Regulation

Good Conflicts of Interest vs. Bad Conflicts of Interest

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The Family Smoking Prevention and Tobacco Control Act, the 2009 law that authorized the FDA to regulate tobacco products, required the appointment of an advisory committee to help the agency do so. The law specifies that no member of the Tobacco Products Scientific Advisory Committee (aside from three nonvoting industry representatives) "shall, during the member's tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any business that manufactures, distributes, markets, or sells cigarettes or other tobacco products." But as Washington Examiner columnist Timothy Carney noted last month, several of the experts appointed to the committee have financial ties to pharmaceutical companies that manufacture nicotine replacement products, which compete not only with cigarettes but with various safer alternatives that the FDA is deciding how to regulate. This week Citizens for Responsibility and Ethics in Washington (CREW), a left-leaning watchdog group, asked the inspector general of the FDA's parent agency, the Department of Health and Human Services, to investigate the decision to appoint two of those panelists:

Dr. Neal Benowitz is a paid consultant for pharmaceutical companies, including Pfizer, GlaxoSmithKline, Novartis and Aradigm, assisting with the design, development and marketing of smoking cessation products. He also has served as a paid expert witness for plaintiffs suing tobacco companies, charging between $275-$600 per hour.

Dr. Jack Henningfield, through his firm, Pinney and Associates, is a paid consultant for pharmaceutical companies seeking approval of smoking cessation products. He is also a partner in a company that holds at least one patent for a nicotine gum. Like Dr. Benowitz, he also has been paid to testify for plaintiffs in tobacco cases.

CREW argues that the appointment of Benowitz, a professor of medicine at U.C.-San Francisco, and Henningfield, vice president for research and health policy at Pinney Associates, violates rules for advisory committees that the FDA adopted in 2008. "Absent a waiver," it says, "committee members cannot participate in particular matters in which they have a financial interest." CREW Executive Director Melanie Sloan elaborates:

Loathing tobacco companies does not justify ignoring clear conflicts of interest. As great as it is that the FDA is finally regulating tobacco products—and as credentialed as Drs. Benowitz and Henningfield may be—there is no excuse for including those paid to consult or create smoking cessation products on the panel. How can we have faith in the TPSAC's conclusions when some of its members have a vested financial interest in the panel's decisions?

Americans for Limited Government and the American Council on Science and Health also have complained about conflicts of interest on the advisory committee, which Michael Siegel first highlighted on his tobacco policy blog in March. Benowitz claims not to understand what the fuss is about:

I really don't see any conflict. My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking. The aim of the committee is also to reduce the adverse health consequences of tobacco use.

Seriously? Companies that manufacture or distribute cigarette substitutes that provide nicotine without smoke, such as snus, tobacco pellets, and electronic cigarettes, could say the same thing: Their aim is to "reduce the adverse health consequences of tobacco use," and make a profit doing so. How is that fundamentally different from what Novartis or GlaxoSmithKline does? The pharmaceutical companies have a lot riding on the FDA's decisions about whether to tolerate and how to regulate alternatives to their nicotine gum, lozenges, patches, and inhalers.

That doesn't mean Benowitz and Henningfield are not qualified to advise the FDA in this area. Aside from their many years of experience with tobacco issues, both are willing to acknowledge that different tobacco products pose different levels of risk, and both are at least theoretically open to the idea of tobacco harm reduction—qualities that distinguish them from many, if not most, public health officials and anti-smoking activists. Still, both seem inclined to favor the kind of regulations that would reduce competition in the market for cigarette substitutes. It would have made sense to balance them with panelists who are more sensitive to the costs of such regulations, and it is plainly irrational to let Benowitz and Henningfield serve on the committee while excluding otherwise qualified experts based on, say, research funding or consulting fees from the smokeless tobacco industry.

Nevertheless, as someone who is still accused of being a tobacco industry flack based on a reprint fee that R.J. Reynolds paid me 16 years ago, I am skeptical of the implication that people like Benowitz and Henningfield take the positions they do because of their financial ties to the pharmaceutical industry. Although strict regulation (or outright prohibition) of nonpharmaceutical cigarette alternatives clearly would benefit the drug companies, there is no need to speculate about financial motives, since tobacco control scientists (and public health academics generally) are, by and large, ideologically predisposed to favor more government intervention. In any case, motives are logically irrelevant in assessing the merits of any particular tobacco policy. Still, it's hilarious that Stanton Glantz, an anti-smoking activist who is notorious for accusing anyone who disagrees with him of secretly working for Big Tobacco, comes to Benowitz and Henningfield's defense by insisting that money doesn't matter.

In a 2007 Reason article, Ron Bailey explored "the overrated risks and underrated benefits" of "conflicts of interest" in pharmaceutical research.

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  1. Citizens for Responsibility and Ethics in Washington? Sounds like a dark sitcom.

    1. Sounds like an ultraright special interest group bent on their corporate agenda!

    2. Mostly unrelated, but I’d like to make a sitcom in the style of The Office, but about a secret police unit in an Orwellian fascist dystopia (the entire series would be shot through “hidden cameras”, set up both by and against to the main characters).

  2. Still, it’s hilarious that Stanton Glantz, an anti-smoking activist who is notorious for accusing anyone who disagrees with him of secretly working for Big Tobacco, comes to Benowitz and Henningfield’s defense by insisting that money doesn’t matter.

    “Logical consistency” is not a term that exists in the Lefty dictionary, Jacob. Nor is “Principles”, but you will find “Expediency” many times over.

    1. “Logical consistency” is not a term that exists in the Lefty dictionary, Jacob. Nor is “Principles”, but you will find “Expediency” many times over.

      Agreed. Not in the Righty dictionary either.

      1. Very true – considering Lefty and Righty are the two wings of the same vulture.

    2. It’s not a lack of logical consistency so much as a lack of any principles other than “whatever is helps me or my side win.” It unfortunately afflicts most of society.

  3. “Everybody hates the tobacco companies …,” Melanie Sloan, executive director of Citizens for Responsibility and Ethics in Washington

    Fuckers.

    1. Having trouble quitting there Barry?

      1. Um, smokin’s bad, mm’kay?

  4. Conflict of interest in a regulatory body? Say it ain’t so!

  5. When is the government going to start regulating farting?

    1. Obviously a money making plot by the “Beano for Cows” group.

      1. obviously a shill for “big farts”

  6. They should be required to recite a statement at the beginning of every meeting: “My clients will earn more money if we are mean to Philip Morris.”

  7. The Natural American Spirit Cigarettes I bought this weekend had little stickers in them to announce that because of the FDA, they’d be changing their regular pack color from light blue to darker blue, and their menthol light pack from dark green to light deco style green. If it were up to me, I’d have ever single person who works at the White House and FDA hung.

    1. They’re not changing the yellow of the Lights, are they?

      1. At least colors and symbols can’t be used to circumvent *other* restrictions.

  8. The Family Smoking Prevention and Tobacco Control Act.

    There. Honesty in government.

  9. I would think that the conflict of interest would work out somewhat differently. The smoking cessation product manufacturers want there to continue to be large numbers of smokers, including new ones, so they can continue to sell their products. At the same time, they also want to make people feel the need to kick the habit. I don’t believe that these two goals are necessarily in conflict.

    1. Read the article (I know, it’s a lot of words). The thing they’re pushing is making tobacco replacements that aren’t made by pharmaceutical companies illegal.

  10. I agree with you today, Ron: conflicts of interest are an over-blown issue. Obviously, we need to root out the most egregious ones, and monitor any significant ones. However, as you noted in your 2007 article, conflicts of interest, particularly low-level second-order ones, are inevitable in professional life and not really something to be concerned with.

    Now, if libertarians would just acknowledge this logic is just as true when you are talking about, say, climate scientists, we might have even broader agreement!

    1. It’s not their conflicts of interest that are so troubling, it’s their questionable conclusions and the fact that all of us are supposed to start trading bogus credits based on them.

      1. So you are admitting that deniers who claim its all about the grant money are wrong? Are you willing to shout this from the rooftops and explain this to them every time they spew this garbage?

        It doesn’t even make much sense. Getting the technically wrong answer is far more damaging to your career over the medium and long term than any hypothetical gain they could make in the short run by attempting to appease some mythical grant reviewer who prefers a particular answer to the truth. It also betrays a mile-wide mis-understanding of both science and the grant-reviewing process. Scientists are always working on several different projects, and adapt their plans as some projects fail and some lead somewhere. Both they and the grant money will move down the fruitful paths.

        1. The grant money thing is not so much a conflict of interest problem as a bais built into the system. More grant money is available for research that assumes anthropogenic global warming, so more research is done based on that assumption. There is not real conflict for individual scientists, but there is an inherent bias in the type of research that gets funded. This is true whether or not the results are valid.

  11. That actually makes a lot of sense when you think about it.

    Lou
    http://www.anonymity-online.net.tc

  12. That actually makes a lot of sense when you think about it.

    http://www.anonymity-online.net.tc

    1. So it doesn’t make any sense when you don’t think about it?

  13. For as long as cigarettes produce smoke they will be under increasing pressure and regulation. Electronic cigarettes produce no smoke – only a water-based, smoke-like vapor that does not leave a smell in clothes or hair. They cannot cause a fire when one falls asleep using them as nothing burns so they are safer. They leave no tar in the lungs. My mother has not touched a regular cigarette since trying hers. You can see one being used at http://www.CleanGreenNicotine.com/ – Electronic cigarettes provide all the satisfaction of smoking without all the negatives.

    1. This is not an advertisement, either!

  14. Family Smoking Prevention and Tobacco Control Act

    So I guess if we put “Family” in the name of the law, everyone will automatically know it’s a good law for the betterment of all.

    Why not just call it the Shiny Happy Puppy Bubbles Rainbows Tobacco Control Act.

  15. It’s not that money doesn’t matter; it’s that failure to disclose it matters (something you do routinely, Jacob), and it’s that where it comes from matters (you took yours from Big Tobacco). Funny how you don’t mention either of these points.

  16. He did, dipshit. Repeatedly.

  17. I learned a lot about snus from an article I read online and it convinced me to make the switch from cigarettes. Everything I have been reading shows me that snus is pretty much harmless because of the way its made. I highly recommend giving the article a read if yall are curious about snus. http://snusauthority.com/blog/about-snus/

  18. Banning cigarettes is an abuse of government power. Nobody can dictated me what to smoke and where to buy. I do hope that online traditional cigarettes shops such as http://www.cigoutlet.net/ will never stop the business.

  19. First a little education on federal advisory committees and their members who are usually considered Special Government Employees (SGEs) and work in this capacity three to ten days total a year usually.

    The rest of the time the SGE has a 9 to 5 job elsewhere. In the case of someone serving as an SGE on the Tobacco Products Scientific Advisory Committee that most likely would be someone who works in the medical or drug field that has some dealings in that subject area.

    The bottom line is that these SGEs are selected to serve based on their expertise which often is related to where they work. Often their work is funded indirectly by businesses in the same area – e.g. university’s research funding coming from a drug company.

    The result is that most SGEs have some financial connections that create conflicts of interest. They are usually resolved by the issuance of a conflict of interest waiver under 18 US Code Section 208(b)(3) after it is determined the expertise of the SGE outweighs his or her conflicting interest. Sometimes the conflicts are resolved by requiring the SGE to recuse himself on any matter affecting an asset or position the hold.

    If you could not do the above you could not get the best and brightest experts to serve on these committees. The alternative would be to just select people at random off the street to serve.

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