Today's Article
Institutions which
assess drugs for FDA
approval often hold
equity positions in the
drug companies,
reveals the
Government
Accountability Project.
assess drugs for FDA
approval often hold
equity positions in the
drug companies,
reveals the
Government
Accountability Project.
The American Spark
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FDA Needs Major Overhaul, Says Whistleblower Agency
By Cliff Montgomery - May 7th, 2009
The Government Accountability Project (GAP) is a not-for-profit organization which promotes "corporate and
governmental accountability by advancing occupational free speech, defending whistleblowers, and
empowering citizen activists."
Last month GAP released a damning indictment of the U.S. Food and Drug Administration (FDA). The FDA is
supposed to provide a serious, unbiased regulation of drug companies' products. Why? Because an unsafe
drug can kill.
But as the study reveals, America's drug cop has far too many ties to the drug companies to be an effective
regulator. And as the current economic meltdown has proven with stunning clarity, millionaires and billionaires
cannot be expected to police themselves.
Below we offer a number of quotes from the GAP report:
"Drug companies spend $14 billion a year testing new drugs. Many of these drugs are life-savers. But too
many are the opposite.
"Tens of thousands of Americans have died from taking United States Food and Drug Administration (FDA)
approved drugs. The painkiller Vioxx alone is responsible for upwards of 55,000 American deaths. Many more
people have died as study participants in poorly monitored, FDA mandated clinical drug trials.
"The tragic fact is that most of these deaths were preventable. To borrow a political campaign cliché, we can
do better. Much better."
"The manufacture and testing of new drugs is the province of the pharmaceutical industry; regulation of the
industry is the job of the FDA.
"In 2006, the top ten drug manufacturers earned nearly $40 billion in profits. With such vast sums at stake, it
comes as no surprise that the drug industry is very focused on expediting the drug approval process.
"The FDA is charged by statute with the critical public health and safety duty of regulating prescription and
over-the-counter drugs, medical devices, biological products, and certain foods.Together, these products
account for roughly 25 percent of all consumer spending in the United States.
"How effectively is the FDA discharging its duty? According to Dr. David Graham, a leading FDA scientist, 'as
currently configured, [the FDA] is incapable of protecting America against another Vioxx. We are virtually
defenseless.'
"Why? In part, the FDA is defenseless because of finances. Federal funding for the FDA has decreased since
1992, forcing the Agency to heavily rely on fees it receives from the very industry it is supposed to regulate. The
industry’s financial grip over the FDA has undermined both the perception and reality of an arms-length
relationship between the regulator and the regulated.
"The drug approval process is now a product of closed-door negotiations between the drug companies and the
FDA. With the leverage of their user fees, drug companies have successfully pressured the FDA to greatly
expedite the timetable for drug approvals, which results in a frequent rush to judgment about a product’s
safety and efficacy.
"The conflicts corroding drug safety, however, run even deeper: They are structural to the FDA and to the
conduct of clinical drug trials. A 2003 study found that approximately two-thirds of academic medical centers
hold equity interests in companies that sponsor research at these institutions. And this study did not even
touch on trials being conducted by for-profit entities on behalf of drug sponsors.
"Marcia Angell, former editor of The New England Journal of Medicine and a senior lecturer at the Harvard
Medical School, maintains that all clinical trials should be administered by the National Institutes of Health:
"The law not only promotes conflicted relations between drug sponsors and universities, but between drug
sponsors and the contract research organizations (CROs) and Institutional Review Boards meant to ensure
the integrity of the trials and the safety of the participants.
"CROs, which conduct clinical trials to assess a drug’s safety and efficacy, sometimes even hold equity
positions in the very drug companies at issue.
"In addition, as the inspector general of the Department of Health and Human Services found in early 2009, in
42 percent of clinical trials, the FDA neither received required forms disclosing doctors’ financial conflicts of
interests nor did the agency take any action about this non-compliance.
"Equally as troubling, the law does not currently require governmental oversight of all human clinical trials."
"Just as a bridge may collapse if its structure is weakened, clinical trials lose their strength if their core is
hollowed out. The litany of recent scandals in clinical trial misconduct, involving products as varied as Vioxx,
Ketek, and ProHeart6, has involved missteps by pharmaceutical manufacturers, regulatory agencies, and
clinician-investigators.
"The situation threatens the credibility of the current drug development system in much the same way that sub-
prime mortgages have threatened the financial system."
"Restoring this system to health will not be easy, and will require hard work – and the courage to change – on
the part of the medical product industry, the U.S. Food and Drug Administration, academic medical centers,
and health care providers. But simply hoping that the system does not collapse is not an option."
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
By Cliff Montgomery - May 7th, 2009
The Government Accountability Project (GAP) is a not-for-profit organization which promotes "corporate and
governmental accountability by advancing occupational free speech, defending whistleblowers, and
empowering citizen activists."
Last month GAP released a damning indictment of the U.S. Food and Drug Administration (FDA). The FDA is
supposed to provide a serious, unbiased regulation of drug companies' products. Why? Because an unsafe
drug can kill.
But as the study reveals, America's drug cop has far too many ties to the drug companies to be an effective
regulator. And as the current economic meltdown has proven with stunning clarity, millionaires and billionaires
cannot be expected to police themselves.
Below we offer a number of quotes from the GAP report:
"Drug companies spend $14 billion a year testing new drugs. Many of these drugs are life-savers. But too
many are the opposite.
"Tens of thousands of Americans have died from taking United States Food and Drug Administration (FDA)
approved drugs. The painkiller Vioxx alone is responsible for upwards of 55,000 American deaths. Many more
people have died as study participants in poorly monitored, FDA mandated clinical drug trials.
"The tragic fact is that most of these deaths were preventable. To borrow a political campaign cliché, we can
do better. Much better."
"The manufacture and testing of new drugs is the province of the pharmaceutical industry; regulation of the
industry is the job of the FDA.
"In 2006, the top ten drug manufacturers earned nearly $40 billion in profits. With such vast sums at stake, it
comes as no surprise that the drug industry is very focused on expediting the drug approval process.
"The FDA is charged by statute with the critical public health and safety duty of regulating prescription and
over-the-counter drugs, medical devices, biological products, and certain foods.Together, these products
account for roughly 25 percent of all consumer spending in the United States.
"How effectively is the FDA discharging its duty? According to Dr. David Graham, a leading FDA scientist, 'as
currently configured, [the FDA] is incapable of protecting America against another Vioxx. We are virtually
defenseless.'
"Why? In part, the FDA is defenseless because of finances. Federal funding for the FDA has decreased since
1992, forcing the Agency to heavily rely on fees it receives from the very industry it is supposed to regulate. The
industry’s financial grip over the FDA has undermined both the perception and reality of an arms-length
relationship between the regulator and the regulated.
"The drug approval process is now a product of closed-door negotiations between the drug companies and the
FDA. With the leverage of their user fees, drug companies have successfully pressured the FDA to greatly
expedite the timetable for drug approvals, which results in a frequent rush to judgment about a product’s
safety and efficacy.
"The conflicts corroding drug safety, however, run even deeper: They are structural to the FDA and to the
conduct of clinical drug trials. A 2003 study found that approximately two-thirds of academic medical centers
hold equity interests in companies that sponsor research at these institutions. And this study did not even
touch on trials being conducted by for-profit entities on behalf of drug sponsors.
"Marcia Angell, former editor of The New England Journal of Medicine and a senior lecturer at the Harvard
Medical School, maintains that all clinical trials should be administered by the National Institutes of Health:
- 'It is self-evidently absurd to look to investor-owned companies for unbiased evaluations of their own
products. Yet many academic investigators and their institutions pretend otherwise, and it is convenient
and profitable for them to do so.'
"The law not only promotes conflicted relations between drug sponsors and universities, but between drug
sponsors and the contract research organizations (CROs) and Institutional Review Boards meant to ensure
the integrity of the trials and the safety of the participants.
"CROs, which conduct clinical trials to assess a drug’s safety and efficacy, sometimes even hold equity
positions in the very drug companies at issue.
"In addition, as the inspector general of the Department of Health and Human Services found in early 2009, in
42 percent of clinical trials, the FDA neither received required forms disclosing doctors’ financial conflicts of
interests nor did the agency take any action about this non-compliance.
"Equally as troubling, the law does not currently require governmental oversight of all human clinical trials."
"Just as a bridge may collapse if its structure is weakened, clinical trials lose their strength if their core is
hollowed out. The litany of recent scandals in clinical trial misconduct, involving products as varied as Vioxx,
Ketek, and ProHeart6, has involved missteps by pharmaceutical manufacturers, regulatory agencies, and
clinician-investigators.
"The situation threatens the credibility of the current drug development system in much the same way that sub-
prime mortgages have threatened the financial system."
"Restoring this system to health will not be easy, and will require hard work – and the courage to change – on
the part of the medical product industry, the U.S. Food and Drug Administration, academic medical centers,
and health care providers. But simply hoping that the system does not collapse is not an option."
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
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