Biologics, generics and orphans…Oh, my!

I am currently vexed about two healthcare issues.  I figure this is the perfect time to mull aloud, that the more people who are thinking about these things the better.  And hopefully we can influence the debate this year on healthcare reform.

First is the inability to create and sell generic biologic drugs in this country because the "Food and Drug Administration (FDA) does not have the authority to review applications for generic versions of biologic drugs like other countries do."  I always wondered what the issue was; now I know.

Isn't the U.S. supposed to be all that and a bag of chips, as OH would say?  How incredibly disappointing.

"Four of the six MS therapies are biologic drugs, which are drugs produced from living cell cultures rather than synthesized chemicals." MS sufferers must  "pay between $16,500 to more than $30,000 a year for their medically necessary drugs." Without the possibility of generics on the horizon, drug companies that produce any of these drugs essentially enjoy a permanent monopoly.

[Digression: the term "medically necessary" bugs me.  There is no cure so doctors can only recommend these for slowing down the disease. This isn't a necessity, it's a crap shoot.  Also, not every drug works for every person.  For example, I received a letter this year from my health insurance company that my injectable will no longer be in their formulary so I should switch to one that is.  But because I had developed a liver toxicity to all others, this is the only one left to me!]

The second is the idea that any drugs for M.S. are "orphan drugs" which, according to Wikipedia, are drugs that have been "developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease."  (In the U.S., "rare" equals fewer than 200,000.)

The National Multiple Sclerosis Society maintains that there are only about 400,000 cases of MS in the U.S., up from 350,000 a few years ago.  But I, and others, believe the number is much higher and that maintaining it is less is a way to keep these drugs defined as quasi-orphan drugs with tax incentives and extended protection from competition.

As a country we should have, and MS activists have been pushing for, a national multiple sclerosis registry, a coordinated system to collect, analyze and track data on multiple sclerosis, like the one I've already been participating in.  (See link to NARCOMS below.)  This would prove our numbers.

As I've posted before, I worry about healthcare.  Well, I worry about healthcare when I'm able to.  When I'm not totally consumed with being ill.

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