Thanks for the link. I'm having difficulty trying to figure out how to sort on that site, perhaps that it because I am not a member. I'm unable to determine how many people are suspected to have died from the interferons (or any other drug) and PML, but I was aware of a few cases a couple of years ago. At that point, many, many thousands of people had been on these drugs though, over several years.

I adamantly disagree that there is no difference.

A FDA approved drug, developed for a specific non-life-threatening condition, should have a higher standard to live up to then a risky drug that a few aggressive doctors and risk-taking patients are willing to try off-label out of desperation.

These drugs are approved/not approved for a particular medical condition, and we should be able to have a sense that safety due diligence has been done BEFORE a drug is put on the market . . . at least for its intended purpose. What happens after that, in this day and age, seems to be (unfortunately??) mostly up to the doctors and patients.

For instance, it seems Tysabri is being rx’d to most anybody now, even though that was not the intended purpose of this drug. It was supposed to be reserved for people who had proven to have extremely progressive RR, and/or where they’ve failed on other MS approved therapies. That isn’t the only demographic using it now though . . . but to be honest, I had little doubt that would happen once it hit the market. That is one of the reasons I argued to have a program such as TOUCH when Tysabri came out.

Of course we are going back over two years now, when we were unable to look back at 30,000 patients and say “without a single case of PML”. Why something was decided “once upon a time”, dredges up the reasons that people fought for this program initially . . . which may or may not apply any longer, to this or to any other drug.

Going back in time though . . . the PML scare was not uncovered until AFTER Tysabri was fast-tracked on the market, and the Biogen execs had cashed out a boatload of shares on the drug (which lost them a lot of credibility). No one, not even Biogen, had any idea if Tysabri alone could cause the PML, especially since one of the people in the Crohns/Tysabri trial who died from PML was on monotherapy at the time he took Tysabri. We knew he had been on immunosuppressants PREVIOUSLY, but we didn’t know how much/what kind of immunosuppressants combined with Tysabri, might cause PML to occur. Personally, I wanted to be sure there was a formalized program, such as TOUCH, so people would be informed of this, and other known and unknown risks.

It’s not just Tysabri, Cellcept, Rituxan, Methotrexate, etc. that are considered potentially dangerous drugs, and it’s not just people with MS who are trying off-label drugs for their condition. This brings to mind the broader question of whether unapproved/off-label drugs (CellCept, Rituxan, Neurotin, etc.) should be permitted to be rx’d by doctors . . . but I don’t think you are meaning to debate that question with your posting?

While it is understandable why we do not have head-to-head trials on these meds, one has to wonder why they don’t at least have the same criteria for recruiting and measuring the effectiveness of a drug intended for the same patient-base. However, this recent study used “evidence-based medicine principles” to compare them . . .

Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison.

Freedman MS, Hughes B, Mikol DD, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A.

Department of Medicine (Neurology), University of Ottawa, Ottawa, Ontario, Canada. mfreedman@ottawahospital.on.ca

The treatment of relapsing-remitting multiple sclerosis (RRMS) has become more effective over the last decade with the advent of the currently available disease-modifying therapies (DMTs). Pivotal clinical studies differ in many characteristics, such that cross-comparisons of relative risk reductions are of limited value and can be misleading.

Our objective was to compare the clinical efficacy of currently approved first-line DMTs in patients with RRMS, applying an evidence-based medicine approach. We reviewed all phase III pivotal trials of DMTs. Six clinical trials of Avonex, Betaseron, Copaxone, Rebif and Tysabri in patients with RRMS were identified for analysis. Only randomized, placebo-controlled, double-blind studies were included. The clinical efficacy endpoints compared were: proportion of relapse-free patients at 1 and 2 years; annualized relapse rate at 2 years; proportion of progression-free patients at 2 years, and proportion of patients free of gadolinium-enhancing lesions at 1 year or 9 months.

Based on these analyses, Betaseron, Rebif, and Tysabri show comparable effects, whereas for several endpoints Avonex or Copaxone did not significantly differ from placebo. In the absence of head-to-head studies for all products used to treat RRMS, it still may be possible to compare treatment effects by applying evidence-based medicine principles. (c) 2008 S. Karger AG, Basel.

PMID: 18437041 [PubMed - in process]
http://neurotalk.psychcentral.com/thread47948.html

I'm not sure of your point, because anyone who knows me, knows I have ALWAYS been one to offer up alternative views and to encourage others to do so the same on the forums.

It is extremely refreshing to have a forum, such as this one, that allow people freedom of speech . . . trust me, there are some out there (usually sponsored by the pharma companies and MS associations), that are known to shut down conversations/posters that are not 100% supportive of “their” agenda.

Cherie