First of all, thanks to my friends (Elizabeth and Joseph) for helping me make (and edit) this video on short notice. I felt this was an important announcement to talk about.
I have included several links to the announcement and other articles I used to create my response to this announcement. Please see them in the Youtube description.
I do realize that this has happened to other drugs, past and present. I will clarify that I have an objection to pulling any medication used in orphan and/or rare diseases, transplants, or other vulnerable groups with little notice and NO contingency plans to ensure that quality generics will be made available for use and produced in sufficient quantity to meet demand worldwide, especially with a drug with a history of recalls for quality and documented shortages even when the drug was being mass produced. I say this because these drugs are life-sustaining medications that cannot be easily substituted.
That said, here’s the video:
I will also point out that this is my own personal opinion and may not align with the thoughts of the TSC Alliance or The LAM Foundation. I speak only for myself. There is also history here that comes into play with this drug and the fight to get it approved that I have not discussed here to keep things clear and concise.
Suffice it to say the patient community did the significant lifting to fight for compassionate use of this drug with little to no help from the manufacturer. Yet, the manufacturer has made nothing but profit from these populaces and has enjoyed longer patent exclusivity than they would have otherwise. To me, there’s a moral and ethical responsibility here if you are going to profit off Orphan drug status to put contingencies in place to turn the patent over to responsible generic manufacturers that can meet demand and to communicate this in a coordinated effort.
Not just an announcement that basically states, ” We aren’t profiting off this drug anymore in the US, so we’ve opted to just stop making it in the United States.” Pfizer made an arbitrary call that there are enough generic manufacturers, not a factual one with documented track records of quality production, as even just a few years ago, they couldn’t manufacture enough drugs to meet demand. In a few years, when worldwide demand may wane or they cease to profit, will they do the same to other countries where in some, even fewer options remain?
(Full disclosure: I took Rapamune for quite a few years until I had a hypersensitivity reaction to the drug after they put me back on it after my transplant in 2016. Right now, I only use compounded rapamune cream for my TSC facial lesions, which I started this summer. This is another facet of use that is not discussed, as I was trying to keep the video short and succinct and hit on the major pain points of this decision.)
As I live And Breathe 