U.S. Rebif users--anyone see this?

[MSSpouse]

Took me a while to pull on the green eyeshade and read through the Merck Q4 2011 results, dated March 6, but I got to it today. Reading through the conference call transcript, I noticed this bit of news of note to U.S. MSers who use Rebif as part of their stay-active plan:

On December 15th we received a warning letter from the FDA related to inspections of some of our production facilities which contribute to the production of Rebif for distribution in the US. The letter primarily addressed several processes related to the manufacturing of Rebif. We are communicating with the FDA to discuss the steps we have already taken as well as the steps we will take in future to resolve the findings noted by the agency. There is no disruption to the supply of Rebif. Patients that have been prescribed Rebif can continue their therapy.

While supply hasn't been disrupted yet, the findings in the letter are nonetheless a little disquieting. You can read the letter here:
http://www.fda.gov/ICECI/Enforcement.../ucm291672.htm

This is another concern for U.S. Rebif users, on top of last year's withdrawal of the application for FDA approval of the HSA-free formulation.

This board attracts folks who take a hands-on approach to their MS treatment. To that end, I encourage all of you to take some time to go through the financial reports of the pharma companies that make the MS drugs. Think of it as learning a new language! You'll see stuff in there that never makes the headlines, let alone the patient brochures. You'll also get an eye-opening look at the priorities and pressures that drive these companies' actions and behaviors.

[AMFADVENTURES]

Granted, capitalism does not seem to be the optimum system under which to pursue a cure for chronic disease. So where does one turn, NMSS (bring in those donations), The NIH (be an activist for funding), the Third World (a hope and a prayer), Nike (other deep pockets with some kind of skin in the game)?

I’m sure it’s a sore point with many of us. If it's not, it should be. But I can’t even begin to see a solution. Of course, the treatments are getting more expensive, as they get better (or maybe I got that backwards).

[MSSpouse]

Interesting perspective--thanks for commenting. I'm sure not arguing against capitalism, but given that it's the system our pharma companies operate under, reading investor communications can be very revealing about what's really going on behind the scenes at the companies that bring us our meds. These companies speak to the investment community very differently from the way they speak to their patients/customers.

That said, here's another illuminating bit from the Q4 2012 earnings conference call:

Rebif capitalised on its strong position as the leading therapy for multiple sclerosis in Europe. It generated higher volumes compared to last year in Europe while US sales benefited from higher prices that more than offset softer volumes.

In other words, in the U.S., prices went up while demand went down. That's a reversal of the usual rules of supply and demand! And in this case, the price of the drug is going up even though U.S. users are denied access to the newer HSA-free formulation which is generally considered to be better for patients.

I continue to believe that the MS community is not served adequately by the current lobbying efforts made on its behalf. I'm sure folks are trying, though.

Here's the link to the whole transcript:

http://www.merckgroup.com/company.me...9.pdf?Version=