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January, 2010

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January 8, 2010

January 1, 2010


Friday, January 8, 2010 "AhhhCHUUU!" Excuse YOU, Ed

I felt fine for Christmas, made it to Wednesday with no thought that I might be getting sick, started Thursday feeling out of it, ended Thursday (New Years Eve) sick. I was medicated and sleeping three hours before the Great Ball fell in Time's Square. I hope everything went well.

I've had the seasonal flu shot. I've had the H1N1 flu shot. I'm an "above average" hand washer and constantly hygiene-aware (as I'm a care giver for a disabled elderly in-law). In spite of these virtues, I'm never surprised to be harboring the nastiest things going 'round. One reason: my live-in elderly in-law frequents an adult daycare these are generally understood to be microbial cesspools. And another reason: I'm working on my seventh more-or-less consecutive year as a user of biologic medicines for P which means my immune system has been compromised in ways that are "not fully understood." I figure my chances of NOT catching everything diminish exponentially year by year....

All this by way of explanation for this late posting.

What's New at FlakeHQ

New Mail ... a new Sherry Sheehan poem ... and more to come.

 Friday, January 1, 2010 When the Fine Print Becomes Real Life

Every now and then an email comes to FlakeHQ with the power of a steam roller. It jerks me back in my chair, opens my eyes wide, shortens my breath and brings sweat to the palms of my hands. I received one of these on December 22nd. It came as a comment to a blog post, but I hastily wrote back to Mike S. and said it would have to be the lead piece in this update's Mail section. I've titled Mike's email, Believes Enbrel Caused His Leukemia. If you've only a minute to spend here right now, by all means spend it reading Mike's story.

Years ago I learned that no matter the statistical significance or insignificance of the number of adverse reactions to a drug under testing, they must be reported to the FDA and are most likely to end up in the fine-print disclosure statement that's packaged with the drug. That knowledge muted my sensitivity to some of the nastier potential consequences. How threatening can some deadly disease be if the risk is less than 1%? Well, the percentages don't matter when the unfortunate victim draws closer to you or IS YOU.

Mike S. has acute lymphoblastic leukemia, though it is currently in remission. This disease is called "acute" because it is an extremely rapid spreading cancer that starts in the blood but metastasizes quickly. There are no clear initial symptoms and the abnormalities in blood can be attributed to a number of things. The only sure way to conclude acute lymphoblastic leukemia is through a bone marrow biopsy. [Wikipedia, "Acute Lymphoblastic Leukemia."] The fact that ALL is not an easy diagnosis to confirm means it takes time; at the same time, the disease spreads so fast it can kill in weeks. Fortunately for Mike S. the methods of diagnosing and treating ALL have been refined and today the number of fatalities among adults with ALL is 50% or less. Think about that statistic. On the other hand, this comes from Amgen's "Prescribing Information" about Enbrel...

"In the controlled and open-label portions of clinical trials of ENBREL, 9 lymphomas were observed in 5723 patients over approximately 11,201 patient years of therapy. This is 3-fold higher than that expected in the general population. While patients with rheumatoid arthritis or psoriasis, particularly those with highly active disease, may be at a higher risk (up to several fold) for the development of lymphoma, the potential role of TNF-blocking therapy in the development of malignancies is not known." page 20, "Prescribing Information."

http://pi.amgen.com/united_states/enbrel/derm/enbrel_pi.pdf

This quotation says a 3-fold increase in the likelihood of contracting a lymphoma was demonstrated in the trials. However, those who participated in the trials (psoriatics, arthritics) may be at higher risk for lymphoma with OR WITHOUT the use of a TNF-blocker like Enbrel. While this sounds a little self-serving, it really is the kind of observation that must be made in any scientific inquiry. The implication is, the tendency for lymphoma among the target population needs to be determined just as rigidly as the trial outcomes. In other words, don't blame the drug without considering other possible causes.

These are the issues, anguishing as they are, that the FDA wrestles. Meanwhile, people like Mike S. know what has happened to them. We know that it could happen to us, too.

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