How Evidence Based Medicine Became an Illusion

Writing in BMJ, researchers argue that evidence-based medicine has become so corrupted that it has essentially become a contradiction in terms.

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In a new opinion piece published in the British Medical Journal, researchers Jon Jureidini and Leemon McHenry argue that “evidence based medicine” is more corporate gimmick than reliable science.

According to the authors, corporate greed, failed regulatory practices, and commercialized academia have made research far less objective and reliable. These developments call the validity of the practices and prescriptions we base on that research into question. To build a more reliable evidence base and to return validity and reliability to academic research, they suggest that we must stop all funding of regulatory bodies by drug companies, tax the pharmaceutical industry to fund genuinely independent research, and make the data from this research available to independent third parties capable of objectively reviewing findings.

“The advent of evidence based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics,” Jureidini and McHenry write.
“The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry-sponsored clinical trials are misrepresented. Until this problem is corrected, evidence based medicine will remain an illusion.”

Many researchers have written about the corrupting influence of pharmaceutical industry money on medical research. Research has shown that more than half of the panel members tasked with developing the DSM-IV were receiving payments from the pharmaceutical industry. The panels on “Mood Disorders” and “Schizophrenia and Other Psychotic Disorders” were comprised entirely of individuals accepting such payments. Industry money also results in “sponsorship bias” in clinical trials where researchers are much more likely to interpret data positively for their sponsors.

There is also a problem with undisclosed conflicts of interest in medical research, with researchers commonly not reporting their acceptance of payments from the pharmaceutical industry. Even when they are as small as paying for a meal, these payments influence physician prescribing practices. This leads to costlier prescribing practices and compromises patient care.

In addition to ghostwriting research, the pharmaceutical industry has an enormous corrupting influence on every step in the research process. Through “ghost management” of research, the industry dictates what research gets funded and how that research is designed, organized, audited, and analyzed. In many cases, this fraudulent, ghost-managed research is more likely to be accepted for publication in academic journals.

Research has also found that pharmaceutical industry money likely corrupts medical education. For example, one author found that the pharmaceutical industry-funded continuing medical education encouraged doctors to increase opioid prescriptions without considering the consequences. Similarly, researchers have found that industry-funded medical education around binge eating disorders is biased towards promoting the use of industry drugs.

The Food and Drug Administration (FDA) in the United States has adopted an accelerated approval process at the pharmaceutical industry’s demand. This accelerated approval process allows the industry to sell ineffective drugs to unsuspecting consumers. In addition to this accelerated approval process, the FDA works with pharmaceutical companies to find ways of making failed drugs marketable, despite their lack of efficacy and the possible dangers of their use.

The current work begins with explaining critical rationalism as championed by Karl Popper. Critical rationalism challenges us not to cling to “cherished hypotheses” but instead to critically evaluate and reevaluate what we think we know about the world based on the outcomes of closely controlled scientific experiments.

For the authors, science must adopt a stance of critical rationalism if it is to have integrity. But unfortunately, corporate involvement in research is causing financial interests to eclipse scientific integrity. For example, the pharmaceutical industry’s ownership of data allows for the suppression of negative clinical trials, hiding adverse events, and refusing to allow independent researchers to evaluate the raw data.

The authors point to 3 significant issues currently destroying the integrity of evidence-based medicine: corporate interests, failed regulation, and the commercialism of academia. The pharmaceutical industry is responsible first and foremost to its shareholders, meaning scientific integrity is very low on their list of concerns. Underfunded universities commonly look to the pharmaceutical industry for funding. In accepting grants, endowments, etc., from corporations, universities begin to prioritize scientific integrity less, becoming little more than “instruments for industry.”

The authors also take issue with who is promoted to leadership positions at the corporate university. Rather than promoting those that make distinguished contributions to their field, universities promote those that are best at fundraising. The result is universities being led by people loyal to the highest paying corporate entity with little research experience or concern for scientific integrity. The industry then targets these managers as “key opinion leaders” (KOL), bribing and flattering them into presenting corporate propaganda as legitimate academic research.

Universities allow these KOLs to present fraudulent misrepresentations of data without consequence under the guise of academic freedom. The KOLs commonly attack, berate, and destroy the careers of their more ethically minded colleagues for criticizing the industry. Those researchers not bought by industry encounter countless roadblocks in getting their research funded and published.

Pharmaceutical companies commonly fund regulatory agencies (for example, the FDA in the United States). The result is bought regulatory agencies overseeing industry-funded research, written by industry agents and fraudulently published under the names of influential academics. Moreover, these regulatory agencies commonly approve drugs produced by their financiers without examining any raw data.

The authors point to three policies they believe could begin to return integrity to medical research. First, regulatory agencies must not be funded by industry. Second, a tax should be imposed on the pharmaceutical industry and used to fund truly independent clinical trials of industry products. Last, the raw data from clinical trials must be made available to independent researchers.

 

 

 

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Jureidini, J., & McHenry, L. B. (2022). The illusion of evidence based medicine. BMJ, o702. https://doi.org/10.1136/bmj.o702 (Link)

17 COMMENTS

  1. This is an extremely depressing article because the sensible proposals suggested to improve the situation have no chance of coming to pass in the United States. In addition to all the problems listed in the article, we have a Congress that is owned by the pharmaceutical industry. In 2020, for example, more than two-thirds of senators and representatives accepted pharmaceutical campaign money.

    Big Pharma’s money has been well spent. Congress has been instrumental in weakening the FDA by allowing pharmaceutical funding of the agency and compromising procedures to approve drugs and medical devices through measures such as the 21st Century Cures Act.

    Yes, changes should be made. But with so many people and institutions profiting how is that going to happen?

  2. Thank you for your article. I find it appalling that people are compromising the integrity of science. As a biologist I was asked to falsify data on my research. I refused. I chose the consequences of my refusal rather than compromising my integrity. If you compromise your integrity what do you have left.

    Evidence Based Medicine is a joke. There is no such thing as evidence based medicine. I pointed that out to my former college advisor that took a job overseeing evidence based medicine. Doctors can’t even diagnose. I could give example after example of poor diagnostic abilities in medical doctors. When you have tachycardia (a resting heart rate in humans above 100 beats per minute) and are diagnosed with clinical depression. I don’t remember tachycardia as a criteria in any of the DSMs. Not to mention, would not an anxiety disorder be a much better misdiagnosis for tachycardia.

    I don’t think there is any way to change the toxic system. It is so far gone that these people have no morals. They dehumanize users of their corrupt system. They refuse to listen. They refuse to change. They have zero incentives to change. They are being rewarded for lying, stealing, killing, and destroying. Why would they change?

    I agree that all raw data should be made available. I think it should be available to everyone. More transparency.

  3. Judging from this article, the authors cited give a valid analysis.

    But then they suggest a branch of Critical Theory as the answer? Critical Theory has failed us in other fields, so I would not trust it to resolve this issue.

    In sports, the team that gets the most points wins the game. This might be called “evidence-based sports.” It might be noted that not all sports have always worked this way!

    I don’t disagree with the idea that a handling for a situation should be based on evidence that it works. But in the long run, we also need saner ways of getting better ideas. If one idea kills 40% of the patients and the other kills 50% of the patients, is it really “evidence-based medicine” to choose the one that only kills 40%? What if the process of finding a handling eliminated one that would not have killed anyone and would have been more effective at making people well?

    So we also need a saner approach to making people well. Medicine has its place, but it is obviously not the total answer, and on top of that, it has been taken over by an industry that is not ethical.

    Several years ago, I got the idea that we needed to re-think the whole subject of how we provide healing services to a population. My first idea was to prohibit profit-making businesses from entering this field. But now that seems a bit superficial. The corporate world has nearly a stranglehold on modern society. And if they take over central governments, then there is no one left with sufficient force of arms (let’s be practical) to enforce any ethical framework on big business. And there are many “non-profits” among the list of offenders.

    So we have been pushed so far towards the edge of the cliff now, that we must either learn how to fly or be willing to fall. We are moving into a world of “miracle and wonder” as prophesized by Paul Simon. “Medicine is magical and magical is art.” We COULD learn to fly, but will we, in time?

    • There is also the question of grouping. If one treatment cures 10 percent of the “ADHD” population, but drugs “reduce symptoms” in 70 percent of the population, the 10 percent treatment will be regarded as “ineffective,” even though it cured one out of 10 people completely. If you have arbitrary and/or purely subjective groupings of subjects, you’re not going to get any meaningful information. A REAL scientist would look at that 10 that WERE cured, and say, “Wow, what is different about these people that treatment X worked so well?” Then they might actually be able to identify a true group that has something in common with each other, and THEN (and only then) can they actually look for causes.

      But too many people are hypnotized by the “Gold Standard” argument and think that anything producing a p value under .05 is “evidence based,” regardless of the triviality of the result or the heterogeneity of the group. It is a setup for drugs to “win” every contest, and I doubt very much if that fact is accidental.

      • I think is sadly very true. So, in my opinion, we do have either capitalism, socialism, communism or marxism as a government. We have a corporation as a government. Some could say that this was inevitable with capitalism, but in my opinion, almost any government or economic system could be the cause or contributing factor. I think this is the case, also in communist or formerly communist countries, too. It was only a matter a time and an unfortunate natural progression. What could be next? Anarchy? That doesn’t sound too appealing, either. However, I will try to stay optimistic that eventually a better, more humane form of government will result. Thank you.

  4. I just watched the Hulu show, Dropout, about Theranos, and the false claims by the people who ran the start up, including Elizabeth Holmes. One of the key moments in the show is the depiction of two lab assistants who have been asked to falsify data (asked, or told rather, to remove results that point to the inaccuracies of the testing mechanism as “outliers”).
    Elizabeth Holmes and her main co-conspirator have both been charged with fraud and are looking at possibly long prison sentences. But it seems that this type of thing is happening every day, in every lab, in every part of the industry. When will the people who run the psych drug trials be charged?

  5. Most everyone knows this. And nobody uses it as a criteria to choose an elected official that might change this….but count researching the best large-screen-tv value as time well-spent.

    I was a Democrat. I assumed they would ‘more likely than not’ champion some pushback or reform for Pharma $. Then I found Schumer’s name at the top.
    The best candidate for reform was Warren.
    On the purity scale, she had the highest marks and best messaging loudly & consistently against Pharma in committee…& the other ‘GE’s of the country.

    Unless & until we organize effectively, vote with this agenda front-of-mind, and come armed with facts (easy)…these articles overstating the obvious to special interest groups (us) is an exercise in futility.

    • I am surprised that you think elected officials can handle this. We have witnessed in my lifetime what amounts to a corporate takeover of the democratic process, using money and their expertise in marketing.

      We have seen most elected officials go along with the wishes of Big Pharma, which, outside of the vaccine controversy, includes a mostly wholehearted endorsement of psych meds.

      I think this is largely on us. We have to find better modes of healing and offer them to people with the result that they abandon “medicine” that doesn’t work and is just profiting off their suffering.

  6. I.e.cox: My initial comment agrees with your points.
    My modest conclusion was addressing the grassroots, organizational, long-game regarding pushback against the power of culturally supported Big Corporate $ that historically has protection from Congress…auto industry safety-THANKS Ralph Nader, Jeffrey Wigand-tobacco, alcohol/hospitality industry lobby-MADD mother’s legislation & settlements…. the gun lobby & legal action regarding Alex Jones AND Remington settlements-Sandyhook parents…recognition of post-partum behaviors in women, disability access laws, Title 9 equality, rape laws/husband’s ‘rights’, child-marraige (U.S.), etc, etc. Oh yeah…& sexual-predator clergy & medical professionals everywhere who are protected by virtue of assumptive character traits AND powerful lobbies…slow change.

    My point is these legislative changes, however modest and s-l-o-w in some cases, are effective because organizer’s goals were 2-pronged….1) carefully crafted (consistent & relentless) messaging effects voter’s donations & votes, eventually. 2) THAT gets politicians attention most effectively. And change CAN result.

    NONE of this came quick & easy. Reforming psychiatry so far has been alot of ‘cathartic’ howling among the converted…who are characterized EFFECTIVELY by the industry as irrational, dangerous, & incompetent. ‘How sad’.

    Public messaging is a complex strategy requiring (a) unified goals.
    Mine is safety in the system that EXISTS NOW…and then carefully carving out the tumors that created/sustain the dangers & misinformation.
    And appearances count alot to the public. When shooters in suburban white schools are frequent headlines, there was the horrible, unfortunate awareness of danger in real-time, ‘ordinary’ lives. Galvanizing and holding that potential threat awareness is what motivates campaign donations….and, ‘magically’, politicians responsiveness.

    Yeah, a flawed system…but it’s worked for other righteous causes against cultural resistance, massive corporate $, & ignorance on a topic that most don’t think applies to them & theirs.

    We know differently.
    Changing how a culture thinks about ‘mental health & mental illness’ is as hard as 2nd Amendment ‘feelings’.
    Pharma has owned the topic, owned the ‘authority’, owns the messaging, & owns the current politicians.

    It can change.

  7. In my opinion, in regard to psychiatry, medicine and other subjects, we do conflate and inflate way too, which if we choose, for instance the anti-psychiatry stance we are not even at the “starting gate.” We expect politics and both elected and non-elected political officials to be the answer. They are not. Even an elected official’s donor history will not prove how they will vote or what their true beliefs around a matter are. Elected officials are just as vulnerable to the influence of not only their constituents, but also their colleagues and probably, even more so, the lobbyists that hover in legislative and other circles. If we want to change things, we must extricate ourselves from the political realm. Like mass media, these days, the bargains made are sadly very rarely, for anyone’s good. additionally, the idea of “evidence-based medicine” reflects very deeply how medicine is no longer medicine for health and well-being, but now is just another arm of the entire legal system. The idea of “evidence” used to, say convict a criminal, is one thing. But now we use “evidence” to convict someone in physical/mental distress. This is the tragedy. “Evidence” belongs in the courtroom. It does not belong in the doctor’s office or examining room, no matter the specialty of the doctor. Thank you.

  8. Strategy & tactics
    My point: Money talks…and gets ACCESS.
    It’s where change starts.
    Consistent, carefully crafted messaging and targeting certain lawmakers appropriately can affect $ and votes.
    See last post.
    So far ‘wanting’ change changes nothing.
    Follow the $. They will follow.

    • Well, Krista, my church is working on a strategy that takes finances and media into account. Who else is following our model?
      But as things stand, with mainstream financial and media corporations well in the hands of psychiatry, we cannot realistically mount a public campaign that can match their current and imagined future efforts.

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