December 8, 2016; New York Times
While most of us have been staring at our screens awaiting the latest Trump administration appointment (or avoiding politics completely), the U.S. Senate and House of Representatives passed what can be considered an extraordinary piece of bipartisan legislation. Dubbed the 21st Century Cures Act, this bill approves $4.8 billion in spending over the next ten years for new research conducted by the National Institutes of Health to address cancer research, mapping the brain, genetic data collection, and prescription drug abuse.
Support for this bill has been overwhelming, with President Obama saying, “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s and helping people seeking treatment for opioid addiction finally get the help they need. This bill will make a difference, and I look forward to signing it as soon as it reaches my desk.” He will likely get the opportunity soon, as the legislation passed in the House 392-26 and in the Senate 94-5.
With the promise of cures for some of the most prevalent diseases, it may seem surprising that anyone voted against the bill. But a closer look at what else has been promised with the 21st Century Cures Act reveals a conflict. Not only will the NIH be able to research and develop cures, some of which have already been researched and completed successfully by private companies, pharmaceutical and medical device companies will also be able to fast track treatments through the U.S. Food and Drug Administration approval process. Of particular note, the Act will allow the FDA to consider “clinical experience” data instead of relying on clinical trials, allow companies to request speedy approval of medicines and technologies for life-threatening or rare diseases, and expedite manufacturing to speed up patient access to new treatments.
It would appear that getting newer and better treatments to patients quicker would be ideal. However, experts question whether this Act also raises patient risk. President of the National Center for Health Research Diana Zuckerman says, “The FDA over all these decades has developed a way to know what products work and which ones don’t, but in the last decade they have been pushed to lower those standards. With this bill, they’d lower them even more.”
The advantage for Big Pharma and medical device companies is readily apparent. It’s no coincidence that over a thousand lobbyists for the sector helped push this bill along. What has yet to be determined is whether the benefit to patients will justify the benefits for the pharmaceutical and medical device industry. The Act does not include a provision regarding the cost to the patient for treatments; as such, it is possible that we are doomed to repeat what happened with anti-retroviral therapy—treatment that is highly effective yet prohibitively expensive—and patients would not benefit much at all.—Sheela Nimishakavi