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NPA Opposes Scott Gottlieb for FDA Commissioner

Posted by Becky Martin, NPA Advocacy Director April 6, 2017 at 10:45 AM

NPA Opposes Scott Gottlieb for FDA Commissioner
Concerns raised over lack of experience in public health,
and extensive financial dealings with industry

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The National Physicians Alliance (NPA) opposes the nomination of Dr. Scott Gottlieb for commissioner of the Food and Drug Administration given his lack of experience in public health, lack of focus on public health concerns over the course of his career, and his extensive financial dealings with drug, device, and other health-care related corporations.

The NPA is a multi-specialty group of doctors from across the country, dedicated to putting our patients’ interests first. We are a non-profit, and take no funds from pharmaceutical or medical device companies. Within NPA a group of us, including several former FDA medical officers, focuses on FDA issues. We work to strengthen the FDA approval process so that the public can trust information about treatments they are prescribed.

On April 5, the Health, Education, Labor, and Pension Committee of the Senate began hearings on Dr. Gottlieb’s nomination. The NPA sent a letter to the Committee expressing our opposition to the nomination, together with several questions we think Dr. Gottlieb should address regarding his expressed views on drug regulation, some of which are inconsistent with scientific evidence and with the best interests of public health.

Dr. Gottlieb worked as a financial analyst before obtaining his medical degree, an addition to his resume he used to good effect when he returned to the financial world to make millions, focusing on the pharmaceutical sector, which has the highest profit margins of any other industry. But the leader of the FDA must put public health interests ahead of the financial interests of drug and device companies. Dr. Gottlieb’s entanglements with industry have always been part of his career; he is likely a great asset to the companies with which he is associated. But this put him in conflict with the best interests of public health, which time and time again we have seen do not always align with corporate interests. We are concerned that Dr. Gottlieb’s confirmation as Commissioner could weaken FDA’s enforcement of approval standards and post-approval drug and device safety regulation.

The FDA approves drugs faster than any other regulatory agency in the world, and in the past, other agencies have looked to the FDA’s high standards, although they are becoming increasingly eroded by commercial and political interests. The FDA approves over 90% of the drugs and devices it evaluates. Dr. Gottlieb’s publications about the agency indicate misunderstandings of how it works and its role. Whether this has been intentional or not, catering towards the best interests and preferences of his clients, is hard to say.

Dr. Gottlieb stands in contrast to the last commissioner, Dr. Robert Califf, whom NPA supported. While he also had many interactions with drug companies, being paid by them as a consultant and to run clinical trials, he was also a distinguished academic cardiologist from Duke University who had a deep understanding of medical science and clinical trials.

The doctors at the NPA have many issues with statements and proposals made by Dr. Gottlieb. For example, he would like to loosen restrictions on off-label promotion of drug and devices. That is, promotion or marketing of uses for drugs and devices that haven’t been approved by the FDA. Doctors can prescribe treatments whether they have been officially approved for a specific disease or not, and sometimes this is indeed warranted. But many studies show that most drugs prescribed off-label do not have evidence of effectiveness behind them, and they have substantially more side effects. If off-label promotions were based on only really well-done studies from academic centers that would probably be OK, but the pharmaceutical companies spend billions on marketing (and on flimsy studies) so this henhouse needs guarding by someone other than a fox, so to speak.

Dr. Gottlieb’s basic understanding of clinical trials is even in question, as reported most recently by the New York Times, 3/29/2017

He criticized the use of a sham treatment, the control or placebo condition, testing a procedure cutting nerves to the kidney to supposedly lower blood pressure. The procedure looked promising, as many do, in early small trials. It seemed an easy high tech fix for high blood pressure, a common problem that leads to serious health consequences, so the early trails generated media hype. But the treatment didn’t work. This could only have been shown by doing the properly conducted controlled trials.

Given Dr. Gottlieb’s deep history and financial entanglement with an industry he will be charged with regulating, his limited experience in clinical testing and his penchant towards pushing more drugs out to the public at a faster pace at the expense of public safety, the NPA cannot support his nomination for FDA commissioner.

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