As a full-time consumer and part-time conspiracy theorist, I've often wondered how meaningful an FDA approval really is. How much trust can I place in their endorsement of the products I buy and the foods I eat?
My suspicious nature went into overdrive in July when the FDA made headlines in a scandal that charged that the agency had used electronic surveillance software to monitor the computer activities of some of its own scientists. Agency officials claim the spyware was used to verify that confidential information was not being improperly transmitted via the computers. The scientists charge it was a retaliatory tactic against them for blowing the whistle on the FDA for what they saw as improper review processes.
At particular issue were imaging devices for detecting breast and colon cancers, which Robert Smith, MD, FDA scientist, believed did not function as the manufacturers claimed and presented potential harm to patients, and resulted in a substantial waste of money for the government programs and insurance companies footing much of the bill.
Smith's concerns reportedly fell on deaf ears. According to an article by Eric Lichtblau and Scott Shane published in The New York Times on July 30, "When Dr. Smith and other medical reviewers began demanding that manufacturers provide them with more clinical data about the safety of their products, FDA managers deemed the requests excessive."
The internal scuffles between Smith and his fellow scientists and their FDA bosses are the stuff John Grisham novels are made of. The whistleblowers claim that a dozen devices were approved or pushed ahead in the approval process despite their safety concerns. The FDA accuses the scientists of being motivated by money.
The dust is yet to settle on this complicated situation that promises to be messy and ugly for quite some time. Smith and several others have been fired. The FDA's image has been tarnished in the court of public opinion. Accusations are flying. Lawsuits are pending.
And, while we don't know who is on the side of right or wrong, the situation does draw attention to the inherent conflict of interest that exists here. If, as Smith and his colleagues charge, the FDA is reluctant to fully review all the documentation and push for more information when necessary because it doesn't want to ruffle the feathers of the device and pharmaceutical companies from which it derives revenue, it calls into question the reliability of the approval process.
Credence is given to this concern by Lichtblau and Shane's article, which states: "The Office of Special Counsel, which investigates whistle-blower grievances, found in a confidential review this spring that Dr. Smith's allegations raised a 'substantial likelihood' of serious problems and required a full review. That has triggered an investigation by Kathleen Sebelius, the secretary of health and human services."
Score one for the conspiracy theorist.
Even if when all is said and done, we learn that FDA management has been wrongfully accused, I will still find it difficult, as an average consumer, to place my full confidence with the agency.
I've heard with my own ears FDA Commissioner Margaret Hamburg, MD, complain that the agency is scrambling to keep pace with the demands of the job and that we all could pay the price.
Speaking at a NEHI conference in Boston in April, Hamburg said, "One of the things that has been such a struggle is that the agency has been unbelievably stretched for resources... The same people that are doing the reviews are developing the guidances and going out into the communities. They are being asked to do too many things at once. They burn out; we have rapid turnover. It's a terrible downward spiral that will serve no one."
This may not be fodder for a conspiracy theorist, but it is not much of a confidence booster either.
Over the upcoming months (years?), I will watch with interest as the FDA drama continues to unfold. I'll do my best to keep an open mind and take the finger pointing with a grain of salt. But, I know that I will also feel a twinge of doubt the next time I see a product bragging on its label about its FDA approval.