The House of Representatives is planning to consider a bill Friday that could give a big cash infusion to medical research, which has been struggling in recent years. But the bill would also tweak the government’s drug approval process in a way that makes some researchers nervous.
Despite those worries, many scientists are cheering on the legislation.
“We’re very excited about the prospects for the 21st Century Cures Act,” says Dave Moore at the American Association of Medical Colleges. His group is part of a coalition of patient groups, scientific societies and research institutions that has been trying to find some way to boost funding for medical research.
Moore says the bill provides a promising path forward because it gets around painful limits on federal spending by setting aside $1.75 billion a year, for five years, specifically to increase funding for medical research.
Research funding has been hampered for more than a decade. The $30 billion budget for the National Institutes of Health has remained flat for that time, which means its buying power has actually dropped by 22 percent.
“Back in 2003, NIH could fund about one out of every three grant applications it received. Now it funds one out of every six,” Moore says. That funding crunch means a lot of good ideas languish — as do the careers of promising young scientists.
Moore says a cash infusion won’t be a cure-all, “but it certainly reverses this decade long trend with the budget not keeping pace with inflation.”
That promise of new funding is helping attract Democrats to vote for a bill that they might otherwise be reluctant to support, says Dr. Jerry Avorn, a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women’s Hospital in Boston.
He’s concerned about provisions in the bill that are touted as streamlining the drug-approval process at the Food and Drug Administration.
“That [goal] sounds pretty good,” Avorn says. But he says the bill is “loaded with a lot of provisions that were heavily influenced by pharmaceutical and biotech and medical device lobbyists that really do some pretty worrisome things.”
His concerns are laid out in a recent commentary in the New England Journal of Medicine. Under this bill (H.R. 6), he says it would be easier to approve a drug based on blood tests rather than the more arduous and expensive tests that show a drug actually improves a person’s health.
“We know we can be led astray by lab tests look better but may not actually help patients,” he says.
Indeed, there’s a long-running scientific debate about the benefits and risks of relying on this kind of information. Jeff Allen, executive director of an advocacy group called Friends of Cancer Research, argues the bill doesn’t lower the standards for drug approval. Instead, he says it will give drug developers a new tool that can help them predict whether a drug is likely to be safe and effective.
If those tools are used earlier in the drug-development process, he says, “it will prevent people from getting a drug that might be harmful, and will actually conserve resources and allow researchers and the FDA to focus on those applications that will be most promising.”
So his group, which gets some drug industry funding, is in favor of the bill.
Avorn counters that if Congress really wants to speed the search for cures, it should simply boost funding for science in universities and other research institutions.
“That’s where innovation comes from, not by making it easier, once those innovations have been turned into a drug, for the company that owns the drug to not have to show that they work in patients,” Avorn says.
The House bill is far from the last word on this subject. The Senate is starting to craft its own, very different approach to this problem. And it’s not clear what a compromise might look like.