Professor Robert Rosenheck presented his blockbuster findings on long-acting risperidone at Stanford Psychiatry Grand Rounds this week. The injectable version of this anti-psychotic medication was heavily marketed as superior to its oral, less expensive cousins. The sticker price of $7,000/year was promised to be worth it because patients would need to be hospitalized far less frequently while on long-acting risperidone. The manufacturer raked in billions of dollars, much of it from the public purse.

But as Bob’s randomized trial in New England Journal of Medicine shows, none of the claims about this drug were true. Fortunately, Bob decided to launch his trial while federal research dollars were more plentiful than they are today. With the current withered state of federal medical research, pharmaceutical industry-funded studies are often the only source of information about whether a medication is effective and cost-effective.

And even when the government can support a study, it is today sometimes dependent on the manufacturer to donate the medication. In the case of the long-acting risperidone study, which was was started 5 years ago, the donation was valuable but not critical (something like a half a million dollars within a ten million dollar federal budget). Today, the federal government budget available for such a study would be less, potentially leaving the researchers dependent on the manufacturer’s donation in order to conduct the trial. This is even moreso the case with recent biologic therapies that cost many times as much as long-acting risperidone.

Why does this matter? If the government approaches a manufacturer of an expensive drug about a study of whether an approved medication is no better than a generic drug or may be harmful to particular groups of patients, the manufacturer has economic veto power. The manufacturer can say, in effect, you can’t afford to do this study without a donation of our medication, and we won’t give it for any study that might harm our market share. On the other hand, if you want to compare the medication to one of our new alternative medications (all of which have more years left under patent protection), why then of course we’d make a public-spirited donation to the scientific endeavor.

[Cross-posted at The Reality-Based Community]

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Keith Humphreys

Keith Humphreys is a Professor of Psychiatry at Stanford University and served as Senior Policy Advisor in the White House Office of National Drug Control Policy in the Obama Administration. @KeithNHumphreys