Column: Farewell to drug regulation? Trump nominates a ‘bona-fide pharma shill’ to head the FDA
Lots of people in the healthcare field heaved a sigh of relief last week when President Trump nominated Scott Gottlieb, a physician, venture investor and former official of the Food and Drug Administration, to be the FDA’s next commissioner. Some healthcare experts were relieved that, whatever Gottlieb’s particular qualities, at least he wasn’t someone from the camp of “we-have-to-destroy-the-agency-to-save-it†species of Trump appointee like, say, Environmental Protection Agency boss Scott Pruitt.
Other expressions of relief came from investors and executives in the pharmaceutical industry. They see Gottlieb as one of their own, with good reason. He has served on advisory boards or held directorships at six drug manufacturing companies at least, and received substantial stipends from many more.
From 2013 through 2015 — the extent of a database maintained by the Department of Health and Human Services — Gottlieb received some $413,700 received from drug companies for consulting, speaking or other services. In 2015 alone, he collected $199,951 from eight drug companies, including GlaxoSmithKline, Squibb, Pfizer and Valeant. All are likely to have regulatory business with the FDA in coming years.
The FDA’s cumbersome approval process has been a long time in the making, but its effects are by now clear to patients, physicians, and drug makers.
— Scott Gottlieb, commissioner-designate of the FDA
Gottlieb also is a venture partner at the investment firm New Enterprise Associates, which claims current investments in 50 biopharma firms, 29 medical device firms and 21 healthcare services firms.
So it shouldn’t come as a surprise that Big Pharma will be happy to have Gottlieb on board. “Thank God it’s Gottlieb,†investment analyst Brian Skorney of Robert W. Baird & Co. told clients in a research note quoted by Reuters. “We view this as a favorable development for the sector.â€
Nor should it be a surprise that critics of the pharmaceutical industry are less sanguine. Surgical oncologist David Gorski, who bird-dogs pseudoscience under the nom de plume Orac, calls Gottlieb “a bona fide, honest-to-goodness pharma shill,†citing his revolving-door journeys from the drug industry to the FDA (where he served as deputy commissioner from 2005 to 2007) and back again.
Gottlieb is “entangled in an unprecedented web of Big Pharma ties,†Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen, told me.
This wouldn’t be the first time that Gottlieb’s conflicts of interest raised eyebrows. Upon taking up his FDA post in 2005, he had to recuse himself for up to a year from participating in matters involving nine drug companies, including Eli Lilly, Roche, Procter & Gamble and Sanofi-Aventis.
As FDA commissioner, however, “we don’t think he can disentangle himself from these conflicts of interest even with recusal,†Carome says. That’s because as the agency’s top dog, Gottlieb will be weighing in on more than “particular matters†involving specific companies, the standard for recusal, but on policies that will have broad effects on entire industries with which he’s been financially linked.
In professional terms Gottlieb, 44, certainly has the requisite qualifications to head a major federal health agency in a conservative Republican administration. Formerly a practicing physician, he’s a clinical assistant professor of medicine at New York University and a resident fellow at the pro-business American Enterprise Institute.
The important question, of course, is how Gottlieb’s ties to the drug industry might affect his policy preferences. The answer can be found in his voluminous writings, including newspaper op-eds and papers in policy journals, where he has advocated faster drug approvals and more tolerant oversight on manufacturers’ marketing.
The most undistilled expression of Gottlieb’s philosophy can be found in a 2012 article he wrote for the conservative journal National Affairs. There he took aim at what he described as the FDA’s flawed culture in which the safety of a drug has become its prime concern. “In so heavily prioritizing one of its obligations — the protection of consumers — the FDA has sometimes… neglected its other key obligation, which is to guide new medical innovations to market,†he wrote. “On the whole, the agency’s reviewers believe it is appropriate to prioritize safety over speed.â€
Gottlieb traced this mindset to the agency’s most legendary success — the blocking of the morning sickness drug thalidomide from U.S. shelves in 1960 by Frances Kelsey, an FDA reviewer. Kelsey’s action, which saved American families from the tide of birth defects caused by the drug in Europe and Japan, “fostered an idealization of the lone reviewer championing an issue of safety against the prevailing orthodoxies, especially when it meant taking on corporate interests,†Gottlieb wrote.
He argued that the pendulum had swung too far in the other direction, turning the FDA’s demands for thorough safety and efficacy studies into a roadblock against prompt approval of life-saving treatments. “The FDA’s cumbersome approval process has been a long time in the making,†he wrote, “but its effects are by now clear to patients, physicians, and drug makers.â€
Gottlieb waved away concerns that drug makers ply doctors with incentives to overprescribe their products, including for conditions for which they haven’t been FDA-approved—so-called “off-label†uses. “There is, of course, no shortage of anecdotes regarding bad doctors and unscrupulous drug-marketing practices,†he acknowledged. “There is a powerful sense inside the FDA today that, once a new drug is approved for one narrow purpose, poorly informed doctors manipulated by drug marketing will prescribe it for all manner of ailments.â€
Gottlieb implied that the FDA’s suspicion of doctors and drug marketers was excessive and unwarranted. But the truth is that the evidence of unscrupulous marketing is more than anecdotal. Dozens of major drug companies have settled accusations of improper marketing for billions of dollars.
They include several companies on whose payrolls Gottlieb has appeared: GlaxoSmithKline, which paid $3 billion in 2012 to settle charges of improper marketing and other practices; Eli Lilly, which paid $1.4 billion to settle similar federal charges in 2009; Squibb, which paid a penalty of $515 million in 2007; and Pfizer, whose $2.3-billion payment in 2009 was described by the Department of Justice as “the largest health care fraud settlement†in the agency’s history. Gottlieb wasn’t associated with any of these cases, but they demonstrate that the FDA’s concerns were hardly misplaced.
Gottlieb’s argument that the FDA’s demands for rigorous safety and efficacy trials are excessive and burdensome also is questionable, though it dovetails nicely with the industry’s viewpoint. FDA statistics and a study by outside experts suggest that the agency has become more efficient in recent years at clearing the path for new drugs. The average time span for FDA review of conventional new drugs has fallen from an average of about 18 months a decade or two ago to about 12 months more recently, while the percentage of approvals of drug applications also has risen, exceeding 90% in 2015.
Yet Big Pharma wants more — and tends to get it. In December, the industry scored a major triumph with the passage of the 21st Century Cures Act. The measure’s backers hailed it as a source of new funding for research agencies such as the National Institutes of Health, but it was in fact a huge deregulatory handout to the pharmaceutical and medical device industries. The act authorized the FDA to loosen clinical standards for judging many new drugs and took the leash off drug companies marketing their products for off-label uses.
The FDA will have to promulgate rules and implement policies under the act — but that process would unfold under the industry-friendly Scott Gottlieb if he’s confirmed. Big Pharma has been trying to get its wish list of deregulatory initiatives through Congress and the White House for years. With Gottlieb’s nomination, it may have landed in deregulation heaven. As for that troublesome consumer-protection culture at the FDA inspired by the lesson of thalidomide, it may be on its way out. What might the consequences be for your health and safety?
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