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.