A report by the Office of the Inspector General of Health and Human Services released today says that the FDA has shirked its duty to oversee federal clinical trials in this country in a big way. Fewer than 200 inspectors are responsible for auditing more than 350,000 trial sites, and central tracking and follow up to inspections is largely absent. According to a report in the New York Times, just one percent of all trials for drugs seeking approval are audited. And despite 348 reports of serious problems that were filed by inspectors between 2000 and 2005, the FDA disqualified results just twice and investigators from conducting further trials just 26 times. Follow-up warnings were issued years after the research subject complained and the inspectors visited.Alarming stuff, especially in light of the recent report that showed up on Pharmalot. Conducted by the Center for Congressional and Presidential Studies at American University (and underwritten by Pfizer) the survey showed that 82 percent of the public trusted the FDA to oversee medications, 67 percent trusted the drugmakers, and 53 percent trusted Congress. Just eight percent had heard of the FDA reform bill (the Prescription Drug User Fee Act reauthorization, or PDUFA) that President Bush signed yesterday.
So what to make of all this?
On the surface, PDUFA:The Next Generation is no cops-and-robbers story made for primetime news. But at its heart, the bill touches on some very cops and robbers issues—like how are clinical trials conducted, and who’s watching out for the safety of the subjects and accuracy of the data? Who knew about the dangers of Vioxx, and when did they know? Was trial data suppressed or ignored? Were doctors under the influence of an especially aggressive Vioxx campaign blitz from drug marketers? Should a regulatory agency be sponsored by the very companies seeking its approval? And there are one hundred more.
Every prescription drug we pick up at the pharmacy has been reviewed and approved by the FDA (54 percent of us knew this). What that means and how safe we are is a very public issue. But there isn’t always a direct translation from what the general public should know about and what it can change. In the case of medical care, public awareness can be eclipsed the long chain of decision-makers in play: patients, doctors, pharmacists, pharmacy benefit managers, providers, regulators, investigators and manufacturers all have a role in what someone takes to feel better.
Patient-prescriber relationships are especially tricky. Unlike a traditional economic relationship where the consumer is also the choosing agent in the market, the physician or nurse in this case acts as an intermediary with the power to choose what drugs a patient pays for and takes. Even if a patient is educated about the issues, knows the ins and outs of treatment guidelines and can find out how much his doctor took from pharmaceutical companies last year, the doctor is still the one making the diagnosis and writing the prescription. The unique nature of this mediated consumer relationship—in which the consumer is not the one wielding the purchasing power—means that the intentions and actions of the prescriber on behalf of the patient must be absolutely clear and free of conflict.
And moving up this chain of medical trust—in the U.S. anyhow—is the FDA, the main gatekeeper and certifier of safety. It has been endowed the power to approve drugs, and to verify and oversee the trials that ultimately test their safety and efficacy. Even the best-intentioned doctors, completely free of conflict with pharmaceutical interests and with their patient’s health first in mind, have to take the FDA’s word—whether it be in the form of an approval or warning—that what they are writing on the script does what the label says it does.
The new FDA reform bill is a step forward. But as Friday’s HHS report shows, we still have a long ways to go.