TCS Daily

When Collaborators Have Chemistry

By Duane D. Freese - July 13, 2006 12:00 AM

A "landmark" treatment; a "new paradigm" of separate companies working to produce a single drug: "proactive collaboration" between the Food and Drug Administration and drug developers.

That's how FDA Acting Commissioner Andrew von Eschenbach described the development of a new single-dose, one-a-day treatment for AIDS -- Atripla -- at a press conference announcing its approval.

I would simplify it: smart people were doing some serious innovating.

Single dose treatments for AIDS have long been a kind of holy grail, as an FDA official said. While Atripla involves no new active ingredient -- it combines three existing antiretrovirals, two made by Gilead and another by Bristol Myers Squib and Merck -- the fact that people can take it once a day means more people can adhere to their taking of pills.

That may not seem like a lot, but as one FDA official noted, "The more pills that need to be taken, the less chance of a good outcome." Indeed, anytime adherence falls below 95%, drug resistance pops up.

In the United States that can mean hundreds or thousands of lives lost. In less developed countries, with their inefficient health delivery systems, corrupt governments stealing pills or delivering fakes and nearly 38 million sufferers, it can mean hundreds of thousands. The disease already has taken 25 million in 25 years.

So, as Frank Oldham Jr., executive director of the National Association of People with AIDS told the Associated Press, "It is a major, major breakthrough for all people living with HIV and AIDS."

And while Charles Farthing, chief of medicine for the AIDS Healthcare Foundation, may have taken it a bit too far in comments to Reuters, he expresses the sentiment: It's incredibly important psychologically for patients ... This turns HIV into high blood pressure."

If only the ARVs were as simple to work with as statins. But they really don't combine together in one pill very easily because of their chemical compositions.

That's why the "amazing happening" wasn't "the fact that innovator companies in the U.S. have actually heeded the call to collaborate," as Veronica Miller of the Forum for Collaborative HIV Research, said, calling for further collaboration for child dosages. Rather it is that the drug researchers in 20 person-years of effort over 18 months were able to develop a technique that would stabilize some incompatible chemicals in a pill that would work taking it once a day.

The fact that Taiyin Yang and her crew of researchers, who cracked the problem of creating a pill with double the half life in plasma of previous drugs so people could take just one a day, are rarely mentioned in most of the news reports speaks volumes about how the press takes for granted the innovative process. But only by their creating bilayer compression can this drug be readily served up in a mud hut in South Africa, as it is in an air conditioned flat in San Francisco.

Duane Freese is deputy editor of TCS Daily.


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