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Vital Signs and Remedies for a Full Spectrum World
by Roxanne Nelson

25 August 2005

No News is Good News

It is amazing that no paper, other than the Seattle Times, happened to take the initiative and point out Scott Gottlieb’s ties to the biotech industry. I have spent a little time searching the web, and nothing at all comes up. There may be other newspapers who did write on it, of course, but what I can say is that there is a considerable dearth of good reporting. Even a Reuter’s story just mentions Gottlieb as a “former AEI scholar.” Was the media just too lazy to go beyond the press release from the FDA?

Scott Gottlieb, MD, a former FDA and Centers for Medicare and Medicaid Services senior official, is returning as FDA’s new Deputy Commissioner for Medical and Scientific Affairs. In this position, Dr. Gottlieb will coordinate medical and scientific affairs for the Office of the Commissioner serving as senior policy advisor to the Commissioner in these areas. Dr. Gottlieb is a practicing physician who most recently worked as a Resident Fellow at the American Enterprise Institute (AEI), a prominent Washington, DC-based think tank and also spent time as an American medical correspondent for the British Medical Journal.

That is from the official FDA press release of July 29, 2005, annoucing new appointments. It took the Seattle Times almost a month to report that this new appointee has a questionable background (for someone who is supposed to be regulating the industry) but at least they ran the story. In fact, it was on the front page, to their credit. So where is everyone else? And why did the FDA’s official release conveniently omit Scotty’s career in biotech investing? I mean, if there’s no conflict of interest, then why not mention it? Surely it’s nothing to be ashamed of.

— roxanne @ 8:02 am — Comments Off

No Conflict of Interest, Says the FDA With a Fat Lip

If you think the FDA hasn’t sunk to its lowest level yet, think again. With all of the heightened concern about conflict of interest, “experts” being paid to parrot corporate rhetoric rather than real science, and unsafe drugs slipping past the FDA’s pretense at regulation (while they stall and kick the dust around on emergency contraception), our hallowed FDA has hired Dr. Scott Gottlieb as a dputy commissioner.

Perhaps you aren’t gagging yet because you don’t know who Dr. Gottlieb is. Well, I’ll tell you. From the Seattle Times:

Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May–”Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38 percent. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, ‘Three Biotech Stocks To Buy Now.’”

In his new job, Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry. Isn’t that a cozy relationship? Is this the only person that the FDA could have found for the job?

Gottlieb says that he “cut” his ties and doesn’t think there’s a conflict of interest. Isn’t that sweet. What a guy. And here’s some of the new and great ideas that Scott brings to the FDA. comes to the FDA with an agenda. He wants to speed up drug approvals, which can be a good or bad thing, depending on what you mean by speeding it up. But in Scotty’s case, I think his concern is more for the investor and the drug company, rather than getting an essential drug safely and quickly to the consumer.

Here’s the clinicher though. Scotty also thinks that “the FDA sends out too many “shotgun warnings” on any particular drug’s emerging side effects, which he said may cause patients to overreact.” My, my, imagine that. Imagine how many people might still be alive if more attention had been paid to the early warnings about Vioxx.

When the FDA announced Gottlieb’s hiring last month, it noted that he had been a practicing physician, a correspondent for the British Medical Journal, and a scholar at the American Enterprise Institute (a conservative think tank)But if there’s no question about conflict of interest, then why did they conveniently not mention his career as editor of the two popular biotech investment newsletters or his work with Wall Street firms.

This whole thing reeks, as does Gottlieb now trying to portray himself as a squeaky clean physician without any industry ties. Just when you think that the FDA can’t sink any lower, and make even a bigger fool of itself.

— roxanne @ 7:09 am — Comments Off