Pernicious influences at the FDA…and what’s new about this?

So the Union of Concerned Scientists issued a press release, and the media bleats “FDA Scientists Blast Agency Priorities.” In the interest of brevity, the qualifier that these blasts emanated from 20% of those surveyed was omitted. Presumably, the other 80% were cowed into submission by their hyperpolitically charged overlords or were just too busy and overworked to be bothered. Of the 20%, various responses indicated various misgivings as noted in the survey summary on the UCS web site.
Job dissatistisfaction at the FDA? Undue influence by outside interests? Poor morale? Suppression of scientific candor? Well, stop the presses!
At the risk of sounding like an acerebrate Fox News cretin, a more fair and balanced approach by the media would be welcome as opposed to making it sound like the FDA is on the verge of implosion. It’s not. The FDA has never been free from problems. The difficulties just seem to change with the political farts, I mean, winds of the moment.

SciBloggists Orac (Respectful Insolence) and and Joseph j7uy5 (Corpus Callosum) reflect my guarded skepticism as pertains to the survey, and the media’s subsequent lamprey-like latching on to it, in their succinct comments to Grrl Scientist’s and Dr. Free-Ride’s blog entries.
The UCS survey questions and much more may be found in pdf form on the UCS website (see “Related Links” in the USC link above). FDA spokeswoman Susan Bro stated that the survey lacked scientific rigor, and there I agree. Ms. Bro may be more accustommed to much larger sample sizes for meaningful statistical significance. However, the USC survey reads more like the “job satisfaction” surveys I have filled out on numerous occasions. Although not scientific, this type of survey gives a qualitative gauge of the workplace atmosphere, and the results are quite useful as a “head’s up” to management.
I have to wonder what the responses would have been if given 20 years ago. The FDA has never been a paragon of efficiency nor completely independent from outside influences. My pecunious employer(s) and the moral values politicos are not the only ones who try to exert their will on the hapless scientists as might be implied by the survey and the media pieces. If one reads through the materials on the USC site, those surveyed cite inappropriate influence by advocacy groups. Anyone remember ACT-UP’s push for rapid approval of HIV meds? This advocacy contributed to creation of fast track process at the FDA. Was there perceived coercion among the FDA ranks then? I’ll bet if the survey had been given at that time, there would have been much wailing and gnashing of teeth over the risk of compromised safety due to fast tracking. Those concerns are legitimate, but the risks:benefits ratios are quite different for drugs to treat nasty and potentially fatal retroviral diseases as opposed to an anti-inflammatory drug originally intended for a subset of arthritic patients.
Friends who are or were FDA scientists some years back had plenty of anecdotal complaints about the obstacles of getting good science done. Their gripes centered around an incredibly burdensome bureaucracy, and how such put a damper on their research.
The following comment, pulled from the USC survey brochure, rings true for many scientific organizations. Those higher up on the food chain become more removed from the data and potentially less objective.

In my experience,it is never the ‘low level’ reviewers in the FDA who breach the integrity of our work.It is usually at much higher levels,such as center directors and above. Those higher levels are so far removed from the scientific work we do that politics has even more sway over their decisions….The people I work with are truly dedicated to serving the American public and doing whatever is in their power to ensure their safety.
– A scientist from the Center for Devices and Radiological Health

Although the UCS survey methodology is “unscientific,” its results certainly dovetail with many other noisy grumblings on problems within the FDA. Some kind of reform (independent post-marketing oversight sounds good to me) is in the best interests of the public and the drug/med devices industry. Transparency and accountability at all levels should be in place. Yet…yet…even with the most robust clinical trials, the most independent reviews, transparency like clear glass, and the best of intentions, there will always be risks associated with a drug. Always. Risks can and should be minimized, but they cannot be eliminated. I don’t hold out hopes that the public, the media, or sadly, some of my fellow scientists at the UCS, will grok that fact.

3 thoughts on “Pernicious influences at the FDA…and what’s new about this?”

  1. I think you are correct: the survey is difficult to interpret without knowing what the results would have been under a different Administration.
    However, with all the different lines of evidence pointing to systematic subversion/distortion/suppression of science under this administration, it is hard to view the survey as anything but another instance of political meddling. Sure, all administrations do it, but the sense of many scientists is that the Bush administration does it much more than any prior administration.
    Incidentally, your point about the undue influence occurring at higher levels of government probably mirrors what I heard from those working in the pharmaceutical industry. Scientists involved in discovery and development are dedicated, altruistic types. The higher you go in the orgnaization, the more likely you are to see some shady business.

  2. Joseph,
    Re: the particularly egregious political meddling by the current administration; I absolutely agree. The machinations of the Bush League with the FDA are, to my mind, unprecedented with the Plan B emergency contraceptive imbroglio as one of the key examples.
    With regard to what you’ve heard about the pharma industry, i.e., the integrity of the scientists in discovery & development vs. the upper echelons, I can state with certainty that this is an accurate observation.
    While I’ve got you here, I thought I’d tell you that I’m a fan of The Corpus Callosum, and hopefully I add a bit of volume to your site hits!

  3. So some FDA employees don’t trust the FDA.
    We the public certainly don’t trust the drug regulators.
    The major concern of big Pharma is that potential jurors don’t trust the FDA.
    Nice contrast between this survey of FDA employees, and a survey by Chicago-based legal consulting firm Zagnoli McEvoy Foley (ZMF) also published this week in the National Law Journal. The research indicates that the “FDA’s positive halo effect which benefited pharmaceutical companies at trial” is all but gone (Jurors’ view of FDA has soured in recent years
    The FDA “halo effect” : Going, going, gone….)
    A 2006 nationwide survey of 404 jury-eligible Americans showed that less than one-third held a positive perception of the FDA. Earlier surveys had shown that “FDA approval could absolve a pharmaceutical company of guilt in a juror’s eyes, as a result of the “rubbing off” of the FDA’s perceived credibility”. Now that’s the important bit – the FDA is no longer effective at absolving companies from corporate criminality.
    So what to do……
    Well make it impossible for anyone to bring legal action against a drug manufacturer for harm caused by one of its products – so long as that product has FDA approval – even in cases of scientific fraud, the concealing of data, misrepresentation of data, or breaches of scientific procedure by the company (FDA regulations make it harder to sue drug companies).
    “Beginning at the end of this month, the new regulations would pre-empt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud–a very hard test to meet,”
    Be scared. Be very very scared.

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