ANTIDEPRESSANTS: Ineffective & Can Increase Cardiovascular Death W/Beta Blockers

Paragraphs 15 through 18 read:  “Dr. Bertram Pitt, a
cardiologist at the University of Michigan School of Medicine, co-wrote an
accompanying editorial in the journal and notes that the relationship between
cardiovascular disease and depression poses intriguing research
questions.”

” ‘The current therapy of depression doesn’t seem to be
doing that much for depression, and certainly hasn’t broken the link between
depression and cardiovascular disease,’
he said in an interview
from Ann Arbor.”

“In fact, he said there’s some evidence that
certain antidepressants increase cardiovascular

death when they’re taken with betablockers.”

” ‘So we have sort
of a real challenge that the current treatment of depression doesn’t seem to be
that effective’.”

http://www.google.com/hostednews/canadianpress/article/ALeqM5gUXXTGCUSLny-RfZ24BUGVERK5zQ

Happy people have lower likelihood of heart attack, Nova Scotia study
indicates

By Anne-Marie Tobin (CP) – 17 hours ago

TORONTO ­ We
hear the advice “Don’t worry, be happy,” and “Smile, smile, smile” in upbeat
song lyrics. And when it comes to the health benefits of a sunny disposition,
they might be on to something.

A 10-year study that tracked more than
1,700 adults in Nova Scotia suggests people who are usually happy, enthusiastic
and content are less likely to develop heart disease.

The study,
published Thursday in the European Heart Journal, is believed to be the first to
show an independent relationship between clinically assessed emotions and
coronary heart disease.

“Being happy means you have less likelihood of
having a heart attack 10 years later,” said psychologist Karina Davidson,
director of the Center for Behavioral Cardiovascular Health at Columbia
University Medical Center in New York.

“What we don’t know yet is if
you’re not a happy person and you were to get an intervention to help you

increase your happiness, would that offset your risk?”

The team looked at
the association between positive affect – defined as the experience of
pleasurable emotions such as joy, happiness, excitement, enthusiasm and
contentment – and cardiovascular events in 1,739 adults in the 1995 Nova Scotia
Health Survey. Trained nurses interviewed the 862 men and 877 women.

“We
taped as they talked about their daily lives, what stresses them, how they
handle those stressors, and we then coded whether they had a lot of positive
affect,” said Davidson, who hails from Vancouver and began the research in 1995
while she was at Dalhousie University in Halifax.

“We had to wait quite a
few years as these people had heart attacks, and then we looked to see whether
being happy predicted fewer heart attacks, and indeed it did.”

The
researchers found that over the decade, participants with no positive affect
were at 22 per cent higher risk of heart attack or angina than those with a
little positive affect, who were themselves at 22 per cent higher risk than
those with moderate positive affect.

But Davidson notes that this is an
observational study, and rigorous clinical trials are needed to support the
findings.

A study would need to follow people with low levels of
happiness, and randomize them so that some receive usual care while others would
receive intervention from a trained professional to help identify ways to
increase joy and excitement in their daily lives.

“The key to adding
pleasurable or enjoyable activities to one’s life is that they also be heart
healthy,” Davidson noted.

“So if you can learn to enjoy going for a walk
after dinner, or going to the gym to do a regular routine, or you always enjoyed
hiking in your younger years and so you go on some hikes on a regular basis,
that will surely improve your heart health.”

One problem, she observed,
is that some people enjoy smoking, eating ice cream or other activities that
aren’t considered heart healthy – so they’d need to be steered away from
those.

Dr. Bertram Pitt, a cardiologist at the University of Michigan
School of Medicine, co-wrote an accompanying editorial in the journal and notes
that the relationship between cardiovascular disease and depression poses
intriguing research questions.

“The current therapy of depression doesn’t
seem to be doing that much for depression, and certainly hasn’t broken the link
between depression and cardiovascular disease,” he said in an interview from Ann
Arbor.

In fact, he said there’s some evidence that certain

antidepressants increase cardiovascular death when they’re taken with
betablockers.

“So we have sort of a real challenge that the current
treatment of depression doesn’t seem to be that effective.”

The study by
Davidson is important because it points out there may be some new approaches, he
said.

“I think if you can be happy and do things that make you happy, you
certainly can‘t lose, and you may have a great advantage in reducing your

cardiovascular risk in the future.”

Copyright © 2010 The Canadian Press.
All rights reserved

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Glaxo Said to Have Paid $1 Billion So Far to Settle Various Paxil Lawsuits

NOTE FROM Ann Blake-Tracy:

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.

Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
Author: Prozac: Panacea or Pandora? – Our Serotonin
Nightmare & Help! I Can’t Get Off My Antidepresant!

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

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

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