STOCKHOLM - 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.
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.
Vera Hassner Sharav, a renowned
drug industry critic
Vioxx was voluntary withdrawn by its manufacturer, Merck and Co, on Sep.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)
labeling ... 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 "labeling
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 cozy" with the drug
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
"cozy" relationship with the drug industry said to be at the root of the
'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
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
Economic and political goals appear to have replaced the need to safeguard
the safety of the U.S. public and agencies' scientific integrity, say
"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
"politicizing 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 favorable light, was obtained
in full under the Freedom of Information Act by the UCS and another
non-governmental organization (NGO), Public Employees for Environmental
While the release of only the report's positive conclusions 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 majority 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
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 emphasized his belief that "my job is to look after drug safety for
the American people."
© Copyright 2004 IPS - Inter Press Service