Australian takes on Gilead

[WyoSue]

Where there's a will, there's a way to get the meds you need.

http://www.abc.net.au/news/2015-08-20/hepatitis-c-sufferer-imports-life-saving-drugs-from-india/6712990

[JimmyMose]

Thanks  Here is a related article

Genotype One: Indian Sofosbuvir and Chinese Daclatasvir  
By Greg Jefferys on August 16, 2015 7

http://blogs.hepmag.com/gregjefferys/2015/08/genotype_one_indian.html

My personal opinion of the current situation only.
Jefferys at his website seams to minimize to potential import problem for US citizens if any with his interpretation of the FDA "guidelines and rules".in my opinion. The FDA guidelines for individuals importing pharmaceutical drugs are only suggestions and they may be interpreted differently by custom, FDA agents and their supervisors.  Some shipments may get to the patient and some may not.

Only real world actual results, law interpretation etc (news) if available and from trusted sources in the future will provide a better idea of the chances of receiving shipments in the US. I really do not know, can't not even guess at this time and make no recommendation one way or the other.

Under proper safety controls, I think they should be allowed.

[Idyllic]

The article says you need a minimum of 84 tablets which is about $100,000 and he found the same treatment with the same drug in India is $900 because the Indian Gov does not recognize Gilead's patent.
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Wow just wow.

Apparently what the guy is doing is legal in Australia.
I hope this does not trigger a cottage counterfeit industry.

[dointime]

I think that the paranoia over fake drugs out of India is overdone.  Sure, if a person goes and buys indiscriminately then maybe they will end up with fake drugs, but if they take the time to research a reputable well-established supplier they will get good meds.  The Indians are not stupid.  They know that the market for hepC drugs is numbered in millions of people and that these people will keep on coming as long as they maintain a good reputation for supplying good drugs.  Why would they risk selling a few counterfeits and be posted on social media as frauds and lose all those potential customers?    

I don't really see any way for there to be safety controls in the country importing the meds unless the government were doing the importing, not private individuals.  And if the government were doing it then we wouldn't have the situation of rationing of these drugs in the first place.

So, suppose that 5% of people get fake drugs and 95% of people get the real thing.  Of those 95%, suppose that 90% are cured.  Seems to me that's much better odds than we had with the old ifn tx.  For years people with hepc have been looking at dismal odds of a cure with horrible side effects and still they have gone for it.  Now, with the new Indian generics  there's a much greater probability of a cure with less side effects but people are freaking out about fake drugs.  It does not make any sense to me.

dointime

[JimmyMose]

This is just the tip of the iceberg. it's not just fake drugs. “significant violations” of manufacturing-quality rules  - microbiological contamination -questionable clinical data -  especially when India has repeatedly turned a blind eye to the rampant problem of falsification of data.

Mylan, Critic of Indian Drugmakers, Warned by FDA on Quality
Anna Edney
August 18, 2015

http://www.bloomberg.com/news/articles/2015-08-18/mylan-plants-in-india-warned-by-fda-for-significant-violations

"Mylan NV, one of the generic drug industry’s biggest critics of poor quality at Indian drugmakers, had “significant violations” of manufacturing-quality rules at three plants in India, U.S. regulators said in a warning letter.
The violations include failure to establish and follow written procedures to prevent microbiological contamination, use of torn gloves, poor monitoring to ensure a contamination-free environment and a failure to investigate product complaints, according to the warning letter from the Food and Drug Administration dated Aug. 6."
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Beware of ‘Made in India’ medicine | Business Line
DINESH THAKUR

http://www.thehindubusinessline.com/opinion/columns/beware-of-made-in-india-medicine/article7531267.ece

August 12, 2015:  
It’s the same old story. A foreign drug safety regulator identifies serious data integrity issues provided by an Indian company. Yet, instead of investigating the accusations in a transparent manner, the Centre predictably cries foul.

Regulators in the European Union ordered the prohibition of sale of about 700 drugs that received approval based on questionable clinical data supplied by GVK Biosciences of Hyderabad. In response, the government called off talks on a long pending free trade agreement with the EU.

Falsifying data

Undermining a treaty that could benefit millions of Indian consumers is worrying, especially when India has repeatedly turned a blind eye to the rampant problem of falsification of data. It is standard practice across the world to approve generic drugs on the basis of safety established by clinical research organisations (CROs) such as GVK Biosciences. In order to ensure that generic drugs are as effective as the innovator drug they copy, it is necessary for CROs to carry out some basic clinical tests on human subjects. Patient information like electrocardiograms (ECGs) provided by the CRO become a key criterion in the approval of such drugs. The European Medicines Agency (EMA) has said that during its inspections of GVK Biosciences, it found “systematic falsification of ECGs for an
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March 12, 2015, 05:00 pm
FDA should follow Europe’s lead on Indian drug suspensions
By Roger Bate and Dinesh Thakur

http://thehill.com/blogs/congress-blog/healthcare/235439-fda-should-follow-europes-lead-on-indian-drug-suspensions

"Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between
July 2008 and 2013."
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Tue Apr 28, 2015 12:42am EDT Related: HEALTH
India's Wockhardt to recall some drugs made in India after U.S. FDA concerns
MUMBAI

Indian generic drugmaker Wockhardt Ltd said on Tuesday it would recall some drugs manufactured at its two plants in India before the U.S. Food and Drug Administration (FDA) banned those sites due to quality concerns.
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Even in Canada

Feds indict Canada Drugs for sales of fake and foreign Avastin
August 11, 2015

http://www.fiercepharmamanufacturing.com/story/feds-indict-canada-drugs-sales-fake-and-foreign-avastin/2015-08-11
The FDA has been doggedly pursuing Canada Drugs and its affiliates after it tied counterfeits of Roche's ($RHHBY) cancer drug Avastin to the online pharmacy and wholesaler. Now the feds have fired off an indictment with a host of charges that include money laundering and conspiracy in addition to selling illegal and counterfeit drugs.

The indictment accuses the Winnipeg-based company and its affiliates in the U.K. and Barbados of selling $78 million worth of illegal drugs, the Associated Press reports. Those include a host of cancer and chemo drugs, including counterfeit Avastin. The feds say the drugmaker got the counterfeits when it bought out the inventory of another company and then shipped the fakes to doctors in the U.S. It also accuses the company of selling unapproved versions of Avastin in the U.S. that were made in Turkey and known as Altuzan there.
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Why India's medical schools are plagued with fraud
REUTERS — PUBLISHED JUN 17, 2015 01:55PM

"India's system for training doctors is broken. It is plagued by rampant fraud and unprofessional teaching practices, exacerbating the public health challenge facing this fast-growing but still poor nation of about 1.25 billion people"

[JimmyMose]

Link for Why India's medical schools are plagued with fraud

http://www.dawn.com/news/1188743

[JimmyMose]

Campaign Against Fake Drugs Gains Momentum
FDA and industry support global framework and collaborations to secure the supply chain.
Aug 02, 2015 By Jill Wechsler Pharmaceutical Technology
Volume 39, Issue 8, pg 16–18

As concerns mount around the world regarding adulterated and counterfeit drugs and medical products, FDA is joining manufacturers and other regulatory bodies to take more aggressive action against “fake pharma” operators. There were more than 2000 incidents of pharmaceutical crime in 2014, according to the Pharmaceutical Security Institute (PSI); these involve diversion, theft, and counterfeiting in more than 100 countries, primarily in Asia.

Illegal drug websites drive such activities, as seen in the latest international crackdown on these operations: the June 2015 Operation Pangea VIII. Led by INTERPOL, the action netted more than 1000 websites selling unapproved and illegal medicines and medical devices worldwide and led to FDA warning letters to approximately 400 websites. Similarly, reports of unauthorized foreign versions of Allergan’s Botox in the United States made headlines, along with the arrest of members of a Miami crime ring for allegedly distributing $200 million in illegally diverted drugs to treat cancer, HIV, and psychological disorders. In April 2015, FDA sent more than 300 letters alerting physicians against purchasing unapproved drugs from Gallant Pharmaceutical International, the target of a vast investigation of illicit sales.

Growing international concerns about a global pandemic in substandard drugs are evident (1). The rise in poor quality medicines and the related increase in resistance to critical treatments for infectious diseases is examined in 17 research papers supported by the National Institutes of Health’s Fogarty International Center and the Bill & Melinda Gates Foundation. Studies sampled antimalarials, antibiotics, and TB treatments for quality and found that up to 41% had either too much or too little active ingredient and other formulation problems (2).

[JimmyMose]

Back to Greg Jefferys  I spent an hour reading through it.

Hi, My name is Greg Jefferys and this site records my experiences since discovering I was infected with Hepatitis C in August 2014 and what happened as I progressed through the shock of the initial diagnosis to trying to find an effective Hep C treatment.

http://hepatitisctreatment.homestead.com/

Carefully read through the pages and pages of My Hep C Diary

It's one of the best super slick sale pitches I have ever heard. Better than "Fast  Eddie" the used car salesman.  He blows smoke over every possible concern, hesitation, question, that you could think of for not proceeding with his way to get treatment. in other words he has answered and eliminated all negativity. intermingled in his "diary, blog"

then when you get to here go to the link
Our local paper heard about the good viral load results and the fact that Sovaldi had been rejected by the PBS again and did a story. Here is the link if you want to read it:
http://www.themercury.com.au/lifestyle/india-mission-clears-deadly-virus/story-fnj64o6u-1227418081555

near the end of that linked page.
“It’s a bloody amazing drug,” he said. “My GP was amazed. All my blood counts are normal in just 28 days."
(Of course it's expected with this treatment for most patients)

NOW THIS IS OVER THE TOP
“Scans a couple of months ago had shown my liver was on the verge of cirrhosis, with serious scarring. An ultrasound I had two days ago showed my liver was now perfect.”

Has anyone here went from verge of cirrhosis F3 to liver was now perfect F0 after first 28 days of treatment?  ( Scans a couple of months (what type) ultrasound  is only mention after 28 days of tx.

I have converted this diary into a kindle book for folk who might like it in that format.
I have added a lot more depth than the original diary contains, it's more of a complete story in book format. I have priced it as low as Kindle allows me to @ $2.99
If you are interested just click here to go to the Kindle page

His email link is on most pages.  Has anyone contacted him and can add more info?  Wonder where emailing will lead to ---- Who, What and How much $$$$ is involved.

[dointime]

Gilead has licensed the manufacture of sofosbuvir and harvoni to some Indian manufacturers and supplied them with the exact instructions for manufacture, plus set out their quality control obligations in the licensing agreement.  Presumably Gilead will have oversight responsibility for those manufacturers and enforce quality control or withdraw their license.  
http://www.gilead.com/responsibility/developing-world-access/access%20partnerships

It is no doubt necessary to choose an Indian manufacturer with a good reputation, for example CIPLA who have an excellent track record for quality control.

Here in the UK about 40% of the drugs used by the national health service are Indian generics and in general I don't hear about people coming to harm from using them as opposed to the more expensive brand name.  Without these Indian generics many less people would receive the drugs that they need because they would not be affordable.

At the end of the day the fact is that not everybody has access to the drugs manufactured by Gilead in the USA.  Those people with hepc know what might happen to them if they do nothing.  Against that they have to weigh up the real risks of Indian generics, which is not easy given the current wave of what I can only call hysteria on both sides of the arguments for and against.  One thing I think we all can agree on is that lives are being lost to hepC and all avenues which might prevent that happening need to be examined, as we are doing here.

dointime    

      

[dointime]

If you look at the list of doctors in any reputable international Indian hospital you can find doctors who trained for many years in the UK and the USA, some having won impressive qualifications in these countries.  

I am not making any comment here on the quality of doctors trained in India, simply pointing out that if somebody is not comfortable with a doctor trained in India then it is not hard to find a doctor in India who trained in the UK or USA who might well have better qualifications and experience than the hepatologist that you are currently seeing.  

dointime