Tuesday, March 31, 2009

University of Wisconsin Online Physician Course in Smoking Cessation Therapy Promotes Chantix as First-Line Therapy But Fails to Disclose Drug Risks

Could University Funding by Pharmaceutical Company that Makes Chantix Be the Explanation?

The Milwaukee Journal-Sentinel reported this Sunday that a University of Wisconsin online course for physicians to teach them how to get their patients to quit smoking is being skewed because of the funding of the program by Pfizer, the manufacturer of Chantix. According to the article, the course promotes the use of Chantix as first-line therapy for smoking cessation, but fails to disclose the reported adverse effects associated with Chantix, including depression and suicide.

According to the article: "A Journal Sentinel investigation found that industry-funded doctor education courses offered at UW often present a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects. Among the findings: Pharmaceutical giant Pfizer is spending $12.3 million on an online UW course for doctors to tell them how to get their patients to quit smoking. A top priority is prescribing Pfizer's drug, Chantix, which has been linked to serious side effects, including a rash of suicides. But mention of the side effects can't be found in course materials." ...

"Some of the biggest money paid to UW has been for its smoking cessation course, part of a national campaign funded by Pfizer. Of the $12.3 million paid by the drug company to fund the course, $3.5 million is going to UW. The course materials heavily promote Pfizer's drug, Chantix, considered to be the most effective drug on the market. But the drug is under investigation by the FDA, and in its relatively short history on the market, it has been linked to serious side effects, none of which is mentioned in the course."

The Rest of the Story

I took the University of Wisconsin online course for myself to see exactly what the course is teaching and what it is disclosing or failing to disclose.

The Journal-Sentinel article is correct. The course promotes Chantix as a "first-line treatment for smoking cessation," but it fails to mention any of the serious potential side effects that have been reported with the use of the drug, and which the FDA itself has required be added to the drug's labeling (in a warning box, the highest level of such warnings).

The course also fails to mention that cold turkey quit attempts have been documented to be far more successful than planned quit attempts with the use of pharmaceutical aids. In fact, the course fails to mention that any course of action other than relying upon drugs as the primary mode of treatment should or could be considered by a physician or patient.

The newspaper article is absolutely correct, then, in concluding that the course "present[s] a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects."

Furthermore, I discovered that the course relies heavily upon and frequently cites as documentation the recommendations of an NIH expert panel on smoking cessation. However, nowhere is it disclosed that the chair of the panel and eight of its members had financial conflicts of interest by virtue of their financial ties to Big Pharma.

In fact, the report of the expert panel is the only evidence cited in the entire course to support its recommendations. Course participants are not informed that this sole source of information and guidance was developed by a panel with severe conflicts of interest.

Do we really want our nation's physicians to be getting their medical training from information sources that are heavily biased because they were compiled largely by individuals with financial conflicts of interest with pharmaceutical companies?

Do we really want our nations's physicians to be potentially misled about the safety of using a drug through the hiding of its reported adverse effects by educators who have financial ties to the very company that manufactures that drug?

This is a great example of how pharmaceutical funding of individuals and institutions is resulting in slanted and heavily biased physician training in a way that could potentially cause serious harm to some patients.

The University of Wisconsin should force the organizers of this course to immediately disclose the potentially severe adverse effects that have been reported with Chantix use, as required for disclosure by the FDA with regards to Chantix labeling.

The University should also force the course organizers to disclose the fact that the expert panel review which serves as the primary (if not sole) source of support for the course recommendations was a conflicted one: the chair and eight panel members had financial ties to Big Pharma.

While I think these two disclosures are essential and without them the course is violating ethical standards, I would note that this will only solve the most egregious aspects of the problem. The underlying issue of the biased recommendations (including the favoring of less effective pharmaceutical treatment compared to the more effective cold turkey quitting) on account of the pharmaceutical company funding will remain.

Monday, March 30, 2009

Absurdity Gone Wild: Health Canada Asks Smokers Not to Use E-Cigarettes Because of Safety Concerns, But Not to Refrain from the Known Toxic Ones

In a health advisory issued last week, Health Canada has warned smokers not to buy or use electronic cigarettes because they "may pose health risks" and "have not been fully evaluated for safety" by the government, but in the same advisory, Health Canada expresses no concern whatsoever about smokers buying or using regular cigarettes which are known to pose health risks and which have been fully evaluated for safety and found to be toxic and potentially deadly.

According to the advisory: "Health Canada is advising Canadians not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada. ... Although these electronic smoking products may be marketed as a safer alternative to conventional tobacco products and, in some cases, as an aid to quitting smoking, electronic smoking products may pose risks such as nicotine poisoning and addiction. ... Canadians who have used e-cigarette products and are concerned about their health should consult with a health care practitioner."

The Rest of the Story
I have to hand it to Health Canada: this is about as absurd and hypocritical an action that I have seen taken by a government health agency in a long time.

Apparently, Health Canada has deemed that electronic cigarettes -- which have little if any known risks -- pose such a risk to the health of smokers that they need to issue an advisory not to use the products, but the same concern does not hold for actual cigarettes, which are known to cause serious diseases and even death among many Canadian smokers.

Electronic cigarettes contain nicotine and may pose a risk of nicotine addiction and therefore smokers must be warned not to use these products. However, actual cigarettes - which also contain nicotine but also contain numerous other toxic chemicals and carcinogens - do not pose a risk serious enough that Health Canada opts to ask smokers not to buy or use those products.

Smokers who are using e-cigarettes should call their doctors immediately to inquire about their health effects. But smokers who are using traditional cigarettes need not discuss the health effects with their doctors. They should just continue to smoke without worrying about the health risks. After all, at least the health risks of their products have been very well-studied and well-documented.

What is the terrible concern that Health Canada has? Are they afraid that smokers might actually switch to these tar-free, smoke-free products and drastically reduce their risk of debilitating disease and death? Are they afraid that these electronic cigarettes might just be a much more effective method of nicotine replacement and successful quitting than pharmaceutical products? Are there afraid that these e-cigarettes might displace sales of pharmaceutical company-produced nicotine replacement products?

It is difficult to understand the source of the hypocrisy and absurdity here, but let me offer two possibilities:

First, it strikes me that there is such a strong relationship between tobacco control and Big Pharma that tobacco control agencies within a national health department might actually feel threatened by the possibility that pharmaceutical smoking cessation products might be displaced by non-pharmaceutical products.

Second, it strikes me that there is a tremendous abstinence-only mindset in tobacco control that isn't capable of even entertaining the possibility that harm could be reduced by a product that is called a cigarette. The very fact that the product is in the form of a cigarette is simply intolerable to many tobacco control advocates. It is not truly the health of smokers that is of concern; it is the act of smoking that is bothersome and unacceptable. So even if that smoking were to save thousands of lives, it is not a viable option. Better that people should use the traditional products and die then switch to a product which has not been fully studied but which is probably much safer.

This is really an ugly situation because if Health Canada does follow through with its threat to remove e-cigarettes from the market, it is going to result in a tremendous disservice to the public's health. Many smokers who would otherwise have been exposed only to nicotine are going to switch back to cigarettes and thus be exposed to not only nicotine, but all the other toxins and carcinogens in tobacco smoke.

The vision of tobacco control practitioners appears to be so clouded by concerns other than health that it is resulting in jaw-dropping absurdity and hypocrisy in public health.

(Thanks to Paul Bergen for the tip).

Sunday, March 29, 2009

IN MY VIEW: FDA Should Not Exert Jurisdiction over Electronic Cigarettes; Instead, FTC Should Ensure that Advertising Claims are Supported

I reported last week that Senator Frank Lautenberg (D-NJ) has announced that he wants the FDA to immediately take electronic cigarettes -- which deliver essentially pure nicotine (with no tar or other tobacco constituents) -- off the market. I argued that although there are potentially serious health effects of nicotine, especially with regards to heart disease, there are no other toxic chemicals and no carcinogens, so there is no risk of cancer or chronic obstructive lung disease. Thus, the introduction of electronic cigarettes into the U.S. market is a potentially life-saving intervention. There is initial evidence that many smokers have found the e-cigarette to be an effective method for smoking cessation. Moreover, it makes sense that smokers would find it more attractive to use an e-cigarette than a nicotine patch. It is quite plausible that many smokers would find the e-cigarette to be an alternative to smoking and it may actually be more successful in keeping them off cigarettes. If true, this would save countless lives, because many smokers would be greatly reducing their health risks by switching to a much safer alternative type of cigarette.

I also pointed out the hypocrisy of Senator Lautenberg and the health groups who supported him in his demand that the FDA pull these products off the market, as these very same groups are supporting legislation that would require the FDA to approve the existing high-risk cigarettes for sale in the U.S.

Here, I argue that the FDA should not exert jurisdiction over electronic cigarettes (which would mean the immediate removal of these products from the market), but instead should simply ask the companies to refrain from making drug claims. These products should be treated as cigarettes, not drugs, and therefore the Federal Trade Commission (FTC) should review the accuracy of the advertising claims. But by no means should the FDA pull the product off the market.

The Rest of the Story

Unfortunately, it is true that at least some of the electronic cigarette companies are making drug claims, which could be construed as placing these products under the definition of a "drug" as defined in the Federal Food, Drug, and Cosmetics Act at chapter 321, section (g)(1). Drugs are defined as products which are "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." Since at least some electronic cigarette companies are promoting their products as providing a "healthier smoking experience" or being the "healthiest alternative smoking product," these can be interpreted as being drug claims under 321(g)(1).

Does this mean that electronic cigarettes must be regulated as drugs under the Federal Food, Drug, and Cosmetics Act and taken off the market?

I believe the answer is no because the federal government could decide that the primary intention of these products is to serve as an alternative type of cigarette and that these products are actually cigarettes and not drugs. The FDA could make a judgment that electronic cigarettes are actually not drugs, but are cigarettes that are inappropriately making a drug claim. The FDA could, instead of asserting jurisdiction and taking the products off the market, ask the companies to refrain from making drug claims and allow the products to remain on the market under such circumstances.

Given the potential public health benefits of electronic cigarettes and the fact that these products do appear to be primarily portrayed as an alternative type of cigarette, I believe this would be the best course of action.

Once classified by the federal government as a type of cigarette that has inappropriately made a health claim and asked to refrain from making such a health claim, the FTC could review the advertising for these products to ensure that any claims made are supported.

Electronic cigarette companies can make factual statements about the nature and components of the product without crossing over into the territory of making a drug claim. For example, these companies can state that the product is free of tobacco, that there is no smoke produced, and that it does not expose users to the carcinogens and other chemicals (other than nicotine) in cigarette smoke. These are ingredient and characteristics statements and not drug claims. The companies merely need to refrain from claiming that the product is healthier than traditional cigarettes.

Of course, electronic cigarettes are almost certainly safer than traditional cigarettes, but by making the claim, the producers are making a drug claim that could allow the FDA to exert jurisdiction over the product.

Let's hope that the FDA takes the action that is most reasonable and most considerate of the best interests of the public's health and that it simply ask the electronic cigarette companies to refrain from making drug claims, rather than taking the product off the market.

Saturday, March 28, 2009

North Star Writers Group Column Highlights Deterioration of Tobacco Control Movement from Health-Based to Pure Ideology

In a column published by the North Star Writers Group, Candace Talmadge highlights the deterioration of the anti-smoking movement, and several other social movements, by ideology-fueled extremism and an unwillingness to consider alternative points of view. The column is entitled "The Biggest Threat to Freedom: Ideologues in Extremis."

Talmadge starts by talking about my own experience in tobacco control and then generalizes to other movements.

She writes: "Michael Siegel is a public health physician who has testified against tobacco companies in seven major trials, including the Florida case that in 2000 resulted in the largest-to-date jury punitive award. He favors smoking bans in all public places and workspaces. Siegel, however, instantly became a pariah among the anti-tobacco movement. Why? He dared question, in an editorial recently published in Tobacco Control, the trend toward banning smokers from the workplace instead of merely proscribing their habit. Morphing from hero to goat isn’t an experience unique to Siegel by any means. Conservative columnist Kathleen Parker had similar rage directed at her last fall when she finally had enough of Republican vice presidential candidate Sarah Palin and dared express that opinion in public. Author Frank A. Schaeffer, prominent in evangelical political circles during the 1970s and 1980s, was equally ostracized when he published a revealing book about the religious right." ...

"The problem is that almost every worthwhile idea or cause, taken to an unyielding extreme, starts doing more harm than good. It contracts into an ideology, and the most extreme (and thus most vocal) adherents of which brook no dissent or even mere questions. Right-wing or left-leaning, the ideologues are making it impossible for the rest of us to discuss issues or move toward policies and legislation that offer something for all sides to accept nd support."

The Rest of the Story

I think this column makes a really insightful point that applies perfectly to the anti-smoking movement. Yes, it began as a noble idea and cause, but recently, in taking it to the extreme, there is a threat that it could do more harm than good. For example, the recent calls for policies that bar smokers from certain public places, disallow smokers from seeking employment, treat parents who smoke as child abusers, and do not allow smokers to adopt children are all examples of actions that would result in more harm than good.

In many ways, tobacco control has contracted into an ideology and its most vocal adherents do not allow any dissent, nor are they willing to even entertain any questions that might challenge the orthodoxy.

Readers interested in a detailed treatment of this point may enjoy listening to my first roundtable interview with the late Gian Turci of FORCES International. Gian called this interview "Dissidence or Orthodoxy?" and describes it thusly: "As he [Siegel] discusses with the host, the tobacco control movement has degenerated into an ideology aimed to control behaviour and culture through demonization, censorship, discrimination and promotion of hatred and intolerance, and for which any means – truthful or not, moral or not – is legitimate to get rid of the smoker. Such ideologies do not tolerate the slightest dissent, and promise harsh punishments for those who dare."

Friday, March 27, 2009

Kick Butts Day 2009: Campaign for Tobacco-Free Kids Misusing and Tricking Kids into Doing Its Special Interest Lobbying for It

This Wednesday was Kick Butts Day 2009, a day on which the Campaign for Tobacco-Free Kids tries to trick kids into supporting the Philip Morris-negotiated FDA tobacco legislation without telling those kids that the bill before Congress prohibits the FDA from taking meaningful action to protect the public from tobacco products and that the legislation is supported by, and was crafted in part by the nation's leading tobacco company.

In my opinion, the Campaign for Tobacco-Free Kids is unethically tricking kids into supporting this legislation because it is not giving them the truth about the legislation. Under the guise of a day to fight Big Tobacco, the Campaign is trying to get kids to support legislation which would actually provide unprecedented special protection to Big Tobacco. Nowhere does the Campaign reveal to the nation's youths that the legislation ties FDA's hands and limits its regulatory authority in a number of important ways -- regulatory limits which are not present for any of the other drugs or products regulated by the Agency. And nowhere does the Campaign inform youths it is recruiting to lobby for this legislation that this is a Philip Morris supported bill, one which contains numerous loopholes inserted specifically to appease the financial interests of the nation's largest cigarette maker.

Consider the following two "tricks" that the Campaign is playing on our kids:

1. Getting the kids to support the FDA legislation without explicitly telling the kids that they will be supporting a specific bill.

One activity set out by the Campaign for Kick Butts Day is entitled "Contact Members of Congress." For this activity, youths are instructed: "Let your members of Congress know that you think the tobacco companies should tell the public what exactly is in their deadly products. You can take action!"

This is ostensibly a trick. By writing Congress and telling lawmakers that you think the tobacco companies should tell the public what exactly is in their deadly products, you are unknowingly expressing support for HR1256, the proposed FDA tobacco legislation. Why? Because that is the legislation currently before Congress which requires tobacco companies to disclose the ingredients in their products. Any policymaker reading a letter from a youth which demands that Congress require the companies to disclose their ingredients is certainly going to read that as supporting the legislation before Congress which would do exactly that.

However, the activity sheet does not inform youths that there is a bill pending in Congress that would require disclosure of ingredients and that their support for disclosure is going to be read as an endorsement of the entire piece of legislation. And furthermore, youths are not informed about what else is in that legislation, including the numerous limits of the FDA's ability to effectively intervene to protect the public's health.

Youths are also told to write letters to Congress urging lawmakers to do something about tobacco companies targeting youths. Again, this is ostensibly a trick to get youths to unknowingly support the FDA legislation, which is clearly what "do something about it" means in this case. With a House vote on the FDA legislation due up next week, what else could "doing something" about it possibly mean?

This is despicable and unethical behavior, because the Campaign is not informing these youths that there is a bill up before Congress and that their letters will be construed as expressing support for that specific piece of legislation. There is an ethical duty here to inform the youths about this piece of legislation and what it would (and would not) do.

In all seriousness, this is the sleaziest maneuver from a tobacco control organization that I have ever witnessed during my 23 years in the tobacco control movement.

To take advantage of kids like this is truly unfortunate.

2. Getting the kids to demand FDA regulation of tobacco products on the basis that they contain arsenic and other toxic chemicals, but without informing them what the legislation would actually do or not do to eliminate these toxins.

In the "They Put What in a Cigarette?" activity, kids are urged to create a display that tells people about the ingredients in tobacco and their common uses as poisons or toxins. For example, kids are to highlight the fact that cigarette smoke contains arsenic, which is used in rat poison and pesticides.

The Campaign for Tobacco-Free Kids makes a specific suggestion for a poster that kids can use. A large poster is displayed on the activity page which states "The FDA keeps arsenic out of lollipops, but not cigarettes." Clearly, the message that the Campaign is trying to get kids to send to Congress is that the FDA should be given regulatory authority over cigarettes because the Agency could then get rid of all the toxic constituents in tobacco smoke.

This is a sham. The FDA legislation would not allow the Agency to require the elimination of all the toxic constituents in cigarette smoke, and in fact, it is not clear whether the Agency could even require the elimination of one such constituent. We don't know whether it is technologically possible for cigarette companies to selectively remove a specific chemical from the smoke, and if it is not possible, then the FDA cannot require it to be done, no matter how many lives it would save, according to a loophole in the legislation.

Passage of the FDA legislation is not going to eliminate arsenic (nor most of the thousands of toxic chemicals) from cigarette smoke, and the Campaign knows it. It is not that simple and the Campaign is misleading youths (apparently intentionally) into believing that this legislation is going to get rid of the toxins from cigarettes.

This is another unethical, and sleazy maneuver.

I think that we as public health practitioners have an ethical obligation not to misuse kids by misleading them and deceiving them in order to trick them into doing our lobbying for us. If we want kids to be involved in tobacco policy advocacy, that's great, but our obligation is to provide them with adequate information so that they can make their own informed decisions about what they choose to support or not to support.

I know for a fact that massive numbers of these kids would be appalled to find out that they were supporting a bill that is supported by Philip Morris. Nowhere in the Kick Butts Day manual does it mention that Philip Morris supports the bill. Not even in a rebuttal to the argument that because Philip Morris supports the bill, we should oppose it. It simply hides the truth from these kids.

If the Campaign for Tobacco-Free Kids wants to lobby for special interest legislation that will protect Philip Morris at the expense of the public's health, it certainly has the right to do so. But it doesn't have the right to trick children and teenagers into supporting this legislation without knowing that they are expressing support for a specific piece of legislation, and without knowing the details of what that legislation encompasses, or the history behind it.

That the Campaign for Tobacco-Free Kids has run a campaign of deception among its constituents (whom it has repeatedly failed to inform of the truth) is unfortunate. But that the Campaign is waging a campaign of deception among the nation's youths is disgraceful and appalling.

Note: One of the activities outlined by the Campaign encourages kids to set up a boxing match where people simulate physical violence against tobacco company executives by punching a mock tobacco industry representative. I could understand punching a cigarette or even a cigarette company logo, but to punch a real person and simulate committing violence against an individual is completely uncalled for and I condemn it.

Thursday, March 26, 2009

Major National Anti-Smoking Group Supports Bans on Smokers in Certain Public Places and Workplaces

On Tuesday, I reported that Royal Oldham Hospital apparently instituted the first policy of its kind - a ban on smokers (not just smoking) in the maternity waiting room. Dick Puddlecote's blog captured a picture of the sign outside the waiting room, which states: "In the interests of others, smokers are not allowed in this room."

Today, I report that a major national anti-smoking organization - Action on Smoking and Health (ASH) - is actually supporting the idea of banning smokers from certain public locations because of the alleged health threat of thirdhand smoke.

In a press release issued yesterday, ASH states: "SmokERS -- not just smoking -- have been barred in a public area at a major hospital, a restriction likely to spread to other areas of the hospital as well as to other hospitals, says Action on Smoking and Health (ASH), a national organization leading the fight to protect nonsmokers from thirdhand tobacco smoke. Public interest law professor John Banzhaf of ASH notes that many steps are being taken to protect nonsmokers from thirdhand tobacco smoke: ... ASH recently forced a major university to stop an employee, who took smoke breaks outside his smoke free office, from working in the same office with a women whose health -- and the health of her unborn child -- were threatened by his thirdhand smoke, according to testimony from two of her doctors. Even in a state with a law which allegedly prohibits discrimination against smokers, a major company prohibits anyone from coming on the premises if they have any detectable odor of tobacco smoke on them. To avoid being barred, smokers likely have to change clothing, shower and shampoo, and use mouthwash."

"Thirdhand tobacco smoke, 'the invisible yet toxic brew of gases and particles clinging to smokers' hair and clothing' [NY TIMES] -- was recently identified in the medical journal Pediatrics as "toxic" and as a cancer risk to nonsmokers of all ages, especially to children of parents who smoke only outside the family home. Indeed, notes Prof. John Banzhaf of ASH, these tobacco smoke residues contain a mix of carcinogens, toxins, and other irritants including highly carcinogenic compounds, heavy metals, hydrogen cyanide (used in chemical weapons), butane (used in lighter fluid), toluene (found in paint thinners), arsenic, lead, and even radioactive Polonium-210 (used to murder a Russian spy). Another study showed that even a smoker's breathe may be harmful to children, and perhaps also to adults. It found that the chemicals in a smoker's breath were sufficient to cause or aggravate respiratory illnesses including asthma, coughs, and colds among children in homes where parents smoked only outside the home as compared with kids in homes where the air was not contaminated by the breath of a smoker."

'"These two studies suggest that society must go beyond merely protecting children from being in the presence of parents and others who smoke in their homes, and think about more effective measures to protect children from parents who smoke anywhere. It also provides a strong scientific basis for agencies which already refuse to permit smokers to adopt children, even if the potential adoptees claim that they only smoke outdoors, and never in the presence of the child,'" says Banzhaf." ...

"Thus, says Banzhaf, adults as well as children should be protected from thirdhand tobacco smoke, and restrictions aimed at smokERS, as well as smoking itself, are likely to increase in the light of these new scientific findings."

The Rest of the Story

In my post reporting the Royal Oldham hospital's policy, I sarcastically offered a series of suggestions for protecting people from thirdhand smoke, such as prohibiting smokers from entering public places or workplaces or from working in child care or educational settings.

In response, Matt (a commenter) wrote: "I understand your article was intended as sarcasm, but there’s also a frightening aspect to it. I have no doubt whatever there’s an anti-smoker nut out there, reading some of your suggestions and exclaiming: “Geez, why didn’t we think of that?”"

It appears that Matt was correct. Presumably after reading my post and finding out about the Royal Oldham policy, ASH read the suggestions, exclaimed "Geez, why didn't we think of that?" and issued its press release calling for the protection of both adults and children from exposure to smokers -- in other words, for a ban on smokers in certain public places.

Most frighteningly, ASH calls for policies that not only protect children from exposure to smoke in the home, but from exposure to parents who smoke anywhere. ASH explicitly calls for policies that ban smokers from adopting children, if if they agree not to smoke in the home or anywhere in the presence of the child.

If we take ASH's suggestions seriously (which we need to), they would call for a ban on smokers working in child care settings or in schools. In order to protect children from "the invisible yet toxic brew of gases and particles clinging to smokers' hair and clothing," society would need to prohibit anyone who smokes from working in a child care center or a school.

Furthermore, we would need to ban anyone exposed to secondhand smoke from working in a child care or educational setting. If you live in a state that allows smoking in restaurants and you often go out to such restaurants to eat, you would have to be prohibited from being a teacher or working in a school in any capacity, lest the smoke that settles on your clothing poisons children in the school.

Disturbingly, ASH distorts the scientific evidence and misreports the findings from the scientific literature to support its radical position. For example, ASH reports that an article in the journal Pediatrics identified thirdhand smoke "as a cancer risk to nonsmokers of all ages, especially to children of parents who smoke only outside the family home." In fact, that article made no such claim. Nowhere in the article does it conclude that thirdhand smoke is a cancer risk to anyone - children or adults.

The scientific evidence does not support a conclusion that even secondhand smoke is a cancer risk to children. There is absolutely no evidence that thirdhand smoke is a cancer risk for exposed children.

It would be bad enough if ASH was merely distorting scientific evidence to try to scare the public about the alleged risks of thirdhand smoke exposure. But to use that distorted and misreported science to support draconian policies that would bar smokers from workplaces and public places, including not allowing them to adopt children or to work in day care centers or in schools, is despicable.

I truly cannot believe how low the anti-smoking movement has sunk. I never could have imagined that we would reach this point, where a major national anti-smoking group is calling on banning smokERS and not just smokING in public places.

When I reported the Royal Oldham story Tuesday, I was wondering whether any anti-smoking groups would join me in condemning the policy. Even then, it never occurred to me that a major anti-smoking group would actually come out and support such a policy and encourage the widespread extension of that policy.

I certainly didn't expect any group to come out and condemn the policy, but the fact that ASH actually believes this is a good thing is absurd.

This would be a really funny story, if not for the fact that it may well result in a system of "smoker apartheid," by which smokers need to be banned from public places because of the unrestrained fanaticism and zeal of an increasingly extremist anti-smoking movement that has completely lost its base in science and in reason.

(Thanks to JustTheFacts for the tip).

Tuesday, March 24, 2009

Senator and Anti-Smoking Groups Want to Ban Less Harmful E-Cigarettes and Protect the Most Toxic Ones

Senator Frank Lautenberg (D-NJ) has announced that he wants the FDA to immediately take electronic cigarettes -- which deliver essentially pure nicotine (with no tar or other tobacco constituents) -- off the market. At the same time, he is a supporter of legislation that would provide special protection to actual tobacco-containing cigarettes and ensure that this most toxic variety of cigarettes always remains on the market and continues to kill hundreds of thousands of Americans each year.

The electronic cigarette is a battery-powered device that contains a nicotine/propylene glycol solution and vaporizes the nicotine, producing a vapor of nicotine that is inhaled by the smoker. Because there is no tobacco, there is no tar and so while the vapor contains nicotine, it does not contain any of the thousands of other constituents of tobacco smoke. Also, because the cigarette produces a vapor, and not smoke, there is no secondhand smoke that could affect others. Moreover, the amount of nicotine delivered can be controlled by the user, allowing the smoker to gradually reduce the level to wean himself off of cigarettes entirely if he so desires.

Senator Lautenberg's call for removing the electronic cigarette from the market, as well as for providing special protection - and government approval - for the much more toxic actual tobacco-containing cigarettes - was endorsed by the American Heart Association, American Lung Association, American Cancer Society, and the Campaign for Tobacco-Free Kids.

Representative Cliff Stearns (R-FL) countered Lautenberg's call for the removal of electronic cigarettes from the marketplace, arguing that these products are designed to help smokers quit, that they have succeeded in doing so for many smokers, that they are safer than tobacco-containing cigarettes, and that they are safer for nonsmokers because they do not produce secondhand smoke.

According to an article in The Hill: "Stearns shot back at Lautenberg on Monday, saying that there is no evidence that the device is harmful. 'Before the FDA takes any immediate action, it should put forward scientific evidence that these products are harmful or unsafe,' he said in a statement. 'These e-cigarettes are smokeless and do not produce carcinogens. The nicotine in e-cigarettes is controlled in a capsule that can help in smoking cessation by allowing the user to reduce gradually the nicotine level, hopefully to zero.' Stearns has sent electronic cigarettes to House Minority Leader John Boehner (R-Ohio) and President Obama to help them quit smoking."

The Rest of the Story

How special that a public policy maker who touts himself as being a champion of the public's health as well as some of the leading national health advocacy organizations are demanding that we ban what is clearly a much safer cigarette than those on the market, but that we allow, protect, approve, and institutionalize the really toxic ones.

This is about as idiotic and irrational an approach as I have ever seen in my 22 years in tobacco control and public health.

One company has a product on the market which delivers only nicotine. There are potentially serious health effects of this nicotine, especially with regards to heart disease. However, there are no other toxic chemicals and no carcinogens, so there is no risk of cancer or chronic obstructive lung disease.

Another company has a product on the market which delivers nicotine plus more than 4000 other chemicals and toxins, including over 60 proven carcinogens, and which we know kills over 400,000 people a year.

Our health groups' response: prohibit the first company from marketing its product, but officially provide government approval of the products manufactured by the second company.

What Senator Lautenberg and the health groups are trying to do is ban a much less harmful type of cigarette but to give an official government seal of approval to the much more toxic one that we know is killing hundreds of thousands of Americans each year.

The logic of these actions completely escapes me.

Or at least the logic did escape me until The Ashtray Blog pointed out that Senator Lautenberg is the recipient of more than $128,000 from pharmaceutical companies (in 2008 alone).

The only real threat that electronic cigarettes pose is not to the public's health, but to the profits of the pharmaceutical companies, which manufacture competing products (nicotine replacement therapy). If lots of smokers turn to electronic cigarettes, rather than pharmaceuticals, in order to try to quit smoking, then the pharmaceutical companies stand to lose lots of money. So perhaps it is not surprising that Senator Lautenberg is standing up to protect the financial interests of the pharmaceutical companies over the interests of the public's health.

The behavior of the health groups is equally mystifying. But perhaps not so mystifying when you consider that the Clearing the Air blog points out that these groups received millions of dollars from a foundation which is largely underwritten by a pharmaceutical company. Might a financial interest explain why these health groups are sacrificing a huge potential benefit to the public's health for the protection of pharmaceutical company profits?

Electronic cigarettes pose a threat to pharmaceutical smoking cessation aids precisely because the pharmaceutical aids are so dismally ineffective. The rates of successful smoking cessation with these pharmaceuticals is less than 10%. Thus, the overwhelming majority of smokers who try to quit using pharmaceutical aids are unsuccessful.

Accordingly, there is a huge potential market for a nicotine delivery system (such as an electronic cigarette) that will be more popular with smokers. The fact that the e-cigarette system is similar to a cigarette may make it much more effective and popular for use among smokers who are trying to quit smoking.

To be sure, this is a potentially life-saving intervention. There is initial evidence that many smokers have found the e-cigarette to be an effective method for smoking cessation. Moreover, it makes sense that smokers would find it more attractive to use an e-cigarette than a nicotine patch.

Furthermore, we know that smokers almost never continue using nicotine replacement to stay off cigarettes. A very small percentage quit, but the overwhelming majority return to cigarette smoking.

In contrast, it is quite plausible that many smokers would find the e-cigarette to be an alternative to smoking and it may actually be more successful in keeping them off cigarettes. If true, this would literally save "countless lives."

But the anti-smoking movement is too much in bed with the pharmaceutical industry to allow this natural experiment to actually take place. The movement is so heavily funded by Big Pharma that it cannot risk the loss of pharmaceutical profits, even if disallowing the experiment comes at the expense of a substantial number of human lives.

While there must be oversight of the claims that e-cigarette manufacturers are making regarding the safety of the product, the attention should be focused on these claims, rather than on an outright ban on this type of cigarette.

Moreover, since the product is clearly being marketed primarily as an alternative cigarette, rather than as a smoking cessation aid, it should not fall under the regulatory jurisdiction of the FDA.

Once again, we see that the scientific evidence base and common sense reasoning are not guiding the tobacco control movement. It is, instead, being guided largely by money. The profits of both tobacco and pharmaceutical companies are being protected at the expense of the protection of the public's health.

It is truly a tragedy.

Smokers Not Allowed in Maternity Waiting Room of Royal Oldham Hospital

In what may be the first policy of its kind, the Royal Oldham Hospital has prohibited smokers from entering a public area of the hospital -- the maternity waiting room -- according to the Freedom to Choose web site. Dick Puddlecote's blog captured a picture of the sign outside the waiting room, which states: "In the interests of others, smokers are not allowed in this room."

The Rest of the Story

If you're straining to accept the credulity of the above, you did indeed read it correctly. The sign doesn't say: "smoking is not allowed in this room," it says "smokers are not allowed in this room."

To the best of my knowledge, this is the first policy ever in which smokers have been prohibited from entering a public place. All other smoke-free policies of which I'm aware have prohibited the act of smoking in various public places. I'm aware of no other policy that has banned smokers from entering a particular place.

Presumably, the "justification" for this policy is that smokers emit thirdhand smoke which could be harmful to patients in the waiting room.

Although there is no scientific evidence that thirdhand smoke -- such as the very minute levels of residual smoke constituents remaining in the breath of smokers or on their clothing -- poses any threat to health, let's go with this rationale for a minute and stipulate that the "claim" being implied by the Royal Oldham Hospital is accurate.

This raises two questions.

First, why would smokers be allowed in any areas of the hospital? After all, it is not just pregnant women who would be at risk from the toxins emitted by smokers. Even more at risk would be patients with respiratory disease. So you certainly wouldn't want to allow smokers on the respiratory floor. Nor would you want to allow smokers in the intensive care units. You certainly wouldn't want to allow smokers in the emergency room or emergency waiting room. In fact, if thirdhand smoke is really so much of a health risk that smokers cannot be allowed in the maternity waiting room, then they really shouldn't be allowed anywhere in the hospital.

Second, why would passive smokers be allowed in the maternity waiting room? If smoke particles that settle on the hair or clothing of a smoker pose a threat to women in the maternity waiting room, then wouldn't smoke that settles on the hair or clothing of a nonsmoker also pose a similar risk? So if a nonsmoker lives with a smoker, that individual's clothing is also going to be contaminated with residual smoke particles. Shouldn't these individuals also be prohibited from entering the waiting room? Shouldn't the sign say: "In the interests of others, active and passive smokers are not allowed in this room," or "In the interests of others, anyone who smokes or has been exposed to secondhand smoke is not allowed in this room."

This raises another interesting question. What if the pregnant woman who is waiting to deliver a baby is herself a smoker? Does this mean she cannot enter her own waiting room? Is there some secret, backdoor passageway into the delivery rooms that smokers must take? Are they asked to wait outside the hospital until their water breaks and then quickly and quietly ushered through hidden passages to get to the delivery room without going near anyone else?

To be consistent, why are only pregnant women afforded the protection of not having to be near smokers. Shouldn't we afford that same protection to infants after they are born? Perhaps the Oldham City Council should consider banning smokers from going within 20 feet of any infant. Of course, that would mean that smokers must not be allowed to enter the day care profession.

And why stop with infants. Children are also very susceptible to the effects of tobacco smoke. So Oldham should also prohibit smokers from being teachers, guidance counselors, or librarians, or from working in or entering a school.

You might ask: what would parents who are smokers do on teacher-parent night? This is not a problem. With advanced video technology, teachers could record a message about each student whose parent smokes and those parents could simply view the video without having to enter the school or classroom.

Astute readers might ask: what about smoking parents who want to pick up their infants from day care? Again, not a problem. Every smoking parent would be paired up with a nonsmoking parent. The nonsmoking parent would be in charge of going into the day care facility and picking up the infants of the smoking parents. The smoking parents would wait comfortably outside while their children are picked up by the nonsmokers. The risk of mixing up or losing a child would be minimal under this system.

Now the really insightful among you will ask the natural question: what about smokers who need to be admitted to the hospital? You can ban smokers from entering the hospital, but what if they are sick or injured and in need of medical attention.

Not a problem, I say. Simply set up a two-tiered system of medical care. You would have separate hospitals for smokers and nonsmokers. That way, the two would never cross paths.

Aha, you might say. What if a nonsmoker has a close family member who smokes, such as her husband? Does this mean that the husband cannot visit the wife while she is in the hospital? Well yes, but again, with advanced video technology, we could set up "virtual" visits with family members over the computer.

Another huge problem is what to do about infants or children whose parents smoke. Those infants and children are going to have clothing that is contaminated with smoke particles and they will therefore be a source of thirdhand smoke. What to do about those kids? Certainly, they cannot be allowed in day care centers or schools. The solution is to set up a two-tiered day care and education system, where there are separate day cares and schools for nonsmoking and passive smoking infants and children.

We already have peanut-free schools. I don't see why we cannot have "thirdhand smoke-free" schools. We already have smoke-free hospitals. I don't see why we cannot have thirdhand smoke-free hospitals.

Of course, there are a large percentage of nurses who smoke. This would not be a problem under my two-tiered system, because they could simply be assigned to work in the thirdhand smoke-laden hospitals. Similarly, teachers who smoke would be assigned to work in the thirdhand smoke-laden schools. The same is true for maintenance staff, administrative staff, and physicians themselves.

Under my policy, anti-smoking advocates should be happy, because it truly addresses the fact that, as reported in a recent Scientific American article: "Smokers themselves are also contaminated…smokers actually emit toxins [from clothing and hair]." Everybody is happy, and we can all peacefully co-exist.

Monday, March 23, 2009

Hayward Begins Ticketing Smokers on Public Streets and Sidewalks to Clean Up City's Image

In what is admittedly an attempt to clean up its image from the "unattractive" appearance of smokers in the city, Hayward (California) began last week to issue tickets to people caught smoking on public streets and sidewalks. The city enacted an ordinance in May which bans smoking in all areas owned by the city, including all public streets, sidewalks, and other public places.

According to an article in the San Jose Mercury-News: "Lighted cigarettes meant lightened purses and wallets for smokers who were caught puffing in public last week, as the city began enforcement of a smoking ban that technically went into effect last summer. The law, passed by the City Council last May, mandates a $50 fine for smoking on sidewalks, streets and other public places, including a 20-foot no smoking zone around outdoor patio areas of restaurants and bars, as well as parks, sports fields, playgrounds and municipal parking lots. ... Police in the area Thursday night issued six citations and four warnings, according to Hayward police Sgt. Steve Brown. 'It's trouble for people who smoke,' said Vic Kralj, owner of the Bistro on B Street, which has sidewalk seating that has traditionally been popular with smokers, but is now posted with "No Smoking" signs. He said a man cited for smoking on Wednesday was found to have outstanding warrants, prompting an arrest and a lot of police activity. 'That doesn't look good, to have six cops in front of your place in the middle of the day,' Kralj said." ...

"'Smoking is unattractive,' [city manager Fran] David said. 'Groups of people smoking can be intimidating to some people, and it may be preventing folks from shopping in Hayward.'"

The Rest of the Story

You know a movement is going too far when its justification for outlawing smoking in certain public places is that it is "unattractive."

I used to be part of a pro-health movement. The goal was, in part, to protect the health of nonsmokers by preventing them from substantial, unavoidable exposure to secondhand smoke.

I guess I missed the part about the movement's goal being to rid our cities of unattractive images, like smokers. I can think of a lot of things that are actually unattractive that we could ban if we wanted to clean up our cities, create a healthier environment for shopping, and bring more people into downtown commercial areas. Smokers are not on my list.

It's one thing to argue that smoking needs to be banned on all streets and sidewalks in order to protect the public's health. That's obviously an outrageous and unsupported argument, but at least it is based on some semblance (no matter how ridiculous and extreme) of a health concern. But to argue that smoking needs to be banned on all city streets and sidewalks because individuals smoking in public are unattractive seems to me to show the complete obliteration of what was once a science-based movement within the field of public health.

If the city wants to ban unattractive images from its streets, then why not do it directly? Just pass a law stating that unattractive people are not allowed on the public streets and sidewalks of Haywood. Or that they have to walk around with bags over their heads. Restrict the downtown streets to attractive models and I guarantee that the city will see an increase in retail store customers.

It appears that the city's new slogan should be: "Unattractive people stay home. You're not wanted in Haywood. You drive our business away."

Friday, March 20, 2009

Fine Print in FDA Legislation Shows that Supporters Know It Will Not Protect the Public's Health: Legislation is a Complete Scam

The fine print in the FDA legislation which I revealed yesterday is important not only because it demonstrates that the bill is unconstitutional, but because it exposes that the supporters of this regulatory approach realize that it will not actually protect the public's health. Thus, the FDA tobacco legislation is a huge scam, in which the Campaign for Tobacco-Free Kids and other groups are deceiving their constituents and the public into believing that the bill will result in safer cigarettes when the legislation itself acknowledges that this is not the case.

Remember that the fine print in question here is the following:

(1) The following statement of purpose of the legislation [section 2(46)]:

"If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending upon the particular language used and its context, such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."

(2) The bill's preclusion of tobacco companies from stating or implying that the FDA regulates cigarettes [section 103(tt)]:

[Cigarette companies may not make] "any statement directed to consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration, including a statement or implication in the label, labeling, or advertising of such product, and that could result in consumers believing that the product is endorsed for use by the Food and Drug Administration or in consumers being misled about the harmfulness of the product because of such regulation, inspection, or compliance."

The Rest of the Story

The fine print reveals that the crafters of the legislation do not themselves believe that the regulation of cigarettes will translate into a safer product. After all, they are admittedly worried that the public's belief that cigarettes will be a safer product by virtue of FDA regulation is false. In fact, they are so worried about this that they have taken the extreme step of interfering with the tobacco companies' free speech rights to preclude the companies from even telling the public merely that cigarettes are regulated by the FDA.

Readers need to appreciate the intrusiveness of this provision on the free speech of cigarette companies. If a company, for example, merely states the following in a press release, it will be in violation of the FDA legislation:

"Philip Morris admits that cigarettes are harmful to health. We are willing to comply with any regulations that the FDA promulgates to decrease the harmfulness of the product."

Can you imagine taking Philip Morris to court for that?

The legislation is so intrusive (unconstituionally so) because apparently its supporters acknowledge that the public may think that cigarettes are safer because of FDA regulation. There is apparently, therefore, no bona fide belief that FDA regulation will actually make cigarettes safer.

Yet the Campaign for Tobacco-Free Kids has claimed that the legislation is going to save "countless lives" by identifying and removing or eliminating toxic constituents from cigarette smoke and toxic ingredients and additives from the cigarette.

This whole thing is a big scam. The Campaign for Tobacco-Free Kids and other groups supporting the legislation actually have no idea whether cigarettes can be made safer merely by regulating particular ingredients, nor do they have any idea what constituents, in what combination, and at what levels, cause the various diseases associated with tobacco use. They have not offered a shred of evidence to support their contention that the bill will save even one life, much less "countless lives" by regulating the safety of the product and its ingredients.

There is no evidence base to support the primary approach being taken in this legislation. If anything, the approach runs counter to the existing science.

And apparently, the bill's supporters are aware of this, because they have taken great pains to make sure that the public does not even think that cigarettes might be made safer by virtue of FDA regulation.

The ultimate irony here is that the Campaign for Tobacco-Free Kids and other groups want to prevent the cigarette companies from telling the public exactly what these groups are telling them. The Campaign has done more to deceive the public into believing that cigarettes are going to be safer than anything that the tobacco companies have done regarding this legislation.

Hopefully, Senator Burr will be able to pull off a near-miracle and defeat this legislation in the Senate. I hope the Senators who oppose this bill succeed in exposing it for the scam that it is.

The public deserves a lot better than this con job.

Thursday, March 19, 2009

Major Section of FDA Tobacco Legislation is Blatantly Unconstitutional and Will Be Struck Down; Bill Will Give FDA Seal of Approval to Cigarettes

Today I reveal that a major section of the proposed FDA tobacco legislation currently being considered by the U.S. House of Representatives is blatantly unconstitutional as it interferes with the First Amendment free speech rights of tobacco companies and will almost certainly be struck down by the courts.


One of the major criticisms I have leveled against the proposed legislation is that it would give cigarettes an FDA seal of approval, thus undermining the public's appreciation of the hazards of smoking and providing the tobacco companies with a golden marketing opportunity. The companies could start boasting that their products are officially approved by the U.S. Food and Drug Administration and that they comply with all federal regulations and requirements regarding the safety of tobacco products.

Can you imagine statements on cigarette packages, advertisements, and web sites which state: "Our products are strictly regulated by the United States Food and Drug Administration. The FDA has approved this product for sale in the U.S. It meets all regulatory safety standards promulgated by the FDA."

To be sure, this would be a public relations bonanza for the industry. I would love to be on the public relations staff of a cigarette company after the law is enacted. Can you imagine the fun the public relations departments of the tobacco companies will have?

Well, apparently in response to my criticism on this point, supporters of the FDA tobacco legislation revised the bill to attempt to prevent the cigarette companies from gaining a public relations benefit from the approval of cigarettes by the FDA.

First, they added the following statement of purpose to the legislation [section 2(46)]:

"If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending upon the particular language used and its context, such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."

Thus, supporters of the bill have explicitly stated that they agree with my concern about the legislation. They acknowledge that the legislation will give cigarettes an FDA seal of approval and provide Big Tobacco with a golden public relations opportunity that will likely result in misleading the American public into believing that cigarettes are less harmful. The bill's supporters assert that communicating to the public that cigarettes are regulated, inspected, and/or approved by the FDA, or that cigarette companies are in compliance with FDA safety standards, will mislead the public and undermine the public's appreciation of the hazards of smoking.

In order to address this glaring problem, the bill's supporters inserted the following section into the legislation [section 103(tt)]:

[Cigarette companies may not make] "any statement directed to consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration, including a statement or implication in the label, labeling, or advertising of such product, and that could result in consumers believing that the product is endorsed for use by the Food and Drug Administration or in consumers being misled about the harmfulness of the product because of such regulation, inspection, or compliance."

By precluding the companies from making statements which assert or imply that cigarettes are regulated or approved by the FDA or that their company is in compliance with FDA regulations, the bill supporters hope to avoid the above problem.

The Rest of the Story

There's just one problem with this approach to the problem: it's unconstitutional.

Prohibiting cigarette companies from making statements which are demonstrably true, and which are undeniable, material facts, is clearly a violation of the First Amendment to the Constitution. The FDA legislation violates the cigarette companies' free speech rights by preventing them from making truthful, verifiable, and non-misleading statements of material fact. Furthermore, no government interest is directly advanced by this prohibition of truthful communication and the restriction is more intrusive than necessary to advance the government's interest in preventing the public from falsely believing that cigarettes are safer.

If the FDA legislation is enacted, it will be undeniably true and verifiable that cigarettes are regulated by the federal government. What government interest is directly advanced by prohibiting companies from making true statements about the regulation of the product and how is such a prohibition the most narrowly tailored approach to advance such an interest?

In 1995, the U.S. Supreme Court addressed a similar issue. Can the federal government prohibit alcohol companies from stating in their labeling the alcohol content of their products?

Because of concern that allowing alcohol companies to disclose the alcohol content of their products might lead to "strength wars" between various companies and to marketing based on the potency of various beer brands, Congress enacted section 5(e)(2) of the Federal Alcohol Administration Act which prohibited beer labels from displaying the alcohol content.

In the case, the U.S. Supreme Court held that the alcohol companies were disclosing "only truthful, verifiable, and nonmisleading factual information concerning alcohol content," and that precluding the communication of this truthful and non-misleading information neither directly advances a government interest nor is tailored narrowly enough to be the least intrusive measure available to advance that interest (see: Rubin v. Coors Brewing Co., 514 U.S. 476 [1995]).

In the case of the FDA legislation, the FDA has the authority to regulate the safety of cigarettes. Thus, a more narrowly tailored alternative to prevent the public from falsely believing that cigarettes are less harmful is to regulate cigarettes so that they are less harmful. And if the FDA cannot regulate cigarettes so that they are less harmful, then what exactly is the point of the legislation in the first place?

Ironically, in order to defend the law, the U.S. government would have to assert that it cannot make cigarettes safer by regulating the product. Otherwise, such regulation would constitute a less intrusive approach to ensure that the public does not falsely believe that cigarettes are safer. But if the government acknowledges that it cannot actually make cigarettes safer, then it has destroyed the very rationale behind the legislation in the first place.

I don't think there is any doubt that section 103(tt) will be struck down by the courts. That will leave the cigarette companies free to communicate to the public (correctly and truthfully) that their products are regulated by the FDA and that the companies are in compliance with the FDA's safety requirements for these products.

It will be a public relations field day.

Wednesday, March 18, 2009

Former "Winston Man" Speaks Out Against Hypocrisy in Anti-Smoking Movement

The man who was the face on Winston cigarette advertisements for six years - David Goerlitz - (who we are fortunate to have as a reader and commenter on the Rest of the Story) speaks out against what he sees as the hypocrisy in the anti-smoking movement, in an article that appeared Sunday in the Winston-Salem Journal.

According to the article: "David Goerlitz, the face of Winston cigarette advertisements for six years, is going through his second bout of disillusionment with the tobacco sector. The first came in November 1988 -- after Goerlitz served as the "Winston Man" for R.J. Reynolds Tobacco Co. from 1981 to 1987. That's when he spoke out against the industry and what he considered as manufacturers' practice of targeting youth worldwide with their products. Goerlitz has offered thousands of testimonial speeches to business and civic groups, as well as educational programs to as young an audience as elementary-school students. ...

"Recently, Goerlitz began speaking out about how politics within the anti-tobacco and health-advocacy fields has affected their message, and how the groups have marginalized his services with their own agendas ... : 'I became disillusioned when no one in power did anything about what could have been a wonderful opportunity to put health and welfare above politics. I guess it's true that greed always will outweigh fear. We got the tobacco industry to admit they would stop marketing to kids, after they had denied it for 50 years. My work was done, and my story was no longer relative. The manufacturers were going to be punished. Let the suits and experts and politicians sort the mess out, all the while being guaranteed an income for the next 25 years, including the Campaign for Tobacco Free Kids and the American Legacy Foundation. People like me were no longer needed to do programs. I was told, in many states I previously had worked in their schools, that studies had been done and research showed that it was not effective to have speakers who were former "addicts." When I was deposed as a fact witness in the early lawsuits, it was calculated that I had done more than 1,000 programs. Since 1998 (when the Master Settlement Agreement was established), I've done only about 250-300, which were repeat clients and schools that I had established a relationship with. Less than 5 percent of the MSA monies went to what it was originally intended for. The public is not aware of this. They seem clueless as to what you and I know about what this is really all about. In my opinion, the MSA should be overturned and ruled unconstitutional.'"

Goerlitz also lamented the loss of the grassroots nature of the tobacco control movement: "The grass-roots tobacco-control agencies, who had the same expectations that I had, no longer exist and they were bullied. My programs usually were/are covered by those agencies through grants. Even the small tobacco companies that were forced to pay the same amount to the states had no say in the negotiations. No one could grasp the enormity of the situation. It was simple -- keep making the little guy pay, keep the smokers arguing for their right to smoke and tax the hell out of them with illegal increases. All the while not realizing the tobacco companies were in cahoots with tobacco control."

The Rest of the Story

This is a very important perspective that David Goerlitz presents. It certainly supports my own perspective, presented through a large number of blog entries, that the tobacco control movement is filled with hypocrisy, has consorted with Big Tobacco in a sell out of the public's health, has created a financial partnership with the tobacco companies, and has destroyed its own grassroots base because of an overriding concern with seeking massive funding for a few national organizations that control all the power in the movement.

I can't possibly highlight all aspects of what David talked about, but let me mention just a few.

First, the Campaign for Tobacco-Free Kids is running a massive campaign of deception to promote the deal it negotiated with Philip Morris, which sells out the health of the American public (especially smokers and the African American community) in order to institutionalize tobacco use and nicotine addiction and protect the profits of the nation's largest tobacco company. The hypocrisy in the Campaign's actions is enormous, as it has criticized the companies for their own deception, but the Campaign is now itself massively deceiving the American public.

Moreover, the Campaign for Tobacco-Free Kids has coopted the entire tobacco control movement. It has taken everything into its own hands, going as far as putting itself out as the sole representative of the tobacco control movement and secretly negotiating with Philip Morris and making decisions regarding what sellouts would be acceptable in order to appease the interests of the nation's largest tobacco company. It didn't consult with the groups affected before selling out their rights and interests. In essence, the grassroots nature of the tobacco control movement has largely been destroyed.

Second, the American Legacy Foundation, while running an effective "truth" anti-smoking campaign, has had a difficult time telling the "truth." It has repeatedly failed to disclose the truth to the American public, and its front group - the Citizens Commission to Protect the Truth - also ran a campaign of deception, failing to disclose its funding from the American Legacy Foundation in a number of court cases. Legacy has also exhibited enormous hypocrisy, from its award given to companies that advertise tobacco to kids - which Legacy bemoans - to its refusal to give money to schools that take tobacco money while at the same time trying to get the tobacco companies to fund its own "truth" campaign.

In the shadow of these huge organizations, the grassroots nature of the tobacco control movement has already largely been lost. The FDA tobacco legislation threatens to completely undermine, if not altogether destroy, the grassroots tobacco control movement.

The Master Settlement Agreement, which created the American Legacy Foundation in the first place, is a huge public health disaster, as David notes. It created a permanent financial partnership between the states and the tobacco companies. There was never any real intention to allocate the money to tobacco control or do anything to protect kids. The true motivating factor was the desire to bring money into the states and to achieve political gains. The citizens of each state were used (I could think of other terms for it) by the Attorneys General to achieve their own selfish political gains.

I congratulate David Goerlitz for speaking out publicly. Hopefully, his perspectives will be seriously considered by leaders of the tobacco control movement and will result in serious change.

Tuesday, March 17, 2009

Evidence Mounting that Chantix May Be Associated with Suicidal Ideation and Behavior; Anti-Smoking Movement Plays a Role in This Possible Tragedy

According to a news article published in the current issue of the Journal of the American Medical Association (JAMA), evidence is mounting that supports the conclusion that use of the smoking cessation drug varenicline (Chantix) is associated with suicidal ideation and behavior in a substantial number of treated patients (see: Kuehn BM. Studies linking smoking-cessation drug with suicide risk spark concern. JAMA 2009;301(10):1007-1008).

According to the article: "A new analysis by the US Food and Drug Administration (FDA) adds to evidence that varenicline might be associated with an increased risk of suicidal thoughts and behavior, including among patients with no psychiatric history. The results, which were published in January, follow warnings from the agency that such a link is likely, as well as label changes noting a possible risk. ... An analysis of adverse event reports submitted to the FDA between May 2006 (when varenicline was approved) and November 2007 found 116 cases of suicidal ideation and 37 cases of suicidal behavior, more than half resulting in death. Half of the patients reporting either suicide ideation or suicidal behavior had a history of psychiatric problems, 26% had no such history, and 24% had an unknown psychiatric history."

The FDA report released earlier this year did not draw any definitive conclusions regarding the link between Chantix and suicidal behavior, although the data presented were cause for great concern. The report concluded: "Together, the AERS [Adverse Effect Reporting System] data suggest a possible association between suicidal events and the use of varenicline and bupropion. Healthcare providers are reminded to closely monitor patients for neuropsychiatric symptoms (e.g., changes in behavior, agitation, depressed mood, and suicidal thoughts and behavior) while they are using varenicline and bupropion as smoking cessation aids. Healthcare providers should report any cases of suicidal ideation and/or behavior in patients taking these drugs to FDA’s MedWatch program at www.fda.gov/medwatch/. Given the well-established health risks of smoking, healthcare providers should continue to work closely with patients to assist them in quitting smoking."

The Rest of the Story

While it is unfortunate that these possible serious, adverse effects of Chantix were not detected until post-marketing surveillance, the real shame in this story is that the anti-smoking movement played a role in this potential tragedy. The movement played a role in two ways.

First, a number of tobacco control researchers and experts failed to recuse themselves from a national expert panel making recommendations for the treatment of nicotine dependence by physicians, despite having significant financial conflicts of interest by virtue of their financial relationships with Big Pharma. This panel went against the evidence base and recommended that every patient be treated with pharmaceutical agents. The panel also recommended that Chantix be used, despite the reported and well-publicized adverse effects.

The presence of these massive financial conflicts of interests creates the appearance that the expert panel was influenced by financial considerations, rather than purely scientific ones. Researchers with financial relationships with pharmaceutical companies have no business making national recommendations for the clinical treatment and approach to nicotine dependence. It is imperative that such recommendations be made by unconflicted researchers. Otherwise, financial interests rather than purely scientific and public health considerations, will enter the picture. That represents a disservice to the public interest.

Second, national and international tobacco control conferences and organizations continue to prostitute themselves by accepting sponsorship from pharmaceutical companies, thus undermining the objective discussion of appropriate smoking cessation strategies and precluding the possibility of deriving and disseminating purely evidence-based recommendations regarding the use of pharmaceutical agents such as Chantix.

Most recently, the World Conference on Tobacco or Health, held last week in Mumbai, was sponsored by Pfizer (the maker of Chantix) and Glaxo Smith Kline, which manufactures a number of smoking cessation medications.

The rest of the story is that the anti-smoking movement has contributed to this possible tragedy by allowing money to interfere with objective science in making and disseminating national and international health policy and clinical practice recommendations. We all understand that health and science, and not politics, should determine clinical practice and health policy. But neither should financial interests affect public health practice and policy. In the case of the anti-smoking movement and smoking cessation practice and policy, money has unfortunately exerted a major influence. If the connection between Chantix and suicide turns out to be real, that undue influence of financial conflicts of interest could be the biggest tragedy of all.

Florida Policy Makers Trying to Protect Big Tobacco by Capping Appeals Bonds; Aim is to Preserve State's Payments from Tobacco Companies

According to an article in the Miami Herald, a movement is underway in the Florida legislature to cap the amount of bonds that the tobacco companies must pay in appealing smokers' lawsuits against them. The purpose of the proposed $100 million cap is to protect the hundreds of millions of dollars in payments that the tobacco companies make to the state each year under the terms of a settlement between Florida and Big Tobacco of its own litigation against the industry.

According to the article: "Bracing for the possibility of big verdicts in nearly 9,000 lawsuits in Florida brought by sick smokers, Big Tobacco is backing legislation that sets a $100 million cap on the collective amount of bonds that would have to be posted to file appeals. Sen. Mike Haridopolos, a Melbourne Republican, said he sponsored the bill because of concerns that large verdicts could threaten tobacco companies' ability to pay hundreds of millions to Florida each year under a landmark settlement reached in 1997. ''If they have all these verdicts against them, they could be forced to file for bankruptcy and we wouldn't get any of those settlement dollars,'' Haridopolos said. Losing parties that appeal a judgment are required to post a bond to cover the full amount of damages plus interest. The bond, usually purchased from an insurance company, guarantees the judgment will be paid if the appeals fail. Haridopolos' bill would eliminate the requirement that tobacco companies post a bond in each case once the value of the bonds reaches $100 million. The limit applies to tobacco companies collectively, not individually. Lawyers for smokers or their survivors contend the tobacco companies face no financial threat because the premium on an appeal bond is generally a fraction of the damages. ''They basically get a free appeal' after the $100 million is reached, said Stephen Barnes, a Tampa lawyer whose firm is handling more than 450 cases. 'This is an extraordinary handout and gift.'''

The Rest of the Story

This unprecedented, proposed bailout of Big Tobacco comes about solely because the state entered into a financial partnership with the tobacco companies by virtue of its settlement of litigation against the companies, in which Florida agreed to drop the lawsuit in return for the payment of hundreds of millions of dollars annually.

It was a brilliant maneuver by the tobacco companies, because they are essentially buying their way out of any serious future threat on their profits. As this story illustrates, state policy makers are jumping at even minor perceived threats to the financial stability of the companies in order to protect them.

This makes the bailout of the bank and car industries look small. Not only is the state bailing the companies out of trouble, it has forged a financial partnership with the companies which ensures that the state will never take any action that would seriously threaten Big Tobacco profits. In other words, the state will never take any action taht would seriously make a dent in smoking rates in the Sunshine State.

This is precisely why the Master Settlement Agreement was such a public health disaster, and why it is such a bad idea to tie cigarette tax revenues to critical government programs, such as children's health insurance (SCHIP). It creates a true financial partnership between the federal or state government and Big Tobacco. It removes any incentive for the government to take an action that would actually make a dent in smoking rates. It results in policy makers bailing out the industry and putting industry profits ahead of the protection of the public's health.

The tremendous public health damage that is done by the long-term financial partnership that is created between the government and Big Tobacco far more than offsets the short-term gains from the cigarette tax increase.

Thus, cigarette taxes, like state tobacco settlements, far from being a "win-win" situation for public health, may in some cases be a "win-lose" proposition.

It is unfortunate that tobacco control groups are unable to see the damage to public health protection that these policies are doing.

Monday, March 16, 2009

New Monograph Shows that Obesity is Equal to or Greater than Smoking in Terms of Health Care Costs to Employers; Will "Fat-Free" Workplaces Be Next?

The American Council on Science and Health (ACSH) has just released a new monograph which reviews the health effects and health care costs associated with obesity. Entitled "Obesity and its Health Effects," the monograph provides a comprehensive review of trends in obesity and overweight, the health effects (organized by chapters devoted to various body systems), and the health care costs.

The report concludes that obesity is the second most important public health problem in the United States, second only to cigarette smoking. But importantly, from the perspective of employer-related health care costs, obesity might even exceed smoking as a problem.

The report reaches a number of important conclusions relevant to the employer-related health costs of obesity. For one, while the overall mortality attributable to obesity is somewhat lower than that due to smoking, the years of life expectancy lost due to obesity are similar. This means that while obesity ultimately kills fewer people, those who die due to obesity generally die at a younger age.

The monograph points out that unlike cigarette smoking, obesity can have significant health effects even at a very early age. For example, it is estimated that about 40,000 adolescents in the U.S. have type 2 diabetes, mostly occurring in individuals who are obese. Obesity in childhood and adolescence also causes hypertension, high cholesterol, early signs of liver disease, gall stones, sleep apnea, and possibly asthma.

Thus, while employee smoking is mainly a concern as employees reach middle-age and beyond, obesity is a concern no matter what the age of the employee.

Second, the report notes that obesity may have a greater effect on morbidity than mortality. Thus, it is associated not only with lost productivity due to death, but also with expensive ongoing losses in productivity and treatment of people who remain alive. According to the monograph: "Obesity is associated with increased rates of a variety of diseases that can cause ongoing health impairment and require long-term treatment, such as diabetes, asthma, and osteoarthritis. The costs of treating these diseases are substantial. Obesity is also associated with increases in cardiovascular disease risk factors, including hypertension and abnormal levels of blood lipids. An individual's likelihood of dying of cardiovascular disease can be reduced if these risk factors are identified and treated, but diagnosis and treatment involve substantial costs for physician visits, diagnostic tests, and medicines.

Overall, the monograph concludes that: "Because of the health conditions associated with obesity, the health care costs of obesity may be in the same range as those of cigarette smoking, even though obesity is responsible for fewer deaths."

According to the monograph, the direct health care costs associated with obesity in the United States, are about $75 billion, while those attributable to smoking are about $75.5 billion per year. The direct health care costs attributable to obesity account for 9% of all health care costs in the U.S., of which about half are paid by Medicare and Medicaid. When indirect costs, such as lost productivity, are factored in, total health care costs associated with obesity are about $117 billion annually.

Finally, while smoking rates are generally decreasing in the U.S., the rates of both obesity and overweight are increasing steadily. Thus, obesity is likely to be an increasing source of higher health care costs for employers long into the future.

The Rest of the Story

An important policy implication of the findings in this monograph is that the precise reasoning being used by anti-smoking advocates to support smoker-free workplace policies also justifies policies by which obese or overweight individuals would not be considered for employment. The exact argument being used by anti-smoking practitioners to advocate for these smoker-free employment policies should, in fact, also be used to keep obese and overweight people out of the workplace, if they are to be consistent in their application of policy.

The findings in this monograph disallow as a justification for the singling out of smokers for non-employment the argument that smoking is the only behavior which produces such enormous costs for employers. Obesity is every bit as much of a problem from the standpoint of employee health care costs. If keeping smokers out of the workplace is justified on the basis of the health care costs they impose, then keeping obese and overweight people out of the workplace is also justified on the same grounds.

One also cannot argue that smoking behavior can easily be changed, while one's weight cannot. If anything, in my clinical experience, people are much more easily able to lose weight than they are to be able to quit smoking. While a sizable proportion of my patients were able to lose substantial amounts of weight, very few of my patients successfully quit smoking. Besides, we can't have it both ways. We can't on the one hand argue that smoking is an addiction and take the cigarette companies to court on the grounds that smokers do not make a free decision about smoking and then on the other hand argue that anyone who wants to quit smoking can easily do so.

To be clear, I think that a policy of throwing out the job applications of obese individuals would be discriminatory, unjustified, and disgusting. But employers who are throwing out the job applications of smokers are doing exactly the same thing and on exactly the same grounds.

Refusing to hire smokers is not only discriminatory, it is also unjustified and disgusting.

Friday, March 13, 2009

Cornell University Considering Complete Ban On Campus Smoking in Order to Have a Safer and Healthier Environment to Work In

According to an article in the Cornell Daily Sun, campus anti-smoking advocates and the local American Cancer Society are supporting a push to ban smoking on the entire campus. The university's current policy already bans smoking in all buildings, including residence halls, and within 25 feet of any building.

According to the article: "Discussion about making Cornell a smoke free campus was recently proposed to the University Assembly by Beth McKinney, employee elected trustee and director of the Cornell Wellness Program. McKinney said that she proposed the idea to the U.A. because the employee assembly had received several suggestions, prompting them to put it on their list of possible projects. The U.A. agreed that it was an interesting topic for discussion, but has not yet made any concrete plans. According to the American Nonsmokers’ Rights Foundation’s website, as of Jan. 4 there were at least 260 colleges and universities around the country that have gone smoke free, including numerous colleges and universities in New York: Cazenovia College, D’Youville College, Maria College, State University of New York-Buffalo, SUNY-Upstate Medical University and Wells College. McKinney said that there would be challenges if Cornell instituted this policy that these other colleges did not face. 'Most of the schools that have gone smoke free are much smaller than Cornell,' McKinney said, noting how Cornell’s size would make instituting the policy very difficult to enforce. ... McKinney, however, explained the benefits of enacting this policy regardless of the challenges. The data suggests smoke free campuses increase the health of the on-campus population."

The expansion of the no-smoking policy to include the entire campus is being supported by the local American Cancer Society, whose director for strategic health alliances was quoted in the article as stating: "We would love to work with [the University]. We would help them in crafting a policy, setting up a timeline, and providing adequate training for supervisory staff that will have to enforce the policy. It should not be promoted as negative. It should be promoted as wanting people to have a cleaner, healthier, safer environment to work in — we know you are valuable resources and we want to protect that."

The Rest of the Story

For those who have never been to Cornell, it is a very widespread and somewhat rural campus with lots of open space. There is absolutely no need to ban smoking throughout the entire campus in order to adequately protect nonsmokers from exposure to secondhand smoke.

As my regular readers know, while I support banning smoking indoors, I do not believe all-out smoking bans on college campuses are warranted, because in outdoors locations people are free to avoid the exposure. This is especially true of a campus environment like that at Cornell.

So the question becomes: what is the rationale for a complete smoking ban on the Cornell campus, it it's not to protect nonsmokers from secondhand smoke exposure?

From the article, it appears that the anti-smoking advocates are considering doing this simply because "everybody else is." And the American Cancer Society is supporting it because it will create a "safer and healthier" environment. But if the problem is not secondhand smoke exposure, then how is it a safer and healthier environment if smokers are forced to go off campus to smoke? Making smokers walk down the hill into the town to smoke doesn't make the campus safer. Smokers are not endangering anyone else if they are not exposing them to secondhand smoke.

Thus, the issue comes down to lifestyle control. It is a coercive intervention that is unduly paternalistic. If that's acceptable, then what is the justification for allowing alcohol use on the campus? Alcohol use is arguably a far greater health and safety problem on the campus. It would truly make the campus a safer and healthier environment to eliminate all alcohol use. But I don't sese the health advocates pushing for that. It is only smoking that is an intolerable unhealthy behavior. All other unhealthy behaviors are tolerable.

In other words, I am asking whether what we are truly seeing here is health promotion, or whether it is actually intolerance for a particular lifestyle decision.