Anyone taking or has taken alemtuzamab/Campath?

This seems the closest to a "cure" I've seen. With people traveling to other countries to get surgeries or have stem cells, I wonder why no one's convinced a doctor to give them this off label. Does anyone know? They've just produced a protocol for giving it to people.


http://health.einnews.com/news/alemtuzumab

[Redwings]

I wonder why no one's convinced a doctor to give them this off label. Does anyone know?

It probably has to do with the stern letter the FDA sent out a few years ago that specifically warned physicians not to prescribe Campath off-label to MS patients. Along with its great effectiveness come some very serious side effects. It was only recently that the extent of those side effects and the need for very strict monitoring were realized. (One patient died during the trial because the signs of one of the side effects weren't recognized.) It's one thing to undertake serious risks when a drug is being used to treat a condition that's fatal, but entirely different when the risks are so serious and the condition (MS) isn't fatal.

In the face of the FDA warning, it would have taken only one bad patient outcome and one huge malpractice lawsuit to ruin a doctor's career. That's too high a price to pay for a doctor who only wanted to help a patient. I'm not sure many doctors could be convinced to take on that risk.

With FDA approval and programs in place for risk management and patient monitoring, the prescribing stigma will be gone. However, some neurologists don't like to prescribe medications that require a lot of monitoring. (Frankly, too much work for them.) Campath could be the medication that really separates the "MS dabblers" from the neurologists who are truly committed to getting their patients on the best possible treatments.

[BigA]

That's true, but there are people going and getting stem cell transplants, which sounds a lot riskier. You'd think with the evidence there would be a clinic in mexico or somwhere offering it. Someone just did a protocol for doing it with some reasonable safety.

[Redwings]

It's important to keep things in the proper perspective. Of course "someone" has developed a prescribing protocol. That's part of designing a clinical trial, advancing through trials and forming the risk-management program, all of which are required by the FDA for drug approval. While a refined protocol is a good sign that Campath is advancing through the approval process for MS (and great news!), it's just standard procedure. Folks need to be careful to not take that out of context and give it more meaning and excitement than it deserves.

As far as it being used in clinics somewhere like Mexico, Campath is too tightly controlled by the manufacturer and FDA regulations to be shipped off into unknown, unregulated environments. A few shipments of Campath might get hijacked, but not enough for anyone to run a clinic off of.

[BigA]

thanks. I get it. It's not that I want unauthorized treatment; it's just that I see people getting such risky treatmetns with little proof. It just seemed to me that if I had to bet on an expensive, unauthorized, grey-market treatment, this would be it.

Let's hope they do well with the approval process.