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Mike Barr and Rob Camp —

The article on the HIV Web sites and how their sponsors might influence their reporting is groundbreaking. TAG could do a great Sunday New York Times Magazine piece using these tables as the essential structure — with just a few interspersed comments and a little background.

The tipranavir article was good, but my frustration as a clinician is that I can’t get what I regard as the most important information available on the tipranavir studies — information that would help me to optimize my use of the drug — anywhere. I can’t get it from studies presented at the conferences. I can’t get it from the news stories about the studies online. I can’t get it in pharma-sponsored throw away journals, or at pharma-sponsored dinners — where attendees are essentially paid to provide focus group type feedback but discouraged to raise any serious questions. And I can’t get any of my colleagues to even recognize the question — which is not asked, much less answered even, in your otherwise good report.

Here it is again:

Dear Sirs and Mesdames —

Given that there is such a small percentage of patients who actually achieve undetectability with tipranavir — even when used in combination with T-20; and given the wide range of T-cell and viral load entry criteria; and given that the patients who clinically really urgently need new drugs are not only least likely to benefit from these drugs but also most likely to blow these last remaining treatment options if ineffective; I would like more specific information, on a case-by-case basis, of the clinical histories of TPV/T-20 failures vs. responders.

I would also like the patients stratified according to T-cell counts, HIV RNA, and number of active agents — in terms of achieving or falling short of these endpoints. To not ask these questions before recommending tipranavir to an ill patient would be highly irresponsible of me. For you not to provide it is itself troubling.

Is there a place for a phone zap-like action pushing these issues to all the relevant parties — certainly Boehringer and Roche/Trimeris, but also key people at FDA?

Roche finally has provided some of these data, but they seem to indicate that the patients who really need salvage therapy are not likely to benefit from it. After obscuring this information completely, they now have a new tactic: just take T-20 earlier! Real case histories as well as actual, specific, stratified data remain unavailable.

Paul C. Bellman, M.D.
New York

Dear TAGline,

Thank you for sending the latest issue. TAG’s e-mail .pdf distribution system is a terrific innovation. The table examining the various sources of Web-based treatment information was very useful. It’s always interesting to see what consumers are reading, and I would like to see the results of your survey once it is complete.

I’m a little disappointed, however, that you picked up on Steve Miles’ recent diatribe. I think Steve is very smart and hilariously funny, but this piece is too cynical (even for this former New Yorker). Other folks who you know well share this view. Instead of ranting and raving at Gilead, Steve should be going off on the FDA — who are really the folks that insist on the TLOVR analysis and other stuff he talks about.

An ACTG researcher (name withheld)

From: “Robyn Meyer”

Subject: News Story: Roche and Trimeris Launch ASAP

Dear Mr. Barr,

I want to make sure you saw the press release from Roche and Trimeris announcing the launch of a new program called Fuzeon ASAP (Accelerated Simultaneous Access Program).

This program provides immediate access to Fuzeon for patients who are starting treatment with Fuzeon in combination with an investigational antiretroviral therapy obtained through an expanded access program. For patients enrolled in Fuzeon ASAP, Roche and Trimeris will provide up to a 60-day supply of Fuzeon at no cost to the patient.

For your reference, please find the attached press release. Please feel free to contact me with any questions.

Robyn Meyer

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