More Tysabri-Related PML Deaths, Up to 20 Now

The subject of Tysabri and Progressive Multifocal Leukoencelopathy (PML) has begun to receive more and more media coverage in the past couple of months. It was under a year ago that Biogen and Elan (the pharmaceutical companies who make and market Tysabri) stopped giving monthly reports directly to the public.

'They' likely decided that filtering that information through the neurologists (in the TOUCH program) would be wiser, perhaps for them anyways.  Fortunately though, a small group of news media outlets are given the reports to release to the public.  The Wall Street Journal (owned by Dow Jones & Company) has been dutifully providing us with the monthly updates.  A history of the press releases are compiled by the Multiple Sclerosis Resource Centre.

I've written previously about Tysabri and PML, with a lengthier discussion of the topic at HealthCentral.  Use the search box located half-way down the sidebar to find older posts as well.

I'm wondering when somebody is going to finally notice that in one year's time, 60 new cases of PML have been reported.  60!!  Last February the number was 35 and this year it is 95.  The number of deaths have increased in one year from 8 to 20.  That's one death per month on average.

When does this begin to become alarming?  If you read my previous posts, you will notice that I usually do give a non-biased accounting of what Biogen is working on in order to reduce the risk of using Tysabri population-wide.  Trying to identify who is most at risk.

I gotta tell you.  It was the highly-vocal patient activists with superior sleuthing skills who put two-and-two together to notice that many of the earlier cases of PML were in people who had used serious immunosuppressants prior to or in connection with Tysabri.

I would fall into that category of patient since I have used Methotrexate for my RA for almost four years.  Now I use Methotrexate and Rituxan, a drug which also carries the PML risk.  However, in the RA world, we have had only three cases of PML reported out of 100,000 patients.  Only three!!  That information is from October 2009.

I mention Rituxan because I have seen Tysabri patients (who rightfully appreciate what this drug does for them) point out other medications which also carry the PML risk.  But the ratio of risk does not compare.

Another curious difference in this month's Dow Jones news release is that the detail of location of the PML cases is not enumerated.  This had been done each month (except two) since September 2009.  Why did they not include the information this month?

My inkling is that several of the 10 new cases came from within the United States.  (According to chatter on the cafepharma message board, two of the ten were from the United States, but this cannot be confirmed.)  Why do I presume/hypothesize that?  Because as recently as December, even a TOUCH nurse described to me that the vast majority of cases were occurring elsewhere.  This was true one year ago and had become the PR message which Biogen pushed.  It is not true now.

But the US case to EU case ratio of last February, a ratio of 1:2, no longer exists.  The ratio  reached 1:1.2 last month, a number which would be surprising to most US patients.

Now I fully acknowledge that this post does not present a balanced and unbiased discussion of the issue.  I've done that in previous writings.  This time I just wanted to get the information out and provide some personal thoughts on the matter.

Below you will find an updated chart reflecting the newly reported cases.  If I learn how many were in the US compared to elsewhere, I will add that information.

Cases of PML reported in patients using Tysabri, including deaths and locations.

I've included the February 2011 Dow Jones report below.

Biogen: 10 More Infections, 4 More Deaths In Tysabri Patients
By Thomas Gryta, Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed 10 more cases of a rare brain infection among multiple sclerosis patients taking Tysabri, a medication it sells with Elan Corp. (ELN, ELN.DB), bringing the total number of affected patients to 95 as of Feb. 2.

The Weston, Mass., biotech company reported that four more of those patients have died, bringing the total to 20.

The cases of the infection--known as progressive multifocal leukoencephalopathy, or PML--are closely watched as the MS market becomes increasingly competitive.

The drug is generally regarded as highly effective, but mostly used for patients that have stopped responding to other drugs or have aggressive cases of the disease. Sales rose 16% in 2010 to $1.2 billion and 56,600 patients were on the drug at the end of December.

Regulators have said that they watch the cases of PML, but have concluded that the benefits of the medicine to MS patients outweigh the risks. Tysabri was withdrawn from the market in 2005 and relaunched in 2006 with a strict access plan that monitors patients.

There is hope that the development of a blood test may better determine the chances of patients contracting PML. Although the overall risk of the infection remains small, it can have devastating and permanent effects, so a test may make patients and physicians more comfortable with using the drug. Biogen and Elan have filed with the Food and Drug Administration to update the label of Tysabri to include information about certain antibodies in the blood being a PML risk factor.

The overall global PML rate is now at 1.16 per 1,000 patients. Although that is above the typical one-in-1,000 rate commonly cited from clinical trials of the drug, a Biogen spokeswoman said the current PML figure falls within that seen in the trials' confidence interval, a statistical tool that helps show the precision of a measurement.

The rate is about 1.64 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.41 case per 1,000 patients in those using it for one to two years, and it is essentially nonexistent in patients using it for less than a year. The rate drops to 1.06 per 1,000 patients for those on the drug between three and four years.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com