Healthy Skepticism Library item: 3673

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Genentech/Biogen Idec: wearing the drug marketing suit well?
Pharmaceutical Business Review 2006 Jan 12
http://www.pharmaceutical-business-review.com/article_feature.asp?guid=5C379035-9AD6-4724-AB96-3ABBD2D9B871

Notes:

Ralph Faggotter’s Comments:

It is interesting to follow the fortunes of ‘biotech’ companies to see how, or if, they differ in their corporate behaviour from regular pharmaceutical companies.

This article has gives one a feeling of de ja vu, suggesting that the differences may not be as pronounced as one might have hoped.

Full text:

Genentech/Biogen Idec: wearing the drug marketing suit well?
12th January 2006
By
A former Genentech employee has sued the company over drug marketing practices.
An ex-Genentech employee has reportedly accused the company, and its marketing partner Biogen Idec, of illegally promoting cancer drug Rituxan as a treatment for rheumatoid arthritis. While the lawsuit is yet more bad press for both firms, Genentech’s latest financial release has already overshadowed the news, and the company’s strong position should see it fend off any impact the suit may have.
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Former employee Paul McDermott filed a whistleblower suit against the companies in July 2005, according to Associated Press reports, but the suit was filed under seal. It has only now become publicly known thanks to the intervention of the Justice Department.

To date, Rituxan (rituximab) has only been approved by the FDA for non-Hodgkin’s lymphoma, but doctors are already prescribing it for other cancer types. Recent clinical trials have also shown promise for the drug in the treatment of rheumatoid arthritis (RA), which has led to off-label use in this indication as well.

Prescribing drugs off-label is not illegal, and can generate substantial additional sales. However, actively promoting a drug for an unapproved indication is illegal, and Genentech has been warned about such activities before. For example, in 1999, Genentech paid a $50 million fine related to improper marketing of Protropin (somatrem) and, in October 2004, received a federal subpoena regarding marketing practices related to Rituxan.

Genentech’s decision to study Rituxan’s potential in RA is understandable as several RA drugs have achieved blockbuster sales and the RA market offers Genentech a key opportunity to increase Rituxan’s sales potential.

The drug’s performance in this indication has been impressive, and Genentech and Biogen Idec have applied for approvals to market Rituxan in RA in the US and Europe (where it is marketed as MabThera). If it can successfully gain an approval, the drug is expected to launch in this indication by the end of 2006.

With its seemingly imminent launch, working to increase physician awareness of Rituxan before it hits the RA market makes sense and should boost initial uptake. However, such activity treads a fine line, and it is the line between education and drug promotion that Mr McDermott’s suit alleges has been crossed.

While Biogen Idec will not relish more bad press after beginning to get back on its feet following troubles with multiple sclerosis drug Tysabri last year, Genentech has survived previous telling-offs regarding drug marketing relatively unscathed and, having just reported record annual revenues, should be able to fend off any ill-effects resulting from the allegations.