The Scientist : NewsBlog Print: Psychiatry researcher steps down

DIsclosure -- I work in university tech transfer (not at Stanford) -- that is the POV from which this is written.

These conflicts issues are difficult to think though and easy to sensationalize. The potential negative consequences of sensationalizing them are not small.

It seems to me that this post, and the earlier one on June 25th, both push toward sensationalizing.

I am grateful in general for the news of the story as it develops, though.

But to the point -- if you read the Stanford letter (as I encourage readers to do), you will find that Stanford vigorously defends its conflicts management process, and provides quite a bit of detail that precisely describes the evolving way it managed the conflicts -- almost all of which seems quite reasonable and careful.

I especially admire the way they acknowledge changes to their policies and procedures as their (and all of our) ideas about how best to manage conflicts evolved.

Since universities are very risk averse, having Schatzberg step down as PI of the grant is a pretty unsurprising thing to do in light of the negative publicity. It seems to be a useful way to try to turn down the heat on this stuff. I don't think it should necessarily be interpreted, as Bob seems to do, to mean that the conflicts in this situation are unmanageable nor that Stanford has conceded serious errors.

Most importantly, the Stanford letter makes a clear claim that Schatzberg is not "running clinical trials" for the drug, as Bob reported back on June 25 (see the first paragraph of that post, the sensationalism of which caught my eye at that time). The Stanford letter indicates that Schatzberg has not been directing trials at Stanford for this drug since 2002. Based on these few documents it is not clear to me when clinical trials began at Stanford. It ~could be~ that there was a time prior to 2002 when Schatzberg did oversee actual dosing of patients; it could be that trials did not start until after 2002. In either event his financial interest in the company was probably much smaller then.

But use of the present tense ("is running clinical trials") on June 25th does not appear accurate, and that was probably the most inflammatory sentence in both posts.

The letter also explains the supposedly "unreported payments" made to Schatzberg in a reasonable way.

And as for "Stanford's ties to the company" the letter claims that at the end of 2002, Stanford changed its policies such that it does not hold stock in licensees conducting clinical trials at Stanford (see last paragraph on page 8)-- so it has sold off the Corcept stock it received under the license deal. That seems quite rigorous to me!

There may be facts I am missing, but it seems to me that when you look at this more closely, the situation is not that bad. I don't know yet...I am interested to see more facts come out before I decide.

One of the interesting things in this letter, is the brief description of how Corcept came to have a license to the patent (which covers a method to use RU-486 - "the abortion drug") to treat depression and AD. It seems that Stanford tried to license it to existing companies, and got no takers. Go figure!

So what do you when you can't license a promising invention and you have a PI who is nonetheless passionate about developing it? You work with the PI to start a company. Which means you are going to have conflicts. Which need to be managed and disclosed. And there will be glitches.

The alternative of course would just be to let promising ideas like this one die, or just keep puttering around with them in the ivory tower. Would that benefit the public? Would that lead to an FDA-approved drug that doctors could prescribe? I don't think so.

This blog could provide a service by helping people clearly think through this stuff in general and this controversy in particular, instead of - as it seems to do to me -- trying to pour gas on the fire.

Just my two cents.

Thanks again for communicating updates on the story.