Laws Imitate ‘Dallas Buyers Club’: States Pass Right-To-Try Legislation
Bills that would legalize the purchase of experimental drugs for terminally ill patients—a theme of a recent Oscar-winning film—are picking up steam at the state level. But a leading pharmaceutical group says the potential danger to patients isn't worth the risk.
The Oscar-winning life story of renegade AIDS patient Ron Woodroof appears ready to live on legislatively.
Bills and ballot initiatives allowing for access to experimental drugs—the issue at the root of Woodroof’s battle with the Food and Drug Administration, immortalized in last year’s Dallas Buyers Club—are drawing support from some states, even as doctors and the pharmaceutical industry take issue with the plan. More details:
A “right to try”: Several states, including Colorado and Louisiana, have passed laws that allow patients to make deals with pharmaceutical firms for access to experimental drugs, which generally require FDA approval before legal distribution. (The governors in those states have signed the bills into law; other efforts are moving forward in Arizona, Missouri, and elsewhere.) A similar bill at the federal level, the Compassionate Freedom of Choice Act of 2014, would provide that the FDA “shall not implement or enforce any law to prevent or restrict … the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.”
What’s behind the push? The bills are backed by the Goldwater Institute, a conservative Arizona-based think tank that focuses on state-level issues. In testimony given to the Louisiana legislature, the institute’s senior attorney, Kurt Altman, questioned why patients in the U.S. are denied access to drugs widely available elsewhere. “Many of these medicines are approved in other parts of the world. People of means can travel to Europe and Japan, where medicines developed here but not approved yet are being used sometimes effectively,” Altman said, according to The Advocate. “It will give access to these medicines when they need it most, when they are terminal.”
Not like the movies: The pharmaceutical industry and some medical ethicists oppose the right-to-try bills. Speaking to the Wall Street Journal, Sascha Haverfield of the Pharmaceutical Research and Manufacturers of America said the best approach is to work within the system. “Successful completion of the clinical trial process is necessary to demonstrate that an investigational medicine is safe and effective, which is required to obtain FDA approval, so that companies may make the medicine available to a broader patient population when clinically appropriate,” he said. Bioethicist Arthur L. Caplan, Ph.D., a professor at New York University’s Langone Medical Center, noted that the circumstances in the Dallas Buyers Club story do not exist today. “The ‘right to try’ laws have been crafted by ideologues who, apparently taking their policy lessons from a movie, still think the FDA is the main roadblock to giving the terminally ill their last shot at life,” Caplan wrote on NBC News’ website.
The Colorado law includes exemptions to protect physicians and hospitals for being sued for prescribing experimental drugs to the terminally ill. With those provisions in place, the Colorado Medical Society and the Colorado Center for Hospice and Palliative Care withdrew their opposition and were neutral on the measure, according to the Denver Post.
Matthew McConaughey, shown in a scene from "Dallas Buyers Club." (Handout photo)