Evelyn Pringle - Big Pharma hits on pregnant women

March 16, 2008

http://www.countercurrents.org/pringle221106.htm

Big Pharma Hits On Pregnant Women

By Pringle

22 November, 2006

Countercurrents.org

If Big Pharma cared one iota about the unborn fetus, at a bare minimum, it

would call off its hired-guns traveling around the country peddling SSRI

antidepressants to pregnant women by convincing doctors to prescribed the

drugs and ignore the studies and FDA warnings that say SSRIs are associated

with serious birth defects.

Less than a month ago, on October 16, 2006, the first lawsuit in the nation

was filed against GlaxoKline in which an infant charges that his

life-threatening lung disorder was caused by exposure to the SSRI Paxil in

the womb during his mother's pregnancy.

was born in Denver, Colorado on October 28, 2004, with

persistent pulmonary hypertension of the newborn (PPHN), a condition in

which the infant’s arteries to the lungs remain constricted after birth and

limit the amount of blood flow to the lungs and oxygen in the bloodstream.

Immediately after birth had to be placed on a ventilator and eventually

had to be placed on an oscillating ventilator for a month.

In his 2 short years on earth, has undergone two cardiac

catherizations, and another procedure to combat gastral reflux caused from

being on a ventilator for so long. Since birth, he has remained on oxygen

and medications to help him breathe and he continues to suffer with eating

and digestive problems.

With their lawsuit, 's parents hope to recover the medical and other

expenses incurred in treating, and attempting to cure ’s condition, as

well as the related illnesses. Some of the related health problems may not

even surface until is a teenager.

A study in the October 3, 2006 Archives of Pediatrics and Adolescent

Medicine by Dr Agnes Whitaker, MD, of Columbia University and the New York

State Psychiatric Institute, and colleagues, reported that low birth weight

infants who require mechanical ventilation, 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.

The research team said, two factors, male gender and days of ventilation

were predictors of motor problems. For each additional week of mechanical

ventilation, they said, total and oral motor problem scores were higher by

0.33 and 0.14 points, respectively.

Legal analysts predict that Glaxo will attempt to reach early settlements

with the families of infants born with birth defects because the company in

no way wants injured toddlers paraded in front of a jury.

Barth Menzies is one of 's attorneys. She is a partner at Baum

Hedlund, a national pharmaceutical products liability law firm with offices

in Los Angeles, Washington, DC and Philadelphia, where she heads the

Pharmaceutical Antidepressant Litigation Department.

Ms Menzies has been waging legal battles against the SSRI makers on behalf

of injured consumers for more than a decade and she currently represents

many other families in Paxil birth defect cases

Liakos is an associate attorney at Baum Hedlund in Los Angeles, and

she is also a member of the firm's Pharmaceutical Antidepressant Litigation

Department, handling Paxil birth defect cases. She explains that between 10%

to 20% of babies born with PPHN do not survive, even when they receive

treatment.

Having been the leader in the Paxil litigation against Glaxo for years now,

and through their intensive litigation and discovery, Baum Hedlund has

evidence that reveals specifics relating to Paxil and birth defects. 's

attorneys do not have to newly learn the inter-workings of Glaxo because

they know how the company operates regarding Paxil and how they analyze or

fail to analyze data.

According to Ms Menzies, studies have shown that infants who are exposed to

selective serotonin reuptake inhibitor antidepressants (SSRIs), after the

20th week of gestation are more likely to develop PPHN than infants who were

not exposed to an SSRI during pregnancy.

In addition to Paxil, the other SSRIs sold in the US include Prozac by Eli

Lilly; Zoloft, from Pfizer; Celexa and Lexapro, from Forest Laboratories;

and Luvox, from Solvay. Wyeth markets Effexor, a serotonin-norepinephrine

inhibitor.

Adding to the problem of curtailing the prescribing of SSRIs to pregnant

women, is the fact that SSRI makers have doctors prescribing the drugs for

many other conditions besides depression, and often for off-label uses,

meaning they are not approved by the FDA.

According to Dr Jay Cohen, author of, " Over Dose: The Case Against The Drug

Companies, " the " drug companies have marketed SSRI antidepressants

vigorously not only to psychiatrists, who are supposed to have some

expertise with these drugs, but also to family practitioners, pediatricians,

gynecologists, internal medicine specialists, and anyone else who can pen a

prescription. "

" But this doesn't mean,” he says, “that they possess in-depth knowledge of

SSRIs or their actions and toxicities.”

A study from the University of Georgia in the June 2006, Journal of Clinical

Psychiatry, found that 75% of the people prescribed antidepressants received

them for a reason not approved by the FDA.

Little 's lawsuit contends that when allowing Paxil to be prescribed to

pregnant women, Glaxo has an ongoing duty of pharmacovigilance. The FDA

describes the term pharmacovigilance to mean " all scientific and data

gathering activities relating to the detection, assessment, and

understanding of adverse events. "

This includes, the agency notes, the use of pharmacoepidemiologic studies

and activities " undertaken with the goal of identifying adverse events and

understanding, to the extent possible, their nature, frequency, and

potential risk factors. "

" During the entire time Paxil has been on the market in the US, " Ms Menzies

says, " FDA regulations have required Glaxo to issue stronger warnings

whenever there existed reasonable evidence of an association between a

serious risk and Paxil. "

" FDA regulations specifically state, " she explains, " that a causal link need

not have been proven before a new warning is issued and they explicitly

allow Glaxo to issue a new warning without prior FDA approval. "

Ms Menzies reports that research as far back as October 3, 1996 in the New

England Journal of Medicine, by Dr Chambers and colleagues, of the

Department of Pediatrics, Division of Dysmorphology and Teratology, at the

University of California–San Diego, indicated a risk of PPHN in babies born

to mothers taking SSRIs.

For this study, the researchers identified 228 pregnant women taking Prozac

between 1989 through 1995, and compared the outcomes of their pregnancies

with those of 254 women who were not taking Prozac.

The study found that babies exposed to the Prozac, during the third

trimester of pregnancy, had significantly higher rates of premature

delivery, respiratory difficulties, admissions to special care nurseries,

jitteriness, and poor neonatal adaptation including cyanosis on feeding.

There have also been studies specific to the use of Paxil during pregnancy

that have shown respiratory problems in exposed infants upon delivery. For

instance, 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 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.

In June 2004, the journal, Prescrire International, reported that newborns

exposed to SSRIs toward the end of pregnancy had breathing and suction

problems and showed signs of agitation, and altered muscle tone. The study

estimated that 20% to 30% of infants were effected and warned that doctors

should be aware of the risks when considering treatment during pregnancy

with Paxil, Celexa, Prozac, Zoloft, and Lexapro.

The following month, on July 9, 2004, WebMd reported that over the past

decade the FDA had received " hundreds " of reports of adverse effects with

infants born to mothers taking SSRIs.

That same month, the FDA changed the labeling for all SSRIs, warning that

upon delivery, some infants exposed to SSRIs required respiratory support,

tube feeding and prolonged hospitalizations.

In May 2005, a University of Pittsburgh study in the Journal of American

Medical Association, combined the previous research and found that women who

took SSRIs late in pregnancy had a three times higher risk of giving birth

to infants suffering from serious respiratory problems, jitteriness, and

irritability in the first couple of weeks after birth.

The drugs involved in this study also included the serotonin norepinephrine

reuptake inhibitor Effexor. The researchers estimated that in any given year

in the US, at least 80,000 pregnant women are prescribed the drugs.

According to psychiatrist, Dr Eydie Moses-Kolko, the lead author of the

study, serious respiratory problems develop in about one out of 100 infants

born to these women.

As a follow-up to her findings of breathing problems in the previous Prozac

study in 1996, Dr Chambers, now an assistant professor of pediatrics at the

University of California, San Diego, and colleagues, performed a case

control study of women on SSRIs who gave birth between 1998 and 2003, to

determine whether PPHN was associated with exposure to SSRIs in late

pregnancy.

The results of the study published in the February 9, 2006, New England

Journal of Medicine, reported that mothers who took SSRIs in the second half

of their pregnancies were 6 times more likely to give birth to babies with

PPHN.

The study found 14 infants with PPHN in the group who had been exposed to an

SSRI, compared to 6 infants with the disorder in the group who were not

exposed to the drugs.

The FDA found the study so alarming that it prompted the agency to hold a

press conference. “This appears to be a very well-conducted study and we

find the results to be very concerning,” said Dr Kweder, deputy

director of the office of new drugs at the FDA.

She also told reporters that women of reproductive age are the " biggest

users of antidepressant drugs. "

Instead of immediately taking action to warn doctors and consumers of this

development, the pharmaceutical industry went into all-out damage control to

protect SSRI profits by encouraging pregnant women to keep taking SSRIs.

A corresponding study in the February 2006, Journal of the American Medical

Association, warned that pregnant women who stopped taking the drugs could

greatly increase their risk of a relapse of depression. The authors of the

study predicted that their findings would prompt some women to stay on SSRIs

throughout pregnancy.

The JAMA study got much more media attention than Dr Chambers, and included

headlines warning about the dangers of relapse in pregnant women going off

SSRIs. Many local television news broadcasts even ran an unedited video

provided by JAMA, featuring a study author and one of his patients.

However, 5 months later, on July 11, 2006, the Wall Street Journal published

an expose on the researchers involved in the study who were encouraging

pregnant women to keep taking SSRIs. " But the study, " it reported, " 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. "

Most of the authors, the WSJ noted, were leading psychiatrists at

Massachusetts General Hospital, the University of California Los Angeles,

and Emory University

The lead researcher, Dr Lee Cohen, a professor at Harvard Medical School, it

reported, " 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. "

Among the most significant of the missing financial disclosures, the Journal

said, were those of study author, Lori Altshuler, director of the Mood

Disorders Research Program at UCLA, who was a speaker or consultant for at

least 5 antidepressant makers.

Vivien Burt and Hendrick were also authors who did not report

financial relationships with SSRI makers, and Dr Viguera, another author,

did not disclose her paid speaking relationship with Glaxo.

All total, the Journal said, " the authors failed to disclose more than 60

different financial relationships with drug companies. "

“The work of these academic researchers,” the article wrote, “highlights the

role of " opinion " or " thought " leaders coveted by drug companies because of

their ability to influence not only the practice of doctors, but popular

opinion as well.”

In the case of SSRI use by pregnant women, the WJS said, the industry-paid

opinion leaders have become dominant authorities in the field and stated:

“They help establish clinical guidelines, sit on editorial boards of medical

journals, advise government agencies evaluating antidepressants and teach

courses on the subject to other doctors. In some cases, the financial ties

between industry and these leading researchers are not disclosed.”

According to the WSJ, as soon as their study was published, Dr Cohen and

some the other authors went out on the lecture circuit, telling doctors

about their findings and pointing out flaws in the studies that found an

increased risks of birth defects with infants exposed to SSRIs.

For instance, the panel of experts who criticized the Chambers study during

the May 17, 2006, continuing medical education lecture, " Psychotropic Drug

Use During Pregnancy, " sponsored by the Massachusetts General Hospital

Psychiatry Academy, was comprised entirely of psychiatrists with financial

ties to drug companies.

During the lecture, the panelists were also critical of the FDA for adding

new warnings about birth defects to Paxil’s label. On December 8, 2005, the

FDA issued a Public Health Advisory after US and Swedish studies showing

that exposure to Paxil in the first trimester of pregnancy to be associated

with an increased risk of heart birth defects.

With the warning, the agency for the first time placed an SSRI in the D

category, its second highest for the risk of birth defects. Category D means

that either controlled or observational studies of pregnant women " have

demonstrated a risk to the fetus. "

The agency did not ban Paxil from use with by pregnant women, but it did go

so far as to say, " FDA is advising patients that this drug should usually

not be taken during pregnancy. "

At the May 17 conference, panelist, Zachary Stowe, from the women's mental

health center at Emory University, described the FDA’s decision to change

the label as " driven by a single set of data that is unpublished, non-peer

reviewed, and somehow this trumps the very nicely done prospective

investigations that have really failed to find this risk. "

However, here once again, according to the WSJ, Dr Stowe has served as an

paid adviser and speaker for several SSRI makers.

In July 2006, corresponding with the WSJ’s expose about the undisclosed

financial relationships of the Cohen study authors with SSRI makers, JAMA

published a correction to announce that 7 of the authors of the February

2006, study had failed to reveal their financial ties with drug companies.

Critics of Big Pharma‘s influence over studies published in medical journals

were quick to respond to the disclosure. On July 11, 2006, Merrill Goozner,

director of the Center for Science in the Public Interest, issued a

statement saying: “It’s clear that the Journal of the American Medical

Association does not evaluate conflict of interest disclosures when articles

are submitted.”

“As a result,” Mr Goozner said, “some authors with blatant conflicts of

interest apparently feel they can ignore the journal’s policy with

impunity.”

“The only solution,” he added, “is for journals to adopt strong penalties

for authors who fail to disclose – a three-year ban from publishing in the

pages in the journal.”

A month later in August 2006, another study in the Archives of General

Psychiatry, by Canadian researchers at the University of British Columbia,

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 Health on August 25,

2006, 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 determined that 14% of the mothers were diagnosed

with depression. They then compared the outcomes of infants born to women

treated with SSRIs to those born to depressed women who were not treated

with SSRIs and found a significantly higher incidence of respiratory

distress in infants exposed to SSRIs by a ratio of 13.9% to 7.8%.

The study reported longer hospitalizations for infants born to mothers on

SSRIs, and found birth weight and gestational age were also significantly

less in SSRI exposed infants.

" 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 October, 2006, the journal, Pediatrics, reported that CDC researchers

cited preterm birth as the leading cause of infant mortality in the US,

accounting for at least one-third of all infant deaths in 2002.

The contribution of prematurity to infant mortality may be twice as high as

originally estimated, reported Dr 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 pounds.

" 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, " the authors wrote in Pediatrics.

There are also studies showing infants born with symptoms of neurological

damage associated with SSRI exposure in the womb. In February 2004 a study

in the American Journal of Pediatrics reported abnormal sleeping patterns,

heart rhythms and levels of alertness linked to SSRIs.

Dr Philip Zeskind, a developmental psychologist and research professor at

the University of North Carolina, Chapel Hill, led the investigation and on

February 22, 2006, told the Sunday Telegraph, " What we've found is that

SSRIs disrupt the neurological systems of children, and that this is more

than just a possibility, and we're talking about hundreds of thousands of

babies being exposed to these drugs during pregnancy. "

In reaching their results, the team of researchers compared 17 babies born

to mothers who took the Prozac, Paxil, Zoloft or Celexa throughout their

pregnancy, with 17 babies born to mothers who had never taken SSRIs.

According to Dr Zeskind, " These babies are bathed in serotonin during a key

period of their development and we really don't know what it's doing to them

or what the long-term effects might be. "

" It could be that they go `cold turkey' when they are born,” he explained in

the Telegraph, “or the serotonin could be having an effect on their brains,

or it could be a bit of both. "

“We're not saying that pregnant women should not take the drugs, because

depression is itself a big problem,” he said. “But these drugs are being

given away like smarties, and this is a big problem,” Dr Zeskind warned.

Legal analysts predict that this first PPHN lawsuit is just the tip of the

proverbial iceberg because there are tens of thousands of infants exposed to

SSRIs in the womb each year.

After the results of her PPHN study were made public, Dr. Chambers says she

heard from women all across the country who took SSRIs during pregnancy and

had babies born with PPHN.

The fact that Glaxo has not ordered its hired-guns to stop promoting the

sale of Paxil to pregnant women, proves that the company plans to go on

sacrificing the lives of babies in the name of profits and that should be a

fairly easy point to get across to a jury.

evelyn.pringle@...

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March 16, 2008