Possible Significant Delay In Release of Generic Harvoni From India

This announcement was posted yesterday from one of my Hep C activist friends in Asia, he has very close connections in India. It is disturbing news and shows just how much reach and influence Big Pharma has across the world, across borders and into government structures.

As I have been repeatedly saying, if you can do treatment now with generics then DO IT NOW. These doorways to generic treatments may close at anytime.

An expert committee in India associated with drug regulators have asked for clinical trials to be conducted by the Indian producers of generic harvoni and generic daclatasvir. This can substantially delay the entry of these two drugs in India. Treatment advocates are working on areas to do away with these trials so that approval would be granted just as it was granted for generic sofosbuvir. It’s possible but uncertain that we will succeed but also possible that the release of generic Harvoni in India will be significantly delayed. This is for the information of all who are waiting for generic harvoni and daclatasvir to be released in India.

18th September 2015

Well I guess it had to happen, when you are battling forces like Big Pharma who have billions of dollars and hundreds of people that they can put into the battle, they are going to figure out some cunning plans and they are going to implement them.

This weeks sees the first phases of Big Pharma’s long term plan to block people’s access to affordable Hep C treatment.

First they are working to prevent the early release of generic Harvoni in India, an important event that millions of Hep C patients around the world have been waiting for. Of course Hep C activists in Asia are trying to prevent this but it is difficult when you know how much money Big Pharma can throw at people in positions of influence in India. Money talks, money buys favours, money buys influence.

If the release of generic Harvoni is delayed in India you can be pretty sure it was big money from Big Pharma that was a major influencing factor.

What else?

APIs

The other great avenue of hope an healing in the last few months has been Chinese APIs. People have been able to purchase Daclatasvir and other Direct Acting Antiviral’s as concentrates and get them made into doses by chemists. Combining these DAAs with Indian Sofosbuvir has enabled access to highly effective and affordable Hep C treatment for all genotypes.

Up to now it has simply been a matter of sending and email, placing an order and sending the money. A week later the API arrived at the door and treatment began.

People were having fantastic results from this approach.

The hint that avenue was closing occurred a couple of weeks back as Mesochem started to tighten its requirements. Now those requirements have tightened further and it seems that very soon only bulk orders of Hep C APIs will be obtainable.

Access to Hep C APIs is also being blocked by sending the fear mongers into the retail pharmaceutical world. In Australia this has taken the form of an official letter warning Compound Chemists not to be involved in making APIs into capsules because this is likely to be part of a scam.

So this will force people into making up their own doses rather than have a professional chemist do it properly for them. Of course that is assuming that people are able to get APIs at all.

Next a leading liver specialist from one of Sydney’s leading hospitals, who sits on a number of boards associated with getting Hep C meds on the PBS, has created his own anti- generic fear campaign by warning of the unreliable quality of India generics. Of course he has done that without ever having had any of said generics tested. And he claims to be an advocate of science, when really he is just a flunky for Big Pharma.

So the mean machine of Big Pharm grinds on, using money and influence to crush the hopes of a cure for the tens of millions of people with Hep C. Using its power and influence to manipulate the media and well placed individuals within the health industry to achieve it goal of blocking access to affordable Hepatitis C treatment.

In Australia the good news is that the Sofosbuvir + Simeprevir is recommended by EASL as a good treatment for Genotype 1 and Simprevir is approved by the PBS here. This means you can get the Sofosbuvir from India and a prescription for the Simeprevir and there you have a pretty damn good combo for G1 and a couple of other Genotypes also.

Yet there is still good news. I received this email yesterday from a guy who opted to treat his Hep G1 with Sof+Riba thinking that a 68% chance of a cure was better than none. He was almost half way through a 24 week course when he heard of the Daclatasvir API and added that to his treatment.

Hi Greg just to let you know my 8 wk results are in. After eight years of knowing and fighting the hep c virus I am virus free! Roll on the next three months with sofosbuvir and daclatasvir .all thanks to you cheers mate .

20th September

A sudden and unexpected Development

A sudden and unexpected development has occurred that reminds us that the reach of Big Pharma into governments and bureaucracies is profound. Because of its money and influence we have just seen how Big Pharma is threatening to postpone or stop the release of generic Harvoni in India.

Now the same kind of thing is happening in Australia. Yes Big Pharma can even reach into the Australian Department of Health.

Yesterday the ADH issued a directive to all Australian compounding chemists telling them not to put Hep C APIs into capsules for people suffering from Hep C.

Yes the Australian Department of Health is trying to stop Hep C patients treating their Hep C with APIs by forcing compounding chemist to stop mixing and encapsulating the APIs making safe doses.

What will the affect of this be?

Well quite simply people will have to start mixing the doses themselves and putting them into capsules themselves. Indeed they have already starting doing so.

So what have the clowns at the Australian Department of Health achieved ? They have removed a safe and effective method of turning the APIs into usable does and forced people to use ‘back yard” methods.

This is typical of the short sighted and narrow mindedness that pervades Australia’s medical “establishment”. Don’t worry about the fact that 2 Australians are dying every day from Hep C. Don’t worry about the fact that here is a cheap accessible and reliable treatment that costs the government nothing and is curing hundreds of Australians of Hep C right now. No… just listen to what Big Pharma wants and do that. Pathetic!

Two Emails on this subject

Hi Greg,

A new development, the compounding pharmacist I used before to make my Daclatasvir API into capsules now refuses to do it . Their professional body has issued a directive that they are not to compound the Daclatasvir due to it coming from China and exposing them to some form of liability. Could you see if your contact in Tasmania will still do it and if so could you give me an introduction or an address and phone number . Big Pharma and vested interests, shit so much for a cohesive Australia, empathy towards fellow Australians is non existent – The pharmacist organization is so corrupt!

And Again

I took my Dac concentrate to the compounding pharmacy. The chemist rang me to say the Australian Health Department has put out a stop on the concentrates being capsulated as they have had reports that some of the chemicals coming in are a scam. He said he would try to talk with the AHD and resolve this problem for me

He received this notification from the AHD yesterday. So this might be the first you hear of it

Regrettable…. I may have to make up the caps myself. It can’t be that difficult can it? Just mix it in a bowl in the correct ratios for an hour with ?glucose? Then pack it up…

I will keep you posted. The Chemist seemed very sorry about this situation but he is concerned about liability down the track. He did say that if my doctor wrote to him to accept any liability he may cap the medication then… I don’t feel my doctor should have to do this… Its not fair… I may have to get a solicitor to write up some sort of disclaimer…

So even in places like Australia Big Pharma can pull strings in government and bend the bureaucrats to do its will.

20th September 2015

And how do we respond to the machinations of Big Pharma and the medical establishment? We find another way. Please read below.

I got this email from one of my friends today, showing humans will use their ingenuity and will always overcome the obstacles placed in front of them:

Last time we were in touch, I was looking for a doctor to give me a

prescription for Indian Sofosbuvir. I didn’t find one and ended up

ordering APIs from Mesochem.

My Sovosbuvir and Ledipasvir APIs arrived this week and I have been

looking for a compounding chemist to make up the capsules. I found one

on Friday afternoon who was happy to make it up (maybe she hadn’t read

her mail yet). I asked her what the procedure was for encapsulating APIs

and the system she told me was far simpler and more accurate than

anything I have come across on the web. I give it here in case you want

to publish it for anyone else who is in this position.

She first weighs out the total amount of the API. So in my case, that’s

400 mg Sofosbuvir + 90mg Ledipasvir for 12 weeks, so 84x400mg = 33.6

grams of Sof and 84x90mg = 7.56 grams of Led. Note that this does not

require a multi thousand dollar milligram scale. 1/10th gram accuracy is

plenty. 1/10th gram over 84 capsules is .1/84 = 1/840 = about 1

milligram error for each capsule. This is well inside any reasonable

tolerance. A .1 gm scale costs under $100.

Then put the weighed APIs into a measuring cylinder. Measuring cylinders

cost under $10 at any laboratory glassware dealer. Use the smallest that

will hold the entire batch. Add excipient (e.g. lactose) to the cylinder

to make up the correct volume. The chemist already knows the correct

volume, because she’s done this before, but the rest of us have to find

the correct volume before we start, which is done by carefully filling

84 capsules with lactose and pouring them into the cylinder. Whatever

volume results is what we have to make up the final mixture to.

Pour the API/excipient mixture into a bowl and mix well. This sounds

like the hardest part of the whole procedure.

Fill the 84 capsules with the mixture. If everything has been done

carefully and accurately the mixture will just fill the capsules without

any waste. If it was thoroughly mixed, the APIs are now distributed

evenly at the correct dosage over the 84 capsules.

One thing she mentioned was that 400 mg Sof + 90 mg Led is a lot to put

in one capsule, and its probably easier to make 168 capsules of 200 mg +

45 mg (i.e. 2 capsules per day), which is easily done by changing the

volume the mixture is made up to.

I left my APIs with her since she said she could have them ready by

Tuesday, but since I need 24 weeks of therapy, I will probably make up

the next batch myself.

So we see again attempts by Big Pharma have failed to stop sick people making a cure for themselves.

We will be free of this disease.

We will regain our health.

We will not be stopped.

We have the means and we will be free of Hep C.

I should also add that in conversations I have had with two doctors on this subject they have both told me that minor variations in the amount of active ingredient between capsules is not critical. Even with factory manufactured meds the absorption of active ingredients by the body varies slightly from day to day so we do not have to worry if one capsule has 400mg of API and the next has 394mg and the next 406 milligrams.

21st September 2015

Well I guess there has been a bit of bad news over the last few days. The compound chemists getting the leaned on. The release date of Indian generic Harvoni getting less certain. I am sorry to have had to report these things but let it be a reminder that there are many cruel and greedy people who do not care one jot for the suffering of others just as long as they can make money. It has always been this way throughout history. We should count ourselves lucky that we have so many options.

Are Britain’s Doctors All Cowards? Some Interesting News On UK Doctors.

As readers of this blog would know I have been raving on about the fact that whilst it is perfectly legal to import these generic Hep C treatments in the UK it is almost impossible to find a doctor in the UK who will write a prescription for a patient with Hep C, even if they are on death’s door.

The pathetic nature of most British doctors is further revealed by this recent discovery from the BMA website:

The British Medical Association’s own website:

From the BMA website:

Question: If a drug is not available on the NHS, can my GP write me a private prescription for it?

Any doctor can write a private prescription for a patient if they feel it is clinically appropriate and they are happy to take responsibility for that prescribing decision. Under the NHS regulations, a GP or his deputy can write a private prescription for a patient but cannot charge the patient for writing a private prescription if the patient is registered for NHS care with that GP or any other GP in the same practice.

The only exceptions to this rule are when an NHS GP writes either a private prescription for:1. Drugs which are being issued solely in anticipation of the onset of an ailment whilst outside the UK, but for which the patient does not require treatment when the medicine is prescribed.

2. Drugs issued for the prevention of malaria.

Worth pushing your doc for a proper prescription. Google link to the doc below

22nd Sept 2015

Things are moving very fast now. The drug companies and their flunkies in government and the medical ‘Establishment’ are trying to stop people accessing affordable treatment for their Hepatitis C. In the USA and the UK they are presently succeeding but not in Australia and many other countries around the world.

In Australia doctors who care about their patients are standing up and countering the efforts of the Professors in the research hospitals who are more concerned about getting their millions of dollars in research grants from the drug companies than actually curing the hundreds of thousands of people with Hep C.

These are the ones who tell people “Wait. Wait. Wait.” And then one day the person who is waiting discovers their liver has become cirrhotic or worse, that they have liver cancer. Don’t “Wait. Wait. Wait.” Get healed now before the disease progresses and the damage to your liver becomes catastrophic. The cure is there now. Just do it!

I would like to share one of the reactions to the news of compound chemists getting leaned on before sharing some good news.

Oh Greg,this is such bad news,I feel like weeping as I am supposed to be

sending my API’s to the compounding chemist tomorrow, also just paid for

API’s from Mesochem for my husband. I will call chemist tomorrow,this is

such a fraught process. One step forward,one step back,perhaps we will all

have to learn how to make up doses ourselves So I will let you know how I

get on,

regards ######

Now the good news. I have received confirmation that a number of caring compound chemists have decided to ignore the “directive” to stop encapsulating APIs and so I have compiled a list of compound chemists who will still do this and was able to pass this info on to the person above.

So good people will stand up and be counted.

Interestingly the problem with doctors that exists in the UK and USA also crosses over into the compounding chemists.

It is impossible to find a compound chemist who will put the APIs into doses in either the USA or the UK…. what is going on in these places?

23rd September 2015

Please Support this Hepatitis C Petition

This link is to a petition started by Ralph Maples to try to bring the issues surrounding Hep C treatment and access to affordable Hep C medicines to the attention of the Australian Government.

Ralph had Hep C for more than 30 years and is unique for being one of the first people in the world to use Chinese APIs to successfully treat his Hep C. Ralph initiated his treatment himself and, after being told he had only 12 months to live (2 years ago), he has been clear of the virus for more than a year now and is full of energy and life. Ralph is a real pioneer and a great inspiration to others, showing that waiting around and letting doctors and bureaucrats decide your future is a recipe to disaster. Please support his petition and read his story by Clicking This Link

More Good News

One of the sayings that I love is: “Evil triumphs when good people do nothing.”

I am really excited to see that the population of compound chemists of Australia is made up of many good people who are responding to the fascist postion of their national body and the Australian Department of Health by ignoring the letter sent telling them telling them to stop encapsulating Hep C APIs.

Yes it is still possible to get your APIs encapsulated in Australia.

But Wait… there’s more.

I have just made a connection that will supply encapsulated Daclatasvir for $350 for 84 doses inclusive of delivery anywhere in Australia. Forget about Mesochem and all their tricky questions, this is going to be SIMPLE.

I am still working on the supply process but should have it all up and running within 24 hours. Things are looking up.

If you need Dac think about this before Big Pharma moves.

Breaking News (does that sound a bit corny?)

Have finalised arrangements with new supplier of Daclatasvir who will supply 84 capsules of Daclatasvir for Aus$350 delivered anywhere is Australia and $420 delivered anywhere in the world.

Each capsule capsule will contain 60mg of Daclatasvir plus inert filler. The Daclatasvir comes from a TGA approved manufacturer and is tested.

A new phase of affordable Hepatitis C treatment begins.

This new supply will be available in two weeks from today.

26th September 2015

I received this email today:

Hello Greg

Just finished my treatment with the generic meds and my AST ,ALT and GGT are back in the normal range , my platlet count is nearly back to normal range ,so it looks like the generics might have cured my HepC 1a.

Looking at the dramas other people are having now getting the generic meds I’m glad I moved quickly to get them back in June; I can’t understand why people stuff around so much.

I’m still in Vietnam and won’t be back to Australia for a few months, so I’ll get my blood checked every week now, if it moves in the wrong direction I’ll

jump on the Harvoni equivalent , very hard to talk to Vietnam Doctor’s about it, all my info is from the Net now, probably for the better!

thanks for your help

#######

Why have I posted the above email? Because I want to make the point again:

Do not put off your treatment!

Maybe your insurance will cover it next year, maybe it won’t.

Maybe the treatment will get listed on the PBS next year, maybe it won’t.

Maybe there will be better drugs available next year, maybe there won’t.

Maybe all these generic options will be gone next year, shut down by the power of billions of dollars of Big Pharma influence.

How would you feel then?

Highly effective and affordable generic treatment options are out there NOW!

Take control of your health, find the treatment option that suits you best and do it now. You could be Hep C free by Christmas.

26th September 2015

Why the picture of the hole?

The Whole Story

I started digging this hole under our house about half way through my treatment. The hole is dug into very dense hard clay. When I started digging it I could only dig for five minutes or so at a time before I became exhausted. So progress was VERY slow.

Toward the end of the treatment, in the last couple of weeks, the Ribavirin was knocking off quite a few of my red blood cells, I did not become anaemic but I got close to it. So even though the virus was gone doing hard physical labour was difficult. I ran out of puff pretty fast, like running at a high altitude. The low red blood cell count had an affect.

Even when I had finished treatment and stopped taking the Ribavirin its effect lingered. Ribavirin accumulates in the body, even when you stop treatment you will feel it there, in you body, in your blood. It took nearly three weeks before I knew the Ribavirin was gone.

And now it has gone and the virus is also gone and you know I can work hard for hours now, non-stop. Mattock, crowbar, shovel… the fatigue is gone, the exhaustion is gone, the brain fog is gone. I am fit and healthy again!

The same thing will happen to you when you have destroyed the Hep C virus. The transformation is amazing and it happens quickly. Everything changes and changes for the better.

I met up with a friend the other day who is exactly the same age as me, 61, she also just completed her treatment.

When I first met her she, like me, had been carrying the Hep C virus for more than 35 year, and like me she showed it.

Now, treatment completed, she looks and acts and sounds ten year younger. It is amazing to have witnessed her transformation. The return of her vitality and energy is inspiring.

So don’t feel as if this virus is going to defeat you… it won’t. The means to be rid of it is here now.

Some people are waiting for generic Harvoni.

Some people are waiting for the PBS or the NHS or their health insurance to cover the cost of the treatment.

Don’t wait.

28th Sept 2015

Another email another brilliant story of healing.

Hi Greg

Time for an update –

I had my first monthly blood test and it showed that I am virus free in only 4 weeks!! Amazing! The crippling fatigue was my most prominent symptom from having Hep C- I used to spend up to eight hours a day lying down (before night sleeping), dragging myself around for necessities in between. Now I am not tired at all and wondering what the hell people do at seven o’clock in the morning! Am looking forward to finding out though – can’t thank you enough.

Hope all is going well with you #####

So the good stories are flowing in, there are a lot of new options, new doors opening this week. Exciting times. Email me for more information on how to get access to various generic Hepatitis C treatment options.

Now you may be wondering why I keep raving on about getting started with an appropriate treatment now. I know I am ranting about it but there is a reason.

Let me tell you the story of a person that I know.

He got Hep C about 25 years ago. He was in a car accident, sitting in the passenger seat beside the driver. The driver had Hep C.

Car accident… glass, blood, cuts and grazes. He caught Hep C from the driver and found out about it within a week.

The Hep C sat in his body for 25 years without doing much. At age 50 it stirred a little and his specialist decided to do 3 monthly check ups. Everything was fine, LFTs were not high, liver showed no lesions or other problems.

Then BANG sometime in between one 3 monthly test and the next the Hep C went crazy. Elevated enzyme levels, three cysts in the liver, the beginnings of cirrhosis. It happened that fast.

Fortunately this happened not long ago and he had heard about the new treatment options and started treating his Hepatitis C with generics about 6 weeks ago and instead of things getting rapidly worse they are now getting rapidly better.

But what would have happened if he had not been getting a 3 monthly check up? What if he had been getting a check up every twelve months? Things could have got a lot lot worse before he started treatment.

What if, instead of starting on the Indian generics immediately he had waited for the generics to get listed on the PBS and was still waiting in 6 months time?

Don’t put off until tomorrow that which you can do today.

A stitch in time saves nine.

A gram of prevention is worth a kilo of cure.

He who hesitates in lost.

Etc Etc

29th September

Well it’s happened. Mesochem is now refusing to supply any APIs to individual persons.

Bang… door slams shut. Lucky for those who have got their meds… unlucky for those that have not.

12 hours later

Good News! I’ve found another source of Daclatasvir, more reliable and no hassles. Yay thanks to Ralph and a network of caring people!

1st October 2015

Well I guess the new month is the time to give you an update on my own life and what has been happening.

Firstly, health wise, things are great. My energy, strength, fitness and general health are improving noticeably every day. It is only when treatment if fully over and the meds have left your system that you really notice just how much the Hep C had knocked you around. Its very profound and very amazing how quickly the body recovers once the viral load has gone.

In my life generally I am pretty much consumed answering emails and helping people organise getting generic medicines for treating their Hepatitis. On average I get over 100 emails every day of the week. So far today I have received more than 130 emails, by the time I go to bed tonight it will be more like 150.

I try to answer all the emails every day because if I do not they back log becomes too big to deal with.

Now I should say here that I am happy to do this. Indeed I feel greatly honored to be able to help people reclaim their health. Having lost my health and had it returned I know there is no greater gift. I am grateful to have received it and I am grateful to be able to help others also get their health back.

It is a great shame that I can not sing the praises of the people who invented these new drugs because their greed has marred the greatness of their gift. Instead I must praise the people in India and China and Australia who have made the generic versions of these new drugs available.

When I am not answering emails I do work around our house. We live in a house built in the 1890’s in southern Tasmania. Being a house built of timber there are always a few jobs to do.

I also work in my vegetable garden, where I grow veggies for our table and also for the kitchen of the hotel in our village.

And of course I go trout fishing at least once a week and try to get out on a river or lake in my kayak at least once a week.

And at least once a week my wife and I go and spend an afternoon with my son and daughter-in-law and my first grandson who is now 9 months old.

When I discovered I had Hep C last year and the prospect of liver cancer loomed large I was really worried that I would not live long enough for my grandson to remember me but now I know that I will and I rejoice for that gift.

My life is very good and I am grateful for it.