In March, Scott Gottlieb, MD, was nominated by President Donald Trump to become the commissioner of the Food and Drug Administration (FDA). Dr. Gottlieb is a former FDA deputy commissioner for policy and a clinical assistant professor at New York University School of Medicine in New York, NY; a resident fellow at the American Enterprise Institute for Public Policy Research in Washington, DC; and an internist at Tisch Hospital in New York, NY.
Among other previous positions, Dr. Gottlieb served as a senior policy advisor to the Administrator at the Center for Medicare & Medicaid Services, and worked to implement the Medicare Prescription Drug, Improvement, and Modernization Act, and the Medicare Part D drug Benefit. Dr. Gottlieb is also a venture partner at New Enterprise Associates, and a managing director of investment banking at TR Winston & Co, a Los Angeles-based, privately held investment bank focused on healthcare, clean energy, and consumer technology.
MDLinx surveyed readers for their opinions on Dr. Gottlieb’s nomination as FDA commissioner. Of the 527 respondents, 435 gave complete responses, and 92 gave partial responses.
All of them were aware that President Trump had announced his intention to appoint Scott Gottlieb as the head of the FDA. Of the 36 comments offered in response to their knowledge of the nomination, a full 18 respondents reported their support for Dr. Gottlieb, commending his appointment. Positive comments included the following:
- “Having such a strong background, I feel he will be well respected. He knows the insurance ins and outs of everything already. The prescriptions the elderly people pay just to keep them alive is ridiculous. The fact he came [up] with Medicare D was the BEST!!!.”
- “Good pick. Drug development needs more efficiency.”
- “Experience is important.”
Fewer negative comments were given, and included these quotes:
- “Another of his poor candidates with profound conflict of interest.”
- “An industry mouthpiece.”
In response to the question “Do you have any concerns about Dr. Gottlieb’s association with—and consulting fees paid to him by—the pharmaceutical industry?” 45.50% responded that they were not concerned, and believed that Dr. Gottlieb’s experience with the pharmaceutical industry helps him understand what is needed to move the FDA forward. The remaining 54.50% responded that they were concerned that his consulting work would interfere with his ability to direct the FDA with the best interests of doctors and patients at the forefront.
- “His consulting work MIGHT interfere…needs to be monitored.”
- “His op-eds in the [Wall Street Journal] and elsewhere have shown a distinct pro-industry bias.”
- “I do have some conflict of interest concerns, but practicing physicians are at least as conflicted because of excessive procedural reimbursements from Medicare and insurance companies.”
- “Interactions with, and consulting fees from, pharma are not prima facie evidence of inability to be impartial in his proposed role. This information simply doesn’t answer the question of his impartiality.”
- “We all know that the FDA is run more by financial interests than true science. I do not think he will lead the FDA in any meaningful way away from that sad tradition.”
- “If he continues in any venue to consult or provide professional input to the pharmaceutical industry while acting as head of the FDA. Otherwise, I believe this experience will help him as director of the FDA.”
A full 47% of respondents reported that they believe the FDA currently moves too slowly, excessive regulation delays release of new drugs and treatments, endangering the population when they could be getting help. An additional 46% reported that they believe the FDA currently functions as it should: Taking the necessary steps to ensure safety and efficacy before approval of new treatments and drugs. Finally, only 7.0% believed that the FDA currently moves too quickly; new drugs may lack testing for safety and efficacy, possibly endangering the population.
When asked about the effects of Dr. Gottlieb’s appointment, 24.4% of survey responders reported that they believed it "may be good" for the pharmaceutical regulatory process. Another 21.8% of survey responders said it "may harm" the pharmaceutical regulatory process, 19.1% of responders said it was "very good" for the pharmaceutical regulatory process, 19.1% of responders "didn’t know whether it was good," and 15.6% reported believing that it is "very bad" for the pharmaceutical regulatory process.
Some other interesting comments included:
- “Again, when everything is driven by money the true purpose of medications is lost and integrity is compromised. I do not think his beliefs are different from anyone else who has held that position. A real difference would only be made if patient care and not finances were put first.”
- “Conflict of interest seems clear, for him; and surely ‘in keeping’ with millionaire Trump's interests in ‘loading the decks’ for the corporations of America. ‘Dr. Gottlieb’ will probably make the medical profession look bad (and what patient care experience did he have?)”
- “Doctor Gottlieb's nomination has been received favorably by the pharmaceutical industry and will hopefully facilitate generics reaching the marketplace.”
- “It may be good or bad. My concern is that it may be more money-driven than beneficial for patients, especially regarding drug safety.”
- “Who better suited for the job than someone who really knows the ins and outs of the pharmaceutical companies!”
- “This fellow does not actually have any patient care experience outside of his training. Very dangerous when it comes to patient care.”
Participants were asked what advice they would give to Dr. Gottlieb in his new position. Responses were numerous and varied. Some advocated for patients, urging him to put patients first:
- “Don’t try to fix what isn’t broken. Remember that patient safety, not corporate profits, is the role of the FDA.”
- “Abide by your Hippocratic Oath. Reverse current trends of exorbitant US Healthcare costs. I have some very ill, dying, and many dead patients who are victims of their disease AND Big Pharma. If you [are] true to the noble spirit of medicine, I support you. If you help enrich any administrative political or corporate bodies in this position, I and others like me will be your worst advocates making your tenure brief and very uncomfortable like my ill, poor patients. Primum non nocere.”
- “Always think of patients first. The FDA has done very little to help patients. They have ignored their consultants, physicians, and [are] indifferent to patients. I know he is a lock for the job and will assume the duty. I would only hope as a physician who took care of patients in the far distant past, he would still consider them first as a physician rather [than] an agent of pharma and big government. He has a great amount of business experience and is very skilled in interactions with various entities, which could be very beneficial for patients.”
- “Many sick and desperate patients are awaiting drugs that have been used in Europe for many years and have been proven to be safe. He must prioritize and expedite the FDA approval and revamp the approval process.”
- “My advice would be to keep the welfare of the patients foremost in his mind. The welfare of the pharmaceutical industry is a distant second place.”
- “Now you work for the American people, not the pharmaceutical industry! Remember your Hippocratic Oath: Do no harm. Do what is right for patients.”
- “We need one sound plan that will allow people with life-threatening diseases to be able to access custom drugs, even if they're still in the clinical trials stage. Figure out how to accomplish this (together with some non-litigious lawyers and insurance companies who won't implode) and the US will be a better place.”
A few comments openly called for him to resign; many others urged “safety first.”
The words “fair,” “open-minded,” “impartial,” independent,” and “scientifically correct” were used often in respondent comments, some of the more urgent of which included the following:
- “Do not listen to the health insurance industry.”
- “Do not let tree huggers stand in the way of good medicine.”
- “Do not allow politics to interfere with science.”
- “Do not allow industry to run the FDA.”
- “Do not be afraid to take action.”