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worser and worser...should be a scandal 8 years 3 months ago #4196

Well,
If Hillary Clinton wins next year, she may be able to exercise some executive action, because she won't be able to get anything through the Republican majority in Congress. If a Republican wins in November, Gilead will be secure in its predatory pricing.
The way I see it, if someone doesn't have the $5000 to $8000 needed to go to India or can't work out a direct import for half that, they probably qualify for patient assistance somewhere. That "treatment exodus" of dollars will come straight out of Gilead's pocket. Up until now, they have had everyone by the short hairs. This kind of market pressure is what is needed right now. There will still be a lot of people caught in the middle, but the medical tourism business is going to get a big boost. and Gilead's revenue is going to take a substantial hit. The insurers should be buying tourism packages for their clients. They could pay for 12 people to get 12 weeks of Twinvir for what they are paying for my 8 week Harvoni treatment alone.

Time will tell.
Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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worser and worser...should be a scandal 8 years 3 months ago #4197

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Thanks Mike,

Yeah, its a crazy world. Take a holiday and get cured into the bargain. Probably not good for global warming if everyone has to fly to Australia or Bangladesh, or take a bus to Canada to get treated... But that's better than filling the pockets of Big Pharma,
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
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worser and worser...should be a scandal 8 years 3 months ago #4200

Thanks 2b and GAJ for the links and especially Vororo for the links and number crunching.

And Tina, a special thanks to you for your link.
www.canberratimes.com.au/comment/big-kar...20151202-gldg59.html

I had a personal little debate battle with someone a year and a half ago on this very issue and I hope the #@(*@! remembers me and my predictions. I also wonder if he's not the person at Gilead that got fired. (Mr. "he's no longer with us" who's name I'm going to be going back looking for later to see if I can determine if I'm correct.) The person I and others were debating took the handle "pharmaguy" and made the mistake of using the personal pronoun "we" when he got worked up, seemingly outing himself as a Gilead exec. (I still can't prove that.)

Read the comments in this article from the Wall Street Journal Blogs dated July 11, 2014.
As is my custom, I used my real name in the comments. (click "view all comments")
blogs.wsj.com/pharmalot/2014/07/11/gilea...-over-hep-c-pricing/

One clip I'll highlight here:

3:48 pm July 15, 2014
Kevin Hilde wrote:

Pharma Guy, you either missed my point, or you're not really understanding Capitalist Theory properly. In true capitalism no monopoly is possible. Only under the coercive power of the state can monopolies be sustained. That's what you're defending, not true capitalism.

Again, even I as a die hard libertarian am not absolutely anti intellectual property. But I certainly do recognize the arbitrary nature of IP rights and their durations. If you're curious, google "Mickey Mouse Copyright" . In Donald Passman's book "All You Need To Know About The Music Business" several times he points out how Copyright laws have been manipulated by the powerful for their own advantage.

It remains true that when government creates levers of power the powerful get their hands on the levers. Regulatory Capture is a growing problem.

To be sure, the US does not have remotely the problems that Russia and China have in that regard, but we are clearly moving that direction, away from true Capitalism, with the EU leading us by a couple body lengths. It's sad, but authoritarianism is currently winning the political battle, and we're headed for an awful mix of socialism and fascism. We'll end up with authoritarian battles swinging back and forth between socialist and fascist with the two gradually ratcheting us away from our constitution and true freedom.

Whether you realize it or not, the pricing decisions of Gilead will play into the hands of the socialist side of the authoritarians. Gilead has a fantastic product. But rather than being happy with very healthy margins they are pricing this drug in such an exorbitant manner that it will bring a backlash that could destroy the industry.

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worser and worser...should be a scandal 8 years 3 months ago #4201

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Patents are important to protect IP, the problem is they produce a monopoly power that is open to abuse.

The world at large needs a mechanism to bring the pendulum back towards the centre.

To swing it all the way from monopoly to "ignore the patent" would be just as problematic as leaving it where it is.

The bottom line is that Sofosbuvir cost $375 million to develop. That's a lot of cash, and a lot of risk. The Pharmasset investors got a great 30 x return, Gilead have got a great (almost risk free) 3 x return in under 3 years. Everyone who took a risk has been paid back in spades and now it's time to provision the world with this cure, and for the next Pharmasset to develop the next great antibiotic.

Big Pharma has gotten fat and lazy - consider statins - we have 9 different ones - that's one great new idea and 8 "me too" clones. Almost all the me to clone money could have been better spent on new ideas.

We need more innovation and less low risk sequels.

To make that happen we need to incentivise it, and the best way to do that is to adopt drug purchase/subsidy policies that look like "we need 2 good solutions to this problem" - who's offering the best prices? New Zealand do exactly that and enjoy medication prices 1/8 what Australia pays and very similar health outcomes.

Australia is idiotic in this regard - we do not need all the statins to be subsidised and doing so removes price competition. It's about time we got a clue and put our tax dollars to better use incentivising new blockbusters, not yet another sequel.
YMMV
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worser and worser...should be a scandal 8 years 3 months ago #4202

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Thanks, khilde,

Just read the "full comments" exchange on your post. I gotta say, y'all got some real tough-talking red-necks in the US!

You have my full respect for trying to argue some kind of basic humanity back into guys like your "pharma guy", who comes across (only slightly) as a more articulate version of Martin Shkreli (he of the soon-to-go-belly-up Turing Pharmaceuticals fame).

It would be very funny (not) if "pharma guy" does indeed turn out to be a former employee of Gilead. But certainly worth forwarding all details directly to the Hilary Clinton camp if you every manage to make the link concrete.

Well, shit happens. And sometimes even good shit might happen.

We live in hope.
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
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worser and worser...should be a scandal 8 years 3 months ago #4206

One quibble on Dr. Freeman's post .... not three years .... Two.

The FDA approved Sovaldi (sofosbuvir) on Dec 6, 2013

For those in Australia through EU time zones, the two year anniversary date is ... tomorrow.

EU approval was Jan 17, 2014 and approval in Japan was not until Mar 26, 2015.

Harvoni approval dates were:
US ... Nov 12, 2014
EU ... Nov 18, 2014
Japan ... July 3, 2015

We should throw an online SCREW GILEAD party!

:woohoo: :evil: :P

My, how time flies.
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worser and worser...should be a scandal 8 years 3 months ago #4207

Put Mike on the guest list!!
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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worser and worser...should be a scandal 8 years 3 months ago #4208

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Hi Kevin,

Gilead bought Pharmasset on Nov 21 2011, then we have the various Phase 3 trials over 2012/13

In my defence I did say UNDER 3 years, which is also wrong because it has been just over 4 years since the purchase and just over 2 years since Gilead got a licence to start printing money.

How about we call it making a motza a minute?

With nearly $30 billion in over 2 years it's around $40 million a day so Pharmasset's original $324 million R&D investment is being returned every 8 days.
YMMV
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worser and worser...should be a scandal 8 years 3 months ago #4211

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James-Freeman-facebook wrote: 'Snip'

........so Pharmasset's original $324 million R&D investment is being returned every 8 days.


When we're talking such big numbers, it's hard for most of us to put into perspective. I think this bit really says what it's about!
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
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worser and worser...should be a scandal 8 years 3 months ago #4219

Okay Doc, I see your point ... 4 years since the investment/purchase.
______________

To everybody ... Again I'll highlight that it took them only 15 days to decide to pursue, negotiate a price, and complete papers .... from Dr. Gane's presentation at "The Liver Meeting”, or AASLD 2011, in San Francisco, to the completion of sale of Pharmasset to Gilead for $11.1 billion .... that's gotta be some kinda record.

www.ft.com/cms/s/2/542ad524-8b77-11e2-b1...0.html#axzz3lD22Lvzo

There is no way this was perceived as a high risk transaction. They saw it as a sure thing ... a "cash cow" in marketing terminology. Their idea that they should be getting Venture Capital style returns is ludicrous.

On the other hand, Pharmasset was in fact funded by Venture Capitalists such that it appears Schinazi only held barely over 4% of his own company. Those people did deserve a good return. (Whatever that may mean.) (I'm holding out on my opinion of Schinazi's relationship with the VA etc. until relevant questions are answered.)

The typical human mind is such that most people don't mentally grasp big numbers. When they hear $11.1 billion what registers is "really big number" and when they hear $3.6 trillion what registers is "really big number." Politicians take advantage of this fact to appear like they're dealing with problems when in fact they're not.

But I'm going to crunch some numbers here to show why I'm not upset by Pharmasset's sale price and its investors' profits while I'm appalled at Gileads prices.

First, it is a known fact that the western world and Japan carry the weight of drug development costs for the rest of the world. In the US, with Medicare/medicaid prohibited from negotiating prices, and insurance companies forbidden to source out of country, the US is the primary cost bearer of Pharmaceutical Company profit taking. Japan with its aging population is likely a distant second with the EU as a single entity coming in third. So let's look at some numbers to see what happens when you spread that $11.1 billion cost around.

$11.1 billion / various HCV Populations

US HCV population ~5.37 million or $2067/patient
This number assumes that the US carries the entire cost of the Pharmasset purchase alone.
As a US citizen I could actually accept that.

If cost is carried by the primary Western World + Japan, S Korea, Singapore * ... HCV population ~10.8 million ... $1028/patient

If cost is carried by the "developed world minus China" (Vororo's number above) ... HCV population ~43 million ... $258/patient

If cost is carried by the whole world .... HCV population ~160 million ... $69.39 /patient

These numbers really aren't very big and bear no relationship to Gilead's price tags. Again, Pharmasset's profits aren't remotely the problem.
______________________
* Australia, Austria, Belgium, Canada, Finland, France, Germany, Ireland, Italy, Japan, New Zealand, Norway, Portugal, Singapore, S. Korea, Spain, Sweden, Switzerland, The Netherlands, USA, UK.
Oops, I forgot Denmark .... oh well, I'm not doing it over .... you get the point.
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worser and worser...should be a scandal 8 years 3 months ago #4224

klhilde:
"These numbers really aren't very big and bear no relationship to Gilead's price tags. Again, Pharmasset's profits aren't remotely the problem."

What's missing from this analysis is the question of whether Pharmasset should bear any responsibility for the future use of sofosbuvir, when they must have had a good idea about how Gilead would use it?

The doc
"Everyone who took a risk has been paid back in spades and now it's time to provision the world with this cure"

The question is - how?
When Pharmasset owned sofosbuvir, they had the capability to ensure the happy situation described above by the doc. Instead they sold out to Gilead. For the sake of argument let's say that you don't think that Pharmasset should own any of the responsibility for the future use of sofosbuvir. Then who is going to oversee the provisioning of the world with this cure? Price competition would help but would it be enough? Right now we have the biotech revolution underway and ever accelerating. Seems to me that the world is missing a vital mechanism to ensure that the fruits coming out if it will be distributed to more than the few elite who can afford them. Unless this question is seriously addressed, Gilead is just the beginning.

dt
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worser and worser...should be a scandal 8 years 3 months ago #4226

Great point K. Most people have no clue what a trillion dollars looks like. The link below helps clear one's vision in that regard:

www.pagetutor.com/trillion/index.html

Basically, a $10,000 bundle of new $100 bills is 1/2 inch thick. Stack up a trillion dollars, and you have a stack 670+ miles high.

Bottom line, Gilead has made and is making a shit load of money. They are not Salks or Curies. Gilead's ENTIRE reason for for existence is to make as much money as possible. Bottom line. Period. End if story. I want cutting edge medical research to continue to be financially rewarding, but the system needs balance.
The global average market price for a cure seems to be around $2000 (+/-) when you take Gilead's stranglehold out of the equation. So, The price in the U.S. Is artificially high. We need, as they say on Wall Street, a market "correction". A viable, affordable alternative will do that. We are getting close. I can feel it.
Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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worser and worser...should be a scandal 8 years 3 months ago #4227

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Yes DT, this is the beginning.

Unchecked it is the beginning of worse.

Checks and balances help maintain equilibrium.
YMMV

worser and worser...should be a scandal 8 years 3 months ago #4235

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To clarify my position, I believe that inventors, IP owners, venture capitalists and pharmaceutical companies should be well rewarded for their endeavors and the risks they take. My comments about doing an Express Scripts with Sofosbuvir and circumventing patents are based purely on Gilead behaving in the same manner as Martin Shkreli did with Daraprim. Similarly my comment quoting Dr James about Pharmasett R&D cost vs days of return were driven by Gilead's justification of their pricing as being due to high R&D costs.

I have just spent the evening with an old friend visiting our shores from Scotland for the first time in 5 years. So I explained to him that I had Hep C and we had a discussion about it. What amazed me was that a well educated, travelled and read 60 year old who had just retired from running his own very successful business had very little idea about the subject. When I mentioned that there were about 180 million chronic sufferers he looked thoughtful then said "No....that would mean more that one in 50 worldwide?" The implication being that I had my figures wrong......after all this disease was a problem of a few young junkies? Oh, and me of course! Having known me 25 odd years he was a little surprised. Therein lies a lot of the problem, we live with this virus and know about it, most don't.

To the current discussion I would like to add:
- the venture capitalists took big risks and put up early monies for Pharmasett to set up - they deserve a good return.
- Schinazi had the vision to set up Pharmasett - he deserved a good return. (My less than flattering comments about him in the other thread relate to his attitude/ethics as evidenced by his 'only working for VA 7/8 of the time' & "I'm sorry you're taking it personally" comments.)
- Pharmasett was publicly listed in 2007, four years prior to Gilead purchase. Neither Schinazi or VCs were majority shareholders or had a lot of control from then on.
- Gilead took 15 days after the announcement about what became Sofosbuvir to determine they would pay almost double market value for shares. (Hard for a shareholder to refuse a gold handshake offer like that)

WTF happened?

I believe someone very astute but totally ruthless at Gilead had the following brainwave:

- Sofosbuvir is a major breakthrough in the treatment of Hep C - a game changer!
- there is a worldwide market of massive proportions.
- said market is reluctant to discuss/protest publicly because of how they caught it or at least the perception presented.
- it is not a 'messy' disease with deaths in the streets or hideous disfigurements that will generate bad publicity about drug access.
- it usually doesn't manifest strongly until later in life when the chronically infected are likely to have capital behind them to pay for treatment.
- the original major wave epidemic of the 60s/70s/80s driven by IVDs in first world and mass immunisation in developing and third world countries was ripe for picking.

Thus Gilead made a snap decision to pay what seemed like over the top price to ensure success in what everyone else saw as a risky move but they saw as a golden opportunity to milk the various markets worldwide for everything they could for as long as possible with absolutely no regard for their fellow man's health.

They made a conscious, considered decision to do this and are the guilty party in this case and the others had very little ability to change the outcome whether they wanted to or not.

We do need checks and balances but I suspect those will have to be market driven in the form of:

- competition fuelled by the desire to get a small fraction of the inflated pie that Gilead have created, by undercutting/obsoleting Sofosbuvir. (Cue China?)
- enough bad publicity to hurt Gilead share prices (we can assist here)

Either of these scenarios may just, if we are lucky, be enough to cause anyone else to apply caution if considering a repeat performance.

G
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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worser and worser...should be a scandal 8 years 3 months ago #4237

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No, G, 'market driven' should never ever be the main factor in curing diseases. PLCs want to make money. PLCs in the pharmaceutical industry should be heavily regulated, by definition. It's as clear as daylight that PLCs in the pharmaceutical industry are completely and utterly out of control at the moment. People like Martin Skreli are a godsend to obscene entities like Gilead. Diversions by the likes of him are fantastic for them. Expect his name to pop up on a bigger level with the Big Pharma gangsters in the not-too-distant future.
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