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News Special

Relying on bad science

12 May 2011. Dr John Lauterbach, member of the Tobacco Products Scientific Advisory Committee, reviews the FDA's Centre for Tobacco Products performance to date and calls for action.

We have just heard from Dr. Lawrence Deyton, Director of FDA Centre for Tobacco Products tell you about the successes of the Centre for Tobacco Products (CTP) since its creation in 2009 in reducing the use of tobacco products particularly among those below the legal age to purchase and use tobacco products.

Now, no one wants the youth of our country using tobacco products so Dr. Deyton and his team at the Centre are to be commended for their efforts in reducing underage use of tobacco products. But what about use of tobacco products by adults?

Good intentions

Congress did not intend to forbid adult use of legally manufactured and marketed tobacco products. Indeed, Congress gave the FDA (Food and Drug Adminstration) the authority to make sure that tobacco products were made under good manufacturing practices using tobaccos and ingredients that were free from contamination, and that such products were not adulterated and/or misbranded.

Tobacco products, many of which were already being made under very high quality standards using the best ingredients would get better not worse. Substandard products such as those produced by unscrupulous manufacturers or imported illegally would be eliminated from the market.

Moreover, users of tobacco products would be given accurate information on which classes of tobacco products presented higher health risks to the user than did other classes of tobacco products.

Furthermore, there would be active support by the FDA for reduced risk tobacco products.

Finally, the CTP staff would include scientists and engineers who were as knowledgeable in the design and production of tobacco products as were their counterparts in industry, and there would be joint research on test methods for the characterisation of tobacco products and tobacco smoke.

Where are the outcomes?

So, why have the good outcomes that would lead to reduced tobacco-related disease not happened?

Apparently, Dr. Deyton and others at the CTP and the FDA do not want them to happen. It appears that they want to continue the scourge of tobacco-related disease in the hopes that the populace will demand the elimination of the tobacco industry and tobacco use.

Quite frankly, some with interests at the CTP and FDA seem to believe that when Congress approved the Family Smoking Prevention and Tobacco Control Act, the “TCA“ for short, it ratified the World Health Organisation's Framework Convention for Tobacco Control (FCTC) treaty.

Is the FCTC running the show?

Indeed, those running the CTP act as if the FCTC is now the law of the land in the USA. CTP staff and some of the voting members of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) have served on WHO committees related to the FCTC.

This is very important because the WHO does not want to reduce the health risks associated with tobacco use. The WHO wants to eliminate all tobacco use, even use of tobacco products whose health risks are indistinguishable from those of medicinal nicotine.

So if we have tobacco products whose health risks are indistinguishable from those of medicinal nicotine, why would we want to ban them?

Well, some would say that the tobacco companies cannot be trusted to make a product as consistently as medicinal nicotine is reportedly made.

There are also those who would tell you that the tobacco companies would submit one set of formulas to the FDA for approval and then do all sorts of things to make the products more addictive, more attractive to youth and other sensitive populations, and more difficult to quit using them.

There are even those who would tell you that the tobacco industry would manufacture such products under unsanitary conditions using contaminated tobaccos from certain third-world countries. The FDA already has rules in place to prevent such abuses; and I will deal with them later in this talk.

The role of TPSAC

What I want to focus on now is the TPSAC and the forces who want to take the word, “science“ out of the Tobacco Products Scientific Advisory Committee.

If we understand what has happened at the TPSAC meetings and the evidence the voting members of TPSAC used to condemn menthol, we will understand some of the thinking at the Centre for Tobacco Products.

The TPSAC is one of over forty scientific advisory committees that the FDA uses to help it deal with controversial scientific issues. The TPSAC has some unique features that differentiate it from other scientific advisory committees used by the FDA and other Federal agencies.

First, the TPSAC, its composition, mission, and initial objectives were specified in the TCA. Second, the TPSAC does not sunset. And, third, there are three (non-voting) industry representatives on the TPSAC, one representing the tobacco growers, one representing small business tobacco product manufacturing industry, and one representing tobacco manufacturing industry.

Most FDA advisory committees only have one industry representative. The advisory committee for FDA's Centre for Food Safety and Applied Nutrition has two industry representatives. So, the TPSAC is unique.

Industry representatives

The three industry representatives on TPSAC have been a troublesome team for the FDA. We have been very professional in asking all the questions the FDA did not want asked.

If you are not familiar with us, let me give you some details.

Mr. Arnold Hamm represents the tobacco growers. Before retiring, Mr. Hamm was CEO of the US Flue-Cured Stabilisation Cooperative. He has extensive knowledge of the growing, curing, and processing of tobacco. Arnold's biography on the TPSAC web site does not say anything about his knowledge of tobacco chemistry and tobacco science, but I quickly found out that he knows more about tobacco than many scientists in the big tobacco R&D labs.

Dr. Daniel Heck of the Lorillard Company has the traditional industry representative position on the TPSAC. Dr. Heck has a doctorate in biochemistry and he is a diplomate of the American Board of Toxicology. Dr. Heck is an expert on toxicology of menthol and the other ingredients that are added to cigarette tobacco used to manufacture cigarettes.

The small business tobacco product manufacturers rightfully argued that they should have a representative on the TPSAC. I was fortunate to be appointed to that position. My career is atypical of those in small business tobacco manufacture. My doctorate is in organic and carbohydrate chemistry, and I spent the first twenty-four years of my time in the tobacco industry at Brown & Williamson Tobacco Corporation after I had been in the food, food ingredient and adhesives industry in the ten years between the time I received my Ph. D. in 1970 and the beginning of my tenure at Brown & Williamson in 1980.

For the next sixteen years, I was involved with the testing of tobacco, smokeless tobacco products, cigarettes, and cigarettes smoke, including some time as Chairman of the Board of the Tobacco Institute Testing Laboratory and Chair of the US Technical Advisory Group to ISO Technical Committee 126 on Tobacco and Tobacco Products.

In 1996, I moved into the scientific and regulatory affairs side of the tobacco business. I had to learn toxicology, which is the basic science of poisons, and obtain board certification in toxicology and maintain that certification as a condition of employment. The combination of my education and experience in chemistry and my more recent training in toxicology was a perfect fit for service on the TPSAC to provide scientific and regulatory expertise.

Differentials in expertise

So, unlike the other scientific advisory committees that help the agency deal with difficult scientific issues, the real expertise on the TPSAC lies with the non-voting industry representatives, not with the voting members of the committee.

Indeed, the difference in expertise between the industry members and the voting members is so great; the FDA has to hide our expertise. Our expertise is listed as „Industry Representative.”

If the FDA listed our expertise, it would make the voting members of the committee look weak. They do not have real world knowledge of tobacco products. The FDA committees dealing with food and pharmaceuticals have academics that are experts in food science and pharmacology, respectively.

So why doesn't the TPSAC have academics who are experts in tobacco science, tobacco chemistry, and tobacco toxicology? This is an important question as it has some far-reaching implications.

First, the number of academics specialising in the tobacco-related sciences has dropped off precipitously as senior faculty members have retired and have not been replaced. As I understand the situation, hiring replacement faculty would require external funding and apparently, there has not been sufficient external funding to hire the faculty we should have.

Even the very useful Tobacco Literature Service at North Carolina State University had to be terminated because there was no financial support.

Second, if we had such faculty members available to serve on TPSAC, the FDA would not want them on TPSAC, as they would ask the wrong questions. Tobacco and tobacco smoke are difficult materials, and those doing serious research soon learn to assume nothing and insist on proof before deciding the validity of a scientific proposition.

Behind the menthol issue

Would the FDA have gotten a recommendation to ban menthol from the TPSAC if they had to provide real scientific proof? Of course not.

Third, the FDA would claim that because faculty may have gotten industry funding that they could not render an unbiased scientific decision.

On the other hand, the fact that some of the voting members on TPSAC reportedly have ties with the medicinal nicotine industry and other anti-tobacco industries is viewed as a good thing. So good, that the FDA did not even get conflict of interest waivers for those TPSAC members.

I do not know how those TPSAC members felt when the TPSAC designated federal official started every meeting with statements that claimed no conflict of interest waivers were needed. Why not stick to the truth and get the waivers admitting the conflicts of interest existed but that the expertise of such committee members was so important that those without conflicts could not take their place?

Indeed, the FDA was so scared of the truth that it had to ban Industry Representative from serving on the menthol report writing subcommittee.

The FDA on behalf of TPSAC solicited confidential information on menthol cigarettes, including sales and marketing information, from the industry for the subcommittee to use.

Since Dr. Heck has been the top scientist at Lorillard, it is easy to make the case that he should not have been in a position to receive information from Lorillard's competitors. But what about Mr. Hamm and myself? Were we working for companies that made or marketed menthol cigarettes? No!

Indeed, I told the FDA at the meeting of the TPSAC on 7 October, 2010, that I was more than willing to sign a nondisclosure agreement and had no conflicts that would prevent me from doing so. However, the FDA did not want me on the writing subcommittee. Why would the FDA want to turn down 24 years experience in R&D and regulatory affairs at the House of Menthol?

The FDA was apparently scared that I would bring the truth to the menthol report writing committee, and the committee would report science and not fiction. If one reads the TPSAC menthol report, one cannot help but see how the committee relied on bad science in the literature to draw its conclusions.

Pseudoscience abounds

Those who write anti-tobacco materials generally stay away from the mainstream journals that cover the sciences associated with product regulation even though scientists from other parts of the FDA publish in such journals. Why?

They know that the reviewers and editors of such journals have little tolerance for pseudoscience. So, those opposed to tobacco publish in journals such as Tobacco Control, Nicotine & Tobacco Research and other journals that welcome less than accurate science as long as it is anti-tobacco.
However, when such pseudoscience has made it to print, the industry, for the most part, has not challenged the bad science. We all knew that the reports on tobacco menthol levels coming from investigators at the Harvard School of Public Health were wrong, but no one made the effort to publish the truth.

One would have thought we would have learned our lesson from the pseudoscience of tobacco ammonia and free-base nicotine.

Fortunately, some of us who are not part of big tobacco, did the science, and got it published. I can assure you that you do not win friends when you write to a journal editor and show him that he let research into his journal that stated, if one took the experimental as it was written, the cigarettes were smoked well into the filter sections and that cigarettes were smoked under such variable conditions as to render the results useless.


Action is required

Big Tobacco needs to step in and do its share to correct the errors in the literature and respond promptly to new ones.

The problems will not go away if we ignore them. If any one doubts this, they only need to read the article by Goodpaster and co-workers on dissolvable tobacco that appeared in a recent issue of the Journal of Agriculture and Food Chemistry.

Unless someone acts, that article is going to be used against dissolvable tobacco when TPSAC considers those products later this year. On the other hand, the TPSAC may not get a chance to review dissolvable tobacco products.

FDA ignores dissolvable tobacco

The FDA apparently is running away from dissolvable tobacco. Why?

Some dissolvable tobacco products likely do not pose any more health risks than nicotine gum, nicotine lozenges, or similar products. Is this why the FDA declared some dissolvables as not being tobacco products?

If the FDA had not taken such action, would it have had to admit that some tobacco products present much less risk of use than other tobacco products do?

Before concluding, I want to go back to a point I mentioned briefly at the beginning of my commentary and that is the FDA's role in helping ensure the quality of tobacco products available to US consumers.

We have heard statements by those associated with the FDA that they do not know what is in our products. We have seen articles by the anti-tobacco forces that allege that the industry is constantly changing its products to make them more addictive, more attractive to sensitive populations, and more difficult to stop using. We have even heard it stated that legally manufactured products might be made with contaminated tobaccos.

However, if such products are out there, the FDA apparently has not taken action even though the Tobacco Control Act authorises the FDA to remove adulterated and contaminated products from the marketplace.

There are anecdotal reports on at least one tobacco blog that consumers have called the FDA about allegedly defective product and that the FDA has failed to investigate such reports.

Substantial equivalence

At the CORESTA Congress last September, Dr David Ashley, Director of the Office of Science at the Centre for Tobacco Products, told the audience that senior corporate executives should know what is in their products. You may have heard about the FDA's Substantial Equivalence rules.

Most tobacco products undergo various changes, as products need to be modified to keep the same hedonic characteristics even though there are year-to-year variations in the tobaccos and changes in the supply of ingredients, many of them natural products, added to tobacco, and the non-tobacco materials such as cigarette paper and adhesives used to fabricate a cigarette. Tobacco manufacturers and their suppliers have worked very diligently over the years to make sure that such differences are not noticeable to consumers.

Paper for paper's sake

Apparently, the FDA did not believe that on 5 January of this year when it wrote its guidance document for determining if a product made before 22 March was substantially equivalent to a product that was on the US market on 15 February 2007.

The FDA said it wanted a full listing of all ingredients in a product before and after the change even if the change were as small as a processing aid used in the plug wrap paper around the cigarette filter.

Note that the FDA did not just want information on the ingredient that changed, it wanted information of all parts of the product even if there were no other changes, and it wanted the reports signed by the CEOs.

As a result, the FDA has received thousands of pages listing on a brand-style-by-brand-style basis detailed data on the ingredients and components of cigarettes, roll-your-own tobaccos and accessories, and most snuff products down to the minutest detail.

As you know, there are hundreds of brand-styles of cigarettes, some of them differing only by the colour of one of the lines on the tipping paper. Each one had to have its own report if it had any changes since 15 February 2007.

One can only wonder how the FDA intends to process all that data and extract any relevant information. If the FDA scientists had read the scientific literature on tobacco and tobacco smoke, they would have found that most US-style cigarettes are substantially equivalent to each other.

However, as we found out at the TPSAC meetings, the FDA does not appear to trust any scientific literature, even that appearing in the most prestigious peer-reviewed journals, with any scientists associated with the industry as one of the authors.

The FDA could have found similar information in our governments own publications including the Institute of Medicine's 2001 publication, „Clearing the Smoke,“ or the most recent report of the Surgeon General on tobacco smoke. They could have even asked us to help them understand which product changes are important and which ones are not.

Will FDA stick to science?

While a healthy scepticism between the regulators and the regulated industries is often desirable, downright distrust is not desirable, and should not be considered acceptable.

While we can hope that the FDA will learn from its mistakes and start using good science for tobacco product regulation, we have no guarantees that will happen.

We know that our legislators do not look favourably on regulatory agencies that do not use good science as the basis for their regulations. We are fast approaching the point when we will need to solicit their help in getting the FDA's tobacco regulatory function back on the path that Congress intended. If we do not do it now, we may not have another opportunity.

Dr John Lauterbach