Thursday, April 2, 2009

PHARMA, TOBACCO, AND THE FDA

Smoking in Bed



As many will know, Congress passed a bill today that would enable the FDA to regulate tobacco for the first time. The New York Times has the story at:


http://www.nytimes.com/2009/04/03/us/politics/03tobacco.html?emc=tnt&tntemail0=y


What is of wider interest here are the political alliances between the tobacco and pharmaceutical industries in recent years, as profoundly different have been their contributions to the public good. Still, their champions--especially regarding limiting regulation and liability--have been many of the same people and organizations. Likewise, the two industries joined in funding the "think tanks" that fostered the ideologies of deregulation and preemption that have been so prominent a part of contemporary policy debates.



Dan Troy is, of course, the most famous. A year before he became FDA Chief Counsel, he successfully argued in the Supreme Court against FDA regulation of tobacco. That is the legacy which Congress is now working to reverse.



The Washington Legal Foundation, which took point in the deregulatory movement in the mid-90s, was also a shared creation of tobacco, pharma, and hard right family foundations. During the '90s, for example, when Republicans under Gingrich worked to disssolve the post-thalidomide FDA (Kefauver-Harris amendments), the WLF published a series of full-page ads in the Wall Street Journal and elsewhere, trumpeting what was described as the near genocidal impact of FDA regulation. More recently, the WLF is known for its fight against regulation of off-label promotion. Indeed, Wiley Rein--the same firm that represented Wyeth in the Levine preemption case--was centrally responsible for the "liberalizing" of off-label drug promotion in a 2000 case (http://www.wileyrein.com/news_release.cfm?press_release_id=2173) The links between the WLF and both pharma and tobacco (especially tobacco) are summarized at http://www.sourcewatch.org/index.php?title=Washington_Legal_Foundation


Many believe that the rage against FDA in the '90s, and against Commssioner David Kessler in particular, was fueled above all by Kessler's attempts then to regulate tobacco.


Today, many in pharma are shocked by the fact that public opinion polls rank the industry close to big tobacco in overall approval ratings. In my view, that shock is well-founded. But the connection has a specific political history of shared alliances and agenda. It does not emerge from nowhere.

8 comments:

  1. So, will the person in charge of tobacco at the FDA be called the Butt Head? How long will it take for Big Tobacco to convince doctors and the FDA to require all children to begin smoking before they can start public school.

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  2. The irony is that now that the FDA is taken over, Tobacco just like big pharma will be able to pay off some key opinion leaders from Harvard to speak on the benefits of smoking, and their conclusions will be the gospel from JAMA next month!

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  3. No big shock about more government involvement in anything anymore. As inefficient as they are. It makes no sense to depend on tobacco taxes to help fund health care and then tax and regulate people out of smoking. Who comes up with this stuff? Now that cap and trade is off the agenda you would think they would be promoting smoking to cover those costs. Fortunately there is talk about decriminalizing marijuana to have some other smokable to tax too. This country is going to pot.

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  4. If you wish to stop smoking, click on "Cold turkey."

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  5. In a March 18 Senate hearing on ‘what is quality health care and who decides,’ an Intermountain Healthcare physician testified on how to improve quality in health care. He recommended that quality measures be built from the bottom up, and then rolled out from point of care to local, state and national systems. To view an example of Intermountain’s care plans, visit this site:
    http://intermountainhealthcare.org/about/quality/institute/Documents/CPMListJensen.pdf

    Senator Jay Rockefeller plead for a redistribution of power in Washington to aid in evaluating the ailing health care system:
    “...one of our problems around here is that we let lobbyists, doctors’ groups, congressmen, and political pressure...make too many decisions. There is something called expertise, and expertise can be very quickly turned into highly sophisticated data if the political process is not involved, either medical or congressional... this place is overwhelmed with lobbyists...and boy do they push for their product. Now, how can you possibly talk with me about a system of quality when you have that kind of activity [clip position 58]?”

    To view the Senate hearing, visit this site:
    http://finance.senate.gov/sitepages/hearings.htm

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  6. I'm not sure what Jay is trying to say. "There is something called expertise, and expertise can be very quickly turned into highly sophisticated data if the political process is not involved."

    How does this relate to a "redistribution of power" in Washington--who is giving? who is getting?

    And is there some notion that "expertise" can be found mostly at the bottom?

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  7. Truly Confused, you are in good company. You can listen to health care reformers grappling with the definition of health care quality and questions about who is in the best position to make decisions about health care here:
    http://finance.senate.gov/sitepages/hearings.htm
    Video clip positions 12:20, 15:45, and 58

    Senator Rockefeller is on a fact-finding mission to define health care quality, and he is looking for a group of independent experts to lead the health care reform effort.

    First, the senator expressed his concern for citizens who have suffered needlessly because the health care they received was not of the best quality. One example he gave is that some individuals have received improper diagnoses and treatments.

    Second, the senator proposed taking physicians groups and lobbyists out of the decision-making processes in health care delivery. More information on this topic can be found here:
    http://www.medpac.gov/documents/20090401_WM_Testimony_DeliveryReform.pdf

    Third, the senator theorized that an independent group such as MedPAC [http://www.medpac.gov/] if given adequate resources, could dissect the health care system and provide valid data on which to base individual and ultimately organizational health care decisions.

    Finally, Senator Rockefeller’s theory is consistent with Senator Grassley’s view that health care decisions should be made by individuals and their physicians as opposed to parties with private interests. In other words, an individual and his physician have access to the most current and applicable knowledge upon which to a) base a diagnosis and b) weigh the risks and benefits of appropriate treatments. Hence expertise can be found at the point of care.

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  8. Ahhhh......

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