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— Tek Roo 2024 (@Tek_Roo) June 6, 2023
XXII does not even name these c-stores
trying to have dawn break on marblehead
I agree your reading comprehension gets in your way:
LOCAL NEWS
Massachusetts pot shops closing in Worcester, Framingham, Northampton; a worker had died after packaging cannabis into pre-rolls
The Trulieve dispensary in Worcester will be closing, along with the company’s pot shops in Framingham and Northampton. (Chris Christo/Boston Herald)
By RICK SOBEY | rick.sobey@bostonherald.com | Boston Herald
June 4, 2023 at 7:12 p.m.
After the recreational marijuana market exploded in recent years across the Bay State, more pot shops will soon be shutting down around the region.
Trulieve Cannabis Corp. recently announced that the marijuana giant will be winding down its operations in Massachusetts. The company’s dispensaries in Worcester, Framingham, and Northampton will close at the end of June, and Trulieve expects that it will cease all operations in the state by the end of the year.
The cannabis behemoth made headlines last year when a worker who was packaging ground cannabis into pre-rolls at Trulieve’s cannabis processing facility in Holyoke suffered an asthma attack and later died in the hospital. The Occupational Safety and Health Administration investigated, and the company later settled with OSHA.
Trulieve isn’t the first cannabis company to shut down pot shops in the state. Late last year, the Source became the first dispensary to close in Massachusetts. The store was located close to other pot shops in Northampton.
Now Trulieve will be taking another marijuana dispensary off the market in Northampton, along with stores in Worcester and Framingham. The company said it’s looking to “preserve cash and improve financial performance.”
“These difficult but necessary measures are part of ongoing efforts to bolster business resilience and our commitment to cash preservation as we continue to focus on our business strategy of going deep in our core markets and jettisoning non-contributive assets,” CEO Kim Rivers said in a statement. “We remain fully confident in our strategic position and the long term prospects for the industry.”
In December, Trulieve had announced a settlement with OSHA that would lead to more health and safety protections for workers at its cannabis manufacturing facilities following the death of an employee.
As part of the agreement, the original $35,219 fine against Trulieve was reduced to $14,502. Under the agreement, Trulieve would study whether ground cannabis dust is required to be classified as a “hazardous chemical” in the occupational setting, according to OSHA regulations.
“Increased-scale manufacturing in our industry is a relatively new endeavor and we are determined to continually ask questions and seek answers to make our workplace the safest and healthiest it can possibly be,” Rivers said. “We already have many protections in place, and we intend to continue our work with state and federal regulators to make sure workers are treated well.”
Rick Sobey
Rick Sobey is a multimedia, general assignment reporter -- covering breaking news, politics and more across the region. He was most recently a reporter at The Lowell Sun. Rick is a Massachusetts native and graduated from Boston University. While not reporting, he enjoys long-distance running.
rick.sobey@bostonherald.com
Try reading comprehension!
"even potheads couldn't smoke that schwag"
No they sell you merda. It cost to buy schwag.
No free lunches. lol
Enjoy the day
Impossible to make money with schwag weed like MRMD sells:
Multi-state marijuana company announces plans to close Massachusetts dispensaries
WCVB : 8:26 AM EDT Jun 2, 2023
FRAMINGHAM, Mass. —
Trulieve Cannabis Corp., a marijuana business operating in 11 states, on Thursday announced plans to exit the Massachusetts industry.
Dispensaries in Framingham, Northampton, and Worcester are set to close their doors on June 30, with Trulieve expecting to completely cease operations in Massachusetts by the end of this year, the company announced.
Cannabis Control Commission records show the business' fourth Massachusetts outpost is a cultivation and product manufacturing site in Holyoke.
“These difficult but necessary measures are part of ongoing efforts to bolster business resilience and our commitment to cash preservation as we continue to focus on our business strategy of going deep in our core markets and jettisoning non-contributive assets," Trulieve CEO Kim Rivers said in a statement provided by the company.
The measures were more immediate in California, where the company decided to close its retail location in Grover Beach and where the company previously closed dispensaries in Palm Springs and Venice.
Harvard University says: Prescription drugs are the 4th leading cause of death.
Risky Drugs: Why The FDA Cannot Be Trusted
July 17, 2013
by Donald W. Light
A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.
All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.
The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.
Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.
The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.
This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA.2 Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what “safe” and “effective” mean. The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information.34 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge.5 6 Patients are the innocent victims.
Although it now embraces the industry rhetoric about “breakthrough” and “life-saving” innovation, the FDA in effect serves as the re-generator of patent-protected high prices for minor drugs in each disease group, as their therapeutic equivalents lose patent protection. The billions spent on promoting them results in the Inverse Benefit Law: the more widely most drugs are marketed, the more diluted become their benefits but more widespread become their risks of harm.
The FDA also legitimates industry efforts to lower and widen criteria prescribing drugs, known by critics as “the selling of sickness.” Regulations conveniently prohibit the FDA from comparing the effectiveness of new drugs or from assessing their cost-effectiveness. Only the United States allows companies to charge what they like and raise prices annually on last year’s drugs, without regard to their added value.7
A New Era?
Now the FDA is going even further. The New England Journal of Medicine has published, without comment, proposals by two senior figures from the FDA to loosen criteria drugs that allege to prevent Alzheimer’s disease by treating it at an early stage.8 The authors seem unaware of how their views about Alzheimer’s and the role of the FDA incorporate the language and rationale of marketing executives for the industry. First, they use the word “disease” to refer to a hypothetical “early-stage Alzheimer’s disease” that supposedly exists “before the earliest symptoms of Alzheimer’s disease are apparent.” Notice that phrasing assumes that the earliest symptoms will become apparent, when in fact it’s only a hypothetical model for claiming that cognitive lapses like not remembering where you put something or what you were going to say are signs of incipient Altzheimer’s disease. The proposed looser criteria would legitimate drugs as “safe and effective” that have little or no evidence of being effective and expose millions to risks of harmful side effects.
No proven biomarkers or clinical symptoms exist, the FDA officials note, but nevertheless they advocate accelerated approval to allow “drugs that address an unmet medical need.” What “unmet need"? None exists. This market-making language by officials who are charged with protecting the public from unsafe drugs moves us towards the 19-century hucksterism of peddling cures of questionable benefits and hidden risks of harm, only now fully certified by the modern FDA.9
The main reason for advocating approvals of drugs for an unproven need with unproven benefits, these FDA officials explain, is that companies cannot find effective drugs for overt Alzheimer’s. Their drug-candidates have failed again and again in trials. The core rationale of the proposed loosening of criteria is that “the focus of drug development has sifted to earlier stages of Alzheimer’s disease…and the regulatory framework under which such therapies are evaluated should evolve accordingly.” Yet they admit there are no “therapies” in this much larger market where (with the help of the industry-funded FDA) companies will not have to prove their drugs are effective. In fact, these FDA officers propose to approve the drugs without ever knowing if they are therapeutic or not. Their commercialized language presumes the outcome before starting. The job of the FDA, it seems, is to help drug companies open up new markets to increase profits for the FDA’s corporate paymasters.
These two FDA officials maintain that “the range of focus must extend to healthy people who are merely at risk for the disease but could benefit from preventive therapies.” Yet they admit we do not know who is “at risk,” nor whether there is a “disease,” nor whether anyone “could benefit,” nor whether the drugs constitute “preventive therapies.” Similar FDA-encouraged shifts have been made for drugs treating pre-diabetes, pre-psychosis, and pre-bone density loss, with few or no benefits to offset risks of harm. This week, based on policy research at the Edmond J. Safra Center for Ethics, a letter of concern was published in the New England Journal of Medicine. The authors write that approval for drugs to treat “early stage Altzheimer’s disease” must meet “a much higher bar – evidence of slowed disease progression.” But without clinical manifestations or biomarkers for an alleged disease, how will such progression be measured?
Advice to readers: Experienced, independent physicians recommend not to take a new drug approved by the FDA until it is out for 7 years, unless you have to, so that evidence can accumulate about its real harms and benefits.10
----
Disclaimer: The assessment and views expressed here are solely the author’s and do not necessarily reflect those of persons or institutions to which he is associated. The comments and suggestions of Gordon Schiff, an expert in prescribing at Brigham and Women’s Hospital, and Robert Whitaker are gratefully acknowledged.
References
1. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Archives of Internal Medicine 2012 (Nov 26);172:1680-81.
2. Hilts PJ. Protecting America's Health: The FDA, Business and One Hundred Years of Regulation. New York: Alfred A. Knopf; 2003.
3. Rodwin M. Conflicts of interest, institutional corruption, and Pharma: an agenda for reform. Journal of Law, Medicine & Ethics 2012;40:511-22.
4. Rodwin M. Reforming pharmaceutical industry-physician financial relationships: lessons from the United States, France, and Japan. Journal of Law, Medicine & Ethics 2011(Winter):2-10.
5. Sismondo S. Ghost management. PLoS Medicine 2007;4:1429-33.
6. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics 2010;24:273-83.
7. Schondelmeyer S, Purvis L. Rx Price Watch Report. Washington DC: American Association of Retired Persons 2012.
8. Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. New England Journal of Medicine 2013 (Mar 13);DOI: 10.1056/NEJMp1302513
9. Young JH. The Toadstool Millionaires: a social history of patent medicines in America before federal regulation. Princeton, NJ: Princeton University Press; 1961.
10. Schiff G, Galanter W, Duhig J, et al. Principles of conservative prescribing. Archives of Internal Medicine 2011;171:1433-30.
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‘Poison in every puff’: Canada to put warning labels on individual cigarettes
Health Canada hopes to lower tobacco use with “virtually unavoidable’” messages.
Cigarettes lined up with warning labels.
The labels on individual cigarettes will feature a rotation of warnings, in French and English, like: “Cigarettes damage your organs,” “Cigarettes cause impotence” and “Poison in every puff.” | Health Canada handout
By JOSEPH GEDEON
05/31/2023 02:45 PM EDT
Updated: 05/31/2023 05:25 PM EDT
In a world first, Canada will soon print health warnings on individual cigarettes.
The labels will feature a rotation of warnings — in French and English, like: “Cigarettes damage your organs,” “Cigarettes cause impotence” and “Poison in every puff.” Each warning will appear in bold, black text at the butt of each cigarette.
“Tobacco use continues to kill 48,000 Canadians each year,” Carolyn Bennett, Canada’s associate minister of health, said Wednesday in a release announcing the news.
“This bold step will make health warning messages virtually unavoidable, and together with updated graphic images displayed on the package, will provide a real and startling reminder of the health consequences of smoking.”
POLITICO’s Health Care Summit on Wednesday, June 7, will explore how tech and innovation are transforming health care and the challenges ahead for access and delivery in the U.S. Register now.
Health Canada said the regulation will go into effect Aug. 1. King-sized cigarettes with the warning will reach stores by April 2024; retailers will carry regular-sized cigarettes with the messaging the following April.
When asked by reporters in Ottawa if there is any evidence that the labels will deter smoking, Health Minister Jean-Yves Duclos said: “Every possible tool works.”
Rob Cunningham, a senior policy analyst with the Canadian Cancer Society, says he considers direct labeling an effective way to lower cigarette usage — pointing to dozens of studies back to 2006.
He said it should not increase the cost of cigarettes: “Tobacco companies have long been accustomed to printing on the filter overwrap.”
Health Canada also announced plans to update tobacco packaging with stronger health warnings and quit-line details that will take up 75 percent of packing.
Canada first added intense visual health warnings to cigarette packaging in 2000. It is estimated 126 countries have, or are finalizing, visual health warnings on packaging, according to 2021 data compiled by Tobacco Free Kids.
Smoking has been on the decline for decades in Canada, with around 3.8 million daily or occasional smokers in 2021 — or just below 12 percent — a drop from 23 percent in 2003, Statista research shows.
The tobacco strategy hopes to lower that number to less than 5 percent by 2035.
FILED UNDER: REGULATIONS, TOBACCO, CANADA, CIGARETTES
POLITICO
last time you told me that XXII was $1.40 and higher
Oh well
Enjoy
Let me correct that for you.
Addition of 200 stores carrying one cartoon of VLN .
That will be returned to the distributor:0(((
Who buys a product that they never heard of?
No one.
Long educational road ahead that is already washed out!
Those stores will not sell a single pack of XXII hay!
lol
same same
go woke go broke
is this how XXII sells product = roflmao
This is the same BS since 2011? 2013?
Opposes Efforts by Tobacco Interests to Interfere with Advancement of FDA Policies to Reduce Adult Smoking
China is bracing for a massive new wave of COVID cases. What it means for the rest of the world
BYERIN PRATER
May 24, 2023 at 4:00 AM EDT
People visit a traditional spring festival flower market, which reopened after closure due to the spread of COVID, in Guangzhou, China, on Jan. 20. Cases of Omicron variant XBB are mounting in China, forming a new wave expected to crest around 65 million cases a week by the end of June.
PHOTO BY STR/AFP VIA GETTY IMAGES
Cases of Omicron variant XBB are mounting in China, forming a new wave expected to crest around 65 million cases a week by the end of June.
Infections will likely reach 40 million per week by the end of the month, senior health adviser Zhong Nashan told attendees at a biotech conference in Guangzhou, according to Bloomberg.
The wave could swell to become the country’s second largest, experts tell Fortune. It will undoubtedly pale in comparison to the country’s first major wave late last year, during which an estimated 37 million people were infected on one day—Dec. 20—alone.
That wave—equivalent to the early days of the pandemic for the rest of the world—occurred after the country abruptly abandoned its yearslong “zero COVID” policy, effectively letting the virus “rip” through a population that had been largely sheltered from the it—and that was vastly undervaccinated.
A ‘largely invisible’ wave
XBB, the “first major highly immune-evasive” group of COVID variants, “will sweep through China,” but the wave will be “largely invisible” due to low rates of testing and reporting, Raj Rajnarayanan, assistant dean of research and associate professor at the New York Institute of Technology campus in Jonesboro, Ark., and a top COVID-variant tracker, tells Fortune.
When it comes to XBB variants, “the rest of the world has seen them all.” But up until recently, “China hasn’t,” he says, adding that the country has a substantial population at high risk of severe outcomes from COVID due to age, immune status, and co-morbid conditions.
Increased circulation of XBB variants in China—and elsewhere—is likely to result in the evolution of new XBB variants, Rajnarayanan said. So far, XBB spawn have remained relatively innocuous for those not at increased risk of severe disease, according to the World Health Organization’s latest situation report, released Thursday.
‘Go back for regular check-ups’
It remains to be seen whether hospitalizations will rise in China, Rajnarayanan and fellow variant tracker Ryan Gregory—a Canadian biologist who has assigned “street names” to so-called “high flying” variants like XBB.1.5, dubbed “Kraken”—tell Fortune.
Hospitalizations can, however, be expected to rise if variants that combine the transmissibility of XBB with the lung involvement of Delta catch on, in China or elsewhere. Trackers are eyeing variants that have a mutation in the spike protein that could cause such a phenomenon. So far, such variants are only prevalent in New Zealand and the European Union, Rajnarayanan says.
The evolution of a veritable XBB-Delta combo isn’t an inevitability, though, Rajnarayanan says.
And while the virus is capable of pivoting at any point, evolving into a more lethal version of itself, it so far hasn’t–—and the chance of it doing so isn’t any greater in China that it is in the rest of the world, where the virus is also spreading unchecked, Dr. Ali Mokdad, a professor at the University of Washington’s Institute for Health Metrics and Evaluation, tells Fortune.
While caution is always warranted when it comes to COVID, people everywhere need to “go back for regular check-ups, and bring their kids in for vaccinations,” Mokdad said.
COVID precautions “saved a lot of lives,” he added. “It’s time for us to go back to normal and make sure it’s not at the expense of other preventative programs.”
Subscribe to Well Adjusted, our newsletter full of simple strategies to work smarter and live better, from the Fortune Well team. Sign up today.
New item at South San Francisco Costco, lost in translation:
insert-text-here
The new COVID variant has symptoms that are similar to allergies. Here’s how to tell the difference
Is it pink eye, allergies… or COVID?
By TROY FARAH
Staff Writer
PUBLISHED MAY 16, 2023 12:00PM (EDT)
Red eyed man holding tissue to his nose (Getty Images/heidijpix)
Nothing in life is certain except death, taxes and that the SARS-CoV-2 virus will keep mutating. Despite both the White House and the World Health Organization recently declaring an end to the public health emergencies characterizing the last three years of the pandemic, the pathogen responsible for COVID continues to circulate, still daily infecting large numbers of people, sometimes hospitalizing and killing them or giving them long-lasting symptoms.
In the U.S., 1,100 people died from COVID the week ending May 3, so even though recent stats suggest COVID deaths dropped in 2022. Still, the disease ranks fourth among the leading causes of death in the U.S., meaning it is still killing a very high number of Americans.
It's true that infections and death are trending downward and we have better tools than ever to control COVID. But it is also true that viruses naturally mutate, often evolving new strategies to evade our defenses.
Meanwhile, as SARS-CoV-2 mutates, its symptoms often manifest differently. And the latest batch of variants that are spreading in North America appear to have symptoms very similar to allergies, especially conjunctivitis or pink eye. That means many people have COVID, thinking it's just related to the weird, exceptionally bad allergy season. Unfortunately, unlike allergies or the flu, there is nothing "mild" about COVID, not even the most recent variants, whose infections can still cause brain damage and long COVID.
The Centers for Disease Control and Prevention (CDC) keep a weekly tally estimating the total percentage of virus strains currently circulating. All of them right now are the children or grandchildren of the omicron variant that emerged in late 2021. For most of this year, Americans have been battling against Kraken (XBB.1.5), but it is slowly being superseded by its offspring, such as Arcturus (XBB.1.16).
According to CDC data, Kraken made up roughly 67 percent of cases in the week ending May 6, a decline from its peak of 84 percent in April. Meanwhile, Arcturus has jumped to around 12.5 percent of cases, a rise from just 1 percent at the end of March.
While the string of numbers and letters in a variants name may seem confusing — which is why the nicknames exist — they can represent significant differences between virus strains that manifest as entirely different symptoms. They may also allow the virus to better infect different areas of the body. The delta strain, for example, was more likely to infect the lower respiratory tract, while omicron primarily affects the upper respiratory tract, generally causing less damage to the lungs.
It's simple to clear up any confusion about whether it's COVID or allergies: Take a test. Even though the virus is constantly mutating, even the take-home COVID tests will still work typically. That's because they are designed to capture a wide variety of mutations to the N protein, which differs from the spike protein, the part of the virus used to enter our cells.
Arcturus first appeared in India, but as it makes its way through North America, it seems to be presenting feverish symptoms more commonly as well as mimicking allergies, specifically conjunctivitis. Often called pink eye, this is a reddish-pink inflammation or infection of the transparent membrane (conjunctiva) that lines your eyelid and covers the white part of your eyeball. It can be quite itchy and caused by bacteria, allergens or viruses. COVID-related conjunctivitis is seemingly more common in children, but so far, much of this data is anecdotal.
In late April, the American Academy of Ophthalmology issued a report that eye symptoms alone are probably not a sign of COVID infection. But if your kid has been exposed to the virus or have other symptoms, such as a fever, body aches, cough, or the prototypical loss of taste or smell, it's recommended to have them tested.
The vaccines still do a decent job of preventing serious illness and death from these emerging strains of COVID, but their ability to protect against infection is waning. Federal health agencies recently approved a second bivalent booster shot for immunocompromised people or those over age 65.
Good Morning Mike
insert-text-here
Does restoration of glutathione matter?
insert-text-here
Does Bucillamine restore glutathione?
Thank you
enjoy the day;0)))
XXII definitely going to 10 cents or worse!
WoW
Quickly climbing to a Bizillion!
What a great life these scalawags have:0(((
Insanity
To Everyone
How soon before the reverse merger?
ok who farted?
MRMD is paying him? Correct?
What do you expect him to say?
What to know about XBB.1.16, the 'Arcturus' variant
A new Covid variant is spreading in the U.S., but will it cause a surge in cases?
XBB.1.16 — dubbed “Arcturus” on social media — is another descendant of omicron. It was first detected in early January and the majority of cases have been seen in India so far. It’s been steadily rising in the U.S. in recent weeks, although it still made up slightly less than 10% of new confirmed Covid cases as of Saturday, according to the Centers for Disease Control and Prevention.
Last week, the World Health Organization deemed XBB.1.16 a “variant of interest” as it continues to spread and outcompete other variants.
Ali Mokdad, a professor of global health at the University of Washington, said it’s still too early to predict what XBB.1.16 will do. But what he’s seen so far has been reassuring.
“We haven’t seen an increase in hospitalizations, we haven’t seen an increase in any of the indicators that make us worry,” Mokdad said.
Is XBB.1.16 more contagious?
Mokdad said that XBB.1.16 is gaining ground on the previously dominant strain in the U.S., called XBB.1.5.
That increased transmissibility appears to be due to the subvariant’s ability to avoid immune detection in the body.
“It can’t be spreading so fast unless it has some immune escape,” Mokdad said.
The virus has two ways of surviving, Mokdad said. One way is to be more infectious and evade immunity from previous infections or vaccinations, “which this one is doing,” he said. The other one is to become really deadly. “We haven’t seen that yet.”
Dr. Peter Chin-Hong, a professor of infectious disease at the University of California, San Francisco, said that aside from the increase in transmissibility, so far XBB.1.16 is not too different from XBB.1.5.
That means that “hopefully, it’s not going to be too different” in terms of how sick it makes people and how well the vaccines work.
What are the symptoms of XBB.1.16?
XBB.1.16 doesn’t appear to be making people sicker than earlier omicron strains, according to Dr. Mike Ryan, the executive director of the WHO’s health emergencies program.
“To my knowledge, we’re not seeing a different spectrum of symptoms or severity associated with this variant of interest,” Ryan said during a media briefing last week.
Some news reports have mentioned that XBB.1.16 infection causes a “new” symptom — conjunctivitis, or pink eye — though the WHO noted that this symptom was already known to be associated with Covid. As early as the spring of 2020 there were reports of itchy, sore eyes in Covid patients. In May 2020, the American Academy of Ophthalmologists noted that mild conjunctivitis could be a symptom of Covid.
"It's not a new symptom," but it may be more common than previously thought, Chin-Hong said.
Do vaccines work against XBB.1.16?
Mokdad said that labs haven’t yet determined how well the Covid vaccines work against XBB.1.16.
Chin-Hong said he wasn't particularly concerned about the vaccines.
"Because it's so similar to XBB.1.5, we think that vaccines will be fine," he said.
Last week, the Food and Drug Administration and the CDC said that older adults and immunocompromised individuals could get a second dose of the updated booster shot, which protects against an earlier omicron subvariant.
Why are there always new variants?
XBB.1.16 certainly won’t be the last new variant that emerges. The subvariant is yet another offshoot of the growing omicron family tree.
XBB.1.16 is a descendant of the XBB subvariant, which itself formed when two strains of omicron subvariant BA.2 combined, according to the WHO.
Already, two other XBB strains, XBB.1.9.1 and XBB.1.9.2 are also rising in the U.S. Together, the two strains account for about 11% of new cases, according to the CDC.
On Wednesday, the WHO's technical lead for Covid-19, Dr. Maria Van Kerkhove, said the XBB.1.9 strains are likely similar to what’s been seen with previous XBBs.
“This just indicates to us that the virus continues to evolve and it will continue to evolve because the virus is circulating pretty much unchecked,” Van Kerkhove said.
nbcnews.com
LOL
XXII is doing a bud light marketing campaign.
When it comes to Marijuana THC is the ticket not CBD.
XXII has no idea of how to make money $$$$$$$$$$$$$$$$$
Roflmao
Have a good day all:0)))
Health officials warn irritating symptom may be returning with latest COVID strain
BY WILL CONYBEARE AND ADDY BINK - 05/01/23 7:05 AM ET
(KTLA) – A new coronavirus subvariant is starting to spread in the U.S. and, according to health experts, it could be causing an annoying symptom to return.
According to the Centers for Disease Control and Prevention, roughly 10% of all COVID cases reported last week were determined to be from the omicron-related XBB.1.16 subvariant, being referred to by some as Arcturus.
After first being reported in January, the World Health Organization declared XBB.1.16 a variant of interest in mid-April, The Hill reports.
The Los Angeles County Department of Public Health is warning residents that this omicron sub-strain of COVID-19 may come with an irritating symptom: conjunctivitis
Pandemic 3 years later: Has the COVID-19 virus won?
Commonly known as pink eye, health officials also reported that pink eye could be linked to COVID early in the pandemic. Then again last year, experts warned there could be a connection between the then-new omicron variant and itchy, irritated eyes.
Now, some health officials are reporting an increase in conjunctivitis cases nationwide.
That includes Los Angeles County, where the health department has warned that pink eye may be the newest possible symptom of COVID.
“Observational data suggests that people infected with XBB.1.16 may be more likely to experience conjunctivitis as a symptom of their COVID infection, along with more traditional COVID symptoms, such as fever, cough and shortness of breath,” the LA County Health Department said in a statement. “Historically, conjunctivitis was reported in 1 to 3% of COVID-19 cases.”
Conjunctivitis occurs when the lining that covers your eyelid and eyeball, the conjunctiva, becomes inflamed, optometrist Dr. Melanie Dombrowski tells Nexstar’s WGHP. Symptoms include eyes becoming pink or red, increased tear production, discharge from the eyes, and itching, irritation, or burning, according to the CDC.
Hair suddenly falling out in the shower? This might be why
Pink eye is common with respiratory infections like the cold and flu.
However, with the limited data available, the department said it is “too early to know with certainty” if XBB.1.16 is truly associated with higher rates of conjunctivitis.
“Residents should be aware that itchy, watery or red eyes may be a sign of a COVID-19 infection and these symptoms should not be simply dismissed as a result of pollen or seasonal allergies, especially if someone more vulnerable to severe illness could be exposed,” the Health Department said. “The fact that we are seeing new strains, with possibly new and different symptoms, tells us that COVID continues to evolve and the way we think about our protections should reflect what we know.”
You should talk to your doctor if you have pink eye as well as pain in the eyes, sensitivity to light, blurred vision, intense redness, symptoms that aren’t improving or get worse, or a weakened immune system, according to the CDC.
Older adults and individuals with underlying health conditions are encouraged to take extra precautions to avoid infection, which includes staying up to date on vaccinations, frequent hand washing, and staying home when feeling sick.
Though officials say Arcturus may be more effective at escaping immune response than other subvariants, it doesn’t appear any more severe.
April 20, 2023
The NIH has poured $1 billion into long Covid research — with little to show for it
Written by Betsy Ladyzhets, Rachel Cohrs
Edited by Derek Kravitz, Erin Mershon
Why we're reporting on the National Institutes of Health's RECOVER initiative and how to republish this story
Long Covid affects an estimated 16 million Americans and the research work by the National Institutes of Health represents the federal government's most high-profile, and costly, attempt to understand and address the disease. This story explores the taxpayer spending and work thus far by NIH's RECOVER initiative. This article was co-reported with STAT News, a newsroom focused on health, medicine, and scientific discovery that is produced by Boston Globe Media. Funding for this project also came from Columbia University’s Brown Institute for Media Innovation. Our ongoing series on the Covid-19 pandemic can be republished under a Creative Commons license. For more information, click the republish button below.
Republish This Story
WASHINGTON — The federal government has burned through more than $1 billion to study long Covid, an effort to help the millions of Americans who experience brain fog, fatigue, and other symptoms after recovering from a coronavirus infection.
There’s basically nothing to show for it.
The National Institutes of Health hasn’t signed up a single patient to test any potential treatments — despite a clear mandate from Congress to study them. And the few trials it is planning have already drawn a firestorm of criticism, especially one intervention that experts and advocates say may actually make some patients’ long Covid symptoms worse.
Instead, the NIH spent the majority of its money on broader, observational research that won’t directly bring relief to patients. But it still hasn’t published any findings from the patients who joined that study, almost two years after it started.
There’s no sense of urgency to do more or to speed things up, either. The agency isn’t asking Congress for any more funding for long Covid research, and STAT and MuckRock obtained documents showing the NIH refuses to use its own money to change course.
“So far, I don’t think we’ve gotten anything for a billion dollars,” said Ezekiel Emanuel, a physician, vice provost for global initiatives, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. “That is just unacceptable, and it’s a serious dysfunction.”
Eric Topol, the founder and director of the Scripps Research Translational Institute, said he expected the NIH would have launched many large-scale trials by now, and that testing treatments should have been an urgent priority when Congress first gave the agency money in late 2020.
“I don’t know that they’ve contributed anything except more confusion,” Topol said.
Patients and researchers have already raised alarms about the glacial pace of the NIH’s early long Covid efforts. But a new investigation from STAT and MuckRock, based on interviews with nearly two dozen government officials, experts, patients, and advocates, and internal NIH correspondence, letters, and public documents, underscores that the NIH hasn’t picked up the pace — instead, the delays have compounded.
It’s difficult to pinpoint exactly why progress is so stalled, experts and patients involved in the project emphasized, because the NIH has obscured both who is in charge of the long Covid efforts and how it spent the money. The broader Biden administration has also missed opportunities for oversight and accountability of the effort — despite the president’s lofty promises to focus on the disease.
The NIH’s blunders have massive ramifications for the more than 16 million Americans suffering from long Covid, in addition to those with other, similar chronic diseases. As the biggest government-funded study on this topic, the NIH initiative, dubbed RECOVER, sets precedents for future research and clinical guidelines. It will dictate how doctors across the country treat their patients — and, in turn, impact people’s ability to access work accommodations, disability benefits, and more.
“The NIH RECOVER study is pointless,” said Jenn Cole, a long Covid patient based in Brooklyn, N.Y., who wanted to enroll in the study but found the process inaccessible. The research is “a waste of time and resources,” she said, and fails to use patients’ tax dollars for their benefit.
In response to STAT and MuckRock’s questions, the NIH and an institute at Duke University managing the clinical trials defended the initiative, without providing a clear explanation for the delays.
The NIH said it chose to fund a large-scale research program instead of small-scale studies to make sure data and processes could be shared across different groups of patients, adding that clinical trials will be launching soon. In these trials, standardized study designs will allow the agency to test multiple treatments across multiple sites. If there are signals a drug works, the agency said it can pivot to devote more resources there.
A Department of Health and Human Services spokesperson said the agency has made progress over the last year in responding to long Covid, and that there are research efforts underway in addition to the RECOVER program.
“The Administration remains committed to addressing the longer-term impacts of the worst public health crisis in a century,” HHS said.
NIH RECOVER's spending
The NIH has spent the majority of its funding for long Covid research on observational studies of patient symptoms, with a smaller amount going to clinical trials.
Clinical research studies ($767.7M)Administrative coordination and communications ($17.3M)Research management services ($35M)Data management and repositories ($156.5M)Clinical trials ($171.5M)
Data via an NIH spokesperson, in response to questions from STAT and MuckRock.
Chart: Betsy Ladyzhets Source: NIH Get the data
In 2020, Congress made an investment of $1.2 billion to learn more about the mysterious ongoing symptoms that were afflicting some people infected with Covid-19. That sort of money to fund research into a chronic condition like long Covid was virtually unheard of.
The money was explicitly earmarked to fund both research to understand the disease and clinical trials to test treatments that could bring patients relief. But more than two years in, the agency hasn’t started testing a single treatment. Nor is it planning to test many in the future. Instead, it’s focused on observational research — and that, too, has produced few insights.
The NIH is planning five clinical trials, each of which will test treatments that may help with a major category of long Covid symptoms. Some of these treatments will be drugs, while others will be behavioral therapies, such as cognitive retraining. Each trial will include 300 to 900 patients, selected based on their symptoms, according to details shared during a webinar in mid-April.
The only trial to be formally announced so far will focus on Paxlovid, testing whether the drug alleviates symptoms by mitigating any ongoing viral infection in patients’ bodies. The study was supposed to start recruiting in January.
But as of April, RECOVER hasn’t signed up a single patient for any of those clinical trials. And the timeline has slipped over and over again.
Initially, in a letter to members of Congress prompted by STAT’s March 2022 reporting on the initiative’s slow start, the NIH told lawmakers that the agency expected to launch clinical trials by that fall. But by August, the estimated launch had slipped to “by the end of 2022.” Then, another delay became public in December, when one of the NIH officials leading RECOVER told advisers that clinical trials would begin by the first quarter of 2023. Now, Duke University, which is overseeing the clinical trial infrastructure, told STAT and MuckRock it expects the first patients to sign up for trials this summer.
Emanuel said the pace of trials shows little urgency on the part of NIH.
“If you don’t have the pathobiology figured out, you try things. You don’t just slow, slow, slow, walk it,” he said.
All five clinical trial protocols are going through safety reviews, and the Food and Drug Administration is reviewing the trials that will test Paxlovid and other drugs, the Duke Clinical Research Institute said. The institute plans to share these protocols publicly when reviews are complete, but did not provide an estimate for when that will happen.
Timeline for NIH's RECOVER initiative
More than two years after the NIH received initial funding from Congress to study long Covid, it has yet to begin clinical trials.
MISSING: summary MISSING: current-rows.
Date Event
December 2020 Congress allocates $1.15 billion to the NIH
February 2021 NIH announces the RECOVER initiative
June 2021 First grants provided to academic institutions
September 2021 NYU announces observational study, begins recruitment
April 2022 Biden issues presidential memo on long Covid
April 2022 NIH requests proposals for clinical trials
June 2022 NIH tells some members of Congress clinical trials will begin in fall 2022
August 2022 Duke Clinical Research Institute announces clinical trials coordination
October 2022 Duke announces Paxlovid study, estimates trials will begin in early 2023
August 2022 Observational study fills all slots for long Covid patients
December 2022 Patients begin sounding alarm on potential exercise study
February 2023 NIH tells patient advocates it doesn't plan to ask for more RECOVER funds
March 2023 Biden administration budget does not include RECOVER funding
April 2023 Duke estimates trials will begin in summer 2023
Source: STAT / MuckRock Get the data
Faster progress is possible. A similar study at Stanford, which received funding directly from Pfizer, was also announced in October 2022 but has already begun recruiting patients. This trial was “able to be more flexible and get the study started faster” in comparison to RECOVER because it’s smaller, said Upinder Singh, the study’s principal investigator. Singh and her colleagues are only testing Paxlovid and doing so at only one location, rather than comparing different treatments.
Duke was also supposed to create a patient registry to collect information about long Covid patients, but that initiative hasn’t been launched, either.
“A patient registry is still planned, but the scope is being reassessed to most effectively meet the needs of the Initiative,” Duke said.
Rather than prioritizing treatments from the start, the NIH used much of its long Covid funding on a large-scale study to track long Covid symptoms and learn how the disease works. This choice has frustrated patients because thousands of other studies have already answered many major questions about the condition.
“We didn’t need to recreate” existing studies that already answered these questions, said Cole, the long Covid patient. Researchers have been compiling lists of common symptoms since summer 2020, she said. For Cole, fatigue and brain fog are the most debilitating aspects of the condition.
And even the symptom study is moving slowly, in part because the initiative has failed to bring in healthy people who could be compared against long Covid patients. RECOVER quickly filled its slots for people who had Covid more than 30 days prior to their recruitment, but is still looking for people who were infected recently, study lead Leora Horwitz said in a statement. Most study sites closed enrollment for long Covid patients at the end of August 2022.
NIH RECOVER's enrollment
As of April 13, 2023, RECOVER is behind on its enrollment goals for adults, pregnant people, and children. The study is recruiting both long Covid patients and healthy people who will serve as controls.
EnrolledGoal
Adult
12,001
15,039
Pregnant
1,671
2,451
Pediatric
3,669
6,000
Chart: Betsy Ladyzhets Source: NIH RECOVER Get the data
The majority of the scientific findings to emerge from RECOVER so far have been based on small groups of patients or on electronic health records, rather than on the thousands of people who signed up to participate.
The crawling pace of the government’s long Covid efforts stand in stark contrast with the government’s wildly successful partnership with the pharmaceutical industry to get Covid-19 vaccines to market in less than 12 months. There are no ongoing efforts to support independent private-sector companies or researchers trying to study treatments for long Covid through the NIH, even though some have proved promising. Just this month, the White House left long Covid out of a $5 billion effort to research next-generation Covid-19 treatments and vaccines.
Long Covid researchers feel there needs to be greater urgency. Singh compared the pressure that she’s currently under to the pressure many scientists faced earlier in the pandemic when studying vaccines and treatments. “We as a scientific community need to focus on long Covid and find solutions for long Covid,” she said.
Topol echoed this sentiment, citing a recent opinion piece in Scientific American that called for an Operation Warp Speed for long Covid treatments. “That’s what should have happened,” he said.
It’s almost impossible to tell where the NIH’s $1.2 billion pot of long Covid money has gone.
There is no single NIH official responsible for leading RECOVER, and the initiative has failed to share basic information that would typically be available for a government research project of this scale.
Unlike Operation Warp Speed and other Covid efforts, the NIH has outsourced much of the work of running RECOVER to outside organizations. New York University, RTI International, Mayo Clinic, Massachusetts General Hospital, and Duke University are responsible for various parts of the initiative.
Many of the research projects associated with RECOVER have been funded through these organizations rather than directly from the NIH. This process makes it hard to track how decisions are made or how money is spent through public databases, said Michael Sieverts, a member of the long Covid Patient-Led Research Collaborative who has a background in federal budgeting for scientific research.
Public records requests that MuckRock filed to the agency in late 2022, intended to answer questions about RECOVER’s funding, are still incomplete as of mid-April. Sieverts has similarly asked questions to NIH officials and received no responses.
NIH RECOVER locations for adults in observational study
53 research centers across the U.S. are participating in NIH RECOVER's adult cohort study, which aims to understand long Covid by tracking patient symptoms.
One site, located in San Juan, Puerto Rico, is not shown.
Map: Betsy Ladyzhets Source: NIH RECOVER Get the data
The organization of RECOVER itself is convoluted, and difficult to figure out even for patient advocates who are directly involved, they said. It’s advised by a complex series of committees, some of which aren’t even posted on the initiative’s website. There’s no one person ultimately responsible for coordinating among the different institutes — and requests for information about the leadership hierarchy have been ignored.
“They don’t have an org chart for the entire thing that exists, after two-plus years,” said Diana Güthe, the founder of Survivor Corps and a RECOVER adviser who has asked at nearly every meeting she’s attended.
Lauren Stiles, a patient advocate and president and CEO of Dysautonomia International who serves on several RECOVER committees, shared similar concerns.
“There’s a complete lack of transparency. When we ask who made this decision … they won’t tell us,” Stiles said.
As a result, when RECOVER says it’s running out of funds, it’s hard to identify who is responsible for major decisions.
In response to questions about the initiative’s budget, the NIH said it has no money available for additional programming. The agency said $811 million has been legally committed to various activities, and the rest is earmarked to support future research activities.
The budget restrictions are having practical impacts already.
A RECOVER advisory committee responsible for ranking and evaluating potential treatment options was put on hiatus “due to a lack of funds,” the committee’s leader told members in late January, per an email exchange shared with STAT and MuckRock that has not been previously reported.
The NIH told STAT and MuckRock that the committee was paused because the clinical trial medicines, devices, and treatment programs have been chosen. However, the agency said that the RECOVER clinical trials are “adaptive platform trials,” which means they are designed with the intention of removing and adding treatments as new information becomes available.
This current budget squeeze didn’t come without warning: The NIH was well-aware last summer that the agency wouldn’t have enough money to run clinical trials that matched the initiative’s goals of reaching patients with diverse symptoms.
One of RECOVER’s co-chairs wrote to Congress in June that “additional resources are necessary” to test the full range of treatments needed.
But the Biden administration isn’t taking any action to get more funding within the agency, or from lawmakers.
NIH acting Director Lawrence Tabak told patient advocates that the agency isn’t planning on directing any further funding for RECOVER within the agency. The agency said that such a request would potentially undercut a failed request for supplemental funding that Congress ignored last year.
The Biden administration didn’t request any new funds for RECOVER in its 2024 budget, a largely aspirational document that reflects the administration’s financial priorities.
The budget did include $130 million in long Covid-related asks for other agencies, including for the Health Resources and Services Administration to support care for long Covid patients with complex needs and to educate primary care providers, and for the Agency for Healthcare Research and Quality to research the delivery of long Covid care and to establish long Covid care hubs.
There’s also little accountability for NIH leaders to disclose how funds are spent or respond to other concerns with RECOVER because an entity intended to oversee long Covid research across the federal government hasn’t been created.
In April 2022, President Biden issued a presidential memorandum calling on federal agencies to “harness the full potential” of the government, in partnership with private sector partners, to respond to long Covid.
The follow-through has been lacking on the initiative’s highest-profile goal.
In August, in a congressionally mandated national long Covid research plan, the Biden administration said it would create an Office of Long Covid Research and Practice at HHS. This month, HHS put out a fact sheet touting the administration’s progress in reaching its goals — and omitted any mention of the office.
An HHS spokesperson said that the department is working to develop the office, and requested funding in next year’s White House’s budget for the Office of the Assistant Secretary for Health to coordinate response efforts to long Covid.
“It seems to have been like, well, if we don’t do anything, maybe no one will notice,” said Güthe. “It’s so important to do an evaluation of what was promised. What’s been accomplished, and what hasn’t?”
A huge chunk of funding to study a chronic illness like long Covid is rare, so any clinical trials that the NIH chooses to run are crucial choices — and some doctors and advocacy groups have voiced serious concerns about the selection of one clinical trial in particular.
That trial would test exercise as a potential long Covid treatment, despite years of research suggesting that exercise could harm patients and set back further study.
Diagnosing Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Many people with long Covid have similar symptoms to people with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), a debilitating condition that often follows viral infection. The defining feature of ME/CFS is intense fatigue and worsening of other health issues after physical or mental activity. This symptom, known as post-exertional malaise, often occurs with a lag, which can make it tough for doctors to diagnose — and even for patients to recognize themselves.
“What often happens is, people will go for a walk, they may not feel it for a day or two, and then suddenly, they feel ill on the third day,” said Adam Lowe, an ME/CFS patient and one of the founders of MEAction UK, the U.K. branch of the Myalgic Encephalomyelitis Action Network. Patients might suddenly become bed-bound and have trouble focusing, he said.
This worsening of symptoms happens because a patient isn’t producing and using energy in the same way as a healthy person, said Todd Davenport, a professor at University of the Pacific who has studied exercise and this condition. It’s an internal change similar to the whole-body exhaustion that a marathon runner might experience at the finish line of their race.
A number of past studies and surveys of patients have demonstrated how dangerous exercise can be for people with ME/CFS. Many patients told to exercise by their doctors later dropped out of studies or treatment regimens, citing worsening symptoms. One infamous trial that pointed to exercise as a potential treatment was later discredited as deeply flawed.
Studying exercise as a treatment could “frame long Covid as something that can be overcome with grit and hard work,” said Jaime Seltzer, the director of scientific and medical outreach at MEAction, arguing that such framing is “unsound and ethically troubling.”
Not all patients with long Covid experience post-exertional malaise, and those who don’t could find exercise helpful, Davenport said. In those cases, slow and careful exercise through a rehabilitation or physical therapy program might help repair energy systems that have fallen out of shape.
But it may be difficult to distinguish between these different groups of patients, unless a clinical trial is set up with the utmost caution. “Ideally, what you would want is a very coherent, very specific set of inclusion and exclusion criteria,” Davenport said. Otherwise, the study would risk producing results that oversimplify long Covid, he added, leading doctors to widely prescribe a treatment that doesn’t work for some or many.
Scientists and patient advocates responsible for advising RECOVER have warned that an exercise trial could harm patients, but received mixed responses. Patients involved in the study sent emails and social media posts demanding that RECOVER stop the planned trial, while MEAction sent a public letter to NIH leaders.
Scientists and clinicians on an NIH advisory committee focused on rehabilitation similarly suggested that post-exertional malaise could be a dangerous result of the trial, according to internal emails shared with STAT and MuckRock. In response, NIH program officer Antonello Punturieri pushed back on the concerns. Punturieri cited clinical guidelines from the World Health Organization and a U.K. agency, even though both recommend against exercise for people with ME/CFS.
In response to these concerns, RECOVER set up internal meetings including researchers in charge of the exercise study, patient representatives, and the initiative’s top advisory committee. “Work is now underway to further revise that protocol” based on these meetings, the Duke Clinical Research Institute said.
The study’s planned revisions will address concerns about patient safety, such as monitoring for post-exertional malaise after exercise. But it’s unclear how the researchers will do this screening, or whether ME/CFS doctors will be involved.
Even with revision, experts and patient advocates remain concerned that the exercise study takes resources away from other research and could lead to harmful recommendations from doctors. If RECOVER finds exercise is helpful for some patients, asked JD Davids, an advocate with Long COVID Justice and author of a petition asking the NIH to stop this trial, “What are the chances that doctors would correctly understand how limited this recommendation is? I think it’s very low.”
It’s not like there aren’t plenty of potential treatment options worth studying.
Topol and other researchers compiled a full table of other treatment candidates for a review paper published in Nature in January. Experts on one of RECOVER’s advisory committees compiled a similar list, for a paper published in March.
Given “the number of other candidate treatments out there, I can’t imagine why you would choose graded exercise therapy,” said Julia Moore Vogel, a researcher at the Scripps Translational Institute living with long Covid, and co-author of the Nature review paper. Vogel is leading a study of wearable devices for long Covid, which will start with about 500 participants despite planning for up to 100,000.
One study has even reported results already, via a preprint shared by The Lancet in early March. The trial found that metformin, a common treatment for diabetes that also has antiviral properties, lowered Covid patients’ risk of developing long-term symptoms by about 42%.
This research group actually didn’t set out to study long Covid, said David Boulware, one of the scientists and an infectious disease physician at the University of Minnesota Medical School. The initial goal was to evaluate potential treatments for acute Covid-19, but the team added long Covid tracking partway through the trial.
And it’s unlikely to get further study without some kind of government assistance. The initial study relied on philanthropic funding, and additional grants would be needed to keep studying this generic drug.
“It’s a great drug, it’s cheap, it’s available worldwide,” Boulware said, “but there’s no profit margin for anyone to study it.”
There may be similar concerns for research into low-dose naltrexone, an off-label use of the addiction drug that has become common for long Covid and other chronic diseases. In low doses, naltrexone can help reduce inflammation in the immune and neurological systems, potentially alleviating long Covid symptoms.
But because the drug has been widely available for decades, pharmaceutical companies aren’t motivated to fund large trials. A few small clinical trials are underway, according to reporting by Rolling Stone.
The lack of help from NIH has left biotech executives frustrated.
“You have to understand what you’re trying to tackle, so we support that, of course. But as patients will tell you, we want intervention, not observation,” said Axcella CEO Bill Hinshaw. His Massachusetts-based company has gone all in on testing a drug candidate to treat long Covid symptoms, without any help from NIH.
Tonix Pharmaceuticals, which is developing a fibromyalgia medication that the company is hoping could be an effective treatment for long Covid symptoms, didn’t receive any funding from NIH either, despite putting in an application.
“I hope there are more therapeutics trials. And I think that the therapeutics trials can go hand in hand with the natural history kind of studies like RECOVER,” Tonix CEO Seth Lederman said.
Patients and experts fear that if RECOVER is the extent of federal effort to study long Covid, the condition could fall into the longstanding pattern of apathy and lack of urgency that has made breakthroughs in chronic illness treatment challenging.
“It’s clear that there are a lot of people at the NIH who are dedicated and determined, trying to figure this out,” said Charlie McCone, a patient representative at RECOVER. As a result, “patients are confused” why only a handful of clinical trials have been planned and none of those have launched yet, he said.
As the NIH initiative drags its feet, patients are left largely on their own to research potential treatments, said Cole, the Brooklyn-based patient, who has been struggling with symptoms since April 2020. “Because we’re not funding these promising treatments, and we’re not disseminating them through the medical system, it’s left to me to figure out how to make that happen for myself,” she said.
Cole, like many others in the long Covid community, feels abandoned by the federal government and health care system at large. If her symptoms worsen to the point that she can no longer work, she said, “the system’s not going to be there to pick me up.”
Infectious Disease
>
Long COVID
Patients Living With Long COVID Offer Insight to FDA
— Agency sought feedback on outcomes that matter most to patients
by Shannon Firth, Washington Correspondent, MedPage Today April 28, 2023
Patients with long COVID and their caregivers shared how the illness has impacted their lives, the treatments they've tried, and their hopes for clinical trials during a virtual public meetingopens in a new tab or window on Patient-Focused Drug Development for Long COVID hosted by the FDA on Tuesday.
Impacts on Daily Living
Jill Anderson, a patient participant, works for a behavioral health community services board in Virginia. Before developing long COVID, she had never had vertigo. Today, she's dizzy all the time.
"I would get up in the middle of the night and take a step out of bed and fall to the floor. It was terrifying how my world was spinning and out of balance," she said.
She has also experienced significant "brain fog," fatigue, and loss of appetite. Anderson currently works remotely on a reduced schedule and is worried she might lose her job.
Another patient participant, Heather Elizabeth Brown, a chaplain and corporate trainer in Detroit, said COVID impacted every major system in her body. "That includes my nervous system ... my reproductive system, digestive, lymphatic, endocrine -- any system you can name has pretty much been affected," she said.
She has had blood clots, lymphedema, fatigue, a stroke, COVID-induced diabetes, high blood pressure, and significant brain fog. During her initial infection, she developed pneumonia in both lungs and had to be on a ventilator for 31 days.
As a corporate trainer, her entire job is built around teaching and communicating, she said. "So having moments of not remembering what I was talking about could be very challenging."
Hopes for Treatment
During the panel discussion focused on treatments, Tammy Wilshire, a patient from the Appalachian Mountains of Pennsylvania, said she had "limited success" with a range of supplements -- vitamins C, D3, B12, and magnesium -- as well as beta blockers for tachycardia, and gabapentin for tremors and worsening fibromyalgia.
Physical therapy showed promise at first, she said, but as its intensity increased, she experienced "crippling fatigue" and a relapse of myalgic encephalomyelitis-chronic fatigue syndromeopens in a new tab or window, a debilitating multi-systemic illness, which forced her to stop.
Angela M. Vasquez, president of Body Politic, a grassroots health justice organization, takes 15 medications, receives weekly infusions of diphenhydramine (Benadryl) and saline, and takes supplements to support "mitochondrial health."
After being reinfected with COVID, she took 15 days of nirmatrelvir-ritonavir (Paxlovid) and found that despite an "extended flare," the medication minimized, to a degree, her cognitive dysfunction and gastrointestinal problems.
Her symptoms also improved following her first vaccine, Vasquez said, and she's come up with a "strict pacing routine" that enables her to work full-time from home, though she has little energy for much else.
A third patient, Daniel Lewis, takes a beta blocker and midodrine for post-orthostatic tachycardia syndrome, and bupropion (Wellbutrin) for fatigue, but each has helped only "a tiny bit."
Asked about their ideal treatments, Wilshire said it would need to reduce her pain and fatigue. Vasquez urged scientists to focus on post-exertional malaise. And Lewis said his "most disabling symptoms" relate to exertion.
Lewis urged FDA officials to expand access to approved drugs that he argues appear promising based on early research, including antivirals, Janus kinase inhibitors, anticoagulants, antiplatelets, metformin, and others.
Other patients described success with Pilates (given the opportunity for strengthening muscles without being physically upright), methylphenidate (Ritalin) for brain fog, supplements, acupuncture, meditation, and other supports from functional medicine doctors.
Shaping Clinical Trials
"Anything that is in person is extensively more difficult, than anything that can be ... done on online," said Liza Fisher, a flight attendant and part-time yoga instructor. In-person clinical trials also add to the cost for participants, many of whom have lost employment and healthcare coverage.
Costs of participating in general are always a factor, Fisher said. In 2021, she contemplated participating in a stem cell trial, but was told by the Houston-based company running the trial that she would have to biobank her stem cells first, which would set her back somewhere between $3,000 and $10,000. Fisher, who was unemployed and receiving disability at the time, quickly dropped the idea.
Fisher also found she was ineligible for another trial because she is currently taking off-label steroids. She also noted that other exclusionary criteria included "activity ranges for vitals," which she said aren't sensitive enough for the long COVID patient population.
As for trials of medications with potential side effects, Fisher said, "To be perfectly honest ... every time I was read a list of side effects, I thought, 'oh, that's my Saturday.'"
When she hears of an intervention or medication in a trial that she thinks could potentially trigger an increase in her symptoms, Fisher considers micro-dosing and slow titration schedules to more carefully assess her reaction, rather than opt out.
As to whether she'd be willing to enroll in a trial in which she might be given a placebo, she said she would, as long as she knew that if the experimental drug or intervention was successful, then she would also have access after the trial was completed.
Another patient participant, Ryan, who chose not to share his last name, said he views a control arm as the most important part of a clinical trial. "Sometimes I'll see a study that's been trialing a medication for 6 months and they've seen moderate improvement, but that's my experience without medication," he said.
Ryan also stressed the need to track biomarkers, such as those measuring micro-clotting, endothelial cell dysfunction, and T-cell disturbances or cytokines, which are tied to immune dysfunction more broadly.
As a logistical matter, Ryan also avoids clinical studies that would require him to drive, because of his brain fog
He is currently enrolled in the RECOVER programopens in a new tab or window at Mount Sinai Hospital in New York City, which is accessible by public transportation.
Asked by FDA officials about outcomes that matter most to patients, Michelle, whose daughter has long COVID and who did not share her last name, said that "being able to tolerate returning to school would be the most meaningful improvement for us."
Other patients, some of whom phoned into the webinar, called for more specific studies of long COVID and women's reproductive health. Others expressed concern over the loosening of mask requirements in healthcare settings, and the number of long COVID patients taking supplements, suggesting that more oversight was needed.
In closing the discussion, Michael Iademarco, MD, MPH, deputy assistant secretary for science and medicine in the Office of the Assistant Secretary of Health, noted that there was a great deal of diversity in the perspectives shared.
"It's a lot to pull together ... but at the end of the day, we have to pull it together, and make some steps forward in the right direction," he said. "And we may not always get it perfectly right, but that's what we're aspiring to do in HHS."
author['full_name']
Shannon Firth has been reporting on health policy as MedPage Today's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team. Follow
1 Comment
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Image of a cannabis plant infected with hop latent viroid next to a healthy plant
The cannabis plant on the left is infected with hop latent viroid; the plant on the right is healthy. (Photo courtesy of Zamir Punja)
The dangerous and infectious hop latent viroid that’s been on the radar of many marijuana growers since its discovery in 2018 has spread beyond North America and is threatening to spiral out of control and cause billions of dollars in industry losses, experts are warning.
Researchers are calling the viroid – which is surfacing across the world – “a hidden threat” and the “biggest concern for cannabis and hop growers worldwide.”
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“It’s an all-out crisis,” said Av Singh, a Canadian cannabis cultivation adviser also working as the chief science officer of Green Gorilla, a Malibu, California-based manufacturer and online retailer of hemp-derived CBD oils, topicals and pet products.
“I think we’re not recognizing how big of a crisis it is.”
Zamir Punja, a professor of plant biology for Simon Fraser University in British Columbia, Canada, said hop latent viroid (HpLVd) is the No. 1 plant pathogen that the cannabis industry needs to be concerned about.
“You can’t adjust anything, such as environmental controls, to fight it,” Punja said. “It’s either there or it’s not.
“And once it’s there, and it’s not recognized, then you just automatically spread it.”
Growers can take preventive steps to curb the spread of the viroid, which can be transmitted from plant to plant through a variety of ways, according to experts.
But it’s hard to stop and might never be eliminated, experts said.
Oussama Badad, co-founder and chief scientific officer of Growmics, a plant research company in Carbondale, Illinois, said the viroid “remains a mystery.”
“The problem is the cannabis industry for the past 20 years at least was based on clones only,” Badad said.
“So everybody is shipping clones from here to there, and nobody was testing, or nobody was aware of any methodology to test for this virus.
“What we did was basically spread it all over the planet. Anybody receiving any plants from the United States, especially from California, has the viroid in their grow.”
Small and stealthy
Experts warned the viroid is stealthy. It’s also very small, asymptomatic and waiting for an opportunity to infect a plant.
The most likely form of transmission is from the everyday trim tools used for vegetative propagation and grafting or human hands.
When the viroid attacks, the plant pathogen moves quickly from the roots to the leaves to the flower in two to three weeks, Punja said.
It is most problematic in hydroponics – rather than outdoor grows – because the viroid can move through water and more easily infect roots that tend to be matted together.
Hop latent viroid doesn’t outright kill the plant.
But a grower can see an infected plant struggling to grow normally because the plant is shorter and the trichomes are underdeveloped or stunted.
The result: lower THC and CBD levels, which can drop as much as 40%.
“It’s almost like the plant just doesn’t have that energy to put into those trichomes,” Punja said.
It’s most noticeable when the plant flowers, Punja said.
He and other researchers suggest it’s that part of the growing cycle where the viroid might become more virulent, perhaps because of the stress the hydroponic plant is undergoing during the 12-hours-on, 12-hours-off lighting change that occurs during the flowering stage.
As a precaution, growers should have their plants tested, down to the roots, Punja said.
But even then, there are no assurances.
“Unfortunately, one test is not enough,” Punja said. “What we’re finding is that the first test will be negative.
“Three weeks later, again negative. Then three weeks later, positive.”
It’s unavoidable
The viroid is likely to be in the soil of grows, researchers said. It’s also in the water of a hydroponic grow. And it’s definitely in the roots.
In addition, the pathogen is in the seed, not on the seed. It also can spread to one’s hands as a grower handles plants, moves them, stacks them, hangs them.
Even one infected plant brushing up against another can transfer the viroid.
Any sort of sap-sucking insect that makes a hole in the plant, especially at the roots, can create a pathway to infection.
The insect itself does not carry the viroid from plant to plant, as far as researchers know now, Punja said.
The viroid also could be airborne. “Other viroids are,” Singh said. “So it may not be that big a stretch to say that it would be in the pollen.”
The viroid is likely to be present in most commercial licensed cannabis production facilities in the United States and Canada.
The frequency of infected plants is estimated to be in the range of 25%-50% in both countries, according to Punja.
Testing by clone cultivator Dark Heart Nursery on 100 cannabis growers in California from August 2018 to July 2021 found that one-third of plants in 90% of those grows were infected.
That finding supports projections that the viroid affects more than 30% of all cannabis plants in the United States.
“This translates into more than $4 billion in annual losses for U.S. growers who were expected to produce more than 7 million pounds of legal cannabis in 2021,” Jeremy Warren, director of plant science for Oakland-based Dark Heart, told MJBizDaily via email.
The viroid is believed to have been first identified at Glass House Farms, which has 5.5 million square feet of total cannabis greenhouse space in Ventura County, California.
Glass House cultivators noticed their plants looking stunted, with a lack of terpenes and cannabinoids, according to company President Graham Farrar, who said he began working with Phylos Bioscience, an Oregon-based cannabis biotech firm, and Dark Heart in 2017 to determine what was really going on.
“It’s actually hard to identify that it’s infected, because the plant looks fairly healthy,” Farrar said.
“If you have six plants and one of them is funky, you think it’s the plant.
“But when you have 10,000 plants, like in our facility, and they’re being fed the exact same nutrient recipe and it’s automated in the same greenhouse and it’s the same strain, then all of a sudden, 10% or 20% of your plants are not producing the way they should, you don’t just say, ‘That’s a bad plant.’
“You start kind of digging into it.”
An RNA sample from an infected plant from Farrar’s grow was examined in a lab, and sequenced, where the lab identified the genome matching the viroid.
“I’d be surprised if (the viroid) is something that ever is gone,” Farrar said. “I think it’s probably something that we’re going to have to live with.”
How to fight it
Help is on the way from multiple sources.
Dark Heart has developed a genetic test to differentiate infected plants from uninfected ones.
The company also helped develop a patent-pending cleaning process to eliminate the viroid from infected specimens.
The Dark Heart lab team has demonstrably eliminated the viroid in 31 strains so far, according to a news release.
In May 2021, Colorado-based Front Range Biosciences introduced a method of cleaning infected plants using tissue culture.
And last month,, Biomerieux, a French diagnostics solutions company, developed a kit to test for the presence of the viroid.
“The solution is good biosecurity SOPs (standard operating procedures) and testing,” Farrar said.
“The viroid is tough, and it is persistent. The latent part is both a blessing and a curse,” he continued. “Right now, it’s nice that it doesn’t wipe out an entire greenhouse.
“But the latent part also makes it particularly hard for testing. If there’s a hope to get rid of it, that would be CRISPR genetic engineering or using selective breeding to breed plants that are resistant to it. So that’s a potential down the road.”
For now, so-called “living soil” can work as a sort of health insurance, Singh said.
“You are trying to optimize the health of the plant. You may not necessarily get as high a yield. You may not get high potency.
“But you have a more robust plant that can definitely keep some of these viruses and viroids more latent or asymptomatic.”
Glass House would like to assist growers in dealing with this viroid crisis.
“I definitely think we’d like to help people get to the point where they can test at a frequency and at a cost that’s affordable,” Farrar said.
“I don’t know if we’ll ever be able to eradicate the viroid, but at least we can keep it at a very low level so that it doesn’t have a negative impact.”
Experts sound alarm over global spread of dangerous marijuana viroid
By David Hodes
April 24, 2023
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Don’t believe the hype. Get realistic market forecasts, state by state insights and benchmarks for all cannabis sectors. Get the 2023 Factbook.
Image of a cannabis plant infected with hop latent viroid next to a healthy plant
The cannabis plant on the left is infected with hop latent viroid; the plant on the right is healthy. (Photo courtesy of Zamir Punja)
The dangerous and infectious hop latent viroid that’s been on the radar of many marijuana growers since its discovery in 2018 has spread beyond North America and is threatening to spiral out of control and cause billions of dollars in industry losses, experts are warning.
Researchers are calling the viroid – which is surfacing across the world – “a hidden threat” and the “biggest concern for cannabis and hop growers worldwide.”
“It’s an all-out crisis,” said Av Singh, a Canadian cannabis cultivation adviser also working as the chief science officer of Green Gorilla, a Malibu, California-based manufacturer and online retailer of hemp-derived CBD oils, topicals and pet products.
“I think we’re not recognizing how big of a crisis it is.”
Zamir Punja, a professor of plant biology for Simon Fraser University in British Columbia, Canada, said hop latent viroid (HpLVd) is the No. 1 plant pathogen that the cannabis industry needs to be concerned about.
“You can’t adjust anything, such as environmental controls, to fight it,” Punja said. “It’s either there or it’s not.
“And once it’s there, and it’s not recognized, then you just automatically spread it.”
Growers can take preventive steps to curb the spread of the viroid, which can be transmitted from plant to plant through a variety of ways, according to experts.
But it’s hard to stop and might never be eliminated, experts said.
Oussama Badad, co-founder and chief scientific officer of Growmics, a plant research company in Carbondale, Illinois, said the viroid “remains a mystery.”
“The problem is the cannabis industry for the past 20 years at least was based on clones only,” Badad said.
“So everybody is shipping clones from here to there, and nobody was testing, or nobody was aware of any methodology to test for this virus.
“What we did was basically spread it all over the planet. Anybody receiving any plants from the United States, especially from California, has the viroid in their grow.”
Small and stealthy
Experts warned the viroid is stealthy. It’s also very small, asymptomatic and waiting for an opportunity to infect a plant.
The most likely form of transmission is from the everyday trim tools used for vegetative propagation and grafting or human hands.
When the viroid attacks, the plant pathogen moves quickly from the roots to the leaves to the flower in two to three weeks, Punja said.
It is most problematic in hydroponics – rather than outdoor grows – because the viroid can move through water and more easily infect roots that tend to be matted together.
Hop latent viroid doesn’t outright kill the plant.
But a grower can see an infected plant struggling to grow normally because the plant is shorter and the trichomes are underdeveloped or stunted.
The result: lower THC and CBD levels, which can drop as much as 40%.
“It’s almost like the plant just doesn’t have that energy to put into those trichomes,” Punja said.
It’s most noticeable when the plant flowers, Punja said.
He and other researchers suggest it’s that part of the growing cycle where the viroid might become more virulent, perhaps because of the stress the hydroponic plant is undergoing during the 12-hours-on, 12-hours-off lighting change that occurs during the flowering stage.
As a precaution, growers should have their plants tested, down to the roots, Punja said.
But even then, there are no assurances.
“Unfortunately, one test is not enough,” Punja said. “What we’re finding is that the first test will be negative.
“Three weeks later, again negative. Then three weeks later, positive.”
It’s unavoidable
The viroid is likely to be in the soil of grows, researchers said. It’s also in the water of a hydroponic grow. And it’s definitely in the roots.
In addition, the pathogen is in the seed, not on the seed. It also can spread to one’s hands as a grower handles plants, moves them, stacks them, hangs them.
Even one infected plant brushing up against another can transfer the viroid.
Any sort of sap-sucking insect that makes a hole in the plant, especially at the roots, can create a pathway to infection.
The insect itself does not carry the viroid from plant to plant, as far as researchers know now, Punja said.
The viroid also could be airborne. “Other viroids are,” Singh said. “So it may not be that big a stretch to say that it would be in the pollen.”
The viroid is likely to be present in most commercial licensed cannabis production facilities in the United States and Canada.
The frequency of infected plants is estimated to be in the range of 25%-50% in both countries, according to Punja.
Testing by clone cultivator Dark Heart Nursery on 100 cannabis growers in California from August 2018 to July 2021 found that one-third of plants in 90% of those grows were infected.
That finding supports projections that the viroid affects more than 30% of all cannabis plants in the United States.
“This translates into more than $4 billion in annual losses for U.S. growers who were expected to produce more than 7 million pounds of legal cannabis in 2021,” Jeremy Warren, director of plant science for Oakland-based Dark Heart, told MJBizDaily via email.
The viroid is believed to have been first identified at Glass House Farms, which has 5.5 million square feet of total cannabis greenhouse space in Ventura County, California.
Glass House cultivators noticed their plants looking stunted, with a lack of terpenes and cannabinoids, according to company President Graham Farrar, who said he began working with Phylos Bioscience, an Oregon-based cannabis biotech firm, and Dark Heart in 2017 to determine what was really going on.
“It’s actually hard to identify that it’s infected, because the plant looks fairly healthy,” Farrar said.
“If you have six plants and one of them is funky, you think it’s the plant.
“But when you have 10,000 plants, like in our facility, and they’re being fed the exact same nutrient recipe and it’s automated in the same greenhouse and it’s the same strain, then all of a sudden, 10% or 20% of your plants are not producing the way they should, you don’t just say, ‘That’s a bad plant.’
“You start kind of digging into it.”
An RNA sample from an infected plant from Farrar’s grow was examined in a lab, and sequenced, where the lab identified the genome matching the viroid.
“I’d be surprised if (the viroid) is something that ever is gone,” Farrar said. “I think it’s probably something that we’re going to have to live with.”
How to fight it
Help is on the way from multiple sources.
Dark Heart has developed a genetic test to differentiate infected plants from uninfected ones.
The company also helped develop a patent-pending cleaning process to eliminate the viroid from infected specimens.
The Dark Heart lab team has demonstrably eliminated the viroid in 31 strains so far, according to a news release.
In May 2021, Colorado-based Front Range Biosciences introduced a method of cleaning infected plants using tissue culture.
And last month,, Biomerieux, a French diagnostics solutions company, developed a kit to test for the presence of the viroid.
“The solution is good biosecurity SOPs (standard operating procedures) and testing,” Farrar said.
“The viroid is tough, and it is persistent. The latent part is both a blessing and a curse,” he continued. “Right now, it’s nice that it doesn’t wipe out an entire greenhouse.
“But the latent part also makes it particularly hard for testing. If there’s a hope to get rid of it, that would be CRISPR genetic engineering or using selective breeding to breed plants that are resistant to it. So that’s a potential down the road.”
For now, so-called “living soil” can work as a sort of health insurance, Singh said.
“You are trying to optimize the health of the plant. You may not necessarily get as high a yield. You may not get high potency.
“But you have a more robust plant that can definitely keep some of these viruses and viroids more latent or asymptomatic.”
Glass House would like to assist growers in dealing with this viroid crisis.
“I definitely think we’d like to help people get to the point where they can test at a frequency and at a cost that’s affordable,” Farrar said.
“I don’t know if we’ll ever be able to eradicate the viroid, but at least we can keep it at a very low level so that it doesn’t have a negative impact.”