April 27, 2012
Submitted to the FDA today, April 27, 2012, by John S. James, AIDS Treatment News:
I strongly support approval of Truvada for PrEP. In the large iPrEx study of men who have sex with men, "No one in iPrEx acquired HIV infection with a drug level that would have been expected with daily dosing" (Dr. Robert Grant, PI, CROI 2011, http://bit.ly/grjVUg). I reported the details exactly a year ago, at http://aidsnews.blogspot.com/2011/04/hiv-prep-explained-critical-prevention.html
The strongest argument against approval is that the mediocre intent-to-treat results reflect the real world, where people don't take their pills. But approval of a treatment that works close to 100% when used once a day opens all sorts of doors for improvement. For example, communication with patients and with future trial participants can be much clearer and more definitive than communication in the iPrEx trial.
Also remember that much of the epidemic results from relatively few superspreaders. The limit of treatment as prevention is that it's almost impossible to identify and treat them in time. PrEP is better, because these people know they are personally at risk; they are likely to protect themselves if given clear messages and an opportunity to do so, eliminating all transmission through them -- a powerful strategy to fight the HIV epidemic.
AHF Debacle: Does Gilead Really Want Truvada Approved for PrEP?
Events in India (not reported in the U.S. so far) raise this question. The full story is summarized in "Anti-AIDS blitz sees pharma firms locked in ugly battle," at http://economictimes.indiatimes.com/articleshow/2586967.cms
The AIDS Healthcare Foundation campaign against Gilead re Truvada PrEP is a roll-out of a similar AHF campaign run almost four years earlier in India, against Cipla -- and clearly run on Gilead's behalf. AHF spent considerable money on full-page ads in Indian newspapers, apparently to get Cipla in trouble with the Indian government for charging less for medicines in Africa than it did in India. While AHF supposedly paid for the anti-Cipla campaign, Gilead gave AHF a grant for far more, according to The Economic Times article cited above. AHF had no visible motive to go after Cipla, but Gilead sure did; alone among Indian pharmaceutical companies making a Truvada generic, Cipla did not accept Gilead's licensing terms, but planned to fight Gilead's claims in Indian courts.
Why might Gilead secretly campaign today against use of its own drug for PrEP? It is not very hard to see why.
Gilead is stuck because it cannot feasibly charge a different and vastly lower price for the same pill for prevention. It's hard enough to promote prevention; now try adding over $13,000 per year out-of-pocket retail price ($13,816 -- $3,406.79 per 90 tablets, on drugstore.com today). This cost will be out-of-pocket in many if not most cases. The Truvada price is what the market will bear to help save a life, and the market will bear much less to relieve a risk people typically think doesn't apply to them, and don't like to think about at all.
Even 10% of the existing price will be too much for prevention. So there will be no significant market for Truvada PrEP, and no significant profit -- while Truvada for treatment remains an enormous gravy train for Gilead.
And if Truvada for PrEP is approved, Gilead will be the "heavy," consistently blocking control of HIV in the U.S., year after year after year. This will be dangerous for the company, especially in the context of so much need and pressure to reduce medical costs. Similarly, Gilead would be the heavy if it refused to apply for PrEP approval.
The AHF campaign to turn the gay community against Truvada PrEP has failed. But Gilead can get about the same benefit by applying to the FDA and being rejected.
Of course we cannot be sure of Gilead's or AHF's intentions, without reading minds. Maybe Gilead and AHF had a falling out. But in considering this application for Truvada PrEP, you should consider that it may be unlike any other you have ever seen. Whatever Gilead's intentions, the company clearly has strong economic and political incentives for its own application to fail.
John S. James
AIDS Treatment News
Note to readers: This very controversial FDA Antiviral Advisory Meeting will be May 10, near Washington DC; recently the schedule was changed to allow an extra hour of public comment. You can submit written comments until May 17; however, written comments had to be submitted by 4 pm today to be distributed in advance to the committee members. (We got ours in with less than 10 minutes to spare, due to computer hassles when using a Linux netbook at the FDA site.) Comments will be published by the FDA, but not immediately.
For more information about speaking and/or submitting comments, Google the FDA's docket number, FDA-2012-N-0218
The AHF has been very active on this issue at the FDA. It has endless money, and it wants to win. We expect an echo chamber at the meeting.
Notice re Comments below: Due to a computer problem, all comments submitted before 4:15 pm Eastern time today (April 30) disappeared -- except for #1. Your comment was not rejected. We never saw it. And we could not publish any comment ourselves.
A successful workaround was to change Blogger's 'Comment Location' setting from 'Embedded' to 'Full page'. Comments should work now. (We recommend this solution to anyone who publishes on Blogger, because 'Embedded' has long caused problems with some browsers. You could lose some but not all comments with no notice, and commenters will think they were rejected when they were not.)
Posted by John S. James at 8:18 PM