March 20, 2009

Harvard Child Psychiatrist Promised Drug Maker Positive Results Before Conducting Studies Of Antipsychotic, ADHD Drug

The New York Times is reporting that controversial Harvard child psychiatrist Joseph Biederman was selling J&J/Janssen on results of clinical trials in children of its antipsychotic Risperdal and its stimulant Concerta in advance of conducting the actual studies. Biederman is of course the godfather of the alleged bipolar child diagnosis and took oodles of money from J&J and other pharma companies, and is under investigation by Sen. Charles Grassley for possible violations of federal research rules regarding conflicts of interest and by Massachusetts General Hospital. You can read my Biederman collection here.

This stuff is amazing.

"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."

In essence, Biederman was telling the company that he'd turn out a study that was positive for the drug in advance of conducting the actual study. That's quite the scientific method he's got there and it ought to make the FDA and everyone else deeply skeptical of any Biederman study submitted to the agency for the drug's pediatric bipolar disorder approval.

Biederman also sought to help out J&J's Concerta, an ADHD drug:

"One set of slides in the documents referred to “Key Projects for 2004” and listed a planned trial to compare Risperdal, also known as risperidone, with competitors in managing pediatric bipolar disorder. The trial 'will clarify the competitive advantages of risperidone vs. other neuroleptics,' the slide stated. All of the slides were prepared by Dr. Biederman, according to his sworn statement.

"In 2005, Dr. Biederman was the lead author of a study comparing Risperdal and Zyprexa, made by Eli Lilly. The study concluded that Risperdal improved subjects’ depressive symptoms but that Zyprexa did not.

"A slide listing 'Key Projects for 2005' mentioned a planned study in adolescents of Concerta, a stimulant manufactured by Johnson & Johnson. The study will 'extend to adolescents positive findings with Concerta in A.D.H.D. N.O.S. in adults,' the slide said, referring to unusual cases of attention deficit hyperactivity disorder.

"In 2006, Dr. Biederman was co-author of a study showing that children given Concerta for a prolonged period did not have reduced growth, allaying a significant concern about the medicine."

The paper quotes an ethicist as saying this evidence casts another "shadow" on Biederman's work. I'd say it slams the door shut.

Posted by Philip Dawdy at March 20, 2009 12:01 AM
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Comments

He trialed Risperdal on children for ADHD in 1999 with Wozniak; he appears to have had his own agenda all along, why people trust that guy and his work is beyond me. While researching the child bipolar evolution for the last decade, it was quite apparent just by watching the abstracts and drugs and how the funding by pharma was adding up. Taking his ADHD studies and using them for (ultimately)pediatric disorder treatment "plans".

Too bad it won't slam the door shut, I mean it would be as if Fuller Torrey became anti med and said SZ doesn't exist.

Posted by: Stephany at March 20, 2009 02:19 AM

Hey Phillip: Did you read to the bottom of the NY Times article where this was found (see below)? Biederman is quite sick. This exchange illustrates just how much of a pathological narcissist he is!

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.
“What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.

Posted by: Tom at March 20, 2009 04:37 AM

Shadow? You gotta be David Hume to want more evidence than this.

Posted by: MedsVsTherapy at March 20, 2009 06:31 AM

At last. This F'er is coooked. Finally. Thank GOD! Career over. (I'm crossing my fingers.)

One of this bastards colleagues at MGH pediatric psychopharmacology diagnosed me with bipolar disorder 9 years ago. Well, obviously I don't have it but the experiences in my home preceeding and all the subsequent ones with the mental health system have seriously deformed me. I was an A+ student and a very talented swimmer and would have gone extremely far in swimming if I had not needed to quit my life to become a patient.

Of course, this doctor put me on risperdal, and never once to my knowledge checked my prolactin levels. Unfortunately, i was able to assemble an extensive bibliography to give to my primary care doctor to convinve him to order bone density measurements, the results of which are pending.

Thats another things these pig-courters are going to have to face. Risperdal caused increases in prolactin that do not return to baseline (normal) in between 60-80% of kids who take it. The best studies, ie, the longest ones show that risperdal induced increases in prolactin do not normalize completely over time -- which happens to be a tidbit, totally unsupported, that the drug mongers will throw out there when their questioned about this.

You have to also wonder how such a drug could affect the timing and more importantly the quality of puberty in adolescents. There is not enough research to answer this question. There is one well-publicized study underwritten by Janssen where they follow kids for only 12 months, and conclude there are no pubertal effects, because Tanner Staging is a really precise tool...

Well, the point of this disheveled rant is that MGH, legally, may be facing more trouble as it concerns this particular effect (the bone desnity)as it relates to their criminal marketing of the drug at their instituion. I wholeheartedly predict that will be the next big point-of-contention they get their pants sued-off for.

Good Luck MGH! You shameless sociopaths.

Posted by: JC at March 20, 2009 10:08 AM

That GOD comment Biederman made should be held in your mind when watching the PBS "medicated child". (online free)a MUST view)

Biederman is a man who created the axis of evil that has harmed so many children's lives, it is sick. F--king bastard! excuse my french.

Posted by: Stephany at March 20, 2009 10:51 AM

I have a very dear and close friend who was done great harm by Dr Biederman in the 80s and 90s. He was basically treated like one of the doctor's guinea pigs and the experiences he had with the medications that were used on him (basically in experimental doses) scarred him for life.

We were a part of the first generation of kids to be heavily medicated, and he suffered greatly under the "care" of this sick and twisted doctor.

I begged him to sue Biederman but he wouldn't. I was disgusted to learn how much that sicko has profited from his "work". I hope they bring him down hard - he deserves to go to jail.

Posted by: Dr G at March 23, 2009 08:03 AM
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