Citing "A Serious Threat" to Medical Professionalism, National Health
Leaders Urge Teaching Hospitals to "Put Patients First" By Abolishing
Gifts, Payments that Unduly Influence Physicians
January 24, 2006
http://www.imapny.org/news/news_show.htm?doc_id=343194
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Congressional Investigators Are Critical of F.D.A.'s Efforts to Detect
Drug
Dangers

http://www.nytimes.com/2006/04/24/washington/24fda.html?_r=1&oref=slogin

By GARDINER HARRIS
Published: April 24, 2006

WASHINGTON, April 23 - Disorganization, bureaucratic infighting and
an inability to force drug makers to conduct needed safety tests have
undercut efforts at the Food and Drug Administration to uncover drug
dangers, government auditors say.

When drug safety specialists raise alarms about certain medicines, they
sometimes feel that their recommendations fall "into a 'black hole' or
'abyss'" at the agency, according to a report to be released Monday by
the Government Accountability Office, the auditing arm of Congress.

Top agency officials sometimes excluded drug safety specialists from
presenting findings at public hearings, and tensions between officials
who approve drugs and those who ensure that they are safe are common,
the report said.

"F.D.A. lacks clear and effective processes for making decisions about,
and providing management oversight of" issues involving the safety of
popular medicines, the report states.

The F.D.A. told the accountability office that its conclusions were
"reasonable," the report said.

Last year, the agency created a drug safety oversight board and asked
the Institute of Medicine to examine its drug safety practices. The
institute's report is due in July. The accountability office said in
its report that the agency's responses so far might help "but will not
address all gaps."

Susan Bro, an F.D.A. spokeswoman, said, "The F.D.A. welcomes the G.A.O.
report and is currently leading a comprehensive and timely effort to
transform the methods our medical and scientific staff use to manage
safety issues."

The report comes after a series of drug withdrawals led agency critics
and some on Capitol Hill to suggest that the agency was failing in its
mission to protect the public from dangerous drugs. Since 2000,
pharmaceutical companies have withdrawn 10 drugs after deaths and other
injuries belatedly demonstrated that the medicines were unsafe.

Many critics have said that the agency should never have approved these
drugs for sale in the first place.

Senator Charles E. Grassley, an Iowa Republican who is chairman of the
Senate Finance Committee, said the accountability office's report
showed that "the F.D.A.'s problems are systemic and cultural, not
isolated or easily fixed."

But Representative Joe L. Barton, a Republican from Texas who is
chairman of the House Energy and Commerce Committee, said the report
"shows that the drug safety system is not in crisis, but the F.D.A.'s
process may need some fine-tuning."

The auditors recommended that Congress vote to give the agency power to
force drug makers to undertake or complete drug safety studies. Mr.
Grassley has proposed legislation that would do that.

When it approves new drugs for sale, the drug agency often requires
manufacturers to study whether the medicines are working as intended
and whether they have unwanted side effects once they get into a
broader market. [Uh, would be nice if folks were required to study if
*all* drugs being marketed actually 'work as intended' and are safe--
before they hit the market even much less *after* they hit the market?
Sheesh. And some thought that was the purpose of the FDA?]

But the agency announced in March that two-thirds of these promised
studies had not even been started, and hundreds of trials have been
pending for years.

In many cases, pharmaceutical makers had guaranteed they would
undertake the studies as a way to speed their drugs' approval.

The Bush administration has opposed efforts to give the agency greater
authority to force drug makers to complete these trials, and top agency
officials have for years told Congressional committees that the agency
did not need any additional authority.

"One senior F.D.A. official and several outside drug safety experts
told us that F.D.A. needs greater authority to require such studies,"
the accountability office's report says.

Dr. Alastair Wood, associate dean of the Vanderbilt medical school,
said the report demonstrated that the drug agency needed more authority
and should create an independent department that evaluates the safety
of medicines.

"It confirms that the current system needs fixing," Dr. Wood said.

The report said the agency lacked the money needed to construct an
effective system to monitor the safety of marketed drugs.

Much of the drug agency's functions are financed by fees paid by drug
makers [surprise, surprise?], but the industry mostly opposed proposals
that would have allowed the agency to use this money to determine
whether already approved medicines cause unexpected injuries or deaths.
And neither the administration nor Congress has provided enough money
to make up the difference.

The accountability office's report said that the drug agency's budget
to undertake its own studies of drug dangers amounted to less than $1
million annually from 2002 to 2005, and that this figure was expected
to rise to only $1.1 million annually through 2010.

Just one clinical trial to study the long-term safety of one drug can
cost as much as $7 million, the report said.

"I think the report is terrific," said Dr. Curt Furberg, a professor of
public health sciences at Wake Forest University School of Medicine.
"The F.D.A.'s office of drug safety has absolutely no clout and no
money, and the report showed that."

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Study Finds a Link of Drug Makers to Psychiatrists

By BENEDICT CAREY
Published: April 20, 2006
http://www.nytimes.com/2006/04/20/health/20psych.html?_r=1&oref=slogin

More than half the psychiatrists who took part in developing a widely
used diagnostic manual for mental disorders had financial ties to drug
companies before or after the manual was published, public health
researchers reported yesterday.

The researchers found that 95 - or 56 percent - of 170 experts who
worked on the 1994 edition of the manual, called the Diagnostic and
Statistical Manual, or D.S.M, had at least one monetary relationship
with a drug maker in the years from 1989 to 2004. The most frequent tie
involved money for research, according to the study, an analysis of
financial records and conflict-of-interest statements.

The percentage was higher - 100 percent in some cases - for experts
who worked on sections of the manual devoted to severe mental
illnesses, like schizophrenia, the study found. But the authors, from
Tufts University and the University of Massachusetts, were not able to
establish how many of the psychiatrists were receiving money from drug
companies while the manual was being compiled.

Lisa Cosgrove, the study's lead author, who is a psychologist at the
University of Massachusetts in Boston, said that although the study
could not prove that the psychiatrists' ties influenced the manual's
development, "what we're saying is it's outrageous that the manual
doesn't have a disclosure policy."

But other experts scoffed at the idea that commercial interests had
influenced either the language or content of the manual. "I can
categorically say, and I was there every step of the way, that
drug-company influence never entered into any of the discussions,
whatsoever," said Dr. Michael First, a psychiatry professor at
Columbia, who coordinated development of the current D.S.M.

Some 400,000 mental health workers, from psychiatrists to nurses, use
the manual to diagnose disorders in patients, and health insurers use
the manual to determine coverage.

In recent years, critics have said that the manual has become too
expansive, including diagnoses, like social phobia, that they say
appear tailor-made to create a market for antidepressants or other
drugs.

The study investigated the financial ties by sifting through legal
files, patent records, conflict-of-interest databases and journal
articles, among other records.

Twenty-two percent of the experts received consulting income in the
years from 1989 to 2004, the study found, and 16 percent served as
members of a drug maker's speakers bureau. Such services are typically
more lucrative than research support.