Friday, January 30, 2009

Nice Article on the Zyprexa Debacle

In the course of this past month I have been blogging about Eli Lilly and Zyprexa (olanzapine) and how the company marketing managed to make a silk purse out of this medication, which we now know to have been massively overhyped both as to its efficacy and its safety. We are now onto their tricks, and Lilly is being hit with record fines--just as Zyprexa is about to go off patent anyway and as Lilly is taking the $16 billion it made on the drug to the bank. A new article, generally very good, on the history of this debacle, called to my attention by a loyal ally of this blog, is:

http://www.rollingstone.com/politics/story/25569107/bitter_pill

Some great quotes-- after starting off talking about how medical investigators have to be wary of placebo effects among the subjects which could produce misleading results, the author goes on: "The story of how Zyprexa and other atypicals [newer drugs for psychosis] became a multibillion-dollar market suggests that the medical community — doctors, researchers, the institutions that back them — may be themselves prone to a placebo effect: the willed conviction that a new drug, presented as a breakthrough, must in fact be one, that a product sold as healing must in fact do good."

And: "[Allen] Jones, [an inspector for the PA inspector general's office turned Zyprexa whistle-blower] an outsider gazing in, thought he saw a basic quid pro quo, a corrupt transaction between two parties that stood to benefit. But it is possible that he missed a more complex and fundamental truth: that the system of developing and marketing drugs is so broken that it can coax corruption out of well-meaning doctors who think they are doing good. Every incremental permission that the atypical makers allowed themselves, and the regulators allowed them — structuring their studies in the most advantageous ways, omitting studies unhelpful to their cause, publicizing only the most supportive data — helped shift the medical perception of the atypicals. The companies didn't need to pay off doctors. They just needed to put the grant money out there and wait for the true believers...to walk through the door."

Indeed if I had one criticism of this otherwise insightful article by Ben Wallace-Wells, it is his readiness to excuse physicians as being subject to a "placebo effect" rather than a "basic quid pro quo." As this blog has documented numerous times, there is sadly enough evidence of the latter to balance out the undoubted occurrence of the former.

Wallace-Wells ends his article with a plea for a return to the older days of psychiatry--when psychiatrists actually spent time with their patients, talked with them, got involved with the events in their lives, and monitored them carefully enough so that no drug side effect was likely to get out of control. He makes a good case that since those days, we have decided that it was too expensive for psychiatrists to spend that sort of time with patients with diseases such as schizophrenia. Let the lower-paid psychologists and social workers hold the patients' hands and let the MD simply show up once a month and write the prescriptions. Unfortunately, that assumes that the newer antipsychotics are rifle bullets that worked directly on the causes of schizophrenia, when based on what we now know they are much more like shotgun shells, if they hit the target at all. Wallace-Wells also cites a WHO study that hints that patients with schizophrenia in other parts of the world, where treatment is short on medications but long on social support, actually do better than in the US.

2 comments:

Bernard Carroll said...

"Indeed if I had one criticism of this otherwise insightful article by Ben Wallace-Wells, it is his readiness to excuse physicians as being subject to a "placebo effect" rather than a "basic quid pro quo." As this blog has documented numerous times, there is sadly enough evidence of the latter to balance out the undoubted occurrence of the former."

As one observer noted long ago, seduction does not occur unless at some level it is desired.

Anonymous said...

Financial conflicts of interest are not the only kind to worry about.

It is very easy to see that a doctor prescribing expensive but not very effective new meds might have a financial interest.

But what about the conflicts that come from maintaining the status quo because it benefits a career or allows one to get grants more easily? The status quo in a great many diseases and medical conditions is not very good at present. Yet those who try to find better ways to treat them are frequently up against a brick wall. I call your attention to the H. pylori discovery which was not made by the NIH, Yale, Harvard or any of our august institutions with large sums of money and big reputations. And it took them too long to admit Warren and his collaborator were correct.

Ethicists need to keep an eye peeled for status quoism hindering medical advances in treatment.