Friday, May 29, 2009

IN MY VIEW: Why Has the Science in Tobacco Control Deteriorated So Much? Because the Tobacco Industry Has Relinquished its Watchdog Role

Yesterday's story about the new study which, based on a cross-sectional correlation between greater enforcement of youth access to tobacco laws and youth smoking rates, concluded that there was a causal relationship, got me thinking about the reason for the deterioration of much of the science in tobacco control that I have been observing during the time I have been writing this blog.

And I think I've uncovered the primary reason for this deterioration: the tobacco companies have relinquished their role as watchdogs over the anti-smoking movement and its scientific claims.

To the best that I can pinpoint it, this shift occurred some time around 2000. Coincident with the tobacco companies' acknowledgment of the health hazards of cigarette smoking, it appears to me that they also changed their strategy with regards to challenging the scientific pronouncements of anti-smoking groups. Prior to that time, the tobacco companies would vigorously challenge the results of anti-smoking advocates' published studies. They would issue press releases, make public comments in newspaper articles, even take out advertisements challenging these conclusions.

But for about the last nine years, the tobacco industry has -- presumably as part of a concerted, strategic decision -- laid low and allowed the anti-smoking advocates' and groups' scientific claims to remain unchallenged. They have remained relatively quiet and are basically allowing the anti-smoking scientific claims to remain unchallenged in the public eye.

I'll tell you why I think this is the critical factor that has led to the deterioration of the quality of tobacco control science.

Back in the 1990's, any time anti-smoking researchers or groups would publish scientific papers, they would be very worried about the potential reaction of the tobacco companies. Prior to submitting any paper, researchers would consider the questions "What will the tobacco companies say?" and "How can we make sure we can defend these conclusions against potential tobacco industry criticism?" The same was true of conclusions disseminated by anti-smoking groups.

In fact, much of my role in the movement was to serve as a source for assessment of the strength of conclusions being made by anti-smoking groups before they went public with them. Every day, I would get calls from anti-smoking groups asking me to review their fact sheets to make sure they were solid and that the claims would be defensible against any potential tobacco industry attacks.

There was a pervasive sense of fear among all of us in tobacco control that if we slipped in the slightest, the tobacco companies would be there to attack us and publicly shoot down our statements.

Thus, we were extremely careful in drawing conclusions. There was a much higher burden of evidence required before causal conclusions were drawn. A single cross-sectional study would almost never be relied upon to draw a causal conclusion, for example.

Without the tobacco companies playing their watchdog role, however, there is no longer this sense of fear. There is no longer a concern about results being attacked or conclusions being challenged. It has become essentially a free-for-all, where anything goes and no one has to worry about their conclusions being challenged. In fact, the movement has evolved into one where challenging its conclusions is tantamount to working for the tobacco industry. Anyone who does challenge the conclusions of the movement is attacked and accused of being a tobacco industry mole or sympathizer. Thus, there is little threat that conclusions of anti-smoking researchers or groups will be challenged in the first place or that if challenged, the individual criticizing the conclusions will be taken seriously.

Back in the day, for example, we would never calculate population attributable risk based on the results of a single study. We would wait until multiple studies provided confirmation of a causal link and only then would we produce estimates of the total population burden of the exposure. Now, a single study suffices for researchers to make population estimates. Just yesterday, I discussed a study where based on a single cross-sectional study, a researcher estimated the total number of smokers prevented by youth access laws nationally. The American Legacy Foundation used a single study to estimate the total number of deaths prevented by the "truth" campaign. Other researchers used a single study to derive estimates of the number of youths who would be prevented from smoking by giving movies that depict smoking an "R" rating.

Ironically, the Rest of the Story is one of the only watchdogs there is to monitor the quality of science in tobacco control.

In the long run, I believe the tobacco companies made a wise decision. First, they help shed their public image as corporations that are undermining the scientific conclusions of the health community. Second, by letting the anti-smoking groups run rampant, they probably realize that these groups will eventually destroy their own credibility by making more and more outlandish statements, until finally, the public loses faith in the scientific integrity of these anti-smoking groups.

Ironically, the tobacco companies actually have a lot more legitimate criticisms of the validity of anti-smoking groups' scientific claims now than they did during the time when the companies were actually challenging these claims.

Another interesting aspect of this story is that I have realized that the peer review process is not necessarily adequate to protect against the publication of poor quality science. The tobacco industry actually played a much more effective role in safeguarding the quality of tobacco control science in the past than the peer review process does now.

Thursday, May 28, 2009

New Study Concludes that Enforcement of Tobacco Sales Laws Reduces Smoking Among Adolescents: But How Good is the Science to Support its Conclusion?

A new study published in the journal BMC Public Health concludes that the enforcement of tobacco sales laws (which prohibit the sale of cigarettes to minors) leads to a reduction in youth smoking.

The study concludes as follows: "This analysis of national data covering 7 years indicates that improvements in merchant compliance that were measured in the U.S. from 1997–2003 as states complied with the Synar Amendment predicted a 20.8% reduction in daily smoking among 10th graders in 2003. ... This is the first study to document that the Synar Amendment achieved its intended effect of reducing adolescent smoking. The current study adds to a substantial body of evidence that demonstrates that improvements in merchant compliance are associated with reduced daily smoking among adolescents. This is the first study to demonstrate an effect of enforcement of tobacco sales laws on a national level. This is important because of concerns that only isolated rural communities could be successful in this regard. This U.S. national study demonstrates that this approach can be effective across an area encompassing wide geographical and demographic variety."

A press release that accompanies the study states: "Our data suggest that a 25 percent increase in compliance of laws prohibiting cigarette sales to minors has about the same deterrent effect as increasing the price by $2.00."

The Rest of the Story

The first thing that should make the reader very suspicious about the validity of the study's conclusions as well as the objectivity of the study is the fact that the paper ignores the existing published research, including a large meta-analysis of numerous studies, which fails to find any relationship whatsoever between merchant compliance rates and youth smoking. That meta-analysis is not even referenced in the article.

The meta-analysis concluded: "Based on data from 9 studies, there was no detectable relationship between the level of merchant compliance and 30-day (r = .116; n = 38 communities) or regular (r = .017) smoking prevalence. There was no evidence of a threshold effect. There was no evidence that an increase in compliance with youth access restrictions was associated with a decrease in 30-day (r = .294; n = 18 communities) or regular (r = .274) smoking prevalence. There was no significant difference in youth smoking in communities with youth access interventions compared with control communities; the pooled estimate of the effect of intervention on 30-day prevalence was -1.5% (95% confidence interval: -6.0% to +2.9%). Conclusions. Given the limited resources available for tobacco control, as well as the expense of conducting youth access programs, tobacco control advocates should abandon this strategy and devote the limited resources that are available for tobacco control toward other interventions with proven effectiveness."

It is quite odd that this meta-analysis would be completely ignored and very curious that it is not even referenced in the paper. Any article with any objectivity dealing with this issue would surely reference the meta-analysis and its findings to have any credibility whatsoever on the issue of the existing literature.

The second thing that should catch the observant reader's eye is the fact that this conclusion of a causal effect comes from a purely correlational study. The study is a cross-sectional one. It correlates youth smoking rates at a single point in time with the rates of compliance with tobacco sales laws. The study does not document that tobacco sales laws have produced any change in youth smoking rates.

This is a critical flaw in the study, and while it does not render the study useless, it does mean that the study fails to demonstrate that the tobacco sales law enforcement is the cause of the reduced smoking rates. A very plausible, and likely, alternative explanation for the observed findings is that communities with lower levels of youth smoking -- probably due to greater anti-smoking sentiment -- were more likely to vigorously enforce the tobacco sales laws.

We know that communities with stronger anti-smoking sentiment are more likely both to have lower youth smoking rates and to engage in interventions to reduce smoking, such as enforcing youth access laws. This is the classic problem of a confounding variable which is related to both the predictor and the outcome variable and which serves as an alternative explanation for the observed relationship between the predictor and outcome variables.

The study does not measure the states' anti-smoking sentiment, smoking prevalence, or any other state-level measures that might give some indication as to these factors, such as education levels or income. In addition, the study does not even measure the presence or absence of state and local restaurant smoking bans, which might have served as at least a proxy for the level of anti-smoking sentiment in these states.

Especially when viewed in light of the existing evidence, this study is non-convincing. It is clearly unable to demonstrate a causal relationship between enforcement of youth access laws and reduced smoking among adolescents. However, the study is a good example of the pitfalls of assuming that correlation equals causation.

Wednesday, May 27, 2009

Appeals Court Upholds Denial of Monetary Remedies in Department of Justice Tobacco Lawsuit

This Demonstrates that Anti-Smoking Groups Were Wrong in their Attacks on Associate Attorney General Robert McCallum

Last week, the United States Court of Appeals for the District of Columbia largely upheld the district court's opinion in the Department of Justice's racketeering lawsuit against the tobacco companies. While anti-smoking groups have focused their publicity on the upholding of the racketeering verdict against the companies, I believe the most important aspect of the appellate court's decision was its upholding of the district court's denial of monetary remedies against the tobacco companies.

To refresh our memories, the Department of Justice, along with several intervening anti-smoking organizations --the Campaign for Tobacco-Free Kids, the American Heart Association, the American Lung Association, the American Cancer Society, and Americans for Nonsmokers' Rights -- had requested three monetary remedies: (1) a national anti-tobacco counter-marketing campaign (to be administered by the American Legacy Foundation or a similar organization); (2) a national smoking cessation program; and (3) a youth smoking reduction program, where companies would have to pay fines if youth smoking prevalence did not drop by specified amounts.

In addition, several of these anti-smoking organizations had attacked then-Associate Attorney General Robert McCallum, accusing him of intentionally undermining the case by reducing the requested amount of the smoking cessation remedy from $130 billion to $10 billion and arguing that he was doing this to protect Big Tobacco because of his having been a "former tobacco industry lawyer."

In an extensive set of commentaries, I criticized the anti-smoking groups for: (1) deceiving the public about McCallum, as he was never a tobacco industry lawyer, but merely a partner in a law firm that represented a tobacco company (McCallum never represented the company himself); (2) issuing an unwarranted and undocumented barrage of personal, political attacks against McCallum; and (3) disregarding the clear law governing the case, which made it obvious that monetary remedies of the type being sought were not consistent with the RICO statute.

Further, I argued that none of the requested monetary remedies would be allowed by the Appeals Court because they were backwards-looking remedies intended to remediate the effects of past wrongdoing, rather than to directly prevent and restrain future RICO violations, which is the only rationale for a civil remedy that is allowable under the RICO statute.

The tobacco companies appealed the district court's decision because they wanted to overturn the racketeering finding. The government cross-appealed because it wanted to overturn the district court's decision to disallow any monetary remedies in the case.

The Appeals Court's Decision

The Appeals Court upheld the district court's decision to disallow all three types of monetary remedies that were requested by the government and the anti-smoking groups.

The counter-marketing and smoking cessation remedies were disallowed by the Appeals Court because they are not aimed at preventing and restraining future RICO violations, but at remedying the effects of past violations, which is not consistent with the RICO statute.

The Court writes: "This [the government's and intervenors'] argument overlooks the explicit instruction of section 1964(a) that district courts may only order remedies 'to prevent and restrain violations of [RICO].' 18 U.S.C.1964(a). Future cigarettes sales, even to addicted smokers, are not by tehmselves RICO violations. The proposed remedies attempt to prevent and restrain future effects of past RICO violations, not future RICO violations, therefore they are outside the district court's authority under section 1964(a). Even those courts that would allow some version of disgorgement under section 1964(a) recognize that the statute is limited to preventing future violations and does not extend to future effects flowing from past violations."

In terms of the youths smoking reduction plan remedy goes, the Court writes: "The intervenors' argument in favor of the youth smoking reduction proposal is based on the incorrect assumption that the underlying RICO violation to be prevented and restrained is Defendants' youth marketing, rather than the false denials of their efforts to market to youth. As noted above, we need not decide whether such denials amounted to RICO violations. Even if they did, the district court correctly concluded that an injunction aimed solely at reducing youth smoking rates does not address the section 1964 goal of preventing and restraining the underlying RICO violation. The intervenors' argument is unavailing."

The Rest of the Story

What this decision demonstrates is that the anti-smoking groups were wrong in their attack on McCallum and their insistence that the reduction of the $130 billion smoking cessation remedy to $10 billion represented an undermining of the case designed to aid the tobacco companies. As it turns out, that change had no effect on the government's case because, as I argued, no smoking cessation remedy was allowable in the first place.

As I wrote on August 18, 2006: "McCallum's decision to substitute a $10 billion smoking cessation remedy for a $130 billion smoking cessation remedy had no impact whatsoever on the case, because as Judge Gladys Kessler ruled, $0 of smoking cessation remedy was allowable under the D.C. Appeals Court's interpretation of the RICO statute."

If anything, McCallum's insistence on changing the request for a massive $130 billion smoking cessation remedy helped the Department of Justice save face somewhat.

Now it will be interesting to see if the anti-smoking groups apologize to McCallum and retract their political accusations, which have now been shown to have had no reasonable basis or merit. Americans for Nonsmokers' Rights (ANR) went so far as calling McCallum a "cancer" in the Justice Department. Certainly, ANR owes Mr. McCallum an apology. It will be interesting to see if ANR retracts its attack and apologizes.

Other groups which had attacked McCallum, accusing him of political interference, and which therefore need to retract their attacks and apologize, include the Campaign for Tobacco-Free Kids and the Stan Glantz Announcement List-Serve.

Tuesday, May 26, 2009

According to U.S. Senator, Philip Morris Was An Author of FDA Tobacco Bill; Campaign for Tobacco-Free Kids Has Apparently Been Lying to the Public

When asked to explain the support of Philip Morris - the nation's largest cigarette company - for the FDA tobacco legislation, the Campaign for Tobacco-Free Kids led its constituents to believe that it was merely a coincidence. And when a major Beltway newspaper reported that the legislation was the result of a negotiation with the largest company within Big Tobacco, the Campaign accused the paper of inaccurate reporting.

Now, however, an impeccable source of insider knowledge about the process that led to the FDA tobacco bill - a United States Senator - has indicated that Philip Morris was not only involved in the negotiations around the legislation but that the nation's leading cigarette company actually co-authored the bill.

According to a statement by Senator Mike Enzi (R-WY): "Trying to make cigarettes safer through a billion-dollar bureaucracy is a waste of time and money. This bill will do nothing to help people quit smoking, or stop kids from taking up this deadly habit. We need to fight the war on tobacco head on, not sign a peace treaty with Philip Morris, one of the authors and strongest supporters of this bill."

According to the statement, which was entitled "Peace Treaty with Philip Morris No Way to Win War on Tobacco," Senator Enzi "denounced HELP Committee approval of a bill requiring the Food and Drug Administration (FDA) to regulate tobacco, arguing that the bill would do nothing to stop anyone from smoking or help them quit, and would place new burdens on a struggling agency."

Enzi was particularly critical of the effect the bill would have on undermining the very mission of the FDA: "When the HELP Committee last marked up this legislation, things were rocky at the FDA. Now they are critical. That agency simply cannot be tasked with regulating tobacco, or its entire public health mission could collapse. FDA approves cures, not poisons. Food safety and drug safety have to be the top priorities for FDA. ... We should be focusing our efforts on increasing the number of inspectors, and on updating the food safety authorities, not on adding an impossible burden that perverts the agency's mission."

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids has been lying to its own constituents and to the public about the history and nature of the FDA tobacco legislation. As it turns out, the truth of the matter is that not only was the legislation a result of a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, but the nation's leading cigarette company was one of the authors of the bill.

In other words, not only was the fox guarding the henhouse, but the fox got to write the rules governing the guarding of the henhouse.

No wonder there are so many loopholes in the bill which weaken the FDA's regulatory authority and protect the special interests of Big Tobacco. No wonder the bill contains unprecedented special protections for Big Tobacco that are not enjoyed by any other industry whose products are regulated by the FDA. No wonder the bill will do nothing to help people quit smoking or prevent young people from taking up this deadly habit. No wonder the bill's "solution" to the tobacco problem is to create a bureaucracy, lace it with an impossible mission, and ties its hands from doing anything that would truly be effective.

Regardless of one's position on the legislation, I believe it is unethical for the Campaign for Tobacco-Free Kids to have lied to its constituents and the public. For that, we deserve an apology (for starters).

Senator Enzi is right on the mark when he argues that the legislation does nothing to help smokers quit or to stop youths from taking up the deadly habit. There is no money in the legislation for smoking cessation programs, nor does the bill provide any programs to stimulate smoking cessation. There is no money in the bill for youth smoking prevention programs, nor does the bill do anything meaningful to keep kids from smoking. The advertising restrictions in the bill are not going to be effective, as the more stringent rules will most certainly be challenged by the tobacco companies and overturned by the Supreme Court, which has already indicated its position on this issue. So it is truly a waste of time and money - the creation of another ineffective bureaucracy - just as Senator Enzi charges.

Senator Enzi is also on the mark when he argues that the bill will pervert the basic mission of the Food and Drug Administration. The agency will be put in the position of approving cigarettes for sale and consumption in the United States. This is, indeed, a perverse position for the federal government to be in.

When the U.S. Senate convenes next week, it will likely enact this Philip Morris-authored legislation into law. Inside sources who are familiar with the bill's support in the Senate have indicated to me that there are more than the 60 votes necessary to force cloture and bring the bill to a final vote. Thus, it is almost certain that the legislation will become law.

While the devastating effects of this bill on the public's health has to be the worst aspect of this story, what makes the story even worse is the fact that it comes about as a result of letting the nation's largest cigarette maker write and negotiate its own legislation. The Campaign for Tobacco-Free Kids not only allowed that, made it possible, and willingly participated in it, but the Campaign also lied about it to its constituents and widely deceived the public.

Next week will cap off not only one of the worst chapters in recent public health history, but also one of the worst chapters in the history of unethical actions by the tobacco control movement.

Friday, May 22, 2009

Senate Committee Approves FDA Tobacco Bill; Aims to Put FDA in the Position of Approving Cigarettes for Sale and Consumption

Late Wednesday night, the Senate HELP (Health, Education, Labor & Pensions) Committee sent forward to the full Senate a bill (already passed by the House) which would put the Food and Drug Administration (FDA) in the awkward position of having to approve cigarettes for sale and consumption in the United States. The FDA, whose existing mission is to approve drugs and drug delivery devices for sale on the basis of their safety, would be in the position of having to approve a deadly product which kills about 400,000 Americans each year.

An article in the Louisville Courier-Journal quoted Wyoming Senator Michael Enzi, the ranking Republican on the committee, as arguing that the “FDA approves cures, not poisons.” The committee vote was largely upon party lines, with 12 of 13 Democrats voting for the bill and 7 of 10 Republicans voting against it.

The bill has recently come under criticism for its inconsistency in banning clove flavoring from cigarettes but not menthol. Clove cigarettes make up less than one-tenth of one percent of cigarettes sold in the United States, while menthol cigarettes account for 28% of domestic sales. Indonesia may initiate a trade complaint against the United States. According to a Bloomberg news article: "The case will depend on 'whether there is anything about cloves that allows you to say this is a health and safety issue.' ... A trade complaint by Indonesia would hinge on whether the U.S. can prove to the WTO that it’s banning clove cigarettes for health reasons and not to protect domestic producers."

The Rest of the Story

This legislation is imprudent, as it would completely undermine the FDA's mission by asking it to approve a deadly product for sale and consumption in the U.S. This foolishness is apparently an acknowledged concern of Senate bill supporters, who are worried that approval of cigarettes by the FDA might cause consumers to get a false sense of security about the safety of the product. Thus, the Senators on the HELP Committee who sent the legislation forward amended it to prevent the tobacco companies from communicating the truth to consumers: that the legislation puts the FDA in the position of approving cigarettes for sale in the United States.

As I have argued earlier, this is likely an unconstitutional provision, as truthful speech is strongly protected under the First Amendment. The cigarette companies will likely challenge this provision and I believe there is a good chance it will be overturned.

But beyond the legal implications, how good can the bill be if its supporters have to add a clause prohibiting the truth about the bill from being communicated to the American people?

While a trade complaint by Indonesia would not likely be successful, the concern about discrimination in the legislation does point to an astute argument against the bill: it does preferentially and inconsistently protect U.S. cigarettes. While menthol and clove are both cigarette additives, the bill is discriminatory by banning the flavoring which is hardly used at all in U.S.-made cigarettes and exempting the flavoring that is common in domestic cigarettes.

By aproving cigarettes, the federal government will join the tobacco companies in being culpable in the deaths of thousands of Americans annually from cigarettes. This is hardly a reasonable position for a federal agency whose charge is to protect the health and safety of the American public.

Wednesday, May 20, 2009

My Interview on E Cigarette Direct Posted Today

My interview with E Cigarette Direct about public policy and scientific issues related to electronic cigarettes and tobacco control appears today. My thanks to the folks at E Cigarette Direct for the opportunity to share my views.

Note: E Cigarette Direct is conducting a survey to assess the experiences of electronic cigarette users, including their success or lack of success in keeping off conventional cigarettes. I link to it here so that electronic cigarette users who are reading this blog have an opportunity to share their own experiences.

Tuesday, May 19, 2009

Based on Conclusions of New Study, Philip Morris Should be Congratulated for Designing a Safer Cigarette and Should be Allowed to Advertise It As Such

As reported here by the Associated Press, and as discussed earlier on this blog, a new unpublished and non-peer-reviewed study by Dr. David Burns of UCSD has concluded that the observed increase in the risk of adenocarcinoma of the lung among smokers is due to an increased nitrosamine content of cigarettes over time. I reported that this conclusion is little more than speculation and that there are alternative hypotheses for the observed changes in lung cancer risk, such as the introduction of low-yield cigarettes which caused smokers to inhale more deeply, delivering more tar to the distal and more susceptible part of the airway. I also criticized the release of the study's conclusion as an example of science by press release, especially since it was so clearly timed to coincide with the Senate's consideration of FDA tobacco legislation, which the study aims to positively influence. Finally, I showed that the study actually demonstrates the folly of the proposed FDA legislation and shows why the bill would create a situation that perpetuates, rather than ends, the fraudulent deception of American consumers regarding the risks of cigarette smoking and changes in those risks associated with changes in cigarette design.

Today, I want to note that the conclusions of Dr. Burns' study -- taken on face value as accurate -- indicate that Philip Morris should be congratulated for having produced a safer cigarette. The Associated Press article, which appeared in the Sacramento Bee, reveals that Philip Morris has succeeded in developing cigarettes with lower levels of nitrosamines. According to the article: "Philip Morris, which supports FDA tobacco regulation, began taking steps with its growers in 2000 that have yielded "significantly lower" nitrosamine levels in recent years' supplies, Sutton [a Philip Morris spokesman] said."

If we accept Dr. Burns' argument, then we must also accept that Philip Morris, by reducing nitrosamine levels in its cigarettes, is reducing lung cancer risk for its smokers and saving lives. We should also accept that Philip Morris has produced a safer cigarette. And we should allow Philip Morris to communicate to consumers that its cigarettes are now safer by virtue of their reduced levels of nitrosamines.

Unfortunately, it just isn't that simple. We just are not able to draw simple conclusions about the relationship between cigarette constituent yield and disease risk, like Dr. Burns has done in his "study." As another tobacco control expert - Dr. Neal Benowitz - is quoted as saying in the same article: "Be careful in assuming lower-nitrosamine cigarettes are less lethal."

The whole point is that we cannot make the assumption that reducing the yield of particular constituents in cigarettes results in a safer cigarette. With the case of low-yield cigarettes, that has clearly not been the case. In fact, as Dr. Burns himself acknowledges, the lung cancer risk of these low-yield cigarettes is actually higher.

Falling into this trap does a disservice to the American public because it leads consumers to believe that cigarettes will be safer when they actually are not. They could even be more dangerous. The FDA legislation essentially makes smokers guinea pigs to try out different ideas about changing the cigarette design but without knowing what the effect will be. But consumers will naturally assume that by virtue of the FDA requiring these changes, cigarettes must be safer.

In other words, the FDA legislation is one big scam. Smokers, and the protection of the public's health, are the big losers. Philip Morris is the big winner.

There's no question that Philip Morris should be congratulated. But not for creating safer, lower-nitrosamine cigarettes. What they should be congratulated for is having the brilliance to correctly guess that if they threw the prospect of weak FDA regulation of tobacco products out in front of the Campaign for Tobacco-Free Kids, the Campaign would bite. Philip Morris must have known that the Campaign would be enticed by the prospect for a pyrrhic victory. After all, being perceived as a victor seems to be the utmost concern of this self-important organization. Even if it comes at the expense of the long-term future of tobacco control and public health and the long-term institutionalization of conventional tobacco products into our societal infrastructure.

Monday, May 18, 2009

IN MY VIEW: ATTUD's Argument to Ban Electronic Cigarettes Makes No Sense

Last Thursday, I revealed that the Association for the Treatment of Tobacco Use and Dependence (ATTUD) had issued a press release and written a letter to the FDA requesting that electronic cigarettes be taken off the market, but had not disclosed the financial conflicts of interest of the letter's authors with pharmaceutical companies. Today, I address the substance of ATTUD's argument.

The basic premise of ATTUD's argument is that electronic cigarettes should be "removed from the market until and unless they are proven safe and effective." The authors do not even speculate about how electronic cigarettes may be unsafe. Nor do they address the question of safe compared to what? If you compare inhaling nicotine with inhaling water vapor, of course inhaling nicotine is not going to be safe. But if you compare inhaling nicotine with inhaling tobacco smoke, it's quite a different story.

From a public health perspective, the important consideration is not whether electronic cigarettes have been proven to be safe, but whether there is strong reason to believe that these products are much safer alternatives to cigarettes that are helping many people stay off cigarettes. There is strong evidence that both of the above premises are true: there is little question that electronic cigarettes are much safer than conventional cigarettes and there is abundant evidence that many smokers are using these products successfully to stay off cigarettes.

There also appears to be very strong evidence that the choice for almost all electronic cigarette users is between e-cigarettes and conventional cigarettes, not between e-cigarettes and nicotine abstinence. Thus, if e-cigarettes are removed from the market, smokers will most likely return to conventional cigarettes. So by calling for a ban on electronic cigarettes, what ATTUD is essentially saying is that they would rather that smokers smoke conventional cigarettes with their known, severe hazards, than that they smoke electronic cigarettes which are almost certainly much safer, although they have not been definitively studied in long-term research to prove that they are devoid of any significant adverse effects.

I really find this to be an absurd argument.

But the position being taken by ATTUD is also an inconsistent one.

Consider the following: the drug Chantix is a smoking cessation drug that is suspected of possibly having severe adverse effects, including suicide. That connection has not yet been proven, however. But you don't see ATTUD calling for Chantix to be removed from the market until it has been proven safe.

Why would ATTUD call for the removal of electronic cigarettes from the market, when there is not even a suspicion that they are causing any severe adverse effects, but call for Chantix to remain on the market when there is serious suspicion that it might be causing people to die? This simply makes no sense.

But ATTUD's argument gets even more absurd. They write: "many smokers attempting to reduce or eliminate their cigarette consumption with 'electronic cigarettes' may become frustrated and give up their cessation attempts. A number of smokers will die in the interval between an unsuccessful attempt and a future attempt."

The absurdity of this statement is that smokers who are deprived of electronic cigarettes are almost assuredly going to resume smoking conventional cigarettes. How is it any better to force all electronic cigarette users to return to conventional cigarettes rather than to take a chance that some e-cigarette users will become frustrated and return to regular cigarette smoking? And how do these smokers become more likely to die because they used electronic cigarettes?

The only way this argument would make any sense whatsoever is if the use of electronic cigarettes was preventing smokers who otherwise would have quit entirely from abstaining completely from smoking. However, ATTUD provides no evidence whatsoever that this is the case.

ATTUD goes on to state: "ATTUD's position is to encourage only those attempts (evidence based) with the highest probability of success." But this is an inaccurate statement, because the types of quit attempts with the highest probability of success are cold turkey attempts.

By ATTUD's own logic, due to the dismal effectiveness of nicotine replacement therapy, these products should be removed from the market because many NRT users will become frustrated and return to smoking, giving up their cessation attempts. A number of these smokers will die between their failed quit attempt and a future attempt.

In fact, there is evidence that the use of NRT may be hindering overall quitting because smokers who use these products for an unsuccessful quit attempt may have even more trouble quitting in the future. They may also be less likely to attempt quitting because of a failed attempt using NRT.

If ATTUD were true to its word, it would argue against the use of NRT and other pharmaceutical agents and urge smokers to instead quit with abrupt, cold turkey quit attempts.

Finally, ATTUD argues that e-cigarettes should be taken off the market because children might start using them. This is an uncompelling argument because the same thing is true of over-the-counter nicotine replacement products. If you are going to take a product off the market because children might theoretically get their hands on it and abuse it, then NRT products would have to be removed from the market as well. If anything, children are much less likely to use electronic cigarettes because unlike traditional NRT products, they cost up to $100 and most kids don't have that kind of money sitting around.

There is no question that research on electronic cigarettes and monitoring of the situation is necessary to make sure that there are not unexpected adverse effects and that children are not purchasing these products. There is also legitimate reason to monitor the advertising claims being made. But banning electronic cigarettes is the wrong response. It is not only the worst possible response from a public health perspective, it is also the one with the least evidence to support it.

Thursday, May 14, 2009

Tobacco Treatment Organization Writes FDA and Issues Press Release to Promote Ban on Electronic Cigarettes

The Association for the Treatment of Tobacco Use and Dependence (ATTUD) yesterday issued a press release to promote a ban on the sale of electronic cigarettes in the United States. The press release highlighted a letter written from the organization to the FDA requesting that the Agency remove electronic cigarettes from the market.

The press release states: "The Association for the Treatment of Tobacco Use and Dependence (ATTUD), the premier professional organization of tobacco treatment specialists, today announced its support of the FDA ban on so-called "electronic" or e-cigarettes. The letter addressed to Acting Commissioner Sharfstein (see below) stated that there is no scientific evidence that the e-cigarettes are safe and effective. "As tobacco treatment professionals we are concerned that smokers desperate to quit will place their faith in unproven therapies," said John Hughes, MD, President-elect of ATTUD and professor of psychiatry at the University of Vermont College of Medicine. "Money spent on unproven treatments is money unavailable for proven, FDA-approved treatments," Dr. Hughes continued. Furthermore, an unsuccessful attempt can precipitate a sense of failure, which can delay another quit attempt for years. Unfortunately, this can mean that some smokers will die or suffer serious disease after an unsuccessful quitting effort. While ATTUD supports the quit attempts of all tobacco users, it strongly encourages all smokers to use FDA-approved and proven medications with the support of tobacco treatment professionals."

The letter to the FDA states: "The Association of Tobacco Use and Dependence (ATTUD) is a non-profit organization of providers dedicated to the promotion of and increased access to evidence-based tobacco treatment for the tobacco user. As such, we are writing to support the Food and Drug Administration (FDA) enforcement action against manufacturers of “electronic cigarettes”. These products should be removed from the market until and unless they are proven safe and effective. As you know, these “electronic cigarettes” are being marketed as
alternatives to cigarettes and other tobacco products. Manufacturers and retailers of these products claim that electronic cigarettes are safe, and even that these products can help smokers quit traditional cigarettes. Simply stated, there is no scientific evidence whatsoever that these products do what these manufacturers and distributors claim nor is there evidence published in peer reviewed scientific journals that these products are safe. ... As the foremost organization of tobacco treatment professionals, ATTUD's position is to encourage only those attempts (evidence based) with the highest probability of success. Fortunately, there are seven (7) FDA approved tobacco treatment medications."

The Rest of the Story

What the Association for the Treatment of Tobacco Use and Dependence fails to disclose, in either its press release or its letter to the FDA, is that the organization has a severe financial conflict of interest regarding the electronic cigarette issue, by virtue of the conflicts of interest of at least two members of its executive board who have financial relationships with pharmaceutical companies that manufacture nicotine replacement products and stand to lose out in a major way if electronic cigarettes become popular.

For example, the incoming president of ATTUD - Dr. John Hughes - who is one of the co-signers of the letter to the FDA, apparently has conflicts of interest by virtue of his having consultancies, honoraria, and research grants/contracts with pharmaceutical companies.

Elsewhere (Drug and Alcohol Dependence, Volume 98, Issue 3, 1 December 2008, Pages 169-178), Dr. Hughes has disclosed that: "In the last 3 years he has received research grants from the National Institute on Health and Pfizer Pharmaceuticals and Sanofi-Synthelabo Pharmaceuticals both of whom are developing smoking cessation treatments. In the last three years, he has accepted honoraria or consulting fees from the following profit or non-profit institutions regarding nicotine or other drug abuse topics: Academy for Educational Development, Acrux DDS; American College of Chest Physicians, Adelphi Consulting, Aradigm; Atrium, Baltimore Research, Campus Consulting, Cambridge Press, Cline, Davis and Mann; Concepts in HealthCare, Constella Group; Consultants in Behavior Change; Cowen Inc, Cygnus, Edelman, Fagerstrom Consulting; Free and Clear; Healthwise, Health Learning Systems, International Marketing Systems, Insyght; Johns Hopkins University; Maine Medical Center, McNeil, Medicus, Nabi, National Institutes on Health; NCI Consulting, Pfizer Pharmaceuticals; Pinney Associates; Research Triangle Institute, Shire Health London; Temple University of Health Sciences; University of Arkansas, University of Auckland; University of Cantabria; University of Greifswald; University of Kentucky, University of Memphis, Warner Pharmaceuticals, Wolters Press, Xenova, and ZS Associates."

Thus, Dr. Hughes is essentially a walking conflict of interest with Big Pharma.

None of this is disclosed in the letter to the FDA or the press release as they appear on the internet.

The current ATTUD president - Dr. Michael Burke - the other co-signer of the letter to the FDA, has apparently received honoraria from Pfizer Health Solutions, a subsidiary of the pharmaceutical company Pfizer, according to a disclosure posted on the ATTUD web site. This is not disclosed in the letter to the FDA or the press release as they appear on the internet.

The position taken by the Association for the Treatment of Tobacco Use and Dependence is an absurd one. They are essentially stating that they'd rather see smokers continuing to remain on cigarettes rather than use electronic ones, even though the latter are demonstrably much safer. The stated reason for this preference is that the electronic cigarettes have not been proven to be safe. But as Jacob Sullum pointed out, this is like telling a drowning person not to use a lifeboat because the lifeboat has not been studied to see if it might have a leak.

In my opinion, what the Association for the Treatment of Tobacco Use and Dependence is really doing is protecting their profits and those of the pharmaceutical companies with which they have significant financial relationships. To be sure, electronic cigarettes represent a huge threat to these pharmaceutical companies, because for once, we have a form of nicotine replacement therapy (NRT) that is actually effective.

Rates of long-term success with pharmaceutical company nicotine replacement therapy are dismal, somewhere on the order of 6-8% and even lower for smokers with lower levels of motivation to quit. However, there is abundant evidence that electronic cigarettes can be very effective in keeping smokers off cigarettes, even heavy, long-term smokers who have had little or no success with traditional NRT in the past.

The accuracy of the letter to the FDA from the Association for the Treatment of Tobacco Use and Dependence is highly questionable where it states that "ATTUD's position is to encourage only those attempts (evidence based) with the highest probability of success." The evidence base shows that those quit attempts with the highest probability of success are cold turkey attempts which are unplanned and taken without the aid of pharmaceuticals. In fact, if ATTUD was truly doing what it says it is doing, it would not be recommending the use of NRT products, but instead would be trying to find ways to motivate smokers to make dramatic cold-turkey quit attempts.

The rest of the story is that ATTUD appears more concerned with serving the interests of its own practitioners, who largely depend upon pharmaceutical money and traditional pharmaceutical-based smoking cessation programs for their livelihood than with serving the interests of smokers and of the public's health.

This has the appearance of an organization which is sacrificing the public's health in order to protect Big Pharma profits, motivated by a bias created by a significant financial conflict of interest with the pharmaceutical companies.

I believe it is unethical for a "health" organization like ATTUD to try to influence public policy with a press release and letter to the FDA without disclosing these significant financial conflicts of interest.

While it is shameful that health organizations are taking the position that a demonstrably safer product should be denied to smokers because of a lack of absolute proof of its safety, leaving them to return to smoking the clearly proven to be much more hazardous conventional cigarettes, it is extremely problematic that such a position should appear to be motivated in part by a financial conflict of interest with Big Pharma and that this conflict of interest is not disclosed in communications to the public, the media, and policy makers that are designed to affect public policy.

Tuesday, May 12, 2009

My Op-Ed on Electronic Cigarettes Published in the Boston Herald

An op-ed piece I wrote on the electronic cigarette issue was published in the Boston Herald yesterday.

I'll let readers read the piece on their own, but the conclusion is as follows:

"It is clear that the real purpose and effect of the FDA tobacco legislation is to protect the conventional cigarette market from competition. And unfortunately, that competition - in the absence of FDA legislation - would come from truly reduced risk products, such as e-cigarettes. This is precisely why Philip Morris was brilliant in enticing the Campaign for Tobacco-Free Kids and other health groups into supporting FDA regulation of tobacco products."

"Today, in extreme irony, these health groups stand as the most vigorous protectors of the current market of conventional cigarettes. As such, they stand as protectors, rather than opponents, of the death and disease caused by the nation’s most hazardous consumer product."

Bill Corr Should Have Refused HHS Nomination; Do We Really Want Someone Who Lobbied for Philip Morris-Negotiated Legislation Running the Department?

An article published last week in the Wall Street Journal questions whether the nomination of a former lobbyist for the Campaign for Tobacco-Free Kids - Bill Corr - violates the Obama Administration's policy of not allowing former lobbyists (within 2 years) to work in areas related to those on which they lobbied.

Although Corr lobbied for the Campaign for Tobacco-Free Kids on tobacco issues, which represent a huge part of the work of the Health and Human Services (HHS) department, he was nominated and recently approved for the position of deputy secretary for the department, the number two position in HHS.

According to the article: "President Barack Obama says lobbyists won't run his administration, but he picked an antitobacco lobbyist with ties to the pharmaceutical industry as the No. 2 official at the Department of Health and Human Services. The nomination of William Corr -- former executive director of the Campaign for Tobacco-Free Kids, where he was a registered lobbyist until September -- highlights the murkiness of Mr. Obama's antilobbyist policy. Mr. Obama requires employees to sign a pledge stating they will not "participate in any particular matter on which I lobbied within the two years before the date of my appointment." Those rules prohibit Mr. Corr from working on tobacco issues, the White House says."

The article also questions whether Corr's ties to the pharmaceutical industry - the Campaign for Tobacco-Free Kids received millions of dollars from Big Pharma - will interfere with his ability to be fair in formulating policy.

Jacob Grier over at Liquidity Preference notes that Corr's ties to Big Pharma could be significant, as the FDA, which is under HHS, will soon decide the fate of electronic cigarettes, which are making a great public health contribution but represent a threat to Big Pharma profits:

"There is, however, a real conflict of interest here. As discussed previously on this blog, the FDA will likely soon take a very active role in tobacco regulation and is in the process of banning electronic cigarettes. There is no evidence whatsoever that the latter are harmful to anyone — anyone except pharmaceutical companies, that is. They have become an increasingly popular alternative to patches and gums for people looking to quit smoking. It’s legitimate to ask if Corr should be involved in their regulation given his ties to the Campaign for Tobacco-Free Kids, which receives funding from pharmaceutical companies and has publicly supported the e-cigarette ban. I have no reason to doubt that Corr will be a perfectly sincere regulator; if anything, I am worried that he will be an excessively zealous one. But he should be held to the same standard as other nominees, not given a free pass because he happened to be a lobbyist for a politically correct cause."

The Rest of the Story

Two aspects of this story have been largely overlooked.

First, do we really want the number 2 person in an agency to be someone who has to recuse himself from just about every major decision that the agency makes. Tobacco is such an important contributor to disease that it is difficult to find a health issue that does not involve, in some way, the issue of tobacco.

While Corr may be able to skirt around the lobbyist policy by arguing that he will recuse himself from tobacco issues, by doing that, he is essentially destroying his own qualifications for the position.

If the HHS deputy secretary were a regular position for which applicants interviewed, how likely would a candidate be to get hired if he said that he was a great candidate for the job, but wouldn't be able to participate in any agency business regarding tobacco?

It's kind of like hiring the head of a Social Services agency who states that he cannot take part in any decisions related to welfare. Well then, what's the point of hiring that person? In fact, that person becomes very unqualified for the position, it seems to me.

Another salient question which has largely been overlooked is whether or not we really want a former lobbyist who pushed for Philip Morris legislation to be leading the nation's chief health agency.

I think lobbying for Philip Morris legislation within two years should definitely be a disqualification for serving as a leader in a federal health agency.

Monday, May 11, 2009

On the Absurdity of the Anti-Smoking Groups' Position on Electronic Cigarettes

The major national anti-smoking organizations - including the American Heart Association, American Lung Association, American Cancer Society, and Campaign for Tobacco-Free Kids - have called for the removal of electronic cigarettes from the market. In their statement, these groups take issue with claims that these products are safer than cigarettes and that they can help people to quit smoking.

The Rest of the Story

The position of these anti-smoking groups is an absurd one, and it demonstrates that they are not really about protecting the public's health after all. If health were the concern, then why would these groups prefer that people smoke conventional cigarettes -- which contain thousands of chemicals and more than 60 carcinogens -- rather than electronic cigarettes, which deliver the nicotine without any of these chemicals and carcinogens?

The absurdity of these groups' position was summarized best by Jacob Sullum, who described it as follows:

"Telling smokers they may not use e-cigarettes until they're approved by the FDA is like telling a floundering swimmer not to climb aboard a raft because it might have a leak."

Sullum's description of the situation is a perfect one.

There are only two mitigating factors that would give legitimacy to the public health groups' position. One is if the use of electronic cigarettes was preventing smokers from quitting smoking. In other words, if smokers who otherwise would have quit entirely were using these products. However, there is no evidence that this is the case. Instead, it appears that electronic cigarettes are helping smokers -- who would otherwise continue to smoke conventional cigarettes -- to keep off cigarettes.

The other mitigating factor would be if nonsmokers were starting to use electronic cigarettes. Again, there is no evidence that this is the case. Electronic cigarettes are clearly being marketed to smokers and there is no evidence that nonsmokers are using these products.

The health groups' questioning of the validity of the claim that electronic cigarettes are safer than conventional ones shows the lack of a role that science plays in the modern day tobacco control movement. Stating that we can't draw such a conclusion until the FDA fully studies the product sounds like something the tobacco industry would have said 50 years ago about the evidence that cigarette smoking is harmful.

The health groups' questioning of the validity of the claim that electronic cigarettes can help people to quit smoking shows an ignorance of the hundreds of testimonials coming from e-cigarette users.

What seems to be behind the anti-smoking groups' concerns is more an ideological opposition to the theoretical idea of a cigarette-like product than any legitimate health concern. The rest of the story is that scientific integrity and health itself are losing out to ideology in the modern-day tobacco control movement.

Thursday, May 07, 2009

The Lessons from History: Scientists Ideas About How to Make Safer Cigarettes Can Severely Backfire

In 1974, the National Cancer Advisory Board - an advisory committee of the National Cancer Institute - made a detailed set of recommendations regarding the regulation of cigarettes. The recommendations called for federal regulation of the tar and nicotine deliveries of cigarettes, which would be administered by a federal agency. The agency would require that cigarette companies gradually reduce the tar and nicotine levels of cigarettes from the 1973 averages of 19.2 mg tar and 1.3 mg nicotine.

Moreover, the agency would seek technical advice from the National Heart and Lung Institute regarding the maximum emissions of various smoke constituents. In addition, an appeal would be made to cigarette companies to preferentially market low tar and low nicotine cigarettes.

Here are the recommendations put forward by the National Cancer Advisory Board:

"1. A Government agency should be empowered to set maximum cigarette levels of tar and nicotine that will become progressively lower than the 1973 averages of 19.2 milligrams and 1.3 milligrams respectively. Such decreases should be undertaken slowly enough to insure that no important increase in the number of cigarettes consumed does occur. These actions should insure that a range of cigarettes including some with very low tar and nicotine contents continue to be available."

"2. Since smoking has a severe impact on cardiovascular and respiratory diseases, the Government agency empowered to regulate maximum emission of undesirable smoke components should get appropriate technical advice from the National Heart and Lung Institute."

"3. Pending the accomplishment of the foregoing recommendations through changes in the existing law, the President of the United States might consider making a public personal appeal to the tobacco and cigarette industry for voluntary and rapid efforts towards preferential marketing of low tar and low nicotine cigarettes, and towards reduction of other smoke components that may be recognized as hazardous."

The Rest of the Story

As the research that was released through the New York Times on Tuesday reveals, the approach recommended by the National Cancer Advisory Board was an utter disaster. The sharp reductions in tar and nicotine yields that the cigarette companies ended up implementing voluntarily did not reduce disease rates and there is evidence that this approach might have actually increased lung cancer risk by inducing smokers to inhale more deeply, resulting in the delivery of smoke constituents to the more susceptible periphery of the lung.

Interestingly, at the same time that it made its recommendations, the National Cancer Advisory Board warned that the recommendation might turn out not to work. Right after its recommendations, the Board quietly stated: "The public must be informed that there is currently no known formula for a safe cigarette, and that the restrictions here suggested are likely to produce, but cannot guarantee a reduction of hazards from smoking." Of course, that didn't stop the Board from going ahead and issuing the recommendation anyway.

Before I get to the main implication of this story, I should note that it is interesting that anti-tobacco lawyers are suing the cigarette companies for following precisely the recommendations set out by the National Cancer Advisory Board. If I were a tobacco company defending such lawsuits, I would cite this 1974 document and assert that my company was merely trying to voluntarily follow the recommendations of the prestigious National Cancer Institute: "Rather than waiting for the federal regulations that were recommended by the Institute, we decided to be a good corporate citizen and to voluntarily implement these recommendations. It is a shame that we are now being sued for having taken these government recommendations seriously."

The primary implication of this story is that the cigarette and the act of smoking are incredibly complex phenomena, and it is far too simplistic to believe that by requiring a particular change in cigarette design or smoke constituents we will be able to predictably and reliably produce reductions in actual human disease risk.

The FDA tobacco legislation will put the FDA in precisely the same position as the National Cancer Advisory Board was in 1974. The FDA will have many ideas about how to produce a safer cigarette. Scientists like Dr. Burns will come forward and claim that they have the solution to the problem: simply change the way the tobacco is cured, or simply do this or do that.

But without being able to test these changes in clinical studies, we will actually have no idea what the effect of these changes will be. While there will be no evidence that these changes will actually produce a safer cigarette, smokers will believe that cigarettes have been made safer by virtue of the FDA regulation of the product and by virtue of the FDA's adoption of product "safety standards."

In essence, the government will be in the position that the tobacco companies were in when they marketed low-tar and low-nicotine cigarettes: the government will be fraudulently deceiving the public into believing that cigarettes are safer but without actual evidence that, as actually used by human consumers, the product will demonstrably reduce the overall risk of disease.

Thus, the FDA legislation will simply transfer the fraud that the cigarette companies were accused of committing over to the federal government. Now, instead of the tobacco companies deceiving the public and making false assurances, the federal government will be taking over that role.

I am not arguing here that a safer cigarette is not possible. I am just arguing that at the present time, we don't have any idea of how to produce it. Moreover, it is not the federal government who is in the best position to design a safer cigarette. It is the cigarette companies, who have the ability to research, test, and develop new products.

The problem with the FDA legislation is that it takes away the ability of the tobacco companies to research, test, and develop new products because it removes the incentive: there is virtually no possibility of ever introducing a truly safer cigarette into the market. This is because the legislation requires companies to prove that the product is safer. To do so, a company would have to market the product for many years and conduct long-term epidemiologic studies. But to do that, the company would need the product to already be approved. So it is a complete catch-22. You can't market a reduced risk product until you prove it is safer. But you can't prove it is safer until you market it for many years. Thus, the bill puts an end to harm reduction as a tobacco control strategy and assures that in the future, the cigarettes we see will be the more dangerous conventional ones, not any truly safer ones.

George Santayana once said: "Those who do not learn from history are doomed to repeat it." Congress - and the public health groups that are supporting the FDA tobacco legislation - are now poised to repeat the unfortunate history of the low-yield cigarette scam (which I might add was a scam not just by the cigarette companies, but by public health groups and the government as well).

Perhaps the greatest lesson from this episode in tobacco control history is that we need to be a little more modest about predicting human risk from cigarette design and constituent changes. When you're dealing with tobacco combustion, you really don't know what you're dealing with until it's all said and done.

Perhaps a more relevant modern quote, then, would be the lyrics from Steve Azar's song "You Don't Know a Thing:"

"When you're young, you think you know it all,
Yeah, you're hot-rod cocky...
Well, you don't know how it'll go ...
Man, you don't know a thing."

(Thanks to Rose for the tip).

Wednesday, May 06, 2009

Anti-Smoking Advocate Commits Science-by-Press Release to Influence FDA Tobacco Bill; But "Science" Turns Out to Be Nothing But Pure Speculation

A prominent anti-smoking researcher and advocate has released conclusions of a non-peer-reviewed study to the media - without making the actual study available - in an admitted attempt to influence the FDA tobacco legislation which will be heard by a U.S. Senate committee on Tuesday.

The story was reported yesterday in an article in the New York Times. According to that article: "For three decades, Dr. David M. Burns has written and edited some of the seminal work on tobacco science and the hazards of modern cigarettes: surgeon general’s reports, National Cancer Institute monographs, World Health Organization studies. ... with the Senate just weeks away from a vote on landmark legislation to regulate tobacco, Dr. Burns, 61, is now willing to sidestep the protocols of peer-reviewed science. ... Dr. Burns says he has new information, based on two years of study, indicating that cigarettes — even the supposedly safer ones — pose a much higher risk of lung cancer than before the surgeon general first declared them a health hazard in 1964. He said the risk of a smoker’s developing lung cancer may be twice as high as it was then, even though tar and nicotine have been reduced."

"Last Thursday, Dr. Burns presented a “late-breaking abstract” — a summary of his findings — in Dublin at a meeting of the Society for Research on Nicotine and Tobacco. And the Campaign for Tobacco-Free Kids, a Washington advocacy group, has been promoting his work to journalists. His thesis has not yet been reviewed by a panel of experts, such as the sort who would vet his research if he were to submit it to a medical publication like The New England Journal of Medicine, where his work has been published in the past. He says he plans to submit an article. But that process can take months — long after the vote on the tobacco bill... . ... Dr. Burns notes that the way much tobacco is cured in the United States increases the level of dangerous compounds called nitrosamines. In the past in this country, and in places like Australia, tobacco was cured in the open air. But many American growers now speed it up with nitrogen fertilizers and propane heaters, leading to the formation of nitrosamines. They are among the 47 known animal or human carcinogens in cigarette smoke."

The Research

The research is described in an abstract and poster from the Dublin conference. Basically, what the study did was estimate the expected lung cancer mortality over the past five decades based on relative risk data from the American Cancer Society's CPS-I study, using actual data on cigarette consumption. The main finding was that while squamous cell lung cancer rates were accurately predicted, there was a substantial (about 50%) underestimate of the adenocarcinoma rates. This finding suggests that the actual relative risk for adenocarcinoma of the lung has increased over time (compared to the mid-1960s), while the relative risk for squamous cell carcinoma of the lung has remained relatively steady. The study also noted that data for Australia indicate that the proportion of lung cancers that are adenocarcinoma has increased to much less of an extent during the past five decades than in the United States.

The Conclusion

Therefore, it follows naturally, the researcher concludes, that the increased risk of lung cancer is due to the curing of tobacco indoors rather than outdoors, which has resulted in increased levels of nitrosamines in cigarettes.

If that conclusion seemed to jump at you from out of nowhere, you're not alone.

There is no basis - and certainly nowhere close to a sufficient basis - to conclude that the explanation of the increased adenocarcinoma rates observed in smokers over time is that the curing process has led to increased nitrosamines.

We have a scientific term for offering that type of explanation: it is called pure speculation.

That explanation is certainly one possibility among many. Another plausible explanation is that the greatly reduced nicotine levels in cigarettes have resulted in very different smoking behavior patterns. It may be that smokers are inhaling more deeply, and that the tar is being delivered into more distal parts of the lung, where adenocarcinoma is more common.

While it may be true that curing processes are one thing that has changed since the mid-1960s, there are many other factors that have changed as well. A huge one is the introduction of filters and the greatly reduced delivery of tar and nicotine.

This researcher is selectively choosing one potential explanation as being the one and only correct reason, but there is absolutely no solid evidence to support this particular conclusion. It is, indeed, pure speculation.

The Rest of the Story

The rest of the story is that rather than being a new scientific finding, this is actually pretty old news. We have known for well over a decade that adenocarcinoma risks have increased among smokers and that the proportion of adenocarcinoma to total lung cancers has been increasing. And there has in fact been an extensive discussion in the scientific literature about the reasons for this phenomenon. A number of plausible explanations have been offered, of which the change in tobacco curing is just one (in fact, it doesn't even appear in the prior literature).

Turn the clock back to November 1995 (fourteen years ago). At that time, the renowned tobacco scientist Ernst Wynder and his colleague - Joshua Muscat - published an article in the journal Environmental Health Perspectives which was specifically intended to address the possible reasons for the increasing risk of adenocarcinoma among smokers (see: Wynder EL, Muscat JE. The changing epidemiology of smoking and lung cancer histology. Environmental Health Perspectives 1995; 103(suppl 8).

In that article, Wynder and Muscat wrote: "In this overview we discuss the steeper increase during recent decades of lung adenocarcinoma incidence compared with squamous cell carcinoma of the lung. In 1950, the ratio of these two major types of lung cancer in males was about 1:18; today it is about 1:1.2-1.4. This overview discusses two concepts that are regarded as contributors to this change in the histological types of lung cancer. One factor is the decrease in average nicotine and tar delivery of cigarettes from about 2.7 and 38 mg in 1955 to 1.0 and 13.5 mg in 1993, respectively. Other major factors for the reduced emission of smoke relate to changes in the composition of the cigarette tobacco blend and general acceptance of cigarettes with filter tips; the latter constitute 97% of all cigarettes currently sold. However, smokers of low-yield cigarettes compensate for the low delivery of nicotine by inhaling the smoke more deeply and by smoking more intensely; such smokers may be taking up to 5 puffs/min with puff volumes up to 55 ml. Under these conditions, the peripheral lung is exposed to increased amounts of smoke carcinogens that are suspected to lead to lung adenocarcinoma. Among the important changes in the composition of the tobacco blend of the U.S. cigarette is a significant increase in nitrate content (0.5% to 1.2-1.5%), which raises the yields of nitrogen oxides and N-nitrosamines in the smoke. Furthermore, the more intense smoking by the consumers of low-yield cigarettes increases N-nitrosamines in the smoke 2- to 3-fold. Among the N-nitrosamines is 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a powerful lung carcinogen in animals that is exclusively formed from nicotine. This organ-specific tobacco-specific nitrosamine (TSNA) induces adenocarcinoma of the lung. All of these factors, the more intense smoking, the deeper inhalation of the smoke, and the increased yields of N-nitrosamines in the smoke of low-yield cigarettes, are considered major contributors to the drastic increase in lung adenocarcinoma among cigarette smokers in recent years."

As you can see, Wynder and Muscat did not attribute the increased risk of adenocarcinoma to changes in the curing process. They did, however, attribute this phenomenon largely to the decreased yields of cigarettes, which led to deeper inhalation and deeper penetration of the smoke constituents into the periphery of the lung, an area which is more susceptible to adenocarcinoma.

The Important Lesson

If there is one thing we have learned, or should learn, from the precise type of research being released through the newspaper yesterday, it is that it is extremely difficult - if not impossible - to predict the effects on human cancer risk of changes in the design and composition of cigarettes.

For many years, public health advocates warned of the dangers of high-tar cigarettes and urged cigarette companies to develop lower yield products. Everyone thought that this innovation would result in decreased morbidity and mortality from cigarette-related diseases. Instead, it turned out that cigarette smokers changed their behavioral patterns in response to the decreased delivery of nicotine and other constituents. As a result, the predicted health gains were never realized (and the situation may actually have been made somewhat worse).

The issue of predicting the precise risk of a particular change in cigarette design and composition is an extremely difficult one. It is not so easy as saying that if we reduce the level of a particular component, the lung cancer rates will decline. In fact, when cigarette companies went along with public health authorities and greatly reduced the yields of every major smoke component, the end result was the absence of any health protection. This is too complex a business for a researcher to come along and tell the New York Times that he has a solution that will prevent 50% of lung cancer deaths.

A number of cigarette companies have experimented with products in which the levels of particular smoke constituents are significantly reduced. The result? It turns out that while the levels of these constituents went down, the levels of other constituents went up. The cigarettes were not any safer.

If the curing process for tobacco were changed, we simply do not know what the effect would be on cancer rates. There are more than 50 carcinogens, of which nitrosamines are just a few. You need to understand the entire profile of carcinogenesis before you can definitively draw conclusions about actual human risk. And you also need to know the way in which the altered product is going to change actual human smoking behavior.

We don't know this, with respect to nitrosamines or any other component, and these researchers from the UCSD School of Medicine have no business touting themselves as holding the solution to preventing 50% of lung cancer deaths from smoking when there has been absolutely zero clinical testing of such a product.

Perhaps the most troublesome aspect of this story, to me, is the damage that it could do. It is a very deceptive and inappropriate public action for a researcher to take. The study has not been peer reviewed, nor is it being released publicly, yet its conclusions - which amount to pure speculation - are being disseminated worldwide in an attempt to influence policy. It is the classic strategy of science by press release.

In conclusion, what we have here is a thinly-disguised (as science) attempt to influence the FDA tobacco legislation, at the last moment, by manipulating the media. Under the guise of science, a researcher has presented what essentially amounts to pure speculation and dressed it up so that it appears to be real science. I can assure my readers that it is nothing of the sort. It is pure correlation. Pure speculation.

In fact, there are equally plausible alternative explanations for the "new" study's findings which involve not only the cigarette design, but also the behavior of smokers. There is nothing new and nothing startling about the phenomenon being presented as a startling new finding. We have known about this for well over a decade and Ernst Wynder himself opined that a primary reason for the increased adenocarcinoma risk associated with lower yield cigarettes is the deeper inhalation and deeper delivery of tar into the more susceptible periphery of the lung.

Rather than argue for the FDA regulation of the design of cigarettes, today's news argues instead that the FDA legislation is a huge public ruse. Under the propaganda that FDA regulation will result in a safer cigarette, the bill to be considered by a Senate committee on Tuesday will actually ensure that truly safer cigarettes do not enter the market. This will protect Philip Morris - the bill's primary supporter - from competition.

If you possess 50% of the cigarette market and your biggest potential competition could come from a novel, reduced risk product, the thing you desire most is to block such products from the market. The FDA legislation does just that by putting insurmountable obstacles in the way of the introduction of safer cigarettes.

Instead, the legislation protects the existing cigarettes on the market. And even worse, it creates the false public perception that the FDA now has the ability to require safer cigarettes when the truth is that the FDA is no more capable than Joe the Plumber of designing a safer cigarette. The only difference is that while Joe the Plumber is not approving cigarettes for public consumption, the FDA - on behalf of the federal government - will be doing just that if this legislation is enacted.

Tuesday, May 05, 2009

FDA Appears Poised to Assert Regulatory Authority over Electronic Cigarettes; Lawsuit Over Jurisdiction is Filed by One E-Cigarette Company

As Jacob Sullum reports at the Reason Online Hit & Run blog, it appears that the Food and Drug Administration (FDA) is poised to assert regulatory jurisdiction over electronic cigarettes. A message from the FDA's Office of Legislation, which was sent out last Wednesday, announces that the Agency will take an "enforcement action" against electronic cigarettes. Apparently, the FDA has already taken some actions to block the sale of electronic cigarettes, as the Blog of Legal Times reports that one electronic cigarette distributor has filed suit against the FDA for blocking imports of electronic cigarettes into the United States.

According to the Blog of Legal Times article, that lawsuit "argues that the FDA has overstepped its regulatory authority by banning shipments of the devices and insisting they need to go through the drug approval process. Electronic cigarettes — often marketed as “e-cigarettes” — are a tobacco-free version of traditional smokes. Users inhale vaporized nicotine from a small, plastic tube that heats up with the help of a tiny battery. The whole contraption is designed to look and feel like a normal cigarette, minus the flame and smoke, and their makers market them as a risk-free way to get a nicotine buzz. Smoking Everywhere’s lawyers from Thompson Hine point out that in 2000, the Supreme Court ruled that the FDA did not have the power to regulate ordinary cigarettes. Therefore, it shouldn’t be allowed to clamp down on their high tech counterparts, the lawyers argue."

The FDA message explains that its chief concerns about electronic cigarettes are that these products may introduce nonsmokers to nicotine use and that they have not been studied so we don't know if they are safe.

Sullum reports that [regular Rest of the Story commenter] Bill Godshall, executive director of Smokefree Pennsylvania, wrote to the FDA, arguing that: "denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users reverting back to smoking cigarettes. ... it is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products."

The Rest of the Story

There is no question that electronic cigarettes are designed and marketed primarily as being an alternative cigarette. Therefore, they should not be subject to jurisdiction by the FDA, which currently has no jurisdiction over cigarettes. Instead, they should be subject to regulation by the Federal Trade Commission, which should ensure that any advertising claims being made are accurate. In addition, efforts should be made to ensure that these products are not sold to minors. However, the last thing in the world that we want from a public health standpoint is for the FDA to regulate (which means ban) electronic cigarettes.

No evidence has been presented to suggest that either of the FDA's concerns are warranted. First, there is no evidence that electronic cigarettes are being used by minors, or by nonsmokers. They are clearly being marketed to smokers, and not to either minors or nonsmokers. A survey by one electronic cigarette company revealed that the average age of electronic cigarette users is 44 and that the average amount smoked by these individuals (prior to using e-cigarettes) is over 1 pack per day.

Second, there is no evidence that electronic cigarettes pose any undue harm relative to the smoking of conventional cigarettes that would warrant their being removed from the market. A laboratory study of the emissions from electronic cigarettes confirmed that the only significant emissions are nicotine and propylene glycol.

I applaud Bill Godshall for being a voice of reason on this issue. The effect of taking electronic cigarettes off the market would not be a reduction in the number of individuals becoming addicted to nicotine. Instead, the result would be an increase in the the number of individuals using conventional cigarettes. Such an action by the FDA would undoubtedly have the effect of harming the public's health by taking away a safer alternative for thousands of e-cig users and essentially forcing them to go back to smoking conventional cigarettes, which we know are far more hazardous.

There is no reason to believe that current electronic cigarette users would quit smoking entirely if e-cigs are pulled from the market. In fact, there is almost no chance of that occurring, since the use of these products has continued their exposure to nicotine. Instead, they will likely return to conventional cigarettes.

While the FDA appears to be acting from ideological concerns, it should remember that its charge is to protect the public's health, not to enforce a particular ideology.

If the FDA doesn't act in the most prudent way, hopefully the courts will recognize that e-cigarettes are exactly that - cigarettes, and thus rule that they should not be subject to FDA jurisdiction.

I would close by noting that this story demonstrates yet another reason why enactment of the FDA tobacco legislation would be a public health disaster. If that legislation is enacted, then electronic cigarettes will be placed under FDA jurisdiction and the product will most likely have to be pulled from the market under the stringent rules established in that legislation for reduced risk products (which make it virtually impossible to market a truly safer product such as e-cigarettes).

This is just another concrete example of how the FDA tobacco legislation would be devastating to the public's health.

We simply cannot afford to allow ideology to get in the way of public health protection.

Finally, it is clear that the real purpose and effect of the FDA tobacco legislation is to protect the conventional cigarette market from competition. And unfortunately, that competition - in the absence of FDA legislation - would come from truly reduced risk products, such as electronic cigarettes. This is precisely why Philip Morris was brilliant and insightful enough to sit down with the Campaign for Tobacco-Free Kids and forge a deal that would give the FDA very limited regulatory jurisdiction over tobacco products, and in a way that protects existing products at the expense of new, potentially reduced risk ones.

Today, the Campaign and its fellow health groups stand as the most vigorous protectors of the current market of conventional cigarettes that one could ever imagine. As such, they stand as protectors, rather than opponents, of the death and disease caused by the nation's most hazardous consumer product.

Monday, May 04, 2009

IN MY VIEW: Why the Argument that Lawyers Who Represent Tobacco Companies are Unethical is Problematic

While I was never aware of this opinion in the tobacco control movement before, it has become clear to me that a number of lawyers and others in the tobacco control movement believe that it is morally reprehensible for an attorney to represent a tobacco company. For example, based solely on the fact that she represented Philip Morris, several anti-tobacco lawyers and tobacco control advocates have personally attacked the ethical character of Senator Kirsten Gillibrand.

In this post, I make the case that representing a tobacco company in litigation is not unethical and that putting forward such an argument actually undermines the integrity of the justice system.

The Rest of the Story

Fundamental to the issue of whether representing a tobacco company is unethical is the question of whether or not cigarette companies deserve a defense in litigation against them.

I believe that an essential element of our justice system is the fact that both sides in litigation have the right to be represented by counsel, and that lawyers on both sides make their cases before the judge or jury. A one-sided system, in which only the plaintiff - for example - was entitled to representation, would be fundamentally unfair and would inevitably lead to the miscarriage of justice.

Therefore, I believe that it is imperative to the integrity of the justice system that tobacco companies, no matter how bad we might think their behavior has been, be represented in legal matters in the courtroom. The tobacco companies are entitled to a legal defense.

Now, if one accepts the above premise, then I believe we cannot view it as unethical for a lawyer to represent a tobacco company. If the fact that a tobacco company is represented by counsel in the courtroom is essential to the integrity of the justice system, then how can it possibly be viewed as unethical and morally reprehensible for an attorney to take on that role?

After all, if the tobacco attorney is playing a role that is essential for the integrity and fairness of the justice system, then how can that individual be considered inherently unethical for accepting that role?

Now this doesn't mean that all tobacco lawyers have acted in an ethical manner. There is a history of misconduct by tobacco lawyers who have acted unethically in doing things like helping to create a fraudulent conspiracy between the tobacco companies, hiding evidence of fraudulent behavior, etc. However, what makes those lawyers unethical is the specific unethical actions they have taken, not the mere fact that they stood in representation of a tobacco company.

By the reasoning of those who argue that representing a tobacco company is inherently unethical, the most appropriate result would be that tobacco companies would not be represented in court. It would be a one-way proceeding, with only the plaintiff being heard.

Now I hope that readers can see why I find the anti-tobacco lawyers' and advocates' argument so problematic. The argument serves to undermine the integrity of the justice system because it essentially calls for a one-sided process, where tobacco companies would not be able to defend themselves and plaintiffs would have their way, no matter how appropriate or inappropriate the plaintiffs' arguments, claims, and requests.

To see one reason why it is so important for both sides to have representation, even if one side is a corporation that people may view as being evil, look at yesterday's Wall Street Journal article about the fabrication of cases against U.S. Silica.

According to the article: "In 2003 alone ... U.S. Silica was served with nearly 20,000 lawsuits claiming it had caused silicosis -- a serious, if rare, lung disease. The tort bar saw silica as the "new asbestos," says Mr. Ulizio, and he had visions of his century-old concern going bankrupt, along with dozens of others. Instead what ensued was a legal thriller, in which the defendants not only beat the suits, but exposed a mob of lawyers and doctors who were fabricating cases, and who are now under investigation. ... In June of 2005, Texas federal Judge Janice Graham Jack -- who was overseeing 9,000 silicosis lawsuits aggregated in her court -- issued an opinion that shook the tort bar to its core. During depositions, the handful of doctors who provided nearly all these diagnoses began to crack, admitting they'd never seen patients, that their secretaries had filled out forms, and that lawyers had told them what to write. It came out that two-thirds of those claiming to have silicosis had previously claimed to asbestosis -- a near medical impossibility. Judge Jack's 249-page scathing opinion unraveled a scam of giant proportions. She accused the doctors and lawyers of "diagnoses that were manufactured for money," provided evidence of fraud, required a Houston plaintiff's firm to pay defense legal costs, and issued sanctions. Within a few months, Congress and a federal grand jury were investigating."

While we might abhor the conduct of tobacco companies and other corporations, the actions of many plaintiff's attorneys have been morally reprehensible as well. It certainly does not follow that only the plaintiff's in tobacco cases should be represented in court, and that such an outcome would lead to the best chances for justice to be served.

We need to have both sides represented to preserve the integrity of the justice system, and therefore, it is not possible to view the act of representing a tobacco company as being inherently unethical.

This commentary comes from someone who has fought tobacco lawyers in the courtroom many times. In my experience, I always viewed the tobacco attorneys as doing their job and doing it extremely well. I also must say that many of the issues dealt with in the courtroom are not black and white. There are shades of grey, and there is a need for representation of alternative points of view.

For example, while I have vigorously argued that certain smokers should be compensated by tobacco companies for damages incurred from using their products, I concede that the issue of whether or not a smoker should be viewed as responsible for the results of his or her own decisions and actions is a difficult one. Different juries have seen the issue in different ways. Some have agreed with me that smokers who became addicted to cigarettes prior to the 1960s (and the warning labels and other publicity about the health effects of smoking) did not make informed, adult decisions and so should not be held responsible. Other juries have ruled differently. It certainly seems appropriate to have both sides present their cases and let the jury decide. I cannot see how it would be inherently unethical for a lawyer representing the tobacco companies to make the case that people should be held accountable for their own decisions and actions in life, no matter how much I might disagree with that position in the case of smokers who began smoking prior to the warning labels.

Another example is the need to follow the precepts of law. While it might be nice for the plaintiff to be able to argue that the cigarette companies should have warned their consumers of the health effects of tobacco products, the law simply does not allow them to make this argument after 1970, when federal preemption of such claims was enacted into law. It was the intention of Congress to preempt such claims and the cigarette company lawyers are acting in accordance with the law when they prevent such testimony in the courtroom. That kind of defense is not unethical. It is actually quite appropriate.

Perhaps the best example of the need for a check on anti-tobacco lawyers is the Department of Justice lawsuit, where the plaintiff asked the Court for huge monetary remedies that are simply not allowable under the RICO statute. According to a Reuters news article, Judge Sentelle (an appellate court judge) admonished the anti-smoking groups for even bringing forward the argument that the panel should allow monetary remedies.

In conclusion, while it may put me in disagreement with the overwhelming majority of my colleagues in tobacco control, I stand by my position that representation of the tobacco companies is an essential part of the justice system and that it is therefore improper and inappropriate to view a lawyer who represents a tobacco company as being unethical.

Once again, I therefore view the personal attacks on the ethical character of Kirsten Gillibrand - which are based solely on her having represented a tobacco company - to be unwarranted, inappropriate, and problematic.