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An Enemy of The Open Society

Is there confidence in vaccine manufacturers?

The llusion of Evidence Based Medicine3

Corporate interests corrupt clinical trials, physicians and universities, undermining the foundation of evidence-based medicine. Philosopher Leemon McHenry and psychiatrist Jon Jureidini argue that the principles underlying Popper’s philosophy of science can protect clinical research from corporate malfeasance in a capitalist economy.

Evidence-based medicine was a paradigm shift that is often praised as one of the greatest achievements of medicine in the twentieth century. This radical change in medical practice is based on epistemological hierarchies of evidence, from opinions of respected authorities, mechanistic reasoning and reports of expert committees at the bottom to various levels of observational studies and finally to randomized, placebo-controlled clinical trials at the apex. Randomized, placebo-controlled clinical trials, recognized as the gold standard of clinical experimentation, generally maintain their position in the hierarchies because when well-designed and well-conducted, they provide a basis for assessing harms and benefits, and help deter extravagant claims of efficacy and safety.

Quite apart from the philosophical difficulties with the very concept of evidence-based medicine, there is one practical problem that has been the main obstacle in its implementation.  The validity of the paradigm depends on reliable data from clinical trials, of which approximately 90% are conducted by the pharmaceutical industry.  Given the strong financial incentive to design, conduct and report the trials to guarantee favorable outcomes in the study drug, evidence-based medicine is betrayed at every step of the process.  The result is a crisis of credibility. 

The one problem confronting the doctor and patient is how to sort out the genuine science from the rigged science when the latter is crafted to look exactly the same as the former?  Medical journal articles, conference presentations, and continuing medical education programs are all dominated by the pharmaceutical industry reporting on safety and efficacy of their own products.  The companies hire for-profit contract research organizations to conduct clinical trials, academic physicians to act as clinical investigators, medical communication companies to ghostwrite publications in the names of academics, and public relations firms to create positive images of drugs for prescribing physicians and the public.  All are eager to serve their client’s best interest over those of good science and patient welfare.

It is often said that science, unlike ideology, is a self-correcting, dispassionate search for the truth.  This very point was powerfully addressed by philosopher of science, Karl Popper, when he advocated for the integrity of science and its role in an open, democratic society.  He argued that scientists should consciously and deliberately seek out errors rather than wait for them to reveal themselves.  A science of real integrity is one in which its practitioners are careful not to cling irrationally to cherished hypotheses for one reason or another and are serious about the outcome of the most stringent experiments, but this is exactly what academic medicine lacks under the sponsorship of the pharmaceutical and medical device industries. As Popper notes, “My own misgivings concerning scientific advance and stagnation arise mainly from the changed spirit of science, and from the unchecked growth of Big Science, which endangers great science.”  He concludes, affluence may be an obstacle to scientific progress -- “too many dollars may chase too few ideas.”

Since the companies have intellectual property rights to the data they generate, they control the dissemination of information.  Scientific progress, however, is thwarted by the ownership of knowledge, especially in clinical medicine where the adverse impact on the research agenda, universities and regulators costs lives. This is especially true when there are worldwide shortages and discontinuations of medicines for serious, life-threatening diseases. Drugs that treat relatively trivial conditions in wealthy first world countries and exorbitant niche drugs for cancer and rare diseases provide enormous profits to the drug companies while other important but less profitable drugs are not developed or discontinued.

It is no surprise that the pharmaceutical industry’s responsibility is to its shareholders over scientific integrity. More concerning is the way in which universities, supposedly the bulwark of scientific integrity, become entangled with business, compromising basic academic values. Universities have responded to reduced funding from government by embracing a neo-liberal market role for themselves, seemingly unconcerned that they thereby become instruments of industry. It suits universities to frame these relationships as “partnerships” with industry, but this shows a disingenuous failure to recognize the asymmetry of that relationship. Pharmaceutical companies are orders of magnitude bigger than universities and have the power, resources and expertise to steer the ‘partnership’ in the way that suits them, so that universities come to serve as agents for the promotion of commercial products.

It is not just the institutions that are used in this way by industry. Increasingly physicians who succeed in the academy are those who have become, in the parlance of industry, “key opinion leaders”. Key opinion leaders tend to be identified early in their career on the basis of synergies with company agenda, affiliation with prestigious universities and charisma. Industry enters into mutually beneficial relationships with key opinion leaders, paying them well to be members of pharmaceutical advisory boards and speakers’ bureaus, building and exploiting their potential influence on the prescribing habits of physicians.  They are supported, for example having their slides prepared, to present results of trials at medical conferences and in continuing medical education lectures, so that attendees misperceive marketing as science. Instead of providing a critical evaluation of the drug’s performance, they become what marketing executives refer to as “product champions.”

 

"How did we ever get to the point where drug companies are allowed to test their own products?"

Critics of scientific misconduct face an uphill battle.  Sometimes academic investigators blow the whistle on the misrepresentations of scientific data, ghostwriters reveal how they were pressured to position drugs with favorable marketing messages, and regulators resist rapid approval of drugs that have not been demonstrated safe and effective.  But they all do so at serious risk to their careers.  Instead of inviting criticism as essential to the process of scientific testing, the industry suppresses it.  Instead of inviting external critics to ensure that design flaws and conformational bias are not slipping into the process of drug testing, potential critics are identified for “neutralization” by public relations campaigns conducted by marketing departments.  Pharmaceutical companies exert an enormous control over what gets done as research and what gets reported in the journals and conferences.  Contrary to the commonly-held belief that medical journals are trusted repositories for reliable medical information, it is extremely difficult to publish criticism of misleading, false and fraudulent reports of pharmaceutical industry-sponsored research.  Even the most well respected medical journals have serious conflicts of interest when considering articles that attempt to set straight the scientific record.

So, how did we ever get to the point where drug companies are allowed to test their own products, rather than having them tested by independent experts as part of a public regulatory system? According to Popper, solutions to social and political problems should be subjected to rational testing and evaluated with intellectual honesty and dispassion. His position is vindicated by the way in which the commercial motive of industry has corrupted evidence-based medicine, in the testing of medicines, but also by co-opting academics, universities and government to participate in the deceptive enterprise. There is, in Popper’s terms, no real effort at a genuine test and nothing that can be trusted as intellectual honesty in the research produced. For him, the pharmaceutical industry is guilty of producing pseudo-science and, in its relentless efforts to suppress criticism, becomes an enemy of the open society.

This is particularly important at a time when there is a  race for COVID19 vaccines. We had hoped that the urgent task of seeking a vaccine would lead to a new level of collaboration whereby research teams would share their progress and even their data, possibly every day or week, so that others could use the best ideas and stringently audit any claims made by a particular research group. We have seen little of this cooperative research in the spirit of Popper. At the best of times, the system of drug development and testing fails to adhere to standards of rigorous science and has produced disasters such as Grünenthal’s thalidomide, Merck’s rofecoxib and Purdue Pharma’s oxycodone.  Now during a global pandemic, what confidence can be placed in the manufacturers of a vaccine?    

 

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Cameron Chelmsford 16 July 2021

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