Indiana became the 11th state last week to sign a controversial ‘Right to Try’ bill into law, allowing some desperately ill patients easier access to non FDA-approved experimental medications. The cause has been popularized in recent years due to the critically-acclaimed film, “Dallas Buyers Club,” which was about smuggling unapproved medications in order to help AIDS patients. Momentum for the laws is building, as 10 more states have some version in play for approval in 2015. The wave of legislation has occurred at the state level, due to a 2007 Federal Appeals Court ruling that patients do not have a constitutional right to medicines that are not federally approved. The Supreme Court refused the case, making any federal legislation essentially impossible. Although these laws have gained rapid popular and political support since the debut of the film, many critics find the law to be both dangerous and ineffective.
Although differing slightly by state, the basic premise of these laws gives doctors and terminally-ill patients the right to ask pharmaceutical companies to try experimental medicines directly, bypassing Food and Drug Administration (FDA) permission. It also exempts doctors who prescribe these experimental drugs from lawsuits as well as some states’ versions of the law offering protection for drug-makers if treatment runs afoul. Beyond its practical applicability, however, the main philosophical focus is on the often multiple-years long regulatory process needed for FDA approval of experimental drugs, especially for patients who don’t have enough time to wait for it. As Frank Burroughs of the Abigail Alliance advocacy group states, the wave of efforts is “very important in elevating the issue on Capitol Hill for passing definitive legislation.”
Not everybody has greeted this wave with such optimism, though. Dr. David Gorski, a Michigan surgeon and medical blogger, raises concerns about the danger and potentially painful effects of these drugs claiming, “They’re far more likely to harm patients than to help them.” Gorski continues, calling the laws “a cruel sham.” His main assertion is that FDA permission is hardly the roadblock for experimental treatment. In fact, the FDA approved 99.5 percent of the nearly 1900 experimental bypass requests it received in fiscal 2014, and has had a “compassionate use” program in place since it was created in 1987 to help stem the AIDS crisis.
It’s the drug companies that have prevented the law from being useful. These companies are generally averse to risking their investment, sometimes close to $1 billion dollars in R&D on a drug, only to have it gain notoriety after a bad experimental outcome and jeopardizing FDA approval. As of January, 2015, there were no documented cases of the law actually helping to obtain experimental medicine outside of the compassionate use provisions. According to bioethics expert, Art Caplan, “It’s more like right to beg. And it’s easy for politicians to pass.” At the same time, these laws may push Congress and the FDA to rethink and streamline the status-quo.
Wall Street Journal – Ed Silverman
New York Times – Julie Turkewitz