Monday, June 4, 2012

CASAA's comment on FDA Draft Guidance for Modified Risk Tobacco Product Applications


The following is the comment letter CASAA has submitted to the FDA. CASAA encourages members to submit their own comments by the end of the day (6/4/12)  at http://www.regulations.gov/?source=govdelivery#!documentDetail;D=FDA-2012-D-0071-0001

Under the FDA's Draft Guidance for MRTP Applications, it would cost any smokeless tobacco manufacturer (and any e-cigarette manufacturer if the agency "deems" they should be regulated by Chapter IX, as the FDA has stated it intends to do) tens of millions of dollars conducting unnecessary research before applying to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes.


The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is pleased to submit this comment on “Draft Guidance for Industry; Availability: Modified Risk Tobacco Product Applications,” Docket ID: FDA-2012-D-0071, hereinafter referred to as “Draft Guidance.” We are commenting in our capacity as representatives of consumers who use alternatives such as smokeless tobacco, dissolvable tobacco, and e-cigarettes as a partial or complete replacement for smoking. Most of us would not have been able to stop smoking otherwise. Those of us who smoked for decades and have switched to smoke-free alternatives are now enjoying improved health.

The FDA has specifically requested comment on Recommendation 2 in the Institute of Medicine (IOM) report, Scientific Standards for Studies on Modified Risk Tobacco Products (MRTPs). Please note that this recommendation is related to Finding 2, which addresses new products, specifically novel MRTPs. The IOM report maintains there is a minimum range of research domains required to evaluate the effect of (novel) MRTPs on individuals and public health.

Section 3, item (4), of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) requires “flexible enforcement authority to ensure that there is effective oversight” of the development, introduction, and promotion of less harmful tobacco products. This flexibility needs to address the difference between totally new (“novel”) products versus established products that have been in general use for years.

The need to act on existing knowledge about smokeless tobacco

Subjecting established and thoroughly studied low-risk smokeless tobacco products to the entire gamut of new testing described in the IOM report is unnecessary, expensive, and time-consuming, and creates an unacceptable delay in providing factual information to the public about less hazardous alternatives to smoking. A consequence of this delay is that, lacking such information, most American smokers will continue smoking, and millions of smokers will die.

In Table 1, TABLE S-1 Evidence Domains Relevant to an MRTP Application and Examples of Types of Findings, the Epidemiological Class calls for:
·         Clear and consistent evidence of reduction in disease
·         No convincing evidence of offsetting increased risk for other diseases
·         No significant evidence of uptake among nonusers or relapse among former users

The years of epidemiological evidence documented in numerous peer-reviewed scientific journal articles have empirically demonstrated that smokers who switched to Western (U.S. or Swedish style) moist snuff (aka “snus”) have reduced risks for all types of cancers [1,2], cardiovascular disease [3,4], and, other lung disease compared with smoking. (While some commentators have tried to claim there are important differences in health effects between Swedish style products and popular forms of American moist snuff, the science does not actually support this claim. The claim is largely moot, in any case, since the segment of the American market that is likely to make applications has shifted to Swedish-style products.)

There is clear evidence of a positive effect on public health in countries where a substantial proportion of smokers have switched, specifically Sweden (based on decades of data) and more recently Norway [5,6].

Specifically, not only has the prevalence of smoking been reduced in those countries, the overall use of tobacco also continued to decline [7-9].

As we would expect from the reduction in smoking, Norway and Sweden have some of the lowest lung cancer mortality rates in the EU [10], and there have been no observed increases in any disease that is blamed on smokeless tobacco use.




IOM’s recommendation for extensive tests on levels of toxins and carcinogens may be appropriate for novel smoke-free products, where they must stand as a poor substitute for epidemiologic evidence, but it forms a distraction from the wealth of epidemiological evidence for established products. If the epidemiology for the product shows no measurable disease risk, then the chemicals within the product present no risk of disease in that particular form, concentration, and context.

Who can conduct the research?

IOM’s Recommendation 10 calls for the manufacturers to use independent third parties to conduct and oversee research. Where does the IOM suggest that manufacturers find such third parties? The Society for Research on Nicotine and Tobacco has instructed its members to ask their institutions to refuse to conduct research on behalf of tobacco companies. Unless the FDA has the power to force educational institutions or scientific organizations to conduct research on tobacco products, this must not be made a requirement.

Evidence about future behavior

The IOM Report outlines that committee’s opinion of what types of evidence should be gathered. Some of this suggests it is necessary to produce evidence about economic (behavioral) phenomena that will occur in an unknown future, with regard to a relatively new situation. Pseudo-scientists are fond of making pronouncements of certainty about what will happen in novel circumstances. Obstructionists like to use the unavoidable uncertainty to claim it is too risky to allow anything. But policy makers acting in the public interest need to make the best possible evaluation and act on it in spite of the uncertainty. It is impossible to know for sure how low-risk alternatives will affect initiation by nonusers or the proportion of switchers that might have “quit completely” if the MRTP had remained unavailable. While there is no reason to expect that many would-be never smokers will decide to switch to smoking after using a low-risk product, it is again impossible to be certain.

For evidence domains that cannot be directly measured, the FDA’s Guidance document needs to specifically address how those data can and should be gathered, how the results will be measured, and the criteria for success. Those should consist of methods that are possible, consistent with proper scientific modesty (psychic powers and time machines are not options, as is certainty). The FDA should not make the mistake of favoring artificial experiments based on non-natural behavior when trying to understand free economic choices and interactive social behavior; just because a method is optimal for evaluating medicinal drugs and is what the agency is most familiar with does not make it optimal – or even useful at all – in other areas of inquiry.

The FDA also needs to provide direction to sponsors regarding how to collect evidence on the effects of the proposed new product on special populations, particularly non-adults who are legally forbidden from using the products.

The reduction in health risks is clear to any observer

Any product that does not require inhaling smoke or a similar chemical mixture presents little to no risk to lung and airway health in an absolute sense, and certainly not when compared to smoking. Respiratory diseases and cancers of the trachea, lung, and bronchus account for 58% of the CDC’s estimated 390,000 annual deaths attributed to smoking [11]. It is not necessary to acknowledge that the evidence does not support the claim that smoke-free nicotine products cause any mortality risk for adult users to see that there would be a reduction. There is no remotely plausible theory that existing smoke-free products cause other health risks that have anywhere close to the magnitude of risk of lung disease (alone) from smoking. If there were a risk that was 10% of that magnitude from smokeless tobacco, there would be compelling evidence of that. Thus, any rational person who is aware of the existing science must conclude that the product is substantially less hazardous to the individual user than continued smoking. It is also obvious that non-combusted tobacco products do not pose any health risks to bystanders.

Every American standard of ethics says these facts should not be hidden from the public. Moreover, good public policy requires that they be incorporated into MRTPAs.

Inaccurate beliefs cause unfortunate decisions

Research shows that use of alternative tobacco products is strongly related to beliefs about the relative harm of those products [12]. Smokers who correctly believe that health risks of smokeless tobacco use are far lower than smoking are more than four times as likely to be willing to try smokeless tobacco [13]. Users of non-combusted tobacco products are much more likely to switch to smoking if they incorrectly believe that smoking is less likely to cause mouth cancer or dental problems. Thus, the best way to prevent people from experiencing a “gateway” transition to smoking is to make certain they understand that smoking is many times more hazardous than any other way of using tobacco.

Time is of the essence

Completing all the tests specified in the IOM report cannot be accomplished swiftly. Meanwhile, an estimated 1,200 Americans will continue to die each day of smoking-related diseases. While we cannot save the ones who will die tomorrow, we can immediately start saving many of those who would otherwise be doomed to die a few years from now by encouraging them to switch to low-risk alternatives.

The FDA could substantially reduce this death toll by doing one of the following:
  • Design a “fast-track” method of obtaining MRTP approval for established products for which there is ample epidemiological evidence of safety and of consumer acceptability as a replacement for smoking.
  • Provide accurate information to the public about relative risks of each class of tobacco products. This effort might include the following:
    • Revise smokeless tobacco product warning label statements, as permitted in Section 205 of the FSTPCA, to accurately reflect product risks. “This product is not a safe alternative to cigarettes” could be amended to read, “This product is much less hazardous than cigarettes, but not 100% safe.”
    • Revise information on the Center for Tobacco Products website to remove unethically misleading and scientifically incorrect statements such as, “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.” [1-6,10]

Opponents of harm reduction may prefer that smokers continue to smoke until they are ready to “quit completely.” However, this is not in the best interests of public health. For the average smoker, smoking for just a few more months before “quitting completely” causes greater health risk than switching to smokeless tobacco and never quitting it [14].

REFERENCES:

  1. Lee PN, Hamling J. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America. BMC Medicine 2009, 7:36
  2. Nordenvall C, Nilsson PJ, Ye W, Nyrén O. Smoking, snus use and risk of right- and left-sided colon, rectal and anal cancer: a 37-year follow-up study. Int J Cancer. 2011 Jan 1;128(1):157-65. doi: 10.1002/ijc.25305.
  3. Hansson J, Pedersen NL, Galanti MR, Andersson T, Ahlbom A, Hallqvist J, Magnusson C.Use of snus and risk for cardiovascular disease: results from the Swedish Twin Registry. J Intern Med. 2009 Jun;265(6):717-24.
  4. Wennberg P, Eliasson M, Hallmans G, Johansson L, Boman K, Jansson JH. The risk of myocardial infarction and sudden cardiac death amongst snuff users with or without a previous history of smoking. J Intern Med 2007; 262: 360–7.
  5. Foulds J, Ramstrom L, Burke M, Fagerstrom K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tobacco Control 2003;12:349–359.
  6. Lee PN. Summary of the epidemiological evidence relating snus to health. Regul Toxicol Pharmacol. 2011 Mar;59(2):197-214. Epub 2010 Dec 14.
  7. Furberg H, Bulik CM, Lerman C, Lichtenstein P, Pedersen NL, Sullivan PF. Is Swedish snus associated with smoking initiation or smoking cessation? Tob Control. 2005 Dec;14(6):422-4.
  8. Ramström LM, Foulds J.Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control. 2006 Jun;15(3):210-4.
  9. Lundqvist G, Sandström H, Ohman A, Weinehall L. Patterns of tobacco use: a 10-year follow-up study of smoking and snus habits in a middle-aged Swedish population. Scand J Public Health. 2009 Mar;37(2):161-7. Epub 2008 Nov 27.
  10. Rodu B, Cole P. Lung cancer mortality: comparing Sweden with other countries in the European Union. Scand J Public Health. 2009 Jul;37(5):481-6. Epub 2009 Jun 17.
  11. Centers for Disease Control and Prevention. Smoking and Tobacco Use, Tobacco-Related Mortality. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/
  12. Lund KE. Association Between Willingness to Use Snus to Quit Smoking and Perception of Relative Risk Between Snus and Cigarettes. Nicotine Tob Res. 2012 Mar 13.
  13. O'Connor RJ, McNeill A, Borland R, Hammond D, King B, Boudreau C, Cummings KM. Smokers' beliefs about the relative safety of other tobacco products: findings from the ITC collaboration. Nicotine Tob Res. 2007 Oct;9(10):1033-42.
Phillips CV. Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments. Harm Reduct J. 2009 Nov 3;6:29. 

3 comments:

amaherparks said...

Well written. Are MRTP products defined in the proposed submittal to include electronic cigarettes? Are any other products in this category?

Elaine Keller said...

WHAT ABOUT E-CIGARETTES?

Currently, the FDA does not regulate e-cigarettes as a tobacco product, but as soon as the FDA issues a "deeming regulation" stating that the Agency is going to regulate ALL tobacco products under the Family Smoking Prevention and Tobacco Control Act, then this regulation will apply to e-cigarettes as well.

Elaine Keller said...

To answer the second part of your question, currently there are no MRTP products. This regulation describes the cumbersome and expensive process that a tobacco company would need to go though in order to have one of their products approved as an MRTP. This would allow them to inform the public that this particular product is less hazardous than smoking. Currently, such a statement is illegal.

We already have decades of research showing that Swedish smokers who switched to snus have no higher rates of smoking-related disease than former smokers who gave up all use of tobacco. It is wasteful to force companies to jump through hoops to prove what we already know. Furthermore, the longer this information is hidden from smokers, the more people will die.