Mutliple Sclerosis Patients Still Being Asked to "Roll the Dice" on Tysbari

It's getting to be old news, but Tysbari, the alleged "wonder drug" for MS patients continues to suffer from a serious side effect: death.

In the third of ten suspected cases this year alone, a patient who had been taking Tysbari for 30 months has developed progressive multifocal leukoencephalopathy or PML, an illness that -- as my Harvard-educated neurologist described it -- "essentially melts the brain."

Initially, it was thought that PML only occurred in patients who were simultaneously taking another MS drug, such as Avonex, Rebif or Copaxone. At that time, in 2005, the drug was pulled from the market. With appropriate precautions and monitoring, it was back on the market the next year. Perhaps that was ill-advised, as the three cases this year did not involve patients on other MS modifying drugs.

Of course Biogen, the maker of Tsybari--and even many doctors--will tell you that the incidents of PML in Tysbari patients is still less than 1 in 10,000.

Fair enough, but compare that to other life threatening risks and those odds don't look so hot.

For example, it's well known that dying as an occupant in an automobile are much higher than say, a commercial jet liner. Specifically, according to the National Safety Council (NSC), your odds of dying in a car are 1 in 261 and the odds of dying in a commercial jet are 1 in 6460. On the surface that suggests that MS patients on Tysbari have less chance to develop PML than dying even in a plane crash.

But hold on! (or hang on! as my British friends would say)

Those odds are over one's lifetime, not the same amount of time an MS patient would be taking Tysbari, which, according to Biogen, should be limited to about 24 months.

Take your odds of dying in a car crash over just one year, and the odds jump significantly to 1 in 20,331; and the odds of dying in a plane jump to 1 in 505,244.

So, now compare those odds to the 1 in 10,000 chance of dying of PML, related to Tysbari use over 2 years. Like I said, "Not so hot."

Any doctor -- that is, good doctor-- will tell you (and my father used to quote this regularly) that the number one rule of medicine is "Don't kill the patient."

So while Tysbari has proven effective in patients that it has not killed; and the decision to adopt such treatment is intensely personal, it's always good to keep in mind the alternative.

While my life with MS is painful and sometimes debilitating; it is far superior to death.

More importantly, MS patients deserve better.

It is absurd that patients be asked to "roll the dice" in terms of their lives for the sake of a drug company's share price. There's money to be made in selling Tysbari, that's clear. However, there are lives to be saved by focusing on safe treatments that do not threaten our lives, even if those treatments don't involve an expensive drug that builds profits for a drug company.

Case in point, I've reported in the past on some antibiotics developed over 100 years ago that have been discovered to have a positive impact on autoimmune patients, such as those suffering from MS. Why do we not see more research into safe alternatives such as this. There is simply no money to be made.

As Chris Rock once said about drug companies, they do not want to actually "cure" you, but keep you taking their medicine for the rest of your life. "They're still *&!# off about the whole Polio thing!"

Cheers,

http://www.businessweek.com/ap/financialnews/D994CK4G0.htm