In a Huffington Post column, former HEW Secretary and Chairman Emeritus of the National Center on Addiction and Substance Abuse (CASA) at Columbia University - Joseph A. Califano, Jr. - lays down heavy criticism of the Surgeon General's report on youth smoking. Specifically, Dr. Califano criticizes the report for meticulous detailing the mechanisms by which menthol cigarettes have led to increased smoking among youth, but then failing to make any recommendation that menthol cigarettes be banned, as have chocolate, strawberry, banana, cherry, and coconut ones. Instead, as Califano points out, the Surgeon General calls merely for "continued surveillance" of menthol cigarettes.
Dr. Califano writes: "In the recent report, Preventing Tobacco Use Among Youth and Young Adults, the Surgeon General sounds more like Inspector Jacques Clouseau in The Pink Panther than the nation's top health officer. After demonstrating beyond a reasonable doubt that menthol flavoring is the key culprit in getting children and young adults to smoke cigarettes, she fails to urge the Food and Drug Administration to exercise its power to ban use of this flavoring by tobacco companies. It's like Inspector Clouseau finding someone holding a smoking gun over the dead victim riddled with bullets and not making the connection that he might be the killer." ...
"The Surgeon General expresses alarming concern that smoking among 12 to 17 year olds and young adults age 18 to 25 has increased. Then after she presents overwhelming evidence that menthol cigarettes are largely to blame for that rise, what does the Surgeon General do? In an Inspector Clouseau imitation, she simply finds that "mentholated cigarettes deserve special note" and "continued surveillance of menthol cigarettes is warranted"--all of this in an appendix to the report!"
Secretary Califano's commentary is very similar to mine of last week, in which I wrote as follows:
"This essentially amounts to a non-recommendation by the Surgeon General. Despite the conclusion that menthol cigarettes enhance the smoking initiation process among youth, have been modified specifically for the youth market in order to enhance initiation, and are contributing to an increased likelihood that youth will smoke cigarettes, the Surgeon General nevertheless fails to conclude that any action is necessary on menthol cigarettes, other than to merely conduct 'continued surveillance.'"
"For those unfamiliar with the technical jargon, "continued surveillance" translates into "do nothing."
"Thus, the story here is that the U.S. Surgeon General does not recommend any action on menthol cigarettes, despite their contribution to the problem of youth smoking, which is reviewed in exhausting detail in her 900 page report."
The Rest of the Story
It seems quite clear - now from two independent observers - that the administration has no interest in treating menthol as a scientific issue. Instead, it appears that decision-making is being done on a political basis. Nothing else could possibly explain the glaring disconnect between the evidence presented in the report on menthol and its role in promoting and supporting youth smoking and the lack of any recommendation to do anything about it, despite the sweeping statements that the same Department has made in recent weeks about how it is going to end the tobacco epidemic as we know it.
This suggests to me that there simply does not exist the political will in the administration to take on anything as potentially controversial as a ban on menthol, especially in an election year. For this reason, I have seriously downgraded my opinion regarding the possible chances for a federal ban on menthol cigarettes to close to zero (officially, I would call it: just a notch above bupkes).
Thursday, March 22, 2012
Wednesday, March 21, 2012
Conflicted Joint Commission Panelist Continues Push for Prescriptions for Every Hospitalized Smoker, As Physician Backlash Begins: Is Conflict Known?
In an article published last week in the New England Journal of Medicine, Dr. Michael Fiore and colleagues defend the new Joint Commission tobacco cessation performance measure set for hospitals, which - strikingly - insists that every smoking patient be discharged with a prescription for a smoking cessation drug (unless it is specifically contraindicated or the patient refuses).
(See: Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures -- will hospitals do the right thing? New England Journal of Medicine 2012; 10.1056/NEJMp1115176.)
The most glaringly odd recommendation is that every patient - whether or not NRT or Chantix or Zyban is right for them - whether or not they have tried these medications in the past and failed, must be prescribed a smoking cessation drug. It is not even clear that a recommendation to consider using over-the-counter products such as many NRT products, would constitute a valid "prescription."
As I have argued, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.
There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.
Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.
However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.
For example, consider a patient with the following history:
Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.
In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.
The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.
In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.
The Rest of the Story
It would be problematic if the recommendation of the Joint Commission were simply a violation of the basic principles of medicine. That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.
The rest of the story is that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...
... an FDA-approved smoking cessation drug.
Moreover, the panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.
The panel chair was Dr. Michael Fiore, who received grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."
Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.
We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."
Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.
On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. Fiore "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."
In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."
According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.
In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."
In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."
I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.
This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.
It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.
Physicians Starting to React
The comments section of the article shows that physicians are now starting to react to this odd recommendation which usurps their autonomy and clinical judgment for the benefit of Big Pharma profits.
One physician - Dr. Stephen Kirk of Salem, New Hampshire - questions the wisdom of a one-size-fits-all policy that undermines clinical judgment of physicians, and which may actually cause patient harm by leading physicians to perhaps prescribe a drug which has severe side effects like suicide (e.g., Chantix).
Dr. Kirk writes: "Unfortunately, this editorial is yet another example of the poor understanding academics have of the practice of primary care medicine. The editorialists seem to have the opinion that smoking cessation is yet another aspect of medicine that can be managed with a TJC promulgated checklist. Despite their opinion, smoking cessation is a common aspect of primary care medicine best addressed between a patient and a physician who has an ongoing relationship with a patient. Several prescription smoking cessation agents have "black box" warnings regarding their potential psychiatric ramifications. Will busy hospital based physicians explore the psychiatric history of their patients prior to their prescribing? Who will be responsible for following these medications over time? With the poor state of inpatient-outpatient communication, isn't such a situation rife with the potential for problematic follow-up? It's unfortunate the editorialists seem to deny the importance of a primary care-patient relationship and applaud subsuming that relationship to yet another "benchmark"."
Another physician - Dr. J. Franklin Roessner of Indianapolis - points out that in his judgment, prescribing drugs is often not the best way to treat smoking dependence (a fact that is borne out in many published studies). Why should he be required to practice medicine in a way that he believes is not going to be effective, or is not in the best interest of his patients? He writes:
"As a pulmonologist in my 10th year of private practice, I have a vast experience treating smokers and helping them quit. I am truly distressed to read that Joint Commission guidelines for tobacco-cessation measures require a prescription be written. I consider myself to be aggressive with smoking cessation counseling and estimate a success rate that is a multiple of those published by the prescription manufacturers. I do offer prescriptions but rarely write one (less than 5 in the last year). Included my counseling is education about "quit aids" and encouraging their use. However, I favor over-the-counter nicotine replacements as they allow the patient greater flexibility and control specifically because there is no prescription required. Further, I also inform patients that the vast majority of people who quit successfully do so "without doctors or prescriptions". Cigarette smoking is a behavior related health care issue similar to obesity and the cognitive-behavioral aspect of treatment is most important aspect. The Federal requirement that hospitalized smokers receive a prescription is an example which highlights many of the problems of our healthcare system."
I wonder whether Dr. Kirk and Dr. Roessner, and many of the other physicians reading the Joint Commission standards, are aware of the severe financial conflicts of interest that led to the Commission's recommendations.
I think that awareness of this long line of conflicts of interest might help these physicians understand where these guidelines are coming from, and whose interests they serve.
(See: Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures -- will hospitals do the right thing? New England Journal of Medicine 2012; 10.1056/NEJMp1115176.)
The most glaringly odd recommendation is that every patient - whether or not NRT or Chantix or Zyban is right for them - whether or not they have tried these medications in the past and failed, must be prescribed a smoking cessation drug. It is not even clear that a recommendation to consider using over-the-counter products such as many NRT products, would constitute a valid "prescription."
As I have argued, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.
There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.
Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.
However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.
For example, consider a patient with the following history:
Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.
In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.
The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.
In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.
The Rest of the Story
It would be problematic if the recommendation of the Joint Commission were simply a violation of the basic principles of medicine. That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.
The rest of the story is that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...
... an FDA-approved smoking cessation drug.
Moreover, the panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.
The panel chair was Dr. Michael Fiore, who received grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."
Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.
We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."
Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.
On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. Fiore "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."
In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."
According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.
In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."
In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."
I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.
This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.
It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.
Physicians Starting to React
The comments section of the article shows that physicians are now starting to react to this odd recommendation which usurps their autonomy and clinical judgment for the benefit of Big Pharma profits.
One physician - Dr. Stephen Kirk of Salem, New Hampshire - questions the wisdom of a one-size-fits-all policy that undermines clinical judgment of physicians, and which may actually cause patient harm by leading physicians to perhaps prescribe a drug which has severe side effects like suicide (e.g., Chantix).
Dr. Kirk writes: "Unfortunately, this editorial is yet another example of the poor understanding academics have of the practice of primary care medicine. The editorialists seem to have the opinion that smoking cessation is yet another aspect of medicine that can be managed with a TJC promulgated checklist. Despite their opinion, smoking cessation is a common aspect of primary care medicine best addressed between a patient and a physician who has an ongoing relationship with a patient. Several prescription smoking cessation agents have "black box" warnings regarding their potential psychiatric ramifications. Will busy hospital based physicians explore the psychiatric history of their patients prior to their prescribing? Who will be responsible for following these medications over time? With the poor state of inpatient-outpatient communication, isn't such a situation rife with the potential for problematic follow-up? It's unfortunate the editorialists seem to deny the importance of a primary care-patient relationship and applaud subsuming that relationship to yet another "benchmark"."
Another physician - Dr. J. Franklin Roessner of Indianapolis - points out that in his judgment, prescribing drugs is often not the best way to treat smoking dependence (a fact that is borne out in many published studies). Why should he be required to practice medicine in a way that he believes is not going to be effective, or is not in the best interest of his patients? He writes:
"As a pulmonologist in my 10th year of private practice, I have a vast experience treating smokers and helping them quit. I am truly distressed to read that Joint Commission guidelines for tobacco-cessation measures require a prescription be written. I consider myself to be aggressive with smoking cessation counseling and estimate a success rate that is a multiple of those published by the prescription manufacturers. I do offer prescriptions but rarely write one (less than 5 in the last year). Included my counseling is education about "quit aids" and encouraging their use. However, I favor over-the-counter nicotine replacements as they allow the patient greater flexibility and control specifically because there is no prescription required. Further, I also inform patients that the vast majority of people who quit successfully do so "without doctors or prescriptions". Cigarette smoking is a behavior related health care issue similar to obesity and the cognitive-behavioral aspect of treatment is most important aspect. The Federal requirement that hospitalized smokers receive a prescription is an example which highlights many of the problems of our healthcare system."
I wonder whether Dr. Kirk and Dr. Roessner, and many of the other physicians reading the Joint Commission standards, are aware of the severe financial conflicts of interest that led to the Commission's recommendations.
I think that awareness of this long line of conflicts of interest might help these physicians understand where these guidelines are coming from, and whose interests they serve.
Tuesday, March 20, 2012
Why I Am Doing This: A Message from an Electronic Cigarette Smoker
Dear Dr. Siegel:
Last Feb 2011 my lung function was measured at 60% and blood/oxygen was dangerously low. I then tried E-Cigs and have not had a tobacco cigarette since. I now have normal lung function and high normal oxygen levels despite the fact that I had smoked for more than 45 years and never could quit. I was killing myself and nothing but e-cigs had ever helped. I admit to being addicted to the e-cig but I believe that they saved my life and want to help as many as possible learn the truth about E-Cigs. If E-Cigs were outlawed, I have no doubt that I would once again take up smoking and start down that dark path again.
The Rest of the Story
Let me first note that this is not the only letter I have received from an electronic cigarette user who has successfully quit smoking and written to express thanks for my willingness to disseminate the truth about the relative health risks of these products compared to regular tobacco cigarettes. In fact I have probably received nearly one hundred similar letters, of which this one is typical.
Let me also note that not once in my career have I ever received a letter from a nicotine patch user, expressing his or her relief and gratitude that nicotine replacement therapy helped to quit smoking and resulted in immediate, measurable improvement in their lung function.
Of course, these anecdotes - in and of themselves - do not constitute valid evidence for making public policy decisions regarding these products. However, the letters are important because they do demonstrate the kind of public health benefits which electronic cigarettes are providing to literally thousands of ex-smokers. This is a critical piece of information which I believe has not adequately been considered by those anti-smoking groups and researchers which have called for the removal of electronic cigarettes from the market, and/or for a stringent regulatory procedure to be put in place before electronic cigarettes are approved for sale.
This truly is the rest of the story, because it's not something that you're going to hear about on anti-smoking web sites, or read about in newsletters sent out by the major national, state, or local anti-smoking organizations. You're only going to hear about stories like this if you seek them out and/or if you are willing to entertain this type of evidence.
Sadly, many tobacco researchers and anti-smoking groups do not consider smokers to be a valid source of information (not worthy of providing useful information, not worthy of holding a job, you get the picture). So this type of anecdotal information has almost completely escaped the radar screen of the official anti-tobacco movement.
I can assure readers that I am always ready to listen to personal accounts, and that this type of anecdotal evidence plays a critical role in informing me about important scientific and policy issues. In the case of electronic cigarettes, the anecdotal information is abundant enough to make it clear that removing electronic cigarettes from the market, as recommended by a number of anti-smoking groups, would be a grave public health mistake, causing many vapers to return to smoking and to suffer substantial and immediate health effects.
While the clinical trial is the "gold standard" of scientific knowledge, it is only one of many ways of knowing. Case studies, case series, and clinical anecdotes play (and have always played) a major role in medical knowledge. They occupy an important place in the overall development of medical knowledge, and can no longer be ignored by the anti-tobacco movement.
Last Feb 2011 my lung function was measured at 60% and blood/oxygen was dangerously low. I then tried E-Cigs and have not had a tobacco cigarette since. I now have normal lung function and high normal oxygen levels despite the fact that I had smoked for more than 45 years and never could quit. I was killing myself and nothing but e-cigs had ever helped. I admit to being addicted to the e-cig but I believe that they saved my life and want to help as many as possible learn the truth about E-Cigs. If E-Cigs were outlawed, I have no doubt that I would once again take up smoking and start down that dark path again.
The Rest of the Story
Let me first note that this is not the only letter I have received from an electronic cigarette user who has successfully quit smoking and written to express thanks for my willingness to disseminate the truth about the relative health risks of these products compared to regular tobacco cigarettes. In fact I have probably received nearly one hundred similar letters, of which this one is typical.
Let me also note that not once in my career have I ever received a letter from a nicotine patch user, expressing his or her relief and gratitude that nicotine replacement therapy helped to quit smoking and resulted in immediate, measurable improvement in their lung function.
Of course, these anecdotes - in and of themselves - do not constitute valid evidence for making public policy decisions regarding these products. However, the letters are important because they do demonstrate the kind of public health benefits which electronic cigarettes are providing to literally thousands of ex-smokers. This is a critical piece of information which I believe has not adequately been considered by those anti-smoking groups and researchers which have called for the removal of electronic cigarettes from the market, and/or for a stringent regulatory procedure to be put in place before electronic cigarettes are approved for sale.
This truly is the rest of the story, because it's not something that you're going to hear about on anti-smoking web sites, or read about in newsletters sent out by the major national, state, or local anti-smoking organizations. You're only going to hear about stories like this if you seek them out and/or if you are willing to entertain this type of evidence.
Sadly, many tobacco researchers and anti-smoking groups do not consider smokers to be a valid source of information (not worthy of providing useful information, not worthy of holding a job, you get the picture). So this type of anecdotal information has almost completely escaped the radar screen of the official anti-tobacco movement.
I can assure readers that I am always ready to listen to personal accounts, and that this type of anecdotal evidence plays a critical role in informing me about important scientific and policy issues. In the case of electronic cigarettes, the anecdotal information is abundant enough to make it clear that removing electronic cigarettes from the market, as recommended by a number of anti-smoking groups, would be a grave public health mistake, causing many vapers to return to smoking and to suffer substantial and immediate health effects.
While the clinical trial is the "gold standard" of scientific knowledge, it is only one of many ways of knowing. Case studies, case series, and clinical anecdotes play (and have always played) a major role in medical knowledge. They occupy an important place in the overall development of medical knowledge, and can no longer be ignored by the anti-tobacco movement.
Wednesday, March 14, 2012
Society for Research on Nicotine and Tobacco (SRNT) Sacrifices Scientific Integrity for Money: Accepts Big Pharma Sponsorships for Annual Meeting
The Society for Research on Nicotine and Tobacco (SRNT) holds its annual meeting this week in Houston.
According to the program, major topic areas for paper sessions include:
An entire session will be devoted to varenicline, with talks including:
According to the program, major topic areas for paper sessions include:
- varenicline;
- dopamine;
- the process of quitting;
- genetics of nicotine addiction; and
- the biology of dependence and withdrawal.
An entire session will be devoted to varenicline, with talks including:
- Extinction of smoking during response to varenicline: is one week long enough?;
- A double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in schizophrenia and schizoaffective disorder;
- The effects of extended pre-quit varenicline treatment on smoking behavior and short-term abstinence: a randomized clinical trial;
- Real world effectiveness of varenicline and nicotine replacement therapy: findings from an outpatient smoking cessation clinic.
- Using nicotine patches for the recommended duration helps smokers quit: a population-based cohort study;
- Effects of motivational interviewing and the nicotine patch for smoking cessation among homeless smokers;
- Medication adherence: who does, who doesn’t, and how to improve it;
- Effect of varenicline on individual nicotine withdrawal symptoms: a combined analysis of eight randomized placebo-controlled trials.
The Rest of the Story
According to the conference program, two of the major sponsors of the conference, which apparently provide financial support for SRNT that helps fund the annual conference, are:
- Pfizer; and
- GlaxoSmithKline
Pfizer, of course, is the manufacturer of varenicline (Chantix) and GlaxoSmithKline makes Zyban. both of these are smoking cessation drugs.
By accepting these sponsorships, SRNT is sacrificing the scientific integrity of the conference. There is no way that the conference can objectively consider the role of pharmaceutical smoking cessation products as part of a broad, national strategy for smoking cessation when the conference is being funded by the very manufacturers of many of those products.
The bias introduced by the Big Pharma sponsorship of the conference is readily apparent. While there are multiple talks about the role of pharmaceutical products in smoking cessation, especially the role of Chantix, noticeably absent from the conference program are the following talks:
- Suicidal ideation and completed suicide as adverse side effects of Chantix: should varenicline be taken off the market?;
- Case reports of varenicline-related deaths among patients with no prior history of depression;
- Population-based data show that smoking cessation drugs are not effective;
- Population-based data show that cold turkey quitting remains the most effective strategy;
- Problems of blinding in clinical trials of smoking cessation drugs; and
- Weaknesses of the transtheoretical model in explaining the process of smoking cessation: the need for anti-smoking media campaigns rather than smoking cessation drugs as the mainstay for a national smoking cessation strategy.
The rest of the story is that although its main purpose is presumably to foster objective scientific consideration of the issues regarding nicotine and tobacco control, SRNT is apparently heavily funded by the pharmaceutical industry. This funding, in my view, creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national or international tobacco control strategies.
This is in no way to fault the individual scientists who will present on these issues at the conference. Nor is it to suggest that any wrongdoing is occurring. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.
It is also important to point out that bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.
I should also note that SRNT is not unique in relying upon pharmaceutical company sponsorship. The 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. And the Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.
I should once again highlight the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) as one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.
Tuesday, March 13, 2012
FDA Press Statement on Surgeon General's Report Highlights FDA Actions to Protect Youth From Cigarettes ... Which is Bupkes
The FDA last week issued a press statement in response to the release of the Surgeon General's report on youth smoking. The statement highlighted the actions of the agency to prevent smoking among youth during the first two years of its jurisdiction over cigarettes.
According to the statement, those accomplishments are as follows:
1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."
2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."
3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."
The Rest of the Story
The rest of the story is that none of the three interventions about which the FDA is boasting are effective in preventing youth smoking and therefore, the FDA has so far done virtually nothing to reduce youth smoking.
Let's take the interventions one by one:
1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."
Guess the total number of cigarette brands made by the Big Tobacco companies that contained fruit or candy flavorings and which were taken off the market, and the total youth market share for these products:
Was it:
a. 15 brands, 18% of the youth cigarette market;
b. 10 brands, 12% of the youth cigarette market;
c. 4 brands, 3% of the youth cigarette market;
d. 2 brands, 1% of the youth cigarette market; or
e. 0 brands, 0% of the youth cigarette market.
The correct answer is:
e. 0 brands, 0% of the youth cigarette market.
The FDA has not taken a single flavored cigarette manufactured by Big Tobacco off the market. The "rest of the story" is that there were no such products on the market to be taken off. Youths were not smoking flavored or candy cigarettes (if you don't include menthol). They were smoking menthol cigarettes, as well as the name-brand products: Marlboros, Newports, and Camels.
The only minor effect of the cigarette flavoring ban was to take some Indonesian cigarettes off the market and a few minor brands. Together, these accounted for less than 0.1% of the market.
Thus, this intervention has had no impact on youth smoking.
2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."
The minimum age for purchase of cigarettes has been enforced for years, and it has been enforced by specific regulation for about 17 years. The ban on vending machine sales, sales of single cigarettes, and give-away of free samples of cigarettes was already enforced in many states and localities, and will have minimum if any effect on youth smoking. The requirements for new smokeless tobacco warnings will not have any impact, just as the old cigarette warnings have no impact. The prohibition on misleading advertising claims, such as the elimination of terms such as "light," have had no effect because cigarette companies simply substituted color patterns to signify the identify of these brands.
Thus, this set of interventions will have minimal, if any, impact on youth smoking.
3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."
Several meta-analyses have demonstrated that these youth access interventions have no impact on youth smoking. There is no relationship between tobacco sales rates to minors and youth smoking prevalence. There are simply too many other ways for youth to obtain cigarettes. Moreover, even if only a few stores are willing to sell to minors, that is enough to maintain the needed supply for youth smokers. This intervention is not only ineffective, but it is also a huge waste of time and resources.
The rest of the story, then, is that so far, the FDA has done virtually nothing to substantially reduce youth smoking. That might be fine, except for the fact that the agency is boasting about its non-existent accomplishments. This sounds more like something that the Campaign for Tobacco-Free Kids would do, not a federal regulatory agency.
Don't get me wrong. This is not all the FDA's fault. After all, the Tobacco Act gives the FDA virtually no ability to take the measures necessary to substantially reduce youth smoking. That was by design. That is the entire point of the law. The Tobacco Act was not a legitimate public health measure. It was a piece of political propaganda, designed to allow anti-smoking groups and politicians to boast that they were fighting Big Tobacco, when instead, all they were doing was creating a tobacco control government bureaucracy that would say much yet do very little. It would make the American public think that their politicians and anti-smoking groups were taking action to reduce tobacco-related morbidity and mortality, but without them actually having to take the courageous actions that would be necessary to accomplish anything meaningful.
According to the statement, those accomplishments are as follows:
1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."
2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."
3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."
The Rest of the Story
The rest of the story is that none of the three interventions about which the FDA is boasting are effective in preventing youth smoking and therefore, the FDA has so far done virtually nothing to reduce youth smoking.
Let's take the interventions one by one:
1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."
Guess the total number of cigarette brands made by the Big Tobacco companies that contained fruit or candy flavorings and which were taken off the market, and the total youth market share for these products:
Was it:
a. 15 brands, 18% of the youth cigarette market;
b. 10 brands, 12% of the youth cigarette market;
c. 4 brands, 3% of the youth cigarette market;
d. 2 brands, 1% of the youth cigarette market; or
e. 0 brands, 0% of the youth cigarette market.
The correct answer is:
e. 0 brands, 0% of the youth cigarette market.
The FDA has not taken a single flavored cigarette manufactured by Big Tobacco off the market. The "rest of the story" is that there were no such products on the market to be taken off. Youths were not smoking flavored or candy cigarettes (if you don't include menthol). They were smoking menthol cigarettes, as well as the name-brand products: Marlboros, Newports, and Camels.
The only minor effect of the cigarette flavoring ban was to take some Indonesian cigarettes off the market and a few minor brands. Together, these accounted for less than 0.1% of the market.
Thus, this intervention has had no impact on youth smoking.
2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."
The minimum age for purchase of cigarettes has been enforced for years, and it has been enforced by specific regulation for about 17 years. The ban on vending machine sales, sales of single cigarettes, and give-away of free samples of cigarettes was already enforced in many states and localities, and will have minimum if any effect on youth smoking. The requirements for new smokeless tobacco warnings will not have any impact, just as the old cigarette warnings have no impact. The prohibition on misleading advertising claims, such as the elimination of terms such as "light," have had no effect because cigarette companies simply substituted color patterns to signify the identify of these brands.
Thus, this set of interventions will have minimal, if any, impact on youth smoking.
3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."
Several meta-analyses have demonstrated that these youth access interventions have no impact on youth smoking. There is no relationship between tobacco sales rates to minors and youth smoking prevalence. There are simply too many other ways for youth to obtain cigarettes. Moreover, even if only a few stores are willing to sell to minors, that is enough to maintain the needed supply for youth smokers. This intervention is not only ineffective, but it is also a huge waste of time and resources.
The rest of the story, then, is that so far, the FDA has done virtually nothing to substantially reduce youth smoking. That might be fine, except for the fact that the agency is boasting about its non-existent accomplishments. This sounds more like something that the Campaign for Tobacco-Free Kids would do, not a federal regulatory agency.
Don't get me wrong. This is not all the FDA's fault. After all, the Tobacco Act gives the FDA virtually no ability to take the measures necessary to substantially reduce youth smoking. That was by design. That is the entire point of the law. The Tobacco Act was not a legitimate public health measure. It was a piece of political propaganda, designed to allow anti-smoking groups and politicians to boast that they were fighting Big Tobacco, when instead, all they were doing was creating a tobacco control government bureaucracy that would say much yet do very little. It would make the American public think that their politicians and anti-smoking groups were taking action to reduce tobacco-related morbidity and mortality, but without them actually having to take the courageous actions that would be necessary to accomplish anything meaningful.
Monday, March 12, 2012
Another Nail in the Coffin for Menthol Ban: Surgeon General's Report Fails to Recommend Any Action on Menthol
Last week, I described what I view as a nail in the coffin for any possible FDA ban on menthol cigarettes: a new FDA study showing that menthol cigarette smokers have lower lung cancer risk than smokers of non-menthol cigarettes. Today, I report what I believe is a second nail in the coffin on a menthol cigarette ban: the U.S. Surgeon General's failure to recommend any action on menthol in her comprehensive report on youth smoking.
After reviewing the data regarding the role of menthol in cigarette smoking initiation among youth, the Surgeon General's report considers various options, but concludes only that the issue deserves "continued surveillance."
Among the Surgeon General's findings are the following:
1. "Some studies suggest that mentholated cigarettes increase the addictive potential of smoking among youth (Wackowski and Delnovo, 2007; Hersey et al. 2010). Furthermore, because mentholation can improve the taste of cigarettes for smokers, this additive may facilitate initiation or inhibit quitting (Giovino et al. 2004)."
2. "Adolescent and young adult smokers smoke menthol cigarettes at a higher percentage than any other age group."
3. "there is evidence that highly addictive, smooth-tasting tobacco products (e.g., menthol cigarettes [with lower levels of menthol]) have been modified for this market, raising concerns about how changes in product design may be contributing to an increased likelihood that tobacco will be consumed by young people."
Despite these three major findings, the report concludes only that: "Continued surveillance of menthol cigarettes is warranted."
The Rest of the Story
This essentially amounts to a non-recommendation by the Surgeon General. Despite the conclusion that menthol cigarettes enhance the smoking initiation process among youth, have been modified specifically for the youth market in order to enhance initiation, and are contributing to an increased likelihood that youth will smoke cigarettes, the Surgeon General nevertheless fails to conclude that any action is necessary on menthol cigarettes, other than to merely conduct "continued surveillance."
For those unfamiliar with the technical jargon, "continued surveillance" translates into "do nothing."
Thus, the story here is that the U.S. Surgeon General does not recommend any action on menthol cigarettes, despite their contribution to the problem of youth smoking, which is reviewed in exhausting detail in her 900 page report.
In my view, this is yet another nail in the coffin for any possible FDA ban on menthol cigarettes. If the Surgeon General, after reviewing the evidence and concluding that menthol contributes toward smoking initiation, nevertheless fails to recommend a menthol ban, then there simply exists no scientific analysis of the issue that would lead a government agency to recommend a ban on menthol cigarettes.
Clearly, the politics is so caught up in the science on this issue that it has become clear that menthol cigarettes are here to stay.
Today should be a day of celebration in Greensboro.
After reviewing the data regarding the role of menthol in cigarette smoking initiation among youth, the Surgeon General's report considers various options, but concludes only that the issue deserves "continued surveillance."
Among the Surgeon General's findings are the following:
1. "Some studies suggest that mentholated cigarettes increase the addictive potential of smoking among youth (Wackowski and Delnovo, 2007; Hersey et al. 2010). Furthermore, because mentholation can improve the taste of cigarettes for smokers, this additive may facilitate initiation or inhibit quitting (Giovino et al. 2004)."
2. "Adolescent and young adult smokers smoke menthol cigarettes at a higher percentage than any other age group."
3. "there is evidence that highly addictive, smooth-tasting tobacco products (e.g., menthol cigarettes [with lower levels of menthol]) have been modified for this market, raising concerns about how changes in product design may be contributing to an increased likelihood that tobacco will be consumed by young people."
Despite these three major findings, the report concludes only that: "Continued surveillance of menthol cigarettes is warranted."
The Rest of the Story
This essentially amounts to a non-recommendation by the Surgeon General. Despite the conclusion that menthol cigarettes enhance the smoking initiation process among youth, have been modified specifically for the youth market in order to enhance initiation, and are contributing to an increased likelihood that youth will smoke cigarettes, the Surgeon General nevertheless fails to conclude that any action is necessary on menthol cigarettes, other than to merely conduct "continued surveillance."
For those unfamiliar with the technical jargon, "continued surveillance" translates into "do nothing."
Thus, the story here is that the U.S. Surgeon General does not recommend any action on menthol cigarettes, despite their contribution to the problem of youth smoking, which is reviewed in exhausting detail in her 900 page report.
In my view, this is yet another nail in the coffin for any possible FDA ban on menthol cigarettes. If the Surgeon General, after reviewing the evidence and concluding that menthol contributes toward smoking initiation, nevertheless fails to recommend a menthol ban, then there simply exists no scientific analysis of the issue that would lead a government agency to recommend a ban on menthol cigarettes.
Clearly, the politics is so caught up in the science on this issue that it has become clear that menthol cigarettes are here to stay.
Today should be a day of celebration in Greensboro.
Friday, March 09, 2012
Canadian Cancer Society Argues that Outdoor Park Smoking Bans are Necessary to Prevent Children from Even Seeing a Smoker
According to an article in the Toronto Star, the Canadian Cancer Society is supporting broad bans on smoking in outdoor places, including parks, in order to prevent children from even having to see a smoker. A spokesperson for the Canadian Cancer Society was quoted as asserting that park smoking bans are justified because they will prevent kids from seeing smokers, which will in turn reduce smoking initiation.
According to the article: "In a move sure to rankle smokers of the nature-loving type, the Lake Simcoe community of Georgina is a breath away from enacting one of the toughest outdoor antismoking bylaws in the province. ... “Sometimes you have to push the bar,” said Mayor Robert Grossi of his northern GTA town’s recently approved report calling for a smoking ban for the town’s beaches, parks and trails. If it passes later this month, the bylaw will sweep across much of the town’s outdoor property — adding to an existing smoking ban on playgrounds, splash pads, skateboard parks, soccer parks and sports fields." ...
"It’s a level of regulation some call heavy-handed and discriminatory toward smokers and potentially harmful to the widely successful campaign to clear restaurants, bars and workplaces of deadly second-hand smoke. “It casts the movement as being fanatical,” said Dr. Michael Siegel, a Boston University public health professor and outspoken supporter of indoor smoking bans. ... “By going to these extremes, I’m afraid the smoke-free movement is going to lose credibility,” Siegel said. “It undermines our very argument for the workplace and makes it more difficult to promote these policies.”" ...
"But advocates say outdoor bylaws force tobacco out of mainstream acceptability, encourage smokers to kick the habit and promote healthy living among impressionable youth. “It’s about decreasing smoking around children so they don’t emulate that behaviour,” said Joanne Di Nardo of the Canadian Cancer Society, a national group that has advocated with city councils across the country for outdoor bans similar to those in Georgina."
The Rest of the Story
Here's why the Canadian Cancer Society's argument doesn't hold water. If it is true that government policies which ban smoking in certain places are justified because of the government's interest in not allowing children to see smokers, so that they are less likely to smoke themselves, then what is the possible justification for allowing any smoking outdoors where smokers might be seen by children?
Why allow smoking in parking lots, on sidewalks, or in streets? Why allow smoking outside of buildings? Why allow smoking in downtown areas? Why allow smoking in any outdoor area?
If the point is to prevent children from having to see a smoker, then why is the Canadian Cancer Society not simply calling for a ban on outdoor smoking? Why not simply confine smoking to the home, so that children of nonsmokers will not have to ever see a smoker. That would certainly reduce smoking initiation rates.
While they are at it, why not ban people from eating fast food, like burgers and fries, in public places? If children see adults eating healthy food rather than fast food, they are more likely to develop healthier patterns of eating themselves.
Why not ban alcohol use in public parks? Well ... alcohol use is often banned in public places. And there's a reason for it. It is considered to be a moral issue. Behaviors like public sex and public drinking are often banned specifically because they are an affront to public morals. The point is that banning smoking in parks to prevent people from seeing a smoker is making smoking into a moral issue, rather than a health issue.
In my view, smoking bans are justified because they protect nonsmokers from the significant harmful effects of secondhand smoke. That is the reason why I've devoted much of my career to lobbying for smoking bans in bars, restaurants, casinos, and other workplaces, as well as in confined outdoor spaces like outdoor restaurant areas and stadiums. Once you cross that line and start justifying smoking bans based on preventing people from even having to see a smoker, then you've not only undermined the legitimate underpinnings behind the entire smoke-free movement, but you've entered an area that you don't want to enter: that of moralizing a legal behavior that is highly addictive and which people cannot easily control.
The rest of the story is that with this reasoning, the Canadian Cancer Society is shifting the battle against tobacco smoke into a battle against smokers. It is transforming a health issue into a moral issue. And most importantly, it is undermining the sound, legitimate basis for smoke-free regulations that are truly necessary to protect people's lives.
According to the article: "In a move sure to rankle smokers of the nature-loving type, the Lake Simcoe community of Georgina is a breath away from enacting one of the toughest outdoor antismoking bylaws in the province. ... “Sometimes you have to push the bar,” said Mayor Robert Grossi of his northern GTA town’s recently approved report calling for a smoking ban for the town’s beaches, parks and trails. If it passes later this month, the bylaw will sweep across much of the town’s outdoor property — adding to an existing smoking ban on playgrounds, splash pads, skateboard parks, soccer parks and sports fields." ...
"It’s a level of regulation some call heavy-handed and discriminatory toward smokers and potentially harmful to the widely successful campaign to clear restaurants, bars and workplaces of deadly second-hand smoke. “It casts the movement as being fanatical,” said Dr. Michael Siegel, a Boston University public health professor and outspoken supporter of indoor smoking bans. ... “By going to these extremes, I’m afraid the smoke-free movement is going to lose credibility,” Siegel said. “It undermines our very argument for the workplace and makes it more difficult to promote these policies.”" ...
"But advocates say outdoor bylaws force tobacco out of mainstream acceptability, encourage smokers to kick the habit and promote healthy living among impressionable youth. “It’s about decreasing smoking around children so they don’t emulate that behaviour,” said Joanne Di Nardo of the Canadian Cancer Society, a national group that has advocated with city councils across the country for outdoor bans similar to those in Georgina."
The Rest of the Story
Here's why the Canadian Cancer Society's argument doesn't hold water. If it is true that government policies which ban smoking in certain places are justified because of the government's interest in not allowing children to see smokers, so that they are less likely to smoke themselves, then what is the possible justification for allowing any smoking outdoors where smokers might be seen by children?
Why allow smoking in parking lots, on sidewalks, or in streets? Why allow smoking outside of buildings? Why allow smoking in downtown areas? Why allow smoking in any outdoor area?
If the point is to prevent children from having to see a smoker, then why is the Canadian Cancer Society not simply calling for a ban on outdoor smoking? Why not simply confine smoking to the home, so that children of nonsmokers will not have to ever see a smoker. That would certainly reduce smoking initiation rates.
While they are at it, why not ban people from eating fast food, like burgers and fries, in public places? If children see adults eating healthy food rather than fast food, they are more likely to develop healthier patterns of eating themselves.
Why not ban alcohol use in public parks? Well ... alcohol use is often banned in public places. And there's a reason for it. It is considered to be a moral issue. Behaviors like public sex and public drinking are often banned specifically because they are an affront to public morals. The point is that banning smoking in parks to prevent people from seeing a smoker is making smoking into a moral issue, rather than a health issue.
In my view, smoking bans are justified because they protect nonsmokers from the significant harmful effects of secondhand smoke. That is the reason why I've devoted much of my career to lobbying for smoking bans in bars, restaurants, casinos, and other workplaces, as well as in confined outdoor spaces like outdoor restaurant areas and stadiums. Once you cross that line and start justifying smoking bans based on preventing people from even having to see a smoker, then you've not only undermined the legitimate underpinnings behind the entire smoke-free movement, but you've entered an area that you don't want to enter: that of moralizing a legal behavior that is highly addictive and which people cannot easily control.
The rest of the story is that with this reasoning, the Canadian Cancer Society is shifting the battle against tobacco smoke into a battle against smokers. It is transforming a health issue into a moral issue. And most importantly, it is undermining the sound, legitimate basis for smoke-free regulations that are truly necessary to protect people's lives.
Thursday, March 08, 2012
Hertfordshire Smokers and Obese Individuals No Longer Eligible for Routine Surgery, According to The Telegraph
According to an article in the The Telegraph, a ban on hip or knee replacement surgery for smokers and persons with a body mass index greater than 30 is being extended to cover all routine surgeries. Based on the article, the only exceptions are for "neurology, cardiac and cancer operations."
The article reports: "Data shows that more than a quarter of Primary Care Trusts in England have brought in new restrictions based on patients’ lifestyle criteria in the last year. It reveals that people are being denied IVF treatment, breast reductions and fat-loss operations based on their weight and whether they smoke. In the case of one trust, NHS Hertfordshire, a controversial ban imposed last year on knee and hip operations for anyone with a body mass index (BMI) over 30 as well as smokers, has been extended to cover all routine surgery. The new Hertfordshire policy, introduced in January, makes exceptions only for neurology, cardiac and cancer operations. ... Dr. Clare Gerada, head of the Royal College of GPs, said some of the restrictions, particularly for IVF, were “dreadful”. She added: “It’s becoming the deserving and the undeserving. I think it’s discriminatory and I find it astonishing.”"
The Rest of the Story
The first thing that readers need to understand is that while smoking and obesity do have adverse implications for healing after surgery and for outcomes in some types of surgery, there is no medical indication to withhold routine surgery from smokers or obese persons. Moreover, even for operations in which a patient might likely fare better if he or she quit smoking, such as knee replacement, there is no medical justification for withholding access to the treatment.
The only possible medical indications for withholding surgery would be if the smoking or obesity was the cause of the disease and the treatment would be unsuccessful or futile in the absence of smoking cessation or weight loss. For example, it wouldn't make medical sense to perform a liver transplant on an alcoholic with cirrhosis of the liver who refuses to quit drinking or enter an alcoholism treatment program. But to deny surgical treatment of a fracture to that person has no medical justification.
Another important factor to consider is that it is extremely dangerous to go down the road of withholding treatment to people because they engage in certain unhealthy behaviors that put them at increased risk of adverse health outcomes. The same reasoning being used to withhold surgery from smokers could be used to justify the withholding of treatment of chronic head injury for boxers or football players. It could justify withholding treatment for anorexia among people who refuse to eat a proper amount of food. It could justify withholding treatment of chronic tendonitis in tennis players or marathon runners. It could justify withholding treatment of hypertension for patients who eat extreme excesses of salt. This is definitely not a road that we want to go down.
A third important factor to consider is that the practice of medicine is based on the ethical principle that medical treatment decisions are based on serving the best interests of the patient, not on casting moral judgments on patient lifestyle choices. And medical treatments should not be made requisite on patient's making particular changes in their lifestyle unless there is a specific medical contraindication.
The reasoning being used by the Hertfordshire NHS would justify the refusal to provide anti-hypertension medication to any person with high blood pressure who does not successfully reduce his sodium intake to less than two grams per day. Any physician in the United States who did such a thing would not only be questioned for ethical reasoning, but he would most likely be sued successfully for malpractice.
I don't understand who the Hertfordshire authorities think they are who can decide which vices (i.e., what health-related behavioral or lifestyle choices) are permissible and which are not permissible in order to be eligible for routine surgery. This is not medically justified rationing. Instead, it is unethical discrimination, moralizing, and bigotry.
The article reports: "Data shows that more than a quarter of Primary Care Trusts in England have brought in new restrictions based on patients’ lifestyle criteria in the last year. It reveals that people are being denied IVF treatment, breast reductions and fat-loss operations based on their weight and whether they smoke. In the case of one trust, NHS Hertfordshire, a controversial ban imposed last year on knee and hip operations for anyone with a body mass index (BMI) over 30 as well as smokers, has been extended to cover all routine surgery. The new Hertfordshire policy, introduced in January, makes exceptions only for neurology, cardiac and cancer operations. ... Dr. Clare Gerada, head of the Royal College of GPs, said some of the restrictions, particularly for IVF, were “dreadful”. She added: “It’s becoming the deserving and the undeserving. I think it’s discriminatory and I find it astonishing.”"
The Rest of the Story
The first thing that readers need to understand is that while smoking and obesity do have adverse implications for healing after surgery and for outcomes in some types of surgery, there is no medical indication to withhold routine surgery from smokers or obese persons. Moreover, even for operations in which a patient might likely fare better if he or she quit smoking, such as knee replacement, there is no medical justification for withholding access to the treatment.
The only possible medical indications for withholding surgery would be if the smoking or obesity was the cause of the disease and the treatment would be unsuccessful or futile in the absence of smoking cessation or weight loss. For example, it wouldn't make medical sense to perform a liver transplant on an alcoholic with cirrhosis of the liver who refuses to quit drinking or enter an alcoholism treatment program. But to deny surgical treatment of a fracture to that person has no medical justification.
Another important factor to consider is that it is extremely dangerous to go down the road of withholding treatment to people because they engage in certain unhealthy behaviors that put them at increased risk of adverse health outcomes. The same reasoning being used to withhold surgery from smokers could be used to justify the withholding of treatment of chronic head injury for boxers or football players. It could justify withholding treatment for anorexia among people who refuse to eat a proper amount of food. It could justify withholding treatment of chronic tendonitis in tennis players or marathon runners. It could justify withholding treatment of hypertension for patients who eat extreme excesses of salt. This is definitely not a road that we want to go down.
A third important factor to consider is that the practice of medicine is based on the ethical principle that medical treatment decisions are based on serving the best interests of the patient, not on casting moral judgments on patient lifestyle choices. And medical treatments should not be made requisite on patient's making particular changes in their lifestyle unless there is a specific medical contraindication.
The reasoning being used by the Hertfordshire NHS would justify the refusal to provide anti-hypertension medication to any person with high blood pressure who does not successfully reduce his sodium intake to less than two grams per day. Any physician in the United States who did such a thing would not only be questioned for ethical reasoning, but he would most likely be sued successfully for malpractice.
I don't understand who the Hertfordshire authorities think they are who can decide which vices (i.e., what health-related behavioral or lifestyle choices) are permissible and which are not permissible in order to be eligible for routine surgery. This is not medically justified rationing. Instead, it is unethical discrimination, moralizing, and bigotry.
Wednesday, March 07, 2012
Menthol Cigarette Ban Dying a Slow Death, As Predicted; New Study Shows Lower Lung Cancer Risk Among Menthol Cigarette Smokers
I have predicted for more than a year that the FDA's consideration of the menthol issue would not result in a ban on menthol cigarettes. When the Tobacco Products Scientific Advisory Committee (TPSAC) came out with its non-recommendation, I opined that this all but killed any chances for a menthol ban. Today's story suggests that not only political, but scientific concerns are now going to make it virtually impossible for the FDA to promulgate a ban on menthol cigarettes.
The Rest of the Story
Last week, a new study out of the FDA's Center for Tobacco Products reported that the risk of lung cancer death is significantly and substantially lower among menthol cigarette smokers than among non-menthol smokers.
See: Rostron B. Lung cancer mortality risk for U.S. menthol cigarette smokers. Nicotine & Tobacco Research 2012. Published online ahead of print on March 1, 2012. doi: 10.1093/ntr/nts014.
The study was a survival analysis of smokers from the 1987 National Health Interview Survey Cancer Control Supplement. Approximately 4800 smokers were followed up to determine mortality rates by linking to the National Death Index. Mortality rates, controlling for a wide set of demographic factors and smoking behavior variables, were compared for menthol and non-menthol smokers.
The results were as follows: "The overall HR [hazard ratio] for lung cancer mortality for menthol smokers was 0.69 (95% CI = 0.45–1.06). The HR for lung cancer mortality for menthol smokers at ages 50 and over was 0.59 (95% CI = 0.37–0.95)."
The study concludes as follows: "We found evidence of lower lung cancer mortality risk among menthol smokers compared with nonmenthol smokers at ages 50 and over in the U.S. population. It is not known, however, if these differences are due to the impact of menthol on cigarette smoking or long-term differences in cigarette design between menthol and nonmenthol cigarettes."
The results of this study comport with those of an earlier study which reported finding a statistically significant adjusted hazard ratio for lung cancer mortality of 0.69 associated with smoking menthol cigarettes vs. non-menthol cigarettes.
It is important to note that these results do not prove that the menthol itself confers a degree of decreased lung cancer risk. It is highly possible, and actually likely, that the real reason for the observed lung cancer mortality difference is that menthol smokers and non-menthol smokers have differing patterns of cigarette use and smoke inhalation. For example, Rostron postulates, quite plausibly, that because of the full flavor and absence of filter tip ventilation of menthol cigarette brands, smokers may not need to inhale as deeply, resulting in reduced tar exposure.
Rostron writes: "Cigarette ventilation is one possible cause of differences in risk for menthol cigarettes, given that the delivery of carcinogenic constituents can be altered by ventilation (Hoffmann & Hoffmann, 1997). Smokers of ventilated cigarettes often inhale more deeply in order to ensure consistent nicotine delivery (Hoffmann & Hoffmann, 1997). Popular menthol brands in the U.S. market often have little or no filter tip ventilation, particularly for their “full-flavor” subbrands (Kozlowski, Mehta, & Sweeney, 1997). As a result, differences in lung cancer mortality for menthol and nonmenthol smokers may be due in part to differences in inhalation caused by product design and not necessarily to menthol itself."
Regardless of the explanation for the reduced lung cancer mortality observed among menthol cigarette smokers, I believe that this finding is going to put the final nail in the coffin for the prospect of any ban on menthol cigarettes.
The Rest of the Story
Last week, a new study out of the FDA's Center for Tobacco Products reported that the risk of lung cancer death is significantly and substantially lower among menthol cigarette smokers than among non-menthol smokers.
See: Rostron B. Lung cancer mortality risk for U.S. menthol cigarette smokers. Nicotine & Tobacco Research 2012. Published online ahead of print on March 1, 2012. doi: 10.1093/ntr/nts014.
The study was a survival analysis of smokers from the 1987 National Health Interview Survey Cancer Control Supplement. Approximately 4800 smokers were followed up to determine mortality rates by linking to the National Death Index. Mortality rates, controlling for a wide set of demographic factors and smoking behavior variables, were compared for menthol and non-menthol smokers.
The results were as follows: "The overall HR [hazard ratio] for lung cancer mortality for menthol smokers was 0.69 (95% CI = 0.45–1.06). The HR for lung cancer mortality for menthol smokers at ages 50 and over was 0.59 (95% CI = 0.37–0.95)."
The study concludes as follows: "We found evidence of lower lung cancer mortality risk among menthol smokers compared with nonmenthol smokers at ages 50 and over in the U.S. population. It is not known, however, if these differences are due to the impact of menthol on cigarette smoking or long-term differences in cigarette design between menthol and nonmenthol cigarettes."
The results of this study comport with those of an earlier study which reported finding a statistically significant adjusted hazard ratio for lung cancer mortality of 0.69 associated with smoking menthol cigarettes vs. non-menthol cigarettes.
It is important to note that these results do not prove that the menthol itself confers a degree of decreased lung cancer risk. It is highly possible, and actually likely, that the real reason for the observed lung cancer mortality difference is that menthol smokers and non-menthol smokers have differing patterns of cigarette use and smoke inhalation. For example, Rostron postulates, quite plausibly, that because of the full flavor and absence of filter tip ventilation of menthol cigarette brands, smokers may not need to inhale as deeply, resulting in reduced tar exposure.
Rostron writes: "Cigarette ventilation is one possible cause of differences in risk for menthol cigarettes, given that the delivery of carcinogenic constituents can be altered by ventilation (Hoffmann & Hoffmann, 1997). Smokers of ventilated cigarettes often inhale more deeply in order to ensure consistent nicotine delivery (Hoffmann & Hoffmann, 1997). Popular menthol brands in the U.S. market often have little or no filter tip ventilation, particularly for their “full-flavor” subbrands (Kozlowski, Mehta, & Sweeney, 1997). As a result, differences in lung cancer mortality for menthol and nonmenthol smokers may be due in part to differences in inhalation caused by product design and not necessarily to menthol itself."
Regardless of the explanation for the reduced lung cancer mortality observed among menthol cigarette smokers, I believe that this finding is going to put the final nail in the coffin for the prospect of any ban on menthol cigarettes.
Tuesday, March 06, 2012
Chick-fil-A Borrows a Page from American Dietetic Association and American Academy of Pediatrics Playbook in Defending Its Support of Anti-Gay Groups
Last week, the Northeastern University Student Senate voted to rescind plans to bring a Chick-fil-A to campus because of the company's financial support of groups which oppose gay and lesbian rights.
Chick-fil-A had been one of a group of restaurants being eyed for vendor spots in the University's new student center. The offer was canceled as a result of Chick-fil-A's support of a number of organizations that oppose gay and lesbian rights, including opposing same sex marriage. These groups include Focus on the Family, the Family Research Council, Exodus International, the Marriage & Family Legacy Fund, and the Fellowship of Christian Athletes. In 2009, Chick-fil-A reportedly contributed $1.7 million to groups that oppose gay and lesbian rights.
Northeastern University is the latest in a string of colleges and universities which have been calling on the removal of Chick-fil-A franchises on their campuses.
In response to Northeastern University's action, Chick-fil-A issued a statement asserting that the University's action was based on lack of complete information. The company argued that its donations were not "anti-gay" even though they are going towards organizations which fight gay rights because the intent of those donations was to support other aspects of those organization's activities, such as to support "inter-city mentors and chaplains for schools and colleges."
According to the statement: "We certainly feel detailed and fair information about our giving has not be shared by some. I want to assure you that the historical intent of our Foundation and corporate giving have been toward compassion, principally by serving youth and families... . As some have looked back at the public giving records of the WinShape Foundation, they have unfortunately misinterpreted this support as having a political agenda, largely referencing any religious or faith-based giving as “anti-gay.” For example, if you take the example of FCA, and ask us what was the purpose of the giving, it was to support inter-city mentors and chaplains for schools and colleges primarily here metro Atlanta. Those monies have been labeled as “anti-gay” because of the affiliation with a faith-based organization."
In another statement, the President of Chick-fil-A added: "At Chick-fil-A, we have a genuine commitment to hospitality for all of our guests. We are not “anti anybody” and have no agenda, policy or position against anyone as some continue to confuse with misleading reports. Instead, we have a 65-year history of providing hospitality for all people and, as a dedicated family business, serving and valuing everyone regardless of their beliefs or opinions. Every morning when we open our restaurants across the country, we strive to treat each customer with honor, dignity and respect. At the cornerstone of this commitment is a belief in the importance of loving your neighbor as yourself. We will not champion any political agendas on marriage and family."
The Rest of the Story
Last year, I criticized the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians for accepting money and partnerships with Coca-Cola and/or PepsiCo, companies which market sugar-laden soft drinks that are undoubtedly contributing to the nation's obesity epidemic.
These health organizations are defending their partnerships with these soda companies by arguing that although Coca-Cola and PepsiCo sell sodas, they also sell other products that are healthy. For example, one member of the American Dietetic Association responded to my blog post by arguing that: "the companies you criticize have a wide variety of products available from good for you to more indulgent. These companies employ many of the best scientists in the world because they want to make a difference in providing healthier options to consumers."
Another ADA member wrote: "Both Coca Cola and Pepsi are massive companies that represent a multitude of brands. According to Cokes own website they have 3500 different brands in over 200 countries including water, fruit juice and soy beverages. Pepsi's brands include Frito Lay, Tropicana, and Quaker. Everyone focuses on the "worst" of these brands, the high calorie sodas, but seems to ignore all of the other possibilities within both Pepsi and Coke."
Essentially, the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians are using the same line of reasoning that Chick-fil-A is using to defend its financial support of groups that oppose gay rights. The ADA, AAP, and AAFP are arguing that while some things which Coca-Cola and PepsiCo sell are major causes of obesity, these companies also sell other products that are not harmful. For example, Coca-Cola sells Coke, but it also sells Dasani water. PepsiCo sells Pepsi and Fritos, but it also sells Tropicana orange juice.
Similarly, Chick-fil-A is defending its support of groups that oppose and fight against gay rights by arguing that these organizations also do some good things, like providing mentoring to youth.
These arguments are both out of the exact same playbook, and the playbook is wrong.
To see how wrong the playbook is, consider the very same line of reasoning applied to some other companies or organizations:
1. The Ku Klux Klan has contributed money to charities, including the Volunteers of America and even the African Methodist Episcopal Church. The Klan also contributes money to social welfare causes, such as aiding the poor. Does this mean that the Ku Klux Klan is therefore not anti-black? Does it excuse anyone who contributes to the KKK? Can you imagine Chick-fil-A trying to defend contributions to the KKK by arguing that it is only trying to support volunteer activities in America and to help the poor - it is not anti-black or anti-anybody. The argument just doesn't work.
2. Philip Morris donates a huge amount of money to charitable causes. It has contributed to hunger relief, disaster relief, youth scholarships, AIDS and domestic violence charities, and many more. Would the ADA, AAP, and AAFP defend taking Philip Morris money by noting that although Philip Morris produces cigarettes, it also does good work for people in need?
3. The modern Nazi Party makes contributions to improve child welfare. In fact, one of the major issues of the modern Nazi Party is "children's welfare." Would anyone defend a contribution to the Nazi Party by arguing that although the organization is anti-black, it does good things for children's welfare?
4. The National Rifle Association has programs to provide gun safety information to youth in an effort to avoid gun-related injury among children. Can you imagine if a gun control organization, such as Stop Handgun Violence, made a contribution to the NRA and defended it by arguing that while the NRA lobbies against gun control measures, it also does some really good things like working to protect children from gun-related injury.
5. Smith & Wesson not only manufactures guns. It also manufactures security systems that play a significant role in the nation's efforts to prevent terrorism. These include high security fencing, traffic control drop arms, security barriers, crash barriers, mass notification alert systems, and advanced intrusion detection systems. Not only that, but Smith & Wesson manufactures a host of traffic safety products that help protect all of us from motor vehicle accidents every day, including median barriers, traffic barriers with anti-ram protection, radar speed sensors, and overheight detection systems to prevent truck accidents. Could a gun control organization credibly defend making a contribution to Smith & Wesson by arguing that although the company manufactures guns - which are responsible for the deaths of 500 children each year - it also makes products that are contributing to traffic safety and homeland security? No public health organization would ever get away with that, because the flaw in the argument is readily seen.
When you donate to, partner with, accept money from, or otherwise align your company or organization with an entity whose agenda includes fighting against gay rights, you cannot separate yourself from that agenda by claiming that you are actually supporting other work that the organization does. You cannot argue that you are not taking any position on gay rights or doing anything that is anti-gay rights because your contribution is actually intended for a charitable purpose.
The point is - by giving money to an organization, taking money from an organization, or partnering with that organization, you are lending your good name to the overall purpose of the other organization. You can't separate out different aspects of the organization.
This is the flaw in Chick-fil-A's argument, and it is why the students at Northeastern did not fail to take into account detailed or additional information that would have changed their minds. They had the information they needed, which is that Chick-fil-A contributes large amounts of money to groups that actively fight against gay rights. The students see no reason to affiliate their university with a company that has an anti-gay agenda, so they are perfectly appropriate in voting not to invite Chick-fil-A to market its products at their university.
But today's rest of the story is that just as Chick-fil-A's argument that they are not taking an anti-gay rights position by supporting groups like Focus on the Family is fallacious, so too is the argument from the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians that by partnering with and taking money from soft drink companies they are not supporting a pro-obesity and anti-public health agenda.
While not intended, these groups are taking an anti-health position by partnering with the corporations that are responsible for a significant part of the nation's obesity epidemic. These corporations actively oppose almost every substantial state law that would significantly reduce obesity by lowering soft drink consumption. And so through the money flowing into their hands from these companies, the ADA, AAP, and AAFP are also taking a stance that opposes legislation to improve the public's health. There's just no way to defend this to take these public health groups off the hook.
Arguing that partnering with Coca-Cola and PepsiCo is acceptable because these companies produce some good products in addition to the junk food and soft drinks that are contributing to the obesity epidemic does not hold Dasani water. When you partner with an organization or exchange funding one direction or the other, you are associating with all aspects of that organization. There's no escape.
There's no escape for Chick-fil-A, nor is there any longer an escape for the American Dietetic Association, American Academy of Pediatrics, and the American Academy of Family Physicians.
Chick-fil-A had been one of a group of restaurants being eyed for vendor spots in the University's new student center. The offer was canceled as a result of Chick-fil-A's support of a number of organizations that oppose gay and lesbian rights, including opposing same sex marriage. These groups include Focus on the Family, the Family Research Council, Exodus International, the Marriage & Family Legacy Fund, and the Fellowship of Christian Athletes. In 2009, Chick-fil-A reportedly contributed $1.7 million to groups that oppose gay and lesbian rights.
Northeastern University is the latest in a string of colleges and universities which have been calling on the removal of Chick-fil-A franchises on their campuses.
In response to Northeastern University's action, Chick-fil-A issued a statement asserting that the University's action was based on lack of complete information. The company argued that its donations were not "anti-gay" even though they are going towards organizations which fight gay rights because the intent of those donations was to support other aspects of those organization's activities, such as to support "inter-city mentors and chaplains for schools and colleges."
According to the statement: "We certainly feel detailed and fair information about our giving has not be shared by some. I want to assure you that the historical intent of our Foundation and corporate giving have been toward compassion, principally by serving youth and families... . As some have looked back at the public giving records of the WinShape Foundation, they have unfortunately misinterpreted this support as having a political agenda, largely referencing any religious or faith-based giving as “anti-gay.” For example, if you take the example of FCA, and ask us what was the purpose of the giving, it was to support inter-city mentors and chaplains for schools and colleges primarily here metro Atlanta. Those monies have been labeled as “anti-gay” because of the affiliation with a faith-based organization."
In another statement, the President of Chick-fil-A added: "At Chick-fil-A, we have a genuine commitment to hospitality for all of our guests. We are not “anti anybody” and have no agenda, policy or position against anyone as some continue to confuse with misleading reports. Instead, we have a 65-year history of providing hospitality for all people and, as a dedicated family business, serving and valuing everyone regardless of their beliefs or opinions. Every morning when we open our restaurants across the country, we strive to treat each customer with honor, dignity and respect. At the cornerstone of this commitment is a belief in the importance of loving your neighbor as yourself. We will not champion any political agendas on marriage and family."
The Rest of the Story
Last year, I criticized the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians for accepting money and partnerships with Coca-Cola and/or PepsiCo, companies which market sugar-laden soft drinks that are undoubtedly contributing to the nation's obesity epidemic.
These health organizations are defending their partnerships with these soda companies by arguing that although Coca-Cola and PepsiCo sell sodas, they also sell other products that are healthy. For example, one member of the American Dietetic Association responded to my blog post by arguing that: "the companies you criticize have a wide variety of products available from good for you to more indulgent. These companies employ many of the best scientists in the world because they want to make a difference in providing healthier options to consumers."
Another ADA member wrote: "Both Coca Cola and Pepsi are massive companies that represent a multitude of brands. According to Cokes own website they have 3500 different brands in over 200 countries including water, fruit juice and soy beverages. Pepsi's brands include Frito Lay, Tropicana, and Quaker. Everyone focuses on the "worst" of these brands, the high calorie sodas, but seems to ignore all of the other possibilities within both Pepsi and Coke."
Essentially, the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians are using the same line of reasoning that Chick-fil-A is using to defend its financial support of groups that oppose gay rights. The ADA, AAP, and AAFP are arguing that while some things which Coca-Cola and PepsiCo sell are major causes of obesity, these companies also sell other products that are not harmful. For example, Coca-Cola sells Coke, but it also sells Dasani water. PepsiCo sells Pepsi and Fritos, but it also sells Tropicana orange juice.
Similarly, Chick-fil-A is defending its support of groups that oppose and fight against gay rights by arguing that these organizations also do some good things, like providing mentoring to youth.
These arguments are both out of the exact same playbook, and the playbook is wrong.
To see how wrong the playbook is, consider the very same line of reasoning applied to some other companies or organizations:
1. The Ku Klux Klan has contributed money to charities, including the Volunteers of America and even the African Methodist Episcopal Church. The Klan also contributes money to social welfare causes, such as aiding the poor. Does this mean that the Ku Klux Klan is therefore not anti-black? Does it excuse anyone who contributes to the KKK? Can you imagine Chick-fil-A trying to defend contributions to the KKK by arguing that it is only trying to support volunteer activities in America and to help the poor - it is not anti-black or anti-anybody. The argument just doesn't work.
2. Philip Morris donates a huge amount of money to charitable causes. It has contributed to hunger relief, disaster relief, youth scholarships, AIDS and domestic violence charities, and many more. Would the ADA, AAP, and AAFP defend taking Philip Morris money by noting that although Philip Morris produces cigarettes, it also does good work for people in need?
3. The modern Nazi Party makes contributions to improve child welfare. In fact, one of the major issues of the modern Nazi Party is "children's welfare." Would anyone defend a contribution to the Nazi Party by arguing that although the organization is anti-black, it does good things for children's welfare?
4. The National Rifle Association has programs to provide gun safety information to youth in an effort to avoid gun-related injury among children. Can you imagine if a gun control organization, such as Stop Handgun Violence, made a contribution to the NRA and defended it by arguing that while the NRA lobbies against gun control measures, it also does some really good things like working to protect children from gun-related injury.
5. Smith & Wesson not only manufactures guns. It also manufactures security systems that play a significant role in the nation's efforts to prevent terrorism. These include high security fencing, traffic control drop arms, security barriers, crash barriers, mass notification alert systems, and advanced intrusion detection systems. Not only that, but Smith & Wesson manufactures a host of traffic safety products that help protect all of us from motor vehicle accidents every day, including median barriers, traffic barriers with anti-ram protection, radar speed sensors, and overheight detection systems to prevent truck accidents. Could a gun control organization credibly defend making a contribution to Smith & Wesson by arguing that although the company manufactures guns - which are responsible for the deaths of 500 children each year - it also makes products that are contributing to traffic safety and homeland security? No public health organization would ever get away with that, because the flaw in the argument is readily seen.
When you donate to, partner with, accept money from, or otherwise align your company or organization with an entity whose agenda includes fighting against gay rights, you cannot separate yourself from that agenda by claiming that you are actually supporting other work that the organization does. You cannot argue that you are not taking any position on gay rights or doing anything that is anti-gay rights because your contribution is actually intended for a charitable purpose.
The point is - by giving money to an organization, taking money from an organization, or partnering with that organization, you are lending your good name to the overall purpose of the other organization. You can't separate out different aspects of the organization.
This is the flaw in Chick-fil-A's argument, and it is why the students at Northeastern did not fail to take into account detailed or additional information that would have changed their minds. They had the information they needed, which is that Chick-fil-A contributes large amounts of money to groups that actively fight against gay rights. The students see no reason to affiliate their university with a company that has an anti-gay agenda, so they are perfectly appropriate in voting not to invite Chick-fil-A to market its products at their university.
But today's rest of the story is that just as Chick-fil-A's argument that they are not taking an anti-gay rights position by supporting groups like Focus on the Family is fallacious, so too is the argument from the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians that by partnering with and taking money from soft drink companies they are not supporting a pro-obesity and anti-public health agenda.
While not intended, these groups are taking an anti-health position by partnering with the corporations that are responsible for a significant part of the nation's obesity epidemic. These corporations actively oppose almost every substantial state law that would significantly reduce obesity by lowering soft drink consumption. And so through the money flowing into their hands from these companies, the ADA, AAP, and AAFP are also taking a stance that opposes legislation to improve the public's health. There's just no way to defend this to take these public health groups off the hook.
Arguing that partnering with Coca-Cola and PepsiCo is acceptable because these companies produce some good products in addition to the junk food and soft drinks that are contributing to the obesity epidemic does not hold Dasani water. When you partner with an organization or exchange funding one direction or the other, you are associating with all aspects of that organization. There's no escape.
There's no escape for Chick-fil-A, nor is there any longer an escape for the American Dietetic Association, American Academy of Pediatrics, and the American Academy of Family Physicians.
Monday, March 05, 2012
FDA and DHHS Harm their Own Case by Pushing Political Propaganda and Over-hyping Significance of Graphic Warning Labels on Cigarettes
At a press conference to announce the new graphic warning labels on cigarettes in 2010, the U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) asserted that the new graphic warning labels would play a major role in preventing youth from starting to smoke and helping current smokers to quit.
FDA Commissioner Margaret Hamburg stated that one major purpose of the graphic warning labels is to "encourage current smokers to quit."
She also noted, quite explicitly, that the government's intention is for cigarette packages to become anti-smoking billboards, emphasizing that: "every single pack of cigarettes in our country will in effect become a mini-billboard...".
The FDA left no doubt that the primary purpose of the graphic warning labels is not merely to provide factual warnings, but to "help strengthen the resolve of current smokers who want to break the habit." Later, the Agency reiterated this point, noting that the purpose of the warning labels is to "help strengthen the ability and commitment of current smokers who are trying to quit."
The Assistant Secretary of Health - Dr. Howard Koh - noted that "countries that combine these graphic health warnings with resources for smokers to access such as a phone number or a web site show more efficacy in terms of reaching smokers and helping them make a decision to quit." The FDA later added the 1-800 quit line number to the graphic warning labels.
In the question session, Commissioner Hamburg noted that one of the major considerations of the Agency is to determine what type of images "have the most impact on people."
The Rest of the Story
Rather than treating the new warning labels with the modest amount of attention they deserve, as this is a marginal intervention that will have minimal impact on the smoking epidemic, the FDA and DHHS insisted on making a huge spectacle of this intervention, turning it into a political propaganda-fest by continually emphasizing how these warning labels are going to play a huge role in ending cigarette smoking as we know it in our nation, and how the next generation of kids is not going to become addicted to cigarettes because they will be scared off by these scary pictures.
Unfortunately, by creating this propaganda show, the FDA and DHHS inadvertently ended up shooting their own legal case for these warning labels in the foot. Why? Because they made it quite clear, with incontrovertible evidence, and in their own words, that the primary purpose of the graphic warning labels is not merely to provide factual information to warn consumers about the health effects of smoking, but to generate an "impact" on smokers and encouraging them to quit smoking.
Moreover, the FDA admitted that the purpose of the regulation is to turn cigarette packages into "mini-billboards" (these are the exact words used by the FDA Commissioner) to help the government spread its anti-smoking message.
While I completely agree with the government's anti-smoking message, I also understand that the First Amendment does not allow the government to require cigarette companies to run advertising campaigns for the government on their cigarette packages, compelling the companies to encourage their own customers not to purchase their products. This is a form of compelled speech that simply does not pass constitutional muster.
In essence, the FDA and DHHS undermined their own legal argument for the warning labels by over-hyping and sensationalizing the likely impact of this marginal - at best - intervention. Had they simply stated that the warning labels were intended to warn smokers more effectively than the current labels that cigarettes and hazardous and addictive, and refrained from all of the propaganda about ending the tobacco epidemic and protecting America's children, then they would not have harmed their legal case.
The rest of the story is that in their zeal to score a political victory and make the public think that the graphic warning labels will play a major role in helping to end the smoking epidemic, the FDA and DHHS seriously harmed their legal case for the warning labels, creating strong evidence that the purpose of the labels is to compel tobacco companies to spread the government's smoking cessation message by turning the packs into government mini-billboards, precisely what the First Amendment does not allow warning labels to do.
FDA Commissioner Margaret Hamburg stated that one major purpose of the graphic warning labels is to "encourage current smokers to quit."
She also noted, quite explicitly, that the government's intention is for cigarette packages to become anti-smoking billboards, emphasizing that: "every single pack of cigarettes in our country will in effect become a mini-billboard...".
The FDA left no doubt that the primary purpose of the graphic warning labels is not merely to provide factual warnings, but to "help strengthen the resolve of current smokers who want to break the habit." Later, the Agency reiterated this point, noting that the purpose of the warning labels is to "help strengthen the ability and commitment of current smokers who are trying to quit."
The Assistant Secretary of Health - Dr. Howard Koh - noted that "countries that combine these graphic health warnings with resources for smokers to access such as a phone number or a web site show more efficacy in terms of reaching smokers and helping them make a decision to quit." The FDA later added the 1-800 quit line number to the graphic warning labels.
In the question session, Commissioner Hamburg noted that one of the major considerations of the Agency is to determine what type of images "have the most impact on people."
The Rest of the Story
Rather than treating the new warning labels with the modest amount of attention they deserve, as this is a marginal intervention that will have minimal impact on the smoking epidemic, the FDA and DHHS insisted on making a huge spectacle of this intervention, turning it into a political propaganda-fest by continually emphasizing how these warning labels are going to play a huge role in ending cigarette smoking as we know it in our nation, and how the next generation of kids is not going to become addicted to cigarettes because they will be scared off by these scary pictures.
Unfortunately, by creating this propaganda show, the FDA and DHHS inadvertently ended up shooting their own legal case for these warning labels in the foot. Why? Because they made it quite clear, with incontrovertible evidence, and in their own words, that the primary purpose of the graphic warning labels is not merely to provide factual information to warn consumers about the health effects of smoking, but to generate an "impact" on smokers and encouraging them to quit smoking.
Moreover, the FDA admitted that the purpose of the regulation is to turn cigarette packages into "mini-billboards" (these are the exact words used by the FDA Commissioner) to help the government spread its anti-smoking message.
While I completely agree with the government's anti-smoking message, I also understand that the First Amendment does not allow the government to require cigarette companies to run advertising campaigns for the government on their cigarette packages, compelling the companies to encourage their own customers not to purchase their products. This is a form of compelled speech that simply does not pass constitutional muster.
In essence, the FDA and DHHS undermined their own legal argument for the warning labels by over-hyping and sensationalizing the likely impact of this marginal - at best - intervention. Had they simply stated that the warning labels were intended to warn smokers more effectively than the current labels that cigarettes and hazardous and addictive, and refrained from all of the propaganda about ending the tobacco epidemic and protecting America's children, then they would not have harmed their legal case.
The rest of the story is that in their zeal to score a political victory and make the public think that the graphic warning labels will play a major role in helping to end the smoking epidemic, the FDA and DHHS seriously harmed their legal case for the warning labels, creating strong evidence that the purpose of the labels is to compel tobacco companies to spread the government's smoking cessation message by turning the packs into government mini-billboards, precisely what the First Amendment does not allow warning labels to do.
Friday, March 02, 2012
Anti-Smoking Movement Gone Too Far?
Charles Adler has produced a segment on this question for Sun News (Canada). A guest who you may know appears at about the 50-second mark.
Thursday, March 01, 2012
District Court Rules Against FDA, Blocks Graphic Cigarette Warning Labels
Yesterday, a federal district court judge issued what amounts to a permanent injunction against the FDA's implementation of its graphic cigarette warning labels, ruling that these labels violate the First Amendment rights of the cigarette companies by compelling speech, and in a way that goes beyond merely providing factual and noncontroversial information. Judge Richard Leon of the federal district court for the District of Columbia confirmed his earlier decision, in which he issued a preliminary injunction against implementation of the graphic warning labels. The FDA has already appealed the decision in the case, which could potentially go all the way to the Supreme Court.
According to a Wall Street Journal article: "A federal judge Wednesday blocked a U.S. government plan requiring large graphic warning labels on cigarette packs, making it less likely the proposed regulation will go into effect later this year. Judge Richard Leon of the U.S. District Court for the District of Columbia sided with tobacco companies who argued the government was violating their constitutional rights to free speech by requiring them to display the labels—including images of a body on an autopsy table and diseased lungs." ...
"In Wednesday's memorandum opinion, Judge Leon sided with tobacco companies who have argued the new regulations unconstitutionally compel speech, noting the First Amendment protects both the right to speak freely and the right to refrain from speaking at all. The federal judge also said the new labels go beyond ``purely factual and uncontroversial disclosures,'' noting that the image of a man exhaling cigarette smoke through a tracheotomy hole doesn't reflect a typical consequence of smoking. "The graphic images here were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking,'' Judge Leon wrote."
In response to the ruling, the Campaign for Tobacco-Free Kids asserted that the decision "ignores decades of First Amendment precedent that support the right of the government to require strong warning labels to protect the public health."
The Rest of the Story
While there is strong First Amendment precedent that supports the right of the government to require strong warning labels to protect the public health, the graphic warning labels proposed by the FDA are not designed primarily to inform consumers about the health risks of smoking. Instead, they are designed primarily to discourage consumers from using the product and to encourage them to quit smoking using a specific quit-smoking hotline service. In essence, the government is using the cigarette package as a billboard for an anti-smoking advertisement and referral system to recruit smokers for the cessation hot line intervention. In my opinion, this form of compelled speech goes beyond the precedent that the Campaign for Tobacco-Free Kids is citing.
While the government can certainly require Keebler to put a warning on its Vienna Fingers to inform consumers that they contain unhealthy ingredients, it cannot compel Keebler to cover half of its package with a message exhorting potential customers not to buy the product and urging them to call a hot line designed to get consumers to stop buying Keebler products.
Those who are defending the legality of the graphic warning labels appear to be missing the key point. They are dwelling on the argument that warning labels are permissible. But they are failing to address the issue of whether these particular "warnings" are true warnings, or whether they are anti-smoking billboards on the face of a cigarette package. Unless the government directly addresses this issue, it is not going to be successful in appealing Judge Leon's decision.
How, specifically, does requiring companies to post a smoking cessation hot line number on a cigarette pack constitute a health warning? Frankly, to me that seems not a warning but an exhortation to quit smoking.
Finally, I must emphasize that I am not disagreeing with the importance of the government taking actions to encourage smokers to quit. I am, in fact, arguing that the government is going about it in the wrong way. Rather than disguising an anti-smoking campaign on the face of a cigarette pack, why not simply run an anti-smoking campaign of its own? The FDA is apparently working on just such a campaign. It remains to be seen how effective the campaign will be. But that is where the resources and attention should be directed.
According to a Wall Street Journal article: "A federal judge Wednesday blocked a U.S. government plan requiring large graphic warning labels on cigarette packs, making it less likely the proposed regulation will go into effect later this year. Judge Richard Leon of the U.S. District Court for the District of Columbia sided with tobacco companies who argued the government was violating their constitutional rights to free speech by requiring them to display the labels—including images of a body on an autopsy table and diseased lungs." ...
"In Wednesday's memorandum opinion, Judge Leon sided with tobacco companies who have argued the new regulations unconstitutionally compel speech, noting the First Amendment protects both the right to speak freely and the right to refrain from speaking at all. The federal judge also said the new labels go beyond ``purely factual and uncontroversial disclosures,'' noting that the image of a man exhaling cigarette smoke through a tracheotomy hole doesn't reflect a typical consequence of smoking. "The graphic images here were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking,'' Judge Leon wrote."
In response to the ruling, the Campaign for Tobacco-Free Kids asserted that the decision "ignores decades of First Amendment precedent that support the right of the government to require strong warning labels to protect the public health."
The Rest of the Story
While there is strong First Amendment precedent that supports the right of the government to require strong warning labels to protect the public health, the graphic warning labels proposed by the FDA are not designed primarily to inform consumers about the health risks of smoking. Instead, they are designed primarily to discourage consumers from using the product and to encourage them to quit smoking using a specific quit-smoking hotline service. In essence, the government is using the cigarette package as a billboard for an anti-smoking advertisement and referral system to recruit smokers for the cessation hot line intervention. In my opinion, this form of compelled speech goes beyond the precedent that the Campaign for Tobacco-Free Kids is citing.
While the government can certainly require Keebler to put a warning on its Vienna Fingers to inform consumers that they contain unhealthy ingredients, it cannot compel Keebler to cover half of its package with a message exhorting potential customers not to buy the product and urging them to call a hot line designed to get consumers to stop buying Keebler products.
Those who are defending the legality of the graphic warning labels appear to be missing the key point. They are dwelling on the argument that warning labels are permissible. But they are failing to address the issue of whether these particular "warnings" are true warnings, or whether they are anti-smoking billboards on the face of a cigarette package. Unless the government directly addresses this issue, it is not going to be successful in appealing Judge Leon's decision.
How, specifically, does requiring companies to post a smoking cessation hot line number on a cigarette pack constitute a health warning? Frankly, to me that seems not a warning but an exhortation to quit smoking.
Finally, I must emphasize that I am not disagreeing with the importance of the government taking actions to encourage smokers to quit. I am, in fact, arguing that the government is going about it in the wrong way. Rather than disguising an anti-smoking campaign on the face of a cigarette pack, why not simply run an anti-smoking campaign of its own? The FDA is apparently working on just such a campaign. It remains to be seen how effective the campaign will be. But that is where the resources and attention should be directed.
Wednesday, February 29, 2012
Master Settlement Agreement Causing Major Budget Woes for States; Further Evidence that MSA Was a Public Health Blunder by the Attorneys General
In 1998, the Attorneys General of 46 states praised themselves for having negotiated a litigation settlement with Big Tobacco that they said had brought to tobacco companies to their knees. At the time of the settlement, Florida's Attorney General - Bob Butterworth - proclaimed that "'The Marlboro Man will be riding into the sunset on Joe Camel."
Even today, the National Association of Attorneys General boasts that: "The MSA is a historic, landmark agreement that affects the lives of all Americans. It generates billions of dollars for Settling States to cover the health care costs generated by smoking and has played a significant role in bringing about a decrease in smoking rates among adults and youth in the United States."
I have long argued that the Master Settlement Agreement was a public health disaster, a huge blunder by the Attorneys General who negotiated and agreed to it. I agree that it is a landmark agreement that affects the lives of all Americans, but not in a good way. It made the states fiscal partners with the tobacco companies, destroying the incentive for states to take any actions that would significantly decrease tobacco sales and revenues. Most of the money that was supposed to be spent on tobacco education, prevention, and treatment has been diverted to all sorts of other uses, mainly to plug holes in state budgets. And in return, what did the tobacco companies get? They were let off the hook in litigation in 46 states, in return for a significant but fiscally stable and predictable payoff. It was a brilliant move by the tobacco companies and a stupid, politically-motivated move by the Attorneys General.
The Rest of the Story
Last week came word that due to the Master Settlement Agreement, California is facing major fiscal problems. You see, it seems that cigarette smoking has been decreasing more rapidly than expected and this decline in cigarette consumption is affecting payments to the state under the MSA. Since the state decided to borrow money against its expected future payments, the declining revenues affect its ability to pay back investors in bonds that were used to securitize the future payments. According to an article in California Watch, there are currently $2.9 billion in outstanding bonds. The need to pay back investors in these bonds could create fiscal havoc, aggravating an already terrible budget situation.
According to the article: "Fewer smokers is bad news for California’s budget. A major bond rating agency sounded an alarm this month, saying the state may have borrowed more than $4 billion against settlement money that might never materialize. A little more than a decade ago, 46 state attorneys general reached a settlement with the four biggest tobacco companies. The companies agreed to pay an estimated $246 billion over a 25-year period to compensate states for tobacco-related health care costs. But there is one quirk: The settlement payments are not fixed, but linked to tobacco sales. Rather than waiting for annual payments, the state and some local governments decided to borrow money against their anticipated future revenue. All told, they’ve issued $16 billion in bonds since 2001. Major bond rating agencies and some municipal finance experts have warned for years that the number of smokers was decreasing more rapidly than expected."
"In December, California had to dip into its reserves to cover bond payments. Dick Larkin, director of credit analysis at Herbert J. Sims & Co., said there were two reasons: fewer smokers and a dispute with the tobacco companies that has resulted in delayed payments.As the state’s finances worsened, officials went back to investors. In 2007, California issued $4.4 billion in tobacco bonds. In order to pay back investors by 2047, it assumes that cigarette consumption will decline by about 1.8 percent per year, according to bond filings. But in the midst of increased taxes and antismoking laws, sales have dropped more quickly than predicted. As a result of the decline and the ongoing dispute with the tobacco companies, annual payments have been less than expected since the settlement was signed in 1998, according to Larkin. If the bonds default, it wouldn’t be bad just for investors. California is one of only a few states that guaranteed a portion of its bonds with general fund revenue. If tobacco settlement money does not cover the debt, the state will have to pick up some of the tab. There are currently $2.9 billion in bonds outstanding that are backed by a state guarantee, according to the state treasurer's office. Although that payment would be subject to legislative approval, it’s unlikely it wouldn’t be approved. “No one would trust California anymore,” Larkin said. “Their name would be mud in the market.”"
This story illustrates the brilliance of the Master Settlement Agreement (from the perspective of the cigarette companies). The states are now fiscally dependent on a steady stream of cigarette revenues. Any substantial drop in cigarette smoking threatens the state's fiscal situation. Thus, there is no incentive to take any action that will substantially reduce cigarette sales. Perhaps this is why we haven't seen many major anti-tobacco initiatives at the state level since the Master Settlement Agreement was signed. We've seen mostly minor initiatives that dilly dally around the margins, but very few which actually aim to put a major dent in cigarette sales.
In direct contrast to what the Attorneys General predicted, the Marlboro Man isn't riding into the sunset on Joe Camel. Instead, they're both having a beer and a good laugh together as they enjoy their trip to the bank.
Even today, the National Association of Attorneys General boasts that: "The MSA is a historic, landmark agreement that affects the lives of all Americans. It generates billions of dollars for Settling States to cover the health care costs generated by smoking and has played a significant role in bringing about a decrease in smoking rates among adults and youth in the United States."
I have long argued that the Master Settlement Agreement was a public health disaster, a huge blunder by the Attorneys General who negotiated and agreed to it. I agree that it is a landmark agreement that affects the lives of all Americans, but not in a good way. It made the states fiscal partners with the tobacco companies, destroying the incentive for states to take any actions that would significantly decrease tobacco sales and revenues. Most of the money that was supposed to be spent on tobacco education, prevention, and treatment has been diverted to all sorts of other uses, mainly to plug holes in state budgets. And in return, what did the tobacco companies get? They were let off the hook in litigation in 46 states, in return for a significant but fiscally stable and predictable payoff. It was a brilliant move by the tobacco companies and a stupid, politically-motivated move by the Attorneys General.
The Rest of the Story
Last week came word that due to the Master Settlement Agreement, California is facing major fiscal problems. You see, it seems that cigarette smoking has been decreasing more rapidly than expected and this decline in cigarette consumption is affecting payments to the state under the MSA. Since the state decided to borrow money against its expected future payments, the declining revenues affect its ability to pay back investors in bonds that were used to securitize the future payments. According to an article in California Watch, there are currently $2.9 billion in outstanding bonds. The need to pay back investors in these bonds could create fiscal havoc, aggravating an already terrible budget situation.
According to the article: "Fewer smokers is bad news for California’s budget. A major bond rating agency sounded an alarm this month, saying the state may have borrowed more than $4 billion against settlement money that might never materialize. A little more than a decade ago, 46 state attorneys general reached a settlement with the four biggest tobacco companies. The companies agreed to pay an estimated $246 billion over a 25-year period to compensate states for tobacco-related health care costs. But there is one quirk: The settlement payments are not fixed, but linked to tobacco sales. Rather than waiting for annual payments, the state and some local governments decided to borrow money against their anticipated future revenue. All told, they’ve issued $16 billion in bonds since 2001. Major bond rating agencies and some municipal finance experts have warned for years that the number of smokers was decreasing more rapidly than expected."
"In December, California had to dip into its reserves to cover bond payments. Dick Larkin, director of credit analysis at Herbert J. Sims & Co., said there were two reasons: fewer smokers and a dispute with the tobacco companies that has resulted in delayed payments.As the state’s finances worsened, officials went back to investors. In 2007, California issued $4.4 billion in tobacco bonds. In order to pay back investors by 2047, it assumes that cigarette consumption will decline by about 1.8 percent per year, according to bond filings. But in the midst of increased taxes and antismoking laws, sales have dropped more quickly than predicted. As a result of the decline and the ongoing dispute with the tobacco companies, annual payments have been less than expected since the settlement was signed in 1998, according to Larkin. If the bonds default, it wouldn’t be bad just for investors. California is one of only a few states that guaranteed a portion of its bonds with general fund revenue. If tobacco settlement money does not cover the debt, the state will have to pick up some of the tab. There are currently $2.9 billion in bonds outstanding that are backed by a state guarantee, according to the state treasurer's office. Although that payment would be subject to legislative approval, it’s unlikely it wouldn’t be approved. “No one would trust California anymore,” Larkin said. “Their name would be mud in the market.”"
This story illustrates the brilliance of the Master Settlement Agreement (from the perspective of the cigarette companies). The states are now fiscally dependent on a steady stream of cigarette revenues. Any substantial drop in cigarette smoking threatens the state's fiscal situation. Thus, there is no incentive to take any action that will substantially reduce cigarette sales. Perhaps this is why we haven't seen many major anti-tobacco initiatives at the state level since the Master Settlement Agreement was signed. We've seen mostly minor initiatives that dilly dally around the margins, but very few which actually aim to put a major dent in cigarette sales.
In direct contrast to what the Attorneys General predicted, the Marlboro Man isn't riding into the sunset on Joe Camel. Instead, they're both having a beer and a good laugh together as they enjoy their trip to the bank.
Tuesday, February 28, 2012
Campaign for Tobacco-Free Kids Decries Tobacco Industry Role in Trade Talks; But Has No Problem Negotiating Federal Tobacco Policy with Big Tobacco
In a statement issued late last week, the Campaign for Tobacco-Free Kids decried the involvement of the tobacco industry in trade policy negotiations. The U.S. is in the process of negotiating the Trans-Pacific Partnership (TPP) Agreement with eight other countries. The Campaign for Tobacco-Free Kids believes that this agreement could have implications for tobacco policy.
According to the Campaign's statement:
"As the United States and other countries negotiate a trade agreement that could impact efforts to reduce tobacco use worldwide, Philip Morris International is trying to buy access and influence by sponsoring an exclusive corporate reception Friday in Washington, DC, that will be attended by top trade and other officials from the countries involved. We urge government officials not to attend this tobacco industry-sponsored reception and to negotiate a trade agreement that protects public health, not the tobacco industry. They should protect children and health around the world, not Philip Morris International, a company with a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."
The Rest of the Story
The rest of the story is that while the Campaign for Tobacco-Free Kids is excoriating government officials for potentially just attending a corporate reception sponsored by Philip Morris International, the Campaign for Tobacco-Free Kids itself participated in a secret negotiation with Philip Morris that resulted in a federal statute that drastically changed the nation's policy toward tobacco.
Thus, if the Campaign wishes to attack any organization for sitting down and negotiating tobacco policy with Philip Morris, it should begin the attack by blasting itself for being the worst example of doing exactly what it is decrying in its public statement.
The Campaign can, if it wants, argue that the negotiation with Philip Morris led to a positive achievement (I disagree vehemently, as my readers well know). Nevertheless, it stands as a hypocrite if it attacks others for merely attending a corporate reception sponsored by Philip Morris when the Campaign actually sat down and negotiated an entire national tobacco policy with the same company.
Why did the Campaign for Tobacco-Free Kids negotiate national tobacco policy with a company that it says has "a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."
Moreover, if Philip Morris has a long history of opposing proven measures to reduce tobacco use and save lives, then I guess we can safely conclude that the Family Smoking Prevention and Tobacco Control Act is not one of them. After all, Philip Morris strongly supported the Tobacco Act. It must, then, not be a measure that will reduce tobacco use and save lives.
It seems to me that the Campaign is caught between a rock and a hard place. If it admits that negotiating with Philip Morris is appropriate as long as the outcome is a good one for public health, then it has no business berating the government for attending a corporate reception sponsored by the tobacco company. If it believes, instead, that negotiating health policy with Philip Morris is inappropriate, then it should turn its attention to itself and criticize itself for doing exactly that.
According to the Campaign's statement:
"As the United States and other countries negotiate a trade agreement that could impact efforts to reduce tobacco use worldwide, Philip Morris International is trying to buy access and influence by sponsoring an exclusive corporate reception Friday in Washington, DC, that will be attended by top trade and other officials from the countries involved. We urge government officials not to attend this tobacco industry-sponsored reception and to negotiate a trade agreement that protects public health, not the tobacco industry. They should protect children and health around the world, not Philip Morris International, a company with a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."
The Rest of the Story
The rest of the story is that while the Campaign for Tobacco-Free Kids is excoriating government officials for potentially just attending a corporate reception sponsored by Philip Morris International, the Campaign for Tobacco-Free Kids itself participated in a secret negotiation with Philip Morris that resulted in a federal statute that drastically changed the nation's policy toward tobacco.
Thus, if the Campaign wishes to attack any organization for sitting down and negotiating tobacco policy with Philip Morris, it should begin the attack by blasting itself for being the worst example of doing exactly what it is decrying in its public statement.
The Campaign can, if it wants, argue that the negotiation with Philip Morris led to a positive achievement (I disagree vehemently, as my readers well know). Nevertheless, it stands as a hypocrite if it attacks others for merely attending a corporate reception sponsored by Philip Morris when the Campaign actually sat down and negotiated an entire national tobacco policy with the same company.
Why did the Campaign for Tobacco-Free Kids negotiate national tobacco policy with a company that it says has "a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."
Moreover, if Philip Morris has a long history of opposing proven measures to reduce tobacco use and save lives, then I guess we can safely conclude that the Family Smoking Prevention and Tobacco Control Act is not one of them. After all, Philip Morris strongly supported the Tobacco Act. It must, then, not be a measure that will reduce tobacco use and save lives.
It seems to me that the Campaign is caught between a rock and a hard place. If it admits that negotiating with Philip Morris is appropriate as long as the outcome is a good one for public health, then it has no business berating the government for attending a corporate reception sponsored by the tobacco company. If it believes, instead, that negotiating health policy with Philip Morris is inappropriate, then it should turn its attention to itself and criticize itself for doing exactly that.
Monday, February 27, 2012
Yet Another Study Shows that Nicotine Replacement Therapy Has Not Improved Population Cessation Rates
A new study published in the journal Tobacco Control concludes that the proliferation of smoking quit lines and the greatly increased use of nicotine replacement therapy over the past two decades have not led to improvements in the rate of smoking cessation on a population level.
(See: Shu-Hong Zhu, Madeleine Lee, Yue-Lin Zhuang, Anthony Gamst, Tanya Wolfson. Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tobacco Control 2012;21:110e118. doi:10.1136/tobaccocontrol-2011-050371)
The study used data from the National Health Interview Survey to examine trends in the population rates of smoking cessation during the period 1991-2010. The findings were as follows: "Cessation rates vary from year to year, but there is no significant upward trend for the whole period. Attempts to fit a linear trend for these two panels of data (weighted by the sample size for each survey year) found the slopes are slightly negative but not statistically significantly different from zero (r=-0.02, p=0.94, all smokers, and r=-0.17, p=0.50 for white smokers)."
The study concludes: "Most importantly, there is no consistent upward trend, which would be expected given the various interventions that have been implemented in the USA over the last two decades. This is a perplexing result."
The article offers several possible explanations for the study findings. Two of the most critical are: (1) "the true effects of interventions are much smaller than reported"; and (2) "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."
The Rest of the Story
The paper correctly notes that: "Pharmacotherapies such as nicotine patches are recommended as first-line quit-smoking aids in clinical practice guidelines." Despite the explosive increase in the promotion of these products for smoking cessation over the past two decades, there has been no improvement in population smoking cessation rates.
This research reinforces the findings of a previous study by Pierce et al., which came to the same conclusion (see: Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annu Rev Public Health 2012; 33:12.1-12.16).
This research highlights a major problem in the anti-smoking movement: Because of the strong pharmaceutical company ties of the leading anti-smoking researchers and organizations, there has not been an objective assessment of the effectiveness of smoking cessation policy, and this has led to an over-emphasis on nicotine replacement therapy and an exaggeration of its benefits.
Not only has the obsession with nicotine replacement therapy and other smoking cessation drugs harmed the public's health by diverting attention away from more effective national approaches, but it has also harmed public health because, as the authors of the present study correctly note: "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."
It would be one thing if the flawed advice being given by the NIH expert panel on smoking cessation (i.e., every smoker should be treated with pharmaceutical agents unless specifically contraindicated) were due simply to an innocent mistake, such as lack of complete knowledge of the effectiveness of various smoking cessation strategies. However, I believe that this is not an innocent mistake. Instead, it is the direct result of financial conflicts of interest which have clouded the judgment of those making national recommendations, including the NIH expert panel on smoking cessation, whose recommendations have heavily influenced the anti-smoking movement and helped to produce today's overemphasis on the power of medications to help smokers quit.
Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the smoking cessation clinical practice guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.
These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.
Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:
Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."
William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."
Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."
Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."
Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."
Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."
C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."
Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."
Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."
GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.
What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.
This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.
Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.
While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.
The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.
As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.
One national expert on smoking cessation who was not on the panel - John Polito - has suggested that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.
Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.
(See: Shu-Hong Zhu, Madeleine Lee, Yue-Lin Zhuang, Anthony Gamst, Tanya Wolfson. Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tobacco Control 2012;21:110e118. doi:10.1136/tobaccocontrol-2011-050371)
The study used data from the National Health Interview Survey to examine trends in the population rates of smoking cessation during the period 1991-2010. The findings were as follows: "Cessation rates vary from year to year, but there is no significant upward trend for the whole period. Attempts to fit a linear trend for these two panels of data (weighted by the sample size for each survey year) found the slopes are slightly negative but not statistically significantly different from zero (r=-0.02, p=0.94, all smokers, and r=-0.17, p=0.50 for white smokers)."
The study concludes: "Most importantly, there is no consistent upward trend, which would be expected given the various interventions that have been implemented in the USA over the last two decades. This is a perplexing result."
The article offers several possible explanations for the study findings. Two of the most critical are: (1) "the true effects of interventions are much smaller than reported"; and (2) "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."
The Rest of the Story
The paper correctly notes that: "Pharmacotherapies such as nicotine patches are recommended as first-line quit-smoking aids in clinical practice guidelines." Despite the explosive increase in the promotion of these products for smoking cessation over the past two decades, there has been no improvement in population smoking cessation rates.
This research reinforces the findings of a previous study by Pierce et al., which came to the same conclusion (see: Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annu Rev Public Health 2012; 33:12.1-12.16).
This research highlights a major problem in the anti-smoking movement: Because of the strong pharmaceutical company ties of the leading anti-smoking researchers and organizations, there has not been an objective assessment of the effectiveness of smoking cessation policy, and this has led to an over-emphasis on nicotine replacement therapy and an exaggeration of its benefits.
Not only has the obsession with nicotine replacement therapy and other smoking cessation drugs harmed the public's health by diverting attention away from more effective national approaches, but it has also harmed public health because, as the authors of the present study correctly note: "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."
It would be one thing if the flawed advice being given by the NIH expert panel on smoking cessation (i.e., every smoker should be treated with pharmaceutical agents unless specifically contraindicated) were due simply to an innocent mistake, such as lack of complete knowledge of the effectiveness of various smoking cessation strategies. However, I believe that this is not an innocent mistake. Instead, it is the direct result of financial conflicts of interest which have clouded the judgment of those making national recommendations, including the NIH expert panel on smoking cessation, whose recommendations have heavily influenced the anti-smoking movement and helped to produce today's overemphasis on the power of medications to help smokers quit.
Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the smoking cessation clinical practice guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.
These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.
Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:
Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."
William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."
Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."
Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."
Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."
Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."
C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."
Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."
Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."
GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.
What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.
This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.
Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.
While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.
The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.
As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.
One national expert on smoking cessation who was not on the panel - John Polito - has suggested that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.
Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.
What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.
The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.
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