Doctors Seen as Key to Tysabri Success
It was barely two hours after a panel recommended to the Food and Drug Administration that it allow the drug Tysabri back on the market when Dr. Joseph Berger got an e-mail inviting him to a special class.
Would Berger, a neurologist at the University of Kentucky’s Multiple Sclerosis Clinic, be interested in earning credits toward updating his medical license by learning more about Tysabri, a treatment for multiple sclerosis?
“The marketing people at Biogen Idec are brilliant,” Berger said. “I think every one of these companies has these various shadow organizations, and that’s how they get their message out without being necessarily linked to it.”
The invitation, from MSLeaders.org -- a website financed by the drug’s manufacturers, Cambridge, Mass.-based Biogen Idec and Ireland’s Elan -- could be a key element to any strategy by the makers as they prepare for Tysabri’s likely return.
While the companies await a decision from the FDA, they’re finding ways to keep people informed about the drug. A key audience is the doctors who would prescribe it to patients with MS.
About 350,000 Americans have MS, an incurable disease of the central nervous system. An estimated 200,000 patients use one of four disease-modifying therapies: Avonex, Betaseron, Copaxone and Rebif.
Three thousand people took Tysabri in clinical trials. Once it was approved, an additional 7,000 patients began therapy and 15,000 awaited insurance verification or were scheduling their first dose when Tysabri was pulled, said Biogen Idec spokeswoman Amy Brockelman
Without Tysabri, Biogen Idec still has a solid presence in the MS drug market: Its Avonex was used by about 32% of patients on therapy in the last 12 months, according to IMS Health.
The FDA approved Tysabri in November 2004, but Elan and Biogen Idec withdrew it three months later after three people taking it in clinical trials contracted a rare, often fatal brain disease called progressive multifocal leukoencephalopathy, or PML. Two of those patients died.
Both companies said they found no additional PML cases among other Tysabri users. An advisory panel to the FDA voted unanimously March 9 to recommend the agency permit Tysabri to be sold again, subject to new restrictions. It cited the drug’s strong ability to help block the recurrence of key effects, such as sudden partial paralysis. The FDA is expected to make its decision in June. Until then, however, the companies are deciding whether or how to get the word out about Tysabri.
Stephanie Foye of Market Rx, a pharmaceutical marketing company, said the direct contact with doctors was a smart move. “They can’t, technically, promote, but educational efforts are allowed,” she said.
A spokeswoman for Biogen Idec would not comment on its marketing strategy, saying that it was premature and that “right now our focus is working with the FDA to make Tysabri available again.”
But the e-mail the University of Kentucky’s Berger received shows inroads the companies are making to get word out to patients, who will go to the physicians for advice on treatment.
Lori Lieberman, 42, of Sharon, Mass., was diagnosed with MS almost four years ago. She had two doses of Tysabri -- which is administered intravenously once a month -- before it was pulled.
Lieberman, a nutritionist, said she usually researched any decisions regarding her health. But the wealth of information, speculation and stories surrounding MS treatments has been overwhelming.
She said she would not go back on the drug if it were reintroduced, partially because she is in fairly good health. She’s the captain of a cycling team, and her last MRI was free of new lesions that would indicate further deterioration of the brain caused by MS. But Lieberman also sensed that her doctor didn’t think Tysabri was the drug for her.
“To a large extent,” she said, “we pick up on the cues from the physician. The cues I picked up before the [FDA] commission were clearly, ‘I wouldn’t dream of putting you on this.’ They seemed to have a great deal of cynicism.”
But if her doctor recommended she return to Tysabri, Lieberman said, “I would absolutely seize the moment.... I would take any hint or suggestion that it would be a desirable thing to do.”
Tim Wurst of Eriban Wurst Inc., a healthcare marketing firm, said it was important for pharmaceutical companies to start courting doctors to try to groom them for the drug’s likely reintroduction.
But, he added, there were different kinds of MS patients. Those suffering from severe disability may be more willing to face the risks associated with Tysabri.
Should Tysabri be reintroduced, Berger wants patients and doctors to act cautiously. The risk of PML -- which some FDA doctors estimate could be 1 in 1,000 -- is not fully understood. “I’m not sure how many physicians have seen a patient with PML.... I think many neurologists in this country may not have seen it,” he said.
MS strikes mostly women ages 20 to 50. The body’s immune system attacks myelin, a fatty coating that acts as insulator and conductor for nerve fibers in the brain. Depending on where the damage is, symptoms, which can come and go unannounced, range from fatigue to blindness to severe disability.
The patients a company would need access to are those like Pam Thorp. The 48-year-old was diagnosed with MS 20 years ago. It began with a stiffness in her neck; now, she wears a leg brace to control muscle spasms and uses a walker.
Like Lieberman, Thorp had two treatments with Tysabri before it was pulled. Unlike Lieberman, she is desperate for the drug’s return to the market. After the two treatments, she said, she noticed improvement in her motor skills.
“I was just devastated when they took it off the market,” she said. “To me, it was well worth a shot.”
