Congress Passes Bill with Billions for Cancer Research

But some consumer groups say new standards for drug approvals could put patients at risk

Consumer Reports / Teresa Carr / December 7, 2016

Congress has passed the most expensive and far-reaching health reform bill since the Affordable Care Act in 2010.

The 21st Century Cures Act, which garnered widespread, bipartisan support in both the House and Senate, is expected to be signed into law by President Obama soon.

The bill signifies an investment of billions of dollars over the next decade to fight cancer, prevent and treat brain disorders, and harness enormous amounts of data to develop individualized treatments based on person’s environment, genes, and lifestyle.

But the bill also lowers the bar for the kind of scientific evidence companies must provide to gain the Food and Drug Administration’s (FDA) approval for their products. It would mean, for instance, that in some circumstances the FDA could rely in part on individual patient experiences with a drug or device, instead of evidence from large-scale, randomized controlled clinical trials.

Rep. Fred Upton, the Republican from Michigan who chairs the House Energy and Commerce Committee and co-sponsored the bill, says the Cures Act "expedites the approval of drugs and devices and includes literally billions of dollars in additional spending for health research so that we can find a cure and the answers to what patients are demanding today.”

Consumer groups, including Consumers Union, the policy and moblization arm of Consumer Reports, have deep concerns that this effort to speed medical innovation comes with a potentially harmful tradeoff for consumers.

“The unfortunate consequence of 21st Century Cures is that less thoroughly tested medications and medical devices will reach the market,” says Lisa McGiffert, director of Consumer Reports’ Safe Patient Project. “And that means that consumers will have less assurance that a new treatment will help and not harm them.”

More Research Dollars

The bill directs $4.8 billion over the next decade to research, in part, to fight cancer.

“Considering that one in two men and one in three women will be diagnosed with cancer in their lifetime, cancer research funding is an investment in yours, mine, and everyone’s health,” says David Pugach, vice president of federal relations at the American Cancer Society Cancer Action Network, the advocacy arm of the ACS.

Pugach says 21st Century Cures represents a “historic opportunity” to accelerate cancer research. “This includes devoting more resources to improve and use new treatments like immunotherapy,” he says, “where the body’s own defenses are used against cancer—as well as creating ways for researchers to more easily share data so they can see patterns across studies more quickly.”

The bill also allocates funds to treat brain disorders, combat opioid abuse, improve suicide prevention programs, and provide mental health care to children. It establishes a task force for research on women who are pregnant or breastfeeding because these women are typically excluded from medical studies.

Faster Drug Approvals, But Lower Standards

The Cures Act loosens requirements for how drugs are studied and approved that have been in place since 1962.

Here's how it usually works: A company submits evidence from studies done under controlled conditions, comparing patients who received the treatment with those who didn't. The studies typically have to show that people who were given the new drug lived longer or felt better than those who didn't get it.

This kind of research can be expensive and time-consuming for drug companies to collect, says Diana Zuckerman, Ph.D., president of the National Center for Health Research, a nonprofit think tank focused on health research. Cancer drugs, for example, can take several years to show that a drug improves survival.

The Cures Act calls on the FDA to approve some drugs more quickly, based on less thorough testing. The problem with this, says Zuckerman, is that “getting drugs to market faster doesn’t help consumers at all if they turn out not to work or causes them harm.”

What Consumers Should Know

Once the Cures Act takes effect, consumers must be especially careful when considering a new medication or medical device, says Orly Avitzur, M.D., Consumer Reports’ medical director.

"When you have a choice, you may want to consider treatments with a proven track record, as you'll have more assurance that they work and are safe," Avitzur says. "Always make sure someone has taken the time to thoroughly explain all the options to you, and the possible risks and benefits of each."

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).