Selling Sickness 2013

“right to try” laws – boon for desperate patients or cruel trick?

Colorado has recently signed the first “Right to Try” law  allowing patients with terminal diagnoses who are out of medical options to apply directly to companies to try drugs that are in development but which have not yet been approved by the FDA. The law was prepared by a Republican physician member of the legislature who received support from the conservative Goldwater Institute.

A long piece on The Goldwater website praising this legislative development uses revealing libertarian rhetoric such as “Patients should be free to exercise a basic freedom – attempting to preserve one’s own life. The burdens imposed on a terminal patient who fights to save his or her own life are a violation of personal liberty.“ It doesn’t seem that the Goldwater Institute or the laws are all that concerned about safety, gathering information useful for other patients, or basic protections of informed consent.

Others have called the Colorado bill a cruel trick, in that it gives false hope to desperate patients who actually already CAN get these experimental drugs through a compassionate access program sponsored by the FDA since the late 1980s and modified and updated several times. The FDA has a written procedure (which some call cumbersome) but it also provides opportunity for immediate access even without the written forms in a true emergency, where the access is needed within a few hours or days.

A further angle of the story is provided in an important recent New York Times piece by a doctor who describes how he and his physician sister got access to experimental drugs for their father directly from a company only to see his death hastened by unexpected side effects.

The FDA has a process for patients, on their own or through their physicians’ intervention, to obtain access to these drugs. Why then are these “right to try” laws being proposed and passed? I (LT) see it as a way to hijack the patient rights rhetoric and link it to anti-government sentiment. The history of patient access to experimental drugs goes back to the HIV/AIDS movement in the 1980s when the government did stand in the way of such access. The extraordinary must-see Oscar-winning movie from 2013, “The Dallas Buyer’s Club,” tells this story and the new Colorado and other bills are named for this film. BUT, 2014 is not 1985, and the FDA is playing quite a different role now, thanks to the brave AIDS and breast cancer activists of those years.

Beware the simplistic analysis that overemphasizes “rights” and fails to discuss “protections.” SELLING SICKNESS teaches us that the government is balancing these all the time — the market is not.

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