Upside Down Incentives in Pharmaceutical Development –Profit over Patients

A good read on why cheap effective drugs may not be coming to the market in the U.S. –as well as solutions. (Full text: AR Kellermann, NR Desai. JAMA. Published online August 17, 2015. doi:10.1001/jama.2015.10114)

Here’s an excerpt:

In 2003, Wald and Law proposed to combine 3 half-dose antihypertensive agents, an intermediate-dose statin, low-dose aspirin, and folic acid into a once per day polypill for primary and secondary prevention of cardiovascular disease. Based on epidemiological models, they estimated that daily use by individuals aged 55 years or older could reduce the incidence of MI and stroke by more than 80%.

In the 12 years since this report was published,3 versions of the polypill have been successfully tested in several phase 2 (safety) studies and a few modest-sized phase 3 (efficacy) trials. Collectively, these studies demonstrated that the polypill was well tolerated, achieved good adherence, and based on intermediate end points, such as reduction of blood pressure and low-density lipoprotein cholesterol level, is efficacious…

The 4 drugs in the current version of the polypill have long histories of safe use. Although all 4 are frequently prescribed in the United States, the US Food and Drug Administration (FDA) has not approved combining them in a single pill…

Although the polypill could produce substantial public health benefits, people in the United States are unlikely to find out anytime soon. This is because the pill’s price is so low (≤$1 per tablet) and the cost of the large clinical trials required for FDA approval is so high, it is unattractive to investors. The inventor’s dilemma is that creating a product that improves health is not enough; the product must also be able to generate a healthy return on investment. In the United States, the surest way to generate a healthy return on investment is to increase health care spending, not reduce it.

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8 thoughts on “Upside Down Incentives in Pharmaceutical Development –Profit over Patients

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