Since June 27, 2007, nearly every major news outlet in the US has broadcast the story that two new studies published in the New England Journal of Medicine found a low risk of birth defects in babies born to women who took selective serotonin reuptake inhibitor antidepressants (SSRI's) during pregnancy.
SSRI's include Paxil by GlaxoSmithKline; Zoloft marketed by Pfizer; Prozac by Eli Lilly; Celexa and Lexapro from Forest Laboratories; Luvox by Solvay, and generic SSRI makers Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
On June 27, 2007, the headline that appeared in countless news outlets that run articles from the Associated Press stated: "Antidepressants Not Risky for Defects."
ABC News reported on June 29, 2007, "Antidepressants Safer Than Believed During Pregnancy,"
"Antidepressants not linked to birth defects," stated the internet headline for News-Medical.net, on July 5, 2007.
These headlines outraged experts knowledgeable about the true risks of birth defects, but none drew more outrage than the headline in a press release put out by the US Centers for Disease Control the day before the story broke which stated: "New Study Finds Few Risks of Birth Defects from Antidepressant Use During Pregnancy."
"The reassuring attitude promoted in the CDC's press release flew in the face of evidence linking SSRI exposure during pregnancy to increased birth defects, and the additional evidence of SSRI toxicity in the developing brain," says Dr Peter Breggin, author of The Antidepressant Fact Book and an expert on SSRIs.
"Women and their doctors who only catch the headlines created by these studies are being grossly misled," he advises. "SSRI's should never be used during pregnancy."
Dr Breggin notes that the CDC instructs pregnant women to speak to their doctors about the risks and benefits of taking SSRI's, but says, "doctors will have read the headlines inspired by the CDC and imagine there is little risk."
The paper, "Exposure to SSRI Antidepressants In Utero Causes Birth Defects, Neonatal Withdrawal Symptoms and Brain Damage," by Dr Breggin and Ginger Breggin, will be published in the upcoming issue of the Ethical Human Psychology and Psychiatry journal to refute the findings of the NEJM studies.
CDC Report and Media Coverage Misleading
The CDC claims the use of SSRI's during pregnancy is justified on the basis that depression has its own hazards. "But these hazards," Dr Breggin states, "pale in comparison to the upheaval that will befall new mothers, fathers and the extended families of the children who are born with profound birth defects."
In addition to disputing the claim that birth defects are rare, experts say the headlines are deceptive because: (1) the studies referred to were limited to women taking SSRI's in the first 3 months of pregnancy; (2) some birth defects develop later in pregnancy; (3) stopping the drugs at the end of 3 months, or at any time, can result in a serious withdrawal syndrome; (4) infants experience a withdrawal syndrome after birth, and (5) the headlines do not mention all the other adverse effects associated with SSRI's.
The headlines dilute the findings of the many studies that have shown serious withdrawal symptoms in newborns exposed to SSRI's, including high-pitched or weak crying, tremors, irritability, convulsions, poor muscle tone, abnormal sleep patterns, feeding difficulties, rapid breathing and respiratory distress, and increased admissions to intensive care units.
In discussing a 2004 study published in the Pediatrics journal, lead author Dr Philip Zeskind was quoted in the February 22, 2004, Sunday Telegraph as stating: "What we've found is that SSRI's 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."
"These babies are bathed in serotonin," he said, "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."
Experts say the headlines are also misleading because they infer that no birth defects were found in the studies when, in fact, the CDC study further confirmed associations between SSRI use and the occurrence of craniosynostosis and omphalocele, as well as certain types of heart defects.
The study also found anencephaly, babies born without a forebrain, to be 2.4 times greater in women taking an SSRI in the first trimester. "This is a catastrophic fatal birth defect that is not correctable," Dr Breggin points out. In babies born with anencephaly, much of the brain does not develop, and the babies are either stillborn or die shortly after birth, according to the National Institute of Child Health and Human Development.
Babies born with omphalocele, an abnormality in which the infant's intestine or other abdominal organs protrude from the navel, were 2.8 times higher in women taking SSRI's.
The severity of this condition varies, but can be life-threatening and usually requires surgery as well as weeks to years of adapting.
Craniosynostosis, a condition in which connections among skull bones close prematurely, was 2.5 times more prevalent. "A 2.8 times greater occurrence of this condition," Dr Breggin explains, "will cause 2,305 more US babies to be born each year with this birth defect as a result of their mothers taking SSRI's in the first trimester of pregnancy."
In September 2005, Glaxo sent out a "Dear Doctor" regarding a label change based on a recent study wherein women who took an SSRI were more likely to have an infant with omphalocele, in addition to craniosynostosis.
The CDC study also found that babies exposed to Zoloft had twice the risk of having a heart defect and 3 times the risk with Paxil. In October 2006, the journal, Epidemiology, reported that babies born to women who took SSRI's during the second or third month of pregnancy had nearly 2 times the risk of having congenital malformations, with the most common being cardiovascular in 29%, muscle and bone malformations in 31% and 14% had digestive malformations.
According to SSRI expert, Dr Grace Jackson, "It was already known in the 1980's and 1990's that the administration of SSRI's to embryonic cultures of rats and mice leads to craniofacial and cardiac defects."
The NEJM studies also showed an increased risk of neural tube defects, which are birth defects of the brain and spinal cord, with the two most common being spina bifida and anencephaly.
With spina bifida, the fetal spinal column does not close completely during the first month of pregnancy, and there is usually nerve damage that causes at least some paralysis of the legs.
A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany, and the new NEJM article noted that some women who took SSRI's throughout pregnancy had infants born with a club foot, where the foot is turned in, stiff and cannot be brought to a normal position. According to the NEJM, women who took Paxil during pregnancy were at a 5.8% increase of having a child born with this defect.
The NEJM articles also suggest that there is an association between SSRI's and anal atresia, a malformation in which the normal perforation or opening for the anus is absent where the end of the intestinal tract has not perforated the skin in the perineal area.
Industry Influenced Media
The industry's control over the mainstream media, evidenced by the broadcast of the NEJM studies, did not happen overnight. It began in the late 1990's when drug companies were granted permission to advertise their products to the public.
Over the last decade, the drug companies have intentionally poured so much money into advertising that the overall operating budgets of the major media outlets and television networks are now highly dependent on the pharmaceutical industry.
In addition to advertising dollars, Big Pharma has mastered the art of using the media to promote the sale of drugs and downplay their risks. Stories featured as health care news, based on rigged studies carefully planted in medical journals are promoted through reports written by PR firms and sent out to all the major media outlets in press releases.
A 2005 report by the UK Parliament found that 75% of clinical trials published in the major journals, including The Lancet, New England Journal of Medicine and the Journal of the American Medical Association, were funded by the drug industry.
Experts say medical professionals can no longer rely on what they read. "The sources of knowledge that doctors have been trained to trust have been taken over by the medical marketing community," says Dr John Abramson, author of the book Overdosed America.
Each year, the Prescription Access Litigation Project announces the "Bitter Pill Awards" to expose Big Pharma's efforts to manipulate consumers through the media. For the year 2004, the group granted, "The Cure for the Human Condition Award," to Paxil maker Glaxo, "For Hawking Pills to Treat the Trials of Everyday Life."
In support of the award, PAL cited an FDA warning letter sent to Glaxo about false advertising in a Paxil TV ad, saying it wrongfully "suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR," when these are simply not approved uses of the drug, PAL noted.
For 2007, the Bitter Pill Award should to go CNN for granting the most airtime to industry-paid front men to downplay the risk of birth defects, with special thanks to Dr Sanjay Gupta.
After hearing Dr Gupta say the use of SSRI's was ok for nursing mothers on CNN on June 12, 2007, without discussing any of the risks of drugs, Larry Bone, an avid advocate for protecting the unborn child from the birth defects linked to SSRI's, wrote this author to state that the use of the TV news segments in recent weeks to promote the sale of these drugs to pregnant women and nursing mothers was "horrifying" and must be stopped.
"The public has a right to be honestly informed about the dangers of SSRI's," he wrote, "and the media has an ethical responsibility to see that pregnant women and nursing mothers are adequately informed about the dangers of these drugs."
"At the very least," he says, "media companies should carry disclaimers at the end of such news segment stating that SSRI's all carry warnings on their labels that the public should read."
The Reported Risks
Experts say it's a crapshoot prescribing these drugs to nursing mothers. "No one yet knows what effects SSRI's may have on nursing infants," Dr Jackson warns, "because no one has studied the long term consequences of administering SSRI's to infants via breast milk."
Furthermore, she adds, no one understands how the in utero exposure to SSRI's changes the wiring of the newborn's brain and, "it has never been proven that there is no effect of giving infants these drugs during the first months or years of post-uterine existence."
Researchers from Columbia University published a study in the October 2004 journal Science, suggesting that exposure to Prozac in the womb and in early childhood may permanently alter the brain's circuitry and disrupt neural development, leading to serious emotional disorders later in life.
The warnings that Mr Bone says viewers should be instructed to read are many. On December 8, 2005, the FDA issued a Public Health Advisory and a press release to announce that the agency was asking Glaxo to change the pregnancy category from C to D, a stronger warning which means, "studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus."
The Advisory said that the FDA "has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations."
The FDA also said that physicians who are caring for women receiving Paxil should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy.
On July 19, 2006, the FDA issued another Advisory after a study lead by Dr Christina Chambers in the February 9, 2006, New England Journal of Medicine, reported a 6-fold increased risk of the life-threatening lung disorder, persistent pulmonary hypertension, in babies born to mothers taking SSRI's and said, "the FDA has asked the sponsors of all SSRI's to change prescribing information to describe the potential risk for PPHN."
According to the FDA Advisory: "Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."
The risk of PPHN was first found by Dr Chambers in a 1996 study where the researchers found 2 cases of PPHN, an unexpected finding since there were relatively few women in the study and both women had taken Prozac late in their pregnancies.
Warnings about the adverse effects of SSRI's in the patient information sheet on the FDA's web site as of July 13, 2007, states: "babies delivered to mothers taking Paxil late in pregnancy have developed problems, such as difficulty breathing and feeding."
"Babies delivered to mothers taking Paxil early in pregnancy are sometimes born with heart problems," it states.
The Web Site Also Warns:
"Persons taking Paxil may be more likely to think about killing themselves or actually try to do so, especially when Paxil is first started or the dose is changed."
"Paxil may cause bleeding problems," the FDA warns, "especially if taken with aspirin, NSAID's (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen) or other drugs that affect bleeding."
The information sheet also advises that Paxil patients, "may become hyperactive, excitable or elated," and, "have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire)."
Other side effects currently listed include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite and sleepiness.
According to Mr Bone, CNN is not the only guilty provider of misleading information about SSRI's. "Major broadcasting companies like CBS, FOX, ABC and NBC," he says, "are no longer worthy of trust when they shamelessly promote a class psychotropic drugs that threaten the public safety."
"Such promotion," he states, "constitutes a flagrant breach of basic television broadcasting ethics and fairness standards each and every time."
Mr Bone also says that the media should acknowledge whether the doctors featured in these segments have received grants or gratuity payments from SSRI's makers.
Risks Versus Benefits
Finally, experts point out that the headlines fail to disclose that SSRI's are ineffective. Clinical psychologist Dr Bruce Levine, author of a new book due out this fall entitled, "Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy," says, "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."
"Even the dice-loaded drug company studies show that antidepressants are, in a scientific sense, a failure," he notes.
"For example," Dr Levine points out, "in 2002 the journal Prevention & Treatment analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone, and it reported that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo."
Another of the world's leading authorities on SSRI's, Dr David Healy, also says that the effectiveness of SSRI's has been exaggerated, and the actual data reveals that only one in 10 patients on SSRI's can be shown to respond specifically to the drug rather than a nonspecific factor or a placebo.
Dr Healy is the author of numerous books on psychiatric drugs including, "The Antidepressant Era" and "The Creation of Psychopharmacology."
He says that, in prescribing SSRI's to pregnant women, he is concerned about "the benefit-harm trade-off," because "without any benefits, the child runs all the risks including the neonatal withdrawal syndrome and birth defects."
Dr Healy points out that the CDC study focuses on linking particular specific defects to particular drugs, and once you do this, "you end up with very small numbers in each group and not a lot of significant findings," he says.
Families seeking legal advice regarding SSRI birth defects can contact the Baum, Hedlund, Aristei, Goldman & Menzies Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
(Written as part of the Antidepressant Birth Defect Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department)
(Evelyn Pringle is a regular columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America)