In spite of my pleadings to correct the fallacious claims in its smoking ban strategy guide, the American Cancer Society continues to urge anti-smoking groups to sensationalize the secondhand smoke health hazard message by telling the public that brief exposure immediately causes hardening of the arteries and heart disease.
It turns out that two major anti-smoking organizations - the American Cancer Society and the International Union Against Cancer - are urging anti-smoking groups to increase the emotional appeal of the secondhand smoke health hazard message by communicating to the public that secondhand smoke can virtually instantly cause hardening of the arteries and heart disease (a point which is clinically impossible - since it takes years for atherosclerosis and heart disease to develop).
In an internal strategy document entitled "Building Public Awareness About Passive Smoking Hazards," the American Cancer Society and International Union Against Cancer offer suggestions to anti-smoking advocates about how to increase the emotional appeal of secondhand smoke health hazard claims. The guide was designed "to help advocates develop practical strategies to overcome specific barriers to effective tobacco control policies."
One strategy put forward to help advocates overcome barriers to the adoption of smoking bans is to convey to the public that some of the effects of secondhand smoke are "virtually instant" because "these messages convey the issue's urgency." Specifically, the strategy urges advocates to emphasize the following two messages:
1. "Immediate effects of secondhand smoke include cardiovascular problems such as damage to cell walls in the circulatory system, thickening of the blood and arteries, and arteriosclerosis (hardening of the arteries) or heart disease, increasing the chance of heart attack or stroke."
2. "Short-term exposure to tobacco smoke has a measurable effect on the heart in nonsmokers. Just 30 minutes of exposure is enough to reduce blood flow to the heart."
According to the document, these messages which convey the instant harm of secondhand smoke are effective because they provoke "an emotional response in almost any listener." The guide goes on to say that an effective message:
a) "conveys the fact that even short periods of exposure are harmful;"
b) "evokes an emotional reaction from the use of scientific terms;"
c) "utilizes startling and memorable imagery;" and
d) "clearly states the risk of grave health conditions such as heart attacks and strokes."
The document describes these communication tactics as "effective advocacy strategies to enact and enforce laws mandating smoke-free public environments."
The Rest of the Story
The message that the immediate effects of secondhand smoke exposure include "arteriosclerosis (hardening of the arteries) or heart disease" is blatantly false on its face. Such an effect is clinically impossible, since it takes years for atherosclerosis and heart disease to develop. You simply cannot develop atherosclerosis as an "immediate" effect of secondhand smoke exposure.
I have been quite clear about my opinion that chronic exposure to secondhand smoke does cause hardening of the arteries and heart disease. But it takes years of exposure. It certainly does not happen immediately.
Even if you look at heavy active smokers, you don't see them developing heart disease or suffering heart attacks within minutes of their first cigarettes. It takes a minimum of 15-20 years before these effects occur. Since most smokers begin smoking in their teens and it is quite unusual to observe heart disease and heart attacks in smokers before they reach 30 years old, it is clear that the atherosclerotic process takes no less than 15 years or so to occur. And this is in extreme cases and under conditions of heavy, repeated, active smoking.
In most cases, we start to observe heart disease in smokers in their 40s - about 25-30 years after the initiation of smoking.
So the claim that secondhand smoke causes heart disease in just 30 minutes is off by a factor of 525,600, or half a million!
The claim that 30 minutes of exposure to secondhand smoke "is enough to reduce blood flow to the heart" is also false, or at least misleading.
It's not accurate to claim that a 30 minute exposure to secondhand smoke reduces the blood flow to the heart because what the Otsuka study actually showed is that there was no reduction in coronary blood flow (see Otsuka R, Watanabe H, Hirata K, et al. Acute effects of passive smoking on the coronary circulation in healthy young adults. JAMA 2001). In other words, 30 minutes of secondhand smoke exposure was documented not to reduce blood flow to the heart.
The truth is that the Otsuka study, which is being used to back up the strategy document's claim that 30 minutes of exposure reduces blood flow to the heart, actually provides documentation that this brief exposure does not reduce coronary blood flow and therefore poses no acute risk of clogged coronary arteries and an acute myocardial infarction (heart attack) in someone without severe pre-existing coronary artery stenosis.
On the contrary, the study reported that: "Passive smoking exposure had no effect on basal coronary flow velocity in either group." In other words, this study documents that a 30-minute exposure to secondhand smoke does not present a threat of reducing coronary blood flow in patients without severe coronary disease.
So the very study that the document relies upon to make its scientific claim actually refutes the very claim that these groups are making.
What makes these false claims particularly troublesome are the following two factors:
1) It is not just an isolated statement by the American Cancer Society. It comes in the context of a strategy guide which is making specific recommendations about exactly what statements anti-smoking groups throughout the world should make about the health effects of secondhand smoke. So the ACS is not just claiming that secondhand smoke exposure immediately causes hardening of the arteries and heart disease, they are instructing anti-smoking groups worldwide to make this statement to the public.
2) It comes in the context of instructing anti-smoking groups how to sensationalize their messages about the health effects of secondhand smoke.
Apparently, the fact that secondhand smoke does not immediately cause the grave health conditions of heart attacks and strokes is no deterrent to the ACS to publicly make such a statement and to encourage all anti-smoking groups to do the same.
But the worst part of the story is that the American Cancer Society has apparently decided to retain these false claims on its web site even after having been informed by an expert on the issue (who they rely upon for other claims that they make - see reference 21, for example) that their claims are wrong.
No matter how many times I email the ACS about this, and no matter how many people at the national and state levels of ACS that I email, I never get so much as a response, I never get an explanation or defense of the claims, and I certainly never get a thank you for pointing out the errors so that the ACS can fix them before misleading anyone else or suffering further embarrassment or further risk of undermining its credibility and scientific reputation.
I would have thought that my May 2006 commentary would have been enough to get the ACS to take this issue seriously. Then, despite no response, I thought that my December 2006 commentary would have caused the Cancer Society to review and correct the document. Then, despite still no response, I thought my March 2007 commentary would have finally served to interest the ACS in defending and preserving its own scientific integrity.
Apparently not.
Nevertheless, it is never too late. A timely and definitive response by the ACS would go a long way towards letting us know that the Cancer Society is sincerely interested in its scientific integrity, and not merely in using the tobacco industry's age-old tactics of dishonesty and deception in order to support its policy agenda.
Monday, August 06, 2007
Friday, August 03, 2007
New York Times Op-Ed Piece Nicely Explains Folly of FDA Tobacco Legislation
An op-ed in today's New York Times by Patrick Basham, director of the Democracy Institute, very nicely explains the folly of the FDA tobacco legislation that was approved by a Senate committee earlier this week.
The piece, entitled "Put Out This Tobacco Bill," reveals that Philip Morris had a pivotal role in writing the bill, working with the Campaign for Tobacco-Free Kids. Basham argues that the bill is bad for public health and that its primary effect would be to protect Philip Morris by reducing competition from other companies.
Basham also points out that the bill would undermine years of public health efforts by giving the public the incorrect perception that cigarettes are safer. In addition, it would put the government in the position of essentially making undocumented claims about the safety of cigarettes, since it would take many years to determine whether any changes required in cigarettes actually reduced risk or not. Furthermore, the bill would end liability for the tobacco companies, and transfer it over to the government.
Basham writes: "Philip Morris, the world’s largest tobacco company, is also firmly behind the bill. In fact, it played a pivotal role in writing the legislation, working with the Campaign for Tobacco-Free Kids. What these strange bedfellows came up with is bad for competition in the tobacco industry and bad for public health. One problem is that under the proposed law, the F.D.A. would regulate any new “reduced-risk” tobacco products. And in so doing, the agency would be responsible for setting standards to determine which tobacco products pose a reduced health hazard. Since the F.D.A. has neither the resources nor the expertise to do this job itself, it most likely would need to turn to the industry for help. Philip Morris, which is miles ahead of its competitors in developing the next generation of tobacco products, would be only too happy to assist. In effect, it would be Philip Morris’s standards and products that would define the F.D.A.’s definition of reduced-risk cigarettes." ...
The piece, entitled "Put Out This Tobacco Bill," reveals that Philip Morris had a pivotal role in writing the bill, working with the Campaign for Tobacco-Free Kids. Basham argues that the bill is bad for public health and that its primary effect would be to protect Philip Morris by reducing competition from other companies.
Basham also points out that the bill would undermine years of public health efforts by giving the public the incorrect perception that cigarettes are safer. In addition, it would put the government in the position of essentially making undocumented claims about the safety of cigarettes, since it would take many years to determine whether any changes required in cigarettes actually reduced risk or not. Furthermore, the bill would end liability for the tobacco companies, and transfer it over to the government.
Basham writes: "Philip Morris, the world’s largest tobacco company, is also firmly behind the bill. In fact, it played a pivotal role in writing the legislation, working with the Campaign for Tobacco-Free Kids. What these strange bedfellows came up with is bad for competition in the tobacco industry and bad for public health. One problem is that under the proposed law, the F.D.A. would regulate any new “reduced-risk” tobacco products. And in so doing, the agency would be responsible for setting standards to determine which tobacco products pose a reduced health hazard. Since the F.D.A. has neither the resources nor the expertise to do this job itself, it most likely would need to turn to the industry for help. Philip Morris, which is miles ahead of its competitors in developing the next generation of tobacco products, would be only too happy to assist. In effect, it would be Philip Morris’s standards and products that would define the F.D.A.’s definition of reduced-risk cigarettes." ...
"Moreover, by setting regulatory standards for reduced-risk cigarettes, the F.D.A. would send a message to both smokers and nonsmokers that smoking is really not very risky. However, it will take several decades before anyone is able to do the epidemiological studies that could demonstrate whether this is true. In effect, this bill tosses aside decades of work by the public health community to convince people either to stop smoking or not to start in the first place. By assigning the F.D.A. responsibility for all tobacco products, the new law would also relieve the industry of any liability for tobacco safety — and pass it along to the government. Few lawmakers seem to understand either the bill’s origins or ramifications. But the Senate should send it back to the committee and start from scratch."
The Rest of the Story
Basham makes many of the same points that I have been making in my commentaries on this issue over the past few months. I think most critically, he points out that lawmakers do not understand either the origins of the bill (that it was crafted largely by Philip Morris and resulted from a negotiation between Philip Morris and the Campaign for Tobacco-Free Kids) or its ramifications.
The Campaign for Tobacco-Free Kids' propaganda and its campaign of deception have been largely successful in misleading policy makers and the public about the origins and true intent behind the legislation as well as its actual implications for the public's health.
For many years, the tobacco companies were able to use deception and dishonesty with great effect to mislead the public about the hazards of smoking and to achieve their desired public policies. Now, it is the Campaign for Tobacco-Free Kids' turn.
Thursday, August 02, 2007
More Deception by Campaign for Tobacco-Free Kids on FDA Legislation: Is a Candid Statement Even Possible for Them?
In two communications sent out yesterday to tobacco control advocates and other constituents, the Campaign for Tobacco-Free Kids continued its pattern of deception by making more wildly deceptive statements.
In the first communication, which was sent out to advocates and issued as a press release, the Campaign stated that the FDA tobacco bill approved by the Senate HELP Committee yesterday requires tobacco companies to reduce or remove harmful ingredients from their products.
The Campaign stated that: "the legislation would grant the FDA authority to crack down on tobacco marketing and sales to kids; require that tobacco companies disclose the contents of tobacco products and reduce or remove harmful ingredients; stop tobacco companies from misleading the public about the health risks of their products; and require larger, more effective health warnings on tobacco products."
In the second communication, the Campaign implied that it supported the amendment, added to the bill yesterday, which adds clove back to the list of banned flavorings in cigarettes.
The Campaign wrote: "Public health groups had opposed an earlier change in the Chairman's Mark (now rescinded) that would have taken clove out of the list of immediately banned flavors."
In the press release, the Campaign also stated that the public has expressed overwhelming support for the proposed FDA legislation, claiming that: "According to a recent national poll, 70 percent of voters support Congress passing the legislation and 72 percent believe passage of the legislation would be an important accomplishment for Congress."
The Rest of the Story
The rest of the story is that the FDA legislation would not require that tobacco companies reduce or remove the harmful ingredients from their products. What it would do is give the FDA the authority to require tobacco companies to reduce or remove certain harmful ingredients from their products. There is a huge difference between the two, and it is therefore deceptive to imply that the bill itself requires that tobacco companies reduce or remove the harmful ingredients from their products.
The legislation merely gives the FDA the ability to require the reduction or removal of particular harmful ingredients. The FDA could not require the reduction or removal of all harmful ingredients (which is implied by the statement), nor does the bill require that the FDA take any particular action at all. In fact, the bill gives the tobacco companies the ability to block any required removal of an ingredient merely by getting a majority of Congressmembers to veto the regulation.
The rest of the story is also that the Campaign for Tobacco-Free Kids opposed, rather than supported, the decision to add clove back to the list of banned flavorings in cigarettes.
While it is true that the health groups initially were not supportive of the idea of taking clove off the list of banned flavorings, once Senator Kennedy made this change, the Campaign for Tobacco-Free Kids opposed the amendment, passed yesterday, which rescinded this change in the bill, which was apparently done as a favor to Philip Morris, which recently began marketing clove cigarettes in Indonesia.
In a communication to tobacco control advocates which emphasized its opposition to the clove amendment, the Campaign expressed concern that the inclusion of clove might violate trade agreements. As I noted yesterday, this is a completely bogus argument. If that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements.
The third part of the rest of the story is that the national poll referred to by the Campaign did not assess respondents' opinions about the actual FDA legislation being considered by Congress. Instead, the poll simply asked people to give their opinions about the general idea of giving the FDA the authority to regulate cigarettes. The question was simply: "Would you favor or oppose the U.S. Congress passing a bill that would give the Food and Drug Administration, known as the FDA, the authority to regulate tobacco products, including restrictions on sales and marketing to children?"
This question does not ask about the specific legislation in question. It does not, for example, ask respondents whether they would support a bill that purports to give the FDA the authority to regulate cigarettes, but ties the Agency's hands by precluding it from eliminating any class of tobacco products, from removing the nicotine, from raising the legal age of purchase of cigarettes, from regulating the places where cigarettes are sold, and from making cigarettes available on a prescription-basis.
I have already commented on why I feel the poll taken by the Campaign, or at least the way the results were reported, represents junk science. Clearly, it is deceptive to suggest that the public has been polled about its opinions regarding S.625. That is not the case. The public has been polled about the general idea of giving the FDA regulatory authority over cigarettes, but not about the specific bill in question.
In fact, the Campaign for Tobacco-Free Kids has refused to even inform the public about the details regarding the legislation. And for good reason: the more that people know, the more likely they are to realize that the bill contains unprecedented special protections for Big Tobacco.
The fact that the Campaign for Tobacco-Free Kids is unable to be truthful about the FDA legislation should be a big clue to the public that the FDA legislation is truly weak. If the legislation were as meaningful as the Campaign makes it out to be, then it wouldn't be necessary to widely deceive its constituents and the public - repeatedly - about the legislation. Instead, the Campaign could simply tell the truth.
The Campaign for Tobacco-Free Kids does not seem capable of simply telling the truth. This may simply be a result of the organization's fear that if the truth gets out there, people may no longer support the bill. But whatever the reason, it is unethical.
Ironically, a bill which is being touted as necessary to force tobacco companies to tell the truth is being supported by the most deceptive tactics I have ever experienced in my tobacco control career.
In the first communication, which was sent out to advocates and issued as a press release, the Campaign stated that the FDA tobacco bill approved by the Senate HELP Committee yesterday requires tobacco companies to reduce or remove harmful ingredients from their products.
The Campaign stated that: "the legislation would grant the FDA authority to crack down on tobacco marketing and sales to kids; require that tobacco companies disclose the contents of tobacco products and reduce or remove harmful ingredients; stop tobacco companies from misleading the public about the health risks of their products; and require larger, more effective health warnings on tobacco products."
In the second communication, the Campaign implied that it supported the amendment, added to the bill yesterday, which adds clove back to the list of banned flavorings in cigarettes.
The Campaign wrote: "Public health groups had opposed an earlier change in the Chairman's Mark (now rescinded) that would have taken clove out of the list of immediately banned flavors."
In the press release, the Campaign also stated that the public has expressed overwhelming support for the proposed FDA legislation, claiming that: "According to a recent national poll, 70 percent of voters support Congress passing the legislation and 72 percent believe passage of the legislation would be an important accomplishment for Congress."
The Rest of the Story
The rest of the story is that the FDA legislation would not require that tobacco companies reduce or remove the harmful ingredients from their products. What it would do is give the FDA the authority to require tobacco companies to reduce or remove certain harmful ingredients from their products. There is a huge difference between the two, and it is therefore deceptive to imply that the bill itself requires that tobacco companies reduce or remove the harmful ingredients from their products.
The legislation merely gives the FDA the ability to require the reduction or removal of particular harmful ingredients. The FDA could not require the reduction or removal of all harmful ingredients (which is implied by the statement), nor does the bill require that the FDA take any particular action at all. In fact, the bill gives the tobacco companies the ability to block any required removal of an ingredient merely by getting a majority of Congressmembers to veto the regulation.
The rest of the story is also that the Campaign for Tobacco-Free Kids opposed, rather than supported, the decision to add clove back to the list of banned flavorings in cigarettes.
While it is true that the health groups initially were not supportive of the idea of taking clove off the list of banned flavorings, once Senator Kennedy made this change, the Campaign for Tobacco-Free Kids opposed the amendment, passed yesterday, which rescinded this change in the bill, which was apparently done as a favor to Philip Morris, which recently began marketing clove cigarettes in Indonesia.
In a communication to tobacco control advocates which emphasized its opposition to the clove amendment, the Campaign expressed concern that the inclusion of clove might violate trade agreements. As I noted yesterday, this is a completely bogus argument. If that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements.
The third part of the rest of the story is that the national poll referred to by the Campaign did not assess respondents' opinions about the actual FDA legislation being considered by Congress. Instead, the poll simply asked people to give their opinions about the general idea of giving the FDA the authority to regulate cigarettes. The question was simply: "Would you favor or oppose the U.S. Congress passing a bill that would give the Food and Drug Administration, known as the FDA, the authority to regulate tobacco products, including restrictions on sales and marketing to children?"
This question does not ask about the specific legislation in question. It does not, for example, ask respondents whether they would support a bill that purports to give the FDA the authority to regulate cigarettes, but ties the Agency's hands by precluding it from eliminating any class of tobacco products, from removing the nicotine, from raising the legal age of purchase of cigarettes, from regulating the places where cigarettes are sold, and from making cigarettes available on a prescription-basis.
I have already commented on why I feel the poll taken by the Campaign, or at least the way the results were reported, represents junk science. Clearly, it is deceptive to suggest that the public has been polled about its opinions regarding S.625. That is not the case. The public has been polled about the general idea of giving the FDA regulatory authority over cigarettes, but not about the specific bill in question.
In fact, the Campaign for Tobacco-Free Kids has refused to even inform the public about the details regarding the legislation. And for good reason: the more that people know, the more likely they are to realize that the bill contains unprecedented special protections for Big Tobacco.
The fact that the Campaign for Tobacco-Free Kids is unable to be truthful about the FDA legislation should be a big clue to the public that the FDA legislation is truly weak. If the legislation were as meaningful as the Campaign makes it out to be, then it wouldn't be necessary to widely deceive its constituents and the public - repeatedly - about the legislation. Instead, the Campaign could simply tell the truth.
The Campaign for Tobacco-Free Kids does not seem capable of simply telling the truth. This may simply be a result of the organization's fear that if the truth gets out there, people may no longer support the bill. But whatever the reason, it is unethical.
Ironically, a bill which is being touted as necessary to force tobacco companies to tell the truth is being supported by the most deceptive tactics I have ever experienced in my tobacco control career.
Wednesday, August 01, 2007
Senate Committee Restores Ban on Clove-Flavored Cigarettes to FDA Bill, Despite Opposition by Campaign for Tobacco-Free Kids
The Senate Health, Education, Labor, and Pensions (HELP) Committee today sent the FDA tobacco bill along to the full Senate, but not before amending it to ban the use of clove as a primary flavoring in cigarettes. Senator Kennedy had secretly inserted the language allowing clove to be used as a flavoring in between the time the bill was originally introduced and the time he presented it to the Senate HELP Committee for mark-up. The original bill banned the use of clove as a primary flavoring in cigarettes. Probably not coincidentally, this change occurred in the wake of Philip Morris spending $5 billion to start marketing clove-flavored Marlboro in Indonesia.
The Rest of the Story
Embarrassingly, while this amendment had no problem getting through the Senate Committee, as the legislators easily saw through the smokescreen that this Philip Morris protection clause was necessary to avoid violation of some imaginary trade laws that somehow interfere with the authority of the U.S. government to issue safety standards for U.S. products, the amendment was opposed by supposedly the leading anti-smoking group in the nation: the Campaign for Tobacco-Free Kids. The Campaign went as far as sending out a communication to tobacco control advocates expressing its opposition to Enzi Amendment #12, and implying that advocates should contact the Senate HELP Committee members and urge them to oppose this amendment.
As I wrote last week about Enzi Amendment #12 (which passed today): "This amendment would remove the exemption for clove as one of only two flavorings allowable (along with menthol). This simply returns the bill to its form prior to Senator Kennedy's addition of the clove exemption in order to protect the financial interests of Philip Morris, which recently began marketing clove cigarettes in Indonesia."
"There is absolutely no reason for any of the health groups to fail to support this amendment, since it simply removes a special protection for Philip Morris which has no place in the legislation, and which wasn't even in the legislation to begin with."
"The explanation that this clause is necessary to avoid violating trade treaties is completely bogus. Besides, if that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements."
The explanation that this clause is a poison pill is also bogus, since the majority of Senators and 195 members of the House sponsored this legislation before Senator Kennedy inserted the Philip Morris clove protection clause.
As I noted earlier, the strategy of the Campaign for Tobacco-Free Kids seems to be as follows: Let's pretend that this is meaningful legislation, but if any changes to the bill are made that would actually make it meaningful, let's oppose those changes because if the bill actually becomes an effective tobacco control measure, it will not pass. We need this to pass as we've staked our reputation on it, so let's make sure that it doesn't develop any real teeth.
You've got to love a group that tries to keep tobacco legislation weak because if it becomes too strong (such that Philip Morris might actually oppose it), it might not pass.
Well I've got news for you. There is no law I'm aware of that says we must pass FDA authorizing legislation right now. If we truly cannot pass meaningful Congressional legislation at the current time, then maybe it's better to wait until we can, rather than force through a bill which is able to pass specifically because it is agreeable to Philip Morris because it offers the nation's leading tobacco company unprecedented special protections.
The choice is not between the FDA legislation or the status quo. The actual choice is between a piece of misguided legislation that is going to undermine 40 years of tobacco control efforts and almost assuredly, increase smoking rates and the development of legislation that would actually make a difference in substantially reducing smoking rates.
By becoming obsessed with FDA regulation of tobacco, the Campaign for Tobacco-Free Kids and other health groups have diverted our attention away from what would be a truly effective national tobacco control measure: raising the federal cigarette tax and funding, for the first time, a high-exposure, national counter-advertising campaign, while supporting similar campaigns in the states.
I think it's time for tobacco control groups and advocates to go back to the drawing board and engage in a broadly inclusive discussion about a national tobacco control policy that would actually be effective: one that uses tried and true prevention methods --- a combination of cigarette tax increases with the revenues going to fund anti-smoking media campaigns. Senator Enzi has already proposed a bill that could easily serve as the foundation for such an effective policy.
There is absolutely no evidence to believe that the minor advertising restrictions in the FDA legislation - which will almost certainly be overturned by the Supreme Court anyway - will do much to reduce youth smoking. There is, however, every reason to believe that the FDA seal of approval for cigarettes will undermine the public's appreciation of the hazards of smoking, which would undoubtedly lead to increased smoking.
What the Campaign for Tobacco-Free Kids is promoting is the worst of both worlds: an obsession with legislation that is going to be a public health disaster; and the distraction of our attention away from potential legislation that could really make a difference in saving lives, using methods that we know work.
The Rest of the Story
Embarrassingly, while this amendment had no problem getting through the Senate Committee, as the legislators easily saw through the smokescreen that this Philip Morris protection clause was necessary to avoid violation of some imaginary trade laws that somehow interfere with the authority of the U.S. government to issue safety standards for U.S. products, the amendment was opposed by supposedly the leading anti-smoking group in the nation: the Campaign for Tobacco-Free Kids. The Campaign went as far as sending out a communication to tobacco control advocates expressing its opposition to Enzi Amendment #12, and implying that advocates should contact the Senate HELP Committee members and urge them to oppose this amendment.
As I wrote last week about Enzi Amendment #12 (which passed today): "This amendment would remove the exemption for clove as one of only two flavorings allowable (along with menthol). This simply returns the bill to its form prior to Senator Kennedy's addition of the clove exemption in order to protect the financial interests of Philip Morris, which recently began marketing clove cigarettes in Indonesia."
"There is absolutely no reason for any of the health groups to fail to support this amendment, since it simply removes a special protection for Philip Morris which has no place in the legislation, and which wasn't even in the legislation to begin with."
"The explanation that this clause is necessary to avoid violating trade treaties is completely bogus. Besides, if that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements."
The explanation that this clause is a poison pill is also bogus, since the majority of Senators and 195 members of the House sponsored this legislation before Senator Kennedy inserted the Philip Morris clove protection clause.
As I noted earlier, the strategy of the Campaign for Tobacco-Free Kids seems to be as follows: Let's pretend that this is meaningful legislation, but if any changes to the bill are made that would actually make it meaningful, let's oppose those changes because if the bill actually becomes an effective tobacco control measure, it will not pass. We need this to pass as we've staked our reputation on it, so let's make sure that it doesn't develop any real teeth.
You've got to love a group that tries to keep tobacco legislation weak because if it becomes too strong (such that Philip Morris might actually oppose it), it might not pass.
Well I've got news for you. There is no law I'm aware of that says we must pass FDA authorizing legislation right now. If we truly cannot pass meaningful Congressional legislation at the current time, then maybe it's better to wait until we can, rather than force through a bill which is able to pass specifically because it is agreeable to Philip Morris because it offers the nation's leading tobacco company unprecedented special protections.
The choice is not between the FDA legislation or the status quo. The actual choice is between a piece of misguided legislation that is going to undermine 40 years of tobacco control efforts and almost assuredly, increase smoking rates and the development of legislation that would actually make a difference in substantially reducing smoking rates.
By becoming obsessed with FDA regulation of tobacco, the Campaign for Tobacco-Free Kids and other health groups have diverted our attention away from what would be a truly effective national tobacco control measure: raising the federal cigarette tax and funding, for the first time, a high-exposure, national counter-advertising campaign, while supporting similar campaigns in the states.
I think it's time for tobacco control groups and advocates to go back to the drawing board and engage in a broadly inclusive discussion about a national tobacco control policy that would actually be effective: one that uses tried and true prevention methods --- a combination of cigarette tax increases with the revenues going to fund anti-smoking media campaigns. Senator Enzi has already proposed a bill that could easily serve as the foundation for such an effective policy.
There is absolutely no evidence to believe that the minor advertising restrictions in the FDA legislation - which will almost certainly be overturned by the Supreme Court anyway - will do much to reduce youth smoking. There is, however, every reason to believe that the FDA seal of approval for cigarettes will undermine the public's appreciation of the hazards of smoking, which would undoubtedly lead to increased smoking.
What the Campaign for Tobacco-Free Kids is promoting is the worst of both worlds: an obsession with legislation that is going to be a public health disaster; and the distraction of our attention away from potential legislation that could really make a difference in saving lives, using methods that we know work.
New York State District Court Decision Has Major Implications for Master Settlement Agreement and Proposed FDA Tobacco Legislation
According to an article from Law.com, a New York district court judge has ruled that the Master Settlement Agreement which New York State entered into with the tobacco companies in 1998 precludes alleged victims of tobacco company wrongdoing in New York from seeking punitive damages against the companies.
In the same case, Judge Charles L. Brieant rejected a defective product claim that had been used successfully in a New York County case that resulted in a $20 million verdict against two tobacco companies. In both cases, the claim was that the companies sold the plaintiff a defective product, in that less harmful alternatives were available that the companies could have sold instead.
In the case (Mulholland v. Philip Morris), Judge Brieant "concluded that the Mulhollands and Philip Morris were "in privity" with the parties to the earlier action [the Master Settlement Agreement], which had been brought by the state on a parens patriae theory. In granting summary judgment dismissing the Mulhollands' punitive damages claims, Brieant wrote that to allow them to claim "a private interest in punitive damages" would violate a strong New York public policy."
In other words, the judge ruled that the Master Settlement Agreement between New York State and the major tobacco companies essentially represented claims brought by all citizens of the state and therefore the settlement resolved the issue of punitive damages for all of these private claims.
This is now the second court to rule that the MSA precludes individual punitive damage claims by smokers. The Georgia Supreme Court came to a similar conclusion in a March 2006 decision.
Judge Brieant also ruled "that there was no feasible alternative to Marlboros because the other safer alternatives that had been offered by the Mulhollands' expert had been rejected by the marketplace. The "reduced carcinogen" and "nonaddictive" cigarettes cited as safer alternatives by the Mulhollands' expert were "indisputably rejected by consumers," Brieant wrote. "A state law requirement that allows only cigarettes with no tar or no nicotine to be sold is a virtual ban on cigarettes," the judge wrote, "just as a requirement that allows only 'alcohol-free' liquor to be sold would be a ban on whiskey."
The Rest of the Story
There are two important implications of this decision.
First, the Mulholland decision confirms my argument that the Master Settlement Agreement is going to be interpreted by at least some courts as precluding additional punitive damage claims by private parties in those states. This is currently the case in Georgia and will be the case in New York if this ruling is affirmed on appeal.
By failing to oppose the Master Settlement Agreement, the Campaign for Tobacco-Free Kids has provided a great deal of immunity to the tobacco companies. Of course, this is nothing compared to the virtual immunity the companies will enjoy if the FDA tobacco legislation is enacted.
In my view, the Campaign for Tobacco-Free Kids has violated and continues to violated the first ethical principle of medical and public health practice - to do no harm. It does great harm to the American public to take away their individual legal rights, especially without their consent.
Second, the decision exposes one of the major loopholes in the proposed FDA tobacco legislation. One of the clauses inserted into the legislation to protect Philip Morris and the rest of Big Tobacco is the preclusion of the FDA from eliminating any particular class of tobacco products, including cigarettes. While I do not oppose this from the perspective that I think it is reasonable for the FDA to ban cigarettes, the more pressing aspect of this loophole is that it likely bars the FDA from making any substantial design requirements in cigarettes -- precisely the kind of changes that would be necessary to produce a potentially safer cigarette.
Why? Because, as Judge Brieant ruled, requiring major design changes in cigarettes that may make the cigarette unpalatable is tantamount to a ban on cigarettes. Thus, such a requirement could be interpreted as violating section 907(b)(3)(A) of the proposed legislation.
If, for example, the FDA decided to remove most of the nicotine from cigarettes and the product thus became unpalatable to smokers, this could easily be construed as a de facto ban on the sale of cigarettes, thus violating section 907(b)(3)(A).
This loophole needs to be removed from the legislation in order for the bill to have any teeth at all (and I'm not saying even then it would result in a safer cigarette - but with this provision, there is not a chance that it could do so, because FDA rules that did anything to change the basic design of the cigarette - which would be necessary to make them safer - would be tied up in court for years and very likely, overturned).
To address the concern about the need for FDA to ban tobacco products without this provision, a provision could easily be added to the bill requiring that in any decision to ban any class of tobacco products, the Agency must consider both the social and economic effects of such a policy. That would remove the requirement that FDA ban cigarettes, yet it would not provide a loophole that would likely block even the slight prospect of the FDA actually requiring a safer cigarette.
Senator Enzi has, in effect, introduced an amendment that would delete section 907(b)(3)(A) of the bill, thus removing this loophole. Unfortunately, the Campaign for Tobacco-Free Kids seems intent on not allowing the bill to gain any teeth, and thus it is opposing this amendment.
The strategy of the Campaign for Tobacco-Free Kids seems to be as follows: Let's pretend that this is meaningful legislation, but if any changes to the bill are made that would actually make it meaningful, let's oppose those changes because if the bill actually becomes an effective tobacco control measure, it will not pass. We need this to pass as we've staked our reputation on it, so let's make sure that it doesn't develop any real teeth.
That's the rest of the story.
In the same case, Judge Charles L. Brieant rejected a defective product claim that had been used successfully in a New York County case that resulted in a $20 million verdict against two tobacco companies. In both cases, the claim was that the companies sold the plaintiff a defective product, in that less harmful alternatives were available that the companies could have sold instead.
In the case (Mulholland v. Philip Morris), Judge Brieant "concluded that the Mulhollands and Philip Morris were "in privity" with the parties to the earlier action [the Master Settlement Agreement], which had been brought by the state on a parens patriae theory. In granting summary judgment dismissing the Mulhollands' punitive damages claims, Brieant wrote that to allow them to claim "a private interest in punitive damages" would violate a strong New York public policy."
In other words, the judge ruled that the Master Settlement Agreement between New York State and the major tobacco companies essentially represented claims brought by all citizens of the state and therefore the settlement resolved the issue of punitive damages for all of these private claims.
This is now the second court to rule that the MSA precludes individual punitive damage claims by smokers. The Georgia Supreme Court came to a similar conclusion in a March 2006 decision.
Judge Brieant also ruled "that there was no feasible alternative to Marlboros because the other safer alternatives that had been offered by the Mulhollands' expert had been rejected by the marketplace. The "reduced carcinogen" and "nonaddictive" cigarettes cited as safer alternatives by the Mulhollands' expert were "indisputably rejected by consumers," Brieant wrote. "A state law requirement that allows only cigarettes with no tar or no nicotine to be sold is a virtual ban on cigarettes," the judge wrote, "just as a requirement that allows only 'alcohol-free' liquor to be sold would be a ban on whiskey."
The Rest of the Story
There are two important implications of this decision.
First, the Mulholland decision confirms my argument that the Master Settlement Agreement is going to be interpreted by at least some courts as precluding additional punitive damage claims by private parties in those states. This is currently the case in Georgia and will be the case in New York if this ruling is affirmed on appeal.
By failing to oppose the Master Settlement Agreement, the Campaign for Tobacco-Free Kids has provided a great deal of immunity to the tobacco companies. Of course, this is nothing compared to the virtual immunity the companies will enjoy if the FDA tobacco legislation is enacted.
In my view, the Campaign for Tobacco-Free Kids has violated and continues to violated the first ethical principle of medical and public health practice - to do no harm. It does great harm to the American public to take away their individual legal rights, especially without their consent.
Second, the decision exposes one of the major loopholes in the proposed FDA tobacco legislation. One of the clauses inserted into the legislation to protect Philip Morris and the rest of Big Tobacco is the preclusion of the FDA from eliminating any particular class of tobacco products, including cigarettes. While I do not oppose this from the perspective that I think it is reasonable for the FDA to ban cigarettes, the more pressing aspect of this loophole is that it likely bars the FDA from making any substantial design requirements in cigarettes -- precisely the kind of changes that would be necessary to produce a potentially safer cigarette.
Why? Because, as Judge Brieant ruled, requiring major design changes in cigarettes that may make the cigarette unpalatable is tantamount to a ban on cigarettes. Thus, such a requirement could be interpreted as violating section 907(b)(3)(A) of the proposed legislation.
If, for example, the FDA decided to remove most of the nicotine from cigarettes and the product thus became unpalatable to smokers, this could easily be construed as a de facto ban on the sale of cigarettes, thus violating section 907(b)(3)(A).
This loophole needs to be removed from the legislation in order for the bill to have any teeth at all (and I'm not saying even then it would result in a safer cigarette - but with this provision, there is not a chance that it could do so, because FDA rules that did anything to change the basic design of the cigarette - which would be necessary to make them safer - would be tied up in court for years and very likely, overturned).
To address the concern about the need for FDA to ban tobacco products without this provision, a provision could easily be added to the bill requiring that in any decision to ban any class of tobacco products, the Agency must consider both the social and economic effects of such a policy. That would remove the requirement that FDA ban cigarettes, yet it would not provide a loophole that would likely block even the slight prospect of the FDA actually requiring a safer cigarette.
Senator Enzi has, in effect, introduced an amendment that would delete section 907(b)(3)(A) of the bill, thus removing this loophole. Unfortunately, the Campaign for Tobacco-Free Kids seems intent on not allowing the bill to gain any teeth, and thus it is opposing this amendment.
The strategy of the Campaign for Tobacco-Free Kids seems to be as follows: Let's pretend that this is meaningful legislation, but if any changes to the bill are made that would actually make it meaningful, let's oppose those changes because if the bill actually becomes an effective tobacco control measure, it will not pass. We need this to pass as we've staked our reputation on it, so let's make sure that it doesn't develop any real teeth.
That's the rest of the story.
Tuesday, July 31, 2007
Under Plan to Use Cigarette Tax to Fund Children's Health Insurance, 22 Million New Smokers Would Be Required to Keep Program Solvent Over Next Decade
According to a report released by the Heritage Foundation, 22 million new smokers will be needed to fund the State Children's Health Insurance Program (SCHIP) by 2017 if a Congressional proposal to use a 61 cent per pack federal cigarette excise tax increase to fund expansion of the program is adopted.
A Senate panel has approved a plan to fund a $35 billion expansion of the SCHIP program using funds generated from a 61 cents per pack increase in the federal cigarette excise tax. The Heritage Foundation report notes that this proposal will make the government dependent upon continued smoking in order to adequately fund children's health insurance.
The major conclusion of the report is as follows: "Policymakers will somehow need to recruit new smokers if they insist on using the tobacco tax revenue to support SCHIP at proposed funding levels over the long term. In just five years, Congress will need over 9 million new smokers. Reauthorizing the program for 2013 to 2017 would require almost 22.4 million new smokers by the end of that period."
Policy makers may need even more smokers than this, since health insurance costs are rising: "But funding problems will likely begin before the end of the five-year horizon. Since the revenues from the tobacco tax are declining while the amount of SCHIP funds needed to maintain a level of purchasing power are increasing, Congress could face a shortage of smokers in just two years. In this case, Congress will need over 6.3 million new smokers between 2010 and 2012, which grows to 9 million new smokers needed in 2013 to support the government’s health program. Funding the expansion of a government health program through a tax on a toxic product with a declining revenue stream is not only paradoxical but also fiscally irresponsible. It is not a reliable source of continued funding."The Rest of the Story
This is exactly the problem that I discussed in my earlier posts about this flawed proposal. You don't make something as critical as children's health insurance dependent upon recruiting a continuing new stream of smokers. Sure - the tax might cause some smokers to quit; however, those smokers need to be replaced in order for the nation's children to maintain their health insurance. This is an absurd way to fund health insurance for the children in this country.
If the cigarette tax is to be increased, revenues must be used for smoking-related causes. This is the one way to avoid the problem of making government programs dependent on recruiting new smokers. If the programs that are dependent on such revenues are programs such as smoking prevention, cessation, research, and treatment, then reducing the funding for them over time is ideal. It is a self-regulating system. As smoking falls, so does the need for the programs, and so does the revenue. Were smoking to increase, the need for the programs goes up, but so does the revenue to fund these programs.
Senator Enzi has introduced a proposal to increase the cigarette tax and use the resulting revenues to fund smoking prevention and cessation programs. He has done so both as an amendment to the FDA tobacco bill, which will be considered by a Senate committee tomorrow, and as a stand-alone bill.
Instead of wasting their time on two absurd proposals - one to ask the FDA to approve the most toxic consumer product on the market and the other to make the health care of our nation's children dependent upon recruiting millions of new smokers - Congress, if it is seriously interested in providing children's health insurance and making a dent in smoking, will nix the FDA and the SCHIP bills, find an alternative funding source to expand SCHIP, and consider using Senator Enzi's ideas as a starting point for a meaningful discussion about how federal policy might actually contribute something substantial to improving the public's health.
Incidentally, the winner of the T-shirt contest is Reynolds American, which designed the slogan "Congress Needs You To Smoke." That sums it up completely. Our policy makers, and ironically - our tobacco control groups - are promoting a measure that would require lawmakers to recruit millions of new smokers in order to provide health insurance for our nation's children.
A Senate panel has approved a plan to fund a $35 billion expansion of the SCHIP program using funds generated from a 61 cents per pack increase in the federal cigarette excise tax. The Heritage Foundation report notes that this proposal will make the government dependent upon continued smoking in order to adequately fund children's health insurance.
The major conclusion of the report is as follows: "Policymakers will somehow need to recruit new smokers if they insist on using the tobacco tax revenue to support SCHIP at proposed funding levels over the long term. In just five years, Congress will need over 9 million new smokers. Reauthorizing the program for 2013 to 2017 would require almost 22.4 million new smokers by the end of that period."
Policy makers may need even more smokers than this, since health insurance costs are rising: "But funding problems will likely begin before the end of the five-year horizon. Since the revenues from the tobacco tax are declining while the amount of SCHIP funds needed to maintain a level of purchasing power are increasing, Congress could face a shortage of smokers in just two years. In this case, Congress will need over 6.3 million new smokers between 2010 and 2012, which grows to 9 million new smokers needed in 2013 to support the government’s health program. Funding the expansion of a government health program through a tax on a toxic product with a declining revenue stream is not only paradoxical but also fiscally irresponsible. It is not a reliable source of continued funding."The Rest of the Story
This is exactly the problem that I discussed in my earlier posts about this flawed proposal. You don't make something as critical as children's health insurance dependent upon recruiting a continuing new stream of smokers. Sure - the tax might cause some smokers to quit; however, those smokers need to be replaced in order for the nation's children to maintain their health insurance. This is an absurd way to fund health insurance for the children in this country.
If the cigarette tax is to be increased, revenues must be used for smoking-related causes. This is the one way to avoid the problem of making government programs dependent on recruiting new smokers. If the programs that are dependent on such revenues are programs such as smoking prevention, cessation, research, and treatment, then reducing the funding for them over time is ideal. It is a self-regulating system. As smoking falls, so does the need for the programs, and so does the revenue. Were smoking to increase, the need for the programs goes up, but so does the revenue to fund these programs.
Senator Enzi has introduced a proposal to increase the cigarette tax and use the resulting revenues to fund smoking prevention and cessation programs. He has done so both as an amendment to the FDA tobacco bill, which will be considered by a Senate committee tomorrow, and as a stand-alone bill.
Instead of wasting their time on two absurd proposals - one to ask the FDA to approve the most toxic consumer product on the market and the other to make the health care of our nation's children dependent upon recruiting millions of new smokers - Congress, if it is seriously interested in providing children's health insurance and making a dent in smoking, will nix the FDA and the SCHIP bills, find an alternative funding source to expand SCHIP, and consider using Senator Enzi's ideas as a starting point for a meaningful discussion about how federal policy might actually contribute something substantial to improving the public's health.
Incidentally, the winner of the T-shirt contest is Reynolds American, which designed the slogan "Congress Needs You To Smoke." That sums it up completely. Our policy makers, and ironically - our tobacco control groups - are promoting a measure that would require lawmakers to recruit millions of new smokers in order to provide health insurance for our nation's children.
Monday, July 30, 2007
New Gallup Poll Reveals that Nearly Half of Smokers Feel Discriminated Against As a Result of Smoking Restrictions
A new Gallup survey released last week reveals that nearly half of smokers (47%) feel unjustly discriminated against as a result of public smoking restrictions. This percentage is up from 32% in 2001, six years ago. The majority of Americans (58%) continue to feel sympathetic toward smokers, which represents no change from 2001.
According to the Gallup press release: "Americans are not blind to the difficulties faced by people who smoke; most say they are sympathetic toward smokers because they understand it is hard to quit even if someone wants to try. However, as the percentage of Americans willing to ban smoking in various public places continues to creep up, close to half of smokers now say they feel unjustly discriminated against by society."
Another important result of the survey: the percentage of Americans who believe secondhand smoke is very harmful (56%) was no higher in 2007 than a decade earlier - in 1997 - when that percentage was 55%.
The Rest of the Story
These results are of particular interest to me because they show that the feelings of many of the smokers who read and comment on this blog are not extreme views, but represent the attitude of about half of all smokers nationwide. I have been roundly criticized by my colleagues for allowing these commenters to express their opinions and have been even more harshly criticized for engaging in a dialogue with these readers, who many of my colleagues have called tobacco moles or angry and deluded. However, these results demonstrate that the views expressed on this blog are not atypical of how smokers in general feel and that these attitudes represent a reality that public health and tobacco control practitioners are going to have to acknowledge and address.
These results also show that anti-smoking groups are quickly stepping out of line from where the public stands in terms of its attitudes towards smokers. The majority of people remain sympathetic towards smokers, and this percentage has not been declining over the past decade. In fact, it actually increased from 53% in 1997 to 58% in 2007.
Why are smokers increasingly feeling discriminated against? The answer is evident if you scroll through the headlines of this blog. The anti-smoking movement is making smokers feel this way by pursuing increasingly discriminatory, invasive, unfair, and unjustified policies.
I believe that the promotion of policies that discriminate against smokers in employment (i.e., refusing to hire smokers or firing existing smokers), treat smokers as child abusers, punish smokers for exposing their children to small increases in health risks, and ban smoking beyond the places necessary to protect the health of nonsmokers are all contributing to the increasing perception among smokers that they are being unfairly targeted and discriminated against.
It should not come as a surprise to tobacco control advocates that discrimination against smokers is resulting in an increased perception of discrimination. It should.
Unfortunately, these numbers are likely to continue to increase, as smoker-free hiring policies, along with draconian bans on smoking in nearly all outdoors areas, are just getting off the ground and are starting to proliferate rapidly.
More importantly, not a single tobacco control organization in this country has been willing to publicly speak out against these discriminatory employment policies. Short of that, the proliferation of this discrimination is not going to stop. As long as businesses perceive that they are acting in the best interests of the public's health as perceived by anti-smoking groups, they will continue to adopt these policies.
The same is true of smoking bans that overstep the need to protect nonsmokers from secondhand smoke exposure. As more and more bans on smoking outdoors are enacted, especially in places where nonsmokers can easily avoid exposure, smokers will continue to feel discriminated against.
Another important finding of this poll is that despite anti-smoking groups' gross exaggerations of the acute cardiovascular health effects of secondhand smoke over the past six years, the proportion of people who believe that secondhand smoke is very harmful has not increased. This suggests that the anti-smoking groups' strategy of trying to increase the public's appreciation of the hazards of secondhand smoke by exaggerating their messages and creating the appearance of a more serious, more ominous, and more immediate threat to the heart than actually exists based on the scientific evidence is backfiring.
Apparently, the "30 minutes of exposure causes heart disease" and "there is no safe level of exposure to secondhand smoke" messages are not working to give the public a greater appreciation of the severity of the hazards of tobacco smoke exposure. If anything, these messages may have ended up being counter-productive, as the past years have seen a plateau in what was previously a rapidly increasing appreciation of the severity of secondhand smoke's hazards.
The proportion of adults who believe secondhand smoke is very harmful increased steadily from 36% in 1994 to 48% in 1996 to 55% in 1997. But it has gotten no higher in the past 10 years.
Even though anti-smoking groups do not seem to care about the scientific inaccuracy of their public messages, they may wish to reconsider their strategy in light of this evidence that the approach is not working.
According to the Gallup press release: "Americans are not blind to the difficulties faced by people who smoke; most say they are sympathetic toward smokers because they understand it is hard to quit even if someone wants to try. However, as the percentage of Americans willing to ban smoking in various public places continues to creep up, close to half of smokers now say they feel unjustly discriminated against by society."
Another important result of the survey: the percentage of Americans who believe secondhand smoke is very harmful (56%) was no higher in 2007 than a decade earlier - in 1997 - when that percentage was 55%.
The Rest of the Story
These results are of particular interest to me because they show that the feelings of many of the smokers who read and comment on this blog are not extreme views, but represent the attitude of about half of all smokers nationwide. I have been roundly criticized by my colleagues for allowing these commenters to express their opinions and have been even more harshly criticized for engaging in a dialogue with these readers, who many of my colleagues have called tobacco moles or angry and deluded. However, these results demonstrate that the views expressed on this blog are not atypical of how smokers in general feel and that these attitudes represent a reality that public health and tobacco control practitioners are going to have to acknowledge and address.
These results also show that anti-smoking groups are quickly stepping out of line from where the public stands in terms of its attitudes towards smokers. The majority of people remain sympathetic towards smokers, and this percentage has not been declining over the past decade. In fact, it actually increased from 53% in 1997 to 58% in 2007.
Why are smokers increasingly feeling discriminated against? The answer is evident if you scroll through the headlines of this blog. The anti-smoking movement is making smokers feel this way by pursuing increasingly discriminatory, invasive, unfair, and unjustified policies.
I believe that the promotion of policies that discriminate against smokers in employment (i.e., refusing to hire smokers or firing existing smokers), treat smokers as child abusers, punish smokers for exposing their children to small increases in health risks, and ban smoking beyond the places necessary to protect the health of nonsmokers are all contributing to the increasing perception among smokers that they are being unfairly targeted and discriminated against.
It should not come as a surprise to tobacco control advocates that discrimination against smokers is resulting in an increased perception of discrimination. It should.
Unfortunately, these numbers are likely to continue to increase, as smoker-free hiring policies, along with draconian bans on smoking in nearly all outdoors areas, are just getting off the ground and are starting to proliferate rapidly.
More importantly, not a single tobacco control organization in this country has been willing to publicly speak out against these discriminatory employment policies. Short of that, the proliferation of this discrimination is not going to stop. As long as businesses perceive that they are acting in the best interests of the public's health as perceived by anti-smoking groups, they will continue to adopt these policies.
The same is true of smoking bans that overstep the need to protect nonsmokers from secondhand smoke exposure. As more and more bans on smoking outdoors are enacted, especially in places where nonsmokers can easily avoid exposure, smokers will continue to feel discriminated against.
Another important finding of this poll is that despite anti-smoking groups' gross exaggerations of the acute cardiovascular health effects of secondhand smoke over the past six years, the proportion of people who believe that secondhand smoke is very harmful has not increased. This suggests that the anti-smoking groups' strategy of trying to increase the public's appreciation of the hazards of secondhand smoke by exaggerating their messages and creating the appearance of a more serious, more ominous, and more immediate threat to the heart than actually exists based on the scientific evidence is backfiring.
Apparently, the "30 minutes of exposure causes heart disease" and "there is no safe level of exposure to secondhand smoke" messages are not working to give the public a greater appreciation of the severity of the hazards of tobacco smoke exposure. If anything, these messages may have ended up being counter-productive, as the past years have seen a plateau in what was previously a rapidly increasing appreciation of the severity of secondhand smoke's hazards.
The proportion of adults who believe secondhand smoke is very harmful increased steadily from 36% in 1994 to 48% in 1996 to 55% in 1997. But it has gotten no higher in the past 10 years.
Even though anti-smoking groups do not seem to care about the scientific inaccuracy of their public messages, they may wish to reconsider their strategy in light of this evidence that the approach is not working.
Friday, July 27, 2007
Anti-Smoking Groups Up in Arms Over Failure to Give "Hairspray" an R-Rating Due to Momentary Teen Smoking
Anti-smoking groups are apparently up in arms over the decision by the Motion Picture Association of America (MPAA) to give the new movie "Hairspray" only a PG rating (instead of an R rating) due to its depiction of momentary teen smoking. The MPAA, in accordance with its new policy which considers smoking as one factor in determining a movie's rating, added a descriptor in the rating tag which notes that the movie contains "momentary teen smoking." The full tag states: "Language, Some Suggestive Content and Mometary Teen Smoking." However, the anti-smoking groups, headed by the SmokeFreeMovies campaign and the American Legacy Foundation, were outraged, complaining that this action does not go far enough and that the film should have received an R rating instead.
SmokeFreeMovies argued that the use of descriptors to note smoking depiction is meaningless: "The MPAA -- acting on behalf of the big media companies -- is pursuing exactly the kind of meaningless policy related to tobacco that we predicted back in 2002, namely just adding a tobacco descriptor to a youth rating."
The movie represents the film version of the Broadway musical (which follows the original 1988 John Waters film) and is set in Baltimore of the 1960s. It is described as containing "a fleeting scene of smoking in a high school bathroom. There are also brief shots of a character billed in the credits as 'smoking teacher' in a faculty lounge, as well as pregnant mothers smoking and drinking during a musical number."
The American Legacy Foundation is quoted as stating: "I don't know that just because a movie takes place in the '60s that it justifies a PG, since 14- and 15-year-olds are in the bull's-eye for the cigarette market. It's really unfortunate and a disappointingly anemic response to a public health problem."
In 1962, the exact year depicted in the film, more than half of men and about one-third of women smoked. It was just about the peak of female smoking in the United States, and was prior to the drastic decline in male smoking rates that began after the release of the 1964 Surgeon General's report.
The Rest of the Story
In the 1960s (as today), people's diets were crappy. People ingested (as they do today) high amounts of fat and low amounts of fruits and vegetables. However, I don't think too many health groups would describe the failure of the MPAA to rate "R" any movie that depicts a poor diet as an "anemic response to a public health problem."
It is clear that these groups were not just whistling Dixie. They actually believe that if a movie depicts smoking at all, even if just momentarily, it should automatically receive an R-rating because this is such a huge public health problem. And now that the MPAA has followed its policy, true to its word, by noting that momentary smoking takes place in "Hairspray," the anti-smoking groups are up in arms because apparently warning parents about this huge threat to our kids - the presence of a puff on a cigarette in a film depicting the 1960s - is not enough. The film needs to be rated R and made "inaccessible" to youths.
As Jacob Sullum noted in his column in today's Los Angeles Times, this approach by the anti-smoking groups could well make smoking more popular by casting it as a forbidden fruit. If a fleeting depiction of smoking is such a remarkable occurrence that needs to be hidden from teens, then doesn't that make smoking seem that much more rebellious and to a teenager - appealing?
Are we really supposed to change history and pretend that smoking didn't exist? If you go strictly by the percentages, the majority of men in 1962 were smokers. Are artists depicting 1962 actually supposed to ignore the historical facts and depict everyone as nonsmokers if they are not interested in producing an adult-oriented film?
Don't we actually want to reveal the truth to kids? Let them see that smoking was widespread. Then, by comparing that with the much lower rates of smoking they see today, they'll come to the realization that smoking is not as "cool" as it used to be. That it seems to be going out of favor. If anything, if they think that no one used to smoke but lots of people do today, it makes it seem like it is a fad.
I suppose that the depiction of racial segregation and discrimination as depicted in the film should also be removed. Perhaps we should also wipe away that aspect of our nation's history as well, so as not to expose kids to anything that might give them ideas. The reality, of course, is that the film is a great tribute to racial equality, integration, and harmony, and the message it sends is an important one.
It's now clear that anti-smoking groups are trying to meddle in artistic expression, not merely attempting to eliminate gratuitous smoking from films.
With this over-reaction and the crusade-like nature of their quest, it seems to me that they lose ground, not gain it.
I can tell you as a parent that the few fleeting scenes of smoking in the movie are of far less concern to me in terms of my kids seeing them than the highly suggestive sexual content of the film. If the film is not going to receive higher than a PG rating for that sexual content, there is no way it should receive an R-rating for the few fleeting scenes of smoking.
SmokeFreeMovies argued that the use of descriptors to note smoking depiction is meaningless: "The MPAA -- acting on behalf of the big media companies -- is pursuing exactly the kind of meaningless policy related to tobacco that we predicted back in 2002, namely just adding a tobacco descriptor to a youth rating."
The movie represents the film version of the Broadway musical (which follows the original 1988 John Waters film) and is set in Baltimore of the 1960s. It is described as containing "a fleeting scene of smoking in a high school bathroom. There are also brief shots of a character billed in the credits as 'smoking teacher' in a faculty lounge, as well as pregnant mothers smoking and drinking during a musical number."
The American Legacy Foundation is quoted as stating: "I don't know that just because a movie takes place in the '60s that it justifies a PG, since 14- and 15-year-olds are in the bull's-eye for the cigarette market. It's really unfortunate and a disappointingly anemic response to a public health problem."
In 1962, the exact year depicted in the film, more than half of men and about one-third of women smoked. It was just about the peak of female smoking in the United States, and was prior to the drastic decline in male smoking rates that began after the release of the 1964 Surgeon General's report.
The Rest of the Story
In the 1960s (as today), people's diets were crappy. People ingested (as they do today) high amounts of fat and low amounts of fruits and vegetables. However, I don't think too many health groups would describe the failure of the MPAA to rate "R" any movie that depicts a poor diet as an "anemic response to a public health problem."
It is clear that these groups were not just whistling Dixie. They actually believe that if a movie depicts smoking at all, even if just momentarily, it should automatically receive an R-rating because this is such a huge public health problem. And now that the MPAA has followed its policy, true to its word, by noting that momentary smoking takes place in "Hairspray," the anti-smoking groups are up in arms because apparently warning parents about this huge threat to our kids - the presence of a puff on a cigarette in a film depicting the 1960s - is not enough. The film needs to be rated R and made "inaccessible" to youths.
As Jacob Sullum noted in his column in today's Los Angeles Times, this approach by the anti-smoking groups could well make smoking more popular by casting it as a forbidden fruit. If a fleeting depiction of smoking is such a remarkable occurrence that needs to be hidden from teens, then doesn't that make smoking seem that much more rebellious and to a teenager - appealing?
Are we really supposed to change history and pretend that smoking didn't exist? If you go strictly by the percentages, the majority of men in 1962 were smokers. Are artists depicting 1962 actually supposed to ignore the historical facts and depict everyone as nonsmokers if they are not interested in producing an adult-oriented film?
Don't we actually want to reveal the truth to kids? Let them see that smoking was widespread. Then, by comparing that with the much lower rates of smoking they see today, they'll come to the realization that smoking is not as "cool" as it used to be. That it seems to be going out of favor. If anything, if they think that no one used to smoke but lots of people do today, it makes it seem like it is a fad.
I suppose that the depiction of racial segregation and discrimination as depicted in the film should also be removed. Perhaps we should also wipe away that aspect of our nation's history as well, so as not to expose kids to anything that might give them ideas. The reality, of course, is that the film is a great tribute to racial equality, integration, and harmony, and the message it sends is an important one.
It's now clear that anti-smoking groups are trying to meddle in artistic expression, not merely attempting to eliminate gratuitous smoking from films.
With this over-reaction and the crusade-like nature of their quest, it seems to me that they lose ground, not gain it.
I can tell you as a parent that the few fleeting scenes of smoking in the movie are of far less concern to me in terms of my kids seeing them than the highly suggestive sexual content of the film. If the film is not going to receive higher than a PG rating for that sexual content, there is no way it should receive an R-rating for the few fleeting scenes of smoking.
Thursday, July 26, 2007
Senate Panel Approves Amendment to FDA Bill to Greatly Strengthen Warning Labels; Amendment Passes Unanimously over Objection of Tobacco-Free Kids
Yesterday, on the first day of its mark-up session on S.625 - the FDA tobacco bill - the Senate Health, Education, Labor, and Pensions Committee voted unanimously to accept an amendment offered by Senator Enzi which greatly strengthens the required warning labels on cigarettes. The bill itself required a series of stronger warning statements than currently appear on the packages. The amendment strengthens these warning statements by increasing the size of warning labels from 30% to 50% of the pack and adding color graphics that depict the negative health consequences of smoking. This is similar to warning labels that have been used with some success in Canada. The Senate panel is expected to continue its deliberations on S.625 today, considering more amendments before taking a vote on whether or not to send the bill forward.
Despite the unanimous vote indicating bipartisan support, and the substantial strengthening of the warning label provisions of the bill, passage of the amendment was opposed by the Campaign for Tobacco-Free Kids.
The Rest of the Story
This adds to the embarrassment that the Campaign for Tobacco-Free Kids and its partner health groups have endured over the past few days as the truth about the history of, and nature of the FDA bill has come to public light.
Despite unanimous bipartisan support, the only group publicly opposing this amendment, which unequivocally adds to the little public health protection that is offered by the bill, was the Campaign for Tobacco-Free Kids, supposedly an anti-smoking and public health group.
What business does the Campaign have opposing an amendment that simply strengthens the warning labels so that there is at least a chance that they may have a deterrent effect?
It is becoming clear that the Campaign for Tobacco-Free Kids has become completely overrun by politics, and in my opinion, by an obsession with the proverbial feather in the cap. So much so that they have lost sight of any responsibility whatsoever to stand up for some principles while claiming to be taking a leadership role to fight to protect the public's health. So much so that their statements have become filled with deception and devoid of substance.
It is getting more and more embarrassing by the minute for the tobacco control groups which are supporting this misguided legislation and which have agreed (albeit tacitly) to follow along with the Campaign's secret deal cut with Philip Morris and its strategy of deception.
Despite the unanimous vote indicating bipartisan support, and the substantial strengthening of the warning label provisions of the bill, passage of the amendment was opposed by the Campaign for Tobacco-Free Kids.
The Rest of the Story
This adds to the embarrassment that the Campaign for Tobacco-Free Kids and its partner health groups have endured over the past few days as the truth about the history of, and nature of the FDA bill has come to public light.
Despite unanimous bipartisan support, the only group publicly opposing this amendment, which unequivocally adds to the little public health protection that is offered by the bill, was the Campaign for Tobacco-Free Kids, supposedly an anti-smoking and public health group.
What business does the Campaign have opposing an amendment that simply strengthens the warning labels so that there is at least a chance that they may have a deterrent effect?
It is becoming clear that the Campaign for Tobacco-Free Kids has become completely overrun by politics, and in my opinion, by an obsession with the proverbial feather in the cap. So much so that they have lost sight of any responsibility whatsoever to stand up for some principles while claiming to be taking a leadership role to fight to protect the public's health. So much so that their statements have become filled with deception and devoid of substance.
It is getting more and more embarrassing by the minute for the tobacco control groups which are supporting this misguided legislation and which have agreed (albeit tacitly) to follow along with the Campaign's secret deal cut with Philip Morris and its strategy of deception.
Wednesday, July 25, 2007
Senator Enzi Responds to Attack from Tobacco-Free Kids by Contrasting His Openness with Campaign's Secret Deal with the Largest Tobacco Company
In response to the Campaign for Tobacco-Free Kids' public charge that Senator Enzi is a fraud who is apparently not sincere about his own proposal to reduce tobacco use, Senator Enzi criticized the Campaign for cutting a secret deal with Philip Morris that protects Big Tobacco profits at the expense of the public's health.
In addition, he has invited the Campaign for Tobacco-Free Kids to talk, become familiar with his position on tobacco issues, and work together to forge a tobacco policy proposal that will be effective in reducing tobacco use.
In his letter to the Campaign, Senator Enzi contrasted his open approach with what he intimates is a lack of honesty, forthrightness, and openness by the Campaign for Tobacco-Free Kids.
Enzi wrote: "You recently made some comments about my record and my position on various issues relating to tobacco. You claimed to know where I stand on these matters. A meeting between us would give me an opportunity to personally set the record straight and let you know where I stand on smoking and other related tobacco issues. I have put my name, and staked my reputation, on a proposal to get rid of tobacco once and for all, and I hope you will take that as seriously as I do."
"Let me be very clear, right from the start, on exactly what my position is. I stand for bringing innovative and new thinking to old and unsolved problems. I stand for helping current tobacco users quit their deadly habit, and making sure that others, particularly children and adolescents, do not start in the first place. I stand apart from the tobacco companies on these matters and I have never taken a dime in campaign contributions from the tobacco industry, and that is not going to change."
"Finally, in contrast to your organization, which cut a deal in the dead of night with the largest tobacco company in the country, I stand for an open debate and an honest and forthright discussion on these issues and the future of tobacco in the United States."
"I believe my plan has the potential to radically change how we tackle tobacco use in this country. But I also recognize that it is not perfect. I welcome your input and insight into improving it. I hope you will join me in working to eliminate the use of this deadly product. Please contact my office at your earliest convenience so that we can clear the air between us, and then get down to the vital task that is before us of truly saving lives."
The Rest of the Story
The truth is finally coming out. I think the public in general, and tobacco control groups and advocates in particular, need to know the truth about how the FDA legislation came about.
The Campaign for Tobacco-Free Kids has been running a campaign of deception, in which they have been misleading their own constituents and the public into thinking that Big Tobacco is uniformly opposed to this legislation. They have also refused to be forthright about the negotiations with Philip Morris that led to this bill, and have refused to answer any questions about that secret process.
Attacking Senator Enzi for being a fraud was going one step too far. Now he has exposed their secret deal with the largest tobacco company, making the Campaign's attack on Enzi seem completely hypocritical. Even worse, Enzi does not take tobacco company contributions and has not sought tobacco industry input or agreement in developing his proposal. This contrasts with the Campaign, which agreed to a deal with provisions specifically negotiated with Philip Morris.
While the Campaign essentially let Philip Morris write its favored legislation, Senator Enzi wrote his legislation without tobacco industry involvement.
So who is actually doing Philip Morris' bidding here? It's clearly not Senator Enzi. But ironically, it is indeed the Campaign for Tobacco-Free Kids. Perhaps they ought to think twice before attacking someone else for doing the industry's bidding.
Supreme Court Justice Louis Brandeis might just as well have been talking about the Campaign for Tobacco-Free Kids efforts to promote this FDA bill when he wrote that "Sunlight is the best disinfectant."
In addition, he has invited the Campaign for Tobacco-Free Kids to talk, become familiar with his position on tobacco issues, and work together to forge a tobacco policy proposal that will be effective in reducing tobacco use.
In his letter to the Campaign, Senator Enzi contrasted his open approach with what he intimates is a lack of honesty, forthrightness, and openness by the Campaign for Tobacco-Free Kids.
Enzi wrote: "You recently made some comments about my record and my position on various issues relating to tobacco. You claimed to know where I stand on these matters. A meeting between us would give me an opportunity to personally set the record straight and let you know where I stand on smoking and other related tobacco issues. I have put my name, and staked my reputation, on a proposal to get rid of tobacco once and for all, and I hope you will take that as seriously as I do."
"Let me be very clear, right from the start, on exactly what my position is. I stand for bringing innovative and new thinking to old and unsolved problems. I stand for helping current tobacco users quit their deadly habit, and making sure that others, particularly children and adolescents, do not start in the first place. I stand apart from the tobacco companies on these matters and I have never taken a dime in campaign contributions from the tobacco industry, and that is not going to change."
"Finally, in contrast to your organization, which cut a deal in the dead of night with the largest tobacco company in the country, I stand for an open debate and an honest and forthright discussion on these issues and the future of tobacco in the United States."
"I believe my plan has the potential to radically change how we tackle tobacco use in this country. But I also recognize that it is not perfect. I welcome your input and insight into improving it. I hope you will join me in working to eliminate the use of this deadly product. Please contact my office at your earliest convenience so that we can clear the air between us, and then get down to the vital task that is before us of truly saving lives."
The Rest of the Story
The truth is finally coming out. I think the public in general, and tobacco control groups and advocates in particular, need to know the truth about how the FDA legislation came about.
The Campaign for Tobacco-Free Kids has been running a campaign of deception, in which they have been misleading their own constituents and the public into thinking that Big Tobacco is uniformly opposed to this legislation. They have also refused to be forthright about the negotiations with Philip Morris that led to this bill, and have refused to answer any questions about that secret process.
Attacking Senator Enzi for being a fraud was going one step too far. Now he has exposed their secret deal with the largest tobacco company, making the Campaign's attack on Enzi seem completely hypocritical. Even worse, Enzi does not take tobacco company contributions and has not sought tobacco industry input or agreement in developing his proposal. This contrasts with the Campaign, which agreed to a deal with provisions specifically negotiated with Philip Morris.
While the Campaign essentially let Philip Morris write its favored legislation, Senator Enzi wrote his legislation without tobacco industry involvement.
So who is actually doing Philip Morris' bidding here? It's clearly not Senator Enzi. But ironically, it is indeed the Campaign for Tobacco-Free Kids. Perhaps they ought to think twice before attacking someone else for doing the industry's bidding.
Supreme Court Justice Louis Brandeis might just as well have been talking about the Campaign for Tobacco-Free Kids efforts to promote this FDA bill when he wrote that "Sunlight is the best disinfectant."
Article Accuses Campaign for Tobacco-Free Kids of Engaging in Secret Negotiations with Philip Morris; Outlines Numerous Flaws of FDA Tobacco Bill
An article published in the current issue of Tobacco Control by Dr. Michael Givel, a professor in the Department of Political Science at the University of Oklahoma, attacks the Campaign for Tobacco-Free Kids for engaging in secret negotiations with Philip Morris, blasts the proposed FDA legislation by highlighting numerous flaws, and argues that the Campaign for Tobacco-Free Kids was outsmarted by Philip Morris.
According to the article, Philip Morris enticed the Campaign for Tobacco-Free Kids to the negotiating table by offering its support for the idea of FDA regulation of tobacco products. But what Philip Morris had in mind was "much weaker and alternative FDA regulation of tobacco. ... The beginning of this highly unusual effort by Philip Morris began in November 2001 when secret negotiations, of which many health advocates were unaware, were initiated between Philip Morris and the Campaign for Tobacco-Free Kids."
The article outlines numerous major flaws in the proposed legislation:
1. "One significant problem in the reduced risks requirements for new tobacco products is that the bill makes it very difficult and expensive to introduce new tobacco products. In combination with allowing menthol as an additive these risk reduction provisions stabilise the current tobacco market favouring current brands including Philip Morris’s Marlboro."
2. "Another significant problem with the bill is that it requires a scientifically unproved claim that removing ingredients will makes cigarettes ‘‘safer.’’ There is currently little conclusive evidence on what ingredients are linked to particular morbidities and mortalities and at what level. In fact proponents have not shown any scientifically reviewed evidence at all as to how this bill would save any lives. Also, the requirement prohibiting nicotine reduction to zero could actually force smokers to smoke more and inhale more deeply.
3. "The bill also provides a significant litigation shield for the tobacco industry. This occurs because an FDA seal of approval on a product will be used as a defence against higher punitive damages in product liability and tort lawsuits."
4. "Another concern with the legislation is that the FDA, which is a consumer protection agency, would be placed in an untenable role of approving a product that also causes significant disease and death.
5. "The bill also gives the tobacco industry numerous avenues to veto and delay any proposed change to tobacco products through legislative veto, judicial review, and administrative hearings."
The article concludes: "It does appear master chess player Philip Morris is eight moves ahead of the health groups so far with this FDA bill."
The Rest of the Story
This outstanding article is a must-read for anyone interested in national tobacco policy. You're not going to get this story from the health groups, but it's the truth and it is essential that all tobacco control advocates understand the rest of the story before they make a decision about whether or not to support the proposed FDA tobacco legislation.
Dr. Givel makes many of the same arguments I have been making on this blog over the past two years. He explains why this legislation actually protects the profits of the nation's largest cigarette manufacturer at the expense of the public's health.
I completely agree that Philip Morris is light-years ahead of the health groups. They saw a weak spot in the health groups and they attacked it with great cunning. The entire approach is brilliant.
In light of this article and its revelations, the Campaign for Tobacco-Free Kids has a little explaining to do.
According to the article, Philip Morris enticed the Campaign for Tobacco-Free Kids to the negotiating table by offering its support for the idea of FDA regulation of tobacco products. But what Philip Morris had in mind was "much weaker and alternative FDA regulation of tobacco. ... The beginning of this highly unusual effort by Philip Morris began in November 2001 when secret negotiations, of which many health advocates were unaware, were initiated between Philip Morris and the Campaign for Tobacco-Free Kids."
The article outlines numerous major flaws in the proposed legislation:
1. "One significant problem in the reduced risks requirements for new tobacco products is that the bill makes it very difficult and expensive to introduce new tobacco products. In combination with allowing menthol as an additive these risk reduction provisions stabilise the current tobacco market favouring current brands including Philip Morris’s Marlboro."
2. "Another significant problem with the bill is that it requires a scientifically unproved claim that removing ingredients will makes cigarettes ‘‘safer.’’ There is currently little conclusive evidence on what ingredients are linked to particular morbidities and mortalities and at what level. In fact proponents have not shown any scientifically reviewed evidence at all as to how this bill would save any lives. Also, the requirement prohibiting nicotine reduction to zero could actually force smokers to smoke more and inhale more deeply.
3. "The bill also provides a significant litigation shield for the tobacco industry. This occurs because an FDA seal of approval on a product will be used as a defence against higher punitive damages in product liability and tort lawsuits."
4. "Another concern with the legislation is that the FDA, which is a consumer protection agency, would be placed in an untenable role of approving a product that also causes significant disease and death.
5. "The bill also gives the tobacco industry numerous avenues to veto and delay any proposed change to tobacco products through legislative veto, judicial review, and administrative hearings."
The article concludes: "It does appear master chess player Philip Morris is eight moves ahead of the health groups so far with this FDA bill."
The Rest of the Story
This outstanding article is a must-read for anyone interested in national tobacco policy. You're not going to get this story from the health groups, but it's the truth and it is essential that all tobacco control advocates understand the rest of the story before they make a decision about whether or not to support the proposed FDA tobacco legislation.
Dr. Givel makes many of the same arguments I have been making on this blog over the past two years. He explains why this legislation actually protects the profits of the nation's largest cigarette manufacturer at the expense of the public's health.
I completely agree that Philip Morris is light-years ahead of the health groups. They saw a weak spot in the health groups and they attacked it with great cunning. The entire approach is brilliant.
In light of this article and its revelations, the Campaign for Tobacco-Free Kids has a little explaining to do.
Column Argues that Jurisdiction over Tobacco Products is the Last Thing in the World that the FDA Needs Right Now
An op-ed piece in the Portsmouth Herald argues that the Food and Drug Administration is so plagued with problems just trying to protect the public from risks in the food and drug supply that this is absolutely not the time to be giving it the tremendous responsibility and enormous task of regulating tobacco products.
The column, written by 60 Plus Association president Jim Martin, states: "For Americans who are 60-plus and for Americans of every age, an over-extended FDA is a prescription for disaster. That’s why I’m alarmed about reports out of China indicating a growing number of tainted products coming into this country. Already, despite a clear mandate and a healthy $2 billion budget, the FDA has proven itself unable to avoid or correct in a timely fashion nationwide outbreaks of deadly E. coli contamination of lettuce, spinach, green onions and other farm products; salmonella contamination of peanut butter; chemical poisoning of pet food, farmed fish, hogs and chickens; and deaths due to dangerous drugs previously approved by this very same agency. In recent weeks, we have learned that the FDA actually inspects less than 1 percent of all imported food."
"The FDA is overwhelmed. Its mandate calls for it to ensure the safety of the nation’s entire food supply, including home-grown and imported. It’s responsible for 11,000 drugs in the marketplace. It’s supposed to examine the safety and efficacy of proposed new drugs, including the burgeoning class of bioengineered pharmaceuticals, and monitor the safety of drugs after they are placed on pharmacy shelves. Additionally, the agency has been charged by the president to play a key role in the administration’s national bioterrorism defense initiatives.
The FDA is buckling under the strain." ...
"With the FDA in such obvious crisis, it is irresponsible, and appalling, for some members of Congress to be promoting legislation that would further burden the agency with regulatory responsibility for the massive tobacco industry."
The Rest of the Story
This excellent column speaks for itself. Just another reason the proposed FDA tobacco legislation is a seriously flawed proposal.
The column, written by 60 Plus Association president Jim Martin, states: "For Americans who are 60-plus and for Americans of every age, an over-extended FDA is a prescription for disaster. That’s why I’m alarmed about reports out of China indicating a growing number of tainted products coming into this country. Already, despite a clear mandate and a healthy $2 billion budget, the FDA has proven itself unable to avoid or correct in a timely fashion nationwide outbreaks of deadly E. coli contamination of lettuce, spinach, green onions and other farm products; salmonella contamination of peanut butter; chemical poisoning of pet food, farmed fish, hogs and chickens; and deaths due to dangerous drugs previously approved by this very same agency. In recent weeks, we have learned that the FDA actually inspects less than 1 percent of all imported food."
"The FDA is overwhelmed. Its mandate calls for it to ensure the safety of the nation’s entire food supply, including home-grown and imported. It’s responsible for 11,000 drugs in the marketplace. It’s supposed to examine the safety and efficacy of proposed new drugs, including the burgeoning class of bioengineered pharmaceuticals, and monitor the safety of drugs after they are placed on pharmacy shelves. Additionally, the agency has been charged by the president to play a key role in the administration’s national bioterrorism defense initiatives.
The FDA is buckling under the strain." ...
"With the FDA in such obvious crisis, it is irresponsible, and appalling, for some members of Congress to be promoting legislation that would further burden the agency with regulatory responsibility for the massive tobacco industry."
The Rest of the Story
This excellent column speaks for itself. Just another reason the proposed FDA tobacco legislation is a seriously flawed proposal.
Tuesday, July 24, 2007
Senator Enzi Invites Health Agencies to Join Him in Reducing Smoking; How the Campaign for Tobacco-Free Kids Undermined the Tobacco Control Movement
In a press release issued yesterday, Senator Mike Enzi (R-WY) invited the directors of the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Food and Drug Administration (FDA) to join him in an effort to design a national plan to greatly reduce smoking rates over the next 20 years, to be spearheaded by a bill he introduced last week that would increase the cigarette tax to fund tobacco prevention and cessation programs, levy penalties on tobacco companies if smoking rates do not decrease substantially, strengthen warning labels on cigarette packages, incentivize states to spend a substantial proportion of their Master Settlement Agreement money on tobacco control programs, and give the FDA authority to eliminate nicotine from cigarettes if the demand reaches a low enough level so that this becomes practical.
According to the press release: "Last week, Enzi introduced the “Help End Addiction to Lethal Tobacco Habits Act” (HEALTH Act), S.1834, a bill to wipe out tobacco use in America through an innovative cap-and-trade program that will shrink the size of the tobacco market over the next 20 years. S.1834 is Enzi’s alternative to the Democrat tobacco bill, which has drawn wide support from Big Tobacco and some anti-smoking organizations. 'I believe my plan has the potential to radically change how we tackle tobacco use in this country,' Enzi wrote. 'I would like to invite you to meet with me to discuss my proposal and how we can work together towards our shared goal: eliminating youth smoking and tobacco product usage and significantly reducing the number of Americans dying from the use of tobacco. Your leadership is desperately needed to move this plan forward and reduce the death and disability caused by tobacco,' Enzi added. 'I welcome your input and insight and hope you will join me in working to eliminate the use of this deadly product.'"
The Rest of the Story
The rest of the story is that this turn of events reveals the way in which the Campaign for Tobacco-Free Kids has undermined the entire tobacco control movement.
This is the way that you develop a national tobacco control strategy. You bring the major health agencies and health groups together and you discuss the most effective ways to reduce tobacco use. In contrast, the Campaign for Tobacco-Free Kids, over the past few years, has basically co-opted the entire tobacco control movement, representing itself as the sole face of the movement and unilaterally negotiating with Philip Morris, through Congressional mediation, a short-sighted and misguided bill which eschews all the major proven approaches to actually reducing smoking that have been documented by scientific research.
In contrast to Senator Enzi's expression of a willingness to discuss issues and consider improvements to his legislation, the Campaign for Tobacco-Free Kids essentially signed off on a deal with Philip Morris that was never, and is still not, subject to any changes, including substantial improvements. There was no real discussion with the tobacco control movement, no consultation with many of the established experts in the tobacco control field who have important insights into the most effective national policy strategies and who have been leaders in the movement over the past two or more decades.
Instead, the Campaign for Tobacco-Free Kids appears to have decided upon its own pet legislation and forced it down the throats of everyone else in the movement.
To make matters unacceptably worse, the Campaign took it upon itself to basically represent the public health community in negotiations that were essentially conducted with Philip Morris, but without approval from the rest of the public health community.
You don't develop an effective national tobacco control policy strategy by negotiating with Philip Morris, letting the nation's leading tobacco company have a large say in what does or does not get written into the policy. That was a fatal mistake, as it simply was destined to result in an ineffective policy.
This is now a source of great embarrassment, as Senator Enzi has stolen the show from the Campaign, showing them up by proposing a real bill - one that actually uses proven, effective interventions that would actually put a substantial dent in smoking rates. A proposal that was not written by or at least tailored to meet the needs of Philip Morris.
If not for the Campaign's obsession with its misguided proposal that completely misses the mark in terms of reducing smoking and sets the nation on an unacceptable course of granting official approval to the most deadly consumer product, it is entirely possible that meaningful discussion within the tobacco control movement would have been able to take place over the past two years, resulting in a uniform coalition of groups and advocates in the movement who would now be prepared to push measures like those outlined in Senator Enzi's proposal successfully through Congress.
The tobacco control movement is woefully prepared to deal with a real proposal for a federal approach to reducing tobacco use, because it is simply not something that has been discussed over the past few years. In my opinion, the only reason it has not been on the agenda is that the agenda has been co-opted by the Campaign for Tobacco-Free Kids.
Now is the time for the other major health groups - including the American Cancer Society, American Heart Association, American Lung Association, and American Medical Association - to break themselves away from the Campaign's stronghold and put themselves on the side of a real proposal. The more quickly that we can end the Campaign's dominance over the movement, the more quickly we'll be able to start talking about some real solutions to this problem.
Now that Senator Enzi's proposal is on the table, the FDA legislation is just not going to look so appealing any more to much of the tobacco control community. Sometimes it takes seeing an alternative to convince people of the folly of a policy proposal.
The fallacy which I believe led many advocates to support the FDA approach was the straw man argument that FDA legislation is better than the status quo. What supporters of the FDA legislation failed to tell you was that this is not a decision between the FDA legislation and the status quo. It is and has always actually been a decision between the FDA legislation and a real bona fide proposal to substantially cut smoking rates using measures that we have known all along are effective.
It's no longer the FDA legislation versus the status quo. There are now two hands on the table. And the Campaign for Tobacco-Free Kids, with its health group partners, have been left holding the rag hand.
According to the press release: "Last week, Enzi introduced the “Help End Addiction to Lethal Tobacco Habits Act” (HEALTH Act), S.1834, a bill to wipe out tobacco use in America through an innovative cap-and-trade program that will shrink the size of the tobacco market over the next 20 years. S.1834 is Enzi’s alternative to the Democrat tobacco bill, which has drawn wide support from Big Tobacco and some anti-smoking organizations. 'I believe my plan has the potential to radically change how we tackle tobacco use in this country,' Enzi wrote. 'I would like to invite you to meet with me to discuss my proposal and how we can work together towards our shared goal: eliminating youth smoking and tobacco product usage and significantly reducing the number of Americans dying from the use of tobacco. Your leadership is desperately needed to move this plan forward and reduce the death and disability caused by tobacco,' Enzi added. 'I welcome your input and insight and hope you will join me in working to eliminate the use of this deadly product.'"
The Rest of the Story
The rest of the story is that this turn of events reveals the way in which the Campaign for Tobacco-Free Kids has undermined the entire tobacco control movement.
This is the way that you develop a national tobacco control strategy. You bring the major health agencies and health groups together and you discuss the most effective ways to reduce tobacco use. In contrast, the Campaign for Tobacco-Free Kids, over the past few years, has basically co-opted the entire tobacco control movement, representing itself as the sole face of the movement and unilaterally negotiating with Philip Morris, through Congressional mediation, a short-sighted and misguided bill which eschews all the major proven approaches to actually reducing smoking that have been documented by scientific research.
In contrast to Senator Enzi's expression of a willingness to discuss issues and consider improvements to his legislation, the Campaign for Tobacco-Free Kids essentially signed off on a deal with Philip Morris that was never, and is still not, subject to any changes, including substantial improvements. There was no real discussion with the tobacco control movement, no consultation with many of the established experts in the tobacco control field who have important insights into the most effective national policy strategies and who have been leaders in the movement over the past two or more decades.
Instead, the Campaign for Tobacco-Free Kids appears to have decided upon its own pet legislation and forced it down the throats of everyone else in the movement.
To make matters unacceptably worse, the Campaign took it upon itself to basically represent the public health community in negotiations that were essentially conducted with Philip Morris, but without approval from the rest of the public health community.
You don't develop an effective national tobacco control policy strategy by negotiating with Philip Morris, letting the nation's leading tobacco company have a large say in what does or does not get written into the policy. That was a fatal mistake, as it simply was destined to result in an ineffective policy.
This is now a source of great embarrassment, as Senator Enzi has stolen the show from the Campaign, showing them up by proposing a real bill - one that actually uses proven, effective interventions that would actually put a substantial dent in smoking rates. A proposal that was not written by or at least tailored to meet the needs of Philip Morris.
If not for the Campaign's obsession with its misguided proposal that completely misses the mark in terms of reducing smoking and sets the nation on an unacceptable course of granting official approval to the most deadly consumer product, it is entirely possible that meaningful discussion within the tobacco control movement would have been able to take place over the past two years, resulting in a uniform coalition of groups and advocates in the movement who would now be prepared to push measures like those outlined in Senator Enzi's proposal successfully through Congress.
The tobacco control movement is woefully prepared to deal with a real proposal for a federal approach to reducing tobacco use, because it is simply not something that has been discussed over the past few years. In my opinion, the only reason it has not been on the agenda is that the agenda has been co-opted by the Campaign for Tobacco-Free Kids.
Now is the time for the other major health groups - including the American Cancer Society, American Heart Association, American Lung Association, and American Medical Association - to break themselves away from the Campaign's stronghold and put themselves on the side of a real proposal. The more quickly that we can end the Campaign's dominance over the movement, the more quickly we'll be able to start talking about some real solutions to this problem.
Now that Senator Enzi's proposal is on the table, the FDA legislation is just not going to look so appealing any more to much of the tobacco control community. Sometimes it takes seeing an alternative to convince people of the folly of a policy proposal.
The fallacy which I believe led many advocates to support the FDA approach was the straw man argument that FDA legislation is better than the status quo. What supporters of the FDA legislation failed to tell you was that this is not a decision between the FDA legislation and the status quo. It is and has always actually been a decision between the FDA legislation and a real bona fide proposal to substantially cut smoking rates using measures that we have known all along are effective.
It's no longer the FDA legislation versus the status quo. There are now two hands on the table. And the Campaign for Tobacco-Free Kids, with its health group partners, have been left holding the rag hand.
Monday, July 23, 2007
Senator Enzi to Introduce Alternative to FDA Tobacco Legislation; Bill Far Stronger than FDA Bill; Embarrassment for Major Anti-Smoking Groups
Senator Michael Enzi (R-WY) has announced that he intends to introduce legislation into Congress that would serve as an alternative to the FDA tobacco legislation that is being supported by many anti-smoking and health groups as well as by Philip Morris.
In contrast to the FDA bill, Senator Enzi proposes an approach that relies on programs and incentives to reduce cigarette consumption and smoking rates, rather than on an attempt to regulate cigarettes to make them safer.
Senator Enzi explains the premise behind his alternative approach to federal tobacco control policy as follows: "Some have suggested that FDA regulation of tobacco is the way toward safer tobacco products. But we know that there is no such thing as a safe cigarette. Proposals to have FDA regulate tobacco are a misguided attempt to force a deadly product into the regulatory structure developed for drugs and devices - products which DO have health benefits. This new scheme for tobacco would be very costly, and would not result in much of a health benefit."
"Furthermore, FDA review and approval of tobacco products sends a terrible public health message - creating the sense that cigarettes are safe or can be made safer, when we know they cannot."
"Importantly, the proposal under consideration by the HELP Committee explicitly states that the FDA will not be permitted to ban nicotine or tobacco. That is not true regulation. That bill would gut the authority that Congress has bestowed and staunchly defended for the FDA - the authority to remove health threats from the marketplace. The FDA cannot be put in the position of approving a product which years of science and the personal experience of far too many Americans has shown to be dangerous. Simply put, tobacco kills people. We can do better."
"We should focus our efforts instead on helping people quit using tobacco, or better yet, to never start. The Enzi HEALTH Act would have a dramatic impact on the number of smokers in this country. ... It would ... use proven approaches to help people quit and implement tried and true prevention programs."
The two most important aspects of the legislation are as follows:
1. An increase in the federal excise cigarette tax, with revenues allocated to support a national counter-advertising campaign and grants to states for tobacco prevention and cessation media campaigns (there are similar provisions for other tobacco products). The amount of the increase varies by tobacco product, but is about 10 cents per pack on cigarettes. Revenues are allocated as follows: 25% to national and state tobacco prevention and cessation programs, including counter-advertising campaigns; 50% to Medicare; 25% to Medicaid.
2. The establishment of a system whereby tobacco companies would have to pay penalties if they do not gradually reduce the number of people who smoke their cigarettes according to a schedule, with a required 90% reduction in smokers over the next 20 years. The penalties begin in 2015, and from 2015 through 2026, the companies must reduce the number of smokers of their brands by 33% from current levels, or else pay $3,500 for each smoker above the 33%. From 2027 on, the companies must reduce the number of smokers of their brands by 90% from current levels.
For example, there are about 45 million smokers today. In 2015, tobacco companies would have to reduce the number of smokers to 30 million. For each million smokers above 30 million in 2015, they would have to pay $3.5 billion. Thus, if the number of smokers in 2015 is reduced to only 35 million, the total penalty would be $17.5 billion. The penalties are adjusted for inflation, so the $17.5 billion would represent the penalty in current dollars, not 2015 dollars. The penalty is assessed annually, so if no progress were made from 2015 on, the companies would be paying $17.5 billion per year.
There are also three other very important aspects to the legislation:
1. Much stronger cigarette and smokeless tobacco warning labels would be required (such as "Smoking kills" and "Cigarettes cause fatal lung cancer"). In addition to the text warning, a color graphic depicting the negative health consequences of smoking and occupying at least 50% of the pack would be required.
2. The FDA would be given explicit authority to require the removal of nicotine from cigarettes and other tobacco products. This represents a very narrow scope of authority given to FDA. The FDA would not be given jurisdiction to regulate the overall safety of cigarettes. They would not be in the business of approving cigarettes for sale (other than approving their nicotine content).
3. States would be incentivized to spend significant portions of their Master Settlement Agreement funds for tobacco control programs. The legislation sets up a matching grant program under which states would receive matching grants if they spend at least 25% of their MSA funds for tobacco control programs. The additional grant would be 50% of any amount spent above 25% of the MSA payment, and could be used for additional tobacco prevention and cessation programs.
The Rest of the Story
It is a long time in the making, and the anti-smoking groups have been so obsessed with trying to achieve futile (and counter-productive) FDA regulation of tobacco products that they have squandered a golden opportunity to promote a federal tobacco policy that actually would make a dent in smoking, but Senator Enzi appears to be the first to have the right idea about what the federal government could and should be doing to control the problem of tobacco use in this country.
Senator Enzi is precisely on the right track, a track which has been eschewed by all the major anti-smoking and health groups because of their obsession with the deal that was essentially negotiated between the Campaign for Tobacco-Free Kids and Philip Morris (with Congressional mediation) two years ago.
In my media interviews over the past few weeks, I have repeatedly been asked what I think the federal government should be doing to control tobacco use, since I don't support the approach of regulating the safety of cigarettes and asking the FDA to approve this deadly product. In response, I have noted my opinion that if Congress sincerely wants to do something about reducing smoking rates, it will dedicate money to the one program which we know is effective in reducing both youth and adult smoking: state-of-the-art counter-advertising media campaigns.
Senator Enzi's proposal establishes what would be the first national tobacco counter-advertising program run by the federal government. It also provides incentives for states to use their Master Settlement Agreement dollars on smoking prevention and cessation programs, provides funding for state tobacco control programs, and increases the federal excise cigarette tax (which will itself reduce cigarette consumption) to pay for these national and state programs.
There are a few weaknesses in the legislation, which I have communicated directly to Senator Enzi's staff, which I feel would need to be addressed. One is a need to remove the provision that allows money to be spent on youth access programs, which have been repeatedly shown not to work. The second is a need to allocate a significant portion of the revenues derived from the penalties for smoking prevention and cessation programs.
But the basic idea behind the HEALTH Act is exactly where the federal government should be in terms of a national tobacco control policy. We should not be spending our precious time and resources in a futile effort to try to develop a safer cigarette, when the product contains over 4,000 chemicals and we have no idea which of those chemicals is responsible for the diseases caused by cigarette smoke. We should not be setting up a system by which the FDA grants its approval to deadly products. We should not be institutionalizing cigarette consumption nor granting unprecedented special protections to Philip Morris and other tobacco companies.
What we should be doing is to get serious about actually trying to reduce the demand for cigarettes. That is something which the federal government has never been serious about.
The HEALTH Act serves as a tremendously valuable contribution because it focuses attention in exactly the area it needs to be if we wish to ever have an effective and meaningful federal policy on tobacco control.
This is an embarrassment for the Campaign for Tobacco-Free Kids and its partners, because they were beaten to the punch by a Senator who they claim is a fraud when it comes to tobacco policy. Frankly, Senator Enzi appears to have a far more insightful, informed, and mature understanding of the direction the federal government needs to be going if it wants to develop an effective tobacco control policy that will actually make a difference in reducing smoking and saving lives, rather than merely shell out window dressing to be able to claim that it is doing something about the problem.
To call the FDA proposal window dressing is actually not appropriate, because the FDA bill is not merely ineffective, it is actually counter-productive and would undermine 40 years of tobacco control efforts in this country.
But what Senator Enzi's proposal reveals is not just the misguided nature of the FDA legislation, but also the failure of the anti-smoking groups to promote meaningful federal tobacco control policy. They have wasted precious time and resources and a rare window of opportunity. They have squandered a real opportunity to have made a difference in the public's health by obsessing with the FDA and the illusion of making cigarettes safer by removing some of their constituents, when the real progress is going to come only by reducing the demand for cigarettes, something which can be done only through a combination of cigarette taxation and allocation of revenue to tobacco prevention and cessation programs, especially counter-advertising.
Senator Enzi is right. These are the tried and true programs for smoking prevention.
The alternative to granting the FDA jurisdiction over tobacco products is not the status quo, as the Campaign for Tobacco-Free Kids and its partners have been suggesting. Actually, the alternative is to establish a meaningful and effective federal tobacco control policy by which we actually use the tried and true methods of reducing smoking: increasing cigarette price and implementing state-of-the-art national and state counter-advertising programs.
The problem is that not only have the Campaign for Tobacco-Free Kids and our other supposed leaders in tobacco control missed the boat to take a ship that is headed for disaster. Instead, they have prevented the correct boat from even coming.
Senator Enzi's proposal steers us in the right direction. Now is the time for the health groups abandon the absurdity of their obsession of the past two years. It is time to have a meaningful discussion about how the federal government can, for the first time, make a difference in the nation's number one public health problem.
In contrast to the FDA bill, Senator Enzi proposes an approach that relies on programs and incentives to reduce cigarette consumption and smoking rates, rather than on an attempt to regulate cigarettes to make them safer.
Senator Enzi explains the premise behind his alternative approach to federal tobacco control policy as follows: "Some have suggested that FDA regulation of tobacco is the way toward safer tobacco products. But we know that there is no such thing as a safe cigarette. Proposals to have FDA regulate tobacco are a misguided attempt to force a deadly product into the regulatory structure developed for drugs and devices - products which DO have health benefits. This new scheme for tobacco would be very costly, and would not result in much of a health benefit."
"Furthermore, FDA review and approval of tobacco products sends a terrible public health message - creating the sense that cigarettes are safe or can be made safer, when we know they cannot."
"Importantly, the proposal under consideration by the HELP Committee explicitly states that the FDA will not be permitted to ban nicotine or tobacco. That is not true regulation. That bill would gut the authority that Congress has bestowed and staunchly defended for the FDA - the authority to remove health threats from the marketplace. The FDA cannot be put in the position of approving a product which years of science and the personal experience of far too many Americans has shown to be dangerous. Simply put, tobacco kills people. We can do better."
"We should focus our efforts instead on helping people quit using tobacco, or better yet, to never start. The Enzi HEALTH Act would have a dramatic impact on the number of smokers in this country. ... It would ... use proven approaches to help people quit and implement tried and true prevention programs."
The two most important aspects of the legislation are as follows:
1. An increase in the federal excise cigarette tax, with revenues allocated to support a national counter-advertising campaign and grants to states for tobacco prevention and cessation media campaigns (there are similar provisions for other tobacco products). The amount of the increase varies by tobacco product, but is about 10 cents per pack on cigarettes. Revenues are allocated as follows: 25% to national and state tobacco prevention and cessation programs, including counter-advertising campaigns; 50% to Medicare; 25% to Medicaid.
2. The establishment of a system whereby tobacco companies would have to pay penalties if they do not gradually reduce the number of people who smoke their cigarettes according to a schedule, with a required 90% reduction in smokers over the next 20 years. The penalties begin in 2015, and from 2015 through 2026, the companies must reduce the number of smokers of their brands by 33% from current levels, or else pay $3,500 for each smoker above the 33%. From 2027 on, the companies must reduce the number of smokers of their brands by 90% from current levels.
For example, there are about 45 million smokers today. In 2015, tobacco companies would have to reduce the number of smokers to 30 million. For each million smokers above 30 million in 2015, they would have to pay $3.5 billion. Thus, if the number of smokers in 2015 is reduced to only 35 million, the total penalty would be $17.5 billion. The penalties are adjusted for inflation, so the $17.5 billion would represent the penalty in current dollars, not 2015 dollars. The penalty is assessed annually, so if no progress were made from 2015 on, the companies would be paying $17.5 billion per year.
There are also three other very important aspects to the legislation:
1. Much stronger cigarette and smokeless tobacco warning labels would be required (such as "Smoking kills" and "Cigarettes cause fatal lung cancer"). In addition to the text warning, a color graphic depicting the negative health consequences of smoking and occupying at least 50% of the pack would be required.
2. The FDA would be given explicit authority to require the removal of nicotine from cigarettes and other tobacco products. This represents a very narrow scope of authority given to FDA. The FDA would not be given jurisdiction to regulate the overall safety of cigarettes. They would not be in the business of approving cigarettes for sale (other than approving their nicotine content).
3. States would be incentivized to spend significant portions of their Master Settlement Agreement funds for tobacco control programs. The legislation sets up a matching grant program under which states would receive matching grants if they spend at least 25% of their MSA funds for tobacco control programs. The additional grant would be 50% of any amount spent above 25% of the MSA payment, and could be used for additional tobacco prevention and cessation programs.
The Rest of the Story
It is a long time in the making, and the anti-smoking groups have been so obsessed with trying to achieve futile (and counter-productive) FDA regulation of tobacco products that they have squandered a golden opportunity to promote a federal tobacco policy that actually would make a dent in smoking, but Senator Enzi appears to be the first to have the right idea about what the federal government could and should be doing to control the problem of tobacco use in this country.
Senator Enzi is precisely on the right track, a track which has been eschewed by all the major anti-smoking and health groups because of their obsession with the deal that was essentially negotiated between the Campaign for Tobacco-Free Kids and Philip Morris (with Congressional mediation) two years ago.
In my media interviews over the past few weeks, I have repeatedly been asked what I think the federal government should be doing to control tobacco use, since I don't support the approach of regulating the safety of cigarettes and asking the FDA to approve this deadly product. In response, I have noted my opinion that if Congress sincerely wants to do something about reducing smoking rates, it will dedicate money to the one program which we know is effective in reducing both youth and adult smoking: state-of-the-art counter-advertising media campaigns.
Senator Enzi's proposal establishes what would be the first national tobacco counter-advertising program run by the federal government. It also provides incentives for states to use their Master Settlement Agreement dollars on smoking prevention and cessation programs, provides funding for state tobacco control programs, and increases the federal excise cigarette tax (which will itself reduce cigarette consumption) to pay for these national and state programs.
There are a few weaknesses in the legislation, which I have communicated directly to Senator Enzi's staff, which I feel would need to be addressed. One is a need to remove the provision that allows money to be spent on youth access programs, which have been repeatedly shown not to work. The second is a need to allocate a significant portion of the revenues derived from the penalties for smoking prevention and cessation programs.
But the basic idea behind the HEALTH Act is exactly where the federal government should be in terms of a national tobacco control policy. We should not be spending our precious time and resources in a futile effort to try to develop a safer cigarette, when the product contains over 4,000 chemicals and we have no idea which of those chemicals is responsible for the diseases caused by cigarette smoke. We should not be setting up a system by which the FDA grants its approval to deadly products. We should not be institutionalizing cigarette consumption nor granting unprecedented special protections to Philip Morris and other tobacco companies.
What we should be doing is to get serious about actually trying to reduce the demand for cigarettes. That is something which the federal government has never been serious about.
The HEALTH Act serves as a tremendously valuable contribution because it focuses attention in exactly the area it needs to be if we wish to ever have an effective and meaningful federal policy on tobacco control.
This is an embarrassment for the Campaign for Tobacco-Free Kids and its partners, because they were beaten to the punch by a Senator who they claim is a fraud when it comes to tobacco policy. Frankly, Senator Enzi appears to have a far more insightful, informed, and mature understanding of the direction the federal government needs to be going if it wants to develop an effective tobacco control policy that will actually make a difference in reducing smoking and saving lives, rather than merely shell out window dressing to be able to claim that it is doing something about the problem.
To call the FDA proposal window dressing is actually not appropriate, because the FDA bill is not merely ineffective, it is actually counter-productive and would undermine 40 years of tobacco control efforts in this country.
But what Senator Enzi's proposal reveals is not just the misguided nature of the FDA legislation, but also the failure of the anti-smoking groups to promote meaningful federal tobacco control policy. They have wasted precious time and resources and a rare window of opportunity. They have squandered a real opportunity to have made a difference in the public's health by obsessing with the FDA and the illusion of making cigarettes safer by removing some of their constituents, when the real progress is going to come only by reducing the demand for cigarettes, something which can be done only through a combination of cigarette taxation and allocation of revenue to tobacco prevention and cessation programs, especially counter-advertising.
Senator Enzi is right. These are the tried and true programs for smoking prevention.
The alternative to granting the FDA jurisdiction over tobacco products is not the status quo, as the Campaign for Tobacco-Free Kids and its partners have been suggesting. Actually, the alternative is to establish a meaningful and effective federal tobacco control policy by which we actually use the tried and true methods of reducing smoking: increasing cigarette price and implementing state-of-the-art national and state counter-advertising programs.
The problem is that not only have the Campaign for Tobacco-Free Kids and our other supposed leaders in tobacco control missed the boat to take a ship that is headed for disaster. Instead, they have prevented the correct boat from even coming.
Senator Enzi's proposal steers us in the right direction. Now is the time for the health groups abandon the absurdity of their obsession of the past two years. It is time to have a meaningful discussion about how the federal government can, for the first time, make a difference in the nation's number one public health problem.
Summary of Major Amendments to be Offered in Committee that Would Substantially Strengthen FDA Tobacco Legislation; All are Opposed by Health Groups
At the Senate HELP Committee mark-up of the FDA tobacco bill - currently scheduled for this coming Wednesday - a number of amendments will be offered that would substantially strengthen the legislation. In this post, I will summarize these amendments.
But first, it is important to note that the health groups supporting this legislation, including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, and American Lung Association, oppose each and every one of these improvements to the bill.
Why would these health groups oppose amendments that will strengthen the legislation and take out some of the loopholes that protect Big Tobacco profits at the expense of the protection of the public's health?
To me, the reason appears to be simple. The Campaign for Tobacco-Free Kids essentially struck a deal with Philip Morris at the Congressional negotiating table two years ago. The two major parties to that negotiation process basically struck a deal, and it appears that the Campaign for Tobacco-Free Kids wants to preserve the terms of that deal because if the deal is broken, it will lose the support of Philip Morris and the whole thing may crumble. This would be a devastating blow to the Campaign, which has put so much on the line (using all kinds of deceptive and unethical tactics to try to even get to this point).
Two things, then, are clear:
First, the Campaign for Tobacco-Free Kids and the other health groups which appear to be taking marching orders from the Campaign apparently have no sincere interest in developing legislation that will be as effective as possible in protecting the public's health from the hazards of tobacco. They have no desire for input from other public health experts, they are not willing to consider criticism of the legislation, they are not willing to consider any changes that would strengthen the bill. There is no opportunity for a dialogue or discourse about what would represent effective regulation of tobacco products or what strategy would be most effective in reducing tobacco use or potentially creating safer cigarettes. All decisions have already been made. It is either this deal with Philip Morris, or no legislation at all. That's the only choice that the health groups are offering to the American people.
Frankly, that's a travesty, because the responsibility of public health is to protect public health, not to sell out the public's health to Big Tobacco merely to enact some legislation and be able to stick a feather in our cap.
Second, it's clear that the propaganda being put out by the Campaign is merely rhetoric. There is little sincerity in their proclamations that their desire is to end special protection for Big Tobacco and save countless lives. If the true desire were to end special protection for Big Tobacco, then the Campaign and its fellow health groups would have no choice but to support these amendments which would, indeed, get rid of special protections for Big Tobacco that Philip Morris has apparently required in order to support the bill. If the true desire were to save countless lives, then there would be no choice but to support amendments which would put the only teeth into the entire bill, which in its present form is devoid of anything that would actually put a dent in tobacco use or create a safer cigarette.
The Campaign for Tobacco-Free Kids told its constituents that it opposed Senator Kennedy's insertion of a last-minute change in the bill which allows tobacco companies to market clove cigarettes. However, the Campaign is not particularly sincere in that opposition, since it now opposes an amendment that would do nothing more than remove that special protection for Big Tobacco.
The Campaign also claims that it opposes this amendment because it would eliminate the bill's chances of passage through Congress. However, a majority of legislators in the Senate have already sponsored the bill with the clove ban in the bill. It would be politically untenable for them to oppose a bill with the exact language that was in the bill which they sponsored, solely because it is now apparent that Philip Morris is actually marketing clove cigarettes in Indonesia!
With those critical observations made, here then is a brief summary of the most important amendments that would strengthen the bill. Note that this is not a comprehensive list, but an attempt to inform the public of some of the most important amendments.
Enzi Amendment #1: This amendment would eliminate the loophole which precludes the FDA from banning any particular class of tobacco product. This would allow the FDA to mandate changes to improve the safety of cigarettes even if those changes required a major re-design of the cigarette. In its present form, this loophole allows the tobacco companies to challenge such a regulation on the grounds that it represents a de facto ban on a class of tobacco products. In addition, the amendment would allow the FDA to ban cigarettes at some point in the future if it becomes economically and socially feasible. A clause would probably need to be added by a further amendment to make it clear that the FDA can consider non-health factors, such as the social and economic feasibility of banning a class of tobacco products in any such deliberation.
Enzi Amendment #2: This amendment would eliminate the loophole which precludes the FDA from getting rid of nicotine in cigarettes. This would allow the FDA to get rid of the nicotine and thus require a cigarette that is greatly reduced in addictive potential. Under the current bill, the FDA cannot get rid of the nicotine, but can only reduce the nicotine yields. This would be a disaster, as smokers would smoke more to compensate for the reduced nicotine. In addition, if the FDA did try to reduce nicotine to extremely low levels, the tobacco companies would be able to tie such a rule up in courts for years, since it is clearly the intent of Congress to reserve to itself any decision regarding making cigarettes non-addictive. There is absolutely no reason for health groups to oppose this amendment, since if it is the intent of Congress to allow the FDA to make cigarettes non-addictive, then there will be no harm in explicitly stating that the FDA can do that. Short of this amendment, it will be clear that Congress' intent is not to allow the elimination or near elimination of nicotine, and any such attempt by the FDA will most certainly be overturned by Congress, using its veto power provided elsewhere in the bill (via yet another loophole).
Enzi Amendment #4: This amendment strengthens the required warning labels on cigarettes by increasing the size of warning labels from 30% to 50% of the pack and adding color graphics that depict the negative health consequences of smoking. This is similar to warning labels that have been used with some success in Canada. Again, there is absolutely no reason for health groups to oppose this amendment since it merely improves the warning labels.
Enzi Amendment #5: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to support cancer research at the National Cancer Institute. This is a far better use of the revenues from a large cigarette tax increase than supporting children's health insurance - the last thing in the world that we want to become dependent upon continued cigarette consumption.
Enzi Amendment #6: This amendment would add menthol and clove to the list of flavorings that cannot be used as a primary flavor in cigarettes. This is a critical improvement, since it affects flavors that Big Tobacco actually does use to recruit smokers. Currently, the legislation bans plenty of flavors, but few, if any of them are actually being used to market cigarettes (when was the last time you saw a cherry cigarette?).
Enzi Amendment #7: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates 50% of the revenues to Medicare, 25% to Medicaid, and 25% to state tobacco education and cessation programs. This amendment alone would do more to reduce smoking than everything else in the FDA bill combined.
Enzi Amendment #8: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to the FDA to allow it to increase the number of its inspectors. The amendment highlights the fact that FDA's ability to safeguard the public from food and drug threats is so impaired that it seems crazy to be considering adding tobacco products to its jurisdiction.
Enzi Amendment #11: This amendment would remove the exemption for menthol as one of only two flavorings allowable (along with clove). If Enzi Amendment #6 passes, then this amendment is not necessary.
Enzi Amendment #12: This amendment would remove the exemption for clove as one of only two flavorings allowable (along with menthol). This simply returns the bill to its form prior to Senator Kennedy's addition of the clove exemption in order to protect the financial interests of Philip Morris, which recently began marketing clove cigarettes in Indonesia. There is absolutely no reason for any of the health groups to fail to support this amendment, since it simply removes a special protection for Philip Morris which has no place in the legislation, and which wasn't even in the legislation to begin with. The explanation that this clause is necessary to avoid violating trade treaties is completely bogus. Besides, if that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements.
Burr Amendment #8: This amendment would strengthen the requirements for making a reduced exposure claim for a tobacco product and ease the requirements for making a reduced risk claim for a tobacco product. The problems with the current modified risk section of the bill are that it (1) makes it virtually impossible for a reduced risk claim to be approved, thus taking away any incentive for a tobacco company to research, develop, and seek to market what might be a truly reduced risk product; and (2) makes it too easy for a reduced exposure claim to be made, thus institutionalizing the fraud which tobacco companies were found guilty of committing in implying that low-tar and low-nicotine cigarettes are safer.
This amendment addresses, to some extent, these problems. First, it makes it at least possible for a reduced risk claim to be made (and thus restores the incentive for companies to develop a truly safer cigarette). Instead of having to conduct long-term epidemiologic studies to prove that a product reduces long-term risks, a company could instead demonstrate that the cigarette reduces actual human exposure to various constituents and that reduction in such constituents results in decreased disease as measured by some clinical marker of disease risk (but short of having to demonstrate reduced risk in a long-term epidemiologic study).
Second, this amendment makes it more difficult to make an undocumented reduced risk claim that might wrongly imply reduced disease risk. Under the current bill, a company merely needs to show that the yield of a certain constituent is reduced and that a reduction in disease risk is "anticipated." This amendment requires the demonstration of reduction in actual human exposure (not just in machine-measured yields). It also requires scientific documentation to back up that a reduction in disease risk is anticipated. The anticipation alone is not enough.
Finally, this amendment would allow the FDA to establish rankings which compare the risks of different classes of tobacco products. Communications of differences in risks between various classes of products is not allowed under the current bill.
Burr Amendment #10: This amendment would require states to spend Master Settlement Agreement funds on tobacco control programs at the amount recommended by the Centers for Disease Control and Prevention, or else they would face a reduction in their mental health and substance abuse block grants. This is a good idea and it would, if effective, actually make a dent in smoking, unlike the FDA bill itself. However, it's not clear to me that the financial penalties for not allocating the required amount of money to tobacco control programs are severe enough. I'm not aware of the amounts that states receive from substance abuse and mental health block grant funding to determine whether this provision would be effective. But clearly, the idea itself is an excellent one.
The Rest of the Story
I must emphasize that even with these amendments, I oppose the FDA legislation and I think it would be a public health disaster. The point is not that these amendments fix the legislation and address the concerns that I have expressed. The point is that they represent a significant strengthening of the legislation, and that it is telling that the health groups which supposedly want to end special protection for Big Tobacco and save countless lives are opposing each and every one of them.
Frankly, I would like to see a few of the amendments enacted into law as a stand-alone bill, while scrapping the rest of the FDA legislation. Some of these amendments demonstrate an appreciation of the types of actions that Congress could take to make a serious dent in smoking, rather than a bill which may appear great on the surface, but which is actually designed to institutionalize tobacco use, protect Big Tobacco at the expense of public health protection, and preserve and protect the profits of the nation's largest tobacco company.
But first, it is important to note that the health groups supporting this legislation, including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, and American Lung Association, oppose each and every one of these improvements to the bill.
Why would these health groups oppose amendments that will strengthen the legislation and take out some of the loopholes that protect Big Tobacco profits at the expense of the protection of the public's health?
To me, the reason appears to be simple. The Campaign for Tobacco-Free Kids essentially struck a deal with Philip Morris at the Congressional negotiating table two years ago. The two major parties to that negotiation process basically struck a deal, and it appears that the Campaign for Tobacco-Free Kids wants to preserve the terms of that deal because if the deal is broken, it will lose the support of Philip Morris and the whole thing may crumble. This would be a devastating blow to the Campaign, which has put so much on the line (using all kinds of deceptive and unethical tactics to try to even get to this point).
Two things, then, are clear:
First, the Campaign for Tobacco-Free Kids and the other health groups which appear to be taking marching orders from the Campaign apparently have no sincere interest in developing legislation that will be as effective as possible in protecting the public's health from the hazards of tobacco. They have no desire for input from other public health experts, they are not willing to consider criticism of the legislation, they are not willing to consider any changes that would strengthen the bill. There is no opportunity for a dialogue or discourse about what would represent effective regulation of tobacco products or what strategy would be most effective in reducing tobacco use or potentially creating safer cigarettes. All decisions have already been made. It is either this deal with Philip Morris, or no legislation at all. That's the only choice that the health groups are offering to the American people.
Frankly, that's a travesty, because the responsibility of public health is to protect public health, not to sell out the public's health to Big Tobacco merely to enact some legislation and be able to stick a feather in our cap.
Second, it's clear that the propaganda being put out by the Campaign is merely rhetoric. There is little sincerity in their proclamations that their desire is to end special protection for Big Tobacco and save countless lives. If the true desire were to end special protection for Big Tobacco, then the Campaign and its fellow health groups would have no choice but to support these amendments which would, indeed, get rid of special protections for Big Tobacco that Philip Morris has apparently required in order to support the bill. If the true desire were to save countless lives, then there would be no choice but to support amendments which would put the only teeth into the entire bill, which in its present form is devoid of anything that would actually put a dent in tobacco use or create a safer cigarette.
The Campaign for Tobacco-Free Kids told its constituents that it opposed Senator Kennedy's insertion of a last-minute change in the bill which allows tobacco companies to market clove cigarettes. However, the Campaign is not particularly sincere in that opposition, since it now opposes an amendment that would do nothing more than remove that special protection for Big Tobacco.
The Campaign also claims that it opposes this amendment because it would eliminate the bill's chances of passage through Congress. However, a majority of legislators in the Senate have already sponsored the bill with the clove ban in the bill. It would be politically untenable for them to oppose a bill with the exact language that was in the bill which they sponsored, solely because it is now apparent that Philip Morris is actually marketing clove cigarettes in Indonesia!
With those critical observations made, here then is a brief summary of the most important amendments that would strengthen the bill. Note that this is not a comprehensive list, but an attempt to inform the public of some of the most important amendments.
Enzi Amendment #1: This amendment would eliminate the loophole which precludes the FDA from banning any particular class of tobacco product. This would allow the FDA to mandate changes to improve the safety of cigarettes even if those changes required a major re-design of the cigarette. In its present form, this loophole allows the tobacco companies to challenge such a regulation on the grounds that it represents a de facto ban on a class of tobacco products. In addition, the amendment would allow the FDA to ban cigarettes at some point in the future if it becomes economically and socially feasible. A clause would probably need to be added by a further amendment to make it clear that the FDA can consider non-health factors, such as the social and economic feasibility of banning a class of tobacco products in any such deliberation.
Enzi Amendment #2: This amendment would eliminate the loophole which precludes the FDA from getting rid of nicotine in cigarettes. This would allow the FDA to get rid of the nicotine and thus require a cigarette that is greatly reduced in addictive potential. Under the current bill, the FDA cannot get rid of the nicotine, but can only reduce the nicotine yields. This would be a disaster, as smokers would smoke more to compensate for the reduced nicotine. In addition, if the FDA did try to reduce nicotine to extremely low levels, the tobacco companies would be able to tie such a rule up in courts for years, since it is clearly the intent of Congress to reserve to itself any decision regarding making cigarettes non-addictive. There is absolutely no reason for health groups to oppose this amendment, since if it is the intent of Congress to allow the FDA to make cigarettes non-addictive, then there will be no harm in explicitly stating that the FDA can do that. Short of this amendment, it will be clear that Congress' intent is not to allow the elimination or near elimination of nicotine, and any such attempt by the FDA will most certainly be overturned by Congress, using its veto power provided elsewhere in the bill (via yet another loophole).
Enzi Amendment #4: This amendment strengthens the required warning labels on cigarettes by increasing the size of warning labels from 30% to 50% of the pack and adding color graphics that depict the negative health consequences of smoking. This is similar to warning labels that have been used with some success in Canada. Again, there is absolutely no reason for health groups to oppose this amendment since it merely improves the warning labels.
Enzi Amendment #5: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to support cancer research at the National Cancer Institute. This is a far better use of the revenues from a large cigarette tax increase than supporting children's health insurance - the last thing in the world that we want to become dependent upon continued cigarette consumption.
Enzi Amendment #6: This amendment would add menthol and clove to the list of flavorings that cannot be used as a primary flavor in cigarettes. This is a critical improvement, since it affects flavors that Big Tobacco actually does use to recruit smokers. Currently, the legislation bans plenty of flavors, but few, if any of them are actually being used to market cigarettes (when was the last time you saw a cherry cigarette?).
Enzi Amendment #7: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates 50% of the revenues to Medicare, 25% to Medicaid, and 25% to state tobacco education and cessation programs. This amendment alone would do more to reduce smoking than everything else in the FDA bill combined.
Enzi Amendment #8: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to the FDA to allow it to increase the number of its inspectors. The amendment highlights the fact that FDA's ability to safeguard the public from food and drug threats is so impaired that it seems crazy to be considering adding tobacco products to its jurisdiction.
Enzi Amendment #11: This amendment would remove the exemption for menthol as one of only two flavorings allowable (along with clove). If Enzi Amendment #6 passes, then this amendment is not necessary.
Enzi Amendment #12: This amendment would remove the exemption for clove as one of only two flavorings allowable (along with menthol). This simply returns the bill to its form prior to Senator Kennedy's addition of the clove exemption in order to protect the financial interests of Philip Morris, which recently began marketing clove cigarettes in Indonesia. There is absolutely no reason for any of the health groups to fail to support this amendment, since it simply removes a special protection for Philip Morris which has no place in the legislation, and which wasn't even in the legislation to begin with. The explanation that this clause is necessary to avoid violating trade treaties is completely bogus. Besides, if that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements.
Burr Amendment #8: This amendment would strengthen the requirements for making a reduced exposure claim for a tobacco product and ease the requirements for making a reduced risk claim for a tobacco product. The problems with the current modified risk section of the bill are that it (1) makes it virtually impossible for a reduced risk claim to be approved, thus taking away any incentive for a tobacco company to research, develop, and seek to market what might be a truly reduced risk product; and (2) makes it too easy for a reduced exposure claim to be made, thus institutionalizing the fraud which tobacco companies were found guilty of committing in implying that low-tar and low-nicotine cigarettes are safer.
This amendment addresses, to some extent, these problems. First, it makes it at least possible for a reduced risk claim to be made (and thus restores the incentive for companies to develop a truly safer cigarette). Instead of having to conduct long-term epidemiologic studies to prove that a product reduces long-term risks, a company could instead demonstrate that the cigarette reduces actual human exposure to various constituents and that reduction in such constituents results in decreased disease as measured by some clinical marker of disease risk (but short of having to demonstrate reduced risk in a long-term epidemiologic study).
Second, this amendment makes it more difficult to make an undocumented reduced risk claim that might wrongly imply reduced disease risk. Under the current bill, a company merely needs to show that the yield of a certain constituent is reduced and that a reduction in disease risk is "anticipated." This amendment requires the demonstration of reduction in actual human exposure (not just in machine-measured yields). It also requires scientific documentation to back up that a reduction in disease risk is anticipated. The anticipation alone is not enough.
Finally, this amendment would allow the FDA to establish rankings which compare the risks of different classes of tobacco products. Communications of differences in risks between various classes of products is not allowed under the current bill.
Burr Amendment #10: This amendment would require states to spend Master Settlement Agreement funds on tobacco control programs at the amount recommended by the Centers for Disease Control and Prevention, or else they would face a reduction in their mental health and substance abuse block grants. This is a good idea and it would, if effective, actually make a dent in smoking, unlike the FDA bill itself. However, it's not clear to me that the financial penalties for not allocating the required amount of money to tobacco control programs are severe enough. I'm not aware of the amounts that states receive from substance abuse and mental health block grant funding to determine whether this provision would be effective. But clearly, the idea itself is an excellent one.
The Rest of the Story
I must emphasize that even with these amendments, I oppose the FDA legislation and I think it would be a public health disaster. The point is not that these amendments fix the legislation and address the concerns that I have expressed. The point is that they represent a significant strengthening of the legislation, and that it is telling that the health groups which supposedly want to end special protection for Big Tobacco and save countless lives are opposing each and every one of them.
Frankly, I would like to see a few of the amendments enacted into law as a stand-alone bill, while scrapping the rest of the FDA legislation. Some of these amendments demonstrate an appreciation of the types of actions that Congress could take to make a serious dent in smoking, rather than a bill which may appear great on the surface, but which is actually designed to institutionalize tobacco use, protect Big Tobacco at the expense of public health protection, and preserve and protect the profits of the nation's largest tobacco company.
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