On October 5 I attended an event entitled “How Fast to Cures?” hosted by Politico, a well-established media organization that publishes a magazine and other content on politics and policy in Washington, DC.
The topic of discussion by four professionals from various realms of the research and health care advocacy world was the increasingly contentious 21st Century Cures Act. The House of Representatives passed its version of the Act last summer, and the Senate is working on its complement. Its ostensible goals are to bring “health care innovation infrastructure into the 21st century,” thereby facilitating scientific discovery and delivery of cures for all matter of diseases. Many people think that many of the provisions of the Act as currently written will make newly approved drugs and medical devices less safe and effective, increase costs of these products, and actually discourage innovation in biomedical research, as colleagues and I outlined in a blog post published in Health Affairs last month. These may be anticipated “unintended consequences” as all-too-frequently happens with legislated “solutions,” or more likely, the legislation is truly intended primarily to benefit the pharmaceutical and medical device companies who fund many of the politicians and organizations advocating for it. […]
So, for completeness, the participants of the forum were: Margaret Anderson, Executive Director of FasterCures, a Center of the Milken Institute, which receives plenty of pharmaceutical sponsorship for their conferences; Mary Woolley, President and CEO of Research!America, which, among its 350 member organizations lists over three dozen corporations including many pharmaceutical companies; Joel White, Executive Director of HealthITNow, which listed as partners FasterCures and Research!America, as well as a number of other organizations with corporate interests and/or heavy corporate sponsorship, e.g. the U.S. Chamber of Commerce, the National Association of the Mentally Ill; and finally Diana Zuckerman, President of the National Center for Health Research, a small research and advocacy organization that uses evidence-based information to encourage new, more effective treatments, programs, and policies. They do not benefit from financial relationships with pharmaceutical or medical device companies.
Everyone delivered their “lines” as expected, with the techie guy referring to “granular insights” more than once. The moderator referred to a commentary Diana had published together with Gregg Gonsalves, an AIDS activist from the ACT-UP era that opined that the 21st Century Cures Act would further erode progress in safety and effectiveness standards made at the FDA since that era. Diana gave a recent example of how her group looked at biomarkers (amyloid plaques in the brain) for Alzheimer’s disease in phase two studies of three drugs that appeared promising. The biomarkers responded to the drugs but the patients didn’t, and for one drug memory loss worsened. Under the standards of 21st Century Cures, she said, these drugs could well have been approved.
Read the full article here.