At the May 6th House Energy and Commerce Committee’s 21st Century Cures Initiative roundtable, participants were asked what steps Congress could take to expedite bringing new treatments and cures to patients.
Francis Collins, director of the NIH, said that what is needed is a “steady trajectory of support” so that scientists are willing to take risks. But what does that mean?
Collins said that over the past 10 years, the NIH has lost 20 percent of its purchasing power. His belief is that this loss has cost jobs and caused a lack of enthusiasm in our investigators, he said.
20%? That sounds like a statement worth investigating – because the NIH budget has grown significantly over the past decade.
“If we could have confidence of a stable trajectory for support, that would mean the world for an enterprise that is currently flagging,” he said. Not sure precisely what that means but, again, perhaps a study of how NIH is spending it’s current budget would help identify the strengths and weaknesses of its allocations – and the strategy behind them. After all, every dollar counts.
Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), said one issue affecting biomedical innovation is the current clinical trials system for drugs.
“The clinical trial system we have is not a system,” Woodcock said. “It takes years and it exhausts investigators.”
Woodcock said the FDA is starting to look at clinical trial networks that are already set up and funded. Testing a new drug in a clinical trial network is faster and “saves a lot of money,” she said.
Additionally, per Dr. Woodcock, since multiple new drugs are studied by the network, “you can do head-to-head comparisons of products.”
She also said there is a lot of innovation in drug manufacturing, and that the FDA will hold a meeting to pursue this avenue in a few weeks.
Another area that the FDA is focusing on is the Critical Path Initiative. Its goal is to bring innovative, high priority therapies to market quickly.
“There is a lot of research that needs to be done on things like biomarkers that would” speed the development of products, Woodcock said.
And, according to Margaret Anderson, executive director of FasterCures (an advocacy group aimed at improving the medical research system that is affiliated with the Milken Institute), “The appropriated dollars that go to the FDA are extremely valuable, and they are not enough.”
This past Sunday, I participated in a point/counterpoint in the pages of the Chicago Tribune with Dr. Kenneth Polonsky, Dean of Biological Sciences Division at Pritzker School of Medicine, and executive vice president, medical affairs, at the University of Chicago.
Dr. Polonsky’s perspective was, more or less, the same as Dr. Collins’, “more money equals more cures.” If only it was so simple. My view (IMHO) is somewhat more nuanced.
And here’s mine:
Outside Opinion: Federal funds should go to medicine-makers
By Peter J. Pitts
Is more federal funding for the National Institutes of Health the best bang for the buck when it comes to using precious tax dollars to advance public health? No.
The NIH budget is about $30 billion. But what does that buy? Where do discoveries that advance public health really come from? Some do come from NIH-funded research — but not nearly the majority. The engine of innovation is the biopharmaceutical industry, which spends in excess of $50 billion annually on research and development. It's not a competition; the NIH and industry complement each other's efforts. But context matters.
The NIH focuses on basic research, the study of fundamental aspects of phenomena without specific applications. The biopharmaceutical industry addresses most of its R&D toward clinical research, science focused on the actual development of new medicines. The NIH provides grants to academic institutions. Industry employs the scientists who do the work and, increasingly, funds academic research.
But there's a problem. While universities love NIH dollars, they are less enamored of industry resources. Why? One reason is that NIH funding counts toward achieving tenure, while similar dollars from biopharmaceutical companies do not. Durbin's legislation would disincentivize more industry-academic partnerships. More government spending is not always the mother of invention.
As the Prairie State's great Sen. Everett Dirksen once (allegedly) quipped, "A billion here, a billion there, and pretty soon you're talking about real money." Some $10 billion annually could be allocated elsewhere to achieve broader access to newer, more targeted therapeutic medicines (and $5 billion could go toward the NIH's good work, hardly a paltry sum). The Food and Drug Administration should be No. 1 on the list to get more money.
The FDA regulates more than 25 percent of the U.S. economy, yet operates on an annual budget of $4.7 billion (about $2 billion generated by industry user fees). The budget's federal funding portion is about one-tenth the NIH's. Why hasn't Durbin proposed additional tax dollars for the FDA's programs on advancing regulatory science, expedited review pathways or more ready access to experimental medicines for desperately ill patients? The FDA doesn't even need $10 billion a year for 10 years to become our nation's leading force in health care innovation. Some $1 billion a year would do the job quite nicely. As to the remaining $9 billion, the line forms to the left.
Alas, headlines for hyped and misleading "NIH-funded cures" are far sexier than those for "more money for drug regulation." They may not be inversely important, but they are equally urgent in advancing 21st-century American health care.