Hey Wiz, I was thinking about this after answering your other post already ...

We don't know if the 23 (+ perhaps the three from the trials) is an accurate number; it could less, or it could be more. Going with the numbers we have though, I don't know there would be any advantage what-so-ever in them publishing this information.

So long as no one "knows", this might work best for them ... don't you think?

Let's <say> that close to 20 patients of the 13-thousand-odd patients who've used it more than 24 months (or maybe 15 patients out of the 6,000 that have used it for 30+ months) .... NOTE: just making up numbers for demonstration purposes ..... have come down with PML. The risk factor for that number of infusions might be as high as 1:100, 1:300 or 1:500.

My question is what useful purpose would it be for Biogen to release that information? So long as no one knows, it's all just "speculation" ... which might anger some people, but it MAY be better than revealing the truth too.

They want to focus on the positives of this med, as they said in June when they told us they don't intend to share the numbers any more. They also said they had hoped they would have a better idea of the cause of PML (from the use of Tysabri) by the time they stopped telling us the PML patient numbers (although that doesn't seem to have happened yet). They are getting closer to maybe identifying a test that will help with mitigating risk though.

In the meantime, I think it was apparent that they intended to keep the PML cases as low-key as possible, now that they are up there with patient numbers/number of infusions.

Ten in one month is crazy, especially if they are ALL in the "high number of infusions category", no matter how many are on the drug right now. For all we know, it might only be 5 though, in which case most everyone would likely sigh with relief at that news (at least compared to 10).

If it really is 10 in the last month though, I would be suprised if they would change their policy of telling people, as I just don't see how that could work for them to do so.

Has anyone noticed exec's cashing in their shares lately?

Cherie

Here is some interesting information reported in an article online today.

http://english.capital.gr/news.asp?id=840194

Public companies are typically required to disclose any material information to investors through a filing with the Securities and Exchange Commission. Officials from the agency didn't respond to requests for comment. By definition, material information is that which a reasonable investor would find important in deciding on how to invest or vote on shareholder matters, said Charles Elson, director of the Weinberg Center for Corporate Governance at the University of Delaware. While that leaves room for interpretation, Elson noted that stock movement can help determine whether information is material

So this means that Biogen can decide what they think a "reasonable investor" would want to know regarding investing or shareholding when they determine what to report to the SEC? If that is true than there is no way to ever know how many PML cases there are.

While the company contends that the PML-related information doesn't help physicians or patients, Morgan Stanley analyst Steven Harr notes that Biogen's decision to stop reporting cases, just as evidence of accelerating risk was developing, may in fact cause increased concern.

Shocking that Biogen is claiming that PML-related info doesn't help physicians or patients.

In addition, other analysts are challenging Biogen's assertion that the PML rate remains "well within" the risk rate implied by the label. Barclays Capital analyst Jim Birchenough said the new cases could push the rate as high as 1-in-700 patients among those patients on the drug for more than two years. Bernstein's Porges estimates the risk jumps to 1-in-400 patients after three years of use.

That is even scarier information.

I'm still waiting for my neurologist to call me back. Maybe she will know something more but I don't really count on it.

I guess I'll call the neuro tomorrow as well as my senator. I haven't received any calls back yet from those I left messages with today.

I have no problem whatsoever to stop Tysabri and go back to Copaxone and just take it every other day. I did ok on Copaxone. If they're withholding this information, what else are they leaving out? :confused:

My letter to my senators (feel free to copy the text to email your senator at the congress.org website)

Biogen Idec produces a medication called Tysabri for the treatment of multiple sclerosis (MS). Tysabri is very expensive for patients and is administered via infusion. There are currently more than 46,000 MS patients taking Tysabri, myself included.

There's a known side effect called progressive multifocal leukoencephalopathy (PML) - a potentially deadly disease, that's listed on the medication packaging and also gives Tysabri a "Black Box" label category and requires consistent patient monitoring for symptoms of PML.

Biogen Idec was previously providing statistical details of new cases of PML so that patients could decide if the risks were worth the benefits of the drug. They recently discontinued their reporting policy and the statistics of PML are not available to the patients taking the risks and paying for the medication.

Last week an EU news agency reported ten new cases of PML and Biogen Idec has stated they will not provide any details on the age, country of origin or length of time taking Tysabri - all necessary details for existing patients to decide if they will continue with this highly effective but potentially dangerous drug.

I urge you to contact the FDA today and also James C. Mullen, CEO of Biogen Idec to insist the company provide the statistical data publicly so that patients taking the risks and paying for this expensive medication will be able to make an informed decision in managing their general health and disease therapy.

It is surprising that a company can legally just quit giving out info about a drug and its side effects. It makes sense that they don't want their investors to freak out, but it may cause a great deal of harm to unsuspecting and uninformed patients.

Good letter to your senators.

gmi

Call the FDA too!
 

Call the FDA as well 1-888-463-6332. I've got a message in.

You know I'd like to add here...and forgive me if you've discussed this but...

Another drug is newly being tagged for causing PML...
it is called Rituxan:

I just saw this yesterday in fact:
http://www.newsinferno.com/archives/13571

I am so proud of all of you being so proactive...I'm not on Ty, but I know that those who decide on that DMD do so with a great deal of forethought.

Just take care of yourselves, and keep on fighting.

I love you guys!!:hug:

Information about the status of the JC Virus Assay - looks close
 

http://www.forbes.com/2009/10/27/ms-...rtner=yahootix

Excerpt from Forbes article

“The test Yednock and his colleagues developed found that something like 50% of the patients have JC virus. There are eight cases of patients who developed PML where Elan and Biogen-Idec have blood samples going back long before the infection happened. All of those cases had JC virus antibodies in their bloodstreams a year before they got PML. “That’s a pretty good starting point,” says Yednock.

Elan has transferred the assay to a commercial laboratory, a step toward making it available to patients. The test, which uses antibodies to detect the presence of JC virus, could be done with just a saliva sample. It has not been evaluated by regulators or the larger scientific community, but the hope is that doctors might be able to use it to pick which patients are the best candidates for Tysabri therapy.”

I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon and I have his direct phone number for future reference. He assured me that the risk is still within the 1:1000 even for patients with a greater number of infusions. The current number of confirmed PML cases is 23.

I explained to him why I disagree with the change in their reporting policy and why I don't think it's acceptable for them to put this duty on the backs of the physicians.

I thanked him for calling but until they change this policy or make it easier for patients to get accurate data and reports, I'll keep working for this to change.