Big Pharma is appropriating the information that doctors need most

REMOVEack in 1982, when I first started my career as a family practitioner in a small town in Boston, I was confident that the care I provided would be as effective as the patients are cared for anywhere in the world. At the time, the death rate among Americans was lower than in comparable countries, resulting in 128,000 fewer deaths annually. Even though healthcare is expensive – costs 2.3% more of our GDP than Medium 11 other rich countries — the rapid growth of HMOs and managed care plans promise to make our healthcare even more efficient.

Over the next four decades, however, the opposite happened. Similar age-adjusted mortality rates improved more in comparable countries, in 2017 there were more than 478,000 Americans die every year. This results in an additional 1,300 deaths daily, the equivalent of three jumbo jets crashing each day. The poor health of Americans every day and our health care system’s inability to reduce preventable deaths have led to a crisis that has even halted the global economy. COVID-19 pandemic. And our overspending has grown to 6.8% of GDP, or $1.5 trillion a year.

This raises an important question: Why do so many smart, well-trained doctors stand by when the American healthcare industry falls into a state of serious dysfunction?

The answer lies in the gradual, commercially invisible, gradual uptake of medical “knowledge” that doctors are trained to believe.

This transition began in the 1970s, when the acceptance rate of grant applications from the National Institutes of Health dropped – from about half of medical research applications to a third. Then, in 1981, President Ronald Reagan cut government support for medical research at the university, pushing academic researchers into the waiting arms of industry, especially pharmaceutical companies. After the College and Small Business Patent Procedures Act was passed in 1980, nonprofits and their researchers were allowed to profit financially from discoveries. conducted while conducting federally funded research.

Former Harvard University President Derek Bok expressed concern on the development of commercial practices in academia: “Making money in the commercial world often comes with a Faustian bargain, in which universities have to compromise their fundamental values ​​— and thus risking their own souls…”

However, the biggest change is still to come.

Over the past few decades, pharmaceutical companies have taken over most of our clinical research. In 1991, academic medical centers (AMCs)—hospitals that train doctors and conduct medical research—receive 80% of what industry spends to fund clinical trials. ready. Pharmaceutical companies rely on academic researchers for their expertise in study design, patient enrollment, and data analysis. This arrangement allows scholars to receive the funding they need while retaining much of their independence. But by 2004, the proportion of commercially funded clinical trials conducted by AMC had dropped from 80 to just 26%.

A review of research contracts between corporations (mainly Big Pharma companies) and academic medical centers shows that 80% allow the commercial sponsor to own, and thus control, the data. from together Conduct research. Furthermore, completely half of research contracts between pharmaceutical companies and academic institutions — partnerships most likely to maintain rigorous research standards — allow Industry insiders write clinical trial reports for publication in scientific journals, relegating the named authors to the revised “proposal” position.

However, thorough peer review ensures that these reports are accurate, right? Wrong. Almost all doctors don’t know, the peer reviewers are access is not granted baseline data on which the findings are reported. Pharmaceutical companies own that data and keep it as secret as “company property”. Reviewers should rely on brief data summaries contained in submitted manuscripts. Reviewers at the most prestigious medical journals are also unable to attest to the accuracy and completeness of the articles they review.

This falsehood was exposed in 2005 when the editors of an article published on New England Journal of Medicine admitted that they had not seen relevant data from a clinical trial related to Merck’s arthritis drug Vioxx. Five years ago, the paper praised the drug’s safety even though neither the editor nor the peer reviewer had been granted access to the baseline data, which showed that three heart attacks occurred in Vioxx-treated patients have not been reported. If this data were properly revealed and analyzed when the manuscript was first submitted, the paper would show that Vioxx significantly increased the risk of heart attack by 5 times compared with over-the-counter naproxen (Aleve). And it is estimated that many of the 30,000 Americans who died from taking Vioxx after the incomplete article was published would not have been exposed to the drug.

To this day, Big Pharma companies still prefer not to disclose their basic clinical trial data. The most recent example involving Pfizer Vaccines against covid-19. In September 2021, a month after the vaccine was fully approved by the U.S. Food and Drug Administration (FDA), a group of medical researchers and scientists sued the agency over the released 451,000 pages of scientific literature that they reviewed prior to issue. fully approved vaccines. Although the agency only asked for 108 days to fully evaluate these documents before officially authorizing the vaccine, the FDA (with Pfizer wanting to join the lawsuit), argued that as soon as it could release the data, it could not be released. whether it is five hundred pages per month, which means it will take seventy-five five before the materials were released in full. On January 6, 2022, U.S. District Judge Mark Pittman ruled that the FDA must release 55,000 (not 500) pages of the document each month until it’s complete.

I want to make it clear that I am a strong advocate of immunization and booster (especially for those 65 years of age and older), the CDC’s analysis of factual data shows that adults who are not vaccinated who were vaccinated in December last year were 41 times more likely to die from COVID. -19 compared with full vaccination and adult booster. But I strongly believe that doctors and the public must have access to the basic clinical trial data on which FDA approval is based now—not in seventy-five years.

The lack of transparency in peer-reviewed clinical trial data is similar around the world. But the effect is much greater in the United States because of our unique pharmaceutical policy. We have no formal reviews comparing the medical benefits and economic value of new drugs with older therapies, so healthcare professionals don’t have access to extreme information. this important.

Federally funded clinical practice guidelines are not allowed to include the relative costs of therapies in their recommendations, which means they don’t take into account the possibility that a drug could bankrupt a patient. unnecessarily or increase the cost of health insurance. Furthermore, the price of brand-name drugs is not regulated in the country, which is why in the US they cost 3.5 times more than in other OECD countries. And unregulated pricing increases the reward-to-risk ratio for over-aggressive US marketing.

Industry control over what doctors believe about optimal treatment explains why new, expensive drugs are used more freely in the US than in other countries. Without access to actual clinical trial data, medical journals are publishing undisclosed articles that doctors then rely on to treat their patients. Although prescription drugs “account for only 17% of U.S. healthcare costs, this has become a “dog-tailed” situation: Drug companies control “knowledge” informing clinical decisions of the physician. This has resulted in skyrocketing pharmaceutical profits and crippling healthcare costs, while doctors have no way of knowing which treatment is more effective — or more effective. Americans deserve better.

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