http://industry.bnet.com/pharma/10007579/glaxo-paxil-and-the-catholic-church-sex-abuse-cover-up-drug-implicated-in-suicide-of-priest/

Glaxo, Paxil and the Catholic Church Sex Abuse Cover-up: Drug Implicated in Suicide of Priest

By Jim Edwards | Apr 7, 2010

GlaxoSmithKline (GSK), which was already the focus of controversy over whether it ignored thesuicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.

The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years.

Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death inSeptember 2002.

The Tucker case stems from 1966, when Debra Tucker was 10 years old and attended the St. Lawrence Parish church in the Diocese of Lafayette-in-Indiana. At the same time, Rick attended St. Mary’s Seminary in the same parish. Between 1966 and 1968, Debra was raped two to four times a month by St. Lawrence’s children’s choir instruction, a lay employee of the church, she alleges. In1968, Tucker had an abortion at the abuser’s behest, and then her family  including Rick, who had no idea what was going on  moved house and the abuse stopped. Debra remained in the area and over the years the abuser painted her house and attended the funerals of both her parents, she alleges.

In July 2000, after Debra discovered that the abuser had also allegedly assaulted his own children, she attended a meeting with Father Tucker, St. Lawrence’s Monsignor Robert Sell and other church officials. She claims that Sell and the church agreed to ensure that the abuser had no further contact with children in the parish and in return she would not sue the church.

After learning that Sell and the church allegedly did nothing about the man, Debra Tucker sued for breach of contract in a separate case not involving GSK.

The parish dragged its feet over the lawsuit, and as Father Tucker waited for word over whether his employers would settle his sister’s case, he became increasingly anxious. He was also worried about an upcoming audit by the diocese because, the judge wrote, he had “advanced himself some monies” and the Church would discover these “irregularities.”

However, his anxieties were misplaced: the audit did not uncover any irregularities in Father Tucker’s bookkeeping, the ruling says. The Tucker family’s lawyer said that the amounts involved were in the $50 range  and thus proof that Father Tucker’s anxiety was a product of the drug and not the situation he was in.

After taking Paxil, Tucker went into a sudden depressive tailspin. His diary for Aug. 30, 2002, just two days after he was prescribed the pill, says:

“Things have gotten behind and I do not know how to catch up. I want to live, but I want out of the pain. I feel like I am in an ocean and I can’t swim to the top for air. . . . I can see no way out of it. I know that if I follow through with the thoughts that come to my mind, there will be people hurt. … Debra I am sorry.”

Father Tucker killed himself on Sept. 18.

Debra Tucker alleges in her complaint against GSK that the company knew as early as 1990 thatPaxil potentially had an increased risk of suicide, and that the company failed to warn patients of the risk of akathisia, psychosis or violent self harm. Akathisia is a profound state of anxiety in which patients, unable to rest, believe they are doomed.

GSK had asked the judge to summarily dismiss the case based because the expert witnesses who testified that Father Tucker’s death was triggered by the Paxil and not the other stresses in his life were inadequate. The judge ruled there was a case to answer.

GSK and Msgr. Sell did not immediately respond to emails and a voicemail requesting comment. I’ve decided not to name the alleged abuser  although his name is published in Debra Tucker’s complaint against the church because I could not reach him for comment.

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration. In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

http://www.philly.com/inquirer/business/20090912_Glaxo_trial_opens_here_Monday_in_what_could_be_Paxil_test_case.html

Posted on Sat, Sep. 12, 2009

Glaxo trial opens here Monday in what could be Paxil test
case

By Sophia Pearson and Margaret Cronin Fisk

Bloomberg News
GlaxoSmithKline P.L.C., the world’s second-biggest
drugmaker, begins a trial in Philadelphia next week in what may be a test case
for more than 600 lawsuits over claims that the company’s antidepressant drug

Paxil causes birth defects.

Patients and their parents say internal
company documents show Glaxo failed to warn consumers about the risks of Paxil
until forced to do so in 2005 by the Food and Drug Administration. In the trial
set to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.

The company, based in
London and with major operations in Philadelphia and its suburbs, faces two more
such trials each month from October through January in state court in
Philadelphia.

“The early cases set the parameters for any global
settlement negotiations,” said David Logan, dean and professor of law at Roger
Williams University in Bristol, R.I.

Paxil, approved by the FDA in 1992,
generated about $942 million in sales last year, 2.1 percent of the total for

the company.

Glaxo has settled other Paxil-related cases, including a
suit brought by the New York Attorney General’s Office accusing the company of
withholding safety data about the antidepressant.

The drugmaker isn’t
liable for Lyam Kilker’s heart defects, and it acted responsibly in testing
Paxil and updating safety information, Kevin Colgan, a Glaxo spokesman, said in
an e-mail.

“The scientific evidence simply does not establish that
exposure to Paxil during pregnancy caused Lyam Kilker’s condition,” Colgan said.
“Very unfortunately, birth defects occur in 3 to 5 percent of all live births,
whether or not the mother was taking medication during pregnancy.”

The
FDA said in an alert to doctors on Dec. 8, 2005, that preliminary studies
suggested Paxil might contribute to heart defects in infants when taken in the
first three months of pregnancy. The government asked the company to update the
label enclosed with the medicine, changing its birth-defect warning.

The
FDA’s action does not prove any connection between Paxil use and birth defects,
Glaxo said in court filings in July.

“GlaxoSmithKline will show it acted
properly and responsibly in conducting its clinical trial program for Paxil, in
marketing the medicine, in monitoring its safety once it was approved for use
and in updating pregnancy information in the medicine’s label as new information
became available,” Glaxo’s Colgan said.

Lawyers for patients say Glaxo
documents show the company had known since 1980 that Paxil could raise the risk
of birth defects.

Excellent article! Many would still be alive and many more
would have avoided being damaged had they been able to see this coming as
clearly as I did years ago when I began warning about these drugs. But it is not
over! There will tragically be many more losses due to the ability of drug
manufacturers to buy the silence this doctor from Tufts says below should
not happen. These settlements need to be made public!

The one glaring omission in this article is a case I am very
familiar with Tobin vs Glaxo. This Paxil-induced murder/suicide
case was allowed to go to court, rather than being settled by Glaxo.
And after hearing all the evidence the jury ruled
that it was clear that Paxil was the main cause of this tragic
murder/suicide that cost 4 lives in one WY family. They ordered Glaxo to pay
$6.3 Million – in my opinion a very small amount for four lives!

But it will not be the end of these types of cases being filed.
The authors did not figure the losses Glaxo will face from those cases
of murder/suicide so their losses could be far greater than detailed
below.

The company hasn’t specified in regulatory filings
the number of suicide, birth-defect and addiction cases settled.

“It’s important to disclose such settlements because
it raises the red flag for both doctors and patients that there might be a
problem,” said Dan Carlat, a psychiatrist at Tufts University School of Medicine
in Boston who writes and edits a blog and a monthly

Psychiatry
Report. “It would motivate
doctors to dig into the literature even more before prescribing these
drugs.”

• About 450 suicide-related Paxil cases were settled. Only about a dozen
  haven’t been, the people said. The $1 billion total doesn’t include more than
  600 claims that Paxil caused birth defects.
• A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million
  to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after
  his mother took Paxil while pregnant. Based on that outcome, an analyst
  estimated the company may potentially face additional verdicts in birth-defect
  cases waiting to be tried in Pennsylvania.
• 600 More Cases
• “A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a
  Panmure Gordon analyst in London, in a note to investors the day after the
  Kilker verdict.
• In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug
  combination fen-phen, has had to set aside about $21 billion to resolve about
  200,000 personal-injury claims over that medicine. Merck & Co. agreed to
  pay $4.85 billion to resolve more than 48,000 claims over the withdrawn
  painkiller.
• Harris Pogust, an
  attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts
  are confidential.
• The suicide settlements included a suit over the death of a 14-year-old
  boy who had been taking Paxil for two months. The parents of Scott Cunningham,
  of Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged
  Glaxo suppressed evidence that Paxil use was linked to the risk of suicide
  attempts by adolescents. Glaxo denied the allegations, according to court
  papers.
• The family settled its suit in May, according to court filings. Family
  attorney Bijan Esfandiari confirmed the settlement, saying the amount was
  confidential.
• About 150 cases over suicides by Paxil users were settled for an average
  of about $2 million, and about 300 over suicide attempts settled for an
  average of $300,000, they said. Some of the claims were resolved before suits
  were filed, according to the people familiar with the matter.
• Glaxo has settled about 10 birth-defect cases, Sean Tracey, a
  Houston-based lawyer who represented the family of a child victim, said in
  court Dec. 2. The settlements averaged about $4 million, the people familiar
  with the cases said.
• Glaxo paid an average of about $50,000 per case to resolve about 3,200
  claims linking Paxil to addiction problems, the people familiar with the cases
  said.
• In its 2008 annual report, company officials noted they had reached a
  “conditional settlement agreement” in January 2006 with Paxil users who
  alleged they suffered withdrawal symptoms after taking the drug. The case,
  filed in Los Angeles federal court, was marked closed in court records in
  February.

Glaxo Said to Have Paid $1 Billion to Settle Paxil

Lawsuits

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By Jef Feeley and Margaret Cronin Fisk

Dec. 14 (Bloomberg) — GlaxoSmithKline Plc has
paid almost $1 billion to resolve lawsuits over Paxil since it introduced the
antidepressant in 1993, including about $390 million for suicides or attempted
suicides said to be linked to the drug, according to court records and people
familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid
$200 million to settle Paxil addiction and birth-defect cases and $400 million

to end antitrust, fraud and design claims, according to the people and court
records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst
at Matrix Corporate Capital in London. “I don’t think this is within the
boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company
filings. It has made public some accords. Glaxo’s provision for legal and other
non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion),
according to its latest annual report. This included all legal matters, not just
Paxil. The company said 112 million pounds of this sum would be “reimbursed by
third-party issuers.”

The drugmaker has reduced its insurance coverage to contain costs, “accepting
a greater degree of uninsured exposure,” the annual report states. “Recent
insurance loss experience, including pharmaceutical product-liability exposures,
has increased the cost of, and narrowed the coverage afforded by, insurance for
pharmaceutical companies generally,” Glaxo said.

Glaxo Comment

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the
market in the U.S. since 1993. Like many other pharmaceutical products, it has
been the subject of different kinds of litigation over the years,” said Sarah Alspach, a
spokeswoman for Glaxo, in an e-mailed statement. “It would be inappropriate and
potentially misleading to aggregate payments in these various types of
litigation.”

Chief Executive Officer Andrew Witty has moved
to replace revenue lost to generic versions of drugs such as Paxil. Worldwide,
Paxil generated about 514 million pounds in sales last year, or 2.1 percent of
the total. Glaxo closed up 5 pence to 1,303 pence in London trading Dec. 11,
down 8.8 percent from a year ago.

About 450 suicide-related Paxil cases were settled. Only about a dozen
haven’t been, the people said. The $1 billion total doesn’t include more than
600 claims that Paxil caused birth defects.

A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to

the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his
mother took Paxil while pregnant. Based on that outcome, an analyst estimated
the company may potentially face additional verdicts in birth-defect cases
waiting to be tried in Pennsylvania.

600 More Cases

“A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a
Panmure Gordon analyst in London, in a note to investors the day after the
Kilker verdict. He still recommended buying Glaxo shares because a likely appeal
may reduce the amount paid by the company.

In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug
combination fen-phen, has had to set aside about $21 billion to resolve about
200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay
$4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.

Harris Pogust, an
attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts
are confidential.

Paxil Is Different

“Paxil’s been different from most drugs,” said Pogust, a lawyer from
Conshohocken, Pennsylvania, who is handling suicide and withdrawal cases.
“You’ve had three major personal injury litigations over one drug — the
suicide, the birth defect and the withdrawal cases. To have three significant
problems with one drug is really unusual.”

The company had $11.7 billion in U.S. Paxil sales for nine years starting in
1997, according to documents made public this year in a Pennsylvania trial. In
2002, the year before Paxil faced generic competition in the U.S., sales of the
drug there were $2.12 billion. Last year, U.S. sales had fallen to $129 million.
Through September of this year, sales were $52 million, down 52 percent from the
same period in 2008.

Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil
users were subjected to an undisclosed, higher risk for suicide and birth
defects.

A Suicide Settlement

The suicide settlements included a suit over the death of a 14-year-old boy
who had been taking Paxil for two months. The parents of Scott Cunningham, of
Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged Glaxo

suppressed evidence that Paxil use was linked to the risk of suicide attempts by
adolescents. Glaxo denied the allegations, according to court papers.

The family settled its suit in May, according to court filings. Family
attorney Bijan Esfandiari confirmed the settlement, saying the amount was
confidential.

About 150 cases over suicides by Paxil users were settled for an average of
about $2 million, and about 300 over suicide attempts settled for an average of
$300,000, they said. Some of the claims were resolved before suits were filed,
according to the people familiar with the matter.

Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based
lawyer who represented the family of a child victim, said in court Dec. 2. The
settlements averaged about $4 million, the people familiar with the cases said.

Hasn’t Specified

The company hasn’t specified in regulatory filings the number of suicide,
birth-defect and addiction cases settled.

“It’s important to disclose such settlements because it raises the red flag
for both doctors and patients that there might be a problem,” said Dan Carlat, a
psychiatrist at Tufts University School of Medicine in Boston who writes and
edits a blog and a monthly Psychiatry Report. “It would motivate doctors to dig into the
literature even more before prescribing these drugs.”

Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims
linking Paxil to addiction problems, the people familiar with the cases said.

In its 2008 annual report, company officials noted they had reached a
“conditional settlement agreement” in January 2006 with Paxil users who alleged
they suffered withdrawal symptoms after taking the drug. The case, filed in Los
Angeles federal court, was marked closed in court records in February.

“Glaxo did not admit liability” in the addiction settlements, the company’s
officials said in a March 2009 filing with the U.S. Securities and Exchange
Commission.

The Other $400 Million

In one of eight accords unrelated to individual suicide, addiction or
birth-defect claims, Glaxo agreed in 2003 to pay $87.6 million to the U.S. and
49 states over claims it repackaged and privately labeled Paxil and another
drug, Flonase, to a health maintenance organization at discounted prices.

Glaxo, denying liability, agreed in 2004 to pay $165 million to settle two
antitrust suits over allegations it engaged in sham patent infringement
litigation to stall approval of generic versions of the drug, court records
show. Of that total, $100 million was for direct purchasers of Paxil, such as
drug wholesalers, and $65 million was for indirect buyers, the records show.

In the same year, Glaxo agreed to pay $2.5 million to New York to resolve
accusations the company withheld safety data about the antidepressant. The
company, calling the claims unfounded, agreed to release safety studies on the
medicine’s effect on children.

In 2005, the company added a black-box warning to its Paxil label that the
drug increased the risk of suicidal thoughts among adolescents, following a
request by the U.S. Food and Drug Administration to do so.

The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba
GlaxoSmithKline, 07-001813, Court of Common Pleas, Philadelphia County,
Pennsylvania (Philadelphia).

To contact the reporters on this story: Jef Feeley in
Wilmington, Delaware, at jfeeley@bloomberg.net and; Margaret Cronin Fisk in
Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated:
December 14, 2009 00:01 EST

lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.”

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration. In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

Glaxo trial opens here Monday in what could be Paxil test case

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits.

NOTE BY DR. TRACY (www.drugawareness.org): In my small church congregation in Utah (maybe 100 families) there were two cases of SSRIs birth defects that I was aware of. In one case the mother was on Paxil and the other was a mother on Prozac. Both babies had to have heart surgery at birth or not long after. Because of that the number of 600 cases that have been filed is no surprise to me at all other than the number seems small in comparrison.

http://www.bloomberg.com/apps/news?pid=20670001&sid=ae8Ie3hNoafw

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)
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By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: September 15, 2009 17:03 EDT

Who is handling this one? Hope the attorneys are using Dr. Pal Paucher whose work has demonstrated this for a very long time.

-Ann

[NOTE: This is being sent to you directly as well as being posted on our "BREAKING NEWS" section of our new website. We are posting new cases there as they come in as well..]

We just had the anniversary of 9/11. And today is the anniversary of the death of baby Indiana. And this week we will have the first Paxil Birth Defect case hit the courts.

So what do all of these have in common? PLENTY!!

Baby Indiana lost her life a year ago today due to the fact that her mother took Effexor during her pregnancy and her parents were not warned of the potentially fatal dangers involved. (Please go to one of the sites below to lend support to her family in their battle to raise awareness and also to see what happened to baby Indy.)

All antidepressants increase serotonin levels. The main function of serotonin is constriction of smooth muscle tissue – the lungs and broncial tubes, the intestines, uterus, and the major organs of the body.

Serotonin was originally given to put pregnant women into labor so is it any wonder that Indy and so many other babies born to mothers on antidepressants are either miscarried or born early?

When serotonin levels go too high it results in Serotonin Syndrome which can be fatal producing death via multiple organ failure as the organs constrict and shut down as happened with baby Indy’s lungs.

Now the 9/11 connection: EVERY WEEK IN THIS COUNTRY WE LOSE AS MANY LIVES AS WE LOST IN THE 9/11 TRAGEDY TO ADVERSE REACTIONS FROM PRESCRIPTION DRUGS PRESCRIBED VIA FDA GUIDELINES – NOT ABUSED, BUT GIVEN AND TAKEN ACCORDING TO FDA GUIDELINES.

Why, are we at war in the Middle East over so few deaths (not that they did not matter or were any less important) as opposed to the thousands upon thousands of needless and senseless deaths that continue to happen every week in America due to these deadly prescription drugs that the world tends to ignore?!!! This is an ongoing, never ending 9/11 tragedy striking every week for years before 9/11 and for many years now since 9/11.

Who are the real terrorists? And why have we not declared war on them?

Now this week another family will go into court to fight the battle their little one cannot fight on his/her own. The birth defects have been known of for some time in medical science, but not shared with the parents of those who should be watching for them.

And just how many are there? We have NO idea. Most families are dealing with them with no idea even yet what the cause is. Last year I was speaking with a father about a business matter who explained he could not speak long because his 15 year old daughter was born with a hole in her heart and he had to run her to a doctor’s appointment.

I immediately asked which antidepressant his wife was taking during pregnancy with his daughter. Without hesitation he turned to his wife and asked, “Honey, which antidepressant were you on when you carried ________? Paxil. It was Paxil remember? That was when you had me start taking it.”

Of course I told him he needed to look up the FDA warnings on the drug and heart defects at birth due to the drug. I then gave him the numbers of several attorneys and explained that his daughter has every right to file for this terrible problem that has so affected her life for the past 15 years and will for the rest of her life that will be cut short as a result of the damage done by the drug.

So how many other 15 year olds are there out there dealing with these birth defects even though they have no knowledge of this being a side effect of their mother’s medication? And how many others like Indy did not survive their damages? We need to know. Hopefully this case finally making its way into court will stir up enough publicity to wake up enough people to give these children and their families answers.

Dr. Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.com
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare (Order #800-280-0730)

http://wp.me/phViU-qd

Today, September 13, 2009 is the one year anniversary of Indiana Delahunty’s death. We encourage you to please go to her parent’s, Christian & Matt Delahunty’s, blog to offer some moral support to the family at this time.

http://indibaby.wordpress.com/

http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11

Test Paxil case hits court next week
September 11, 2009 — 10:43am ET | By Tracy Staton
Related Stories

* AP: Glaxo reps aided Paxil ghostwriting
* Supremes ask for Obama view in vaccine case
* Glaxo under scrutiny in EU
* U.S. Paxil probe broadens
* Grassley asks FDA for Paxil review

GlaxoSmithKline and a bunch of plaintiffs’ lawyers will have their eyes on a Philadelphia court next week. That court is hosting a bellwether liability case over claims that the antidepressant Paxil causes birth defects. Glaxo faces some 600 lawsuits with similar claims. “These cases are sort of like the canary in the coal mine,” law professor David Logan told Bloomberg. “The early cases set the parameters for any global settlement negotiations.”

In this first case, plaintiff Michelle David claims that Paxil caused heart defects in her son Lyam Kilker and that Glaxo failed to warn about the drug’s potential to cause birth defects. As you know, FDA asked Glaxo in 2005 to update Paxil’s label with information on heart defects in infants. Glaxo says the FDA’s action doesn’t prove that Paxil causes birth defects; its own studies after the warning “have been inconclusive with mixed results,” the company says.

But David’s attorney says that Glaxo failed to follow up on early animal studies that suggested Paxil might cause birth defects, and that the company designed Paxil studies to use low doses of the drug to avoid triggering adverse events. “In 1998, GSK internally concluded that it had received an ‘alarming’ number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public,” the lawyers said in a court filing. We’ll be hearing much more from both sides next week.

- read the Bloomberg piece

Read more: http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11#ixzz0Qq0vDCIS

Dropping “cold turkey” off any medication, most especially mind altering medications, can often be MORE DANGEROUS than staying on the drugs.

The most dangerous and most common mistake someone coming off the SSRI antidepressants makes is coming off these drugs too rapidly. Tapering off very, very, VERY SLOWLY–OVER MONTHS (and for long-term users—a year or more), NOT JUST WEEKS!—has proven the safest and most effective method of withdrawal from this type of medication. 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 in half or taking a pill every other day. 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.  Learn More   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 does not hit 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
• 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

Although the book 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 tape on withdrawal. The tape contains newer and updated information on safe withdrawal from these drugs. The tape details over an hour and a half the safest ways found over the last ten years to withdraw from antidepressants. It also lists many alternative treatments that can assist you in getting though the withdrawal. And it contains information on how to rebuild your health after you have had it destroyed by the drugs so that you never end up on these drugs again. The tape is very inexpensive and will save you thousands in medical bills which you will spend trying to do it on your own. Many have lamented that they wished they would have had the information on this tape before attempting withdrawal.To order Dr. Tracy’s book or audio, “Help, I Can’t Get Off My Antidepressant,” click here.

This is a tape doctors can also benefit from when attempting to withdraw their patients from these drugs that the World Health Organization has now told us are addictive and produce withdrawal.

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 if you are 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 reaction. 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.”

click here. order a CD download.

Reuters

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming. U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

1/13/2003

LA judge denies class action for Glaxo Paxil suit

Reuters

To learn more, go to http://www.baumhedlundlaw.com.

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming.

U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Glaxo, Europe’s biggest drug maker, argued that it would be difficult for the court to determine if each member of a large class experienced the alleged withdrawal symptoms, including nausea and dizziness.

In October, Pfaelzer rejected a request from the same attorneys that advertisements stating that Paxil is “non-habit forming” be permanently barred.

The company was supported in court by the U.S. Food and Drug Administration, which said it had previously reviewed in-depth Paxil’s side effects and concluded that the drug is not habit forming and, as a result, the ads did not mislead.

The Paxil users are suing the British-based drug maker in federal court in Los Angeles, claiming that it deliberately played down the severity of withdrawal symptoms associated with abruptly stopping the drug.

Paxil, Glaxo’s top-selling product, reached sales of $2.7 billion last year.

©2002 Reuters Limited.

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.
Donald Schell vs. SmithKline Beecham

7/23/2002

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

http://www.counterpunch.org/giombetti0723.html

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.

GSK was sued in federal district court in Cheyenne by family members of Donald Schell, the Gillette, Wyoming man who killed his wife, daughter, granddaughter and then himself on February 13, 1998 after two days on the pharmaceutical giant’s anti-anxiety/depression drug Paxil. The plaintiff’s position was that Paxil was the primary cause of Donald Schell’s actions in the murder-suicide. The jury agreed and the judge in the trial rejected GSK’s challenge of the validity of the scientific data presented to the jury by the plaintiff’s. As a public service I will be publishing the crucial expert testimony and cross examination of British psychiatrist and psychiatric historian David Healy soon.

GSK appealed the verdict in the case in Denver, but recently gave up, I have been told by Healy. The deal in the appeal settlement GSK made with the plaintiff’s calls for the company getting all of its documents back, and a set of confidentiality statements from the plaintiffs side to not release anymore details of the case not already in the public domain. This is an important development in the history of psychiatric medicine. The jury verdict forced GSK to cave in to the demands of the Medicines Control Agency, the British government agency that regulates prescription drugs, that it place a suicide warning on Paxil. GSK has had to place a suicide warning on Paxil in Britain for about a year now. Now the question remains will this same warning ever make it over to this side of the Atlantic, with as much publicity as the hormone replacement story has gotten? Not likely, I believe, but I hope I am wrong.

Even though there isn’t a widely publicized suicide warning being given for Paxil, or any other drug in its class, known as “Selective Serotonin Reuptake Inhibitors,” or “SSRI’s,” it’s not like there is a complete information black out about these newer generation psychiatric drugs in consumer prescription drug guides.

For example, in the recently published 10th edition of The Pill Book, it warns patients taking SSRI’s (i.e. Celexa, Luvox, Paxil, Prozac and Zoloft) that “The possibility of suicide exists in severely depressed patients and may be present until the condition is significantly improved. Severely depressed people should be allowed to carry only small quantities of SSRI’s to limit the risk of overdose.” The term “overdose” can just as easily be read as “killing themselves.” Also, “As many as 1/3 of people taking an SSRI experience anxiety, sleeplessness and nervousness.” In other words all the symptoms that can push a depressed person over the edge and into a suicide attempt. Finally, the recently published 5th edition of The Physicians’ Desk Reference Pocket Guide to Prescription Drugs warns patients considering taking the SSRI known as Zoloft “May also cause mental or emotional symptoms such as: Abnormal dreams or thoughts, aggressiveness, exaggerated feeling well-being, depersonalization (“unreal” feeling), hallucinations, impaired concentration, memory loss, paranoia, rapid mood shifts, SUICIDAL THOUGHTS, tooth-grinding, WORSENED DEPRESSION (emphasis is the authors).”

Now why on Earth are pharmaceutical companies allowed to get away with marketing these drugs as “anti-depressants,” or “anti-anxiety” agents when they can produce in patients exactly what they are supposed to treat at such high rates? This is the deeper question about the mass marketing of these drugs the mass media is simply avoiding by a combination of cowardice, laziness and just outright ignorance in reporting on these issues.

Rick Giombetti is a freelance writer who. lives in Seattle. Visit his website at: http://rjgiombetti.blogspot.com/. He can be reached at: rickjgio@speakeasy.net