You Can Report Side Effects To The FDA?
15 CommentsBy Ed Silverman // April 2nd, 2008 // 11:16 am
A new poll finds that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doctor or hospital, but only 35 percent were aware that they can report these side effects to the FDA and only 7 percent indicated they would inform the agency. Instead, 79 percent reported they would tell their doctor, although conventional widsom says not all docs send all those side effect reports to the FDA MedWatch system.
In 2004, about 423,000 adverse events were collected by the FDA, even though drug reactions account for nearly 700,000 emergency room visits each year, according to Consumers Union, which notes that drugmakers are required to report adverse events to the FDA, yet docs and patients do so voluntarily. An Institute of Medicine report found that in 2004, only 21,500 of the more than 422,000 reports that year came from docs and patients.
By contrast, Americans were very familiar with drug advertising. Not surprisingly, 81 percent reported seeing or hearing an ad for a prescription med within the past 30 days. Among them, virtually all – 98 percent – viewed an ad on television, according to the survey by the Consumer Reports National Research Center. When asked if they think prescription drug ads should include info to report an adverse drug reaction to the FDA, 87 percent of consumers said TV ads should contain the info, and 90 percent said print ads should do the same.
To close the knowledge gap, Consumers Union this morning says it gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and website be included in all TV drug ads so people can easily report their serious side effects to the agency. Consumers Union is the non-profit organization that publishes Consumer Reports. Here is the survey.
Tom
It’s important to make sure that such a program is highly structured and well thought out, or it risks doing more harm than good. Collecting patient reports requires an interactive process to convert lay interpretations of adverse events into information an FDA medical reviewer can actually use - preferably with confirmation by a treating health professional or through the provision of redacted medical records. There also needs to be an efficient way for the FDA to filter out the millions of non-serious, common side effects and requests for medical advice that patients will inevitably phone in and concentrate on those events that are truly rare, serious, and not fully described in the label. Like mining for gold, a huge amount of soil and rock has to be processed and sifted to find the nuggets. This initiative could, in theory, produce a scientific payoff , but only with a significant and dedicated allocation of resources and a way to perform intensive, personal follow-up on important adverse events. The question - and it’s one I can’t answer - will the huge investment that’s needed generate an adequate benefit, or will this turn out to be just a public relations excercise?
Justice in Michigan
Tom makes excellent points. It would certainly be preferable if such reports could be made at least in conjunction with a treating HCP, but we know how rarely that happens.
In any case, yes, everything depends on how this is structured and what/who is on the other end.
Michael
The thing is - that is already being done by many of the major companies. FDA mandated about 6 months go that any DTC print ad prominently display an 800# and URL telling the consumer where they could report any AEs.
Chris
Agreed - Tom makes much sense. The costs necessary to validate each reported AE would be astronomical and JiM mentioned recently how meagre the FDA budget is currently so it’s difficulr to see where the funds will come from.
It’s interesting to see this proposal in the context of other govt (not private sector) initiatives intended to improve information exchange including today’s independent clinical trial review and the earlier govt funded ‘academic detailers’ I think it was called.
Seems to me the one recurring theme in this is the central role of pharma to enact all the policies under review. They are able and capable of managing all these proposals, and sme would argue already do so to an acceptable degree. Perhaps money spent encouraging/mandating improvements in the way pharma fulfills its responsibilities would be more effective than these open-ended and somewhat improbable ideas.
Just A Thought
I’m not so sure that the issue is whether you CAN report side effects. Or if people are aware that they can report. Rather, it is if the FDA is actually paying attention to those adverse reaction reports once they get them.
Or maybe it is that, like the drug company, the FDA must run interference after approving a dangerous medication before they take any action. Seems like reporting is not a completely futile thing to do, just, you can’t really expect a timely reaction. That is what is dangerous about this system
It is important for people to know where to report.
HorusCat
You all make excellent points. What I would proffer is 1) what a consumer interprets as a side effect may be totally unrelated to the medication–thus this poll isn’t necessarily accurate. What kind of side effect sends you to the doctor or hospital? A rash may send someone to the doctor, yet as a side effect to medication (except for a few exceptions like Lamictal) it’s a non-event. I’d like a little more information before I gasp in dismay.
2) If a side effect truly is bad enough to push a patient to the doctor, the doc will probably mention it to the rep, and the rep has to report it. I don’t call in every report of drowsiness I get with my med, but anything beyond the most common nuisance side effects, I call in.
HorusCat
And one thing I didn’t think of…how many of those side effects occur with generics? No reps to report those. And some, like rash with penicillin, are important and warrant a trip to the doc, if only to be warned never to take penicillin again.
Justice in Michigan
One anecdote doesn’t make an argument, but here goes … I had a significant AE related to an eye med I was taking some years ago. It was confirmed on three rechallenges (the third of which I barely got through).
HC writes, ” If a side effect truly is bad enough to push a patient to the doctor, the doc will probably mention it to the rep.” In my own case, I am quite sure this never happened.
Turns out, a few years later, a well-known (worldwide) opthamologist got intersted in the issue. I had seen him once; he ended up contacting me, more because of a shared professional connection than the fact that I had been his pt.. A number of other cases suddenly came out of woodwork (wherever that is), mainly because he and some fellow researchers actively searched for them. Article about it appeared in relevant journal, but label has still not been changed.
This took five years and an almost perfect storm of fortuitous circumstances. I conclude the following: we probably never seen more than the tip of the iceberg, even with serious AEs; there is no “natural process” in which they will inevitably become known; becoming known is only tangentially related to a label change; the whole reporting process needs to be rethought at all ends. It won’t happen either automatically or by a few tweaks here and there.
Justice in Michigan
I gues one other lesson implicit in the others. A passive reporting system like Medwatch is doomed to failure - whether one is relying on docs, companies, or pts to report. This needs to supplemented by more active surveillance based on what one already might anticipate as class effects and the like. My own situation could easily have been predicted from the basic science, had anyone cared to pursue it.
There have been a few such programs in the past. But when FDA started throwing things out of the window to make their half of the PDUFA payments, these were some of the first programs to go.
HorusCat
Justice,
Point well taken.
HC
Just A Thought
HorusCat,
Interesting comments because my above post started out much longer and I edited out the part where I asked if the drug companies have to report adverse reactions to the FDA verbatim. I didn’t think so. And I do not mean to sound nasty at all, but…
A drug company rep is not a doctor or a licensed pharmacologist (am I wrong?). By not reporting some or all of the symptoms that are reported to you, you may well be hiding a grouping of common symptoms that might represent a bigger problem. No?
IE: AEDs (anti-epileptic drugs). A person refills his medication or switches to a new one. In doing so he gets fuzzy headed, numb face and lips, tunnel vision and hearing, auras (partial seizures), tremors, and a rash.
He goes to his doctor because he is sick, but any of these things CAN occur with AEDs. So what would you report? The rash? Maybe there is something really wrong with that drug to cause such an onslaught of adverse reactions. Could be a bad lot, could be the NMP (new manufacturing process) of an older drug, could be a change in one of the excipients.
All symptoms should be reported to MedWatch. In fact, it would be nice if the drug reps reported them to MedWatch personally. Of course the rep would probably lose his job. It is scary that one might assume that the patient may just have something else going on and not report his adverse reactions.
As it is, the FDA gets the information 5th hand after everyone else makes their assessment.
1st) patient, 2nd) doctor, 3rd) drug company rep, 4th) the drug company (lawyers?), and 5th) the FDA.
What are the chances the FDA is going to get accurate information if everyone in between sees fit to omit what they believe to be a minor incident?
Just A Thought
Just saying because “the most common nuisance side effects” may be different from one drug to another.
HorusCat
JaT,
You bring up a valid point. I think it comes down to one of those pornography things: I know it when I see it. If a doc says he gave a patient Zoloft and the patient had mild loose stools, that is a nuisance side effect. If the doc says the patient had diarrhea for a couple of days, that seems reportable. You are right, we should report absolutely every mention of anything adverse in conjunction with our drugs. In real life, that just isn’t going to happen. In the case you mentioned above, the AED, that doesn’t seem to me to be nuisance side effects. Nuisance with gabapentin is drowsiness. Serious is patient having trouble waking up. Numb lips, etc., are not one of the 2-3 most common side effects.
We don’t call MedWatch–most companies have a reporting mechanism. We can report minor events through our computer system; or we can make a phone call. Whoever is on the other end gets as much data from us as possible (we don’t have patient name and all that, because that would be HIPAA violation, but we can give doctor name, phone number, fax number, etc). I have had doctors report that they received a phone call from the company to clarify events, and even, in the case of one serious event, pretty extensive follow-up from both the company and the FDA.
The system is, as you say, a passive system that relies on human judgment. The big obstacle is how to sort through all the static and find the signal. Maybe a computer-sort program where adverse events get scanned into a program, which sorts for commonalities with drug names and adverse event symptoms. So if Drug A came up in conjunction with symptoms X, Y and Z with a certain frequency, a flag came up and brought human inspection into play. One problem with that is sometimes a really serious side effect may occur very rarely (like PML with Tysabri)–another problem would be the lack of commonality of language with how people describe adverse events. One person’s sedation is another person’s good night sleep.
Dr R.D.Steinbaum
One thing is for sure.The answer to this problem is not more statistics.
The problem is clear:patient are taking chemical drugs that are dangerous and toxic for the organism.
The Pharm Industry are far away from honesty,close to greedy.You can expect from them more and more [dirty]tricks to fill their pockets
The solution for this problem in not existing.Only partial answers is what we have.Reporting can be one,but leave us with a feeling of futile
Grieving
Medwatch? A joke. I’ve gone through many Medwatch reporting data for Zyprexa, which killed my son. Some are very succinct and thorough, especially those written by doctors. Since my son’s doctor disappeared, I don’t know what he might have reported other than the nothing he did report. I reported the death of my own son and never even received a standard email to tell me it had been received. And of course the FDA did nothing until three front page newspaper articles embarrassed them to place a warning in early 2004 - for all atypicals. No singling out the one with the worst reported side effects.
I like Consumer Union’s idea but can see Pharma working around it and the FDA doing nothing..as usual.