Letter of the Day | Pharma companies should be held accountable
THE EDITOR, Madam:
For some time now, it has been known, but probably not widely recognised, the tremendous control exerted by the big pharmaceutical companies over medical research and publications, and over the major international and national health regulatory authorities – this, by virtue of their massive financial contributions to these agencies.
This reality was magnified during the recent COVID-19 episode when Big Pharma, in concert with the World Health Organization, the Food and Drug Administration and National Institutes of Health in the United States, and other national health regulators, was allowed to produce and proclaim a medical intervention as “safe and effective” without adequate evidence, declare it as the main means of dealing with the epidemic (to the exclusion of other measures), and even propose mandatory use with serious consequences for disobedience.
As more and more evidence emerges concerning the degree of deception and corruption that has prevailed, growing anger and indignation is amplifying the previously muted question “So what can we do about it?” into a loud demand –“Something MUST be done about it!”
Two recent articles published in the British Medical Journal (BMJ) have joined the chorus: In The illusion of evidence-based medicine, the authors argue that evidence-based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia. “Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence can we have in a system in which drug companies “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue.” (Published March 16, 2022)
The second article, From FDA to MHRA; are drug regulators for hire? (published June 29, 2022), exposes several elements of the problem:
1.Industry Fees. “Industry money saturates the globe’s leading regulators. Even the FDA - the most well-funded regulator - reports 65 per cent of its funding for the evaluation of drugs comes from industry user fees”
2. External advisers. “A BMJ investigation last year found several expert advisers for COVID-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers”.
3. Transparency, conflicts of interest and data. “Recently, a group of more than 80 professors and researchers, called the Public Health and Medical Professionals for Transparency, sued the FDA for access to all the data which the agency used to grant licensure for Pfizer’s COVID-19 vaccine. The FDA argued that the burden on the agency was too great and requested that it be allowed to release appropriately redacted documents at the rate of 500 pages per month, a speed that would take approximately 75 years to complete. In a win for transparency advocates, this was overturned by a US Federal Court judge, ruling that the FDA would need to turn over all the appropriately redacted data within eight months. Pfizer sought to intervene to ensure “information that is exempt from disclosure under the FOI act is not disclosed inappropriately”, but its request was denied.”
4. Speedy approvals. “Today, all major regulators offer expedited pathways that are used in a significant proportion of new drug approvals” and, in the opinion of Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, “accelerated approvals generally have a lower burden of proof for efficacy”.
5. The Regulatory-Industry Revolving Door. “A ‘revolving door’ has seen many agency officials end up working or consulting for the same companies they regulated”.
The article records one expert’s opinion that “it is no longer possible for doctors and patients to receive unbiased, rigorous evaluations from drug regulators” and that non-profit organisations need to be established to carry out this function transparently and independent of industry.
The medical fraternity cannot continue to yield to this bondage. We must demand evidence and assurance of drug efficacy and safety from sources independent of the drug manufacturers.
We must struggle to maintain the priority of doctors’ ongoing medical education, doctor-patient relationship in the context of confidentiality, mutual trust, and patient informed consent, over and above imposed dictates from regulatory authorities under the power of hierarchical structures which have financial profit rather tha human wellness as their ultimate concern.
DR CHARLES ROYES