Glaxo gets Hit with another Paxil Birth Defects Lawsuit

October 17, 2006, 12:00AM. By Evelyn Pringle

Denver, COTwo years ago, little Eric Jackson was born with persistent pulmonary hypertension, a life-threatening lung disorder in which an infant's arteries to the lungs remain constricted after birth, limiting the amount of blood flow to the lungs and oxygen in the bloodstream.

Persistent pulmonary hypertension (PPHN) is associated with substantial infant mortality and morbidity and between 10 and 20 percent of infants born with the disorder end up dying even when they receive treatment.


Several life-saving medical procedures have already been performed on Eric. At birth he was placed on a ventilator, and eventually had to be placed on an oscillating ventilator for a month. He then had to undergo two cardiac catherizations, and another procedure to correct additional medical problems caused from being on a ventilator for so long.

Eric still needs oxygen and medications to help him breathe and he also suffers with eating and digestive problems.

Eric's mother, Lisa Boden of Denver, Colorado was prescribed the selective serotonin reuptake inhibitor antidepressant, Paxil (SSRI), while pregnant and took the drug right up until Eric was born. Paxil use by pregnant women has been found to associated with a 6 times increased risk of PPHN in newborns.

On October 16, 2006, Eric's mother and father, Christopher Jackson, filed a lawsuit against Paxil maker, GlaxoSmithKline, in a state court in Pennsylvania alleging that Ms Boden's use of Paxil during her pregnancy resulted in Eric being born with PPHN due to Glaxo's failure to warn about the risk of PPHN associated with Paxil.

In the lawsuit, Eric is represented by Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, DC and Philadelphia. Baum Hedlund attorney, Karen Barth Menzies, says the family has endured "a terrible ordeal."

Based in part, on the company's long history of concealing the adverse side effects of Paxil, Ms Menzies says she believes that Glaxo has known about the risk of PPHN, or at the least should have known, and therefore should have warned medical professionals and consumers about the risk of the lung disorder.

Attorney Menzies has been battling Glaxo and the makers of other SSRIs for a decade. Besides representing clients against the drug giants, she has been writing articles and giving speeches around the world warning about the risks of SSRI.

She has testified before lawmakers, and the FDA, about the harmful effects of SSRIs and the failure of the drug companies to come clean about their dangers. In one appearance before the FDA, she ended her testimony by saying, "Put me out of business for the right reasons. Warn about these drugs."

FDA regulations require Glaxo to issue a warning to medical professionals and consumers whenever there is reasonable evidence of an association between Paxil and a serious risk. The regulations specifically say that a causal link need not be proven before adding a warnings. In fact, they explicitly allow Glaxo to issue a warning about a risk without prior approval from the FDA.

Ms Menzies will have no problem showing a jury that Glaxo was aware of the risk of respiratory problems in infants born to mothers taking SSRIs because researchers have been reporting breathing problems in newborns associated with the use of SSRIs during pregnancy for more than a decade.

As far back as 1996 a study published in the New England Journal of Medicine found that babies exposed to the SSRI, Prozac, during the third trimester of pregnancy had significantly higher rates of premature delivery, admissions to special-care nurseries, jitteriness, and poor neonatal adaptation including respiratory difficulty and cyanosis on feeding. The study also found that the birth weight of infants exposed to Prozac was lower, and their birth length was shorter.

To reach its results, the NEJM study identified 228 women on who took Prozac while pregnant during the period of 1989 through 1995, and compared the outcomes of their pregnancies to 254 women who were not taking the SSRI.

In 2003, researchers at the Motherisk Program at the University of Toronto reported that exposure to Paxil in late pregnancy was associated with a significantly higher rate of transient neonatal complications among 55 exposed newborns, when compared to infants exposed to Paxil in early pregnancy or to newborns with no exposure, and respiratory distress was the most commonly reported adverse reaction.

Also in 2003, a study in the American Journal of Psychiatry reported that SSRIs readily cross the placental barrier and expose the infant to increased serotonin levels during early development.

In February 2004, a study in Pediatrics reported that "first-trimester use of SSRIs has been associated with higher rates minor physical anomalies and miscarriages, thus suggesting possible early effects of SSRI exposure on embryonic development."

Five months later, in June 2004, the journal Prescrire International reported neonatal complications after intrauterine exposure to SSRIs and said newborns exposed toward the end of pregnancy showed signs of agitation, altered muscle tone, and breathing and suction problems. The study found that an estimated 20% to 30% of infants were effected and said doctors should be aware of these risks when considering SSRI treatment for pregnant women.

On July 9, 2004, WebMd reported that the FDA was concerned by reports that SSRIs may cause adverse effects in newborns when mothers take the drugs late in pregnancy and that over the past decade the FDA had received "hundreds" of reports of adverse effects in newborns.

As a result of the numerous reports, in July 2004, the FDA changed the labeling for all SSRI, warning that upon delivery some infants exposed to SSRIs required prolonged hospitalizations, respiratory support, and tube feeding.

In December 2005, the FDA issued a warning about two studies that found an increased risk of heart birth defects in babies born to Paxil users and moved the drug into the D category which means definite harm has been shown to occur by maternal use of the drug to the unborn fetus.

Paxil (paroxetine) was approved for use in the US by the FDA in 1993. In large part due to extremely aggressive and creative marketing campaigns, the drug quickly became one of the world's most widely prescribed drugs.

Glaxo has doctors in just about every field of medicine prescribing the drug for a wide variety of ailments including generalized anxiety disorder (GAD), social anxiety disorder (SAD), obsessive-compulsive disorder (OCD), and depression.

Critics, including court certified experts on SSRIs, say that most of these so-called "mental disorders" do not even exist. Rather, they are inventions of Glaxo and other drug companies used to justify the sale of these high priced SSRIs. According to the August 2002 Mother Jones Magazines, "Pharmaceutical companies have come up with a new strategy to market their drugs: First go out and find a new mental illness, then push the pills to cure it."

Jonathan Leo, associate professor of anatomy at Western University of Health Sciences, and author of, "The Biology of Mental Illness," says, "The basic tenet of biological psychiatry is that mental illness is an "organic" disease, meaning that the patient has too much or too little of a neurotransmitter, too much or too little of a receptor, or an overactive or underactive neuronal circuit."

"Never," he says, "has a theory with so little scientific evidence been so well accepted by the American public-three of the seven most commonly prescribed drugs are now mood elevators."

By implementing creative marketing schemes, SSRIs have become the easiest drugs to push. Drug companies now offer and advertise free depression screening surveys in high schools, colleges, and on web sites online.

The industry has even designated October 5, as "National Depression Screening Day," in the US and Canada, complete with TV and newspapers ads telling people where to go to find the free screening sites in their community on that day.

This blatant drug pushing has gotten so out of hand, that according to Mr Leo, this chapter in the history of psychiatry goes beyond the issue of whether there is a link between SSRIs and side effects. "The entire affair calls into question the behavior of the profession over the past decade;" he states, "years from now historians will be writing about how during the past decade academic psychiatry sold itself to the pharmaceutical companies."

"Ghostwritten papers, company written papers, editors refusing to publish articles critical of the "science", NIMH press releases announcing the latest new research findings while ignoring contrary data, and psychiatrists calling their critics "quacks," he writes, "all point to major problems with the profession-not just a minor glitch."

This is exactly what happened when the Chambers study on PPHN was released in February 2006. As a follow-up to her previous study in 1996 that suggested a possible association between use of the SSRI, Prozac, late in pregnancy and the risk of PPHN, Dr Christina Chambers and her team of researchers performed a case control study to determine whether PPHN was associated with exposure to SSRIs during late pregnancy.

The results of the study were published in the February 9, 2006, New England Journal of Medicine and reported that mothers who took SSRIs, in the second half of their pregnancies were nearly 6 times more likely to give birth to infants with PPHN.

The study found 14 infants with PPHN in the group who had been exposed to an SSRI after the 20th week of pregnancy, compared to 6 infants with PPHN in the control group who were not exposed to the drugs.

That means that PPHN "occurred about six times more frequently in women taking SSRIs," said lead author Dr Chambers, an assistant professor of pediatrics at the University of California, San Diego.

The study was so alarming that it prompted the FDA to hold a news conference. "This appears to be a very well-conducted study and we find the results to be very concerning," said Dr Sandra Kweder, deputy director of the office of new drugs at the FDA.

The same month the study was published the industry went into full damage control and took active steps to encourage pregnant women to keep taking SSRIs. A widely publicized study in the February 2006 issue of the Journal of the American Medical Association, warned that stopping SSRIs greatly increased the risk of pregnant women relapsing into depression.

In the article, the authors predicted that their findings would prompt some women to stay on their medication throughout pregnancy. "That was good news for the makers of big-selling antidepressants who have recently faced growing questions about the safety of their medications when used during pregnancy," the July 11, 2006 Wall Street Journal said,

Six months after the study's publication in JAMA, the WSJ provided a little background information about the researchers who encouraged pregnant women to keep taking SSRIs.

"But the study," it wrote, "and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants."

The lead author, Dr Lee Cohen, the WSJ said, "is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers."

According to the WSJ, as soon as the study was published, Dr Cohen and some the other authors hit the lecture circuit, telling doctors about their findings and pointing out the flaws in the recent studies that had found increased risks to newborn of mothers who used SSRIs.

All total, the Journal said, "the authors failed to disclose more than 60 different financial relationships with drug companies."

According to JAMA, its policies require that authors disclose financial ties to the industry. Its editor-in-chief, Catherine DeAngelis, told the WSJ that JAMA was not aware of the financial relationships between Dr Cohen and his co-authors and the drug companies.

After being made aware of the situation, in July 2006, JAMA published a correction to report that 7 of the authors of the February 2006 study failed to reveal that they had financial relationships with the SSRI makers.

With all the bogus free screening programs in place, depression has become the top money-maker and the pharmaceutical industry is trying to cash in every way possible even gaining approval for treatment with a device that is implanted and was developed for the treatment of epilepsy, followed up by another planted promotional article in a medical journal.

On July 18, 2006, Bloomberg News reported that the journal, Neuropsychopharmacology, would correct a review of Cyberonics' depression treatment device to disclose that the scientists who wrote the article had financial ties to the company.

The links not disclosed in this journal involved 8 of the nine authors who were paid members of a scientific advisory committee for Cyberonics.

The study's lead author, Charles Nemeroff, is also chairman of the Cyberonics advisory board and on top of that, he is the editor-in-chief of the Neuropsychopharmacology journal itself.

The reviewing article called the epilepsy treatment device "a promising and well-tolerated intervention" for people with depression who are not helped by other treatments. The FDA approved this highly controversial treatment in July 2005, over the objections of "more than 20" FDA scientists, according to a report by the Senate Finance Committee.

Failing to report the connections violated the journal's policy, Kenneth Davis, the journal's publisher and president of the American College of Neuropsychopharmacology, told Bloomberg in an interview.

The acknowledgements for the article did thank Sally Laden for "editorial support in developing early drafts of this manuscript."

However, according to the July 18, 2006 Wall Street Journal, "Ms. Laden is a professional medical writer who was hired by Cyberonics to help compile the review article." The WSJ described her admitted involvement in the article as:

"She said the company provided her with materials from the company's advisory board meetings to help draft the review article. Ms. Laden said she prepared the first draft of the review piece which then went through many revisions based on edits and suggestions by the listed authors. All of the authors were involved in preparing the final version of the review article, she said."

"This was not a ghostwritten project," Ms. Laden told the WSJ. "I was just a facilitator."

But she declined to tell the WSJ how much she was paid by Cyberonics for her work.

"This is about as classic an example as you'll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations," said Bernard Carroll, a member of the neuropsychopharmacology group who is the retired chairman of the department of psychiatry at Duke University, in a phone interview with Bloomberg.

"This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation," he said in the interview.

Mr Carroll and Robert Rubin, a professor of psychiatry at the University of California, Los Angeles, told Bloomberg that in 2003, Mr Nemeroff also failed to disclose his financial interests in depression treatments in a review he wrote for the journal, Nature Neuroscience, including that he held ownership of a patent on one product.

Back then they wrote and complained to the editors of Nature, and their letter and an article in the New York Times prompted the publishers to change their policy and require that authors of reviews disclose all their financial links to products they write about.

In a rare turn of events for a case of wrongdoing involving the pharmaceutical industry, Mr Nemeroff apparently could not take the heat because on August 29, 2006, News Target, reported that "the editor of the medical journal Neuropsychopharmacology, Charles B. Nemeroff, has resigned his position after drawing criticism for failing to disclose his financial ties to a medical company whose device he endorsed in his journal."

"The surprise is not that Nemeroff lacks fundamental ethics and abused his power as a medical journal editor to pad his own pockets; the surprise is that he got caught," says Mike Adams, a consumer health advocate and critic of unethical practices in conventional medicine.

"Notice," he points out, "how he only published a correction after being exposed by the Wall Street Journal?"

"You have to remember," Mr Adams explains, "that virtually everyone in conventional medicine -- from doctors to journal editors to FDA advisory panel members -- claim they operate with such supreme intellect that they are immune to financial influence, and thus there is no need for them to even disclose conflicts of interest."

"They seem to demand, 'How dare you question our judgment?' while simultaneously pocketing cash from pharmaceutical companies or medical device manufacturers," Mr Adams notes.

"The arrogance is astonishing," he says.

Until stepping down in July 2004, Richard Smith was an editor for the British Medical Journal for 25 years. For the last 13 of those years, he was the editor and chief executive of the BMJ Publishing Group, responsible not only for the profits of the BMJ, but for the whole group which published some 25 other journals.

In a 2005 paper in the Public Library of Science, Mr Smith says that more than paid advertisements in medical journals influencing doctors and consumers, he sees a bigger problem with these studies, and particularly clinical trials, being published in medical journals.

According to Mr Smith, "readers see randomised controlled trials as one of the highest forms of evidence."

Unlike advertising he says, a large trial in a major journal has that journal's stamp of approval, will be distributed around the world, and "may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial."

For a drug company, he says, a favorable trial is worth thousands of pages of advertising, "which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution," he explains in the paper.

The doctors receiving the reprints may not read them, he acknowledges, but they will be impressed by the name of the journal. "The quality of the journal will bless the quality of the drug," he says.

Since the embarrassing disclosure about the drug companies' hidden involvement in the pregnancy related SSRI studies in mid-summer, more health problems have been reported in infants born to women taking SSRIs. On August 25, 2006, Reuters Health reported a study published in the Archives of General Psychiatry, conducted by Canadian researchers at the University of British Columbia, that found babies born to women who took SSRIs during pregnancy to be at an increased risk of having respiratory distress and low birth weight.

Lead investigator, Dr Tim Oberlander, told Reuters that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."

The researcher reviewed health records for almost 120,000 live births between 1998 and 2001 and found that 14% of the mothers were diagnosed with depression. They then compared the outcomes of babies born to 1451 depressed mothers treated with SSRIs during pregnancy to those born to 14,234 depressed mothers who were not treated with SSRIs and found a significantly greater incidence of respiratory distress, 13.9% verses 7.8%, and longer hospitalization for infants born to mothers on SSRIs. Birth weight and gestational age were also significantly less in SSRI-exposed infants and a significantly greater proportion of babies were born before 37 weeks.

"These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression," Dr Oberlander told Reuters.

In the October, 2006, issue of Pediatrics, CDC researchers reported that preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all infant deaths in 2002.

The contribution of prematurity to infant mortality may be twice as high as originally estimated, reported Dr William Callaghan, MD, MPH, and colleagues.

The research team looked at the top 20 causes of infant deaths in 2002, and found that 34% occurred in preterm infants, 95% of whom were born before 32 weeks gestational age of 32 weeks and weighed less than 3.3 lbs.

"On the basis of this evaluation, preterm birth is the most frequent cause of infant death in the United States, accounting for at least one third of infant deaths in 2002," the authors wrote in Pediatrics. "The extreme prematurity of most of the infants and their short survival indicate that reducing infant mortality rates requires a comprehensive agenda to identify, to test, and to implement effective strategies for the prevention of preterm birth."

Finally, a study in the October 3, 2006 Archives of Pediatrics and Adolescent Medicine reported that low birth weight infants with no obvious disability early on can have subtle and cognitive deficits discernable at age 16. The study sample represented a cohort of babies who were born at or admitted to one of three hospitals in New Jersey between September 1, 1984 and June 30, 1987.

Scores on the Wechsler Abbreviated Scales of Intelligence test were generally within the normal range but showed an overall downward shift, so that on average they were lower for the 474 adolescents who weighed less than 2,000 grams at birth, according to Dr Agnes Whitaker, MD, of Columbia University and the New York State Psychiatric Institute, and colleagues.

Two factors, male gender and days of ventilation, were independent predictors of motor problems, the team said. For each additional week of mechanical ventilation, total and oral motor problem scores were higher by 0.33 and 0.14 points, respectively.

Legal analysts say to look to Glaxo attorneys to try and attempt to reach early settlements with the families of children born with birth defects because they in no way want those injured children showing up in court in front of a jury.