When it comes finding new ways for state lawmakers to protect negligent pharmaceutical companies, we find that the American Legislative Exchange Council (here, here) can be so accommodating! For example, ALEC provides three - count ‘em three – ALEC-approved choices to assist any state lawmaker bent on further subsidizing this industry: option 1, complete immunity for marketing unsafe FDA-approved drugs (only one state – Michigan - has had the nerve to do this, although states like Wisconsin are trying); option 2, shifting the standard of proof entirely in the drug company’s favor (some North Carolina lawmakers are hot to trot on this idea); and finally, immunity from punitive damages for FDA-approved drugs. (Actually, option 3 is an old idea, even popping up in congressional bills like the federal “medical malpractice” bill H.R. 5, which has passed the U.S. House of Representatives and yet remains in a state of perpetual mark up.)
So interesting that these anti-government folks think the FDA gets it right every time when it comes to drug safety. Perhaps today’s news will dampen their pro-government enthusiasm? Nah, probably not.
The Institute of Medicine has come out with study finding that the agency isn’t protecting the public from safety problems that arise once a drug is on the market. Who would have thought? IOM concludes, “the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle.” IOM is calling on the FDA to “review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues.”
Writes U.S. News and World Report,
The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted.
A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor.
As Reuters notes,
"It's impossible to know all the risks and benefits of a drug before approval," said Dr. Ruth Faden, co-chair of the IOM committee. The IOM called on the FDA to monitor drug safety at regular intervals over time.…
Currently, the FDA must only check for new safety issues after the drug has been sold for 18 months, or after it has been used by 10,000 patients, whichever is later. It relies upon reports of side effects submitted by the drugmaker, doctors or patients.…
Dr. Faden, who is also director of the Johns Hopkins Berman Institute of Bioethics, said extensive post-approval monitoring is critical because safety concerns with a drug may only become apparent once it has been used for many years, and by thousands of patients.
And backing all of this up is a new study in Journal of the American Medical Association, “an analysis of over 40,000 clinical trials registered in a government database, [where] researchers found that many of those studies -- looking at the effects of drugs, devices or behavioral interventions -- were small and of inconsistent quality. … The majority of those trials -- 62 percent -- reported recruiting 100 or fewer patients. Two-thirds were conducted at a single research site.”
Of course, none of this really should surprise anyone given how under-resourced the FDA is, how lax our regulatory laws are, and how conflicts of interest routinely interfere with this agency’s safety role. Check out last Sunday’s editorial in the New York Times.
Honestly, how much more evidence do we need that FDA-approval is barely a minimum standard for drug safety and clearly shouldn’t become a “get out of jail free” card for the drug industry?