Blood Money: J&J Buys Positive Risperdal Pediatric “Studies”

J&J gave money in return for positive drug studies, court documents say

Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist explicitly to generate data to help expand sales of the company’s antipsychotic drug Risperdal in children, according to court documents.The documents shed new light on Johnson & Johnson’s close relationship with Joseph Biederman, a Harvard University psychiatrist at the center of a controversy involving the dramatic increase in antipsychotic drugs, including Risperdal, prescribed for children, often for unapproved uses.

Johnson & Johnson spent at least $700,000 to fund the Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital. The purpose of the center, according to an internal company e-mail contained in the court documents, was to “generate and disseminate data supporting the use” of Risperdal in children and adolescents.

Risperdal is used to treat bipolar disorder and schizophrenia.

The e-mails were from 2001 and 2002, long before the U.S. Food and Drug Administration approved Risperdal for use in children in 2006. Physicians are allowed to prescribe drugs for unapproved uses or patients, but drugmakers are barred from marketing drugs for such off-label uses and can face civil charges and steep fines.

Officials at Ortho-McNeil-Janssen Pharmaceuticals Inc., the Johnson & Johnson subsidiary in Titusville, N.J., that makes Risperdal, said they funded the center “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

The company said it promoted its products “only for their FDA-approved indications.”

Biederman did not return a phone call.

The documents were provided by plaintiff lawyers pursuing a class-action suit against Johnson & Johnson, contending that such a powerful drug should not have been widely recommended for children.

The court papers show Johnson & Johnson:

Budgeted $6.4 million to hold “educational summits” and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;

Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;

Discussed clinical trials for drugs as “growth opportunities” and tied trial proposals to sales potential.

Biederman is a Harvard researcher and psychiatrist whose work has fueled a rapid rise in diagnoses of bipolar disorder in children. His studies, often on small numbers of children and funded by drug companies, have expanded the use of what are known as atypical antipsychotics in children.

Children are believed to be much more vulnerable to the side effects of these drugs, which include weight gain, breast milk production in both sexes, facial tics and muscle tremors.

Last Tuesday, a panel of federal drug experts said antipsychotic medicines were overused in children and urged the Food and Drug Administration to do more to warn doctors of their risks.

Besides Risperdal, atypical antipsychotics include Zyprexa, made by Eli Lilly & Co.; Seroquel, made by AstraZeneca P.L.C. and others.

The documents, which resulted from discovery efforts in the lawsuits, portray Biederman as using his influence to get money out of Johnson & Johnson.

In an e-mail from November 1999, for example, Johnson & Johnson marketing executive John Bruins warned his bosses to quickly issue a $3,000 check to Biederman to pay for a lecture.

“Dr. Biederman is not someone to jerk around,” Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”

Bruins also suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor’s request for a $280,000 research grant. “I have never seen someone so angry,” Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”

In the court documents, e-mails from Johnson & Johnson executives said Biederman had asked the company to fund a pediatric research institute at Massachusetts General Hospital, resulting in a donation of at least $700,000 in 2002. Biederman is listed as the chief of the Johnson & Johnson Center for Pediatric Psychopathology.

Biederman is the subject of investigations by Harvard and by Sen. Charles Grassley (R., Iowa) for failing to disclose to Harvard at least $1.4 million in funds from Johnson & Johnson and other companies. Laws require researchers to disclose such relationships to their employers, to protect the integrity of medical research.

Massachusetts General said yesterday in a statement that it planned to investigate the allegations raised in the court documents.

Harvard said it was not connected to Massachusetts General Hospital or to the pediatric institute there. A university spokesman said he could not comment on Harvard’s review.

Biederman first told Grassley he had received $3,500 from Johnson & Johnson, but the company told the senator’s office the figure was $58,169 in 2001.


Contact staff writer Miriam Hill at 215-854-5520 or 

Goodwin Goes Down, Save Sandford Campaign, and Much More

What an appropriate piece of news to learn about this weekend, and the timing is amazing. Gardiner Harris of The New York Times reported this weekend that Frederick Goodwin, a [racist – according to other reports] psychiatrist who hosts “The Infinite Mind” on NPR, is going down, big time. He’s just the latest in a series of bought doctors recently exposed, who have been extremely influential in psychiatry and the national movement towards increased drugging. Here’s some background about the eugenicist efforts that Goodwin and others have been involved in as recently as the 90s: “Beware The Violence Initiative Project.” 

Here is the NYT article, which states that NPR is canceling their satellite broadcast of “The Infinite Mind” and that if they had known Goodwin took so much money from pharmaceutical companies, they never would have broadcast the show in the first place. So I have to say, ‘Good Job’ to NPR! Now this begs the question of how long it will take for media groups to start paying attention and pull a Grassley. When are they going to get suspicious and start investigating the corruption taking place within the “scientific” community?

Hats off to Gardiner Harris, Charles Grassley, and NPR. Job well done. 

So why do I say that the timing of this report is amazing? It’s just a general observation that it seems like the time is right for news like this to break… and here are a few reasons why…

I just returned from the NFWL (National Foundation of Women Legislators) Conference and it was amazing! 

So many people at this NFWL conference heard about Goodwin’s crash and burn career catastrophe and I can’t think of a better way to see these “doctors” exposed than in The New York Times, right before a Presidential transition, just as people are hoping to expand their mandatory mental health “treatment” programs and launch America into one giant Orwellian nightmare

I also got to meet so many interesting women legislators and leaders from all over the country, not to mention I finally got to meet Dr. Mary Ann Block and Dr. Julian Whitaker.

One story that was told during the conference was about a woman whose 6-year-old granddaughter told her mom when Hillary Clinton was running for President that that was wrong, because it’s illegal for her to run for that office. The mother asked why in the world the daughter would say such a thing, and the daughter replied that: “If a woman could be President, then there would have been a woman President by now.”

It’s kind of chilling, and yet kind of cute, just because there are so many things that come out of children’s mouths that just seem to have a hint of truth underneath the innocent incorrectness…

One thing that impressed me about the conference was the sincerity and dedication of all of these women to living their passion and making the world a better place. With all of the people I told about The MOTHERS Act, I was really kind of amazed how many were instantly sympathetic, supportive, concerned, or outraged. When you spend so much time seeing the hurt and death and force that is taking place it’s easy to forget how many people are out there who do care.

So to all those federal, state, or local women legislators out there who may be reading this blog or looking into The MOTHERS Act as we speak, I pray that you will take the message to heart that this is an issue you can really make a difference on. It is sad when we have to become defensive for our own rights, the protection of our lives and our babies, our freedom, informed consent, etc.

I’ve spent a lot of time lately thinking about the people who are still suffering because of psychiatric drugs, electroshock, etc. and about all those who have yet to be conceived who will never draw a breath because of these drugs. I want to leave you with a few links – food for thought. A lot of news continues to break all over the place concerning the financial relationships connecting psychiatrists, drug companies, “scientific” medical journals, government agencies, etc.

Don’t forget if you are a psychologist or otherwise involved with the American Psychological Association to read Dr. Zampardi’s letter concerning the ethics violations that demand a response from the candidates for APA president.

Check out Julie Edgington’s blog:

This is a MindFreedom Campaign to help Ray Sandford, who just so happens to be an involuntary outpatient victim of court ordered ECT or electroshock “therapy” at Mercy Hospital, in Coon Rapids, MN (this is the same hospital where I was an involuntary “patient” for two days in 2004 right after I became homicidal and suicidal on Zoloft).

MindFreedom is calling on the public to write or call Governor Pawlenty to ask for intervention. I would like to add that if anyone knows a good attorney or investigative journalist who can do something, please contact them. Also, don’t forget that we should call the two Minnesota Senators, Amy Klobuchar and Norm Coleman.

As for “Mercy Hospital” – this is the same hospital that locked me up in the psych ward away from my son when I was 9 days postpartum (3 days after starting on Zoloft to ‘prevent’ PPD after Isaac almost died from choking at 3 days old), where I was forced to continue taking Zoloft in order to get out – where I had to fake being better to get out, threaten to call the media and lawyers – where I was told I was just like Andrea Yates and all those other “Texas moms” who killed their children and would probably kill my baby if I didn’t do what they said I should do.

I gave Mercy Hospital a call last week to let them know what I think of their plan for Sandford’s “treatment” and to protest the fact that his doctor can give him one week’s reprieve from the “treatment” due to protests, but apparently the continued forced ECT is supposed to somehow logically remain therapeutic or in his best interest… The director of the ECT department refused to acknowledge Mr. Sandford is a patient due to confidentiality reasons, but she did tell me she was glad I was better. That is probably the only time in her career she has had the opportunity to say that to a former imprisoned patient.

Check out

See also, “The USA is Living Beyond Its Means” with David Walker, former GAO head. He spoke at the NFWL Conference, just after Dr. Whitaker (who spoke about financial problems in the Medicaid and Medicare system), on the problems with our out-of-control financial system and government budget deficits.

Pringle: Pharmaceutical Hustlers Part 2 (SSRI Pushers)

Pharmaceutical Industry Hustlers – Part II

Pushers of SSRI Antidepressants

To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.

Collectively, these antidepressants are referred to as SSRI’s (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.

The drug companies, “by their sheer economic clout,” have become the single most dominant influence in our healthcare system, and the “ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence,” says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, “The Last Normal Child,” in the July 13, 2008, San Francisco Chronicle.

“In this climate,” he explains, “drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches.”

That is why we are seeing famous (or infamous) Newsweek cover boys – like a 10-year-old “who has taken 38 psychiatric medications in his short, unhappy life,” he says.

Dr Joseph Glenmullen, author of “Prozac Backlash,” testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.

Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a “most dangerous scenario” when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.

He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.

He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. “How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?” he asked.

“Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality,” he pointed out.

Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. “Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists,” says Dr Diller.

He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs “not only because it is expensive, but because they don’t really want to find out whether their drugs continue to work over time or if long-term side effects develop,” he states in the paper, “A Prescription for Disaster,” published by on May 23, 2002.

“Currently, that kind of research is a job for the country’s trial lawyers,” he writes.

“But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature,” Dr Diller points out.

Highly Paid Hustlers in motion

The “failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children,” according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, “Children in Clinical Research: A Conflict of Moral Values,” published in the American Journal of Bioethics.

No SSRI was approved for children before 2003. However, by “the early 1990’s, it didn’t matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old,” says Professor Jonathan Leo in the 2006 paper, “The SSRI Trials in Children: Disturbing Implications for Academic Medicine.”

He points out that “the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist,” he says, “the profession endorsed the use of them well before any of the major studies in children were even published.”

“It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns,” according to Professor Leo.

“If a trend is created ‘because everyone else is doing it’ then it appears that the child psychiatry profession’s use of these drugs in the late 1990’s more closely resembled a trend instead of a logical scientific undertaking,” he explains.

The first major studies claiming SSRI’s were safe and effective for children began to appear in the late 1990’s. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the “well-accepted prescribing patterns,” to doctors in every field of medicine, there are the names of the same “Highly-Paid Hustlers,” also known as “key opinion leaders,” because they are supposedly so highly respected by their peers.

They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as “manic-depression” was now “bipolar disorder,” and in the mid-90’s, Dr Biederman, and a few more “opinion leaders” started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.

“Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill,” says Dr Diller, in an article entitled, “Are Our Leading Pediatricians Drug Industry Shills?” in the July 13, 2008, San Francisco Chronicle.

“Biederman and his team,” Dr Diller writes, “are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.”

“The science of children’s psychiatric medications is so primitive and Biederman’s influence so great,” he says, “that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs.”

“This happens in the absence of a drug trial of any kind – instead,” Dr Diller notes, “the decision is based upon word of mouth among the 7,000 child psychiatrists in America.”

”That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic,” he says.

“If true,” Dr Diller notes, “this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day.”

Until the “bipolar” profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.

Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.

In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.

Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the “respectable” medical journals continue to publish this kind of trash.

He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.

This “Preschool Psychopharmacology Working Group” claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. “The purpose of this effort,” the authors note, “is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.”

Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.

On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the “pharmaceutical giant Pfizer.”

Judging by the results of this “study,” the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of “disorders” is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the “Terrible Twos.”

Sad aftermath

Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, “Medication Madness.”

Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with “drug-intoxicated brains.”

Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.

Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that “young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood.”

“They rely on a false belief that drugs can solve problems,” he says, “rather than relying on their own innate creative potential or the help of family, friends, and schooling.”

“Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients,” Dr David Healy explains in the 2006 paper, “The Latest Mania: Selling Bipolar Disorder.” But he says:

“All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine.”

“The extensive prescription of these medications for children,” Dr Diller warns, “without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”

“Catastrophic side effects may be rare,” he says, “but they become predictable when we treat so many children with so many drugs.”

“There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit,” says Dr Fred Baughman, author of, “ADHD Fraud – How Psychiatry Makes Patients of Normal Children.”

“Because the children made into ‘patients’ are normal to begin with,” Dr Baughman contends, “those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning.”

“What should we call it when children die pursuant to a fraudulent diagnosis,” he asks. “First degree murder? Second degree murder? Justifiable homicide? Manslaughter?”

In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. “For us it has been four and a half years without resolution or closure,” says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.

“Every day hurts,” Mathy says. “One never gets over the loss.” Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.

They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.

The Downings would later learn that their daughter’s physician was on Pfizer’s payroll. “Although we realize that Candace’s doctor only made about $12,000 acting as a Pfizer consultant, it’s not the amount that bothers us,” Mathy says.

“It’s the medical compromise. It’s the lack of informed consent. It’s placing economical gain above the well-being of an innocent child and a trusting family,” she states.

“I just want to know when ‘Greed before Need’ will diminish and doctors will once again place a patient’s well-being first,” she says, “before financial gain.”

“What has happened to the Hippocratic Oath that doctors are supposed to take?” Mathy wants to know.

Rough estimates

In “Let Them Eat Prozac,” Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.

These figures made it possible for him to estimate how many people had made suicide attempts. “If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac,” he writes, “then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used.”

“Conventional wisdom is that there is one suicide for every ten attempts,” he explains. “These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents.”

Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. “The FDA estimated their database picked up only between one and ten per cent of serious adverse events,” he writes.

“This gives a spread between 20,000 and 200,000 suicides on Prozac,” he concludes.

There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.

“If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly,” he warns in a June 2003 briefing paper on “Antidepressants and Suicide.”

Evelyn Pringle

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department

Pharmaceutical Industry Hustlers Part I: SSRI Pushers, by Evelyn Pringle

Pharmaceutical Industry Hustlers – Part I

SSRI Antidepressants Pushers

After twenty long years, it appears that the epidemic in mental disorders in America might be coming to an end. It won’t happen because of any great medical breakthrough but rather because the perpetrators of the greatest healthcare fraud in history are finally being exposed. The demolition of the giant “psycho-pharmaceutical complex” appears to be on the horizon.

For far too long, the focus has been on the drugmakers only. In recent months, the spotlight has shown where it belongs – on the highly-paid opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by doctors in every field of medicine and the research institutions that enabled the process.

The antidepressants known as selective serotonin reuptake inhibitors, or SSRI’s, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of the storm. These drugs have been prescribed to more Americans than any other class of medications over the past two decades. Cymbalta, Effexor and Wellbutrin are often referred to as SSRI’s, but they are slightly different chemically. However, the drugs all carry similar side effects and warnings.

The top sales pitch for SSRI’s has been the “chemical-imbalance-in-the-brain” myth. “There is no evidence whatsoever that depression is caused by a biochemical imbalance,” says Dr Peter Breggin, one of the world’s leading experts on psychiatric drugs and author of the new book, “Medication Madness.”

People take for granted pronouncements such as, “You have a biochemical imbalance,” and “mental disorders are like diabetes,” he explains in the book.

“In reality,” Dr Breggin writes, “these are not scientific observations – they are promotional slogans, so adamantly repeated in the media and by individual psychiatrists that people assume them to be true.”

“The psycho-pharmaceutical complex fosters these falsehoods in order to promote the widespread use of their products,” he says. “Reluctant patients by the millions are pushed into taking drugs by doctors who tell them with no uncertainty that they need medication.”

“If you have got a biochemical imbalance in your brain,” Dr Breggin advises in the book, “the odds are overwhelming that your doctor put it there with a psychiatric drug.”

All Eyes on Glaxo

At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly SmithKline Beecham), due to reports that the company is under investigation by the US Department of Justice, as well as the Senate Finance Committee, with Iowa’s Senator Charles Grassley, the ranking Republican on the Committee, leading the charge.

The report that led to the investigation by Senator Grassley was generated in litigation and was only recently made public after it was unsealed by the court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School and author of “The Antidepressant Solution” and “Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives.” He was retained as an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman. The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved, that people taking the drug were 8 times more likely to engage in suicidal behavior than people given a placebo, or sugar pill. Now, it stands to reason that even the most depressed person would decline to take Paxil if given these facts. Also, parents certainly would decline if they were told about the risks.

Dr Glenmullen explains that, by submitting what he refers to as “bad” Paxil numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to the label when the drug was approved. “GlaxoSmithKline’s ‘bad’ Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992, with no warning to doctors or patients of the significant increased risk of suicidal behavior,” he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the “run-in” period of the studies as if they happened in the placebo group. The run-in period, also called the “wash-out” phase, occurs when all patients are taken off their existing drugs to let the old drugs wash out of their systems, and all patients are given placebos. The rationale for washing out old drugs is to prevent them from confusing the results of the study, so that patients start out in a similar condition, according to the report.

The official trial only begins after the wash-out phase, once the patients are assigned to receive either the antidepressant or a placebo. The patients who continue to receive the placebo are referred to as the “placebo group.”

“Confusing the pre-study placebo wash-out phase with the placebo group in the actual study is improper,” Dr Glenmullen writes, “especially when the concern is a potentially lethal side effect.”

The “correct data shows that suicide attempts in patients on Paxil occurred at a rate eight times higher than the rate in patients on placebo,” he notes.

Senator Grassley has also asked the FDA to go back and review the clinical trial data submitted on Paxil. In a statement on the Senate floor on June 11, 2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the FDA.”

“We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public,” he stated. “These companies are selling drugs that we put in our bodies, not sneakers.”

“When they manipulate or withhold data to hide or minimize findings about safety and/or efficacy they put patient safety at risk,” Senator Grassley said. “And with drugs like Paxil, the risks are too great.”

A good start

As the Glaxo scandal unravels, the public will learn that other antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories are equally guilty. Likewise, there are many more supposedly independent academic doctors who have been receiving substantial financial benefits from drug companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy Wilens, Stanford’s Alan Schatzberg, Brown University’s Martin Keller, Melissa DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush, who operated out of the University of Texas, might be a good place to start, but the trail of Big Pharma’s funding “academic research” for marketing purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley’s June 4, 2008 statement in the Congressional record, although conflict-of-interest disclosure forms make it appear that the Harvard psychiatrists only received a couple hundred thousand from drug companies over the past 7 years, the true figures show Dr Biederman received over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6 million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we know that even these millions do not account for all of the money.”

Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6 million in one drug company. Ed Silverman reports on Pharmalot that there are “30 or so physicians at two dozen universities which the Senate Finance Committee is probing concerning disclosure of grants from drugmakers.” The names of those 30 doctors, along with the research mills they operate out of, need to be made public.

The new book, “Side Effects: A Prosecutor, a Whistleblower, and a Best-selling Antidepressant on Trial,” by investigative journalist Alison Bass, provides the inside scoop on the fraudulent SSRI research conducted at Brown University by Dr Keller.

The book also supplies background information on the financial ties between the so-called “opinion leaders” in psychiatry and the other antidepressant makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as a team a decade ago to promote Bristol-Myers Squibb’s antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium that touted the benefits of Serzone, and Dr Keller was one of the paid speakers at the event. The same year, Dr Keller received $77,400 in consulting fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also touting the benefits of Serzone. The drug was removed from the market in 2004 after it was found to cause liver damage but not before a number of patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998 tax return. But during her research for “Side Effects,” she discovered he had earned personal income from Glaxo in 1998, as well as subsequent years. Keller admitted as much during a September 2006 deposition for a lawsuit filed against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the amount of money the academics are pulling in. The pharmaceutical industry also has a stronghold on most major research institutions in this country. Many could not exist if the drug companies withdrew all their research funding, a state of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students.”

Universities keep corrupt academics on board for good reason. “Side Effects” reports that, between 1990 and 1998, “Martin Keller brought in nearly $8.7 million in research funding from pharmaceutical companies.”

The clinical trial industry itself provides a perfect slush fund. Spending in the U.S. was an estimated $25 billion in 2006 and is expected to reach about $32 billion by 2011. Most of the money for trials comes from private industry, and federal funding assumes a second place position, with the National Institute of Health budgeting $3 billion for clinical trials in 2006, according to the paper, “State Medical Board Responses To An Inquiry On Physician Researcher Misconduct,” by Dr Stefan Kruszewski, Dr Richard Paczynski and Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.

Paxil Study 329

“Side Effects” also covers the whole sordid affair on Paxil Study 329, the most infamous fraudulent pediatric trial of all time. The study “offers a landmark for the point at which science turned into marketing,” according to Dr David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School of Psychological Medicine at the University of Wales , and an outspoken critic of the psycho-pharmaceutical complex, with 21 books to his name, including “The Creation of Psychopharmacology.”

He explains that, in 1998, Glaxo’s original assessment of Study 329 had concluded that it and another study had shown Paxil did not work for children, but that it would not be “commercially acceptable” to publicize this finding. “Instead the positive findings from the study would be published; they were in an article whose authorship line contains some of the best known names in psychopharmacology (Keller et al., 2001),” Dr Healy writes in the 2007 paper, “The Engineers of Human Souls & Academia.”

Dr Keller gets most of the “credit” for the study, which was completed in the mid-90’s. Keller et al had some difficulty getting it published at first, but finally found a journal willing to take the bate in 2001, the Journal of the American Academy of Child and Adolescent Psychiatry. In all, 20 academics allowed their names to be attached to this ghostwritten infomercial, and not one has stepped forward to acknowledge wrongdoing or to admit that a mistake was made.

Long before the paper was published, the authors of study 329 were fanned out all the way to Canada giving lectures and presentations to prescribing doctors at medical conferences and seminars to promote the off-label use of Paxil for kids. More than any other paper, Study 329 led to an epidemic in pediatric prescribing. “After its publication, the use of antidepressants for children skyrocketed,” Dr Glenmullen notes.

These handsomely paid “key opinion leaders” all deserve to have their names in lights, especially Drs Graham Emslie and Karen Wagner from the University of Texas .

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only payment she reported to the university was $600 in 2005, according to Senator Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a “state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.”

“The Children’s Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers,” the Morning News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records show Dr Emslie may have made up to “$125,000 from drug companies since 2004,” according to the report in the Morning News.

While Dr Keller took the lead on pushing Paxil for children and adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was the queen bee on Zoloft studies. The co-authors of papers that appear in the medical literature encouraging the use of SSRI’s for kids include Drs Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.

Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry department after Senator Grassley’s investigation revealed that he failed to disclose to his university more than a million dollars in drug industry income. All total, Nemeroff had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among the authors of the SSRI papers and studies highlighted in the 2006 Third Edition of, “Essentials of Clinical Psychopharmacology,” described as “a synopsis and update of the most clinically relevant material from ‘The American Psychiatric Publishing Textbook of Psychopharmacology,'” by none other than Drs Schatzberg and Nemeroff.

Keep Following the Money

On July 10, 2008, Senator Grassley extended his investigation to include psychiatry’s top industry-funded front group with a letter to Dr James Scully, Medical Director and Chief Executive Officer of the American Psychiatric Association, asking for “an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided to the American Psychiatric Association.”

The Senator wants records from January 2003 to the present. According to the July 12, 2008, New York Times, in 2006, the “industry accounted for about 30 percent of the association’s $62.5 million in financing.”

A factor rarely discussed in this debate is the amount of money doctors who prescribe SSRI’s make during brief office calls charged at regular rates. This practice has taken a tremendous toll on public healthcare programs and has resulted in higher insurance premiums and overall healthcare costs for all Americans.

In fact, the bilking of public healthcare programs is what led to the current investigations by the Finance Committee, which has the responsibility of overseeing spending in Federal programs. When doctors prescribe drugs for unnecessary uses, public programs not only have to pay for the drugs, they must also pay the fees of the prescribing doctors and for the medical care for injuries caused by the drugs. Government spending tied to the prescribing of psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services’ Office of Inspector General, discussed kickbacks to doctors and told the panel:

“Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective.”

Mr Morris explained that, “kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements.”

Vermont is a rare state in requiring the pharmaceutical industry to disclose the money paid to doctors. On July 8, 2008, Vermont ‘s Attorney General William Sorrell released the state’s annual report on “Pharmaceutical Marketing Disclosures,” which lists the payments made by drug companies in 2007. Of the top 100 recipients, once again, psychiatrists received the highest payments. Eleven psychiatrists received a total of $626,379, or about 20% of the total value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it’s impossible to embarrass them. Last year, the press ran major stories when this report came out, highly critical of how much money they were making. This year, the average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of the top 10 drugs for which disclosures were reported, five are used to treat mental illness and include Lilly’s Cymbalta and Forest Lab’s Lexapro. Ironically, Cymbalta sales are also up 25%, according to Lilly’s latest SEC filing.

Overall, estimates indicate that the drug industry spends $19 billion annually on marketing to physicians in the form of gifts, travel, meals and other consulting fees, according to a May 22, 2008, press release by Senator Grassley’s office. In the November 1, 2007, New England Journal of Medicine paper, “Doctors and Drug Companies – Scrutinizing Influential Relationships,” Dr Eric Campell, associate professor at the Institute of Health Policy at Massachusetts General Hospital and Harvard Medical School, writes:

“Individual physicians can take some steps to maximize the benefits for patients and minimize the risks associated with their own industry relationships. They can start by recognizing that such relationships are designed to influence prescribing behavior and by carefully considering the potential effects that their own associations may have on their patients.”

“And they can bear in mind,” he says, “that the costs of industry dinners, trips, and other incentives are passed along to their patients in the form of higher drug prices.”

Antidepressant prescribing is more rampant in this country than any other. The US accounted for 66% of the global market in 2005, compared to 23% in Europe and 11% for the rest of world, according to a December 2006 report by Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital visits in 2005 showed that the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions issued by primary care physicians. They have remained in the number one position ever since. Last year, 232 million prescriptions were filled for antidepressants worth nearly $12 billion, according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler’s pay package was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A previous CEO, David Shedlarz, left last year with an “exit package” worth over $34 million. In 2007, the total value of Wyeth’s then-CEO Robert Essner’s pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of the mental illness epidemic occurring only in the US . Attorneys General all over the country are using consumer fraud statutes to sue the drug giants to recoup the money lost due to the illegal off-label promotion of psychiatric drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of individuals and entities such as insurance companies in California , Florida , Illinois , Massachusetts , Minnesota , Missouri , New Jersey , North Dakota , Ohio and Washington .

The cases are based on documents showing Glaxo promoted Paxil for kids, fully aware that Paxil failed to out-perform a placebo in the clinical trials and had higher suicidality rates. A national class settlement of individual claims was reached in April 2007 in which Glaxo agreed to reimburse parents for all of the money paid for Paxil prescriptions for their children. A national class settlement on behalf of third party payors (insurance companies) was just approved in September 2008.

If not for the few law firms willing to stay the course, the truth would never have been revealed. Baum Hedlund has been pursuing the SSRI makers for nearly two decades. Most recently, it has taken up the fight for babies born with birth defects caused by SSRI’s.

Because the industry was so successful at keeping the original SSRI trial data hidden, the drugs’ most serious side effects largely became public only as a result of the bravery and integrity of such medical experts as Dr Healy, Dr Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an increased risk of suicidality, knowing all the long that the risk existed. Now, the companies are making the irresponsible argument (in defense of lawsuits claiming they failed to warn doctors and the public of the risk) that the FDA did not require them to add a warning, so they are immune from liability.

Worse yet, the industry-controlled FDA under the Bush Administration is supporting this audacious preemption defense and siding with the SSRI makers against private citizens in courts all over the country, telling judges to rule in favor of the drug companies and throw out the SSRI cases before they even make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case involving federal preemption, in Wyeth v Levine, on November 3, 2008.

Evelyn Pringle

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department

Postpartum Support International Reliance on Emory Studies to Justify Pregnant and Nursing Mothers’ Use of Drugs

Evelyn Pringle tipped me off to another connection between Postpartum Support International (PSI) and industry-influenced information. If you go to this link on their site, you can see information being forwarded to moms from the Emory Women’s Mental Health Program as well as Massachussetts General Hospital (who also takes money from drug companies while simultaneously promoting The MOTHERS Act and claiming that drugs like Paxil are safe for pregnancy).

Charles Grassley’s investigations into major psychiatric opinion leaders have consistently demonstrated undisclosed financial conflicts of interest. The latest investigation led to Dr. Nemeroff’s voluntary surrender of his post at Emory as the head of the Psychiatry Department. Grassley found Nereroff made millions of dollars off SRRI makers and only disclosed a small fraction of the amount.

Here are some of the Nemeroff articles that PSI links to: 

Sertraline in the Treatment of Women with Postpartum Onset Major Depression
Stowe Z.N., Casarella J., Landry J.C., and Nemeroff C.B. (1995) “Sertraline in the Treatment of Women with Postpartum Onset Major Depression”. Depression. 3:49-55. 

Women at Risk for Postpartum Depression
Stowe Z.N., and Nemeroff C.B. (1995) “Women at Risk for Postpartum Depression”. American Journal of Obstetrics and Gynecology. 173:639-645.

Diagnosis and Treatment of Postpartum Depression
Winn S.S., Stowe Z.N., and Nemeroff C.B. “Diagnosis and Treatment of Postpartum Depression”. Clinical Advances in the Treatment of Psychiatric Disorders. 10:1-11(Jan/Feb 1996)

Depression During Pregnancy and the Puerperium
Llewellyn A., Stowe Z.N., and Nemeroff C.B. (1997) “Depression During Pregnancy and the Puerperium”. Journal of Clinical Psychiatry. 58 [suppl. 15]:26-32.

The Use of Lithium and Management of Women with Bipolar Disorder During Pregnancy and Lactation
Llewellyn A., Stowe Z.N., and Nemeroff C.B. (1998) “The Use of Lithium and Management of Women with Bipolar Disorder During Pregnancy and Lactation”. Journal of Clinical Psychiatry. 59 [suppl 6]:57-64.

Paroxetine in Breast Milk and Nursing Infants
Stowe Z.N., Cohen L.S., Hostetter A, Ritchie J.C., Owens M.J., and Nemeroff C.B. (2000) “Paroxetine in Breast Milk and Nursing Infants”. American Journal of Psychiatry. 157:185-189.

Parental Depression: Animal Models of an Adverse Life Event
Newport DJ, Stowe ZN, Nemeroff CB. (2002) Parental depression: animal models of an adverse life event. American Journal of Psychiatry. 159(8): 1265-1283.

The Pharmacokinetics of Sertraline Excretion into Human Breast Milk: Determinants of Infant Serum Concentrations
Stowe ZN, Hostetter AL, Owens MJ, Ritchie JC, Sternberg K, Cohen LS and Nemeroff CB. (2003) “The Phamacokinetics of Sertraline Excretion into Human Breast Milk: Determinants of Infant Serum Concentrations”. J Clinical Psychiatry. 64(1):73-80.

Alterations in Platelet Serotonin Transporter Binding in Women with Postpartum Onset Major Depression
Newport DJ, Owens MJ, Knight DL, Ragan KA, Morgan N, Nemeroff CB and Stowe ZN. (2004) Alterations in Platelet Serotonin Transporter Binding in Women with Postpartum Onset Major Depression. J Psychiatr Res 38: 467-473.

Psychopharmacology During Pregnancy and Lactation
Newport DJ, Stowe ZN. Psychopharmacology during pregnancy and lactation. In Schatzberg A, Nemeroff CB, eds. (2006) Essentials of Clinical Psychopharmacology, Second Edition. Washington DC: American Psychiatric Publishing, Inc. pp 745-77.

Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes
Newport DJ. Calamaras MR. DeVane CL. Donovan J. Beach AJ. Winn S. Knight BT. Gibson BB. Viguera AC. Owens MJ. Nemeroff CB. Stowe ZN. (August, 2007) Atypical antipsychotic administration during late pregnancy: placental passage and obstetrical outcomes. American Journal of Psychiatry. 164(8):1214-20.

Persistent Auditory Hallucinations that are Unresponsive to Antipsychotic Drugs
Nicolson SE, Mayberg HS, Pennell PB, Nemeroff CB. (2006) Persistent auditory hallucinations that are unresponsive to antipsychotic drugs. Am J Psychiatry. 163(7):1153-1159.

Recent Advances in the Neurobiology of Neuropeptides: Focus on Corticotropin-Releasing Factor
Nemeroff CB and Owens MJ. (1986) “Recent advances in the neurobiology of neuropeptides: focus on corticotropin-releasing factor”. Biological Psychiatry. 1985. (Shagass et al., Eds.). Elsevier Publishing, Amsterdam, 103-105.

Preclinical and Clinical Studies with Corticotropin-Releasing Factor: Implications for Affective Disorders
Owens MJ and Nemeroff CB. (1988) “Preclinical and clinical studies with corticotropin-releasing factor: Implications for affective disorders”. Psychopharmacology Bulletin 24:355-359.

Reduced Corticotropin-Releasing Factor (CRF) Binding Sites in the Frontal Cortex of Suicides
Nemeroff CB, Owens MJ, Bissette G, Andorn AC and Stanley M. (1988) “Reduced corticotropin-releasing factor (CRF) binding sites in the frontal cortex of suicides”. Archives of General Psychiatry 45:577-579.

Acute Effects of Alprazolam and Adinazolam on the Concentrations of Corticotropin-Releasing Factor in the Rat Brain
Owens MJ, Bissette G and Nemeroff CB. (1989) “Acute effects of alprazolam and adinazolam on the concentrations of corticotropin-releasing factor in the rat brain”. Synapse 4:196-202.

Neurotransmitter Regulation of CRF Secretion In Vitro
Owens MJ and Nemeroff CB. (1989) “Neurotransmitter regulation of CRF secretion in vitro. Corticotropin-Releasing Factor: Basic and Clinical Studies of a Neuropeptide “(EB DeSouza and CB Nemeroff, Eds.). CRC Press, Inc., Boca Raton, FL, 107-114.

Postnatal Development of Brain Corticotropin-Releasing Factor Receptors in the Rat
Pihoker C, Cain ST, Owens MJ and Nemeroff CB. (1991) “Postnatal development of brain corticotropin-releasing factor receptors in the rat”. Horizons in Endocrinology Volume II. Serono Symposia 76, (M Maggi and V Geenen, Eds.). Raven Press, NY.

Excretion of Sertraline in Human Breast Milk and Nursing Infants
Stowe ZN, Owens MJ, Landry JC, Kilts CD, Ely T, Llewellyn A and Nemeroff CB. (1997) Excretion of Sertraline in Human Breast Milk and Nursing Infants. American J. Psychiatry 154:1255-1260.

The Effects of Acute Antipsychotic Drug Administration on the Neurotensin System of the Developing Rat Brain
Kinkead B, Owens MJ and Nemeroff CB. (2000) “The effects of acute antipsychotic drug administration on the neurotensin system of the developing rat brain”. Brain Research Dev Brain Res 124:1-10.


The list goes on, but I think you get the idea.

New York Times: “Top Psychiatrist Failed To Report Drug Income” by Gardiner Harris

The New York Times 

Printer Friendly Format Sponsored By

October 4, 2008

Top Psychiatrist Failed to Report Drug Income

One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.

The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.

In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from that company — 17 times the figure he had agreed on.

The Congressional inquiry, led by Senator Charles E. Grassley, Republican of Iowa, is systematically asking some of the nation’s leading researchers to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.

“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Mr. Grassley said. “The current system for tracking financial relationships isn’t working.”

The findings suggest that universities are all but incapable of policing their faculty’s conflicts of interest. Almost every major medical school and medical society is now reassessing its relationships with drug and device makers.

“Everyone is concerned,” said Dr. James H. Scully Jr., the president-elect of the Council of Medical Specialty Societies, whose 30 members represent more than 500,000 doctors.

Dr. Nemeroff is a charismatic speaker and a widely admired scientist who has written more than 850 research reports and reviews. He was editor in chief of the influential journal Neuropsychopharmacology. His research has focused on the long-term mental health risks associated with child abuse as well as the relationship between depression and cardiovascular disease.

Dr. Nemeroff did not respond to calls and e-mail messages seeking comment. Jeffrey L. Molter, an Emory spokesman, wrote in an e-mail statement that the university was “working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley.”

The statement continued: “Dr. Nemeroff has assured us that: ‘To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures.’ ” On Friday night, Emory announced that Dr. Nemeroff would “voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues.”

Mr. Grassley began his investigation in the spring by questioning Dr. Melissa P. DelBello of the University of Cincinnati after The New York Times reported her connections to drug makers. Dr. DelBello told university officials that she earned about $100,000 from 2005 to 2007 from eight drug makers, but AstraZeneca alone paid her $238,000 during the period, Mr. Grassley found.

Then in early June, the senator reported to Congress that Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School, and a colleague, Dr. Timothy E. Wilens, had reported to university officials earning several hundred thousand dollars each in consulting fees from drug makers from 2000 to 2007, when in fact they had earned at least $1.6 million each.

Then the senator focused on Dr. Alan F. Schatzberg of Stanford, president-elect of the American Psychiatric Association, whose $4.8 million in stock holdings in a drug development company raised concerns.

Mr. Grassley has sponsored legislation called the Physician Payment Sunshine Act, which would require drug and device companies to publicly list payments to doctors that exceed $500. Several states already require such disclosures.

As revelations from Mr. Grassley’s investigation have dribbled out, trade organizations for the pharmaceutical industry and medical colleges have agreed to support the bill. Eli Lilly and Merck have announced that they would list doctor payments next year even without legislation.

The National Institutes of Health have strict rules regarding conflicts of interest among grantees, but the institutes rely on universities for oversight. If a university fails, the agency has the power to suspend its entire portfolio of grants, which for Emory amounted to $190 million in 2005, although the agency rarely takes such drastic measures.

Dr. Nemeroff was the principal investigator for a five-year $3.9 million grant financed by the National Institute of Mental Health for which GlaxoSmithKline provided drugs.

Income of $10,000 or more from the company in any year of the grant — a threshold Dr. Nemeroff crossed in 2003, 2004, 2005 and 2006, records show — would have required Emory to inform the institutes and take steps to deal with the conflict or to remove Dr. Nemeroff as the investigator.

Repeatedly assured by Dr. Nemeroff that he had not exceeded the limit, Emory did nothing.

“Results from N.I.H.-funded research must not be biased by any conflicting financial interests,” John Burklow, a spokesman for the health institutes, said in the kind of tough statement that in the past has rarely been followed by real sanctions. “Officials at Emory are investigating the concerns.”

“Failure to follow N.I.H. standards” on conflict of interest, Mr. Burklow continued, “is very serious, and N.I.H. will take all appropriate action to ensure compliance.”

In 2004, Emory investigated Dr. Nemeroff’s outside consulting arrangements. In a 14-page report, Emory’s conflict of interest committee detailed multiple “serious” and “significant” violations of university procedures intended to protect patients.

But the university apparently took little action against Dr. Nemeroff and made no effort to independently audit his consulting income, documents show.

Universities, too, can benefit from the fame and money the deals can bring — a point Dr. Nemeroff made in a May 2000 letter stamped “confidential” that he sent to the dean of Emory’s medical school. The letter, which was part of a record from a Congressional hearing, addressed Dr. Nemeroff’s membership on a dozen corporate advisory boards (some of the companies’ names have since changed).

“Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an endowed chair to the department and that there is some reasonable likelihood that Janssen Pharmaceuticals will do so as well,” he wrote.

“In addition, Wyeth-Ayerst Pharmaceuticals has funded a Research Career Development Award program in the department, and I have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the same. Part of the rationale for their funding our faculty in such a manner would be my service on these boards.”

Universities once looked askance at professors who consulted for more than one or two drug companies, but that changed after a 1980 law gave the universities ownership of patents discovered with federal money.

The law helped give birth to the biotechnology industry and led to the discovery of dozens of life-saving medicines. Consulting arrangements soon proliferated at medical schools, and Dr. Nemeroff — who at one point consulted for 21 drug and device companies simultaneously — became a national model.

He may now become a model for a broad reassessment of industry relationships. Many medical schools, societies and groups are considering barring doctors from giving lectures on drug or device marketing.

For all his fame in the world of psychiatry, Dr. Nemeroff has faced ethics troubles before. In 2006, he blamed a clerical mix-up for his failing to disclose that he and his co-authors had financial ties to Cyberonics, the maker of a controversial device that they reviewed favorably in a journal he edited.

The Cyberonics paper led to a bitter e-mail exchange between Dr. Nemeroff and Claudia R. Adkison, an associate dean at Emory, according to Congressional records. Dr. Adkison noted that Cyberonics had not only paid Dr. Nemeroff and his co-authors but had also given an unrestricted educational grant to Dr. Nemeroff’s department.

“I can’t believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing,” Dr. Adkison wrote on July 20, 2006.

Two years earlier, unknown to the public, Emory’s conflict of interest committee discovered that Dr. Nemeroff had made more serious blunders, including failing to disclose conflicts of interest in trials of drugs from Merck, Eli Lilly and Johnson & Johnson.

His continuing oversight of a federally financed trial using GlaxoSmithKline medicines led Dr. Adkison to write Dr. Nemeroff on July 15, 2004, that “you must clearly certify on your annual disclosure form that you do not receive more than $10,000 from GSK.”

In a reply dated Aug. 4, Dr. Nemeroff wrote that he had already done so but promised again that “my consulting fees from GSK will be less than $10,000 per year throughout the period of this N.I.H. grant.”

When he sent that letter, Dr. Nemeroff had already earned more than $98,000 that year from GlaxoSmithKline. Three weeks later, he received another $3,844.56 for giving a marketing talk at the Passion Fish Restaurant in Woodbury, N.Y.

From 2000 through 2006, Dr. Nemeroff earned more than $960,000 from GlaxoSmithKline but listed earnings of less than $35,000 for the period on his university disclosure forms, according to Congressional documents.

Sarah Alspach, a GlaxoSmithKline spokeswoman, said via e-mail that “Dr. Nemeroff is a recognized world leader in the field of psychiatry,” and that the company requires its paid speakers to “proactively disclose their financial relationship with GSK, and we believe that healthcare professionals are responsible for making those disclosures.”