Squeezed between meetings …

November 21, 2008 – 5:41 pm

It’s been a busy week for me in and out of the office (I’ve had two days of this week full of meetings and today will be a meetings marathon). This week was also a busy one in terms of news. President-elect Barack Obama is tapping Sen. Tom Daschle as Health and Human Services Secretary for his administration; Henry Waxman triumphed over John Dingell to become chairman of the House Energy and Commerce Committee; and AstraZeneca is cutting 1,400 jobs and selling its over-the-counter medicine producer to GlaxoSmithKline. There’s a lot of other stuff, too, in the blogs, but due to time constraints, I am going to do a shorter post now and update this weekend. Check back on Monday morning for more … also, check out my post about the pharmaceutical industry and social media from Thursday.

Daschle appointment stirs debate

At GoozNews, Merrill Goozner says, “In choosing former Senator Tom Daschle to head the Health and Human Services department, President-elect Barack Obama sent a clear signal that he is serious about pursuing health care reform legislation in the new year.”

Mr. Goozner has some enthusiasm for the appointment. “Daschle knows Capitol Hill and knows health care,” Mr. Goozner says. “He just wrote a book on the subject that called for federalization of the system under what amounts to a Federal Reserve Board for health. Clearly, he’s not afraid of bold reforms. But, just as importantly, he has the knowledge that will allow him to make his mark in the short run by instituting bold administrative changes at the agencies under his new command, especially the Center for Medicare and Medicaid Services. Changes in the government’s two big health care programs, which account for half of all health care spending, can pave the way for changes throughout the system.”

At DrugWonks, Peter Pitts also praised the choice of Mr. Daschle, particularly in considering who he might appoint as FDA Commissioner. “Tom Daschle is a terrific choice for HHS for many reasons,” Mr. Pitts says. “Most importantly, he’s a grown-up. Daschle’s sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.”

So who could be nominated for FDA Commissioner? Ex-Pfizer whistleblower Dr. Peter Rost is saying it should be him (he’s even changed the name of his blog to “Peter Rost for FDA Commissioner”). Apparently this all started with the survey John Mack is running at the Pharma Marketing Blog, where folks have voted Dr. Rost into the lead. Stay tuned …

Rich Meyer, at World of DTC Marketing, believes the pharma and medical device industries may need someone like Dr. Rost as FDA Commissioner. “Peter Rost is right!” Mr. Meyers says. “This industry consistently shoots itself in the foot and then backs off and shoots itself in the other foot ultimately leaving it crippled. The logic of trying locked doors in hopes of finding an open one to market products is beyond me and obviously something needs to be done to ensure that they get the message LOUD and CLEAR.”

Around and about …

If you recall the flap about the nondisclosure of industry ties by participants in the NPR Sirius Satellite Radio channel program “The Infinite Mind” last May (the one that focused on the link between antidepressants and suicide, in which the experts declared the worries were exaggerated) there’s even more to the story. Ed Silverman at Pharmalot broke the news that the host of the program, Fred Goodwin, has his own ties to the industry. (Mr. Silverman also provides all of the back story about the May program in the post. And just to clarify, NPR does not produce “The Infinite Mind,” just carries the program on its channel.)

“According to Glaxo documents given to Grassley’s sleuths, since 2000, Glaxo paid Goodwin more than $1.2 million in speaking fees and over $100,000 in expenses,” Mr. Silverman says, and links to the New York Times story on the subject. (Here is what Sarah Rubenstein at the Wall Street Journal Health Blog has to say on the subject.)

Philip Dawdy at Furious Seasons also was interested in Mr. Goodwin’s conflicts of interest. “I’m completely blown away that such immense conflicts of interest made their way onto a public radio show and for so many years,” he says.

And speaking of conflicts of interest, Jack Friday at PharmaGossip picked up the story from the Harvard Crimson about medical students holding a protest and calling for stronger conflict-of-interest policies from the university. Ed Silverman at Pharmalot and Sarah Rubenstein at the Wall Street Journal Health Blog also picked up the story.

Bob Ehrlich at DTC-in-Perspective wants FDA to look at if the reporting of risk effects in DTC that is required by fair balance is scaring consumers. “It would be interesting to see consumers place the odds of occurrence after seeing ads,” he said. “I bet they vastly overstate the odds of serious side effects happening to them. Clearly the media is guilty of hyping negative outcomes with their ‘death in your medicine cabinet’ type stories. I do not want to under play sides effects but I also want a system that portrays them accurately.”

Jim Beck and Mark Herrmann at the Drug and Device Law Blog summarize the article in Forbes by Professor Richard Epstein of the University of Chicago Law School on Wyeth vs. Levine. “Professor Epstein favors preemption, but he thinks that Wyeth’s position does not go far enough: Wyeth seeks preemption only because of a conflict between the warnings that the FDA required and the warnings that Levine insisted were necessary,” these bloggers say. “Epstein prefers ‘field preemption,’ in which FDA regulation would displace state law whether or not the FDA-mandated warnings conflict with those sought by a plaintiff, because the FDA alone should control drug labeling.”

Dr. Derek Lowe at In the Pipeline looks at last week’s ruling about brand companies being liable for generic copies of their drugs. “How Wyeth can be held liable for the use of a product that it did not manufacture, did not label, and did not sell is a mystery to me,” he says. He points out what Mr. Beck and Mr. Herrman have to say on the topic.

Dr. Daniel Carlat at the Carlat Psychiatry Blog is not happy that the AMA’s Council of Ethical and Judicial Affairs is reversing its previous position and recommend that industry support of CME continue. “This does not make me proud of my profession,” he says.

Some humor: PharmaGossip’s Jack Friday revives Pharma Giles (Giles, where are you, we all miss you!) in a conversation about the Jupiter study. I wish I had caught this last week!