FDAAA Trials Tracker: leaderboard for pharma companies that break FDA clinical trial rules

Ben Goldacre (previously) led a team that created the FDAAA Trials Tracker, "A live informatics tool to monitor compliance with FDA requirements to report clinical trial results." Read the rest

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.

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Meet Science: How clinical trials work

Did you know that, with a properly conducted series of clinical trials, it can take upwards of 20 years before a medical discovery makes it from the lab to the hospital?

Judy Stone, an infectious disease specialist who does clinical research, has a guest post on the Scientific American blog network today, explaining the basics of clinical trials—where they came from, and how they can go wrong.

She's going to be publishing a series of posts on this topic, and is looking for input on what you want to know about clinical trials. Disclaimer: As a clinical researcher, Stone has a goal here. She'd like to see more people volunteering for clinical research, and part of what she's interested in is the gaps in knowledge that make people wary of participating, or leave them unaware that they can participate. Your input would be helpful.

Image: Pills Phial, a Creative Commons Attribution Share-Alike (2.0) image from luca_volpi's photostream

Clinical trials seek to learn whether a drug (or device) works as expected—it’s unknown, until tested in people. That’s why early phase trials use only a few people, and more are added as experience is gained. Sometimes unexpected discoveries are made along the way. For example, Rogaine was discovered by an astute clinician researcher during a clinical trial studying high blood pressure. The drug, minoxidil, originally under study as an anti-hypertensive medication, was serendipitously found to have the unexpected side effect of stimulating hair growth, prompting a whole new line of products for baldness.

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