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"Right. My job was to please him. That's a diret quote."

HEALTH:  Intimidation, Politics and Drug Industry
Cripple U.S. Medicine

Ritt Goldstein

STOCKHOLM, Dec 30 (IPS) - While the U.S. Food and Drug
Administration (FDA)  is supposed to safeguard the
nation's medical products, drawing upon the  substantive
expertise of its drug scientists in vigilant dedication to the  
public's health, that is not the case today.

Documentation, interviews and recent drug debacles
depict a brutally different reality, with the Vioxx scandal
alone estimated to have resulted  in 30,000-55,000 U.S.
deaths.

"You have an agency in denial -- the FDA still
maintains it made no mistake  in the approval or regulation of
Vioxx," says the agency's associate safety  director, Dr David J
Graham.

Vioxx was voluntary withdrawn by its manufacturer,
Merck andCo, on Sep.  30, 2004 due to substantively increased
risk of heart attack and stroke.  Since then, questions have
been raised regarding similar problems in other  pain medications
like Celebrex and Aleve.

Graham, who provided the figures on the Vioxx deaths,
also told IPS that --  despite the recent linkage between some
antidepressants and suicide -- the  FDA is in the
process of "misleading the public in their (antidepressant)  
labelling ... taking care of business rather than patient safety."

Graham, whose November testimony before the U.S.
Senate Finance Committee  rocked the FDA's leadership, warned that
while the agency's proposed new  label for the class of
antidepressants known as SSRIs cites a "suicidality"  rate of one-two
percent, a senior FDA official acknowledged in September  that
number was based upon drug trials that "failed to capture most of
the reactions of suicidality."

A 20-year FDA veteran, Graham then noted that an
alternative trial found  "the actual rate was somewhere around
seven or eight percent," an  incredibly substantive difference
from the proposed FDA numbers.

Investigation reveals that dangers of drugs are being
deliberately  downplayed, and the public misled.

Notably, a March 2003 report by the U.S. Department
of Health and Human  Services Inspector General (DHHS-IG),
Janet Rehnquist, found that just 12  percent of FDA
scientists were completely confident that "labelling  decisions
adequately address key safety concerns."

In his most recent congressional testimony on Nov.
18, Graham named five  drugs as candidates for market
withdrawal: Accutane, an acne treatment;  Bextra, the pain medication;
Crestor, which lowers cholesterol; Meridia, a  weight reduction drug;
and Serevent, an asthma medication.

All of the preceding drugs' manufacturers were
reported declaring their  medications safe, paralleling
similar pronouncements made by Merck and  Company prior to its
withdrawal of Vioxx.

At the same time, the Senate Finance Committee
chairman, Iowa republican  Charles Grassley, expressed his belief
the FDA was "too cosy" with the drug  industry.

Graham urged Congress to pursue legislation
separating the FDA offices that  address drug safety from the drug
review and approval structure, arguing  that creating an
independent body to review drug problems would avoid the  need to seek
action on problem medications from the very individuals who  had
approved them, which is now what happens.

Both the FDA and the National Institutes of Health
(NIH) have come under  increasingly strong criticism for alleged
distortion of research, their  "cosy" relationship with the drug industry
said to be at the root of the  problem.

'The National Institutes of Health: Public Servant or
Private Marketer?' headlined the Dec. 22 'Los Angeles
Times', which revealed that while  physicians have relied on the NIH
to draft medical standards, the agency's  researchers accepted
"substantive fees and stock from drug companies ... an unabashed
mingling of science and commerce."

The NIH creates treatment guidelines for use by
physicians, but documentation reveals that many of those working at
the institutes to  create the guidelines were quietly on
the pay of the drug companies whose  products they were
suggesting.

"It's more than manipulation -- they (the FDA and
NIH) put their seal of  approval on things that they knew were
false, were wrong ... they've  betrayed the trust. Instead of
servants of the public, they became truly  agents and promoters
of the Industry," said Vera Hassner Sharav, a renowned  drug
industry critic whose years of work as head of the Alliance for
Human  Research Protection (AHRP) broke much of the ground
for today's revelations.

"Now we're seeing the pattern, we're seeing that it
isn't one drug, not one  company, but rather the entire
enterprise," added Hassner Sharav in an  interview.

What continually resurfaces is federal agencies'
effective abdication of  their watchdog role, interrupted only
by scientists of integrity who have  gone beyond their
agency structures in attempting to alert the public to  
growing dangers.

Economic and political goals appear to have replaced
the need to safeguard  the safety of the U.S. public and
agencies' scientific integrity, say  observers.

"Over the last couple of years, we ... began to hear
reports out of a  number of the federal agencies that
'something was going on', that research  and analysis by government
scientists was being systematically censored or  ignored ... or
misrepresented in some way," said Kathleen Rest, executive  
director of the Union of Concerned Scientists (UCS).

In an interview Rest described what she saw as a
"pattern," one of  "politicising or manipulating scientific advisory
boards." The UCS -- whose  membership encompasses much of the
cream of America's scientists, including  a number of Nobel
laureates -- also found "evidence and cases of agencies  
manipulating or suppressing scientific analysis."

The March 2003 FDA report by the DHHS-IG, whose
public release presented  only information portraying the agency in
a favourable light, was obtained  in full under the Freedom of
Information Act by the UCS and another non-governmental
organisation (NGO), Public Employees for Environmental  
Responsibility (PEER).

While the release of only the report's positive
conclsions further  highlights the official spin being broadly
put on research findings, all of  those interviewed spoke of
the devastating potential of disseminating  misleading
scientific data. Graham described the yearly death toll from  
Adverse Drug Reactions (ADRs) across the full spectrum of available  
medication as "massive."

Both the 'Journal of the American Medical Association' and
Britain's  'Lancet' have described ADRs as the fourth leading
cause of death in the  United States. But despite such
severe human costs, the full version of the  DHHS-IG report revealed
that about one-fifth of FDA scientists had "been  pressured to
approve or recommend approval" for a medication
"despite  reservations about the safety, efficacy or quality of
the drug."

According to Graham, "the agency (FDA) has never
given a high priority to  safety." Instead he saw its main pursuit
as the "review and approval of  drugs," adding that the vast
majorty of agency resources were expended in  this effort.
Accordingly, those who work in review and approval areas have  the
most influence upon FDA policy, he added.

Confirming reports of the pressures applied to
government experts who dare  to speak out, Graham warned,
"intimidation of scientists who threaten the  status quo at FDA is
routine."

He described how, after he sought the withdrawal of
an arthritis drug  called Arava, his superior addressed
his concerns that the medication  induced liver failure.

"The division director spent the first 10 minutes of
that meeting screaming at me. Basically, standing up,
jugular veins bulging in his neck, eyes sort  of bugging out of his
head, screaming ... basically trying to intimidate me  so
that I'd change my conclusion."

Arava is still on the market today.

Citing another instance, Graham recalled his 1999
attempt to have the  diabetes drug Rezulin withdrawn for also
inducing liver failure. He noted  that while Britain withdrew
the drug in 1997, the FDA delayed Rezulin's  market recall until
2000, citing a policy of "risk management," though  Graham noted
that his findings already indicated the futility of such an  
approach.

Those marketing Rezulin "were making roughly two
million dollars a day" on  the medication, Graham added, so
the extra market time provided a financial  bonus to the
medication's makers.

The scientist also described how he was given a poor
performance evaluation  after providing accurate congressional
testimony on drug safety  shortcomings. His supervisor at the
time informed him "my job was to please  him," describing that as
a "direct quote."

When asked if this meant his job was "not to
safeguard the public," Graham  replied, "right, my job was to
please him."

Complicating efforts to maintain scientific
integrity, Graham noted that  existing federal protections for
whistleblower have been gutted, and that a  current whistleblower
protection bill is being blocked in Congress.

Despite obvious concern over the potential
ramifications for his future,  Graham emphasised his belief that "my
job is to look after drug safety for  the American people." .

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