Effect Measure

FDA gets back to business (as usual)

The US Food and Drug Administration is celebrating its centenary, but a good proportion of its scientists are not so thrilled with what it has become. The Union of Concerned Scientists (UCS) just released a survey of 997 FDA scientists, co-sponsored by Public Employees for Environmental Responsibility to a total of 5918. This is not the world’s best response rate, so the results can’t be claimed representatives. But what it revealed is disturbing in itself. One hundred eighty three scientists in this sample reported they “have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document.”

Forty percent of respondents fear retaliation for voicing safety concerns in public. This fear, scientists say, combines with other pressures to compromise the agency’s ability to protect public health and safety. More than a third of the respondents did not feel they could express safety concerns even inside the agency.

[snip]

The survey also revealed other compelling points of concern:

* 61 percent of the respondents knew of cases where “Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.”

* Only 47 percent think the “FDA routinely provides complete and accurate information to the public.”

* 81 percent agreed that the “public would be better served if the independence and authority of FDA post-market safety systems were strengthened.”

* 70 percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of “protecting public health*and helping to get accurate science-based information they need to use medicines and foods to improve their health.” (UCS Press Release)

FDA is not unique in the Bush administration and the Republican congress. Whether it is the science of climate change, stem cells or health and safety, science takes a back seat to lobbyists, corporate influence and religious pressure.

In other words, business as usual.

Comments

  1. #1 Marissa
    July 21, 2006

    We’re rolling back science-based evidence in favor of religious views. As a woman, what gets my goat is that a bunch of men are still telling us what drugs we can take without running the gauntlet when it comes to reproduction issues. I think any pharmacist who fails to fill a prescription for a woman on “religious grounds” should be fired.

  2. #2 Orac
    July 21, 2006

    I can’t help but notice that the response rate for the survey was pretty low, only about one in six. Consequently, although I’m no fan of the Bush Administration’s science policy, I really have to question just how valid the results of this survey are. The respondents are a pretty self-selected group.

  3. #3 revere
    July 21, 2006

    Orac: That is not the correct way to interpret this. It is true that one cannot generalize to all FDA scientists and say that 20% feel they have been interfered with. It is not valid for that purpose. The true figure might be only 4% (cannot be less) or 80+%%. The selection bias works in both directions. What it does say is that 183 FDA scientists felt this way. If a couple of hundred faculty at my university — which is a lot bigger than the FDA — felt that way it would be a major scandal. So this is indeed informative, just not informative for the purpose you were envisioning.

  4. #4 Steph
    July 21, 2006

    I know this is off-topic, but I couldn’t wait. I just saw this and thought of your previous “sunshine” posts. Eeyaw, is all I can say.

    From NYTimes

    Report: Leavitt Benefits From Foundation

    By THE ASSOCIATED PRESS
    Published: July 21, 2006
    Filed at 2:30 a.m. ET

    WASHINGTON (AP) — Health and Human Services Secretary Mike Leavitt and his relatives created a charitable foundation that allowed them to claim millions of dollars in tax deductions yet provided little to charity, according to The Washington Post.

    The Internal Revenue Service has called the tax structure used to create the Leavitt foundation a Type III supporting organization, one of its ”Dirty Dozen” tax scams. Christina Pearson, an HHS spokeswoman, said the foundation’s activities are ”totally legal and proper.”

    Much of the money from the foundation — set up in 2000 with nearly $9 million from Leavitt family assets — went into investments or loans to the family’s business interests and real estate holdings, the Post reported Friday.

    The Leavitt organization donated less than 1 percent of its assets in 2002, 2003 and 2004, according to the Post. Standard private foundations are required to donate at least 5 percent of their assets to charitable causes, but the Leavitts set up their foundation under a provision of the federal tax code that allows a lower level of giving, the newspaper reported.

    The Leavitt Foundation donated $49,087 of its $9 million trust, or 0.5 percent, in 2002 and $52,312, or 0.6 percent, in 2003, the Post reported. Since 2000, Mike Leavitt alone has claimed about $1.2 million in tax write-offs.

    ”They’re basically sitting on all this money, getting a charitable write-off and doing nothing with it,” said Rick Cohen, executive director of the National Committee for Responsive Philanthropy. Cohen reviewed the foundation’s records and tax returns at the Post’s request.

    Congress is considering changing the tax structure under proposals by Senate Finance Committee Chairman Charles Grassley, R-Iowa.

  5. #5 revere
    July 21, 2006

    Steph: Yikes. Pretty sleazy.

  6. #6 Orac
    July 22, 2006

    That is not the correct way to interpret this.

    Perhaps not, but that’s the way it’s being reported, both in the media, and, unfortunately, right here by a few ScienceBloggers. Indeed, in a lot of the commentary I’ve seen, there is no mention of the very low response rate, much less discussion of its significance. In a poll such as this is a VERY important bit of information, wouldn’t you agree?

    The poll is being presented as strong evidence that there is a problem when in fact it is nothing more than a possible indication. And let us not forget who commissioned the poll. It’s a political document. The poll may very well indicate a serious problem, but it’s hard to say from what is presented.

    Let’s just say that I agree that there probably is a problem based on other information and the history of the Bush Administration. I’m just not as impressed by this survey as a lot of others seem to be.

  7. #7 Tom
    July 22, 2006

    If I understood the response rate — about 16-17 percent –I think that is pretty decent for a mail survey. I would think that the response should be fairly representative too.

  8. #8 NH
    July 22, 2006

    Orac: If even one scientist at the FDA answers in an anonymous survey that he has been asked to lie in a report, I have concerns. If another scientist corroborates that this is happening by relating his own experience, I don’t have much doubt that the practice is rampant. If 20% answer thus, what more do we have to know? Why 20% of 1000 surveyed would answer falsely on this question, I simply can’t imagine. When will the Bush record stand on its own?

  9. #9 revere
    July 22, 2006

    Orac, Tom: Yes, the response rate is typical for a mail survey. The results were reported complete with the size of the population ( which I duly reported). I disagree with Orac in that the use of sampling and statistics is intimately tied to the kind of information one wishes to get from it. He is not impressed that 183 FDA scientists (of those willing to respond) felt they were interfered with. I am impressed and for some of the reasons he indicates. One must interpret statistics in the context of known information, background, theory, etc. This has nothing to do with politics. It is just as true with any empirical scientific data gathering. I also disagree that most reports suggest these data indicate that 20% of FDA scientists have been interfered with. Most of the reports I have seen report what we did, that it is 20% of the respondents. Few make anything of the estimated proportion (which is unknown but bounded between 4 and 85%) given the data, but there is a well known difference between raw numbers and proportions. They mean something different and need to be interpreted differently. Orac doesn’t think a minimum of a couple of hundred FDA scientists who feel interfered with is impressive. I do. Orac mentions the significance of the very low response rate. What is that significance? As Tom suggests, it is typical of surveys where respondents are asked to fill in forms by mail or other formats. So this isn’t abnormally low for those types of surveys and isn’t significant for that fact. Orac and I disagree about whether the response rate is a significant problem for deriving information that there is a problem at the FDA concerning political interference in science. I don’t he has made his case.

  10. #10 mobius
    July 22, 2006

    Orac: The author of THIS article clearly states, “This is not the world’s best response rate, so the results can’t be claimed representatives.”

    Your contention, “The poll is being presented as strong evidence that there is a problem when in fact it is nothing more than a possible indication”, is itself nothing but a straw man.

  11. #11 DrKLD
    July 22, 2006

    I seem to remember a similar situation at US Fish and Wildlife where a fairly large number of scientists reported outside political interference regarding their findings and conclusions. Are the UCS findings poltically motivated and/or charged? Maybe, but any time you have nearly 200 scientists claiming high levels of intereference and coercion with regards to empirical data or conclusions it should be of great concern. Couple these findings with the rather interesting “administrative oversight” of the FDA over the last 6 years and, well, I’m not feeling any great level of psychological ease with FDA output.

  12. #12 Aubrey Blumsohn
    July 23, 2006

    “If even one scientist at the FDA answers in an anonymous survey that he has been asked to lie in a report, I have concerns.”

    Precisely!

    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.