Turning the tide on conflicts of interest

Medical reviewers at the US Food and Drug Administration are vital for the effective regulation of drugs. They are tasked with interpreting whether the balance between a drug’s known harms and potential benefits in pivotal trials is favorable. They must do this using their best judgment, within the context of alternative treatments, current course of illness and biology of disease. Previously when regulators leave governmental service, some have gone to work for the industries they previously regulated, drawing criticism in these pages1,2.

Although this practice of a “revolving door” has been criticized, to our knowledge it has never been studied systematically in the context of the US FDA. We sought to characterize the frequency with which medical reviewers at the US Food and Drug Administration subsequently work or consult for the biopharmaceutical industry. We focused on hematology-oncology drug reviewers because of our knowledge of this area, because more hematology-oncology drugs are approved than any other class of medicines,3 and because the approval of cancer drugs with small or marginal benefits and toxicity has increasingly fallen under scrutiny4.

To do this, we began by ascertaining all US FDA hematology oncology drug approvals from the FDA website: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm from 2006 to 2010.

We excluded approvals that solely consisted of changes in drug formulation, conversion of accelerated to traditional approval, and for approvals that did not directly treat a hematologic or oncologic condition (e.g. imaging products, a viral vaccine).

For each drug, we searched the FDA database (Drugs@FDA.gov) to identify all available medical reviews between 2001 and 2010. Reviewer names, degrees, and titles were extracted. Reviewers of multiple approvals were considered only once. We did not search prior to 2001 because it appeared that data were inconsistently reported during this time. We did not search after 2010, as this would leave little opportunity for reviewers to leave the FDA and seek alternative employment.

We conducted our investigation between December 2015 and February 2016. We used publicly available information from the Department of Health and Human Services (DHHS) personnel website, Linked-In, PubMed, and pharmaceutical company industry websites to document any subsequent jobs for these medical reviewers. First, all reviewers names were checked against the DHHS personnel website to see if they were currently employed there. Attention was focused on individuals who were not listed as an FDA employee as of February 2016. We then searched for all reviewers’ names using LinkedIn, and noted individuals who had both FDA and a pharmaceutical development or consulting company listed as employers. Descriptive statistics were performed.

The Revolving Door
We were able to identify 55 unique medical reviewers of oncology drug approvals between 2001 and 2010. Fifty (90%) had the highest degree of MD, 4 (7.7%) also had a PhD, and 2 (3.8%) also held an MPH degree. Two reviewers (3.8%) had a PhD alone. There were 1 CRNO (certified registered nurse in oncology), CRNP (certified registered nurse practitioner) and MBBS each.

Figure 1 shows the subsequent jobs of medical reviewers. Fifteen out of 55 (27%) later worked for the biopharmaceutical industry or as consultant to it. Fourteen career trajectories were ascertained through LinkedIn, and one through a former reviewer’s publication history that listed subsequent affiliation. Twenty seven (49%) continue to work at the US FDA. Only 8 (14%) reviewers’ current employer could not be identified, though they are known not to be current employees of DHHS agencies.

Of the 15 former FDA reviewers with subsequent industry ties, 10 worked for a pharmaceutical company, 3 consulted for pharmaceutical companies, and 2 had done both since leaving the FDA.

In short, we found that over a quarter of hematology oncology drug reviewers left the FDA to work or consult for the biopharmaceutical industry 27% (15/55). In addition, among those who left the FDA, over half (58%) worked or consulted for the pharmaceutical industry (15/26).]

Our study is limited by the focus on a single therapeutic area (hematology-oncology), and we encourage others to track the careers of reviewers in other fields. If anything, we are likely to have underestimated the extent of this phenomenon, as not all reviewers’ future careers could be identified. We encourage the FDA to analyze this question, using their comprehensive roster of employees.

We are concerned by the sizable percentage of medical reviewers at the FDA later work for or consult for the pharmaceutical industry. The transition from regulator to advising companies who are the subject of regulation may seem logical, but it raises concern of whether regulators consistently and indefatigably act in the public’s interest, if the prospect of subsequent employment in the industry is available and prevalent.

Jeffrey Bien MD
Department of Medicine
Oregon Health & Science University

Vinay Prasad MD MPH 1 2,3
1Division of Hematology Oncology/ Knight Cancer Institute/ Oregon Health & Science University
2 Department of Public Health and Preventive Medicine/ Oregon Health & Science University
3 Senior Scholar in the Center for Health Care Ethics / Oregon Health & Science University

Corresponding author:
Vinay Prasad, MD MPH
Assistant Professor of Medicine
Oregon Health & Science University
3181 SW Sam Jackson Park Road

References

1. Godlee F. Turning the tide on conflicts of interest. BMJ. 2011;343.
2. Mindell JS, Reynolds L, Cohen DL, McKee M. All in this together: the corporate capture of public health. BMJ. 2012;345.
3. Mullard A. 2015 FDA drug approvals. Nat Rev Drug Discov. 2016;15(2):73-76.
4. Mailankody S, Prasad V . 5 Years of Cancer Drug Approvals. JAMA Oncology 2015.