What do new lesions REALLY mean?

[fishead]

Too funny!!

Tawanda,

SOOOOOO glad you saw the humor in my post , b/c it was meant to bring some silliness. I am NOT making fun of the persons lesions (heck I HAVE some too, don't know how many/don't WANT to know)

[October22]

So.

Thanks to everyone! I'm only about a year and a half in and am astonished at how much I still don't know and how many more stages of processing there are. Best advice I ever got was to take a year or two to do that.

I know this doesn't go here but what are everyone's thoughts on Lemtrada? It's not approved yet but might be by end of year. Anyone interested in it?

[Marco]

What doesn't make sense is if Lemtrada is "so great," why couldn't the company clearly represent that to the FDA. Genzyme has been down that road before and know what to expect.

They failed to:
1) properly compute the trial statistics
2) convince the FDA the safety profile warranted approval
3) prove the efficacy of the drug

I hope Europe will release some post-marketing safety data on Lemtrada. Like many others, I could have taken Campath years ago, but didn't see the upside. Now it's been taken off the market to significantly jack up the price and it has less appeal now. I believe the demand went up for Lemtrada because the FDA says it was "off limits." Just like with CCSVI. I was an early adopter of Tecfidera, but I want nothing to do with Lemtrada until some reliable data shows up.

I do know people that took Campath and are doing well. I also know Jim Fixx died at 52 and George Burns lived to 100. Anecdotal information does not equal clinical science.

[October22]

Interesting. I just believed what I read about the FDA denial. My neuro is pretty high on it and thinks it'll be the new standard of treatment. I can't find a whole lot of info on it online except the one guy that is doing great and some clinical trial stuff.

Thanks for the info!

[Marco]

Cladribine and Lemtrada would be new induction therapies. I am a firm believe in induction therapy and believe it will be the eventual standard of care for MS patients.

How many times did your neurologist prescribe campath to MS patients when they had a chance? Every neurologist that has been around for more than 5 years had the opportunity to prescribe campath, but most of them elected not to. Why? Because they considered the risks to be greater than the benefit. A name change and price increase has not improved the risk versus benefit equation.

The FDA noted Lemtrada's, "multiple serious and potentially fatal safety issues." Of course, the manufacturer would disagree, they'd be insane not to. A number of doctors have come out against the FDA, but most were involved in the trials and therefore have a conflict of interest. Most of the news reports present Sanofi's argument against the FDA, but do not actually go into the FDA's reasoning for disapproval. You also do not see oncologists lined up to support the drug and they have the most experience with it.

Ultimately, if the drug manufacturer cannot articulate the benefit over the risks that should be a red flag.