News: Senator Kennedy and the FDA Page 2

By Jonathan On Jul 5, 2017

When it turns out their purported solution would actually institutionalize the very problem at hand, I think it’s time to do more than simply ask questions.

Read Newest Articles: Senator Kennedy and the FDA Page 3

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

March 22, 2007
By Michael Siegel
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.

Read more from Michael Siegel

What is Teddy smoking?
By Dr. Elizabeth M. Whelan
March 7, 2007
Last week the Senate began hearings on a bipartisan bill to give the Food and Drug Administration regulatory control over cigarettes and other tobacco products. The bill’s proponents, including Sen. Ted Kennedy, Massachusetts Democrat, argue that FDA authority over tobacco will lead to a safer cigarette, stronger warning labels and a reduction in cigarette-related deaths.
    At first blush, this sounds like great news. But tragically, the proposed legislation will have exactly the opposite effect — and will likely increase smoking-related deaths. How could such an apparently well-meaning proposal be so insidious?
    First, the bill — which goes by the warm and fuzzy name “Family Smoking Prevention and Tobacco Control Act” — promises to make smokes safer by removing so-called “dangerous” chemicals.
    The problem is that it’s not a few, or a few hundred, of the 4,000-plus “chemicals” in cigarettes are deadly: It is the inherent toxicity that results when the products of tobacco combustion are inhaled into the lungs and get into the circulation.
    Worse, the legislation calls on the FDA to reduce the addictive nicotine in cigarettes — but prohibits the agency from completely eliminating nicotine. If the nicotine is reduced, smokers will smoke “harder” to get the desired nicotine jolt — thus taking in more of the very hazardous products of combustion. Again, it is not the nicotine itself that causes disease but inhaling the “junk” that forms when tobacco burns.
    Nicotine is highly addictive — and smokers want their “fix.” Studies of “light” cigarettes reveal that while they may contain less nicotine, smokers compensate by smoking more of them, making the health risk at least equivalent to smoking “regular” cigarettes.
    Another problem is the bill would mandate stronger warning labels on all tobacco products, likely giving the impression they are all equally dangerous — and thus protect cigarette companies from the first real business challenge they have faced in decades: competition from “clean” sources of nicotine, including smokeless tobacco.
    In Sweden, programs over the last 20-plus years have encouraged men to use smokeless products (known as “snus” — a small tea-bag like pouch filled with tobacco put between gum and cheek) instead of cigarettes. The smokeless product delivers a relatively “clean” dose of nicotine — and the result has been a substantial decline in lung cancer and other cigarette-induced diseases. This form of “harm reduction” has great potential to reduce cigarette smoking in the U.S. and reduce its associated mortality, by helping addicted smokers quit (smokeless tobacco presents minimal health risks compared to cigarette smoking).
    The proposed bill, however, will mandate a severe warning on smokeless products — a warning that totally misrepresents the relative risk of that product compared to cigarettes, thus largely removing the threat to cigarette sales that would follow if the switch to smokeless occurred here as it did in Sweden.
    Finally, assigning the FDA authority over tobacco is clearly at odds with the agency’s mission and opens the door for cigarettes being perceived as “FDA approved.” If the industry complies with FDA mandates to remove “toxins” and lower nicotine, it can declare itself “in compliance.”
    The industry will imply is has an FDA “seal of approval” and must therefore be safe — or safer. This will be a godsend to the tobacco industry in court, as they will be able to deflect liability against sick smokers’ lawsuits by merely pointing to the new FDA regulation and saying they adhere to the rules. This is exactly the sort of counterproductive result of regulation that Philip Howard pointed to as evidence of “The Death of Common Sense” in his 1994 book by that name.
    One has to ask our elected officials: What are you folks smoking? You propose that the agency primarily in charge of approving and regulating lifesaving pharmaceuticals and protecting us form food-borne pathogens must now oversee — and bestow a veneer of legitimacy upon — an industry responsible for the needless deaths of more than 400,000 Americans annually?

    Dr. Elizabeth M. Whelan is the founder and president of the American Council on Science and Health.

Some Smokers Must Die So That Others Never Exist

March 7, 2007
Jacob Sullum

When David Kessler was head of the Food and Drug Administration, he was so eager to regulate tobacco products that he pretended his agency already had the statutory authority to do so. (The Supreme Court disagreed.) Now that Congress may actually give the FDA the power Kessler tried to grab, the current administrator, Andrew von Eschenbach, is noticeably less enthusiastic:

Government regulation of tobacco could backfire by inadvertently forcing smokers to light up more and inhale more deeply, the head of the Food and Drug Administration said Tuesday.

In an interview with The Associated Press, Dr. Andrew von Eschenbach said that if the FDA reduced nicotine levels in cigarettes, people would tailor their smoking habits to maintain current levels of the addictive drug.

“We could find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position FDA is in; we approve products that enhance health, not destroy it,” said von Eschenbach, a cancer surgeon….

“What I don’t want to see happen is that we are in a position where we are determining that a cigarette is safe,” von Eschenbach said.

Von Eschenbach is right to worry that reducing nicotine content, which the Family Smoking Prevention and Tobacco Control Act would allow the FDA to do, would make cigarettes more dangerous by encouraging “compensatory behavior.” A number of studies have found that people tend to smoke more or smoke more intensely to compensate for reduced nicotine yields. The compensation is not universal or perfect, but the upshot is that exposure to toxins and carcinogens is higher than suggested by official “tar” yield. This observation is the main reason critics of the tobacco companies accuse them of committing fraud by implying that “light” cigarettes are safer than regular cigarettes. As I’ve noted, anti-smoking activists tend to forget this concern when they imagine government-ordered changes in cigarette yields.

But there is a “public health” rationale for cutting nicotine yields, even with the knowledge that doing so will result in more smoking-related disease over the short term. The argument is that lower nicotine levels will make cigarettes less appealing to new smokers, thereby reducing smoking-related disease over the long term. Depending on various contingencies (including the emergence of a black market in full-strength cigarettes), the net result might be fewer tobacco-related deaths. The idea is to kill more of today’s smokers so fewer will die in the future. If that strikes you as a heartless, unjust policy that elevates a collectivist calculation of social welfare above the rights of individuals, you are beginning to understand the logic of “public health.”

Addendum: In today’s Washington Times, Elizabeth Whelan, president of the American Council on Science and Health, warns that the Family Smoking Prevention and Tobacco Control Act “will likely increase smoking-related deaths.” In addition to the danger of nicotine restrictions, she notes that the bill would help maintain the myth that all tobacco products are equally dangerous, deterring cigarette smokers from switching to smokeless tobacco, which is far less hazardous. (I made similar points in a 2003 column.) Whelan also worries that the FDA seal of approval will falsely reassure smokers that cigarettes are safer than they used to be even in the absence of actual safety improvements.

FDA Chief: Tobacco Rules Could Backfire
FDA Chief Tells AP Regulating Tobacco Could Actually Harm Public Health

Mar. 6, 2007

(AP) Government regulation of tobacco could backfire by leading smokers to light up more often and inhale more deeply, the Food and Drug Administration chief said Tuesday.

In an interview with The Associated Press, Dr. Andrew von Eschenbach said that if the FDA reduced nicotine levels in cigarettes, people would change their smoking habits to maintain current levels of the addictive drug. Bipartisan legislation introduced last month would give the FDA broad regulatory authority over tobacco and its ingredients, including nicotine.

A nicotine expert said von Eschenbach’s fears may be unfounded. Dr. Neal Benowitz of the University of California, San Francisco, said a small study sponsored by the National Cancer Institute _ which von Eschenbach once led _ suggested gradually reducing nicotine levels doesn’t force smokers to compensate by smoking more or inhaling more deeply. In fact, Benowitz said, a gradual reduction can wean smokers from the habit.

And a backer of the legislation said von Eschenbach misunderstood its thrust: “The bill gives the FDA the authority to adjust nicotine levels _ if doing so is demonstrated to save lives,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “The status quo is the tobacco industry decides how much nicotine and other toxic substances are in tobacco products.”

In 1996, the FDA moved to regulate tobacco. The Supreme Court ruled in 2000 that Congress had not authorized the agency to do so. Von Eschenbach said repeatedly that the issue of regulating tobacco is a complex one.

“What I don’t want to see happen is that we are in a position where we are determining that a cigarette is safe,” he said, while acknowledging smoking kills more than 400,000 Americans a year. He later suggested regulation wasn’t the solution.

“We have the opportunity to take a very important comprehensive, public health approach to this problem. And it’s not a matter of giving FDA regulation or authority. It’s a matter of addressing the public health problem that’s before us,” von Eschenbach said.

The newly introduced bill would let the FDA act to discourage children from starting smoking and to encourage adults to quit, in part by reining in advertising, bolstering existing sales restrictions and strengthening warning labels. It also would let the FDA order the elimination or reduction of harmful and addictive ingredients in tobacco. The agency couldn’t ban nicotine outright, but the bill would give the FDA the power to reduce nicotine levels.

“The Bush administration has consistently undercut public health efforts to effectively regulate tobacco products and reduce youth smoking. In that context, this latest statement by an administration official is no surprise,” said Sen. Edward Kennedy, D-Mass., a co-author of the Family Smoking Prevention and Tobacco Control Act.

In an hourlong interview with AP reporters and editors, von Eschenbach repeatedly said the FDA doesn’t need more regulatory authority. When asked if the FDA needed more money, he suggested the agency needs to look at “enhancing our efficiencies, maximizing our outputs for the dollar invested on part of the American people.”

Von Eschenbach used a racing metaphor to describe his vision of the FDA’s role as a regulatory agency: Its guidelines, regulations and policy are like guardrails that rigidly hem in a speedway that the agency has worked to clear of speedbumps, he said.

_On food safety, von Eschenbach said the FDA was working to improve systems that can prevent outbreaks, enhance its ability to detect problems, trace them t their source and pre-empt the further distribution of contaminated products. A recent AP analysis found FDA food inspections fell off by nearly half between 2003 and 2006.

“I don’t think you can inspect the problem away. I believe inspections are an important component of verification that processes that you put in place to prevent and eliminate the problem are working,” von Eschenbach told AP.

_On food from cloned animals, the FDA chief said it’s the agency’s duty to tell consumers whether it’s safe, but not necessarily to allay fears. The dairy industry worries cloning fears will turn people away from milk.

“Once we have defined that, how that gets implemented into our societal context, in terms of products and trade and those sorts of things, those are issues I think that go beyond FDA,” he said.

_On drug safety, von Eschenbach rejected a wholesale refocusing of the agency’s attention to the safety of drugs once they are on the market. Instead, he said, the FDA should emphasize safety throughout what he called the life cycle of a drug, from pre-approval throughout its time on the market.

“I don’t think it is something we should view as simply FDA’s shifting its priorities from one place to another place. I see it as a seamless continuum on a broad front,” he said.

Major Anti-Smoking Groups and their Politicians Get High Marks for Meaningless and Deceptive Propaganda

3/1/07
By Michael Siegel
In an unusual change of pace from my past criticism of the major anti-smoking groups for their role in deceiving the public about the details regarding the proposed FDA tobacco legislation, I am today awarding these groups, and the politicians who are working hand-in-hand with them, a grade of A+ on my meaningless and deceptive propaganda report card.

The Rest of the Story

Leading the charge and making a substantial contribution to the A+ grade is Senator Edward Kennedy, who came up with this whopper of public deception:

“If Congress fails to act and smoking continues at its current rate, more than 6 million of today’s children will ultimately die from tobacco-induced disease.”

Of course, this statement implies that by Congress acting, and enacting the proposed legislation, Congress will prevent these 6 million kids from dying from tobacco-induced disease. It indicates that the legislation will reduce smoking prevalence so that smoking does not continue at its current rate.

But the truth is that the proposed legislation will not reduce smoking prevalence, and it might even increase it. Supporters of the legislation are banking on strict advertising regulations to curtail youths’ exposure to cigarette advertising, and in turn, to reduce smoking initiation. However, as I explained yesterday, the Supreme Court is virtually certain to find unconstitutional any advertising restrictions that might result in a meaningful reduction in youth exposure to cigarette advertising.

On the other hand, by giving tobacco products an FDA seal of approval, public perception of the dangers of smoking is likely to be undermined. This would be expected to lead to an increase, not a decrease, in smoking prevalence.

The second whopper of public deception goes to the Campaign for Tobacco-Free Kids, which in its Senate testimony tried to make Congress believe that there is no opposition to the proposed legislation within the public health community:

“It [Senate bill 625] has been endorsed by every major national public health organization… .”

Clearly, the Campaign is trying to convince Congress that the legislation is universally supported by public health practitioners. The truth, however, is that the public health community is deeply divided on this issue. A large number of public health organizations and advocates vehemently oppose the legislation. In fact, I personally am working with a coalition of at least two dozen public health advocates to try to derail the legislation.

To tell Congress that every major national public health organization has endorsed the legislation is close to a complete lie. What saves it from being a complete lie is the word “major.” By leaving room to argue that they interpret “major” in their own particular way, the Campaign spares itself from perjury in front of Congress.

But would it really be accurate and forthright to state, for example, that the American Association of Public Health Physicians (AAPHP) is not a major national public health group? The AAPHP has helped lead the fight against the FDA tobacco legislation for the past two years.

The AAPHP’s mission statement makes it clear that this is indeed a major national public health organization: “AAPHP will expand its role as an influential national organization. Public Health physicians will, in greater numbers, convene under the AAPHP banner to develop their policy and advocacy plans and strategies. AMA, ACPM, other physician and public health organizations, and others, will increasingly seek AAPHP assistance in their policy deliberations. Working together we will help improve the health information of the nation through effective application of public health principles, and the development of data-driven population based services.”

Perhaps the Campaign’s testimony is not an outright lie – but if it isn’t a lie, then it is a downright insult to the major national organization of public health physicians in this country, who have now been discounted as being a major national public health organization. Take that, public health physicians! You are not important. Your organization, while national and related to public health, is not major. You – public health physicians – are just a minor player in our public health system. So go back to your doctor’s offices. No one needs to know about your position on this legislation (since you’re against it).

I can kind of see why proponents of this legislation need to resort to wild, grandiose, exaggerated, meaningless and deceptive propaganda: because when you actually talk about the specific merits of the proposed legislation, you realize that it is actually an absurd regulatory framework that would institutionalize continued deception of American consumers and lead to devastating effects on the public’s health. But it would protect Philip Morris’ profits.

Who’s deceiving who here?

In some ways, the deception by the anti-smoking groups supporting this legislation is greater than that of the tobacco companies over the past years. At least with smoking, it was pretty obvious that the companies were lying or stretching the truth. Here, unless you read the actual bill for yourself (which few people are going to do), you’d have no way of knowing that our major anti-smoking groups and the politicians standing with them are deceiving you.

I guess it is perfectly honest for me to state that every major national public health organization is deceiving the public about the proposed FDA legislation. Since every major national public health organization has apparently endorsed the legislation and since the rhetoric regarding the legislation is deceiving the American people, my contention seems perfectly valid.

In conclusion, then, every major national public health organization in the United States is part of a campaign that is deceiving the public about the proposed FDA legislation.