John Fauber’s latest stories in the Milwaukee Journal Sentinel are must-reads for anyone who uses medications and wants to know if the drugs they’re taking are safe, effective, and worth the money spent on them. These recent pieces in Fauber’s growing body of excellent work stand out not only because they examine some commonly prescribed drugs for some common illnesses, but also because they raise some tough questions about the Food and Drug Administration, and show why press coverage of the country’s regulatory agencies is as critical as ever.
In late December, an investigation by the Journal Sentinel and its partner, MedPage Today, revealed that more than 3,000 deaths and some 20,000 hospitalizations have been linked to diabetes drugs over the last decade, including such widely promoted drugs as Januvia, Byetta, and Victoza. Fauber, along with reporters Elbert Chu and Coulter Jones of MedPage Today, told readers “none of the 30 new diabetes drugs that came on the market were proven to improve key outcomes such as reducing heart attacks or strokes, blindness or other complications of the disease.” Yet the sales of these drugs are big business, with 2013 sales reaching $23 billion—more than the combined revenue of the National Football League, Major League Baseball, and the National Basketball Association, Fauber wrote.
The FDA approved these diabetes medicines—and cancer drugs which Fauber’s team reported on in October—based on what’s called a surrogate measure, or a stand-in or a proxy for the eventual desired clinical outcomes (like, extending lives). For example, a surrogate measure for a diabetes drug might show that it lowers blood sugar that might ward off serious complications like strokes or amputations, but hasn’t been proven to prevent strokes or amputations. With cancer, a surrogate measure might show that based on a CT scan or an MRI image, a drug reduces the size of a tumor, but that doesn’t mean it lengthens a patient’s life. In October, Fauber and team found that of 26 cancer drugs approved between 2004 and 2011, three increased survival rates while a fourth—still on the market—actually slightly reduced survival. There’s no proof of improved survivial rates for the other 22 drugs. “We’re paying top dollar for drugs that do very little,” Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York, told Fauber, adding “we’ve been pushing more and more drugs into the market to make more and more of a market.”
The drive to get more drugs to market faster began in the Clinton administration when the drug industry and Beltway politicos teamed up to loosen regulations for pharmaceuticals—including allowing drug approval based on surrogate measures, getting drugs approved with fewer clinical trials, and permitting drug companies to advertise off-label uses for their drugs—much of which the Journal Sentinel described in its reports. In December, Fauber reported that many diabetes drugs are commonly used to treat pre-diabetes, although the FDA has not approved them for that use. “Doctors say the convergence of new drugs and the expanded definitions for diabetes and pre-diabetes has led to an over-medicalization of blood sugar disorders,” Fauber wrote.
Fauber, Chu, and Jones’ work from December and October should be a jumping-off point for other reporters to take the story further. Three strands in particular call for additional scrutiny.
• What do patients actually know about the drugs they are taking and what should they do with that knowledge? The consumer story needs telling. Fauber reported that some drugs, like the diabetes agent Victoza, carry a “black box” warning for cancer, meaning the drug poses significant, serious or life-threatening risks. Yet Victoza is the leading drug in its class, according to its manufacturer Novo Nordisk. What’s a consumer to do? What should patients do when offered a thyroid cancer drug like Cometriq, which causes swelling, pain and blisters on hands and feet? That drug was approved despite the toxic side effects and patient-reported outcomes that suggest no quality-of-life benefits. (And that brings up those end-of-life stories we need more of.)
• What’s wrong with the FDA’s adverse events reporting system, a database of (voluntary) case reports from doctors, pharmaceutical companies and consumers? This and other regulatory measures are ripe for investigation. Six years ago, Fauber reported, the Government Accountability Office found the FDA didn’t have the resources to keep its reporting system up-to-date. As Fauber’s team has shown, simply telling the public a drug is “FDA approved” is no guarantee it’s safe and effective.
• Where do doctors fit into this? Although ProPublica as well as the Milwaukee Journal Sentinel have exposed drug company payments to doctors, it’s hardly clear such exposes, as good as they’ve been, have made doctors more careful about prescribing unsafe drugs. “I think most doctors don’t fully understand that the recent drugs approved for diabetes haven’t been proven to reduce organ failure and might actually carry risks,” Harvard Medical School professor Jerome Avorn told Fauber. It might be enlightening for reporters to survey docs in their coverage area to ask about their prescribing patterns.
For me, the big picture takeaway here is the need for the media to follow up on important legislation that affects the public’s health and safety years later. Regulatory changes made two decades ago and sold under the guise of modernizing the FDA are having, as Fauber shows, profound consequences for patients today. I’m reminded of the prescient words of Thomas Moore, a senior fellow in health policy at the George Washington University Medical Center, who told me in the late ’90s that these changes “eroded the FDA’s essential role that a drug should be properly tested and results independently evaluated.” Even back then, Moore said there were signs drugs not adequately tested were reaching the market. “Speed can be a mistake,” he said.
And, reporters take note, we may be in for another round. According to a Monday Associated Press story, Sen. Lamar Alexander, the new Chair of the Senate Committee on Health, Education, Labor and Pensions, “said modernizing the National Institute of Health and Food and Drug Administration is a necessity and he is seeking to examine the FDA’s process for drug and device review.” There can be more to “modernizing” than meets the eye.