SS: Don, congratulations on getting the injunction to stop direct
to consumer television spots, which state that Paxil is not habit forming.
DF: The preliminary injunction was granted a day later the US ATTY, at the request of FDA, asked the judge to stay the order for a while, which she has done. It was scheduled for Sept 1, and is now stayed until the justice department can brief her on the issue. We are on solid ground on procedural and substantive issues here. On the psychiatric issue they are wrong. The issue with the FDA is dependency. If you recall the DMS-IV, there are seven criteria for dependency, any three of which mandates a valid diagnosis of dependence. One of those is "drug seeking behavior." They seem to be arguing that Paxil is not addicting because there is no drug seeking behavior.
SS: Of course, if it were not so available we would see lots of drug seeking behavior.
DF: I'm scheduled to meet with the FDA next week. I'm mad and disgusted as hell that the FDA is so blatantly in the camp of the pharmaceutical companies. We've embarrassed them we did the job they refused to do for ten years and now they have egg on their face . They are basically bought and sold.
SS: So what do you intend to do?
DF: The point is that for a psychiatrist there are six other criterion the justice dept is trying to put the whole definition of dependence on this one criterion . drug seeking. "Habit forming" is not a medical term so how can the government define this when it is not a medical term? How can they say that the judge has no jurisdiction and that only the FDA has the exclusive jurisdiction to regulate prescription drug advertising?
SS: Is it true that when David Healy reviewed the drug company information for the murder-suicide trial in Wyoming that he found documentation that SmithKline (SKB) knew Paxil was addicting?
DF: They would never use those terms. Healy found out that in healthy volunteer studies, about 24% of volunteers suffered withdrawal.
SS: Beyond all of the legal details, does it seem that the court has a common sense understanding of what is going on, of the over prescription and subsequent addiction on a mass scale?
DF: No. In the abstract the judge I argued this Two or three of them (defense witnesses) said that our experts are scaremongers doing disservice and scaring the public when they really need the medication. But we are not even saying it is addictive, but we do want them to take away the claim that it is not habit forming.
SS: Does this have anything to do with the actual class action?
DF: As a practical matter this injunction shows what the judge is thinking . That she knows it is misleading Technically has no bearing on decision coming up in October.
You might ask, "How can this lawyer who took biology 101 how can I know more than their doctors?" I have seen the real data and they haven't. It is a simple matter of cooking the books . I'm going to prove this next week I'll tell you where they cooked it. In the original data, 2963 people took Paxil, 1152 took tricyclics , and there were 554 placebo patients. Initially when trials were over in November 1989 Paxil had 49 suicide events which is 1.65% (completed and attempted) and one with placebo (.02) the rate in tricycles was 1.48% Teicher came up with an article 2/90 in the American Journal of Psychiatry that Prozac causes suicide. That actually caused suspension of further SRIs in the pipeline Later that year SKB got a call from the FDA project officer on Paxil - he said not to worry about suicide, and that Teicher is just a public relations problem. He said that we have to deal with this PR problem remold them (the data) to answer Teicher. - SKB resubmitted the same population only the 49 suicide events on Paxil went down to 45 and placebo up to 8 and the revised data - report was signed out with no review. On 10/5/92 when it was reviewed, data between Paxil and placebo was not statistically different.
SS: Was the project manager paid off by SKB?
DF: It doesn't necessarily work that way. It is not a simple matter of bribing a few officials. Next Wednesday I meet with the FDA - 2 deputies, a
MD and an attorney. It took threats to issue the meeting. I told Dr. Woodcock, if you won't look at this I'm going to the press. They are going to cringe when I come in the door after this injunction We couldn't have a more unfriendly opposition. We have the truth and the light on our side. I challenged them to turn over the original 4000 records for independent review they are not willing to submit their data. They do submit methods but not the data. They describe the epidemiology involved in their methods, but not the raw data that they analyze. What kind of science is it that? The more light that shines on this the meaner and more desperate they get.
Lets make the label fair and accurate.
SS: The suicide issue really stands out.
DF: It is all part of the misrepresentation of Paxil.
SS: Good luck, Don.
Reprinted from "uncoventional Psychiatry" (Vol 1, issue 2) with the permission of Stuart Shipko, MD. For more information Panic attack treatment and other mental health issues, please visit his web site.
© Stuart Shipko 2002