The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

More Adverse Effects Linked to SSRI Celexa

Evelyn Pringle November 14, 2006

According to testimony at an inquest into the deaths of Roxanne Richardson, 30, and her children, Luke, 3, and Grace, 20 months, an autopsy revealed that at the time of their murders, husband and father-turned-killer, Michael Richardson, had Celexa in his system higher than prescribed which may have caused him to become agitated and irritable.

When he arrived at the Richardson home on July 12, 2004, Detective Sergeant Fox said the four bodies lay side by side on a bed. The medical evidence was that Mrs Richardson had been stabbed in the chest and then suffocated, the children had been suffocated, and Mr Richardson had died from a gunshot wound, according to the November 1, 2006 Sidney Morning Herald.

A far cry from alleviating his depression, on the day of the tragedy, while pumped full of Celexa, Mr Richardson wrote in his diary: “I’m hurting so much, nothing matters to me any more except my family and they are getting taken away from me.”

Over the past 15 years, there have been a growing number of criminal cases where people have claimed that their aggression and violence was caused by the use of antidepressants like Celexa, a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

Psychiatrist, Dr Peter Breggin, author of 20 books including, “Toxic Psychiatry,” has been researching psychiatric drugs and serving as an expert witness and consultant in civil and criminal cases involving drug companies for more than 25 years.

In 1972, he founded The International Center for the Study of Psychiatry and Psychology (ICSPP), a non-profit research and educational network, focused on the impact of mental health theory and practices upon patient well-being, personal freedom, and family and community values. He also founded the journal, Ethical Human Sciences and Services.

According to Dr Breggin, all SSRIs can produce stimulation or activation with the potential for increased agitation, disinhibition, irritability, aggression, hostility, mania, and crashing into depression and suicide.

“They can also cause a flattening of emotional responses,” he notes, “including a loss of caring, that can unleash dangerous actions.”

“Beginning with the widespread use of Prozac in the early 1990s,” he says, “the struggle to gain public and professional recognition of antidepressant-induced suicide and violence has a long and stormy history. “

The debate peaked in 1994 when Dr Breggin testified against Eli Lilly in a case of Prozac-induced suicide and mass murder by a postal worker in Kentucky.

“My testimony, in effect,” Dr Beggin recalls, “was that the perpetrator, Joseph Wesbecker, hadn’t gone “postal,” he’d gone “Prozacal.”

After the drug company won a split jury decision at the end of the trial, the judge figured out that the trial had been fixed. “The plaintiffs,” Dr Breggin says, “had been paid off by the drug company to conduct a fake trial that was rigged to end in favor of the drug company.”

In the end, when the judge realized what happened, he was outraged and voided the verdict.

According to Dr Breggin, while the FDA and antidepressant makers continue to deny that SSRIs cause violence, many lives continue to come to tragic ends.

It wasn’t until late 2004, that the FDA finally made drug companies add a black box warning to the labels of SSRIs about the increased risk of suicide among patients taking the drugs, even though Dr John Abramson MD, author of, “Overdosed America,” and a clinical instructor at Harvard Medical School, says the FDA knew about the increased suicide risk since before the drugs were approved.

The findings from a study published in the Archives of General Psychiatry in 2000, he says, evaluating the findings from the “pivotal studies” submitted to the FDA on the 7 new antidepressants approved between 1987 and 1997, including Prozac, Zoloft, Paxil, Effexor, Serzone, Remeron, and Wellbutrin SR, went largely ignored.

In studies that included depressed but not suicidal patients, the completed suicide rate for those taking one of the new antidepressants was 842 in 100,000 per year, or 0.84%, while the rate of suicide for patients taking a placebo was less than half at 360 in 100,000, or 0.36%.

“In other words,” Dr Abramson explains, “the pre-approval studies considered by the FDA to be highest quality and most important for these 7 new and supposedly safer and more effective antidepressants showed that treating 1000 depressed non-suicidal patients for one year with the new drugs led to about 5 more successful suicides than if the same group of 1000 patients had been treated with a sugar pill.”

“This is an enormously high death rate,” he points out.

And although the incidence of violent behavior is not included in the above report on antidepressants, Dr Abramson says, “it certainly seems logical that when the risk of violent actions against self are more than doubled, that the incidence of violent actions against others might be similarly affected.”

At the very least, he notes, this possibility should have been studied.

Critics say, getting the FDA to issue warnings about the increased suicide risk with SSRIs was like pulling teeth. According to investigative journalist and author of, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill,” Kelly Patricia O’Meara, “based on the evidence that twice as many children in clinical trials showed a greater risk of suicidality taking the antidepressants, coupled with the evidence that the antidepressants in the majority of the clinical trials were no more effective than sugar pills, the FDA had little choice but to “request” the pharmaceutical companies add the black-box warnings.”

Also in 2004, what would become a steady stream of studies showing harm to infants born to mothers taking SSRIs began to emerge.

In February 2004, the study, “Maternal Selective Serotonin Reuptake Inhibitor,” by Philip Zeskind PhD and Laura Stephens, in the journal 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.”

The study also reported that third-trimester use off SSRIs had been associated with lower gestational age, low birth weight, higher rates of neonatal intensive care unit admissions.

In June 2004, a French study published in the journal Prescrire International, reported that newborns exposed to SSRI during pregnancy showed signs of agitation, altered muscle tone, and breathing and suction problems.

The following month, in July 2004, the FDA changed the labeling for all SSRIs, warning that some newborns exposed to SSRIs had developed problems requiring respiratory support, tube feeding and prolonged hospitalizations.

But as it turns out, the FDA had received hundreds of reports of adverse effects in infants born to mothers taking SSRIs over the past decade, according to WebMd. The most common adverse events reported included irritability, trouble eating, body rigidity, and respiratory problems, said Kathleen Phelan, a safety evaluator in the division of drug risk evaluation, to WebMD.

A February 2005 study in the journal, Lancet, screened the World Health Organization’s database on SSRI adverse reactions in cases of neonatal convulsions and withdrawal syndrome, and found that by November 2003, there was a total of 93 case reports of maternal SSRI use in babies born with convulsions or withdrawal syndrome.

An analysis of the reports showed 64 cases were associated with Paxil, 14 with Prozac, 9 with Zoloft, and 7 were associated with Celexa.

Research released earlier this year linked SSRI use by mothers during pregnancy to infants born with the life-threatening persistent pulmonary hypertension (PPHN) lung disorder. According to a study by researchers at the University of California, San Diego School of Medicine, in collaboration with Boston University’s Slone Epidemiology Center, in the February 9, 2006 New England Journal of Medicine, babies born to women who took SSRIs in the second half of pregnancy, had a 6 times greater risk of developing the lung disorder.

In September 2005, studies conducted by Danish and US researcher determined that SSRI use in the first trimester of pregnancy was linked to a 40% increased risk of birth defects such as cleft palate and that cardiac defects in newborns also appeared to be 60% more likely with women who used SSRIs.

In February 2006, a study conducted in Israel found that one out of 3 infants exposed to SSRIs in the womb showed signs of drug withdrawal at birth, including high-pitched crying, tremors, and a disturbed sleep pattern.

On April 7, 2006, the BBC reported a Canadian study of almost 5,000 pregnant women that found mothers on SSRIs were twice as likely to have a premature birth and also nearly twice as likely to have low birth weight infants and stillbirths.

Less than 3 months later, in July 2006, the FDA issued an advisory that warned against taking SSRIs together with triptans, drugs used to treat migraine headaches, because a life-threatening condition called serotonin syndrome may occur. The condition, the FDA said, causes serious changes in how the brain, muscles and digestive system work due to high levels of serotonin in the body.

Last month, doctors at the Cornell Medical Center, in New York, who were treating the two men for infertility, including one who was on Celexa, found that when the men stopped taking the SSRIs, their fertility problems disappeared, only to resume again when they went back on SSRIs.

The problem is believed to be caused by an adverse effect of SSRIs on both the concentration and swimming ability of sperm. The men were tested over a 2-year period

Dr Peter Schlegel, who presented the research at the American Society for Reproductive Medicine conference, in New Orleans, explained that:

“The patients had normal sperm counts and motility before medication. On the medication they have severe deterioration of both. The same patients going on and off medication had the same pattern. It shows a strong association.”

Impotence and delayed ejaculation are well-known side-effects of SSRIs, and now Dr Schlegel says he believes that the drugs may be preventing sperm from getting into semen.

“These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them. It’s a dramatic effect and it’s never been described before,” said Professor Schelgel in the Guardian on October 24, 2006.

“We believe that while it’s had a profound effect on these two men,” he said, “it could be having a significant but more subtle effect on many more men.”

But no matter how many adverse events are found to be associated with SSRIs, there seems to be no way to curtail the over-selling of these drugs to all populations. For the year ending March 31, 2006, Forest Laboratories top selling drugs were the SSRIs, Celexa and Lexapro, which when combined, accounted for 68% of the drug maker’s sales.

However, there may be a few dents in the company’s profit margin for SSRIs in the coming years because according to Forest Lab’s Annual Report filed with the SEC on June 14, 2006, the company is a named defendant in approximately 25 active product liability lawsuits, with most alleging that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.

In addition, Forest Labs may not know it yet, but the company will soon be hit with the first Celexa-related birth defect lawsuit alleging that the company engaged in “repeated and persistent fraud” by misrepresenting, concealing and otherwise failing to disclose, information concerning the safety and effectiveness of Celexa in treating pregnant women.

Named plaintiffs in the case will be Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and her baby Gavin Shore, who was born with heart birth defects. Attorney, Robert Kwok, of the Houston, Texas lawfirm Robert Kwok & Associates, LLP, is handling the case.

To cover lawsuits, according to Forest’s Annual Report, the company maintains $140 million of product liability insurance coverage per “occurrence” and in the aggregate.

However, in conclusion the Report points out that, “litigation is subject to many factors which are difficult to predict and there can be no assurance that we will not incur material costs in the resolution of these matters.”

Filed under: 2006, Birth Defects, Celexa, Forest, Kwok, sex, SSRIs, suicide

FDA – The Rest of the Story

Evelyn Pringle March 7, 2007

The 12,000-employee FDA regulates products that account for more than $1.5 trillion in yearly sales, or about a 10th of the US economy. Besides food and drug safety, the agency also enforces regulations covering medical devices and cosmetics.

The FDA is part of the executive branch of government and therefore, any filing of reports by companies where critically important safety data is willfully omitted is a criminal offense under US Code: 18 USC 1001- Fraud and False Statements, according to Barry Turner, a professor of law and medical ethics in the UK.

Mr Turner explains that concealing dangerous side effects is a willfully misleading act and that any company that engages in a course of action that involves withholding data about adverse reactions is committing a crime.

However, in order to find a company guilty of fraud, there would probably have to be a showing that FDA officials were not involved in the underlying act, and this is where the whole case would fall apart because Big Pharma has so successfully infiltrated the nation’s top regulatory agency that there are no “clean hands” so to speak.

Since the Bush administration took over the FDA, there has been several unsuitable Commissioners. Mark McClellan was the official leader in 2003, but after being embarrassed on 60 Minutes when asked why Canadian drugs were not safe enough to be imported for use by Americans, he moved on to a less visible position.

After that, Lester Crawford served as Acting Commissioner until his nomination for full-time Commissioner was approved in August 2005. However, Mr Crawford’s tenure was also short-lived and he abruptly resigned two months after he was confirmed.

About a year later, on October 2006, Mr Crawford pleaded guilty to charges of having a conflict of interest and false reporting of information about his stock holdings with pharmaceutical companies during the years he was employed at the FDA. Going back to 2002, investigators found that Mr Crawford had filed 7 false reports with the government ethics office and Congress.

Last month, on February 27, 2007, Judge Deborah Robinson, sentenced Mr Crawford to three years of supervised probation, 50 hours of community service, plus fines of roughly $90,000 for lying about the stocks that he and his wife owned in companies that were regulated by the FDA.

The judge would not agree to let Mr Crawford off the hook as easily as proposed. “While the total fine exceeds what the parties agreed to,” she said at the hearing, “the fine is well below the maximum under the statute.”

The Bush administration’s original nomination of Mr Crawford was nearly derailed a number of times. On July 18, 2005, a member of the administration’s own party, Senator Charles Grassley (R-Iowa) took to the Senate floor to respond to the nomination and gave a caustic critique of the FDA as a whole and Crawford’s conduct specifically.

“My oversight of the FDA,” he stated, “leads me to the conclusion that there are cultural and systemic problems at the FDA.”

“Unfortunately,” he said, “Dr. Crawford has long been part of that same culture and system.” Senator Grassley also elaborated further in stating:

“During Dr. Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent. First, with Dr. Mosholder finding a link between anti-depressants, children and suicide. And second with Dr. Graham’s allegations regarding the FDA, Vioxx and post-marketing safety generally. Dr. Graham’s testimony before the Finance Committee suggests that the problems are systemic.

“Oversight of the FDA exposed the cozy relationship that exists between the FDA and the drug industry. It revealed that the FDA negotiated for almost two years with Merck about how to change the Vioxx label so people would know about the risk of heart attacks.”

The evidence is overwhelming, Senator Grassley said, that the FDA must change to better protect the people. “Dr. Crawford,” he stated, “does not appear willing to be the man to change the FDA.”

A few months earlier, several Democrats had also raised strong objections to the nomination. On April 6, 2005, following a closed-door meeting, Senators Patty Murray (D-Wash) and Hillary Rodham Clinton (D-NY), members of the Senate Health Education and Labor Committee, announced their intention to place a “hold” on Dr Crawford’s nomination, citing the FDA’s failure to act on a host of public health issues, including the Plan B contraceptive approval, during his tenure as Acting Commissioner.

On June 15, 2005, Senators Murray and Clinton delayed consideration of the nomination by the full Senate. “At a time when the FDA needs a strong leader to restore its reputation,” Senator Clinton said in a statement, “I fear that Dr. Crawford’s record demonstrates a lack of vision and drive to ensure that the FDA upholds its gold standard of drug regulation.”

“He has failed,” she explained, “to address the concerns raised by his own employees about the needs of the agency.”

“And he cannot provide assurances,” she continued, “that the FDA will make science, not ideology or other interests, the cornerstone of its decision making.”

“The Senators’ hold will remain,” the statement said, “in effect until FDA issues a yes or no decision on the over-the-counter application of Plan B emergency contraceptives.”

“We are asking FDA to explain,” they Senators stated, “why they are delaying an over-the-counter application for Plan B that even their own Advisory Panel overwhelmingly recommended for approval.”

“I fear that the case of Plan B,” Senator Murray noted, “highlights a leadership problem at FDA – a leadership that can be biased or open to undue influence.”

On July 15, 2005, Senators Clinton and Murray lifted the hold after receiving assurance from Health and Human Services Secretary, Mike Leavitt, that the FDA would act on the Plan B application by September 1, 2005.

Once the nomination was confirmed, that assurance turned out to be meaningless and September 1, came and went. However, 23 days later, Dr Crawford resigned after serving only two months as Commissioner, and Andrew von Eschenbach became the Acting Commissioner.

The emergency contraceptive at the center of the controversy, Plan B, had been available with a prescription since 1999. In 2003, Barr Laboratories sought FDA approval to sell it over-the-counter, arguing that it could reduce the number of unintended pregnancies and abortions as an emergency contraceptive to be used within 72 hours of unprotected sex.

On May 6, 2004, Mr Crawford rejected a 23 to 4 vote by the FDA’s Advisory Committee for Reproductive Health Drugs to approve over-the-counter sale of Plan B, in effect overruling a scientific consensus that overwhelmingly found the drug safe and effective.

At the time, critics accused FDA officials of ignoring scientific evidence due to pressure from social conservatives, and they of course denied the allegations.

However, much of the outrage that erupted a year later when it came time for Mr Crawford’s confirmation as Commissioner, was fueled by Dr David Hager, an obstetrician-gynecologist, and a Bush appointee to the FDA Advisory Committee, who was known to be one of the 4 members that voted against the approval of Plan B.

In 2002, the original appointment of Dr Hager was for chairman of the Advisory Committee. However, the nomination drew an onslaught of protests due to his ideological views such as refusing to prescribe contraceptives to unmarried women and advocating the use of prayer for the relief of premenstrual syndrome.

Critics said they objected to Dr Hager holding a position where he could have an impact on decisions affecting women’s health, and finally to put an end to the controversy, the administration announced that Dr Hager would serve on the committee but not as chairman.

In May 2005, the media began reporting that after the Committee voted to approve Plan B, the FDA had asked Dr Hager to write a minority opinion advocating against the recommendation and submit it to Dr Crawford.

On May 12, 2005, the Washington Post, quoted a sermon given by Dr Hager at Asbury College in Kentucky, in which Dr Hager discussed his part in the FDA’s decision to reject the advisory panel’s recommendation.

“I was asked,” he stated, “to write a minority opinion that was sent to the commissioner of the FDA.”

“For only the second time in five decades,” Dr Hager said, “the FDA did not abide by its advisory committee opinion, and the measure was rejected.”

“I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision,” he stated.

“Once again,” Dr Hager told the audience, “what Satan meant for evil, God turned into good.”

Less than two weeks later, on May 23, 2005, fifty-one members of congress sent a letter to Dara Corrigan, Acting Principal Deputy Inspector General at the Department of Health and Human Services requesting an investigation of the FDA’s request for a opinion from Dr Hager during consideration of Barr’s application to allow OTC sales of Plan B.

After an investigation, the Government Accountability Office said the decision not to approve Plan B was highly unusual, made with atypical involvement from high level FDA officials, and likely was made months before the formal announcement.

On May 30, 2005, as Paul Harvey would say, The Nation magazine published “the rest of the story,” in an article titled, “Dr. Hager’s Family Values,” by Ayelish McGarvey, which stated in part:

“In both his medical practice and his advisory role at the FDA, his ardent evangelical piety anchors his staunch opposition to emergency contraception, abortion and premarital sex.

“Through his six books–which include such titles as Stress and the Woman’s Body and As Jesus Cared for Women, self-help tomes that interweave syrupy Christian spirituality with paternalistic advice on women’s health and relationships–he has established himself as a leading conservative Christian voice on women’s health and sexuality.”

However, Linda Carruth Davis, co-author of, Stress and the Woman’s Body, is Dr Hager’s former wife of 32 years, and told the Nation that her ex-husband’s public moralizing on sexual matters clashed with his deplorable treatment of her during their marriage.

In the article, Ms Davis revealed that Dr Hager had repeatedly sodomized her without her consent for years. “I probably wouldn’t have objected so much, or felt it was so abusive if he had just wanted normal sex all the time,” she explained to Ms McGarvey.

“But it was the painful, invasive, totally nonconsensual nature of the sex that was so horrible,” Ms Davis said.

For seven years, she told the Nation, Dr Hager sodomized her while she slept, roughly once a month until their divorce in 2002. Sometimes, Ms Davis said, she fought him off and he would quit for a while, only to circle back later that same night, and at other times, she would just try and get it over with.

At other times, she said, she attempted to avoid his predatory advances by sleeping in other rooms, or trying to stay awake until he was asleep, but nothing worked.

According to Ms McGarvey, “As disturbing as they are on their own, Linda Davis’s allegations take on even more gravity in light of Hager’s public role as a custodian of women’s health.”

“Some may argue that this is just a personal matter,” she wrote, “between a man and his former wife–a simple case of “he said, she said” with no public implications.”

“That might be so,” she continued, “if there were no allegations of criminal conduct, if the alleged conduct did not bear any relevance to the public responsibilities of the person in question, and if the allegations themselves were not credible and independently corroborated.”

“But given that this case fails all of those tests,” Ms McGarvey states, “the public has a right to call on Dr. David Hager to answer Linda Davis’s charges before he is entrusted with another term.”

“After all,” she correctly points out, “few women would knowingly choose a sexual abuser as their gynecologist, and fewer still would likely be comfortable with the idea of letting one serve as a federal adviser on women’s health issues.”

The day after the Nation published the story, Dr Hager resigned stating: “I will no longer be on the advisory committee after June 30.”

According to Ms McGarvey, Ms Davis had told a handful of people about the abuse during her marriage, and several longtime confidantes confirmed that she had told them at the time it was occurring. Ms Davis’ attorney and a close friend of 25-years also spoke to Ms McGarvey on the record, and several others spoke to her off the record.

As for Dr Hager, he told the reporter, “My official comment is that I decline to comment.”

Filed under: 2007, Bush, David Hager, FDA Crawford, Plan B, sex, von Eschenbach

Sex and Psych Drugs – Young Couples Beware

Evelyn Pringle June 2, 2009

Although the adverse effects of women taking psychiatric drugs while pregnant related to birth defects and infant withdrawal syndrome are often discussed or reported, the serious adverse effects on the sex lives and reproductive systems of millions of young couples are rarely mentioned.

Whatever the reason, due to the ever widening marketing campaigns by the psycho-pharmaceutical industry, young people need to be warned before they get conned into taking psychiatric drugs.

Sexual dysfunction, including lack of libido, orgasmic dysfunction and delayed ejaculation, are common side effects of using SSRI antidepressants, according to the May 2005 report, “The Marketing of Depression: The Prescribing of SSRI Antidepressants to Women,” by Dr Janet Currie. The report warns:

“There are concerns that not all sexual dysfunction may fully resolve after termination of treatment. Since SSRIs are prescribed more often for women, women are more frequently affected by SSRI-induced sexual dysfunction. Because SSRIs can also lead to a worsening of depression, paradoxical effects, emotional blunting or detachment, reduced emotional activity, memory loss and confusion, these effects, in conjunction with sexual dysfunction, can negatively affect intimate relationships.”

In 2006, Dr Antonei Csoka, from the Department of Obstetrics, Gynecology and Reproductive Sciences, at the University of Pittsburgh, and Dr Stuart Shipko, in private practice, in Pasadena, California published a paper titled, “Persistent Sexual Side Effects after SSRI Discontinuation,” in Psychotherapy & Psychosomatics.

The paper documented three cases of fairly severe and permanent sexual dysfunction resulting from prior use of SSRIs in two men and one women.

“These case studies have important clinical implications,” the authors note. “They suggest that when patients develop sexual dysfunction as a side effect of SSRIs, clinicians should be alert to the possibility that restoration of sexual function may not correlate temporally with medication cessation.”

In recent studies, “doctors have specifically asked about sexual difficulties, and found that they are present in up to 83% of patients,” the authors report.

“Patients are often willing to continue taking SSRIs despite sexual side effects, but the possibility of increasing the probability of dysfunction remaining after discontinuance should be taken into consideration,” they state. “Such persistent side effects could even worsen the long-term prognosis of depression.”

“I suspect that these three cases are just the tip of the iceberg and that possibly thousands of people are similarly affected,” Dr Csoka told this author in an email.

In July 2005, WebMD noted that sexual side effects can cause significant problems of their own. “For both men and women, this means being unable to initiate, participate fully in, or enjoy sex, and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery,” the article pointed out.

On the website, Prozac.com, under possible side effects of Prozac, “decreased sex drive” and “impotence” are listed. It also states Prozac “can cause changes in sexual desire and satisfaction.”

After five years of tracking Big Pharma’s disease mongering and off-label marketing schemes, I can say without a doubt that the sickest plot ever devised is the legislation moving through the US Senate right now referred to as the “Mothers Act,” for short.

This is the sickest of all marketing schemes because it is aimed at young couples in child bearing years and reaches into the cradle where the brains and bodies of the most vulnerable victims will be forcibly drugged through pregnant and nursing mothers without any voice of their own in the matter.

Although the language in the Act says postpartum conditions refers to “postpartum depression” and “postpartum psychosis,” the campaigns run through websites like Postpartum Support International, Postpartum Progress and PerinatalPro, are using the bill as a vehicle to diagnose pregnant and nursing mothers with a whole list of pregnancy related “mood” and “anxiety” disorders to further a new cottage industry in the works for treating these women.

For instance, one website is run by Karen Kleiman, who happens to have her own counseling agency called the “Postpartum Stress Center,” and quite a few books to sell. On this website you can even buy some books directly with paypal and bypass Amazon.

“The Postpartum Stress Center specializes in the diagnosis and treatment of prenatal and postpartum depression and anxiety disorders,” the homepage says.
Services offered at the Center include, “Screening for prenatal and postpartum depression and anxiety,” and “Psychiatric evaluation and follow-up.”

The postpartum websites continuously argue that the Act does not promote screening women, but the bill they tried to slip through Congress last year specifically called for screening women and referring them for services. The language in the 2008 bill stated: “To ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.”

The truth is, universal screening has always been the goal of this blatant off-label marketing scheme because no psychiatric drug has been FDA approved as safe for use by pregnant women and screening opens the door for drug treatment. The screening language was removed only after strong objections were raised about the prospect of requiring all women to be screened and referred to treatment.

The history of the attempts to pass this legislation clearly shows screening was the plan. For instance, Dr Katherine Wisner is professor of psychiatry, obstetrics, gynecology and reproductive sciences and epidemiology at the University of Pittsburgh School of Medicine, and her work in promoting screening as well as drug use by pregnant and nursing mothers is constantly cited on the postpartum websites.

In an editorial in the December 2006, Journal of the American Medical Association, Dr Wisner recommended “that the United States take steps to implement a universal screening program, in which all women are screened between two- and 12-weeks postpartum,” the University reported in a December 5, 2006 news release with the heading, “JAMA Editorial Notes Childbearing Presents Unique Vulnerability for Psychiatric Illness, Making Effective Screening, Education and Treatment Essential.”

“Those presenting with symptoms of a psychiatric disorder should be treated immediately after diagnosis,” Dr Wisner said in the University news release.

The Mothers Act is said to be modeled after a New Jersey law in the home state of the bill’s main sponsor, Senator Robert Menendez. “The State of New Jersey has been the first to address the problem on the governmental level by legislating that all women receive screening and education for postpartum depression; the law went into effect in October (2006),” the University pointed out.

Six months prior to the JAMA editorial calling for “universal screening” and “treating immediately,” on August 5, 2006, Medical News Today ran the headline: “Commonly Used Anti-depressants Safe And Effective For Treating Postpartum Depression,” for a study led by Dr Wisner published in the Journal of Clinical Psychopharmacology.

The researchers compared the tricyclic, nortriptyline, and Pfizer’s Zoloft, but there was no placebo group to see if the drugs worked any better than a sugar pill, which countless studies have shown they rarely if ever do.

“We’ve been treating postpartum depression based on the assumption that drugs that work for a woman with depression under usual circumstances will work for a woman who experiences depression after giving birth, but there have not been studies that provide scientific proof that this was an effective and safe course of treatment,” Dr Wisner told Medical News.

“Treating these women based on that assumption was simply not good enough, and we felt compelled to provide scientific evidence to guide postpartum depression treatment decisions,” she stated.

The disclosure by Medical News said Pfizer provided the Zoloft for the study but did not provide any direct financial support for the conduct of the study. It was noted that Dr Wisner is a member of Pfizer’s speaker’s bureau and has a grant from Pfizer for a study of ziprasidone (antipsychotic Geodon) pharmacokinetics during pregnancy, and is also a member of the speaker’s bureau for GlaxoSmithKline.

A 2005 paper in JAMA reported that Dr Wisner had received grant funding from Pfizer and “is a member of the speaker’s bureau for Pfizer, GlaxoSmithKline, and Shire.”
Dr Wisner is also “a distinguished fellow of the American Psychiatric Association,” the University website notes.

In a running list of Mothers Act supporters, the PerinatalPro website, which is actually another site run by the owner of a treatment center, Susan Stone, with a book for sale, lists the APA as endorsing the bill. This Big Pharma front group will probably go down in history as the most notorious disease mongering association of all time.

A prime example of disease mongering at its worst can be found in a May 21, 2008 headline by US News and World Reports stating: “Postpartum Depression Strikes New Fathers, Too,” with a story based on research presented at the APA’s annual meeting.

Ten percent of new fathers and 14% of new mothers are affected by depression, psychologist James Paulson, assistant professor of pediatrics at Eastern Virginia Medical School in Norfolk, told US News.

“If untreated, a father’s postpartum depression can be harmful to the child as well as to both parents,” the article noted.

On May 8, 2008 WebMD reported that then APA President, Dr Nada Stotland, said first-time new dads are at greatest risk for postpartum depression and apparently the causes of this newly discovered mental disorder are as follows:

“The life changes for a new dad are enormous. Just thinking about the costs of raising the kid to 21, maybe for life, can be terrifying. And all the unspoken fears: Will my wife still be as interested in me? Will my baby be as cute as my brother’s baby?”, Stotland explained to WebMD.

Stotland has served on the speakers’ bureaus of Glaxo and Pfizer, according to Slate Magazine. In 2006, the pharmaceutical industry accounted for about 30% of the APA’s $62.5 million in financing, the July 12, 2008 New York Times reported.

Pfizer’s 2008 grant report shows donations of more than $700,000 to this “non-profit.” Lilly gave grants totaling more than $600,000 in both the first and second quarter of 2008. In 2007, the APA received over $400,000 from Lilly and another $450,000 went to the American Psychiatric Foundation.

Last summer, an investigation by the Senate Finance Committee, led by Iowa Senator Charles Grassley Senator accused the now president of the APA, Dr Alan Schatzberg of Stanford, of failing to disclose payments of over $70,000 from Johnson & Johnson and Lilly in filings with the University. The Senator also revealed Schatzberg’s stock ownership of millions of dollars in a company seeking to commercialize a depression drug. Schatzberg has since stepped down as chair of the psychiatry department at Emory.

On May 29, 2009, Katherine Stone wrote on the Postpartum Progress website: “The MOTHERS Act is not sponsored by the pharmaceutical industry.”

“Its only sponsors,” she said, “are the Senators (Menendez) and Representatives (Rush) who created it and brought it to a vote, thanks to the unending insistence of Carol Blocker, the mother of Melanie Blocker Stokes, who committed suicide while suffering from postpartum psychosis.”

“Its endorsers, I might point out, include the American College of Obstetricians & Gynecologists, the March of Dime, the National Healthy Mothers Healthy Babies Coalition, the Children’s Defense Fund and NOW,” she says, and also mentions a new one, the National Perinatal Foundation.

However, Katherine did not mention the main supporters listed on PerinatalPro, including the Depression and Bipolar Support Alliance, Mental Health America (MHA), National Alliance for the Mentally Ill (NAMI), National Council for Community Behavioral Healthcare, and the Suicide Prevention Action Network USA and the APA.

This sudden omission might have something to do with an article I wrote titled, “Just Say No to the Mothers Act,” in which I showed all the drug company money directly flowing to these front groups in great detail.

On June 2, 2009, Amy Philo, the leader of “Unite For Life,” a coalition of 50 groups against the Mothers Act, posted the dollar amounts funneled to these main supporters of the Act on her website, based on estimates from specific excerpts from the “Just Say No,” article, also posted on the site. The total she came up with was between $13,095,010 and $16,487,497.

The variation in the total amount resulted from the fact that front groups will often list how much companies give by wide margins For instance, the 2007 Annual Report for the Depression and Bipolar Alliance says the group received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.

The 2006 annual report for Mental Health America shows the group received over $1 million from Lilly, Bristol-Myers, and Wyeth in 2006. Pfizer and Janssen gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. Glaxo gave the group between $50,000 and $100,000.

As I have previously pointed out, Pfizer’s 2008 grant report shows a $20,000 grant to a Mental Health America group in Georgia to sponsor: “Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders.”

Next, I found a June 8, 2008 newsletter put out by the Georgia group that advertised Katherine Stone as the speaker for the lectures paid for by Pfizer. However, the Georgia group called the program: “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders.”

E-news said attendees of her presentation would learn in part: “One size does NOT fit all: Why postpartum depression is just part of a spectrum of mood disorders women may experience & what to look for.”

Without disclosing the large amount, e-news stated: “This special hour of learning is made possible by a grant from Pfizer.”

But in checking the Georgia group’s website yesterday, the ad there contained no mention of the fact that Pfizer paid the tab.

Pfizer markets drugs now commonly called “mood stablizers,” such as the anticonvulsants Lyrica and Neurontin, and the antipsychotic Geodon, 3 antidepressants including Zoloft, and Viagra, a big seller, likely due in part, to all the sexual side effects caused by psych drugs.

After Senator Grassley demanded an accounting, the National Alliance for the Mentally Ill, the executive director, Michael Fitzpatrick, admitted that “pharmaceutical companies contributed an average of 56% of national NAMI’s budget annually for the period 2005 to 2009,” in an April 28, 2009 letter to NAMI leaders and members.

Amy’s total does not include money to the National Healthy Mothers Healthy Babies Coalition, which receives money from Wyeth, Glaxo, J&J, Merck, and Sanofi Pasteur.

The total amount funneled through the Suicide Prevention Action Network USA is not available because it recently merged with the American Foundation for Suicide Prevention and Pfizer and Lilly were the only drug companies with public disclosures of their grants to both groups.

Dr Charles Nemeroff, another disgraced shrink who recently stepped down as the chair of the department of psychiatry at Emory University after 17 years, took over the presidency of the Foundation for Suicide Prevention for a 3-year term in 2008. Nemeroff’s resignation came after Senator Grassley revealed that he had earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory. Amy included this amount in the estimated total.

The list of members on councils and committees on the Foundation’s website includes Alan Lipschitz, MD, from Glaxo, Steven Romano, MD, of Pfizer, David Norton from Johnson & Johnson, and Cathryn Clary, MD of Pfizer, along with APA president, Alan Schatzberg, and Dr Frederick Goodwin, who had his radio show thrown off the air last fall after Senator Grassley revealed that he failed to tell listeners that he was receiving millions of dollars from drug companies.

The “Directors” of the Foundation include Pfizer’s Cathryn Clary, and Philip Ninan, MD of Wyeth Pharmaceuticals.

Katherine has herself listed online for hire on LinkedIn with a lead-off pitch that reads: “Talented, award-winning marketing and PR professional returning to the workforce after brief sabbatical as full-time mom.”

“Skills include experiential marketing concept development, brand positioning, marketing strategy, social networking, and public relations campaign development and execution,” she writes.

“Used break from full-time employment to become an expert at social media, creating most widely-read blog in the U.S. in her niche,” the summary says in obvious refererence to the Postpartum Progress site.

At the end, Katerine includes a paragraph on her days as an agent for the the public relations firm Cohn & Wolfe. This firm’s clients have included Lilly, Merck, Novartis, Pfizer and the American Foundation for Suicide Prevention.

Another website with links to all the others, is run by Lauren Hale, the Postpartum Support International Georgia coordinator. Her site seems dedicated to minimizing any negative information that comes out about taking psych drugs while pregnant or harm to the fetus. Once a commentary or article is posted on her site, the other gals usually put up a link to it on theirs to get maximum exposure on the internet.

For instance, on April 29, Hale used her site to discount some of the top experts in the field quoted in the May 2009 Vogue article, “Pregnant Pause,” by Alexis Jetter, which stated: “With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines.”

“What alarms doctors is the sheer number of pregnant women who use SSRI antidepressants – perhaps as many as 250,000 in the U.S. each year – when we still know so little about how the drugs effect babies,” Jetter reported.

“SSRI usage dramatically increases the chances that a baby may be miscarried, born prematurely or too small, suffer erratic heartbeats, and have trouble breathing,” she noted.

The rise to 250,000 appears to be quite a jump considering that back in the May 2005 Journal of the American Medical Association, researchers estimated that in any given year about 80,000 pregnant women in US were prescribed SSRIs.

In the article, Jetter quotes Dr Adam Urato as saying, “these antidepressants are portrayed almost like prenatal vitamins that will level out their mood and lead to a healthier baby. But antidepressants have not been shown to decrease rates of miscarriage or birth defects or low birth weight. On the contrary, they’ve been shown to increase those problems.”

Hale’s commentary was titled, “Thoughts on exploring a “Pregnancy Pause,” and she also sent it to Vogue. “I methodically refuted and balanced the article’s bias against medicating with anti-depressants during pregnancy,” she writes on her site.

On May 6, Karen Kleiman provided a link to “Thoughts” on her website and told readers, “Please take the time to read her very thoughtful and well-researched post.” The same day, Katherine also posted a link on Postpartum Progress with the headline, “Hale Responds to Vogue Piece on Antidepressants in Pregnancy.”

Not surprisingly, Hale specifically singled out the comments made by Dr Urato in the Vogue article. In 2006, Urato was responsible for exposing the fact that the financial ties of the authors to SSRI makers were not disclosed in a paper titled, “Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment,” published in the Journal of the American Medical Association, which led to major media coverage and a public admonition by the editor of JAMA reporting that seven authors had failed to reveal their financial ties to drug makers.

A letter from Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

The Wall Street Journal reported that, “the study 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,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

Most of the authors, the Journal noted, were leading psychiatrists at Harvard’s Massachusetts General Hospital, Emory University, and the University of California Los Angeles.

The American Psychiatric Associations’s pumping up SSRI sales at their annual meeting via a new male diagnosis of PPD may cause problems for couples who want more children for more reasons than lack of interest in sex by one or both partners. On October 24, 2006, the Guardian reported that a study by doctors at the Cornell Medical Center found that two patients who had normal sperm counts and mobility before taking SSRIs had a severe deterioration of both when they began taking the antidepressants.

The doctors, who were treating the two men for infertility, found that when the men stopped taking the SSRIs, their fertility problems disappeared only to resume again when they went back on SSRIs.

The problem is believed to be caused by an adverse effect of SSRIs on both the concentration and swimming ability of sperm. The men were tested over a 2-year period and Dr Peter Schlegel, who presented the research at the American Society for Reproductive Medicine conference, in New Orleans, explained that:

“The patients had normal sperm counts and motility before medication. On the medication they have severe deterioration of both. The same patients going on and off medication had the same pattern. It shows a strong association.”

Impotence and delayed ejaculation are well-known side-effects of SSRIs but now Dr Schlegel says he believes the drugs may be preventing sperm from getting into semen.

“These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them. It’s a dramatic effect and it’s never been described before,” he advised in the Guardian article.

“We believe that while it’s had a profound effect on these two men,” he said, “it could be having a significant but more subtle effect on many more men.”

Two years later, on September 24, 2008, Bloomberg News reported another study from Cornell University that found Paxil may impair fertility by damaging DNA in sperm.

The study of 35 healthy men who were given the antidepressant “found that the amount of damaged DNA in the men’s sperm rose to 30.3 percent after four weeks, from 13.8 percent,” the report noted.

“We suspect the other SSRIs would have similar effects,” Dr Schlegel told Bloomberg.

The treatment for all these “mood” and “anxiety” disorders women will be screened for as a result of the Mothers Act, includes not only antidepressants, but also drugs used as “mood stabilizers,” such as the antipsychotics Zyprexa, Seroquel, Risperdal, Invega, Geodon and Abilify, and antiseizure medications, along with benzodiazepines like Ativan and Xanax and sleeping pills such as Ambien or Lunesta.

In most cases patients are given combinations of different types of drugs at the same time. In fact, two different drug classes, Zyprexa and Prozac, are combined in Lilly’s Symbyax, and prescribed for “treatment resistant” depression. This one is a real money maker, selling at $1,564 for ninety 12-25mg capsules on DrugStore.com in May 2009.

For a simple diagnosis of “postpartum obsessive-compulsive disorder,” after her first pregnancy, Katherine Stone took “Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, and etc.,” according to a line in a story about the treatment she received on her website, which was removed after I wrote about it.

In a blog describing her treatment during her next pregnancy, where she admits she took Cymbalta throughout, Katherine identifies her shrink. “I saw my fabulous psychiatrist at Emory every month (Hi Dr. Newport!),” she writes.

That would be the Dr Jeffrey Newport at Emory University who has received research support from Lilly, Glaxo, Janssen, and Wyeth, and has served on speaker’s bureaus and/or received honoraria from AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according disclosures in the August 2007 study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes.”

Another author listed on this antipsychotic study is Charles Nemeroff.

On April 29, 2009, Philip Dawdy’s headline on the popular website Furious Seasons, read: “10 Percent Of Depressed Patients Now Take Antipsychotics,” based on statements made during a conference call by executives of Abilify maker Bristol-Myers Squibb.

“Forget about Prozac Nation, this is Atypical Nation,” he said. “Antipsychotics are now the top revenue producing class of drugs, topping even statins.

The labeling on Risperdal says Risperdal “can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use.”

“Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection,” the label notes.

A Patient Fact Sheet by the American Society for Reproductive Medicine, explains that, “Hyperprolactinemia is a condition in which too much prolactin is present in the blood of women who are not pregnant and in men.”

“In women, this results in a decline in the body’s production of progesterone after ovulation which, in turn, can lead to irregular ovulation and infrequent menstruation, cause you to stop menstruating altogether, or cause your breasts to start producing milk, a condition called galactorrhea,” it states.

“Men also can experience galactorrhea,” the Society says. “High prolactin levels in men can also lead to impotence, reduced libido, and infertility.”

A 2005 paper titled, “Medication-Induced Hyperprolactinemia,” from the Mayo Clinic reports that other classes of medications that cause hyperprolactinemia include antidepressants.

“The clinical consequences of hyperprolactinemia include galactorrhea and hypogonadotropic hypogonadism, the latter manifesting as oligomenorrhea or amenorrhea in women, erectile dysfunction in men, and loss of libido and infertility in both sexes,” the paper states.

A July 1, 2000 paper in the American Family Physician, by Dr Nancy Phillips, lists psychoactive medications that cause “disorders of desire” as antipsychotics, barbiturates, benzodiazepines, SSRIs, Lithium and Tricyclic antidepressants.

The list of drugs that cause “disorders of arousal” also includes benzodriazepines, SSRIs and Tricyclic antidepressants. These drugs, as well as antipsychotics and amphetamines (ADHD drugs) are reported to cause “orgasmic dysfunction” in the paper.

Purely to increase profits, people are encouraged to take psychiatric drugs for life and in some cases can never get off because the withdrawal syndrome is so severe.

It would be interesting see how many patients would be willing to begin a life-long treatment regimen if doctors were required to warn that it could mean the end of a normal sex life.

It would also be interesting to know how many patients are given the opportunity to check with their partners to see how long they will remain in a sexless relationship.

Correction: The article above mistakenly says that Alan Schatzberg stepped down as chair of the psychiatry department at Emory. He is at Stanford and he has not stepped down as chair of the psychiatry department. The statement should have been that Schatzberg of Stanford has “resigned his position as principal investigator on a federal research grant in response to the committee’s scrutiny,” the Stanford Daily reported.

Filed under: 'ADHD', 2009, AFSP, anticonvulsants, antipsychotics, APA, front groups, MHA, mothers act, NAMI, PPD, pregnant, sex, SSRIs

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