Thursday, March 22, 2007

AMA Ignores FDA Commissioner's Concerns; Suggests FDA Tobacco Legislation Will Save Millions of Lives; Offers No Explanation for How

While acknowledging the Food and Drug Administration (FDA) Commissioner's concerns that granting the agency the authority to regulate tobacco products will give cigarettes an FDA stamp of approval and undermine the public's appreciation of the hazards of smoking and while also acknowledging that reducing nicotine levels could lead to increased smoking, which would kill more people due to increased tar delivery, the American Medical Association (AMA) reiterated its support for the proposed FDA tobacco legislation in an editorial in the current issue of the American Medical News.

In the commentary, the AMA acknowledges that: "Some public health experts, including the FDA's own acting commissioner, expressed concern that agency regulation will send a message that 'safer' cigarettes are possible or will lead people to adjust their smoking habits to maintain current nicotine intake levels."

However, without addressing these concerns in any way, the AMA goes on to support the FDA tobacco legislation, suggesting that it will save millions of lives but not offering any indication of how:

"These and other issues certainly will be aired in the months ahead. But the attention will not lessen the need for action. Supporters say FDA oversight has the potential to save hundreds of thousands, even millions, of lives. Doctors, who see firsthand every day the damage done, know that meaningful steps to curb tobacco's reach are imperative. Weighing the evidence, the verdict -- that the time is right for Congress to provide the FDA with this authority -- is quite clear. Lawmakers should not squander this opportunity."

The Rest of the Story

This opportunity to do what?

To give tobacco products an FDA seal of approval so that tobacco companies can boast to the public that their products have been officially approved for sale by the United States Government?

To defraud the American people by making them think that cigarettes are safer when in fact, the truth is that reductions in tar and nicotine have no direct correlation with the safety of the product in actual use?

To provide virtual immunity for tobacco companies by allowing them to defend all lawsuits by saying that they now follow strict government guidelines in all of their production and marketing activities?

To sacrifice the lives of smokers -- by increasing their inhalation of tar -- in order to try to reduce nicotine levels and reduce kids' potential addiction to cigarettes?

To provide unprecedented special protections for Big Tobacco -- protections not enjoyed by any other company whose products are regulated by the FDA?

To ensure that all major decisions regarding tobacco policy are placed in the hands of Congress rather than in the hands of an appropriate regulatory body?

To prevent the possibility that the FDA could prohibit the sale of cigarettes at youth community centers?

To eliminate even the possibility that a truly safer cigarette could ever be discovered and marketed?

I agree that there is a great opportunity to be squandered. But the opportunity to be squandered is the chance to provide Philip Morris with the most coveted protection it could possibly ask for: virtual immunity from further litigation and an absolute lock on market share by stifling any serious possibility of competition.

What is so striking about the AMA's commentary is that they jump from point A to point C with nothing in between.

A: There are several potentially serious problems with the proposed legislation that could result in severe harm to the public's health. There are also potential benefits.

B: ?

C: The verdict is quite clear. Congress should not squander this opportunity.

It seems that step B is missing. Step B -- a careful and thoughtful weighing of the costs and benefits -- would be a critical missing link in establishing the jump from point A to point C.

But the AMA jumps right over that one.

Are we to seriously believe the AMA's suggestion that this legislation will save millions of lives when the Association doesn't so much as offer an explanation of how exactly the legislation will save even one life, much less millions?

I do, however, have to applaud the AMA for one thing. At least they didn't take the cowardly step that the Campaign for Tobacco-Free Kids took and merely claim that the legislation will save "countless" lives. The Campaign isn't able to actually count the lives because those saved lives don't exist. No plausible mechanism has yet been offered for how the legislation will save lives.

At least the AMA is willing to pin a number on its claim. We don't have any idea of the mechanism, but at least we now know that the proposed legislation will save millions of lives.

Boy - it would sure be nice for me to be able to make bold and grand claims like that without having to support them, back them up, or even offer a plausible mechanism for the purported effect.

Let me just try it to see how it feels...

...The proposed FDA legislation represents effective and meaningful legislation to protect the lives of Americans and their children from the number one cause of preventable death in the United States -- tobacco products kill 400,000 Americans each year. How can we allow these deaths to continue? How can we allow the FDA to stringently regulate a box of macaroni and cheese but to not even know the ingredients in a pack of Marlboros? If enacted, the FDA legislation will protect our children from the dangers of tobacco. It will save at least 10 million lives. This opportunity to save countless lives must not be squandered. We owe it to our children. It's time to end special protection for Big Tobacco. The FDA is the right agency. And this is the right time.

Feels great. Maybe I should apply for a job as a writer for one of these major anti-smoking groups.

So what exactly is the purported mechanism by which the FDA is going to save millions of lives?

Could it be magic? A massive placebo effect? A huge reduction in societal stress because the public no longer has to listen to the propaganda being spewed forth by the Campaign for Tobacco-Free Kids? The death of Lord Voldemort from increased carbon monoxide levels in the low-nicotine cigarettes which he certainly smokes?

Your guess is as good as mine. If you have any ideas, send them in. I'd really like to know.

If you are a public health group lobbying for a major piece of federal legislation and you are making a grandiose claim that the legislation is going to save millions of lives and that Congress needs to enact the legislation despite its severe failings, I think it is your obligation to make clear how the bill is going to save lives. And how the benefits will outweigh the deleterious public health consequnces of the legislation. What is the mechanism? What is the basis for your claim of X million lives saved? What is the supporting documentation?

Opponents of the legislation are providing documentation to support their opinion that the bill would have deleterious public health effects. Hardly a day goes by now where The Rest of the Story doesn't present research evidence to support the opinions it has put forward. But from the supporters of the legislation, we hear nothing but propaganda and rhetoric.

This is a quite serious concern, because one of the basic ethical principles of public health is transparency. It is our responsibility to be forthright with the public about the basis of our opinions about public policy, not to merely express our support or opposition for those policies.

The core ethical principle of transparency was spelled out in a Tobacco Control article (see Fox BJ. Framing tobacco control efforts within an ethical context. Tobacco Control 2005;14[Suppl II]:ii38-ii44).

Fox writes: "The tobacco control community should strive for transparency in its dealings. If the tobacco control community fails to explain its dealings within an appropriate framework, it may be perceived as biased or hiding relationships, and it could lose its reputation for independence."

Another important ethical principle that I fear is being violated is the community-level equivalent of the principle of informed consent, which is spelled out in the American Public Health Association Code of ethics. Just as public health organizations must provide individuals with full and accurate information before enrolling these individuals in research studies, public health organizations must also provide the public with full and accurate information that is necessary to make decisions on policies that affect them:

"Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community's consent for their implementation. ... there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. ...Such processes depend upon an informed community. The information obtained by public health institutions is to be considered public property and made available to the public."

I don't think that the groups supporting this legislation have made available to the public the relevant information needed for the public and policy makers to make an informed decision about the proposed policy. In fact, even the sponsors of the legislation themselves seem not to have been properly informed about the bill's ramifications. For example, it was reported that prior to the testimony on the legislation before his Committee, Senator Kennedy had never even heard about the concerns in the public health community that this legislation could have potentially negative public health consequences.

If this is to be a legitimate public health policy consideration and not merely a political maneuver, then the Congress needs to be informed about the debate raging in the public health community about this approach to regulating tobacco products, as well as about the specific drawbacks of the approach and of the specific provisions of the legislation that were inserted for the protection of Philip Morris' profits.

The public deserves more from the AMA and other groups claiming that millions of lives will be saved than merely a big fat question mark.

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