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Maryland follows New Jersey in Seprafilm Suit
AG Gansler: Genzyme Corp. Pays $22.28 Million for Fraudulent Marketing of ' Slurry' Improperly Used in Surgery Maryland Medicaid to receive $85,000 from Seprafilm allegations
AG Gansler: Genzyme Corp. Pays 22.28 Million for Fraudulent Marketing of ' Slurry' Improperly Used in Surgery Maryland Medicaid to receive 85,000 from Seprafilm allegations
Mar 10, 2014 (Menafn - M2 PRESSWIRE via COMTEX) --Attorney General Douglas F. Gansler announced today that Maryland, joined by other states and the federal government, has secured a settlement resolving allegations that Genzyme Corporation triggered false claims to be submitted to federal and state health care programs for unapproved use of a "slurry" version of its Seprafilm adhesion barrier. Genzyme will pay 22.28 million under the settlement. Maryland Medicaid will receive 84,627.69, to be shared with the federal government, which provides funding for the program.
"Cutting corners shows little concern for the wellbeing of the people who used this product and for the general public whose tax dollars support the Medicaid program," said Attorney General Gansler. "The profit from the fraudulent sales of this product will be forfeited and returned to its intended use."
Seprafilm is intended to reduce post-surgical adhesions by forming a bio-resorbable (broken down and assimilated back into the body) barrier between abdominal tissue and organs. This Food and Drug Administration (FDA)-approved product is for use in open abdominal surgery, but not for minimally invasive procedures such as laparoscopic surgery.
The settlement resolves allegations that Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as "slurry." Genzyme sales representatives traded recipes for slurry and trained each other how to produce it. The slurry was used in laparoscopic surgeries by inserting a catheter filled with the mixture into the body and applying it into the abdominal cavity. As a result of this conduct, Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to federal health care programs for uses that were not FDA-approved and therefore, not reimbursable.
Genzyme is a biotechnology corporation based in Cambridge, Mass., and was acquired by Sanofi-Aventis SA in April 2011.
Attorney General Gansler thanked Medicaid Fraud Control Unit Deputy Director Shelly Marie Martin for her work on this case. A National Association of Medicaid Fraud Control Units (NAMFCU) team participated in the investigation and conducted settlement negotiations with Genzyme.
Attorney General of Maryland 1 (888) 743-0023 toll-free / TDD: (410) 576-6372
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CollaGUARD adhesion barrier now in distributed in UK and Germany
01 Feb, 2012
ASHBURN, VA., February 1, 2012 /PRNewswire/ –– Innocoll Inc. announced it has entered into a License and Distribution Agreement with Flynn Pharma Ltd. in the United Kingdom and with Inresa Arzneimittel GmbH in Germany for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Breaking News Seprafilm Genzyme
Attorney General J.B. Van Hollen Announces Settlement with Genzyme Corporation to Resolve Allegations of Off-Label Marketing
March 07, 2014
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Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government to settle allegations thatGenzyme Corp. (Genzyme ) marketed and caused false claims to be submitted to federal and state health care programs for use of a "slurry" version of its Seprafilm adhesion barrier. Seprafilm is a thin film intended to reduce adhesions after surgery by forming a bio-resorbable barrier between abdominal tissue and organs. Genzyme is a biotechnology corporation based in Cambridge, Mass. , and was acquired by Sanofi-Aventis SA in April 2011 . As part of the settlement, Wisconsin Medicaid will receive $44,698.27 in restitution and other recoveries. Medicaid is a health insurance program for the needy and disabled jointly funded by the state and federal governments. The agreement resolves allegations that Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as "slurry." Genzyme sales representatives traded recipes for slurry, and trained each other in how to create it. The slurry was used in laparoscopic surgeries by inserting a catheter filled with the mixture into the body and applying it into the abdominal cavity. Seprafilm isFDA -approved for use in open abdominal surgery but not for minimally invasive surgeries, such as laparoscopic surgery. Allegedly, as a result of this conduct,Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to health care programs for uses that were not reimbursable.
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Should women with chronic pelvic pain have adhesiolysis?
Pelvic adhesions are found in up to 50% of women with CPP during investigative surgeries and adhesiolysis is often performed as part of their management although the causal or casual association of adhesions, and the clinical benefit of adhesiolysis in the context of CPP is still unclear. Our aim was to test the hypothesis of whether laparoscopic adhesiolysis leads to significant pain relief and improvement in quality of life (QoL) in patients with chronic pelvic pain (CPP) and adhesions.
Methods: This was a double-blinded RCT.
This study was conducted in 2 tertiary referral hospitals in United Kingdom over 4 years. Women with chronic pelvic pain (CPP) were randomized into having laparoscopic adhesiolysis or diagnostic laparoscopy.
Women were assessed at 0, 3 and 6 months for Visual analogue scale scores (VAS) and Quality of Life (QoL) measures (SF-12 and EHP-30).
Results: A total of 92 participants were recruited; 50 qualified to be randomized, with 26 in the adhesiolysis and 24 in the control group. The results are expressed in median (interquartile ranges).
In women who underwent adhesiolysis, there was a significant improvement at 6 months in VAS scores (-17.5 (-36.0 - -5.0) compared to controls (-1.5 (-15.0 - 4.5; p = 0.048); SF-12 scores physical component score (25.0 (18.8 - 43.8)) compared to controls (6.3 (-6.3 - 18.8); p = 0.021), SF-12 emotional component score 32.5 (4.4 - 48.8) compared to controls -5 (-21.3 - 15.0); p <0 -5="" -="" .0074="" 15.0="" 32.5="" 48.8="" and="" being="" compared="" controls="" domain="" ehp-30="" emotional="" nbsp="" p="" span="" the="" to="" well="">
Conclusions: This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding. In selected population of women presenting to the gynecological clinic with chronic pelvic pain, adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life.Trial registration number: ISRCTN 43852269 http://www.controlled-trials.com/isrctn/pf/43852269
Author: Ying C CheongIsobel ReadingSarah BaileyKhaled SadekWilliam LedgerTin C Li
Credits/Source: BMC Women's Health 2014, 14:36
http://7thspace.com/headlines/453858/should_women_with_chronic_pelvic_pain_have_adhesiolysis.html
Methods: This was a double-blinded RCT.
This study was conducted in 2 tertiary referral hospitals in United Kingdom over 4 years. Women with chronic pelvic pain (CPP) were randomized into having laparoscopic adhesiolysis or diagnostic laparoscopy.
Women were assessed at 0, 3 and 6 months for Visual analogue scale scores (VAS) and Quality of Life (QoL) measures (SF-12 and EHP-30).
Results: A total of 92 participants were recruited; 50 qualified to be randomized, with 26 in the adhesiolysis and 24 in the control group. The results are expressed in median (interquartile ranges).
In women who underwent adhesiolysis, there was a significant improvement at 6 months in VAS scores (-17.5 (-36.0 - -5.0) compared to controls (-1.5 (-15.0 - 4.5; p = 0.048); SF-12 scores physical component score (25.0 (18.8 - 43.8)) compared to controls (6.3 (-6.3 - 18.8); p = 0.021), SF-12 emotional component score 32.5 (4.4 - 48.8) compared to controls -5 (-21.3 - 15.0); p <0 -5="" -="" .0074="" 15.0="" 32.5="" 48.8="" and="" being="" compared="" controls="" domain="" ehp-30="" emotional="" nbsp="" p="" span="" the="" to="" well="">
Conclusions: This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding. In selected population of women presenting to the gynecological clinic with chronic pelvic pain, adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life.Trial registration number: ISRCTN 43852269 http://www.controlled-trials.com/isrctn/pf/43852269
Author: Ying C CheongIsobel ReadingSarah BaileyKhaled SadekWilliam LedgerTin C Li
Credits/Source: BMC Women's Health 2014, 14:36
http://7thspace.com/headlines/453858/should_women_with_chronic_pelvic_pain_have_adhesiolysis.html
Men get adhesions
Do Men Get Adhesions?
David Wiseman PhD, MRPharmS, Founder, International Adhesions Society
It is a common myth that only women are prone to adhesions. While it is
certainly true that women have more “internal parts” that require surgery, which
inevitably leads to adhesions, men are not excluded from the problem of
adhesions.
A simple look at the national statistics collected from hospital discharges (ICD9
codes) from the most recent data available (2001-2005) reveals the following:
• Over 50,000 men were discharged from hospital in 2005 with a diagnosis
of peritoneal adhesions (568.0), accounting for 28% of such diagnoses,
compared with 72% for women.
• Over 37,000 men were discharged in 2005 with a diagnosis that included
the specific diagnosis of intestinal adhesions with (ie causing) bowel
obstruction (560.81). This number accounts for 38% of cases, compared
with 62% for women.
• Men also accounted for 37% of discharges with a principal diagnosis (as
opposed to an incidental diagnosis) was intestinal adhesions with
obstruction (560.81). Their length of stay was slightly higher than that of
women in 3 of the five years studied and their hospital charges exceeded
those of women in every year by as much as $2500.
• Over 2000 men and women died every year with a diagnosis of intestinal
adhesions with obstruction, representing about 3% of the total discharges
with that diagnosis. The contribution of males to this death rate was in
every year slightly higher than that of women in proportion to their
discharges, by 10-15% in the years 2002-2005, and about 2% in 2001.
Overall discharges for men and women have been climbing at the same rate over
the five year period studied.
More of this article http://www.adhesionrelateddisorder.com/DoMenGetAdhesions.pdf
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