Deaths Wellbutrin* 2006-08-02 Washington DC ++468 Deaths Reported to FDA Thru 2003 : Freedom of Information
Summary:

Paragraphs 10 and 11 read: "Debby Painter and I have since requested certain FDA documents through the “Freedom of Information It’s OK For You to Have Act”. We eventually received the FDA’s MedWatch data on Wellbutrin from 11/01/97 through some unspecified time up until February 2003 (the date on the attached letter). The FDA makes every attempt to avoid being specific. They also chose not to specify which formulations of Wellbutrin these reports referred to. The report I received listed 37,822 total adverse reactions and “total death outcomes” were 468, which I’m assuming included my personal favorite: 16 reports of “pulse absent”. There were 202 reports of “completed suicide” and 152 suicide attempts listed as such, although others were given more euphemistic designations like the 216 “non-accidental” overdoses. Other unusual adverse reactions were “murderer (2 reports), “rapist”, “incest” and “divorce”.

Paragraph 12 reads: "Debby and I also eventually received very abbreviated and much redacted copies of portions of the NDAs (New Drug Applications) for all Wellbutrin formulations, the last one arriving over a year after the FDA received the request. The Wellbutrin IR (immediate release) NDA documented 14 deaths, including 9 suicides, in the initial clinical trials12. There were also 14 suicide attempts. Glaxo reported to the FDA that these “adverse events” were “not attributable to the study drug” and that was good enough for the FDA. Somehow these “events”, or what is known in English as “deaths”, never appeared in the Product Information Guides (PIGs) or the PDR (Physician’s Desk Reference) under “warnings and precautions” or “adverse reactions” which is supposed to include ALL ADVERSE EVENTS OBSERVED during clinical trials, not just those that the company decides that it’s OK for us to know about. However, being masters in the art of covering their corporate butt, Glaxo nonchalantly tossed this disclaimer into the PIG: “all treatment emergent adverse events are included except...those events not reasonably associated with the use of the drug...” So, you have 23 non-suicidal people (suicidal people were excluded from participating in these antidepressant drug tests) who COINCIDENTALLY take the same experimental drug and COINCIDENTALLY wind up wanting to kill themselves.

http://www.forces.org/evidence/kill/cintorrino.htm


SMOKE AND MIRRORS;
How Glaxo's Zyban  can help you stop smoking if you're willing to stop breathing


Imagine going to your family doctor to get a referral for a stress test. Your blood pressure is high and you have some other minor complaints. Your wife’s uncle is a cardiologist and he suggested that this is what you do. Nothing scary about that. Much less terrifying than, say, a rectal exam. Your doctor tells you that you should not get that stress test. They’re dangerous. Instead, you really ought to stop smoking and there is a pill that can get you to do just that. You would later read in your medical records that you were “counseled strongly” to stop smoking although you were “precontemplative” about the whole idea. He hands you a prescription and heads for the door, saying something about leaving for vacation and running late. You take your first pill later that day because it was prescribed by a licensed medical doctor and it’s safety and efficacy has been confirmed by the United States Food and Drug Administration. And everyone knows that smoking is bad for your health. Five weeks later you lose your mind. Later on you start losing control of the rest of your body. And, yeah, you still smoke.

The drug Zyban, which also goes by the name of Wellbutrin when prescribed for depression or any other excuse for writing a script that a doctor can come up with, plunged my husband into a nightmare of insanity and physical illness. While caring for my two small boys and a husband whose behavior came to resemble that of the acid freaks and cokeheads that populated my youth, I began desperately searching for the answers that the “medical profession” had been unable or unwilling to provide. To desperately seek medical help and be mocked or disbelieved is an experience that is difficult to describe and one that no one should have to endure.

The uncle who recommended the stress test happens to be a very prominent and extensively published MD and research scientist: a fact that impresses the heck out of a lot of people. I was always impressed by him too because, unlike the majority of MDs that I’ve encountered, he actually knows what he’s talking about. This would hardly be the first time that I imposed upon him for free medical advice, but it would prove to be one of the last times. He had a friend and colleague who was researching Gulf War Syndrome which, as my uncle was quick to recognize, has a strikingly similar list of symptoms to what my husband Anthony was experiencing post-Zyban1. This list includes a chemically-induced porphyria that was also often found in people exposed to Agent Orange2. I won’t explain porphyria here except to say that it is a serious enzyme disorder. I had to spell it once for an MD in the emergency dept. and I’m lucky I can do that. In fact all of the drug’s victims that I would eventually encounter who were tested for this form of porphyria tested positive. Of course I was never to hear from this friend of my uncle. By then I was not surprised. I’d learned that most doctors attempt to achieve financial nirvana by repeating the mantra “it’s never the drug, it’s never the drug…” I was slowly becoming conversational in Jargon, a language which doctors tend to use they way my mother and grandmother used Yiddish – to avoid being understood. It was becoming more difficult for doctors, including my uncle, to evade my questions. When during one phone conversation I pressed my uncle for information on metabolic pathways and the toxic accumulation of metabolites he responded, “That’s what lawyers are for!” I took the hint. Though at the time I had not yet become aware of the connection between getting published and kissing pharmaceutical company behind, I knew this much: I was on my own.

Prior to this point in my life I had never considered the Internet to be a very useful, let alone vital, source of information. My opinion would undergo a drastic change. I scoured the Internet for information. I came across others who had the same experiences on the same drug as Anthony. Part of that common experience was the diagnosis of “bi-polar disorder” subsequent to their adverse reaction. It seems that everyone who was forthcoming with the details of their Zyban/Wellbutrin experience had been blissfully unaware of the fact that they were suffering from bi-polar disorder until the drug brought their affliction out of it’s hiding place. Not surprisingly it seems that most doctors are blissfully unaware of the diagnosis of “Bipolar IV”3, or drug-induced bipolar disorder. Fairly recently we all learned of news personality Jane Pauley’s discovery of her own latent bi-polar disorder which had, apparently, never given her a minute of trouble until the age of fifty, coincidentally after taking steroids and antidepressants. If an intelligent, informed woman like her could buy into that pharmaceutical con game then what chance did the “average Joe” stand. She was quoted as saying that now she’ll need to take her medication for the rest of her life. Emory psychiatrist Charles Raison MD has been quoted as saying “All of us in psychiatry have seen first episode mania after putting a person on antidepressants”. And so a new psychiatric medication customer is born.

Ironically, the first person to respond to my cyber SOS was the only victim of this drug that I personally know who escaped the “bipolar” label. This was largely due to the fact that her initial reaction to the drug involved dystonia, which in English means a movement disorder and which in reality meant that she couldn’t move. She survived on large doses of Valium, which most likely prevented the onset of mania. Having extensive medical documentation of the physical damage that Wellbutrin caused her to suffer she was able to retain the legal services of Thomas Girardi4 of “Erin Brockovitch” fame on a contingency basis. She has since entered into a secret settlement with the drug’s manufacturer, GlaxoSmithkline (formerly Glaxo Wellcome), and will no longer accept my phone calls out of a very legitimate fear of legal repercussions.

Several years prior to her settlement with GSK this woman had teamed up with Debby Painter, a Michigan wife, mother and smoker who tried to stop smoking with Zyban. This caused her to stop breathing at times, although she always managed to resume breathing and thereby avoid dying. Barely. Debby had experienced every symptom that Anthony did and a few more that Anthony did not due to his lack of female reproductive organs. The two women wound up starting a message board and a website offering information to others who found themselves in similar circumstances.

In April of 2000 they were contacted by Thomas Hatfield PhD, an environmental chemist at 3M Corp. He had used Zyban a/k/a Wellbutrin to stop smoking and wound up with a heart attack, a diagnosis of bipolar disorder, 2 additional inches in height and an assortment of painful and disturbing side effects that didn’t seem to be going away. With the help of sympathetic coworkers he managed to hold onto his job with 3M, which at the time involved doing damage control with regard to an environmental disaster that 3M created with PFOA5, a chemical used in the manufacture of Teflon. Although the cover-up was initially successful, a lawsuit was filed in 2004 by some of 3M’s neighbors in Cottage Grove, MN6. In response to this lawsuit 3M Spokesman Rick Renner said, “We are not aware of any evidence that our production or use of these compounds has caused problems with the soil or water on any properties in the vicinity of our facility”. Yeah, right.

With access to 3M’s state-of-the-art equipment Dr. Hatfield began testing blood and pill samples donated by those who had been experiencing adverse effects of the drug far longer than the manufacturer would admit was possible. What he found was metabolites (substances produced by metabolism) of the drug in blood drawn months and even years after the sample donor had taken their last pill. Some of the pills he tested contained more impurities and degradation products than “active ingredient” (bupropion). He suggested a possible cause for the unexpectedly high levels of impurities: “Zyban is manufactured for Glaxo-Wellcome by Catalytica Pharmaceuticals7. Although Catalytica’s address is given as Greenville, North Carolina, only a small office is maintained at that site. Zyban is actually manufactured in Italy at a facility owned by Catalytica. As recent as May of this year (2000) Catalytica under contract to Glaxo was sent a formal warning letter from the FDA regarding unsafe sanitation practices8. They weren’t cleaning up one production batch to specifications before beginning production of the next.” Addressing the issue of instability and degradation after the fact, Glaxo has since submitted several patent applications for bupropion (generic term for Wellbutrin/Zyban) with a stabilizer. One such patent application reads “It is clearly again seen that even at low temperature there is sizeable degradation”9. After compiling all his data, Tom Hatfield submitted his findings to the FDA prefaced by this request: “I would ask that this letter be kept confidential within the FDA”. Dr. Hatfield was not quite ready to lose his job. He needn’t have worried; the FDA couldn’t have cared less.

None of my friends or relatives believed that I couldn’t find a lawyer willing to sue a drug company for damages from this drug. They thought that I was too lazy to pick up the phone and call a couple of law firms. I lost track of how many lawyers I’ve contacted a long time ago, but I’ll never forget the response I got from Andy Vickery whose claim to fame was a 6.5 million dollar verdict against Glaxo in a Paxil murder/suicide case10 and more recently a failed attempt as Christopher Pittman’s defense attorney11. He said he’d be happy to represent me if I could get a medical doctor to say the drug did it. I felt like Dorothy when she had finally made her way to the Wizard of Oz only to be told he could help her get home, no problem, just bring him the broomstick of the Wicked Witch. I wasn’t going home any time soon.

Debby Painter and I have since requested certain FDA documents through the “Freedom of Information It’s OK For You to Have Act”. We eventually received the FDA’s MedWatch data on Wellbutrin from 11/01/97 through some unspecified time up until February 2003 (the date on the attached letter). The FDA makes every attempt to avoid being specific. They also chose not to specify which formulations of Wellbutrin these reports referred to. The report I received listed 37,822 total adverse reactions and “total death outcomes” were 468, which I’m assuming included my personal favorite: 16 reports of “pulse absent”. There were 202 reports of “completed suicide” and 152 suicide attempts listed as such, although others were given more euphemistic designations like the 216 “non-accidental” overdoses. Other unusual adverse reactions were “murderer (2 reports), “rapist”, “incest” and “divorce”.

One needs to bear in mind when discussing MedWatch statistics that according to the FDA they only represent between 1 and 10% of the actual numbers. Most people never heard of MedWatch and doctors are not inclined to spend their valuable time making MedWatch reports or informing you of it’s existence. Having been informed by my uncle’s wife, I filled out a MedWatch report for my husband and checked off the box on the form that said I DO NOT want the FDA to give my information to the manufacturer. I later received a lovely letter from GlaxoSmithKline expressing their regret upon learning of my husband’s experience and asking that I have him sign a release form so that they can access his medical records for the advancement of science and the good of all mankind.

Debby and I also eventually received very abbreviated and much redacted copies of portions of the NDAs (New Drug Applications) for all Wellbutrin formulations, the last one arriving over a year after the FDA received the request. The Wellbutrin IR (immediate release) NDA documented 14 deaths, including 9 suicides, in the initial clinical trials12. There were also 14 suicide attempts. Glaxo reported to the FDA that these “adverse events” were “not attributable to the study drug” and that was good enough for the FDA. Somehow these “events”, or what is known in English as “deaths”, never appeared in the Product Information Guides (PIGs) or the PDR (Physician’s Desk Reference) under “warnings and precautions” or “adverse reactions” which is supposed to include ALL ADVERSE EVENTS OBSERVED during clinical trials, not just those that the company decides that it’s OK for us to know about. However, being masters in the art of covering their corporate butt, Glaxo nonchalantly tossed this disclaimer into the PIG: “all treatment emergent adverse events are included except...those events not reasonably associated with the use of the drug...” So, you have 23 non-suicidal people (suicidal people were excluded from participating in these antidepressant drug tests) who COINCIDENTALLY take the same experimental drug and COINCIDENTALLY wind up wanting to kill themselves.

In November of 2003 I received an email from an address that I didn’t recognize. It went something like this: “My wife went to the doctor sick. He gave her samples of Wellbutrin. 6 days later she was dead. Please help. Allan.” A similar message would appear on the message board at Debby’s website a day or two later. I responded as I normally do to messages from desperate family members of the injured or dead. I sent my phone number and an offer of whatever help I could supply. Allan Routhier called. He told me the story of how his young son and sister-in-law found his wife in their basement with part of her head shot off in what the police deemed an obvious suicide. It took him months, all the while in shock, to figure out how and why this unimaginable event could have taken place. His first thought was that she had to have been murdered. Eventually he turned, as we all had, to the Internet. Until that time he hadn’t yet connected his wife’s sudden, inexplicable suicide with the opened sample packet of Wellbutrin found after her death. Now he knows that she was murdered.

In September of 2004, with the statute of limitations running out, I filed suit against Glaxo as a pro se plaintiff, in other words – without a lawyer. I filed my complaint in the Supreme Court of New York State and included Dr. Hatfield’s findings13. GSK’s lawyers had the case moved to federal court where I would be required to provide expert testimony. Tom Hatfield, a colleague and his superiors at 3M were subsequently contacted by Glaxo’s lawyers who seemed very interested in what Dr. Hatfield might know. 3M lied to Glaxo, a company that they had done business with in the past, and said that none of Dr. Hatfield’s research into bupropion took place at 3M.

When a patient is given a drug “everything is a crap shoot” according to SmithKline Beecham executive George Poste14. He knows that adverse drug reactions are the 4th largest cause of death in this country15. It’s only number 4 because most drug reaction deaths are blamed on something else, like suicide or heart attack or lack of a pulse. If that statistic isn’t disturbing enough here’s a fact that’s more disturbing: pharmaceutical companies know how to prevent many of these deaths but they’re not telling you. I’ll tell you in one word – pharmacogenetics.

Also included in my complaint against GSK is the fact that my husband has a genetic polymorphism of the CYP450 enzyme system. In English this means that a gene that controls an enzyme that breaks down, or metabolizes, certain chemicals so that they can be eliminated from the body is defective. If a chemical/drug is not metabolized properly it can accumulate in the body, potentially and usually reaching toxic levels. Glaxo funded research on pharmacogenetics, or how genetics affect drug metabolism, prior to my husband’s adverse event16. They know that about 10% of the population are very likely to experience the toxic affects of this drug up to, and including, death. Now I know it too. I found out the hard way. Morality would dictate that this ability to predict whose life would be at greatest risk would be used to prevent tragedy. Economics would dictate that you don’t intentionally scare off 10% of your customers. In corporate America economics trumps morality. Being a fiscally responsible corporate entity with their eye on the bottom line, Glaxo has used their genetic know-how to weed volunteers out of their clinical trials who might screw up their numbers by, say, going insane or dying. Then they gladly sell their toxic concoctions to 100% of their potential customers.

Recently, Allen Roses, Glaxo’s own Worldwide Vice-President of Genetics, made this bold statement: “The vast majority of drugs - more than 90% - only work in 30-50% of the people”. Naturally, he chose not to go into detail about what happened to everyone else. At an FDA Science Advisory Board meeting on the subject of pharmacogenetics a “representative of industry” (pharmaceutical company executive), Dr. Shine, posed the million dollar question to Dr. Janet Woodcock of the FDA “First of all, just for clarification, Janet, when you made the statement ‘free exchange of data’ I presume that means between the FDA and industry, and that it doesn’t mean that it goes on the web” to which Dr. Woodcock eventually replied after much disclaiming and bureaucratic bullcrap “To answer your question, no”17. What’s the big secret Dr. Woodcock? And who do really work for anyway?

Allan asked the FDA in person. “Whose side is the FDA on?” he demanded to know when he traveled from his home in Massachusetts to the last FDA public hearing on the subject of antidepressants and suicide in pediatric patients18. He wanted everyone to know that it wasn’t only kids who were killing themselves. Of course the FDA already knew this and so did “industry”. He recounted for me his experience of listening to pharmaceutical company representatives touting the indispensable benefits of their products for hours, going so far into the realm of the inhuman as to crack jokes in a room filled with grieving parents who had to patiently await their turn to speak for their allotted 3 minutes. He personally witnessed over 60 people give testimony on the destruction of their lives and families and the two who spoke up in favor of the drugs, one of the two having an obvious tie to Big Pharma. The corporate media interviewed the two pharmaceutical cheerleaders and threw in interviews with two victimized family members in the interest of equal time. The FDA has yet to answer his question regarding whose side they’re on.

Allan Routhier is currently being represented by Alan Milstein of Sherman, Silverstein, Kohl, Rose & Podolsky in his lawsuit against Glaxo and the doctor who gave his wife Wellbutrin.19 Like Anthony, she had gone to the doctor with a legitimate health concern. In this case it was severe abdominal pain and other gastrointestinal problems. Like Anthony she left the doctors office with the recommendation that she use Wellbutrin. Who needs any of those ridiculous diagnostic tests? Diane Routhier eventually received an accurate diagnosis anyway – after her autopsy. Gallbladder disease.

My case is still pending and was written up in Mealey’s Litigation Report in the article “New York Couple Claims Tainted Wellbutrin Caused Suicide Attempt”20. I don’t believe these drugs have to be “tainted” to kill people. These “antidepressants” are just modern versions of “speed”. When I was a kid in the ‘60s public service TV spots warned us that “speed kills”. I grew up in an apartment complex in Brooklyn comprised of 20 story buildings. There weren’t a lot of guns but there were a lot of windows. Many young people used those windows as exits. Our parents always had a simple explanation for those suicides: “they were on drugs”.

Alison Cintorrino
Contact: ATCintorrino@cs.com


REFERENCES
1. Downey DC. Porphyria and chemicals. Med. Hypotheses. 1999 Aug; 53(2) : 166 – 71
2. Veteran’s Administration Agent Orange Registry
3. Diagnostic and Statistical Manual of Mental Disorders 4th Edition
4. Anderson, et al. v Pacific Gas & Electric
5. Hatfield, T. 2001 Screening Studies on the Aqueous Photolytic Degradation of Perfluorooctanoic Acid (PFOA) 3M Environmental Laboratory. Lab request number E00-2192 St. Paul, MN
6. Jennifer Bjorhus, St. Paul Pioneer Press, October 14, 2004 “3M Faces Cottage Grove Suit: Chemical-contamination claim joins two others filed in Alabama”
7. On 12/15/2000 Catalytica Inc. was acquired by DSM N.V. and spun out it’s 2 subsidiaries Catalytica Combustion Systems and Catalytica Advanced Technologies as a single new entity: Catalytica Energy Systems.
8. FDA Warning Letter released 9/19/2000 to Dr. Paolo Verardi, Quality Director, Glaxo Wellcome S.p.A., Via A, Fleming, 2, 37135 Verona, Italy
9. Cyclodextrin stabilized pharmaceutical composition of bupropion hydrochloride, United States patent 6,462,237 Gidwani et al October 8, 2002
10. Tobin v GlaxoSmithKline (D. Wyo. June 6, 2001)
11. The State of South Carolina v Christopher Frank Pittman
12. Wellbutrin IR NDA #18-644
13. Anthony Cintorrino and Alison Cintorrino v SmithKline Beecham Corp. d/b/a GlaxoSmithKline
14. Nature Biotechnology October 1998
15. Journal of the American Medical Association April 15, 1998
16. Pharmacogenetics Workshop Background Paper, Robert Snedden, October 29, 1999 The Wellcome Trust
17. At Department of Health and Human Services, Food and Drug Administration Science Advisory Board Committee Meeting, April 9, 2003
18. Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee, September 14, 2004
19. Allan Routhier, as Administrator and Personal Representative of the Estate of Diane Routhier vs. Timothy G. Keenan, M.D. and GlaxoSmithKline, Inc. d/b/a GlaxoSmithKline
20. Mealey’s Litigation Report, Antidepressant Drugs, volume 1, Issue #3. October 2004