Wednesday, July 6, 2016

This is bonkers: people are buying generic sofosbuvir API and making their own?

I am rather skeptical about this report, but it is fascinating and terrifying to think about. From the Economic Times of India (via the Endpoints e-mail newsletter): 
Patients are buying the active ingredients that go into making the medicine off the internet and making their own capsules. The 'Chinese rat poison' that patients are gleeful about is a reference to the active pharmaceutical ingredients purchased in bulk from a Chinese manufacturer off the internet, which they are using to formulate their doses.  
"A year ago, we did not have the access to Sofosbuvir combination, because of which we would buy the API from China and India and formulate our own drugs. Now, we see in countries like the US, Romania, Canada and the UK, patients are buying the API and formulating the Hep C drugs. People are doing this because desperate times call for desperate measures. The drug is too expensive for people to buy, which is forcing them to resort to these measures," Dr James Freeman founder of the FixHepCBuyers Club in Australia told ET.
...Jefferys explains buying a 12-week treatment of Indian generic Harvoni to treat Hep C genotype 1 will cost about $1,400, including shipping. To buy the API equivalent would be less than $750. The API route has also become an easier way to deceive the customs who get suspicious looking at the larger parcels of medicines that are shipped in bottles... 
For what it is worth, there actually is a FixHepCBuyers club website; dunno anything about that.

So here's what I want to know - who is making generic sofosbuvir in India? Is it coming out of the licensed plants in India? And if you're making generic sofosbuvir, who are you selling to? (If you're rolling your own sofosbuvir tablets, how do you know you're getting the right dose? You doing QC on that stuff? How do you even know it's the right material?)

Assuming this is actually happening, it seems that we find out what happens when you have relatively poor patients, unethical generic manufacturers, a high price for a drug and a globalized industry. Hard to say what to do (and I'm not a direct Gilead shareholder*), but it seems to me that lowering the price of Sovaldi to the point at which these generic manufacturers are run out of business might be a good idea.

Other weird questions: Has this happened before? If you were Gilead, what could you do about it? (Should you go and bust the sellers in India? Can you, from a legal perspective?)

*I'm sure I own Gilead stock indirectly via index funds. 

20 comments:

  1. this has happened before, in early 90s - with Gileads AIDS medications (tenofovir) before it was approved in US: it was already as API on the black market, for desperate patients willing to try anything (I have this story from tenofovir inventor)

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  2. If I were Gilead and wanted to stop it, I would sneak a tainted batch on the black market to cause panic. If you want to stay legal you can do impurity profile forensics to guess the likely version of the manufacturing route, and try to link it to a particular producer. But good luck with fly by night labs around Shanghai - I think they must have figured out that doing knockoffs of expensive drugs can be just as lucrative as cooking dope, and lot less risky

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  3. Even before Viagra was approved I was told by a colleague who went to visit family in China post-Green card that one could get sildenafil API and pretty much any other western drug at open street markets in Bejing. Suggestion was with most being produced by the major Chinese firms (read government owed/supported). Similar stories came from Indian co-workers. Therefore anecdotally I would hazard such black market practice you blog about has always gone on with certain drugs however the increasingly high prices are exacerbating the issue and doubtful that a legitimate manufacturer could ever lower the prices enough to run anyone out of that type business model.

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  4. Could be 3rd party producers. Or it could just be the outsourced Chinese firms that make the regular stuff, just running an extra after-hours shift. They do it with knockoff designer clothes too!

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    1. I could be wrong, but I suspect that Gilead controls its API supply chain quite tightly.

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    2. Aww you poor thing,

      Do you still believe that chemists in India or China are less competent than white chemists? Do you still believe that commodification and globalization won't destroy the careers of "skilled" people like you?

      Do you still believe that the governments and institutions in other countries are as subservient to financialized capitalism as those in the west- esp the USA? Do you still believe that the writ of companies run by white men (and women) still matters outside the USA and its European puppet states?

      Maybe you don't want to read the proverbial writing on the wall. Then again, it was people like you who were the biggest cheerleaders of unrestrained corporatism and financialized capitalism- under the delusional belief that doing so might make you rich. BTW, how is that working out?

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  5. Hello chemgobbler, I and many others are now cured because we purchased meds through the hep c buyers club. Dr James Freeman presented his study to EASL this year in Spain and got a standing ovation. Easl conclusion - there is a definitive place for generics in the treatment of hep c.

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  6. Interesting reading http://fixhepc.com/ no matter what your views on the issue are. The price difference between the US and India for sofosbuvir (apparently generic in India) is incredible.

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  7. CJ: In a World that is used to sense of entitlement at a price I want, the patent system 1s rendered useless! Yep, I do not have to export the drug to the USA but I can still make lot of $$$$. Think of "Breaking Bad' similarities! If this trend continues I can have a bootleg efforts, where I can pull up a mobile lab stocked with chemicals and do my chemistry. Who needs FDA etc. and there is enough market (illegal) and internet for such a scenario. As a trained organic and medicinal chemist, am deeply depressed!

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  8. Following on from anon 12:06 (also me) it is generic in India

    http://www.fiercepharma.com/sales-and-marketing/cipla-revs-up-for-generic-sovaldi-launch-India.

    Not sure about the cost of a 12 week holiday in India, but i'm sure that is an option for people too without resorting to smuggling pills or APIs

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  9. I currently work in a pharmacy and this is somewhat frightening to me, considering a large portion of the customers can't even take their already manufactured pills correctly, nor do they know what they're called, their purpose or strengths/concentrations. I mean if we went by their ideas then they'd all be on mg strength levothyroxin, which is really in micrograms. Although I suppose that's a subtle difference if you're not a chemist, but to not know the name, magnitude of the strength or what it's for seems a bit careless to me.

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  10. Gilead voluntarily licensed its new pan-genotypic treatment to Indian suppliers, hopefully this will make a dent in the illegal and dangerous home formulations.

    http://www.thehindu.com/sci-tech/hepatitis-c-treatment-maybe-available-in-india-soon/article8815578.ece

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    1. Should have read more carefully, I assumed the people formulating their own Harvoni were in India. Yeah, I'm sure the licensees are all under obligation not to sell API into the US or Western Europe, and doing so would jeopardize their legitimate business in India and other countries. So the suppliers are probably unlicensed, and who knows what kind of quality they are producing. And anyway, poor formulation of good API is still a threat to patient safety.

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  11. Compounding chemists in Australia encapsulate Chinese APIs from an approved Australian government source with each batch tested for purity by GC/MS. What's wrong with that? I'd say nothing, but I'm just a retired chemist so what do you young whippersnappers say?

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  12. Oops, I meant LC/MS

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    1. 1. Chinese APIs
      2. LC/MS is not sufficient to establish quality for APIs.

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    2. Thanks, I'm aware of the modern pharmaceutical supply chain, fella. Doesn't mean I trust their track record with cGMP, especially with something relatively complex like sofosbuvir.

      You need to decide which account you post with, your own or anonymously.

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    3. No matter, I won't be posting here again.

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  13. Australia has it's own version of the F.D.A. that oversees testing on these drugs and I didn't mean to imply that LC/MS was the only testing done on these A.P.I.S. Since nothing will satisfy you, I guess we simply agree to disagree.

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