USDOJ- News; False Claims Act Case- Look Closely (090226)
Mort Zuckerman
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Subject: USDOJ False Claims Act Case- Look Closely
Date: Feb 26, 2009 9:14 AM
USDOJ NEWSRELEASE, BELOW
===============================================
http://www.fda.gov/ohrms/dockets/ac/01/slides/3680s2_11.pdf
http://www.actionlyme.org/USDOJ_COMPLAINT_RICO.htm
The diagnostic standard for "Lyme Disease" is fraudulent
and was changed in 1994 at a fake conference in Dearborn
Michigan. The older standard was to perceive Lyme as
a Relapsing Fever organism:
http://www.actionlyme.org/CDC_DOCUMENTS_1990.htm
http://www.actionlyme.org/Dattwyler_Luft_Bb_DNA_in_CSF.htm
http://www.actionlyme.org/CRYMEDISEASE_CHP3_B.htm
It was all about the false claim that Lyme
was "only an inflammatory disease with high
antibodies," but the ALDF/Yale/NYMC/ and now
IDSA crooks all certainly knew differently.
Here is Ray Dattwyler saying that the sickest
patients are "seronegative":
http://www.actionlyme.org/index.1455.jpg
I realize that no one wants me to be the
whistleblower because I'm female and not an
MD and I am not Pam Weintraub- a science
WRITER. It's all too much for the USDOJ and
the US Medical Community to admit I am the
whistleblower for "Lyme Disease."
It's not something they can handle, emotionally.
They, the *entire* AMA and USDOJ don't have the
personal integrity to admit they were wrong and
worse, that I was right. It's about their
lack of courage.
Kathleen M. Dickson
---------------------------------------------------------------------------------
http://www.usdoj.gov/opa/pr/2009/February/09-civ-163.html
Department of Justice SealDepartment of Justice
FOR IMMEDIATE RELEASE
Wednesday, February 25, 2009
WWW.USDOJ.GOV
CIV
(202) 514-2007
TDD (202) 514-1888
United States Files Complaint Against Forest Laboratories for
Allegedly Violating the False Claims Act
Pharmaceutical Company Allegedly Marketed Drugs for Unapproved
Pediatric Use and Paid Kickbacks
WASHINGTON – A Complaint was unsealed today in U.S. District Court in
Massachusetts against a New York pharmaceutical company for alleged
False Claims Act violations arising from the company’s marketing the
drugs Celexa and Lexapro for unapproved pediatric use and for paying
kickbacks to induce physicians to prescribe the drugs.
Acting Assistant Attorney General Michael F. Hertz; United States
Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in
Charge of the Federal Bureau of Investigation - Boston Field Division;
Susan J. Waddell, Special Agent in Charge of Health and Human Services
- Office of Inspector General, Office of Investigations; Mark
Dragonetti, Resident Agent in Charge of the Food and Drug
Administration, Office of Investigations - Office of Inspector
General; and Jeffrey Hughes, Special Agent in Charge of the Northeast
Field Office of the Veterans Affairs Office of the Inspector General,
announced that the civil Complaint against Forest Laboratories Inc.,
of New York, New York, alleged that the company’s illegal promotional
practices surrounding its antidepressant drugs Celexa and Lexapro
caused thousands of false and fraudulent claims to be submitted to
federal health care programs.
The Complaint alleges that a double-blind, placebo-controlled,
pediatric trial found Celexa no more effective than the placebo for
pediatric use and that, in the study, more patients taking Celexa
attempted suicide or reported suicidal thoughts than those in the
group taking the placebo. The negative efficacy data led the FDA to
deny Forest’s request to approve Celexa for pediatric use. It is
further alleged that, despite the FDA’s denial of a pediatric
indication, Forest actively promoted pediatric use of the drugs and
misled physicians and the public by failing to disclose the results of
the negative study. The same study was among those later considered by
the FDA when it mandated that Forest add a "black box" warning to both
the Celexa and Lexapro labels.
The Complaint alleges that Forest sought to induce physicians and
others to prescribe Celexa and Lexapro by providing them with various
forms of illegal remuneration, including cash payments disguised as
grants or consulting fees, expensive meals and lavish entertainment
and other valuable goods and services, all in violation of the federal
anti-kickback statute.
Neither Medicaid nor TRICARE ordinarily cover drugs for off-label uses
unless the off-label use is for a medically accepted indication. The
United States alleges that federal health care programs have paid
thousands of false and fraudulent claims for Celexa and Lexapro
prescriptions that were not covered for off-label pediatric use and/or
were ineligible for payment as a result of illegal kickbacks paid by
Forest.
Prior to filing its Complaint, the government had intervened in two
separate whistleblower actions against Forest that had been commenced
under the qui tam provisions of the False Claims Act. The False Claims
Act allows for private persons to file whistleblower suits to provide
the government information about wrongdoing. Under the statute, if it
is established that a person has submitted or caused others to submit
false or fraudulent claims to the United States, the government can
recover treble damages and $5,500 to $11,000 for each false or
fraudulent claim filed. If the Government is successful in resolving
or litigating its claims, a proper whistleblower can receive a share
of between 15 percent and 25 percent of the amount recovered.
This investigation was conducted by the U.S. Attorney’s Office for the
District of Massachusetts, the Civil Division of the U.S. Department
of Justice, the Federal Bureau of Investigation, the Office of
Inspector General of the Department of Health and Human Services, the
Office of Criminal Investigations of the Food and Drug Administration
and the Office of Inspector General of the Department of Veteran’s
Affairs.
###
"[Real] scientists are *fiercely* independent. That's the good
news."-- NIH's Top Fool, Anthony Fauci