There is a big flaw in the logic of evidence-based medicine as the basis for the practice of medicine as we know it, a practice based on science; one that determines care down to the level of the individual patient. This flaw is nestled in the heart and soul of evidence-based medicine, which (as we have seen over the last two years) is not free of politics. It is naive to think that data and the process of licensure of new drugs is free from bias and conflicts of interest. In fact, this couldn’t be any farther from the truth. The COVID-19 crisis of 2020 to 2022 has exposed for all to see how evidence based medicine has been corrupted by the governments, hospitalists, academia, big pharma, tech and social media. They have leveraged the processes and rationale of evidence-based medicine to corrupt the entire medical enterprise.
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.This ideal of the integrity of data and the scientific process is corrupted as long as financial (and governments) interests trump the common good.
Medicine is largely dominated by a small number of very large pharmaceutical companies that compete for market share, but are effectively united in their efforts to expanding that market. The short term stimulus to biomedical research because of privatization has been celebrated by free market champions, but the unintended, long term consequences for medicine have been severe. Scientific progress is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.
As the US government, particularly NIAID, controls a significant amount of the grants and contracts of most academic institutions in the USA, NIAID employees also can determine what research is conducted and who is funded to conduct that research.
Those who succeed in academia are likely to be key opinion leaders (KOLs in marketing parlance), whose careers can be advanced through the opportunities provided by industry. Potential KOLs are selected based on a complex array of profiling activities carried out by companies, for example, physicians are selected based on their influence on prescribing habits of other physicians. KOLs are sought out by industry for this influence and for the prestige that their university affiliation brings to the branding of the company’s products. As well paid members of pharmaceutical advisory boards and speakers’ bureaus, KOLs present results of industry trials at medical conferences and in continuing medical education. Instead of acting as independent, disinterested scientists and critically evaluating a drug’s performance, they become what marketing executives refer to as “product champions.”
- Regulators must be freed from drug company funding. This includes the FDA funding -which must come directly from the government, as opposed to pharma fees, as now is the case. Tying employee salaries to pharma fees creates a huge conflict of interest within the FDA.
- The revolving door between regulators like the FDA, the CDC and big pharma (as well as tech/media) must stop. Employment contracts for regulatory government positions must have “non-compete” clauses whereby employment opportunities are limited upon leaving these regulatory agencies. Likewise, big pharma executives should not fill leadership positions at regulatory agencies.
- Taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymised individual patient level trial data posted, along with study protocols. These data to be provided on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results.
- Clinical trial data must be made public. Trial consent forms are easily changed to make this anonymized data freely available.
- Publication of data must be open and transparent. The government has a moral obligation to trial participants, real people who have been involved in risky treatment and have a right to expect that the results of their participation will be used in keeping with principles of scientific rigor.
- The government and it’s employees has a moral obligation to the public to conduct clinical trials in ways that are non-biased by industry.
- The Foundation for the CDC and the Foundation for the NIH, which runs clinical trials and studies for these organizations (while their boards are made up of pharma industry executives and employees) must be decommissioned. We have laws in this country whereby the government does not accept volunteer labor, or direct donations to influence government decisions. These NGOs are doing just that. These practices must be stopped. They are intentionally using these organizations to bypass federal laws concerning exertion of undue influence on federal decision making.
- Off label drugs must continue to be used by the medical community. The early treatment protocols, which have saved countless lives, have documented the important role that physicians have played in finding cheap and effective treatments for COVID as well as many other diseases. Let doctors be doctors.
- Scientific and medical journals must be stopped from taking monies from big pharma. This includes the sales of reprints, banner ads, print ads, etc.
- Government must stop interfering with the publishing of peer reviewed papers and social media. A free press must remain free from coercion from government. We all know countless examples, such as the Trusted News Initiative (TNI) and White House meetings with big tech to influence what is allowed to be printed. And the billion dollars spent by the US Government to promote these EUA/unlicensed “vaccine” products that do not prevent infection or transmission of the SARS-CoV-2 virus. This is a direct assault on our first amendment rights. It also skews evidence based medicine.
- Informed consent, one of the foundations of modern medicine, has been stymied by the FDA, NIH, the CDC hospitalists, big tech and social media. They have been hiding data and skewing results. When people can not get the information they need to make an informed decision, evidence-based medicine can not function correctly.
- The government and it’s employees must stop picking winners and losers. Evidence-based medicine requires a non-biased playing field.
- Industry concerns about privacy and intellectual property rights should not hold sway.