Tam Hunt: How Is ‘Big Pharma’ Ruining Health Care? A Conversation with Dr. John Abramson | Opinions

The corruption of science by money is not a new concern. In fact, it’s become so embedded as a problem that it’s almost cliché.

Richard Smith, former editor and chief executive of the prestigious British Medical Journal, wrote an essay way back in 2005 that says it all right in its headline: “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies.”

He followed up in an even more scathing essay in 2021, suggesting that “It may be time to move from assuming that research has been honestly conducted and reported to assuming it to be untrustworthy until there is some evidence to the contrary.”

Smith wasn’t alone in his concerns.

“Journals have devolved into information laundering operations for the pharmaceutical industry,” wrote Richard Horton, editor of The Lancet, another highly prestigious medical journal, in March 2004.

That same year, Marcia Angell, former editor of The New England Journal of Medicine, another prestigious academic medicine publication, also wrote that medical journals were “primarily a marketing machine” and “Big Pharma” was co-opting “every institution that might stand in its way.”

John Abramson, a lecturer in health-care policy at Harvard Medical School, has taken these critiques quite a bit further in his latest book, Sickening: How Big Pharma Ruined American Healthcare and How to Repair It.

He demonstrates in numerous case studies just how much our medical research establishment has been corrupted by “Big Pharma.” This is a code red kind of moment, he argues.

We discuss the implications of his research in the interview below.

Tam Hunt: Your new book reveals an indeed sickening and widespread corruption of the medical and health-care industry, but you focus a lot on the role of top medical journals like JAMA and NEJM in the growing inaccuracy of and sometimes actually fraudulent medical research industry. What has been the response of these journals, either publicly or privately, to your book so far?

John Abramson: No response whatsoever. I think their Plan A has been silence, which has been working quite well to keep the issues I raise out of the public consciousness.

TH: You suggest that British journals have better protections in place against corruption of medical research, but are these protections actually effective? A recent in-depth piece looked at the overly close relationship between The Lancet and the Bill & Melinda Gates Foundation-funded Institute for Health Metrics and Evaluation (IHME) at the University of Washington, and found much to criticize based on the number of articles published from the IHME team in The Lancet.

Is The Lancet much better than JAMA or NEJM? Where does BMJ fall in the hierarchy of least corrupt medical journals?

JA: My impression is that Lancet is not different than NEJM or JAMA. As I write in the book, 41% of Lancet’s income (in 2005) came from selling reprints back to drug companies, which is the business model for the most prestigious journals.

BMJ is different: they publish fewer large clinical trials, and have a much more robust discussion of the full range of issues, including those that are critical of the pharmaceutical industry.

TH: Have you faced retaliation from employers, colleagues or patients for your work in exposing the widespread corruption of our health-care system?

JA: I have not faced retaliation, though there has been a near-blackout of coverage of my book by commercial media since publication on Feb 8. This is very different than the coverage I received as an unknown author after my first book, Overdo$ed America, was published in 2004. Of course, the situation with commercial media could still change.

TH: Given the great power of “Big Pharma” and “Big Insurance,” and the natural tendency of medical professionals to not rock the boat (at least not too much), how would you encourage your colleagues in medicine and the teaching profession to find the courage to start pushing back on the widespread corruption your book demonstrates?

JA: This is an excellent question. The first step is for physicians to become educated about the extent to which the information that they trust is influenced by and designed to serve the interests of commercial entities.

This is the reason why I wrote Sickening, and very much hope that the book will serve that purpose. Even the most basic facts, like that peer reviewers and guideline writers don’t have access to the underlying data from clinical trials and therefore must trust the mostly corporate-managed reports of clinical trials published in medical journals.

TH: You make a powerful case that the medical research industry is fundamentally corrupted in the United States, but you also open your book with a discussion of COVID-19 that takes the public mortality stats and vaccine research as valid on its face.

Shouldn’t we apply the same very strict scrutiny to the COVID-19 pandemic, related research and claims regarding COVID-19 therapeutics that you apply to other “Big Pharma” therapeutics in your book?

JA: This important question highlights the dilemma that commercial control of research, lack of data transparency, and known past violations of scientific integrity pose to health-care professionals, public health experts and, most important, consumers.

First, we know that pharmaceutical research and communication of results are largely controlled by the manufacturers. In the case of the COVID vaccines, the Food & Drug Administration has also been complicit in the lack of data transparency.

Two prime examples of the interaction between commercial control and FDA complicity are the full FDA approval of Pfizer’s vaccine and the approval of second boosters for people over 50 years of age as well as younger immunocompromised people.

The FDA promised to hold advisory committee meetings before approvals, so the data could be discussed openly by experts and shared with the public. But advisory committee meetings were not held prior to either approval.

The FDA and Pfizer’s withholding of the data submitted for full approval of the vaccine in August 2021 was so unyielding that they fought a FOIA request to release the information, volunteering to release the information at such a slow pace that full disclosure would have taken 76 years.

The FDA (and Pfizer, which was attempting to join the lawsuit on behalf of the FDA) were taken to U.S. District Court, where Judge (Mark) Pittman ruled the documents had to be released over an eight-month period.

Similarly, for the second booster, the FDA accepted data from two observational studies done in Israel, after that country approved a second booster without supporting evidence.

After approval of the second booster in Israel, an observational population-based study that looked at people age 60 and over found “the adjusted rate of severe COVID-19 in the fourth week after receipt of the fourth dose was lower than that in the three-dose group by a factor of 3.5 (95% confidence interval [CI], 2.7 to 4.6).”

But this is a “natural experiment,” the results of which we can be certain to have been distorted by the residual “healthy vaccinee” effect — the same phenomenon that left Americans believing for many years that post-menopausal hormone replacement therapy made women healthier when, as revealed by a well-designed RCT that was finally done, the truth was that more women who took HRT were likely to be healthy in the future, independent of the effect of HRT.

A second, much smaller observational study was done on Israeli health-care workers who did and did not choose to receive a second booster. Although this study was subject to the same biases as the larger study, narrowing of the population studied to health-care workers narrowed the socio-economic spectrum of the population and thus can be assumed to have narrowed the potential.

The study concluded “a fourth vaccination of healthy young health-care workers may have only marginal benefits.”

The FDA accepted these two studies and approved a second booster for people 50 and over (without so-called evidence for people between 50 and 60), and the stituation remained beneath the public’s radar because the FDA failled to keep its promise to hold advisory committee meetings before approvals.

All of this leaves us with nontransparent and likely commercially biased data supporting the FDA’s approvals.

But the fact that the drug companies and the FDA may collude to prevent transparency and independent review does not mean the vaccines do not provide protection against serious illness in certain populations from this deadly virus. Doctors have to make decisions with inadequate information.

Of course, we would all be better off if the inadequacy of the information were given its due in the mainstream press, but that’s not the world we live in. During the peak of the last Omicron wave, death rates for fully vaccinated and single-boosted adults varied between 1/20th and 1/40th as high as in unvaccinated adults.

These data suffer from all the weakness of the large Israeli population-based observational study. Nonetheless, doctors and each of us consumers must decide for ourselves whether the “story” being told by the real-world data trump the bias and inadequacies of the commercially sponsored, FDA-accepted data.

In other words, although we should not be in this position, we need to make a decision with inadequate information.

TH: More specifically, FDA released in early 2022, after a court order, a number of documents concerning their approval of the Pfizer Comirnaty vaccine, which it had previously refused to do.

As reported widely, FDA’s previously released summary of its “basis for regulatory action” (p. 23) showed that there were in fact a few more deaths (21) in the vaccine group in Pfizer’s trial than in the placebo group (17).

More significantly, FDA’s documents released on March 1, 2022, showed 1,223 fatalities and 42,086 reports of injury in the first three months of use of the Pfizer EUA vaccine, without attributing these events necessarily to the vaccine.

Do these new data, released after the fact, cast doubt on the almost universally accepted claims (published starting with Polack et al. 2020) about the efficacy of Pfizer’s EUA and Comirnaty vaccines (these are different products) to prevent the most serious COVID-19 outcomes and that they are “safe and effective”?

JA: These data are voluntarily reported adverse events, subject to many biases, including preexisting scientific and political predispositions. They should be treated as “hypothesis generating” rather than evidence.

My opinion is that the concerns these data raise are addressed by the lack of excess deaths in the vaccinated population as described above.

TH: Are there similar concerns about FDA’s approval of the Johnson & Johnson one-dose vaccine, in light of the FDA’s recent decision to highly restrict its use because of concerns about thrombosis with thrombocytopenia syndrome (TTS, arising from blood clotting issues)? Was the FDA premature in issuing its EUA for the J&J vaccine?

JA: Maybe. But remember an EUA is issued in the face of serious health threat without fully established safe and effective therapeutic options.

The real question here is were the clotting issues associated with the J&J vaccine brought to the FDA, health-care professionals and the public in a timely fashion? If so, one could argue that the risks taken by the EUA approval did not outweigh the probable gains.

I am agnostic on the answers to these questions — but they must be asked.

TH: Do these and related issues support the notion that the EUA process, which is relatively new, may need fundamental reform?

JA: Of course our EUA process needs reform. Situations are almost certain to arise in the future that present a grave health threat but have no established therapy. As is often the case, doctors must make decisions without adequate information.

The problem with our EUA process is not that it makes new therapies available in emergencies with a lower bar of evidence. The problem is that our pharmaceutical regulation, i.e. the FDA, has been so captured by industry that our EUA process does not mandate — absolutely and with no exceptions — that as soon as data become available to the manufacturer it must be made available to the public. Period, full stop.

This is not complicated. Overcoming the imbalance in power between the pharmaceutical industry and Americans’ health that allows this craziness to continue is complicated.

TH: Is it correct to assume that you avoided discussion of these COVID-19 controversies in your book in order to not detract from the main messages of your book about Big Pharma more generally?

JA: Quite the contrary. I brought some of these controversies right up front in the introduction of the book to communicate the message from the outset: Pharma’s single goal is to maximize financial returns to their investors.

This is not an accusation, rather a simple fact. They design, conduct, analyze and disseminate clinical research to further that primary goal.

Pharma also has a virtual monopoly on the production of what is taken for knowledge about its products.

Health-care professionals and the public are, especially in the United States, left in the compromised position of having to make medical therapeutic decisions without adequate information. The system is designed to maximally exploit this asymmetry of information.

Nonetheless, one out of four truly new drugs (“new molecular entities”) that are approved by the FDA has medical value that was not previously available.

But, especially in the United States, doctors have little to no resources that help them discern which new drugs are truly helpful and which are being pushed simply for their financial potential. It’s sickening.

TH: What actions should regular people take to mitigate the issues you highlight so clearly in your book?

JA: The problems with our health-care system that leave Americans’ healthy life expectancy ranking 68th in the world yet spending an excess $1.6 trillion annually on health care are not going away in the near future. If anything, we are moving in the wrong direction.

So the most important thing that regular people can do is to disconnect from the health-care industry’s propaganda that the path to good health is through new, improved and very expensive medical innovation.

Health-care professionals and the public have become chained to the thrall of medical innovation. The fact is that about 20% of our health is determined by health care — yet that 20% can be very important.

But 80% of our health is determined by how we live our lives. Healthy life habits — not smoking, exercising at least five times a week, eating a healthy diet and drinking in moderation — go a long way.

Nonetheless, there will be times when you and your family members need and will benefit from conventional medical care. Find a doctor you trust, be cautious, use tried and true therapies before adopting the latest, greatest and most expensive therapy — understanding that the commercial push often hypes new therapies that may be less effective than established care.

And finally, hopefully at some point in the future, Americans will have the opportunity to believe in good government again (as in the post-World War II years).

The corporate capture of government over the past four decades, especially with regard to health care, is probably the greatest risk to our health today.

— Tam Hunt is a lawyer and a writer. The opinions expressed are his own.