Addendum: There's an interesting article in the June 2005 MIT Technology Review about Rotarix: The Vaccine That Almost Wasn't. According to the article, GSK is actually working pretty hard to deploy a rotavirus vaccine in the developing world. So I stand corrected. Here's what the MIT article says:
If GSK is really pioneering the deployment of new drugs to the developed world, why isn't there more about it in the news? Or has this been pretty big news? Did I miss it? In either case, it's pretty clear that GSK is doing a lot better than Merck/Rotateq.
Now for my original post:
As much as we value people who hop on airplanes to other places and spoon formula into the mouths of needy children, we should also cheer the people woh spend their lives in the lab. Pharmacologists really can make a difference.
A recent news release announced the successful testing of a vaccine for rotavirus, which kills 5 million children (mostly babies) each year. The vaccine has been effecetive in 98% of trials. They tested it on 68,000 infants.
Good news, eh? Hmm. It's hard to say. I was a bit confused by some of the language in the Science Daily articile, so I followed it to the original source. The Science Daily article was a perfect copy of a press release from the Eastern Virginia Medical School. Both of them noted that the RotaTeq vaccine was just a byline for an article in the New England Journal of Medicine about another vaccine, developed by GlaxoSmithKline. It also mentioned an editorial which "underscores the need for a rotavirus vaccine"
So I looked up the articles in the New England Journal of Medicine (a publication of the Massacchusetts Medical Society) I didn't even have to use my college's academic search. They're one of the sane journals and provide some free access to the fulltext of some new articles. So here they are:
The Promise of New Rotavirus Vaccines, by Roger I. Glass, Umesh D. Parashar.
Safety and Efficacy of a Pentavalent Human-Bovine (W3C) Reassortant Rotavirus Vaccine, by lots and lots of authors listed, probably mostly Timo Vesikari and David O Matson. Dr. Vesikari seems to have been pretty involved in Rotavirus research over the last decade at least. Dr. Matson is on staff at the Eastern Virginia Medical School, so there's clearly a connection. So far so good.
Dr. Vesikari's name brought me to a WebMD article, which is much more sensible than the Eastern Virginia Medical School press release. WebMD: New Rotavirus Vaccines Show Success. It looks like the study was a head-to-head betwen Merck's Rotateq and GlaxoSmithKline's Rotarix.
There's a lot of money to be made. In the U.S., around 80% of all infants get rotavirus, even though it's only fatal to a small number (deaths result from dehydration associated with the infection). According to a report by AVANT, a Phase II & III, clinical trails company, "The economic burden in the United States is estimated at over $1 billion from rotavirus desease in direct medical and indirect societal costs"
By 2004, AVANT had received over $2 million dollars to test this drug. Avant expects to receive about $5.5 million dollars to test Rotarix. Furthermore, they expect royalties on sales of Rotarix.
The AVANT is not entirely clear on their role in the trials. They only admit to Phase I, II testing of 215 subjects, not to being involved in the 65,000 patient trial done in Europe by GlaxoSmithKlein. Perhaps they had to be more careful and spend a lot more money for the initial trials. I don't know the drug industry too well. $25,000 per patient is probably cheap compared to other projects, when you think of all the time, product, and personell that goes into this.
AVANT didn't really expect to make much money on the early-phase clinical trials. They didn't even expect to make much money on royalties. Rather, they sold a portion of their royalties to Paul Capital Partners, a $4 billion dollar company who, among other things, purchases royalties from promising drugs. AVANT expects up to $61 million dolars from the Paul Royalty Fund II, L.P..
Remember, all this money going around is only related to a group that did an initial testing of 215 patients. (hmm. Other sources say that AVANT inlicensed the vaccine, which is a substantially bigger project that probably involved tweaking the vaccine for the large-scale testing that followed. Lots of lab work.)
This little investigation has shown me the power of press releases. They are often just pasted into the news sources, or if people are particularly savvy (like at WebMD), they are paraphrased into the news sources.
That's how we get figures that tell us that it could save half a million lives.
More information about rotavirus and the vaccines can be found on the Brown University Rotavirus page for BIO 160.
I think that it's OK if people have to throw around massive amounts of money to develop drugs and vaccines. It costs a lot to hire good researchers, techs, and marketing consultants. You have to find patients to test your new idea. You have to buy lab equipment and synthesize the materials. The medical industry is very costly. If we really want to help half a million babies, it's worth the expenditure, and the profits should go to the people who did the work.
But even though the people developing this vaccine talk about saving half a million lives, it won't reach the people who need it most. They might sleep at night knowing that they're making a difference, but are they really?
According to an article in Emerging Infectious Diseases (Global illness and deaths caused by rotavirus disease in children):
This brings us back to the original article about Rotateq, the first of the two vaccines I mentioned. The article states that after they get things going in the U.S. and other rich countries, Merck plans to look into its uses in developing nations. Heh. That's right. Target the biggest need last because it is the poorest area.
I'm sure they'll get around to it--someday, after they make a barrel of money in the developed world (some of the articles are horrible, with headlines suggesting that since Rotarix works in Mexico, it might work in Africa. It's a pill, for goodness sake! How callous can you be toward poor people?) But in the meantime, they have no compunction against citing the great global need and getting good press.