Patients & doctors better monitor side effects with the aid of I.T.

Information technology is making it easier for people who use medications to report their side (a.k.a. adverse) effects and thus improve the completeness of drugs' profiles, taking this out of the hands of pharmaceutical companies.

Currently, accoring to the 3 October 2006 WSJ article "Researchers Ask PatientsTo Help Fill Gap in DataOn Side Effects of Statins," there is a reporting system in place: the FDA's Adverse Event Reporting System, which collects reports on drugs from "doctors, pharmacists, pharmaceutical companies and patients."

Predictably, the drug companies assert that the AERS works fine. In response to UCSD's Statin Effects Survey site, drug companies "say there already are extensive data on statin side effects. Pfizer, maker of the top statin brand, Lipitor, says 400 clinical trials of 80,000 patients have produced a 'substantial amount of data by which to assess the drug's safety,' says Barbara LePetri, senior medical director in Pfizer's cardiovascular group."

While that is a substantial sample size, drug companes are perceived to be less than trustworthy, and the AERS upon which many reports are based has flaws.

[B]etween 1999 and 2002, the number of adverse events being reported dropped 21%, due in large part to procedural changes that mean "non-serious" events are less likely to be entered into the database, either because the drug has been around for three or more years or because the product labeling already warns consumers about the issue, according to a report last summer in the Archives of Internal Medicine.

AERS is particularly problematic when it comes to statin therapy, some doctors say. For one, men are the biggest users of statins, but the Archives report noted that women are far more likely to report adverse drug effects than men. But perhaps the bigger problem is that many purported side effects of statins -- muscle aches, thinking problems and fatigue, among others -- are common complaints associated with aging. As a result, patients may talk to their doctor about mild aches, memory problems or fatigue, but many doctors just tell them it's part of getting old and don't think to report the complaint as a side effect of statin use.

UCSD's effort, funded by a Robert Wood Johnson Foundation grant, was founded to address patients' frustrations. "'They say "My doctor won't listen to me or my doctor says it can't be related to the drugs,"' says Dr. [Beatrice ] Golomb," who is the creator of the statin site.

There is a far more ambitious project brewing between the FDA and MIT, so reports a CBS News HealthWatch article from 18 August 2006. Their system would "detect unanticipated problems with prescription drugs and medical devices" by scanning through "federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns."

A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies like the Veterans Administration, would be better at recognizing patterns suggestive of emerging problems, [the FDA's deputy commissioner for scientific and medical affairs Scott] Gottlieb said[, comparing it to the current AERS.]...

The FDA also plans to begin publishing reports for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.

This push to use I.T. to improve the monitoring of drugs is likely the result of the Vioxx tragedy.