Monday, August 23, 2010

"Making a Killing": New Carl Elliott Article in Mother Jones

There's a fascinating article by Carl Elliott in the current issue of Mother Jones. It's called "Making a Killing," and it shows how clinical trials have become marketing exercises for the pharmaceutical industry, sometimes at the expense of patients' lives. (You can read the article here, but you will need to complete a free registrations process).

The focus is on Astra Zeneca, maker of the antipsychotic Seroquel. Elliott tells the tragic story of Dan Markingson, a young man with schizophrenia who killed himself in a particularly gruesome way in May of 2004. At the time, Markingson was enrolled in an Astra Zeneca-funded study called the CAFE study. The acronym CAFE stands for "Comparison of Atypicals in First Episode of Psychosis." As the name implies, this study randomly assigned patients to three possible antipsychotics: Seroquel, Risperdal, and Zyprexa. The bottom line result, according the abstract in the American Journal of Psychiatry, was that the three drugs were equally effective.

However, Elliott makes the case that the study was rigged in various ways by the Astra Zeneca marketers to ensure that Seroquel would, at the least, not look any worse than its competitors. While this devious tactic may not be much of a news flash, Elliott is
claiming that something more insidious happened--namely, that Dan Markingson was pressured to put his life on the line for a drug company's profits.

Elliott acknowledges that there are risks in any clinical study. When the study is trying to answer a significant scientific questions, these risks may be reasonable. But when the study is designed to boost sales of a drug, these risks are very hard to defend.

As Elliott puts it: "It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goals of AstraZeneca."

I had read the CAFE study before, but as I was preparing this post, I noticed aspects of the design that had not struck me in the past. The study may well have been manipulated in order to make Seroquel look good. In my next post I will delve into the specifics, so stay tuned.


Bernard Carroll said...

Another distressing aspect is that the CAFE study was conducted by the same people who ran the CATIE project. CATIE was funded by NIH and it rightly drew praise for exploding the marketing myth that the new antipsychotic drugs are better and safer than the earlier drugs. The newer drugs are also much, much more expensive, so they generate billions for the corporations.

Now we have the spectacle of the same academic investigators signing on for this blatant experimercial called CAFE that had no scientific merit – it was just a marketing exercise. What were they thinking? And what were the IRBs at Columbia and elsewhere thinking when they approved this undistinguished study?

As the saying goes, money talks.
Worse, this kind of pretend clinical trial treats patients as commodities.

Anonymous said...

Unfortunately, I couldn't access the article so I will wait for it to be accessible publicly next week.

Anyway, as one who has been critical of psychiatry for not exposing these types of abuses, I wanted to highly commend you for blogging about the Dan Markingson tragedy. I was familiar with the story but had no idea that it actually may be worse than folks initially thought it was.

Dr. Carroll, thank you for your comment. I always look forward to your posts.

Anonymous said...

At the time of the CATIE study I was a patient at a participating facility. They had a habit of enrolling us in studies. Of course, officially, it was with informed consent because we signed all the appropriate papers. I didn't resist most of the studies too much. But the CATIE study I resisted. I was pressured to enroll. Eventually they left me alone, but one of my friends caved in and was enrolled in the study.

I've learned that, while academic hospitals/clinics have their benefits, they definitly have their drawbacks. I really felt that my care would be in jeopardy if I didn't participate in the studies that were presented to me. When I didn't want to participate in the CATIE study, I felt I was taking a big risk with my healthcare.

I didn't have to participate in CATIE to find out that atypicals aren't necessarily better than Trilafon. It turns out, for me, 1 atypical and Trilafon is much better than 2 atypicals.

Anonymous said...

I wouldn't normally do this with an embargoed piece, but here's a link to the Mother Jones article in pdf form: article

Sara said...

Thanks to the August 24 2:42 PM Anonymous for posting the MJ article. I haven't read it yet but I'm pretty sure it won't really be news to me. Mad in America by Robert Whitaker was published several years ago now and that outlines very well just how corrupt and dangerous the clinical trials for atypicals really were from day one. I honestly believe clinicians have had blinders on about how the drugs are affecting the "disease process" and kidding themselves enormously about what's going on with standard paradigms of care. I think I detect a bit of enlightenment finally penetrating Dr. Carlat's thinking. I hope so. Certainly the fact that he is blogging on articles like this one is a good sign. Thanks!

Joel Hassman, MD said...

Just bought the issue last night, mostly due to the headliner at the top about clinical trial issues, and now reading here it is about Seroquel, I pat myself on the back for the purchase!

Got to tell you, I am sick of the hassles to get authorizations for these new versions of now generic drugs, like Lexapro for Celexa, Pristiq for Effexor, Invega for Risperdal. Why aren't colleagues working in primary care psychiatric settings realizing this bs to write for these "new" drugs is not worth the hassles?

Notice I did not mention Seroquel XR. As I do not acknowledge it, the way it is being marketed "off the cuff" for anxiolytic purposes. I hope AZ crashes and burns with what I interpret as florid greedy intents.

Note I word that as my interpretation, not a slanderous/libelous intent. You have to watch out for what you write now, thanks to the recent ruling about consequences for participating at blogs and other internet commentary.

By the way, have been living a New England summer here in Maine, Dr C. It has been nice, but also illuminating. Back to my old haunts in September.

Neuroskeptic said...

Thanks for the MJ link, will take a look.

On a similar note, a paper's just come out called From Evidence-Based Medicine to Marketing-Based Medicine. Guess what it's about. Lots of stuff on Seroquel, amongst others.

...... said...

A disabled female psychiatric patient was forced into an unethical Eli Lilly drug trial for psychotic depression. She was not globally competent due to severe PTSD. Her medical record was doctored to exclude her real diagnoses and a long history of suicide by train attempts. She ended up in the placebo group, was out of control for about a month, with terrible suffering, only being treated with Ativan. She was broken out of the study and forced to go back and forth to another hospital for ECT. She escaped from the ambulance, threw herself under a train, and later died of her injuries. I reported it to DMH who had reviewed the case but not notified law enforcement of the manslaughter. I was retaliated against for contacting DMH. I had tried to prevent such cases in the first place, but was retaliated with a personal attack. Paul Appelbaum was part of this scenario. A Boston Globe investigation stopped the study.