WELLBUTRIN - FDA: Two hundred two [202] Completed Suicides in 5 Years, 3 months

[Guest guest]

Thanks to Rosie for sending the following:

(I believe this article might have already been posted for your benefit

previously, but it is well worth the read or re-read).

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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 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 . 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 ey’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 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 Girardi4 of “

Brockovitch” fame on a contingency basis. She has since entered into a

secret settlement with the drug’s manufacturer, Glaxokline (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 did and a few more that 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 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 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 GlaxoKline 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

Kline Beecham executive 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, 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 , she had gone to the

doctor with a legitimate health concern. In this case it was severe

abdominal pain and other gastrointestinal problems. Like 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@...

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. , 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. , MN

6. Bjorhus, St. 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 GlaxoKline (D. Wyo. June 6, 2001)

11. The State of South Carolina v Pittman

12. Wellbutrin IR NDA #18-644

13. Cintorrino and Alison Cintorrino v Kline Beecham Corp.

d/b/a GlaxoKline

14. Nature Biotechnology October 1998

15. Journal of the American Medical Association April 15, 1998

16. Pharmacogenetics Workshop Background Paper, 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. G. Keenan, M.D. and GlaxoKline,

Inc. d/b/a GlaxoKline

20. Mealey’s Litigation Report, Antidepressant Drugs, volume 1, Issue #3.

October 2004