This danger is why there has been so much concern over the pushing of EPO for the “normal” fatigue from chemotherapy. And as in so many cases, the evidence, which was first reported in The Lancet, was generally ignored by the medical establishment in the US, for reasons that we can speculate about.

DTCA for EPO was intense and constant, appearing on TV, the Internet, and in both general interest magazines and special cancer publications like CURE ,Coping MAMM, Women with Cancer, etc. The manufacturers have been major sponsors of all manner of patient support meetings and conferences.

Some of the very first warnings of EPO directed to consumers appeared on the website CLL Topics, written by Chaya Venkat, a retired scientist who is a caregiver for a CLL patient ( her husband). Independent websites like this one are very, very rare. There are some update links with the article . See:

The Dark Side of Epoetin
November 22, 2003

http://clltopics.org/Complications/EpoDarkSide.htm

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GAO Criticizes FDA Regulatory Letters on Violative DTC Ads

The FDA continues to be slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer (DTC) advertising rules, according to a report by the Government Accountability Office (GAO).

Last year, the agency took an average of six months to issue regulatory letters citing violative DTC materials, Marcia Crosse, head of the GAO’s healthcare division, told a House Oversight and Investigations Subcommittee last week. In one case, the agency took more than three years to issue a regulatory letter, she said.

Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review — a policy for which there was no apparent need — it took less than a month to send such letters, Crosse said.

The FDA has not improved since a 2006 GAO report found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter,” according to the GAO report accompanying Crosse’s testimony. “In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”

Moreover, only two regulatory letters on DTC advertising went out in 2007 — one warning letter and one untitled letter — compared with 15–25 regulatory letters each year between 1997–2001, before the legal review policy. Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” the GAO report said — approximately 6,000 in 1999 as compared with 21,000 in 2007.

The GAO report can be viewed at http://www.gao.gov/new.items/d08758t.pdf.

http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=256550&sk=&date=&pageID=3

Sounds like he understands his job.

DT was at FDA 2001-4.

“The ad campaign ran through 2005. On Feb. 27, 2007, when the agency was reviewing the labels, Troy - who by then was with Sidley Austin - sent an email to his former OCC colleagues:

“A woman named Leah Walker from Amgen has asked for a meeting with Tom Abrams, Lesley Frank and
Mark Askine from DDMAC,” Troy wrote. “It would be great if you could make sure that someone at OCC makes sure that people understand the limits of their authority. I will keep you posted about what I hear.” Troy’s email was addressed to Jeffrey Senger, then the agency’s deputy associate general counsel.”

Who is it that DT wants to be sure understands “the limits of their authority”? Those at DDMAC?

I believe Tom Abrams has been at DDMAC for some time. As I recall, he drafted the second and more severe warning letter to Merck re: their Vioxx shortly before DT became FDA Chief Counsel.

Just checking my own interpretation.