Burdensome clinical trial regulations are blocking patient access to innovation
Every day, advances in technology are providing researchers with more information to develop better treatments. But, are patients gaining access at the same rate of innovation?
“The innovations remain stuck in the laboratories or kept within elite medical institutions, left untranslated into medications, equipment and other therapies that would help doctors, health insurers and the public,” the San Diego Union Tribune reports in a lengthy investigation. “Fixing the bottleneck has become its own branch of medical science.”
In a literal sense, geographic problems are one barrier to patients’ access to innovative new treatments. At the Precision Medicine Summit in San Diego, surgical oncologist Timothy Yeatman, director of Gibbs Cancer Center, cited the early investments required under the costly and burdensome clinical trial process.
“Billions of dollars (are) lost in opening trials at sites where there are no patients,” Yeatman said. “If you can screen for patients ahead of time … and then not doing the site visit until you absolutely positively know there’s a patient there … you won’t have goose eggs when you open a trial. And these $100,000 site openings will disappear.”
Dangerous Medicare experiment impeding patient access to treatments
One Georgia Congressman warns that a federal health agency is threatening patients’ access to life-saving treatments.
“The Center for Medicare and Medicaid Innovation within the Centers for Medicare and Medicaid Services has proposed a dangerous experiment with Part B drug payments,” writes U.S. Rep. Buddy Carter, who represents Georgia’s 1st Congressional district. “Under the experiment, Medicare payments would be significantly below a physician’s acquisition costs for a drug. This will put patients at risk by potentially forcing them to abandon the best treatments for a cheaper, less effective alternative.”
Writing at The Hill, Carter explains how the proposal will undermine patients access to the treatments prescribed by their doctors.
“This will put patients at tremendous risk, potentially forcing them to abandon the best treatments for other treatments that have proven less successful,” he writes. “Ultimately, CMS will create an end run around the doctor-patient relationship to dictate treatments. This is unacceptable.”
Earlier this summer, Carter joined 240 of his colleagues in sending a letter to the Centers for Medicare and Medicaid Services calling for an end to the plan. He’s also co-sponsored legislation to prohibit CMS from moving forward with this “dangerous” experiment.
Quote of the Day: Precision medicine helps improve patient access to innovation
“In its simplest terms, it’s the right drug for the right patient at the right time.”
— Damian Doherty, editor of the Journal of Precision Medicine, describing the implications of precision medicine.
Bill to grant California patients access to experimental treatments
California patients could soon gain access to experimental treatments.
The Los Angeles Times reports that the California State Assembly approved final approval to “right-to-try” legislation. Authored by Assemblyman Ian Calderon, Assembly Bill 1668 would allow “drug and medical device manufacturers to make their products available to terminally ill patients, even if the products have not yet been cleared by the federal Food and Drug Administration.”
Last year, Governor Jerry Brown vetoed an identical “right-to-try” proposal, saying that the federal government should take the lead. Calderon is hopefully that the governor has had a change of heart.
“That’s going to be the conversation with the governor: ‘Look, we’ve done it your way,'” he told the LA Times. “Over 30 other states now have this on the books. It’s a better way of doing things.”