When I began my career as a family physician in a small town in Boston in 1982, I was confident that the care I would provide would be as effective as the care patients receive anywhere in the world. At the time, the death rate for Americans was lower than comparable countries, resulting in 128,000 fewer deaths per year. While healthcare was expensive — costing 2.3% more of our GDP than the average of 11 other rich countries — the rapid growth of HMOs and managed care plans promised to make our health care even more effective and efficient.
In the ensuing four decades, however, the opposite has happened. The same age-adjusted death rate has improved so much more in comparable countries that more than 478,000 Americans died each year in 2017. This translates to an additional 1,300 deaths per day, which is equivalent to three jumbo jets crashing every day. Americans’ everyday ill health and the inability of our healthcare system to reduce preventable deaths amounts to a crisis that dwarfs even the COVID-19 pandemic. And our excess spending has risen to 6.8 percent of GDP, or $1.5 trillion a year.
This raises an important question: Why have so many smart, educated physicians watched as the U.S. healthcare system descended into a state of serious dysfunction?
The answer lies in the gradual, almost invisible commercial takeover of the medical “knowledge” that doctors are trained to trust.
This transition began in the 1970s, when the acceptance rate of grant applications for funding from the National Institutes of Health shrank — from about half of medical research applications to one-third. Then, in 1981, President Ronald Reagan cut government support for medical research at universities, pushing academic researchers even more into the waiting arms of industry, especially pharmaceutical companies. Following the passage of the University and Small Business Patent Procedures Act in 1980, nonprofit institutions and their researchers were allowed to benefit financially from the discoveries made while conducting federally funded research.
Former Harvard University president Derek Bok expressed concern about the growth of commercial activity within academia: “Making money in the commerce world is often accompanied by a Faustian agreement whereby universities must compromise their core values - risking their souls in the process.” to make…”
However, the biggest shift was yet to come.
In recent decades, the pharmaceutical companies have taken over most of our clinical research. In 1991, academic medical centers (AMCs) — hospitals that train physicians and conduct medical research — received 80 percent of the money the industry spent to fund clinical trials. The drug companies relied on academic researchers for their expertise in designing studies, enrolling patients and analyzing the data. This arrangement allowed academics to get the funding they needed while still retaining much of their independence. But by 2004, the percentage of commercially funded clinical trials conducted by AMCs had fallen from 80 to just 26 percent.
A look at the research contracts between companies (usually Big Pharma companies) and academic medical centers shows that 80% allowed the commercial funder to own and thus control the data of jointly conducted research. In addition, half of research contracts between drug companies and academic institutions — the partnerships most likely to maintain high research standards — allowed industry insiders to ghostwrite clinical trial reports for publication in scientific journals, relegating said authors to ” suggestions for” revisions.
Nevertheless, a thorough peer review ensures that these reports are accurate, right? wrong. Unbeknownst to almost all physicians, peer reviewers are not given access to the underlying data that serves as the basis for the reported findings. The pharmaceutical companies own that data and keep it confidential as ‘company property’. Reviewers should rely on brief data summaries included in the submitted manuscripts. Peer reviewers of even the most prestigious medical journals cannot confirm the accuracy and completeness of the articles they review.
This sham was brought to light in 2005 when the editors of an article published in the New England Journal of Medicine admitted that they had not seen relevant data from a clinical trial of Merck’s arthritis drug Vioxx. Five years earlier, the paper had praised the drug’s safety, although neither the editors nor peer reviewers had access to underlying data showing that three heart attacks that had occurred in patients treated with Vioxx went unreported. If this data had been properly disclosed and analyzed when the manuscript was first submitted, the paper would have shown that Vioxx significantly increased the risk of heart attack compared to over-the-counter naproxen (Aleve). And many of the estimated 30,000 Americans who died as a result of taking Vioxx after the incomplete paper was published would not have been exposed to the drug.
To this day, Big Pharma companies are unwilling to disclose their underlying clinical trial data. The most recent example was Pfizer’s COVID-19 vaccine. 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 for releasing 451,000 pages of scientific papers it had evaluated before it was awarded. . the full approval of the vaccine. While it took the agency just 108 days to adequately evaluate these documents before formally approving the vaccine, the FDA (with Pfizer seeking to join the lawsuit) argued that the fastest way to release the data is 500 pages a month. was, meaning it would be seventy-five years before the documents were fully released. On January 6, 2022, U.S. District Judge Mark Pittman ruled that the FDA must release 55,000 (not 500) pages of the documents each month until they are complete.
I want to be clear that I’m a big believer in getting vaccinated and boosted (especially for people age 65 and older), the CDC’s analysis of real-world data shows that unvaccinated adults last December had 41 times the risk to die from COVID -19 compared to fully vaccinated and boosted adults. But I am equally as convinced that physicians and the public should have access to the underlying clinical trial data on which FDA approval is based now — not seventy-five years from now.
The lack of transparency of clinical trial data in peer review is similar around the world. But in the US, the effect is much greater because of our unique pharmaceutical policies. We don’t have a formal assessment comparing the medical benefit and economic value of new drugs to older therapies, so healthcare professionals don’t have access to this all-important information.
Federally funded clinical practice guidelines are not allowed to include the relative costs of therapies in their recommendations, meaning they do not account for the possibility of a drug unnecessarily bankrupting patients or driving up health insurance costs. Furthermore, the price of branded drugs is not regulated in this country, which is why they cost 3.5 times more in the US than in other OECD countries. And unregulated pricing raises the reward-to-risk ratio for overly aggressive marketing practices in the US
Industry control over what doctors think about optimal therapies explains why new, expensive drugs are more widely used in the US than in other countries. Without access to actual clinical trial data, medical journals publish uncontrolled articles that doctors then rely on to treat their patients. Although prescription drugs account for “only” 17% of US health care spending, this has become a “tail-wagging” situation: The drug companies control the “knowledge” that informs physicians’ clinical decisions. This leads to soaring pharmaceutical profits and crippling healthcare costs, while doctors don’t know which therapies are more effective or efficient. Americans deserve better.
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was original published at “https://time.com/6171999/big-pharma-clinical-data-doctors/”