The DIY Clinical Trial

[Thanks to duplicity for suggesting this show.]

Chelsea noted in her post for Marcia Angell on Big Pharma last week that we were were thinking about a whole series on our pharmaceutical nation. It actually occurs to me now that tomorrow’s sports doping show might qualify, but this fantastic pitch from our loyal (and not at all duplicitous) listener duplicity certainly does:

I just came across this news item about a group of cancer patients who are putting together a sort of open-source Phase III clinical trial for terminal cancer at thedcasite.com.

Basically there’s a compound that has been shown to reduce human tumors growing in rodents, but no major trial of the drug has been performed in humans — at least partially because there is no money in a potential patent for the drug, which is the way Big Pharm recoups its losses in funding large-scale human clinical trials of experimental drugs. The drug is available online (‘for veterinary use,’ to bypass the FDA), and terminal cancer patients have been ordering it and plan to track their response to the group as a database (should we suggest a wiki?). Scientifically speaking, this would not provide proof of the drug’s effectiveness unless it is properly done (as Dr. Evangelos Michelakis is trying), but such trials are arduous, expensive, heavily regulated and controlled, and necessarily slow.

The bioethical questions surrounding drug development, trials, and approval notwithstanding, an analysis of this situation could provide insight into how and why medical treatment is dominated by large corporations, the role of the internet in and the overall pace of contemporary medicine, access to experimental drugs for terminally ill patients (on which I seem to recall a New York Times Magazine or New Yorker piece on not too long ago), and a whole slew of other questions. It’s clearly life-or-death in some people’s minds, but the question lingers about whether it really works or it’s going to be like a set of other promising anti-cancer drugs that have been disappointing.

duplicity, in a show pitch to Open Source

Duplicity should get an extra scoop of ice cream for this.

I’m putting calls out to the people running this bottom-up, democratized, decentralized clinical trial, as well as Dr. Evangelos Michelakis, who did the original research that’s gotten people so excited. More soon.

You might be used to public radio stations (and shows!) asking the public for money, but when’s the last time you read a direct appeal from a medical researcher?

This is part of a recent funding update from Dr. Evangelos Michelakis, the Alberta cardiologist who is spearheading DCA research:

We continue to be moved by your sustained interest and support of our efforts. We have been working tirelessly over the past several months to bring this research from the laboratory to the level of a clinical trial. This is a very challenging endeavor since it is not supported by the pharmaceutical industry. The process of bringing a drug from animal research to clinical trial takes a few years. However over the past three months, we have made significant progress towards achieving our goals….

More importantly, we would like to remind you that this work, at least at its early stages, will not be able to be completed without your ongoing support.

Dr. Evangelos Michelakis, in a letter in DCA Research Information

Are citizen-funded research initiatives and patient-run clinical trials the wave of the future — or a brief detour on the way back to Big Pharma’s business as usual?