FDA Chief Counsel Undercut Changes In Procrit Ad
6 CommentsBy Ed Silverman // May 12th, 2008 // 3:50 pm
The FDA made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s Proctit improved “fatigue” associated with chemotherapy-induced anemia, The Cancer Letter reports.
The ads, which were widely credited with making ESA drugs into the biggest-selling class of oncology drugs, were allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel got involved in the controversy.
The details of the doomed effort by FDA staff to modify the Procrit campaign emerged in documents that were placed in the public record at the May 8 hearing of the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigation. (Look here).
A sequence of internal FDA emails released by the committee shows that Dan Troy (pictured) was inquiring about a call from Richard Pazdur, the head of the FDA Office of Oncologic Drugs, to Amgen and J&J, which licensed Procrit from Amgen. At the time, Troy was FDA general counsel, although he has since returned to private practice, and apparently represents J&J, according to the newsletter.
At the time, the newsletter writes, the FDA was reviewing the EPO labels in light of toxicity and tumor data that had emerged from two Amgen studies. Apparently, Pazdur requested the drugmakers to stop their DTC ads while the agency formulated the wording of a black box warning.
The documents trace an effort by FDA staff to stop the Procrit campaign, which ran between 1998 and 2005, which featured the tagline “Strength for Living.” An agency letter to J&J called it “misleading because it implies that Procrit iimproves strength and may improve survival when the outcomes have not been demonstrated by adequate and well-controlled clinical trials.”
At some point, OCC became involved, the newsletter writes, citing the documents. Handwritten notes from a May 29, 2002, teleconference titled “TC w/DDMAC re: Procrit” state: “Overall message fr. OCC—try to find middle ground. Fix in context rather than yanking material.” DDMAC is FDA’s Division of Drug Marketing, Advertising and Communications.
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.
Scott Amey, general counsel for the Project on Government Oversight, tells The Cancer Letter that the episode should be reviewed by FDA ethics officials. matter. And Howard Ozer, an expert in ESA drugs, and professor and chief of hematology and oncology at the University of Oklahoma Cancer Center, tells the newsletter the documents point to political intervention.
The newsletter story is longer, but is available only through subscription.
david egilman
can you spell corrupt?
Justice in Michigan
I’m not sure I follow the implications of this excerpt:
“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.
Justice in Michigan
should have been the word “promotion” after Vioxx, above
Justice in Michigan
Tom Abrams has been at FDA since 1993, now fifteen years. There is an interesting interview/profile of him at:
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.
Justice in Michigan
This summary of a recently completed GAO report. It was in 2002 that DT effectively gutted the warning letter process by routing them all through his own office (the OCC). See paragraph 3.
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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.
Joana Ramos
Those who are hearing about this issue for the first time may not be aware that the underlying issue is not just the concern about EPO being inappropriately over-promoted as a antidote to chemo-induced fatigue, but that EPO was actually causing tumor cells to grow faster , and with resulting higher mortality rates. I presume that this was not mentioned in the public excerpt from The Cancer Letter because this info is now known in the oncology field.
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