Time to Listen to Patients
Posted: Tuesday, April 13, 2010
by Joel Hirschhorn
http://www.delusionaldemocracy.com
It sounds beyond belief, but the big world of physicians, pharmaceutical companies, research institutions and government regulatory agencies have never created a system to seriously collect information from patients taking new medicines. What the whole health care system needs to learn is what kind of side effects actual patients experience, some of which may be a nuisance while others can be deadly serious.
Dr. Basch noted that he first became interested in this subject when he attended a presentation of the results from a study of a new cancer drug. Though the researchers had not found fatigue to be much of a problem, other doctors in the audience said their patients had suffered terribly from it while on the drug, so much that some had to quit taking it. The formal study had completely missed that serious side effect.
Further work found that all kinds of problems - such as fatigue, nausea, appetite loss, vomiting, diarrhea, constipation - were reported by patients earlier and more often than by doctors and nurses because of biases, subjective interpretations, and the loss of information in a complicated system.
One solution is to use a system where both doctors and patients report information.
Here is something few people know. The US Food and Drug Administration does have a system, Medwatch, that lets doctors and patients report problems that they think are adverse events from drugs already on the market. However this is a passive system that waits for submitted information rather than systematically surveying patients taking drugs before and after they are commercialized.
"Patients have a lot to say," Dr. Basch said. All we need now is for a great system to be created to listen to patients. That way we may see far fewer drugs that turn out to cause very serious side effects but only after considerable harm has been done to a lot of people who have used the new drugs. And drug companies may work harder to either eliminate the side effects or develop drugs without them.
This Article has been viewed 772 times. (Not updated in real-time.)
Top-level comments on this article: (2 total)"One solution is to use a system where both doctors and patients report information."The wonderful, compassionate pharma companies would never allow the big bad government to do that. That would in some twisted way be regarded as big brother by our wonderful, fair, compassionate pharma companies. Good luck America.
Actually, through the 7-10 years of testing a new drug, the patients' response to a drug is documented. The pharma companies do this as mandatory testing for every new drug going to market.You are correct about Medwatch, which is kind of like a police department in that a problem has to exist before it is notified, yet there is no other alternative. The pharma companies, believe it or not, test the new drug well beyond the time they probably should because the alternative - a Class I recall (a recall mandated by the FDA because of death) - will kill the company.I see what you're saying, though. The information given to the pharma during this testing is considered 'proprietary' and so the government doesn't see this info. Would be nice to have them receive the test results also.Good job, sir.The bigger point is that the numbers of people actually using a drug are enormously greater than the numbers used in the original testing of the drug to get government approval and the former are not reporting their side effects.
We want your comments! If you can read this, you don't have javascript enabled, so you can't use this comment system. Please enable javascript.