I like Consumer Union’s idea but can see Pharma working around it and the FDA doing nothing..as usual.

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.

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?

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.

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.