Dr Gupta’s letter suggests that the reduction in lung cancer in both
Sweden and Connecticut is highly likely to be due to a reduction in
smoking in both places. This is entirely unsurprising, and as far as
Sweden is concerned is precisely what we suggested in the original paper
he referred to:
“There has been a larger drop in male daily smoking (from 40% in 1976
to 15% in 2002) than female daily smoking (34% in...
Dr Gupta’s letter suggests that the reduction in lung cancer in both
Sweden and Connecticut is highly likely to be due to a reduction in
smoking in both places. This is entirely unsurprising, and as far as
Sweden is concerned is precisely what we suggested in the original paper
he referred to:
“There has been a larger drop in male daily smoking (from 40% in 1976
to 15% in 2002) than female daily smoking (34% in 1976 to 20% in 2002) in
Sweden, with a substantial proportion (around 30%) of male ex-smokers
using snus when quitting smoking. Over the same time period, rates of lung
cancer and myocardial infarction have dropped significantly faster among
Swedish men than women and remain at low levels as compared with other
developed countries with a long history of tobacco use.” (p349,
abstract)1.
The idea that smoking and lung cancer rates may fall to a similar or
greater degree in other places is entirely irrelevant to whether or not
snus played a role in smoking reduction in Swedish men. Indeed, in the
original paper we stated clearly that:
“Both within and outside Sweden, smoking is primarily influenced by
factors other than availability of smokeless tobacco (for example, real
price of cigarettes, health education, smoke-free air policies, industry
marketing, etc).” (p357)1
It is therefore entirely unsurprising that these types of factors
will have influenced smoking and lung cancer rates in the United States
and every other country, regardless of whether or not snus is available. A
key point in our original paper that distinguished Sweden from other
countries was that smoking rates WITHIN that country have fallen
significantly faster in men than women, and that this appeared to be
related to the fact that men in Sweden use snus much more than women. So
although these comparisons between one country in Europe and a state in
the US are almost entirely irrelevant to the question of the effect of
snus use on lung cancer rates in Sweden, the more appropriate comparison
(if one wanted to make one) would be of the difference in decline of lung
cancer rates between men and women in Sweden as compared to changes in
that difference in the US. It is not clear whether the data presented in
Dr Gupta’s letter was for men, women or both.
Since the publication of our original paper there have been
subsequent publications that have confirmed that in Sweden, men who start
using snus are less likely to become daily smokers, that men who smoke and
then start using snus are more likely to stop smoking, and that a higher
proportion of men than women in Sweden have quit smoking, with the
difference largely attributable to snus use2,3. It had previously been
suggested that the men who quit smoking in Sweden are not the same ones
who start using snus (and that snus use is therefore not involved in men
quitting smoking)4. However, studies have now verified that in fact a
sizeable proportion (26-29%) of Swedish men who quit smoking use snus as a
smoking cessation aid2,5.
It is now crystal clear that their transfer of nicotine dependence
onto snus has accelerated the rate of decline of smoking among Swedish men
in substantial numbers. That transfer from an extremely harmful form of
tobacco use (cigarette smoking) to a much less harmful form (snus) has
contributed to a reduction in the rate of smoking-caused diseases in
Swedish men.
1. Foulds J, Ramstrom L, Burke M, Fagerstrom K. The effect of
smokeless tobacco (snus) on public health in Sweden. Tobacco Control 2003;
12:349-59.
2. Ramström LM, Foulds J. The role of snus (smokeless tobacco) in
initiation and cessation of tobacco smoking in Sweden. Tobacco Control
2006 Jun;15(3):210-4.Pdf available at:
http://www.tobaccoprogram.org/staffarticles.htm
3. Furberg Furberg H, Bulik C, Lerman C, et al. Is Swedish snus associated
with smoking initiation or smoking cessation? Tob Control.2005; 14:422-
424.
4. Tomar SL, Connolly GN, Wilkenfeld J, Henningfield JE. Declining smoking
in Sweden: Is Swedish Match getting the credit for Swedish tobacco
control’s efforts? Tobacco Control2003; 12:368-59
5. Gilljam H, Galanti MR. Role of snus (oral moist snuff) in smoking
cessation and smoking reduction in Sweden. Addiction 2003;98:1183-9.
Dr Gupta’s comparison of trends in lung cancer mortality and smoking
prevalence in Sweden and Connecticut purports to undermine the claim that
increasing snus use in Sweden has contributed to declining lung cancer
rates there.
Dr Gupta argues that some factor other than snus must have been at
work because the ratio of lung cancers between Sweden and Connecticut has
remained constant despite the large differenc...
Dr Gupta’s comparison of trends in lung cancer mortality and smoking
prevalence in Sweden and Connecticut purports to undermine the claim that
increasing snus use in Sweden has contributed to declining lung cancer
rates there.
Dr Gupta argues that some factor other than snus must have been at
work because the ratio of lung cancers between Sweden and Connecticut has
remained constant despite the large difference in snus use between the two
places. He identifies this “other factor” as a declining cigarette smoking
prevalence that he attributes to tobacco control policies.
We agree that a decline in cigarette smoking in both countries
explains the lung cancer trends but we don’t see how this rules out a role
for snus. This is exactly the mechanism by which proponents of snus would
claim that snus use reduces smoking prevalence, namely, that population
smoking prevalence declines because existing smokers switch to snus and
new tobacco users use snus rather than cigarettes (Ramström and Foulds
2006).
The fact that smoking prevalence declined in Connecticut as a result
of more traditional tobacco control policies simply shows that there is
more than one way to reduce smoking prevalence. The fact that the decline
in cigarette smoking over the time period examined was greater in Sweden (
-13%) than in Connecticut (-8%) supports the hypothesis that the addition
of snus to more conventional tobacco control policies has increased the
decline in smoking prevalence.
We concede that the comparison does not prove that snus was
responsible for the decline in lung cancer rates in Sweden, but it is much
more supportive of the claims for snus than Dr Gupta allows.
Yours sincerely
Coral Gartner and Wayne Hall
References
Ramström, L. M. and J. Foulds (2006). "Role of snus in initiation and
cessation of tobacco smoking in Sweden." Tobacco Control 15(3): 210-214.
Some tobacco control community members believe that advocating the
use of snus, a form of Swedish smokeless tobacco said to be less harmful
than cigarettes, would prove an effective harm reduction strategy against
tobacco related diseases. One important basis for such a claim is the
fact that snus is widely used in Sweden (23% men used snus daily in 2002),
where the incidence of cancer caused by tob...
Some tobacco control community members believe that advocating the
use of snus, a form of Swedish smokeless tobacco said to be less harmful
than cigarettes, would prove an effective harm reduction strategy against
tobacco related diseases. One important basis for such a claim is the
fact that snus is widely used in Sweden (23% men used snus daily in 2002),
where the incidence of cancer caused by tobacco is relatively low, and the
observation that the Swedish are switching from smoked tobacco to snus.
One way of looking at this claim of harm reduction through the use of snus
is to compare tobacco related cancer rates in Sweden to those in the state
of Connecticut, where use of any kind of smokeless tobacco including snus
has been consistently rare.
The table below provides a comparison of age adjusted incidence rates
for Sweden and Connecticut. As the data show, the incidence of tobacco
related cancer is much lower in Sweden, about one half that of
Connecticut. Trend data for Sweden seemingly provide further supportive
evidence to the harm reduction hypothesis, as a dramatic increase in snus
use in Sweden (0.4 kg/person in 1970 to 0.9kg/person in 2000) coincides
with a decreasing cigarette consumption (1.1kg/person in 1970 to
0.6kg/person in 2000) resulting in a decrease of tobacco related cancer
from 97.8 per 100,000 in 1966-1970 to 56.7 per 100,000 in 1993-1997.1,
However, if snus has a harm reduction effect, the incidence of
tobacco related cancers should not only decline in Sweden as snus use
increases, but it should decrease more in Sweden than in Connecticut,
where the consumption of smokeless tobacco has remained <1% over 1990s.
However, the data below demonstrate that the ratio of the incidence of
tobacco related cancer in Sweden and Connecticut has remained constant at
about 0.5 since 1973, and the same ratio for lung cancer has been stable
at about 0.4 since1960. Rather than snus causing the decrease in tobacco
related cancer in Sweden, these data suggest that another factor was
responsible in reducing cancer incidence in both Sweden and Connecticut.
That factor is likely to be the decline in cigarette use, which fell in
men from about 28% to 15% (Sweden) and 26.7% to 18.7% (Connecticut) from
1985-2003.1,3 During the period of 1970s to 1990s, both populations were
exposed to smoking reduction strategies such as increased awareness of
health risks, increased prices, a change in social norms regarding tobacco
use, etc but both places did not have an increase in snus use. Thus, the
data do not seem to support the hypothesis that the decrease in tobacco
related cancers in Sweden is due to increasing use of snus.
References
1. Foulds, J., Ramstrom, L., Burke, M., Fogerstrom K. Effect of
Smokeless tobacco (snus) on smoking and public health in Sweden. Tobacco
Control, 2003; 12:349–359.
2. Cancer Incidence in Five Continents. Vol. I-VIII. Lyon:
International Agency for Research on Cancer.
3. CDC. State System: State Tobacco Activities tracking and
evaluation system. Tobacco Use Supplement to the Current Population
Survey. 2006. Available at http://apps.nccd.cdc.gov/statesystem/. Accessed
January 17, 2007.
Reduction as a permanent solution may give people false expectations
Thanks to Dr. John R Hughes for his interesting remarks of 20 January 2007
to our article (TC 15:472-480). We have the following comments:
1. Dr. Hughes states that our main finding (no health benefit from
reducing cigarettes) has not been found in the few prior prospective
studies of this topic. This is not correct. Based on a large study
population in C...
Reduction as a permanent solution may give people false expectations
Thanks to Dr. John R Hughes for his interesting remarks of 20 January 2007
to our article (TC 15:472-480). We have the following comments:
1. Dr. Hughes states that our main finding (no health benefit from
reducing cigarettes) has not been found in the few prior prospective
studies of this topic. This is not correct. Based on a large study
population in Copenhagen, Dr. Nina S Godtfredsen and co-workers have
reported the same results in a series of publications, references given in
our article. Dr Hughes’ remarks imply that there may be other prospective
studies that give other results. We have not been able to find other
prospective studies that take up this problem.
2. Our article reports on results from three examinations; for the
majority of participants the interval between the examinations was five
years. A subgroup of the study population was nominated ‘sustained
reducers’. They were heavy cigarette smokers at the first examination, had
reduced their daily cigarette consumption by at least 50 % at the second
examination, and had remained as ‘reducers’ at the third examination.
Their mean consumption at the three examinations was 23.6 – 10.0 – 10.4
cigarettes per day (table 6 in our article).
Dr Hughes states that “the question at each follow-up did not ask about
smoking since the last follow-up”. This is correct, and we agree with Dr
Hughes that it is unknown what the rate of smoking really was between
follow-ups in sustained reducers. The sustained reducers had, however, a
mean daily consumption that was almost the same at the second and third
examination, and in our opinion, the most reasonable explanation is that
their daily cigarette consumption had stabilised at a consumption level
which actually was at least 50% lower than at the first examination. We
also underline that at the second examination, reducers had a serum
thiocyanate level that was lower than in heavy smokers, and close to the
serum thiocyanate level in moderate smokers (table 3 in our article).
3. Dr Hughes states that reduction actually increases motivation to quit.
In our paper, we state explicitly:”Undoubtedly, reduction in consumption
may have a place as a temporary measure in systematic smoking cessation”.
Our conclusion that advising reduction may give people false expectations,
refer to reduction as a permanent solution. We think that the results of
our study and of those of the Copenhagen Study, with study populations of
more than 70 000 persons together, give a sound basis for this conclusion.
Age Tverdal,
Professor
Norwegian Institute of Public Health,
Oslo
Kjell Bjartveit
Director Emeritus
National Health Screening Service
Oslo
The recent study by Tverdal and Bjartveit (TC 15:472-480, 2006) that
found no health benefit from reducing cigarettes had several assets not
found in the few prior prospective studies of this topic; e.g. the
reducers had reduced by over 50% and several outcomes were measured.
I would, however, like to make two comments. First, one asset of the
study was the examination of "sustained reducers;" i.e., those who...
The recent study by Tverdal and Bjartveit (TC 15:472-480, 2006) that
found no health benefit from reducing cigarettes had several assets not
found in the few prior prospective studies of this topic; e.g. the
reducers had reduced by over 50% and several outcomes were measured.
I would, however, like to make two comments. First, one asset of the
study was the examination of "sustained reducers;" i.e., those who
reported reduction at two consecutive examination. Although this
estimation of sustained reduction is superior to that in prior studies,
the question at each follow-up did not appear to ask about smoking since
the last follow-up but rather asked about smoking at the current time;
thus, in actuality, it is unknown what the rate of smoking really was
between follow-ups in "sustained reducers." As a result, there is still
the possibility that these results are false positives. Having said that,
I do believe the burden of proof is on those who believe reduction is
helpful to provide more rigorous tests.
Second, the concluding sentence of the abstract states advising
reduction may "give people false expectations." While this may be true to
some extent, advising reduction does not appear to undermine motivation to
quit but actually increases motivation to quit. Dr Carpenter and I
published a review paper of 19 studies (that did not come out until after
this current study was submitted). None of these studies suggested
reduction undermined motivation to stop smoking. Instead, 16 of the 19
found smoking reduction increased the probability of future cessation.
(NTR 8:739-749, 2006). Thus, I believe smoking reduction can be beneficial
to smokers if they see reduction not as an end itself but as way to
quitting. In fact, surveys suggest this is exactly how the large majority
of smokers see reduction (Hughes et al, NTR, in press)
My attention has been drawn to an error in our paper. At reference #3
we state that Addisson Yeaman was legal counsel to Philip Morris. He was
in fact legal counsel to Brown & Williamson. The mistake arose because
the document was in the Philip Morris collection and was misinterpreted as
being a Philip Morris document. Also, it dates from 1963, not 1964 as
stated.
After nearly two-fold efficacy over placebo in most clinical studies, NRT has proven no more effective than quitting without it in all real-world quitting surveys conducted since adoption of the June 2000 Clinical Practice Guideline (CPG): Minnesota 2002, California 2003, London 2003, Quebec 2004, Maryland 2005, UK NHS 2006, and Australia 2006.[...
After nearly two-fold efficacy over placebo in most clinical studies, NRT has proven no more effective than quitting without it in all real-world quitting surveys conducted since adoption of the June 2000 Clinical Practice Guideline (CPG): Minnesota 2002, California 2003, London 2003, Quebec 2004, Maryland 2005, UK NHS 2006, and Australia 2006.[1]
In the most recent survey, among smoking patients of Australian family practice physicians, patients quitting cold turkey doubled the rates of nicotine patch, gum, inhaler and bupropion quitters and accounted for a whopping 88% of all success stories (1,942 of 2,207).[1]
In fact, after more than two decades of use, NRT still cannot point to a single real-world performance victory in which those engaging in nicotine replacement prevailed over those engaging in nicotine cessation. The question we should all be asking ourselves is why?
On 10/27/06 the CDC reported that for the first time since 1997 the U.S. smoking rate failed to decline. I submit that intimidating physicians into betraying two decades of practice observations may increase profits for those marketing replacement nicotine, bupropion and varenicline but not without substantial needless loss of life.
Primary fault for our stalled U.S. rate is not with physicians. Whether nicotine or pain meds, it rests upon pharmacology dependent medical school curriculum developers who continue to ignore the core basics of chemical dependency recovery counseling. It also rests upon the very June 2000 Clinical Practice Guideline (CPG) here employed to coerce compliance by suggesting that physicians "might be hard pressed to defend" against civil malpractice liability if they fail to see CPG recommendations as imposing legal duties.
The authors' objective is clearly admirable. Far too many physicians ignore ever advancing circulatory, pulmonary and mental health carnage fostered by years of chemical dependency upon smoking the highly addictive super-toxin nicotine. Imagine 81 IARC identified cigarette carcinogens (including polonium) slowly building time-bombs throughout the body, when the only action taken by the average physician is to tell the patient what, to them, is already obvious - "you need to quit."
But in pounding the proverbial square peg into roundness the authors misstate the CPG's key objective, grossly overstate the document's credibility and, as already noted, confuse clinical efficacy with real-world effectiveness. As Professor Branzhaf notes, standards of care are born of consensus among impartial experts, rather than statements from hired guns. The CPG is anything but impartial. Although physicans have a duty to assist those dependent upon smoking nicotine they have no legal obligation to follow a pharmacology use directive that two decades of practical experience has convinced them is totally ineffective, a finding supported by all real-world evidence to date.
The authors fail to note that CPG recommendation seven (R7) totally consumes the remaining recommendations. It reads, "Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting tobacco cessation." Not with "some" patients but "all."
PHS adoption of CPG R7 instantly discredited all non-pharmacotherapy counseling, support and behavioral cessation programs as being no longer in accord with U.S. cessation policy. Nicotine cessation programs that refused to integrate nicotine replacement found themselves in a state of policy illegitimacy with obvious financial and accreditation implications. Their choices were to stick with a true nicotine cessation format that within 3 days creates a nicotine free work space with the onset of full dopamine pathway neuronal re-sensitization (down-regulation), or amend the program to advocate use of chemicals which delay dopamine pathway re-sensitization for weeks or months.
Since 2000 the CDC's primary quit smoking web page has evidenced total government abandonment of support for the cessation efforts of the 80 to 90% of U.S. smokers whose natural instincts are nicotine cessation, not replacement. PHS policy does not treat CPG R7 as optional. Smokers visiting the CDC website are told that key to quitting is to "get medication and use it correctly."[2] The page lists seven pharmacotherapies that include five different NRT delivery vehicles. It then clearly suggests that clinical study efficacy findings are being mirrored in real-world effectiveness in asserting that "all of these medications will double your chances of quitting and quitting for good." The CDC knows or should know that this assertion is false.
Our government knows: (1) that nicotine is a psychoactive chemical producing an alert dopamine/adrenaline high with vasoconstriction, an increase in heart rate and blood pressure, heightened senses and an underlying "aaah" sensation; (2) that those with a quitting history are likely to have trained themselves to recognize their withdrawal syndrome; (3) that those seeking participation in pharmacology studies were not cold turkey quitters expecting to endure their withdrawal syndrome but instead those seeking "medications" that promised some degree of withdrawal syndrome reduction; (4) that a June 2004 review of NRT study blinding assessments concluded that NRT studies were generally not blind as claimed in that "subjects accurately judged treatment assignment at a rate significantly above chance";[3] and (5) that never once in any real-world quitting method survey to date has NRT use proven more effective than quitting without it.
How many nicotine cessation programs survived R7? Very few. But if your patients type "quit smoking" into any major search engine they should encounter one or more such programs as government abandonment of abrupt nicotine cessation education, skills development, counseling and support has fostered demand.
Ironically, a November 2003 persistent use study in this journal found that nearly 40% of nicotine gum users are chronic long-term users of greater than six months. Imagine R7 effectively banishing the very programs that could have aided those getting hooked on the cure. Under current policy where are they to turn to reclaim neurochemical control?
The authors paint a picture of the CPG having been created by an independent panel of experts. The authoring panel had 17 members of which 11 openly acknowledge financial ties to the pharmaceutical industry in CPG Appendix C.[4] The panel chairman, who was also the director of the Center for Tobacco Research and Intervention (CTRI), discloses 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." In 1996 he was openly labeling himself "a consultant to Glaxo Wellcome."[5] In 2005 he testified that the Robert Wood Johnson Foundation (RWJF) provided CTRI with more than $8 million in funding since 1998, that he had served as director of the RWJF National Program Office Addressing Tobacco in Managed Care since 1996, and that since 1998 he had sat in a $50,000 a year university chair funded by GlaxoSmithKline.[6]
GlaxoSmithKline markets nicotine gum, a nicotine lozenge and nicotine patch. The RWJF clearly knows it could gain philanthropy credibility by severing financial and board member ties to Johnson & Johnson (J&J) and its product line, which includes a nicotine patch, nicotine inhaler and nicotine spray, but it hasn't. Instead it remains J&J's largest shareholder with a quarter of board members having been former J&J executives.
RWJF claims that in August 1998 it contributed $102,016 to CTRI as its share toward updating the CPG. It notes that on September 14-15, 1999, panel members met in Madison, WI, where they evaluated findings and prepared a draft of the new Guideline. It also asserts that "the final version was submitted to RWJF and the USPHS for approval."[7] Also of note, RWJF paid at least $235,654 toward CPG dissemination.[8]
The only fair conclusion is that pharmacology influence had major impact on the CPG. Stakeholders have no business managing the writing of U.S. cessation policy and the practice must stop. Imagine if the panel had included educators and counselors who had devoted their life to highly effective programs involving nicotine cessation, programs that RWJF and pharmaceutical companies would have zero interest in studying and promoting. Allowing more than one lone voice would likely have prevented R7 from consuming all other recommendations, and cost the pharmaceutical industry billions.
I seriously doubt that many reviewing the CPG in 2000 grasped that the document was effectively outlawing pharmacology's only serious competitor, cold turkey. How many today grasp why pharmacology seems so wonderful inside clinical trials yet so dismal once outside clinic doors?
How many smokers wanting to quit cold turkey would you expect to join a clinical trial offering a 50/50 chance of free medicine? For those seeking withdrawal syndrome diminishment, how many with a prior quitting history would be able to recognize full-blown withdrawal or, some degree of relief of withdrawal symptoms if assigned to the active group? How meaningful would clinical results be if frustrated or fulfilled expectations determined who survived and who relapsed? Real-world performace evaluations compel pharmacology quitters to at last go head-to-head with real cold turkey quitters. It's strange how the CDC relies upon surveys to establish every tobacco truth except the most effective quitting method.
Is it fair to blame the CPG and specifically R7 for bringing a decline in the U.S. smoking rate to a halt? I believe it is. Let me briefly explain why. First, think about two decades and hundreds of millions spent bashing and trashing quitter confidence in the most productive method the world has ever known, cold turkey. Still, this year it will generate more than 80% of all long-term successful quitters.
Those supporting R7 like to tell smokers that, "on average, it takes between three to five serious quit attempts before breaking free of tobacco dependence. Some may be successful on the first try, others may take three or more tries. I like to tell people to visit our clinic, that every time you make an effort, you're smarter and stronger, and you can use that information to increase the likelihood that your subsequent quit attempt is successful."[9]. What they fail to reveal is the precise lesson eventually learned or that the statistics they quote belong to nicotine cessation not nicotine replacement.
Reflect on the amazing influence upon the mind of a quitter who smokes nicotine just once after quitting, in generating a new salient dopamine "aaah" prefrontal cortex "pay attention" memory. It's an "aaah" that their missing dopamine killjoy enzyme (suppressed by nicotine) allows them to savor far longer than normal. It isn't just that their mind tasted another stolen dopamine "aaah" sensation but that it will not allow them to forget. Just one powerful puff is the single greatest predictor of full and complete relapse back to their old level of nicotine intake or higher.
We call it the "Law of Addiction."[10] This critical relapse lesson does not always come easy but eventually the failed quitter begins to see a bright line in the sand that says, "just one powerful puff of nicotine and I will again throw all this hard work out the window."
It should be obvious that toying with the very chemical that the school of hard-quitting-knocks was eventually supposed to teach them to leave alone muddies the learning waters. Renaming nicotine "medicine," labeling its use "therapy" and two decades of telling quitters that they need to replace missing nicotine has clearly interfered with a natural learning process.
Lastly, we know that unlike cold turkey quitting, where each new attempt actually increases the odds of success (unless the lesson becomes clouded by toying with pharmacology), with each subsequent NRT attempt the odds of success appears to decline. Shiffman's OTC NRT patch and gum meta analysis published here in TC in March 2003 found a 93% six-month relapse rate. But in the only two nicotine patch studies that have examined second time patch use rates, an average of 99% relapsed within six months. (100% Tonneson 1993, 98.4% Gourlay 1995). With second time NRT use rates climbing, this important yet little known finding should disturb all.
I submit that physicians have a legal duty to believe their ears and eyes above clinical study assertions that will never ever be duplicated in real-world use. I too encourage physicians to read and rely upon all aspects of the CPG except for pharmacology performance efficacy claims and use recommendations.
John R. Polito
Nicotine Cessation Educator
Editor WhyQuit.com
As the public interest attorney and law professor who first developed
the concept of using legal action as a weapon against the problem of
smoking (e.g., getting antismoking messages on TV and radio, driving
cigarette commercials off the air, starting the nonsmokers’ rights
movement, etc.), I was delighted to read a paper suggesting the
feasibility of using legal action to more effectively prod physicians to
warn patient...
As the public interest attorney and law professor who first developed
the concept of using legal action as a weapon against the problem of
smoking (e.g., getting antismoking messages on TV and radio, driving
cigarette commercials off the air, starting the nonsmokers’ rights
movement, etc.), I was delighted to read a paper suggesting the
feasibility of using legal action to more effectively prod physicians to
warn patients about smoking, and to assist them in quitting.
Actually, by way of full disclosure, my organization [Action on
Smoking and Health (ASH), http://ash.org] had made a similar suggestion in
2003, [http://ash.org/recommendations] and the New York City Health
Department warned even earlier that, "because physician intervention can
be so effective, failure to provide optimal counseling and treatment is
failure to meet the standard of care – and could be considered
malpractice." [City Warns Docs -- Help Patients Stop Smoking -- or Else,
New York Post (12/13/02)].
The Clinical Practice Guidelines referred to in the article greatly
strengthen such law suits because courts and juries are often confused by
– and therefore tend to throw up their hands regarding – testimony by
competing physicians as to the standard of what other physicians do.
Therefore they are increasingly likely to adopt, as a appropriate standard
of care, some official document which represents a consensus among
impartial experts, rather than statements from “hired gun” medical
witnesses. This is even more true where, as in the case of the tobacco
guidelines, they have been adopted and put into practice by prestigious
medical organizations.
Dr. Siegel makes some interesting observations but, as a physician
rather than an attorney, he appears to be out of his field, and – with
all due respect – perhaps out of his depth (despite his participation in
some tobacco litigation), in bluntly stating that the “legal reasoning in
[the] malpractice article is not sound.” As someone with almost 40 years
of experience with anti-tobacco litigation – and who has been called the
"Ralph Nader of the Tobacco Industry," an "Entrepreneur of Litigation,
[and] a Trial Lawyer's Trial Lawyer,” "a Driving Force Behind the Lawsuits
That Have Cost Tobacco Companies Billions of Dollars," and "The Law
Professor Who Masterminded Litigation Against the Tobacco Industry," let
me speak frankly in suggesting from a lawyer’s perspective why the legal
reasoning is sound and why the legal threat is very real.
While it is technically true that the plaintiff must prove – and then
only by a “preponderance of evidence” and not “to a medical certainty” –
that he would have quit if only the physician has warned him and assisting
him in doing so, in practice this is not a major burden for several
reasons.
1. To survive the initial motion to dismiss – where the defendant
asks the court to throw out the law suit so that defendant (and his
insurance company) will not be put to the burden of defending it – the
judge must assumes all allegations in the legal complaint are true unless
they are clearly impossible on their face. Thus a judge would refuse to
dismiss any law suit which alleged that the plaintiff would have quit if
the physician had warned him to do so, even if such a proposition were
clearly against the great weight of evidence. This refusal to grant the
motion opens the door to pre-trial discovery – including depositions,
demands for the physician’s time, documents, and records, etc. – places
a blot on his record, and perhaps interferes with his ability to obtain
malpractice coverage at favorable rates. That threat alone may motivate
many physicians (and their medical organizations and insurance companies)
to settle or – better yet – to follow the guidelines next time.
2. In most jurisdictions, a judge will charge the jury that there is
a legal presumption that the plaintiff would have heeded a warning, and
this jury charge is usually given even regarding small-print routine
warnings on tools, drugs, etc. which were merely inadequate rather than
nonexistent. This presumption – which in effect shifts the burden on this
issue onto the defendant – is likely to be far stronger where the specific
face-to-face warning from a physician mandated by the guidelines was not
even given, since judges as well as jurors know that warnings from
authority figures in white coats are likely to be far more effective that
tiny-print warnings on jars or packages. The presumption and jury charge,
by the way, is generally given even if the defendant introduces strong
empirical evidence that the plaintiff would not have heeded the warning.
3. The question of whether the plaintiff would have heeded the advice
and assistance of the physician if he or she had given it is a factual
issue for the jury to decide, and the issue must be left to them if
reasonably people could possibly differ – as they obviously can on this
question. Experience clearly suggests that, faced with a sympathetic and
very ill plaintiff who swears that he would have heeded a warning if it
had been given, and a physician who (as his lawyer will argue) “thumbed
his nose at his professional obligation, ignored the simple guidelines of
a governmental commission and the unanimous advice of his peers,” the
jury’s sympathy for the plaintiff will incline them to award him some
damages, even if empirical evidence as well as common experience suggests
how hard it often is to quit.
4. The same is true with regard to the burden on the plaintiff to
prove that, had he quit, he would not have had the medical problem of
which he now complains. Sympathy may well be more important in a jury’s
consideration of this issue than dry empirical and statistical evidence
and related arguments put forth by “rich doctors and their greedy
insurance company lawyers.” Moreover, since juries are so firmly
convinced that smoking causes lung cancer, arguments about latency periods
– and just when the first cell turned from healthy to pre-cancerous and
then to cancerous – are not likely to be very persuasive. Plaintiff
attorneys may also try to sue in situations based upon other diseases and
medical problems triggered and/or exacerbated by smoking – e.g., heart
attacks – where arguments based upon early damage and long latency periods
will have less traction.
5. Antismoking lawyers do not have to win every case, most cases, or
even one out of every ten cases to put strong pressure on hospitals,
medical organizations, insurance companies, and ultimately on individual
physicians to begin complying with the guidelines to avoid the risk of
being sued and the possibility – however large or small it may appear –
of losing such a law suit. In this regard, many older physicians may
remember an interesting parallel.
6. Prior to 1975, it appeared that it was not the custom and
practice of psychiatrists to issue warnings when their patients made
threats in the presence of their doctor to do serious harm to spouses,
friends, and other third parties. When the Supreme Court of California
ruled in the Tarasoff case that such a failure to warn could give rise to
legal liability if the patient carried out the threat, most psychiatrists
reportedly changed their own policies quickly, without even waiting for
the subsequent jury verdict which found the physician liable. There are,
of course, many other instances where changes were quickly made in medical
practice and procedure in response to law suits, and sometimes even to the
threat of law suits. Indeed, it would be far better for those in the
profession who do not currently follow these guidelines to begin doing so
now, rather that waiting for one or more tests of this legal reasoning.
7. Attorneys are likely to be eager to bring such cases since the
damages are likely to be high, and they will involve far less research and
preparation than traditional medical malpractice cases which often require
a very careful review of the patient’s entire medical record to find
examples of alleged errors, detailed medical research to be sure what the
standard of care is, and the need to find qualified medical witnesses
willing to testify that the named defendant violated the general standard
of care required in this specific situation. It’s obviously much easier
to find a plaintiff who had not been adequately advised and assisted to
quit, and to find a witness who will testify that the guidelines do in
fact represent an expert consensus as to the appropriate standard of care
which are followed by prestigious institutions. Also, remember the old
adage: “never underestimate the tenacity and creativity of an attorney on
a contingency fee.”
One final comment goes far beyond the narrow issue of liability for
failing to assist patients to quit smoking. Dr. Siegel seems to suggest
that any malpractice action based upon a physician’s failure to warn a
patient of a potential risk, or to suggest a treatment (medication,
operation, or other course of action), is doomed to failure if the
proposed treatment is less than 50% effective: “Until such time as there
is a truly effective treatment for smoking cessation (one that works most
of the time), there really can be no basis for establishing a causal
relationship between the breach of duty and the incurred injury.” In
other words, by this reasoning, it would appear that the medical community
would have no legally enforceable duty to do anything at all (including
refraining from negligence) where the chance of success – much less the
patient’s ultimate chance of survival – is less than 50%. But several
courts have ruled directly to the contrary, finding that even plaintiffs
whose conditions were so grave that their chance of survival was less than
50% still have a valid cause of action against a physician whose
negligence decreases those already poor odds. Good physicians should never
act negligently toward a patient, gambling that the dismal chance that a
proposed treatment will be effective will shield them from liability.
I find the argument provided in the paper to be non-compelling
because it fails to provide any reasonable argument for how the 3rd
showing in a medical malpractice case - that there is a causal
relationship between the breach of duty and the incurred injury - could
possibly be met in a smoking malpractice case. This would require proving
to the jury that the physician's failure to warn the patient to quit
smoking was th...
I find the argument provided in the paper to be non-compelling
because it fails to provide any reasonable argument for how the 3rd
showing in a medical malpractice case - that there is a causal
relationship between the breach of duty and the incurred injury - could
possibly be met in a smoking malpractice case. This would require proving
to the jury that the physician's failure to warn the patient to quit
smoking was the cause of the injury sustained by the patient.
This would imply that 3 things would have to be shown: (1) that the
patient would have quit smoking if only the physician had advised them to
quit and followed the PHS guidelines; and (2) that the reason the patient
did not quit smoking was that the physician failed to advise them to quit
and failed to follow the PHS guidelines; and (3) that if the patient had
quit smoking, he would not have developed the injury.
These seem to be unreasonable, if not impossible, points to prove.
How can we possibly know that a patient would have successfully quit
smoking if only the physician had followed the guidelines? Unfortunately,
the overwhelming scientific evidence cited in the paper supports a
conclusion that the patient would most likely not have quit smoking, even
if the physician had followed the guidelines. The data demonstrate that
the cessation success rate, even with physician treatment, is dismal. The
success rate does not even come close to approaching 50%; thus, it is more
likely than not that even with physician advice to quit smoking, the
patient would not have been successful in quitting smoking.
The success rates reported in the PHS guideline itself are generally
below 20%. This means that it is much more likely than not (in fact 4
times out of 5) that a patient who goes through the suggested intervention
will fail to quit smoking.
I view this as an intractable problem in the use of the PHS CPG in
medical malpractice lawsuits for failure to properly treat tobacco
dependence. Until such time as there is a truly effective treatment for
smoking cessation (one that works most of the time), there really can be
no basis for establishing a causal relationship between the breach of duty
and the incurred injury.
Finally, it is important to note that one would not only have to show
that the plaintiff would have quit smoking had only the physician advised
them to quit; one would also have to show that had the person quit
smoking, they would not have developed the injury. However, we know that
many former smokers still develop smoking-related injuries. It is not
clear that one could show that the plaintiff wouldn't have developed the
disease even if they had successfully quit smoking, especially for a
disease such as lung cancer where risk decreases slowly following smoking
cessation.
The paper by Henningfield, Rose and Zeller is an important
contribution to understanding the all-too-clever manipulation of language
by tobacco industry in defending its manufacture and marketing of an
addictive product. It is useful to note, as on the authors' Table 1, that
while the industry now publicly acknowldeges that cigarette smoking is
addictive, it never mentions nicotine as the principal addictive agent.
The...
The paper by Henningfield, Rose and Zeller is an important
contribution to understanding the all-too-clever manipulation of language
by tobacco industry in defending its manufacture and marketing of an
addictive product. It is useful to note, as on the authors' Table 1, that
while the industry now publicly acknowldeges that cigarette smoking is
addictive, it never mentions nicotine as the principal addictive agent.
The former attribution puts the onus on the smoker who can choose to be
addicted or not; the latter would require the industry to be responsible.
Dr Gupta’s letter suggests that the reduction in lung cancer in both Sweden and Connecticut is highly likely to be due to a reduction in smoking in both places. This is entirely unsurprising, and as far as Sweden is concerned is precisely what we suggested in the original paper he referred to:
“There has been a larger drop in male daily smoking (from 40% in 1976 to 15% in 2002) than female daily smoking (34% in...
Dr Gupta’s comparison of trends in lung cancer mortality and smoking prevalence in Sweden and Connecticut purports to undermine the claim that increasing snus use in Sweden has contributed to declining lung cancer rates there.
Dr Gupta argues that some factor other than snus must have been at work because the ratio of lung cancers between Sweden and Connecticut has remained constant despite the large differenc...
Dear Editor
Some tobacco control community members believe that advocating the use of snus, a form of Swedish smokeless tobacco said to be less harmful than cigarettes, would prove an effective harm reduction strategy against tobacco related diseases. One important basis for such a claim is the fact that snus is widely used in Sweden (23% men used snus daily in 2002), where the incidence of cancer caused by tob...
Reduction as a permanent solution may give people false expectations Thanks to Dr. John R Hughes for his interesting remarks of 20 January 2007 to our article (TC 15:472-480). We have the following comments: 1. Dr. Hughes states that our main finding (no health benefit from reducing cigarettes) has not been found in the few prior prospective studies of this topic. This is not correct. Based on a large study population in C...
The recent study by Tverdal and Bjartveit (TC 15:472-480, 2006) that found no health benefit from reducing cigarettes had several assets not found in the few prior prospective studies of this topic; e.g. the reducers had reduced by over 50% and several outcomes were measured.
I would, however, like to make two comments. First, one asset of the study was the examination of "sustained reducers;" i.e., those who...
My attention has been drawn to an error in our paper. At reference #3 we state that Addisson Yeaman was legal counsel to Philip Morris. He was in fact legal counsel to Brown & Williamson. The mistake arose because the document was in the Philip Morris collection and was misinterpreted as being a Philip Morris document. Also, it dates from 1963, not 1964 as stated.
After nearly two-fold efficacy over placebo in most clinical studies, NRT has proven no more effective than quitting without it in all real-world quitting surveys conducted since adoption of the June 2000 Clinical Practice Guideline (CPG): Minnesota 2002, California 2003, London 2003, Quebec 2004, Maryland 2005, UK NHS 2006, and Australia 2006.[...
As the public interest attorney and law professor who first developed the concept of using legal action as a weapon against the problem of smoking (e.g., getting antismoking messages on TV and radio, driving cigarette commercials off the air, starting the nonsmokers’ rights movement, etc.), I was delighted to read a paper suggesting the feasibility of using legal action to more effectively prod physicians to warn patient...
I find the argument provided in the paper to be non-compelling because it fails to provide any reasonable argument for how the 3rd showing in a medical malpractice case - that there is a causal relationship between the breach of duty and the incurred injury - could possibly be met in a smoking malpractice case. This would require proving to the jury that the physician's failure to warn the patient to quit smoking was th...
The paper by Henningfield, Rose and Zeller is an important contribution to understanding the all-too-clever manipulation of language by tobacco industry in defending its manufacture and marketing of an addictive product. It is useful to note, as on the authors' Table 1, that while the industry now publicly acknowldeges that cigarette smoking is addictive, it never mentions nicotine as the principal addictive agent. The...
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