Evelyn Pringle April 2006
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, including: Dizziness, Headache, Muscle Spasms, Tremor, Electric Shock-like Sensations, Other Strange Tingling or Painful Sensations, Nausea, Diarrhoea, Flatulence, Dreams, including Vivid Dreams, and 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, and 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 to 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 year 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."