March 8, 2006 at 09:39:55

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Genentech and Biogen Legal Troubles - When It Rains It Pours

By Evelyn Pringle (about the author)     Page 2 of 4 page(s)

opednews.com     Permalink

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.

“The new drug industry model is peer-to-peer marketing, using medical professionals – the prescribing doctors – themselves,” Attorney Zelcs said in the March 3, 2006 Union-Tribune. “But once you start to influence that process with financial considerations, it starts to compromise what ought to be independent judgment.”

Mr McDermott is not the first person to call foul when it comes to Genentech's off-label promotion activities. The company has been called on the carpet several times under similar allegations. In 1999, Genentech settled with the FDA for $50 million over charges that it paid doctors to prescribe its human growth hormone, as well as other, “more aggressive activities,” according to Red Herring on October 5, 2004.

In October 2004, Genentech received a subpoena from the office of the US Attorney in Philadelphia requesting documents related to the off-label promotion of Rituxan in an investigation said to be both civil and criminal in nature.

As sales of the drug soared, simple arithmetic demonstrated that Rituxan was being prescribed for nonapproved uses, says journalist Penny Crabtree, in the March 3, 2006 Union-Tribune.

Rituxan was approved to treat non-Hodgkin's lymphoma only when chemotherapy failed or the disease had returned after at least one chemotherapy treatment.

"About 58,000 people are diagnosed with non-Hodgkin's lymphoma each year," Ms Crabtree notes. "Of those, roughly 12,760 have the slow-growing form that Rituxan was intended to treat," she said.

"One study of Rituxan use at a single academic hospital, between 1998 and 2001," Ms Crabtree said, "found that 75 percent of all administrations of the drug were for off-label purposes."

More than $1.1 million was spent on Rituxan for off-label use at that hospital, she says, compared with $355,000 for FDA-approved uses, according to the 2003 study in the American Journal of Managed Care.

Last month, the drug makers under fire, got a bit of good news. On February 10, 2006 CNN Money Line reported that regulators had approved Rituxan for patients with diffuse large B-cell lymphoma, a fast-growing form of the disease.

But CNN says approval is unlikely to have a dramatic effect on Rituxan sales as most cancer doctors have already been using it for large B-cell lymphoma on an "off-label" basis even though it had not officially been approved for the indication.

On February 28, 2006, more good news was announced when the FDA granted Rituxan approval for the treatment of RA.

Geoff Porges, an analyst for Sanford Bernstein, said he expected the RA indication to add about $400 million to annual US sales of Rituxan, according to the February 28, 2006 Washington Post.

As an RA drug, Rituxan is expected to compete with Orencia, a recently approved medicine from Bristol-Myers Squibb.

However, Biogen executive Burt Adelman told the Post that he expected Rituxan to do well against Orencia as physicians may prefer to go with the better-known drug.

According to the Post, George Porges is not so sure that Rituxan will outsell other drugs. "Porges predicted that while oncologists are comfortable with the drug, rheumatologists may be somewhat reluctant to give patients a medicine that suppresses the immune system over a long period of time."

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