errorhttp://rjgiombetti.blogspot.com/2002_09_08_rjgiombetti_archive.html

It's been a tough spell for British based pharmaceutical giant Glaxo-Smith-Kline, or GSK, for the past year and three months. First, it's top selling anti-anxiety/depressant drug Paxil was found to be primarily responsible for a 1998 murder-suicide in a federal district civil trial in Wyoming in June 2001. GSK has since quietly settled its appeal of the case, a major courtroom defeat for the company.

Then last month the plaintiffs in a Paxil withdrawal lawsuit convinced a federal judge in Los Angeles to order GSK to stop claiming in its advertising that the drug is not habit forming and causes no withdrawal symptoms in patients. A peculiar, and some would say blatantly political, intervention in the case by Attorney General John Ashcroft's Justice Department then followed the judge's ruling. The matter of whether or not Paxil is addicting is for the Food and Drug Administration, not a court, to decide argues the Justice Department. In a shocking revelation, the Justice Department says the FDA has scientists willing to toe GSK's line and say Paxil is not addicting. The judge in the case withdrew the ruling in order to give GSK time to appeal, so the ads claiming Paxil is not habit forming are back on the air for now.

But the line coming from GSK and the FDA is contradicted by the thousands of stories that have been documented at Canadian Frank Streicher's Quit Paxil website: http://www.quitpaxil.org. Or you can browse through some of the stories of patients on Paxil trying to go through withdrawal at the Paxil Yahoo Group: http://groups.yahoo.com/group/paxil/. Here is a September 8 posting by Kim titled, "This Is Terrible": "Hi, everyone. I am going through a terrible withdrawal. I went from 30mg to 20 to 10 to 5 and now I am completely off Paxil. But it is not completely out of me. I have been off Paxil now for a week now and everyday is a struggle. Mood swings, dizzy spells, severe muscle aches, shocks throughout my head and body when I move my eyes. I feel like I am going crazy. I can't think straight and my animals are being neglected. I would have NEVER taken this if I knew this would happen. I was Prozac years ago and had no problems coming off. I can't wait to get this out of my body and clear my head. Here's a testimonial you won't be seeing in any Paxil ad from Rina in Toronto posted August 5: "Taking Paxil since 1995 and I am now 330 lbs. I take 40 mg daily. Any advise on how to get this out of my life?" Weight gain is a commonly reported side effect of these drugs.

With GSK desperately scrambling to save Paxil's remaining marketing life, it's worth asking who we are to believe in a case like this. A jury in a federal district court has already refused to buy GSK's line that Paxil is less likely to cause suicide than sugar pills and older antidepressant drugs in its clinical trials. It's worth noting that the key expect witness in that case, psychiatrist and psychiatric historian Dr. David Healy of the University of Wales, made an interesting discovery while he combed through GSK's archives of its Paxil clinical trial data: "One of the extraordinarily interesting things about the healthy volunteer data in Harlow (England) was that they have a group of studies there where totally healthy volunteers, people like members of the court here, go on this drug for very brief periods of time, a week or two at the most, and after only two weeks on the drug SKB (SmithKline Beecham, the pre-Glaxo merger company that used to own the patent for Paxil) recognized that they're having physical dependence on this drug, so when the drug is halted there are withdrawal syndromes."

That testimony was objected to by GSK's counsel and upheld by the judge in the case because it wasn't relevant to the matter of Paxil and suicide (Healy's testimony in the case can be read at my blog starting on August 27: http://rjgiombetti.blogspot.com/2002_08_27_rjgiombetti_archive.html. But it sure is relevant to the question of whether not GSK and its pre-merger predecessor falsely marketed Paxil as a drug that is not habit forming and causes no withdrawal symptoms. The most interesting aspect of Healy's testimony is GSK's lack of any interest in studying topics that might make Paxil look bad, like linking its drug to suicide. If GSK did have any data that might link Paxil to suicide, it was always conveniently buried in the archives and forgotten. Is there any reason not to suspect the same thing was done to any company data that might link Paxil to withdrawal symptoms in patients and trial subjects? Healy's testimony suggests there is good reason to suspect the same thing was done with the clinical trial data demonstrating a link between Paxil and withdrawal symptoms. If the FDA has any studies into Paxil and addiction, then I would like to see them. I doubt the federal agency has much to go on when it comes to convincing a jury in a law court that Paxil is not addicting.

This is why the issue of Paxil and addiction is a matter completely within the jurisdiction of a civilian law court. Would a group of FDA scientists, most with links to the pharmaceutical industry no doubt, do anything else besides rubber stamp the company line coming from GSK on Paxil and addiction? Does the sun rise in the east and set in the west? Is the sky blue on a sunny day?

With the likelihood that there is little or no clinical trial data for GSK to back up its position on Paxil and addiction, who else should we listen to other than the patients who have experienced withdrawal symptoms while quitting Paxil and their doctors, like Healy or Harvard's Joseph Glenmullen, both of whom support the plaintiff's desires to see the Paxil ads pulled from the airwaves? Below is a summary of my e-mail correspondence with one of the 35 plaintiff's in the Paxil withdrawal lawsuit, Trisha Spinelli of Evergreen, Colorado.

Rick Giombetti: First, give a little biography. How old are you and where did you go to school, and what, if any degrees do you have. What kind of work do you do when you are not writing and not engaged in activism on mental health and psychiatric drug issues?

Trisha Spinelli: I was born on March 16, 1946 in Los Angeles. I graduated from East Anchorage High School and attended LA Valley College and UCLA. I was on the dean's list and the honor society. From 1976 to 1995, I worked in various capacities in the entertainment industry, beginning with Warner Special Products where I was the licensing coordinator for Warner/Electra/Atlantic Records. I then took a position at IRS Records as the Director of Advertising and Tour Coordination. In 1981, I moved to New York City and continued my career in the record business. I also produced and acted in a television show and had an art gallery in Manhattan. In 1988, I moved back to LA to produce a video series for a celebrity design company for which I was also the Managing Director. In 1990, I produced a music video series titled "Shindig: and also produced the music video for the blockbuster movie "Ghost." My video work was aired on both MTV and VH-1. In 1991, I moved to Evergreen, Colorado to produce a country music album with the former drummer of the band "Chicago." I also managed and produced many local music groups. My last assignment in the record industry was when I launched a nation media campaign for Flat Canyon Records. In 1993, I started a gourmet bakery specializing in Italian breads and worked with my husband in various restaurants that he owned. In September 1997, I began writing a spy novel about the use of psychotropic drugs as a form of mind control. I recently published the novel with title "Blind Reason" (Under the pen name Patricia Griffon and listed for sale at Xlibris.com, Amazon.com and Barnes and Noble's website, plus in bookstores). It was written during the time that I was recuperating from taking Paxil.  Most of the plot was borne of my experience with this drug and it was the writing of this book that kept me going during my recovery.

RG: Describe your experience taking and then trying to quit taking Paxil.

TS: I started taking Paxil in July 1997 after it was suggested by my nurse at a mental health clinic in Evergreen. My previous experience with psychiatric drugs did not go well. I took Zoloft for one day back in 1994, didn't like the side-effects and flushed it down the toilet after reading the insert that listed "suicide" as the first adverse reaction. I took Elavil for four days in 1996 before quiting because of the side-effects. My nurse assured me that Paxil had no side effects, was not addictive and would help me deal with my anxiety and frustration caused by the intense pain from injuries sustained in a 1993 automobile accident. I started out on 2.5 mg per day of Paxil and worked my way up to 10 mg by the third week of July. >From the beginning, I did not like the way Paxil made me feel. I was assured by my nurse that whatever effects I was experiencing would subside and I would feel a lifting of mood within four to six weeks. With each incremental increase of Paxil, I began to feel more agitated. I was having trouble sleeping and was prescribed Xanax to take before I went to bed. By the fourth week in July, I was unable to leave my house because of the side effects of Paxil. I had a ringing in my ears, and generally felt agitated and very unlike myself. I was experiencing light and sound sensitivity. All the while the inner restlessness increased, and I began to have bizarre thoughts. My anger continued to mount and I would explode in violent rages and verbal outbursts. My husband did not understand what was happening to me. He encouraged me to come to the restaurant and work. But the restaurant was 40 miles away in Denver and I did not feel that I could safely drive that distance. The few times I did drive after taking Paxil, I often had an urge to cross the median of the freeway into oncoming traffic. This was very frightening I had never had such thoughts in my life. On 20 mg of Paxil I began to feel totally disconnected from my body. I had horrible nightmares. I began to have intense sugar and carbohydrate cravings. I was irritable and moody, but at the same time I felt emotionally blunted. I was experiencing what I now know is akathisia, an inner restlessness. I had to keep moving. I cleaned my house obsessively. I cleaned out the closets and gave away most of our clothes. I couldn't seem to sit still for five minutes. My husband suggested that I stop taking the Paxil.

In September 1997, I decided to stop taking Paxil cold turkey. Within three days of going off cold turkey, I began to experience "brain shivers" and "electrical zaps" in my head. It felt as though someone had placed a wire against my temple and turned on the juice. Then came the paralyzing nausea, dizziness, diarrhea, blurred vision, headaches, mini-blackouts, and extreme muscle pain in my body and legs. I was unable to move. I could not walk across the room without bracing myself against the wall for support. There were several times when I actually crawled on my hands and knees from the bedroom to the living room because I could not stand up. I would sit for hours in one chair and stare into space, afraid and unable to move. My husband described me as a "zombie."


My pharmacist advised me to get back on a 20 mg dose of Paxil again and gradually wean myself off the drug over a period of five months. The withdrawal symptoms went away after I went back on 20 mg. I withdrew faster than my pharmacist recommended since I really wanted to quit this awful drug and end my nightmare. I gradually tapered my daily dose down to 2.5 mg per day and took my last dose by the end of the third week of December 1997. I had severe nausea for approximately six weeks after that, along with headaches, brain zaps, and vertigo. In fact, the withdrawals were so intense that during the entire month of January 1998, I never left my house. Over the next six to eight months, these symptoms gradually subsided, but I was terrified that I would never fully recover from the withdrawal experience. The memory loss, cognitive deficits, light and sound sensitivity, and word retrieval problems persist to this day. Never in my life have I been through such hell. I can honestly say that it wasn't until January 2000 that I began to feel even the slightest bit like myself. During my two-year Paxil nightmare, I did hundreds of hours of research into how drugs such as Paxil affect the brain and how difficult it is to withdraw from this drug.

RG: Explain what the plaintiff's claims are in the case you and the 34 other plaintiffs have brought against Glaxo and why did you decide to become involved in this civil suit and how did the suit come about?

TS: First, I participated as a declarant in the Paxil suit filed by Don Farber back in 2000.  Over a period of months, I continually told him that my Internet activities made it very clear that the problem with Paxil was worthy of a class action lawsuit because in the few years that I had done research on SSRIs, I had come in contact with literally thousands of people whose lives were rent asunder by this drug. In fact, during the worst of my withdrawal, I screamed at the doctor who prescribed it, "You'll see, within 5 years there will be a class action lawsuit to get this drug off the market!"  I knew back then that I could not be the only person who had suffered such debilitating side effects from a medication that was being touted as safe and effective, with little or no side effects and NO potential for addiction.  And yet, there was no information available from the manufacturer about this phenomenon, in fact, they continually denied that there was such a thing as withdrawal, and if it did exist, it was mild and temporary.  Some of the plaintiffs become so sick when trying to withdraw from Paxil that they have simply given up ever being able to get off of it safely.  This is NOT a minor problem and we as plaintiffs want the manufacturer to reveal what it knows and to properly label their product with the warnings that are desperately needed, and to compensate us for the suffering we have endured as a result of their failure to adequately warn the medical community and the consumer of potential problems.

RG: Like the many other people who have experienced problems with Paxil and other SSRI drugs ("Selective Serotonin Reuptake Inhibitors": Celexa, Luvox, Paxil, Prozac, Zoloft) I noticed you've taken your concerns about them to the Internet. How would you grade the performance of the mass media in covering this issue of these drugs from the perspective of the patients who take them?

Initially, I got involved in the Internet because the mass media that reported on the crimes in which an SSRI was involved downplayed the fact that any medication might have contributed to the school shootings, murder/suicides, etc. In fact, the prevailing theme in the media seemed to be that the person had NOT taken his medication as prescribed, pointing the wagging finger of blame at mental illness for these atrocities rather than investigating whether or not the medication itself might have contributed to these incidents. The first couple of years of internet activity for me beginning in 1997 proved to be very frustrating because there were no message boards where other victims could gather. Then about two or three years ago, I discovered the QuitPaxil.org site, and the website started by Kelly Owen who was interviewed on 20/20 regarding the side effects of Paxil. Then the Prozacawareness site started, and after that the SSRI Crusaders site sprung into action.  I have met so many wonderful people who have lost a loved ones to this drug (or another SSRI), or have suffered years of medical problems themselves from having taken it.  The primary objective of all these sites is to raise awareness about the potential side effects while on the medication, and the side effects while withdrawing. It is disturbing that there are so many medical professionals who simply are uneducated in the mechanism of the drugs, how they affect the body and mind, and what constitutes the cluster of symptoms euphemistically referred to as "discontinuation syndrome," i.e. withdrawal.