Generic Harvoni and Daclatasvir

Before I start off this new page I would like to share this brilliant diagnostic tool that is on the web. In a few simple steps it looks at your genotype and general liver health and produces a simple comparative chart of how effective the various Hepatitis C treatment options will be.

In saying that it is not as comprehensive as the EASL Report on Hep C treatments but its a lot more fun and easier to read! Click the link below

http://hcvsvrpredictor.liverdoc.com/#/

5th August 2015

Generic Harvoni and Daclatasvir

Here is a worrying post from Gilead’s website… Thanks to David for bringing it to our attention. NOT a surprise but annoying.

“There can be no guarantee that marketing approval for Harvoni® will be granted in any of the low- and middle-income countries where registration is pending; any marketing approval, if granted, may have significant limitations on its use.”

The most likely containment procedure that Gilead might put in place is limiting sales to a one month supply at a time. This is what was done in Pakistan with Sovaldi.

Once again I am appalled at the greed of these huge, wealthy drug companies. That they should plot and scheme of ways to make obscene profits while people die slow and terrible deaths knowing that the cure is there but is being priced out of their reach. Not because the drug is expensive to make but because the makers are just so damn greedy!!!

Generic versions of Harvoni are the big hope for people with Hep C genotype 1. However there are alternatives, such as Sofosbuvir and Daclatasvir. This combination is also very effective against a number of Hep C genotypes but being treated with a combination of the two branded versions is even more expensive than Harvoni! A three month Sofosbuvir and Daclatasvir treatment would cost you about US$135,000

Now here I am going to stick my neck out here and say that I know of a number of people who have purchased generic Daclatasvir from Mesochem in China.

The product is in concentrated powder form with 6 grams of concentrate constituting an 84 dose lot for a 3 month Hepatitis C treatment and cost is about US0 delivered. These same people have had the product tested and it tests pure and bona fide. They have also found chemists with the skills and expertise to divide the concentrate into the correct doses and put it into capsules with the appropriate filler and the correct capsule type, apparently it is not a hard thing to organise.

The people who have done this are pioneers and are getting good results for their brave choices.

Here I must make very clear that I have no connection at all with Mesochem. I have emailed their representative Rachel several times to discuss the product, the company and prices. If a person should choose to try this path then they would have to contact Rachel directly and deal with her. It is a choice that a person must make themselves based on the best available information and medical advice.

I can also say that I know of two doctors and some other medical groups that have chosen this particular course.

The contact person is Rachel, email: rachel@mesochem.com

India Generic Sofosbuvir Manufacturers

I would like to point out that the factories that make the licensed generic Sofosbuvir in India are inspected and approved by numerous international authorities. For example Cipla, which makes Hepcvir is approved by US FDA, WHO-Geneva, MHRA-UK, TGA-Australia, SUKL-Slovak Republic, APVMA-Australia, MCC-South Africa, PIC-Germany, Danish Medical Agency, ANVISA-Brazil, INVIMA- Colombia, NDA-Uganda, Department of Health-Canada and MOH-Saudi Arabia and a whole lot more.

So here we have a Company that has been approved by virtually every significant government pharmaceutical authority on Earth, that has been producing quality low cost medicines for 80 years.

Another example is Hetero Pharmaceuticals who manufactures Sofovir.

Hetero offers a proven history providing reliable supply of both drug substance and drug product to most of the world’s top 20 global pharmaceutical companies and is the largest manufacturer of APIs and intermediates to the Indian pharmaceutical industry.

In addition, Hetero’s cGMP-compliant manufacturing facilities are approved by the highest regulatory authorities in each region (e.g., US FDA, WHO-Geneva, Australian TGA, Spanish Agency of Medicines & Healthcare Products, ANVISA-Brazil, IDA-Netherlands, etc.

Does anyone really believe that Cipla or Hetero are going to make fake medicines??? A reality check by all paranoid medical professionals is required.

Personally I consider that there is an underlieing racist Paranoia in this perception that because a drug is not made in a “first world” country like the USA or Switzerland then it is somehow suspect.

It continually surprises me that this type of totally illogical fear of fake, or counterfeit, medicines arises amongst educated medical professionals. Of course there are counterfeit medicines just like there are counterfeit Rayban sunglasses and counterfeit Rolexes and counterfeit dollar bills but this does not stop us buying sunglasses or Rolexes or using dollar bills. It just means one needs to use a little common sense when buying these things. Know the supplier. If you buy a set of Raybans off a guy selling them from a barrow in a side street then there is a pretty good chance they are going to be fakes. If you buy them from a shop that is an authorised Rayban dealer and has been in business for 40 years from the same premises then you can be pretty sure that you are buying real Raybans; it’s not rocket science it’s just common sense. The same applies to generic drugs. Do the research on the manufacturer and supplier, it’s not hard. If you are not sure than ask someone, like me, who knows. I am happy to suggest reliable suppliers. Contact Me

Many of these medical professionals who are so fearful of fake meds, particularly in the UK but also in other countries such as Australia, do not even know that it is perfectly legal for their patients to import these medications for personal use. This is very surprising given that such information is so important to helping patients with Hep C achieve good health outcomes.

Some people have suggested to me that this ‘ignorance’ is actually the result of a sustained campaign of misinformation mounted by Big Pharma to try to stem the flow of generics into first world countries.

8th August 2015

USA deliveries of Sofosbuvir for personal use.

My friends from India recently successfully completed a “worst case scenario” delivery of a three month treatment of Sofosbuvir and Ribavirin tablets to the USA.

As some of you may know the way that Customs works in most countries is that there is a random sampling of goods arriving from overseas origins. In the USA this random sampling has increased due to the issues surrounding international terrorism.

In practical terms this means that, lets say, one in every ten parcels comes in for superficial scrutiny and one in every twenty comes in for close inspection.

Close inspection means that contents and documentation is thoroughly inspected.

This happened recently with a shipment of Sof/Riba to a person with Hep C in the USA. This shipment had all its documents and contents inspected by Customs. The recipient was contacted and further supporting medical documents were asked for. The parcel and documents were then brought to the attention of the FDA who also inspected them closely. The result was nearly three weeks of official inspection of this shipment by every related US government entity.

Result?

The shipment of 84 generic Sofosbuvir tablets and 504 Ribavirin tablets was delivered to the person who ordered them and that person has now begun treatment.

So much for all the nonsense being peddled around by the fear mongers that it is illegal to import medicines for personal use into the USA.

My message to you folk in the USA; don’t get sucked in by the fear mongers, right now hundreds of people around the world are being cured of their Hep C by using Indian generic medicines. Despite what some people say your government does not want you to be sick or to die. If you can find a couple of grand then you can be well on the way to curing yourself of Hepatitis C.

Most other countries have very easy rules for importation of meds for personal use by their citizens. If you need help just write to the relevant government authority in you country, explain the situation and get an official ruling. You might be surprised how easy this process is. It might be even as simple as checking a government website.

If you need help or advice about your country please feel free to contact me as I am building a data base on various countries’ rules regarding importation of medicine for personal use.

10th August 2015

A detailed analysis of the FDA position on importing medication for personal use.

The Legality of Importing Medicines into the USA for personal use.

The issue of importing generic Indian Hep C medication is a controversial one in the USA. Not because it is illegal, because it is not illegal, but because there is so much misinformation about this, particularly in Hepatitis C forums and other Hep C social media groups. This misinformation comes as complete myths, half truths and outright lies. One can only assume that most of this misinformation has its source in persons or entities with a vested interest in dissuading people from using Indian generics to cure their Hep C.

By happy coincidence I am doing my PhD on the development of myths in the news media so it’s an area in which I have some understanding and considerable interest.

There are two area’s to consider when asking the question “Is it legal to import medicine for personal use into the USA?”

What is the FDA’s official attitude to this?

and

How is this reflected in reality?

Firstly I will analyze the FDA’s published policy, which is found on their website at this address: http://www.fda.gov/Aboutfda/Transparency/Basics/ucm194904.htm

My comments are inserted in the FDA text in red print.

The FDA official post reads as follows:

“In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.” (This can reasonably be described as a preamble)

“FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:”

1. “The drug is for use for a serious condition for which effective treatment is not available in the United States. “(Obviously Hep C is a serious condition. The big question here are the two words “not available”. Firstly low cost generic Sofosbuvir is not available in the USA. People then argue, “Ah yes but Sovaldi is available.” This is only partially true because it is not available to everyone. It is available to some people but not most. It is available if a person has the correct health insurance or it is available if a person is wealthy enough to pay the $90,000 to $180,000 for a treatment or it is available if a person qualifies for some form of charity treatment. Otherwise Sovaldi is not available.

Here we have to get a little legalistic (I apologize for this getting complex but I will finish with a simple summary).

The word “available” is the critical word here:

The standard dictionary definition of “available” is: “Able to be used or obtained; at someone’s disposal.”

synonyms: obtainable, accessible, easy to be had, ready for use, at hand, to hand, at one’s disposal, at one’s fingertips, within easy reach.

So if something is too expensive for a person to purchase then it is not available to them. For example a penthouse in Manhattan is not available to me because I cannot afford one; nor is a Rolls Royce or a 50 carat diamond or a first class airfare. These are all not available to me because of their price.

Therefore the Hep C treatment using Sovaldi in the USA “is not available” if a person genuinely cannot afford it. I believe that any reasonable person would agree with this.)

2. There is no commercialization or promotion of the drug to U.S. residents;

(This means that the person importing the drug does not plan or intend to promote or commercialize the drug to U.S. residents. In other words that the drug is solely for personal use.)

3. The drug is considered not to represent an unreasonable risk;

The FDA ruling on generic drugs is: “Generic drugs are chemical equivalents of approved brand name drugs. Since the safety and effectiveness of the brand name drugs have already been shown, generic drugs do not have to be tested for safety and effectiveness, as long as the generic drug is shown to be the same as an already approved drug. Generic drugs are approved under abbreviated new drug applications (ANDAs).”Gilead licensed India generics all conform to this requirement of being the same as already approved Sovaldi.

4. The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and

5. Generally, not more than a 3-month supply of the drug is imported

My summary:

1.Low cost generic Sofosbuvir is not available in the USA and Sovaldi is not available to most, or many, people.

2.If importing for personal use there is no intention for commercialization.

3.Generic Sofosbuvir is the chemically the same as the approved Sovaldi and does not represent an unreasonable risk.

4.You cannot bring in more than a three month supply

How is this reflected in reality?

In reality many people are bringing in many different forms of medicine for personal use. I know of a number who have brought generic Sofosbuvir into the USA. I have not heard of even one single person who has been prevented from receiving a shipment of generic Hep C meds from India so long as they conform to the FDA requirements mentioned above. It might have happened but I’ve not heard of it.

13th August 2015

Well it’s one of those weeks when a whole lot of stuff is converging for the perfect storm… well I hope it’s not a storm; but a whole lot of stuff is converging.

Tomorrow is the last day of my 12 week treatment on generic Sofosbuvir and Ribavirin. By co-incidence I am also booked in for my last lot of blood tests and my viral loads tomorrow as well: 9 a.m. sharp! I will share the results when I have them next week.

After the blood tests I drive out to meet the film crew from a national current affair program who are planning a story on the whole Hep C controversy. Then on the weekend I am hoping a similar story will be taken up by the national newspapers.

If those two things happen I am again hoping that one of the stories will get picked up by an international news service and cause some ripples around the world.

The Hep C story needs more attention!

Tens of millions of people are suffering and dying from a disease that could be cured… even entirely removed from the Earth as has been done with Smallpox and is being done with Polio; the only thing preventing the cure of these millions and millions of people and the eradication of this terrible disease is greed. Greed and the power that immensely wealthy corporations can exert over governments and individual politicians.

It could be a busy week for me next week.

14th August 2015

Another interesting day.

It began in the morning with me swallowing the last Sofosbuvir tablet of my 12 week treatment and ended with me swallowing the last of the Ribavirin. I’m very glad to have finished the pill popping!

After breakfast I went straight into the Hobart Hepatitis Clinic to organise blood and viral load tests and met the clinic’s new nurse who is replacing J while she is on long service leave. We discussed how many people in Tasmania and Australia have begun using India generic Hep C medication and how many other clinics and doctors are supporting the patients who are taking this course in order to gain access to otherwise inaccessible medication.

After I had my bloods taken I drove out to Huonville to meet up with the film crew again. This time they were interviewing M who was one the first person in Tasmania that I had helped to get the Indian generics. She is a bit more than nine weeks into her treatment and generously and bravely agreed to be interviewed by the current affairs program. I did ask a number of people but the stigma associated with Hep C is such that all felt uncomfortable with the idea of a national news story on their very personal battle with this disease, which I totally understand. Only M agreed to an interview.

It was very moving for me sitting in the background and listening to M’s story again, hearing of the debilitating effects of the disease and the soul destroying knowledge that the cure exists but is inaccessible because of price. The waiting and hoping that one might get on a trial or that some other miracle will happen.

Another amazing co-incidence occurred because M had received her 8 week viral load report the previous day and she had agreed not to tell me about it so that she could spring it to me on camera.

Brilliant news… her viral load has come down from the millions to none detected! It was a privilege to share in her joy.

It was also great to see how she was looking ten years younger than the first time I had met her and bubbling with energy and vigor.

After the the filming was done I went up the Huon River trout fishing, no mobile phone reception and not a computer for miles. The river was in flood and each fish I hooked managed to use the flood currents to throw the hook and escape. Lucky fish, unlucky me! But it was a lovely relaxing day.

Back at home I swallowed my last three Ribavirin tablets with dinner and then settled down to work through my correspondence.

Finished the night with a game of Canasta with my lovely wife who again beat me.

15th August 2015

I have written previously of UK Doctors’ fear of prescribing generic Hep C medicine (genericnophobia) and have recently had correspondence with a London GP and a Welsh patient consulting a liver specialist in Wales that sheds some light on the source of this strange psychological condition, genericnophobia, which affects more than 90% of British medical practitioners.

The source appears to be the legal department of the British Medical Association, the Doctors’ Union, who appear to be advising British medical practitioners that they are entering “a legal minefield” if they prescribe India generics.

Really???? That is strange because British doctors prescribe their British patients India generic medicines every single day as about 40% of all medicines prescribed in the UK are made in India.

The big difference here is that prescribing these particular Hep C Indian generics will save countless lives but at the same time deprive huge and powerful multi-national pharmaceutical companies of a small portion of their already obscenely massive profits.

Has Big Pharma has got the British Medical Association running scared?

It looks like that to me.

Has there been a legal minefield in Australia where the legal system is essentially the same as in the UK and doctors are now routinely prescribing generic Hep C medicines for their patients? The simple answer is no… quite the opposite, people who have been sick for years are now well again. People who were desperate for a cure are now being cured.

So where is the legal minefield?

Or is the British Medical Profession being manipulated by a Big Pharma inspired fear campaign while British people with Hep C are growing sicker and dying?

What happened to a doctor’s primary concern being the health of their patients?

Make up your own mind about what is happening but it looks like the BMA is being manipulated to me!!!

Yet there is hope.

The article below is a news article from the Imperial College London, one of the world’s most eminent medical colleges. It describes the terrible suffering caused by the current pricing policies on the new Hep C medicines and refers to the great results happening in Australia because medical practitioners in Australia helping their patients get access to the Indian generic medications.

Australia might have lost the Ashes but we are winning the battle against Hep C. (that’s a cricket based comment for readers who have never heard of cricket or the Ashes)

http://www3.imperial.ac.uk/newsandeventspggrp/imperialcollege/medicine/newssummary/news_6-8-2015-17-29-53