Angie spoke to Jennifer at Internationale Ludwigs-Apotheke last night and the 3 month limit is
still imposed as it is a customs restriction. With what we have plus the new supply we will only have enough medication for maybe through January of ’06. She did tell us that the insurance that is the issue here is a protection mechanism, in order to protect themselves from a lawsuit in the United States. This policy recently ran out and is prohibitively expensive, and difficult to find an agency to carry such a policy. Because of this they are not willing to absorb the cost for only 50 patients in the US and Canada who take this medication. This is understandable from a business perspective, however it leaves those of us that need this medication with no alternative, which as we know has serious consequences.
After the conversation with Jennifer, Angie spoke with Karin at Falk foundation, the manufacturer of CDCA.. She said in that the Falk foundation is in contact with other European pharmacies to see if they would be willing to take over the distribution of the medication to the US. She doesn’t seem to optimistic as the insurance regulations seem to be difficult and/or expensive to obtain that most pharmacies wouldn’t touch it with a 10′ pole. She is also in contact with a company in the US, I’m not sure if she said the name or not but my wife thinks it is probably Rare Disease Therapeutics, the company that was bringing the medication into the US for Dr. Salen’s study before all of this mess.
She said the drug sits on the shelves of nearly every pharmacy in Germany and that if we knew personally, someone in Germany that they could send it to us as they are not bound by the same restrictive regulations that pharmacies are. The issue is not that they can’t ship to the US, it’s the insurance required to do so that’s at issue here.
I have sent Dr. Salen an e-mail with numerous questions, and again, requested the contact information of the patients in his study. I feel that the importance of showing some strength in numbers is very real at this point could be instrumental in getting something done to be able to get this drug without traveling to Germany.
We have begun to contact various individuals at Rare Disease Therapeutics, the United Leukodystrophy Foundation, and the FDA. It’s too early yet to tell how things are going to proceed but we will keep the news updated as we get more of it.