The wider role of regulatory scientists
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1991 (Published 27 April 2017) Cite this as: BMJ 2017;357:j1991All rapid responses
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Doshi and Godlee identify a serious accountability gap regarding the integrity of information in medical journals. (1) The gap is real, poses a threat to the public, and needs to be closed. But can the FDA close it? The answer is that in theory, yes, it can. The FDA has the expertise to do so. But the public should not hold its breath.
Why? In principle the FDA is well situated as an oversight agency to ensure that the information published in medical journals is aligned with FDA reviews. But institutionally it is beset by problems rooted in neo-liberal policies that undermine effective oversight. Those policies see regulations as an obstacle to getting drugs to market as quickly as possible and have broken down firewalls between the private and public sector. Industry is seen as the FDA’s main client and pays for the bulk of drug reviews. The regulator is paid by the regulated. Commercial conflict of interest (COI) has become a structural feature at the FDA .
The corrosive affects of Neo-liberal polices led FDA scientists to express concerns over institutional corruption to President Obama when he was in office. (2) There is a good reason why previous heads of FDA have called for the agency to become independent. (3) Regulatory capture is well documented and a threat to the public. (4) And under the Trump administration the FDA is poised to embrace more of an anti-regulatory mindset that sees the agency’s main mission to facilitate an industry agenda for faster drug review despite a history of concerns surrounding the pace and quality of review. (5)
Against this backdrop it difficult to see how FDA scientists will be empowered to perform the wider regulatory role envisioned by Doshi and Godlee. A dramatic change in culture at the FDA is required for it to become aligned with the public interest and to effectively close accountability gaps. And for this to occur politicians need to address a major accountability gap involving their own commercial COIs. Indeed it starts at the the top with the FDA ‘s political masters who rely heavily on private industry for campaign contributions. Until politicians end their own commercial COIs the status quo will likely prevail and it will be business as usual - accountability gaps and all.
Mark Wilson
Bio-ethicist
Guelph On, Canada
1. Doshi P, Godlee F. The wider role of regulatory scientists. BMJ 2017;357:j1991
2. http://fortune.com/2016/06/27/fda-commissioners-independent/
Editorials
3. Mundy A, Favole JA. FDA scientists ask Obama to restructure Drug Agency. The Wall Street Journal Available from: http://www.wsj.com/articles/SB123142562104564381
4. Angell M. FDA: this agency can be dangerous. The New York Review of Books [Internet]. 2010 Sep 30. Available from: http://www.nybooks.com/articles/2010/09/30/agency-can-be-dangerous
5. Lenzer J. Trump to nominate Scott Gottlieb as FDA commissioner despite industry links. BMJ 2017; 356
Competing interests: No competing interests
The Wider Role Of Regulatory Scientists
Doshi and Godlee’s April 26, 2017 editorial “The Wider Role Of Regulatory Scientists” calls for drug regulatory authorities, specifically the U.S. Food and Drug Administration (FDA) to essentially “police” the world’s medical literature to correct for misrepresented publications to improve prescribing and reduce costs. (1)
The authors make the incisive argument for accessing free publicly available FDA drug approval documents and professional product labels prior to prescribing a new drug. Even if the resources were available this appears to be outside the agency’s legal mandate that would present barriers to implementing Doshi and Godlee’s suggestion.
Belatedly, rofecoxib (Vioxx), celecoxib (Celebrex), paroxetine (Paxil), and oseltamivir (Tamiflu) are cited as examples of top selling drugs whose success is not supported when simply accessing the FDA approved professional product labels for these drugs.
Unfamiliarity with the existence of and lack of time to read FDA documents is a manifestly weak excuse for those who claim to practice evidence-based therapeutics. Prescribers appear to be unfamiliar with the regulatory requirements for new drug approvals that lead to confusion in interpreting the therapeutic value of new drugs based on published journal article.
A question that arises from Doshi and Godlee’s editorial is what are the roles and responsibilities of prescribers?
Rather than shifting responsibility for the quality of the published literature to drug regulatory authorities and conjuring excuses for prescribers not reading, a useful role for journal editors could be to promote the legal and scientific requirements for drug approvals and accessing FDA documents such as approval packages and professional product labels prior to prescribing. This information should also be extended to patients and their families.
References
1. Doshi P, Godlee F. The wider role of regulatory scientists. BMJ 2017;357:j1991
Competing interests: No competing interests
Re: The wider role of regulatory scientists
We support the editorial by Doshi and Godlee and hope that it will lead to enhanced communication between regulatory scientists, medical journals, and the public.
Doshi and Godlee rightly ask why regulatory science rarely informs the medical evidence base and urge regulators to be in better communication with journals so that evidence held by regulators, especially, when different from journal publications can be part of process of editing the scientific record.
Material posted online by the FDA is routinely accessed by watchdog groups (e.g. Health Reform Group of Public Citizen) but otherwise seems to live in limbo---it is there but is not routinely accessed or cited in medical journal publications. As the data transparency movement gathers steam it would seem important to initiate courses in medical schools to train doctors to utilize regulatory reports and advisories as valuable parts of the drug information landscape. Discrepancies between medical journal accounts and regulatory reports should be embraced as case studies in research methods and history of medicine courses. These kinds of courses would liberate regulatory science from the odd obscurity of being hidden in plain sight and insert it more fully into fruitful discussions about drug benefits and harms.
We also commend Doshi and Godlee for urging regulatory scientists to reach out to their colleagues. This has not been a part of regulatory culture where non-communication about differences in the interpretation of data appears to be the norm.
For example, in 2002, there was a faculty ethics seminar at Harvard Medical School during which Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, was asked why the agency had not intervened in the matter of the discrepancy between what the FDA knew about celecoxib safety and the CLASS trial article as published in JAMA. Audience member Dr. Marcia Angell, former editor of the New England Journal of Medicine, asked Dr. Woodcock:
’Do you ever write a letter to the editor if you feel that an article has misrepresented the results of a study that the FDA has reviewed?’ Dr. Woodcock said that this had been done in the past, but the FDA did not do so in this case, adding, ‘I don’t know why’ (Abramson, 2005, 37-38).
This response is an example of how regulatory culture valorizes non-communication. Doshi and Godlee point out that former Deputy Commissioner Joshua Sharfstein’s “Transparency Initiative” (2009) fizzled when attempting to push back against the norm of institutional silences in the face of “misleading information.”
Doshi and Godlee point to some reasons for the persistence of these patterns of non-communication including regulatory reluctance to police the published literature and legal concerns about rights of commercial free speech. In addition, we believe that reforming user fees, currently incorporated into institutional budgets would be essential in promoting a climate where regulatory scientists would become more pro-active about their concerns.
There is an important debate about whether the introduction of user fees in the 1990s constituted “regulatory capture” per se or whether it accelerated and intensified an already pre-existing pro-industry pattern (inter alia Lexchin, 2013.) Whatever the case, any reform in improving communications between regulatory scientists, medical journals and the public will have to address the impact of user fees. Our position is that user fees ought to be eliminated in an effort to achieve an ethos of regulatory science that, by virtue of its being funded by tax dollars, prioritizes the safety and well-being of the public over the interests of industry. The trend in the United States, however, seems to be shifting in the opposite direction. Recent budget proposals in the U.S. project a 31 percent decrease in direct public funding of the FDA, a loss that the new administration seeks to offset by increasing user fees that are paid by drug and device manufacturers when they submit new products for regulatory approval for the American market (Robbins, 2017).
Finally, there is an elephant in the room---and that is the harsh treatment visited upon whistleblowers who have resisted the regulatory culture of silence. We conclude, as a reminder, with a link to the well-known Senate testimony of the FDA’s Dr. David Graham, dated November 18, 2004, during the VIOXX scandal. Given the current anti-regulatory climate, we worry that regulatory scientists will be further constrained and silenced.
Dr. Harriet G. Rosenberg, PhD
Emerita
Health and Society Program
York University
Toronto, Ontario
Dr. Adrienne Shnier, PhD
JD Candidate
Osgoode Hall Law School
York University
Toronto, Ontario
Sources
Abramson, John. 2005. Overdosed America: The Broken Promise of American Medicine. New York: Harper Collins
Graham, David J. November 18, 2004. Testimony of David J. Graham, MD, MPH. Access via: https:/www.finance.senate.gov/imo/media/doc/111804dgtest.pdf
Lexchin, Joel. 2013. Health Canada and the Pharmaceutical Industry: A Preliminary Analysis of the Historical Relationship. Health Policy, 9(2), 22-9.
Robbins, Rebecca. May 22, 2017. Trump Budget Proposes Massive Cuts to Medicaid, Science, and Biomedical Funding. Access via: https://www.statnews.com/2017/05/22/trump-budget-health-science/
Sharfstein, Joshua. January 2011. FDA Transparency Initiative: Improving Transparency to Regulated Industry. Transparency Task Force, U.S. Department of Health and Human Services, Food and Drug Administration. Access via: https://www.fda.gov/downloads/AboutFDA/Transparency/TransparencytoRegula...
Competing interests: No competing interests