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Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, according to an investigative report published Thursday by The BMJ.

The report examines whether drug regulators in six countries, including the U.S., “have sufficient independence from the companies they are meant to regulate.”

Investigative journalist Maryanne Demasi found significant conflicts of interest have developed between drugmakers and the agencies charged with drug regulation, resulting in a negative impact on the quality of pharmaceutical products that reach the public.

In all 6 countries, ‘Big Pharma’ provided bulk of drug regulator funding

The issue of conflicts of interest between pharmaceutical regulators and “Big Pharma” is not new. Demasi referred to a 2005 example from the U.K., where the House of Commons health committee investigated the drug industry’s influence on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA), the U.K. equivalent of the U.S. Food and Drug Administration.

The committee expressed concern that pharma’s funding of the MHRA and similar agencies could lead them to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.”

“Nearly two decades on, little has changed,” Demasi reported. “Industry funding of drug regulators has become the international norm.”

Demasi based her conclusion on interviews with regulators in Australia, Canada, Europe, Japan, the U.K. and the U.S.

She asked them about their funding, the level of transparency in their decision-making and data and their drug approval processes.

According to Demasi, her findings broadly indicate, “industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”

Demasi said “industry money saturates the globe’s leading regulators,” with the majority of their budgets — “particularly the portion focused on drugs” — coming from the pharmaceutical industry.

For instance, the FDA, despite being the most highly funded of the six regulatory authorities studied, receives 65% of its funding for drug evaluation from industry user fees.

In 1995, the European Medicines Agency (EMA) received just 20% of its funding from industry fees. Today, that figure is 89%.

At the high end, 96% of Australia’s regulatory budget comes from industry monies, while even the regulatory authority with the smallest percentage of the six — Canada (50.5%) — still receives the majority of its funding from pharma companies.

Australia’s regulatory authority, during the 2020-2021 time period, approved more than 90% of drug applications.

Pharma funding contributes to lower-quality drugs and healthcare

Demasi references several academic studies which, over a span of several decades, “have raised questions about the influence funding has on regulatory decisions,” especially in the context of a series of “drug and device scandals,” involving “opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, and pacemakers.”

Focusing on the U.S., Demasi cited the example of a 1992 law, the Prescription Drug User Fee Act (PDUFA), passed in the aftermath of the AIDS crisis.

The legislation permitted the pharmaceutical industry to directly fund the FDA through “user fees,” which were “intended to support the cost of swiftly reviewing drug applications” via the funding of “additional staff to help speed the approval of new treatments.”

What in fact happened, according to Demasi, is that “the FDA moved from a fully taxpayer-funded entity to one supplemented by industry money.”

Over time, PDUFA user-fee funding has increased thirty-fold — from around $29 million in 1993 to $884 million in 2016, Demasi said.

This has contributed to “a decline in evidentiary standards, ultimately harming patients,” due to practices such as the creation of “PDUFA dates” — referring to deadlines for the review of applications by the FDA, as well as “a host of ‘expedited pathways’ for speeding drugs to market” —- a practice Demasi describes as having become “a global norm.”

The BMJ article quotes Donald Light, a sociologist based at Rowan University in New Jersey, who has extensively studied drug regulation. He told BMJ:

“Like the FDA, the [Therapeutic Goods Administration (TGA) was founded to be an independent institute.

“However, being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.

“It’s the opposite of having a trustworthy organisation independently and rigorously assessing medicines. They’re not rigorous, they’re not independent, they are selective, and they withhold data.”

Light said doctors and patients “must appreciate how deeply and extensively drug regulators can’t be trusted so long as they are captured by industry funding.”

Industry funding helps ‘green light’ new medications

Demasi presents figures showing the high percentage of drug approvals across the six regulatory agencies studied.

For instance, 68% of new drugs in the U.S. are approved by the FDA via an “expedited pathway,” as are 50% in Europe.

In the U.K., 98.5% of new medicines are approved by the MHRA.

All six regulators offered an expedited process for the approval of new medicines. Accelerated approval processes have, according to Demasi, “resulted in new drugs which were more likely to be withdrawn for safety reasons, more likely to carry a subsequent black box warning, and more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.”

This is partly due to the lower burden of proof required for accelerated approvals.

The BMJ article quotes Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, who, along with two others, resigned from an FDA advisory committee in 2021, in protest over the FDA’s approval of Aduhelm, a controversial Alzheimer’s drug.

Kesselheim told The BMJ:

“The accelerated approval pathway explicitly changes the underlying efficacy ‘standard’ in that it allows approval based on changes to a surrogate measure that is not well-validated, and is only reasonably likely to predict clinical benefit.”

In June 2021, NPR reported that Aduhelm was approved by the FDA “against the wishes of nearly every member on the [advisory] panel,” leading Kesselheim to tweet “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”

In other instances, according to Demasi, conflicts of interest plague not just the regulators, but also their advisory panels, whose purported role is “to provide independent expert advice.”

For instance, Demasi referred to a previous BMJ investigation from 2021, which “found several expert advisers for covid-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers —ties the regulators judged as acceptable.”

Regulators turn over responsibility of assessing patient data to the drug companies

Another significant finding of Demasi’s investigation is that drug regulators commonly turn over responsibility for assessing patient data from drug trials to the pharmaceutical companies themselves.

Specifically, the regulatory agencies “use summaries provided by the pharmaceutical companies” rather than their own assessments.

Demasi notes that such patient data is “not routinely published in the public domain” by these companies, citing the example of the Pfizer COVID vaccine documents, which were ultimately made public via court order. Demasi described this ruling as “a win for transparency advocates.”

Demasi points out that Australia’s regulatory agency, TGA, said it “conducts its covid-19 vaccine assessments based on ‘the information provided by the vaccine’s sponsor,’ while vaccine manufacturers retain the individual participant-level datasets from the trials.”

A ‘revolving door’ between the regulators and the regulated

Demasi also described a state of “regulatory capture” expanding beyond dependency on drug manufacturer funding to a “revolving door” between the regulatory agencies and “the companies they had previously been regulating.”

This is glaringly apparent in the case of the FDA. Demasi found that “nine out of 10 of its past commissioners between 2006 and 2019 went on to secure roles linked with pharmaceutical companies.”

For instance, its most recent ex-commissioner, Stephen Hahn, “is working for Flagship Pioneering, a company that acts as an incubator for new biopharmaceutical companies.”

And, the FDA’s current commissioner, Dr. Robert Califf, confirmed in February 2022, received $2.7 million from Verily Life Sciences, and previously held a position on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals, in 2021.

Prior to this, Califf had served as FDA commissioner under the Obama administration.

In yet another example, Philip Krause, formerly a senior figure in the FDA’s vaccine division, “secured a role in the biotech sector.”

Demasi also cited a 2016 BMJ study, which found that “more than a quarter of the FDA employees who approved cancer and hematology drugs between 2001 and 2010 left the agency and now work or consult for pharmaceutical companies.”

One further example cited by Demasi comes from the U.K., where Ian Hudson, previously the MHRA’s chief executive between 2013 and 2019, “now serves on the board of biotech company Sensyne Health and is a senior adviser for the Bill & Melinda Gates Foundation.”

Prior to heading the MHRA, Hudson “held various senior roles at pharmaceutical giant SmithKline Beecham.”

Such conflicts of interests appear to have far-reaching impacts on the safety of medicines, as well as other vital products, that reach the public.

For instance, The Defender recently reported that 95% of the members of a USDA committee that advises the agency on food safety guidelines maintained ties to “Big Pharma” and “Big Food.”