Old News, but Still Important: The Selling of Risperdal

In the previous post I mentioned Kate Petersen at PostScript:
http://postscript.communitycatalyst.org/?p=2840
--who in turn cites Ed Silverman at Pharmalot:
http://www.pharmalot.com/2011/06/jj-risperdal-project-subverted-scientific-integrity/
--who in turn gives credit to--but I don't have all day, sorry.

Anyway, the short version. In 1995, Johnson & Johnson funded a project led by three prominent academic psychiatrists to write Schizophrenia Practice Guidelines. Things being pretty loosey goosey back then regarding conflicts of interest, no one really made any bones about these guidelines being a tool to market the drug Risperdal (risperidone). The academics freely consulted the J&J staff and shared drafts with them. J&J for this privilege paid a total of $515K to the three medical schools where these psychiatrists were based.

Now, how to get folks to read and follow these wonderful new guidelines? The three docs then proceeded to establish a firm called Expert Knowledge Systems. EKS was set up to take drug company money, use it to publicize and advocate for the new guuidelines, and incidentally to pay some cash to the three docs, now that they had their own organization and were no longer getting the grants through their medical schools. EKS ended up taking in more than $900K from J&J.

Still back around 1996-7, EKS launched an effort with the Texas Medication Algorithm Project to help them design a drug protocol to assist state Medicaid mental health programs in designing (presumably) cost-effective ways to treat their patients with drugs. Not surprisingly, the TMAP protocol, which was then heavily peddled to other states, ended up recommending Risperdal a good percentage of the time, over cheaper generic alternatives that have since been shown to be just as effective and perhaps safer.

As I discussed in HOOKED, in 2004, a former Pennsylvania state investigator (who was fired when he started raising inconvenient questions) blew the whistle on how TMAP was really a drug-selling scam. In 2006 the Texas attorney general joined this suit, which is scheduled finally to come to trial in November.

So why all the fuss here and now? Some of the documents related to this whole debacle are only now coming to light--what I said above comes from a report from David Rothman at Columbia prepared last October (see link in Pharmalot post), though the bulk of the relevant documents in this case remain sealed. One regularly encounters objections from Pharma when we accuse them of sleazy practices--this is all old news; this stuff happened in the 1990s for heaven's sake, of course we gave up doing those things years ago. And indeed that may be true. But here we come to my old refrain--just how would we know? When only now in 2011 are we starting to find out about stuff that happened back in 1996, on the basis of what sort of faith are we to accept the assertions that nothing like this happens today? Ed Silverman points out that if J&J settles the case pretrial, one result could be that the other documents will remain out of the public eye. And Kate Petersen focuses her analysis on whether today's more stringent conflict-of-interest rules would have prevented all this from happening, and concludes that it's iffy.

Finally, a footnote. One of the three academic psychiatrists who started that ball rolling in 1996 was Dr. Allen Frances, chair of psychiatry at Duke. We have encountered Dr. Frances in these pages before: http://brodyhooked.blogspot.com/2009/06/will-psychiatrys-dsm-v-be-huge-growth.html. In that post, about psychiatry's DSM-V controversy, Dr. Frances was on the side of the angels as I depicted him, criticizing the aspects of the new DSM-V from the vantage point of his own role as a chief architect of DSM-IV, and accusing DSM-V of being way too ready to add new, dubious psychiatric diagnoses which are almost sure to increase drug prescribing across the board. For his pains, Dr. Frances was immediately condemned by his peers at the American Psychiatric Association, and accused of being motivated by conflict of interest because he had authored a book that was based on DSM-IV. Back then I trusted the statements of people like Dr. Danny Carlat that Frances was the good guy in this dispute. Had I known about this older history, I would at least have seen the logic of suspecting that Dr. Frances might have been motivated by money in the stand that he took. Whether Dr. Frances is a reformed former offender who has now seen the light, and has come over to the right side, I will leave to my psychiatry colleagues to determine.