Side Effect Reports Are Up. Any Idea Why?
3 CommentsBy Ed Silverman // September 10th, 2007 // 8:01 am
Is there a doctor in the house? The FDA received 2½ times more reports of serious health problems linked to medication in 2005 than it did in 1998, according to a study in the Archives of Internal Medicine. Reports of serious problems grew four times faster than the total number of US outpatient prescriptions, and such medication-related health problems account for an estimated 3% to 6% of hospital admissions, USA Today writes.
“The overall message is that the drug-safety evaluation system is not working,” co-author Curt Furberg, a medical epidemiologist at Wake Forest University in Winston-Salem, N.C., and former member of the FDA’s drug safety and risk management advisory panel, tells the paper. “Harmful drugs are getting into the marketplace.”
Another possible explanation: Doctors and patients simply have become more likely to submit the voluntary adverse-event reports, especially in light of high-profile safety withdrawals and lawsuits, the study suggests. But if that were true, the researcher write, reports would have increased for all meds, which wasn’t the case.
In addition, reports of serious adverse events not mentioned on a label represented 87 percent of the increase from 1998 to 2005, the authors write. If doctors and patients simply were more likely to report problems, reports of adverse events mentioned on the label would have increased just as much, the study indicates.
A PhRMA official agrees that such reports have been increasing, but disputes Furberg’s explanation. “We do believe there is a broad change in spontaneous reporting,” says Alan Goldhammer, PhRMA’s associate vp for regulatory affairs. Many adverse events reported to the FDA come by way of the drug companies, which tend to classify them as not mentioned on the label, he says. “The product labeling can be pretty narrow.” And he notes that some of the drugs with the most reports, according to the study, were narcotics that have been on the market for years.
Reasons for the increased reporting aren’t fully understood, FDA spokeswoman Julie Zawisza says. “While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase.” She says they include heightened public awareness of drug safety and the ability to submit reports via the Internet.
Dr. Sal Giorgianni
With all due respects to Dr. Furberg I do not think that the reporting system is broken at all; quite the opposite may be true. I do not have all of the data at hand to do a proper analysis of what may be going on here but I think there are several reasonable hypotheses to consider. Reporting may be up because of a) ever growing use of electronic reporting methods; b) heightened public and practitioner sensitivity to drug product side effects; c) the overall impact of more intensive press coverage of the issue; d) continual erosion of the “trust and good faith†barrier that tends to blunt such reporting and e) the potential causal relationship between the temporal rise in the use of illegal/tainted/counterfeit pharmaceuticals and the reported incidence of side effects and/or lack of efficacy interpreted as side effects. The later matter is one that should very carefully be assessed. It is quite possible that the good Doctor Furberg, long the critic of PhARMA companies, nay be correct that harmful products are getting into the supply chain but not because they are bad medicinals but because they are badly produced products.
The public deserves more analysis of this important epidemiologic signal. It needs to be addressed methodically and with scientific rigor. All possibilities need to be explored and jumping to conclusions will not help anything.
Hank
I tend to agree with Dr. G’s hypotheses about why reporting may be up - both the technology and the heightened sensitivity to ADRs. But still no idea why some classes more than others.
Furberg’s comment, as I read it, was meant to apply to the reporting/evaluation system, not the medications themselves. Most of us know that Medwatch catches 1-10% of serious AEs, a considerably lower percentage than in most other developed countries. We also know that every major study that has looked at the U.S. drug safety system - FDA’s own, Institute of Medicine, GAO, etc. have said the same thing as Furberg. They aren’t blaming the drugs themselves either.
LILLY
The quality of health for the average American is being neglected. Every Federal or
State Patient Safety Law that has been approved does not provide scrupulous
patient care. Because of the unethical conduct that Congress is commanding
healthy individuals are needlessly prescribed harmful medications that cause
unnecessary suffering, promoting untimely death. Most doctors do not monitor report adverse side effects. Patients are reportiin the adverse side effects and the medical profession is denying that medications are more than ever causing danger and death.
The recent Bill HR 3580 that was approved does not really provide patient safety
care in America. As usual it provides more protection for the pharmaceutical
Companies.