Wisconsin Health Committee passes experimental drug bill

Critics argue this sidesteps process to protect
patients, which could cause more harm than good.

MADISON, Wis. — The state Assembly Health Committee, in a bipartisan vote Wednesday, approved a bill opposed by the largest advocacy group for Wisconsin doctors that would expand the number of experimental drugs available to terminally ill patients.

Critics, most forcefully the Wisconsin Medical Society, argue that quickly approving experimental drugs sidesteps the process that’s designed to protect patients, could give false hope and in some cases cause more harm than good.

But Republican Rep. James Edming, R-Glen Flora, argued that the measure is designed to give hope to people who are running out of options.

“The next step for these folks is the obituary column,” Edming said. “If I was laying on my death bed, I would try anything.”

And Democratic Rep. Chris Taylor said she saw the mother of a close friend diagnosed with cancer who was unable to get into clinical drug trials die within a year.

“I really do think this offers some potential,” said Taylor, of Madison. “And it isn’t perfect, but very few things are perfect.”

Taylor and fellow Democratic Rep. Lisa Subeck, of Madison, joined with all Health Committee Republicans in voting for the bill. Democratic Reps. Debra Kolste and JoCasta Zamarripa voted against it.

The full Assembly plans to vote on the measure next week. It would also have to pass the Senate and be signed by Gov. Scott Walker before becoming law. The companion bill has yet to be introduced in the Senate.

Walker told reporters Wednesday he was “interested in the idea” and hoped it could complement changes at the federal level to speed up drug approval that President Donald Trump mentioned Tuesday in his speech to Congress.

“There’s a growing frustration the federal government isn’t moving quickly enough on things that could provide tremendous relief and maybe even save people’s lives,” Walker said.

The bill would require patients seeking the experimental drugs pending approval by the Food and Drug Administration to certify that they have a terminal illness, they’ve considered other options and have gotten recommended for treatment. It would also extend limited legal liability to doctors, pharmacists and others who participate.

One of the Medical Society’s biggest concerns is that patients will forego taking part in clinical trials to instead try experimental drugs, lobbyist Mark Grapentine said.

In an attempt to address the concern, the committee adopted an amendment requiring patients seeking experimental drugs to first be ineligible or unable to participate in a clinical trial within 100 miles of their homes, or to be determined unsuitable for any clinical trial by their doctor.

“We’re just saying when the other options have been exhausted, then let them move forward,” said the bill’s sponsor, Rep. Patrick Snyder, R-Wausau, in an interview.

But Grapentine said that doesn’t go far enough to address concerns the group has. Doctors are worried that sidestepping the FDA process for having access to new drugs and treatments doesn’t advance the best science for patients overall or individuals at a time when they are desperate for help, he said.

The Health Committee also amended the bill to require that doctors tell patients about the financial and health costs of potential experimental treatments. That will put doctors in a difficult position, given that they’re being asked to provide information about drugs that haven’t completed the FDA’s clinical trial process, Grapentine said.

Given the lack of data about how many patients are using experimental drugs in the 31 states that already have such laws, Grapentine said it’s also difficult to know whether it would even have much impact in Wisconsin.

“This all might be moot anyway because there may not be a lot of desire by individuals to put themselves through this,” he said.

The Wisconsin Academy of Family Physicians is also opposed to the measure, while the conservative group Americans for Prosperity supports it. Trump, in his speech to Congress on Tuesday, advocated for speeding up what he called the “slow and burdensome approval process” at the FDA.

Republican Sen. Ron Johnson, of Wisconsin, is advocating for a federal law. And the state bill has bipartisan support, with 17 of 33 senators and 45 of 99 Assembly members co-sponsoring it.