Tuesday, August 07, 2012

Federal Court Rules that Lawsuit Against FDA for Conflicts of Interest on TPSAC Can Proceed

A federal district court judge has ruled that a lawsuit filed against the FDA by Lorillard and R.J. Reynolds, seeking an injunction against the use of the TPSAC's menthol report because of conflicts of interest on the panel, can proceed.

According to a CBS News article: "A federal judge has denied a Food and Drug Administration (FDA) motion to dismiss a suit filed by two of the nation's largest cigarette makers that claimed the advisory panel that reviewed tobacco products for the FDA had financial conflicts of interest. In an order posted Wednesday, U.S. District Court Judge Richard Leon in Washington said that the suit filed by Lorillard Inc. and R.J. Reynolds Tobacco Co. can move forward. The suit filed last year alleges financial conflicts of interest and bias by several members of the Tobacco Products Scientific Advisory Committee and asks the court to stop the federal agency from relying on the panel's recommendations." ...

"In a statement, Lorillard said: "The practice of appointing members to a government scientific advisory committee who have financial interests that violate conflict-of-interest laws and regulations should be subject to judicial review, as the court has now recognized." ... In the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The suit specifically alleges that some committee members have conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and have financial ties to pharmaceutical companies that make smoking-cessation products." ...

"Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said the suit is an effort by the tobacco companies to 'obstruct effective policies to reduce tobacco use and to discredit anyone who advocates such policies.'"

The Rest of the Story

I don't agree with the Campaign for Tobacco-Free Kids that the suit is an effort to discredit anyone who advocates policies to reduce tobacco use. I think it is an effort to try to get rid of several specific individuals who have severe conflicts of interest by virtue of their financial ties to pharmaceutical companies or who have benefited financially from testifying against the tobacco companies in court and who could potentially use information gleaned during their work with TPSAC in future litigation testimony.

In other words, I agree that there is sufficient legal basis for the suit to move forward.

If this were a federal advisory committee providing guidance to the EPA on how to proceed with environmental regulation and four members of the advisory committee had financial ties to chemical companies, then by all means we would want the courts to review the appointments of those conflicted panelists. Just because the issue here is tobacco doesn't negate the need to ensure scientific objectivity in agency decision-making.

Now I do differ somewhat from Lorillard and R.J. Reynolds in my opinion on the basis for the lawsuit. I do not view the expert testimony as being a disqualifying conflict of interest. While it is true that panelists could potentially glean information from the proceedings which could subsequently be used in lawsuit testimony, I believe that needs to be handled at the judicial level at the time of their subsequent testimony. The companies would have legitimate grounds to contest the ability of those witnesses to testify. The potential use of confidential or proprietary information should be addressed at the level of the FDA panel itself. Those participants should be required to sign a statement attesting that they will not use any such information in litigation or otherwise share confidential or proprietary information with the public. And since the past litigation has already occurred, unless a scientist is currently a paid witness in an ongoing trial, I don't see the need to disqualify such a panelist, although I do believe that these other protections are warranted.

On the other hand, I completely agree that the financial conflicts of interest by virtue of four of the TPSAC members having financial relationships with Big Pharma companies that manufacture smoking cessation products should be disqualifying. The TPSAC is directly recommending policies that will have an impact on pharmaceutical companies that manufacture these drugs. Some of the recommendations could in fact have billion-dollar ramifications for various pharmaceutical companies, or for the industry as a whole. Therefore, it is inexcusable to allow these financially conflicted members to serve on the FDA advisory panel.

I have written extensively on this topic, opining that the four conflicted members of the TPSAC panel should resign because of their financial conflicts of interest.

I have also taken issue with the Campaign for Tobacco-Free Kids' argument that this lawsuit is baseless because the Campaign never provided a legal argument.

Here is what I wrote in March 2011:

In response to the lawsuit brought by R.J. Reynolds and Lorillard against the FDA to prevent it from relying on recommendations from an advisory panel which the tobacco company plaintiffs argue is impermissibly constituted due to the financial conflicts of interest of three panelists with pharmaceutical companies that manufacture smoking cessation drugs, the Campaign for Tobacco-Free Kids has attacked these companies, accusing them of acting the way they have for decades and asserting that the lawsuit is groundless.

The entirety of the Campaign for Tobacco-Free Kids' argument for why the financial conflicts of interest of three advisory committee members is permissible under the law is as follows: "Their lawsuit is groundless. The FDA's Tobacco Products Scientific Advisory Committee was constituted and is acting in accordance with the 2009 law granting the FDA authority over tobacco products, as well as other relevant federal laws."

The Rest of the Story

As usual, the Campaign for Tobacco-Free Kids is issuing propaganda devoid of any solid argumentation. There is a serious issue that needs to be addressed and rather than presenting an argument for why it is permissible to have conflicted panelists on an FDA advisory committee, the Campaign is falling back on its usual rhetoric.

Despite the Campaign for Tobacco-Free Kids' knee-jerk dismissal of the lawsuit, the complaint puts forward a very serious issue: Are we serious about ensuring that federal advisory panels make their recommendations based on an impartial review of the science, rather than under the influence of financial conflicts of interests of the panelists?

In this case, three of the TPSAC members - Drs. Henningfield, Samet, and Benowitz - have severe financial conflicts of interest with Big Pharma. They have served as consultants to, or received funding from, pharmaceutical companies that manufacture smoking cessation drugs. The financial interest of these companies is directly affected by the recommendations that TPSAC is going to put forward on a number of items already on its agenda, including menthol and dissolvable tobacco products.

For example, a menthol ban would be a financial boost for smoking cessation drug companies. As many people affected by the menthol ban would attempt to quit smoking, such a ban would yield a direct financial benefit to companies that manufacture smoking cessation drugs. Thus, it is unacceptable to have panelists who have financial interests in these companies.

Similarly, with dissolvable tobacco products, a ban on these products would be in the best financial interests of pharmaceutical companies that manufacture smoking cessation drugs. As dissolvable tobacco products could serve as a potential competitor (these products could be marketed to help smokers quit using cigarettes), they are a potential threat to smoking cessation drugs. Once again, it is unacceptable to have panelists who have financial interests in these companies.

Rather than directly address this critical issue and explain why it believes that these severe financial conflicts of interest are permissible under the Federal Advisory Committee Act, the Campaign for Tobacco-Free Kids has relied upon its usual propaganda and rhetoric. That rhetoric may have worked years ago, but we are now living in a new era, when (ironically, thanks to the Campaign for Tobacco-Free Kids), tobacco companies are now under federal regulation. And with federal regulation, the law must be obeyed. This is what the Campaign appears to fail to understand. Ironically, this is the Campaign's own doing, as it is the Campaign which promoted the Family Smoking Prevention and Tobacco Control Act in the first place, putting the tobacco companies under federal regulation and thus giving them the protection of the laws that govern federal regulation-making.

The magnitude of the problem is perhaps illustrated best by the fact that GlaxoSmithKline has intervened directly with the FDA, urging the Agency to take dissolvable tobacco products off the market. How then, can the FDA allow a GlaxoSmithKline consultant (Henningfield) to be a part of the decision-making process on whether dissolvable tobacco products will be banned? This is every bit as bad a conflict as having a drug company consultant on an FDA advisory panel that is making a recommendation on the approval of a drug made by that company.

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