From Project on Government Oversight:

In recent years, Senator Grassley exposed several academic physicians for taking large amounts of money from companies with a direct financial interest in their research, some of it funded by the NIH. The list reads like a who’s who in academic research:

• Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant.  Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.

• Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
• Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.

US health agency revises conflict of interest rules

From Reuters – August 23 – 2011

by  Alina Selyukh

WASHINGTON,  – The U.S. National Institutes of Health revised on Tuesday its 16-year-old conflict of interest rules for medical researchers, lowering the amount of money that constitutes a financial conflict and expanding the required disclosures.

The 1995 regulations effectively put responsibility for tracking scientists’ financial conflicts of interest on their universities. The rule required researchers to disclose conflicts to their institutions, which then had to assure the NIH the conflict had been managed, reduced or eliminated.

The new rule extends that requirement so researchers report not only the fact of a conflict of interest, but also its details such as value, specific nature, why it is a conflict and the impact it might have on research.

It lowers the amount a researcher must disclose if received from an industry or held in company stock to $5,000 from about $10,000.

Research institutions, in turn, are now required to report that information to the federal grant-awarding agency alongside details of how the conflicts are managed. Also, before spending any grant money, the institution has to post information about the financial conflicts on a public website.

The new rules will affect about 2,000 organizations that are awarded public health science funding every year and some 38,000 scientists who participate in research funded by these grants and have a “significant financial interest,” NIH said.

Concern about the integrity of research in the United States has grown since 2008, when Iowa Republican Sen. Charles Grassley criticized prominent Harvard University psychiatrist Dr. Joseph Biederman and others for failing to fully disclose payments from drug companies.

In a more recent example, medical device maker Medtronic Inc (MDT.N) came under fire over accusations that doctors paid by the company had failed to disclose major side effects from a bone growth drug in clinical trials.

A 2009 report by the Institute of Medicine, one of the National Academies of Sciences that advises U.S. policymakers, called on doctors to strictly disclose research funding to strengthen protection against conflicts of interest. The report called for virtually anyone involved in medicine — academic medical centers, journals, professional societies, researchers and doctors — to set up or strengthen conflict of interest guidelines.

From 1996 to 2007, relationships between individual academic researchers and industry nearly doubled, according to a study cited by NIH in its final rule. From 1994 to 2003, the amount of financial support for biomedical research almost tripled to $94.3 billion, with 57 percent of that funding coming from industry sources, according to analysis cited by NIH. (Additional reporting by Anna Yukhananov; editing by Andre Grenon)

http://www.reuters.com/article/2011/08/23/health-science-conflicts-idUSN1E77M1PB20110823

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Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting  standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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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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Pharmalot – April 25, 2011

By Ed Silverman

The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice.

Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story).

The feds want Millar to be compeled to testify because his testimony “may be necessary to the public interest.” However, prosecutors expect that he would refuse to testify or otherwise provide any info on the basis of his privilege against self-incrimination, according to court documents (read this). As of this morning, the order compelling his testimony has not been filed with the court.

As indicated previously, the trial threatens to evolve into a spectacle where Glaxo execs and Glaxo lawyers – notably, the King & Spalding law firm that frequently represents the drugmaker – turn the courtroom into a finger-pointing match among people who once labored on the same side of the pharmaceutical battlefield (see here).

http://www.pharmalot.com/2011/04/feds-want-glaxo-exec-to-testify-in-stevens-case/

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Pharmalot

by Ed Silverman – April 12, 2011

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The press are ranting today about a “new study” that shows boys with “Conduct Disorder” or “antisocial behavior” have differences in “size and structure of their brain” that is linked to their behavior.

Before we point out just how lame this new study is on a scientific level – let’s start with the fact that it was was funded by Wellcome Trust. If the name Wellcome sounds familiar it’s because  it was named after, and established in order to administer the fortune of American born pharmaceutical giant, Sir Henry Wellcome (Glaxo-Wellcome later became GlaxoSmithKline).

Secondly, let’s look at the “study” and break it down. This  marketing campaign study took 65 male adolescents with the diagnoses of “conduct disorder” and compared it to a group of 27 male “healthy” adolescents (just over 1/3 the size of the conduct disorder group), and scanned their brains for changes. The first omitted datum in this “study”  is that there is no mention of previous psych drug usage/history which is documented to cause changes in brain chemistry— -if these 65 males were already diagnosed with “Conduct Disorder” how do we know whether they were taking drugs documented to cause brain changes – such as Antipsychotics—documented to cause brain atrophy (shrinkage).

(Reuters Life!) – Brain scans of aggressive, antisocial teenage boys with the condition known as conduct disorder have found differences in the size and structure of parts of the brain that may be linked to their behavior.

A study by British scientists showed the differences were there regardless of the age at which the patients developed the disorder — a finding which challenges the view that adolescents who develop conduct disorder are merely imitating badly behaved peers and do not have differences in their brains.

Conduct disorder (CD) is a psychiatric condition characterized by higher than normal levels of aggressive and antisocial behavior. It is more common in boys than girls, can develop in childhood or in adolescence, and experts say it affects around five out of every 100 teenagers. Children and adolescents with CD are at greater risk of developing further mental and physical health problems when they are adults.

http://www.reuters.com/article/2011/04/01/us-teenage-brain-scans-idUSTRE7304WO20110401

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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 Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye 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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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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CounterPunch New Year’s Edition
December 31, 2010 – January 2, 2011

by Martha Rosenberg

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted “no conflicts of interest” and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified.

The meeting’s Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau.

Doctors on other speaker bureaus like Shire’s Ann Childress and Wyeth’s Claudio Soares gave presentations and workshops that — surprise! — extolled company drugs.

And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff’s book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book’s preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Schatzberg was investigated by the Senate in 2008 which found “a lack of consistency” between what he earned from drug companies and what he reported to Stanford where he continues to head the psychiatry department. He owns $6 million of stock in a company he co-founded, Corcept Therapeutics, which sought FDA approval for a psychiatric drug despite Schatzberg’s APA position.

Nemeroff, for his part, left Emory University in disgrace after a 2008 Congressional investigation unearthed $1.2 million in drug industry income, his $9 million NIH grant was terminated (a rare occurrence) and he was banned from further NIH grants for two years. But he resurfaced as head of the psychiatry department at the University of Miami in 2009 after the medical school dean, Pascal Goldschmidt, was assured by crony Thomas Insel, director of the National Institute of Mental Health (NIMH), that Nemeroff could still draw NIH money, according to the Chronicle of Higher Education. It was payback for when Nemeroff got Insel a job, say observers. Nemeroff still sits on NIH scientific panels reviewing others’ grant applications, ensuring further cronyism.

Ghostwriting, of course, solves the “Company-Says-Company’s-Product-Is-Great” problem and increases the chance of a paper’s publication in a journal. It helps “authors”‘ careers and may even spur their individual prescribing habits since studies show doctors prescribe more of a drug they are paid to promote.

But the consumer version, unbranded advertising, is also effective: radio and TV commercials posing as public service announcements that push “awareness” of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES) and drive worriers to sites where they can self-diagnose with simple quizzes.

Meanwhile, the consumer version of bought doctors is “Astroturf” or patient front groups like the “grassroots” National Alliance on Mental Illness (NAMI), investigated by Congress for drug industry links. These bought patients flash mob the FDA with sob stories when an expensive drug is up for approval and lobby Medicaid to not substitute less expensive drugs, inflating entitlement program and insurance premium costs for industry’s benefit.

In the war against drug industry duplicity, company employees are increasingly reporting misdeeds thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement sums, in some cases. And last month the Justice Department filed the first criminal, not civil, charges against a the drug industry operative, Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. But as long as politicians like former Louisiana Rep. Billy Tauzin, who headed the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to parlay a career’s worth of knowledge and relationships to sell product, the government is essentially fighting itself.

Read the article here: http://www.counterpunch.org/rosenberg12312010.html

For more information on the APA/Conflicts of Interest see:

CCHR: American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits http://www.cchrint.org/2010/05/21/apa-leaders-called-upon-to-cut-drug-company-ties-and-put-the-lives-of-children-ahead-of-personal-profits/

CCHR: DSM Panel Members Still Getting Pharma Funds http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/

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