OK, was in a hurry yesterday (and am still today), but found this December 2008 Scientific American article which clears up a lot. It turns out that the second ingredient in Coartem -- lumefantrine -- is not a placebo, but rather is a "a broad-spectrum antibiotic that stays in the body for about seven days." Artemether clears the system in three days, so it's good to have the antibiotic still around, apparently. Having both the drug and the antibiotic in the same pill can be important in the third world, where compliance is a problem.
The CSPI in 2008 was very favorable to the drug -- "It is the preferred treatment for falciparum malaria because many strains are resistant to choloroquine. As the strain developed resistance, there was a horrible need for new drugs, and this drug met it."
But the main thing I learned was in the following bracketed paragraph at the end of the article:
"[The Tropical Disease Priority Review Voucher law, which took effect this fall, allows drug companies that develop treatments for neglected diseases like malaria an expedited review by the FDA. That means that in the future, Novartis can bring another, more lucrative drug candidate before the agency for quicker approval — or sell that right for hundreds of millions of dollars, Goozner says. “Yes, well, this is a gift from heaven,” Silvio Gabriel, who manages Novartis' malaria initiatives, told today's New York Times.]"
I wonder how heavily Novartis lobbied for that law. I haven't been able to find anything one way or the other. The law was based on a proposal by David B. Ridley, Henry G. Grabowski and Jeffrey L. Moe, all business school professors, in a Health Affairs article with "research support" provided by the GlaxoWellcome Foundation and the Center for the Advancement for Social Entrepreneurship.
As of July 2011, it appears that the ONLY drug to receive a priority review voucher was Coartem, and that Novartis tried to use it for its anti-arthritis drug ILARIS, but an FDA committee had voted 11-1 against approval, so it seemed unlikely that the PRV would do Novartis any good. The FDALAWBLOG post does mention that at the time PRVs were introduced, it was thought that they would trade for $50-$500 million, due to the potential for faster approval of blockbuster drugs.
A little more digging shows that when Novartis applied for the PRV for ILARIS, people thought Novartis was gaming the system, because Coartem was already on the market and in use outside the US, and didn't really require FDA approval to begin with. So the big question is why was Congress so stupid as to create an "incentive" law whose only effect was to give an apparent windfall to Novartis? Why can't they draft legislation that makes it clear that the rewards are only for new initiatives taken AFTER enactment of the law, not before?
I've looked into the sponsors -- Sam Brownback and Sherrod Brown -- and don't find any obvious links to big Pharma or Novartis. Brown actually seems to be fighting the good fight against big Pharma outsourcing, which he says results in poor quality control (I wonder what Roger Bate would say about that), as well as against the recent post-approval KV Pharmaceuticals price hike from $10 to $1500 for an injection of anti-preemie drug Makena (which might have to be injected 20 times over the course of a pregnancy). So really, it might just have been stupidity.
The CSPI in 2008 was very favorable to the drug -- "It is the preferred treatment for falciparum malaria because many strains are resistant to choloroquine. As the strain developed resistance, there was a horrible need for new drugs, and this drug met it."
But the main thing I learned was in the following bracketed paragraph at the end of the article:
"[The Tropical Disease Priority Review Voucher law, which took effect this fall, allows drug companies that develop treatments for neglected diseases like malaria an expedited review by the FDA. That means that in the future, Novartis can bring another, more lucrative drug candidate before the agency for quicker approval — or sell that right for hundreds of millions of dollars, Goozner says. “Yes, well, this is a gift from heaven,” Silvio Gabriel, who manages Novartis' malaria initiatives, told today's New York Times.]"
I wonder how heavily Novartis lobbied for that law. I haven't been able to find anything one way or the other. The law was based on a proposal by David B. Ridley, Henry G. Grabowski and Jeffrey L. Moe, all business school professors, in a Health Affairs article with "research support" provided by the GlaxoWellcome Foundation and the Center for the Advancement for Social Entrepreneurship.
As of July 2011, it appears that the ONLY drug to receive a priority review voucher was Coartem, and that Novartis tried to use it for its anti-arthritis drug ILARIS, but an FDA committee had voted 11-1 against approval, so it seemed unlikely that the PRV would do Novartis any good. The FDALAWBLOG post does mention that at the time PRVs were introduced, it was thought that they would trade for $50-$500 million, due to the potential for faster approval of blockbuster drugs.
A little more digging shows that when Novartis applied for the PRV for ILARIS, people thought Novartis was gaming the system, because Coartem was already on the market and in use outside the US, and didn't really require FDA approval to begin with. So the big question is why was Congress so stupid as to create an "incentive" law whose only effect was to give an apparent windfall to Novartis? Why can't they draft legislation that makes it clear that the rewards are only for new initiatives taken AFTER enactment of the law, not before?
I've looked into the sponsors -- Sam Brownback and Sherrod Brown -- and don't find any obvious links to big Pharma or Novartis. Brown actually seems to be fighting the good fight against big Pharma outsourcing, which he says results in poor quality control (I wonder what Roger Bate would say about that), as well as against the recent post-approval KV Pharmaceuticals price hike from $10 to $1500 for an injection of anti-preemie drug Makena (which might have to be injected 20 times over the course of a pregnancy). So really, it might just have been stupidity.
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