Drip Drip Drip - Paxil Info Leaks Out

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Tue, 25 Apr 2006 22:38:52 -0400

[sSRI-Research] Pringle - Drip Drip Drip - Paxil Info Leaks Out

 

 

 

 

http://www.lawyersandsettlements.com/articles/paxil.html

 

 

 

Drip Drip Drip - Paxil Info Leaks Out

April 25, 2006. By Evelyn Pringle*

 

Secrecy agreements in litigation hide information about defective

products or a company's negligence, and sometimes go so far as to

prohibit the parties from discussing that there ever was a lawsuit.

Such is the case with Paxil and as a result, unwitting patients

continued to take the drug long after its dangers were known to

GlaxoSmithKline.

 

Many lawsuits filed against Glaxo have been settled out of court, with

confidential agreements that prevent the public from knowing about the

harmful effects of the Paxil.

 

Previously sealed documents and internal company memos suppressed with

protective orders, prove that Glaxo knew about the problems with Paxil

before it received FDA approval, but continued to sell the drug for

over a decade without warning consumers.

 

Long overdue legislation is currently pending in both the US House of

Representatives and the Senate known as Sunshine in Litigation Act of

2005, which basically says that a court shall not enter an order

restricting the disclosure of information obtained through discovery,

an order approving a settlement agreement that would restrict the

disclosure of such information, or an order restricting access to

court records in a civil case

 

Glaxo currently faces thousands of lawsuits over Paxil side effects

related to addiction, dependence, and a severe withdrawal syndrome.

 

SSRIs (selective serotonin reuptake inhibitors) like Paxil, are not

addictive in the sense that " an individual would mortgage their

livelihoods and all they hold dear for further supplies of the drug, "

according to Dr David Healy MD, FRCPsych, North Wales Department of

Psychological Medicine

 

SSRIs can hook patients in the sense of making you " physically

dependent, " he explains.

 

Dr Healy, is considered an expert on Paxil and has had access to

confidential studies from the Glaxo archives. The common symptoms of

withdrawal, he says, break down into two groups. The first group may

be unlike anything you have had before, he warns, to include:

 

Dizziness

Headache

Muscle Spasms

Tremor

Electric Shock-like Sensations

Other Strange Tingling or Painful Sensations

Nausea, Diarrhoea, Flatulence

Dreams, including Vivid Dreams

Agitation

 

The second group overlaps with general nervousness, Dr Healy says, and

may lead to you or your physician to think that all you have are

features of your original problem. These symptoms include:

 

Depression

Lability of Mood

Irritability

Agitation

Confusion

Fatigue/Malaise

Flu-like Feelings

Insomnia or Drowsiness

Mood Swings

Sweating

Feelings of Unreality

Feelings of being Hot or Cold

 

These symptoms appear in anywhere between 20% to 50% of patients

taking SSRIs, Dr Healy says, sometimes within hours of the last dose.

 

In the class action case against Glaxo settled in 2005, In re: Paxil

Products Liability Litigation, MDL No 1574, CD Calif, the plaintiffs

were forever silenced by a strict confidentiality clause incorporated

into the settlement agreement.

 

This author obtained a copy of the lawsuit's complaint, dated August

23, 2001, as well as a copy of the settlement agreement with a secrecy

clause that states in relevant part:

 

Plaintiffs and their attorneys, " will not make any statements, either

directly or indirectly, by implication or innuendo, to anyone,

including but not limited to consultants, experts, the press or media,

concerning the amount or other terms of such settlement or

settlements, or the nature and substance of settlement negotiations,

or describing or characterizing the settlement in any way. "

 

Plaintiffs and their attorneys " will not, either directly or

indirectly, publicize the fact of the settlement and that any inquiry

into the settlement, its amount, meaning, interpretation or

comparative value, or the negotiations leading to the settlement by

anyone, including but not limited to the press or media, will be met

only by a statement that the case has been resolved, and will decline

any requests for interviews by the press or media regarding the

settlement, its history or its terms. "

 

The clause even extends the internet specifically in that plaintiffs

and attorneys " will not maintain and instead will discontinue any

website references to Paxil discontinuation or withdrawal. "

 

And, it says, they " agree to refrain from any future internet postings

regarding Paxil discontinuation or withdrawal. "

 

Paragraph 5 of the lawsuit's complaint says that over a 2 years

period, " plaintiffs' attorneys have been individually contacted by

approximately 500 Paxil withdrawal victims. "

 

And, the pain and suffering experienced by each individual is the

direct result of Glaxo's " failure to warn users of Paxil's addictive

nature, the drug's inducement of physical or psychologic dependency,

and its infliction of dependency/withdrawal syndrome when the

patient's Paxil dosage is reduced or terminated, " the complaint states.

 

Paragraph 16, lists withdrawal reactions that " can summed up as one or

more of the following complaints: jolting electric " zaps, " dizziness,

light headedness, vertigo, incoordination, gait disturbances,

sweating, extreme nausea, vomiting, high fever, abdominal discomfort,

flu symptoms, anorexia, diarrhea, agitation, tremulousness,

irritability, aggression, sleep disturbance, nightmares, tremor,

confusion, memory and concentration difficulties, lethargy, malaise,

weakness, fatigue, paraesthesias, ataxia, and/or myalgia. "

 

Paragraph 7, says: " These reactions are " unexpected " to the victims

and even their physicians because the manufacturer has deliberately

failed to properly warn of this. "

 

" Both physician and patient unwittingly use Paxil without knowing the

drug's addictive traits, " the complaint says.

 

Paragraph 8, charges that because Glaxo has suppressed the

information, patients and physicians are fooled into thinking that the

reactions are caused by another condition, such as relapse into

depression, thus prompting incorrect and unnecessary medical

treatment, including increased dosages of Paxil.

 

While researchers have acknowledged the potential for withdrawal

reactions with all SSRIs, Paxil is by far the worst. Citing data from

the World Health Organization, the lawsuit's complaint states: " Paxil

has the highest incidence rate of withdrawal adverse experiences of

any antidepressant drug in the world. "

 

Starting in December 2001, Glaxo finally added a minimizing precaution

to Paxil's label of some possible " discontinuation " side effects

affecting " 2 percent or greater " of patients based on studies.

 

However, documents reveal that Glaxo has always known about the

withdrawal syndrome. For instance, in 1993, in a report that occurred

5 months after Paxil arrived on the market, Stoker and Eric noted

Paxil withdrawal at the American Psychiatric Association's annual

meeting in San Francisco, May 22-27, 1993.

 

The authors of the study conducted 2 week tapering off periods for 186

patients in 6 to 12 week doubled blinded comparative studies. Low dose

and high dose groups were studied. Paxil's low dose group actually did

worse than the high dose group, suffering 42% withdrawal rate,

compared to 38% in the high dose group. And, both occurred even though

the tapering off regime was initiated during dosage reduction.

 

The lawsuit's complaint specifically describes close to 10 studies

that reveal a high rate of withdrawal symptoms since Paxil came on the

market that Glaxo was fully aware of.

 

A fact well-evidenced in internal company documents. A previously

suppressed, May 1, 1997, Glaxo memo to, " Paxil Selling Team, " on the

" discontinuation syndrome, " defines the withdrawal syndrome as, " a

class effect that can occur when an SSRI is stopped abruptly. Symptoms

may include asthenia, flu-like symptoms, fatigue, dizziness, nausea,

and sleep disturbances (insomnia, vivid dreams or nightmares). "

 

However, the memo instructs Glaxo sales representatives to avoid using

the term and says: " instead of 'withdrawal syndrome,' which implies

addictive properties, try to refer to this phenomenon as

'discontinuation symptoms.' "

 

Eight months later, in a December 1, 1997, " Business Plan Guide, "

sales representatives were instructed to " minimize concerns

surrounding discontinuation symptoms, " and told to explain to doctors

that the " discontinuation incident rate is two in 1,000 patients. "

 

However, according to a 1997 review, one study found that 25% of

patients experienced at least one discontinuation symptoms, verses

5.9% taking a placebo. In another study of patients with major

depression, 42% experienced at least 1 discontinuation symptom.

 

Another internal memo kept hidden with a protective order, states:

" Discontinuation: why this is an issue, " followed by, " '97

Seroxat/Paxil sales to end Sept already exceed $1 Billion " .

 

This particular memo carries a cartoon-like picture of a big black

money-bag.

 

In Paxil literature, Glaxo flat-out lied to patients and specifically

said that the drug was not addictive. For example, a pamphlet made

available at doctors' offices and disseminated to patients, asked the

question: " Is Paxil addictive? "

 

The pamphlet then states: " Paxil has been studied both in short-and

long-term use and is not associated with dependence or addiction. "

 

The withdrawal syndrome is real and in fact, it is now known that

infants of women who take SSRIs in the last 3 months of pregnancy, may

experience symptoms of withdrawal, including convulsions, according to

a study published in the February 4, 2005 issue of the journal Lancet.

 

In addition, experts warn against the use of Paxil and other SSRIs

with children. According to Fred Baughman Jr*, MD, an adult and child

neurologist in private practice for 35 years, " most antidepressants

have not proved effective in treating depression in children and some

studies suggest they may cause some children to become acutely suicidal. "

 

Yet in 2002, Dr Baughman says, " nearly 11 million prescriptions for

the drugs were given to children, 2.7 million of them to children

under 12. "

 

A report by an expert witness, previously sealed with a protective

order, reveals how Glaxo concealed and manipulated data concerning

Paxil-induced suicidality and how suicide attempts in studies by

patients on Paxil were underreported and attempts by people taking a

placebo were inflated.

 

Excerpts from the report were published by psychiatrist, Peter

Breggin, MD, in Ethical Human Psychology and Psychiatry, (Volume 8,

Spring 2006, pp. 77-84). Dr Breggin is a founder of the International

Center for the Study of Psychiatry and Psychology (ICSPP) and the

author of the Antidepressant Fact Book (2001).

 

His report also documents how Glaxo hid the incidence of akathisia

(agitation with hyperactivity) and stimulation, which he says, are

known risk factors for suicidality and violence.

 

Dr Breggin's original report was based on a 3-day review of Glaxo's

sealed files, and was written for the California case of Lacuzong v

GSK, and attached to a July 21, 2001, affidavit submitted in a case

filed by the widow of a man who drowned their two children and himself

in a tub after taking Paxil for three days.

 

At Glaxo's insistence, the report remained sealed. However, in the

more recent case of Moffett v Glaxo, in the US District Court for the

South District of Mississippi, the report was filed in the public record.

 

" The drug companies, " says Dr Breggin, " settle almost all legal cases

brought against them in order to seal incriminating scientific data. "

 

" The publication of a previously sealed medical expert report is a

rare event, " he explains, " the first in my experience. "

 

In the book, The Antidepressant Solution, author Dr Joseph

Glenmullen*, a clinical instructor in psychiatry at Harvard Medical

School, recommends tapering off antidepressants by following a 5-Step

Antidepressant Tapering Program, to reduce both the incidence and

severity of withdrawal reactions.

 

" Research has shown that when patients stop antidepressants cold

turkey they can have high rates of withdrawal reactions, " Dr

Glenmullen advises, " which vary depending on the particular drug. "

 

" In studies involving hundreds of patients, 66 percent of patients

stopping Paxil, " he says, " have withdrawal reactions. "

 

 

* The writer, Evelyn Pringle, and Drs Baughman and Glenmullen are

members of this group. Vince

 

 

 

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