Evelyn Pringle July 24, 2007
On July 27, 2007, Bush's Big Pharma friendly CDC issued a press release clearly aimed at increasing the sale of SSRIs to pregnant women. "Use of certain antidepressants, selective serotonin-reuptake inhibitors most commonly known as SSRIs, during pregnancy does not significantly increase the risk for most birth defects," the CDC wrote.
The press release cited a new CDC study released in the New England Journal of Medicine and further stated, "a second study on SSRI and birth defects, also published in the June 28 issue of NEJM, did not find such an association with birth defects overall, but did find significant associations between specific SSRIs and several birth defects."
Since the CDC put out the press release, hundreds of headlines have flooded the internet citing the new studies as proof that there is a low risk of birth defects with SSRI use during pregnancy, and the results of the studies have been reported as breaking health care news by every major media outlet in the US.
The pharmaceutical industry as a whole has spent a fortune buying influence in the media since 1997, when the government lifted restrictions on direct-to-consumer advertising.
In an article titled, Physicians and Bribery, published by News Target on July 7, 2005, Dani Veracty says the real story about prescription drugs is not being told because the drug makers are controlling the budgets of the major media companies by pumping hundreds of millions of dollars into TV, magazine, newspaper and online advertising.
"Because of this," he states, "the media companies out there don't want to say anything bad about these prescription drugs."
In the July-August Columbia Journalism Review, contributing editor Judy Lieberman, reported that at the end of 2004, drug-company ad revenue for Time Magazine totaled $67 million; for Newsweek $43 million; and for The New York Times took in $13 million.
By 2004, she reported, advertising revenues for the five networks including CNN and Fox news was $1.5 billion.
The drugs in the NEJM studies included Prozac by Eli Lilly, Zoloft from Pfizer; Paxil by GlaxoSmithKline, Celexa and Lexapro from Forest Labs; Luvox by Solvay, Effexor by Wyeth, and generic SSRI makers include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
Prior to the arrival SSRIs on the market, depression was estimated to affect only 100 people per million and patients with depression sought help from a medical professional trained in psychiatry and the treatment of disorder.
However, the rate of depression is now estimated to be in the range of 50,000 to 100,000 cases per million, or between a 500 to 1,000-fold increase, according to Jane Currie in the Marketization of Depression, in the May 2005 journal Women and Health Protection.
In April 2004, the CDC reported that antidepressants topped the list of drugs prescribed to women at visits to doctor's offices and outpatient departments, followed by estrogens and progestins, antiarthritics, and medicines for acid/peptic disorders, in the Journal of Women's Health.
By 2005, the CDC recently reported, antidepressants were the most prescribed drugs in the US during visits to doctors and hospitals and were prescribed far more often than even medications used to treat high blood pressure, cholesterol, diabetes, and headaches.
Yet, a recent analysis of studies on the efficacy of 12 second-generation antidepressants including SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), released on January 25, 2007, by the Agency for Healthcare Research and Quality's (AHRQ), a division of the US Department of Health and Human Services, offers little support for the wide-spread use of these medications.
The AHRQ reviewed efficacy in treating major depressive disorder, dysthymia and subsyndromal depression (including minor depression), and also evaluated comparative efficacy for maintaining remission and for treating accompanying symptoms such as anxiety or insomnia or neurovegetative symptoms.
The review included 187 studies deemed to be of good or fair quality, including 89 head-to-head randomized controlled trials, 57 placebo-controlled randomized studies, with 126 of the studies sponsored by drug companies and 17 funded by government agencies or independent sources, and analyzed the effectiveness of Cymbalta, Wellbutrin, Effexor, Celexa, Lexapro, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft, and Desyrel, many of which are now also sold in generic form.
Overall the analysis found that in controlled studies, during 6 to 12 weeks of treatment, well over a third of the patients, or 38%, saw no improvement in their condition and 54% had only partial improvement and did not achieve remission.
In light of this clear lack of efficacy, it should be noted that as early as August 2004, the FDA label for SSRIs warned that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric”
According to one of the world's leading experts on SSRIs, Dr Peter Breggin, author of The Antidepressant Fact Book, “few physicians realize that meta-analyses have shown that antidepressants work no better than placebo at lifting depression.”
So in the case of pregnant women he says, “The risk/benefit ration weighs a placebo effect against increased parental suicide and violence, and babies with congenital defects, babies undergoing withdrawal reactions, and babies whose brains have been forever changed by being soaked in SSRIs during their development.”
Dr Breggin also notes that the NEMJ researchers failed to consider the serious withdrawal reaction in newborns and the potentially disastrous consequences of SSRI use by pregnant women. "Withdrawal reactions confirm that the brain of the fetus has been bathed in SSRIs and that it has suffered significant functional changes," he warns.
"It should be no surprise that it is not good to bath the growing brain in toxic drugs like SSRIs," he says, "because serotonin is intimately involved in the development of the brain in utero and SSRIs inhibit normal brain cell development."
Experts say, SSRI use creates an unnecessary risk for fetus. Dr David Healy, another leading authority on SSRIs, and the author of "The Creation of Psychopharmacology," and "The Antidepressant Era," says, "the overwhelming majority of women who are prescribed SSRIs are at little or no risk for suicide or other adverse outcomes from their nervous state."
He points out that every pregnant woman may have symptoms of depression such as anxiety, disturbed sleep, fatigue, or a loss of interest in sex. "But having depressive symptoms and being depressed are two different things," he states.
Dr Healy also notes the lack of efficacy shown with SSRIs, and says the risks of the neonatal withdrawal syndrome and serious birth defects to the infant far outweigh any benefits of their use by expectant mothers.
Houston Attorney, Robert S Kwok, is outraged by the new campaign to promote the use of SSRI with pregnant women. "It's ludicrous to think a woman is at greater risk of depression during her pregnancy and should take antidepressants despite the proven risk to her developing fetus," he states, "yet physician "opinion leaders" with industry ties are actively trying to convince doctors and patients of just that."
Mr Kwok represents the family of Gavin Shore, a baby born with a severe cardiac defect known as Shone's Anomaly after his mother was prescribed the SSRI Celexa during pregnancy and says Gavin's mother was not warned that taking an SSRI could double the risk of her baby being born with a severe heart defect.
Although some of the reports citing the NEMJ studies in media mentioned that Glaxo money was involved in funding the CDC study, most neglected to mention the financial contributions of the other drug companies for the study, or the steady stream of drug money that flows to the medical facilities and researchers involved in the studies.
When combined, the named universities, hospitals and researchers involved have received money from Lilly, Pfizer, Wyeth, Glaxo, Aventis, Sanofi Pasteur, and the 3 companies that make generic versions of SSRIs.
The CDC study lists Harvard Medical School and Massachusetts General Hospital as participating and the Harvard Medical School receives nearly 25% of its funding from non-government sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck, according to an April 12, 2006 report in The Phoenix.
In addition, The Phoenix noted, SEC filings showed Harvard stock holdings of $16 million with Merck, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer.
In one NEJM study, Dr Jan Friedman reported receiving honoraria for consulting from I3 Research, which is actually a huge conglomerate of "research" firms with names that begin with i3. The April 12, 2006 Phoenix reported that a firm called i3 Innovus, which co-authored 16 medical-journal articles in 2005, “provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.”
The Phoenix also noted that this i3 firm had a Boston office for its vice-president of US operations, Milton Weinstein, who also happened to be a professor at Harvard Medical School and Harvard School of Public Health.
The same group of industry backed research institutions credited in the NEJM CDC study, began the disinformation campaign to boost the sale of SSRIs to pregnant women more than a year ago when "experts" at Harvard and Mass General published a study to intentionally dilute the finding of a mounting number of studies that found serious birth defects to be associated with the use of the drugs by pregnant women.
In response to a study in the February 2006, New England Journal of Medicine that showed infants exposed to SSRIs in the womb were 6 times more likely to be born with the life-threatening lung disorder, persistent pulmonary hypertension, a study appeared in the Journal of the American Medical Association the same month warning that stopping SSRIs could greatly increase the risk of pregnant women relapsing into depression.
On February 1, 2006, the Associated Press described the methods used by the Massachusetts gang when conducting the JAMA study and said researchers "followed 201 pregnant women with histories of major depression who were taking drugs such as Prozac, Zoloft, Effexor and Paxil."
"Because of ethical concerns," the article said, "the researchers did not randomly assign the women to either stop or continue medication."
Instead, the AP reported, the women decided what to do and then the "researchers watched what happened."
But the actual report on the study shows that of the 201 participants, 13 miscarried, 5 terminated their pregnancy, 12 were lost to follow-up prior to the end of pregnancy, and 8 chose to withdraw from the study.
So when reporting on the few pregnant women that remained, the study said mothers were 5 times more likely to suffer a relapse than those who continued taking the drugs.
However, a highly relevant finding rarely mentioned, in what turned out to be this wee little study, is that 26% of the women who remained on the drugs became depressed anyways.
The study authors noted that of the 82 women who continued antidepressant treatment throughout pregnancy, 21 or 26% relapsed. But there were only 65 women in the group that discontinued the drugs, so the results logically showed a higher rate of relapse when 45 became depressed.
Moreover, nearly 2 years before the study was published in JAMA, on January 13, 2004, the lead author, Dr Lee Cohen was quoted in the New York Times as saying about 75 to 80% of pregnant women who go off antidepressants will relapse during the pregnancy.
Six months after JAMA ran the study, the July 11, 2006 Wall Street Journal explained why the 13 "experts" might encourage pregnant women to keep taking SSRIs, in stating the lead author, Dr Cohen, who was a Harvard Medical School professor and director of the research program at Massachusetts General, was a longtime consultant to the 3 antidepressant makers, a paid speaker for 7, and his research work was funded by 4 drug companies.
In fact, the Journal reported, “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."
And just like clock-work, the Cohen's study was widely cited in other journals promoting the sale of SSRIs to pregnant women. "In summary, it seems clear that the risks of not receiving adequate antidepressant treatment thus far outweigh the risks of adverse events, not only in infants but in mothers as well," wrote Dr Pierre Blier of the University of Ottawa in editorial in the Journal of Psychiatry and Neuroscience, 2006;31(4):226-8.
"The population," he warned, "should therefore learn to fear the illness more than the antidepressant."
But as it turns out, Dr Blier conflicting interests included among others, being a consultant with Lilly, Forest Labs, Janssen, Wyeth and Sanofi-Aventis, and a contract employee with Forest Labs. He was also in the speaker's bureau for Lilly, Forest Labs, and Wyeth, and received grant funding from Lilly, Forest Labs and Wyeth.
The JAMA study, along with a brief note from Dr Cohen himself, was also featured in the Spring 2006 issue of Massachusetts General Hospital's Center for Women's Health Newsletter, in a publication that downplayed the risk of just about all the birth defects discovered in recent years including heart birth defects and the infant withdrawal syndrome.
Since 1990, JAMA has required authors of studies to list all financial interests and has published the disclosures. In an online editorial in July 2006, JAMA editor, Dr Catherine DeAngelis announced her intention to enforce the policy in part by publicizing any author's failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard Medical School and included Dr Cohen's study.
On July 11, 2006, citing material promoting the events, the Wall Street Journal reported that the Massachusetts General psychiatry academy planned to conduct Continuing Medical Education seminars in a dozen cities across the US, with Dr Cohen overseeing a segment on the treatment of pregnant women with psychiatric disorders.
One of the funding sources for the seminars was revealed less than a year later on May 1, 2007, when the Journal reported the major recipients of the $11.8 million that Eli Lilly gave out during the first three months of 2007, and said the largest single grant "was $825,000 to Massachusetts General Hospital's psychiatry department for a year-long educational program with more than 150,000 registrants."
It should be noted that Lilly introduced the first SSRI, Prozac, in the late 1980s and its current best-selling antidepressant Cymbalta earned the company $1.3 billion in 2006.
The financial ties between the researchers and SSRI makers was brought to the attention of the JAMA editor by Dr Adam Urato and a letter from Dr 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.
However, all that being said, the Cohen study is still being cited to promote the use of SSRIs with pregnant women, and as recently as April 26, 2007, in a paper by Dr Claudio Soares, director of Women's Health Concerns Clinic, McMaster University, Ontario in Journal Watch Women's Health, a publication put out by the NEJM.
"Results of a recent prospective study of pregnant women," he wrote, "who were taking antidepressants at or near the time of conception demonstrated that women who opted to discontinue treatment during pregnancy were five times more likely to relapse than were those who stayed on treatment."
"Despite the cautionary remarks commonly made by most regulatory agencies and medical societies about the use of psychotropic medications during pregnancy," Dr Soares states, "considerable data supporting the efficacy and reproductive safety of antidepressants have accrued."
"Conversely," he warns, "evidence suggests that untreated depression has negative consequences for both mother and child."
"In summary," Dr Soares states, "clinicians should bear in mind the mounting evidence about the adverse effects of uncontrolled depression during pregnancy."
But here too, Dr Urato, wrote a response to this obvious sales pitch objecting to the total lack of citations to studies that support the assertion that the risks of birth defects associated with SSRI are rare and that the benefits of SSRIs use to avoid relapse into depression outweigh the risks.
But most concerning, Dr Urato wrote, "is the complete lack of financial disclosure information to go along with the article."
"As I was reading this piece," he wrote, "I kept thinking to myself "'Boy, this sounds like it was written by someone working for the antidepressant makers.'"
And sure enough, Dr Urato found that Dr Soares is on the Speaker's Bureau for Forest Labs, Wyeth, Glaxo, and Pfizer and has received honoraria as a research consultant for Sepracor, Glaxo, Wyeth, and Neurocrine.
Mr Kwok is also highly critical of the increasingly common practice of using "opinion leaders" like Dr Soares to sell SSRIs to pregnant women, but states, “there will come a time when the drug manufacturers will have to face the music on SSRIs causing PPHN, and that time is coming soon."
He says his firm has an abundance of new cases that prove it's no coincidence that pregnant mothers on SSRIs have an increased likelihood of giving birth to babies with PPHN in families where there is no history of respiratory illness.
“Just yesterday,” Mr Kwok states, “I spoke to a mother who birthed a baby with a serious breathing disorder that requires regular use of a nebulizer, a device used to administer medication via liquid mist to the airways, commonly used in treating asthma and other respiratory diseases."
"This young mother is now at risk of losing her job," Mr Kwok reports, "since her infant requires full time care."
He says doctors should be instructed to screen patients who are pregnant or planning to become pregnant and inform them of the risks of SSRIs to a developing fetus. "At least educate this “class” of women," he says, "so they may make informed personal decisions."
"Sure, the loss of this “class” may cost the drug manufacturers some profit," he notes, "but it's the right thing to do and it will save many families a lifetime of torture caring for a sick child like we see over and over again.”
The need to recapture pregnant women as customers is crucial for some SSRI makers. For instance, Forest Labs reported that Lexapro and Celexa accounted for 68% of the firm's total sales for the year ending March 31, 2006, in its Annual Report filed with the SEC.
Back in May 2005, researchers from the University of Pittsburgh estimated that in any given year at least 80,000 pregnant women in US are prescribed SSRIs, in JAMA.
(This article is written as part of a series on Celexa related litigation and is sponsored by Robert Kwok & Associates, LLP)
Showing posts with label birth defects. Show all posts
Showing posts with label birth defects. Show all posts
Sunday, August 8, 2010
CDC Leads SSRI Disinformation Media Blitz
Evelyn Pringle July 20, 2007
In a June 27, 2007 press release that made headlines all over the world the US Centers for Disease Control announced that birth defects associated with the use of antidepressants by pregnant women are rare. As proof for this claim, the CDC cited two new studies published in the New England Journal of Medicine.
Over the following 2 weeks hundreds of stories magically appeared in newspapers with headlines splashed all over the internet and "medical experts" appeared live on all the major television networks to tout the new studies as major health "news" in a well-coordinated media blitz clearly aimed at promoting the sale of selective serotonin reuptake inhibitor antidepressants (SSRIs) to pregnant women.
The well-coordinated blitz downplayed all the serious birth defects that have been reported in numerous studies over the past several years and all the warnings issued by the FDA over the past several years about the fetal harm known to be associated with the drugs.
The antidepressants included in the NEJM studies included Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
The public needs to know that the CDC study was funded in part by GlaxoSmithKline, the maker of Paxil, which carries the strongest FDA warnings about birth defects developing in infants exposed to the drug in the womb.
Experts point out that the hundreds of headlines failed to disclose the best kept secret about SSRIs - that the drugs do not work. "When tested in head-to-head competition it would take more space than a newspaper article will permit to explain how hard the researchers have to "work" to "prove" that these antidepressants work at all," says SSRI expert, Dr Grace Jackson, author of "Rethinking Psychiatric Drugs: A Guide for Informed Consent."
A fact also not mentioned in the headlines is that the studies were limited to women who took the drugs during the first trimester of pregnancy and the research consisted of mostly phone conversations that took place years ago with women who relied on their own memories without reviewing any medical records or actual pharmacy prescription data.
Most importantly, experts say, the researchers diluted the FDA warning about studies that found babies exposed to SSRIs after the 20th week of pregnancy, have a 6-fold increased risk of developing persistent pulmonary hypertension, a life-threatening lung disorder.
On July 19, 2006, the agency issued a Public Health Advisory and said, "the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN."
The Advisory warned that: "Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies" and "Babies with PPHN can be very sick and may die."
On October 16, 2006, the first PPHN related lawsuit was filed against Glaxo on behalf of the family of an infant born with the disorder after exposure to Paxil in the womb, by Attorney Karen Barth Menzies, a partner in the Baum Hedlund law firm and the leader of the firm's Antidepressant Litigation Department.
According to Ms Menzies, "FDA regulations require Glaxo to issue stronger warnings whenever there is reasonable evidence of an association between a serious risk and Paxil."
She points out that research indicated the risk of PPHN in a study published more than 10 years ago on October 3, 1996, in the New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego.
"FDA regulations specifically state that a causal link need not be proven and allow Glaxo to issue a new warning without prior FDA approval," Ms Menzies notes.
She reports that infants born with PPHN often require mechanical assistance to breath but 10% to 20% of infants do not survive even when they receive treatment.
The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.
The headlines about the NEJM studies in the media were also misleading because the researchers did find that Zoloft and Paxil were associated with "significant increases" in specific birth defects, and stated the "current study suggests that specific SSRIs may increase the risk of specific birth defects, and further studies will need sufficient power to pursue these important clinical questions."
Heart birth defects in infants exposed to Paxil were found to occur 3 times more often and heart defects were 2 times higher in newborns exposed to Zoloft. The CDC researchers reported that by using an "embryologically based classification" of heart defects, "we found a doubling of the risk of septal defects" associated with Zoloft use, and "a tripling of the risk of right ventricular outflow tract obstruction defects" associated with Paxil.
The studies also found a nearly 6-fold rise in the risk of clubfoot in children of women who used Paxil and reported other birth defects including (1) anencephaly, (2) craniosynostosis; and (3) omphalocele.
Anencephaly, a neural tube defect where much of the brain does not develop, was found to be 2.4 times higher, and omphalocele, a condition in which the infant's intestine or other abdominal organs protrude from the navel was 2.8 times more prevalent overall and 6.4 times higher with Paxil.
Craniosynostosis, an abnormality in which connections of the skull bones close prematurely, was found to be 2.5 times greater, and the neural tube defect, spina bifida, a condition where the spinal column does not completely close in the first month of pregnancy, was also noted.
Experts warn that far more infants will be born with birth defects in the coming years as a result of tens of thousands of infants being exposed to SSRIs in the womb every year.
In addition to birth defects, many other serious adverse events have been found to be associated with SSRIs over the past decade. Studies have shown the drugs to be linked to suicidality, violent and homicidal behavior, abnormal gastrointestinal and uterine bleeding, fertility problems, sexual dysfunction, a decrease in bone density, and a severe withdrawal syndrome in patients and infants born to mothers taking the drugs.
The risk associated with depression in pregnancy is suicidality. But one of the world's leading authorities on SSRIs, Dr Peter Breggin, reports that SSRIs are known to increase the risks of suicide. "In fact," he says, "the new FDA labels for antidepressants specifically warn about SSRI-induced suicidality in youth and in young adults, the very group most likely to become pregnant."
"The SSRIs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well," Dr Breggin advises.
As a direct result of the industry's control over the mainstream media, the public is never properly warned about serious risks found to be associated with a drug because if the story gets told at all, it will only be in the news for a day or two, and then "medical experts" will suddenly show up on "news" programs for 2 or 3 days in a row to present what amounts to an infomercial to discount the risks reported in the study.
The industry's control of the media began back in the late 1990s when the ban on direct-to-consumer advertising was lifted. Since then, the industry has invested so much money in advertising that all the media companies in the US are now dependent on drug money.
Due to this control, the industry paid shills are now dispatched on a regular basis to disseminate false information about the risks and benefits of a drug using the public airwaves even when an advertisement that contained the same bogus information would result in the sanction of a drug company for presenting false and misleading information to the public.
Drug companies basically bribe the medial journals to print their studies because the editors know the company will purchase thousands of copies for distribution to prescribing doctors, with full knowledge that most doctors will never read the whole study, but will remember the misleading headline because it was published in the "reputable" medical journal.
And Big Pharma funnels money to researchers in a variety of ways. Dr Marcia Angell, a nationally recognized authority on medical ethics and a former editor of the New England Journal of Medicine, had this to say in a the NEJM in 2000, about the financial ties between the industry and researchers:
"The ties between clinical researchers and industry include not only grant supports, but also a host of other financial arrangements.
"Researchers also serve as consultants to companies whose products they are studying, join advisory boards and speakers bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings"
After a rigged study is planted in a medical journal, the next step in the marketing scam is to provide a favorable report on the findings, also ghost-written by the drug maker or a PR firm, in a press release that is sent out to all the major news outlets which guarantees that headlines about the results will appear all over the world.
From there, the company uses the media to plant feature stories to reinforce the headline of the press release and in many cases, the news articles will quote the information verbatim from the drug maker's press release.
In the final act, the media provides the company with a platform for the "medical experts" to reach consumers to tout the new study on all the major networks in "news" segments which in turn sends patients running to their doctors with news of the miraculous new findings and demanding a prescription for the drug.
In the book, "Trust Us We're Experts," by Sheldon Rampton and John Stauber, the authors document the many techniques used by PR firms hired to pump out propaganda through the press and refer to the mainstream media as the "disinfotainment industry."
They report that the psychiatric manipulation industry is enormous and pays out about $10 billion a year to propaganda experts and that about 40% of all stories in the media are planted by PR firms.
Because most news stories on radio and TV are nothing more than a rehashing of stories published in newspapers, the book notes, the news Americans receive every day amounts to nothing but propaganda.
The success of the media backed campaign to sell SSRIs to pregnant women by discounting the years of studies showing serious harm to the fetus is clear evidence that "disinfotainment industry" is still paying high dividends to all shareholders in the US.
In a June 27, 2007 press release that made headlines all over the world the US Centers for Disease Control announced that birth defects associated with the use of antidepressants by pregnant women are rare. As proof for this claim, the CDC cited two new studies published in the New England Journal of Medicine.
Over the following 2 weeks hundreds of stories magically appeared in newspapers with headlines splashed all over the internet and "medical experts" appeared live on all the major television networks to tout the new studies as major health "news" in a well-coordinated media blitz clearly aimed at promoting the sale of selective serotonin reuptake inhibitor antidepressants (SSRIs) to pregnant women.
The well-coordinated blitz downplayed all the serious birth defects that have been reported in numerous studies over the past several years and all the warnings issued by the FDA over the past several years about the fetal harm known to be associated with the drugs.
The antidepressants included in the NEJM studies included Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
The public needs to know that the CDC study was funded in part by GlaxoSmithKline, the maker of Paxil, which carries the strongest FDA warnings about birth defects developing in infants exposed to the drug in the womb.
Experts point out that the hundreds of headlines failed to disclose the best kept secret about SSRIs - that the drugs do not work. "When tested in head-to-head competition it would take more space than a newspaper article will permit to explain how hard the researchers have to "work" to "prove" that these antidepressants work at all," says SSRI expert, Dr Grace Jackson, author of "Rethinking Psychiatric Drugs: A Guide for Informed Consent."
A fact also not mentioned in the headlines is that the studies were limited to women who took the drugs during the first trimester of pregnancy and the research consisted of mostly phone conversations that took place years ago with women who relied on their own memories without reviewing any medical records or actual pharmacy prescription data.
Most importantly, experts say, the researchers diluted the FDA warning about studies that found babies exposed to SSRIs after the 20th week of pregnancy, have a 6-fold increased risk of developing persistent pulmonary hypertension, a life-threatening lung disorder.
On July 19, 2006, the agency issued a Public Health Advisory and said, "the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN."
The Advisory warned that: "Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies" and "Babies with PPHN can be very sick and may die."
On October 16, 2006, the first PPHN related lawsuit was filed against Glaxo on behalf of the family of an infant born with the disorder after exposure to Paxil in the womb, by Attorney Karen Barth Menzies, a partner in the Baum Hedlund law firm and the leader of the firm's Antidepressant Litigation Department.
According to Ms Menzies, "FDA regulations require Glaxo to issue stronger warnings whenever there is reasonable evidence of an association between a serious risk and Paxil."
She points out that research indicated the risk of PPHN in a study published more than 10 years ago on October 3, 1996, in the New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego.
"FDA regulations specifically state that a causal link need not be proven and allow Glaxo to issue a new warning without prior FDA approval," Ms Menzies notes.
She reports that infants born with PPHN often require mechanical assistance to breath but 10% to 20% of infants do not survive even when they receive treatment.
The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.
The headlines about the NEJM studies in the media were also misleading because the researchers did find that Zoloft and Paxil were associated with "significant increases" in specific birth defects, and stated the "current study suggests that specific SSRIs may increase the risk of specific birth defects, and further studies will need sufficient power to pursue these important clinical questions."
Heart birth defects in infants exposed to Paxil were found to occur 3 times more often and heart defects were 2 times higher in newborns exposed to Zoloft. The CDC researchers reported that by using an "embryologically based classification" of heart defects, "we found a doubling of the risk of septal defects" associated with Zoloft use, and "a tripling of the risk of right ventricular outflow tract obstruction defects" associated with Paxil.
The studies also found a nearly 6-fold rise in the risk of clubfoot in children of women who used Paxil and reported other birth defects including (1) anencephaly, (2) craniosynostosis; and (3) omphalocele.
Anencephaly, a neural tube defect where much of the brain does not develop, was found to be 2.4 times higher, and omphalocele, a condition in which the infant's intestine or other abdominal organs protrude from the navel was 2.8 times more prevalent overall and 6.4 times higher with Paxil.
Craniosynostosis, an abnormality in which connections of the skull bones close prematurely, was found to be 2.5 times greater, and the neural tube defect, spina bifida, a condition where the spinal column does not completely close in the first month of pregnancy, was also noted.
Experts warn that far more infants will be born with birth defects in the coming years as a result of tens of thousands of infants being exposed to SSRIs in the womb every year.
In addition to birth defects, many other serious adverse events have been found to be associated with SSRIs over the past decade. Studies have shown the drugs to be linked to suicidality, violent and homicidal behavior, abnormal gastrointestinal and uterine bleeding, fertility problems, sexual dysfunction, a decrease in bone density, and a severe withdrawal syndrome in patients and infants born to mothers taking the drugs.
The risk associated with depression in pregnancy is suicidality. But one of the world's leading authorities on SSRIs, Dr Peter Breggin, reports that SSRIs are known to increase the risks of suicide. "In fact," he says, "the new FDA labels for antidepressants specifically warn about SSRI-induced suicidality in youth and in young adults, the very group most likely to become pregnant."
"The SSRIs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well," Dr Breggin advises.
As a direct result of the industry's control over the mainstream media, the public is never properly warned about serious risks found to be associated with a drug because if the story gets told at all, it will only be in the news for a day or two, and then "medical experts" will suddenly show up on "news" programs for 2 or 3 days in a row to present what amounts to an infomercial to discount the risks reported in the study.
The industry's control of the media began back in the late 1990s when the ban on direct-to-consumer advertising was lifted. Since then, the industry has invested so much money in advertising that all the media companies in the US are now dependent on drug money.
Due to this control, the industry paid shills are now dispatched on a regular basis to disseminate false information about the risks and benefits of a drug using the public airwaves even when an advertisement that contained the same bogus information would result in the sanction of a drug company for presenting false and misleading information to the public.
Drug companies basically bribe the medial journals to print their studies because the editors know the company will purchase thousands of copies for distribution to prescribing doctors, with full knowledge that most doctors will never read the whole study, but will remember the misleading headline because it was published in the "reputable" medical journal.
And Big Pharma funnels money to researchers in a variety of ways. Dr Marcia Angell, a nationally recognized authority on medical ethics and a former editor of the New England Journal of Medicine, had this to say in a the NEJM in 2000, about the financial ties between the industry and researchers:
"The ties between clinical researchers and industry include not only grant supports, but also a host of other financial arrangements.
"Researchers also serve as consultants to companies whose products they are studying, join advisory boards and speakers bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings"
After a rigged study is planted in a medical journal, the next step in the marketing scam is to provide a favorable report on the findings, also ghost-written by the drug maker or a PR firm, in a press release that is sent out to all the major news outlets which guarantees that headlines about the results will appear all over the world.
From there, the company uses the media to plant feature stories to reinforce the headline of the press release and in many cases, the news articles will quote the information verbatim from the drug maker's press release.
In the final act, the media provides the company with a platform for the "medical experts" to reach consumers to tout the new study on all the major networks in "news" segments which in turn sends patients running to their doctors with news of the miraculous new findings and demanding a prescription for the drug.
In the book, "Trust Us We're Experts," by Sheldon Rampton and John Stauber, the authors document the many techniques used by PR firms hired to pump out propaganda through the press and refer to the mainstream media as the "disinfotainment industry."
They report that the psychiatric manipulation industry is enormous and pays out about $10 billion a year to propaganda experts and that about 40% of all stories in the media are planted by PR firms.
Because most news stories on radio and TV are nothing more than a rehashing of stories published in newspapers, the book notes, the news Americans receive every day amounts to nothing but propaganda.
The success of the media backed campaign to sell SSRIs to pregnant women by discounting the years of studies showing serious harm to the fetus is clear evidence that "disinfotainment industry" is still paying high dividends to all shareholders in the US.
Taking Zoloft During Pregnancy Linked to Birth Defects
Evelyn Pringle June 7, 2007
Less than a year ago, in July 2006, the FDA issued a Public Health Advisory on a birth defect found to be associated with Zoloft and other selective serotonin reuptake inhibitor antidepressants by a study in the February 2006 New England Journal of Medicine that found a higher risk of a life-threatening lung disorder in infants exposed to SSRIs, stating:
"A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy."
PPHN infants have difficulty making the transition from breathing inside the womb to normal breathing after delivery, often leading to respiratory failure that requires mechanical ventilation. Even when treated, between 10% to 20% of babies born with PPHN do not survive.
Between 1998 and 2003, the research team interviewed 377 women who had recently given birth to a baby with PPHN, with questions about medical history and the drugs taken during pregnancy and found that 3.7% of the infants had been exposed SSRIs after the 20th week of pregnancy, or about 6 times the rate among healthy infants in a comparison group born at the same time.
Infants with PPHN typically show abnormal muscle cell growth in their respiratory system. Previous investigations have found that SSRIs tend to accumulate in adult users' lungs and serotonin can promote the proliferation of certain muscle cells. This may explain how the drugs could have an effect on the developing fetus, according to the study authors in the NEJM.
This birth defect is also not as rare as once thought. After the results of the PPHN study were released in February 2006, the lead author and researcher, Dr Christina Chambers, told the Wall Street Journal that women contacted her from all over the US who had given birth to babies with PPHN after using SSRIs during pregnancy.
Medical experts say its important to recognize that Pfizer promotes Zoloft for many disorders besides depression, meaning women may be taking the drug even though they have never been diagnosed with depression. According to the FDA, in addition to depression, Zoloft is approved to treat obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder.
In March 2006, Health Canada issued its own warning, "advising women who are taking antidepressants known as selective serotonin reuptake inhibitors and who are pregnant or intend to become pregnant to discuss the situation with their doctor, due to potential risks to the baby."
On April 7, 2006, the BBC reported that a Canadian study from the University of Ottawa of almost 5,000 mothers found that SSRI use during pregnancy doubled the risk of delivering a stillborn baby and that women who took the drugs were also more likely to have a premature or low-birth-weight baby.
The study found almost 20% of women who used SSRIs gave birth prematurely, compared to 12% of those who did not use the drugs and that babies born to women using SSRIs were also more likely to have seizures.
On August 25, 2006, Reuters Health reported another Canadian study that found that babies born to women who took SSRIs during pregnancy appear to be at increased risk of having a low birth weight and to develop respiratory distress.
Lead investigator Dr Tim Oberlander told Reuters that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."
The research team at the University of British Columbia, Vancouver, examined data for almost 120,000 live births between 1998 and 2001, and found 14% of the mothers who were diagnosed with depression.
The study compared the outcomes of babies born to depressed mothers treated with SSRIs and of those born to depressed mothers who were not treated, and there was a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, and longer hospital stays for infants born to mothers on SSRIs, the team reported in the Archives of General Psychiatry.
Birth weight and gestational age were also significantly less in SSRI infants, and a significantly greater proportion were born before 37 weeks. "These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression," Dr Oberlander told Reuters.
Preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all infant deaths in 2002, and the contribution of prematurity to infant mortality may be twice as high as originally estimated, according to Dr William Callaghan and colleagues in the October 2006 Pediatrics journal.
For the study, the researchers looked at the top 20 causes of infant deaths in 2002 and found that 34% of the deaths occurred in preterm infants, 95% of whom were born before 32 weeks gestational age and weighed less than 3.3 lbs. Two-thirds of the deaths in preterm infants occurred in the first 24 hours of life, the research team found.
The fact that SSRIs are highly addictive also adds to the health risks that a pregnant woman faces if she is already taking Zoloft. "A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor," said Dr Sandra Kweder, deputy director of the FDA's Office of New Drugs, in a March/April 2006 update on the FDA's Web site.
But on the flip-side of the coin, continuing to take Zoloft places the infant at risk for withdrawal. A February 2006 study in the Archives of Pediatrics & Adolescent Medicine reports that nearly one-third of infants born to women taking SSRIs show symptoms of withdrawal including tremors, high-pitched crying, gastrointestinal problems and sleep disturbances. The researchers found that 13% of the 60 newborns exposed to SSRIs exhibited severe symptoms of withdrawal.
An earlier study in the February 2004 Pediatrics journal found abnormal heart rhythms, sleeping patterns, and levels of alertness in babies exposed to SSRIs in the womb. Dr Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, and lead author, referred to the results as alarming.
The researchers compared one-day-old babies of mothers who took SSRIs with babies of mothers who did not and looked at sleeping and waking patterns, movements and heart rates. According to the study, infants exposed to SSRIs tended to be locked in one "sleep state" and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants."
In July 2004, the rising number of reports prompted the FDA to alter labeling for the entire SSRIs, warning that some newborns exposed to SSRIs and Effexor in the womb had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.
Critics also say, an important point to consider when weighing the risks and benefits of taking Zoloft during pregnancy, is that most experts who have evaluated all the clinical data on SSRIs say the benefits of the drugs are minimal.
In the July 2005 British Medical Journal, Moncrieff & Kirsch state in part: (1) Recent meta-analyses show [SSRIs] have no clinically meaningful advantage over placebo; (2) Methodological artifacts may account for the small degree of superiority over placebo; and (3) Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.
Less than a year ago, in July 2006, the FDA issued a Public Health Advisory on a birth defect found to be associated with Zoloft and other selective serotonin reuptake inhibitor antidepressants by a study in the February 2006 New England Journal of Medicine that found a higher risk of a life-threatening lung disorder in infants exposed to SSRIs, stating:
"A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy."
PPHN infants have difficulty making the transition from breathing inside the womb to normal breathing after delivery, often leading to respiratory failure that requires mechanical ventilation. Even when treated, between 10% to 20% of babies born with PPHN do not survive.
Between 1998 and 2003, the research team interviewed 377 women who had recently given birth to a baby with PPHN, with questions about medical history and the drugs taken during pregnancy and found that 3.7% of the infants had been exposed SSRIs after the 20th week of pregnancy, or about 6 times the rate among healthy infants in a comparison group born at the same time.
Infants with PPHN typically show abnormal muscle cell growth in their respiratory system. Previous investigations have found that SSRIs tend to accumulate in adult users' lungs and serotonin can promote the proliferation of certain muscle cells. This may explain how the drugs could have an effect on the developing fetus, according to the study authors in the NEJM.
This birth defect is also not as rare as once thought. After the results of the PPHN study were released in February 2006, the lead author and researcher, Dr Christina Chambers, told the Wall Street Journal that women contacted her from all over the US who had given birth to babies with PPHN after using SSRIs during pregnancy.
Medical experts say its important to recognize that Pfizer promotes Zoloft for many disorders besides depression, meaning women may be taking the drug even though they have never been diagnosed with depression. According to the FDA, in addition to depression, Zoloft is approved to treat obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder.
In March 2006, Health Canada issued its own warning, "advising women who are taking antidepressants known as selective serotonin reuptake inhibitors and who are pregnant or intend to become pregnant to discuss the situation with their doctor, due to potential risks to the baby."
On April 7, 2006, the BBC reported that a Canadian study from the University of Ottawa of almost 5,000 mothers found that SSRI use during pregnancy doubled the risk of delivering a stillborn baby and that women who took the drugs were also more likely to have a premature or low-birth-weight baby.
The study found almost 20% of women who used SSRIs gave birth prematurely, compared to 12% of those who did not use the drugs and that babies born to women using SSRIs were also more likely to have seizures.
On August 25, 2006, Reuters Health reported another Canadian study that found that babies born to women who took SSRIs during pregnancy appear to be at increased risk of having a low birth weight and to develop respiratory distress.
Lead investigator Dr Tim Oberlander told Reuters that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."
The research team at the University of British Columbia, Vancouver, examined data for almost 120,000 live births between 1998 and 2001, and found 14% of the mothers who were diagnosed with depression.
The study compared the outcomes of babies born to depressed mothers treated with SSRIs and of those born to depressed mothers who were not treated, and there was a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, and longer hospital stays for infants born to mothers on SSRIs, the team reported in the Archives of General Psychiatry.
Birth weight and gestational age were also significantly less in SSRI infants, and a significantly greater proportion were born before 37 weeks. "These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression," Dr Oberlander told Reuters.
Preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all infant deaths in 2002, and the contribution of prematurity to infant mortality may be twice as high as originally estimated, according to Dr William Callaghan and colleagues in the October 2006 Pediatrics journal.
For the study, the researchers looked at the top 20 causes of infant deaths in 2002 and found that 34% of the deaths occurred in preterm infants, 95% of whom were born before 32 weeks gestational age and weighed less than 3.3 lbs. Two-thirds of the deaths in preterm infants occurred in the first 24 hours of life, the research team found.
The fact that SSRIs are highly addictive also adds to the health risks that a pregnant woman faces if she is already taking Zoloft. "A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor," said Dr Sandra Kweder, deputy director of the FDA's Office of New Drugs, in a March/April 2006 update on the FDA's Web site.
But on the flip-side of the coin, continuing to take Zoloft places the infant at risk for withdrawal. A February 2006 study in the Archives of Pediatrics & Adolescent Medicine reports that nearly one-third of infants born to women taking SSRIs show symptoms of withdrawal including tremors, high-pitched crying, gastrointestinal problems and sleep disturbances. The researchers found that 13% of the 60 newborns exposed to SSRIs exhibited severe symptoms of withdrawal.
An earlier study in the February 2004 Pediatrics journal found abnormal heart rhythms, sleeping patterns, and levels of alertness in babies exposed to SSRIs in the womb. Dr Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, and lead author, referred to the results as alarming.
The researchers compared one-day-old babies of mothers who took SSRIs with babies of mothers who did not and looked at sleeping and waking patterns, movements and heart rates. According to the study, infants exposed to SSRIs tended to be locked in one "sleep state" and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants."
In July 2004, the rising number of reports prompted the FDA to alter labeling for the entire SSRIs, warning that some newborns exposed to SSRIs and Effexor in the womb had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.
Critics also say, an important point to consider when weighing the risks and benefits of taking Zoloft during pregnancy, is that most experts who have evaluated all the clinical data on SSRIs say the benefits of the drugs are minimal.
In the July 2005 British Medical Journal, Moncrieff & Kirsch state in part: (1) Recent meta-analyses show [SSRIs] have no clinically meaningful advantage over placebo; (2) Methodological artifacts may account for the small degree of superiority over placebo; and (3) Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.
Lawmakers Want to End Big Pharma Recruitment Schemes - Part 1
Evelyn Pringle May 29, 2007
Federal lawmakers are stepping up the pace to put a stop to the pharmaceutical industry's customer recruitment schemes used to boost the sale of psychiatric drugs by tugging at heartstrings in promoting mental health screening programs as suicide prevention tools.
On May 18, 2007, US House of Representative Ron Paul (R-Texas), a physician by calling, introduced a federal legislative bill HR 2387 that would block federal funding for any mandatory mental health screening programs. At last count, 12 other members of the House were listed as co-sponsors of the bill.
First of all, contrary to the lie that the industry is trying to sell the pubic, there is no epidemic of child suicides. There are roughly 50 million school-age children in this country, and according to the June 16, 2006, Washington Post, there were only 1,737 suicides by children and adolescents in 2003, the last year for which national statistics are available.
In addition, experts have said over and over that screenings do not work. A March 28, 2002 paper, "Suicide in the United States," by Jane Pearson, PhD, chairman of the National Institute of Mental Health Suicide Research Consortium at the time, states: "[W]hen researchers have tried to predict suicide using as many known risk factors as possible, they are still unable to predict who will and who will not commit this act."
In the paper, she also verifies a real danger that screening critics are concerned about, in stating that, "a prevention program for high-school aged youth found that participants were more likely to consider suicide a solution to a problem after the program than prior to the program."
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, "No matter how we define mental illness in children or adults, it cannot be found by simple screening."
"Nobody can, by merely looking at someone else, or even on the basis of a pen and pencil questionnaire," he says, "differentiate the transient emotional disturbances we all have from those which last longer."
Dr Lehrman also says screenings won't prevent suicide because those who are contemplating it usually won't tell. "Only when gross insanity exists can "mental illness" be recognized on inspection - and then we need neither experts nor screening," he states.
"There are as many causes of depression as there are people suffering from it," he explains
"Troubled people can indeed benefit from good mental health care," he advises, "But good treatment requires addressing voluntarily a patient's unique individual problems."
"For this, screenings are unnecessary," he adds.
The drugs marketed with the screening programs are the new generation of selective serotonin reuptake inhibitor antidepressants (SSRIs), including Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, which were falsely promoted as more effective than the older class of drugs in treating depression while the increased risk of suicide by patients taking the drugs was concealed.
The other drugs are the new class of atypical antipsychotics with brand names of Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon. It should be noted that the atypicals were FDA approved for the limited use of treating adults with schizophrenia and manic episodes of bipolar disorder, also known as manic-depression, the most serious of all mental illnesses.
These new drugs obviously do not work. A June 2005 study lead by researchers from Harvard Medical School, funded mostly by the National Institute of Mental Health, found that although there has been a dramatic rise in the treatment of mental disorders over the past decade, there had been no corresponding drop in the rate of suicidal thought and behaviors in adults.
The study pointed out that there had been a huge increase in the use of antidepressants during the 10-year period studied, but the rate of suicidal ideation, gestures and attempts has not changed at all.
Dr Barry Duncan, author of "What's Right With You," also says, "rates of depression have not changed for thirty years," and, "suicide rates, despite the millions taking antidepressants, have not reduced."
Dr Duncan points out that more than 150 million prescriptions worth $14 billion were written for antidepressants in 2003 alone.
However, evidence continues to mount that shows SSRIs are linked to suicide. On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.
"In an analysis of 'unnatural' deaths recorded by the Virginia Medical Examiner's Office for 1987 through 2003," MedPage wrote, "Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims."
This latest study echoes a report by records researcher Ken Kramer that found most child suicides in Florida were by children who are already on psychotropic drugs. Mr Kramer analyzed every autopsy and toxicology report on every child suicide in the state of Florida from 2000 to 2004.
"The majority," Mr Kramer says, "had already received psychiatric drug treatment even with the FDA warnings that say these drugs can cause mania, suicide, psychosis, worsening depression and even homicidal thoughts."
A recent March 2007 report by the Government Accountability Office on Pediatric Drug Research states: "About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing."
Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.
It is illegal for a drug maker to promote off-label uses, but doctors are allowed to prescribe a drug for any use they choose. However, almost without exception, the lawsuits now pending against psychotropic drug makers accuse the companies of influencing doctors to prescribe the medications for off-label uses.
Critics say this profit-driven drugging of patients recruited with screening programs has got to stop, because a whole generation of Americans are becoming disabled right before our eyes, and lawmakers should realize that the government is going to have to pay to care for these disabled people for life and not just their medical care, but for their very existence.
Linda Hurcombe, author of "Losing a Child: Explorations in Grief," admits that her concerns about mental health screening programs arise from a personal tragedy. She is a US citizen living in the UK where prescription drug advertising is illegal, but her daughter fell victim to drug advertising while she was visiting the US.
"A few years ago my undepressed teenage daughter saw an antidepressant ad on American television," Linda explains, "and on her return to our rural home she went to her doctor and asked for the drug."
"It took her about eight minutes to persuade the doctor," Linda says, "followed by 63 days of descent into chaos which ended in her suicide by hanging."
"As far as patient advocacy is concerned," she notes, "it is alluring to an increasingly health-aware public to demand more knowledge."
"But what sort of 'knowledge' is likely from a gaggle of marketing moguls?" she points out.
"We must give the marketing men and women their due," Linda says, "as they medicalize the human condition from the cradle to the grave."
"Disturbing examples," she points out, "include toddlers taking mint-flavoured Prozac for bipolar disorder, antsy kids being calmed with methamphetamines, people diagnosed with 'intermittent explosive disorder' [read 'anger'], being medicated instead of addressing the causes of the stress in their lives."
Linda has a new book, "Depression: healing emotional distress," coming out soon.
Even with the limited approved uses for atyicals, last year drug makers sold more than $15 billion in antipsychotic drugs, according to data compiled by Bloomberg. Lilly's Zyprexa generated $4.4 billion in sales last year, and Johnson & Johnson's Risperdal had sales of $4.2 billion. Sales of Abilify climbed 41 percent to $1.3 billion.
Some of the known adverse events associated with these drugs include rapid weight gain and high blood sugar levels which are risk factors for diabetes, and disfiguring tics, dystonia which produces involuntary, often painful muscle contractions, heart attacks and sudden death in elderly patients.
Sales figures are so high because the makers of atypicals have doctors prescribing the drugs for all kinds of unapproved uses. On May 10, 2007, the New York Times reported that when Anya Bailey developed an eating disorder at 12 years old, her mother took her to a psychiatrist at the University of Minnesota who prescribed Risperdal.
Risperdal is not approved for treating eating disorders or any disorder in 12 year olds.
Anya gained weight, the Times noted, but within 2 years, she developed a crippling knot in her back the result of a nerve condition called dystonia, and now receives regular injections of Botox to unclench her back muscles and she often wakes up crying in pain.
The Times reported that the mother was surprised to learn that her daughter received a drug for a treatment not approved by the FDA, but was more surprised to learn that the psychiatrist who supervised Anya's care received more than $7,000 from 2003 to 2004 from Risperdal maker Johnson & Johnson, in return for giving lectures about one of the company's drugs.
These new drugs are being fed to so many people in all age groups for uses not approved by the FDA that experts say its often impossible to determine whether a symptom is caused by a mental disorder or a side effect from a drug.
Dr Elliot Valenstein, PhD, author of "Blaming the Brain", says, "It is now difficult to find mental patients who have not had a history of drug treatment, and as a result many of the brain abnormalities found in these patients are probably iatrogenic, that is, produced by the treatment rather than being the cause of the disorder."
"It is well established," he advises, "that the drugs used to treat a mental disorder, for example, may induce long-lasting biochemical and even structural changes, which in the past were claimed to be the cause of the disorder, but may actually be an effect of the treatment."
Dr Lehrman warns that the screening programs will "harm thousands of Americans by giving them stigmatizing diagnoses which can follow them for the rest of their lives, and then drugging them."
In some cases, patients, including children as young as 2, are being given SSRIs, atypicals and ADHD medications all at the same time in drug cocktails that would make any patient act crazy. And when the weird behaviors start, the dosages of the drugs are increased and often another medication is added to the mix to treat the "new strange behaviors" which are actually side effects from the drug cocktail.
The serious side effects associated with these drugs are only now being revealed to the public and health care providers because the drug companies concealed studies that showed the adverse events had occurred in their own clinical trials years ago.
Also, the drug makers are starting to pay dearly for a decade of illegal marketing practices and the concealment of the adverse effects of the drugs.
For instance, to date, Eli Lilly has spent more than $1 billion to settle out of court with about 26,000 Zyprexa victims, with still more litigants waiting in the wings. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.
The company is also facing lawsuits by 10 states and 4 class actions, filed on behalf of shareholders, charging Lilly with fraud in promoting the off-label sale of Zyprexa while concealing its side effects.
Zoloft maker Pfizer's March 2007 SEC filing states in part, "A number of individual lawsuits have been filed against us in various federal and state courts alleging personal injury, including suicide and suicide attempt in certain cases, as a result of the purported ingesting of Zoloft."
Pfizer will no doubt be facing more lawsuits in the near future because Zoloft has now been linked to life-threatening birth defects in babies born to mothers who took the drug during pregnancy.
Federal lawmakers are stepping up the pace to put a stop to the pharmaceutical industry's customer recruitment schemes used to boost the sale of psychiatric drugs by tugging at heartstrings in promoting mental health screening programs as suicide prevention tools.
On May 18, 2007, US House of Representative Ron Paul (R-Texas), a physician by calling, introduced a federal legislative bill HR 2387 that would block federal funding for any mandatory mental health screening programs. At last count, 12 other members of the House were listed as co-sponsors of the bill.
First of all, contrary to the lie that the industry is trying to sell the pubic, there is no epidemic of child suicides. There are roughly 50 million school-age children in this country, and according to the June 16, 2006, Washington Post, there were only 1,737 suicides by children and adolescents in 2003, the last year for which national statistics are available.
In addition, experts have said over and over that screenings do not work. A March 28, 2002 paper, "Suicide in the United States," by Jane Pearson, PhD, chairman of the National Institute of Mental Health Suicide Research Consortium at the time, states: "[W]hen researchers have tried to predict suicide using as many known risk factors as possible, they are still unable to predict who will and who will not commit this act."
In the paper, she also verifies a real danger that screening critics are concerned about, in stating that, "a prevention program for high-school aged youth found that participants were more likely to consider suicide a solution to a problem after the program than prior to the program."
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, "No matter how we define mental illness in children or adults, it cannot be found by simple screening."
"Nobody can, by merely looking at someone else, or even on the basis of a pen and pencil questionnaire," he says, "differentiate the transient emotional disturbances we all have from those which last longer."
Dr Lehrman also says screenings won't prevent suicide because those who are contemplating it usually won't tell. "Only when gross insanity exists can "mental illness" be recognized on inspection - and then we need neither experts nor screening," he states.
"There are as many causes of depression as there are people suffering from it," he explains
"Troubled people can indeed benefit from good mental health care," he advises, "But good treatment requires addressing voluntarily a patient's unique individual problems."
"For this, screenings are unnecessary," he adds.
The drugs marketed with the screening programs are the new generation of selective serotonin reuptake inhibitor antidepressants (SSRIs), including Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, which were falsely promoted as more effective than the older class of drugs in treating depression while the increased risk of suicide by patients taking the drugs was concealed.
The other drugs are the new class of atypical antipsychotics with brand names of Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon. It should be noted that the atypicals were FDA approved for the limited use of treating adults with schizophrenia and manic episodes of bipolar disorder, also known as manic-depression, the most serious of all mental illnesses.
These new drugs obviously do not work. A June 2005 study lead by researchers from Harvard Medical School, funded mostly by the National Institute of Mental Health, found that although there has been a dramatic rise in the treatment of mental disorders over the past decade, there had been no corresponding drop in the rate of suicidal thought and behaviors in adults.
The study pointed out that there had been a huge increase in the use of antidepressants during the 10-year period studied, but the rate of suicidal ideation, gestures and attempts has not changed at all.
Dr Barry Duncan, author of "What's Right With You," also says, "rates of depression have not changed for thirty years," and, "suicide rates, despite the millions taking antidepressants, have not reduced."
Dr Duncan points out that more than 150 million prescriptions worth $14 billion were written for antidepressants in 2003 alone.
However, evidence continues to mount that shows SSRIs are linked to suicide. On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.
"In an analysis of 'unnatural' deaths recorded by the Virginia Medical Examiner's Office for 1987 through 2003," MedPage wrote, "Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims."
This latest study echoes a report by records researcher Ken Kramer that found most child suicides in Florida were by children who are already on psychotropic drugs. Mr Kramer analyzed every autopsy and toxicology report on every child suicide in the state of Florida from 2000 to 2004.
"The majority," Mr Kramer says, "had already received psychiatric drug treatment even with the FDA warnings that say these drugs can cause mania, suicide, psychosis, worsening depression and even homicidal thoughts."
A recent March 2007 report by the Government Accountability Office on Pediatric Drug Research states: "About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing."
Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.
It is illegal for a drug maker to promote off-label uses, but doctors are allowed to prescribe a drug for any use they choose. However, almost without exception, the lawsuits now pending against psychotropic drug makers accuse the companies of influencing doctors to prescribe the medications for off-label uses.
Critics say this profit-driven drugging of patients recruited with screening programs has got to stop, because a whole generation of Americans are becoming disabled right before our eyes, and lawmakers should realize that the government is going to have to pay to care for these disabled people for life and not just their medical care, but for their very existence.
Linda Hurcombe, author of "Losing a Child: Explorations in Grief," admits that her concerns about mental health screening programs arise from a personal tragedy. She is a US citizen living in the UK where prescription drug advertising is illegal, but her daughter fell victim to drug advertising while she was visiting the US.
"A few years ago my undepressed teenage daughter saw an antidepressant ad on American television," Linda explains, "and on her return to our rural home she went to her doctor and asked for the drug."
"It took her about eight minutes to persuade the doctor," Linda says, "followed by 63 days of descent into chaos which ended in her suicide by hanging."
"As far as patient advocacy is concerned," she notes, "it is alluring to an increasingly health-aware public to demand more knowledge."
"But what sort of 'knowledge' is likely from a gaggle of marketing moguls?" she points out.
"We must give the marketing men and women their due," Linda says, "as they medicalize the human condition from the cradle to the grave."
"Disturbing examples," she points out, "include toddlers taking mint-flavoured Prozac for bipolar disorder, antsy kids being calmed with methamphetamines, people diagnosed with 'intermittent explosive disorder' [read 'anger'], being medicated instead of addressing the causes of the stress in their lives."
Linda has a new book, "Depression: healing emotional distress," coming out soon.
Even with the limited approved uses for atyicals, last year drug makers sold more than $15 billion in antipsychotic drugs, according to data compiled by Bloomberg. Lilly's Zyprexa generated $4.4 billion in sales last year, and Johnson & Johnson's Risperdal had sales of $4.2 billion. Sales of Abilify climbed 41 percent to $1.3 billion.
Some of the known adverse events associated with these drugs include rapid weight gain and high blood sugar levels which are risk factors for diabetes, and disfiguring tics, dystonia which produces involuntary, often painful muscle contractions, heart attacks and sudden death in elderly patients.
Sales figures are so high because the makers of atypicals have doctors prescribing the drugs for all kinds of unapproved uses. On May 10, 2007, the New York Times reported that when Anya Bailey developed an eating disorder at 12 years old, her mother took her to a psychiatrist at the University of Minnesota who prescribed Risperdal.
Risperdal is not approved for treating eating disorders or any disorder in 12 year olds.
Anya gained weight, the Times noted, but within 2 years, she developed a crippling knot in her back the result of a nerve condition called dystonia, and now receives regular injections of Botox to unclench her back muscles and she often wakes up crying in pain.
The Times reported that the mother was surprised to learn that her daughter received a drug for a treatment not approved by the FDA, but was more surprised to learn that the psychiatrist who supervised Anya's care received more than $7,000 from 2003 to 2004 from Risperdal maker Johnson & Johnson, in return for giving lectures about one of the company's drugs.
These new drugs are being fed to so many people in all age groups for uses not approved by the FDA that experts say its often impossible to determine whether a symptom is caused by a mental disorder or a side effect from a drug.
Dr Elliot Valenstein, PhD, author of "Blaming the Brain", says, "It is now difficult to find mental patients who have not had a history of drug treatment, and as a result many of the brain abnormalities found in these patients are probably iatrogenic, that is, produced by the treatment rather than being the cause of the disorder."
"It is well established," he advises, "that the drugs used to treat a mental disorder, for example, may induce long-lasting biochemical and even structural changes, which in the past were claimed to be the cause of the disorder, but may actually be an effect of the treatment."
Dr Lehrman warns that the screening programs will "harm thousands of Americans by giving them stigmatizing diagnoses which can follow them for the rest of their lives, and then drugging them."
In some cases, patients, including children as young as 2, are being given SSRIs, atypicals and ADHD medications all at the same time in drug cocktails that would make any patient act crazy. And when the weird behaviors start, the dosages of the drugs are increased and often another medication is added to the mix to treat the "new strange behaviors" which are actually side effects from the drug cocktail.
The serious side effects associated with these drugs are only now being revealed to the public and health care providers because the drug companies concealed studies that showed the adverse events had occurred in their own clinical trials years ago.
Also, the drug makers are starting to pay dearly for a decade of illegal marketing practices and the concealment of the adverse effects of the drugs.
For instance, to date, Eli Lilly has spent more than $1 billion to settle out of court with about 26,000 Zyprexa victims, with still more litigants waiting in the wings. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.
The company is also facing lawsuits by 10 states and 4 class actions, filed on behalf of shareholders, charging Lilly with fraud in promoting the off-label sale of Zyprexa while concealing its side effects.
Zoloft maker Pfizer's March 2007 SEC filing states in part, "A number of individual lawsuits have been filed against us in various federal and state courts alleging personal injury, including suicide and suicide attempt in certain cases, as a result of the purported ingesting of Zoloft."
Pfizer will no doubt be facing more lawsuits in the near future because Zoloft has now been linked to life-threatening birth defects in babies born to mothers who took the drug during pregnancy.
Saturday, August 7, 2010
April 2007 Big Pharma Litigation Update - Drugs - Part II
Evelyn Pringle April 12, 2007
The anti-epileptic drug, Depakote (valproate), marketed by Abbott Laboratories, is one of the most heavily prescribed medications for off-label use. Experts say the evidence of harm caused by Depakote is just beginning to emerge.
According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, "we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions."
Bayer is under fire for hiding the adverse effects of the anti-clotting drug, Trasylol, used in heart surgery, and will no doubt be hit with plenty of lawsuits in the not to distant future, considering that Dr Dennis Mangano, the lead author of new study in the February 7, 2007, Journal of the American Medical Association, says that the Trasylol may be responsible for 10,000 deaths over five years.
On December 15, 2006, the FDA announced new labeling for Trasylol, and said a study suggests that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.
Because Trasylol is administered during surgery, many victims may not even realize they have been injured by the drug. But plenty have, according to Dr Mangano, who says that in 2006, Trasylol, was administered to 246,000 patients.
Another drug on the legal chopping block is the Parkinson's drug, Permax. As far back as December 2002, doctors at the Mayo Clinic reported heart valve disease in 3 patients who had been taking Permax, similar to damage caused by the Fen-Phen combination.
In 2004, HealthDay News reported that a study had confirmed previous findings that the drug could damage heart valves and surgery would be needed to correct it. Two new studies in the January 4, 2007, New England Journal of Medicine, report that the number of Permax patients who have developed valve damage is higher than expected.
One study, which included 155 patients taking various Parkinson's drugs, and 90 healthy patients in a comparison group, and found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.
The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other types of Parkinson's drugs, and patients taking the highest doses of Permax had a 37 times greater risk.
"This is not a rare side effect," says Dr Bryan Roth, a professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM.
"That's an extraordinarily high incidence," he warns. "That makes this a serious problem."
Heart valve damage is a life-threatening condition and costly to treat. Replacement requires open heart surgery, where the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine, according to the Texas Heart Institute. No drug can reverse valve damage, making replacement surgery the only option. Medical experts are advising all Permax patients to undergo testing for valve damage.
The drug was introduced to the US market by Eli Lilly, but Valeant Pharmaceuticals now sells Permax. On March 29, 2007, Permax was pulled off the market after the FDA reviewed new information that associates it with heart problems.
During the last 2 decades, the antidepressants, known as selective serotonin reuptake inhibitors, or SSRIs, have been prescribed for more unapproved uses than any other class of drugs in history. A June 2005, study in the Journal of Clinical Psychiatry, found that 75% of SSRI prescriptions written were for unapproved uses.
SSRIs have now been linked to suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.
On April 10, 2004, the British Medical Journal, criticized the authors of studies on SSRI's for exaggerating the benefits and downplaying the harm, including suicidality, and discussed a study of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only 2 in children in the placebo group.
The Paxil suicide risk is not limited to children. An August 22, 2005, study by Norwegian researchers of over 1,500 adults, found 7 Paxil patients attempted suicide compared to only 1 attempt in the group on a placebo, and recommended that warnings not to prescribe Paxil to children should also apply to adults.
According to Forest Lab's Annual Report filed on June 14, 2006, the company is a named defendant in approximately 25 lawsuits, with the majority involving the company's top selling SSRI drugs, Celexa or Lexapro, for inducing suicidality.
A wrongful death lawsuit was filed in September 2005, by the Pogust & Braslow law firm in Conshohocken, Pennsylvania, on behalf of the family of 32-year-old man who unexpectedly committed suicide soon after being prescribed Lexapro.
A steady stream of lawsuits have been filed against GlaxoSmithKline over Paxil, stemming from the company's concealment of the drug's link to suicide, birth defects, violence and withdrawal syndrome.
On March 23, 2006, the California-based Baum Hedlund law firm filed a national class-action lawsuit against Glaxo on behalf of the mother of an 11-year old Kansas boy who committed suicide, and a teenager in Texas who attempted suicide while taking Paxil.
She says, Baum Hedlund has documents obtained in litigation that show there was an awareness of the suicide risk as far back as the late 1970's, a decade before the first SSRI was approved for sale in the US.
A new round of Paxil lawsuits began on October 16, 2006, when Baum Hedlund filed a case alleging that Paxil use during pregnancy resulted in an infant being born with a life-threatening lung disorder, PPHN. Between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.
On July 28, 2006, Baum Hedlund also filed a lawsuit on behalf of the parents of an infant who was born with congenital heart birth defects as a result of his mother taking Paxil during pregnancy. Since birth, the child has undergone 3 open-heart surgeries and will likely have to undergo more and possibly a heart transplant at some point in the future.
Based on the company's legendary history of concealing adverse effects, the lead attorney on the case, Karen Barth Menzies, says believes Glaxo has known about these risks and should have warned prescribing doctors and consumers about these birth defects long ago.
The Houston law firm of Robert Kwok & Associates is handling a Celexa birth heart defects case in Kentucky. The mother was prescribed Celexa during pregnancy, and her baby was born with Shone's Complex, a form of congenital heart disease that consists of defects that lead to the obstruction of blood flow from the heart to the body.
Legal analysts are predicting that SSRI makers will offer early settlements in cases involving birth defects to avoid having these families appear before a jury.
Pfizer is still being sued left and right over adverse effects related to the epilepsy drug Neurontin. In 2004, the company pleaded guilty to charges involving a massive off-label marketing scheme and agreed to pay the second-largest settlement ever in a health care fraud prosecution of $403 million. By 2002, a full 94% of Neurontin sales were for off-label use, according to the August 16, 2004 USA Today.
Many private lawsuits involve Neurontin-induced suicidality. The Pogust & Braslow law firm is handling a case for Natalie Biedenbender, whose husband committed suicide at age 39, after being prescribed the drug off-label for back pain.
"Although Neurontin is prescribed for scores of off-label indications," Attorney Derek Braslow reports, "since 1999, the off-label use continues to be most common in the areas where the company focused its illegal marketing efforts, such as bipolar disorder, peripheral neuropathy, and migraine."
Two lawsuits were recently filed against Novartis and Astellas Pharma, the makers of the topical skin creams, Elidel and Protopic, used to treat eczema. Alan and Dayna Thomson filed a lawsuit in December 2006 after their daughter Haley died after using Elidel, and Ashley McDonald filed a lawsuit in January 2007 after being diagnosed with lymphoma following her use of Elidel.
In another case, Traci Reilly, of Naperville, Illinois, developed breast cancer after applying Protopic and Elidel for a condition that caused patches of discolored skin on her breast.
Protopic and Elidel belong to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin in organ transplant patients. Use of these drugs has long been known to increase the risk of cancer, and the drugs were labeled accordingly for use in transplant patients.
Protopic and Elidel have only been on the market for about 5 years and together have already been prescribed to more than 7 million people. In 2006, the FDA added a black box warning to the skin creams about the cancer risk.
On February 21, 2007, Tom Moore, the author of several books on the pharmaceutical industry, told CBS News that he had studied about 1,200 cases of suspected injuries pertaining to Protopic and Elidel reported to the FDA through 2005 and found more than 100 potential cancer cases in children and adults, with most involving lymphoma or skin cancer.
The anti-epileptic drug, Depakote (valproate), marketed by Abbott Laboratories, is one of the most heavily prescribed medications for off-label use. Experts say the evidence of harm caused by Depakote is just beginning to emerge.
According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, "we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions."
Bayer is under fire for hiding the adverse effects of the anti-clotting drug, Trasylol, used in heart surgery, and will no doubt be hit with plenty of lawsuits in the not to distant future, considering that Dr Dennis Mangano, the lead author of new study in the February 7, 2007, Journal of the American Medical Association, says that the Trasylol may be responsible for 10,000 deaths over five years.
On December 15, 2006, the FDA announced new labeling for Trasylol, and said a study suggests that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.
Because Trasylol is administered during surgery, many victims may not even realize they have been injured by the drug. But plenty have, according to Dr Mangano, who says that in 2006, Trasylol, was administered to 246,000 patients.
Another drug on the legal chopping block is the Parkinson's drug, Permax. As far back as December 2002, doctors at the Mayo Clinic reported heart valve disease in 3 patients who had been taking Permax, similar to damage caused by the Fen-Phen combination.
In 2004, HealthDay News reported that a study had confirmed previous findings that the drug could damage heart valves and surgery would be needed to correct it. Two new studies in the January 4, 2007, New England Journal of Medicine, report that the number of Permax patients who have developed valve damage is higher than expected.
One study, which included 155 patients taking various Parkinson's drugs, and 90 healthy patients in a comparison group, and found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.
The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other types of Parkinson's drugs, and patients taking the highest doses of Permax had a 37 times greater risk.
"This is not a rare side effect," says Dr Bryan Roth, a professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM.
"That's an extraordinarily high incidence," he warns. "That makes this a serious problem."
Heart valve damage is a life-threatening condition and costly to treat. Replacement requires open heart surgery, where the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine, according to the Texas Heart Institute. No drug can reverse valve damage, making replacement surgery the only option. Medical experts are advising all Permax patients to undergo testing for valve damage.
The drug was introduced to the US market by Eli Lilly, but Valeant Pharmaceuticals now sells Permax. On March 29, 2007, Permax was pulled off the market after the FDA reviewed new information that associates it with heart problems.
During the last 2 decades, the antidepressants, known as selective serotonin reuptake inhibitors, or SSRIs, have been prescribed for more unapproved uses than any other class of drugs in history. A June 2005, study in the Journal of Clinical Psychiatry, found that 75% of SSRI prescriptions written were for unapproved uses.
SSRIs have now been linked to suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.
On April 10, 2004, the British Medical Journal, criticized the authors of studies on SSRI's for exaggerating the benefits and downplaying the harm, including suicidality, and discussed a study of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only 2 in children in the placebo group.
The Paxil suicide risk is not limited to children. An August 22, 2005, study by Norwegian researchers of over 1,500 adults, found 7 Paxil patients attempted suicide compared to only 1 attempt in the group on a placebo, and recommended that warnings not to prescribe Paxil to children should also apply to adults.
According to Forest Lab's Annual Report filed on June 14, 2006, the company is a named defendant in approximately 25 lawsuits, with the majority involving the company's top selling SSRI drugs, Celexa or Lexapro, for inducing suicidality.
A wrongful death lawsuit was filed in September 2005, by the Pogust & Braslow law firm in Conshohocken, Pennsylvania, on behalf of the family of 32-year-old man who unexpectedly committed suicide soon after being prescribed Lexapro.
A steady stream of lawsuits have been filed against GlaxoSmithKline over Paxil, stemming from the company's concealment of the drug's link to suicide, birth defects, violence and withdrawal syndrome.
On March 23, 2006, the California-based Baum Hedlund law firm filed a national class-action lawsuit against Glaxo on behalf of the mother of an 11-year old Kansas boy who committed suicide, and a teenager in Texas who attempted suicide while taking Paxil.
She says, Baum Hedlund has documents obtained in litigation that show there was an awareness of the suicide risk as far back as the late 1970's, a decade before the first SSRI was approved for sale in the US.
A new round of Paxil lawsuits began on October 16, 2006, when Baum Hedlund filed a case alleging that Paxil use during pregnancy resulted in an infant being born with a life-threatening lung disorder, PPHN. Between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.
On July 28, 2006, Baum Hedlund also filed a lawsuit on behalf of the parents of an infant who was born with congenital heart birth defects as a result of his mother taking Paxil during pregnancy. Since birth, the child has undergone 3 open-heart surgeries and will likely have to undergo more and possibly a heart transplant at some point in the future.
Based on the company's legendary history of concealing adverse effects, the lead attorney on the case, Karen Barth Menzies, says believes Glaxo has known about these risks and should have warned prescribing doctors and consumers about these birth defects long ago.
The Houston law firm of Robert Kwok & Associates is handling a Celexa birth heart defects case in Kentucky. The mother was prescribed Celexa during pregnancy, and her baby was born with Shone's Complex, a form of congenital heart disease that consists of defects that lead to the obstruction of blood flow from the heart to the body.
Legal analysts are predicting that SSRI makers will offer early settlements in cases involving birth defects to avoid having these families appear before a jury.
Pfizer is still being sued left and right over adverse effects related to the epilepsy drug Neurontin. In 2004, the company pleaded guilty to charges involving a massive off-label marketing scheme and agreed to pay the second-largest settlement ever in a health care fraud prosecution of $403 million. By 2002, a full 94% of Neurontin sales were for off-label use, according to the August 16, 2004 USA Today.
Many private lawsuits involve Neurontin-induced suicidality. The Pogust & Braslow law firm is handling a case for Natalie Biedenbender, whose husband committed suicide at age 39, after being prescribed the drug off-label for back pain.
"Although Neurontin is prescribed for scores of off-label indications," Attorney Derek Braslow reports, "since 1999, the off-label use continues to be most common in the areas where the company focused its illegal marketing efforts, such as bipolar disorder, peripheral neuropathy, and migraine."
Two lawsuits were recently filed against Novartis and Astellas Pharma, the makers of the topical skin creams, Elidel and Protopic, used to treat eczema. Alan and Dayna Thomson filed a lawsuit in December 2006 after their daughter Haley died after using Elidel, and Ashley McDonald filed a lawsuit in January 2007 after being diagnosed with lymphoma following her use of Elidel.
In another case, Traci Reilly, of Naperville, Illinois, developed breast cancer after applying Protopic and Elidel for a condition that caused patches of discolored skin on her breast.
Protopic and Elidel belong to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin in organ transplant patients. Use of these drugs has long been known to increase the risk of cancer, and the drugs were labeled accordingly for use in transplant patients.
Protopic and Elidel have only been on the market for about 5 years and together have already been prescribed to more than 7 million people. In 2006, the FDA added a black box warning to the skin creams about the cancer risk.
On February 21, 2007, Tom Moore, the author of several books on the pharmaceutical industry, told CBS News that he had studied about 1,200 cases of suspected injuries pertaining to Protopic and Elidel reported to the FDA through 2005 and found more than 100 potential cancer cases in children and adults, with most involving lymphoma or skin cancer.
Off-Label Depakote Sales Stronger Than Ever
Evelyn Pringle February 11, 2007
The epilepsy drug, Depakote, earned Abbott Laboratories $384 million in the 4th quarter of 2006, and overall sales rose 18.5% to $1.2 billion last year.
The rising sales are a result of Depakote (valproate) being increasingly prescribed for conditions other than epilepsy like mood disorders, manic depression and migraines. Doctors are also prescribing Depakote as a mood stabilizer in off-label combinations with other drugs for uses that have never been FDA approved or tested for safety and efficacy.
Although in the US, drug companies are prohibited by law from promoting the sale of a drug for an off-label use, once a medication is FDA approved for once indication, doctors are free to prescribe it for other conditions if they believe it will be beneficial to a patient.
However, in recent years the rate of off-label prescribing has become epidemic and many drug companies have paid huge fines after being caught promoting drugs for unapproved uses and many more are currently under investigation for illegal marketing schemes.
In 2001, a study by the Agency for Healthcare Research and Quality (AHRQ) found that about 21% of prescriptions written in the US are for conditions not indicated on the label and cardiac medications and anticonvulsants were the most commonly prescribed for unapproved uses. Most off-label use, the study pointed out, occurs without scientific support.
Depakote is one of the drugs prescribed most often off-label, and experts say its not unusual to find patients on Depakote along with 3 or 4 other medications all at once.
On October 13, 2006, the FDA revised the labeling for Depakote to warn of adverse events associated with use of the drug during pregnancy and said that Depakote should only be considered for women of childbearing years if it was essential for the treatment of their condition and the risks and benefits were fully discussed with the patient.
According to the North American Antiepileptic Drug Pregnancy Registry, Depakote use during the first trimester of pregnancy is linked to a 4-fold increased risk of congenital malformations when compared with other antiepileptic drugs (AEDs). The rate malformations with infants exposed to Depakote was 10.7%, or 16 cases in 149 births.
The Registry is set up to determine the safety of anticonvulsants to help gauge the frequency of malformations, such as heart defects, spina bifida and cleft lip. Only major malformations are included in the Registry, defined as a structural abnormality of the infant with surgical, medical, or cosmetic importance.
The CDC reports that the risk of spina bifida among infants born to mothers receiving Depakote during the first trimester is estimated to be 1% to 2%, compared to 0.14% to 0.2% in the general population according to the American College of Obstetricians and Gynecologists.
Although Depakote is most strongly associated with neural tube defects, the FDA notes that other anomalies have also been reported, such as craniofacial defects, cardiovascular malformations, and anomalies involving various body systems with some fatal.
Drugs that cause malformations are known as teratogens. A teratogen can disturb the development of the fetus, halt the pregnancy, or permit the pregnancy to proceed but produce a congenital malformation or birth defect.
Due to the rate of off-label prescribing, pregnant women may be receiving Depakote for other indications and the FDA warns that the increased risk associated with Depakote in pregnant women treated for epilepsy likely reflects an increased risk in treatment for other conditions as well, such as migraines or bipolar disorder.
Depakote has now been moved into "Category C" for pregnant women, which means animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women, or no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
In the case of Depakote, numerous animal studies have established drug-induced teratogenicity. Increased malformations, as well as growth retardation and death, have been found in rats, mice, rabbits, and monkeys following prenatal exposure to the drug, according to the FDA's information listed on Depakote.
Malformations of the skeletal system are the most common structural abnormalities observed in animals, but neural tube closure defects have been seen in mice exposed to plasma Depakote concentrations exceeding 2.3 times the upper limit of the human therapeutic range during periods of embryonic development.
An oral dose equal to about 50% of the maximum human daily dose administered to pregnant rats produced skeletal, cardiac, and urogenital malformations and growth retardation in the offspring. Behavioral deficits have also been reported in the offspring of rats given Depakote throughout most of the pregnancy.
An oral dose of approximately 2 times the maximum human daily dose produced skeletal and visceral malformations in rabbits exposed during organogenesis.
Skeletal malformations, growth retardation, and death have been observed in rhesus monkeys following administration of an oral dose equal to the maximum human daily dose during organogenesis.
The initial report from on-going human study titled, "Neurodevelopmental Effects of Antiepileptic Drugs," in the August 8, 2006, journal, Neurology, found that major congenital abnormalities were more common in infants exposed to Depakote than those exposed to one of 3 other AEDs.
A team of researchers led by Dr Kimford Meador, of the University of Florida, are conducting a study on pregnant women with treated for epilepsy from October 1999 to February 2004, receiving either Depakote, Dilantin, Lamictal, or Tegretol.
The initial report, focuses on the rate of serious adverse events including fetal death or major congenital malformations defined as structural abnormalities with surgical, medical, or cosmetic importance identified during pregnancy, at birth, between birth and 1 year, or at 73 weeks.
The researchers identified 6 fetal deaths and 22 malformations that included malformed hearts and genitals, cleft palate, and artery deformities, with 20.3% found in women taking Depakote.
Based on these initial findings, the researchers advised that Depakote should not be used as the first choice for women of childbearing potential, and if used, its dose should be limited when possible.
In an interview with Shawna Cutting, posted on Epilepsy.com, Dr Meador explained how he became interested in doing the study. "Over the years," he said, "I began to think that these effects might be dramatic in children while their brains are developing, because they could add up over many years."
"That made me think that the effect might be even greater in a fetus because brain development there is so rapid," he said.
"The process of physical growth and the attainment of intelligence and problem-solving ability that begins in infancy; any interruption of this process by a disease or disorder is called developmental delay," Dr Meador explained.
He said studies of animals clearly showed that some antiepileptic drugs could affect behavior of the offspring.
His on-going study will track children until they are 2 or 3, but says children need to be followed until they are at least 6. "This age is so important," Dr Meador said during the interview, "because this is when measures such as IQ begin to match up with adult measures."
"If you measure a child's IQ at 3 years of age," he explained, "it may not predict the child's development."
"But a measurement at 6 years of age," he said, "statistically will predict what will happen when this kid is an adult."
He also noted that this is an important point because children begin school at that age and whatever is going on will effect their learning and said, a "disturbing report" on a study from England suggested that Depakote was producing worse effects.
The epilepsy drug, Depakote, earned Abbott Laboratories $384 million in the 4th quarter of 2006, and overall sales rose 18.5% to $1.2 billion last year.
The rising sales are a result of Depakote (valproate) being increasingly prescribed for conditions other than epilepsy like mood disorders, manic depression and migraines. Doctors are also prescribing Depakote as a mood stabilizer in off-label combinations with other drugs for uses that have never been FDA approved or tested for safety and efficacy.
Although in the US, drug companies are prohibited by law from promoting the sale of a drug for an off-label use, once a medication is FDA approved for once indication, doctors are free to prescribe it for other conditions if they believe it will be beneficial to a patient.
However, in recent years the rate of off-label prescribing has become epidemic and many drug companies have paid huge fines after being caught promoting drugs for unapproved uses and many more are currently under investigation for illegal marketing schemes.
In 2001, a study by the Agency for Healthcare Research and Quality (AHRQ) found that about 21% of prescriptions written in the US are for conditions not indicated on the label and cardiac medications and anticonvulsants were the most commonly prescribed for unapproved uses. Most off-label use, the study pointed out, occurs without scientific support.
Depakote is one of the drugs prescribed most often off-label, and experts say its not unusual to find patients on Depakote along with 3 or 4 other medications all at once.
On October 13, 2006, the FDA revised the labeling for Depakote to warn of adverse events associated with use of the drug during pregnancy and said that Depakote should only be considered for women of childbearing years if it was essential for the treatment of their condition and the risks and benefits were fully discussed with the patient.
According to the North American Antiepileptic Drug Pregnancy Registry, Depakote use during the first trimester of pregnancy is linked to a 4-fold increased risk of congenital malformations when compared with other antiepileptic drugs (AEDs). The rate malformations with infants exposed to Depakote was 10.7%, or 16 cases in 149 births.
The Registry is set up to determine the safety of anticonvulsants to help gauge the frequency of malformations, such as heart defects, spina bifida and cleft lip. Only major malformations are included in the Registry, defined as a structural abnormality of the infant with surgical, medical, or cosmetic importance.
The CDC reports that the risk of spina bifida among infants born to mothers receiving Depakote during the first trimester is estimated to be 1% to 2%, compared to 0.14% to 0.2% in the general population according to the American College of Obstetricians and Gynecologists.
Although Depakote is most strongly associated with neural tube defects, the FDA notes that other anomalies have also been reported, such as craniofacial defects, cardiovascular malformations, and anomalies involving various body systems with some fatal.
Drugs that cause malformations are known as teratogens. A teratogen can disturb the development of the fetus, halt the pregnancy, or permit the pregnancy to proceed but produce a congenital malformation or birth defect.
Due to the rate of off-label prescribing, pregnant women may be receiving Depakote for other indications and the FDA warns that the increased risk associated with Depakote in pregnant women treated for epilepsy likely reflects an increased risk in treatment for other conditions as well, such as migraines or bipolar disorder.
Depakote has now been moved into "Category C" for pregnant women, which means animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women, or no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
In the case of Depakote, numerous animal studies have established drug-induced teratogenicity. Increased malformations, as well as growth retardation and death, have been found in rats, mice, rabbits, and monkeys following prenatal exposure to the drug, according to the FDA's information listed on Depakote.
Malformations of the skeletal system are the most common structural abnormalities observed in animals, but neural tube closure defects have been seen in mice exposed to plasma Depakote concentrations exceeding 2.3 times the upper limit of the human therapeutic range during periods of embryonic development.
An oral dose equal to about 50% of the maximum human daily dose administered to pregnant rats produced skeletal, cardiac, and urogenital malformations and growth retardation in the offspring. Behavioral deficits have also been reported in the offspring of rats given Depakote throughout most of the pregnancy.
An oral dose of approximately 2 times the maximum human daily dose produced skeletal and visceral malformations in rabbits exposed during organogenesis.
Skeletal malformations, growth retardation, and death have been observed in rhesus monkeys following administration of an oral dose equal to the maximum human daily dose during organogenesis.
The initial report from on-going human study titled, "Neurodevelopmental Effects of Antiepileptic Drugs," in the August 8, 2006, journal, Neurology, found that major congenital abnormalities were more common in infants exposed to Depakote than those exposed to one of 3 other AEDs.
A team of researchers led by Dr Kimford Meador, of the University of Florida, are conducting a study on pregnant women with treated for epilepsy from October 1999 to February 2004, receiving either Depakote, Dilantin, Lamictal, or Tegretol.
The initial report, focuses on the rate of serious adverse events including fetal death or major congenital malformations defined as structural abnormalities with surgical, medical, or cosmetic importance identified during pregnancy, at birth, between birth and 1 year, or at 73 weeks.
The researchers identified 6 fetal deaths and 22 malformations that included malformed hearts and genitals, cleft palate, and artery deformities, with 20.3% found in women taking Depakote.
Based on these initial findings, the researchers advised that Depakote should not be used as the first choice for women of childbearing potential, and if used, its dose should be limited when possible.
In an interview with Shawna Cutting, posted on Epilepsy.com, Dr Meador explained how he became interested in doing the study. "Over the years," he said, "I began to think that these effects might be dramatic in children while their brains are developing, because they could add up over many years."
"That made me think that the effect might be even greater in a fetus because brain development there is so rapid," he said.
"The process of physical growth and the attainment of intelligence and problem-solving ability that begins in infancy; any interruption of this process by a disease or disorder is called developmental delay," Dr Meador explained.
He said studies of animals clearly showed that some antiepileptic drugs could affect behavior of the offspring.
His on-going study will track children until they are 2 or 3, but says children need to be followed until they are at least 6. "This age is so important," Dr Meador said during the interview, "because this is when measures such as IQ begin to match up with adult measures."
"If you measure a child's IQ at 3 years of age," he explained, "it may not predict the child's development."
"But a measurement at 6 years of age," he said, "statistically will predict what will happen when this kid is an adult."
He also noted that this is an important point because children begin school at that age and whatever is going on will effect their learning and said, a "disturbing report" on a study from England suggested that Depakote was producing worse effects.
Consequences of Rampant Off-Label Prescribing of Depakote
Evelyn Pringle February 7, 2007
The antiepileptic drug, Depakote, is one of the most heavily prescribed medications for off-label use. The Epilepsy Foundation reports that there are an estimated 1 million women in the US with epilepsy, but the number of women being treated with antiepileptics is two to three times higher than the number of women with the disorder.
Experts say the evidence of harm caused by the massive off-label prescribing of Depakote (valproate), marketed by Abbott Laboratories, is just beginning to surface.
According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, "we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions."
Drugs are FDA-approved for specific indications, but they can be prescribed off-label for other conditions if a doctor deems it appropriate. Although drug makers are prohibited by law from promoting their drugs for off-label uses, its a well known fact that they do it all the time.
"Off-label" includes prescribing drugs for uses that are not listed in the FDA-approved labeling; increasing the recommended dose or duration of treatment; combining one drug with other drugs; or prescribing a drug for patient populations, such as children or the elderly, for whom it was not approved.
The truth is, millions of patients are receiving powerful psychotropic drugs like Depakote that have not been approved for treating their specific illness because drug makers are using every trick in the book to boost profits by getting doctors to prescribe their drugs off-label, and as a result patients are serving as guinea pigs.
Off-label use, by definition, means the drug lacks sufficient clinical evidence to demonstrate safety and effectiveness, and therefore, prescribing a drug for unapproved uses exposes patients to the unknown risks of a medication that has no proven benefit.
Doctors are prescribing Depakote together with other drugs in combinations that have never been tested on any patient population. Experts say its not uncommon to see patients, including very young children, taking Depakote along with 3 or 4 other psychiatric drugs all at the same time.
And, contrary to what the drug makers say publicly, they know exactly how many prescriptions are written off-label for each and every drug they sell because they purchase records that show the prescribing habits for all doctors in the US, from data mining firms so that sales representatives can keep track of the prescribing habits of their doctor-customers.
On August 6, 2006, former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, that she received reports on all the doctors in her sales territory broken down by drug category which she said helped her determine which doctors "were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc."
Ms Slattery-Moschkau claims she could immediately measure the success of a perk simply by looking at the prescribing records. "If I brought in lunch one week," she stated, "I could see the following week if that lunch had an impact."
For good reason, drug companies are willing to pay top dollar for these records. According to the Chronicle, in 2005, the data main data mining firm, IMS Health, had revenues of $847 million from its "Sales Force Effectiveness Offerings."
Over the past few years, there have been many reports in the media about the over-prescribing of psychiatric drugs, but not much has been written about the off-label sale of Depakote. "In recent years," Dr Kruszewski says, "Depakote may have escaped some of the media scrutiny of other antiepileptic drugs, like Neurontin, Topamax and Gabitril."
"As a clinical investigative psychiatrist," he states, "my concern is that Depakote is widely used on and off-label for so many neuropsychiatric conditions."
"It has widespread use," he notes, "for mood disorders, mood swings, anxiety, drug withdrawal states, agitation, aggression, panic disorders and psychosis."
"It is not a benign drug," he warns.
Dr Kruszewski says a number of recent reports by scientific experts, including one on birth defects discussed in Neurology Journal Watch, are worrisome. "Depakote, in a dose-dependent fashion," he states, "is associated with fetal abnormalities and fetal death."
"Depakote appears to increase the risk of spina bifida and significantly increases the risk of other neural tube defects," he notes.
"Fetal serum concentrations," he explains, "are typically 1.4 times greater than those of the mother and incur a longer half-life."
"The evidence is uncertain," he says, "regarding what neurological or other effects are sustained by breast-fed infants of mothers who take Depakote."
One of the recent studies cited by Dr Kruszewski is the Neurodevelopmental Effects of Antiepileptic Drugs, published in the August 8, 2006, issue of Neurology, which reported that major congenital abnormalities are more common in infants whose mothers received Depakote during pregnancy than infants exposed to other antiepileptic drugs.
To determine whether fetal outcomes varied as a result of exposure to four different drugs, a group of researchers led by Dr Kimford Meador, of the University of Florida in Gainesville, conducted a study on pregnant women with epilepsy from October 1999 to February 2004, enrolled in 25 epilepsy centers in the US and UK. A total of 333 mothers were followed, each receiving either Depakote, Lamictal, Dilantin, or Tegretol.
The researcher's initial report in this ongoing study, focused on the incidence of serious adverse events including major congenital malformations or fetal death, with major malformations defined as structural abnormalities with surgical, medical, or cosmetic importance detected during pregnancy, at birth, from birth to 1 year, or at 73 weeks.
All total, the researchers found there were 6 fetal deaths and 22 malformations, with 20.3% being attributed to Depakote. The birth defects noted included malformed hearts and genitals, cleft palate, and artery deformities.
The risks of birth defects with Depakote have actually been known for quite some time. Back on April 29, 2004, WebMD warned that infants born to women taking Depakote were more likely to have birth defects, and said that whenever possible women should avoid taking the drug not only during pregnancy, but also during childbearing years.
WebMD discussed a study presented at the annual meeting of the American Academy of Neurology, that found death of the fetus, birth defects, and developmental delays, such as walking and speech delays, occurred in 28% of children exposed to Depakote compared with just 2% of infants exposed to Lamictal.
The research team even presented the data from its 5-year study a year earlier than planned because the findings were so alarming.
Lead researcher, Dr Page Pennell, of Atlanta's Emory University School of Medicine, told WebMD, "The evidence against the use of [Depakote] by women during pregnancy is mounting, but the message has not gotten out."
She pointed out that "the drug is being increasingly prescribed for other conditions like migraines, bipolar disorder, and mood disorders."
Depakote is but one of many psychiatric drugs that are not recommended for pregnant women but were recently found to be prescribed off-label to pregnant teens in foster care in Texas.
In fact, Depakote was one of the drugs most prescribed off-label for Texas foster children in general, and the most prescribed anticonvulsant. In fiscal 2004, there were 18,705 prescriptions written for Depakote and its generic equivalent, totaling $1,652,776, making it the third most prescribed psychotropic drug to foster children, according to Health and Human Services Commission and Texas Comptroller of Public Accounts, in a June 2006, Special Report, Foster Children: Texas Health Care Claims Study.
A review of Medicaid records during the investigation that resulted in the report, revealed several cases in which pregnant girls received "category D" medications such as Depakote. The FDA places drugs in the "D" category only when post-marketing data has shown they pose a clear risk to the fetus.
As a whole, anticonvulsants were the second most expensive psychiatric drug category for foster children that year supposedly prescribed as "mood stabilizers," at a cost of $4.8 million. According to the Zito/Safer External Review, anticonvulsant use for mood stabilization is a poorly evidenced area of psychopharmacology for children and adolescents. But nonetheless, the Texas Medicaid program was charged an average of $111 per prescription for their off-label use.
In addition to the increased risk of birth defects in infants born to pregnant girls on Depakote, the National Institute of Mental Health reports other serious side effects associated with use of the drug by teenage girls:
"According to studies conducted in Finland in patients with epilepsy, valproate may increase testosterone levels in teenage girls and produce polycystic ovary syndrome in women who began taking the medication before age 20. Increased testosterone can lead to polycystic ovary syndrome with irregular or absent menses, obesity, and abnormal growth of hair. Therefore, young female patients taking valproate should be monitored carefully by a physician."
Dr Kruszewski says doctors and women of childbearing age both need to be aware of the risks to the fetus from Depakote, if a seizure medication is absolutely necessary during pregnancy. Because women often do not know they are pregnant in the initial 4 to 8 weeks of the first trimester, he recommends that women and their doctors plan ahead to use a different drug before a pregnancy begins.
The antiepileptic drug, Depakote, is one of the most heavily prescribed medications for off-label use. The Epilepsy Foundation reports that there are an estimated 1 million women in the US with epilepsy, but the number of women being treated with antiepileptics is two to three times higher than the number of women with the disorder.
Experts say the evidence of harm caused by the massive off-label prescribing of Depakote (valproate), marketed by Abbott Laboratories, is just beginning to surface.
According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, "we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions."
Drugs are FDA-approved for specific indications, but they can be prescribed off-label for other conditions if a doctor deems it appropriate. Although drug makers are prohibited by law from promoting their drugs for off-label uses, its a well known fact that they do it all the time.
"Off-label" includes prescribing drugs for uses that are not listed in the FDA-approved labeling; increasing the recommended dose or duration of treatment; combining one drug with other drugs; or prescribing a drug for patient populations, such as children or the elderly, for whom it was not approved.
The truth is, millions of patients are receiving powerful psychotropic drugs like Depakote that have not been approved for treating their specific illness because drug makers are using every trick in the book to boost profits by getting doctors to prescribe their drugs off-label, and as a result patients are serving as guinea pigs.
Off-label use, by definition, means the drug lacks sufficient clinical evidence to demonstrate safety and effectiveness, and therefore, prescribing a drug for unapproved uses exposes patients to the unknown risks of a medication that has no proven benefit.
Doctors are prescribing Depakote together with other drugs in combinations that have never been tested on any patient population. Experts say its not uncommon to see patients, including very young children, taking Depakote along with 3 or 4 other psychiatric drugs all at the same time.
And, contrary to what the drug makers say publicly, they know exactly how many prescriptions are written off-label for each and every drug they sell because they purchase records that show the prescribing habits for all doctors in the US, from data mining firms so that sales representatives can keep track of the prescribing habits of their doctor-customers.
On August 6, 2006, former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, that she received reports on all the doctors in her sales territory broken down by drug category which she said helped her determine which doctors "were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc."
Ms Slattery-Moschkau claims she could immediately measure the success of a perk simply by looking at the prescribing records. "If I brought in lunch one week," she stated, "I could see the following week if that lunch had an impact."
For good reason, drug companies are willing to pay top dollar for these records. According to the Chronicle, in 2005, the data main data mining firm, IMS Health, had revenues of $847 million from its "Sales Force Effectiveness Offerings."
Over the past few years, there have been many reports in the media about the over-prescribing of psychiatric drugs, but not much has been written about the off-label sale of Depakote. "In recent years," Dr Kruszewski says, "Depakote may have escaped some of the media scrutiny of other antiepileptic drugs, like Neurontin, Topamax and Gabitril."
"As a clinical investigative psychiatrist," he states, "my concern is that Depakote is widely used on and off-label for so many neuropsychiatric conditions."
"It has widespread use," he notes, "for mood disorders, mood swings, anxiety, drug withdrawal states, agitation, aggression, panic disorders and psychosis."
"It is not a benign drug," he warns.
Dr Kruszewski says a number of recent reports by scientific experts, including one on birth defects discussed in Neurology Journal Watch, are worrisome. "Depakote, in a dose-dependent fashion," he states, "is associated with fetal abnormalities and fetal death."
"Depakote appears to increase the risk of spina bifida and significantly increases the risk of other neural tube defects," he notes.
"Fetal serum concentrations," he explains, "are typically 1.4 times greater than those of the mother and incur a longer half-life."
"The evidence is uncertain," he says, "regarding what neurological or other effects are sustained by breast-fed infants of mothers who take Depakote."
One of the recent studies cited by Dr Kruszewski is the Neurodevelopmental Effects of Antiepileptic Drugs, published in the August 8, 2006, issue of Neurology, which reported that major congenital abnormalities are more common in infants whose mothers received Depakote during pregnancy than infants exposed to other antiepileptic drugs.
To determine whether fetal outcomes varied as a result of exposure to four different drugs, a group of researchers led by Dr Kimford Meador, of the University of Florida in Gainesville, conducted a study on pregnant women with epilepsy from October 1999 to February 2004, enrolled in 25 epilepsy centers in the US and UK. A total of 333 mothers were followed, each receiving either Depakote, Lamictal, Dilantin, or Tegretol.
The researcher's initial report in this ongoing study, focused on the incidence of serious adverse events including major congenital malformations or fetal death, with major malformations defined as structural abnormalities with surgical, medical, or cosmetic importance detected during pregnancy, at birth, from birth to 1 year, or at 73 weeks.
All total, the researchers found there were 6 fetal deaths and 22 malformations, with 20.3% being attributed to Depakote. The birth defects noted included malformed hearts and genitals, cleft palate, and artery deformities.
The risks of birth defects with Depakote have actually been known for quite some time. Back on April 29, 2004, WebMD warned that infants born to women taking Depakote were more likely to have birth defects, and said that whenever possible women should avoid taking the drug not only during pregnancy, but also during childbearing years.
WebMD discussed a study presented at the annual meeting of the American Academy of Neurology, that found death of the fetus, birth defects, and developmental delays, such as walking and speech delays, occurred in 28% of children exposed to Depakote compared with just 2% of infants exposed to Lamictal.
The research team even presented the data from its 5-year study a year earlier than planned because the findings were so alarming.
Lead researcher, Dr Page Pennell, of Atlanta's Emory University School of Medicine, told WebMD, "The evidence against the use of [Depakote] by women during pregnancy is mounting, but the message has not gotten out."
She pointed out that "the drug is being increasingly prescribed for other conditions like migraines, bipolar disorder, and mood disorders."
Depakote is but one of many psychiatric drugs that are not recommended for pregnant women but were recently found to be prescribed off-label to pregnant teens in foster care in Texas.
In fact, Depakote was one of the drugs most prescribed off-label for Texas foster children in general, and the most prescribed anticonvulsant. In fiscal 2004, there were 18,705 prescriptions written for Depakote and its generic equivalent, totaling $1,652,776, making it the third most prescribed psychotropic drug to foster children, according to Health and Human Services Commission and Texas Comptroller of Public Accounts, in a June 2006, Special Report, Foster Children: Texas Health Care Claims Study.
A review of Medicaid records during the investigation that resulted in the report, revealed several cases in which pregnant girls received "category D" medications such as Depakote. The FDA places drugs in the "D" category only when post-marketing data has shown they pose a clear risk to the fetus.
As a whole, anticonvulsants were the second most expensive psychiatric drug category for foster children that year supposedly prescribed as "mood stabilizers," at a cost of $4.8 million. According to the Zito/Safer External Review, anticonvulsant use for mood stabilization is a poorly evidenced area of psychopharmacology for children and adolescents. But nonetheless, the Texas Medicaid program was charged an average of $111 per prescription for their off-label use.
In addition to the increased risk of birth defects in infants born to pregnant girls on Depakote, the National Institute of Mental Health reports other serious side effects associated with use of the drug by teenage girls:
"According to studies conducted in Finland in patients with epilepsy, valproate may increase testosterone levels in teenage girls and produce polycystic ovary syndrome in women who began taking the medication before age 20. Increased testosterone can lead to polycystic ovary syndrome with irregular or absent menses, obesity, and abnormal growth of hair. Therefore, young female patients taking valproate should be monitored carefully by a physician."
Dr Kruszewski says doctors and women of childbearing age both need to be aware of the risks to the fetus from Depakote, if a seizure medication is absolutely necessary during pregnancy. Because women often do not know they are pregnant in the initial 4 to 8 weeks of the first trimester, he recommends that women and their doctors plan ahead to use a different drug before a pregnancy begins.
Glaxo Writing Checks Left and Right to Settle Paxil Legal Battles
Evelyn Pringle December 6, 2006
GlaxoSmithKline is no doubt looking forward to the New Year because the end of this one is becoming costlier by the month.
On November 1, 2006, the Associated Press reported that Glaxo had agreed to pay $63.8 million to settle a class action lawsuit with allegations that Glaxo promoted Paxil for use with children and adolescents while withholding negative information about the drug's safety and effectiveness.
Members of the class include all US residents who bought Paxil for their children, and those people who have records of their purchase can reportedly get a full refund.
According to the Associated Press, Madison County, Illinois, Judge Ralph Mendelsohn, approved the settlement on October 6, 2006, and unsealed the agreement on October 27. The judge has scheduled a hearing for March 9, 2007 to determine whether the settlement is fair and whether the plaintiffs' attorneys are entitled to the fee they are requesting.
Another similar class action antitrust case filed against Glaxo, on behalf of consumers and third party payers, who paid all or part of the purchase price of Paxil, was settled on April 22, 2005 for $65 million.
In that case, the plaintiff's alleged that they were forced to pay too much for Paxil because Glaxo unlawfully maintained a monopoly and excluded competition by (1) conducting sham patent infringement litigation against generic Paxil makers which triggered automatic 30 month stays of generic competition; (2) made intentional misrepresentations to the Patent and Trademark Office; and (3) made intentional misrepresentations to the FDA which enabled Glaxo to exclude generic competition.
However, although Glaxo doled out $65 million, it refused to admit guilt. Paragraph 22 of the final Order in that case, dated April 22, 2005 states:
"Neither this Final Order and Judgment, the Settlement Agreement, nor any of its terms or the negotiations or papers related thereto shall constitute evidence or an admission by Defendant, that any acts of wrongdoing have been committed, and they shall not be deemed to create any inference that there is any liability therefore."
What this says is that Glaxo maintains it did nothing wrong but it wrote out a check for $65 million just to get the natty little plaintiffs off its back and furthermore, the court says no inference of guilt should be drawn by the $65 million pay-off.
Fair enough, never mind the inference of guilt, but how much does this not-guilty penalty cost consumers in terms of increased drug prices?
In settling the latest Madison County class action, Glaxo also denies all the allegations, and says it will pay the $63 million to keep the cost of litigation down. However, there are indications that this case might not end as smoothly as Glaxo planned because plaintiff's attorneys in competing class actions have filed objections to the settlement.
Jim Gottstein, an attorney who recently won a landmark case in the Alaska Supreme Court that does away with forced drugging with psychiatric medications in state institution, sees major problems with the way this latest Glaxo settlement went down.
"One of the abuses in class actions," he says, "is defendants finding lawyers supposedly representing the class who are willing to push settlements that are unfairly favorable to the defendants, thus allowing them to limit their liability."
"The amount and other aspects of this proposed settlement," he notes, "raise questions about whether that has happened here."
"It still seems like a small amount," Mr Gottstein points out, "assuming far more than $63 million was spent on Paxil prescribed to people under 18."
He also says the settlement may result in a large payment to the lawyers for what may not be very much work, and notes that the first time this case surfaced was when a settlement had already been secretly negotiated with the immediate effort to kill the other class actions that seemed to be proceeding along a forthright path.
These on-going legal proceedings against Glaxo seem like one never-ending vicious cycle. Glaxo overcharges consumers, then runs up legal costs for years denying the charges, and then in the end, pays millions to settle the charges but is allowed to deny guilt, and then ups the prices on its products to cover the penalty.
The latest 2 settlements are eerily similar to the fraud case Glaxo settled in the summer of 2004, in which New York State Attorney General, Eliot Spitzer, charged the company with hiding studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer, the company had conducted at least 5 studies on the use of Paxil with children, but only published one, and even it revealed questionable results. Glaxo ended up paying more than $2 million to settle those charges and also had to agree to publish all of its clinical trials online.
How many get out of jail free cards does Glaxo get? In that case, Mr Spitzer estimated that by suppressing the studies showing that Paxil was not effective with children and that it may cause them to commit suicide, Glaxo made $55 million off prescriptions written for children in 2002 alone.
Glaxo was also recently busted for another overcharging racket across the globe. On November 9, 2006, the Comet reported that "BRITAIN'S largest drugs company is facing a bitter pill in the form of a bill from Whitehall that could be for over �1 billion."
"An independent report on behalf of the Department of Health has revealed that GalxoSmithKline," the Comet said, "may have over-charged the NHS by a staggering �280 million a year for at least five years."
It seems Glaxo agreed to price cuts in talks with the British government in 1999, but the Pharmaceutical Price Regulation Scheme independent arbitration panel, set up by the Department of Health, has now determined that the company continued to bill the government the full price for 5 years after agreeing to the lower prices.
Less than 2 months earlier, on September 11, 2006, Glaxo announced that it has settled its tax dispute with the US Internal Revenue Service, in a statement to the London Stock Exchange. "This settlement resolves all the issues which were in dispute in this case," the company said.
"Under the agreement," Glaxo stated, "the final net cash cost to GSK will be approximately 3.1 billion dollars which covers federal, state and local taxes, interest and also the benefit of tax relief on the payments made."
According to Glaxo, the settlement covered the dispute for the years between 1989 and 2000, which was set to go to trial in February 2007, and also covers the subsequent years of 2001 to 2005.
At the end of the statement, came the customary denial of wrongdoing. "GSK was confident of the strength of its position," it stated, "but in view of the size of the potential financial exposure, as well as the continued level of resource being applied to the case, GSK concluded that it was in the best interests of its shareholders to reach this settlement, thereby removing the costs and uncertainty of future litigation."
For its part, the IRS said that Glaxo will pay $3.4 billion all total, once interest is included, making it the largest single payment ever to resolve a US tax dispute.
In another potentially troublesome legal development, last month Glaxo was hit with the first of likely many more lawsuits to come, filed on behalf of an infant who was born with persistent pulmonary hypertension, a life-threatening lung disorder, following exposure to Paxil in the womb during his mother's pregnancy.
Attorney, Karen Barth-Menzies, a partner at Baum Hedlund, a national law firm with offices in Los Angeles, Washington, DC and Philadelphia, is the lead attorney on the case, and says a study published in the New England Journal of Medicine, back on October 3, 1996, led by Dr Christina Chambers, of the Department of Pediatrics, at the University of California-San Diego, indicated an increased risk of the lung disorder in infants born to mothers who were prescribed SSRI antidepressants like Paxil.
As a follow-up, Dr Chambers and colleagues performed a study of women who gave birth between 1998 and 2003, published in the February 9, 2006, New England Journal of Medicine, that found mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with the lung disorder.
According to Jennifer Liakos, an associate attorney at Baum Hedlund in Los Angeles and a member of the firm's Antidepressant Litigation Department involved in Paxil birth defect cases, between 10% to 20% of infants born with persistent pulmonary hypertension do not survive, even after they receive treatment.
GlaxoSmithKline is no doubt looking forward to the New Year because the end of this one is becoming costlier by the month.
On November 1, 2006, the Associated Press reported that Glaxo had agreed to pay $63.8 million to settle a class action lawsuit with allegations that Glaxo promoted Paxil for use with children and adolescents while withholding negative information about the drug's safety and effectiveness.
Members of the class include all US residents who bought Paxil for their children, and those people who have records of their purchase can reportedly get a full refund.
According to the Associated Press, Madison County, Illinois, Judge Ralph Mendelsohn, approved the settlement on October 6, 2006, and unsealed the agreement on October 27. The judge has scheduled a hearing for March 9, 2007 to determine whether the settlement is fair and whether the plaintiffs' attorneys are entitled to the fee they are requesting.
Another similar class action antitrust case filed against Glaxo, on behalf of consumers and third party payers, who paid all or part of the purchase price of Paxil, was settled on April 22, 2005 for $65 million.
In that case, the plaintiff's alleged that they were forced to pay too much for Paxil because Glaxo unlawfully maintained a monopoly and excluded competition by (1) conducting sham patent infringement litigation against generic Paxil makers which triggered automatic 30 month stays of generic competition; (2) made intentional misrepresentations to the Patent and Trademark Office; and (3) made intentional misrepresentations to the FDA which enabled Glaxo to exclude generic competition.
However, although Glaxo doled out $65 million, it refused to admit guilt. Paragraph 22 of the final Order in that case, dated April 22, 2005 states:
"Neither this Final Order and Judgment, the Settlement Agreement, nor any of its terms or the negotiations or papers related thereto shall constitute evidence or an admission by Defendant, that any acts of wrongdoing have been committed, and they shall not be deemed to create any inference that there is any liability therefore."
What this says is that Glaxo maintains it did nothing wrong but it wrote out a check for $65 million just to get the natty little plaintiffs off its back and furthermore, the court says no inference of guilt should be drawn by the $65 million pay-off.
Fair enough, never mind the inference of guilt, but how much does this not-guilty penalty cost consumers in terms of increased drug prices?
In settling the latest Madison County class action, Glaxo also denies all the allegations, and says it will pay the $63 million to keep the cost of litigation down. However, there are indications that this case might not end as smoothly as Glaxo planned because plaintiff's attorneys in competing class actions have filed objections to the settlement.
Jim Gottstein, an attorney who recently won a landmark case in the Alaska Supreme Court that does away with forced drugging with psychiatric medications in state institution, sees major problems with the way this latest Glaxo settlement went down.
"One of the abuses in class actions," he says, "is defendants finding lawyers supposedly representing the class who are willing to push settlements that are unfairly favorable to the defendants, thus allowing them to limit their liability."
"The amount and other aspects of this proposed settlement," he notes, "raise questions about whether that has happened here."
"It still seems like a small amount," Mr Gottstein points out, "assuming far more than $63 million was spent on Paxil prescribed to people under 18."
He also says the settlement may result in a large payment to the lawyers for what may not be very much work, and notes that the first time this case surfaced was when a settlement had already been secretly negotiated with the immediate effort to kill the other class actions that seemed to be proceeding along a forthright path.
These on-going legal proceedings against Glaxo seem like one never-ending vicious cycle. Glaxo overcharges consumers, then runs up legal costs for years denying the charges, and then in the end, pays millions to settle the charges but is allowed to deny guilt, and then ups the prices on its products to cover the penalty.
The latest 2 settlements are eerily similar to the fraud case Glaxo settled in the summer of 2004, in which New York State Attorney General, Eliot Spitzer, charged the company with hiding studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer, the company had conducted at least 5 studies on the use of Paxil with children, but only published one, and even it revealed questionable results. Glaxo ended up paying more than $2 million to settle those charges and also had to agree to publish all of its clinical trials online.
How many get out of jail free cards does Glaxo get? In that case, Mr Spitzer estimated that by suppressing the studies showing that Paxil was not effective with children and that it may cause them to commit suicide, Glaxo made $55 million off prescriptions written for children in 2002 alone.
Glaxo was also recently busted for another overcharging racket across the globe. On November 9, 2006, the Comet reported that "BRITAIN'S largest drugs company is facing a bitter pill in the form of a bill from Whitehall that could be for over �1 billion."
"An independent report on behalf of the Department of Health has revealed that GalxoSmithKline," the Comet said, "may have over-charged the NHS by a staggering �280 million a year for at least five years."
It seems Glaxo agreed to price cuts in talks with the British government in 1999, but the Pharmaceutical Price Regulation Scheme independent arbitration panel, set up by the Department of Health, has now determined that the company continued to bill the government the full price for 5 years after agreeing to the lower prices.
Less than 2 months earlier, on September 11, 2006, Glaxo announced that it has settled its tax dispute with the US Internal Revenue Service, in a statement to the London Stock Exchange. "This settlement resolves all the issues which were in dispute in this case," the company said.
"Under the agreement," Glaxo stated, "the final net cash cost to GSK will be approximately 3.1 billion dollars which covers federal, state and local taxes, interest and also the benefit of tax relief on the payments made."
According to Glaxo, the settlement covered the dispute for the years between 1989 and 2000, which was set to go to trial in February 2007, and also covers the subsequent years of 2001 to 2005.
At the end of the statement, came the customary denial of wrongdoing. "GSK was confident of the strength of its position," it stated, "but in view of the size of the potential financial exposure, as well as the continued level of resource being applied to the case, GSK concluded that it was in the best interests of its shareholders to reach this settlement, thereby removing the costs and uncertainty of future litigation."
For its part, the IRS said that Glaxo will pay $3.4 billion all total, once interest is included, making it the largest single payment ever to resolve a US tax dispute.
In another potentially troublesome legal development, last month Glaxo was hit with the first of likely many more lawsuits to come, filed on behalf of an infant who was born with persistent pulmonary hypertension, a life-threatening lung disorder, following exposure to Paxil in the womb during his mother's pregnancy.
Attorney, Karen Barth-Menzies, a partner at Baum Hedlund, a national law firm with offices in Los Angeles, Washington, DC and Philadelphia, is the lead attorney on the case, and says a study published in the New England Journal of Medicine, back on October 3, 1996, led by Dr Christina Chambers, of the Department of Pediatrics, at the University of California-San Diego, indicated an increased risk of the lung disorder in infants born to mothers who were prescribed SSRI antidepressants like Paxil.
As a follow-up, Dr Chambers and colleagues performed a study of women who gave birth between 1998 and 2003, published in the February 9, 2006, New England Journal of Medicine, that found mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with the lung disorder.
According to Jennifer Liakos, an associate attorney at Baum Hedlund in Los Angeles and a member of the firm's Antidepressant Litigation Department involved in Paxil birth defect cases, between 10% to 20% of infants born with persistent pulmonary hypertension do not survive, even after they receive treatment.
Friday, August 6, 2010
Lexapro Legal Problems Mount Against Forest Laboratories
Evelyn Pringle November 15, 2006
According to Forest Laboratories' Annual Report, for the year ending March 31, 2006, Celexa and Lexapro, accounted for 68% of the company's sales.
The drugs belong to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
Sales of Lexapro, the filing notes, increased 16% in the 4th quarter to $464,100,000, compared to $399,381,000 in the same quarter a year ago.
However, the Report filed with the SEC on June 14, 2006, also says that Forest Labs is currently a named defendant in approximately 25 active SSRI related lawsuits, with most of the cases claiming that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.
On November 7, 2005, Forest moved to consolidate all of the cases pending in Federal courts into a multidistrict proceeding, and on February 6, 2006, its motion was granted and multidistrict litigation was established with the cases then pending transferred to Judge Rodney Sippel in the US District Court for the Eastern District of Missouri.
But the company's legal troubles by far are not limited to a few civil lawsuits. The US Attorney's Office for the District of Massachusetts is investigating whether Forest has committed not only civil violations but also criminal violations of the Federal Anti-Kickback laws with "off-label" promotional activities in the marketing of Lexapro and other products.
As part of the investigation, Forest first received a subpoena from the Office of Inspector General of the Federal Office of Personnel Management requesting documents relating to Celexa, but the company has since received another subpoena from the US Attorney's Office related to Lexapro and other products.
The subpoenas request documents relating to a broad range of the company's marketing and promotional activities dating back to January 1, 1997, all the way up to the present.
The truth is, right along with all the other SSRI makers, Forest has been marketing Lexapro for the off-label treatment of a wide variety of ailments in part, by promoting the notion that every uncomfortable feeling is caused by a "chemical imbalance." However, according to Dr David Healy, "none of the SSRI manufacturers can tell us what constitutes a proper chemical balance of serotonin in the brain."
"Thus," he says, "the truth is that Lexapro and its serotonergic cousins lie somewhere on the continuum between "magic bullets and snake oil."
Dr Healy is one of the world's leading authorities on SSRIs and the author of, "The Antidepressant Era," and "The Creation of Psychopharmacology."
To expand the market for SSRIs, the drug companies have transformed everyday sadness, stress, and worry into mental disorders that demand one cure: drugs. Strong emotions felt after the death of a loved one, or a divorce, or job loss are now irrational and symptoms of mental illness.
In fact, over the past 15 years Big Pharma has managed to cultivate the development of a whole new batch of mental illnesses, with names like generalized anxiety disorder, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder, by simply greasing the palms of the so-called psychiatric "experts" who determine the criteria for the inclusion of a disorder in the Diagnostic and Statistical Manual for Mental Disorders (DSM).
Other more recent additions to the DSM, intended to further widen the customer recruitment net to specifically target children, have names like reading disorder, mathematics disorder, disorder of written expression, and oppositional defiant disorder.
And with the inclusion in the DSM, comes the guaranteed payment for the drugs to treat the disorder from public and private health insurance programs. The first edition of the DSM had a little over 100 disorders; the latest edition lists close to 375.
The mass marketing of mental illness has led many people experiencing minimal symptoms of distress to believe they need drugs to exist. And because most doctors are not trained on the side effects of SSRIs, patients can exhibit a wide range of actions or behaviors that appear to be symptoms of another "disorder," and are then prescribed more drugs to counter the unrecognized adverse reactions to the first.
Even the medical education courses that doctors must take each year to maintain their professional license are most of the time sponsored by drug companies which means the courses are intended to increase the sale of specific drugs, and to educate doctors on their adverse effects would defeat the whole purpose of the seminar.
In fact, experts say the drug makers continue to ignore and discount all of the adverse effects associated with SSRIs. For instance, sexual dysfunction, such as lack of libido or interest, orgasmic dysfunction in women, and delayed ejaculation in men, are extremely common but seldom mentioned. Studies have shown that as high as 70% of patients on SSRIs experience sexual side effects.
According to WebMD, on July 2005, these side effects cause significant problems of their own. "For both men and women, this means being unable to initiate, participate fully in, or enjoy sex," the article states, "and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery."
But then not to worry, because a study in the January 1, 2003, Journal of the American Medical Association says that people experiencing SSRI related sexual dysfunction may be helped by simply taking another pill, Viagra.
And, although the FDA has not approved Viagra for women, some "experts" recommend that women experiencing SSRI related sexual problems should give it a shot anyways.
Whenever possible, patients are convinced that they need to take SSRIs for life. It would be interesting to see the results of a survey that asked patients if they would be willing to begin a life-long drug treatment if it meant waving good-by to a normal healthy sex life.
As a follow-up, a survey should also be conducted on the partners of SSRI patients to find out how long they will be willing to remain in what often becomes a sexless relationship.
The drug companies have also tried for years to discount the many studies showing an increased risk of suicide in patients taking SSRIs, when compared to patients taking a placebo, by claiming that suicide is a side effect of depression.
This claim is an insult to the intelligence of consumers. If that assertion were true, there would be more suicides by people taking placebos, not the other way around.
An FDA patient information sheet for Lexapro now says: "Persons taking Lexapro may be more likely to think about killing themselves or actually try to do so, especially when Lexapro is first started or the dose is changed."
"People close to persons taking Lexapro can help by paying attention to changes in user's moods or actions," the paper says. "Contact your health-care professional right away," it warns, "if someone using Lexapro talks about or shows signs of killing him or herself."
"If you are taking Lexapro yourself and you start thinking about killing yourself," it instructs patients, "tell your health-care professional about this side effect right away."
That simple warning, critics say, added to the doctor and patent information sheet for SSRIs when the problem was first discovered could have saved tens of thousand of lives.
One of the Lexapro-induced suicide lawsuits mentioned in Forest's Annual Report, was filed by Raymond Badyna, as the administer of his deceased son, Ray Badyna's estate.
The action was filed in the US District Court for the District of New Jersey on September 25, 2005, by attorneys, Derek Braslow and Harris Pobust, of the Pogust & Braslow, LLC law firm in Conshohocken, Pennsylvania.
On September 30, 2003, Ray was prescribed Lexapro by his primary care physician who noted that Ray was experiencing anxiety, depression and was having problems relaxing and sleeping at night.
Ray's doctor said that he prescribed Lexapro because he believed the drug was effective in treating depression and anxiety based on research that was distributed by Forest Labs.
However, the drug did not help and Ray's condition immediately began to deteriorate. Friends and co-workers spoke with Ray concerning his use of Lexapro and they recall that Ray said that he was not feeling himself and feeling very strange.
At his sister's birthday party on October 4, 2003, the family observed Ray as appearing extremely withdrawn, tired and isolated. His sister noticed that he was pacing back and forth throughout the house, looked uneasy, and that his hands were shaking.
His sister became convinced that something was seriously wrong with Ray and she was right. Unbeknownst to his family, Ray was suffering from suicidal ideation and had expressed thoughts about harming himself to others.
In a conversation with his friend, Ray complained that Lexapro was making him "feel weird" and said that he "had very strange thoughts running through his mind."
On October 7, 2003, while at work, Ray got what should have been great news when he was notified that his year to date performance had qualified him to receive the, "Countrywide Circle of Excellence Award," for the second consecutive year in a row.
Two days later, on October 9, 2003, Ray, age 32, committed suicide by overdosing and cutting his wrists. An autopsy showed the presence of Lexapro in his bloodstream.
Ray's death was senseless. He life was a model for the all-American success story. He was popular, outgoing and sociable and had a loving close relationship with his family.
Ray had a college education, and a good career in real estate and owned his own home, as well as four other investment properties, and even a boat.
Family members, friends and co-workers alike, all say Ray was outgoing, had a great sense of humor, enjoyed life and seemed to everything to live for, prior to being prescribed Lexapro. If Ray's family members had been told to watch for the warning signs that Ray was exhibiting, they would have intervened, and he would be alive today.
The family's lawsuit alleges that in "the last decade there has been a host of peer-reviewed scientific literature linking the SSRI drugs, of which Lexapro is one, to violence - both self-directed and directed towards others."
Among others, the complaint specifically cites a peer reviewed article published in 2000, on an epidemiological study, funded in part by Eli Lilly and SmithKlineBeecham, that reports that the incident of deliberate self-harm of people on SSRI medications is 5.5 times higher than that of people on the more traditional tricyclic antidepressants.
"Had Ray or his physician known of the increased risk of suicide and suicidal ideation from Lexapro," the family's lawsuit states, "Ray would have never taken the drug."
Next year's annual report will have new additions to the list of lawsuits against Forest. For instance, in July 2006, Mark Bibbee, filed a lawsuit after losing his only 2 sons to Lexapro-induced suicides. The family's attorney, Charles E Grisi, filed the action in Summit County Ohio Common Pleas Court.
David Bibbee was only 27 when he killed himself on February 23, 2003 at his fathers home, and Brian Bibbee was only 24, when he committed suicide 17 months later at his mother's home on July 24, 2004.
The lawsuit charges that Forest Labs knew of the increased risk of suicide, yet failed to conduct tests to see how often the problem occurred and failed to properly warn doctors, pharmacists and patients of the risk, or provide ways to reduce the risk.
The lawsuit points out that a link between SSRIs and suicide was first noted in 1990, even though the FDA did not issue a public health advisory until March 2004, more than a year after David's death and about four months prior to Brian's death.
"Strong warnings and instructions, coupled with reasonable effort to 'get the word out' could still have saved Brian Bibbee's life," the lawsuit states.
"Unfortunately," the complaint charges, "Forest took the path of least resistance and greatest profits by doing only the minimum amount that the FDA urged it to do."
"Therefore," the lawsuits states, "this warning was 'too little, too late' for David and Brian Bibbee."
These three cases of unexpected suicides by young people taking Lexapro are not isolated incidents. Jo Ann Kelly has been trying to raise awareness about the increased risk of suicide associated with SSRIs since her son, David died of a self inflicted gun shot wound after he was prescribed Lexapro for an anxiety disorder.
A few days before his death, Jo Ann noticed a dryness of skin and an increased agitation in David, and her son-in-law noticed a yellowish appearance in David's eyes.
Jo Ann became frantic and feared that her son might not be metabolizing the Lexapro correctly so she called to schedule a doctor's appointment but could not get in for 2 days.
The day of the appointment came too late; David had already shot himself.
Over the past several years, studies have shown that SSRIs are associated with serious birth defects in babies born to women who use the drugs during pregnancy. Within the last year, the FDA has added warnings to the labels on SSRIs about the risks of heart birth defects and a life-threatening lung disorder.
As a result of the new revelations about birth defects, lawsuits are now being filed against the SSRI makers on behalf of injured infants.
Medical professionals say the value of any drug must be determined by weighing its benefits against its risks. In the case of SSRIs, the benefits, if any, are a topic of great controversy. An analysis of studies submitted to the FDA between 1987 and 1999, on the six most popular SSRIs, found that approximately 80% of the positive responses to the drugs were the same in patients participating in the placebo groups.
Simply put, with all the known harms identified over the past 20 years associated with SSRIs, they do not even work.
According to Forest Laboratories' Annual Report, for the year ending March 31, 2006, Celexa and Lexapro, accounted for 68% of the company's sales.
The drugs belong to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
Sales of Lexapro, the filing notes, increased 16% in the 4th quarter to $464,100,000, compared to $399,381,000 in the same quarter a year ago.
However, the Report filed with the SEC on June 14, 2006, also says that Forest Labs is currently a named defendant in approximately 25 active SSRI related lawsuits, with most of the cases claiming that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.
On November 7, 2005, Forest moved to consolidate all of the cases pending in Federal courts into a multidistrict proceeding, and on February 6, 2006, its motion was granted and multidistrict litigation was established with the cases then pending transferred to Judge Rodney Sippel in the US District Court for the Eastern District of Missouri.
But the company's legal troubles by far are not limited to a few civil lawsuits. The US Attorney's Office for the District of Massachusetts is investigating whether Forest has committed not only civil violations but also criminal violations of the Federal Anti-Kickback laws with "off-label" promotional activities in the marketing of Lexapro and other products.
As part of the investigation, Forest first received a subpoena from the Office of Inspector General of the Federal Office of Personnel Management requesting documents relating to Celexa, but the company has since received another subpoena from the US Attorney's Office related to Lexapro and other products.
The subpoenas request documents relating to a broad range of the company's marketing and promotional activities dating back to January 1, 1997, all the way up to the present.
The truth is, right along with all the other SSRI makers, Forest has been marketing Lexapro for the off-label treatment of a wide variety of ailments in part, by promoting the notion that every uncomfortable feeling is caused by a "chemical imbalance." However, according to Dr David Healy, "none of the SSRI manufacturers can tell us what constitutes a proper chemical balance of serotonin in the brain."
"Thus," he says, "the truth is that Lexapro and its serotonergic cousins lie somewhere on the continuum between "magic bullets and snake oil."
Dr Healy is one of the world's leading authorities on SSRIs and the author of, "The Antidepressant Era," and "The Creation of Psychopharmacology."
To expand the market for SSRIs, the drug companies have transformed everyday sadness, stress, and worry into mental disorders that demand one cure: drugs. Strong emotions felt after the death of a loved one, or a divorce, or job loss are now irrational and symptoms of mental illness.
In fact, over the past 15 years Big Pharma has managed to cultivate the development of a whole new batch of mental illnesses, with names like generalized anxiety disorder, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder, by simply greasing the palms of the so-called psychiatric "experts" who determine the criteria for the inclusion of a disorder in the Diagnostic and Statistical Manual for Mental Disorders (DSM).
Other more recent additions to the DSM, intended to further widen the customer recruitment net to specifically target children, have names like reading disorder, mathematics disorder, disorder of written expression, and oppositional defiant disorder.
And with the inclusion in the DSM, comes the guaranteed payment for the drugs to treat the disorder from public and private health insurance programs. The first edition of the DSM had a little over 100 disorders; the latest edition lists close to 375.
The mass marketing of mental illness has led many people experiencing minimal symptoms of distress to believe they need drugs to exist. And because most doctors are not trained on the side effects of SSRIs, patients can exhibit a wide range of actions or behaviors that appear to be symptoms of another "disorder," and are then prescribed more drugs to counter the unrecognized adverse reactions to the first.
Even the medical education courses that doctors must take each year to maintain their professional license are most of the time sponsored by drug companies which means the courses are intended to increase the sale of specific drugs, and to educate doctors on their adverse effects would defeat the whole purpose of the seminar.
In fact, experts say the drug makers continue to ignore and discount all of the adverse effects associated with SSRIs. For instance, sexual dysfunction, such as lack of libido or interest, orgasmic dysfunction in women, and delayed ejaculation in men, are extremely common but seldom mentioned. Studies have shown that as high as 70% of patients on SSRIs experience sexual side effects.
According to WebMD, on July 2005, these side effects cause significant problems of their own. "For both men and women, this means being unable to initiate, participate fully in, or enjoy sex," the article states, "and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery."
But then not to worry, because a study in the January 1, 2003, Journal of the American Medical Association says that people experiencing SSRI related sexual dysfunction may be helped by simply taking another pill, Viagra.
And, although the FDA has not approved Viagra for women, some "experts" recommend that women experiencing SSRI related sexual problems should give it a shot anyways.
Whenever possible, patients are convinced that they need to take SSRIs for life. It would be interesting to see the results of a survey that asked patients if they would be willing to begin a life-long drug treatment if it meant waving good-by to a normal healthy sex life.
As a follow-up, a survey should also be conducted on the partners of SSRI patients to find out how long they will be willing to remain in what often becomes a sexless relationship.
The drug companies have also tried for years to discount the many studies showing an increased risk of suicide in patients taking SSRIs, when compared to patients taking a placebo, by claiming that suicide is a side effect of depression.
This claim is an insult to the intelligence of consumers. If that assertion were true, there would be more suicides by people taking placebos, not the other way around.
An FDA patient information sheet for Lexapro now says: "Persons taking Lexapro may be more likely to think about killing themselves or actually try to do so, especially when Lexapro is first started or the dose is changed."
"People close to persons taking Lexapro can help by paying attention to changes in user's moods or actions," the paper says. "Contact your health-care professional right away," it warns, "if someone using Lexapro talks about or shows signs of killing him or herself."
"If you are taking Lexapro yourself and you start thinking about killing yourself," it instructs patients, "tell your health-care professional about this side effect right away."
That simple warning, critics say, added to the doctor and patent information sheet for SSRIs when the problem was first discovered could have saved tens of thousand of lives.
One of the Lexapro-induced suicide lawsuits mentioned in Forest's Annual Report, was filed by Raymond Badyna, as the administer of his deceased son, Ray Badyna's estate.
The action was filed in the US District Court for the District of New Jersey on September 25, 2005, by attorneys, Derek Braslow and Harris Pobust, of the Pogust & Braslow, LLC law firm in Conshohocken, Pennsylvania.
On September 30, 2003, Ray was prescribed Lexapro by his primary care physician who noted that Ray was experiencing anxiety, depression and was having problems relaxing and sleeping at night.
Ray's doctor said that he prescribed Lexapro because he believed the drug was effective in treating depression and anxiety based on research that was distributed by Forest Labs.
However, the drug did not help and Ray's condition immediately began to deteriorate. Friends and co-workers spoke with Ray concerning his use of Lexapro and they recall that Ray said that he was not feeling himself and feeling very strange.
At his sister's birthday party on October 4, 2003, the family observed Ray as appearing extremely withdrawn, tired and isolated. His sister noticed that he was pacing back and forth throughout the house, looked uneasy, and that his hands were shaking.
His sister became convinced that something was seriously wrong with Ray and she was right. Unbeknownst to his family, Ray was suffering from suicidal ideation and had expressed thoughts about harming himself to others.
In a conversation with his friend, Ray complained that Lexapro was making him "feel weird" and said that he "had very strange thoughts running through his mind."
On October 7, 2003, while at work, Ray got what should have been great news when he was notified that his year to date performance had qualified him to receive the, "Countrywide Circle of Excellence Award," for the second consecutive year in a row.
Two days later, on October 9, 2003, Ray, age 32, committed suicide by overdosing and cutting his wrists. An autopsy showed the presence of Lexapro in his bloodstream.
Ray's death was senseless. He life was a model for the all-American success story. He was popular, outgoing and sociable and had a loving close relationship with his family.
Ray had a college education, and a good career in real estate and owned his own home, as well as four other investment properties, and even a boat.
Family members, friends and co-workers alike, all say Ray was outgoing, had a great sense of humor, enjoyed life and seemed to everything to live for, prior to being prescribed Lexapro. If Ray's family members had been told to watch for the warning signs that Ray was exhibiting, they would have intervened, and he would be alive today.
The family's lawsuit alleges that in "the last decade there has been a host of peer-reviewed scientific literature linking the SSRI drugs, of which Lexapro is one, to violence - both self-directed and directed towards others."
Among others, the complaint specifically cites a peer reviewed article published in 2000, on an epidemiological study, funded in part by Eli Lilly and SmithKlineBeecham, that reports that the incident of deliberate self-harm of people on SSRI medications is 5.5 times higher than that of people on the more traditional tricyclic antidepressants.
"Had Ray or his physician known of the increased risk of suicide and suicidal ideation from Lexapro," the family's lawsuit states, "Ray would have never taken the drug."
Next year's annual report will have new additions to the list of lawsuits against Forest. For instance, in July 2006, Mark Bibbee, filed a lawsuit after losing his only 2 sons to Lexapro-induced suicides. The family's attorney, Charles E Grisi, filed the action in Summit County Ohio Common Pleas Court.
David Bibbee was only 27 when he killed himself on February 23, 2003 at his fathers home, and Brian Bibbee was only 24, when he committed suicide 17 months later at his mother's home on July 24, 2004.
The lawsuit charges that Forest Labs knew of the increased risk of suicide, yet failed to conduct tests to see how often the problem occurred and failed to properly warn doctors, pharmacists and patients of the risk, or provide ways to reduce the risk.
The lawsuit points out that a link between SSRIs and suicide was first noted in 1990, even though the FDA did not issue a public health advisory until March 2004, more than a year after David's death and about four months prior to Brian's death.
"Strong warnings and instructions, coupled with reasonable effort to 'get the word out' could still have saved Brian Bibbee's life," the lawsuit states.
"Unfortunately," the complaint charges, "Forest took the path of least resistance and greatest profits by doing only the minimum amount that the FDA urged it to do."
"Therefore," the lawsuits states, "this warning was 'too little, too late' for David and Brian Bibbee."
These three cases of unexpected suicides by young people taking Lexapro are not isolated incidents. Jo Ann Kelly has been trying to raise awareness about the increased risk of suicide associated with SSRIs since her son, David died of a self inflicted gun shot wound after he was prescribed Lexapro for an anxiety disorder.
A few days before his death, Jo Ann noticed a dryness of skin and an increased agitation in David, and her son-in-law noticed a yellowish appearance in David's eyes.
Jo Ann became frantic and feared that her son might not be metabolizing the Lexapro correctly so she called to schedule a doctor's appointment but could not get in for 2 days.
The day of the appointment came too late; David had already shot himself.
Over the past several years, studies have shown that SSRIs are associated with serious birth defects in babies born to women who use the drugs during pregnancy. Within the last year, the FDA has added warnings to the labels on SSRIs about the risks of heart birth defects and a life-threatening lung disorder.
As a result of the new revelations about birth defects, lawsuits are now being filed against the SSRI makers on behalf of injured infants.
Medical professionals say the value of any drug must be determined by weighing its benefits against its risks. In the case of SSRIs, the benefits, if any, are a topic of great controversy. An analysis of studies submitted to the FDA between 1987 and 1999, on the six most popular SSRIs, found that approximately 80% of the positive responses to the drugs were the same in patients participating in the placebo groups.
Simply put, with all the known harms identified over the past 20 years associated with SSRIs, they do not even work.
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