Image: Dr. Francis Collins and Janet Woodcock
In a very public spat, US National Institutes of Health Director Francis Collins and US Food and Drug Administration commissioner Scott Gottlieb criticized each other in recent weeks, and in the process criticised the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group.
Gottlieb included Collins, a long-time critic of large drug companies, on a team designed to look for a gene sequence that could be used as a screening tool for new drugs, and which he claims could reduce costs for the healthcare system by up to 80%. The agency put Collins on notice last week, threatening him and several other staff members if he continued the hunt.
Collins responded in kind a week later, saying he was at the agency because he was willing to be “the voice of sanity” at a time when the drug companies were fighting so hard to keep the status quo.
More than 10,000 compounds, Collins argued, are in the FDA’s lab, many more than the agency actually tests for. “Where is the conversation? Let’s have the conversation,” he said.
For the most part, Collins and Gottlieb both vehemently disagreed about whether the search for a single gene sequence could eliminate the need for expensive late-stage drug trials, something that the government currently subsidises more than $US350 million ($480 million) annually. Even Collins said the search is far from ending with the current staff and with existing resources, according to Today, part of the New York Times. “Frankly, this will go on for years and years,” he said.
The NEJM piece was the first public acknowledgment that the NIH was involved in a private programme, conducted without involvement of the FDA, that was looking for this particular gene sequence. It also suggested that the program was inspired in part by decades of hostile encounters with a cancer pharma firm, Millennium Pharmaceuticals, and the backlash over the US’s averse response to the company’s attempt to undermine the Affordable Care Act. The hunt, Collins wrote, has even exceeded the legal limits of the NIH’s limited authority over the institute.
Collins’s letter confirmed that he and a few other NIH staff members were working to find the gene sequence, an informed source told me. This story was originally broke in a number of publications this week by The Atlanta Journal-Constitution and WSB.
A source close to PhRMA, who asked not to be named, contacted Gizmodo and provided a statement to Gizmodo, saying that rather than the individual programme, PhRMA “staunchly supports the continued development of innovative research and development in supporting targeted healthcare options for patients”.
It continued: “We greatly value the relationship of our members and we are committed to ensuring that R&D activities are transparent and supported through comprehensive enterprisewide policies and safeguards to protect patient health and safety. Dr. Collins is right to caution the NIH against over-interfering in the development of new and transformative technologies, as could be harmful to the biomedical community.”
If Collins and his team were looking for a specific gene sequence for the FDA, the request is very clear.
Updated 3.01pm. EDT, 7 June 2018 to reflect change of reference to PhRMA from a trade association.