Dying patients seeking drugs may not see much change with new law
Cancer patients who have run out of options are the largest group that could benefit from the new Right to Try law intended to ease access to experimental drugs, thanks to the more than 1,000 oncology medicines in development in the U.S.
But don’t expect the floodgates to open.
That is the consensus that emerged from more than two dozen interviews at the recent American Society of Clinical Oncology meeting in Chicago, the biggest cancer gathering in the world. Bloomberg talked to executives at pharmaceutical giants from Merck & Co. to Johnson & Johnson; small biotechnology companies developing what could become the hottest new treatments; and doctors at the forefront of oncology research.
Merck, which has the blockbuster cancer drug Keytruda and a pipeline of experimental products, typified the industry’s viewpoint — that an existing system to provide desperate patients access to experimental drugs works well enough. The drugmaker was one of the big winners at the Chicago meeting, presenting data showing Keytruda prolonged the lives of patients with advanced lung cancer longer than chemotherapy.
“The best form of access is an approved drug,” said Roy Baynes, senior vice president of global clinical development at Merck Research Laboratories. But before a treatment is on the market, “there are ways, particularly if there is unmet medical need and there is nothing in the space, there are already mechanisms that can be activated.”
A key component of Right to Try is to allow dying pa“People tients who run out of options, through their doctors, to directly ask drugmakers for access to medicines under development, eliminating the Food and Drug Administration from the process. The goal was to remove a hurdle, although the FDA said that it has approved more than 99 percent of applications under its expanded access program.
“I’m not sure it really changes things for patients,” said Joanne Lager, head of oncology development at French drugmaker Sanofi. “I haven’t heard of any cases where a patient wants a drug, the company wants to give it and the FDA has said no.”
At the Chicago conference, some doctors expressed concern that desperate patients may be taken advantage of .
Gisueppe Del Priore, chief medical officer at Tyme Technologies Inc., agreed.
might be tempted to circumvent them; it could be dangerous,” said Del Priore, whose small biotech firm is working on its first cancer drug and has an existing process in place to provide the treatment for compassionate use.