Annual APA Meeting Commercialized
Dr. Jeffrey Levine, a psychiatrist from Albert Einstein dubbed this year's
annual meeting in Philadelphia, "the American Psychiatric Association
GlaxoSmithKline Convention."
The Washington Post reports (below) : "in several dozen symposiums during the
weeklong meeting, companies paid the APA about $50,000 per session to control
which scientists and papers were presented and to help shape the presentations."
The companies' need to sell newly minted psychiatric drugs drives the entire
field: You can bet that every paper paid for by drug companies recommended that
company's product for varied psychiatric "disorders / conditions"--some newly
minted, others yet to be declared.
Psychiatrists aren't waiting for patients to seek their help, they are actively
recruiting them. In particular, innocent children are being targeted through
"screening" dragnets for "conditions" they do not have--in order to start them
on psychiatric drugs.
For example, fourteen year old children are being "screened" for schizophrenia
in Connecticut schools although there is no scientific, verifiable diagnostic
tool for identifying anyone who will develop schizophrenia.
Yale University psychiatrists have embarked on a Prevention through Risk
Identification, Management and Education (PRIME). Children are being targeted on
the basis of speculation--not scientific evidence. Fourteen year old children
are being recruited by psychiatrists who claim --without scientific
evidence--that the children are "at risk" for schizophrenia, a debilitating
psychiatric condition. These industry paid investigators would subject these
children to potent anti-psychotic drugs whose documented severe side
effects--such as diabetes and cardiac abnormalities-- have been linked to these
drugs. The drugs' long term consequences --especially in children whose
developing brains put them at greater risks of harm, have yet to be identified.
This strategy assures drug manufacturers a wider market for their drugs--the
children will likely become lifelong customers as a result of early exposure.
Furthermore, these powerful drugs may cause permanent damage to these children's
developing brain.
Despite the written acknowledgement by Dr. Benedetto Vitiello, NIMH’s Director
of Child and Adolescent Treatment and Preventive Interventions Research Branch,
that there exists:
"diagnostic uncertainty surrounding most manifestations of psychopathology in
early childhood,” the NIMH sponsored the Preschool ADHD Treatment Study (PATS)
experiment on three year old tots. Little children-- whose parents are paid
$645--are being recruited to test psychostimulant drugs that may cause them far
more harm than any potential benefit.
[See, Vitiello, B. (2001). "Psychopharmacology for young children: Clinical
needs and research opportunities," Pediatrics, vol. 108: 983-990.]
THE WASHINGTON POST
Source:
http://www.washingtonpost.com/wp-dyn/articles/A11056-2002May25.html
Industry Role in Medical Meeting Decried
By Shankar Vedantam
PHILADELPHIA -- In the days leading up to the American Psychiatric Association's
annual meeting here this past week, pharmaceutical companies mailed attendees
hundreds of free phone cards, as well as invitations to museums, jazz concerts
and fancy dinners.
As thousands of psychiatrists streamed into town, they were greeted by a highway
billboard advertising AstraZeneca Pharmaceuticals's anti-psychotic medicine
Seroquel. Each of the 19,000 attendees was given a gray bag with the insignia of
the meeting and the orange logo of GlaxoSmithKline PLC, the maker of the
antidepressant Paxil. Outside the giant convention center, curb signs for buses
ferrying doctors to their hotels advertised Eli Lilly and Co., the maker of
Prozac.
In one part of the convention hall, companies erected 20 foot-high monuments to
their medicines and handed out promotional material, candies and gifts. Company
executives hailed passing physicians, imploring them to stop and pick up
information. And in several dozen symposiums during the weeklong meeting,
companies paid the APA about $50,000 per session to control which scientists and
papers were presented and to help shape the presentations.
The perks, freebies, handouts, promotions and corporate sponsorships are not
unique to the APA's meeting or to psychiatry. But many psychiatrists
increasingly feel that the industry's aggressive promotional activities are
particularly troublesome in their field, potentially swaying psychiatrists into
writing prescriptions for the products of companies that woo them, raising
health care costs and tilting the profession away from insight-oriented
psychotherapies to a near-total focus on medications.
"A line has been crossed in terms of pharmaceutical company marketing," said
Henry Levine, a psychiatrist from Bellingham, Wash.
Officials at the APA defended the sponsorships and symposiums, and said the
money helped pay for a vast range of educational activity and advocacy on behalf
of the mentally ill. They said the bottom line is that no physician would ever
mistreat a patient whatever the inducement.
"Of course, it's going to bias us -- the question is whether the bias is
benign," said David McDowell, a Columbia University psychiatrist who helped
monitor industry sponsorships for the APA. Without industry money at the
gigantic Philadelphia Convention Center, he said, "we'd be sitting in the
basement of the YMCA."
Jeff Trewhitt of the Pharmaceutical Research and Manufacturers of America said
ties between companies and doctors have led to more informed medical practices
and better knowledge about how drugs work. He said new guidelines taking effect
on July 1 will ask companies not to give doctors tickets to sports and
entertainment events, and to offer them only modest meals.
The industry-sponsored symposiums at this conference are unusual -- most major
medical associations do not allow them -- said James Thompson, the APA's deputy
medical director. If companies want to take advantage of the conferences of
those other groups, they have to set up their own "satellite symposiums."
Thompson and other APA officials said allowing the symposiums to be part of the
convention permits doctors to first screen the studies for scientific accuracy.
Drug companies then select the papers they want to sponsor, and APA officials
monitor the proceedings for signs of bias or marketing.
The diagnosis and treatment of mental illness have risen sharply in recent
years. While studies show that many patients are still untreated, pharmaceutical
marketing has raised fears that others are getting prescriptions they do not
need.
Concern over psychiatry's ties with industry was widespread enough to be the
focus of several panels at this year's convention. Some psychiatrists said the
association should simply sever all ties with industry. Harvard Medical School
psychiatrist David Osser suggested that companies pool symposium money into a
common fund, which could then be used to conduct sessions chosen exclusively by
mental health professionals. Andrew Ho, a University of California at Los
Angeles psychiatrist, said the extent of industry involvement -- and the
dependence of the association on the money -- raised questions about who was
controlling the association and the profession.
"Let's face it -- they make the money back" through greater sales and
prescriptions, said Robert Eilers, a psychiatrist in the state Office of Mental
Health in New Jersey, in a session where several doctors assailed top APA
officials. "It's totally out of control."
Levine told APA officials that even patient organizations such the National
Alliance for the Mentally Ill had been shunted to the "far, far corner of the
auditorium" as funding companies got center stage in the exhibitors' hall.
Officials at the APA warned, however, that there were no simple answers to
questions about industry influence in psychiatry. "There are strings attached,"
agreed Stephen Goldfinger, the APA's top monitor of industry sponsorship at the
conference, at a session discussing potential conflicts of interest. "When you
dance with the devil, you can't control all the steps."
Led by Columbia University psychiatrist Philip Muskin, APA officials said that
doctors were very much in control of the convention and that the idea of setting
up a common pool of money for symposiums was "naive." Industry would never
sponsor symposiums they have no control over, said Muskin, and warned that the
critics were forgetting the many important educational and advocacy services
that would be slashed if the money was refused.
"Are you willing to pay $3,000 a year for membership dues if we didn't take drug
company money?" asked Anand Pandya, a psychiatrist who helps the APA evaluate
new research presented at the conference. "That's how much you would pay."
The APA's 31,000 psychiatrists -- who account for three in four American
psychiatrists -- currently pay about $540 in dues to the national association,
and between $200 to $500 in state dues, said the APA's Thompson.
Part of the APA's dependence on industry sponsorship is because the association
has been ailing financially, and revenue from the annual convention represents
about 22 percent of all funding. That money is becoming increasingly important,
as revenue from dues has dropped in recent years from $11 million in 1998 to
$9.9 million last year, and is expected to drop further. The association has run
at a loss for three out of the past four years.
Thompson said that it is ultimately the responsibility of physicians to evaluate
what they hear for scientific accuracy and signs of bias. Goldfinger said that
observers and evaluation sheets at the symposiums rated each session and that
warning letters were sent to researchers whose presentations fell short or who
had shown biases for particular medicines. If a pattern of bias is observed,
said Goldfinger, scientists would be barred from presenting research at the APA
for five years.
In the three years the policy has been in place, he said, nobody has been so
sanctioned.
In the end, the appearance of a conflict of interest may be more harmful than
any actual conflict itself. Several doctors noted that it may even keep good
treatments from receiving the attention they need.
Jeffrey Levine, chairman of psychiatry at Bronx-Lebanon Hospital Center, an
affiliate of the Albert Einstein College of Medicine in New York, said he had
once been approached by a marketing representative who complained that a
particular drug was not being made available in Levine's hospital. Levine said
he thought the medicine was effective, and would likely have recommended that it
be added to the formulary, but hesitated because he was worried that others
might think he was in the pocket of the drug industry.
"There isn't a simple headline or a bottom line," he said. At his panel
discussing the ethics of industry influence in education, Levine dubbed the
meeting "the American Psychiatric Association GlaxoSmithKline Convention."
Still, he noted that the psychiatric residents who had presented data about the
dangers of conflicts of interest would not have been able to attend without
industry funding. Saying that a company marketing representative he knew had
helped arrange a grant, he added: "It has paid for our residents to come here
today. Now you all don't know that, but it's got to be said."
For another
example of the influence the drug companies are having on policy, note that the
following _Boston Globe_ article 5/27/02 reports that Pfizer did not like it
when Dr. Alastair J. J. Wood said of the FDA process to approve their drugs:
''What we have today is an unseemly parade of people trying
to protect their own financial interests.''
His comment may now cost Wood the top post at the Food & Drug
Administration.
http://www.commondreams.org/headlines02/0527-02.htm
Published on Monday, May 27, 2002 in the _Boston Globe_
Drug Industry Costs Doctor Top FDA Post
by Michael Kranish
WASHINGTON - Dr. Alastair J. J. Wood had every reason to believe he was about to
be nominated by President Bush to one of the nation's most important health
jobs: commissioner of the Food and Drug Administration.
His medical credentials were unchallenged. Equally important, the Vanderbilt
University pharmacologist was being pushed strongly by Senator William Frist,
the Tennessee Republican who is perhaps Bush's most important medical adviser.
Then, just as word leaked that Wood had won the job to head the 8,000 scientists
and other employees who regulate one-fourth of US consumer spending, the
pharmaceutical industry and its allies struck back. If Wood became commissioner,
one influential industry ally wrote in a conservative online magazine, the FDA's
message to patients wanting life-saving drugs would be: ''Drop dead.''
The article said Wood was obsessed with drug-safety review and, applying the
coup de grace, announced that he was ''a buddy of Senator Ted Kennedy'' - even
though Wood had never met or spoken to the Massachusetts Democrat.
Within days, the White House dumped Wood. ''There was a great deal of concern
that he put too much emphasis on the safety,'' Frist said in an interview,
bluntly explaining why his friend was jettisoned.
The story of Wood's near-nomination - his embrace and subsequent rejection by
the Bush White House, and the attacks on him - vividly illustrates one of the
most important political and economic battles in Washington. At its heart is a
basic question: Should the government become more lenient or more aggressive in
screening new drugs for safety? At stake are the fortunes of patients as well as
of many biotech companies, some of which are in their own life-or-death
struggles over key medicines awaiting FDA approval.
Wood, in his first public comments about the way his nomination was dropped
earlier this year, is more bemused than bitter, marveling at the way his stock
soared and plummeted based on what he calls ''made up'' allegations first aired
in the online publication. The FDA job, he is convinced, has become the medical
industry's equivalent of a Supreme Court justice nomination, in which any
candidate with a long written record becomes easier to attack.
Just as Robert Bork lost his bid to be a Supreme Court justice in 1987 under the
burden of his voluminous writings and rulings, Wood, the drug therapy editor of
the New England Journal of Medicine, was sunk partly because he had a paper
trail, and once called for an independent board to investigate potentially
deadly drugs. That is an idea opposed by some in the industry who prefer
collecting their own reports of adverse drug reactions and passing them on to
the FDA, which then reviews whether its approval of the drug was appropriate.
Wood remains puzzled at the opposition, saying the FDA may have an inherent
conflict of interest in reviewing the safety of drugs on which it already has
staked its prestige through approval. ''I think we should have a better
understanding [of why] a drug causes a series of deaths,'' Wood said. ''I think
it is unfortunate the way this ended.''
The fight over Wood comes at a time when the FDA is in turmoil. Leaderless in
the 16 months since Bush took office, the agency is under extraordinary
pressures: The drug industry and some patient groups want faster approval and
fewer safety reviews, while some public interest groups have charged that the
agency is already too closely tied to industry and too quick to approve
dangerous drugs that cause deaths.
The Bush administration is torn between these political and financial pressures.
Of the $10 million given by pharmaceutical companies to politicians in the 2002
cycle, 72 percent went to members of the GOP, according to the Center for
Responsive Politics, which tracks contributions.
The administration does not want to be painted as being too cozy with the
industry, so for more than a year, it considered and rejected one potential
nominee after another.
One of the rejects was Michael Astrue, the counsel of Cambridge's Transkaryotic
Therapies Inc. He was dropped after Kennedy, who chairs the Senate Committee on
Health, Education, Labor, and Pensions, said Astrue was too closely tied to
industry.
Another candidate was Dr. Raymond Woosley, who bowed out when he was offered the
job as dean of the University of Arizona College of Medicine.
It was Woosley who recommended his friend, Wood, even though he anticipated
problems. ''It is pretty clear that anyone who has said anything that industry
doesn't like isn't going to make it,'' Woosley said in an interview. Still,
primarily because of Frist's recommendation, the White House liked Wood. Frist,
a heart surgeon at Vanderbilt before becoming a senator, has helped Bush
formulate his policy on issues such as stem cell research. After the biotech
industry complained in a letter to the White House about the ''political
vacuum'' caused by a leaderless FDA, the administration responded by saying a
commissioner would be nominated within weeks, leaking word that Wood was the top
choice.
Wood, 55, appeared well-qualified for the job. Born and educated in Scotland, he
came to the United States in 1976 for a fellowship in clinical pharmacology at
Vanderbilt, where he is now associate vice chancellor.
The pharmaceutical industry, meanwhile, was deeply concerned about who would
lead the FDA. In 2001, the FDA approved only 24 new drugs, compared with 53 in
1996. Many industry officials have complained that the underfunded and
overburdened agency is agonizingly slow in approving any new drug, hurting
profits and denying potentially life-saving drugs to the sickest patients.
Some in the industry, however, said they were reluctant to publicly attack Wood,
partly out of fear of earning the ire of someone who might wield such enormous
influence over the industry. That problem was solved by Robert Goldberg.
Goldberg is not a lobbyist or a pharmaceutical company employee. But for more
than a decade, Goldberg has been writing research papers that are mostly
friendly to the industry. A former Newton resident who worked at Brandeis
University's Gordon Public Policy Center, Goldberg lives in New Jersey and is
senior fellow at New York's Manhattan Institute, a free-market think tank. The
institute's motto is telling: ''Turning intellect into influence.''
''The people I know in clinical pharmacology, in the research trenches, went
berserk when they heard about Wood,'' Goldberg said. Goldberg, who said he has
''received support from the pharmaceutical industry in the past, as you might
expect,'' decided to go after Wood in an article that appeared in the online
version of the conservative National Review magazine.
If Wood became commissioner, Goldberg wrote, the FDA would be so tough on drug
manufacturers that the government's message to patients would be ''Drop dead.''
Goldberg wrote that Wood would be a ''clone'' of former FDA commissioner David
Kessler, who was appointed by Bush's father, and who Goldberg and many in the
drug industry believed was an overzealous regulator. (Kessler did not return a
call seeking comment.) Kessler had been backed by Senator Orrin Hatch, a Utah
Republican, just as Wood was backed by Frist, Goldberg said, warning that the
Tennessee senator's blessing was no assurance for the industry.
''Like Kessler, he is a doctor sponsored by a Republican senator - and a buddy
of Senator Ted Kennedy, the guy who really nominates FDA commissioners,''
Goldberg wrote. Six days later, the Wall Street Journal echoed some of the same
complaints in an editorial titled, ''It's Not Ted's FDA.'' Wood said the
articles became the talk of a White House meeting; a White House official did
not return a call seeking comment.
The pharmaceutical industry, meanwhile, was taking a more activist approach,
alerting member firms and spreading word about Wood in Washington. Pfizer was
''the most aggressive,'' Goldberg said, in circulating information about Wood.
Pfizer spokesman Andrew McCormick declined to confirm or deny Goldberg's
statement, saying, ''We are not going to comment on someone's interpretation.''
But speaking generally, he said, ''I think along with other companies in the
industry we have noted that the approvals from our perspective at the agency
have slowed down significantly and we are concerned about that.''
''I think we expressed the thought that whoever is chosen to head FDA should
look at risk-benefits in a balanced way,'' McCormick said.
Pfizer and some other pharmaceutical companies had a reason to be concerned
about Wood. In May 2001, Wood sat on an FDA advisory committee that was
considering whether to make three allergy prescription drugs into
over-the-counter products: Pfizer's Zyrtec, Schering-Plough's Claritin, and
Aventis's Allegra.
Wood favored the measure, but it was opposed by the drug makers. In some cases,
the repositioning of a drug into an over-the-counter product can cost a
manufacturer tens of millions of dollars because such products sometimes are
sold at a much lower price and are not covered under most health plans.
''What we have today is an unseemly parade of people trying to protect their own
financial interests,'' Wood said at the hearing.
Nine months later, when Wood was on the verge of becoming the chief drug
regulator, the industry did not forget his comments. A White House official
called Wood and told him the nomination was off. ''He said, `It's not going to
happen,''' Wood recalled.
Three months afterward, the White House still hasn't announced a nominee,
although there is speculation that Dr. Lester Crawford, the deputy FDA
commissioner, might get the nod, even though he would be an unusual pick given
his background as a veterinarian.
As for Goldberg, he is proud of the role he played in the rejection of Wood and
is setting up a project he calls the Center for Medical Progress.
''Pharmaceutical industries,'' Goldberg said, ''are more than welcome to
contribute.''
© Copyright 2002 Globe Newspaper Company
http://www.commondreams.org/headlines02/0526-03.htm
Published on Sunday, May 26, 2002 in the Observer of London
