BMJ Investigation Finds FDA Commissioners Enriched by Industry

A new investigation, published in the British Medical Journal (BMJ), delves into conflicts of interest at the Food and Drug Administration (FDA) due to its leader’s extensive ties to the drug industry, which it is meant to regulate.

While incoming FDA commissioners are required by law to divest their investments in pharmaceutical companies, most (9 out of the last 10) go on to work for the industry after their tenure at the FDA. The BMJ investigation, conducted by senior editor Peter Doshi, also reports how shady investment practices have allowed at least one FDA chief to remain invested in pharmaceutical companies during their tenure.

“The revolving door between the FDA and industry surprises few anymore, despite the widely acknowledged potential it has for undermining public trust in government … But the story of Margaret Hamburg … is less well known,” Doshi writes.

“Like her colleagues, Hamburg had relationships with FDA-regulated companies before and after her stint at the FDA’s helm. But unlike her colleagues, Hamburg was allowed to hold financial interests in an exclusive hedge fund managed by her husband’s company. And in an analysis conducted by The BMJ, the hedge fund consistently invested in FDA-regulated drug companies during Hamburg’s time at the FDA.”

Robert Califf, the current commissioner of the FDA, is presently serving his second stint in that position. Before being named commissioner under President Obama in 2016 and again under President Biden in 2022, Califf was legally required to terminate his various ties to pharmaceutical companies. As an example of such ties, the current work points to Califf’s position as a senior advisor for Verily Life Sciences. This appointment paid him $2.7 million between his two stints as the FDA commissioner. When questioned about his industry ties during his most recent confirmation, Califf pointed to the Biden administration’s ethics pledge as a balance against conflicts of interest.

While these ethics pledges may prevent some conflicts of interest on paper, they may not stop former FDA commissioners from gaining enrichment from the industry they were meant to regulate in practice. As an example of the ineffectiveness of these pledges, Doshi presents Scott Gottlieb. Gottlieb served as FDA commissioner under the Trump administration with a similar ethics pledge that included a ban on lobbying activities for five years after working as the FDA commissioner. Not only was this pledge rescinded after Trump left office, but the pledge did not exclude a former FDA commissioner from seeking employment with the pharmaceutical industry. Gottlieb was nominated to Pfizer’s board of directors three months after leaving the FDA.

While the FDA-to-industry board of directors pipeline and its subsequent erosion of public trust have been well documented, the current work focuses on the less well-known shady investment practices that allowed at least one FDA commissioner to invest in pharmaceutical companies even as she was meant to be regulating them.

Margaret Hamburg served as the FDA commissioner under the Obama administration from 2009 to 2015. Her husband, Peter Brown, was a senior employee at the hedge fund Renaissance Technologies. During her stint as FDA commissioner, Hamburg and Brown were both allowed to retain their investments in the Medallion Fund, a Renaissance Technologies investment vehicle only open to firm employees and close associates. The medallion fund has averaged a 39% return per year for its investors over 30 years, making it one of the most successful investments of its kind. During Hamburg’s tenure as FDA commissioner, the Medallion Fund was significantly invested (over $1 billion in holdings) in numerous pharmaceutical companies she was supposedly regulating, including AstraZeneca, Amgen, Johnson and Johnson, and GlaxoSmithKline, among others.

Although incoming FDA commissioners are legally required to terminate investments in the pharmaceutical industry, the Office of Government Ethics (OGE) allowed Hamburg to retain her interests in the Medallion Fund. The FDA and the OGE have refused to explain why this was allowed. According to the current investigation, the only explanation came from an anonymous administration official speaking to the Wall Street Journal in 2009. According to this official, Hamburg was allowed to retain her investment in the Medallion Fund because the fund uses automated trading based on an algorithm that “does not allow for human tracking or input except in rare instances … meaning that neither Dr. Hamburg nor her husband would be in a position to direct their Medallion account to companies or areas affected by the FDA.”

However, during a 2014 senate investigation into the abuse of structured financial products, Brown testified that the Medallion Fund’s algorithm was tweaked by human programmers once or twice a week on average. This would allow the fund “to direct trades to particular options to reduce or increase its portfolio size.” This means the claim that Hamburg and Brown could not direct their Medallion account to companies affected by the FDA was false. For Hamburg’s entire tenure as FDA commissioner, she was in a position to profit from regulatory decisions made by the FDA, which was a clear conflict of interest.

Between 2009 and 2010 alone, the Medallion Fund paid Hamburg and Brown over $3 million. Additionally, between 2008 and 2010, Brown received over $1 million per year in payments from Renaissance Technologies. The exact amount paid to Brown is unknown as FDA disclosure paperwork does not require that spouses of commissioners be any more specific than reporting “over $1,000,000.”

Brown did not respond to a request to be interviewed for the present investigation and declined to explain the discrepancies between his public claims that Medallion’s algorithm was not frequently altered by humans and his senate testimony that it was, in fact, altered at least weekly. Hamburg also declined to be interviewed, but communicated through a proxy that ethics pledges, much like the ones that allowed Gottlieb to accept a board seat at Pfizer 3 months after leaving the FDA, prevented conflicts of interest during her tenure.

The 2014 Senate investigation into Renaissance Technologies concluded that the fund had failed to pay over $6 billion in taxes. In 2021, they settled with the government and agreed to pay around $7 billion. The fund’s current and former investors were responsible for the outstanding tax bill, with those who served on the board between 2005 and 2015, including Peter Brown, owing the greatest share. Brown and Hamburg declined to tell BMJ how much of the settlement they had to pay.

Research has shown that the FDA has approved drugs based on dubious evidence for their efficacy. In 2023, the FDA approved the drug Lexapro for use in children as young as seven despite an increased risk of suicide and no meaningful benefits. They also recently approved the antipsychotic brexpiprazole for use in Alzheimer’s patients despite research showing no clinical benefit, no improvement in quality of life, and an increased risk of death. In December 2022, a congressional investigation found that the FDA acted inappropriately in approving Biogen’s Alzheimer’s drug aducanumab despite the  FDA advisory board’s voting unanimously against its approval. The FDA responded by approving a second Biogen Alzheimer’s drug just days later without taking an advisory board vote at all. The FDA’s oversight of medical devices has also exposed patients to harm. When whistleblowers have come forward to challenge corrupt industry practices, the FDA has teamed with the industry in using mob tactics to silence them.

 

****

Doshi, P. (2024). Revolving doors: board memberships, hedge funds, and the FDA chiefs responsible for regulating industry. BMJ 2024;385:q975. (Link)