The federal Food and Drug Administration has turned a blind eye to tens of millions of dollars paid by Big Pharma to doctors who play crucial roles in advising the nation’s prescription drug watchdog on the safety and effectiveness of medications sold for billions of dollars annually to the American public.
Science magazine deserves credit for its investigation of conflicts of interest it found by examining readily available public records on payments received by more than 100 physician advisers to the FDA over a four-year period.
Reporter Charles Piller and graphics editor Jia You took an important and different look at records, scrutinizing doctors disclosed drug company funding after their service on elite panels that assist FDA staff in the review and approval of products before they can go to market. Under fire by drug safety and other public advocates, and with intense peer pressure, doctors — grudgingly — have come to accept the notion that they should avoid conflicts of interest before sitting on such influential oversight groups.
But Science magazine reported that the FDA and others have neglected to examine the financial and career boost that Big Pharma gives to advising doctors post hoc from consulting with the federal overseer. As Piller wrote:
Off 107 physician advisers who voted on the committees Science examined, 40 over a nearly four-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and seven more than $1 million. Of the more than $26 million in personal payments or research support from industry to the 17 top-earning advisers—who received more than $300,000 each—94 percent came from the makers of drugs those advisers previously reviewed or from competitors. Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.
The magazine quoted ethicists in the medical science who questioned not only these Big Pharma payments but also the other perks and preferences awarded to FDA advisers, “benefits that come later, even years after a drug approval vote—jobs, money, professional prestige, and influence.” Carl Elliott, a medical ethicist at the University of Minnesota in Minneapolis who long has assailed “pay later” or “postponed reward” schemes, told Science: “You do something positive for a company that you feel confident is going to pay you back for it later on. And they do.”
Science reported that it found pay later practices in FDA panelists who had advised on 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014.
The agency declined comment on the story, and researchers named in the magazine investigation denied they had conflicts of interest or were improperly influenced by Big Pharma’s post hoc pay and perks. Several said, in retrospect, they offered their best professional judgements on drugs before them and have clear consciences still about their FDA advice.
To be fair, Science noted that the federal watchdog agency faces challenges in assembling the elite expertise it needs to review and approve drugs. Depending on the medication and condition, only a few physician-researchers may have the knowledge and experience to offer invaluable insights on select and increasingly specialized and costly medications — and these rare individuals often already will be highly connected in their area of expertise.
Still, as Science reported, other pillars in the medical science world, including respected journals in which important research gets reviewed and published, safeguard against conflicts of interest, before and after. The European Medicines Agency, described by the magazine as an FDA analog, spells out its conflicts rules, barring financial ties to the industry three years before advisory service but not necessarily after. The Europeans investigate on their own or after whistle-blower tips about experts’ failure to disclose conflicts.
In contrast, the FDA’s screening system is hidden from public view. The agency apparently does not check post hoc payments, which can be found in journal citations and federal data bases, such as the large and public cache of disclosures with the Centers for Medicare and Medicaid Services.
In my practice, I not only see the harms that patients suffer while seeking medical services but also their struggles to get fair, impartial, reliable, and useful information about accessing and affording safe, effective, efficient, and even excellent medical care, notably with prescription medications. With product prices skyrocketing, patients and doctors alike grapple with confusion about costly and even dangerous drugs. The FDA oversight and judgments about complex products is critical.
Yes, the FDA has a big and complicated role as a prescription drug watchdog, and it must rely on external experts for help. But it needs to preserve its credibility and integrity, ensuring it keeps an appropriate distance from Big Pharma and its meddling, including by wealthy corporations spreading lucre and rewards on decision-makers and -influencers.
With two media organizations now investigating and pointing out huge gaps in the credibility of the FDA’s drug review and approval processes — with not only pay later schemes but also Big Pharma underwriting of expedited oversight — isn’t it time for lawmakers on Capitol Hill, too, to wake from their incessant dozing to do their part as the agency’s public bosses and watchdogs? That goes, too, for President Trump and Alex Azar, the head of the massive Health and Human Services agency of which the FDA’s a part.
As voters and constituents, we may need to do our part to remind elected officials and policy-makers that the FDA works on our behalf, for our safety, protection, and benefit. The nonsense that regulators ought to cozy up with and assist Big Pharma to exploit patients to profiteer isn’t only wrong, it’s unacceptable.