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Biogen Idec's Social Media Ties Save Tysabri Again; FDA Watching

On November 2, Biogen Idec updated the prescribing label for its blockbuster multiple sclerosis drug Tysabri (natalizumab) after consultation with the FDA. Aside from acknowledging that the risk of developing progressive multifocal leukoencephalopathy (PML), an often fatal brain infection, increases with longer duration of treatment, no other revisions concerning the risk of PML were required. The fact that this biologic remains a cornerstone treatment for adult patients with relapsing forms of MS -- only the second drug to ever return to U.S. pharmacy shelves after having been withdrawn -- speaks volumes to the growing influence of the Web.

The Internet has radically changed pharmaceutical marketing and sales. No longer do drug companies need legions of attractive and personable salespeople to "detail" physicians on the efficacy and patient benefits of their choice drugs. With an average annual spend of $150,000 per primary care sales representative and $300,000 per specialty rep, leveraging the Internet is a more cost-effective proxy by which to disseminate educational (meant to persuade) information to doctors, medical staffs, health care administrators, and patients. Scrip tracking (sales lingo for how much -- and what -- drugs a physician is prescribing), free sample requests, and patient educational brochures -- all can be handled by one techie sitting in a cubicle these days. A two-day FDA-sponsored public hearing on heretofore unregulated use of web-enabled social media tools used to promote prescription drugs to consumers is getting underway in Washington DC.

Biogen does utilize a drug-specific salesforce (90+) for Avonex and another 90+ reps to exclusively market Tysabri -- plus a small neuroscience group (of about 200) selling both MS drugs -- to select opinion leaders and high-value (volume prescribing) physicians. Nonetheless, the company was ahead of the pack in recognizing the value an online media presence adds to product marketing and brand awareness. In the battle for market share and sales, the company has successfully conveyed the Tysabri message to providers and potential customers alike through popular social media websites like YouTube, where the Tysabri Recovery Series recounts personal testimonials from MS patients on how the biologic has helped them lead normal lives. Branded promotions and drug/ disease updates can be found on a plethora of websites, from Facebook and MySpace, to the latest fad, Twitter.

That the Internet is both a powerful tool for finding information quickly on MS and an effective means by which the more than 400,000 Americans living with MS can connect and chat with others through online MS communities has not been lost on Biogen management. In addition to mandatory patient enrollment in the Tysabri Touch Prescribing Program, Biogen offers MS patients who are thinking about -- or have chosen -- Tysabri therapy a number of options to get more involved in their treatment decisions: programs ranging from the TYSABRI Mentor Program to a Webinar Series that lets the patient dial in on the phone to hear a healthcare professional discuss treatment information. There are a number of third-party informative, patient-centric services available to MS patients online, too, such as the National Multiple Sclerosis Society. As mentioned, Biogen's Internet investments yielded unprecedented dividends when the FDA reintroduced Tysabri back onto the U.S. market after PML safety concerns forced its initial withdrawal.

Figure 1Despite the increasing amount of PML cases that have been diagnosed since Tysabri was re-introduced to the U.S. market in July 2006, Tysabri's benefit-risk profile remain favorable, as observed in the 69 percent improvement in physical function in a post-hoc analysis of treated patients (see Figure 1 to the right; click for a larger version). And, the message that "Tysabri's benefits outweigh the risk it poses to MS patients" is seen in the confidence survey of neurologists who agree with that statement: up 18 percent in one 12-month period to 63 percent (see Figure 2, below, and click for a larger version).

Figure 2A legitimate concern raised by drug safety watchdogs, like The Health Research Group, a DC-based nonprofit of the advocacy group Public Citizen (founded by well-known corporate gadfly Ralph Nader), is whether or not the ethical line has been blurred between company-sponsored web portals (profit-driven) and unbranded, patient-driven websites (representing the public's health interests). Does anyone really know how much money Biogen has donated to MS advocacy groups, including the National MS Society? Or, what incentives have been provided to nonprofits to communicate positive clinical trial data to their constituents?

Although I'm not a conspiracy theorist, one might speculate that the invisible finger of Biogen was behind the explosive online propaganda campaign (emphasizing the drug's benefits) that erupted following the 23rd and 24thconfirmed cases of PML in patients taking Tysabri (in October - early November).

At the very least, any resultant FDA initiative from this week's public forum should focus on the need for increased transparency due to the entangled interests that have arisen between industry and "independent" patient-centric advocacy groups. By the way, I was just informed that PML-patient # 14 passed earlier this week. Funny thing -- her death didn't make headlines -- anywhere. If confirmed as the fifth PML fatality related to drug therapy, how ironic that patient empowerment has already been betrayed by its chosen medium.

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