This sounds like a good thing to me:
http://www.pharmalot.com/2008/06/consumers-report-more-adverse-events-than-docs/
Interesting article. Good that consumers are more aware.
I, the mother, reported my son’s death from Zyprexa to Medwatch, being sure that the doctor would not, nor would the people at the intensive care unit. I also reported my daughter’s reaction of suicidality from Lamictal and was told by the FDA to tell this to Glaxo.
It has always been my opinion that this reporting, and the Medwatch System, are ill-used or seldom used, no matter how many people report adverse effects. It is amusing to me that all the Pharma people here self righteously say that they are all ordered to report an adverse effect when it is their own companies that are so often responsible for hiding the evidence of lethal effects from others in the company, federal regulators, and saddest of all, the victims.
I think that what we are seeing here is that individual healthcare consumers are no longer content to sit back and passively accept what comes their way in terms of healthcare. The rise of internet sites like medications.com has given them a tool to educate themselves and bypass the traditional sources of information.
Tom said “The value of individual adverse events is that, collectively, they can give the FDA a signal that an issue needs to be studied in more detail with epidemiology studies or some other methodology.”
Actually not true. If you look at textbooks of pharmacoepidemiology “epidemiology” is not listed as one of the factors used to establish causality of a side effect being related to a drug. Nor is conducting a clinical trial, which is neither ethical nor feasible. Individual case reports are, however, used, as are other factors including rechallenge with recurrence of the side effect.
As for healthcare consumers I think medicine / the body should be taught in school so that people have the basic framework to educate themselves about prescription drugs and other relevant issues. I mean your health is just as important as the history of ancient China, right? And we don’t teach anything in school. As for unanticipated side effects and adverse effects for prescription medications that come out after approval I think there should be a government agency separate from the FDA to review data and provide real surveillance. With PDUFA drug surveillance has been pretty much scrapped. Talk to anyone at the FDA and they will tell you off the record that they have no ability to do drug surveillance. It’s pretty much a crap shoot for consumers and with preemption on the horizon the last check (i.e. the courts) will be gone too. Maybe Just in Mich can give us a little lecture about that.
Time effect meaning that the side effect occurred after the drug was started. I would also add challenge-rechallenge (side effect goes away when off the drug, and comes back when you go back on) which was cited in the textbook pharmacoepidemiology as being sufficient in itself as support for causality, and class effect (other drugs in the same class cause similar side effect). You can’t do a randomized clinical trial to determine if Chantix causes suicidality: it is neither ethical or feasible. This is one example but I could go on and on. In the absence of this you need a method to assess causal relationships between drugs and adverse events. Healthcare consumers would not (and should not) accept the fact that in the absence of a randomized clinical trial or an “epidemiological” study that there is no evidence that a drug is associated with an adverse event. The textbooks on pharmacoepidemiology don’t use this logic, why should they.
Or this -For what it’s worth, here is my family’s experience with the FDA MAUDE database…
My mother died from an adverse reaction to a medical device. When she was in the hospital, the doctors and the hospital did not seem to have consulted the database because we were told that only 3 other people had reacted to the medical device in the way that she had reacted. After she passed away, we called the FDA and were told of the MAUDE database. We found that there were many reports concerning this medical device, most of which match the reactions that my mother endured. As of today, there have been 271 reports on the MAUDE database concerning this device…271 reports concerning this device and no changes to the labeling or removal of the medical device from the market. There have been several deaths reported, although, other than from my family’s own report, my mother’s is not one of them. The medical device company has never reported her reaction as a death, it is reported as “required intervention”. I believe that if a salesperson reports that a person has suffered an adverse event, it is indicated in the MAUDE report. That, also, has not happened in my mother’s case. I have to think that my mother’s doctor would have reported this information to the sales rep, given the fact that he said he would never use the medical device again.
I guess the bottom line, as far as I’m concerned, is this. Physicians don’t use the database to access information about adverse events, the FDA does not use the database to monitor medical devices and sales reps do not use the database consistently to report adverse events.
This database was designed as a way for the FDA, medical professionals and consumers to monitor medical device adverse events. It appears, in my mother’s case, that it has failed.