In December, Grassley wrote to Wyeth and DesignWrite, a medical education and communications company, regarding allegations that Wyeth hired DesignWrite to draft articles promoting the company’s hormone therapy products and seek academic investigators to sign on as the primary authors. Previously, Grassley had written to Merck and Scientific Therapeutics Information, a medical publishing company, regarding similar allegations reported in the Journal of the American Medical Association related to articles on Merck’s VIOXX studies.

He sent the letter on July 1 to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, The Journal of the American Medical Association and The New England Journal of Medicine. Grassley asked for the editors’ written responses by July 22, 2009.

For the full press release, go to: http://finance.senate.gov/press/Gpress/2009/prg070209.pdf.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

on the  $1.1billion included in the recovery Act for comparative effectiveness research.  The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given condition.

Not only will these  findings enhance medical decision-making by patients and their physicians,  they will likely  close the door a little bit more to the success of off-label marketing of pharmaceuticals for indications that have little to no science to back up the claims of efficacy. Physicians will hopefully have a readily available source from which to compare treatments and drugs.

The 10th largest pharmaceutical company in the world, Eli Lilly & Co. admitted to off-label use of Zyprexa; specifically, the organization promoted the drug for dementia in elderly populations, a usage that was not approved by the Food and Drug Administration. Additionally, Lilly trained its sales force to disregard the law by promoting Zyprexa for off-label uses. Thus over a period of two years (September 1999-March 2001), Lilly earned “hundreds of millions of dollars” through consistent criminal violations of the Food, Drug, and Cosmetic Act.

Of the civil settlement, $438 million will go to the federal government and up to $362 million will be allocated to states included in the settlement.  As a component of its restitution, Lilly will undergo five years of U.S. monitoring against future lawbreaking.  Independent from the current settlement, the company also faces lawsuits across twelve states for improper and off-label drug marketing.

This monumental case was initiated by Lilly sales representatives who in 2003 filed complaints against Lilly under the terms of the federal False Claims Act.  For their actions, the whistleblowers will receive over $78 million— or 18 percent of the settlement— in addition to possible shares of state settlements.

To learn more go here. or if you have information about Pharmaceutical Fraud contact Nolan & Auerbach P.A.

The government’s investigation of the pharmaceutical fraud began as the result of a whistleblower lawsuit under the False Claims Act by a former sales representative for Orphan. Orphan engaged in a scheme to expand the market for Xyrum by marketing and promoting the drug to physicians for “off-label” use which included using a psychiatrist in promotional speaking engagements. The psychiatrist with the approval of Orphan sales personnel also showed physicians how to obtain reimbursement from Medicare and Medicaid for these unapproved uses. The criminal prosecution arose out of a criminal misbranding scheme by which physicians would write presciptions for Xyrum that were not reimburseable for Medicare and Medicaid.

“Pharmaceuticals manufactured under strict standards can still injure or kill if used for unapproved purposes. Here, the risk was not from willful abuse by users; it was from a concerted campaign by the manufacturer to push a drug for off-label uses. This posed a serious health risk and constitutes a serious crime,” said FBI Assistant Director-in-Charge, New York Field Office, Mark J. Mershon.
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