Thursday, October 13, 2005

FDA Plagued by Problems, Overtaken by Politics: Folly of Putting Tobacco Products Under FDA Regulation Becoming Clear

A story on NPR's All Things Considered yesterday as well as an article in this week's The Cancer Letter have highlighted the serious problems that are plaguing the Food and Drug Administration.

According to the NPR story, a series of recent missteps could severely hurt the FDA'’s credibility. Former FDA Commissioner Dr. David Kessler indicated that this is the worst shape that FDA has ever been in, that the Agency has become overrun by politics, and that the public's health is being compromised by politics.

Kessler said that he believes this is the lowest level of trust in the Agency that he has ever seen. He stated that he's not even sure that the White House trusts the FDA.

To make matters worse, President Bush tapped another political appointee to run the Agency, which, according to Kessler, is already suffering from being controlled by politics, rather than a primary concern for the public's health. He indicated that it's one thing to de-regulate certain industries, but when it comes to the safety of drugs, politics simply shouldn't enter the picture.

The NPR story explains how the FDA has recently been accused of being more interested in protecting drug industry profits than Americans'’ health. This has resulted in what one analyst called a "hemorrhage of talent" from the Agency. Even the approval process for the FDA Commissioner has become highly politicized.

To make matters much worse, The Cancer Letter reports that politics and dismissal of ethics has infested the highest level of the FDA and the HHS (Department of Health and Human Services). According to the article, Acting FDA Commissioner Andrew von Eschenbach (a family friend of President Bush) was cleared to head NCI and FDA even though heading both organizations represents a clear and unmanageable conflict of interest. While NCI "has vested interests in many compounds and works in partnership with pharmaceutical companies, FDA has the power to stop trials to protect patients from unwarranted risk. Most importantly, the agency approves drugs."

In addition, an even larger conflict of interest arises because Von Eschenbach is not only head of the FDA but also vice chairman of the board of C-Change, "a coalition of cancer groups heavily funded by pharmaceutical companies and headed by former President George Bush and his wife Barbara Bush. Peter Dolan, CEO of Bristol-Myers Squibb Co., and Gary Reedy, a vice president at Johnson & Johnson , also hold board seats."

How can Von Eschenbach possibly regulate the pharmaceutical industry and properly protect the interests of human research subjects and patients across the nation if he heads a group that is heavily funded by the pharmaceutical industry and runs that group shoulder-to-shoulder with the heads of pharmaceutical companies?

The fact that Von Eschenbach was cleared for such a role despite these inherent conflicts of interest suggests, according to the article, that politics, rather than the public's health, is now dictating policy in HHS, including at the FDA.

Perhaps the most telling quote comes from Michael Clark, a former federal prosecutor who is now a private attorney and editor of the LJN Bioethics Legal Review: "If this were a horse race, Dr. Eschenbach would be a 'trifecta' pick for conflicts of interest by adding the FDA to his NCI and C-Change affinities."

Merrill Goozmer, the director of the Integrity of Science Project at CSPI (Center for Science in the Public Interest) stated: "So here you have companies who are bringing products before FDA, and he is sitting on the board of a non-profit organization with them; what more do you have to say? It's a conflict of interest for the same reason that we don't allow the head of the Securities and Exchange Commission to own stock in the companies he is auditing."

Alan Milstein, a New Jersey health care attorney, expressed his concern that the very health of the American people is being placed in jeopardy because of the conflicts of interest that the government has waived: "Human subjects will be left without the protection of the government. When you are talking about cancer patients in trials, who are desperate for a cure, they are a vulnerable population. These are a class of subjects who need protection...This is the head of the FDA! If you need to set up a mechanism by which this guy avoids conflicts of interest, then he shouldn't be there."

The Rest of the Story

And now, with this backdrop, and in spite of the fact that the FDA seems to be controlled more by politics than by the interests of the public's health, the Campaign for Tobacco-Free Kids wants to put the entire regulation of the nation's most hazardous consumer product into the hands of...

...the FDA.

This is the worst possible time to be even talking about putting the regulation of tobacco products into the sole hands of the FDA. It is about the last thing I think that we as public health advocates should want to do right now.

Even if the proposed FDA legislation were not ridden with loopholes (as I think it is), I do not think it is in the best interests of the public's health to put the public's trust into the FDA to appropriately regulate a product that already kills 400,000 people a year. The agency doesn't even seem able to regulate far less hazardous products - why would we want to ask them to now regulate the most hazardous consumer product of all?

And to make things ever so much worse, the Campaign for Tobacco-Free Kids, in the negotiations with Philip Morris that I spoke of earlier, has for some strange reason agreed to institutionalize the politicization of FDA's proposed regulation of tobacco products by giving Congress an explicit, statutory role in the most critical aspects of tobacco product regulation and in the oversight of the whole regulatory process.

This is clearly not an appropriate time to entrust FDA with protecting the public from the hazards of tobacco products, but even if it were, the absolutely last thing a public health group should have done is to negotiate a bill that gives Congress a statutory role in the regulation of these products!

Not only does the bill entrust Congress (in other words, politics) with making the all-important decisions regarding the elimination of nicotine from cigarettes and the elimination of certain types of tobacco products (which I think means any substantial changes in cigarette design or in the composition of cigarette smoke - which would require substantial changes in cigarette design) but it entrusts Congress with making any decision regarding where tobacco should be sold, whether a prescription should be required for the product, and the age of purchase of cigarettes.

And to top it all off, the legislation gives Congress oversight over the entire regulatory process by explicitly giving Congress the authority to overturn any FDA tobacco regulation. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.

Now I already suspect I know what the response to my argument may be: "Isn't it better to have some regulation of tobacco products rather than no regulation at all?"

Well you know what? I think the answer is a resounding no.

Bad regulation of tobacco products is about the worst thing that could happen. What tobacco control practitioners need to realize is that if FDA regulation of tobacco products is enacted, it will essentially end, if not greatly undermine, the public health practice of tobacco control as we now know it, especially at the state and local levels.

First, it would create an FDA "stamp of approval" for tobacco products, which would likely decrease the public's perception of the inherent harm of tobacco products. By officially sanctioning the products, the government would be giving the public a false perception of a level of safety.

Second, it would create a perception that the tobacco problem has been taken care of, and no further interventions are necessary. It would become almost impossible to convince state legislators, for example, to allocate substantial funds for tobacco control once FDA is given authority to regulate the product.

Third, it would essentially end tobacco litigation, by allowing the cigarette companies to argue (correctly) that they have already submitted to FDA regulation and so no further punitive or injunctive relief is required. If this legislation is enacted prior to the resolution of the DOJ tobacco lawsuit, it will completely decimate that lawsuit.

Fourth, it would produce an enormous amount of goodwill for the tobacco companies by enabling them to tell the public (accurately) that they now fully comply with a comprehensive system of federal regulation of their products.

Before we take such a leap and essentially bring tobacco control at a local level to a grinding halt in order to achieve federal regulation of the product, I think we better be pretty darn sure that the federal government is going to do a spectacular job. But with TFK having given Congress an integral role in the regulatory process in its proposed policy intervention, that is simply not going to be possible.

And even if it were, there is very little in the legislation that would guarantee that there would be any substantial reduction in the toxicity of cigarettes or in the number of lives lost due to tobacco use.

The rest of the story suggests that this is absolutely not the time to be thinking about putting the regulation of tobacco products into the hands of the FDA.

And if that weren't convincing enough, it is certainly not the time to be explicitly giving Congress the ultimate statutory oversight over the already-politicized Agency.

I think the Campaign for Tobacco-Free Kids should, at very least, withdraw its support for this ill-advised and ill-timed legislation. If TFK truly believes that this is the best thing since sliced bread, then fine, let it keep it on the back burner and bring it back up once the FDA is straightened out, but even for those who support this legislation, this is certainly not the time to be making such a move.

4 comments:

John R. Polito said...

Yes the FDA is a mess but is tobacco control any less a mess? Think about it. The American Legacy Foundation's website lists its #1 partner as Time-Warner, the media giant responsible for helping enslave more youth to nicotine than any other.

Then we have Tobacco Free Kids, and the tobacco company with a 49% market share, agreeing that the smoking and chewing of a natural insecticide should be regulated by the U.S. agency responsible for overseeing the safety of medicines. Medicine?

We have the pharmaceutical industry's "New Definitions Division" to thank for that. And we thought Big Tobacco was good. These guys were bold enough to label an extremely addictive teratogen that's more lethal than strychnine and three times deadlier than arsenic as "medicine," term it's use "therapy," and redefine "quitting" to mean quitting smoking but not necessarily quitting nicotine.

Is nicotine replacement therapy (NRT) a bad hoax upon smokers? I truly believe it is. The foundation of all NRT claims are double-blind odds ratio victories over placebo device users. But nicotine is a psychoactive chemical producing alert dopamine adrenaline intoxication. If a smoker has any prior quitting history at all they know what it feels like to both be deprived of nicotine and to have it present.

A June 2004 a study by Mooney found that only 17 of 73 double-blind placebo controlled NRT studies conducted assessments to determine if they were in fact blind. Twelve of the 17 (or 71%) failed their own blinding assessment. This link is to a full text copy of Mooney’s blinding assessment review - http://whyquit.com/studies/NRT_Blinding_Failures.pdf

It is thus false for anyone, including Tobacco Free Kids, to suggest that NRT studies were blind. Why is this important? I believe it's important because Tobacco Free Kids and most other health advocates see the FDA as already regulating nicotine as "medicine" and in their minds nicotine laden tobacco is simply an extremely dirty drug delivery device for the exact same substance.

I predict that detailed blinding data will someday soon become available and that NRT's house of cessation cards will come tumbling down. Contrary to the garbage being peddled by the pharmaceutical industry, with a 93% six month failure rate OTC NRT is not an effective aid to smoking cessation (see http://tc.bmjjournals.com/cgi/content/full/12/1/21?ijkey=5.ko5/Oz4yutI ).

If the FDA does end the marketing of NRT for smoking cessation, how much sense will it make for Tobacco Free Kids to continue its half-baked plan to have the FDA forever legitimize and normalize chemical dependency upon nicotine?

How hard would it be for Tobacco Free Kids to support a substitute bill which simply reads, "The states and their political subdivisions shall have full authority to regulate the marketing and sale of tobacco and all other nicotine delivery vehicles, expressly including but not limited to authority to require additional warnings, to establish the age of use, to regulate and/or ban all exterior or point of sale marketing, to require that minors be excluded from all tobacco sales locations, or to impose a partial or total ban on the sale of any or all nicotine delivery vehicles, including tobacco."

John R. Polito

Anonymous said...

Dr. Mike-in my view, I am most concerned about my husband and the fight he is beginning re: a surgery he recently had. Tendonitis, and successful recuperative therapy. One of the Drs. made sure that thruout his (the Dr)report that my husband would not heal appropriatly due to his smoking of cigarettes.It has already beeen proven a falsehood, as he has been cleared for any work by his primary Dr. Is this a clearing of the path for insurance denials down the road?
We have both tried the "patch gum Zyban" and those Nic delivery systems are horrid. Zyban/generic left us feeling....well not feeling at all! I cannot live as an automaton ever-way too scary. Dead Zone.
Please Stop Legislating My Behavior
Thank you for Listening.
Capri
Madison, WI

Michael Goodyear said...

Yes,the FDA has its problems, now extremely well publicised, but the alternatives are worse. I think it is still better to have tobacco being scutinised.

benpal said...

"First, it would create an FDA "stamp of approval" for tobacco products" ... and wouldn't the FDA be exposed to class action litigation in the same way the tobacco industry was up to now? After all, they legalize a product which is toxic "if taken as intended".