people with healthy kidneys, Wagner says.
“The kidneys themselves are not the problem,” he says. “There is long-term retention of gadolinium – a known toxic metal – regardless of the brand and irrespective of kidney function. There are thousands of members of social media groups focused on the chronic adverse effects of gadolinium-based contrast agents.”
Now, Wagner leads a team of researchers exploring how gadolinium triggers the systemic reaction in some patients.
https://hsc.unm.edu/news/2022/02/doctor-researches-toxic-side-effects-rare-earth-metals-mri.html
Gadolinium offers extra insight into our body’s condition. But, is it safe?
Gadolinium-based contrast agents (GBCAs) were safely delivered to millions of patients throughout the world since 1988, and their usage has definitely benefitted many individuals by allowing doctors to detect neurological disorders earlier and more accurately. GBCAs frequently have minor side effects. Injection-site discomfort, nausea, itching, rash, headaches, and dizziness are the most prevalent adverse effects. Patients with significant renal issues are more likely to experience serious, but uncommon side effects, including gadolinium poisoning and nephrogenic systemic fibrosis 1 .
One of the biggest radiological concerns in recent years is the safety of GBCAs used in magnetic resonance imaging (MRI). As a study showed that gadolinium deposited in the brain and remained there, radiologists began to question the safety of gadolinium 2 . Results showed that the high signal intensity in patients’ brains is correlated with the number of GBCAs administrated. The new findings have sparked a major debate in radiology about the safety of these agents. For all GBCAs of MRI, the Food and Drug Administration (FDA) mandates a new class warning and additional safety precautions in terms of gadolinium staying in the patients’ bodies, including the brain, for months to years after taking these medications 3 .
It is known that patients with renal insufficiency cannot filter the gadolinium from their body, so it is included as a FDA warning label on the contrast packaging. However, there was less evidence showing patient safety issues in those with normal renal function. Boxed warnings are also mentioned for recognized hypersensitivity relationships that can arise in individuals, especially in those with allergic diseases. Using GBCA in MRI has been questioned in recent years as evidence has emerged linking gadolinium to nephrogenic systemic fibrosis (NSF) and gadolinium deposition. Although most gadolinium is removed by urine after an MRI scan, a minimal amount stays and can accumulate over time, according to research published in 2017. This is an important concern for people who need to have MRI scans on a frequent basis 1 . Linear and macrocyclic agents are the two types of GBCAs depending on their chemical forms. Several studies indicated that the linear agents remain more in the brain than macrocyclic agents. However, new research has revealed that all treatments, including macrocyclic, leave some gadolinium in the brain. While gadolinium accumulation in the brain has been the focus of attention in recent years, the authors claimed that, in animal tests, 100 times more gadolinium was found to be retained in the skin and bones than in the brain 4 . The patients with multiple sclerosis (MS) should have brain MRIs both during relapse and remission (every few months) to assess disease activity. In the individuals with MS, the dentate nucleus (DN) T1 hyperintensity was detected 5 .
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>>> Flood of Fake Science Forces Multiple Journal Closures tainted by fraud
THE WALL STREET JOURNAL
By Nidhi Subbaraman
May 14, 2024
https://joannenova.com.au/2024/05/so-much-for-peer-review-wiley-shuts-down-19-science-journals-and-retracts-11000-fraudulent-or-gobblygook-papers/
https://www.wsj.com/science/academic-studies-research-paper-mills-journals-publishing-f5a3d4bc
Fake studies have flooded the publishers of top scientific journals, leading to thousands of retractions and millions of dollars in lost revenue. The biggest hit has come to Wiley, a 217-year-old publisher based in Hoboken, N.J., which Tuesday will announce that it is closing 19 journals, some of which were infected by large-scale research fraud.
In the past two years, Wiley has retracted more than 11,300 papers that appeared compromised, according to a spokesperson, and closed four journals. It isn’t alone: At least two other publishers have retracted hundreds of suspect papers each. Several others have pulled smaller clusters of bad papers.
Although this large-scale fraud represents a small percentage of submissions to journals, it threatens the legitimacy of the nearly $30 billion academic publishing industry and the credibility of science as a whole.
Scientific papers typically include citations that acknowledge work that informed the research, but the suspect papers included lists of irrelevant references. Multiple papers included technical-sounding passages inserted midway through, what Bishop called an “AI gobbledygook sandwich.” Nearly identical contact emails in one cluster of studies were all registered to a university in China where few if any of the authors were based. It appeared that all came from the same source.
One of those tools, the “Problematic Paper Screener,” run by Guillaume Cabanac, a computer-science researcher who studies scholarly publishing at the Université Toulouse III-Paul Sabatier in France, scans the breadth of the published literature, some 130 million papers, looking for a range of red flags including “tortured phrases.”
Cabanac and his colleagues realized that researchers who wanted to avoid plagiarism detectors had swapped out key scientific terms for synonyms from automatic text generators, leading to comically misfit phrases. “Breast cancer” became “bosom peril”; “fluid dynamics” became “gooey stream”; “artificial intelligence” became “counterfeit consciousness.” The tool is publicly available.
Generative AI has just handed them a winning lottery ticket,” Eggleton of IOP Publishing said. “They can do it really cheap, at scale, and the detection methods are not where we need them to be. I can only see that challenge increasing.”
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My uncle, Art Pace, was one of the founders of GE Healthcare. I was surprised to see it sold.
>>> Merck to buy eye-focused drug developer EyeBio for as much as $3 bln
Reuters
by Christy Santhosh
May 29, 2024
https://www.reuters.com/markets/deals/merck-acquire-eye-drug-company-eyebio-up-3-bln-2024-05-29/
May 29 (Reuters) - Merck (MRK.N), opens new tab on Wednesday agreed to buy privately held biotech EyeBio for as much as $3 billion, as it looks to diversify its portfolio of experimental drugs with treatments for eye diseases.
The drugmaker agreed to pay $1.3 billion in cash and another $1.7 billion in future milestone-based payments for EyeBio, and will gain access to its retinal disease drug Restoret as part of the deal.
The deal is the latest in a string of recent acquisitions by Merck to reduce its reliance on blockbuster immunotherapy Keytruda, which is expected to face rivals by the end of the decade when it is set to lose patent protection
Merck had said in February it was in the market for deals of up to $15 billion. Its recent acquisitions include a $10.8 billion deal for Prometheus Biosciences in 2023 and the purchase of Elanco's (ELAN.N), aqua business for $1.3 billion in February this year.
Merck's proposed acquisition of EyeBio would boost its limited presence in the eye diseases space, BMO Capital Markets analyst Evan Seigerman wrote in a research note.
While the deal was on the smaller side, "we are encouraged by the progress Merck continues to make diversifying its revenue base ahead of its Keytruda (loss of exclusivity)", he said.
Restoret is expected to enter a mid- to late-stage trial as a treatment for diabetic macular edema, a type of swelling in the eye, in the second half of 2024.
It is also being tested in patients with neovascular age-related macular degeneration, a disease which leads to abnormal blood vessel growth in the eye and affects more than 200 million people worldwide.
EyeBio, which operates as Eyebiotech Ltd, has operations in the U.S. and the UK. It was founded by SV Health Investors, which is backed by Kate Bingham — the former head of the UK's COVID-19 vaccine taskforce.
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H5N1 - the next pandemic?
>>> What a US farmworker’s case of bird flu tells us about tracking the infection
CNN
by Brenda Goodman
5-3-24
https://www.msn.com/en-us/health/other/what-a-us-farmworker-s-case-of-bird-flu-tells-us-about-tracking-the-infection/ar-AA1o5Z6a?OCID=BingNewsSerp
A US farmworker who caught bird flu after working with dairy cattle in Texas appears to be the first known case of mammal-to-human transmission of the virus, a new study shows.
The dairy worker sought care in late March after developing painful red, swollen, weeping eyes with burst blood vessels. He had no fever, however, and his lungs were clear, according to a letter about the case that was published in the New England Journal of Medicine on Friday.
He reported no contact with sick or dead birds or other animals, but he did have repeated direct close contact with dairy cows in the same part of the state with other infected herds.
Even though the man didn’t become seriously ill, his case is important because it confirms that humans can be infected with H5N1 after contact with cows. At the same time, it also leaves critical questions unanswered about a virus that the study authors said has “pandemic potential,” and it illustrates how hard it will be to track the infection in this vulnerable population of workers, where testing positive for an infectious disease might mean losing days of work and pay.
“For farmworkers specifically, certainly these are folks that are that are living in a state of economic desperation, and what they’re not going to do is, they’re not going to test for something if they don’t have paid sick leave, because they cannot afford to be sent home and told to stay home and not work,” said Elizabeth Strater, director of strategic campaigns for United Farm Workers.
Strater says UFW, like other groups, has heard rumors that there are dairy workers who are sick but don’t want to be tested, but she said it’s nothing that they’re able to confirm.
Health officials in Texas said they did test other sick dairy workers, including some with red eyes, but they turned out to have other illnesses, not bird flu.
“The people tested volunteered to be tested,” said Lara Anton, senior press officer with the Texas Department of State Health Services.
“It’s likely there were other people with symptoms who did not want to be tested so we cannot say with absolute certainty that no one else contracted H5N1. We can say for sure some of the people on dairy farms tested positive for other respiratory viruses that are commonly circulating in the human population,” Anton said.
In the case of the man who did test positive for bird flu, he took antiviral medications and recovered without any lasting problems, and his close family members received the drugs as a precaution, the letter says.
Swabs of the patient’s eyes and lungs revealed something interesting, too: His eyes were teeming with the H5N1 virus, but there was hardly any virus in his lungs. That could mean the worker was infected through his eyes – either by rubbing them with contaminated hands or through splashes of contaminated milk – rather than through his lungs, and the virus never migrated there, or that the virus couldn’t get a foothold in his lungs because it was adapted primarily to infect birds, not cells in the human airway.
The letter on the case was written by researchers at the US Centers for Disease Control and Prevention along with doctors at the Texas Department of State Health Services and researchers at the Texas Tech Bioterrorism Response Laboratory.
Health officials said they couldn’t do further investigation of how the man was infected because “epidemiological investigations were not able to be conducted at the farm” where he worked. They were also unable to test other workers at the same farm.
That kind of testing is critical to answer questions about how the worker became infected, whether others were being infected and if so, for how long they were infected and what kind of symptoms they had, if they had any at all.
The CDC is looking for farms that will allow it to conduct such a detailed study.
“Understanding the current avian flu outbreak among dairy cattle is a vital priority to help protect human health,” the agency said in a statement to CNN. “Discussions are under way with farms in multiple jurisdictions to participate in CDC-led epidemiological studies. In the meantime, states continue to test symptomatic farm workers and monitor those who have been exposed to infected animals. CDC also continues to closely monitor a robust, nationwide flu surveillance system. To date, it has not detected any unusual flu activity.”
At a news briefing Friday, White House spokesperson Karine Jean-Pierre said the administration was monitoring the situation “very closely and taking this very seriously.”
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>>> IDEXX Laboratories (NASDAQ:IDXX) is a global leader in veterinary diagnostics, software and water microbiology testing. The company’s innovative products and services help veterinarians deliver high-quality care and enable early detection and treatment of pet diseases. IDEXX’s strong competitive position, global presence and innovation focus position it well for continued growth. The increasing humanization of pets, the growing demand for veterinary care and the rising awareness of early disease detection’s importance are key megatrends supporting IDEXX’s long-term prospects.
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https://finance.yahoo.com/news/ai-bot-predicts-7-stocks-175326496.html
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>>> Simulations Plus (NASDAQ:SLP) is a leading modeling and simulation software provider for drug discovery and development. The company’s innovative software platform helps pharmaceutical and biotechnology companies accelerate the drug development process, reduce costs and improve success rates. Simulations Plus’ strong market position, expanding customer base and focus on innovation position are good for continued growth. The increasing complexity of drug discovery, the growing demand for efficient drug development processes and the rising adoption of computer-aided drug design are key megatrends that support Simulations Plus’ long-term prospects.
This is another stock in the healthcare industry sort of in the same boat as TCMD. Do not expect massive returns, but the possible gains are significant enough to include in a high-risk, high-reward basket of stocks. The company beat top-line estimates by nearly 6% in the recent quarter and has some of the best margin and cash positions, with negligible debt and $108 million in cash. Revenue growth is expected to be around 15% annually and 20-30% EPS growth going forward. However, you are paying a hefty premium for this stock, so I do not think life-changing returns are possible. However, it is still one of the AI stock picks worth buying for potential double-digit returns.
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https://finance.yahoo.com/news/ai-bot-predicts-7-stocks-175326496.html
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>>> Why big Medicare Advantage insurers may root for Biden to lose in 2024
The Biden administration has delivered consecutive blows to the industry that offers private-sector Medicare alternatives
Yahoo Finance
by Janna Herron
Apr 11, 2024
https://finance.yahoo.com/news/why-big-medicare-advantage-insurers-may-root-for-biden-to-lose-in-2024-080028510.html
Insurance giants have a bigger stake in this year’s presidential election after recent moves by the Biden administration cut into the profitability of Medicare Advantage plans.
In the last week, the Centers for Medicare and Medicaid Services (CMS) delivered consecutive blows to the industry that offers these private-sector Medicare alternatives, denting insurance stocks and pulling down estimates of future earnings.
Insurers will get paid less than expected next year for providing these plans, while, at the same time, they must abide by new, and probably costlier, regulations. Other key changes rolling out over the next three years could also nick their bottom lines.
The industry expects a second term for President Joe Biden would bring more of the same at a time when the youngest baby boomers become Medicare-eligible and more of the older ones seek healthcare services.
"Do I want to say it's a historic level of regulations? If it's not, it's got to be close to it," Whit Mayo, an analyst with Leerink Partners, told Yahoo Finance. "Biden is no friend to the industry right now."
'A major change'
The new regulations have come hard and fast recently.
Last week, the government said it would increase its payments to Medicare Advantage (MA) insurers by 3.7% in 2025. That’s "marginally worse" than the earlier proposed rate, Mayo said, and “inconsistent with almost any historic precedent.”
It also caught the industry by surprise because many expected CMS to incorporate the uptick in healthcare service volumes in the fourth quarter.
A few days later, CMS finalized other rules around health equity, behavioral healthcare services, and supplemental benefits that would require more action from insurers.
The agency also established new rules on how much insurers can compensate a broker selling Medicare Advantage plans to ensure seniors are steered into plans that best meet their needs — not into ones that are most profitable.
“CMS does not want an agent to have preference over any plan based on commissions…so this is a major change,” Mayo said.
These efforts are weighing down insurer stocks.
Year to date, shares of Humana (HUM) — which has the largest exposure with MA accounts making up 77% of its total revenue — are down 30%.
The stock of UnitedHealthcare (UNH) has declined nearly 13% since the beginning of the year. MA accounts make up 31% of UnitedHealthcare's total revenue, according to Ann Hynes, managing director at Mizuho Americas.
In a note last week to investors, Hynes estimated the 3.7% increase in the MA payment rate could be a 2% and 4% "headwind" for UnitedHealthcare’s 2025 earnings, a 2% to 6% drag on both CVS Healthcare Corp.’s (CVS) and Centene Corp.’s (CNC) profits, and an 8% anchor on Humana’s bottom line.
One of the three "key upcoming catalysts" for Humana’s stock, Hynes wrote, is “the 2024 Presidential election.”
On the horizon
More change is on its way under the Biden administration’s CMS that could also upend insurance profits.
The agency recently put out a new patient risk coding model. Each patient receives a risk score based on the number and severity of their health conditions. The unhealthier the patient, the higher the risk score and the more money CMS pays to insurers.
Under the new model, risk scores will overall likely decline, meaning fewer dollars will flow to insurers. How much exactly? The model, which will be fully phased in 2025, is expected to save Medicare $11 billion this year, per CMS estimates. Next year, it will likely be more.
How Medicare Advantage plans are rated by CMS is also changing.
CMS ranks each plan annually using a one-to-five-star scale, with five being the best, based on a variety of metrics. The idea is to reward plans that provide quality care with reimbursement and bonuses while cracking down on mediocre plans by reducing CMS payments and restricting their marketing.
Over the next three years, CMS plans to increase or decrease the weighting of some measures, eliminate others, and add a health equity index to the ranking. Insurers work hard to maintain at least a four-star rating on their plans to get a 5% quality bonus, which, by law, must be invested into plan benefits.
"That's what gives you a competitive advantage in the market," Mayo said.
Insurers also remain under pressure from increasingly vocal healthcare providers, which are dropping some Medicare Advantage plans due to too many denials, delays, and refusals to pay for care that Original Medicare would usually cover.
October surprise, anyone?
Under Donald Trump, those changes may not be carried out.
"I think the perception among the investment community is that, under a Trump administration, the environment would be more favorable,” Mayo said. “Just not as much regulation, maybe even roll back."
It may be seniors — historically one of the most reliable voting blocs — who may get the last word.
Mayo expects insurers will readjust some of the MA benefits so they can grow — or at least hold — their margins in light of the recent changes, a reversal of the years-long cycle of "massive" investment in these perks.
Extras like a supplemental grocery benefit could be eliminated for next year, while the share that patients pay out of pocket for services such as dental or vision care could increase.
Seniors will see those reductions in benefits or increases in co-insurance during Medicare’s annual open enrollment period, when they choose their health insurance for next year. Open enrollment kicks off Oct. 15, less than a month before the presidential election on Nov. 5.
That means the 33 million Americans now enrolled in Medicare Advantage plans, making up over half of Medicare-eligible adults, may get mad after their plan drops benefits that enticed them to sign up in the first place.
They may carry that anger into the voting booth. That may be what insurers are hoping for.
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>>> Cal-Maine Foods, largest producer of eggs in US, finds bird flu in chickens at Texas plant
USA Today
by Natalie Neysa Alund
April 3, 2024
https://www.yahoo.com/news/cal-maine-foods-largest-producer-132035566.html
The largest supplier of eggs in the United States halted production after chickens at a Texas plant tested positive for the highly contagious bird flu - the latest in a spike of cases across the nation.
Cal-Maine Foods on Tuesday announced chickens at its facility in Parmer County, in the state's southwestern panhandle, tested positive for pathogenic avian influenza (HPAI) resulting in slaughter of nearly 2 million chickens - 1.6 million hens and 337,000 pullets (young hens).
The announcement less than 24 hours after the Centers for Disease Control reported a person in Texas had been infected with the virus after coming into close contact with dairy cattle and just over a week after sick dairy cattle in Texas and Kansas tested positive for the virus.
The culled Texas chickens represent about 3.6% of the company’s total flock as of Tuesday, the supplier wrote in a news release.
Production at the Texas facility temporarily ceased while the company follows the protocols prescribed by the U.S. Department of Agriculture, the company said.
Bird flu is spreading in a few states: Keeping your bird feeders clean can help
Cal-Maine Foods is largest producer of eggs in the nation
Headquartered in Ridgeland, Mississippi, Cal-Maine Foods is the largest producer and distributor of fresh shell eggs in the nation and said it sells most of its eggs in states across the Southwest, Southeast, Midwest and MidAtlantic.
The company said it "remains dedicated to robust biosecurity programs across its locations; however, no farm is immune from HPAI. HPAI is still present in the wild bird population and the extent of possible future outbreaks, with heightened risk during the migration seasons, cannot be predicted."
Cal-Maine Foods said it was working "to secure production from other facilities" to minimize disruption to its customers.
Human case of bird flu found in Texas: Case comes on heels of outbreak of virus among cattle
Person infected with bird flu in Texas
In a separate news alert this week, the Texas Department of State Health Services reported the patient became "ill following contact with cows presumed to be infected with avian influenza" and that their primary symptom was conjunctivitis, also known as pink eye.
The person who tested positive for bird flu in Texas is only the second known human case in the United States, state and federal officials said this week.
Bird flu in dairy cattle in Kansas, Texas
Last week the USDA announced last week HPAI had been found in unpasteurized clinical samples of milk from ill cows at two dairy farms in Kansas and one in Texas, plus a swab from a dairy cow in Texas.
Wild migratory birds are believed to be the source of the infection, the USDA said, and viral testing and epidemiologic efforts remained underway.
What is bird flu?
Bird flu is a disease caused by a family of flu viruses primarily transmitted among birds.
Avian influenza viruses, according to the CDC and USDA, are classified into two groups: low pathogenic avian influenza (LPAI) (often seen in wild birds) and HPAI, found mostly in domestic poultry. According to the CDC, LPAI viruses cause mild or no disease, and HPAI cause severe disease and high mortality rates in infected birds.
Bird flu has cost the government roughly $660 million and in recent times raised the price of eggs and poultry. At least 58 million birds were slaughtered last year to limit the spread of the virus.
Bird flu spread to humans is low risk, USDA says
The first case of avian influenza in a person in the United States was reported in Colorado in April 2022.
Federal and state health authorities are investigating the outbreaks, and the USDA said the risk to the general public contracting is low as the viruses have only rarely been transmitted from person to person.
"However, people with close contact with affected animals suspected of having avian influenza A have a higher risk of infection," Texas health officials wrote in a news alert earlier this week.
Bird flu symptoms in humans
Human infection with the bird flu can happen during close contact with infected birds or when people touch sick birds or their saliva, mucus and feces, the CDC said. People contract the virus when it gets into a their eyes, nose or mouth, or when it is inhaled.
Those who contract the virus often experience mild illnesses including an eye infection and upper respiratory symptoms or no symptoms at all, while others can develop a severe sometimes fatal disease like pneumonia.
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HUM, UNH - >>> US health insurers slide as final Medicare payment rates fall below expectations
Reuters
4-2-24
https://www.msn.com/en-us/money/markets/us-health-insurers-slide-as-final-medicare-payment-rates-fall-below-expectations/ar-BB1kWIXt?OCID=ansmsnnews11#;
(Reuters) - Shares of U.S. health insurers tumbled between 6% and 12% on Tuesday after the final 2025 rates for Medicare Advantage (MA) payments by the government implied a cut and triggered worries about a margin squeeze.
The rates, which indicated a 0.2% fall in average payments, are unchanged from what was proposed in January, despite pressure from companies and industry groups to incorporate a late-year surge in medical care demand.
The U.S. Centers for Medicare & Medicaid Services typically raises the final reimbursement from the advanced notice.
The rates could pile more pressure on margins at insurers already struggling with high medical costs, and uncertainty around insurance claims processing due to the fallout of a hack at UnitedHealth's tech unit.
Shares of Medicare-focused insurer Humana fell the most, plunging more than 12% to a near four-year low of $308.22. UnitedHealth slumped 6.6%, while CVS Health sunk 7.7% in early trading.
The steep losses also dragged down the blue-chip Dow index and the benchmark S&P 500 in morning trading. [.N]
The "less-than-favorable rate updates, which coupled with the potentially clouded claims development in light of the Change Health cyberattack ... may put the once-golden Medicare Advantage market in somewhat less favorable standing," said Citi analyst Jason Cassorla.
The CMS, in a final notice published on Monday, said it had not observed higher demand for medical care during the fourth quarter of 2023, in sharp contrast to recent comments from insurers such as Humana and UnitedHealth.
The closely watched proposal determines how much insurers can charge for monthly premiums, plan benefits they offer and, ultimately, their profits.
The high costs, coupled with low rates, put pressure on insurers to cut the number of benefits they cover, said BoFA Securities analyst Kevin Fischbeck in a note.
"The amount of benefit cuts needed could begin to weigh on the perceived value of Medicare Advantage," he said.
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>>> Pfizer Inc. (NYSE:PFE) -- Number of Hedge Fund Holders: 79
https://finance.yahoo.com/news/20-best-stocks-buy-now-183621401.html
Number of Times Stock Appeared in Top Picks of Financial Media: 3
Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. On March 4, investment advisory Cantor Fitzgerald maintained an Overweight rating on Pfizer Inc. (NYSE:PFE) stock with a price target of $45.
Among the hedge funds being tracked by Insider Monkey, Florida-based investment firm Citadel Investment Group is a leading shareholder in Pfizer Inc. (NYSE:PFE) with 11.6 million shares worth more than $334 million.
In its Q4 2023 investor letter, Diamond Hill Capital, an asset management firm, highlighted a few stocks and Pfizer Inc. (NYSE:PFE) was one of them. Here is what the fund said:
“Among our bottom contributors in Q4 were BorgWarner and Pfizer Inc. (NYSE:PFE). Biopharmaceutical company Pfizer was pressured as COVID sales were slower than expected in Q4. However, outside COVID-related sales, the base business is performing as expected, and the company is starting a cost-cutting program that should restore margins to pre-pandemic levels. We continue to like Pfizer for its diversified business, strong cash flow generation capabilities and balance sheet, and solid leadership under a quality CEO.”
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>>> Zoetis Inc. (NYSE:ZTS) -- 14-day RSI: 32.16
https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html
Number of Hedge Fund Holders: 50
Parsippany, New Jersey-based Zoetis Inc. (NYSE:ZTS) is a leading animal health company with a portfolio and pipeline of medicines, vaccines, diagnostics, and technologies offered in over 100 countries. Formerly a subsidiary of Pfizer Inc. (NYSE:PFE), the company became independent through a spinoff in 2013.
Zoetis Inc. (NYSE:ZTS) has been continuously making efforts to increase its product franchises in major markets. During the fourth quarter, the company received approvals for Simparica Trio, the company’s triple combination oral parasiticide for dogs, in China. While the company’s injectable monoclonal antibody for the alleviation of pain associated with osteoarthritis in cats, Solensia, received approval in Brazil.
Zoetis Inc. (NYSE:ZTS) has paid regular dividends since its spinoff from Pfizer Inc. (NYSE:PFE) with consecutive dividend increases for several years. The board of directors of the company declared a dividend of $0.432 per share for Q2 2024, on February 6.
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>>> Novartis AG (NYSE:NVS) - 14-day RSI: 37.75
https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html
Number of Hedge Fund Holders: 28
Basel, Florida-based Novartis AG (NYSE:NVS) focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.
On February 6, Novartis AG (NYSE:NVS) announced that it has entered into an agreement to acquire MorphoSys AG (NASDAQ:MOR) in a transaction implying a total value of €2.7 billion. The transaction expands and complements the company’s pipeline in oncology and enhances its global footprint in hematology.
On February 23, BMO Capital analyst Etzer Darout initiated coverage of Novartis AG (NYSE:NVS) shares with a price target of $114 with a ‘Market Perform’ rating for the shares. The target price represents a potential upside of 15.15% based on the latest share price.
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>>> Amgen, Inc. (NASDAQ:AMGN) - 14-day RSI: 37.92
https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html
Number of Hedge Fund Holders: 69
Thousand Oaks, California-based Amgen, Inc. (NASDAQ:AMGN) is a leading biotechnology company discovering, developing, manufacturing, and delivering innovative human therapeutics with a focus on areas of high unmet medical need.
On February 6, Amgen, Inc. (NASDAQ:AMGN) released its financial results for the Q4 2023. Its revenues increased by 20% y-o-y to $8.2 billion, while it generated a net income of $767 million. The normalized EPS for the quarter was recorded at $4.71, which surpassed the consensus by $0.12.
Earlier on October 6, 2023, Amgen, Inc. (NASDAQ:AMGN) completed the acquisition of Horizon Therapeutics plc in an all-cash transaction implying an equity value of nearly $27.8 billion. The acquisition strengthened the company’s inflammation portfolio by adding first-in-class, early-in-lifecycle medicines which treat rare inflammatory diseases.
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>>> UnitedHealth unit will start processing $14 billion medical claims backlog after hack
Reuters
by Leroy Leo
https://www.msn.com/en-us/money/companies/unitedhealth-unit-will-start-processing-14-billion-medical-claims-backlog-after-hack/ar-BB1kntGE?OCID=ansmsnnews11
(Reuters) - UnitedHealth Group said on Friday its Change Healthcare unit will start to process the medical claims backlog of more than $14 billion as it resumes some software services disrupted by a cyberattack last month.
The company has been scrambling to resume services at the technology unit that was hit by a cyberattack on Feb. 21, disrupting payments to U.S. doctors and healthcare facilities and forcing the U.S. government to launch a probe.
Community health centers that serve more than 30 million poor and uninsured patients have been especially hit.
The company has advanced payments of more than $2.5 billion so far to provide assistance to healthcare providers financially affected by the disruption, an increase from the over $2 billion it had disclosed on Monday. UnitedHealth also extended the repayment period for providers, who will now have 45 business days to return the relief funds.
Change Healthcare is a key player in the U.S. healthcare system that depends heavily on insurance, processing about 50% of medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories.
The unit was breached by a hacking group called ALPHV, also known as "BlackCat", creating a knock-on effect that the largest U.S. health insurer is expected to take several months from which to fully recover.
The health insurer said its software for preparing medical claims Assurance went online on Monday, while its largest clearinghouse Relay Exchange will resume on the weekend of March 23.
A clearinghouse acts as a middleman between a healthcare provider and a health plan that checks claims to ensure they do not contain errors before forwarding them for payment.
The insurer said it will work with payers to ensure there are a maximum number of available locations for claims and is actively coordinating with other clearinghouses to make sure there are no capacity issues.
UnitedHealth had suspended paperwork required to get approval for insurance coverage for most outpatient services, as well as review of inpatient admissions for government-backed Medicare Advantage plans to help those impacted.
UnitedHealth also expects to engage all those who submitted claims during the week of March 25.
The company's other products that handle eligibility of claims such as Clearance and Coverage Insight as well as pharmacy claims submission software MedRx and Reimbursement Manager are expected to go online next week.
Several more products are likely to go online over the weeks of April 1 and April 8, the company said.
Some products, however, were not listed in Friday's update as it does not yet have clarity of when they will be restored, the company said, adding it will provide updated information as those timelines become clear.
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Resmed - >>> Introducing the AirFit F40: Experience Unprecedented Freedom with the Comfort and Optimized Seal Performance of ResMed’s Smallest Full-Face CPAP Mask
GlobeNewswire
ResMed Inc.
March 6, 2024
https://finance.yahoo.com/news/introducing-airfit-f40-experience-unprecedented-140500242.html
Enhances sleep apnea therapy by combining the ease and comfort of an ultra-compact, under-the-nose full-face design with the effectiveness of a traditional over-the-nose full-face mask.
Featuring the AdaptiSeal™ cushion made of 100% soft silicone to adapt to various facial contours, allowing for a secure and comfortable seal throughout the night.
96% of patients using the AirFit F40 said they have the freedom to sleep in their preferred position and change positions through the night.1
SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- ResMed (NYSE: RMD, ASX: RMD), a global leader in digital health and cloud-connected medical devices that transform care for people with sleep apnea and other chronic respiratory diseases, today announced the U.S. launch of the AirFit F40, an ultra-compact, full-face mask offering the comfort of smaller masks without sacrificing performance in order to help improve sleep apnea therapy compliance.2
Finding the right mask with the right fit and comfort can be daunting, especially for individuals requiring high-pressure CPAP treatment. The AirFit F40 addresses this problem by providing the necessary pressure support in a more comfortable, lower-profile full-face mask. The mask is ideal for people who sleep on their side, are claustrophobic, and want the stability and seal of a universal fit mask in a minimalist design. In a ResMed clinical study, 88% of patients rated AirFit F40's mask cushion as soft and comfortable and 100% found AirFit F40 easy to use.3
"Most users prefer smaller and more streamlined masks, but traditional under-the-nose full-face masks can be challenging to fit properly, maintain a seal, and handle higher pressures. Our new AirFit F40 addresses this problem by offering the best of both worlds: an ultra-compact full-face mask with the high seal performance of an over-the-nose mask – bridging the gap between compactness and effectiveness in full-face masks,” said Justin Leong, ResMed chief product officer.
A key feature of the AirFit F40 is the AdaptiSeal™ cushion, a 100% soft silicone cushion designed to maintain a facial seal, even when moving around during sleep. Additional features include:
A fully flexible frame that keeps the assembly away from patients’ eyes and ears.
A full-face mask with a quick-release short tube, reducing tube drag and offering a convenient way to detach and reattach the mask to the device during the night.
Headgear without top strap adjustment, which makes for an easier setup and adjustment process.
A new textile material and a dark grey color, offering a more modern look.
AirFit F40 is the latest in ResMed’s family of innovative CPAP masks, connected devices, and digital health technologies for helping millions with sleep apnea, COPD, and other chronic diseases sleep, breathe, and live better.
AirFit F40 masks are available in the U.S., with plans to launch in Canada, followed by EMEA, Latin America, and APAC. For more information, visit ResMed.com/AirFitF40.
About ResMed
At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD, and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we help improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems in more than 140 countries.
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A Board to discuss Healthcare stock ideas -
Healthcare -
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AbbVie (ABBV) - Research unit from Abbott Labs (349 Bil) --------------------------------------- 3.2% (Healthcare)
Amgen (AMGN) - Biopharma (177 Bil) ------------------------------------------------------------------ 2.7% (Healthcare)
AstraZeneca (AZN) - Pharmaceuticals (270 Bil) (UK) ---------------------------------------------- 1.7% (Healthcare)
Cencora (COR) - Pharmaceuticals distribution (Amerisource Bergen) (44 Bil) --------------- 0.9% (Healthcare)
Danaher (DHR) - Diverse healthcare related, other (172 Bil) ------------------------------------- 0.4% (Healthcare)
Elevance Health (ELV) - Health benefits company (formerly Anthem) (128 Bil) -------------- 1.2% (Healthcare)
Eli Lilly (LLY) - Pharmaceuticals (857 Bil) -------------------------------------------------------------- 0.6% (Healthcare)
Encompass Health (EHC) - Post acute heathcare services, hospitals (9 Bil) ---------------- 0.8% (Healthcare)
Ensign Group (ENSG) - Skilled nursing + rehabilitative svcs (9 Bil) ---------------------------- 0.2% (Healthcare)
Icon PLC (ICLR) - CRO development svcs to biopharma ind (Ireland) (23 Bil) --------------- 0% (Healthcare)
Johnson & Johnson (JNJ) - Diverse healthcare products (389 Bil) (Berkshire) ----------- 2.9% (Healthcare)
LeMaitre Vascular (LMAT) - Medical devices for peripheral vascular disease (2 Bil) ------- 0.7% (Healthcare)
Medpace Holdings (MEDP) - CRO (10 Bil) ------------------------------------------------------------- 0% (Healthcare)
Pfizer (PFE) - Pharmaceuticals (160 Bil) --------------------------------------------------------------- 5.9% (Healthcare)
Quest Diagnostics (DGX) - Diagnostic testing services (17 Bil) -------------------------------- 2.0% (Healthcare)
ResMed (RMD) - Products for sleep apnea (33 Bil) -------------------------------------------------- 1.0% (Healthcare)
Steris (STE) - Infection prevention, heathcare products + svcs (Ireland) (23 Bil) ------------ 0.9% (Healthcare)
Stryker (SYK) - Diverse medical, surgical devices, implants (132 Bil) --------------------------- 1.0% (Healthcare)
UFP Technologies (UFPT) - Diverse packaging, component products (1.7 Bil) --------------- 0% (Healthcare)
Zoetis (ZTS) Veterinary drugs and vaccines (83 Bil) ------------------------------------------------- 1.0% (Healthcare)
__________________________________________________________________
Healthcare
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CRO Services -
Icon PLC (ICLR) - CRO development svcs to biopharma ind (Ireland) (20 Bil) ---------------- 0%
IQVIA Holdings (IQV) -- CRO, analytics (Quintiles) (44 Bil) ---------------------------------------- 0%
Medpace Holdings (MEDP) - CRO (10 Bil) ------------------------------------------------------------- 0%
Diagnostics + Research -
Agilent (A) - Bio analytical solutions and services (46 Bil) ----------------------------------------- 0.6%
Danaher (DHR) - Diverse healthcare related, other (172 Bil) ------------------------------------- 0.4%
Idexx Labs (IDXX) - Veterinary diagnostic products and services (46 Bil) ---------------------- 0%
Lab Corp of America (LH) - Diagnostic testing svcs, CRO services (Covance) (21 Bil) --- 1.2%
Quest Diagnostics (DGX) - Diagnostic testing services (17 Bil) --------------------------------- 2.0%
Mettler-Toledo Intl (MTD) - Precision instruments for diverse applications (32 Bil) ---------- 0%
Thermo Fisher Scientific (TMO)- Analytical instruments, equip, reagents (230 Bil) -------- 0.2%
Distribution -
Cardinal Health (CAH) - Drug and medical product distribution (27 Bil) ------------------------ 1.8%
Cencora (COR) - Pharmaceuticals distribution (Amerisource Bergen) (44 Bil) ---------------- 0.9%
McKesson (MCK) - Pharma distribution, med supplies, IT svcs (69 Bil) (Berkshire) ------- 0.5%
Healthcare Facilities -
Chemed (CHE) - Hospice and palliative health care1 svs, Roto Rooter (9 Bil) ---------------- 0.3%
Encompass Health (EHC) - Post acute heathcare services, hospitals (9 Bil) ----------------- 0.8%
Ensign Group (ENSG) - Skilled nursing + rehabilitative svcs (9 Bil) ---------------------------- 0.2%
Health Information Services -
GE Healthcare (GEHC) - Imaging, ultrasound, patient care solns (39 Bil) ---------------------- 0%
Simulations Plus (SLP) - Modeling + simulation software for drug development (863 mil) 0.6%
Healthcare Plans -
IShares US Healthcare Providers (IHF) (0.39%) ---------------------------------------------------- 0.7%
Elevance Health (ELV) - Health benefits company (formerly Anthem) (128 Bil) -------------- 1.2%
Humana (HUM) - Health benefits company (62 Bil) -------------------------------------------------- 0.6%
Molina Healthcare (MOH) - Managed healthcare services, Medicare, Medicaid (21 Bil) --- 0%
UnitedHealth Group (UNH) - Health benefits company (440 Bil) -------------------------------- 1.3%
Medical Devices -
iShares US Medical Devices ETF (IHI) (0.40%) ------------------------------------------------------ 0.5%
Abbott Labs (ABT) - Diverse healthcare products (209 Bil) --------------------------------------- 1.9%
DexCom (DXCM) - Continuous glucose monitoring systems (43 Bil) ----------------------------- 0%
LeMaitre Vascular (LMAT) - Medical devices for peripheral vascular disease (2 Bil) ------- 0.7%
Quipt Home Medical (QIPT) - In-home med equip, supplies, respiratory, etc (220 mil) ----- 0%
Steris (STE) - Infection prevention, heathcare products + svcs (Ireland) (23 Bil) ------------ 0.9%
Stryker (SYK) - Diverse medical, surgical devices, implants (132 Bil) --------------------------- 1.0%
UFP Technologies (UFPT) - Packaging, component products (814 mil) ------------------------ 0%
Medical Instruments + Supplies -
Cooper Companies (COO) - Contact lenses, medi devices for women's health (20 Bil) ---- 0%
Hologic (HOLX) - Diagnostics, breast health, Gyn surgical, skeletal health (20 Bil) ---------- 0%
ResMed (RMD) - Products for sleep apnea (33 Bil) -------------------------------------------------- 1.0%
West Pharmaceuticals (WST) - Drug packaging and delivery systems (4.1 Bil) ------------ 0.8%
Pharma -
AbbVie (ABBV) - Research unit from Abbott Labs (349 Bil) --------------------------------------- 3.2%
Amgen (AMGN) - Biopharma (177 Bil) ------------------------------------------------------------------ 2.7%
AstraZeneca (AZN) - Pharmaceuticals (270 Bil) (UK) ----------------------------------------------- 1.7%
Eli Lilly (LLY) - Pharmaceuticals (857 Bil) --------------------------------------------------------------- 0.6%
Johnson & Johnson (JNJ) - Diverse healthcare related products (389 Bil) (Berkshire) -- 2.9%
Merck (MRK) - Pharmaceuticals (305 Bil) --------------------------------------------------------------- 2.6%
Novartis (NVS) - Pharmaceuticals (209 Bil) ------------------------------------------------------------ 3.7%
Novo Nordisk (NVO) - Pharmaceuticals (482 Bil) (Denmark) ------------------------------------- 1.0%
Pfizer (PFE) - Pharmaceuticals (160 Bil) ---------------------------------------------------------------- 5.9%
Zoetis (ZTS) Veterinary drugs and vaccines (83 Bil) ------------------------------------------------- 1.0%
___________________________________________________________________
Name | Symbol | % Assets |
---|---|---|
Johnson & Johnson | JNJ | 8.47% |
UnitedHealth Group Inc | UNH | 5.80% |
Merck & Co Inc | MRK | 5.39% |
Pfizer Inc | PFE | 5.06% |
Abbott Laboratories | ABT | 3.56% |
Medtronic PLC | MDT | 3.52% |
Amgen Inc | AMGN | 3.14% |
Thermo Fisher Scientific Inc | TMO | 2.92% |
AbbVie Inc | ABBV | 2.84% |
Eli Lilly and Co | LLY | 2.40% |
Name | Symbol | % Assets |
---|---|---|
Abbott Laboratories | ABT | 12.57% |
Thermo Fisher Scientific Inc | TMO | 12.41% |
Danaher Corp | DHR | 10.58% |
Medtronic PLC | MDT | 10.33% |
Intuitive Surgical Inc | ISRG | 4.71% |
Edwards Lifesciences Corp | EW | 4.47% |
Stryker Corp | SYK | 4.27% |
Becton, Dickinson and Co | BDX | 4.19% |
Boston Scientific Corp | BSX | 4.15% |
IDEXX Laboratories Inc | IDXX | 3.71% |
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