Sen. Grassley Investigates Lilly/WebMD link Reported by Washington Post

Dear Friends and Colleagues,

Freelance writer and
cartoonist Martha Rosenberg has worked diligently to reveal the conflict of
interest in many of the pharma/medical  situations.

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Rosie Meysenburg
Moderator:
www.SSRIstories.com

http://www.opednews.com/articles/GrassleyInvestigates-Lill-by-Martha-Rosenberg-100224-629.html

Grassley Investigates Lilly/WebMD link Reported by Washington
Post

By Martha Rosenberg (about the
author
)     Page 1 of 2 page(s)

opednews.com Permalink

For OpEdNews: Martha Rosenberg – Writer

It is
not too hard to find evidence of links between WebMD and drug giant Eli
Lilly.

A 2002 article on the gigantic medical site about pain and
depression says “Lilly is a WebMD Partner,” and an advertising award in 2004
went to the FCB “client” Eli Lilly & Co./WebMD–not clients.

Banner
and skyscraper ads for Lilly‘s blockbuster antidepressant Cymbalta on WebMD‘s
home page never seemed to yield to other advertisers in 2009–and the Washington

Post reported Lilly and WebMD to be partners in 2000.

Now Sen. Charles
Grassley (R-Iowa), ranking Republican on the Senate Finance Committee, is
investigating financial ties between Lilly and WebMD Health Corp because of a

WebMD TV ad exhorting people to undergo a Lilly depression screening.

You
can joke about the need to tell people they are depressed–do people need to be
told they have a headache?–but pharma’s screening ruse to recruit new
patient pools for the volatile drugs among teens, adolescents and new mothers is
not funny.

3,500 news articles about antidepressant linked violence
appear on the web site, SSRIstories.com, including 700 murders, 200
murder-suicides, 51 school shooting incidents and 54 postpartum depression cases
since 1989.

In addition to WebMD, WebMD Health Corp. includes the web
sites Medscape, MedicineNet, eMedicine, eMedicine Health, RxList, theHeart.org,
and drugs.com. Original partners and investors says the Washington Post included
“Microsoft, DuPont, Rupert Murdoch’s News Corp. (and his Fox TV networks),
Silicon Graphics and Netscape founder Jim Clark, drug maker Eli Lilly, and EDS,
the computer services company founded by H. Ross Perot.”

Lilly is not the
only pharma company receiving unmarked product placement on WebMD.

Last
summer, a video featured a woman patient confessing she was fearful of life
while a voice over said she needed treatment for “general anxiety disorder” and
the camera showed bottles of Forest Pharmaceuticals’ antidepressant
Lexapro moving down the manufacturer’s assembly line
. Get it? No disclaimer
on the video or “sponsored content” appeared.

Another unsponsored WebMD

video last summer urged people on antidepressants to remain on their therapy
“despite side effects” and a third suggested women concerned about cancer, heart
attack and stroke risks of postmenopausal hormone therapy should continue their
treatment at lowered doses. Hang in there, valued customers.

A search for
Wyeth (now Pfizer) antidepressant Effexor a few months ago on WebMD elicited a
JAMA study finding Effexor superior to other antidepressants by a Wyeth funded
second author, Graham Emslie, MD. Effexor was the drug Andrea Yates took when
she drowned her five children in 2001, a case found on
SSRIstories.

Questions about conflict of interest have surfaced at
WebMD‘s Medscape too which administers many of the lucrative drug company
sponsored continuing medical education [CME] courses in the US which doctors
must complete to keep their state licenses.

Last year psychiatrist Daniel
Carlat, MD–who recounts his adventures as a Wyeth paid Effexor promoter in the
New York Times magazine–writes that he received, as a member of Medscape, an
envelope with “a brochure from Forest Laboratories advertising Lexapro, and
nothing else. It was creepy, like Invasion of the Body Snatchers.”

While
Lilly is known for launching the SSRI antidepressant revolution with Prozac,
Cymbalta does much of the heavy lifting now with worldwide sales of $3.075
billion in 2009.

Many remember Cymbalta as the drug 19-year-old healthy
clinical volunteer Traci Johnson killed herself on, during trials on the Lilly

campus in 2004–soon after FDA investigations into suicide/antidepressant
links.

Traci had no depression history said Rev. Joel Barnaby, a
spokesman for the Johnson family, who called Lilly‘s decision to proceed with
Cymbalta’s launch as scheduled “offensive” posturing.

Five others
suicides occurred during Cymbalta clinical trials, said the FDA and twice the
rate of suicide attempts were seen in women prescribed the drug for stress
urinary incontinence–also patients with no depression to blame.

Others
remember Cymbalta as the drug Carol Anne Gotbaum, daughter-in-law of New York
City Public Advocate Betsy Gotbaum, was taking during her macabre death in
police custody at the Phoenix’s Sky Harbor airport in 2007.

But now Lilly
and WebMD are pushing Cymbalta for pain since it was approved for
fibromyalgia in 2008. “Across cultures, patients who complain of pain tend to be
depressed,” says the 2002 article which calls WebMD and Lilly partners, a
finding from a “huge international study by Prozac manufacturer Eli Lilly and
Company.”

“Could your muscle aches be related to depression?” hawks WebMD

text under the heading, “Recognizing the Symptoms of Depression.” Next to it is
a picture of a depressed women with arrows pointing to the pain in her head and
neck, chest and stomach, arms and hands, legs and feet and of course
back.

“Print out this symptom diary, and fill it out. Then take it to
your doctor to discuss what may be causing your symptoms.”

This content,
we’re told, is “selected and controlled by WebMD‘s editorial staff” but “funded
by Lilly USA.”


Martha Rosenberg is
columnist and cartoonist based in Chicago I

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ANTIDEPRESSANTS: Tell All Book: “Side Effects: Death”: by Former Lilly Exec

Paragraphs two & three read:  “Many of the
horrific school, workplace and mass shootings that have plagued parts of the
world over the years
may not have occurred if the pharmaceutical
industry had been completely honest about the side effects of psychotropic
medication, according to the new book Side Effects: Death – Confessions of a
Pharma Insider
by former executive director of the Swedish Branch of Eli

Lilly & Company John Virapen.”

“Virapen claims that
anti-depressants and selective serotonin reuptake inhibitors
(SSRIs
) were known to have suicidal and homicidal side effects, even during
clinical trials.
Thanks to spin marketing and paid, positive articles in
scientific journals, he points out, the adverse reactions were often ignored or
given little thought by prescribing physicians and patients.”

http://www.prlog.org/10514103-what-big-pharma-knows-sideeffectsdeath.html

What Big Pharma Knows – “Side Effects: Death

Former pharmaceutical executive director reveals industry
secrets

FOR IMMEDIATE RELEASE
PR Log (Press
Release)
Feb 01, 2010 – P.O. Box 9949, College Station, TX.
77842 • Phone/Fax: 877-376-4955
http://www.virtualbookworm.cominfo@virtualbookworm.com

FOR IMMEDIATE RELEASE
Contact: Virtualbookworm.com Publishing Inc.

877-376-4955
reviews@virtualbookworm.com

What Big Pharma
Knows – “Side Effects: Death

Many of the horrific school, workplace and
mass shootings that have plagued parts of the world over the years may not have
occurred if the pharmaceutical industry had been completely honest about the
side effects of psychotropic medication, according to the new book Side Effects:

Death – Confessions of a Pharma Insider by former executive director of the
Swedish Branch of Eli Lilly & Company John Virapen.

Virapen claims
that anti-depressants and selective serotonin reuptake inhibitors (SSRIs) were
known to have suicidal and homicidal side effects, even during clinical trials.
Thanks to spin marketing and paid, positive articles in scientific journals, he
points out, the adverse reactions were often ignored or given little thought by

prescribing physicians and patients.

Virapen also asserts the
pharmaceutical industry has engaged in bribery and other major forms of
corruption to gain approval for and in the marketing of many drugs used to treat
such conditions as Attention Deficit Hyperactivity Disorder (ADHD),
schizophrenia, arthritis, pain, diabetes and many others. The industry also
“makes up” illnesses to enhance sales and market shares, he says.

To
boost sales, Virapen writes, large pharmaceutical corporations spend about
$35,000–$40,000 per year and per practicing doctor to persuade them to prescribe
their products. In addition to covering or “massaging” the negative effects of
drugs, many of the companies engage in “off-label marketing,” which encourages
physicians to prescribe the medicines for conditions for which they haven’t been
approved, Virapen reveals.

Born in British Guyana, John Virapen went
from a door-to-door conman to a pop star, to a pharmaceutical representative to
executive director of one of the largest drug companies in the world. He admits
to participating in bribery, false information and deception to help launch and
market some of the most popularly prescribed (and most dangerous) drugs. In an
effort to exorcise his demons and expose the tactics and dangers of the
pharmaceutical industry, he wrote this expose.

The book has been
published in four languages around the world and is a best-seller in Europe.

Side Effects: Death – Confessions of a Pharma Insider is available in
softcover (ISBN 978-1-60264-516-5) and e-book (ISBN 978-1-60264-517-2) hardcover
from Virtualbookworm.com, Amazon.com, and Barnesandnoble.com. This book can also
be ordered from most bookstores around the United States and United Kingdom.
More information can be found at the book’s official website, www.sideeffectsdeath.com.



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Lilly admits paying docs to peddle drugs – at what cost??

As part of a large government fine of $1.4 BILLION Eli Lilly, makers of Prozac, Cymbalta, Stratera, Cialis, etc. has begun to disclose payouts to doctors to peddle their wares/drugs. When you consider the long reaching damaging effects of that, you realize that the fine is nothing compared to the loss of lives that are the end result.
Let’s look at just a few facts:
1. The third leading cause of death in America is “properly prescribed (following FDA and AMA guidelines) prescription drugs. That does not count those taking these drugs “off label” or in higher amounts than recommended, etc., but only taking them as recommended by those who are suppose to know safest prescribing guidelines.
2.

Eli Lilly and Co. paid Jacksonville-area doctors thousands of dollars as consultants to market drugs

Maker of Prozac and Cialis was forced to publish doctor names and compensation.

  • Story updated at 11:29 PM on Friday, Sep. 4, 2009

Drug companies routinely pay physicians as experts in the course of marketing their products. While legal, the practice is widely criticized as a conflict of interest that drives up drug costs.

One pharmaceutical company paid more than $76,000 to Jacksonville-area doctors and other medical providers in the first three months of this year.

That’s according to the first publicly released information to document the long-hidden financial ties between drug companies and doctors.

Eli Lilly and Co., the maker of Prozac, Cymbalta and Cialis, was forced to begin publishing the names and compensation of its paid consultants as part of a $1.4 billion settlement with the federal government last January.

Among the names that became public were those of several physicians practicing in the Jacksonville area. For the full story, including names of the physicians, see Sunday’s Business section of the Times-Union.

Comments

Wendell's picture

Dr.’s are as bad as politicians!

Submitted by Wendell on Fri. 9/4/2009 at 5:09 pmDr.’s are as bad as politicians!

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  • Dr’s Got To Make A Living Too

    Submitted by fearlessfan on Fri. 9/4/2009 at 9:05 pmYou shouldn’t blame the doctors, it’s the high dollar Pharmaceutical companies who are pushing the dough.   Anybody in their right mind would take it especially if its legal; too heck with ethics.

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  • It is all about ethics

    Submitted by rs471911 on Sat. 9/5/2009 at 10:50 am Recently I was in my doctor’s waiting room, 45 minutes past my scheduled appointment. During my wait I watched as 4 pharmaceutical reps, one after another, walked right in to see the doctor and peddle their drugs. The nurse said the doctor sees each rep personally. When I finally saw the doctor I asked if he saw more pharmaceutical reps or patients a day. He gets perks for prescribing their drugs. The scariest part was I heard him asking one of the reps for medical advice. He is no longer my doctor.

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  • I had the same thing happen to me six years ago///

    Submitted by Xenon on Sat. 9/5/2009 at 1:53 pmI also was waiting for a appointment for over 45 minutes and was shocked at the people walking in and out without signing in. Finally when i was checking out, three representatives were in the hallway laughing and talking with the Doctor and talking about a upcoming quail hunt, Montana hunting trip and a deep sea fishing trip at their expense, one female representative turned to me and handled me a pen, with pharmaceutical advertisement on it as i was trying to sign my check and said to me, “Just keep it, a sovernier.” Smiled perkily and turned back to the group and the Doctor.

    I have not been back since. I just wish integrity, honor, honesty and accountability would come back along with true patriotism for our country and it’s citizens. My age is showing…

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    Antidepressant use doubles in U.S., study finds

    “Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.
    [Note by Ann Blake-Tracy: Far too many doctors are prescribing two and even three antidepressants at a time which should never be done due to the high potential of resulting Serotonin Syndrome from the combination.]
    “During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications . . . “
    [Note by Ann Blake-Tracy: Additional supporting data to add to the story we just sent out on 81% of those diagnosed with Bipolar Disorder having been previously treated with antidepressants or Ritalin type drugs – making these popular drugs the main triggers for Bipolar Disorder and manic psychosis.]

    Antidepressant use doubles in U.S., study finds

    1 in 10 are taking medication to improve mood, fewer going to talk therapy

    By Maggie Fox

    updated 2:44 p.m. CT, Mon., Aug 3, 2009

    WASHINGTON – Use of antidepressant drugs in the United States doubled between 1996 and 2005, probably because of a mix of factors, researchers reported on Monday.

    About 6 percent of people were prescribed an antidepressant in 1996 — 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found.

    “Significant increases in antidepressant use were evident across all sociodemographic groups examined, except African Americans,” Dr. Mark Olfson of Columbia University in New York and Steven Marcus of the University of Pennsylvania in Philadelphia wrote in the Archives of General Psychiatry.

    “Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.

    More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health.

    Drugs that affect the brain chemical serotonin like GlaxoSmithKline’s Paxil, known generically as paroxetine, and Eli Lilly and Co’s Prozac, known generically as fluoxetine, are the most commonly prescribed class of antidepressant. But the study found the effect in all classes of the drugs.

    Olfson and Marcus looked at the Medical Expenditure Panel Surveys done by the U.S. Agency for Healthcare Research and Quality, involving more than 50,000 people in 1996 and 2005.

    “During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications and less likely to undergo psychotherapy,” they wrote.

    Newer drugs, more social acceptance
    The survey did not look at why, but the researchers made some educated guesses. It may be more socially acceptable to be diagnosed with and treated for depression, they said. The availability of new drugs may also have been a factor.

    “Although there was little change in total promotional spending for antidepressants between 1999 ($0.98 billion) and 2005 ($1.02 billion), there was a marked increase in the percentage of this spending that was devoted to direct-to consumer advertising, from 3.3 percent ($32 million) to 12 percent ($122.00 million),” they added.

    Dr. Eric Caine of the University of Rochester in New York said he was concerned by the findings. “Antidepressants are only moderately effective on population level,” he said in a telephone interview.

    Cost may be deterrent to talk therapy
    Caine, who was not involved in the research, noted that several studies show therapy is as effective as, if not more effective than, drug use alone.

    “There are no data to say that the population is healthier. Indeed, the suicide rate in the middle years of life has been climbing,” he said.

    Olfson and Marcus said out-of-pocket costs for psychotherapy and lower insurance coverage for such visits may have driven patients away from seeing therapists in favor of an easy-to-prescribe pill.

    The rise in antidepressant prescriptions also is seen despite a series of public health warnings on use of antidepressant drugs beginning in 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in children and teens.

    In February 2005, the U.S. Food and Drug Administration added its strongest warning, a so-called black box, on the use of all antidepressants in children and teens.

    Copyright 2009 Reuters. Click for restrictions.

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    ICFDA Warning on Drug Discontinuation

    Taper off very, very, very slowly!!!!!!!!!!!!!!

    Dropping “cold turkey” off any medication, most especially mind altering medications, can often be MORE DANGEROUS than staying on the drugs. With antidepressants the FDA has now warned that any abrupt change in dose, whether increasing or decreasing the dose, can produce suicide, hostility, or psychosis – generally a manic psychosis when you then get your diagnosis for Bipolar Disorder. Of course drug-induced Bipolar is temporary so you need to learn more about that if it has already happened to you. We have a DVD on explaining this and how to recover from it: “Bipolar? Are You Really Bipolar or Misdiagnosed Due to the Use of or Abrupt Discontinuation of an Antidepressant”: https://store.drugawareness.org/product/bipolar-disorder-streaming/

    The most dangerous and yet the most common mistake someone coming off any antidepressant, atypical antipsychotic, or benzodiazaphine makes is coming off these drugs too rapidly. Tapering off VERY, VERY, VERY SLOWLY–OVER MONTHS OR YEARS (The general rule of thumb for those on antidepressants (ANY antidepressant, not just the current antidepressant – add up all time on any of them) for less than a year is to take half the amount of time on them to wean off and for long-term users for each 5 years on psychiatric drugs of any kind  the general rule of thumb is at least a year or more.), NOT JUST WEEKS OR MONTHS!—has proven the safest and most effective method of withdrawal from these types of medications. Thus the body is given the time it needs to readjust its own chemical levels. Patients must be warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them.

    WARNING: The practice of taking a pill every other day throws you into withdrawal every other day and can be very dangerous when you consider the FDA warnings on abrupt changes in dose.

    This cannot be stressed strongly enough! This information on EXTREMELY gradual withdrawal is the most critical piece of information that someone facing withdrawal from these drugs needs to have.

    A REMINDER: IT IS EASIER TO GET DOWN OFF A MOUNTAINTOP ONE GUARDED STEP AT A TIME THAN TO JUMP FROM THE TOP TO THE BOTTOM.

    No matter how few or how many side effects you have had on these antidepressants, withdrawal is a whole new world. The worst part of rapid withdrawal can be delayed for several months AFTER you quit. So even if you think you are doing okay you quickly find that it becomes much worse. If you do not come off correctly and rebuild your body as you do, you risk:

    • Creating bouts of overwhelming depression
    • Producing a MUCH longer withdrawal and recovery period than if you had come off slowly
    • Overwhelming fatigue causing you to be unable to continue daily tasks or costing your job
    • Having a psychotic break brought on by the terrible insomnia from the rapid withdrawal, and then being locked in a psychiatric ward and being told you are either schizophrenic or most likely that you are Bipolar.
    • Ending up going back on the drugs (each period on the drugs tends to be more dangerous and problematic than the previous time you were on the drugs) and having more drugs added to calm the withdrawal effects
    • Seizures and other life threatening physical reactions
    • Violent outbursts or rages
    • REM Sleep Behavior Disorder which has always been known as a drug withdrawal state and is known to include both suicide and homicide – both committed in a sleep state.

    Although my book, Prozac: Panacea or Pandora? Our Serotonin Nightmare!, contains massive amounts of information you can find nowhere else on these drugs, it does not have the extensive amount of information contained in the CD focusing mainly on withdrawal issues. The CD contains newer and updated information on safe withdrawal from these drugs. It details over an hour and a half the safest ways found over the past 30 years to withdraw from antidepressants and the drugs so often prescribed with them – the atypical antipsychotics and benzodiazapenes. And it explains why it is safest to withdraw tiny amounts from all of the medications at the same time rather than withdrawing only one at a time.

    It also lists many safe alternative treatments that can assist you in getting though the withdrawal and lists other alternatives to avoid which are not safe after using antidepressants. And it contains information on how to rebuild your health after you have had it destroyed by these drugs so that you never end up feeling a need to be on these drugs again.

    The CD is very inexpensive and will save you thousands in medical bills which far too many end up spending trying to do it on your own without this information. (One woman who decided she was okay coming down twice as fast as recommended paid a terrible price. After withdrawing she suffered the REM Sleep Disorder early one morning and attacked her husband with a baseball bat (for which she has no memory) and which ended their lifelong courtship and marriage. And cost her $30,000 to be in a psychiatric facility where they put her on five more drugs plus the antidepressant she had just withdrawn from! You can see why many have lamented that they wished they would have had the information on this CD before attempting withdrawal.

    To order Ann Blake-Tracy’s book go to: https://store.drugawareness.org/product/prozac-panacea-or-pandora-our-serotonin-nightmare-2014-ebook-download/

    To order the CD, “Help! I Can’t Get Off My Antidepressant!” go to: http://store.drugawareness.org/product/help-i-cant-get-off-my-antidepressant-mp3-download/

    This is a CD doctors can also benefit from when attempting to withdraw their patients from these drugs which the World Health Organization has now told us are addictive and produce withdrawal. And doctors have begun to recommend the CD to their patients.

    The Aftermath of Antidepressants

    In 2005 the FDA issued strong warnings about changes in dose for antidepressants. They warned that ANY abrupt change in dose of an antidepressant, whether increasing or decreasing the dose….so that would include switching antidepressants, starting or stopping antidepressants, forgetting to take a pill, skipping doses, taking a pill one day & not the next, etc…. can cause suicide, hostility, and/or psychosis – generally a manic psychosis which is why so many are given a diagnosis for Bipolar Disorder after this withdrawal reaction that can so severely impair sleep leading to a psychotic break.

    Clearly coming down too rapidly can be very, very dangerous. We encourage you to arm yourself with knowledge by downloading our CD on safe withdrawal.

    http://www.drugawareness.org/wp-content/uploads/wpsc/product_images/thumbnails/helpicant.jpgclick here. order a CD download.

    WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

    The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

    Ann Blake Tracy, Executive Director,
    International Coalition for Drug Awareness
    www.drugawareness.org & http://ssristories.drugawareness.org
    Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

     

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    Strattera Deaths (German TV Request) False Reports from Eli Lilly

    Wed Nov 12, 2008

    We have received a request from a German TV crew who is doing a special on Lilly’s newer ADHD medication, Stratera. These investigative reporters from Germany are doing a 45 minute piece and looking for experiences of tragedy /suicide or severe adverse reactions in children treated for ADHD with this drug. I know we have had reports, but I do not keep close track anymore of which drug is involved after so many cases because all these drugs work basically the same way. An antidepressant is an antidepressant no matter what you callmit or what you prescribe it for or how you explain its supposed uniqueness. So if you or someone you know has been through a Strattera-induced nightmareand would be willing to help get some exposure of this in the press, please get in touch with me so that I can put you in touch the reporters.

    O nce you read the following article on Strattera deaths you will see how very important it is to get information about this drug out to the public –

    especially throughout the UK and Europe. What is going on here IS CRIMINAL!!
    And here is just one example out of the article below that is full of data on how
    the government agency in the UK who oversees these drugs is ignoring
    critical information – even fatalities, and doing NOTHING but making excuses
    for their own behavior:

    MHRA has for almost three years been in possession of data showing that
    Strattera in many cases actually can cause or worsen the œcondition it is
    claimed to alleviate. More than 700 reports were submitted to the manufacturer,
    Eli Lilly, about Strattera inducing “œpsychomotor hyperactivity. Lilly called
    this an exacerbation of the “œunderlying ADHD”. If we would apply this to
    the area of real medicine and to diabetes we could say that the patient got a
    diabetes medication with resulting heavy increase in blood sugar level. Such a
    medication would probably be withdrawn very fast from the market. But the
    MHRA has not yet, after three years, succeeded to get even a bad quality review
    of these cases done not even from the manufacturer.

    Do read the rest of the information because it is clearly eye opening!! This
    newer ADHD drug, Strattera, which is really an SSRI antidepressant, is
    getting away with murder right under everyone’s noses. So definitely if you
    know someone who is willing to talk to this news crew about their experience with
    this drug, please do let me know ASAP.

    Thank you,

    Ann Blake-Tracy, Executive Director,
    International Coalition for Drug Awareness
    _www.drugawareness.org_ (http://www.drugawareness.org/) &
    _www.ssristories.org_ (http://www.ssristories.org/)
    Author of Prozac: Panacea or Pandora? – Our
    Serotonin Nightmare & the audio, Help! I Can’t
    Get Off My Antidepressant!!! ()

    _atracyphd1@…_ (mailto:atracyphd1@…)

    _http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_
    medicines_agency_refuses_to_act.htm#_
    (http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
    dicines_agency_refuses_to_act.htm#
    )

    October 20, 2008
    _Print this article_
    (http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
    dicines_agency_refuses_to_act.htm#
    )

    Strattera adverse effects: UK Medicines Agency refuses to act
    By Sepp Hasslberger

    Categories
    _Pharma_ (http://www.newmediaexplorer.org/sepp/pharma.htm)

    Janne Larsson, an investigator and reporter in Sweden, has obtained
    information about adverse event reports on Eli Lilly’s ADHD drug Strattera,
    using the Swedish freedom of information laws. The data, coming from both the FDA’s
    adverse reaction database and from reports to the UK’s Medicines agency, shows
    numerous adverse effects and scores of deaths by suicide.

    Yet the agency, even after repeated prodding by Larsson to initiate action,
    has refused to budge or even acknowledge that there is a problem. MHRA
    apparently accepts the drug’s producer Eli Lilly’s data rather than its own and
    the
    FDA’s adverse event reports.

    Image credit: _Monheit Law_
    (http://www.monheit.com/strattera/contact_lawyer.asp)

    Larsson says: An investigation of MHRA™s handling of the harmful effects of
    the ADHD drug Strattera has proven the following:

    MHRA has ignored data about instances of death among children in connection
    with Strattera treatment. At least 41 children have died. The agency has not
    investigated the reported cases and does not even have a compiled summary of
    cases with fatal outcome. Further the agency has allowed the manufacturer Eli
    Lilly to give false information about the number of fatal cases and has
    taken no action against the company once the false information was revealed.

    MHRA has for almost three years been in possession of data proving that
    Strattera can cause agitation, mania and psychotic reactions with hallucinations
    among children. Yet no warning has been issued to doctors and parents. The
    agency has withheld these disastrous consequences despite clear evidence. Due
    to bureaucratic procedures no warnings have been issued even if Eli Lilly reluc
    tanly conceded to include these harmful reactions in its information to the
    public almost a year ago.

    MHRA has for almost three years been in possession of data showing that
    Strattera in many cases actually can cause or worsen the œcondition it is
    claimed to alleviate. More than 700 reports were submitted to the manufacturer,
    Eli Lilly, about Strattera inducing œpsychomotor hyperactivity. Lilly called
    this an exacerbation of the œunderlying ADHD. If we would apply this to
    the area of real medicine and to diabetes we could say that the patient got a
    diabetes medication with resulting heavy increase in blood sugar level. Such a
    medication would probably be withdrawn very fast from the market. But the
    MHRA has not yet, after three years, succeeded to get even a bad quality review
    of these cases done“ not even from the manufacturer.
    The background data for these conclusions can be found in the following text
    and in the linked documents. When reading the data below please remember the
    promise from the MHRA: we take any necessary action to protect the public
    promptly if there is a problem._MHRA, About us_
    (http://www.mhra.gov.uk/Aboutus/index.htm) [1]

    Note that the linked documents (within letters described below) in most
    cases could not be obtained in UK where the issuance of them would be deemed as
    prejudicing œthe ability of the Assessory body to offer impartial advice and
    where the MHRA wants to allow marketing authorisation holders the chance to
    respond to regulatory action and make commercial decisions before data are
    in the public domain. (MHRA, e-mail about FOIA-request, 29th September,
    2006). However the documents could be obtained in Sweden, even if the MHRA has
    tried to stop the issuance of them by implying that publication could threaten
    the relations between Sweden and UK.
    Deaths among children in connection with Strattera treatment

    In May I submitted detailed data about cases of Strattera death to the MHRA.
    1st October I finally got an answer from the Scientific Assessor of the
    Vigilance and Risk Management of Medicines (VRMM). 7th October I got an answer
    from Professor Kent Woods, CEO of the MHRA, referring to the letter sent by the
    Scientific Assessor.

    My data about Strattera deaths can be found _in the letter_
    (http://jannel.se/Strattera.death2.pdf) Strattera: Eli Lilly gave false
    information about
    deaths from Strattera treatment “ a request for full investigation from 15th
    May. [2]
    The answer from the Scientific Assessor shows that MHRA is continuing to
    ignore data about instances of death among children and adults in connection
    with Strattera treatment. Despite limited resources and having to rely on data
    released by reluctant medical agencies I had been able to produce a summary of
    reported cases of Strattera death. Thats much more than the MHRA, with its
    immense resources, had been able to do.

    The agency was provided with specific data about instances of death forming
    an excellent starting point for a full investigation. But instead of using
    the data the MHRA used its energy to explain why it is impossible to
    investigate these cases further, and in doing so presents some remarkable
    comments.

    The Scientific Assessor states _in the letter 1st October_
    (http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3]:

    in order to calculate the total number of reports with a fatal outcome
    it is not simply a case of adding up reports with a fatal outcome mentioned
    in our assessment reports of the PSURs [Periodic Safety Update Reports] and
    those available on the FDA website as these different sources may contain
    duplicate information. [Emphasis added.]

    I fully agree and it takes only a casual reading of my letter from 15th May
    to find out that much care has been taken to exclude possible duplicates. It
    is quite easy to see that the data presented about fatal cases in my letter
    is NOT simply a case of adding up reports with a fatal outcome. The only
    way to come to another conclusion would be not to look in the first place and
    it is a condemnation of the effectiveness of the agency to state the following
    in the letter:

    We have looked at the data you have sent us to see if they can add insight
    to the statutory sources of data we have received and do not think that they
    are of benefit as we cannot verify their source or accuracy. (p. 3)
    [Emphasis added.]

    I must add to all the data provided in my letter 15th May that the our

    of the information about fatal cases is FDA™s Medwatch system and the PSURs
    (submitted directly to the MHRA). I must make it clear that is very easy for
    a lay person to find out that almost all reports about fatal outcome from
    Strattera treatment submitted to the FDA came from Eli Lilly!

    Thus the our of the information about fatal cases was in most of the
    cases the manufacturer itself“ Eli Lilly. And yet the MHRA has not been able
    to verify the source or accuracy of the information. The MHRA Scientific
    Assessor states in the letter:The sources of data that regulators use such
    as company data, spontaneous adverse reaction reports and literature are set
    out in European and national law.
    My FOIA request earlier this year to get a compilation of fatal cases in
    connection with Strattera treatment was answered 12th August:

    Thats very good and now we know that the data I submitted to the MHRA about
    all fatal cases from Strattera treatment “ in the absolute majority of cases
    were known by and reported via the manufacturer Eli Lilly.
    The MHRA holds no data other than that previously released to you [the
    misleading data from Eli Lilly in November 2007, see my letter from 15th May
    for
    more data] which was the data provided by the company. If you have any
    questions about FDA data or the data provided by the company, you should
    contact those organisations.

    In other words the MHRA didn’t have a compiled summary of cases with fatal
    outcome in August and the agency has not to this point been able to compile
    such a summary.

    As the agency has not been capable of getting the data or not even been
    capable of using the specific data submitted for its use in a full
    investigation NO action is taken despite the many verified deaths among
    children in connection with Strattera treatment. This disregard for the safety of children is a scandal which should lead to a full formal investigation by the
    Department of Health.

    Drug induced agitation, mania and psychosis with hallucinations

    Ive been contacted by parents asking if Strattera can induce mania and
    psychosis with hallucinations. Their children have had such symptoms. The
    parents have not found any warnings about it and their childrens doctors don’t
    think that the symptoms are caused by the drug. The parents were desperate.

    However the MHRA has known for almost three years that Strattera can cause
    agitation, mania and psychotic reactions with hallucinations among children,
    but has refused to issue warnings about it.

    The Scientific Assessor from the MHRA _in the letter of 1st October_
    (http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3] now confirms my
    earlier arguments that the agency had knowledge about these effects a long time ago:

    following an initial request in the assessment report for the Periodic
    Safety Update for the period (dates 27-05-2005 to 26-11-2005) we asked Eli
    Lilly for more information to enable us to review this issue in more detail. (p. 2)

    This means that in the period ending 26th November, 2005 at the time when
    Strattera was approved only in UK and four other European countries, but not
    in the 22 additional European countries where it is now approved Eli Lilly
    and the MHRA had knowledge about these disastrous effects in children taking
    Strattera. But neither the MHRA nor Eli Lilly told anything about it and
    Strattera was approved in 20 additional European countries in April 2006.
    Image credit: _Wikimedia Commons_
    (http://commons.wikimedia.org/wiki/Image:Strattera_atomoxetin.jpg)

    Professor Kent Woods, CEO of the MHRA seems to be very misinformed by his
    staff when answering about Strattera in a recent _letter of 7th October, 2008_
    (http://jannel.se/answer.kent.woods.pdf) . In the letter Professor Woods
    states [4]:

    The MHRA is committed to ensuring that all safety concerns are subject to
    robust scientific assessment and the best possible regulatory action is taken
    in a timely manner. We strive to maintain the highest standards of work and
    review our practices to ensure these standards are maintained or improved
    upon where necessary. (p. 1)

    In their 3rd March, 2006 report Psychiatric Adverse Events Associated with
    Drug Treatment of ADHD: Review of Postmarketing Safety Data [5], the FDA
    stated that there was compelling evidence for a likely causal association
    between [Strattera/amphetamine drugs] and treatment emergent onset of signs and/or
    symptoms of psychosis or mania, notably hallucinations, in some patients.

    (p. 17) 360 reports about the drug inducing these effects had been received
    up to June 2005.

    From this FDA report the MHRA had knowledge about the œcompelling evidence for Strattera causing these effects on or about 3rd March, 2006 but did nothing.

    In August the same year (2006) the MHRA requested the same data set from Eli
    Lilly that was submitted to the FDA and which formed the basis of the FDA
    report for Strattera. The data was sent to the MHRA some days later. But the
    agency then decided not to do anything with the information. Instead it was
    decided that Eli Lilly the manufacturer should do an analysis of the data
    and submit its conclusions to the agency.

    Professor Kent Woods says in his letter: An important aspect to this [ robust scientific assessment, highest standards] is ensuring that data from all available sources have been consider This may be true in some other area but it is definitely not true for the
    safety work around Strattera. A very good example of this is the complete
    rejection of the robust scientific assessment of Strattera in the FDA report.
    Answering the question why the agency did not use the compelling evidence for harm in the FDA report _an official at the MHRA declared in a letter_
    (http://jannel.se/mhraanswer.pdf) [6]:

    Changes to European product information are based on assessment by EU
    regulators, agreement between member states and in line with legal requirements
    about product information, not on conclusions of FDA assessors. (25th May,
    2007) [Emphasis added.]

    Responsible officials at the MHRA had instead decided to rely completely on
    the analysis of the manufacturer of the drug Eli Lilly. (In an article in
    the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and
    Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented:
    Asking a drug company to review its own product is crazy, but it goes on quite a lot.
    ) [7]

    At the end of 2007/beginning 2008 Eli Lilly submitted its review of
    Strattera induced agitation, mania and psychosis with hallucinations to the
    MHRA. It was a complete whitewash.

    In summary: FDA was very clear about the psychosis-inducing effects of
    Strattera; the MHRA did not listen. Instead the MHRA turned to the
    manufacturer. Eli Lilly tried to explain away all the bad results found in its review. For
    the full history about MHRA’s failure in this area and for a comparison of
    the FDA report with the Lilly report, please see the following letter: _The
    ADHD drug Strattera“ actions needed now_
    (http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] from January 2008, and
    the letter _The ADHD drug Strattera“
    an analysis of reports of drug induced mania, psychosis and hallucinations_
    (http://jannel.se/strattera.mhra.March.08.pdf) [9] from March 2008.

    In the letter from March [9] Eli Lilly’s whitewash report for the period up
    to November 2007 is presented. At the end of that report Lilly says [10]:

    Nevertheless, Lilly will consider adding language regarding psychotic symptoms
    including hallucinations to its product information sheet. (p. 1279)

    Larsson – _Suicides & Psychiatric Drugs_
    (http://www.newmediaexplorer.org/sepp/suicide.psychiatricdrugs.pdf)

    And so we come to October 2008 and the letters from Professor Kent Woods and
    from the Scientific Assessor for Strattera. We are reassured that the MHRA
    is acting to ensure that Strattera is used as safely as possible that

    all safety concerns are subject to robust scientific assessment and the best
    possible regulatory action, that any new safety signals are evaluated in
    an independent, scientifically robust manner (Woods); we are told that

    discussions between European Member States and Eli Lilly are ongoing to agree
    on the most appropriate information to be included in the product information
    for patients and prescribers; we are told to be patient, to understand that
    it takes time from the point where œupdates have been agreed for inclusion in
    the product information to the point where these will appear in the packs
    in the market place due to movement of stock in the supply chain, and that
    the appearances are estimated to be within the next 6 months (Scientific
    Assessor).

    It is probably hard to find a more obvious violation of the promise¦ we
    take any necessary action to protect the public promptly if there is a
    problem than the case described above. The worried parents still have no answers if
    Strattera can induce the symptoms they find in their children. And the MHRA
    knew about it three years ago but withheld the data. This should be
    included in the investigation of the agency by the Department of Health.

    Strattera causing hyperactivity“ the condition it was supposed to alleviate In my earlier letter to the Department of Health (29th August) I took up the data about the 700 forgotten cases of hyperactivity. I referred to my _letter 2nd January to the MHRA_
    (http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] and gave data about the
    fact that Eli Lilly had withheld sensitive information and classified harmful effects as an exacerbation of the underlying ADHD.

    The logical solution would have been for the MHRA to request all data about
    this security risk, followed by an independent review of the data. But this
    was not done and as expected nothing is still done. MHRA asked Lilly for an
    explanation about this signal stemming from Periodic Safety Update Report
    5 (dates 27-05-2005 to 26-11-2005) but got no answer. Three years later the
    Scientific Assessor from the MHRA writes in the letter from 1st October:

    The information submitted by the MAH [Market Authorization Holder] has been
    evaluated and the MAH will be requested to provide further detailed
    information within the next 2 months to ensure the issue has been investigated
    in a thorough and scientific manner. (p. 2) [3]

    The MHRA got this safety signal almost three years ago and is still in
    the process of getting some sensible answers from Eli Lilly.

    ————

    I again request the Department of Health to take action. This does not
    concern only the children in UK; it concerns the children in the whole of
    Europe, indeed it concerns all the children of the world.

    The failure of the agency will also mean that psychiatrists within The
    Guideline Development Group in NICE can push through more treatment with
    Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for
    harmful effects and the psychiatrists with close relations to the manufacturers
    of the drugs can unimpeded recommend these medicines to unsuspecting
    doctors and parents.

    The answers given by Professor Kent Woods and the Scientific Assessor did
    not in any way handle my concerns. On the contrary, they finally proved that a
    full formal investigation of the matters raised above is needed.

    Yours sincerely,

    Janne Larsson

    Reporter – investigating psychiatry
    Sweden
    _janne.olov.larsson@…_ (mailto:janne.olov.larsson@…)

    [1] MHRA, About us, _http://www.mhra.gov.uk_ (http://www.mhra.gov.uk/)
    [2] Larsson, Strattera: Eli Lilly gave false information about deaths from
    Strattera treatment“ a request for full investigation, May 15, 2008,
    _http://jannel.se/Strattera.death2.pdf_ (http://jannel.se/Strattera.death2.pdf)
    [3] MHRA, Re: letter of 9th September 2008 to “Assessor responsible for
    Strattera, October 1, 2008,
    _http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf_
    (http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf)
    [4] MHRA, Re: Open letter to Pr. Kent Woods (10th August 2008), October 7,
    2008
    _http://jannel.se/answer.kent.woods.pdf_
    (http://jannel.se/answer.kent.woods.pdf)
    [5] FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD:
    Review of Postmarketing Safety Data, released March 3, 2006.
    _http://www.fda.gov/ohrms/dockets_
    (http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.\
    pdf
    )
    [6] MHRA, answer FOI request, May 25, 2007,
    _http://jannel.se/mhraanswer.pdf_ (http://jannel.se/mhraanswer.pdf)
    [7] Daily Mail, Heart attacks and suicides… yet the dangers were all kept
    so quiet. So how CAN you trust your medicine? July 7, 2008,
    _http://www.dailymail.co.uk/_
    (http://www.dailymail.co.uk/health/article-1033132/Side-effects-include-suicide-\
    heart-attacks-So-prescribed-drugs.html
    )
    [8] Larsson, The ADHD drug Strattera – actions needed now, January 2, 2008,
    _http://jannel.se/letter.mhra.strattera.jan08.pdf_
    (http://jannel.se/letter.mhra.strattera.jan08.pdf)
    [9] Larsson, The ADHD drug Strattera – an analysis of reports of drug
    induced mania, psychosis and hallucinations, March 9, 2008,
    _http://jannel.se/strattera.mhra.March.08.pdf_
    (http://jannel.se/strattera.mhra.March.08.pdf)
    [10] Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania,
    Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic
    Safety Report 9 for Strattera, 2008,
    _http://jannel.se/Lilly_psychosis_strattera.pdf_
    (http://jannel.se/Lilly_psychosis_strattera.pdf)

    See also:

    _Doctors told to curb use of Ritalin in hyperactive children_
    (http://www.timesonline.co.uk/tol/news/uk/science/article4813727.ece)
    _Children’s suicide attempts raise concerns about ADHD medication_
    (http://www.theglobeandmail.com/servlet/story/RTGAM.20080703.wadhd03/BNStory/spe\
    cialScie

    nceandHealth/home)
    _The ADHD drug Strattera: Lilly to issue warnings about psychosis,
    hallucinations, mania and agitation_ (http://jannel.se/strattera.psychosis.doc)
    _Strattera side effects_ (http://www.bonkersinstitute.org/stratteraffex.html)

    _Strattera – 10,988 adverse “psychiatric reactions” reported in less than
    three years_ (http://www.24-7pressrelease.com/view_press_release.php?rID=16662)
    _Attention Deficit Hyperactivity Disorder? No, they’re just naughty, say
    experts_
    (http://www.dailymail.co.uk/news/article-1031436/Attention-Deficit-Hyperactivity\
    -Disorder-No-theyre-just-naughty-say-experts.html#
    )

    508 total views, no views today

    Amby Cole vs. Eli Lilly

    Eli LillyAmby Cole vs. Eli Lilly

    Lilly faces another Prozac lawsuit
    Tennessee widow says husband hanged himself 13 days after drug was prescribed.

    By Jeff Swiatek
    jeff.swiatek@indystar.com
    The Indianapolis Star

    The lawsuit, filed last week in U.S. District Court for the Western District of Tennessee, is the latest in more than 200 lawsuits against Prozac maker Eli Lilly and Co.  since the early 1990s.

    Amby Cole vs. Eli Lilly

    6/25/2002

    Lilly faces another Prozac lawsuit
    Tennessee widow says husband hanged himself 13 days after drug was prescribed.

    http://www.starnews.com/article.php?prozac25.html,business

    By Jeff Swiatek
    jeff.swiatek@indystar.com
    The Indianapolis Star

    To read the lawsuit go to: http://www.justiceseekers.com/files/NLPP00000/060.PDF

    A Tennessee woman charges that Prozac caused her husband to hang himself 13 days after being prescribed the drug by his cardiologist for chest pain and loss of weight.

    The lawsuit, filed last week in U.S. District Court for the Western District of Tennessee, is the latest in more than 200 lawsuits against Prozac maker Eli Lilly and Co. since the early 1990s.

    Plaintiff Amby Cole, joined by her two children, says in the lawsuit that Milton Cole’s death in June 2001 “fits the signature pattern” of suicide caused by the Prozac family of antidepressants.

    Cole wasn’t seriously depressed or suicidal and “became nervous, jittery and aggravated” after taking Prozac, the lawsuit says.

    The wrongful-death and product-liability lawsuit charges that Prozac causes violent side effects that are dose-related, but Lilly “chose not to pursue” a lower-dose Prozac and put a once-weekly version on the market only last year.

    “Lilly did not start marketing a once-a-week Prozac until its patent rights had been adjudicated as over and it was threatened in the marketplace with a generic formulation,” the lawsuit says.

    Lilly has always maintained that Prozac’s side effects don’t include suicidal or violent thoughts. In the only two Prozac civil suits to come to trial, juries have sided with Lilly.

    Attorneys for plaintiffs in the latest suit are J. Houston Gordon of Covington, Tenn., and Andy Vickery of Houston. Call Jeff Swiatek at 1-317-444-6483.

    Copyright 2002 The Indianapolis Star

    709 total views, 1 views today

    5/01/2001 – World Health Organization – SSRI Addiction

    “A league table of withdrawal and dependency side-effects, published by the
    WHO, shows that drugs including Prozac and Seroxat [Paxil] have produced far
    more complaints from patients than old-fashioned tranquillisers . . . SSRIs
    (selective serotonin reuptake inhibitors), including Prozac, are more
    addictive than tranquillisers such as Valium.”

    Yesterday, in several major newspapers Lilly placed full page ads offering a
    coupon for a month of free Prozac. Do you think they warned the consumer in
    those ads that these free pills were addictive? Because so few doctors are
    aware of this withdrawal and do not know how to withdraw patients from SSRIs,
    after the month on the “free” pills the patient would have to continue to
    purchase the drug until they could find my tape on how to get off Prozac
    safely.

    If you had told me ten years ago, shortly after I began researching the SSRIs
    and dealing with patients going through horrific withdrawal from Prozac, that
    it would take TEN years for the World Health Organization to finally see what
    I was seeing, I would not have believed it. It was so obvious! But I have
    waited and waited and waited as I have warned and warned and warned of this
    addiction and withdrawal and finally today we see the WHO admit it.

    At least the WHO have warned the public now, but where is the FDA? Will they
    finally at least admit this much about SSRIs? All of these organizations that
    society thinks are there to protect them – where were they as millions
    suffered needlessly? How many times do we need to see this repeated with one
    drug after another before we realize that there is no protection to the
    consumer via these agencies? Obviously “buyer beware” most definitely applies
    in this arena of prescription drug use. This is why I feel it is so important
    to educate the public about these drugs.

    You can mark my words when I say that this is only one of MANY more
    admissions that will continue to come confirming all the warnings that I gave
    in my book about the SSRI antidepressants, Prozac: Panacea or Pandora?

    Ann Blake-Tracy, Executive Director,
    International Coalition For Drug Awareness
    www.drugawareness.org and author of
    Prozac: Panacea or Pandora? ()

    http://news.independent.co.uk/uk/health/story.jsp?story=69366

    01 May 2001
    Home > News > UK > Health

    World health watchdog warns of addiction risk for Prozac users

    By Robert Mendick

    29 April 2001

    Prozac, billed for years as a harmless wonder drug, often creates more
    problems than the depression it is supposed to be treating, warns the head of
    the World Health Organisation’s unit monitoring drug side-effects.

    Professor Ralph Edwards says Prozac and drugs similar to it are
    overprescribed. A league table of withdrawal and dependency side-effects,
    published by the WHO, shows that drugs including Prozac and Seroxat [Paxil]
    have produced far more complaints from patients than old-fashioned
    tranquillisers prescribed by doctors in the 1970s. Campaigners say this
    proves that the drugs called SSRIs (selective serotonin reuptake inhibitors),
    including Prozac, are more addictive than tranquillisers such as Valium.

    “SSRIs are probably over-used,” says Professor Edwards. “They are used for
    relatively minor psychiatric problems, and the issue of dependence and
    withdrawal has become much more serious. You risk creating a greater problem.
    For serious psychiatric problems, it is worth the risk. But if you are just
    tired or going through a bad patch, well, people get over that without
    medication.”

    A spokeswoman for Eli Lilly, makers of Prozac, accepted there are potential
    side-effects including head-aches, dizziness, sleeplessness and nausea but
    added: “The benefits of Prozac far outweigh the downsides. Extensive
    scientific and medical experience has demonstrated that Prozac is a safe,
    effective antidepressant that is well-tolerated by most patients.”

    Prozac has been taken by an estimated 35 million people worldwide since its
    launch a decade ago. But the reputation of SSRIs as wonder drugs is being
    questioned. Research by Dr David Healy, at the University of Wales, appeared
    to show that two people in a trial group of 20 became violent after taking an
    SSRI.

    Dr Healy’s research may be presented as evidence in a High Court case being
    brought by the family of Reginald Payne, a retired teacher who was taking
    Prozac when he killed his wife then jumped off a cliff. The family is suing
    Eli Lilly, claiming negligence and saying the pharmaceutical firm failed to
    warn Mr Payne of side-effects, which they say include suicidal and violent
    behaviour.

    The experiences of Ramo Kabbani on Prozac prompted her to set up the Prozac
    Survivors Support Group. In two years, it has taken 2,000 calls. Ms Kabbani
    claims SSRI withdrawal causes side-effects ranging from flu-like symptoms
    such as dizziness and aching muscles to suicidal tendencies. She began taking
    Prozac to combat depression after the death of her 27-year-old fiance from a
    heart attack.

    “The medication stopped me working through the feelings of grief which had
    caused the depression.” she says. “When I came off Prozac I became
    super-sensitive and very emotional. I found it worse going through withdrawal
    than going through the depression.”

    Council for Involuntary Tranquilliser Addiction 0151 949 0102; Prozac
    Survivors Support Group 0161 682 3296.

    895 total views, no views today

    5/16/2000 In Houston lawyer, Lilly has a colorful foe

    Sorry, we should have gotten this to you sooner. There is too much happening
    to keep up with it all! This is an article from the paper in the home of Eli
    Lilly, the Indianapolis Star. They did a good job on this article about Andy
    Vickery and his firm. The firm has been an answer to prayer for many families
    who could not find an attorney with the courage to take on these companies
    who manufacture SSRI antidepressants.

    Ann Blake-Tracy

    In Houston lawyer, Lilly has a colorful foe

    Passionate adversary and able phrase-maker has engaged in 14 suits against
    the company.

    By Jeff Swiatek

    The Indianapolis Star

    Last updated 12:49 AM, EST, Monday, April 24, 2000

    HOUSTON — He’s Eli Lilly and Co.’s legal nightmare: an outspoken,
    Yale-educated Texas trial lawyer who loves suing big corporations and has his
    sights set on one in Indianapolis.

    “The dark side,” Andy Vickery calls his corporate targets, drawing out the
    words for effect.

    He’s indulged himself in 14 lawsuits against Lilly. The charge: that Lilly’s
    best-selling antidepressant, Prozac, made some users “go bonkers,” as Vickery
    puts it.

    Prozac lawsuits are old hat for Lilly. Fewer than 10 of the nearly 300 Prozac
    lawsuits Lilly has faced over the years remain on the dockets. And the
    consensus among most trial lawyers is that new Prozac lawsuits aren’t
    winnable.

    “It’s not an easy litigation. I gave it up,” said Indianapolis lawyer Vernon
    J. Petri, who handled numerous Prozac cases in the early 1990s.

    But in Vickery, Lilly faces a wise-cracking nemesis-at-law who has brought
    new focus and heightened publicity to Prozac litigation. He’s done it despite
    the limited legal muscle of his small, three-lawyer firm.

    At age 52, with more than 50 trials under his belt, Vickery sees himself as
    an advocate for victims of Prozac and similar antidepressants.

    “A public health catastrophe,” he calls the alleged tendency of Prozac and
    related antidepressants to cause some users to turn violent or suicidal.

    Vickery, who says he’s never used Prozac himself, is outspoken, dogged and
    prone to outlandish legal tactics.

    In one case, he managed to question his rival, Lilly’s chief lawyer for
    Prozac litigation, James T. Burns, on the witness stand — a scenario another
    Lilly lawyer termed “very unusual.” In another, he sued lawyer Paul Smith of
    Dallas, who in 1994 tried the first Prozac case against Lilly.

    Such tactics have gotten Vickery called “irresponsible” by a Lilly attorney
    and “a vulture” by Smith’s former co-counsel, Chicago attorney Nancy Zettler.

    “He belongs to a species that I think represents generally a problem to
    American society,” says Mitchell E. Daniels Jr., Lilly’s senior vice
    president of corporate strategy and policy.

    Vickery shrugs off the criticisms, saying, “I am not going to shy away from
    saying what needs to be said.”

    Shy is one thing he’s not.

    Happy to talk to a reporter from Lilly’s hometown, he shows up for a noon
    lunch appointment at his high-rise office near Houston’s downtown, tieless
    and complaining of muscle aches from a recent match of handball.

    Lunch, it turns out, will be the daily buffet served up in a wooden-beamed
    meeting hall of Christ Church Cathedral, a massive stone structure among
    downtown’s glass-and-steel skyscrapers.

    Vickery heads there in the leather-upholstered Jaguar he bought his wife for
    her 40th birthday.

    Vickery picked the Episcopal church’s buffet to send a message about himself
    back to Indianapolis, a message he makes sure is understood after he polishes
    off his plate of Tex-Mex food and strolls outside on smooth stone floors.

    “This is my church,” he says, pointing out a niche in a stone wall where he
    plans for his ashes to one day be interred. “I get so tired of Eli Lilly
    saying it’s only Scientologists that oppose them.”

    Passionate adversary

    The Prozac basher who wants Lilly to know he doesn’t spend nights reading
    science fiction novels by Scientology founder L. Ron Hubbard is a
    speed-reading, gadget-obsessed, Georgia native who’s on his second marriage
    but still reveling in his first love of trial law.

    “He is without question the most passionate person I have ever known,” says
    his law partner, Paul Waldner. “I’ve snow-skied with Andy and seen him go
    downhill faster than teen-agers ever would, yodeling the whole time.”

    A fan of anything high-tech, Vickery embraced computers early for his legal
    work and employs the latest software to track the complex litigation he
    handles. “He wouldn’t go to the bathroom without his laptop,” Waldner says.

    Vickery met his wife, Carol, nine years ago. The divorcees got married two
    years later.

    At their home in an upscale area of Houston, she says, life with Vickery is
    “like summer camp.” Her husband enjoys spending time with her two children,
    tending a rose garden, barbecuing for friends and going sea-kayaking at their
    Gulf Coast beach house, she says.

    So it’s no surprise that, when Vickery’s enthusiasms carry over into the
    stuffy profession of law, he sometimes skirts the line of what’s expected.

    “He crowds it, he’s right up on it,” says Waldner, a past president of
    Houston Trial Lawyers Association, who remembers Vickery beginning one legal
    document by quoting lyrics to a B.B. King song.

    Settled 11 cases

    Because only two Prozac civil lawsuits have ever come to trial, Prozac
    litigation is an informational black hole where cases tend to be quietly
    resolved out of court and only Lilly knows the details.

    Even so, it’s clear that Vickery has fared well in this high-stakes game of
    suing over one of the world’s most well-known drugs.

    “I have never dropped or dismissed a case,” he boasts.

    In the past two years, 11 Prozac suits that Vickery filed or joined as
    counsel have been settled out of court, he says. Terms remain confidential,
    but presumably include cash payments by Lilly in exchange for clients
    dropping all charges.

    Last year, in a Hawaii courtroom, Vickery tried only the second Prozac case
    to come before a jury. He represented the children of Hawaii retiree William
    Forsyth Sr. who, 11 days after going on Prozac to treat panic attacks,
    stabbed his wife, June, to death and impaled himself.

    The jury voted 11-0 to absolve Lilly of blame. The verdict “ripped my heart
    out,” says Vickery, who calls the decision a low point in his career.

    Undeterred, Vickery has appealed that decision, continues to pursue two other
    Prozac cases, and hints at filing more, possibly in Indianapolis.

    Vickery won’t discuss fees from the confidential Prozac settlements, trying
    to suggest they leave something to be desired.

    “I’m not counting on Eli Lilly for my retirement, I can tell you that,” he
    says.

    Vickery admits to feeling Quixote-like as he duels Lilly’s lawyers over its
    No. 1 drug.

    “It takes a kind of idiot to do it,” he says. “You are fighting one of the
    richest pharmaceutical companies in the world over the thing most dear to
    them.”

    Prozac is firm’s focus

    Vickery has waged his fight over Lilly’s dearest drug from the 29th floor of
    an office high-rise just west of Houston’s downtown.

    The heart of Vickery & Waldner is an oversized storage closet dubbed “the
    Prozac room.” It overflows with boxes, files and tapes from Prozac
    litigation. Newspaper clippings and snapshots of plaintiffs cover part of one
    wall.

    Lately, Vickery & Waldner has expanded its focus to sue other antidepressant
    makers, including Pfizer over its popular drug Zoloft.

    Vickery & Waldner drums up business, in part, by soliciting on its Internet
    Web site, www.justiceseekers.com.

    The site contains a Prozac room of the virtual sort, packed with screenfuls
    of documents and articles about the drug. The firm also handles medical
    malpractice cases and has represented hemophiliacs who received AIDS
    virus-tainted blood.

    Vickery took on his first Prozac case at the request of Richard W. Ewing, a
    long-time friend who’s the third lawyer at the firm.

    Ewing in 1991 sued on behalf of the family of Texas rancher Bernie A.
    Winkler, who shot himself in his driveway after taking Prozac for six weeks.
    Later, Ewing turned the case over to Vickery, who found Prozac litigation
    much to his liking.

    He’s spent much of the past four years filling the Prozac Room with
    subpoenaed documents.

    Vickery & Waldner plans to leave its crowded rented quarters and build its
    own office building in a residential area of the city.

    For now, Vickery taunts the “dark side” from a worn wooden desk looking out
    floor-to-ceiling windows to a grand view of the Houston skyline.

    More than 20 photos, most of family, are hung and propped about. On his
    computer screen floats a screen-saver of actress Michelle Pfeiffer in a red
    dress. Opposite sits an ornate Bible opened to a highlighted verse from
    Isaiah with the admonishment “Learn to do well, seek judgment, relieve the
    oppressed.”

    “To keep my focus,” Vickery says, of the Bible.

    The focus of Vickery’s Prozac suits is another book: the Physicians’ Desk
    Reference. U.S. doctors rely on the 3,000-plus-page volume to inform them of
    a drug’s side effects.

    Lilly’s refusal to expressly list violent behavior, including suicide, as a
    possible side effect of Prozac, forms the basis of Vickery’s lawsuits. Lilly
    contends putting such a dire warning on Prozac’s package label is unwarranted.

    “Any label change (about suicide and violence) for Prozac was never on the
    table, never negotiable from our standpoint,” says Lilly’s Daniels.

    Vickery hauls the weighty red book from a shelf and opens to Prozac and its
    long list of side effects.

    “They warn about rashes, by god, but nothing about suicide,” he says. “To
    satisfy me, and that sounds very egocentric, all Lilly would have to do is
    put in a bold-faced, boxed warning. This isn’t lawyer nitpickery. This is
    very important how it appears and where.”

    Gift of gab

    Vickery grew up in middle-class, Southern Baptist family in Atlanta, the
    middle son of a homemaker mother and a father who ran an insurance agency.
    His father told him at age 11 that the boy’s gift of gab marked him for
    lawyering.

    Gifted with academic smarts as well, Vickery graduated high school as class
    valedictorian and became the first Ivy Leaguer in his family. He enrolled at
    Yale University as an American studies major, going on to earn a law degree
    at the University of Georgia School of Law.

    To pay for Yale, Vickery had enrolled in ROTC. He fulfilled his military
    obligation as an Army attorney, serving in one of the Army’s most notorious
    cases: the trials of Lt. William Calley Jr. and others who took part in the
    massacre of Vietnamese civilians at My Lai.

    As a young lawyer, Vickery also clerked for U.S. Appeals Court Judge John R.
    Brown in Houston, a man known for his colorfully argued opinions.

    It was Brown who impressed on Vickery the value of the trenchantly put phrase.

    “The judge told me, ‘An idea poorly expressed dies aborning,”‘ Vickery says,
    displaying a book of quotations given him by the man he calls “my judge.”

    Vickery has taken the advice to heart. In his latest lawsuit, filed in Hawaii
    in January by the parents of teen-ager Hugh Blowers, who hanged himself at
    home after taking Prozac, Vickery opined that the boy’s life “was sacrificed
    on the altar of Lilly’s profits.”

    His legal writing, complete with exclamation marks and sarcastic footnotes,
    once provoked U.S. District Court Judge S. Hugh Dillin to call a Vickery
    Prozac brief “inflammatory” and “scurrilous.”

    The brief in question came in a Vickery lawsuit that was the last of 75
    federal Prozac cases consolidated in Dillin’s court in Indianapolis. In
    March, the judge remanded the case back to Texas courts.

    Those on the receiving end of a Vickery legal blast may cringe on hearing he
    has no plans to rein in his colorful self-expression.

    He does admit, though, that there’s a limit to the time he’ll invest dueling
    Lilly and other antidepressant makers in court.

    “They whip my a– three times and I’m outa there. I just can’t take any more
    than that,” he says, swiveling in his office seat.

    But until Vickery’s third lost verdict, Lilly will remain in his sights, he
    vows. “They know damn well I’m not going to quit.”

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