Grain Of Salt

There’s been plenty of coverage in the past week on the latest drug company to hit an ethical bump in the road of marketing their atypical antipsychotic, coverage we didn’t feel like we could add much to. Instead, I encourage you to read Furious Seasons’ take on it, the first blogger to break the story online (Philip is also in the middle of a fund-raiser, so consider putting a few bucks in). He’ll have continuing updates on the story. CL Psych also has his typical initial witty analysis, and Dr. Carlat has weighed in on the secret documents and sexual relationships involved. CL Psych has since published a more thorough analysis of what the documents show, research-wise.

But what I found amusing (and enlightening) was yesterday’s entry on Furious Seasons about one of the top 5 largest prescribers of Seroquel in the U.S., Community Mental Health Service in Chicago, IL, apparently run by Dr. Michael Reinstein. Exhibit 17 from the court documents provided by Furious Seasons shows how they were apparently threatening AZ with reducing their prescriptions of Seroquel if AZ didn’t push more research opportunities their way:

This group, in particular John Sonneberg, Ph.D., Director of Research has been extremely persistent in recent months with demanding research from AZ. Their comments to several AZ employees suggest since they use large volumes of Seroquel they should by default be doing research on our behalf. They have further implied that should they not get research funding that they would switch patients currently on Seroquel to competitive agent(s).

Our Clinical colleagues have significant and numerous issues in past with the quality of research that this group has produced in the past. Matters such as not getting informed consent from study participants, modification of protocols without permission […]. There is little confidence that Good Clinical Practices can be adhered to. Their research is often criticized by peers in Psychiatry.

Now take that analysis with a grain of salt as the opinion of one AZ employee explaining the background of the situation to a superior, and it was written 8 years ago. We do not know the truth or accuracy of these statements.

If true, however, apparently some researcher-practitioners seem to have had little ethical regard for promoting a product in a quid-pro-quo arrangement — send us lucrative research contracts, or we’ll stop prescribing as much of your drug. The sliminess of these alleged practices is truly astonishing.

You need look no further than something like this that was occurring 8 years ago (we have no idea if these kinds of practices are still going on; we hope not) to see how troubled the relationship between industry and researchers has become. But the exhibit also shows something we don’t see enough of in these kinds of disclosures — a pharmaceutical company standing up for its own internal quality standards and trying their best not to be shaken down.

You can also view another interesting discussion in Exhibit 42, where John Tumas at AZ argues for full disclosure of a study that apparently did not show great results for Seroquel, something called “COSTAR.” COSTAR, sadly, was never published as Tumas argued that it should have been. A decade ago, Tumas rightfully predicted the negative backlash all pharmaceutical companies have been enduring now for a few years for suppressing negative clinical trial data.

These are extremely interesting disclosures, and we suspect that as court cases proceed regarding this and other medications, we’ll see more of these kinds of things to come.