An editorial in the May 5th issue of the New England Journal of Medicine (NEJM) recounts the tale of Makena. It starts back in 2003, when a landmark study funded by the NIH showed a decrease in preterm births for certain high-risk women who receive treatment with 17 alpha-hydroxyprogesterone caproate (17OHP). 17OHP is the only medication ever to have shown benefit for this problem; therefore, on the basis of this study, it was used widely. It was not a commercially available medication, but could be obtained from certain compounding pharmacies for about $15-$20 per weekly dose.
Many groups, hoping for a more easily obtainable and standardized drug, welcomed the FDA’s decision this past February to grant exclusive rights to Ther-Rx and KV Pharmaceutical Company to manufacture 17OHP under the name Makena. Their welcome turned into astonishment when Ther-Rx announced that Makena would be priced at $1500 per dose.
Gregory J. Divis Jr., the pharmaceutical company’s chief executive, attempted to defend the indefensible by saying that Makena could help offset some of the costs associated with preterm birth, and that “These moms deserve the opportunity to have the benefits of an FDA-approved Makena.” (The NEJM article estimates the total annual preventable medical costs associated with preterm births in this country to be $519 million. At $15 per dose of 17OHP compounded in the local pharmacy, it would cost $41.7 million to attain those savings. At $1500 per dose of 17OHP marketed as Makena, it would cost $4.0 billion to save that $519 million.)
The plot thickens. On March 30th, the FDA issued a statement that it does “not intend to take enforcement action against pharmacies that compound 17OHP” when a valid prescription is written. In other words, the FDA granted Ther-Rx a patent on the medication; but when they saw the grievous abuse of that patent, they in essence revoked it! (Was that an unethical reneging on a promise, or an ethically justified intervention to thwart pharmaceutical highway robbery?) Ther-Rx generously reduced the price to a mere $650 per dose, and my OB colleagues inform me that Ther-Rx’s representatives have contacted many physicians’ offices and suggested that patients no longer have the option of using compounding pharmacies, but must instead use Makena.
It is not just Ther-X’s rapacity that is so breathtaking, but their audacity as well. Has our society become so cozy with the idea of medicine as industry that a company actually has reason to believe it can commit such profligacy in broad daylight? What part should the profit motive play in providing medical care? Where’s the line between reasonable return on investment and unscrupulous opportunism? Maybe it’s like what Supreme Court Justice Potter Stewart said about pornography: I can’t define where the line is, but I know it when I see it.
I visited the Makena website, and read an online brochure that asserted, “Ther-Rx cares about you and your baby.” I don’t doubt that they care; I just wonder if they would still care if it weren’t so darned lucrative.