Friday, January 15, 2010

DOJ: Johnson and Johnson Paid Big Kickbacks to Push Risperdal in Nursing Homes

For background, start with Ed Silverman's post on Pharmalot:
Then go to the DOJ press release (1 page):
Then finally if you want all the details go to the actual complaint (34 pages):

Based on whistleblower disclosures, the Feds are charging Johnson & Johnson with paying tens of millions of dollars in illegal kickbacks to Omnicare, a pharmacy management company that deals with nursing homes, to promote the use of Risperdal (which J&J is licensed to market). Omnicare has already settled charges against it for $98M. The basic drill was: Omnicare pharmacists reviewed charts of nursing home patients with dementia and then recommended to the physicians that they add Risperdal if the patient showed signs of agitation or inappropriate behavior due to dementia. The docs (who did not know that these pharmacists were basically being paid bribes to recommend Risperdal) agreed with the recommendations about 80 percent of the time.

This is bad for at least three reasons:

Drugging demented patients so that they behave nicely and don't bother stretched-thin nursing home staff (so-called chemical restraints) is a bad mode of geriatric practice. Risperdal does nothing to reverse or ameliorate dementia.
Even if it was OK to drug demented old folks, there are much cheaper drugs that are equally good (or bad) for sedating them, and there's no advantage to being sedated by a top-price drug.
Risperdal has been linked to several severe side effects, most notably weight gain, which in many older patients is bad enough to trigger Type II diabetes.

None of this is all that new if you've been following the marketing methods of the big drug firms closely. What is particularly striking in this case, to me, is that the charge includes details about just how the kickbacks were paid. There are a number of problems with paying kickbacks, especially if the patients are covered by Medicaid, as often is true in nursing homes. So the payments have to be hidden in a variety of ways. One way J&J elected to hide kickback money was to pay it out in the form of "education" grants. For instance, while four-fifths of the docs meekly accepted the recommendations to start Risperdal, there were those nasty few who balked. So J&J paid out a grant to "educate" the Omnicare pharmacists on the proper techniques to overcome the objections of those rebellious physicians. (See complaint, pp. 22-24)
I mention this example because we are often told in academia that such-and-such a payment or gift from a drug company is ethically harmless because it's in the form of an "education" grant. So my question is--now that we have even clearer evidence that the industry is quite happy to use "education" as a cover for illegal kickback payments (assuming that the DOJ allegations turn out to be supported at the end of the day), how can we believe that other "educational" grants from industry are benign? Not to put too fine a point on it, can we trust anything at all that these people tell us?
Now, let's admit right off that the events in this charge supposedly occurred around 1999-2003, given how long it takes DOJ to do an investigation of this sort and get all their ducks in a row for a prosecution. Some will no doubt then insist that this is all old history. That bad behavior was then; nowadays of course the industry would never do such a thing. To which my answer is once again-- not to put too fine a point on it, can we trust anything at all that these people tell us?

1 comment:

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