Rituxan gained FDA approval in 1997, as a treatment for a certain type of non-Hodgkin's lymphoma. Roughly 12,760 patients in the US have the form of cancer Rituxan was approved to treat. Yet by 2005, sales of the drug grew to $1.8 billion in the US. A lawsuit filed by a former Rituxan salesman explains how this happened.
On January 11, 2006, Dow Jones reported that Paul McDermott, who worked for Genentech Inc, from March 2004 until April 2005, had filed a whistleblower lawsuit in July 2005, in the US District Court in Maine against Genentech, and its marketing partner, Biogen Idec, alleging the companies illegally promoted Rituxan as a treatment for rheumatoid arthritis (RA).
The allegations in the lawsuit's complaint describe a blatant kickback scheme aimed at defrauding government health care programs like Medicare and represent a powerful indictment of the pharmaceutical industry’s all too common systematic recruitment of doctors to promote the off-label use of drugs.
The lawsuit alleges Genentech and Biogen defrauded programs that spent money on Rituxan prescriptions for arthritis. Since most RA patients are senior citizens, Medicare was most often billed for payment.
For cancer, Rituxan costs about $20,000 for a six-treatment course. For rheumatoid arthritis, it costs about $9,088 for a six-to nine-month treatment, according to the March 3, 2006 Union-Tribune.
So legal problems aren't the only concerns surrounding off-label drug promotion. "When an expensive drug is used for off-label treatments – particularly when clinical data hasn't established that it works for that purpose," the Union reports, "it adds to the burden of a financially strapped health care system, some experts say."
By law, doctors can prescribe drugs for an unapproved use, but drug makers are not allowed to promote their products for those uses.
As a Genentech sales representative, Mr McDermott alleges he worked as a "professional educational liaison," a job that involved recruiting doctors to promote Rituxan as a treatment for rheumatoid arthritis.
He alleges sales representatives were sent to the offices of rheumatologists, even though Genentech had no products approved for such treatments.
The complaint alleges Genentech and Biogen used "sham" consulting agreements to pay rheumatologists identified as "key opinion leaders," who were expected to influence other doctors to prescribe Rituxan for arthritis.
According to the complaint, Genentech and Biogen would identify key opinion leaders among rheumatologists and signed them on as consultants.
Then drug company representatives would set up “rheumatoid arthritis roundtable dinners” at fancy steak houses in major cities and the key opinion leaders were flown in and paid between $2,000 to $2,500 to give a presentation on the off-label use of Rituxan.
The complaint says rheumatologists are used because, “materials promoting Rituxan for off-label treatment of rheumatoid arthritis are more fully accepted and integrated into physicians’ personal belief systems when they are presented as educational in nature in contrast to material that is clearly identified as promotional.”
The suit points out that some physicians refused to participate after learning they could not change the slides or materials prepared by company representatives.
As another promotional technique, the complaint alleges that Genentech identified key journals where articles should appear promoting the off-label use of Rituxan, and encouraged the consultants to write articles that would appear in those journals, and in some cases, wrote the articles for the consultants.
For obvious reasons, off-label drug use is potentially dangerous. According to George Zelcs, Paul McDermott's attorney, prescribing drugs for unapproved uses undermines the scientific process in place to determine whether drugs are safe and beneficial.
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