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Cuba may be the best place to land if you are on a cruise ship with Corona Virus.
https://cuba-solidarity.org.uk/news/article/3956/cuba-gives-permission-for-cruise-ship-carrying-corona-patients-to-dock-citing-solidarity-and-health-as-a-human-right
"President of the BioCubaFarma group Eduardo Martinez explained that the socialist island has developed 22 drugs that are set to be used to contain the outbreak.
So far it is known that one of the drugs manufactured by Cuba, Interferon B, has managed to effectively cure more than 1,500 patients from the coronavirus and is one of 30 drugs chosen by the Chinese National Health Commission to combat respiratory disease.
It was first developed in 1986 by a team of researchers from the Centre for Genetic Engineering and Biotechnology (CIGB) and introduced into the Cuban health system.
Mr Martinez described Interferon B as “the flagship product of the set of Cuban medicines” with the drug developed in both Cuba and China in a joint venture as part of an agreement between the socialist countries.
He said the drug could also be exported to other countries to help contain the spread of the virus and treat those that are showing symptoms."
U.S. Pharmacy Benefit Managers..A modern day drug cartel.
Google "percentage of profit from healthcare insurance" and and the first thing you see is this:
Do Health Insurance Companies Make Profits? - Verywell Health
https://www.verywellhealth.com › Health Care › Health Insurance
May 22, 2019 - Under the MLR rules, insurers that sell individual and small group health insurance coverage must spend at least 80 percent of premiums on medical claims and quality improvements for members. No more than 20 percent of premium revenue can be spent on total administrative costs, including profits and salaries.
John Arnold: Are pharmacy benefit managers the good guys or bad guys of drug pricing?
By JOHN ARNOLD AUGUST 27, 2018
In the ongoing debate over drug prices, the pharmaceutical industry has been highly effective in shifting the blame to the middlemen — in particular to pharmacy benefit managers. As they currently operate, pharmacy benefit managers are part of the problem. But if incentives were realigned, pharmacy benefit managers could — and should — play more of a vital role in controlling runaway prices for prescription drugs.
PBMs started with the idea that their buying power would reduce health care costs and pass the savings on to consumers. They act like giant buying networks for drugs, representing consumers from multiple employers and insurers. In economic terms, they aggregate demand, which gives them leverage in the market.
PBMs use their buying power, combined with utilization management strategies, to lower the total cost of pharmaceuticals. They have been largely successful: Almost all payers have, at least until recently, chosen to contract with pharmacy benefit managers rather than manage drug procurement internally. PBMs are used by commercial insurers, in Medicare for its Part D benefit, and in the Medicaid program — particularly by Medicaid managed care organizations.
Moreover, in a market with competitive alternatives — such as generics and multiple name brands — pharmacy benefit managers should be able to move patients from more expensive brand drugs to less expensive versions and extract lower prices by playing brands off one another. Net prices are often lower than list prices, but because of the rules of engagement around pharmacy benefit managers and manufacturers, the true cost to the PBM is often opaque. And that’s where things start to go wrong with the PBM model.
Related: Imagine there are no PBMs. It’s easy if you try
These companies are supposed to use their formulary power, management tools, and price concessions to benefit the insurers they serve which, in turn, are supposed to pass the savings on to their customers through more generous benefits and lower premiums. In general terms, pharmacy benefit managers have three revenue sources: fees from the supply chain, rebates from manufacturers, and pharmacy “spreads” — the difference between what they pay for drugs from a pharmacy and what they get paid by the insurer.
This model has generated significant criticism lately for good reason. Commercial insurers complain that pharmacy benefit managers are not passing through the rebate revenue they should. In Medicare, the Medicare Payment Advisory Commission has consistently raised concerns that pharmacy benefit managers are not choosing the lowest-cost drugs. And recent work by 46brooklyn suggests that pharmacy benefit managers are charging Medicaid managed care organizations, or MCOs, much more for generic drugs than they are paying pharmacies.
So where did pharmacy benefit managers go wrong? In three areas: consolidation, rebate revenue, and transparency.
Like everything in else in health care, pharmacy benefit managers have consolidated. There are now three large PBMs — CVS, Express Scripts, and UnitedHealth’s Optum — that account for more than 70 percent of claims volume. Concentrated market share should allow pharmacy benefit managers to extract deeper concessions from manufacturers and the rest of the supply chain. But market power has made a flawed business model sticky, with payers finding few alternatives to the shared rebates.
Related: The Trump administration can’t decide whether drug industry middlemen are the enemy — or part of the solution
A second problem involves rebates. Many industries offer incentives of shared savings to align the interests of an intermediary and a buyer. And because payers do not know in advance which drugs and in what volumes they will need when signing a multiyear contract, a fixed-price contract is not realistic. However, rebates are now distorting incentives.
Instead of placing the lowest-priced drug on the formulary and passing the savings to insurers, pharmacy benefit managers may simply supply the drug with the highest rebate. Pharma argues that rebates increase list prices. They also fail to lower premiums if they are not passed on to insurers. But rebates aren’t the only cause of rising drug prices. For example, prices are high and increasing for drugs that don’t offer rebates and in markets without rebates, such as Medicare Part B.
Which brings us to transparency. The drug pricing world is shrouded in secrecy. Some economists argue that price discrimination — when no one knows what anyone else is paying — results in bigger discounts. This is similar to airline ticket pricing. Most travelers buy tickets without knowing what anyone else is paying for other seats on the same flight. Pharmacy benefit managers may be able to get deeper discounts from drug manufacturers if the drug companies can keep the size of the discounts secret and not have to offer them to every other PBM.
Yet economists argue that transparency is one of the characteristics of a well-functioning market. Most government contracting requires full transparency. Greater transparency in drug pricing could encourage competition and force manufacturers to cut prices to gain market share, especially for drugs that compete within a class.
The problem of secretive pricing is further complicated because the whole system of out-of-pocket expense is based on list prices. After all, it is difficult to build a copay model based on net prices if those prices are not transparent. Basing consumer expense on an artificial price to maintain the negotiating leverage of pharmacy benefit managers forces patients to overpay.
Related: Mega-mergers would mean the death of standalone PBMs. Should consumers mourn or rejoice?
The flaws in the system have reached a breaking point. Anthem accused Express Scripts of failing to pass on rebates and sued for $15 billion. Ohio recently terminated its pharmacy benefit managers contracts for issues around spread pricing. Meanwhile, others are attempting to internalize the PBM-insurer conflict by reintegrating. Cigna is trying to buy Express Scripts and CVS Health is buying Aetna.
Pharmacy benefit managers could provide significant value, but the business model must become more closely aligned with the interests of patients and payers. Pharma would love nothing more than to see the PBM model implode, creating the opportunity to extract higher prices by negotiating against smaller, less sophisticated buyers.
Some have proposed that all rebates should be eliminated and pharmacy benefit managers should simply charge fees. But how would payers evaluate the effectiveness of the PBMs? The shared rebate system was designed to align incentives around discounts. A new fee model that better aligns the interests of consumers, insurers, and pharmacy benefit managers must be developed.
Perhaps foundations should support the formation of a nonprofit PBM governed by its customers, similar to the nonprofit generic drug company being launched. The Laura and John Arnold Foundation has supported the development of value-based pricing through the Institute for Clinical and Economic Review, which can be used by pharmacy benefit managers to select drugs that maximize patient value rather than the size of the rebate. CVS recently announced it would use ICER pricing in establishing its formulary.
It is easy to cast pharmacy benefit managers as the bad guys of drug pricing, but with changes to the basic business model, they may be consumers’ best hope for holding down the price of pharmaceuticals.
John Arnold co-founded, with his wife, Laura, the Laura and John Arnold Foundation in 2010.
With Cigna’s recent announcement that it intends to purchase Express Scripts, five of America’s top health insurance companies now own or plan to own pharmacy benefit managers (PBMs).
The move is the latest example of vertical integration in the health insurance industry. This pattern continues at a time when PBMs are receiving intense scrutiny regarding their candidness and effectiveness in lowering drug costs.
Which other big-name companies are bringing PBMs into their fold, and why are they doing it? As Aetna CEO Mark Bertolini said in his 2017 Q1 earnings call, it seems “going forward, the PBM relationship as a standalone model is a troubled relationship.” Let’s explore why.
A Trend in the Making
As recently as 2017, the three largest PBMs operated by completely different business models: Express Scripts remained independent, OptumRx was owned by an insurance company, and CVS Caremark was run by pharmacy chain CVS Health. Now, they could all soon be under the control of nationwide insurers.
Back in 2015, we saw UnitedHealth Group’s OptumRx purchase then fourth-largest PBM, CatamaranRx. We also saw Aetna announce its intention to acquire Humana; a deal which the Department of Justice blocked a year and a half later after their antitrust review. The failed acquisition would have brought Humana’s PBM services in-house for Aetna.
In October 2017, Anthem announced that it would not renew its contract with Express Scripts, but instead, launch its own PBM, IngenioRx, in 2020. More recently, Aetna also made clearer its intention to control a PBM with its December 2017 proposal to merge with CVS Health in a $69 billion deal. And just last month, Cigna divulged its agreement to purchase Express Scripts for $52 billion.
Five Top Nationwide Insurers and Their PBM Partners
Insurers PBM Partners
UnitedHealth Group OptumRx (in-house); CatamaranRx (purchased 2015)
Anthem IngenioRx (launching in-house in 2020)
Aetna CVS/Caremark (purchase under review)
Cigna Cigna Pharmacy Management (in-house); Express Scripts (purchase under review)
Humana Humana Pharmacy Solutions (in-house)
Clearly insurance companies have an interest in reining in control of PBM operations, but why the acquisitions and consolidation?
Why we're fighting the American Medical Association
The AMA protects corporate interests, not doctors and patients – and now it’s trying to stop Medicare for All
This Saturday, nurses, physicians, and medical students plan to walk out of their clinics and on to the streets of Chicago to confront the American Medical Association at the organization’s annual meeting. Health providers know that the outrageous costs and shameful inequality of American medicine are no accident – and that their patients’ lives are at stake.
The AMA claims to represent the interests and values of our nation’s doctors. But it has long been the public relations face of America’s private health insurance system, which treats healthcare as a commodity. This approach has resulted in some of the worst health outcomes in the industrialized world: the highest rate of infant mortality, the highest number of avoidable deaths, and health spending that eats up nearly 18% of America’s GDP.
The AMA is a major reason why 28 million Americans still don’t have health insurance. Despite recent polls showing that a majority of doctors support the single-payer system Medicare for All, which would fully insure all Americans, the AMA is leading the fight against universal coverage.
By money spent, the AMA is the nation’s third largest lobbying organization of the last 20 years, behind only the US Chamber of Commerce and the National Association of Realtors. By deploying powerful lobbying and misleading media campaigns, the AMA has opposed or hijacked nearly every health reform proposal of the last century, from Social Security to Medicare to the Affordable Care Act.
The AMA has also been a relentless opponent of universal healthcare. In 1949, the group waged an unscrupulous war against President Truman’s proposed national health insurance program, spending millions of dollars to have a political-consulting firm mislabel single-payer healthcare as “socialized medicine”. In 1961, the group doubled down on fearmongering when they hired Ronald Reagan to record an advertisement warning Americans that the passage of Medicare, an imperfect but popular health program for seniors, was a “short step to all the rest of socialism”.
Americans borrowed a whopping $88bn last year simply to pay for medical expenses. So much for private insurance
The AMA, however, is finding it increasingly difficult to keep healthcare providers and patients scared of single payer.
Despite industry claims that Americans are “satisfied” with their private health plans, insured patients are saddled with exorbitant co-pays, premiums, and deductibles that keep them from actually getting the care they need. A single illness or injury pushes many Americans into bankruptcy. According to a recent Gallup poll, Americans borrowed a whopping $88bn last year simply to pay for medical expenses. So much for private insurance.
Most Americans – 70% – now favor the creation of a publicly financed but privately delivered single-payer health insurance program, better known as Improved and Expanded Medicare for All. Americans are desperate for affordable healthcare, a system that prioritizes patients over commerce, centers clinical decisions in the hands of physicians, and results in lower costs and better outcomes.
In February, Representative Pramila Jayapal, along with 106 co-sponsors, unveiled the Medicare for All Act of 2019 (HR 1384), while Senator Bernie Sanders’ revamped Medicare for All Act enjoys support from most of the leading Democratic presidential candidates. Even former President Barack Obama recently admitted that his signature health initiative – the Affordable Care Act – is no substitute for single payer.
Faced with soaring public support for Medicare for All, this past summer the AMA joined the “Partnership for America’s Health Care Future”, a benign-sounding corporate group which represents the pharmaceutical and private insurance industries and aims to “change the conversation around Medicare for All”. In order to protect their own economic interests, the “Partnership” is waging a well-funded campaign to turn elected officials away from single-payer by rallying Democrats around the ACA and preventing the Democratic party from including Medicare for All in its 2020 platform.
The campaign is merely the latest example of how the AMA uses the prestige of its white-coated members to push for market-based health reforms that maintain the status quo of our fractured health system: one in which some Americans have a lot, others have a little, and some are left with absolutely nothing.
Medical students and professionals have had enough. This Saturday’s protest is only one example. Last year, the Medical Student Section of the AMA put pressure on their leadership with a resolution demanding the organization suspend its decades-long opposition to single-payer. Single-payer activism is growing on medical school campuses across the nation, perhaps a preview of what the next generation of doctors will expect.
The public agrees with the evidence that Medicare for All is the answer to our broken health system. Until the AMA’s priorities change, it will remain an obstacle to the good of our patients.
Life expectancy in the U.S. still going down...
Caregivers are in real trouble.
Many of them have to hold down three jobs:
1) Real world job
2) Taking care of mum or pop
3) Acting as a legal and medical advocate, dietitian, and physical therapist for mum or pop.
The truth is that the elderly are not getting the best possible care under current standards because it isn't possible financially or physically due to finite resources. It is completely absurd to propose a program that requires effort and resources that is magnitudes above the current SOC. (referring to the exhasustive program proposed in this link: https://www.prweb.com/releases/reversal_of_cognitive_decline_100_patients/prweb15929561.htm)
It ain't gonna happen.
As the Baby Boom generation ages, 10,000 people turn 65 daily. For the first time in U.S. history, there are more than 50 million seniors. This trend is expected to continue until 2029, when the youngest Baby Boomers will turn 65 years old. A third of those older than 65 live alone, and half of the "oldest old" — those beyond 85 — are on their own at this late life stage.
The aging population, coupled with the high cost of senior living and in-home care, is driving a growing demand for family caregivers – a trend that is expected to continue through the next several decades and beyond.
This guide provides a comprehensive look at the state of caregiving in 2018, as well as information to help family caregivers move forward with practical tools they can use today.
THE NEW NORMAL
A 2015 survey conducted by the National Alliance for Caregiving and AARP, Caregiving in the U.S., approximately 34.2 million Americans provided unpaid care to an adult age 50 or older in the last 12 months, while 43.5 million provided unpaid care to an adult or child during the same 12-month period. Other findings include:
More than 8 out of 10 caregivers (82%) provide unpaid care for one other adult.
--15% provide care for two adults.
--3% provide unpaid care for three or more adults.
--16.6% of Americans (39.8 million caregivers) provide care for an adult (age 18 or older) with a disability or illness.
In a new Merrill Lynch study, eight in ten Americans say caregiving is "the new normal." While four in ten Americans 50+ believe they're likely to need care at some point in their lives, the truth is, seven in ten Americans turning 65 today will need care for prolonged periods.
The price tag for informal caregiving is staggering: more than $500 billion. If these family members were replaced with skilled nursing care, the cost would jump to $642 billion annually. In fact, in 2013, the value of unpaid care exceeded the total value of Medicaid spending and paid home care in the same year – a total of $470 billion, an increase of $20 billion from 2009.
These numbers only continue to climb as the population ages. And aging it is, with the U.S. Census Bureau reporting that the number of U.S. residents age 65 and older reaching 49.2 million (15.2% of the population) in 2016, a rise from 35 million (12.4% of the U.S. population) in the year 2000. The median age is also increasing in many areas of the U.S. In 2016, two-thirds of all counties (66.7%) in the United States experienced an increase in median age, and two counties had median ages over 60:
--Sumter, Florida: 67.1 years
--Catron, New Mexico: 60.5 years
Between 2000 and 2016, nearly all counties (95.2%) across the U.S. experienced an increase in median age, with 56 counties having an increase in median age of 10 or more years. This trend is driven by a longer life expectancy: The average life expectancy in the U.S. was 68 years in 1950, rising to 79 years by 2013.
...
Caregivers of adults are 49.2 years old, on average, but nearly half (48%) of all caregivers of adults are between the ages of 18 and 49. Caregivers who provide more hours of care per week tend to be older (an average of 51.8 years old) compared to those who provide less hours of care per week (48.0 years old). Overall, the majority of caregivers are adults between the ages of 45 and 64, with nearly one-fourth (23%) of adults in this age group caring for an aging adult. Nearly one in five (17%) of adults age 65 and older are caring for an aging adult, and among this group, 29% are providing care for a spouse or partner, while 33% are providing care for a friend or neighbor.
... full article at link below
I’m skeptical about … the FDA
July 28, 2016 Bob Clare
The Food and Drug Administration is a huge federal bureaucracy overseeing the safety and efficacy of more than a trillion dollars’ worth of consumer goods annually, ranging from medicines to cosmetics to foods, vaccines, and veterinary products. But you should think twice before believing that the FDA has only your best interest at heart. Over the past 25 years the ties between the FDA and Big Pharma have become increasingly cozy. Starting in 1992 with the Prescription Drug User Fee, the FDA began charging for drug approval, a cool $2,374,200 per drug as of 2016. This certainly gives the impression of a quid pro quo relationship (even if it doesn’t exist). Additionally, appointing folks who used to lobby and conduct research for Big Pharma into key leadership positions within the FDA reeks of conflict of interest. For example, in 2009, President Obama appointed former lobbyist and Monsanto executive, Michael Taylor, as Deputy Commissioner for Foods. Then, in February of this year, Robert Califf was promoted from his position as Deputy Commissioner for Medical Products and Tobacco to head the agency. This is interesting because, in a former life, the Duke cardiologist and researcher had financial ties to Eli Lilly, Merck, and Novartis, among others, and served as a board member and consultant for Faculty Connection LLC, a company whose sole purpose is to help pharmaceutical companies evade and manipulate FDA regulations. Isn’t this akin to putting the wolf in charge of the hen house? Of course, none of this started with Obama. Similar issues plagued the Bush administration where the FDA chair proved a difficult position to fill. Lester Crawford served just 2 months before resigning, and for nearly half of Bush’s tenure, the FDA chair remained vacant.
In 2000, USA Today reported that more than half of the FDA’s investigators had financial ties to the pharmaceutical companies whose drugs they were evaluating. It is a testimony to the power of self-delusion that many of these same investigators report that their evaluations are free of bias or conflict of interest. In 2006, the Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to 5,918 FDA scientists to evaluate the state of science at the FDA. The results were not pretty:
--18% responded, “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.”
--61% knew of cases in which Department of Health and Human Services or FDA political appointees had inappropriately injected themselves into FDA determinations.
--60% knew of situations where commercial interests had attempted to induce the reversal, withdrawal, or modification of an FDA determination.
--Only 47% believed that the “FDA routinely provides complete and accurate information to the public.”
--40% felt that they could not express public health concerns without fear of retaliation.
--Fewer than half (44%) reported respect for the integrity and professionalism of FDA leadership.
--40% rated agency morale as “poor” or “extremely poor.” Only 4% rated morale as “excellent.”
Wow, and I thought morale in the ER was lousy. Compared to the FDA we’re as happy as pigs in slop.
The pressure to approve drugs has gotten so bad that, in 2009, the Wall Street Journal reported on a letter received by President Obama’s transitional team leader, John Podesta, in which nine FDA scientists alleged that managers ordered, intimidated, and coerced them to manipulate data in violation of the law, further stating that the FDA is “fundamentally broken.” Regardless of the truth of their allegations, the fact that they were made is cause for concern.
Despite the expense, time, and red tape involved with drug approval, the hurdles aren’t all that high. A drug need show only that it is safe and more effective than a sugar pill to gain the FDA’s blessing. But what is “safe?” Rezulin, a diabetes drug with a monthly prescription rate of 300,000, was pulled 3 years after its approval in 2000, due to a mere 90 cases of Rezulin-associated liver failure and just 63 deaths. The overwhelming majority of patients taking the drug benefited from it. Just 1 in 23,000 patients experienced liver failure, and yet this was enough to get the drug pulled.
Meanwhile, t-PA, a clot dissolving drug used to treat stroke, remains on the market and heavily promoted by the American Stroke Association despite causing fatal brain hemorrhages in 1 in every 33 patients who receives it. Even under the best of circumstances, the drug is only marginally effective, helping just 12% of stroke patients. In 10 of the 12 major randomized controlled trials, thrombolytic drugs like t-PA fared no better, or performed worse, than a placebo. But the FDA put its faith in the 2 trials with positive findings. There are no trials showing a mortality benefit; the fatality rate is about 1% higher in patients receiving t-PA than in those who don’t. Although the data suggests t-PA fails on both safety and efficacy counts, it remains the first-line agent used to treat stroke at every major stroke center in the country. Whereas, I’ve seen several deaths from t-PA, I’ve seen no cures. And still the band plays on.
With all the forces of greed aligned against it, perhaps we should be thankful that the FDA gets it right as often as it does, but the agency can do better. New drugs are approved based on data supplied by manufacturers and selected peer review studies, so it’s not fair to blame the FDA if the data provided has been fudged, smudged, or smeared. Even when the data is accurate, there may not be enough of it. Most of the time there simply aren’t enough test patients to reveal all the side effects destined to surface once the drug gains a wider audience. This is why a post-market surveillance system is so important. An example where both the FDA and the manufacturer failed to protect the public is the drug Vioxx (rofecoxib).
Coming on the heels of Pfizer’s blockbuster drug Celebrex, Merck’s copycat version, Vioxx, was approved by the FDA in May of 1999 to treat inflammatory pain, promising fewer GI side effects than traditional NSAID drugs like naproxen, ibuprofen, and aspirin. It won FDA approval after just 6 months (usual time 10 to 12 months) based solely on unpublished, non-peer review data supplied by Merck. And just like Celebrex, Vioxx became a blockbuster, garnering sales of $280 million during its first year, on it way to $2.5 billion in annual sales. Questions regarding Vioxx’s safety, however, emerged almost immediately with publication of the VIGOR (VIoxx Gastrointestinal Outcomes Research) Trial. The goal of the study was to demonstrate Vioxx’s superiority over a traditional NSAID (naproxen) with regard to GI side effects when used to treat rheumatoid arthritis. And Merck was certainly pleased when their drug passed this hurdle, showing a 50% reduction in clinically relevant GI events like ulcers and GI bleeding. Unfortunately, compared with the much cheaper naproxen, Vioxx-takers suffered a five-fold increased risk of heart attack (0.1% vs 0.5%). Merck spun this to mean that naproxen must be cardioprotective, because the alternative was to admit that their billion-dollar baby was killing people. Merck dug in its heels, starting with a press release issued in May of 2001 entitled “Merck Reconfirms Favorable Cardiovascular Safety of Vioxx.” But there was nothing favorable about the drug. It was expensive, it didn’t work well to relieve pain, and it caused heart attacks. As the evidence mounted, so did the lawsuits. After initially standing behind their claims, Merck ended up pulling the plug on Vioxx less than 4 ½ years after its approval. A year later, researchers with access to Kaiser Permanente’s huge data base of patients, proved that naproxen was not protective, that Vioxx was harmful, and that the drug was likely responsible for between 88,000-140,000 heart attacks and cardiac deaths during its short-lived life. It took until January of this year for Merck to settle the last of the class-action lawsuits, agreeing to a payout of $830 million, raising the company’s total expenditures for lawsuits and government investigations to $8.5 billion—pretty much wiping out all of the drug’s prior earnings. Could this debacle have been prevented?
Merck may not have been culpable in knowing the cardiovascular dangers when it first filed for FDA approval, but it certainly put on blinders afterward. Once a drug is on the market, post-market surveillance continues with companies required to report safety data to the agency at quarterly intervals for 3 years. The FDA also relies heavily on its Adverse Event Reporting System, a voluntary, anonymous, non-peer-review system wherein manufacturers, doctors, and patients can report adverse events through the FDA’s website (see: www.fda.gov/Safety/Medwatch/HowToReport/default.htm). The data is reviewed quarterly by scientists at the Center for Drug Evaluation and Research who then report on their findings. The FDA has the authority to require manufacturers to conduct additional safety trials, but the agency never requested anything from Merck. Meeting in August of 2001, more than 2 years after the drug’s approval and more than a year after the VIGOR Trial, the FDA’s Arthritis Advisory Committee pointed no fingers and requested no safety studies. Meanwhile, Merck kept its head in the sand and continued pouring $100 million annually into direct-to-consumer-advertising (another reason why this practice should be banned). Each time a new study appeared reporting on the cardiovascular dangers of Vioxx, Merck predictably and unashamedly pooh-poohed the science. But it was Merck who was guilty of bad science having funded their own seeding trial to promote Vioxx’s use. Such trials are not designed to further scientific inquiry, but rather to promote drug sales. To get around the illegality of outright bribery, drug companies pay doctors to enroll patients into a trial, ostensibly to look at some property of the drug—safety, efficacy, comparative effects—it doesn’t really matter; the real purpose is to get physicians into the habit of writing for the drug. After a review of Merck’s internal documents, a group of independent researchers concluded that the Merck sponsored ADVANTAGE Trial “was actually a sophisticated marketing tool designed to allow optimal ‘seeding’ of positive experiences among primary care physicians.” Shame, shame, shame.
So the Vioxx thing happened a long time ago. Isn’t it safer today? The short answer is no. Avandia, a diabetes drug, remains on the market despite a plethora of lawsuits and a study showing a 43% increased risk of heart attack with its use. A similar diabetes drug, Actos, has been associated with an increased risk of heart failure and bladder cancer. It, too, remains on the market. And there are many, many more examples.
What can we learn, and what can be done? First, these episodes show us that shareholder pressures on pharmaceutical companies to recoup R&D costs and generate profits are enormous. When companies spend more on marketing than they do on R&D, that’s a problem. Unfortunately, it’s not one that can be solved by letting the markets fend for themselves. In a for-profit healthcare system, greed will always trump science, so unless we want to eliminate privately owned pharmaceutical companies altogether, we are stuck with regulating them. Simple fines won’t cut it. Here’s a partial list of some of the more recent fines imposed on the pharmaceutical industry: Nov. 2011, Merck, $950 million; May 2012, Abbott, $1.5 billion; Jul. 2012, GlaxoSmithKline, $3 billion; Oct. 2012, Boehringer Ingelheim, $95 million; Dec. 2012, Amgen, $762 million; Dec. 2012, Sanofi-Aventis, $109 million; Nov. 2013, Johnson & Johnson, $2.2 billion; Feb. 2014, Endo, $193 million. Get the picture? Fines of even a billion dollars aren’t adequate to induce these companies to clean up their act. Without jail time, don’t expect things to change.
Second, regulators working for the FDA haven’t kept us safe. They, too, face enormous pressures both from within and outside the agency to approve drugs. The growing private/public alliance serves only the pharmaceutical industry. The public pays for government regulatory agencies. The public also pays for drugs. We have both the right and the moral obligation to demand better from the FDA. To pick a former pharmaceutical lobbyist to head the agency is a disgrace. There needs to be a major culture change, starting at the top. But with either Trump or Clinton as our next president, I don’t see this happening. Both are in bed with industry
Third, it is vital that we, as a society, continue to finance independent research. More than 80% of all trials are now industry sponsored. Trials demonstrating positive findings are 5-times more likely to be published than those with negative findings, although it is the latter that often provide the more relevant information. Encourage your congressman to continue funding independent research. Most breakthroughs are serendipitous. Research for knowledge’ sake is far more likely to generate new findings that can then be used for clinical application, whereas research for profit simply introduces more “me too” drugs into an already crowded market.
Fourth, these examples show the importance of maintaining vigilance. Side effects, both good and bad, often only become manifest when hundreds of thousands of people begin taking a drug. The FDA must be free and willing to impose after-market studies without fear of industry reprisal. Consider that after the FDA approved the diabetes drug Januvia (sitagliptin) in October 2006, Merck had a fully functional website up and running within 90 minutes, drug reps were seeing physicians regarding the drug’s use within 2 days, at which point webcasts and educational programs were already airing on the internet. By day 8, Merck had reached 70% of their target physicians, and shipments of the drug were stocked on pharmacy shelves. By week 2, Merck had discussed their drug with managed care organizations responsible for 73% of the entire insured US population. By the end of the first month, 20% of all new diabetes prescriptions written by endocrinologists and 14% of those written by primary care physicians were for Januvia. If drug companies can achieve such amazing efficiency and success in their efforts to make money, we should be able to employ similar tactics to save lives. In the meantime, remain skeptical of pharmaceutical ads, and don’t forget that the best way to prevent yourself from becoming a guinea pig is to engage in a healthy lifestyle. Instead of medicating, try meditating. Instead of running to a doctor, try running to a park. You’ll thank me; no, seriously, you will.
References:
“Voice of Scientists at FDA: Protecting Public Health Depends on Independent Science,” Union of Concerned Scientists: Citizens and Scientists for Environmental Solutions, 2006; Cambridge, MA, ucsusa.org.
Alicia Mundy and Jared Favole, “FDA Scientists Ask Obama to restructure Drug Agency,” Wall Street Journal, Jan 8, 2009, online.wsj.com.
A. Faich et al., “Troglitazone (Rezulin) and Hepatic Injury,” Pharmacoepidem. Drug Safety 2001: 10 (6): 537-47.
The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group, “Tissue Plasminogen Activator for Acute Ischemic Stroke,” NEJM 1995; 333 (24): 1581-87.
Claire Bombardier et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,” NEJM 2000; 343; 1520-28.
David Graham et al., “Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with Cyclo-Oxygenase 2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Nested Case-Control Study,” Lancet 2005; 365: 475-81.
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I worked for a company that was negotiating with the Chinese for technology to create an elder care robot to assist in their elder care effort.
In China one younger person may be responsible for four elders because of Mao's one child policy. They are in crisis mode but you don't hear much about it. The image below is from a 1990 journal article.
The Chinese knew this was coming, it was probably the impetus for creation of a Universal Healthcare policy.
https://www.jstor.org/stable/pdf/2949087.pdf?seq=1#page_scan_tab_contents
The living conditions described to us were worse than this:
Boxed in: life inside the 'coffin cubicles' of Hong Kong – in pictures
Coffin cubicles in Hong Kong.
https://www.theguardian.com/cities/gallery/2017/jun/07/boxed-life-inside-hong-kong-coffin-cubicles-cage-homes-in-pictures
Studies like this 2004 study do not address the issue of living conditions;
https://www.tandfonline.com/doi/abs/10.1080/13607860412331336823
This is the public face of elder care in China as of 2010:
https://confuciusmag.com/elderly-in-china
China's senior care demands continue to increase: survey
Source: Xinhua| 2018-05-20 19:03:39|Editor: Lu Hui
BEIJING, May 20 (Xinhua) -- Some 15.3 percent of China's elderly reported a need for additional care, according to a recently released report on the living condition of the country's senior citizens.
This figure has increased by 9 percentage points from 2000, according to the Survey Report on the Living Conditions of China's Urban and Rural Older Persons (2018), which was published by Social Sciences Academic Press.
The percentage of urban elderly reporting a need for care rose from 8 percent to 14.2 percent between 2000 and 2015. In comparison, the percentage in rural areas increased from 6.2 percent to 16.5 percent during the same time.
The need for care among elderly aged 80 and above displayed a sharper increase. The rate rose substantially from 21.5 percent in 2000 to 41.0 percent in 2015, while those aged 79 and below requiring care rose from 5.1 percent to 11.2 percent.
The types of care desired by elderly include at home doctor visits, housework services, health education, and psychological counselling, according to the report.
A total of 222,700 Chinese aged 60 and above from across the country answered the survey, which has been conducted every five years since 2000 by the China National Committee on Aging.
My week in Lucky House: the horror of Hong Kong's coffin homes
A general view of residential and commercial buildings in Yau Tsim Mong District, a popular location for ‘coffin homes’ in Hong Kong.
by Benjamin Haas in Hong Kong
The residents of Lucky House in Hong Kong are anything but fortunate. They are some of the poorest people in the most expensive city in the world.
In one of its 46 sq metre (500 sq ft) apartments, 30 residents live in purpose-built plywood bunk beds each with its own sliding door, colloquially known as coffins. Two rows of bunks, 16 bunks in each row – still space for two more people.
The residents are retirees, working poor, drug addicts and people with mental illnesses, mostly those unable to keep pace with the spiralling cost of housing in Hong Kong.
In many ways their home feels like a railroad sleeper car, but even more cramped and uncomfortable, and with none of the charm or romanticism that comes with train travel.
For a week I lived at Lucky House, crammed in a stuffy bunk teeming with bed bugs at night, my days spent lazing around with not much to do besides talk to the other residents, stare at my mobile phone and sleep.
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About a year ago, her devoted GP advised that we consider 24/7 care – not immediately, as robbing her of autonomy would only accelerate her descent to dependence – but soon.
I couldn’t afford to buy a house with a granny flat, or convert our home, which has stairs, to accommodate my mother’s limited mobility. My brother lives abroad and travels extensively. So with my mother’s grudging approval (she is a fiercely independent spirit), he and I looked into other options. They were not good. “Domiciliary carers”, who’d visit mother at home, are expensive. If we wanted someone with a proven track record, we’d have either to rely on the local authority and top up, out of our own pocket, the assistance they offered, or turn to agencies, which charge about £20 an hour.
The alternative, a care home, was terrifyingly pricey: a single room in a London care home costs over £30,000 a year.
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Cost was only one concern, however. The past few years have thrown up hair-raising stories about the abuse of elderly patients in care homes, where staff have been caught on hidden cameras beating their charges, kicking and mocking them.
Viola Richter works in the Emmendinger Altenpflegeheim (care home) in southern Germany, near the country’s border with Poland. She claims the practice of Germans going east to spend their last days is set to spread, as other northern European countries face a similar care crisis prompted by a dramatic increase in the ageing population, lack of care workers and rising prices.
East European care enjoys a good reputation. “One reason,” according to Richter, “is that the concept of ageing is very different there. Because it is a family-centred society, everyone pitches in to help with elderly relatives. They may have very little autonomy, but the elderly stay at the heart of the family.” Richter has noticed that, while her fellow Germans look on her job as nothing more than “wiping bottoms”, in the east assisting the elderly is respected as a crucial contribution to the nation’s welfare.
It is true that carers, in both Britain and Germany, have low status. Madeleine Starr, head of innovation at Carers UK, thinks it “scandalous that we don’t value our care sector more”. She points out: “This is a low-skilled sector with relatively poor pay: although agency recruits can charge more, it’s not unusual for the rest to earn only the minimum wage and pay their own travel expenses on top of that.”
In Britain, the sector is also heavily regulated. A family wishing to hire a carer would be responsible for doing CRB and employment checks, as well as income tax. The state, explains Starr, is keen to formalise such arrangements, to avoid the Treasury being cheated out of taxes.
The scenario is very different in Italy, where, as Starr reports, “light touch registration” prevails. Families who hire badanti pay the equivalent of their employee’s NI contributions (contributi). The rest is about employer and employee succeeding in arrangiarsi – coming to an agreement. The badanti usually hail from eastern Europe – thousands of women from Ukraine and Bulgaria have come to Italy since the Soviet Union collapsed – and lack professional training. Italians don’t seem fussed, and I can see why. Registered nurses may offer clinical competence, but “caring” is holistic: interesting conversation, a healthy diet, a walk outside. For that, the only requirement is a compassionate individual who regards their charge as a human being rather than a tiresome burden.
Katerina Ivanova, my father’s Ukrainian carer, fits the bill admirably. Patient, good-humoured and energetic, she values her role not only for the 2,000 euros a month, but for the relationship she has forged with my father. “He can make me terribly cross,” she admits during one of our regular Skype sessions, “but the truth is, I’m very fond of him. Back home, we’d never allow an elderly man to live on his own: loneliness is more debilitating than illness.”
Katerina, who has a doctorate in chemical engineering, lives with my father in a spacious flat that costs a fraction of what it would in London. She works six days a week, and assists him with bathing and dressing. She ensures he gets out for a walk, takes his medicines daily, and eats properly (no hardship, given that she is a fabulous cook). Katerina drives him to doctors’ appointments as well as on excursions; and when we come to visit, she spoils my nine-year-old daughter with gelati and the local amaretti.
More than 20% of the total Italian population is aged 65 or more. By the year 2050, this figure is expected to rise to 34% because of the country’s longer life expectancy, which is currently at 78 to 80 for men and 84 to 85 for women. In fact, about 20% of the senior citizens and 6% of the country’s total population are over the age of 80. Therefore, Italy definitely needs to focus on its elderly care as well as in-home senior care services.
Unlike the US and UK, when it comes to caring for the elderly in Italy, there is a lot of emphasis on family support. Looking after the older members of the family is regarded as a responsibility or a “social duty”, especially by the women and this also includes taking care of extended family. Normally, Italian institutions and communities only get involved if an elderly person has no family; old age homes are regarded as the “last resort” in Italian culture. Therefore, less than 1% of the senior population is currently using home care services.
However, in the recent past, the demand for elderly homecare services has increased to a great extent; yet, the supply remains fairly limited. Considerable differences can also be seen in the development and distribution of services for the elderly, particularly between the northern and southern parts of the country.
Unfortunately, there are no gated communities only for the elder, as often seen in the US. Elderly people, who are fairly fit and independent live in regular properties, with no special amenities for senior citizens.
Healthcare for the elderly
While the National Health System and the Local Health Authorities in Italy have been controlled by the municipality since 1978, care for the elderly was entrusted to communities and general practitioners that are organized by associations as well as the municipality. In fact, right up until the 1990s, the Italian authorities were oblivious to the health problems and requirements of older people. However, things began to change in 1992 with the “Objective: Ageing Persons”. The National Plan for senior citizens now aims at better coordination of medical and social services, which can be integrated within a person’s home care service system. Their framework for elderly care includes –
Home care: This consists of a service with social importance like personal care, house help, meals, as well as health importance, like medical and nursing care, which can be provided to a senior citizen within the comfort of his own home. Integrated homecare services seek to keep an older person at home for as long as possible.
Day centers: These comprise of a semi-residential structure within a district, where elderly people can spend a couple of hours each day. These centers are operational 5 days per week, 7 hours each day and can admit up to 20 elderly people. They provide not only healthcare services but also many types of social care services, like promotion of personal autonomy, job therapy, entertainment and so on.
Nursing homes: These services include residential structures that have been organized into smaller groups to provide healthcare, social care services and functional rehabilitation for those who are disabled. The support staff in nursing homes generally includes doctors, nurses, social workers and psychologist. Elderly patients staying in nursing homes may receive extensive or intensive care, depending upon their situation.
Extensive care at nursing homes for the elderly comprises of long-term rehabilitation and accommodation though hospitalization is limited to the acute stage only.
Intensive care includes rehabilitation with high medical importance as well as hospice for terminal patience. This service also provides palliative care for patients as well as their families.
Retirement for expats
Italy does not offer any kind of retiree program. In spite of the fact that Italian elderly care is not at par with countries like the US, UK and Canada, several people above the age of 65 choose to retire in Italy. Senior expats living in Italy need to obtain a retirement visa or an elective residency visa.
Will vaccines become "personalized medicine"?
Lawrence Solomon: One-size-suits-all vaccines will soon be replaced by safer, more effective ones
Today’s vaccines are failing. Personalized vaccines that reflect an individual’s genetic profile are coming
Vaccines as we know them are on the way out. On the way in are personalized, precision vaccines, created through a new discipline called vaccinomics that promises to protect a higher proportion of the population at far lower cost and without the real and potential harms that mass vaccination programs inflict on some people.
“The old paradigm isn’t working anymore,” Dr. Gregory Poland, head of the Mayo Clinic’s Vaccine Research Group explains matter-of-factly. “It didn’t work with HIV, it doesn’t work with other complex viruses and pathogens.” It didn’t even work with measles, which countries in the west had declared eliminated. Now measles is coming back and it isn’t likely to stop, not until old-school vaccine scientists give up their “cherished dogma,” recognize the many limitations in today’s vaccines and adopt 21st century thinking.
Traditional vaccines work on a century-old model of “Isolate, Inactivate, Inject” — the tried-but-not-always-true method of making a vaccine by isolating a pathogen, stripping it of its potency and then injecting it into us. This crude approach to developing a vaccine, reliant on observation rather than theory, becomes all the cruder by delivering it in one-size-suits-all fashion. As one example, women tend to be much more responsive than men to vaccines, yet women are given the same high dose as men, even though women report far higher rates of adverse effects after vaccination. Are we “over-dosing” women, Dr. Poland asks? Likewise, different ethnic groups, different age groups, and other demographics, though responding differently, are treated indiscriminately.
Vaccinomics — vaccinology informed by genomics — turns the traditional vaccine model on its head by making the individual the starting point, rather than the end point, in the vaccine creation process. Vaccines work — or don’t — on the basis of cumulative interactions in our bodies driven by a host of immune response genes and other factors. Because different gene sequences determine how different vaccines at different doses affect us, vaccines in the ideal should be customized to the individual.
In Dr. Poland’s view, that ideal, once unthinkable, is now within reach. The cost of determining an individual’s gene sequence is today $1000. Within a year, the cost is expected to plummet to $100 or less, making it economically feasible to produce gene sequences for us all. Armed with that information, vaccine doses can one day be sized to an individual’s particular genetic profile, eliminating today’s one-size-suits-all approach that sees some individuals receive doses too weak to offer any protection, others doses several times stronger than needed. These gene sequences can also save lives. Dr. Poland described the case of a young woman who arrived at the Mayo Clinic, her brain destroyed by a rare adverse reaction to the yellow fever vaccine, taken because she planned to be a missionary in Africa. Once gene sequencing is the norm, and science can identify what genes or gene combinations pose dangers in response to which vaccines, such tragedies can be avoided.
For reasons such as this, the vaccine research team at Mayo Clinic — one of the world’s largest, most respected and most prolific — promotes the growing discipline of “adversomics,” which aims to understand the adverse effects that can come of vaccines. The science here is daunting, since the variables that could cause a vaccine to do harm involve “a complex interaction of past exposures and infections, current physical and emotional health, and the individual’s genome and microbiome,” or the countless microorganisms that reside in our bodies. Yet this science is also doable, with some successes already logged.
Adverse reactions to vaccines may be in part “genetically predetermined,” Dr. Poland says, giving examples of different reactions, linked to genes, in various vaccines. “For example, a small percentage of children who get vaccine-induced fever after MMR [measles, mumps and rubella] will develop febrile seizures. I’d like to see predictive tests or preventive therapies that could be administered with the vaccine to prevent these reactions.”
The sciences of vaccinomics and adversomics depend on advances in collecting and analyzing biological data, and here a massive research effort is required, to comprehensively track all the adverse events that occur, and the circumstances surrounding them. This effort could pay off both directly, in the scientific discoveries to be had, and indirectly, in winning over the growing number of people who are now skeptical of vaccine safety, and have helped create the demand for adversomics. These skeptics often come from the elite in society — they tend to be well educated, affluent, and highly motivated — making their buy-in necessary for widespread vaccine use to occur. “The current science doesn’t allow for an informed understanding of an individual’s genetically determined risk for an adverse event due to a vaccine,” Dr. Poland explains. His expectation: Once people have risk information, informed choices will follow.
Dr. Poland has had his detractors — when he first unveiled vaccinomics in 2005 many in his field reacted with hostility. Many still see him as unrealistic. Inertia in the establishment is also working against him. Although he has close working relationships with both the U.S. Centers for Disease Control and major pharmaceutical companies, neither are vaccinomics enthusiasts, both prefer the security of the status quo. Yet vaccinomics is already a force, with the air of inevitability. Scientific American calls it “one of the most innovative scientific concepts of the decade.” The Scientist calls it “one of the hottest omics fields.” The vaccinomics concept is now being proposed to promote vaccine safety by researchers at major institutions in Canada and Europe as well as the United States.
As vaccinomics becomes mainstream, its commercialization will likely come not from the ranks of Big Pharma but from that of the many entrepreneurial pharma upstarts, backed by venture capitalists. Big advances generally come from outside the establishment, notes Dr. Poland, the man who coined the term “vaccinomics” and who will be known as the Father of Vaccinomics.
