And, I doubt he is the only one doing this . . .

"Suspected PML Cases For Biogen, Elan MS Drug Not Alarming
12-08-08 1202ET

By Thomas Gryta

Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Tysabri, the controversial multiple sclerosis drug sold by Biogen Idec Inc. (BIIB) and Elan PLC (ELN), caused 22 suspected cases of a rare brain infection through early October, according to reports filed with the Food and Drug Administration, a level deemed unalarming by physicians.

Biogen didn't dispute the figures but has declined to disclose the number of suspected cases, arguing it doesn't help physicians and patients and doesn't measure the true risk for progressive multifocal leukoencephalopathy ...

Wall Street, though, has sought more information about the number of suspected PML cases in order to better assess the drug's future prospects, considered key for both companies. Analysts and investors have questioned Biogen's reticence to disclose more.

Dow Jones Newswires compiled its number of suspected cases by reviewing 3,441 Tysabri adverse event reports filed by doctors and Biogen between July 2006 and Oct. 6, 2008. The 22 suspected were determined to be negative for PML, except for two confirmed in July. The third confirmed PML case was announced after Oct. 6. ...

As of Sept. 30, more than 35,500 patients use Tysabri, with 9,500 patients on it for at least 18 months and 3,700 for more than two years. The timeline is important because two patients with PML in 2005 were using the drug for more than two years. This past summer marked the two-year anniversary of Tysabri's re-launch, raising Wall Street's anxiety over PML-related news. ...

Klein is comforted that PML may be treated with plasmapharesis, a process that removes large molecules from the blood, speeding up Tysabri's removal and allowing the immune system to fight the PML infection.

All three recent PML cases were treated with plasmapharesis and have survived the often fatal condition. Biogen reported that the first two have shown improvement, while the third patient "seems to be doing well."
"It is starting to raise the question of whether PML associated with Tysabri could be a survivable adverse event instead of an almost fatal disease," said Naomi Aoki, Biogen's spokeswoman.

The FDA database also shows 160 deaths among Tysabri patients, but Biogen reports all deaths to the FDA database regardless of any apparent relationship to the drug. The company asserts there is no evidence of a mortality issue.

Physicians note that death is not a common occurrence in MS patients, but that some physicians use the drug as a last resort for advanced MS patients, which may distort the data.

Heightened Vigilance
The FDA said it subjects Tysabri to heightened vigilance because of the PML risk and the previous market withdrawal. The agency stressed that it assesses all serious adverse events reported with Tysabri.

Nonetheless, observers - including the FDA and Biogen - note that the adverse events reporting system may not represent an accurate number of suspected PML cases. More cases are likely suspected, and then dismissed, before getting documented in the database.

"The challenge is that the symptoms of PML are very subtle and hard to distinguish from MS," said Robert Fox, medical director at the Mellen Center for MS at Cleveland Clinic.

Fox said it is "not infrequent" that he holds use of Tysabri in a patient on suspicion of PML. He and Jeffery each have consulted for Biogen in the past.

Citigroup analyst Yaron Werber believes disclosing the number of suspected cases helps Wall Street more than it does physicians or patients. Antony Page, who teaches corporate law at Indiana University, notes that Biogen's lawyers have likely formed an argument that disclosing the suspected cases isn't material information.

Meanwhile, Barclays Capital analyst Jim Birchenough contends the number of confirmed cases is likely higher, arguing that Biogen's strict policy on how to confirm PML keeps the number lower.

"When physicians suspect PML and you can't rule it out definitively, I think that is something that should be disclosed by the company," he said.
Biogen disagreed and remained confident that it hasn't missed any confirmed cases of PML. In the meantime, the company is hoping to establish a regular system to keep Wall Street updated.

"Our goal is to move towards a more quarterly update," Aoki said. Biogen will handle each case individually and continue disclosing cases by filing with the Securities and Exchange Commission if it provides insights to physicians or has news material to investors.

http://www.smartmoney.com/news/on/?s...7-1202&print=1


NOTE:

**"Klein is comforted that PML may be treated with plasmapharesis, a process that removes large molecules from the blood, speeding up Tysabri's removal and allowing the immune system to fight the PML infection."*

The problem with that is plasmapharesis (which "speeds up Tysabri's removal") is suspected of causing IRIS in some people who have PML . . . which is potentially as serious as the initial PML.

Cherie