Ah, the brief summary. Inside the FDA many joke that it is like the Holy Roman Empire – neither brief nor a summary. And if you want to throw in “fair balance and adequate provision,” well, go right ahead. Same issue – too much information equals not enough comprehension.
It’s not a new problem. FDA took a crack at addressing it in January 2004 with a draft guidance on new ways to approach the brief summary. (I was proud to have been part of that effort.) Then, in January 2006, came the agency’s New Labeling Rule – an attempt to make the PI more user-friendly (the “user” being the physician). More recently the FDA has launched its "safe use" initiative, trying to reconfigure patient medical information (PMI) in more potent and health literate ways to plural constituencies. To date, all of these efforts met with only modest success.
This is an important public health issue. (In 2006, Dr. Jerry Avorn and Dr. William Shrank of Harvard Medical School wrote a paper in The New England Journal of Medicine calling it “linguistic toxicity.”)
The issue comes front and center again in a short article that appeared in Sunday’s edition of the New York Times, “Side Effects? These Drugs Have a Few.”
Some snippets:
Dr. Jon Duke of Indiana University was trying to figure out why his patient’s blood platelets were abnormal. Could it be a side effect of one of the dozen drugs the man was taking, a number that is not uncommon among elderly people?
He began reading the label of each and every drug. “I was just overwhelmed,” Dr. Duke said. The lists of possible adverse reactions went on and on. Now he knows why. In a new paper in the Archives of Internal Medicine, Dr. Duke and two colleagues report that the average drug label lists 70 possible side effects and some drugs list more than 500. “This was beyond even what I’d expected,” he said.For anyone who has ever had to watch an entire Flomax commercial, the listing of a drug’s side effects is almost a joke. But the question is, why does the list continue to grow?
That same year, the Food and Drug Administration suggested making labels clearer with a new format and advised drug makers: “Exhaustive lists of every reported adverse event, including those that are infrequent and minor, commonly observed in the absence of drug therapy or not plausibly related to drug therapy should be avoided.”
But, Dr. Duke found, instead of decreasing in the years after the agency issued guidelines, the average number of side effects rose to 94, as compared to 67 for those whose labels predated the new format. Some potential complications are weird, like “compulsive gambling.” Others, like “nausea” are so common — it’s listed on 75 percent of drug labels — that they almost seem like a universal issue.
Listing every inkling of an adverse reaction can help drug companies in lawsuits, Dr. Duke said. If someone sues about a side effect that is listed in the drug’s package insert, the company can say patients had been warned.
The Pharmaceutical Research and Manufacturers Association says the companies are just complying with the F.D.A.’s requirement that they reveal all of a drug’s risks, “even if a clear causal connection between the medicine and the observed adverse event cannot be fully established,” a spokesperson for the group wrote in an e-mail.
And the F.D.A., in an e-mail, said “extensive lists of rare and minor adverse events for which there are no data to support a causal relationship” are not useful.
That last statement from the FDA is pretty quixotic when you consider both the volume of warning letters and their content. Perhaps the above e-mail hasn’t yet made it down to DDMAC.
But the big problem is that the current liability system doesn’t reward lawyers who focus on real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort” firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
