Posts Tagged ‘Paxil’

Paxil and Prozac Linked to Risk of Heart Birth Defects

Monday, June 27th, 2011

AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

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Beware the ghost(writer)s of medical research

Friday, June 17th, 2011

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
and Dr. Sergio Sismondo
Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.


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The Small Group of Thoughtful, Committed Citizens Has Been Drugged

Tuesday, May 24th, 2011

OpEdNews
By David Swanson
May 23, 2011

Movements for justice have historically been driven by a small percentage of any population. One percent of Americans nonviolently occupying Washington, D.C., could make Cairo and Madison and Madrid look like warm-up acts. It is certainly true that a small group of thoughtful, committed citizens is the only thing that ever has changed the world for the better.

So, what happens if a society picks out a significant slice of its population, one including many thoughtful and committed citizens, and drugs them?

The Drug Enforcement Administration (DEA) held a first-time, one-day, little publicized event last September that allowed people to turn in their extra prescription drugs. The DEA reports collecting 242,000 pounds or 121 tons. A second such day was held in April with 376,593 pounds or 188 tons of pills collected. This is the stuff nobody wants and is willing to hand in to the government. This is not the amount that’s out in circulation. That amount is no doubt in proportion to the roaring flood of television ads for the stuff. “More Americans currently abuse prescription drugs,” says the DEA, “than the number of those using cocaine, hallucinogens, and heroin combined. . . . [I]ndividuals that abuse prescription drugs often obtained them from family and friends, including from the home medicine cabinet.” And that’s just the users said to be abusing.

Ted Rall suggested drugging to me as a possible explanation for the big mystery staring us in the face, namely why Americans sit back and take so much more than other people from their government. The Patriot Act is being put on steroids with hardly a peep of protest. The “Defense Authorization Act” now before Congress would give presidents virtually limitless power to single-handedly make wars or imprison people. This is the biggest formal transfer of power in the U.S. government since the drafting of its Constitution. This undoes the American War for Independence. But perhaps we’d still be 13 colonies if Prozac and Zoloft had come along sooner.

“Like many people,” says Rall, “I have often wondered why so many Americans seem so emotionally flat and politically apathetic in response to a political and economic landscape that cries out for protest, or at least complaint. Could it be that our society’s most angry — justifiably angry — are being medicated into quiescence?” It does seem possible. I don’t mean to discount the fact that the United States imprisons record numbers of people. I’m willing to share some blame with our education system, our so-called news media, our religiosity, the two-party trap, and several other likely factors. But drugs looks like the big one that is nonetheless hardest to see. People don’t usually tell you they’re drugged, but chances are at least one in 10 people you meet is.

Two years ago, a study found that “the number of Americans taking antidepressants doubled to 10.1 percent of the population in 2005 compared with 1996, increasing across income and age groups.” One year earlier, another study had found that close to 10 percent of men and women in America were taking drugs to combat depression, and that 11 percent of women were taking antidepressants.”

Author and clinical psychologist Bruce Levine tells me this may be even worse than it sounds. “If you are around certain populations,” Levine says, “that 10 percent stat seems very low, especially among healthcare professionals and college students.” College students? I can remember them getting pretty thoughtful and committed in times past. “And that 10 percent,” Levine adds, “only includes the ‘official antidepressants’ such as Prozac, Paxil, Zoloft, Lexapro, Wellbutrin, Effexor, etc. This stat doesn’t include people using ADHD drugs such as Ritalin, Adderall, etc. to stimulate themselves.”

Adderall, Levine explained, is an amphetamine that affects the same neurotransmitters as cocaine (dopamine, serotonin, and norepinephrine), “and if one takes the antidepressant Effexor (affects serotonin and norepinephrine) at the same time one is taking the antidepressant Wellbutrin (affects dopamine), one can sense the hypocrisy in labeling certain psychotropics (drugs that affects neurotransmitters) as ‘antidepressants’ and other psychotropics as ‘ADHD psychostimulants.’ Lots of people — especially young people — are popping ‘Addies’ (street name for Adderall) to ‘motivate’ them to get them through their lives, especially during exam time.”

Levine said he’s counseling a young man who is supplementing his income by selling ADHD psychostimulant drugs to his fellow college students. He gets the best price around final exam time. “He told me, ‘Bruce, you’ve got to do better improving the self-esteem of these young kids who you are counseling.’ Why, I ask him, why do you care? ‘Well,’ he says, ‘these little brats who are getting their freebie prescription Addies feel so crappie about themselves that they are giving away their Addies to their older brothers for free just so they will hang out with them, and all those freebie Addies on the market are driving price down for me.”

Levine stresses that Adderall, like nicotine or caffeine or cocaine, provides a buzz that antidepressants do not. In fact, he points out, the so-called antidepressant drugs make people twice as likely to commit suicide. Levine concedes that some people swear antidepressants have saved their lives, but points out that people will say that about a placebo as well. The evidence, Levine says, shows antidepressants working no better than a placebo at lifting people out of depression.

Antidepressants may bear as Orwellian a name as the Patriot Act, but Levine finds the latter easier to talk about with people. “I get less grief,” Levine tells me, “when I talk about something like anarchism and Emma Goldman than when I talk about antidepressants’ effectiveness and [author] Irving Kirsch, as abstract political ideologies are far less threatening than people’s very own drugs.” Political movements may in fact be less threatening to those in power, because of people’s drugs.

Read article here:  http://www.opednews.com/articles/The-Small-Group-of-Thought-by-David-Swanson-110523-181.html

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Panel to Examine Murder and Suicide Associated With Antidepressants

Tuesday, March 22nd, 2011

The Huffington Post, March 22, 2011
by Dr. Peter Breggin

Click image to visit the Psychiatric Drug Database

On Saturday morning April 9th of this year, a panel discussion will be held for the public and professionals on the theme of “Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives.”

The two-hour presentation focuses on suicide and murder potentially caused by antidepressant medications. It is part of the international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living (April 8-10, 2011 in Syracuse, New York).

The panel will present a unique examination of an antidepressant-related suicide from three perspectives: Mathy Downing, the mother of a twelve-old-child who committed suicide; Karl Protil, the lawyer in her case, which was settled without any admission of negligence; and myself as the medical expert in the case. Mathy will be accompanied by her surviving daughter. Other family members will tell the stories of two more children who committed suicide, a father who committed suicide, and a husband who murdered his two young children–all while taking prescribed antidepressants.

A great deal is now known about suicide and violence in association with the newer antidepressants such as Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Luvox (fluvoxamine), Celexa (escitalopram), Lexapro (escitalopram), Cymbalta (duloxetine), Effexor (venlavaxine), Pristiq desvenlafaxine), and Wellbutrin (bupropion).

The FDA has imposed a Black Box on all antidepressant labels that warns against the risk of suicidal behavior in children, youth and young adults. Click here to find the example of Prozac’s official prescribing information. More importantly and more broadly, the new labels also warn about the risk of aggression, hostility, mania, and an overall worsening of the individual’s mental condition, for all ages. The new FDA-approved labels also include a Medication Guide, which the FDA urges prescribers to give to patients and their families. Originally intended for children taking antidepressants, it now has no age limitation and pertains to all ages. The Medication Guide warns patients and their families to be aware of the possibility of suicidal and violent behavior, mania, and a long litany of other dangerous mental abnormalities.

The new FDA-approved antidepressant labels confirm that the risks are highest at the start of medication therapy or during changes in dose, either up or down. To a great extent, the labels read like my prior publications, one of which was given by the FDA to its outside expert committee that recommended the changes to the labels.

Unfortunately, many psychiatrists, internists, family doctors, nurse practitioners and other professionals continue to prescribe these medications, too often without providing adequate information to the patient and the family. As a result, I was asked to write about the implications of these new labels for the most widely read psychiatric journal for primary care prescribers. The panel at the Empathic Therapy Conference, the first of its kind, will explore these tragedies and put a human face on them through the presence and presentations of surviving family members.

Other aspects of the conference will describe empathic approaches to helping a wide variety of emotional conditions and problems in children and adults. Speakers will bring unique and inspiring approaches to children and adults given psychiatric diagnoses, ordinary folks who are suffering from stress, street people overcome by psychosis, military personnel recovering from PTSD and head injuries, and elderly victims of dementia. Professionals and the general public are welcome at the Empathic Therapy Conference in Syracuse, New York, April 8-10, 2011. Continuing education credits (CEs) for 29.5 hours are available.

Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books including Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock and Biochemical Theories of the “New” Psychiatry, as well as his newest book, Medication Madness. The Empathic Therapy Conference brings together more than forty presenters and a diverse audience from around the world. Professionals and nonprofessionals are welcome. Learn about the conference at http://www.empathictherapy.org.

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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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A sugared pill

Wednesday, March 9th, 2011

Financial Times
By Andrew Jack
March 8, 2011

Stefan Kruszewski, a US psychiatrist who has been a whistleblower against pharma companies in three recent cases that resulted in settlements, warns that the legacy of the past will generate yet more pain. “Some companies have got better,” he says. “But there is more to come out.”

When Daniel Carlat, a psychiatrist in Massachusetts, was flown to New York with his wife by Wyeth, the “training” weekend he attended in a luxury hotel was topped off with a Broadway show. It was early 2001 and he had just agreed to the US pharmaceuticals company’s proposal that he give talks to doctors about its antidepressant Effexor.

During the following year, he was regularly paid fees of $750 a time to drive to “lunch and learn” sessions where he would speak for 10 minutes to emphasise the drug’s advantages to fellow doctors, using slides prepared by the company. “It seemed like a win-win,” he recalls. “I was prescribing it, educating doctors and making some money.”

But within a few months, he became disillusioned with his co-option as a marketing representative. He was selectively presenting clinical data that put the drug in a positive light to physicians who had been targeted by the company through “data mining” techniques that identified their individual prescription patterns.

Dr Carlat has spoken out as part of a growing backlash against such aggressive marketing tactics, which are leading to significant changes in the relationship between doctors and drug companies. But even as pharmaceuticals executives argue that such problems belong to the past and were always exaggerated, they are bracing for both intensifying penalties and calls for further reform.

“In some ways, our industry lost its way and failed to fully appreciate the evolving expectations of our stakeholders,” Deirdre Connelly, head of North American operations at GlaxoSmithKline, told a conference in January. While playing down the extent of the problem, she conceded: “No matter the reasons, at the end of the day, we must regain the public’s trust.”

Her comments came as the UK-based company put aside provisions of £2.2bn ($3.6bn), largely to cover a settlement under negotiation with the US district attorney’s office for Colorado over sales and promotional practices between 1997 and 2004 for drugs including its antidepressants Paxil and Wellbutrin. A report in January by Morgan Stanley, the investment bank, predicted a surge in litigation, including against GSK, as still undisclosed “whistleblower” lawsuits and regulatory settlements translate into claims totalling billions of dollars for the industry in the coming months.

At the heart of the problem is a wide-ranging, cosy and opaque relationship between companies and physicians – one that often includes money or other benefits changing hands. For most in the industry, such links are essential to understanding diseases and patient needs, developing effective medicines and providing education on them to prescribers.

US authorities have taken the lead, investigating practices used in other countries as well as at home. Authorities elsewhere, including in the UK, France and Italy, have also been scrutinising arrangements.

Chris Viehbacher, head of Sanofi-Aventis, the French drugmaker, rejects the suggestion that payments need cause insuperable problems. “Doctors are professionals and I have every confidence in their judgment,” he says, arguing that payments from companies need not undermine the integrity of prescribers.

Yet others argue that payments to doctors have at times resulted in the prescription of medicines to patients who do not stand to benefit, risking suboptimal or even dangerous treatment and substantial and unnecessary costs to health systems.

“The industry has made important steps to clean up its act, but more needs to be done,” says Richard Horton, editor of The Lancet, the medical journal. He chaired a working party at the UK’s Royal College of Physicians two years ago that launched recommendations to rebalance the relationship between the industry, academia and the taxpayer-funded National Health Service. In the face of a lack of consensus and practical difficulties, many have yet to be implemented.

He and others say questionable links between doctors and industry reached their apogee in the US at the start of the millennium, when fierce competition among companies at a time of slowing innovation resulted in the creation of a slew of “me too” drugs, often with little advantage over existing treatments. Pressure from increasingly aggressive makers of low-cost generic versions of out-of-patent proprietary products heightened the urgency of maximising sales. Companies were spending heavily on media advertisements – often including celebrity endorsements – to persuade patients to lobby doctors for prescriptions of their products.

Above all, a wave of takeovers spurred by falling productivity left newly expanded groups such as Pfizer with thousands of sales “reps”, often recruited more for their charm than their medical expertise, charged with visiting doctors to persuade them to prescribe their drugs. This created an “arms race” among leading companies, often with barely distinguishable products.

One tool used in the US was “sampling”, whereby reps would leave free supplies of their often costly drugs with doctors, who were able to hand them out to patients without medical insurance. They also paid for physicians’ meals and even petrol.

In Europe and most other industrialised regions, direct-to-consumer advertising of prescription medicines is typically banned or tightly controlled, and free samples are less relevant in markets where drugs are largely paid for by governments.

Yet close links between sales reps and doctors have been widespread – and not always limited to small gifts such as pens, notepads and coffee mugs. There have also been allegations of significant payments, some of which are under scrutiny by federal investigators focusing on the overseas activities of companies operating in the US.

In the UK, US-based Abbott Laboratories was severely reprimanded by the Association of the British Pharmaceutical Industry in 2006 after reps took doctors to Wimbledon matches, greyhound races and a lap-dancing club. Two years later, Swiss-based Roche suffered the same fate after encouraging the sale of weight-loss pills to individuals in private slimming clinics not qualified to prescribe.

. . .

Practising doctors are required by their own professional bodies to participate in “continuing medical education” sessions to keep up to date. But speakers and themes can be influenced by drugmakers. Often flown business class with their spouses to resorts in exotic locations, doctors around the world attend scientific conferences where companies hold “satellite” sessions presenting their products in a favourable light.

While Dr Carlat participated in such “speaker bureaus”, other “key opinion leaders” were paid as consultants for a variety of services. Those inc­luded advice on the design and writing up of clinical drug trials and adding their names and credibility to articles ghost-written by specialist authors hired by the companies.

A series of studies has demonstrated that industry-sponsored trials published in medical journals – a cornerstone of marketing to doctors – generally favour their drugs. Trials with less promising results are not generally published. This can distort the true picture of risks and benefits of medicines.

The full extent of such marketing activities and any distortion of prescribing practices is unclear. But “sunshine” legislation introduced as part of US President Barack Obama’s healthcare reforms is beginning to reveal the amount companies have been willing to spend. According to an analysis by ProPublica, an investigative journalism agency, the first eight companies to disclose their spending paid a total of $320m in 2009-10 to 18,000 doctors, the top 10 of whom received more than $250,000 each.

Such transparency is itself accelerating reform. Companies – some forced by legal settlements, others persuaded by the requirements of government funders and medical journals – are making details of their clinical studies available on public websites, allowing scrutiny by independent researchers. GSK this year changed its payment system for reps, hiring and assessing them based on medical expertise and removing commissions linked directly to sales.

Organisations including Britain’s ABPI, its Swedish counterpart Lif, and Efpia, the European Union-wide trade body for the sector, have introduced ever tougher codes of conduct that have restricted gifts, drug samples, entertainment and travel. In the US, the independent Institute of Medicine has called for far more aggressive measures to control continuing medical education, in order to put content at arm’s length from drug companies. The National Institutes of Health, the US federal research funder, is revising its conflict of interest codes for grant recipients, and many medical schools have taken similar steps to clamp down on industry influence on faculty members.

But such measures have proved partial. Disclosure of clinical trial results remains patchy, and pledges to publish payments to doctors in Europe are less comprehensive than those in the US. The ethics code of Phrma, the US trade grouping, has no enforcement mechanism. Ifpma, the international body, has only ever considered – and then rejected – four complaints against companies.

Susan Chimonas, of New York’s Columbia University, says the medical profession must take more responsibility. She highlights a recent study that found the majority of US medical schools had weak or non-existent conflict of interest guidelines on payments to their faculty. “It takes two to tango,” she argues. “Industry is behaving the way industry is expected to in a capitalist system, but the medical profession has lost its way. Prescribers are willing partners.”

In the UK Des Spence, a Glasgow doctor who founded a national chapter of the No Free Lunch movement, which rejects drug company hospitality, points out that the NHS is supposed to provide registers of payments to doctors, but few disclosures have been made. The General Medical Council, the profession’s regulator, has shown little interest.

. . .

The greatest pressure for reform has come from governments and health insurers. A growing trend towards rigorous and continuing comparative data on drugs’ safety, efficacy and cost-effectiveness is shifting prescription powers from individual doctors to technical organisations such as the UK’s National Institute for Health and Clinical Excellence.

The result has been a cull in tens of thousands of drug reps in the industrialised world in the past few years, although their numbers have been growing in the less-regulated emerging markets to which the pharmaceuticals companies are increasingly turning. If some of the more egregious payments to doctors are on the wane, that leaves more subtle issues such as the independence of continuing medical education. If the drug industry pulls back, either individual doctors or their employers will have to provide funding instead.

With austerity measures squeezing government health spending in many countries, and UK changes giving more powers to family doctors, the solution will not be easy. Stefan Kruszewski, a US psychiatrist who has been a whistleblower against pharma companies in three recent cases that resulted in settlements, warns that the legacy of the past will generate yet more pain. “Some companies have got better,” he says. “But there is more to come out.”

Read the rest of the article here:

http://www.ft.com/cms/s/0/ae7099a0-49bc-11e0-acf0-00144feab49a.html#axzz1G80Pn69u

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Dealing With Depression Naturally

Tuesday, March 8th, 2011

FOX News, March 8, 2011
by Chris Kilham

If your life is making you unhappy, then making positive changes may be the very best prescription of all

According to a study published in the Archives of General Psychiatry, approximately 10 percent of Americans are taking antidepressant medications.

This means that over 31 million Americans are gobbling Prozac, Zoloft, Celexa, Elavil, Norpramin, Luvox, Paxil, Wellbutrin and other antidepressant psychiatric drugs like M & M’s. This drug use accounts for billions of dollars in pharmaceutical sales annually (9.6 U.S. billion in 2008).

Yet according to a landmark study published in the Journal of the American Medical Association, antidepressant medications work – as well as placebos and not more. In other words, people in depression studies who are given sugar pills instead of antidepressant drugs do as well as the group who gets the drugs.

Before you ask yourself whether you should simply take a Tic Tac instead of a Paxil, there is more disheartening news about these drugs. Many Americans are taking antidepressant medications instead of changing their own behavior or life circumstances. According to Maryland medical doctor Ronald Dworkin, “Doctors are now medicating unhappiness. Too many people take drugs when they really need to be making changes in their lives.” If you are beating your nose with a hammer, do you stop hitting yourself, or do you continue, and take a pain pill?

Digging more deeply into the mystery of antidepressants, George Washington University health analyst Thomas Moore examined unpublished studies conducted by drug companies  with various antidepressants. Approximately 40 percent of the studies conducted on this class of drugs have never been published — because in those 40 percent of studies, antidepressants do not demonstrate effectiveness. In other words, in the unpublished studies, they didn’t work. In even further research, Irving Kirsch of the University of Connecticut looked at results from varying doses of antidepressants. The difference in effectiveness between small doses and large doses was virtually non-existent.

It gets even gloomier. A U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications. Many who do respond to medication slip back into major depression within a short while, despite sticking with drug treatment. And then there are the “side effects,” which are really effects pure and simple. The most common effects of antidepressant drugs include nausea, insomnia, anxiety, restlessness, loss of sex drive, dizziness, weight gain, tremors, sweating, sleepiness, fatigue, dry mouth,  diarrhea, constipation and headaches. People over 65 are at extra risk of falls, fractures and bone loss, newborns of mothers on SSRI antidepressants can go through drug withdrawal, and among teens, the use of antidepressants can increase suicidal tendencies. Any sober assessment of these effects points to the fact that there is something terribly wrong with this entire class of drugs. Remember what Hippocrates said “First of all, do no harm.”

Many intangibles add up to either a happy life or a sad one. Do you spend enough time with your family? Your friends? Do you relax? Do you do things you love? Do you enjoy your work? If you answer no to these questions, you probably have good cause to feel depressed. But popping a pill won’t help if you are not living in a fulfilled way.

What about natural approaches to depression? A number of doctors believe that nutritional deficiencies play a key role in many cases of depression. After all, brain chemistry depends on nutrient intake for proper balance. Really, it’s no surprise that a junk food-eating culture would be increasingly mentally out of sorts. No brain food means poor brain function. This is where omega 3 fatty acids come in, notably DHA, which is essential for proper brain function. These essential fats greatly enhance brain health and mood. The best way to get them is to eat fresh seafood, especially wild salmon. But omega 3 fatty acid supplements from fish oil are also available.

According to the National Institutes of Mental Health, anxiety and depression often go hand in hand. Many people find that they can relieve or reduce anxiety by meditating. There are many ways to meditate. By setting aside time every day, you can calm your body and mind, change your brainwaves, and alter your mood for the better.

Regular exercise is also associated with improved mood. Exercise enhances circulation, modifies brain chemistry for the better, enhances overall energy, improves vitality and contributes greatly to well being. You don’t need to go to a gym, either. Just get outside and walk. Do so briskly for at least half an hour each day, and notice how much better you feel.

On the herbal side, Rhodiola rosea is the big antidepressant. Many forward-thinking psychiatrists have turned to Rhodiola as a first line of treatment, instead of pharmaceuticals. Psychiatrists Richard Brown and Patricia Gerbarg in New York are ardent advocates of Rhodiola for depression and mood enhancement, and have written profusely about it. Dr Hyla Cass of UCLA also is an advocate. Meanwhile, dozens of studies demonstrate significant improvement in all parameters of mental function with Rhodiola rosea. My favorite brands? Rhodiola Energy by Enzymatic Therapy, and Rapid Rhodiola by EuroPharma.

If your life is making you unhappy, then making positive changes may be the very best prescription of all. Many people are so buried by work and stress that they forget to take time to live, to enjoy themselves and to savor life itself. I remember once meeting a psychiatrist at one of my talks. He was retired, and I was deeply impressed by what he shared.

“I practiced psychiatry for twenty-eight years,” he said. “And I never once gave anybody a prescription.” I asked him what he did for his patients instead.

“I talked with them,” he replied. As Rabbi Earl Grollman, author of several books on grief says, “the mentionable is manageable.” Maybe talking is a good place to start.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

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Finally—An Official Admission: Psychiatric Drugs Cause Violent & Homicidal Behavior

Friday, January 7th, 2011

NOTE FROM CCHRINT: Finally.  An admission.  From TIME Magazine no less.  We at CCHR would  like to take this opportunity to point out that it was due to CCHR’s efforts in 1991 that the FDA held public hearings on the antidepressant Prozac causing violence and suicide in patients.  Scores of victims and families gave testimony along with medical experts that people with no prior history of violence or suicidal behavior  became so under the influence of an antidepressant.   However, the FDA panel, comprised of individuals and psychiatrists with heavy conflicts of interest and numerous ties to the pharmaceutical industry, ignored the evidence.   It would take the FDA 13 years to finally issue black box warnings that antidepressants can induce suicidality.  They have yet to issue black box warnings on antidepressants causing violence…. despite the fact numerous school shooters have been under the influence of such drugs.   Watch CCHR’s exclusive footage of the 1991 FDA hearings on Prozac.

TIME MAGAZINE – JAN 7, 2011

Top Ten Legal Drugs Linked to Violence

by Maia Szalvitz

When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek  drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they’re used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons.

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior.

8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence

7.Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.

6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.

5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.

4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain’s dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.

3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs.

2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.

1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it’s 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn’t necessarily be ruled out as an option for those trying to quit, however.

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Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma

Tuesday, December 7th, 2010
AlterNet — December 6, 2010
by Martha Rosenberg
Here are some of the dicey drugs many Americans are hooked on,
thanks to greedy pharmaceutical companies.

Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement — 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 — manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma’s admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the “very dynamic ADHD market” to Shire’s globalization efforts and “investments we have made in new uses for our existing products.”

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD “new starts” that are helping Shire “grow the market,” and the “co-administration market” of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. “We don’t see those patients show up again until their mid-to-late 20s,” laments Cola.

ADHD drugs, in addition to “robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors,” as Anatomy of an Epidemic author Robert Whitaker puts it, can also be deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no “real risk” and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds “are told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs,” a phenomenon also known as the co-administration market.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the last decade than direct-to-consumer advertising and Viagra put together, no pun intended: over 60 million prescriptions were filled in the US in 2007 with many patients reporting their depression lifted.

But some critics say for mild depression, SSRIs don’t work at all and are no better than placebo.

And others say they can add aggression, bizarre behavior, self-harm and suicidal thoughts to depression. In fact, there are 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988 including the well known gun massacres at Columbine (1999), Red Lake (2005), NIU and likely, Virginia Tech (2007).

SSRIs have non-behavioral perks both sides agree on: life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition, osteoporosis.

Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It’s linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sex? SSRIs are so linked to dysfunction even the pharma-identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. But there is a solution (besides going off SSRIs) says WebMD: Add another antidepressant that’s not an SSRI, like Wellbutrin!

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you’re giving a psychoactive drug for pain. “After three months of taking Savella [another SNRI], I started self-destructing and cutting myself,” writes a 40 year old woman on askapatient.com. “I don’t know why or anything, but it does similar to Prozac where it makes you think and do weird things.”

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix’s Sky Harbor airport in 2007.

SNRI’s are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. told AlterNet he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It’s also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That’s similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Read the rest of the article here: http://www.alternet.org/story/149078/nation_of_pill_poppers_19_dangerous_drugs_shamelessly_pushed_by_big_pharma?page=entire

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5 Myths About Depression Treatments

Friday, December 3rd, 2010

COUNTER PUNCH, December 3, 2010

By Bruce E. Levine,
Clinical Psychologist

A warning: for people satisfied with their standard depression treatments, debunking myths about them may be troubling. However, for critically thinking depression sufferers who have not been helped by antidepressants, psychotherapy, or other standard treatments, discovering truths about these treatments can provide ideas about what may actually work for them.

Critical thinkers have difficulty placing faith in any depression treatment because science tells them that these treatments often work no better than placebos or nothing at all, and if one lacks faith in a depression treatment, it is not likely to be effective. In fact, it is belief and faith—or what scientists call “expectations” and the “placebo effect”—that is mostly responsible for any depression treatment working. Critical-thinkers can find a way out of depression when their critical thinking about depression treatments is validated and respected, and they are challenged to think more critically about their critical thinking.

Myth 1: Antidepressants Are More Effective than Placebos

Many depressed people report that antidepressants have been effective for them, but do antidepressants work any better than a sugar pill? Researcher Irving Kirsch (professor of psychology at the University of Hull in the United Kingdom as well as professor emeritus at the University of Connecticut and author of The Emperor’s New Drugs) has been trying to answer that question for a significant part of his career.

In 2002, Kirsch and his team at the University of Connecticut examined 47 depression treatment studies that had been sponsored by drug companies on the antidepressants Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Many of these studies had not been published, but all had been submitted to the Food and Drug Administration (FDA), so Kirsch used the Freedom of Information Act to gain access to all the data. He discovered that in the majority of the trials, antidepressants failed to outperform sugar pill placebos.

“All antidepressants,” Kirsch reported in 2010, “including the well-known SSRIs [selective serotonin reuptake inhibitors], had no clinically significant benefit over a placebo.” While in aggregate, antidepressants slightly edge out placebos, the difference is so unremarkable that Kirsch and others describe it as “clinically negligible.”

Why are so many doctors unaware of the lack of superiority of antidepressants as compared to placebos? The answer became clear in 2008 when researcher and physician Erick Turner (currently at the Department of Psychiatry and Center for Ethics in Health Care, Oregon Health and Science University) discovered that antidepressant studies with favorable outcomes were far more likely to be published than those with unfavorable outcomes. Analyzing published and unpublished antidepressant studies registered with the FDA between 1987-2004, Turner found that 37 of 38 studies having positive results were published; however, Turner reported, “Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, [falsely] conveyed a positive outcome (11 studies).”

Myth 2: If the First Antidepressant Fails, Another Antidepressant Will Likely Succeed

In The Noonday Demon, the popular 2001 book about depression, writer and depression sufferer Andrew Solomon repeated the then urban legend that “more than 80 percent of depressed patients are responsive to medication.” Solomon accurately cites a journal article that states this statistic; however, following the “reference trail,” I discovered that the journal article that Solomon cited refers to a second article for evidence of this statistic, but this second journal article mentions nothing about 80 percent of depressed patients responding to some medication.

The National Institute of Mental Health (NIMH) was aware that there was no research to back up the assertion that 80 percent of depressed patients improve if they keep trying different medications, so NIMH funded “Sequential Treatment Alternatives to Relieve Depression” (STAR*D), the largest ever study of sequential depression treatments. STAR*D results were published in 2006.

In Step One of STAR*D, all depressed patients were given the antidepressant Celexa, and in Step Two, patients who failed to respond to Celexa were divided into different groups and received other treatments (mostly different drug treatments) in place of or in addition to Celexa. If their second treatment failed, there was a third and, if necessary, a fourth treatment step.

In every STAR*D treatment step, remission rates were either equal to or significantly lower than the customary placebo performance in other antidepressant studies, but to the exasperation of many scientists, there was no placebo control in this $35 million U.S. taxpayer funded STAR*D study. (STAR*D researchers disclosed receiving consulting and speaker fees from the pharmaceutical companies which manufacture the antidepressants studied in STAR*D.)

In March 2006, NIMH triumphantly announced that 50 percent of depressed people saw remission of symptoms after the first two STAR*D steps. However, NIMH failed to mention in its press release that in the same time it took to complete these first two steps—slightly over 6 months—previous research shows that depressed people receiving no treatment at all have a spontaneous remission rate of 50 percent.

In November 2006, following the completion of all four STAR*D steps, STAR*D authors claimed a 67 percent cumulative remission rate, which again exasperated many scientists because this number failed to incorporate STAR*D’s extremely high relapse and dropout rates. In an American Journal of Psychiatry editorial that accompanied STAR*D authors’ report, J. Craig Nelson, M.D, stated, “I found a cumulative sustained recovery rate of 43 percent after four treatments, using a method similar to the authors but taking relapse rates into account.” However, even 43 percent turns out to be an inflated rate.

Separate analyses of STAR*D in 2010 by psychologist Ed Pigott and medical reporter Robert Whitaker revealed that STAR*D researchers had inflated remission numbers by switching mid-study to a more lenient measurement, and also by including patients who were not depressed enough at baseline to meet study criteria. But even taking the STAR*D data as is, Pigott’s analysis revealed that less than 3 percent of the entire group of depressed patients who began the STAR*D study can be ascertained as having a sustained remission (i.e., actually participated in the final assessment without relapsing and/or dropping out).

Myth 3: Electroconvulsive Treatment (ECT) is an Effective Last Resort

Andrew Solomon in The Noonday Demon alsostates, “ECT seems to have some significant impact between 75 and 90 percent of the time. About half of those who have improved on ECT still feel good a year after treatment.” Is ECT really that effective?

In 2004, researcher Joan Prudic, M.D. and her team at New York State Psychiatric Institute conducted a major study of ECT, which involved 347 patients at seven hospitals. Reported were both the immediate outcomes and the outcomes over a 24-week follow-up period. With respect to immediate outcomes, Prudic reported: “In contrast to the 70 to 90 percent remission rates expected with ECT, remission rates, depending on criteria, were 30.3 to 46.7 percent.” Even worse for ECT advocates, Prudic noted that, “10 days after ECT, patients had lost 40 percent of the improvement.”

There are also studies comparing ECT with a placebo (called “sham ECT”). In sham ECT, patients receive muscle-relaxing and anesthetizing drugs that routinely accompany ECT, and they are hooked up to the ECT apparatus, but they receive no electric voltage. Psychiatrist Colin Ross reports, “No study has demonstrated a significant difference between real and placebo (sham) ECT at 1 month post-treatment.”

Myth 4: Cognitive Behavior Therapy (CBT) is the Best Psychotherapy for Depression

First, the good news about CBT. The only non-drug treatment examined in STAR*D was a form of cognitive therapy (which was not fully detailed by STAR*D authors and only administered in Step Two). Among those who failed Celexa in the first step, three groups in Step Two switched from Celexa to one of three antidepressants, and their remission rates ranged from 25 to 26.6 percent; but one group in Step Two switched from Celexa to cognitive therapy, and its remission rate was 41.9 percent. STAR*D researchers did not assess whether any differences in treatment effectiveness were statistically significant.

Another group in Step Two maintained Celexa and added cognitive therapy, and this “Celexa plus cognitive therapy” group’s remission rate was 29.4 percent, not as high as the group that received cognitive therapy without medication. This begs the question: Is it also a myth that “antidepressants plus psychotherapy” works better than either treatment alone? Research psychologist David Antonuccio at the University of Nevada School of Medicine reports, “Combined psychotherapy and drug treatment do not appear to be superior to therapy or drug treatment alone.”

What psychotherapy is best for depression? While Americans hear most about CBT, it turns out that CBT or some form of cognitive therapy is no more effective for depression than any of several other types of psychotherapy. In 2008, psychologists Pim Cuijpers and Annemicke van Straten at the University of Amsterdam reported on a meta-analysis of 53 studies, each of which compared two or more different types of psychotherapy for depression. Included were varieties of “cognitive-behavior therapy,” “psychodynamic therapy,” “behavioral activation therapy,” “social skills training,” “problem-solving therapy,” “interpersonal therapy,” and “nondirective supportive therapy.” The major finding? “No large differences in efficacy between major psychotherapies for mild to moderate depression.”

So, if psychotherapy technique is not all that important, what is? Psychologist Bruce Wampold at the University of Wisconsin reviewed the psychotherapy outcome literature, examining hundreds of studies and meta-analyses, for his book The Great Psychotherapy Debate. Wampold unequivocally states that outcome effectiveness does not depend on the specific techniques of psychotherapy but instead depends on so-called “non-specific” factors such as the nature of the alliance between therapist and their client, and clients’ confidence in the therapy and in their therapist. “Simply stated,” Wampold concludes, “the client must believe in the treatment or be led to believe in it.”

Myth 5: No Treatment for Depression Works

In April 2002, an NIMH-funded study on the antidepressant Zolof, the herb St. John’s wort, and a placebo had some curious results. The findings were that 32 percent of placebo-treated patients experienced remission, better than the 25 percent remission for the Zoloft-treated patients or the 24 percent remission for the St. John’s wort-treated patients. Most scientists would say that this study shows that neither Zoloft nor St. John’s wort worked, but those subjects who had positive outcomes with these two treatments would disagree. So, does this study show that antidepressants and St. John’s wort are not helpful, or does it show that “expectations,” belief,” and “faith” are the likely factors that make all treatments work?

When assessing whether a specific treatment is effective, scientists are trained to rule out the effect of expectations. Researchers evaluate a depression treatment as effective if, in a controlled study, the treatment outcome is significantly better than a placebo. However, the reality of depression treatments is that expectations, faith, belief, and the placebo effect are—far and away—the most important reasons why anything works.

Read the rest of the article here: http://www.counterpunch.org/levine12032010.html

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