http://www.justice.gov/opa/pr/2011/May/11-civ-565.html
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Wednesday, May 4, 2011
Pharmaceutical Giant, Serono, Agrees to Pay $44.3 Million to Settle False Claims Act Case
WASHINGTON - P harmaceutical manufacturers Serono Laboratories Inc., EMD Serono Inc., Merck Serono S.A, and Ares Trading S.A. have agreed to pay $44.3 million to resolve False Claims Act allegations in connection with the marketing of the drug Rebif, the Justice Department announced.
The settlement resolves allegations that Serono paid health care providers from the launch of Rebif in about January 2002 through December 2009, to induce them to promote or prescribe Rebif, a recombinant interferon injectable that is used to treat relapsing forms of multiple sclerosis. Serono is alleged to have made payments to providers for hundreds of speaker training meetings and programs, as well as payments for attending consultant, marketing and advisory board meetings, all at upscale resorts and other locations. Serono’s actions allegedly resulted in the submission of false claims to federal health care programs including Medicare and Medicaid for the payment of Rebif, i.e., claims that were tainted by kickbacks.
“It’s imperative that medical determinations are guided by a patient's needs, not tainted by illegal incentives or fraud,” said Tony West, Assistant Attorney General of the Civil Division. “We are committed to ensuring that the chronically ill and other vulnerable members in our communities who rely on Medicare and Medicaid programs receive the best possible care.”
“Health care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “All consumers have the right to know that their health care provider’s judgment about medications they should take has not been undermined by kickbacks from pharmaceutical manufacturers.”
“In settling this second case with Serono, the Office of the Inspector General extended Serono’s existing corporate integrity agreement by three years, and required enhanced provisions such as specifically requiring that company directors and senior executives take responsibility for ensuring and monitoring compliance with federal law,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS-OIG). “If we can alter the cost-benefit calculus of some directors and executives, OIG can influence corporate behavior without putting access to government health care benefits at risk.”
Under the agreement announced today, the proceeds from the settlement will be split between the federal government and various states, with the United States receiving $34.6 million to resolve the federal claims and the states receiving $9.7 million to settle their respective claims under Medicaid.
The settlement is part of the government's emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT), which was announced by Attorney General Eric Holder and HHS Secretary Kathleen Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $5.7 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $7.3 billion.
The settlement was the result of an investigation by the U.S. Attorney’s Office for the District of Maryland with assistance from HHS-OIG; the Department of Defense Criminal Investigative Service; and the Civil Division of the U.S. Department of Justice.
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I FIND IT EVEN MORE INTERESTING THE NUMBER OF CANADIAN NEUROLOGISTS WHO WORK AS CONSULTANTS FOR THIS COMPANY. I WONDER HOW MANY KICK-BACKS THEY RECEIVE FROM THIS GIANT !
https://www.facebook.com/topic.php?uid=110317832313822&topic=586
WILL ANGIOPLASTY FOR M.S. PATIENTS EVER GET A FAIR TRIAL ?
How can we trust the M.S. Society of Canada or their researchers to promote or investigate CCSVI if almost all of the major players have contracts with numerous pharmaceutical companies ?
Below is a list of the professional disclosures from the ECTRIMS conference in Sweden in October of 2010. I`ve shortlisted the number of neurologists involved to those who currently serve on a committee with the MS Society of Canada, the committee of experts appointed by the Canadian Institutes of Health Research or who are participating either as lead investigator or secondary investigator in one of the CCSVI studies funded by the MS Society of Canada.
CANADIAN MS NEUROLOGISTS DOING RESEARCH AND PRESENTING AT THE ECTRIMS CONFERENCE IN SWEDEN
LIST OF DISCLOSURES FROM THE ABSTRACTS OF THE ETRTIMS CONFERENCE
ALL PAGE REFERENCES ARE TO THE FOLLOWING DOCUMENT
http://msj.sagepub.com/content/16/10_suppl/S7.citation
.......................................................................................................
2. DR. ANTHONY FEINSTEIN, Member of the Canadian MS Society Medical Advisory Board and the Clinical and Population Health Research Grants Review Committee
PAGE S11
Disclosure: Dr. Feinstein has received honoraria from Merck Serono, Bayer
HealthCare Pharmaceuticals and Teva Neuroscience.
.......................................................................................................
3. DR. MARK S. FREEDMAN,Member of the Canadian MS Society Medical Advisory Board, Participant Researcher of one of the studies funded by the MS Society of Canada in the $ 2.4 million.
PAGE S23
Disclosure: Dr Freedman has received grant support from Genzyme, and has acted
as an advisor/consultant/steering committee member or speaker for
Bayer, Biogen Idec, Teva, Merck Serono, Novartis and sanofi-aventis.
PAGE S119
Disclosure: M Freedman has received personal compensation for serving as a con-
sultant for BioMS, Bayer, Novartis, Merck Serono and has received
honoraria from Bayer, Pfizer, EMDSerono, Teva, Biogen Idec, and
Genentech.
PAGE S280
Disclosure: M Freedman has received personal compensation for serving as a con-
sultant for BioMS, Bayer, Novartis, Merck Serono and has received
honoraria from Bayer, Pfizer, EMDSerono, Teva, Biogen Idec, and
Genentech.
PAGE S291
Disclosure: Mark Freedman has received research support from Genzyme and has
acted as advisor/consultant/steering committee member or speaker
for Bayer, Biogen Idec, Teva, Merck Serono, Novartis, sanofi-aventis
Hadj Benzerdjeb is an employee of sanofi-aventis.
PAGE S348
Disclosure: Dr Freedman has received grant support from Genzyme, and has acted
as an advisor/consultant/steering committee member or speaker for
Bayer, Biogen Idec, Teva, Merck Serono, Novartis and sanofi-aventis.
......................................................................................................
4. DR. LUANE METZ, Member of the Multiple Sclerosis Society of Canada Medical Advisory Board and the Clinical and Population Health Research Grants Review Committee
PAGE: S152
Disclosure: Dr. Metz has nothing to disclose with respect to this trial, but has
received research funding from the MS Society of Canada,
Neuroscience Canada, and the Network of Centres for Excellence
(the Stem Cell Network) and from several philanthropists through
the Hotchkiss Brain Institute, and has consulted to Teva
Neuroscience, Biogen-Idec, EMD-Serono, Novartis, and Bayer.
PAGE : S242
Disclosure: O. Cedile, M. Løbne, H. Toft-Hansen and T. Owens have nothing to
disclose.
......................................................................................................
6. DR. PAUL O’CONNOR, Member of the Canadian MS Medical Advisory Board, Member of the Canadian MS Society Biomedical Research Grants Review Committee, and Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada
PAGE: S23
Disclosure: Paul O’Connor has received consulting fees and/or research support
for MS trials from Actelion, Bayer, Biogen Idec, BioMS, Cognosci,
Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche,
sanofi-aventis, Teva and Warburg Pincus.
PAGE: S34
Disclosure: Dr O’Connor has received support in the form of consultation fees or
study grant support from the following companies: Bayer, Biogen
Idec, EMD Serono, Novartis, Sanofi Aventis, Actelion, Eli Lilly,
Genentech, Roche, and Warburg Pincus.
PAGE: S120
P O’Connor has received personal compensation for consulting from
Biogen Idec, Bayer, Genentech, Roche, Teva, sanofi avventis, and
Novartis. He has received grant support from Bayer, Genentech,
sanofi aventis, BioMS, and Novartis.
PAGE: S142
Paul O’Connor has received consulting fees and/or research support
for MS trials from Actelion, Bayer, Biogen Idec, BioMS, Cognosci,
Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche,
sanofi-aventis, Teva and Warburg Pincus.
PAGE: S143
Disclosure: P O’Connor has received consulting fees from Biogen Idec, Sanofi-
Aventis, Novartis, EMD Serono, Bayer, Teva Neuroscience and
Genentech.
PAGE: S147
Disclosure: Paul O’Connor Consulting fees from Biogen Idec, Sanofi Aventis,
Novartis, EMD Serono, Bayer, Teva Neuroscience, Genentech
PAGE: S159
Disclosure: P O’Connor has received compensation for consulting from Biogen
Idec, Bayer, Genentech, Roche, Teva, sanofi-aventis, Novartis; and
grant support from Bayer, Genentech, sanofi-aventis, BioMS, and
Novartis.
PAGE: S170
Disclosure: P O’Connor has received consultancy and research grant support from
Bayer, Biogen-Idec, EMD Serono, Teva, Genentech, Roche, Sanofi-
Aventis and Novartis.
PAGE: S290
Disclosure: Paul O’Connor Consulting fees from Biogen Idec, Sanofi Aventis,
Novartis, EMD Serono, Bayer, Teva Neuroscience, Genentech
PAGE: S291
Disclosure: Paul O’Connor has received consulting fees and/or research support
for MS trials from Actelion, Bayer, Biogen Idec, BioMS, Cognosci,
Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche,
sanofi-aventis, Teva and Warburg Pincus.
PAGE: S295
Disclosure: Paul O’Connor Consulting fees from Biogen Idec, Sanofi Aventis,
Novartis, EMD Serono, Bayer, Teva Neuroscience, Genentech
PAGE: S348
Disclosure: Paul O’Connor has received consulting fees and/or research support
for MS trials from Actelion, Bayer, Biogen Idec, BioMS, Cognosci,
Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche,
sanofi-aventis, Teva and Warburg Pincus.
......................................................................................................
7. DR. JODIE BURTON, Member of the Biomedical Research Grants Review Committee, MS Society of Canada
PAGE: S152
Disclosure: Dr. Burton has nothing to disclose with respect to this trial, but has
but has received research support from Direct-MS, unrestricted travel
and educational support from TEVA Neuroscience Canada, Biogen
Idec Canada and EMD Serono and has served on advisory boards for
Biogen Idec Canada.
.....................................................................................................
9. DR. ANTHONY TRABOULSEE, Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada, , Recipient and Principal Researcher of one of the studies funded by the MS Society of Canada in the $ 2.4 million.
PAGE: S111
Disclosure: Anthony Traboulsee received honoraria for data safety monitoring
committee participation from Merck Serono and Daiichi, honoraria
for lectures from Bayer, Merck Serono, Teva Neurosciences and
receives research support from the Canadian Institutes for Health
Research and the Multiple Sclerosis Society of Canada.
PAGE: S142
Disclosure: Anthony Traboulsee has received personal compensation from: Merck
Serono for data safety monitoring board (DSMB) membership and for co-chairing a symposium; Bayer Health Care for speaking; TevaNeurosciences for chairing a symposium; Neura as a member of an editorial advisory board; Daiichi for DSMB membership.
PAGE: S261
Disclosure: Anthony Traboulsee received honoraria for data safety monitoring
committee participation from Merck Serono and Daiichi, honoraria
for lectures from Bayer, Merck Serono, Teva Neurosciences and
receives research support from the Canadian Institutes for Health
Research and the Multiple Sclerosis Society of Canada.
.........................................................................................................
10. DR. AARON MILLER, Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada
PAGE: S23
Disclosure: Dr Miller has received research support from Acorda Therapeutics,
BiogenIdec, Genentech, Genzyme, Sanofi-aventis, and Teva
Neuroscience; has served as a consultant to Acorda Therapeutics,
BiogenIdec, BioMarin, Daiichi-Sankyo, EMD Serono, Glaxo Smith
Kline, Merck Serono, Novartis, ONO, and Teva Neuroscience; and
on the speakers bureau for Acorda Therapeutics, Biogen Idec, EMD
Serono, Pfizer, and Teva Neuroscience.
PAGE: S348
Disclosure: Dr Miller has received research support from Acorda Therapeutics,
BiogenIdec, Genentech, Genzyme, Sanofi-aventis, and Teva
Neuroscience; has served as a consultant to Acorda Therapeutics,
BiogenIdec, BioMarin, Daiichi-Sankyo, EMD Serono, Glaxo Smith
Kline, Merck Serono, Novartis, ONO, and Teva Neuroscience; and
on the speakers bureau for Acorda Therapeutics, Biogen Idec, EMD
Serono, Pfizer, and Teva Neuroscience.
.....................................................................................................
12. DR. BRENDA BANWELL, Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada, Recipient and Principal Researcher of one of the studies funded by the MS Society of Canada in the $ 2.4 million.
PAGE: S19
Disclosure: B Banwell has received speaker’s honoraria from Merk-Serono, Teva
Neuroscience, and Biogen-IDEC.
PAGE: S58
Disclosure: Dr. B. Banwell has received speaker’s honoraria from Merk-Serono,
Teva Neuroscience, and Biogen-IDEC. Dr. B Banwell serves as an
Editor for Multiple Sclerosis, for which she received no remuneration.
PAGE: S201
Disclosure: B Banwell has received speaker’s honoraria from Merk-Serono, Teva
Neuroscience, and Biogen-IDEC. Dr. B Banwell serves as an Editor for
Multiple Sclerosis, for which she received no remuneration.
PAGE: S216
Disclosure: Dr. B. Banwell has received speaker’s honoraria from Merk-Serono,
Teva Neuroscience, and Biogen-IDEC. Dr. B Banwell serves as an
Editor for Multiple Sclerosis, for which she received no remuneration.
........................................................................................................
13. DR. JERRY WOLINSKY, Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada
PAGE: S23
Disclosure: Over the last 12 months, Dr. Wolinsky has served on advisory boards
or data monitoring committees, has consulting agreements, or
received speaker honoraria from Acorda Therapeutics, Bayer
HealthCare, Consortium of MS Clinics, Eli Lilly, EMD Serono, Facet
Biotech, Johns Hopkins University, Medscape CME, Novartis,
Peptimmune, sanofi-aventis, Serono Symposia International
Foundation, Teva and Teva Neurosciences, the National Multiple
Sclerosis Society, Northwestern University, the University of Buffalo,
the University of South Florida Professionals Conferencing and UCB;
royalties for outlicensed monoclonal antibodies through the UTHSCH
to Millipore (Chemicon International) Corporation since 1993; and
receives research or contractual support from the Clayton Foundation
for Research, the NIH [2 U01 NS045719-06 (PI of the subcontract to
UTHSCH for image analysis), 2RO1-EB002095-06A1 (Co-I)], and
sanofi-aventis; he was compensated for his efforts as an Associate
Editor for ACP Medicine, BC Decker.
PAGE: S159
Disclosure: J Wolinsky has received compensation from Antisense Therapeutics,
Ltd., Genentech, Inc., EMD Serono, Novartis, sanofi-aventis, Teva
Pharmaceuticals, Teva Neurosciences, and UCB for consulting ser-
vices. Dr. Wolinsky has received compensation from BCDecker for
serving as an Associate Editor of ACP Medicine. He has also received
royalty payments from Chemicon for licensed technology and finan-
cial support for research activities from sanofi-aventis and the
National Institutes of Health.
PAGE: S306
Disclosure: .Wolinsky has received compensation from Novartis as an advisor.
........................................................................................................
14. DR. RUTH ANN MARIE, Member of the Expert Committee to the Canadian Institute of Health Research that refused to fund clinical trials in Canada, Participant Researcher of one of the studies funded by the MS Society of Canada in the $ 2.4 million.
PAGE: S334
Disclosure: Ruth Ann Marrie has consulted for Berlex, BioMS, EMD Serono and
Sanofi Aventis.
PAGE: S335
Disclosure: Ruth Ann Marrie has consulted for Berlex, BioMS, EMD Serono and
Sanofi Aventis.
.........................................................................................................
15. DR. AMIT BAR OR, Participant Researcher of one of the studies funded by the MS Society of Canada in the $ 2.4 million.
PAGE: S291
Disclosure: Amit Bar-Or has received research support from Biogen-Idec,
Genentech and Teva Neuroscience, and received fees for consulting,
serving on scientific advisory boards and/or speaking activities from
Bayer, Bayhill Therapeutics, Berlex, Biogen-Idec, BioMS, Diogenix, Eli-
Lilly, Genentech, GSK, Guthy-Jackson/GGF, Merck-Serono, Novartis,
Ono Pharmacia, Roche, sanofi-aventis, Teva Neuroscience andWyeth.