The ink was barely dry on statements from the head of the federal Food and Drug Administration about a planned external, independent review of the agency’s tobacco oversight division when one of its top regulators created a personnel stink of his own.
Matt Holman, chief of the office of science in FDA’s much-criticized Center for Tobacco Products, ended his 20-year government career.
He quit — to go to work for Philip Morris International, the global tobacco conglomerate and maker of Marlboros.
Micah Berman, an associate professor of public health and law at Ohio State University, had a blunt assessment of the spinning career move that lands a medical scientist who the agency said publicly “has in recent years been ‘preparing for and overseeing review’ of marketing applications for e-cigarettes and other nicotine-delivery products to a Big Tobacco giant:
“It is embarrassing for the FDA, which sees itself as a public health agency, to have its employees go to a company that is a leading manufacturer of death.”
Experts quoted by the New York Times said that no law or agency regulation prevents moves like Holman’s. He said he had consulted with FDA ethics experts and had recused himself from agency business, as is required, during his outside employment discussions. He will be barred from appearing before his former agency on matters “in which he ‘participated personally and substantially during government service,’” the newspaper noted.
Holman asserted that he took his new post because he thinks his new employer recognizes the health risks of burning tobacco cigarettes and wants consumers for their benefit and protection switched to other nicotine-delivery systems. Still, as the New York Times reported:
“To critics, Dr. Holman’s move is a particularly concerning example of the ‘revolving door’ between federal officials and the industries they regulate; in this case, one that has garnered a high degree of public distrust. It has also raised questions about agency approvals, including that of Philip Morris’s IQOS, a ‘heat-not-burn’ tobacco device, which some researchers have found troubling. IQOS is not sold on the U.S. market now because of patent litigation, but if that were resolved, the device could face fresh FDA reviews.”
As the newspaper also reported:
“As head of the FDA science office, Dr. Holman played a key role in approvals of electronic cigarettes and similar devices, which manufacturers have had to submit for review to stay on the market in recent years. The FDA said that before an order is issued on an application, it undergoes review by multiple employees in the tobacco center’s science office, including the director. IQOS, the Philip Morris product that Altria has a license to distribute in the United States, was one of the approved products. It is sold in Korea, Japan, and other countries. A company spokesman said U.S. sales were expected to resume next year, but it might have to undergo another review before that.
“Critics of the IQOS approval include Stanton Glantz, a retired professor of medicine, and his colleagues at the University of California, San Francisco, who published a study saying the device contained toxins, some potentially carcinogenic and some at higher levels than in combustible cigarettes. The agency’s approval ‘disregarded valid scientific evidence and misapplied the public health standard mandated by law,’ the study in the journal Tobacco Control concluded. Dr. Glantz said … that Dr. Holman ignored another major study showing that e-cigarette use — outside of controlled studies of quitting efforts — was not associated with reduced rates of smoking. He said approvals have done little to deal with the problem of dual-use, or using cigarettes and e-cigarettes, which is worse for overall health. Of Dr. Holman’s departure, Dr. Glantz said, ‘good riddance.’”
In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent health care. This has become an ordeal due to the skyrocketing cost, complexity, and uncertainty of treatment and prescription medications, too many of which turn out to be dangerous drugs.
Patients, doctors, hospitals, insurers — indeed, all of us — need outstanding public servants with health, medical, and scientific expertise to be our trusted guardians and advocates, providing evidence-based recommendations on the best policies possible for our individual and collective well-being. The world has become so complex, uncertain, and interconnected that we cannot huddle in the dark or in tiny health havens while diseases and other threats to our wellness explode all around us.
It is clear, however, that smoking persists as a leading cause of preventable death, killing 480,000 Americans annually, according to the Centers for Disease Control and Prevention. This nasty habit, research has proven conclusively, leads to various kinds of cancer, especially of the lung, as well as damaging the heart, circulatory system, and other body functions.
If you don’t smoke, please don’t start. If you smoke, talk to your doctor, and make the challenging effort to stop. There are other ways to do so without taking up vaping. No one argues it is good for you — just that it is less harmful and another possible way to quit smoking. That’s a dubious health argument, akin to asking whether it’s “better” to die in a car or plane crash. It’s really unacceptable.
We also cannot find it acceptable for the powerful FDA to keep operating a revolving door of its experts jumping to the rich, giant companies from which they are supposed to protect the public. As Stat, the science and medical news site, and the Washington Post’s 202 health newsletter both noted that along with the defection of Berman, Big Tobacco’s PMI in recent days has hired away FDA Chief of Staff Keagan Lenihan to be the company’s vice president of government affairs.
It also is important to recall that the revolving door is a whopping problem in FDA’s prescription drug oversight. As Science magazine reported:
“[A] 2016 study in The BMJ [medical journal], researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a 9-year period in the hematologyoncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry … Through web searches and online services such as LinkedIn, however, Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated.”
The agency-to-Big Pharma stampede is such a problem that the left-leaning Center for Economic and Policy Research — arguing the public’s interest and protections are under threat — has set up a whole project and web site to track the “revolving door.”
Not good. We have much work to do to safeguard our health and protect our official watchdogs from pernicious undercutting by profit-hungry corporations. The announced FDA review of its tobacco — and food — divisions clearly does not go far enough. The well-intentioned scrutiny by an FDA-connected foundation won’t do. It is long past time for Congress to use its authority as taxpayer’s watchdog of watchdogs to really dig into the FDA and vastly improve its crimped, flawed protection of the public.