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Dr James.
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22 July 2017 at 7:40 am #26624
Well said, rohhcvfighter!
It’s been a year and a month or so since I began treatment with generic DAA’s, and had frankly lost track.
Getting free of Hep C definitely sets one on a different course. Instead of waiting for the next shoe to drop, it’s all about making up for lost time and setting a new course.
Sounds a bit selfish, and so it was. Admittedly, the decision to save my own life was extremely selfish and self serving, and ‘insurance be damned’, making the decision to get well – in retrospect – was one of the best decisions I’ve ever made.
In the intervening time, I’ve lost my former GP to retirement and gained another through insurance. A nice enough guy, who was surprised to learn that I had to wait a year for an appointment to even see a Gastroenterologist, and was shocked to learn that when my specialist finally prescribed Harvoni, the insurance company said in no uncertain terms”you can have your prescription filled, but we won’t pay for it”.
Looking over my stats, he didn’t even mention Hep C. A year after starting treatment, and after a previous UND result ordered by former GP, my labs were normal. Completely unremarkable with a few minor niggles (cholesterol a bit high, need to exercise – walking is fine – watch the diet, etc) .
There was apparently absolutely no reason to bring up an issue that had been resolved long before I had been assigned to him.
So, I brought it up.
Pointed out to him that after loosing both hips to Hep C, undergoing a spine surgery which saved my ability to walk, and after loosing several teeth to Hep C, I was no longer having orthopedic or dental issues, that Hep C was a systemic illness, and that I was thankful to finally, once and for all, to be free of it.
I also pointed out, rather specifically, that I had been cured with generics.
Perhaps I was a bit too insistent, or pedantic, or my breath wasn’t fresh enough. It was like a curtain closing abruptly. Although my new GP remained courteous, and professional, the guy couldn’t wait to get out of the exam room.
No worries though. I’m happy, and well and free of Hep C, and that’s all that really matters
7 October 2017 at 9:10 pm #26914Not sure if this is the right forum but I need insight any US FDA issues anyone might have had. I received my prescription 2 weeks ago and I am glad to say all is well with no side effects so I have been elated. Unfortunately, i received a letter of action from the FDA today and now i am deflated. Has anyone in this program experienced any FDA issues that I might be able to get some insight about this type of issue? Thanks.
13 October 2017 at 8:06 am #26922Hello Are215,
As far as I know you are the first!
What did it say?
Can you send it through privately so I can have a look?
Did it have a title? This is important because:
Depending on the nature of the violation, it is the FDA’s practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action.
Advisory action letters include Untitled and Warning Letters. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. Warning Letters are issued for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Warning Letters are posted on FDA’s website.An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter. However, Untitled Letters serve as an initial notification to firms that FDA is aware of their violations of federal law. It often serves to document formal notification by FDA to the person or firm, and allows the firm to come into compliance without further FDA action.
The Center for Veterinary Medicine (CVM) is posting Untitled Letters on its website to keep the public informed about persons or firms violating the law. We expect that posting these letters will deter other similar violations.
Anyway, if you got your medications from us, and in the event anything further happens I will personally fund your legal defence.
YMMV
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