By Trudy Lieberman, Rural Health News Service
As new drugs and medical devices are developed, it’s understandable that the public, always in love with new technologies, wants to use them. They also want them to be safe, and most people think they are. It comes down to a balancing act that will soon be tested in Washington.
In the fall, the U.S. Senate is likely to approve legislation that shifts the scales more in the direction of getting “cures” to market faster, and that could be a big step backward in regulating medical devices—things like breast implants, coronary stents and artificial knees.
The 21st Century Cures Act sailed through the House of Representatives in July on the premise that need outweighed the risk of inadequately tested products. Dr. Rita Redberg, a well-known cardiologist at the University of California San Francisco Medical Center, told me, “the emphasis has been on getting drugs and devices on the market quickly, not on making sure they are safe.”
In a New York Times op-ed Redberg wrote, “The bill would severely weaken not strengthen, the FDA’s already ineffective regulatory scheme for medical devices. The device industry, may stand to benefit from this legislation, but the health of the public does not.”
What does the legislation, pushed by the $110 billion device industry and patient advocacy groups, do? In a nutshell it changes the way FDA (Federal Department of Agriculture) approves new drugs and devices. Manufacturers of so-called “breakthrough” devices would be able to submit evidence of safety and efficacy based on sources other than clinical trials, the gold standard. In other words, with a clinical trial, scientific evidence determines whether a new product can be sold.
Under the 21st Century Cures Act a manufacturer could submit evidence that a device is safe and effective based on case histories; that is, it could offer the experiences of individuals that a new product should come to market. If patients showed some benefit, manufacturers could submit those experiences to the FDA.
According to Redberg, the proposed law would mean “anecdotal evidence rather than scientific studies, could be used to approve drugs and devices.” She told me, “This will result in a lot of dangerous drugs and devices on the market with no evidence. Allowing case studies as the standard is crazy. It lowers the data standard to non-existent.”
To understand what’s happening, you have to go back to 1997, another time when the same coalition of drug and device makers, patient groups and Washington think tanks interested in deregulation convinced Congress to lower the approval standards. It reduced the number of clinical trials to establish safety and efficacy from two or more to one or more and allowed device companies to select and pay for-profit firms to review their products instead of the FDA—a sort of fox-in-the-hen house arrangement.
Redberg’s work shows there are fewer trials. A 2009 study published in The Journal of the American Medical Association (JAMA) showed that 65 percent of pre-market approvals for cardiovascular devices were based on a single study, and those studies were often prone to bias and lacked strength. John Fauber, a reporter at the Milwaukee Journal Sentinel, has documented deaths and injuries resulting to patients who’ve taken cancer and diabetes drugs that were approved under the 1997 looser standards.
If the current legislation passes, device makers could conduct the more rigorous trials to see if their products really are safe and effective after they’ve already been on the market. This is hardly foolproof. Sometimes trials are delayed for years after a product is sold, and many are never completed.
What’s troubling about all this is the lack of critical discussion of the proposed changes in the media and elsewhere. There has been, however, plenty of commentary and op-eds supporting the 21st Century Cures Act. “You’d think Mother Teresa had written this bill considering the overwhelming praise it’s getting,” says Gregg Gonsalves, a research scholar at the Yale Law School.
In the Huffington Post, TV personality Katie Couric, a former FDA commissioner and the founder of a disease advocacy group claimed the legislation “does not reduce safety standards.” They talk about “genetic analysis” and “newly discovered biomarkers,” to evaluate new drugs, but don’t mention products could be marketed without clinical trials.
As our standards for drugs and devices take a U-turn, the death of Dr. Frances Kelsey who died in early August at age 101 should remind us what happens when marketing trumps safety. Kelsey was the F.D.A. official who kept the drug thalidomide off the U.S. market because of safety concerns.
No one wants another thalidomide scandal, but what are we willing to risk to sell drugs and devices faster perhaps without sufficient testing?
Editor’s note: The Rural Health News Service is funded by a grant from The Commonwealth Fund and is distributed through the Nebraska Press Assn. Foundation, Colorado Press Assn., South Dakota Newspaper Assn., Hoosier (IN) State Press Assn. Foundation, Illinois Press Foundation, Wyoming Press Assn. and California Newspaper Publishers Assn. Foundation.