Legislators heard emotional testimony Thursday from an Emporia woman about a bill to allow access to drugs in preliminary federal testing.
They also heard questions about whether the “Right to Try” legislation is sound policy or an ideological quest that will give terminal patients false hope.
Versions of “Right to Try” have passed in Missouri, Colorado, Arizona, Michigan and Louisiana.
Like Missouri’s version, Kansas’ version, House Bill 2004, is based on model legislation from the Goldwater Institute, a conservative think tank from Arizona with a focus on limited government.
It seeks to allow Kansans with terminal illnesses who otherwise have been unable to enter clinical drug trials to access drugs that have passed the first phase of trials with the U.S. Food and Drug Administration. They would still need the permission of their doctors and the drug manufacturers.
The bill was introduced by three conservative Republican legislators: Rep. Craig McPherson from Olathe, Rep. Brett Hildabrand from Shawnee and Rep. Mike Kiegerl from Olathe.
Hildabrand told the House Health and Human Services Committee that the full FDA approval process routinely takes more than 10 years and the bill is “all about compassion.”
“This is a liberty issue, where patients have the right to determine for their own person what is best for them, so that government bureaucracy would not stand in the way of their health care needs,” he said. “These are terminally ill patients. These are patients whose doctors have essentially given them a death sentence.”
Emporia resident Kelli Johnson told legislators about when a doctor at the Mayo Clinic in Minnesota diagnosed her with amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease. The doctor informed her that the illness would slowly paralyze her and that most people only live two or three years after the diagnosis.
Johnson now uses a motorized wheelchair and speaks with difficulty because of her weakening diaphragm. She told legislators she remains “fully aware of what’s happening” to her as she loses physical function.
She said she realizes the risks of taking unapproved drugs but sees little downside.
“The worst-case scenario is it will make me die faster, and even then we might learn something,” Johnson said.
Rep. Barbara Bollier, a retired physician from Mission Hills, asked Johnson if she had applied for the FDA’s “expanded access” program, which allows more people into clinical trials.
Johnson said she had not, largely because it takes a physician more than 100 hours to fill out the paperwork to apply.
John Carney, president of the Center for Practical Bioethics in Kansas City, said the bill does not meet ethicists’ five-part test for sound public policy that seeks to “rescue” patients facing imminent death.
The five parts, he said, are that the patients must be easily identifiable, they must be under acute risk of impending death, there must be a reasonable chance of rescue, the risks or costs to the rescuer must be acceptable and the circumstances leading to the rescue must be exceptional.
Carney said the legislation introduced in Kansas does not do enough to identify who it will benefit or provide a reasonable chance that they actually would benefit.
The first phase of FDA trials involve very small samples of patients, and they test only to ensure a drug’s immediate safety, not its effectiveness.
“We are not bound nor should automatically assume we ought to provide a treatment that offers no benefit,” Carney said.
He also said drug manufacturers are not likely to agree to give their products to medically fragile patients who are not part of a formal trial, for fear of skewing results.
The FDA has expanded access to clinical trials for terminal patients in recent years and has pledged to continue streamlining the process, Carney said.
Carney’s group officially testified as neutral on the proposal, as did the Kansas Department of Health and Environment and the Kansas Medical Society.
KDHE officials said the bill left ambiguity as to who would be responsible for paying for negative side effects that a Medicaid patient might suffer as a result of taking an unapproved drug.
The Kansas Medical Society, which represents doctors throughout the state, offered an amendment to clarify that doctors who help their patients gain access to such drugs would not be liable for negative consequences. McPherson said those who introduced the bill would be supportive of the amendment.
The medical society also questioned whether federal law still would restrict terminal patients in Kansas from taking unapproved drugs.
Rep. Dan Hawkins, the chairman of the House health committee, asked one of the bill drafters from the Goldwater Institute about its legality. Hawkins noted that a federal appeals court in Washington, D.C., had recently ruled against a similar measure.
Kurt Altman, the Goldwater Institute researcher, said that decision had limited reach and passing HB 2004 would strike a blow for states’ rights.
“Medical regulation and rights of this sort are generally left to the states,” Altman said.
Andy Marso is a reporter for KHI News Service in Topeka, a partner in the Heartland Health Monitor team.
