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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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April 25, 2007

A New HIV Therapy. Yawn?

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Posted by Derek

Pfizer got a tiny bit of good news yesterday when an FDA panel recommended their new HIV drug, Maraviroc, for approval. There are several stories that can be told about this news, so let's try a few: The business story is that this is not going to make a lot of difference for the company, because the drug isn't going to be a first-line therapy. They have to hope that it performs well and can expand its use, because a $25 to $50 million/year drug is a roundoff error on the scale of Pfizer's financial concerns. So much for the money.

The drug development story is that this will be the first CCR5 inhibitor to reach the market. That's a useful benchmark by the standards of this blog, because back in 2002, in my second month of blogging, I wrote about this class of drugs. The first CCR5 inhibitors had already made it into human patients by that time, and here we are, five years later, and one of them is just about to make it to market. Patience is supposed to be a virtue, but in the drug business, it's a case of making that virtue out of necessity.

And the big philosophical story is how the world has changed in the last twenty years. Here's a new HIV medication, one with a new mechanism, and it makes the second business page of the paper if it makes it at all. A completely new drug for a dreaded disease is coming, and no one thinks it'll do all that well, because of all the competition, y'know. It'll be given to people who've failed courses of treatment with all the other HIV drugs out there, and unless you're paying attention it's hard to keep up with all of them.

For people who remember the 1980s, all this still feels strange - imagine a message from the future popping up in 1985, saying: "In twenty years, the viral disease with by far the most crowded market, the largest number of possible therapeutic options and the widest variety of drug mechanisms will be. . .HIV". Actually, that would have scared everyone even more than they already were, because it would sounded like the worst predictions from that era had come true. In reality, HIV isn't even in the top 15 causes of death in the US, with the most recent figures I can find putting its contribution to the death rate a bit below that of aortic aneurysm. (Some other parts of the world are a different story, of course, although the 1980s predictions for them were even more apocalyptic.) But all in all, I'm fine with living in a world where new drugs against deadly diseases aren't necessarily front-page news. . .

Comments (12) + TrackBacks (0) | Category: Infectious Diseases


COMMENTS

1. Ken Fish on April 25, 2007 1:36 PM writes...

Hi
I'm not sure what to make of today's blog! It is good to think that there is plenty of choice in the ARV line up, and now there's even a 'fall back drug' but you know here in Africa HIV is not a yawning matter. If Fizzer sorry Pfizer doesn't think it'll make money then give the manufacturing rights to an African company and let us make it for who ever wants it!
Fish
South Africa

Permalink to Comment

2. Joe on April 25, 2007 1:52 PM writes...

Why can't it be known that selenium defeats HIV?

CONCLUSIONS: Daily selenium supplementation can suppress the progression of HIV-1 viral burden and provide indirect improvement of CD4 count. The results support the use of selenium as a simple, inexpensive, and safe adjunct therapy in HIV spectrum disease. "Suppression of human immunodeficiency virus type 1 viral load with selenium supplementation: a randomized controlled trial." Hurwitz BE, et al. This study only used 200 mcg per day. It is safe to use 800 mcg per day for extended periods. I've been doing it for a year, even though I'm not HIV positive. It is really good for the immune system. You won't catch a cold or the flu.

There are 179 medical journal articles on PubMed that show selenium is very potent in this regard.

Permalink to Comment

3. LNT on April 25, 2007 3:09 PM writes...

"Patience is supposed to be a virtue, but in the drug business, it's a case of making that virtue out of necessity."

I read an eye-opening article a few days ago. We complain about the long timelines in the drug industry -- try looking into the oil industry. 20 years ago, Exxon dug it's first exploratory well off the coast of Angola. 20 years and $5 BILLION later, the site is commercially viable. At least we generally think in terms of less than a decade and under $1 billion for a new drug.

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4. TNC on April 25, 2007 6:13 PM writes...

Growing up in the late '80's - early '90's, the predictions got pretty dire in terms of comments like "by the year 2000 (or whatever), everyone will know someone who died of AIDS or has HIV"...

Glad to hear that some, not all, dire predictions don't come true.

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5. Simon on April 25, 2007 9:03 PM writes...

Good news, Maybe I will try Maraviroc, if it's proved to be useful. I have my own HIV blog, I will let other HIV poz people to know this.

Permalink to Comment

6. SRC on April 25, 2007 10:29 PM writes...

TNC,

Eventually one comes to realize that dire predictions are almost invariably grossly exaggerated, and most are complete nonsense.

Nuclear war (1955-1965), population bomb (1968), global cooling (1975), killer bees (1980), HIV (1985), Alar (1989), ozone hole (1990), silicone breast implants (early 1990s), Y2K (duh), thiomersal (sputtered along 1999-present), power lines and cancer (early 2000s), cell phones and cancer (early 2000s), shark summer (2003), (mumbles sotto voce) global warming (now), cell phones and bees dying off (just getting rolling), excessive toilet paper use (already skidding - apologies to Sheryl Crow).

Combine one nanomole of journalists needing a story with one mole of gullible/neurotic/agenda-driven/none-too-bright laymen, shake vigorously, and voila! Another doomsday catastrophe looms...we have to do something! It's for the children!

Permalink to Comment

7. D on April 26, 2007 11:09 AM writes...

Ken Fish

Considering in South Africa, there's an insistence that something other than HIV causes AIDS, I'm not sure we should care what Pfizer does with the drug. South Africa insists it's a different disease than the one caused by HIV, and it's done precious little to stop transmission of the virus as a result. Seems to be something related to showers, as I recall. That's not the same thing as what Pfizer's drug is designed to deal with.

And if you want new drugs developed for when HIV becomes resistant to the Pfizer drug, you'll have to provide the money for that research. Usually that money is provided by profits. South Africa hasn't been particularly good about paying for the research, either. I don't see anyone in South Africa working for free, why should Pfizer do the same?

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8. CJ Croy on April 26, 2007 12:18 PM writes...

Joe,

It would be much easier to take you altmed proponents seriously if you didn't constantly lie.

1. There are not "There are 179 medical journal articles on PubMed that show selenium is very potent in this regard.", there are 179 articles indexed on PubMed that mention the words "selenium" and "HIV" together.

2. It does not 'defeat' it. It is not a magic bullet that instantly cures HIV and allows you to run out and have hot wild monkey sex. Your own cited studies describe is a useful adjunct to the existing therapies. An electric drill is a useful adjunct when installing light sockets, but that doesn't mean you don't need screws, plates, and other parts too.

3. There is no coverup. The NIH has a section on Selenium and HIV on their website. The possible benefits are already widely known.

4. Telling everyone to take everything that MIGHT make them healthier is how you get people killed. You cannot tell if the benefits outweigh the risks without careful research.

Permalink to Comment

9. John Q. on April 26, 2007 2:51 PM writes...

"In reality, HIV isn't even in the top 15 causes of death in the US..."

Perhaps not. What I find more interesting is how many will die prematurely as a result of it. As an extreme hypothetical, assume 180 million people under the age of 40 has HIV. In many many years, HIV would fast become the leading cause of death.

My only point is that the quoted statistic is junk.

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10. Morten on April 28, 2007 11:16 AM writes...

I find it interesting that there are drugs targeting every single protein that HIV encodes and now one human protein and we still can't kill it. Food for thought for anyone making anti-virals IMO.
And it seems kinda stupid that a drug that's most effective early in infection should be a second line of defense (and I'm saying this as someone who isn't a Pfizer fan).

Permalink to Comment

11. Morten on April 28, 2007 11:55 AM writes...

Wait, I take that back - PEP treatment should kill it after all.

Permalink to Comment

12. Devices R Us on April 28, 2007 12:05 PM writes...

In response to John Q (9), the quoted statistic is for the U.S. where there are a million more or less infected folks. If you are talking about sub-saharan africa, you don't have to wait, AIDS is one of the leading causes of death right now. On the other hand, 180 million is about 5x the current estimate of world-wide HIV infections so your numbers are a bit high.

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