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"If people have no bread, let them eat cake" 6 years 8 months ago #25016

  • rohcvfighter
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Hello Everybody,

in the last couple of weeks I noticed in my country a campaign about hepatitis (including HCV) which is saying almost the same things as in the past (get checked, talk with your doctor, HCV can now be treated), but missing a very essential point: the HCV treatment is given only to few, while a large number of people remain untreated. The reason is simple: only very expensive treatment is being provided and since the money is a huge problem, only few people will get the medication.

I asked myself again, what is the point to let people know that HCV can be cured, only that they will not have this chance?

This reminded me a famous quote from some hundreds of year ago: "if people have no bread, let them eat cake". It is stupid, but this is a truth that cannot be denied.

To give some numbers: in my country there are more than 600 000 people with HCV and with some luck, only ~12 000 will be treated this year with branded medication.
In plain English: 98% of sick people will watch how 2% will eat a cake.

The generic HCV drugs are the "bread" people need: is much cheaper and may be legally imported.

One more thing: I updated my signature today including the video from FixHepC about how to become a hero so that people may find easily the way to buy the "bread" :). And of course to share it if they wish.

Cheers,
RHF
In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR52 achieved
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"If people have no bread, let them eat cake" 6 years 8 months ago #25027

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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 :)
Failed Interferon 96', G1a, VL = 9 - 5.5 Million, F3/A3, AST 111, ALT 190, Generic DAA treatment Sof/Led (Mylan - India MYHEP LVIR) - 8 June, 2016
2 Week Results 20 June, 2016 AST 19, ALT 32
4 Week Results 06 July, 2016 AST 22, ALT 30, VL = 35
6 Week Results 20, July 2016 VL only = HCV RNA Detected, Non-Quantifiable <15
8 Week Results 04 August 2016, Labs, LFTs Normal, VL = UND
12 Week Results 31 August, 2016 LFTs Normal, VL = UND
EOT + 4 Weeks, LFTs Normal, VL = UND, "SVR4"
SVR12, 21 Nov 2016. CURED!!!
The following user(s) said Thank You: DrJames, klhilde, coral, Gaj, splitdog, rohcvfighter, Donna, Iain, Mnem

"If people have no bread, let them eat cake" 6 years 5 months ago #25332

Not 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.
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"If people have no bread, let them eat cake" 6 years 5 months ago #25340

  • DrJames
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Hello 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:

www.fda.gov/AnimalVeterinary/GuidanceCom...cement/ucm042132.htm

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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