Ilena Rose
2008-10-04 23:06:20 UTC
News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com
When you realize the number of medical decisions based on these 'MD's
for hire" "opinions" ... they are the real Healthfrauds.
www.BreastImplantAwareness.org/QuackWatchWatch.htm
October 4, 2008
http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=1&bl=&ei=5087&en=80352c05b6d4b135&ex=1223265600&pagewanted=print&oref=slogin
Top Psychiatrist Didnt Report Drug Makers Pay
By GARDINER HARRIS
One of the nations 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 nations
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 isnt
working.
The findings suggest that universities are all but incapable of
policing their facultys 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. Grassleys 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. Nemeroffs outside consulting
arrangements. In a 14-page report, Emorys 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 Emorys medical school. The
letter, which was part of a record from a Congressional hearing,
addressed Dr. Nemeroffs 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. Nemeroffs department.
I cant 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, Emorys 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.
http://ilenarose.blogspot.com
When you realize the number of medical decisions based on these 'MD's
for hire" "opinions" ... they are the real Healthfrauds.
www.BreastImplantAwareness.org/QuackWatchWatch.htm
October 4, 2008
http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=1&bl=&ei=5087&en=80352c05b6d4b135&ex=1223265600&pagewanted=print&oref=slogin
Top Psychiatrist Didnt Report Drug Makers Pay
By GARDINER HARRIS
One of the nations 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 nations
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 isnt
working.
The findings suggest that universities are all but incapable of
policing their facultys 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. Grassleys 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. Nemeroffs outside consulting
arrangements. In a 14-page report, Emorys 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 Emorys medical school. The
letter, which was part of a record from a Congressional hearing,
addressed Dr. Nemeroffs 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. Nemeroffs department.
I cant 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, Emorys 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.