IOM Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products

[Bill Godshall]

As instructed in Section 911 of the FSPTCA, on Thursday, February 3, FDA's Director for tobacco Products Lawrence Deyton assigned the National Academies Institute of Medicine (IOM) Committee on Scientific Standards for Studies on Reduced Risk tobacco Products to advise the FDA on the minimum standards for scientific studies to allow the marketing of modified risk tobacco products, and for post-market studies of marketed products.
http://www8.nationalacademies.org/cp/meetingview.aspx?MeetingID=4923&MeetingNo=1

After Introductions, Deyton's presentation and Q&A with committee members,
Committee: Scientific Standards for Studies on Reduced Risk Tobacco Products
Public comments were presented by eight interested parties. Mine is below.

Statement by:
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

Hello,

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for past misdeeds, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

There appear to be three different types of modified risk or reduced exposure applications that will be submitted to the FDA via Section 911 of the FSPTCA:
- those comparing a smokefree tobacco product to cigarettes,
- those comparing a cigarette to other cigarettes, and
- those comparing a smokefree product to other smokefree products.

Existing scientific evidence indicates that all cigarettes pose similar morbidity and mortality risks, and that all smokeless tobacco products marketed in the US pose similar morbidity and mortality risks. So additional evidence is needed before one cigarette can be determined to be less hazardous than another, and more evidence is needed before one smokeless tobacco product can be determined to be less hazardous than another.

In sharp contrast, many decades of scientific evidence confirms that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarette smoking, and that switching to smokefree tobacco products reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokefree alternatives.

Since >99% of all tobacco attributable deaths in the US are caused by the repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco products, it is vitally important for this committee to acknowledge these exponential differences of risk and encourage the FDA to incorporate this into the establishment of criteria for evaluating modified risk and reduced exposure tobacco product applications.

In the absence of reduced risk marketing claims, population surveys confirm that several million smokers have already switched to smokeless tobacco products even though the vast majority of smokers inaccurately believe that smokeless tobacco is just as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every non-tobacco user in America begins to use smokeless tobacco.Even if many more non-tobacco users begin using smokeless tobacco products, the truthful marketing of smokefree tobacco products as lower risk or reduced exposure alternatives to cigarettes can only further reduce tobacco morbidity and mortality (to a meaningful degree).

Therefore, this committee should encourage the FDA to not require new costly studies for a smokefree tobacco product to claim it is less hazardous than cigarettes. But post-market surveillance would be helpful.

Requiring additional scientific studies before a company can make these types of modified risk or reduced exposure claims would be a “truth tax” for far less hazardous smokefree alternatives, would unfairly protect cigarettes from market competition by lower risk alternatives, and would threaten instead of improve public health.

Once the FDA begins approving truthful modified risk or reduced exposure claims for smokeless tobacco products compared to cigarettes, the agency also will be prompted to evaluate and eliminate the 25 year old intentionally misleading Congressionally mandated warning on smokeless tobacco products and advertisements stating: “This product is not a safe alternative to cigarettes,” which has confused most smokers to believe that smokefree products are just as hazardous as cigarettes.

Please remember that smokers have a human right to accurate and relevant health information and legal access to far less hazardous alternatives. The IOM and FDA should ensure that.

Thank You,

 

[Bill Godshall]

Here's Elaine Keller's statement, also at http://www.casaa.org/news/article.asp?articleID=115&l=a&p=

Testimony to IOM Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products

Good afternoon. My name is Elaine Keller and I have been smoke-free since March 27, 2009. I am Vice President of the non-profit organization, Consumer Advocates for Smoke-free Alternatives Association, CASAA for short.

CASAA congratulates you on being selected to be a member of this body. You have been entrusted with extremely important work. You have the opportunity to save millions of lives, and as a former smoker I offer some suggestions today to help you accomplish that goal.

Over the past 20 years, more than 8 million citizens have died of smoking-related diseases. During that time, the number of adult smokers grew from 43.8 million to 46.6 million. Clearly, we need a more effective approach.

CASAA was founded by several thousand former smokers who had been unable to stop smoking, despite using all the recommended methods, as well as patches, gum, and other medicines—repeatedly. Many of us rely on nicotine to help us concentrate, stay alert, remember what we need to, relieve chronic pain, combat chronic fatigue, or to ward off depression and anxiety. Some of us become dysfunctional without nicotine. Nicotine is being studied as treatment for a variety of diseases related to cognition and mood, as well as for the prevention of Parkinson’s and Alzheimer’s. Switching from smoking to inhaling vaporized nicotine from an electronic cigarette enabled us to regain our physical health without sacrificing our cognitive and emotional health.

We were astonished and outraged to learn that, decades before the invention of electronic cigarettes, we could have stopped inflicting smoke-related damage to our bodies without becoming nicotine-abstinent. We were deceived about the relative safety of non-combusted tobacco products. The government and so-called public health organizations misapplied the word “safe” in the messages, “This product is not a safe alternative to smoking” and “There is no safe form of tobacco.” Most folks think they’re saying there is no safer form of tobacco than smoking. These messages encouraged smokers who did not want to give up nicotine to keep inhaling smoke, when they could have switched to products that reduce smoking-related disease risks by up to 99%! Their half-truths have killed millions of smokers and continue to do so today.

We need scientists to tell us the truth, the whole truth, and nothing but the truth.

It is imperative to use the correct benchmarks. The level of harm against which to measure “Modified Risk” must be the harm caused by smoking. Likewise, the benchmark for “Reduced Exposure” must make the comparison against the number and quantities of harmful chemicals in cigarette smoke.

Twenty years of research shows that switching to snus, a type of moist snuff, reduces health risks to the same level as former smokers who gave up all tobacco use. No additional research should be required to grant this product the status of “Modified Risk” tobacco product

Publicize the fact that any non-smoked source of nicotine reduces exposure to the harmful effects of tar, carbon monoxide, particulates, and thousands of chemicals created by the process of combustion. Lacking evidence to the contrary, all smoke-free sources of nicotine should be granted a minimum status of “Reduced Exposure.”

Every tobacco cigarette that a smoker lights up could be the one that tips the balance—the one that causes irreversible harm. Lives are at stake. Please do your work well, and do it quickly. Thank you.

 

[Bill Godshall]

Here's Scott Ballin's statement:

Brief Comments to the Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products

February 3, 2011

Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW
Washington DC 20015
202 686-8898
email: ScDBa@aol.com

I first want to thank the Committee and the Institute of Medicine staff for allowing me five minutes this afternoon. I am Scott D. Ballin. The views I am presenting today are my own and are based upon several decades of work and interest in tobacco control and tobacco, nicotine, and alternative product regulation.

In its Chapter on the "Implementation of a Science-based Policy of Harm Reduction" (Chapter 7,Clearing the Smoke), the IOM rightly noted that a balance would be needed in order to prevent two possible types of errors in dealing with reduced risk products: "(1) allowing reduced risk claims that turn out to be erroneous, and (2) deterring the development of modified risk products that would reduce exposure to known toxicants (and would eventually be shown to reduce disease risk) if they were marketed.". The Committee further acknowledged "that manufacturers", (broadly speaking), "might forego the necessary investment in product development because of doubts that the accuracy of their claims can be defended successfully to unduly skeptical regulators". Clearing the Smoke also was correct in my estimation to include as one of its principal recommendations that "Manufacturers (broadly speaking) have the necessary incentive to develop and market products that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of tobacco-related disease". I encourage all of the Committee members to take the time to review that chapter in the Clearing the Smoke report as well as looking at many of the other recommendations in the report. While that report is 10 years old, its relevance is as fresh and refreshing as if it was written last year.

I note all this because I think this Committee has both a challenge but more importantly an opportunity to find the balance that will be necessary for establishing the 'minimum standards for scientific studies' and for conducting the necessary post-marketing surveillance. As you conduct your important work you should be ever mindful of the consumer and users who will expect that the information they receive will be truthful, accurate, complete, and non-misleading. For years we in public health have 'talked' about giving consumers full and complete information and now, using sound science, we have the opportunity to do just that.

I also encourage the Committee and the IOM staff to use many of the already existing knowledge bases, experiences and expertise that exist at the FDA, other agencies and in the private sector, including soliciting the views and expertise of many others who may have nothing to do with the tobacco issue but may have significant contributions to make in the areas of scientific standard setting, labeling (including different types of claims and disclosures) and marketing. The food model and FDA's health claims and labeling guidance, may be of particular use (something also referenced in Clearing the Smoke). There, allowances for making claims and providing the consumer with truthful accurate information is based on several 'levels' of science. A heath claim (one that contains a disease- specific reference) requires a higher level of scientific agreement (significant scientific agreement -SSA), whereas one that relates to a function/ structure claim requires a different standard of scientific agreement. Labeling and marketing should be determined based upon the risks, relative risks and intended uses of the product whether it be a combustible product, a noncombustible product or a therapeutic. In other words each product should be given a science-based risk profile that will determine the types of informational disclosures and claims that could be allowed.

I also suggest that we consider redefining our terms about the spectrum of products in the market place. Calling any tobacco product that is a not burned a 'smokeless product' is no longer accurate or even useful. I prefer to use the term Smoking Replacement Product or SRP because that allows us to look at the growing spectrum of noncombustible products (tobacco, nicotine, and alternatives) in terms of risks and relative risks and intended use, and to label and set marketing standards for such products based on those risks.

While the scope of the Committee's charge is to be focused on 'modified risk tobacco products', to do its job, the Committee should also look at the growing spectrum of products in terms of the risks and relative risks of other products. The combusted cigarette should be considered as the reference point in terms of high risk while other nicotine products such as gum and patches should be considered low risk. As Section 911(h) of the Family Smoking Prevention and Control Act notes:

The Secretary shall require for the marketing of a product ....that any advertising or labeling concerning modified risk products enable the public to comprehend information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health- related conditions associated with the use of tobacco products.

In considering the conditions for marketing of modified risk products the Secretary (and indirectly the IOM Committee) is to take into account the effects on both the individuals and the population as a whole.-- two very important considerations. But, it is important to recognize that the statute uses the words 'take into account' which suggests a more flexible 'consideration of' rather than a more definitive requirement. It should also be pointed out that there is nothing in the statute that prevents the FDA (or the IOM Committee for that matter) from considering other important factors. One such factor for example might be the taking into account of:

"the likelihood that persons who smoke or use higher toxic tobacco products will continue to smoke or use such products in lieu being given lower risk alternatives"

I also encourage the committee not to forget or leave out the science of tobacco agriculture. Tobacco is an agricultural- based plant and how it is grown, treated, cured, processed, and eventually manufactured and used can have significant impacts on risks. There is a great deal of research being conducted on the plant and I think the Committee would benefit from including such research as part of your deliberations and consideration.

I have spent more than 30 years in the 'tobacco- war trenches". I think it is time we start shifting away from those 'wars of words and rhetoric' that dominated the 1980's and 90's and begin focusing on finding science- based solutions that will serve the interests of the American consumer and the public's health. That will be a challenge for some. Like it or not, engagement, dialogue, transparency and cooperation amongst a wide spectrum of stakeholders is what will be needed in the coming months and years.

I hope that the Committee, Dr. Stratton and staff her will conduct its work in a transparent, fair, thoughtful, and inclusive manner and produce a report and set of recommendations comparable to the kind of high-quality report that was produced in Clearing the Smoke.

While I am not scientist or researcher, I offer my assistance to the Committee and to the staff.

Thank you.

 

[Bill Godshall]

Public Comments to the IOM Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products were made by:

1. Scott D. Ballin - Health Policy Consultant
2. Christopher Proctor - British American Tobacco
3. Daniel McGoldrick - Campaign for Tobacco Free Kids
4. Michael Ogden - R.J. Reynolds Tobacco Company
5. Jim Solyst - Environ (Swedish Match)
6. Bill Godshall - Smokefree Pennsylvania
7. Elaine Keller - The Consumer Advocates for Smoke-Free Alternatives Association
8. Mohamadi Sarkar - Altria Client Services

 

[Bill Godshall]

Of the 8 people who made public comments at the IOM Cmte meeting, 7 advocated tobacco harm reduction products, while CTFK's Danny McGoldrick advocated unattainable scientific standards that would prevent the FDA from approving any modified risk application by any smokefree tobacco product to truthfully claim it is less hazardous than cigarettes.

 

[Bill Godshall]

One of the IOM Committee members, Stephen Hecht, has repeatedly and grossly exaggerated the health risks of smokeless tobacco to scare/prevent smokers from switching (while being paid by the NIH).

Smokeless Tobacco: Unsafe Alternative
Snuff Not Safe: Smokeless Tobacco Delivers More Of Some Dangerous Carcinogens Than Cigarettes
Medical News: Smokeless Tobacco Called Unsafe Cigarette Substitute - in Oncology/Hematology, Other Cancers from MedPage Today
Similar Exposure to a Tobacco-Specific Carcinogen in Smokeless Tobacco Users and Cigarette Smokers — Cancer Epidemiol Biomarkers Prev
New Report Challenges Idea That Snuff Is A 'Safer' Substitute For Cigarettes

And just several weeks ago, Hecht claimed that smoking one cigarette can cause genetic damage posing cancer risks within minutes.

'A stark warning:' Smoking causes genetic damage within minutes after inhaling
AFP: Smoking causes gene damage in minutes
Smoking Causes Cancer Linked DNA Damage Within Minutes
HealthDay Articles
Smoking causes genetic damage within minutes - The Times of India
Smoking Damages DNA Within Minutes, Research Shows
Smoking can cause genetic damage in minutes--study | TheMedGuru
Immediate Consequences of Cigarette Smoking: Rapid Formation of Polycyclic Aromatic Hydrocarbon Diol Epoxides - Chemical Research in Toxicology (ACS Publications)

Commenting on Hecht's most recent fear mongering claims, Paul Bergen wisely points out that exaggerating health risks of smoking one cigarette can discourage smokers from quitting
Research once again undermines reasons for quitting smoking « Tobacco Harm Reduction: News & Opinions

 

[pianoguy]

Outstanding stuff, Bill! That rebuttal by Paul Bergen certainly hit close to home with me. I had been smoking for 40 years, and had lost my parents and father-in-law to smoking-related illnesses. I figured I had sealed my own doom, so why bother quitting - previous attempts had left me miserable, anyway. I am so grateful to have discovered the e-cigarette, and to have left tobacco cigarettes behind.

 

[Placebo Effect]

Great post Bill. Glad to see that only CMTFK were there advocating against harm reduction.

 

[DC2]

Is the FDA likely to take up the recommendations made by this committee, or is this just a formality?

 

[Bill Godshall]

DC2 inquired

Is the FDA likely to take up the recommendations made by this committee, or is this just a formality?

Only time will reveal what the IOM Cmte recommends and what the FDA does with it, but our past/present/future actions have/will influence both the Cmte recommendations, and future FDA decisions.

 

[Thulium]

DC2 inquired


Only time will reveal what the IOM Cmte recommends and what the FDA does with it, but our past/present/future actions have/will influence both the Cmte recommendations, and future FDA decisions.

Bill,

I don't mean to pin you down to a prediction, but in your opinion: Was enough groundwork laid down that you believe could translate into truly reasonable policies on MRTPs (with an eye on harm reduction) or is it more likely that their path was determined prior to these hearings and they were looking for justification?

 

[Vocalek]

Dr. Deyton made it very clear that FDA gets to make the regulations, determine the levels of products, but the IOM was only being asked to specify what scientific tests that the FDA should require the tobacco companies to conduct as proof that they have met the (undefined) requirements of any (unidentified) level.

The members of the IOM committee were cautioned to only use the law itself as guidance and to make no attempt to define terms from the Tobacco Act such as "reasonably likely" or "measurable and substantial reduction." They were also told "Committee should not draw guidance from, or base its conclusions on past IOM reports."

Here is a metaphor for what I was hearing. Think of the IOM as a construction firm. The FDA is a prospect who comes to the firm for a quotation. The prospect says, "I won't tell you the location for the building, how large it should be, or what materials should be used. You must make sure that it is reasonably likely that we will accept the building you put up for us, and you should no draw guidances for the design from any building that you have constructed in the past. Now how much is it going to cost us?"

Dr. Deyton said that the Tobacco Act,

Authorizes the FDA to use a population health standard for the regulation of modified risk tobacco products. FDA must consider:

• The relative health risks to individuals posed by the product;
• The likelihood that current users who would otherwise stop will instead switch to the product;
• The likelihood that persons who do not use tobacco products will begin using the product; and
• The risks and benefits from the use of the product compared to the use of products for smoking cessation approved to treat nicotine dependence.

All I can say is that I hope the Committee is wise enough to point out that it is a pipe dream to believe that if you don't approve any modified risk products, all smokers will spontaneously decide to quit anyway.

That has not been the case for the last 20 years. Why should it change now?

Also, when they look at risks and benefits of a proposed modified risk product that they assign an adequate score to the very real risk that 95% of smokers will continue smoking if products approved to treat smoking cessation are the only alternative offered. In other words, the researchers need a way to compare effectiveness at allowing people to maintain smoking abstinence, as differentiated from nicotine abstinence, of a modified risk tobacco product and an approved nicotine dependence treatment product.

 

[CJsKee]

For gawd sakes!!! I just find it incredible that these people are spending so much time and so much of our money on such nonsense! Even so, thanks so much Elaine and Bill for representing our interests.

 

[rothenbj]

They have known for longer than twenty years that there were much safer alternatives to smoking and have not only chosen to ignore that fact, but also promoted that "xx is not a safe alternative to smoking". Unless there is a sincere effort to change that mindset, I can only see a lot of lip service followed by approval to long term use of existing/future BP products to try to extinguish BT/non-BP products. I sincerely hope I'm wrong.

 

[Bill Godshall]

Please remember that it's the other federal health agencies (CDC, US SG, SAMHSA, NIH, etc.), not the FDA, that have knowingly and intentionally misled smokers about the comparable health risks of smokefree alternatives for the past 25 years.

The FDA has only been regulating tobacco products for the past 18 months, and has only done what the FSPTCA requires the agency to do so far. Although the FSPTCA established excessively high and totally unwarranted hurdles for the FDA to approve modified risk tobacco product claims (but not as much to approve reduced exposure claims), truly objective health risk/benefit analysis by the IOM and FDA should allow the approval of MR and RE claims by smokefree tobacco products as compared to cigarettes.

My biggest concern is that the FDA will be more concerned about protecting Congress' and its own asses for requiring and implementing the smokeless tobacco warning "This product is not a safe alternative to cigarettes" that has been repeatedly cited and greatly expounded upon by federal, state and local health health agencies for 25 years to mislead most Americans to believe that smokeless tobacco products are just as hazardous as (or more hazardous than) cigarettes.

In order to for the FDA to do the right thing and approve modified risk tobacco product claims (by smokeless products that want to truthfully claim they are less hazardous than cigarettes), the FDA almost certainly will have to propose eliminating that warning, publicly acknowledge the warning is grossly misleading, and basically apologize for the federal government's 25 year policy of misleading tobacco consumers and the public.

Since government agencies rarely make a mea culpa, we need to aggressively pressure the FDA to eliminate that warning label on smokeless tobacco products, and shame Congress for enacting it.

To convince the IOM Cmte to do the right thing, we also should expose IOM Cmte member Stephen Hecht's decades of activism (disguised as scientific research) to knowingly and intentionally deceive the public (and the public health community) about the comparable health risks of smokeless tobacco versus cigarettes.

 

[Vicks Vap-oh-Yeah]

Unfortunately, when one pressures the FDA, the FDA tends to dig in its heels and spout the company line. They've got too much face to lose on acknowledging their mistakes - the entire pharma and food industry are regulated by them - industries that are worth trillions of dollars to this economy.

The FDA bases its decisions and actions on a simple tennant: Protecting the Public Health. There's a lot of faith in Americans that the FDA will uphold that tennant. Tear that faith out from under the agency, and it'll topple...creating a LOT of anarchy in the food and pharma industries....and send shockwaves through our economy at the same time. THAT'S why they are steadfast to refuse to admit a mistake of such magnitude.

Unfortunately, they are in a damned if they do, and damned if they don't situation with that warning. If they admit they screwed up, they lose a lot of the faith, perhaps enough to topple the agency. If they continue to stick to their guns, smokers DIE....and run the risk of the truth willing out eventually, leading back to the loss of faith et. all.

A Mexican Standoff of titanic proportions - the FDA is well and truly too large to fail, but too large to continue, as well...

 

[Rosco]

That's some great responses. Thanks Bill and Elaine.

 

[Bill Godshall]

To send your comments to this IOM Committee, go to the following weblink and click on Provide FEEDBACK
Project: Scientific Standards for Studies on Reduced Risk Tobacco Products

I suggest making comments similar to those made by Elaine, Scott and me.

Sending them scientific studies on the health risks of smokeless tobacco products is also recommended. Since the FDA still considers e-cigarettes to be "drug devices" instead of "tobacco products", any research or other comments on e-cigarettes should mention that the IOM Cmte may want to include them in the scope of this project since federal court rulings make is very likely the FDA will promulgate regulating them as tobacco products in the near future.

And please remember that we need to win over this IOM Committee, not piss them off.

 

[Vocalek]

To send your comments to this IOM Committee, go to the following weblink and click on Provide FEEDBACK
Project: Scientific Standards for Studies on Reduced Risk Tobacco Products

I suggest making comments similar to those made by Elaine, Scott and me.

And please remember that we need to win over this IOM Committee, not piss them off.

I echo that. While I was speaking, I saw interest and concern on the faces of many of the committee members. This was a stark contrast to the expression on Dr. Deyton's face. He clearly did not like what I was saying.

Remember that the committee members are not FDA employees and many may be actually open to the concept of tobacco harm reduction.

 

[Placebo Effect]

I sent in a comment endorsing your comments, as well as Bill's. I also noted that the Committee should consider recommending that the American tobacco companies increase the nicotine in their snus products.