Failing To Report Severe Drug Side Effects: A National Embarrassment

[btdt]

http://www.forbes.com/sites/luketimmerman/2015/05/01/under-reporting-of-severe-drug-side-effects-a-national-embarrassment/

 

"Chances are that many readers of this column have had an adverse drug reaction or have a family member who has suffered from a similar situation. One estimate published in 1998 in theJournal of the American Medical Association said that adverse drug reactions ranked somewhere between the fourth and sixth-leading causes of death in the U.S."

"That report, based on data from the mid-1990s, didn’t lead to the sort of change that many hoped. You might think that 20 years later, in an Internet age with powerful information technology tools in so many hands, that drug side effects would routinely be reported in detail, and in real-time.

Nope. Only about 500,000 reports were sent to the FDA in 2010, about one-tenth of the estimated number of serious adverse drug reactions. Things have improved somewhat in the past couple years, as there were about 700,000 such reports of hospitalizations, life-threatening situations, and other severe adverse reactions, according to FDA data. But under-reporting is still the norm. If my dad hadn’t asked his doctor to file a Medwatch report two weeks later, I’m confident he would have been among the vast majority of patients whose severe side effects would have gone unreported.

The post-market safety surveillance system is a mess and always has been. Doctors are busy, and they already have plenty of paperwork. The FDA doesn’t have the resources to do truly rigorous post-market safety surveillance, so it concentrates most of its energy on reviewing data from controlled clinical trials before it allows a drug on the market. The pharmaceutical industry is required to pass along reports of serious adverse events to regulators, but it has always treated this as a cost and a low priority. Lately, the industry has sought to cut costs on drug safety monitoring by outsourcing work to India, as was described recently in the Wall Street Journal."

"One systematic review that attempted to measure the magnitude of under-reporting found that across 37 studies, in 12 countries, the median under-reporting rate was 94%, according to results published in 2006 in the journalDrug Safety. Another review published three years later in the same journal found that under-reporting of adverse events was mainly caused by physician ignorance, the fear of looking ridiculous for reporting merely suspected adverse drug reactions, procrastination, indifference, insecurity and complacency. In a twisted bit of logic, the researchers found that many doctors didn’t report adverse events because they figured the FDA only allows safe drugs on the market. Apparently these physicians fail to realize that regulators need to get their data points from somewhere."

"Given my job as a biotech journalist, I’ve known about systemic weaknesses in adverse event reporting for a long time. I’ve written about the problem. But it’s one thing to write about in the abstract, and another thing when one of your loved ones is affected by those systemic weaknesses."

"Luke Timmerman is the founder and editor of Timmerman Report, a subscription publication for biotech insiders."

This is a 3 page article that I have cherry picked for information jut enough to get you to look I hope...more at the link