Art. 3 of the Universal Declaration of Human Rights (UDHR) proclaimed by the United Nations General Assembly in Paris on 10 December 1948 states: “Every one has the right to life, liberty and security of the person” (“Tout individu a doit à la vie, à la liberté et à la sûreté de sa personne”)
One could think that the right to life includes the right to exercise a basic freedom – attempting to preserve one’s own life- without having to get permission from the FDA to use the drug of their choice.
But in the name of its congressionally-mandated authority to protect the public from therapies that are not safe and effective, the FDA has created an approval system so strict that before a drug can be made available to the general public, it must undergo a lengthy and expensive clinical trial process to determine its safety and efficacy, which takes on average 10 to 15 years and over $800 million dollars to complete (1)
Forty percent of cancer patients attempt to enroll in clinical trials, but many of these patients are turned away because they do not meet the stringent eligibility requirements or because they do not live near or have the ability to travel to a medical facility where the trial is being conducted.
Last week Colorado became the first state to allow terminally ill patients to have access to experimental medicine not yet approved by the FDA. Missouri and Louisiana are poised to follow; Colorado’s “Right to Try” bill allows patients and doctors to work together to secure experimental treatments with the permission of a pharmaceutical company. Insurance companies are not required to pay for the treatment, and drug manufacturers can choose whether to charge for the medication or to provide it to the patient free of charge. People diagnosed with a “terminal disease” (“terminal disease” being defined as an advanced stage of a disease with an unfavorable prognosis and no known cure) will have the option of accessing investigational drugs which have passed basic safety tests, provided there is a doctor’s recommendation, informed consent, and the willingness of the manufacturer of the medication to make such drugs available.
Sen. Irene Aguilar, a physician and bill co-sponsor, has taken to calling the legislation the “Dallas Buyers Club” bill, after the 2013 film that adapted the story of an AIDS patient who smuggled unapproved pharmaceuticals from Mexico to Texas in order to treat symptoms. “When you’re terminal and there’s a drug out there that might help you, it can seem that the obstacles to get that drug are insurmountable,” she said.
So far Colorado’s bill got a careful “no-comment” from state doctors’ groups, hospitals and health insurers. The bill was amended to clarify that healthcare providers and insurers aren’t liable if a patient who uses a drug outside clinical trials gets sick or dies.
(1) “2013 Profile Biopharmaceutical Research Industry,” PhRMA, 2013, http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf