Can Business (Ethically) Trust the FDA?

Some people take for granted that government regulators are watching over our safety with an eagle eye.
Others are skeptical, because they think regulatory agencies are either underfunded, or in the back pocket’s of industry.

Is it ethically OK for a company, in defending its own behaviour, to trust in, rely upon, and point to a regulatory decision?

Case in point: this story from the Washington Post: BPA Ruling Flawed, Panel Says

The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found.

In a highly critical report to be released today, the panel of scientists from government and academia said the FDA did not take into consideration scores of studies that have linked bisphenol A (BPA) to prostate cancer, diabetes and other health problems in animals when it completed a draft risk assessment of the chemical last month. The panel said the FDA didn’t use enough infant formula samples and didn’t adequately account for variations among the samples.

So, what are manufacturers to do now? The FDA says BPA is safe. But at least some reputable scientists think the FDA is wrong about that. Can companies go ahead, in good conscience, and use BPA in their products? On one hand, one might think it fair that companies be allowed to rely, ethically, on the advice of the top health-regulatory agency in the land. I mean, few things can be guaranteed, with 100% certainty, to be safe, but if the FDA’s word isn’t good enough, whose is? It’s not a rhetorical question. In writing about GM foods, I’ve said, look, not only do the FDA and Health Canada and the World Health Organization agree that GM foods are safe, but basically every reputable scientist in the world says so, too. But what about cases where there’s disagreement? Of course, it can’t be the case that just any scientific disagreement is sufficient to call a halt to production. How much is enough? In the case of BPA, I’m inclined to say that the FDA’s ruling makes it legal to use BPA, but ethically dubious. There is a very respectable sub-set of scientists who have grave reservations. That distinguishes this from the GM foods case. Of course, just what counts as “enough” scientific disagreement to tilt the landscape of ethical corporate behaviour is a big question. Any thoughts?

4 comments so far

  1. Colin on

    I don’t know how I ended up on the email updates list for this blog, but I’ve read it off and on for a month or two now and it seems you’re trying to deal with issues you see as important, albeit from a somewhat conservative standpoint.Speaking about ethics, which I would say inherently implies care, concern and empathy for [at least the majority of] society as a whole and people in it, it seems to me irresponsible to say that GM foods are totally safe and that no reputable claims to the contrary exist. This is just as ridiculous as saying the FDA and Health Canada are good, reliable, uncorruptable organizations who always follows its stated primary objective to protect the health and safety of individuals by restricting or controlling substances which are known to cause harm.The amount of ‘mistakes’ that have taken place over decades with such deeply-entrenched, corporate-funded disregard for adverse health effects on people should immediately dispel this notion. However neither would I say that they exist only as front organizations for multinational pharma and industrial agriculture [though they support and are supported by these interests], there are many policies and people within these organizations that are designed and work very hard to actually protect peoples’ health. So given that both very safe and very toxic foods and drugs get approved for general consumption, and that very safe and very toxic foods get denied legality as well, I would say that we should look very hard at your [not] rhetorical question, given that the FDA’s word is certainly NOT good enough for me!!Call me non-progressive, but I think that short-sighted human meddling in simple natural processes turns out disastrous much more often than not, and where the very nature of species is concerned, especially in the direct food chain, I would err on the side of caution.The incidence of the FDA ignoring scientific evidence in favour of approving high-profit but dangerous products is high and well-documented, I would say that even reproducing the opinion that this is a trust-worthy regulatory body is unethical on your part.And I challenge you to find me evidence that GM Foods are totally healthy over long term, that has been conducted without any financial, directorial or managerial support from anyone standing to gain financially from GM foods gaining greater support.As always with these kinds of debates, why can’t we err on the side of health and safety? How long did it take for the FDA to accept that no matter how much money there is to be made, smoking just isn’t good for you? Or DDT? Or radiation even? Simple things that we now have as a greater society accepted as bad ideas, even though for so long we had to fight for people to not be able to say endlessly “there’s just not enough evidence?” Anyway I’ll post back to your GM post separately with a few more thoughts.Thanks for adding my comment to your blog discussion, I think it’s important to keep open as many voices as possible.

  2. Chris MacDonald on

    Colin:As for the FDA, do note that I was asking, not answering. I honestly don’t know what a well-intentioned company is to do, when there are *some* scientists who disagree with the FDA. As for the safety of GM foods (not really the topic here), most food scientists and plant geneticists are funded neither by industry nor by the FDA. Please tell me if I’m wrong, but I know of NO reputable doubts about GM food by those non-industry-funded scientists. As for the challenge to find evidence that GM foods are totally safe in the long run, I’ll re-use an example I used a couple of weeks ago here. I don’t have empirical evidence that the radiation from TV broadcasts won’t give me cancer. But we only need to understand the relevant physics to know that the radiation that makes up TV broadcast signals are too weak to disrupt molecular bonds in our cellular DNA. I get my genetic info second hand, but my understanding from plant geneticists is that the case of GM food is like that: if you understand the underlying science, it’s obvious that there’s no problem (at least for human health).(By the way, I only add people to my mailing list *by request.* If you’re on my list, it’s either because you requested it, or someone else requested on your behalf. Let me know if you’d like to be removed.)Chris.

  3. Douglas on

    This brings into question the current debate as to whether a pre-emption law should be allowed to protect drug companies being sued by states for adverse effects related to their products, the basis being that the FDA is the “final word” on question of safety and efficacy of medicines. See http://www.pharmalot.com/2008/10/fda-staff-objected-to-preemption-policy-report/

  4. Chris MacDonald on

    Here’s an active link to the item Douglas cited above:< HREF="http://www.pharmalot.com/2008/10/fda-staff-objected-to-preemption-policy-report/" REL="nofollow">http://www.pharmalot.com/2008/10/fda-staff-objected-to-preemption-policy-report/<>


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