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Tuesday, October 21, 2008

The FDAs "Back-Door Dealings" w/ BigPharma & YOUR Kids!

FDA makes back-room deal on cold medicine?

With the election so close, I'd hate for a good piece of political theater to go unnoticed. Recently, the Consumer Healthcare Products Association – a shill for the drug companies – announced that it was voluntarily adding language to cough medicine labels advising they not be used for children under 4.

It was heart-warming to see Big Pharma stepping in to protect our youngsters. But knowing, of course, that they'd never voluntarily do such a thing, I immediately smelled a rat.

Little did I know, the rat was our own government.

A report has just surfaced claiming that the voluntary warning on cold medicines only happened after the drug companies had a closed-door meeting with the FDA to arrive at some compromise on the issue. Which, of course, makes me ask:

ARE YOU KIDDING ME?!?

The agency that is supposed to police the drug companies is actually giving them an equal seat at the table. Instead of just instituting a policy on these medicines that the FDA finds safe and reasonable, it first has to bring in the drug companies and get their say on the matter.

And here's the worst part – some FDA researchers and advisors are claiming that the science suggested that these medicines were of no benefit for kids under 12. The under-4 age limit was a compromise with the drug companies, who make $280 million a year selling cold medicines taken by kids.

It's not the FDA's job to compromise with big business. The FDA is supposed to be protecting us from the excesses of Big Pharma – not treating them as a partner. This agency is officially so out of hand and off-mission, it's hard to have confidence in anything they do any more.

I'm glad to see some people who witnessed this insanity coming forward and reinforcing what I truly believe – the under-4 limit on these medicines is wholly inadequate. If you have a child or grandchild with a cold, the oldest remedy is still the best – lots of fluids and plenty of rest.



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2 comments:

Jeff said...

As a dad and a doctor, I find children’s cough and cold medications a very scary topic. I used believe the drug companies, and think that as long as my patient’s or I dosed the children’s cold & cough medications right, then everything would be OK. But when I researched this further, it turns out that children have died from “over dose” of ALL THE MAJOR CHILDRENS COLD AND COUGH MEDICINES even when given the correct dose. (http://pediatrics.aappublications.org/cgi/reprint/108/3/e52?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cough+medications&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT).

Here are a few interesting facts:

1. Last October 2007, the drug companies promised the FDA that they would change all their labeling to say “do not use” for children under the age of 2, but I was just in the store last week, and most of packages still had the old labeling! They do not warn of the dangers in children under 2. So why should we believe that the drug companes will maintain their “voluntary” new labeling for children under 4? They make these voluntary changes to avoid federal regulation, and then promptly change their labeling once the hype has died down.

2. The FDA reviewed safety and effectiveness data this last fall and its expert panel said that “right now the current cold & cough medications should not be given to children under 6.” Here is a link to the FDA’s minutes, “http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf”, see page 6. The FDA made a public advisory in January 2008 about never using it for children under 2, because the Drug companies are fighting them on the panels ruling to never use cold and cough medications on children 2 to 6. Since these drugs were previously allowed by the FDA, the FDA is forced to go though “due process” before they are willing to make an official public statement about never giving these medications to children 2 to 6.

3. The number of infant deaths attributed to cold and cough medicines is dramatically underreported. New research published in the Journal of the American Academy of Pediatrics demonstrated that there were at least “10 unexpected infant deaths that were associated with cold-medication” in 2006 alone in the state of Arizona. Extrapolated over the US and Canadian population, that would be over 500 deaths a year associated with cold-medication! (http://pediatrics.aappublications.org/cgi/content/abstract/122/2/e318)

4. The thing that the drug companies don’t want anyone to know is that these medications never underwent the rigorous safety and effectiveness studies modern medications have to go though, they we grandfathered in the early 1970’s because at that time experts felt like they seemed to work, and they seemed safe enough.

5. The FDA recently said that they do not want to pull the medications for children under 6 because they are afraid that parents will give children adult doses because “parents would have no other alternatives.” The truth is that the American Academy of Pediatrics has said that buckwheat honey is a safe alternative. Some researchers from Penn State have shown that Buckwheat honey is better then the OTC drugs for children’s cough. There is a web site that talks about this, and gives lots of research to help parents be better informed about how to help their kids. Check out http://www.honeydontcough.com/

-Daddydoctor

CJ said...

-Daddydoctor, thanks for sharing that very important post. Yes many are wizeing up to the chenangins of the FDA and their "love-affair" with Big-Pharma. Read down all the way and you will see where children are involved as victims of the Big-Pharm / FDA Anti-depressant Farce. Check this out;

Anti-Depressands an FDA Farce

SSRI Antidepressants Pushers
November 16, 2008. By Evelyn Pringle

After twenty long years, it appears that the epidemic in mental
disorders in America might be coming to an end. It won't happen
because of any great medical breakthrough but rather because the
perpetrators of the greatest healthcare fraud in history are finally
being exposed. The demolition of the giant "psycho-pharmaceutical
complex" appears to be on the horizon.

For far too long, the focus has been on the drugmakers only. In
recent months, the spotlight has shown where it belongs - on the
highly-paid opportunists responsible for fueling the epidemic in
prescribing of psychiatric drugs by doctors in every field of
medicine and the research institutions that enabled the process.

The antidepressants known as selective serotonin reuptake inhibitors,
or SSRI's, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at
the center of the storm. These drugs have been prescribed to more
Americans than any other class of medications over the past two
decades. Cymbalta, Effexor and Wellbutrin are often referred to as
SSRI's, but they are slightly different chemically. However, the
drugs all carry similar side effects and warnings.

The top sales pitch for SSRI's has been the "chemical-imbalance-in-
the-brain" myth. "There is no evidence whatsoever that depression is
caused by a biochemical imbalance," says Dr Peter Breggin, one of the
world's leading experts on psychiatric drugs and author of the new
book, "Medication Madness."

People take for granted pronouncements such as, "You have a
biochemical imbalance," and "mental disorders are like diabetes," he
explains in the book.

"In reality," Dr Breggin writes, "these are not scientific
observations - they are promotional slogans, so adamantly repeated in
the media and by individual psychiatrists that people assume them to
be true."

"The psycho-pharmaceutical complex fosters these falsehoods in order
to promote the widespread use of their products," he says. "Reluctant
patients by the millions are pushed into taking drugs by doctors who
tell them with no uncertainty that they need medication."

"If you have got a biochemical imbalance in your brain," Dr Breggin
advises in the book, "the odds are overwhelming that your doctor put
it there with a psychiatric drug."

All Eyes on Glaxo

At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly
SmithKline Beecham), due to reports that the company is under
investigation by the US Department of Justice, as well as the Senate
Finance Committee, with Iowa's Senator Charles Grassley, the ranking
Republican on the Committee, leading the charge.

The report that led to the investigation by Senator Grassley was
generated in litigation and was only recently made public after it
was unsealed by the court. It was submitted by Dr Joseph Glenmullen,
a Clinical Instructor in Psychiatry at Harvard Medical School and
author of "The Antidepressant Solution" and "Prozac Backlash:
Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other
Antidepressants with Safe, Effective Alternatives." He was retained
as an expert by the Los Angeles-based law firm of Baum, Hedlund,
Aristei & Goldman. The litigation involves several Paxil-induced
suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA
approved, that people taking the drug were 8 times more likely to
engage in suicidal behavior than people given a placebo, or sugar
pill. Now, it stands to reason that even the most depressed person
would decline to take Paxil if given these facts. Also, parents
certainly would decline if they were told about the risks.

Dr Glenmullen explains that, by submitting what he refers to as "bad"
Paxil numbers to the FDA, Glaxo was able to avoid adding a warning
about suicide to the label when the drug was
approved. "GlaxoSmithKline's 'bad' Paxil numbers carried the day: The
FDA approved Paxil on December 29, 1992, with no warning to doctors
or patients of the significant increased risk of suicidal behavior,"
he writes.

Instead, Glaxo listed suicide and suicide attempts that took place
during the "run-in" period of the studies as if they happened in the
placebo group. The run-in period, also called the "wash-out" phase,
occurs when all patients are taken off their existing drugs to let
the old drugs wash out of their systems, and all patients are given
placebos. The rationale for washing out old drugs is to prevent them
from confusing the results of the study, so that patients start out
in a similar condition, according to the report.

The official trial only begins after the wash-out phase, once the
patients are assigned to receive either the antidepressant or a
placebo. The patients who continue to receive the placebo are
referred to as the "placebo group."

"Confusing the pre-study placebo wash-out phase with the placebo
group in the actual study is improper," Dr Glenmullen
writes, "especially when the concern is a potentially lethal side
effect."

The "correct data shows that suicide attempts in patients on Paxil
occurred at a rate eight times higher than the rate in patients on
placebo," he notes.

Senator Grassley has also asked the FDA to go back and review the
clinical trial data submitted on Paxil. In a statement on the Senate
floor on June 11, 2008, he said: "Essentially, it looks like
GlaxoSmithKline bamboozled the FDA."

"We cannot live in a nation where drug companies are less than
candid, hide information and attempt to mislead the FDA and the
public," he stated. "These companies are selling drugs that we put in
our bodies, not sneakers."

"When they manipulate or withhold data to hide or minimize findings
about safety and/or efficacy they put patient safety at risk,"
Senator Grassley said. "And with drugs like Paxil, the risks are too
great."

A good start

As the Glaxo scandal unravels, the public will learn that other
antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest
Laboratories are equally guilty. Likewise, there are many more
supposedly independent academic doctors who have been receiving
substantial financial benefits from drug companies than are currently
identified in the media as being under investigation.

Exposing Harvard University's Joseph Biederman, Thomas Spencer,
Timothy Wilens, Stanford's Alan Schatzberg, Brown University's Martin
Keller, Melissa DelBello at the University of Cincinnati, and Drs
Karen Wagner and John Rush, who operated out of the University of
Texas, might be a good place to start, but the trail of Big Pharma's
funding "academic research" for marketing purposes certainly does not
end with a handful of psychiatrists.

According to Senator Grassley's June 4, 2008 statement in the
Congressional record, although conflict-of-interest disclosure forms
make it appear that the Harvard psychiatrists only received a couple
hundred thousand from drug companies over the past 7 years, the true
figures show Dr Biederman received over "$1.6 million," Dr
Spencer "over $1 million" and Dr Wilens "over $1.6 million" in
payments from the drug companies.

"Based on reports from just a handful of drug companies," he
states, "we know that even these millions do not account for all of
the money."

Senator Grassley also notes that Dr Schatzberg owns stock worth more
than $6 million in one drug company. Ed Silverman reports on
Pharmalot that there are "30 or so physicians at two dozen
universities which the Senate Finance Committee is probing concerning
disclosure of grants from drugmakers." The names of those 30 doctors,
along with the research mills they operate out of, need to be made
public.

The new book, "Side Effects: A Prosecutor, a Whistleblower, and a
Best-selling Antidepressant on Trial," by investigative journalist
Alison Bass, provides the inside scoop on the fraudulent SSRI
research conducted at Brown University by Dr Keller.

The book also supplies background information on the financial ties
between the so-called "opinion leaders" in psychiatry and the other
antidepressant makers. For instance, Ms Bass explains that Drs
Schatzberg and Keller worked as a team a decade ago to promote
Bristol-Myers Squibb's antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored
symposium that touted the benefits of Serzone, and Dr Keller was one
of the paid speakers at the event. The same year, Dr Keller received
$77,400 in consulting fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of
Medicine also touting the benefits of Serzone. The drug was removed
from the market in 2004 after it was found to cause liver damage but
not before a number of patients died.

Ms Bass reports that Keller did not report any income from Glaxo on
his 1998 tax return. But during her research for "Side Effects," she
discovered he had earned personal income from Glaxo in 1998, as well
as subsequent years. Keller admitted as much during a September 2006
deposition for a lawsuit filed against Glaxo, she says.

It is no longer a case where Americans need only be concerned about
the amount of money the academics are pulling in. The pharmaceutical
industry also has a stronghold on most major research institutions in
this country. Many could not exist if the drug companies withdrew all
their research funding, a state of affairs that did not occur by
accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the
Scientific Misconduct Blog, when all is said and done:

"The chief villains remain our academic institutions and medical
leadership. They have colluded with and have acted as apologists for
commercial scientific fraud. They have tolerated the telling of lies
by senior academics. They have encouraged the prostitution of
medicine. They have allowed abuse of the most fundamental safeguards
of science. Most importantly, they have set terrible examples for our
students."

Universities keep corrupt academics on board for good reason. "Side
Effects" reports that, between 1990 and 1998, "Martin Keller brought
in nearly $8.7 million in research funding from pharmaceutical
companies."

The clinical trial industry itself provides a perfect slush fund.
Spending in the U.S. was an estimated $25 billion in 2006 and is
expected to reach about $32 billion by 2011. Most of the money for
trials comes from private industry, and federal funding assumes a
second place position, with the National Institute of Health
budgeting $3 billion for clinical trials in 2006, according to the
paper, "State Medical Board Responses To An Inquiry On Physician
Researcher Misconduct," by Dr Stefan Kruszewski, Dr Richard Paczynski
and Marzana Bialy, in the Journal of Medical Licensure and Discipline
2008: Vol 94 No 1.

Paxil Study 329

"Side Effects" also covers the whole sordid affair on Paxil Study
329, the most infamous fraudulent pediatric trial of all time. The
study "offers a landmark for the point at which science turned into
marketing," according to Dr David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales
School of Psychological Medicine at the University of Wales, and an
outspoken critic of the psycho-pharmaceutical complex, with 21 books
to his name, including "The Creation of Psychopharmacology."

He explains that, in 1998, Glaxo's original assessment of Study 329
had concluded that it and another study had shown Paxil did not work
for children, but that it would not be "commercially acceptable" to
publicize this finding. "Instead the positive findings from the study
would be published; they were in an article whose authorship line
contains some of the best known names in psychopharmacology (Keller
et al., 2001)," Dr Healy writes in the 2007 paper, "The Engineers of
Human Souls & Academia."

Dr Keller gets most of the "credit" for the study, which was
completed in the mid-90's. Keller et al had some difficulty getting
it published at first, but finally found a journal willing to take
the bate in 2001, the Journal of the American Academy of Child and
Adolescent Psychiatry. In all, 20 academics allowed their names to be
attached to this ghostwritten infomercial, and not one has stepped
forward to acknowledge wrongdoing or to admit that a mistake was
made.

Long before the paper was published, the authors of study 329 were
fanned out all the way to Canada giving lectures and presentations to
prescribing doctors at medical conferences and seminars to promote
the off-label use of Paxil for kids. More than any other paper, Study
329 led to an epidemic in pediatric prescribing. "After its
publication, the use of antidepressants for children skyrocketed," Dr
Glenmullen notes.

These handsomely paid "key opinion leaders" all deserve to have their
names in lights, especially Drs Graham Emslie and Karen Wagner from
the University of Texas.

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the
only payment she reported to the university was $600 in 2005,
according to Senator Grassley. Dr Wagner also failed to disclose
earnings of more than $11,000 from Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a "state
mental health plan naming the preferred psychiatric drugs for
children has been quietly put on hold over fears drug companies may
have given researchers consulting contracts, speakers fees or other
perks to help get their products on the list."

"The Children's Medication Algorithm Project, or CMAP, was supposed
to determine which psychiatric drugs were most effective for children
and in what order they should be tried at state-funded mental health
centers," the Morning News explains.

The academics who developed the CMAP include Drs Wagner and Emslie.
Records show Dr Emslie may have made up to "$125,000 from drug
companies since 2004," according to the report in the Morning News.

While Dr Keller took the lead on pushing Paxil for children and
adolescents, Dr Emslie was the main man on the Prozac trials, and Dr
Wagner was the queen bee on Zoloft studies. The co-authors of papers
that appear in the medical literature encouraging the use of SSRI's
for kids include Drs Biederman, Schatzberg, Wilens and, of course,
Charles Nemeroff.

Dr Nemeroff was recently forced to resign as chairman of Emory's
psychiatry department after Senator Grassley's investigation revealed
that he failed to disclose to his university more than a million
dollars in drug industry income. All total, Nemeroff had earnings of
$2.8 million from drug companies between 2000 and 2007, but failed to
report at least $1.2 million.

A complete list of academics who should to be investigated can be
found among the authors of the SSRI papers and studies highlighted in
the 2006 Third Edition of, "Essentials of Clinical
Psychopharmacology," described as "a synopsis and update of the most
clinically relevant material from 'The American Psychiatric
Publishing Textbook of Psychopharmacology,'" by none other than Drs
Schatzberg and Nemeroff.

Keep Following the Money

On July 10, 2008, Senator Grassley extended his investigation to
include psychiatry's top industry-funded front group with a letter to
Dr James Scully, Medical Director and Chief Executive Officer of the
American Psychiatric Association, asking for "an accounting of
industry funding that pharmaceutical companies and/or the foundations
established by these companies have provided to the American
Psychiatric Association."

The Senator wants records from January 2003 to the present. According
to the July 12, 2008, New York Times, in 2006, the "industry
accounted for about 30 percent of the association's $62.5 million in
financing."

A factor rarely discussed in this debate is the amount of money
doctors who prescribe SSRI's make during brief office calls charged
at regular rates. This practice has taken a tremendous toll on public
healthcare programs and has resulted in higher insurance premiums and
overall healthcare costs for all Americans.

In fact, the bilking of public healthcare programs is what led to the
current investigations by the Finance Committee, which has the
responsibility of overseeing spending in Federal programs. When
doctors prescribe drugs for unnecessary uses, public programs not
only have to pay for the drugs, they must also pay the fees of the
prescribing doctors and for the medical care for injuries caused by
the drugs. Government spending tied to the prescribing of psychiatric
drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and
Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at
the Department of Health and Human Services' Office of Inspector
General, discussed kickbacks to doctors and told the panel:

"Kickbacks potentially increase the costs to Federal programs because
they encourage overutilization and may encourage the prescribing of
more expensive drugs when clinically appropriate and cheaper options
(such as generic drugs) may be equally effective."

Mr Morris explained that, "kickbacks offered to prescribing
physicians by pharmaceutical manufacturers take a variety of forms,
ranging from free samples for which the physician bills the programs
to all-expense-paid trips and sham consulting agreements."

Vermont is a rare state in requiring the pharmaceutical industry to
disclose the money paid to doctors. On July 8, 2008, Vermont's
Attorney General William Sorrell released the state's annual report
on "Pharmaceutical Marketing Disclosures," which lists the payments
made by drug companies in 2007. Of the top 100 recipients, once
again, psychiatrists received the highest payments. Eleven
psychiatrists received a total of $626,379, or about 20% of the total
value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it's
impossible to embarrass them. Last year, the press ran major stories
when this report came out, highly critical of how much money they
were making. This year, the average amount rose by 25%.

The report also analyzes the payments based upon the drugs being
marketed. Of the top 10 drugs for which disclosures were reported,
five are used to treat mental illness and include Lilly's Cymbalta
and Forest Lab's Lexapro. Ironically, Cymbalta sales are also up 25%,
according to Lilly's latest SEC filing.

Overall, estimates indicate that the drug industry spends $19 billion
annually on marketing to physicians in the form of gifts, travel,
meals and other consulting fees, according to a May 22, 2008, press
release by Senator Grassley's office. In the November 1, 2007, New
England Journal of Medicine paper, "Doctors and Drug Companies —
Scrutinizing Influential Relationships," Dr Eric Campell, associate
professor at the Institute of Health Policy at Massachusetts General
Hospital and Harvard Medical School, writes:

"Individual physicians can take some steps to maximize the benefits
for patients and minimize the risks associated with their own
industry relationships. They can start by recognizing that such
relationships are designed to influence prescribing behavior and by
carefully considering the potential effects that their own
associations may have on their patients."

"And they can bear in mind," he says, "that the costs of industry
dinners, trips, and other incentives are passed along to their
patients in the form of higher drug prices."

Antidepressant prescribing is more rampant in this country than any
other. The US accounted for 66% of the global market in 2005,
compared to 23% in Europe and 11% for the rest of world, according to
a December 2006 report by Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and
hospital visits in 2005 showed that the most commonly prescribed
drugs were antidepressants, with 48% of the prescriptions issued by
primary care physicians. They have remained in the number one
position ever since. Last year, 232 million prescriptions were filled
for antidepressants worth nearly $12 billion, according to a March
2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing
all the way to the bank. For example, in 2007, Pfizer CEO Jeff
Kindler's pay package was worth $9.5 million, according to the March
14, 2008, Wall Street Journal. A previous CEO, David Shedlarz, left
last year with an "exit package" worth over $34 million. In 2007, the
total value of Wyeth's then-CEO Robert Essner's pay package was $24.1
million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a
result of the mental illness epidemic occurring only in the US.
Attorneys General all over the country are using consumer fraud
statutes to sue the drug giants to recoup the money lost due to the
illegal off-label promotion of psychiatric drugs and the concealment
of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney
General consumer fraud class-action lawsuits against Glaxo since
2004, on behalf of individuals and entities such as insurance
companies in California, Florida, Illinois, Massachusetts, Minnesota,
Missouri, New Jersey, North Dakota, Ohio and Washington.

The cases are based on documents showing Glaxo promoted Paxil for
kids, fully aware that Paxil failed to out-perform a placebo in the
clinical trials and had higher suicidality rates. A national class
settlement of individual claims was reached in April 2007 in which
Glaxo agreed to reimburse parents for all of the money paid for Paxil
prescriptions for their children. A national class settlement on
behalf of third party payors (insurance companies) was just approved
in September 2008.

If not for the few law firms willing to stay the course, the truth
would never have been revealed. Baum Hedlund has been pursuing the
SSRI makers for nearly two decades. Most recently, it has taken up
the fight for babies born with birth defects caused by SSRI's.

Because the industry was so successful at keeping the original SSRI
trial data hidden, the drugs' most serious side effects largely
became public only as a result of the bravery and integrity of such
medical experts as Dr Healy, Dr Glenmullen and Dr Breggin, who could
not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning
about an increased risk of suicidality, knowing all the long that the
risk existed. Now, the companies are making the irresponsible
argument (in defense of lawsuits claiming they failed to warn doctors
and the public of the risk) that the FDA did not require them to add
a warning, so they are immune from liability.

Worse yet, the industry-controlled FDA under the Bush Administration
is supporting this audacious preemption defense and siding with the
SSRI makers against private citizens in courts all over the country,
telling judges to rule in favor of the drug companies and throw out
the SSRI cases before they even make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a
case involving federal preemption, in Wyeth v Levine, on November 3,
2008.

By Evelyn Pringle

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum,
Hedlund, Aristei & Goldman's Pharmaceutical Litigation Department

www.baumhedlundlaw.com)

AND THEN THIS:

Paxil Birth Defects: Two Women, One Cause
November 15, 2008. By Lucy Campbell

Brampton, Ont: Two women, both taking the selective serotonin
reuptake inhibitor (SSRI) Paxil while pregnant, have launched
independent lawsuits against GlaxoSmithKline (GSK) , alleging the
pharmaceutical company failed to adequately warn them of the risks of
taking the drug while pregnant.

The most recent case is that of Shannon Cote, a 29-year mother, whose
son was born 10 years ago with heart defects that her lawyers argue
are directly related to her use of Paxil while pregnant.

Shannon became pregnant in 1997, at a time when she was suffering
from depression and low self esteem. So her health care professional
prescribed the SSRI for her and assured her that unlike other
antidepressants it was fine to take during pregnancy. However, as it
later became known, Paxil was and is not safe to take during
pregnancy. And the Food and Drug Administration (FDA) noted that in
the new labeling for the drug in December 2005, several years too
late for Shannon and her son.

Another case is that of a young woman who gave birth to a baby girl
in September 2005, just 4 months before the FDA warning was issued.
Faith's daughter, Meah, was born with a hole in her heart. Like
Shannon, Faith was told that she would be fine taking Paxil while
pregnant. In fact it was approved for the treatment of anxiety even
in pregnant women.

Faith had no reason to doubt this information, she had been taking
the antidepressant since 2002. In fact, she didn't doubt the
information until she read an article in the local paper about
another woman in a similar situation who was suing GSK alleging the
drug maker was aware of Paxil side effects that could result in birth
defects. That's when Faith had her "Ah Ha" moment: she realized that
Meah's heart defect was likely not 'the luck of the draw' but rather
a Paxil birth defect.

Paxil Birth Defects – What About the Moms?

Both Shannon and Faith suffer as a result of the Paxil birth defects
their children have. Shannon suffers from severe psychological
problems that have affected her everyday life, and that's in addition
to the medical and financial realities of caring for a child with a
defective heart.

And Faith, after enduring 7 months of hospital visits to her baby,
continues to worry about her daughter's health. "My daughter has a
huge, awful scar down her chest that will grow with her," she said.
And, Meah is smaller than other children her age. "She's little, and
if there's a cold or anything going around she gets it and she
suffers far more."

Did GSK Know?

The fundamental fact that both women no doubt wrestle with is that
these birth defects were preventable. And that is why they are suing
GSK. The FDA warning issued in December 2005 mentioned an increased
risk for serious heart defects associated with the use of Paxil in
pregnant women.

The warning was based on data from 2 studies which showed a 1.5 to 2
times increased risk of giving birth to a child with a heart defect
compared with pregnant women not taking the anti-depressant. In
addition to the warning, the FDA actually placed Paxil in its second
highest category for risk of birth defects, advising patients
that "this drug should usually not be taken during pregnancy."
In a later warning, the FDA said that Paxil "should generally not be
initiated in women who are in their first trimester of pregnancy or
in women who plan to become pregnant in the near future."

It is highly likely that GSK had some indication that there could be
problems with Paxil during pregnancy prior to the FDA warnings, and
that is what the attorney's for Shannon and Faith hope to establish.

If you have had a baby born with abnormalities which could be related to the use of Paxil or another SSRI, consider contacting a lawyer.