Posts Tagged ‘paroxetine’

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Study shows antidepressants cause major increase in miscarriages (68%) yet pregnant women still being targeted for usage

Thursday, June 24th, 2010

Before It’s News
June 23, 2010

This study comes on the heels of ones showing these drugs cause birth defects. But even now, regulatory agencies aren’t taking action.

Medical powers-that-be are pressing to identify women “at risk” of depression during pregnancy—likely to push them into taking anti-depressants. Now, a study has shown that SSRI and SNRI antidepressants can increase miscarriages by 68 percent. These drugs have also been associated with birth defects. Now, that is truly depressing.

A study published in the online edition of the Canadian Medical Association Journal reported a 68% increase in miscarriages in women who take modern antidepressants. Paroxetine, the SSRI sold as Paxil or Seroxat, and venlafaxine, the SNRI sold as Effexor, were especially risky, and taking more than one antidepressant was also particularly dangerous.

As previously documented in Babies of Women Taking Antidepressants Born With Deformities, Dr. Anick Bérard, PhD, one of the study’s authors, has also noted that antidepressants have been associated with birth defects. It shouldn’t, of course, come as any surprise that an agent guilty of causing birth defects would also result in miscarriages.

Overall, antidepressant use was found to increase the risk of miscarriage by 68%. Paroxetine increased the risk by 75% and venlafaxine more than doubled the risk to a 110% greater chance of spontaneous abortion.

In comparison, the increased risk of miscarriage due to untreated depression is 19 percent.

It’s obvious that increased miscarriage risks of 68 percent, 75 percent, and 110% with SSRI and SNRI treatment make a 19 percent increase in untreated pregnancy depression pale by comparison.

Read entire article: http://beforeitsnews.com/news/84/868/Antidepressants_Cause_Major_Increase_in_Miscarriages.html

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Lawyers & Settlements—Mom Alert: Would you want a 68% Higher Risk of Miscarriage? (Antidepressants & Pregnancy study)

Thursday, June 3rd, 2010

Lawyers & Settlements
By LucyC
June 2, 2010

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), serotonin– norepinephrine reuptake inhibitors (venlafaxine) and “other antidepressants” (serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors).

This study is just the latest to show an association between, well, for lack of a better term let’s say “serious adverse events” and SSRIs and SNRIs in particular.

Read entire article:  http://www.lawyersandsettlements.com/blog/mom-alert-would-you-want-a-68-higher-risk-of-miscarriage-03819.html

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New Study—Taking Antidepressants While Pregnant More Than Doubles Risk of Miscarriage

Tuesday, June 1st, 2010

Los Angeles Times
By Thomas H. Maugh II
May 31, 2010

Taking antidepressants during pregnancy increases the risk of spontaneous abortions by about two-thirds, Canadian researchers reported Monday. The increased risk was greatest with the family of drugs known as selective serotonin reuptake inhibitors (SSRIs), especially paroxetine and venlafaxine, and when more than one family of drugs were used.

Depression in women is most common during the child-bearing years, and estimates suggest that as many as 15% of pregnant women suffer from it. Because of fears about the effects of drugs, particularly psychiatric drugs, during pregnancy, only about 3.7% of women use them during the first trimester. Most studies looking at the use of antidepressants during pregnancy have focused on their effects on the fetus. Small studies of their effects on abortion have produced inconsistent results. Expecting mothers cannot routinely stop using the drugs, however, because that also presents risks to both the mother and the fetus.

Producing a controlled clinical trial examining the effects of the drugs is virtually impossible because few women would be willing to participate, experts said. The only way to get at the data is to examine it retrospectively.

In the new study, Dr. Anick Berard, director of the University of Montreal’s Research Unit on Medications and Pregnancy at University Hospital Center Sainte-Justine used information from the Quebec Pregnancy Registry to identify 5,124 women who had a spontaneous abortions between 1998 and 2003 — before warnings about the risks of the drugs became more common — and compared them with about 10 times that many carefully matched women who did not have abortions. A separate database provided information about prescriptions the women had filled.

Read entire article:  http://latimesblogs.latimes.com/booster_shots/2010/05/antidepressants-during-pregnancy-increase-risk-of-sponaneous-abortion-study-finds.html

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UK Drug Regulatory Agency issues warning about potential birth defects from Prozac

Thursday, April 29th, 2010

Lawyers & Settlements
By Heidi Turner
April 28, 2010

London, England: The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency in the UK responsible for medicines and medical devices, has issued a warning about potential SSRI birth defects related to the use of fluoxetine (Prozac).

The MHRA issued the warning in its monthly drug safety update. The agency warns that there is a small risk of congenital cardiac defects in infants of mothers who took fluoxetine during the first trimester of pregnancy. According to the safety update, the risk is similar to that posed by paroxetine (Paxil/Seroxat).

The MHRA notes that an analysis of data from seven cohort studies found a slightly increased risk of congenital cardiac defects when fluoxetine was taken early in pregnancy. Those cardiac defects reportedly varied and ranged in severity from reversible ventricular septal defects to transposition of the great vessels. The safety update notes that the increased absolute risk is less than two per 100 pregnancies.

Prozac is an antidepressant classed as a selective serotonin reuptake inhibitor (SSRI). The MHRA says that there is not enough data to conclude that other SSRIs carry the same risk, but it is unwilling to rule out the possibility of a “class effect,” meaning other drugs in the same class may carry the same risks.

The agency also says that the risk of giving birth to an infant with congenital cardiac defects should be weighed against the risks of having untreated depression during pregnancy, which carries its own risks, including low birth weight, preterm delivery and lower Apgar scores.

Read entire article:  http://www.lawyersandsettlements.com/articles/14025/interview-ssri-birth-defects-side-effects-pphn.html

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Child/Teen Suicide Rate 5 Times Higher for Kids on Antidepressants; Researchers Say findings support FDA Black Box Warnings

Monday, April 12th, 2010

WebMD
By Jennifer Warner
April 12, 2010

The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds.

Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.

Previous studies have shown that children and teenagers who begin to use SSRI (selective serotonin reuptake inhibitor) antidepressants may have an increase in suicidal thoughts and behaviors, but researchers say this is the first study to compare the child and teen suicide risk among different individual SSRI antidepressants.

The study followed 20,906 children in British Columbia between the ages of 10 and 18 who had been diagnosed with depression and prescribed an antidepressant over a nine-year period.

During the first year of antidepressant use, there were 266 attempted suicides and three suicides.

Researchers found no significant difference in child and teen suicide risk among the five SSRI antidepressants studied (fluoxetine, fluvoxamine, citalopram, paroxetine, and sertraline). Tricyclic antidepressants showed risks similar to the SSRIs.

Overall, the child and teen suicide rate after initiation of antidepressant use among participants in the study was five times higher than the rate reported among all teens aged 13 to 17 in British Columbia, which researchers say reflects the higher suicide risks among the depressed.

“Our analysis supports the decision of the Food and Drug Administration to include all antidepressants in the black box warning regarding increased suicidality risk for children and adolescents initiating use of antidepressants,” write researcher Sebastian Schneeweiss, MD, ScD of Harvard Medical School and colleagues in Pediatrics.

Read entire article:  http://www.webmd.com/depression/news/20100412/teen-suicide-risk-similar-among-antidepressants

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Antidepressant no more effective than sugar pills in treating depression

Tuesday, January 5th, 2010

Andrew Stern
Reuters
January 5, 2010

Mild to severe depression might be better treated with alternatives to antidepressant drugs, which do not help patients much more than an inactive placebo, researchers said Tuesday.

Combining data from six studies that examined the effectiveness of two commonly prescribed antidepressants — paroxetine and imipramine — found the drugs produced benefits only slightly greater than a placebo in patients with mild to severe depression.

“They would have done just as well or just about as well with a placebo,” said Robert DeRubeis, a psychologist at the University of Pennsylvania, Philadelphia, who with colleagues performed the meta-analysis.

Paroxetine is one of a popular class of drugs, selective serotonin reuptake inhibitors, and is sold under the brand name Paxil by GlaxoSmithKline. Imipramine is an older tricyclic antidepressant drug developed in the 1950s.

The so-called placebo effect is powerful in treating depression, where people believe they are helped even though they are taking an inactive sugar pill, DeRubeis said.

Read entire article:  http://www.reuters.com/article/idUSTRE60454020100106

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GlaxoSmithKline ordered to pay $2.5 for Paxil-caused birth defects in first of 600 such cases

Tuesday, October 13th, 2009

Jef Feeley and Sophia Pearson
Bloomberg.com
October 13, 2009

GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

“The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, the family’s lawyer, said in an interview after the verdict.

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=a3MSErCD3DfY

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Doped Up and Duped – nearly impossible to find independent studies of psych drugs with no Pharma ties

Monday, August 10th, 2009

David Healy
guardian.co.uk
August 8, 2009

Adverse effects of widely-prescribed drugs are often overlooked because there is so little truly independent academic evidence

Since 2005, the SSRI paroxetine, first marketed by GlaxoSmithKline as Seroxat, has carried warnings of risk of birth defects. In the US litigation in which I have been asked to give evidence, the plaintives will argue that, even before they were launched, there was good laboratory evidence that the SSRIs might cause problems, and, following their initial marketing, evidence emerged over a decade ago from clinical use that the drugs actually do cause problems.

Yet these drugs have been actively promoted, de facto primarily to women of child-bearing years. How could this happen?

Part of the problem is that having gone to their GP with a nervous problem, many women become dependent on a prescribed SSRI and find it impossible to stop using it whether they wish to get pregnant or if they find they are pregnant while on treatment. But few, if any, of these women will have been informed of either the risk of birth defects or the risk of becoming addicted. Why not?

What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now effect huge changes in medical culture within months. In this case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company-written.

Read entire article: http://www.guardian.co.uk/commentisfree/2009/aug/08/seroxat-pharmaceutical-birth-defect

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