Who should pay for patients with a deadly diagnosis to receive experimental drug treatments? For decades, the cost was borne by drugmakers. But ALS patients-- backed by Congress-- have found a new solution: the federal government.
“We don’t typically expect the government to pay for things until we know they work,” said Holly Fernandez Lynch, a University of Pennsylvania bioethicist. “But the system we have in this country relies on drug companies to develop our drugs, and private companies are not in the business of providing their products for free.”
During the 1980s and 1990s, Gonsalves and other HIV activists were instrumental in pushing drugmakers to provide early access to experimental medications.ALS patients say most companies in their field are tiny startups that can’t afford such costs. Drugmakers have other reasons to deny access, including concerns that unexpected safety problems could hurt their approval chances.
“Unless the drug is a miracle drug, it’s unlikely you would see efficacy in this type of research,” said Dr. Walter Koroshetz, of the National Institute of Neurological Disorders and Stroke. Wallach spent several years working on the legislation with congressional staffers. It passed the House last year by a 423-3 vote, a rare display of bipartisanship that also underscored the group’s political clout.
“We used millions of dollars for our small expanded access program,” said Mary Kay Turner, a company executive. “So we did the maximum we could, but it was just a tiny sliver.” “Historically their only option was to go on the internet and try to buy these supplements or alternative therapies,” said Bedlack, who consults for several drugmakers.
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