[PAA-Discuss] Fwd: Sharav - Big Pharma's Crime Spree

Wed Feb 3 16:04:18 EST 2010

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From: Vince Boehm <vince_19805 at yahoo.com>
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Sent: Wed, Feb 3, 2010 2:49 pm
Subject: Sharav - Big Pharma's Crime Spree

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                  Vera Sharav

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http://www.ahrp.org

FYI

In December, 2009, Bloomberg News published an investigative report by
David Evans reported, "Big Pharma's Crime Spree" documenting major court
settlements:
"Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug
companies have paid a total of $7 billion in fines and penalties. Six 
of the
companies admitted in court that they marketed medicines for unapproved
uses."
See: 
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10
and http://www.ahrp.org/cms/content/view/653/109/

Indeed, it is estimated that 15% of drug sales in the U.S. are for
unapproved uses "without adequate evidence the medicines work."

Below, The Wall Street Journal brings the criminal rap sheets of
pharmaceutical industry giants up to date: Novartis, Astra Zeneca, 
Johnson &
Johnson.

Several points need to be borne in mind:
1. The prescription drug industry has descended into criminal marketing 
that
includes fraud, evidence falsification, bribery and kickbacks--all to 
expand
the market.

2. The drugs involved in criminal marketing are hazardous toxic drugs 
whose
severe adverse effects--including drug-induced life-shortening chronic
disease--far outweigh any trivial short-term clinical benefit. Had the
evidence of the magnitude of harm been fully disclosed, these drugs 
would
not have been approved in the first place.

3. Unless and until company CEO's and the prominent bought and paid for
physicians involved in the criminal promotion of harmful drugs are 
tried and
imprisoned for these crimes, companies will escalate the scope of 
criminal
drug promotion because the financial incentives are so large and the
penalties are a pittance by comparison.

As Shelley Slade, a former Justice Department lawyer who now represents
corporate whistleblowers through the firm Vogel, Slade & Goldstein LLP, 
in
Washington, D.C. said: large criminal monetary penalties and civil
settlements don't appear to deter companies sufficiently. "It's not 
going to
stop until the government puts some of these executives in jail," she 
said.
"Many of these companies view the fines as a small fraction of what they
have gained through illegal schemes, and just a cost of doing business."

Contact: Vera Hassner Sharav
veracare at ahrp.org
212-595-8974

http://online.wsj.com/article/SB10001424052748704194504575031122614926414.html
THE WALL STREET JOURNAL
Drug Marketing Remains an Issue
By JEANNE WHALEN

Novartis AG's agreement to settle criminal allegations involving 
marketing
of an epilepsy drug is the latest in a string of cases showing that 
improper
marketing practices are still a problem years after the U.S. government
started cracking down on them.

Pfizer Inc. and Eli Lilly & Co. paid big fines and pleaded guilty to 
illegal
marketing of their drugs over the past year, while AstraZeneca PLC in
September reached a preliminary deal to pay $520 million to settle a 
federal
investigation into its marketing. It declined to say whether it would 
admit
wrongdoing in the final settlement.

This month, the Justice Department charged Johnson & Johnson with paying
"tens of millions of dollars in kickbacks" to a nursing-home pharmacy
company to boost sales of J&J drugs. J&J said its conduct was "lawful 
and
appropriate."

Novartis this week said its U.S. subsidiary struck an agreement with the
U.S. Attorney's Office in Pennsylvania to settle a criminal 
investigation of
the company's marketing of the epilepsy drug Trileptal. Novartis agreed 
to
plead guilty to violating the U.S. Food, Drug and Cosmetic Act, and to 
pay a
$185 million fine. Novartis had already disclosed that the U.S. 
Attorney's
Office was investigating allegations that Novartis promoted the drug
off-label, and scrutinizing "payments made to health-care providers in
connection with this medicine." The settlement agreement is "contingent 
on
court approval," Novartis said.

It added that it is still negotiating with the investigators "to resolve
civil claims relating to Trileptal," and said it has set aside $397 
million
in provisions in connection with the Trileptal investigations. The same
investigators are also probing "potential off-label marketing" and 
payments
to health-care providers involving five other Novartis drugs, the 
company
said: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. A Novartis
spokeswoman declined to comment further. A spokeswoman for the U.S.
Attorney's Office in Pennsylvania said she couldn't comment on any
investigations.

The U.S. government has been pursuing alleged wrongdoing in drug 
marketing
for well over a decade, attempting to punish the worst offenders in an
industry that racks up sales of more than $300 billion a year in the 
U.S.
But the recent stream of high-profile cases shows that sales tactics are
still an area of concern.

"Combating health care fraud is a top priority of the Department of
Justice," said Tony West, Assistant Attorney General of the Justice
Department's Civil Division. "When it comes to marketing drugs that so 
many
of us rely on, the government expects pharmaceutical companies to be 
honest
in the claims they make about the drugs they sell."

Improper marketing often occurs when drug companies are promoting 
therapies
that are similar to others on the market, says Patrick Burns, director 
of
communications at Taxpayers Against Fraud, a watchdog group in 
Washington,
D.C. "In that kind of marketplace, the business isn't about the drug. 
It's
about the kickback and it's about market expansion through illegal
promotion," he said.

One of the most common illegal tactics companies use is "off-label"
marketing, when sales reps encourage doctors to prescribe drugs for 
uses for
which they aren't approved by the Food and Drug Administration. Doctors
themselves are allowed to prescribe drugs any way they see fit, but the 
law
says companies can't promote them for unapproved uses.

The government has also accused companies of making payments to doctors 
to
get them to prescribe certain drugs, both on and off-label. These 
payments
can take several forms that are often legitimate, including consulting 
fees
and research grants. Corporate whistleblowers often draw the 
government's
attention to alleged wrongdoing, sparking federal investigations.

The industry's main trade group in the U.S.-the Pharmaceutical Research 
and
Manufacturers of America, or PhRMA-says it is important for drug 
companies
to be able to compensate doctors for legitimate advice and research that
supports drug development and medical practice. The group's code of 
conduct
says companies "should continue to ensure" that these payments "are 
neither
inducements nor rewards for prescribing or recommending a particular
medicine or course of treatment." A PhRMA spokeswoman said she couldn't
comment on specific investigations facing certain companies. Some drug
companies have taken steps to make their relationships with doctors more
transparent. GlaxoSmithKline PLC, for example, recently began capping 
its
annual payments to U.S. doctors at $150,000 and publishing the figures.

Glaxo had previously disclosed that federal investigators were probing 
its
marketing of nine drugs between 1997 and 2004, including scrutinizing 
its
financial relationships with health-care providers.

In a recent interview, David Brennan, chief executive of AstraZeneca, 
said
government fines have made drug companies "more sensitive than we've 
ever
been" about preventing illegal promotion of drugs.

But Shelley Slade, a former Justice Department lawyer who now represents
corporate whistleblowers through the firm Vogel, Slade & Goldstein LLP, 
in
Washington, D.C., said large criminal monetary penalties and civil
settlements don't appear to deter companies sufficiently. "It's not 
going to
stop until the government puts some of these executives in jail," she 
said.
"Many of these companies view the fines as a small fraction of what they
have gained through illegal schemes, and just a cost of doing business."

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