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GRAHAM on FDA: My job was to please him not to safeguard public
GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by Zee on 01-02-05 13:37
http://tinyurl.com/5fnbr
"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Vioxx was voluntary withdrawn by its manufacturer,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." .
-30-
Re: GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by Mike on 01-02-05 15:06
"Zee" wrote in message news:e5f4a9c2.0501021337.7e607283@posting.google.com...
> http://tinyurl.com/5fnbr
>
> "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.
As if it's ever been the case. As with all government
bureaucracies, what started as a well-meaning public
health organization has devolved into a corrupt
abomination which does far more harm than good.
The FDA should be abolished, or something very close
to abolished, along with the DEA, ATF and the other
institutionalized domestic terrorist organizations.
Re: GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by listener on 01-02-05 17:02
"Mike" wrote in news:33rd35F42n80uU1@individual.net:
> "Zee" wrote in message
> news:e5f4a9c2.0501021337.7e607283@posting.google.com...
>> http://tinyurl.com/5fnbr
>>
>> "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.
>
> As if it's ever been the case. As with all government
> bureaucracies, what started as a well-meaning public
> health organization has devolved into a corrupt
> abomination which does far more harm than good.
>
> The FDA should be abolished, or something very close
> to abolished, along with the DEA, ATF and the other
> institutionalized domestic terrorist organizations.
>
>
>
Thanks for making your feelings very clear.
L.
Re: GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by Zee on 01-03-05 02:20
What are DEA and ATF? Many of us are not American.
Zee
Re: GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by Carey Gregory on 01-03-05 10:48
"Zee" wrote:
>What are DEA and ATF? Many of us are not American.
DEA = Drug Enforcement Administration
ATF = [Bureau of] Alcohol, Tobacco and Firearms (should be abbreviated BATF)
Both are US federal law enforcement agencies.
Re: GRAHAM on FDA: My job was to please him not to safeguard public -- Posted by Zee on 01-03-05 12:27
Oh. I guess we have something similar subsumed into a couple federal
and provincial departments...and the RCMP.
Zee
Carey Gregory wrote:
> "Zee" wrote:
>
> >What are DEA and ATF? Many of us are not American.
>
> DEA = Drug Enforcement Administration
>
> ATF = [Bureau of] Alcohol, Tobacco and Firearms (should be
abbreviated BATF)
>
> Both are US federal law enforcement agencies.
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