Zyban, A Personal Account


 
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Imagine going to your family doctor toget a referral for a stress test. Your blood pressure is high and youhave some other minor complaints. Your wife’s uncle is a cardiologistand he suggested that this is what you do. Nothing scary about that.Much less terrifying than, say, a rectal exam. Your doctor tells youthat 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 todo 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 andheads for the door, saying something about leaving for vacation andrunning late. You take your first pill later that day because it wasprescribed by a licensed medical doctor and it’s safety and efficacy hasbeen confirmed by the United States Food and Drug Administration. Andeveryone knows that smoking is bad for your health. Five weeks later youlose your mind. Later on you start losing control of the rest of yourbody. And, yeah, you still smoke.

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

The uncle who recommended the stress test happens to be a very prominentand extensively published MD and research scientist: a fact thatimpresses the heck out of a lot of people. I was always impressed by himtoo because, unlike the majority of MDs that I’ve encountered, heactually knows what he’s talking about. This would hardly be the firsttime that I imposed upon him for free medical advice, but it would proveto be one of the last times. He had a friend and colleague who wasresearching Gulf War Syndrome which, as my uncle was quick to recognize,has a strikingly similar list of symptoms to what my husband Anthony wasexperiencing post-Zyban1. This list includes a chemically-inducedporphyria 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 enzymedisorder. I had to spell it once for an MD in the emergency dept. andI’m lucky I can do that. In fact all of the drug’s victims that I wouldeventually encounter who were tested for this form of porphyria testedpositive. Of course I was never to hear from this friend of my uncle. Bythen I was not surprised. I’d learned that most doctors attempt toachieve financial nirvana by repeating the mantra “it’s never the drug,it’s never the drug…” I was slowly becoming conversational in Jargon, alanguage which doctors tend to use they way my mother and grandmotherused Yiddish – to avoid being understood. It was becoming more difficultfor doctors, including my uncle, to evade my questions. When during onephone conversation I pressed my uncle for information on metabolicpathways and the toxic accumulation of metabolites he responded, “That’swhat lawyers are for!” I took the hint. Though at the time I had not yetbecome aware of the connection between getting published and kissingpharmaceutical 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 bea very useful, let alone vital, source of information. My opinion wouldundergo a drastic change. I scoured the Internet for information. I cameacross 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 wasforthcoming with the details of their Zyban/Wellbutrin experience hadbeen blissfully unaware of the fact that they were suffering frombi-polar disorder until the drug brought their affliction out of it’shiding place. Not surprisingly it seems that most doctors are blissfullyunaware of the diagnosis of “Bipolar IV”3, or drug-induced bipolardisorder. Fairly recently we all learned of news personality JanePauley’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 anintelligent, informed woman like her could buy into that pharmaceuticalcon game then what chance did the “average Joe” stand. She was quoted assaying that now she’ll need to take her medication for the rest of herlife. Emory psychiatrist Charles Raison MD has been quoted as saying“All of us in psychiatry have seen first episode mania after putting aperson on antidepressants”. And so a new psychiatric medication customeris born.

Ironically, the first person to respond to my cyber SOS was the onlyvictim of this drug that I personally know who escaped the “bipolar”label. This was largely due to the fact that her initial reaction to thedrug involved dystonia, which in English means a movement disorder andwhich in reality meant that she couldn’t move. She survived on largedoses of Valium, which most likely prevented the onset of mania. Havingextensive medical documentation of the physical damage that Wellbutrincaused her to suffer she was able to retain the legal services of ThomasGirardi4 of “Erin Brockovitch” fame on a contingency basis. She hassince entered into a secret settlement with the drug’s manufacturer,GlaxoSmithkline (formerly Glaxo Wellcome), and will no longer accept myphone calls out of a very legitimate fear of legal repercussions.

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

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

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

None of my friends or relatives believed that I couldn’t find a lawyerwilling to sue a drug company for damages from this drug. They thoughtthat 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, butI’ll never forget the response I got from Andy Vickery whose claim tofame was a 6.5 million dollar verdict against Glaxo in a Paxilmurder/suicide case10 and more recently a failed attempt as ChristopherPittman’s defense attorney11. He said he’d be happy to represent me if Icould get a medical doctor to say the drug did it. I felt like Dorothywhen she had finally made her way to the Wizard of Oz only to be told hecould help her get home, no problem, just bring him the broomstick ofthe Wicked Witch. I wasn’t going home any time soon.

Debby Painter and I have since requested certain FDA documents throughthe “Freedom of Information It’s OK For You to Have Act”. We eventuallyreceived the FDA’s MedWatch data on Wellbutrin from 11/01/97 throughsome unspecified time up until February 2003 (the date on the attachedletter). The FDA makes every attempt to avoid being specific. They alsochose not to specify which formulations of Wellbutrin these reportsreferred to. The report I received listed 37,822 total adverse reactionsand “total death outcomes” were 468, which I’m assuming included mypersonal favorite: 16 reports of “pulse absent”. There were 202 reportsof “completed suicide” and 152 suicide attempts listed as such, althoughothers 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 thataccording to the FDA they only represent between 1 and 10% of the actualnumbers. Most people never heard of MedWatch and doctors are notinclined to spend their valuable time making MedWatch reports orinforming you of it’s existence. Having been informed by my uncle’swife, I filled out a MedWatch report for my husband and checked off thebox on the form that said I DO NOT want the FDA to give my informationto the manufacturer. I later received a lovely letter fromGlaxoSmithKline expressing their regret upon learning of my husband’sexperience and asking that I have him sign a release form so that theycan access his medical records for the advancement of science and thegood of all mankind.

Debby and I also eventually received very abbreviated and much redactedcopies of portions of the NDAs (New Drug Applications) for allWellbutrin formulations, the last one arriving over a year after the FDAreceived the request. The Wellbutrin IR (immediate release) NDAdocumented 14 deaths, including 9 suicides, in the initial clinicaltrials12. There were also 14 suicide attempts. Glaxo reported to the FDAthat these “adverse events” were “not attributable to the study drug”and that was good enough for the FDA. Somehow these “events”, or what isknown in English as “deaths”, never appeared in the Product InformationGuides (PIGs) or the PDR (Physician’s Desk Reference) under “warningsand precautions” or “adverse reactions” which is supposed to include ALLADVERSE EVENTS OBSERVED during clinical trials, not just those that thecompany decides that it’s OK for us to know about. However, beingmasters in the art of covering their corporate butt, Glaxo nonchalantlytossed this disclaimer into the PIG: “all treatment emergent adverseevents are included except...those events not reasonably associated withthe use of the drug...” So, you have 23 non-suicidal people (suicidalpeople were excluded from participating in these antidepressant drugtests) who COINCIDENTALLY take the same experimental drug andCOINCIDENTALLY wind up wanting to kill themselves.

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

In September of 2004, with the statute of limitations running out, Ifiled suit against Glaxo as a pro se plaintiff, in other words – withouta lawyer. I filed my complaint in the Supreme Court of New York Stateand included Dr. Hatfield’s findings13. GSK’s lawyers had the case movedto federal court where I would be required to provide expert testimony.Tom Hatfield, a colleague and his superiors at 3M were subsequentlycontacted by Glaxo’s lawyers who seemed very interested in what Dr.Hatfield might know. 3M lied to Glaxo, a company that they had donebusiness with in the past, and said that none of Dr. Hatfield’s researchinto bupropion took place at 3M.

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

Also included in my complaint against GSK is the fact that my husbandhas a genetic polymorphism of the CYP450 enzyme system. In English thismeans that a gene that controls an enzyme that breaks down, ormetabolizes, certain chemicals so that they can be eliminated from thebody is defective. If a chemical/drug is not metabolized properly it canaccumulate in the body, potentially and usually reaching toxic levels.Glaxo funded research on pharmacogenetics, or how genetics affect drugmetabolism, prior to my husband’s adverse event16. They know that about10% of the population are very likely to experience the toxic affects ofthis drug up to, and including, death. Now I know it too. I found outthe hard way. Morality would dictate that this ability to predict whoselife would be at greatest risk would be used to prevent tragedy.Economics would dictate that you don’t intentionally scare off 10% ofyour customers. In corporate America economics trumps morality. Being afiscally responsible corporate entity with their eye on the bottom line,Glaxo has used their genetic know-how to weed volunteers out of theirclinical trials who might screw up their numbers by, say, going insaneor dying. Then they gladly sell their toxic concoctions to 100% of theirpotential 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 intodetail about what happened to everyone else. At an FDA Science AdvisoryBoard meeting on the subject of pharmacogenetics a “representative ofindustry” (pharmaceutical company executive), Dr. Shine, posed themillion dollar question to Dr. Janet Woodcock of the FDA “First of all,just for clarification, Janet, when you made the statement ‘freeexchange of data’ I presume that means between the FDA and industry, andthat it doesn’t mean that it goes on the web” to which Dr. Woodcockeventually replied after much disclaiming and bureaucratic bullcrap “Toanswer your question, no”17. What’s the big secret Dr. Woodcock" And whodo really work for anyway"

Allan asked the FDA in person. “Whose side is the FDA on"” he demandedto know when he traveled from his home in Massachusetts to the last FDApublic hearing on the subject of antidepressants and suicide inpediatric patients18. He wanted everyone to know that it wasn’t onlykids who were killing themselves. Of course the FDA already knew thisand so did “industry”. He recounted for me his experience of listeningto pharmaceutical company representatives touting the indispensablebenefits of their products for hours, going so far into the realm of theinhuman as to crack jokes in a room filled with grieving parents who hadto patiently await their turn to speak for their allotted 3 minutes. Hepersonally witnessed over 60 people give testimony on the destruction oftheir 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 mediainterviewed the two pharmaceutical cheerleaders and threw in interviewswith two victimized family members in the interest of equal time. TheFDA has yet to answer his question regarding whose side they’re on.

Allan Routhier is currently being represented by Alan Milstein ofSherman, Silverstein, Kohl, Rose & Podolsky in his lawsuit against Glaxoand the doctor who gave his wife Wellbutrin.19 Like Anthony, she hadgone to the doctor with a legitimate health concern. In this case it wassevere abdominal pain and other gastrointestinal problems. Like Anthonyshe left the doctors office with the recommendation that she useWellbutrin. Who needs any of those ridiculous diagnostic tests" DianeRouthier eventually received an accurate diagnosis anyway – after herautopsy. Gallbladder disease.

My case is still pending and was written up in Mealey’s LitigationReport in the article “New York Couple Claims Tainted Wellbutrin CausedSuicide Attempt”20. I don’t believe these drugs have to be “tainted” tokill people. These “antidepressants” are just modern versions of“speed”. When I was a kid in the ‘60s public service TV spots warned usthat “speed kills”. I grew up in an apartment complex in Brooklyncomprised of 20 story buildings. There weren’t a lot of guns but therewere a lot of windows. Many young people used those windows as exits.Our parents always had a simple explanation for those suicides: “theywere 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 PhotolyticDegradation of Perfluorooctanoic Acid (PFOA) 3M EnvironmentalLaboratory. Lab request number E00-2192 St. Paul, MN
6. Jennifer Bjorhus, St. Paul Pioneer Press, October 14, 2004 “3M FacesCottage Grove Suit: Chemical-contamination claim joins two others filedin Alabama”
7. On 12/15/2000 Catalytica Inc. was acquired by DSM N.V. and spun outit’s 2 subsidiaries Catalytica Combustion Systems and CatalyticaAdvanced Technologies as a single new entity: Catalytica Energy Systems.
8. FDA Warning Letter released 9/19/2000 to Dr. Paolo Verardi, QualityDirector, Glaxo Wellcome S.p.A., Via A, Fleming, 2, 37135 Verona, Italy
9. Cyclodextrin stabilized pharmaceutical composition of bupropionhydrochloride, 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, October29, 1999 The Wellcome Trust
17. At Department of Health and Human Services, Food and DrugAdministration Science Advisory Board Committee Meeting, April 9, 2003
18. Joint Meeting of the Psychopharmacologic Drugs Advisory Committeeand the Pediatric Advisory Committee, September 14, 2004
19. Allan Routhier, as Administrator and Personal Representative of theEstate of Diane Routhier vs. Timothy G. Keenan, M.D. andGlaxoSmithKline, Inc. d/b/a GlaxoSmithKline
20. Mealey’s Litigation Report, Antidepressant Drugs, volume 1, Issue#3. October 2004
 

 

 

 

 

 

 

 

 

 

 

 

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