Six months after telling Congress that the FDA may loosen conflict of interest rules because finding qualified experts to serve on advisory committees has become increasingly difficult, FDA commish Margaret Hamburg has issued an about-face and now says the rules should remain intact. She confessed her change of heart before a House committee hearing yesterday on user fees.
Why the reversal? For months, FDA data has actually shown that the percentage of conflict of interest waivers granted for advisory committee members has remained below targets. At the same time, the FDA vacancy rate for advisory committees has remained low (see here and here). In other words, finding qualified experts is not a problem.
Yet, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, last year was openly pushing to relax the rules, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 (you can read more here). Two years ago, the agency tweaked its procedures for granting waivers (see this).
The effort by FDA officials to roll back the rules, which were passed in 2008 after an arduous campaign to promote greater transparency at the agency, alarmed some consumer advocates, who argue that the concerns expressed by Hamburg and Woodcock have more to do with pressure from the pharmaceutical industry than actual difficulties finding unconflicted experts for panels.
Last fall, three US Senators introduced a bill to reverse FDA regs that bar experts with financial ties to drug or device makers from serving on committees without a waiver. The impetus has been a heated debate over the FDA approval process for devices, although drugmakers share the sentiment. "Our view is there a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts," Geno Germano, who heads the Pfizer specialty care and oncology unit, told the House Energy & Commerce Committee yesterday.
But in recent months, Hamburg and Woodcock were undermined by their own data, as has been reported more than once (see this and this). Consequently, Hamburg could no longer - at least, not easily - that the FDA was truly having difficulty finding qualified experts.
"At the present time, we are not bumping up against our cap in terms of waivers," she told the committee. "We don't, at the moment, see major areas where a legislative fix is required." Of course, Hamburg would have known this last summer if she had reviewed agency data before issuing her earlier statements.
2 Comments
Glad to hear Dr. Hamburg has seen the light. There's hope for her, if Congress will ever give her better tools in both the regulatory and fiscal areas. At present, the FDA is like a movie set - two-dimenisonal; giving the appearance of a real regulatory agency.
As for Janet Woodcock, she never met a pharma she didn't like.
It's all one big money laundering game when it some to 'hiding the money.' The doctors know it, the FDA knows it, and HHS knows, and yet, no one does anything about it.
Simply put, look at any FDA-approved waiver, and you'll find the key word: GRANT. Here's an example from one waiver signed off by the FDA on one extremely conflicted individual who sought to sit on a major advisory committed:
"Dr. [my redaction] advised the FDA that he has financial interest related to the above topic that could potentially be affected by his participation in the matter at issue. Dr. [my redaction] reported that he has joint stock [redacted] (competing firm) at a current value of [redacted]. Additionally he reported that his institution has a GRANT [emphasis added] from [redacted] competing firm). The grant is current and his institution receives [redacted] per year from 2006-2007. Dr. [my redaction] receives no salary from the grant. The grant is to study a licensed, approved drug (redacted) in(my redaction) drug currently used in other cancer therapies. Dr (my redaction) also reported that his institution has a grant from (redacted) (competing firm). The grant is current and his instution receives (redacted) per year from 2006-2008. Dr. (my redaction) receives no salary from the grant. The grant is to study an investigational drug (redacted) that is also being studied in several types of cancer. It is unlikely that Dr. (my redaction) participation in the discussions on (date) of the (therapy and subject) cancer will have a direct and predictable effect on his financial interest...."
Now, what you need to know is that the grants are nothing more than ways by which pharmaceutical houses and/or contract research organizations (CROs) launder money intended to reach these very doctors. The money is "awarded" as grants to the doctor's institution and works its way to the doctor from there.
Here's how it works. Any payment at all that goes to a principal investigator (PI) in a clinical trial usually goes to their medical school or organization, and then, after a series of administrative transfers, minus overhead etc., a certain percentage trickles down to the actual clinical department in which the investigator is working and contributes to department salaries.
These grants are the lifeblood of the department's/doctor's work, and without them, his or her work would be dead in the water.
So doctors can fill out all the waivers required, and the FDA can continue to approve them, but the charade is well known, and its impacts well recognized, as has been reflected in the decisions on a number of advisory committee panels.
Knowing this, one is tempted to ask: how many people have died at the hands of the FDA because of the biased decisions made by empaneled members who signed waivers that perverted the facts relative too their COIs and who voted with their wallets?
Put another way, how many people who have served on advisory committees and who received grants to work on competing drugs should never have been within a country mile of the committes on which they served?