This Wednesday, the Senate Committee on Health, Education, Labor and Pensions (HELP) will consider the nomination of Dr. Scott Gottlieb to head the Food and Drug Administration (FDA) with a floor vote possible at the end of April.
Gottlieb has made millions of dollars consulting for and investing in the pharmaceutical industry and continues to be heavily tied to multiple drug and device makers. From 2013-2015, we know he received over $400,000 from the pharmaceutical industry. However, the information on how much doctors receive from pharmaceutical companies has only been public since 2013, making it difficult to estimate just how much Gottlieb has received over his career. We know his ties to the industry go back to the early 2000s, when he sat on the board of five different pharmaceutical companies. According to his biography, he has now served or is serving on the board of nine different pharmaceutical companies, with each board appointment paying an average $250,000 to $300,000 per year according to Harvard government professor Daniel Carpenter. In addition to sitting on boards, he has served as a private consultant and collected speaker fees from many different pharmaceutical companies. He has branded himself as a Wall Street expert on investments in health care; he has been a venture partner at New Enterprise Associates since 2007 and the managing director of T.R Winston bank since 2013, both of which have significant investment portfolios in healthcare.
The magnitude of his conflicts of interest are highlighted by the Wall Street Journal report that his gross income from January 2016-March 1, 2017 was $3 million in speaking, retainer, and consultant fees. He has offered to recuse himself for one year from meetings involving companies he has relationships with. But as Susan Wood, former director of the FDA Office of Women’s Health, points out, it will be impossible to recuse himself from all meetings that will affect a company’s profits given just how deeply connected to the industry he is.
We have strong concerns that if Gottlieb is confirmed, he will move to fulfill Donald Trump’s promise to deregulate industry, weaken the FDA, and rush unproven drugs and devices to market. A strong regulatory process with robust and diverse clinical trials and evidence-based approval is critical to women’s health.
In a powerful critique of the nomination in the New England Journal of Medicine, Dr. Daniel Carpenter notes that “Gottlieb would differ starkly from previous FDA commissioners.”
[H]is previous experience in academic medicine, applied science, and government service is threadbare. He worked at the FDA and the Centers for Medicare and Medicaid Services as a political appointee (first a consultant, then deputy commissioner from 2005 to 2007), not a civil servant. Observers (including a former editor of the Journal) were puzzled when he ascended to deputy commissioner because his experience had been dominated by investment advising, including as editor of the “Forbes/Gottlieb Medical Technology Investor.” His principal writings consist of essays in newspaper and think-tank policy outlets. By contrast, previous commissioners came to the agency with scientific, academic, or government experience. For more than a century, the FDA has been led by commissioners with a primary background in science or in public health, and usually both.
Here at the NWHN, we helped shine a spotlight on Gottlieb when, as a member of the Bush administration, he sought to promote pharmaceutical profits over the objections of the FDA’s scientific experts.
As the deputy commissioner for medical and scientific affairs in 2005, for example, he pushed for looser restrictions on how drug and device makers could market their products directly to consumers. And emails leaked to Time Magazine that same year showed him trying to push for drug approvals that the agency’s scientists had recommended against. After a patient death prompted the FDA to stop a clinical trial for a multiple sclerosis drug, Gottlieb wrote that it was an “overreaction to place a clinical hold” on the trial. As Time reported, “an FDA scientist rejected [Gottlieb’s] analysis and replied that the complication ‘seems very clearly a drug-related event.’”
In fact, in its 2005 piece, Time placed Gottlieb’s appointment to the post in the same category of unqualified partisan appointments as Michael Brown’s disastrous stint at FEMA during the Hurricane Katrina crisis. They quoted an agency scientist as saying Gottlieb’s leadership “really confirmed people’s worst fears that he was only going to be happy if we were acting in a way that would make the pharmaceutical industry happy.”
Then, as now, Gottlieb’s significant financial ties to industry made him their man on the inside at our expense. Back in the private sector, he continued to promote industry talking points even at the cost of women’s health.
The NWHN played a critical role in the creation of the Women’s Health Initiative (WHI), the largest long-term study of older women’s health ever conducted. Despite strong opposition from industry lobbyists, the NWHN pushed for evidence of the safety and efficacy of menopause hormone therapy. We helped convince Congress to fund the National Institutes of Health (NIH) to be able to carry out this vital research.
In 2002, the NIH announced that one form of hormone therapy being tested, Prempro, was found to cause breast cancer in previously healthy women and halted part of the WHI study. Prempro is a Pfizer drug, a company from which Gottlieb has received thousands of dollars as a consultant. Despite expert analysis that resoundingly proved the connection between Prempro and breast cancer, he claimed the results were, “premature, indefinite, or just plain wrong.” Echoing his approach in the multiple sclerosis trial, he even argued that the NIH was wrong to inform women of the risk of taking Prempro when they did, claiming that “the data were rushed to print with a carefully orchestrated PR blitz” and that the NIH’s decision was politically motivated. The fact that Gottlieb criticized the public announcement of the results of a federally-funded study in what was so clearly a consumer safety concern is deeply troubling. Rigorous follow-up research has shown that the NIH was right to warn the public: widespread discontinuation of hormone therapy in 2002-2003 was associated with a sharp decline in breast cancer incidence rates in the U.S.
Meanwhile, his nomination comes at a particularly challenging time for the agency. Last year, Congress rushed through a controversial bill, the 21st Century Cures Act, during its lame duck session that erodes many of the standards ensuring drugs and devices are effective and safe before they receive approval. The bill passed on the false notion that bureaucratic red tape is keeping lifesaving drugs off of the market even though the FDA is already the fastest drug approval organization in the world, and it has continued to accelerate in speed over the past several decades. In the 1980s, the drug approval process took 30 months, now it takes 8.5 months. The incoming commissioner will play a top role in determining how the FDA implements these provisions. Similarly, members of Congress will look to the new commissioner as they work on reauthorizing legislation governing the industry user fees that make up a sizable part of the FDA’s budget.
A commissioner with long-standing, personal financial ties to industry and a history of promoting their profits at the risk of our health both in and out of government cannot be counted on to put consumers’ best interests first. Women’s health and lives are at stake. We deserve better.