Yearly Archives: 2008

Received this from MindFreedom today:

Sunday NY Times: Congress discovers that Harvard psychiatrist
covered up drug money

Tomorrow’s Sunday New York Times (8 June 2008) will have an item
about a drug money cover-up by a world-famous Harvard psychiatrist
who is considered a catalyst for the enormous increase in psychiatric
drugging of USA kids. See the text of the article below.

NY Times reports that US Congressional investigators led by Senator
Charles E. Grassley discovered that Harvard’s Dr. Joseph Biederman
illegally did not disclose to Harvard authorities much of the more
than a million dollars he received from psychiatric drug companies.

Says NY Times: “[Dr. Biederman’s] work helped to fuel a controversial
40-fold increase from 1994 to 2003 in the diagnosis of pediatric
bipolar disorder.” Please forward. At bottom is commentary from
MindFreedom and how you can take action.

~~~~~~~~~~~~~~~~~~~

NY Times article with photos on MindFreedom web site:
http://www.mindfreedom.org/kb/psych-drug-corp/ny-times-biederman-
harvard/grassley-v-harvard

Or on NY Times web site:
http://www.nytimes.com/2008/06/08/us/08conflict.html?hp

~~~~~~~~~~~~~~~~~~~

Sunday New York Times

Child Experts Fail to Reveal Full Drug Pay

By Gardiner Harris and Benedict Carey

June 8, 2008

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.

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.”

– end –

~~~~~~~~~~~~

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:

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

or use this web address:

http://tinyurl.com/ypj8vf

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

or use this web address:

http://tinyurl.com/2wtnz9