Jun 08, 2008 01:00 AM

 

Child Experts Fail to Reveal Full Drug Pay

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

NY Times photos, right: top: Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees. bottom: Dr. Joseph Biederman belatedly reported at least $1.6 million in consulting fees.

By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked recently to check again, he reported receiving $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.

The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

John Burklow, a spokesman for the National Institutes of Health, said: “If there have been violations of N.I.H. policy – and if research integrity has been compromised – we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it.”

The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.

Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.”

Ms. Kneller said the doctors had been referred to a university conflict committee for review.

Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings, and he placed the letters along with his comments in The Congressional Record.

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children’s lives over time, experts say.

In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.

Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.

“It’s really been an honor system thing,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”

Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

Mr. Grassley asked Harvard for the three researchers’ financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

“Basically, these forms were a mess,” Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Prompted by Mr. Grassley’s interest, Harvard asked the researchers to re-examine their disclosure reports.

In the new disclosures, the trio’s outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.

At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

Longtime critics of the group see its influence differently. “They have given the Harvard imprimatur to this commercial experimentation on children,” said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale – well below the 50 percent change that most researchers now use as the standard.

Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.

More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

Original story in NY Times click here.

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Comment by MindFreedom director David W. Oaks:

Commentary by David Oaks, Director, MindFreedom International

I was was once a Harvard student. Grandson of coal miners, at Harvard on scholarships, I developed mental and emotional problems.

Harvard psychiatrists ordered my forced psychiatric drugging in a Harvard teaching hospital, McLean. Harvard psychiatrists told me point blank I had to stay on powerful neuroleptic (“antipsychotic”) drugs for the rest of my life.

They were wrong.

I graduated anyway in 1977. With honors. I’ve been off all psychiatric drugs ever since.

In my senior year, a Harvard volunteer agency — Phillips Brooks House — placed me in a psychiatric survivor group (thank you PBH!). I’ve spent the last few decades working to prevent psychiatric human rights violations.

But I almost became one of the early teenagers to be diagnosed bipolar (and “schizophrenic”) and placed on neuroleptics for all this time.

An unreported problem is that a diagnosis of “psychosis” like “bipolar” can lead to decades, or a life-time, of neuroleptic drugging (antipsychotics). We at MindFreedom are pro-choice on the personal health care decision to take a prescribed neuroleptic, but these drugs really are pushed and pushed hard without adequate advocacy, information, alternatives, etc.

To check out what mainstream medicine has long known about what long-term neuroleptics can do the frontal lobes of primates, check out the monkey study in this folder:

https://mindfreedom.org/kb/psychiatric-drugs/antipsychotics/neuroleptic-brain-damage

Ben Carey, one of the reporters for the above great NY Times article, has done a lot of work on investigating psychiatric drug industry corruption, and he should be applauded. But Ben and I have communicated, and he knows about the neuroleptic brain damage story. But — like all other mainstream media — he has chosen not to report it.

ACTION: Thank Ben Carey for his courageous reporting, but ask when he will report that neuroleptics cause frontal lobe shrinkage.

E-mail for Ben Carey is: bencarey@nytimes.com

Perhaps somewhere in some college — perhaps Harvard? — there is hopefully a future “Al Gore of mental health” who will one day show PowerPoint slide shows to millions of people about this “Greenhouse effect” of the mind:

The tragic and literal mass chemical lobotomy of millions of young people through decades of neuroleptics, needlessly, without any informed consent about the structural brain change, when humane alternatives exist but are not offered.

Yes, diabetes and weight gain from neuroleptics are horrendous, and can kill.

But chemical lobotomy?

That could have been me.

And I take that personally.

You can also thank Senator Grassley, and let him know about the neuroleptic brain damage issue. Very few elected officials have ever been informed.

MindFreedom supports legislating criminal penalties for individuals such as Dr. Biederman; make his a humane prison, with lots of humane alternatives for rehabilitation, but sentence some real time behind bars, and we can begin to address this crisis.

You can also encourage Sen. Grassley to pass laws to help make behavior like Dr. Biederman’s a criminal offense.

Sen. Grassley web contact form:

http://grassley.senate.gov/public/index.cfm?FuseAction=Contact.Home

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ACTION ACTION ACTION: Please forward to all appropriate places on &
off Internet, NOW!

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Follow-up:

The Wall Street Journal ran this brief follow-up on The New York Times article:

 Harvard Psychiatrists Under Fire for Drug-Company Funding

  By Scott Hensley Wall Street Journal

June 9, 2008

A controversial Harvard psychiatrist whose research and recommendations have paved the way for the wide use of antipsychotic drugs in kids has received more than $1.6 million in consulting fees from drugmakers since 2000, and he failed to properly disclose much of the funding, the New York Times reports.

Joseph Biederman is a polarizing figure in psychiatry. As the Boston Globe put it in a profile last year: “No one has done more to convince Americans that even small children can suffer the dangerous mood swings of bipolar disorder than Dr. Joseph Biederman of Massachusetts General Hospital.” When asked in 2007 by the Globe about his drug company funding, he declined to provide it, but said Harvard Medical School and Mass General approved all his income.

Two colleagues of Biederman’s also earned at least $1 million in fees from drugmakers from 2000 to 2007 and may not have reported the funding properly. The discrepancies were found in documents provided to Congressional investigators. A NYT graphic here summarizes the issues and provides comments from the three psychiatrists.

The disclosure gaps could violate NIH rules on conflict of interest and could lead to sanctions. Policies at Harvard Mass General forbid researchers from conducting clinical tests with a drug if they receive payments greater than $20,000 from the company that makes it, according to a letter from Sen. Charles Grassley (R-Iowa).

Last fall Grassley asked Harvard and Mass General for the conflict-of-interest forms from the doctors as part of his look into financial ties between drugmakers and doctors. The forms were a “mess,” he said, and made it look as if the doctors had only taken a few hundred thousand dollars sums from industry over a seven-year period. After the doctors took another whack at disclosures and Congressional investigators compiled figures from drugmakers, the amounts involved soared to more than $1 million per doctor.

From the Senate floor last week, Grassley asked, “Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” Grassley doesn’t and has introduced the Physician Payments Sunshine Act to require reporting of payments by makers of drugs, devices and medical supplies.

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THIS FOLLOW-UP BY BLOOMBERG NEWS (update 2) reports Dr. Biederman is currently recruiting four to six year olds…

http://www.bloomberg.com/apps/news?pid=20601124&sid=aXgL9xC2OWho&refer