Saturday, February 16, 2013

More Deja Vu: Why KOLs Don't Blow the Whistle

The text for today's sermon is:

Barry Meier reports in the Times that Johnson & Johnson's orthopedic device subsidiary, DePuy, had numerous warnings from its own paid consultants about the dangers of its Articular Surface Replacement artificial hip implant, a couple of years before they had to take it off the market and now face 10,000 patient lawsuits. As usual, it's only when lawsuits are filed and the legal discovery process leads to release of internal company documents that we discover what was actually going on.

Meier has been around this block a few times-- see HOOKED for a discussion of his book, Pain Killer, about how Purdue Oharma bought out national pain experts in defense of their drug OxyContin. But surprisingly, Meier sounds surprised when he writes: "It might not be surprising to find that executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so."

Well, both HOOKED and this blog have reported repeated instances of this very phenomenon. Indeed, if you want to read some really snippy comments, hunt up the e-mails among marketers in the drug company when one of their "consultants" starts making public statements about the dangers of a drug. You can see the logic--we bought and paid for this guy; so how come he's now cut the marionette strings and is dancing to his own tune?

Which, by the way, ought finally to put full stop to the commonly heard rationalization among docs who take large wads of industry cash and still proclaim their independence: I'm a scientist, you can't buy my opinion. Well, Johnson & Johnson did, and they are hardly alone.

The artificial hip episode replays a couple of techniques that we've seen before, as ways to keep docs docile and not likely to spread the word about a newly discovered danger of a profitable product:
  • It's only you: A company may be getting reports from all over about patients having adverse reactions, yet still reply to each reporting physician that they were shocked to get his note because he's the only one who has seen this happen. Physicians who can be persuaded that they are seeing something none of their peers are seeing are much more likely to doubt the accuracy of their own observations than to pursue a disclosure strategy. (This ploy goes all the way back to the way Chemie Grunenthal pushed thalidomide back in the late 1950s in Europe.)
  • Smear campaigns: The industry is not above retaliation against its KOLs. Meier reports, "For example, when Dr. Lawrence D. Dorr, an orthopedic specialist, warned fellow surgeons in an open letter in 2008 that a hip implant made by Zimmer Holdings was flawed, he became the subject of a whisper campaign that questioned his skills as a surgeon. ...'The first thing that a company does is to put out a campaign that a surgeon does not know how to operate,' said Dr. Dorr, who was a consultant to Zimmer when he wrote the letter. 'It hurt my practice for a year.'"
 Incidentally, if you thought that J&J were newcomers to shady behavior, check out previous posts:

Hat tip to one of my most faithful and helpful readers for the Meier article.

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