The physician and senator from Northwest Portland and Beaverton shared concerns raised by medical ethicist John Tuohey of Providence that HB 2300 unnecessarily exposes patients to untested drugs without safeguards for patient safety.
Right-to-try legislation that passed the House unanimously faces a more difficult path through the Senate because of opposition from a key lawmaker, the physician-Sen. Elizabeth Steiner Hayward, D-Portland, who raised ethical concerns about HB 2300.
The bill gives terminally ill patients the opportunity to try medications that have been approved in other countries, but have only cleared the first phase of the laborious and expensive approval process required by the U.S. Food & Drug Administration. Under the bill, patients could bypass the FDA with the agreement of their doctors and pharmaceutical companies.
Steiner Hayward seconded the thoughts expressed by the Rev. John Tuohey, a medical ethicist at Providence Health & Services, who argued that the FDA’s current compassionate use waiver was both sufficient and safer than the libertarian policy perspective of HB 2300:
“No one ever likes to believe that there’s nothing else that can be done to treat a disease, and that the time has come to begin to manage one’s final days, and HB 2300A appears to provide another avenue to keep hope alive,” Tuohey told the Senate Health Committee on Monday. “It does so, however, without the proven safeguards to assure patient safety, financial stability and clinically reasonable options that are currently in place, and the evidence makes clear
“People who are vulnerable need protection from unrealistic or unsafe options,” he continued. “They are facing enough difficult decisions. The real justice issue of access to experimental drugs is not for the terminally ill, but for the poor and minority communities who rarely get into approved clinical trials. We should allow the new FDA process for compassionate use time to prove itself before opening the door to more non-scientific use of experimental drugs.”
House Bill 2300 is modeled after legislation promoted nationwide by the libertarian think tank the Goldwater Institute, but it has strong bipartisan backing from both the House Health Chairman, Rep. Mitch Greenlick, D-Portland, and another physician-legislator, Rep. Knute Buehler, R-Bend.
Greenlick was attracted to the legislation because of his own battle with a rare form of lymphoma, which he survived because of his access to clinical trials of experimental medication.
“I reacted very quickly to it, and I went into remission in about three months,” Greenlick said. “Those were drugs that in most circumstances wouldn’t have been available.”
Kurt Altman, a policy wonk at the Goldwater Institute, testified that the compassionate use waiver was granted about 99 percent of the time, but it still takes weeks to get approval for patients who don’t have time on their side. He claimed the waiver only applies to drugs in the late stages of the decade-long FDA approval process, while HB 2300 would give patients, with the approval of two physicians, access to medications making their way through the second and third phase of FDA trials.
“There are only 1,000 [compassionate use waiver] requests to the FDA,” Altman added. “Four hundred and fifty thousand die of cancer each year.”
Steiner Hayward compared Right-to-Try to the Death with Dignity law, something she supports, but which many physicians do not. “A lot of physicians are unwilling to be a part of it,” she said. “I’d be stuck between a rock and a hard place to fulfill my own oath as a doctor” with Right-to-Try.”
Some ethicists have pointed out that despite the great-sounding rhetoric of state lawmakers who support Right-to-Try, pharmaceutical companies are under no obligation to give patients access to their unapproved drugs, creating a false hope of a different kind — not false hope that the drugs might work, but a false hope that HB 2300 will remove a barrier to access. The bill does indemnify healthcare providers and drug manufacturers from civil liability for assisting a terminally ill patient who uses the drugs.
Steve Buckstein of the Cascade Policy Institute, the local conservative think tank that often takes it cues from the Goldwater Institute, also referenced the Death with Dignity Law as well as Dr. Jack Kevorkian, the late Michigan physician who spent most of his final years in prison for practicing euthanasia.
Buckstein said he knew the first person Kevorkian assisted with suicide, Janet Adkins of Oregon. Instead of exercising her right to die, Buckstein argued that HB 2300 might have allowed her to exercise her right to combat early onset Alzheimer’s — for which there is no cure, either approved or experimental. “The patient should have more choice in the matter when they have a terminal illness,” Buckstein said.
June 2, 2015
The Lund Report