A piece of government legislation known as the “21st Century Cures Act” was passed last week by both houses of Congress. It’s a bill that will increase funding for medical research, provide a much-needed overdo of federal policy pertaining to mental health care, and will speed the development and approval of many experimental treatments for diseases that include cancer, Alzheimer’s, and others.
Mostly, it’s a piece of legislation that has enjoyed wonderful bipartisan support and may wind up being one of the most notable moves of the Obama administration.
“We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time,” President Obama proclaimed upon the bill’s passing. “It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause. And I think it indicates the power of this issue and how deeply it touches every family across America.”
For mesothelioma victims, the bill could be a godsend, primarily because some $1.8 billion is earmarked for cancer research. This was a nod to Vice President Joe Biden, who was devastated at the recent loss of his son Beau to brain cancer.
The VP vowed upon his son’s death that a cure for cancer would be found soon. That part of the bill has been renamed the “Beau Biden Cancer Moonshot”.
The drug industry has long been critical of regulations that often bottleneck the approval of new medicines and slow the ability to reach patients who desperately need these drugs.
There are provisions in the 21st Century Cures Act that will unclog at least some of these jams, leading the way for a shorter path between development and use in human patients.
While most applaud the provisions, some see them as a danger to patients. In an article in the Washington Post, Harvard Medical School professor Aaron Kesselheim said, “All these pathways or provisions of the bill are intended to expedite approval of these products — and, if implemented the wrong way, can lead to substantial negative consequences for patients taking these products, when they are not proven to work and are potentially unsafe because they’ve been pushed through the regulatory process.”
But most agree that the act is a huge step forward for patients battling cancers like mesothelioma, which are rare and have, therefore, lacked the funding dollars needed to make any huge strides.
There have been no great leaps in meso treatment since the addition of Alimta® to the treatment regimen nearly a dozen years ago. Though studies are being conducted with immunotherapy drugs such as Opdivo, it may be some time before it becomes a regular option for treatment…though the 21st Century Cures Act may help speed the process.
Specifically, the legislation includes a provision that changes the way the FDA handles genetically-targeted drugs for individualized treatment. This includes both gene therapy and immunotherapy drugs like Opdivo and Keytruda.
With the passage of the bill, the process of submitting applications for these types of drugs will become simpler, with reviews and approvals happening more quickly. It’s a win-win situation for mesothelioma victims and all cancer sufferers.