Monday, September 26, 2011

Same Song, I Lost Count of Which Verse

Time to get out the ol' standard form again:

Drug Company: Scios Division of Johnson & Johnson
Drug: Nesiritide (Natrecor)
Settled Federal charges of: Misbranding, off label marketing
Fine paid: $85M
Fine as % of Sales of Drug during Peak Year: 37% (2004)
Company Admits Guilt?: Can't tell from news report

The above from Bloomberg News:

Hat tip to the Health Care Renewal Blog which also provides good backstory analysis:

Now, you may ask, why am I bothering even to mention this judgment involving the chump change of $85M, when the record for settlements in such cases is now well upwards of $1B? As HCR informs us, the reason is well summarized in two commentaries by cardiologist Dr. Eric Topol:

What we have here is a drug (brand name Natrecor) that was approved by the FDA based on very slimsy evidence involving surrogate endpoints and despite considerable suggestion of risk of harm, for congestive heart failure, a condition for which many other treatment options exist. The company then aggressively marketed the drug for an off label use, weekly "tune-ups" by injection, and instructed cardiologists how to get big bucks in reimbursement for these "tune-ups," similar to what cancer docs get for injecting chemotherapy. Dr. Topol wrote in 2005 that more than 600,000 patients were getting these tune-ups despite the lack of any evidence that this use of the drug was helpful and despite these being off-label.

Finally, a company-sponsored trial was published in July, 2011, showing no excess deaths or cases of renal failure from nesiritide, but no benefits either when added to a regimen of other drugs. In short, Scios was making a lot of money for several years (before warnings such as Topol's took hold around 2004-5) on a drug that could not have helped and may very well have hurt a lot of folks.

If you wanted firm evidence of the Inverse Benefit Law in action--
--I can't think of a more obvious case.

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