It’s been said that the more things change, the more they stay the same, meaning that it may seem like there’s been a change, but the underlying reality is the same as it was before the perceived change. The change in the spotlight here is the Senate confirmation of Trump’s nominee, Dr. Scott Gottlieb, to head the FDA. Dr. Gottlieb replaces Dr. Robert Califf, the Agency’s acting head and a 2016 Obama appointee.
Gottlieb got the Senate stamp of approval by a 57-42 vote on Tuesday, May 9. The Republicans, for the most part, were quite pleased. Sen. Mitch McConnell (R-KY), the Senate Majority Leader, said, “As a practicing physician with a wealth of policy experience, Dr. Gottlieb has the necessary qualifications to lead the FDA at this critical time. Not only has he worked in hospitals, interacted directly with those affected by disease and treatment, but he also has developed and analyzed medical policies in both the public and private sectors”
Tom Price, Secretary of Health and Human Services, lauded Dr. Gottlieb’s confirmation, saying the new FDA chief’s “background will be crucial” to keeping the FDA’s high standards intact. He added that the good doctor’s experience will help bring “new, innovative solutions” to the country’s health issues.
That background is suspiciously similar to Dr. Califf’s in that Dr. Gottlieb is well known in Big Pharma. He should be, given that he’s held positions on Daiichi Sankyo’s and GlaxoSmithKline’s advisory boards and performed consulting work for several others. Dr. Gottlieb, again like Dr. Califf, has significant connections to the industry he now oversees.
Dr. Califf founded a research institute at Duke University. The institute is heavily funded by Big Pharma and other medical companies. Dr. Gottlieb has investments in the industry, some via New Enterprise Associates, a venture capital firm and others via investment bank T.R. Winston & Company.
Just as Price said Dr. Gottlieb’s experience makes him the perfect person for the job, Health and Human Services issued the following statement about Dr. Califf, pre-confirmation.
“Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new lifesaving therapies to the market.”
Dr. Califf promised to be impartial in the performance of his duties for the Agency. So has Dr. Gottlieb. The latter’s promise included divestment from the many health-related companies with which he’s involved. It also included a voluntary one-year recusal when it comes to decisions that involve those businesses.
As with Dr. Califf, there was opposition to Dr. Gottlieb’s confirmation. And, despite Dr. Califf being an Obama nominee, some of that opposition came from the Democrats. That’s where the opposition to Dr. Gottlieb came from, too.
Senator Patty Murray (D-WA) spoke out during the pre-vote debate saying, “He [Dr. Gottlieb] has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first. I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”
Interestingly, Senator Joe Manchin (D-WV) said something quite similar about Dr. Califf. “Dr. Califf’s past involvement [with drug makers] will have an impact on his effectiveness and leadership capabilities, and I cannot, in good conscience, allow his confirmation.” Apparently, Dr. Gottlieb’s “unprecedented industry ties” have precedents after all.
Perhaps the most outspoken senator to try to prevent Dr. Gottlieb’s confirmation is Senator Edward Markey (D-MA). Sen. Markey focused on opioids during Dr. Califf’s confirmation hearing and did so again during Dr. Gottlieb’s. The powerful class of painkillers has become a big problem in the U.S. with increased rates of addiction and overdose.
In Dr. Gottlieb’s case, the concern centers on the new FDA chief’s ties to the industry; specifically, the fact that Dr. Gottlieb once served as a paid expert witness for Cephalon. The company was sued over the way it marketed fentanyl, an opioid drug related to several deaths by overdose.
Sen. Markey said, “We need FDA to be a tough cop on the beat, not a rubber stamp approving the latest big pharma painkillers.”
Many of the same sentiments were stated during Dr. Califf’s confirmation hearing, too.
Other concerns included the FDA’s regulation of tobacco, including e-cigarettes. Senator Sherrod Brown (D-OH) wondered if Dr. Gottlieb would continue to support that regulation or, as a result of pressure from Big Tobacco, do away with existing regulations.
The senator said, “His job is to police big tobacco, to stand between these multi-million dollar marketing executives and the 15-year-olds who are attracted to these products. And he’s invested in these companies in the past. So can we really trust him?”
Another Democratic senator, Maggie Hassan (D-NH) brought up Dr. Gottlieb’s opinions of women’s health issues saying, he has a “record of putting politics ahead of science when it comes to women’s health. I’m concerned under his leadership the FDA will play political games with women’s health once again.”
All of these are valid concerns. Of course, done is done and Dr. Gottlieb is the new head of the FDA. That doesn’t remove the concerns; it simply serves to make them stronger. Only time will tell what direction the new chief will take the Agency.
One thing is certain, though: the more things change, the more they stay the same.