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Church
of Scientology of Canberra
Freedom
Below is a thoughtful article sent to us by email,
shown
here in the public interest:
Tue,
27 April
2010
Huma
Khan
and Pierre Thomas
ABC
News
Drug
Giant AstraZeneca to Pay $520 Million to Settle Fraud Case
Justice
Department Alleges Pharmaceutical Firm Illegally Marketed Schizophrenia
Drug
Pharmaceutical giant AstraZeneca will pay $520 million in fines to
settle charges by the federal government that it illegally marketed the
anti-psychotic drug Seroquel to children and elderly patients for uses
not approved by the Food and Drug Administration.
AstraZeneca, one of the country's biggest drug firms, allegedly pulled
in hundreds of millions of taxpayer dollars through Medicare and
Medicaid kickbacks and scams. Seroquel is used to treat schizophrenia
in patients older than 13, and bipolar disorder in patients older than
10.
The FDA approved Seroquel to treat only psychotic disorders,
specifically short-term treatments of schizophrenia, bipolar mania and
bipolar depression. The government claims that AstraZeneca
intentionally marketed the drugs -- by paying kickbacks to doctors --
for a variety of illnesses for which it had never been tested,
including aggression, Alzheimer's, anger management, anxiety,
attention-deficit hyperactivity disorder, dementia, depression, mood
disorder, post-traumatic stress disorder and sleeplessness. It was
given to the elderly, children, veterans and inmates, who were treated
as "guinea pigs," according to the acting U.S. attorney for the Eastern
District of Pennsylvania.
Under the Food, Drug and Cosmetic Act, pharmaceutical firms must
specify the intended uses of a medicine in its new drug application.
Before a drug is approved, the FDA determines that it is safe and
effective for the use proposed by the company. Once approved, the drug
may not be marketed or promoted for off-label uses.
The whistleblower who reported the alleged fraud will get more than $45
million as a reward, according to sources.
Of the money AstraZeneca pays, the federal government will get $302
million, and states will share up to $218 million. The company also
faces multiple other lawsuits over Seroquel, which is one of its
best-selling drugs.
"These were not victimless crimes -- illegal acts by pharmaceutical
companies and false claims against Medicare and Medicaid can put the
public health at risk, corrupt medical decisions by health care
providers, and take billions of dollars directly out of taxpayers'
pockets," Attorney General Eric Holder said today at a news conference
announcing the settlement.
AstraZeneca denied the charges but its general counsel, Glenn
Engelmann, said in a statement that moving forward and resolving the
case was "in the best interest" of the company.
"While we deny the allegations, AstraZeneca takes its obligations very
seriously under its agreements with the government," Engelmann said.
"The company is committed to meeting the expectations and obligations
of a leading biopharmaceutical company, while continuing to provide
valuable medicines to millions of patients."
This is not the first case of such abuse and it's unlikely to be the
last because the settlements are usually "chump change" for such firms,
said John Abramson, clinical instructor at Harvard Medical School and
author of "Overdo$ed America: The Broken Promise of American Medicine."
"As long as the rewards are greater than the penalties for this kind of
scientific misrepresentation and fraud, it will continue," he said.
"The pharmaceutical industry is playing hardball and they're willing to
accept these as long as there are no individual criminal penalties or
the financial penalties are so high that shareholders would revolt when
these cases of fraud and misrepresentation are settled."
AstraZeneca paid $355 million in 2003 after pleading guilty to charges
that it encouraged physicians to illegally request Medicare
reimbursements for its cancer drug Zoladex, and bribed doctors to buy
it.
Other drug giants have also been embroiled in similar controversies and
have admitted to using illegal marketing tactics. In March, Pfizer was
told to pay $142.1 million for violating U.S. racketeering law by
illegally promoting its epilepsy drug Neurontin for non-authorized
illnesses. Pfizer also agreed in September to pay $2.3 billion for not
branding its anti-inflammatory drug Bextra and promoting it for uses
other than those specified on the label.
That case became the biggest health care fraud settlement ever. Eli
Lilly agreed in January 2009 to pay $1.4 billion for promoting its
anti-psychotic drug Zyprexa for uses not approved to by the FDA.
Experts said one of the key challenges is that the current law doesn't
require pharmaceutical firms to disclose their research and data. So
even if they have knowledge that a particular drug is more harmful than
originally thought, they may not disclose it.
Because of that, even when pharmaceutical companies find problems with
a particular medicine, "they continue to push the drug aggressively and
hope they can make a billion dollars before someone finds out," said
Jerome Kassirer, professor at Tufts University School of Medicine in
Boston.
"When you think about the extent of the money involved in these
settlements, it's relatively modest," Kassirer added. "When you think
about the total worth of the companies, they can shake off a settlement
like this without much in the way of influence on their bottom line or
their stock prices. That's one of the reasons why they keep doing
this."
Another problem is that because this data is not available to doctors,
many of them can easily be duped without realizing they are being
manipulated.
The company targeted its illegal marketing of Seroquel towards doctors
who do not typically treat schizophrenia or bipolar disorder, such as
physicians who treat the elderly, primary care physicians, pediatric
and adolescent physicians, and in long-term care facilities and
prisons, according to the charges. Some doctors were paid cash, others
were sent to lavish resorts to encourage them to market and prescribe
the drugs for unapproved uses.
"It's an enormous problem and it's much more than a financial problem,"
Harvard's Abramson said. "The real issue is that doctors are being
manipulated in prescribing very potent medicines. ... The real issue is
the consequences to people's health."
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207642-Drug-Giant-AstraZeneca-to-Pay-520-Million-to-Settle-Fraud-Case
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