ssri safety - we're the guinea pigs

Hope I'm not boring everyone, but this is how it works (if you don't already know).

No long-term studies of either the efficacy or the effects of the current ADs have been done - even though most of the drugs have now been around for years - because the manufacturers have never been required to do the long-term studies.

What's happened instead, is the so-called "post-marketing" experience. What this really means is that you and I have been guinea pigs. The meds reached a point in development where they had FDA (and equivalent) approval, for short-term use, then started to be used in the marketplace, ie prescribed. None of them have actually been approved for long-term use - they can't be, without the research to prove that they're OK.

Over time, negative reactions have been reported by patients to individual doctors, who have a drug safety monitoring system in each country and information is pooled globally. But the numbers of adverse reactions have to be huge, globally, for anything to be done.

Now, those numbers finally are huge and things are starting to be done. The investigations currently underway in the UK and the US are researching for symptoms of worsening depression and withdrawal - because that's what vast numbers of patients have been complaining about. Arse-about face, isn't it, if you'll excuse my language. Like I said, we've been the guinea pigs.

Following are some excerpts from an antidepressant study published in Jan this year by Thomas Moore, a New York scientist. They describe the "adverse reactions" reporting system, its limitations and the lack of subsequent responsibility by the drug manufacturers:

"Limitations
Reporting of drug adverse events in the U.S. is entirely voluntary for consumers
and health care professionals, and only a small fraction of all events are ever reported to the FDA. Drug manufacturers must report all serious adverse events of which they become aware (typically from consumers or health care professionals) but are not required to monitor safety systematically. The reporting of an adverse event typically establishes that an observer suspected the drug was responsible, but does not in itself establish that the drug caused the event reported. Variation in adverse event reporting rates can occur for reasons unrelated to the safety of the target drug."

"In January 2004 the FDA revealed that it had detected “a signal of increased risk”
in four of the seven drugs studied, and possibly in a fifth. But the agency said it was
going to re-request and analyze the data still again.
Nevertheless, all this activity was based on clinical trials data submitted to the
U.S. and British regulatory agencies. This study addresses the same issues using the
second major source of drug safety data, reported adverse events."

"In the United States the reporting of adverse events associated with prescription
drugs is purely voluntary for those who experience these events or observe them in the course of medical practice. However, pharmaceutical companies must report to the FDA the adverse events associated with their drugs of which they become aware—even though they have no obligations under law to seek out or search for adverse events that do not come to their attention spontaneously.
The FDA in turn publishes for public research use extracts of all the adverse event
reports that it has received. Personally identifiable information is first removed, and the event narrative is replaced with a list of standard medical terms that best describe the event that occurred. The existence of an adverse event report does not in itself establish that the drug caused the event. However, in most cases it indicates that an observer (a health professional, patient or family member) suspected that that drug was responsible."

(I have put the following in caps because it is so distressing ... Juno)

"SINCE IT IS KNOWN THAT ONLY A FRACTION OF ALL ADVERSE EVENTS ARE REPORTED TO THE FDA, FROM THESE DATA IT IS REASONABLE TO ESTIMATE THAT HUNDREDS OF THOUSANDS OF PERSONS EXPERIENCED INJURY ASSOCIATED WITH ANTIDEPRESSANT DRUGS, AND THOUSANDS DIED. THE LARGE TOLL OF INJURY IS EXPECTED, GIVEN THAT ANTIDEPRESSANT DRUGS ARE SO WIDELY USED."

"A more accurate picture of the adverse event report time trend comes from
limiting the focus to reports of events that are serious, and for which the manufacturer has not previously warned doctors and patients. These are called expedited reports. These events are the principal focus of the adverse event reporting system and must be sent to the FDA within 15 days.
The volume of these expedited reports fluctuated, but increased over the time period, growing by approximately 50% over the five-year period.
These expedited reports are those most likely to contain a signal to the manufacturers about new adverse events about which doctors and patients have not been warned."



This is the situation all over the world and as "complainants", that is, patients talking to each other in forums like this, we have a far greater awareness of the truth than our doctors do (lunatics in danger of taking over the asylum?! Damn right we are ...) Our doctors are relying on information that's coming from where - drug companies? Right. Or medical regulating bodies? Right. Or their colleagues? Same thing.

And the very most insidious part of all this is that depressed people can't trust their instincts anymore (generally our "instincts" have let us down when we're depressed, or they've been suppressed by the medication), we doubt our own judgement, we're frightened, we don't know who to trust ...

The best bet, for safe advice, as I see it, is anything that comes from the SSRI SUPPORT site. Here's the link again:

http://www.paxilsupport.homestead.com/

It's not just paxil - it's all of them, and it's UK-based but with a great US input.

Keep the faith.

Juno