The Oregon House Health Committee is seriously considering a proposal backed by a libertarian think-tank that would give terminally ill patients and their doctors permission to use drugs that have not been granted approval by the U.S. Food and Drug Administration.
The legislation mirrors a proposal that won sweeping support in a handful of states, including Democratic-controlled Colorado and Republican-controlled Michigan, as well as Arizona, where voters approved it in a ballot measure. The New England Journal of Medicine took up the ethical debate behind the concept in an issue last month.
House Bill 2300 “would not compel physicians or drug companies to provide any treatment,” said Steve Buckstein, the founder of the Cascade Policy Institute. “It would simply allow terminally ill patients the right to try to save their lives by allowing access to investigational medicines that have not yet been approved by the U.S. Food and Drug Administration.”
In the 1980s, tens of thousands of people died in the AIDS tragedy each year while the U.S. Food and Drug Administration lurched along with its methodical and incredibly expensive approval process for drugs, yet treatments for HIV were made available to patients in other modern countries with arguably better health systems, a Kafkaesque situation dramatized in the movie “Dallas Buyers Club.”
Today, drugs that help manage HIV and prevent AIDS have received the FDA’s blessing, but Americans with other terminal illnesses, such as cancer and Lou Gehrig’s Disease, still have to wait while their counterparts in Europe, Japan and other advanced countries receive treatments that their countries’ health authorities have approved.
Drugs that could slow the disease or alleviate the symptoms of amyotrophic lateral sclerosis have been proposed to the FDA, but it will likely take a decade for them to get approval under the glacial deliberation of the federal agency, regardless of how much money is raised by the ALS ice-bucket challenge, a fundraiser made popular by social media.
“While this process may keep unsafe or ineffective drugs off the market, it may also keep effective drugs away from critically ill patients for so long that they literally die waiting,” Buckstein said.
HB 2300 would allow some patients with terminal illnesses to take matter into their own hands, and, with the aid and counsel of a prescribing physician, try drugs under consideration by the FDA that would otherwise likely not be approved while they’re still alive.
Buckstein said the Arizona campaign was aided by the family of Diego Morris, a 13-year-old boy who likely would have died of cancer had his family not taken him to the United Kingdom to receive treatment that the FDA had not sanctioned.
HB 2300 provides a chance for the Cascade Policy Institute, which typically finds a friendlier audience among the Republican Party, to partner on legislation with the liberal chairman of the House Health Committee, Rep. Mitch Greenlick, D-Portland, who has a history of standing with the American Civil Liberties Union on legislation when few other Democrats will. Greenlick said that HB 2300 did not come before his committee on behalf of Cascade Policy Institute, though the group is the bill’s chief supporter.
“I think we have to see what the final form we have for it and what kind of support,” Greenlick told The Lund Report.
Greenlick appointed freshman Rep. Knute Buehler, R-Bend, to convene a work group with parties concerned about the legislation, including Providence Health & Services and the Oregon Medical Association, to reach an agreeable solution -- an assignment that Buehler, a physician, seemed eager to undertake.
Buehler’s task will be to shape a bill that keeps the “right-to-try” concept intact while putting enough sideboards on the legislation to ensure that Oregon is not flooded with unsafe snake oils that, as Providence’s Jessica Adamson put it, “do more harm than good.”
Matthew Hayes, a Cascade Policy Institute research associate, suggested that the bill be amended to allow only the use of drugs that had gone through Phase I of the FDA approval process, which ensures that the drugs have been tested and are not toxic.
Oregon Medical Association lobbyist Bryan Boehringer said his organization took a neutral view on HB 2300, but he said amendments like Hayes’ would make for a better bill.
Other amendments Buckstein suggested that would make the bill more liberal include opening the process up to minors (with parental consent) and allowing the drugs to be sold at-cost. In its current form, HB 2300 prohibits companies from charging for the unapproved medications.
In lengthier submitted testimony, Dr. Doug Koekkoek, Providence’s top Oregon executive, professed more detailed reservations with HB 2300, including the increased vulnerability of families who might be pressured to try questionable solutions. “Right-to-try” also risks undermining clinical integrity by allowing physicians to rely on treatments that might not be backed by sound science.
Koekkoek said that patients already have existing options available to them, including participation in clinical trials and FDA permission for compassionate use.
But Rep. Cedric Hayden, R-Cottage Grove, a dentist and the new vice-chairman of the Health Committee countered this idea, noting the FDA only grants such permission to a few thousand people every year.
