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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
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