How many, really?

[MSSpouse]

An interesting tidbit from the January 7 issue of The Economist:

[Teva] is the world's biggest generic drugmaker, but nearly a fifth of its sales in 2010 came from a patented blockbuster, Copaxone, a drug used to treat Multiple Sclerosis.
--"Battling borderless bugs," p. 55

If Teva, with $17 billion in revenue for the trailing 12 months, is getting 20% or $3.4 billion of its sales from just one of the several DMDs now widely used, it really makes you wonder how many folks have been diagnosed in the U.S. and other MS hot spots around the world. We need better data on this.

[Bigrushfan]

Thanks for posting this. I did not see this article and must get this issue of the Econimist.

Teva, the world's biggest generic drug maker. This seems somewhat ironic if you look at Copaxone. When will the generic version of Copaxone be available? It's been on the market for more than a decade now. Can anyone answer this question?

Indeed, what a blockbuster drug. The price keeps going up and up (in the US it has doubled over the past five years) to take advantage of the growing demand. My neurologist in the states tells me he puts on average at least 10 people a month on Copaxone. This is just one of a dozen neurologists in a relatively small town in the US. Who knows what the number of new patients per month to go on Copaxone is? Given the rising price and growing demand for Copaxone, the 17 Billion in annual revenue seems about right.

I live in Europe most of year and know that Copaxone is not as widely prescribed and used to treat MS here as it is in the US. Rest assured, Teva is working to rectify this.

Don't get me wrong. I have been taking Copaxone for 6 years now. It is truly a great drug that does its job and keeps MS at bay. If you don't believe me, I just ran a half marathon last Sunday and managed a new personal best just a few minutes shy of reaching a 1 hr, 30 min run. Clearly, without Teva this would not have been possible. I try to remain mindful of this fact before I start casting stones. It doesn't hurt, though, to ask questions every now and then from those copanies profiting the most from helping people with MS stay active.

Your post, however, raises a different question and a good one at that. How many people are being diagnosed each year with MS and where? What treatment (medication) is being used the most? If I go by what my doctor says there has to be some 1000 people a year if not more diagnosed in my city alone with a population of 125,000. I too wish I had better data on this.

[MSSpouse]

We need a better count of how many people have MS, for lots of reasons. For starters, I think that if folks got a clearer picture of just how many people are living with this disease it would go a long way toward destigmatizing it. It also could help to draw more research dollars to finding better treatments and, ideally, prevention and a cure. The often-cited 400,000 figure for the U.S. (dating from 1985) seems to me almost comedically low--well, it would be funny if it weren't about MS!

I also wonder if we have an accurate picture of the 'typical' MS patient. We often hear that 2/3 of the patients are women, 1/3 are men, and that most people are diagnosed between the ages of 20 and 40. The composition of the dozen or so people in my circle with MS is quite different from that. I get a little irked by the assumptions that are made about who gets MS, because they very nearly caused my MSer spouse's diagnosis to get missed. (Boo to the assumption-making internist who ruled out MS based on demographics, bravo to the emergency room PA who looked at the symptoms her patient presented, ordered the right tests, and made the right call.)

[garyp]

Different agencies and societies have different numbers...starting at 250k and going up to 1m. There is no official registry of MS sufferers - no one is keeping track.

Most MS drugs have what is called "Orphan Drug" status from the FDA. Orphan Drugs are intended for small population groups and/or rare diseases. If a drug qualifies for organ drug status, then it has longer patent protection - this is so that there is a longer time period to recoup the investment on smaller patient populations.

[MSSpouse]

Gary, that's exactly my point. We need better data on how many folks have MS, and some decent demographics on that population.

WRT orphan drug status, if I recall correctly, Avonex had it and as a result had exclusivity--something that goes beyond patent protection--in the US market for beta interferon. That protection was due to expire sometime in the previous decade. This kept Rebif off the US market until its makers were able to demonstrate it was more effective and thus be allowed on the US market before the expiration. If I understand the situation correctly, Rebif doesn't have orphan drug status inasmuch as it clearly doesn't have the market exclusivity that comes with it. For that matter, the exclusivity only lasts seven years and it's been on the US market longer than that.

It's interesting that orphan drug status has historically been given to some MS drugs (anyone know about Gilenya?), given that it's not exactly a small population that has the disease, and that the very active marketing around these drugs suggests they are quite profitable! Orphan drug status can be useful in some situations, but given the Avonex/Rebif history, we see that sometimes it can serve to restrict US patients' access to helpful therapies.

[andersimp]

# of us in this club

we are not tracked by CDC, thus no one has accurate #
also, some docs don't want to dx re: insurance issues ...
so lobby CDC!

[MSSpouse]

Yes, it's clear that MS is not being tracked in any way, and why not is a puzzlement, to say the least. It has been a concern of mine for some time now that MS patients do not have an effective lobbying effort.

One sign of this was seen during last year's federal budget battles. A proposal from the White House to fund an actual effort to count and track MS diagnoses, with a very modest price tag, was quickly eliminated once negotiations with Congress began. We can get some clues about MS numbers from the financials of publicly traded drug companies, but why are we left grasping for clues when those with so many other diseases are armed with facts? The CDC can't do a darned thing without funding from Congress, and in this area they aren't giving it. And they probably will continue not to, until there is a much more serious and effective lobbying effort in place.