February 28, 2013
I was as surprised as everyone else when the FDA announced that Lawrence Deyton announced that he was leaving as head of the Center for Tobacco Products and that Mitch Zeller was becoming the new head.
Having some time to digest the change, I think that Mitch is a perfect person for the job. Mitch has extensive experience at the FDA, including as David Kessler’s point person on tobacco, and, as a lawyer, will be well-positioned to go head-to-head with the FDA’s notoriously difficult lawyers. He also has gone toe-to-toe with the tobacco companies and knows that they are fundamentally different from the pharmaceutical and medical device companies that the FDA is used to dealing with.
There is no question that Mitch could do a great job. The question is whether the Administration will let him do a great job. (There have been many media reports of the White House sitting on the FDA over issues such a food safety and women’s health.)
February 28, 2013
Gavin Newsom, California’s lieutenant governor, has filed an initiative to increase the tobacco tax by $1 with the money devoted to student financial aid for higher education. This initiative spans two areas in which I have been active for decades: tobacco control and higher education funding.
February 25, 2013
C Everett Koop, the Surgeon General in the 1980s who first called for a smoke free society by the year 2000, died yesterday at age 96. While we didn't reach his goal by 2000, we are well on our way.
Dr. Koop was a visionary and courageous leader whose defining personal quality was towering personal integrity who was willing to act on the scientific evidence.
Even when we disagreed (as on abortion), there was always mutual respect.
I was honored to visit Dartmouth last December to give a lecture in his honor and was able to visit him at home, where he was being cared for by his wife, Cora Hogue Koop. The love was palpable.
We should all be inspired to work harder and do better.
February 24, 2013
The American Law Institute, which produces influential reports on the law, recently published a lame response to our paper in the Iowa Law Review demonstrating how the tobacco companies quietly worked behind the scenes to get the ALI to recommend laws and judicial interpretations that shielded the tobacco companies from liability for the death and destruction they caused for decades.
Rather than dealing with the massive evidentiary record that we presented, the ALI dismissed the problems of conflict of interests by asserting that we just did'nt understand how the law works.
Needless to say, we responded, pointing out that the ALI ignored the substance of our paper.
Hopefully some ALI members will demand that the organization actively engage the serious problems that we identified. (One already has.)
In the meantime, no one should take ALI's recommendations seriously as independent objective advice.
February 14, 2013
Judge Gladys Kessler’s ruling that the major cigarette companies formed an illegal “enterprise” to defraud the public and that those efforts to defraud the public are continuing and likely to continue in the future, provides an amazingly well-documented (and, surprisingly, readable) history of the tobacco industry activities over more than a half century, including, in particular, how the tobacco companies sought to manipulate scientific discourse and the policy making process. These issues are of central importance to the FDA in deciding how to interact with the tobacco industry.
Yet, in the many discussions with people at the FDA I have been astonished that, while they are generally aware of the decision, no one seems to have actually read it or the DC Court of Appeals decision upholding Judge Kessler’s Findings of Fact.
While some of the decision deals with legal technicalities (such as why the Racketeer Influenced Corrupt Organization Act applies) and the nature of the remedy, much of the 1683 page decision represents carefully documented factual conclusions with citations to specific supporting evidence.