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Observations on the important role of science in the development of tobacco, nicotine and other alternative harm reduction products in a "New Era" of product regulation
April 2011
Contact: Scott Ballin
email: ScDBa@aol.com
Tel: 202 686-8898
-Introduction
-Sec. 911 (FSPTC Act) -- Modified Risk tobacco Products
-The Role of Science - Who will do it? Who should do it? and under what kinds of circumstances?
-Observations and Conclusions
Introduction
For several years, I have suggested that in a regulated environment, such as that of the Food and Drug Administration (FDA), it should be science and not rhetoric and emotion that guided regulatory policy. I called FDAs acquisition of regulatory authorities and oversight over tobacco a New Era to be governed by science and the active engagement of a growing spectrum of stakeholders and experts. I recognize that accepting this 'new era' in the area of product regulation will be very difficult for many who still have strong and passionate emotions about the tobacco industry.
Many sections of the Family Smoking Prevention and Tobacco Control Act (referred to from hereon out as the FDA tobacco statute) will rely on science in determining how products are to be regulated. Implementing the requirements in many of these sections is going to take time. There are many provisions in the statute that, because of advances in science, technology, new product development, and shifts in the market place, already warrant being revised and amended because they are either outdated, unworkable, confusing, or may even have adverse consequences on the public health.
There is also no question that there has been an ongoing convergence and competition between manufacturers of tobacco products, the pharmaceutical industry and other corporate manufacturers that further enhances the need for the restructuring of the already outdated current law. All tobacco, nicotine, and alternative products should be brought under the same regulatory umbrella in what should be renamed as the FDAs,Center for Tobacco, Nicotine and Alternative Products. The differences between products have become increasingly blurred. All of these products, as I and many others have suggested, should be regulated based on risks, relative risks and intended uses, not necessarily on who is manufacturing them. Science based Risk profiles should be established for all of these products, not only in terms of a general category but the specific product in question. This would--
- better serve our public health interests;
- infuse competition into the market place ( a good thing in a regulated environment);
- serve the interests of the consumer;
- give manufacturers a better regulatory 'road map';
- weed out and push irresponsible manufacturers off the playing field; and
- provide the needed consistency and yet flexibility for dealing with new and currently unknown challenges and opportunities in the future.
Given the requirements of the FDA tobacco statute and its reliance on science for setting regulatory policy, I have also suggested that the tobacco wars as we have known them (at least in the United States, and Europe to begin with) must be scaled back and toned down while we increasingly shift to using science and civil dialogue as a means for dealing with these existing and new challenges and opportunities. This includes modifying our definitions of the growing spectrum of products and refocusing on public health (rather than merely on the evil 'tobacco industry'). We must recognize and accept that not all tobacco products (or other nicotine products for that matter) carry equal risk and that it is not the tobacco that causes the greatest amount of harm but rather how that product is grown, cured, treated, manufactured and most importantly used that will determine the level of risk. In some ways all nicotine products including gums, patches, lozenges, e-cigarettes, sprays and other products should be considered modified tobacco products as the nicotine contained in these products is derived from tobacco. For all of these products and other noncombustible more traditional forms of tobacco, I also prefer to use the term Smoking Replacement Product (SRP).-- moving away from such terms as 'smokeless' which no longer serve to define the growing spectrum of noncombustible products on the market.
There are several indications of how important the area of tobacco, nicotine and alternative harm reduction is becoming. Legal and public relations battles are being waged over e-cigarettes and other products. Pharmaceutical companies have asked FDA to keep tobacco dissolvables off the market because they see them as competition. FDA seems somewhat perplexed as to how products should and should not be classified, as in the case of Star Scientific's Ariva and Stonewall BDL products. Last fall the FDA's Center for Drug Evaluation and Research (CDER) and not the Center for Tobacco Products, held a workshop on the long term use of NRT. During the discussion the issue of tobacco kept coming up, even though CDER has no authority over tobacco. In February of this year, the Institute of Medicine's Committee on Scientific Standards for Studies on Reduced Risk Products, held its first meeting. That committee has been established at the request of the FDA's Center for Tobacco Products to:
'advise it on the minimum standards for scientific studies to allow the marketing of reduced risk products and for post-market studies for approved products.'
Section 911 of the Family Smoking Prevention and Tobacco Control Act itself, which spells out how modified risk tobacco products can brought into the market place, is another indication of how in this science driven "New Era', the issue of reduced risk or modified tobacco products (and in my view nicotine and other alternatives) is becoming increasingly important. The growing confusion that we are now experiencing will not abate unless and until changes are made in how all of these products are to be defined and how they are to be more consistently regulated (Look for a more detailed Observation piece on this in a few weeks).
There are many in tobacco control who will continue to look at the tobacco issue as if we were still in the 1980 s and 1990s, where the primary focus became attacking Big Tobacco at every turn for its decades of deceptions and lies perpetuated on the public. Because of those years of deceptions, including deceptions by the so-called 'scientific arms' within the tobacco industry, many in tobacco control still cling to the idea that industry science cannot and should not be trusted or relied on. I respect their decisions to continue to make that their focus and am proud that I was an active part of that approach especially in the late 1980's and early 1990's. But that was then and now is now and like it or not it is a very different environment (a regulatory environment covering a much large spectrum of products and manufacturers) we are working in. This is no longer about just Big Tobacco, this is about how new science- based reduced risk products (tobacco, nicotine, and alternative products) should be brought to the market place --- and what kind of science will be necessary for determining how such products should be labeled and marketed, including the types of claims and truthful information that should acceptable and/or required. Yes, we need to monitor, challenge, and confront the tobacco industry and we need to be increasingly vigilant with respect to other manufactures of all tobacco and nicotine products. But with a regulatory body in place to review the science, the 'playing field' has been radically altered. There is a great deal of good that can out of this if it is done correctly. Bogus research from the industry just isn't going to make the grade in a regulated environment. Those days are over.
At the same time, in a science based regulated environment we should also be providing incentives ( as suggested by the IOM in its 2001 report, Clearing the Smoke) to those developing these new lower risk products, and encouraging good scientific research- not suppressing it.
Sec. 911 (FSPTC) -- Modified Risk Tobacco Products
Section 911(a) of the FDA statute does not open up by saying say Big Tobacco or even to tobacco manufacturers but states it's coverage over the review and approval of modified risk products more broadly by saying that:
No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to ......"
I find this important because in spite of the shortcomings of the FDA tobacco statute, it does in part acknowledge that the development and marketing of such products could come from a much broader spectrum of interests that includes, not just the traditional tobacco companies but the pharmaceutical industry, manufacturers of products such as e-cigarettes, food companies, dietary supplement companies or other entities. This section also makes it very clear that it is the ''person" introducing such products into the market place who will be responsible for providing the necessary science to back up their products and to also provide the data and information required for post marketing surveillance. This obviously includes a spectrum of possible interests, including (like it or not) the more traditional tobacco companies.
All of this also calls into question the outdated language used in defining what we have commonly and generally called the 'tobacco industry' , something always having negative connotations. Am I to assume that if a pharmaceutical company, a food company, an entrepreneur, a biotech company, a dietary supplement company or an individual develops a product that contains tobacco in it, that they believe and can scientifically established that it significantly reduces the serious risks associated with smoking, that they become a part of the tobacco 'evil empire' and will be branded ,tar and feathered as we have consistently done to Big Tobacco in the past? In today's regulated environment of competing and overlapping interests such a question seems to no longer be of much relevance.
The Role of Science- Who will do it, who should do it, and under what kinds of circumstances ?
The science now needed to deal with the growing complexity of the tobacco, nicotine and alternative products market place will have to come from a variety of directions and interests.
Some of the research will come in the form of traditional government grants from agencies like the National Cancer Institute and in the near future I expect the Food and Drug Administration. And while some of these funds are 'assured' because they will be provided by way of the 'user fees' paid by the tobacco industry to the FDA, other grant money will most likely remain at current levels or be substantially cut due to growing deficits and a poor economy.
While many in public health still want to ignore or ridicule industry science, I for one now find that, given the mandates and requirements of the FDA tobacco statute, this is the time where we want to know more, not less, about what research is going on not just in the more traditional tobacco industry but in the pharmaceutical industry as well. And this is the time where I would want to see more money invested in private sector independent research on reduced risk products including using unrestricted grants from the tobacco industry, the pharmaceutical industry and many others. At the same time it is important that funding must be provided in a way that those corporate interests do not use the research or the relationship with an academic institution or researcher for political and public relations gains.
A number of meetings have been held by the public health/research community to discuss whether private sector academic researchers should accept tobacco industry money. I wish to pose a broader question for consideration and ask, "What are the conditions and parameters under which funding can be provided by not only by the tobacco companies but the pharmaceutical companies and other corporate interests as well?" With FDA oversight and with companies now being required to substantiate their 'modified risk products' , the scenario under which these issues have been debated and discussed has changed.
Who are we referring to when we talk about the 'tobacco industry' today? There are large companies, small companies making many very different products, some which are much more hazardous than others. Many traditional manufacturers of tobacco are expanding their product portfolio's buying or creating new companies ( some that manufacture and sell nicotine products) in the process. Pharmaceutical companies see these actions as 'competitive' and must undoubtedly be considering producing some modified risk tobacco-based products in addition to their more tradition NRT type products. And there are the e-cigarette manufacturers (a very diverse group) who are producing both nicotine and tobacco based products.
Why is it that for so long, pharmaceutical money has been allowed to permeate many NGO's and research institutions interested in tobacco control--- funding which is often used to fund not only research but tobacco control conferences and meetings as well? What make this justifiable while funding from a company that manufactures tobacco- based products is not? Conflict of interest concerns and undue influences exist across many areas, not just in the tobacco and nicotine environment, and we should be seeking to develop models that will work effectively regardless of the source of funding. One can obviously make a distinction between the traditional tobacco companies and others but in today's environment, the required integrity of the research being done (particularly research needed to support a modified risk product application to a regulatory agency like the FDA) may in fact be very comparable and should be our primary concern. All corporate funding should follow the same rules and parameters in the future.
Observations and Conclusions:
1.That, there should be a 'shared consensus' that additional scientific research needs to be conducted in the area of tobacco, nicotine, and alternative products harm reduction.
2. That FDA oversight, including such sections of the statute governing modified risk products (Sec. 911), have altered the way in which any company or individual (tobacco, pharmaceutical, biotech, food etc.) will be allowed to develop, label and market products that are viewed as being reduced risk.
3. That, tobacco, nicotine, and alternative products harm reduction research should be funded and conducted by a spectrum of interests in both the private and public sectors, including by the manufacturers of such products who will be required by both the statute and regulations to submit scientific data and information to the FDA in order to gain approval by the agency.
4. That all manufacturers of modified risk products should be encouraged and allowed to provide funding to private sector academic institutions but only under the strictest of requirements and parameters which ensure the greatest integrity for the researcher and the institution (some models have already been suggested and are in place).
5. That given changes in science, technology and the market place, serious consideration must be given to reforming the current FDA tobacco statute as well as FDA's nicotine policies that will allow the FDA to implement a more uniform, rational, workable and integrated regulatory system that establishes regulations based on risks, relative risk and intended uses of tobacco, nicotine, and alternative products. This should include serious consideration of bringing all of these products under a single umbrella within a Center for Tobacco, Nicotine and Alternative Products.
6. Science should be used to determine the types of claims and information that would be allowed on tobacco, nicotine and alternative products and their advertising. Something comparable to the model used for food labeling claims and information could be established.
7. All corporate interests, NGO's, academic institutions, researchers should strive to be transparent in their activities and relationships and strive to accept and enforce the necessary conflict of interest policies that will allow research to move forward but which is not compromised. This should include making research available to both those in the private and public sectors.
8. That civil engagement and dialogue must be incorporated into both the public and private sectors so that important issues (many of them related to science) can be transparently discussed in a civil manner.
9. A formula for the possible implementation of a successful and workable tobacco, nicotine, and alternative harm reduction initiative might be as follows:
Rational and Consistent Regulation + Science + Competition + Incentives + Civil Engagement + Transparency = An effective, workable, and flexible tobacco, nicotine, and alternative products harm reduction strategy.
