Full credit to Farrell Delman, president of the TMA, for lining up an illustrious and well-balanced list of speakers representing all stakeholders involved in the issue of tobacco regulation.
Next to industry representatives, this included prominent figures from numerous health organisations, such as Dr Joel Nitzkin of the Association of Public Health Physicians, Dr Michael Siegel of Boston University School of Public Health and Dr Patrick Basham of the Democracy Institute, to name just a few, and, of course, Dr Lawrence Deyton, the newly appointed head of the FDA’s Center for Tobacco Products (CTP), who was a keynote speaker.
In his speech to the over 200 attending delegates, he came across as a man who means business, expects co-operation from the tobacco industry and will use all the powers at his command to counteract any confron‧tation tactics. This said, he is also willing to engage with the industry, listen to what they have to say, and, above all, will base decisions on evidence-based science.
This is certainly more than can be said of his Framework Convention on Tobacco Control (FCTC) counterparts who refuse point blank to have anything to do with the tobacco industry or any other stakeholders who do not subserviently tow their line. Not surprisingly, the FCTC came in for some harsh criticism, both from the podium and the delegates. As one attendee put it: “The recent INB-4 was the non-event of the year, too much politics and not enough expertise.”
Scepticism remains
It is still far too early to really be able to judge whether the CTP will stand by its guns and base decisions purely on evidence-based science, as the recent decision shows, which requires smokeless tobacco products to carry the same warning labels as cigarettes, although they are considerably safer. The dilemma, of course, was that the law required a decision by June 2010, whereas the definitive hearings on the subject are not due until November 2010. And as Dr Deyton put it clearly: “I am here to implement the law.”
The next smokeless issue coming up will be e-cigarettes, where FDA policy, even well before Dr Deyton’s appointment, tended to be rather negative. The fact is that e-cigarettes are in principle far superior to the conventional nicotine replacement therapies (NRTs) marketed by the pharmaceutical companies as an aid to quitting, as shown in recent head-on trials. The problem is that they are not marketed as medical devices (which would put them under FDA jurisdiction) and the quality control of the nicotine capsules is not without question marks.
Had the pharmaceutical industry invented the e-cigarette they would be heralded as the greatest thing since sliced bread, but marketing would have been considerably more professional. Appropriate trials would have been done in advance and quality control would be above suspicion – and prices would likely be higher too.
And here comes the CTP’s next dilemma. If the e-cigarette manufacturers can get a grip on their quality control problems, the CTP would have a difficult time banning them.
And as the FDA acts as a worldwide benchmark, a lot of countries would follow suit in case of approval. In fact, the WHO would even have to put e-cigarettes on their list of essential drugs, after they quietly sneaked NRTs (gums and patches) on to the list in May 2009, which would likely cause a heart attack or two in Geneva. E-cigarettes are an anathema to anti-smoking organisations as they do not pose the health risks associated with smoking tobacco and are the only product which seriously threatens to undermine their ideology, so the political pressure behind the scenes is immense.
Criticism of the panel
Which neatly leads on to another topic heavily discussed offstage at the TMA meeting, the composition of TPSAC, the FDA’s Tobacco Products Scientific Advisory Committee. Of the nine voting members, four are associated with Big Pharma, two of them so heavily that they have become the subject of public controversy. So, quite obviously, Big Pharma has got its fingers in the pie somehow, but this need not necessarily be viewed as negatively as some tobacco representatives fear.
If these panel members are really “indirect” representatives of Big Pharma then they know perfectly well which scientific standards the pharmaceutical industry applies. And if they applied the code of conduct and scientific standard that are the norm in companies like Pfizer and GlaxoSmithKline, for example, when quoting scientific references in their detail aids to physicians, then all the politically motivated pseudo-studies masquerading as science would be thrown overboard. And that would be good news for once. So, let us wait and see how scientifically correct this panel really is before judging.
As evidence-based science is to be the deciding standard (see interview), then Dr Deyton and his team are not to be envied. Some decisions will no doubt upset the tobacco industry and others will, by scientific necessity, have anti-smoking organisations fuming. That is the worthwhile price one has to pay for scientific integrity versus being a political puppet.
Illicit trade exploding
Another topic at the TMA meeting was the subject of growing illicit trade. Now that professional criminal and terrorist organisations have become firmly entrenched in the illicit trade, they are intent on expanding their “market shares” by whatever means. And every substantial tax hike is a hidden bonus for their business, contrary to what the WHO has been thinking for the past 35 years. As the panelists agreed, any tax hike without an appropriate increase in law enforcement just makes the situation worse.
What the meeting showed: there are a lot of uncertainties ahead with no easy answers, but where there is a will to co-operate, there is way, and this applies to all parties concerned.
William McEwen | 
