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A suicide draws attention to the ethics of psychiatric drug testing

This is a really important long read that we all need to pay attention to. It concerns how we treat people with who are suffering from paranoid delusions — and how we treat people whose families worry that they are a threat to others. It concerns the relationships between doctors and the pharmaceutical industry. It concerns the ethics of clinical trials — the risks we run as we test potential treatments that could help many, or hurt a few, or both. If we want to reform mental health care, this needs to be part of the discussion.

In 2004, Dan Markingson committed suicide. The story behind that death is complicated and depressing. At the Molecules to Medicine blog, Judy Stone documents the whole thing in three must-read chapters. Many people find help in psychiatric drugs, and credit those drugs with making their lives better. (Full disclosure, I'm one of them. I have used Ritalin for several years. I am temporarily on an anti-depressant.) But we have to pay attention to how those drugs get to us. This isn't just about treating people. It's about the process that gets us there. Because, if that process is compromised, the treatments we get won't be as effective and lives will be lost along the way.

Markingson began to show signs of paranoia and delusions in 2003, believing that he needed to murder his mother. He was committed to Fairview Hospital involuntarily after being evaluated by Dr. Stephen Olson, of the University of Minnesota. He was subsequently enrolled on a clinical trial of antipsychotic drugs—despite protests from his mother. This study was a comparison of atypical antipsychotics for the treatment of first episodes of schizophrenia (aka the CAFÉ study), sponsored by AstraZeneca. The study’s structure was that of a Phase 4 randomized, double-blind trial comparing the effectiveness of three different atypical antipsychotic drugs: Zyprexa (olanzapine), Risperdal (risperidone) and Seroquel (quetiapine), with each patient to be treated for a year.

After about two weeks on study treatment in the hospital, Markingson was discharged to a halfway house—again over his mother’s objections. Over the coming months, Dan’s mother, Mary Weiss, continued to express concerns about her son’s deterioration, even asking if her son might have to kill himself before anyone else would take notice…then, in fact, her son violently committed suicide on May 7, 2004, mutilating himself with a box cutter. The University of Minnesota and their IRB have maintained that the study was conducted appropriately and that they have no responsibility for Dan’s death. Dan’s mother and bioethicist Carl Elliott believe otherwise.

We’ll explore some of the major issues of contention in this case over several posts, as illustrative of basic clinical research principles, including adequacy of informed consent, IRB oversight, conflicts of interest, and coercion, including threats to a bioethicist whistleblower.

Read the first part of the story

Read the second part: How clinical trials should be done and how they were done in this case.

Read the third part: Conflicts of interest between the researchers and the pharmaceutical industry.

Image: Pills (white rabbit), a Creative Commons Attribution (2.0) image from erix's photostream

It's time for psychiatrists to stop being so friendly with pharmaceutical companies

Psychiatry is "committing professional suicide" because psychiatrists are far too willing to accept gifts, food, trips, and free samples from the pharmaceutical companies that push psychiatric drugs, says psychiatrist David Healy. Worse, he says, those same drug companies have been caught hiding dangerous results from the FDA and doctors, covering up that malfeasance, and attempting to silence critics (including Healy himself). At Time's Healthland blog, Maia Szalavitz shows that Healy makes a persuasive case against the pharmaceutical giants and in favor of patients, doctors, and the federal government doing more to hold these companies accountable. Maggie

"Printing" pharmaceuticals with a 3D printer

A Nature Chemistry paper by researchers from the University of Glasgow describes a process for "printing" pharmaceutical compounds from various feedstocks, and supposes a future in which we have diagnosis/medication manufacturies at home. The process uses an off-the-shelf 3D printer technology to assemble pre-filled "vessels" in ways that create the desired chemical reaction in order to produce medicines. It's a scaled-down version of the industrial process used to manufacture drugs in bulk, and the paper's principal, Prof Lee Cronin, calls it "reactionware." From the BBC:

"We can fabricate these reactionware vessels using a 3D printer in a relatively short time. Even the most complicated vessels we've built have only take a few hours.

"By making the vessel itself part of the reaction process, the distinction between the reactor and the reaction becomes very hazy. It's a new way for chemists to think, and it gives us very specific control over reactions because we can continually refine the design of our vessels as required.

"For example, our initial reactionware designs allowed us to synthesize three previously unreported compounds and dictate the outcome of a fourth reaction solely by altering the chemical composition of the reactor."

...Prof Cronin added: "3D printers are becoming increasingly common and affordable. It's entirely possible that, in the future, we could see chemical engineering technology which is prohibitively expensive today filter down to laboratories and small commercial enterprises.

"Even more importantly, we could use 3D printers to revolutionise access to health care in the developing world, allowing diagnosis and treatment to happen in a much more efficient and economical way than is possible now.

"We could even see 3D printers reach into homes and become fabricators of domestic items, including medications. Perhaps with the introduction of carefully-controlled software 'apps', similar to the ones available from Apple, we could see consumers have access to a personal drug designer they could use at home to create the medication they need."

'DIY drugstores' in development by Glasgow University researchers

Birth control recall

Failing to prevent pregnancy is a pretty big failure for a birth control pill. Pfizer is trying to avoid that outcome by recalling 1 million packets of potentially defective pills. What's the problem? Every packet contains 3 week's worth of birth control pills and a week's worth of sugar pills—basically to keep you in the habit of taking a pill every day even during your period week. Some of the defective packs don't contain enough sugar pills. That's not really a problem. In others, however, the actual birth control pills have been swapped for extra sugar pills. That's what Pfizer is worried about. The recall includes Pfizer Lo/Ovral-28 tablets and Akrimax Pharmaceuticals brand Norgestrel and Ethinyl Estradiol tablets. Maggie

Pharmaceutical company funds documentary about over-eating

fat kitty big.jpg

GlaxoSmithKline is financing a documentary about over-eating, in the hopes that it will boost sales of Alli—their over-the-counter drug that blocks your body from absorbing some of the fat you eat. (Fun game: Read the recent Science Question from a Toddler on poop and see if you can guess what the common side-effects are.)

Glaxo says they won't have control over the content of the film and won't even be pushing to make sure Alli gets mentioned. They simply want to educate Americans about the fact that they eat too much.

The partners say they hope to emulate "An Inconvenient Truth," Al Gore's celebrated 2006 documentary on climate change. It cost an estimated $1.5 million to produce and sold $50 million in tickets worldwide. Ms. Ferdinando summarized the film as "the 'Inconvenient Truth' of mindless eating," with the story taking a "behind-closed-doors, fly-on-the-wall" approach that highlights unhealthy relationships people have with food.

Artistically, the problem I see here is that successful documentaries—and really documentaries in general—are usually about challenging popular perception and either making a case for a viewpoint that's counter to "common-sense" or informing people about a situation that's mostly being ignored. The thesis "Fat People Eat Too Much" does not exactly fit into that mold.

New York Times: Glaxo, diet drug maker, to pay for film on eating

Image courtesy Flickr user yukariryu, via CC