Hard News: Hep C: When doctors do the wrong thing
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Here's the ODT's article on the issue from late last year
https://www.odt.co.nz/news/dunedin/health/sdhb-slated-hep-c-stand
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Thank you Russel, well told. At the start though, regarding Gilead's attempting to recoup it's development costs, don't worry about that- they achieved that in about the first month of sales. In fact, they have smashed every previous records for profit, over cost for bringing to market- unprecedented in the world. Next nearest took 9 years to make the profit they made in 18 months- this is in the whole of the pharma industry history, It is never enough money, for them.
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Russell Brown, in reply to
Thank you Russel, well told. At the start though, regarding Gilead's attempting to recoup it's development costs, don't worry about that- they achieved that in about the first month of sales.
Amended accordingly :-)
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Ed Gane sounds pretty amazing. I've never met him but I have heard about his brilliance and skill from so many unrelated friends and colleagues who have.
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Dr Andrew Hill from the Chelsea and Westminster hospital and I penned an article in Liver International about the Hep C drugs and their development costs.
In short Sofosbuvir was proven up for a total sunk cost of $281 million by a NASDAQ listed company called Pharmasset and we know this with real precision as this drug was Pharmasset's only product. Gilead bought Pharmasset and made $31 billion out of these drugs in the first 3 years - also a matter of public record. Since the article was published Gilead have made over another $10 billion, so the total ROI is now 160x funded by government and insurers.
http://onlinelibrary.wiley.com/doi/10.1111/liv.13157/full
For completeness Gilead purchased Pharmasset towards the end of 2011 for $11 billion (a substantial premium over it's $7 billion valuation on the NASDAQ) so have made 4x their money back in the last 5 1/2 years. They have done this despite taking NONE of the initial development risk - they just bought the patent. During that 5 1/2 years about 1 million people have been treated with Gilead medication. During the same period around 4 million people died of Hep C and the infection rate remains higher than the cure rate.
In other words a cure has been invented but we have made next to no impact on the disease.
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When I lived in Cambodia, we used to get university text books printed in India for next to nothing. The publishers - O'Reilly, McGraw-Hill, No Starch Press etc used to licence the content to Indian publishers for a nominal fee, and charge people in western countries $100-150 per copy. It was the only way most Indians would be able to afford them. And the publishers wouldn't have sold a lot of copies at the western price.
Then US college students started ordering their own copies from India over the internet, so the publishers pulled the plug on the whole programme.
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Bart Janssen, in reply to
so the total ROI is now 160x funded by government and insurers.
I'm torn by this kind of stuff. Yes absolutely these companies are making huge amounts of money from successful drugs and it's really trivial to see how unfair that is on patients.
But for every drug that is successful there are many that fail completely and somehow these companies have to cover that cost.
The real problem, and one that isn't being fixed, is the shareholder push to maximise profit. If at any point a company doesn't do that they get sued by the shareholders.
Underneath it all is the cost of doing the basic research that leads to these drugs, that cost is almost always borne by the taxpayer and if any money is returned to the research teams it's at a very early stage and a tiny amount. That's the part of the system that is broken in the worst way.
The basic research engine is starving for funding while at the other end the companies are maximising profit. It's a system that isn't working anymore as can be seen by the lack of funding for novel antibiotics which are low profit drugs.
I'm not particularly defending these big companies just that only assessing the successful drugs is unreasonable.
Overall I'd say using businesses to develop new drugs is well and truly broken in so many ways (bad reporting of trial data is another issue). But unless we can figure out a way of funding it through taxation then we're screwed.
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linger, in reply to
Although, as Ben Goldacre has repeatedly noted (especially in Bad Pharma), the “but we need to fund research” argument is severely undermined by the facts that (i) drug companies spend more on (ethically dubious) advertising than on research, and (ii) most of their products are not radically new drugs requiring expensive research, but instead tweaks or repackagings of existing drugs just sufficient to allow a patent extension, and (iii) the actual quality of drug company "research" intended to establish the effectiveness of their drug is often shockingly poor.
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Bart Janssen, in reply to
Yeah I edited to add that as you were typing Linger.
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Russell Brown, in reply to
But for every drug that is successful there are many that fail completely and somehow these companies have to cover that cost.
The real problem, and one that isn’t being fixed, is the shareholder push to maximise profit. If at any point a company doesn’t do that they get sued by the shareholders.
James' comment above nails it in a way I couldn't – there was a race to get DAAs to market and Gilead's spend was more about buying a company for its IP than any development risk.
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Russell Brown, in reply to
In other words a cure has been invented but we have made next to no impact on the disease.
I think, as Ed Gane constantly points out, that there's eminent potential to eliminate Hep C within countries like Australia and New Zealand. Countries with rampant new infection rates are gonna be much harder.
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If the Hep C was contracted via blood transfusion the drugs would be funded by ACC as Treatment Injury. Ed Gane's team in Auckland help prepare these claims for patients I hope SDHB is doing the same?
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Wow, an example of where zone locking actually kills people. Also, "high quality" trade agreements will make this sort of work around illegal.
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[edit - others have made this point far more eloquently. Teach me to read from the bottom up]
But for every drug that is successful there are many that fail completely and somehow these companies have to cover that cost.
Sadly the pharma companies have got themselves into positions of effective monopolies. By being very big and by having overly generous IP protection from our governments. This means that they spend less on R&D and more on marketing than would be considered the norm. Simply put, they are gouging.
R&D also tends to focus on creating new versions of existing drugs rather than on ground breaking new cures. This article only scratches the surface, but you get the idea (with added John Oliver):
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Russell Brown, in reply to
Wow, an example of where zone locking actually kills people. Also, “high quality” trade agreements will make this sort of work around illegal.
Indeed. Gilead priced to the market all around the world. Obviously Pharmac, as the direct negotiator, can't do the workaround, but – let's say, in a case where someone's on a sickness benefit – you'd think MSD could. $1500 to get someone fit for work again seems like a bargain.
And the fact that Professor Gane, who ran the damn trials, feels free to refer people to parallel-imported Gilead drugs suggests the latitude is fairly wide.
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you can't complain to the Health and Disability Commissioner about rudeness, but people shouldn't come away from their doctor crying and hurt.
see Right 1 of the HDC Code: "Respect".
Please do complain. -
Rosemary McDonald, in reply to
you can’t complain to the Health and Disability Commissioner about rudeness, but people shouldn’t come away from their doctor crying and hurt.
see Right 1 of the HDC Code: “Respect”.
Please do complain.My understanding is that one can complain to the H&D Commission about services rendered but not services denied.
Remember...eligibility for government funded health and disability services does not confer entitlement.
Being eligible gives a person a right to be considered for publicly funded health or disability services (ie, free or subsidised). It is not an entitlement to receive any particular service. Individuals need to meet certain clinical and other assessment criteria to receive many services.
Methinks Hazel may be farting into a strong wind with a complaint...the bastards have shit like this all sewn up.
Sincerely hope I'm wrong.
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WH,
The BMJ article James Freeman’s article refers to is worth reading too.
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How awful. Individual drug researchers will have a variety of motivations, but drug companies exist to make profit, and I don’t think we can expect them to be philanthropic.
I would expect all doctors to be fighting for their patients’ health, though.The situation has parallels in this recent Buzzfeed story about HIV-prevention and the NHS:
"He had heard about a new drug regime that was being used to prevent HIV. The medication’s brand name is Truvada, and the regime – which involves taking this antiretroviral pill every day – is dubbed PrEP: pre-exposure prophylaxis. Owen, fearful of contracting the virus amid this unleashed world, couldn’t decide whether to start taking the drug, let alone how to obtain it.
PrEP was not available on the NHS and a private prescription would cost about £500 per month. But a major NHS study was underway to ascertain how effective the drug was, and who should be given it.”
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“This person said, ‘We have a handful of people who use our clinic and they have been self-sourcing generics from this website and we have been discreetly doing the monitoring – discreetly checking their blood periodically to check that there’s active levels of the drug.’”
In one sentence, everything was possible. There was somewhere to buy the non-branded versions of the drug – and at around £50 a month, a tenth of the price of a private prescription. And there was, potentially, a way to ensure the drugs were working properly. At the time, because PrEP was not available on the NHS, neither – officially – were the urine and blood tests needed to check that the drugs were not adversely affecting kidney function (which some antiretrovirals can do) and were not fake.”
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“A new and unexpected battle began in March 2016. After 18 months of discussions with the HIV sector, NHS England derailed the commissioning process – the path that leads to a drug being funded – for PrEP. Suddenly, all the doctors and charities who thought that it might soon become available to patients were left disappointed.”
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“A legal battle commenced, brought by the National AIDS Trust, to counter NHS England’s claim that it was not their responsibility to provide PrEP as HIV prevention was the job of local councils. At each step of this process, as news reports described what was happening, traffic to IWantPrEPNow continued to climb.You should read the full article because it’s amazing. But long story short, an HIV-positive homeless man saved thousands of others from becoming HIV-infected, by directing them to reliable sources of generic drugs. He did this for no payment, while GPs, sexual health clinics, and specialists felt unable to do it.
The guy’s a hero. But how did it come to this??
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Sacha, in reply to
one can complain to the H&D Commission about services rendered but not services denied
Correct in general (and a huge problem in itself), but this seems to be about the nature of delivered services (ie: the conduct of the consultation session itself rather than any subsequent potential treatment).
If any person does not feel they have been listened to, understood, acknowledged - respected - then by all means they can complain. Being the first formal Right shows where the women's health advocates who drove the Cartwright process prioritised that.
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Worik, in reply to
But for every drug that is successful there are many that fail completely and somehow these companies have to cover that cost.
Some one else replied that most drugs are not expensive to develop but are tweaks (to make it patentable again) and some one else pointed out that the companies spend more on marketing (given the nature of the medical profession I am glad they do their own marketing, but that is another story of another failure)
I would like to add that the expensive research is no longer (in general) done by big Pharma but by startups using high risk investment money (or spun out of University Departments). Big Pharma buys what is successful and ignores the rest. Drastically reduces the costs of drug development.
Crocodile tears, this is about profits.
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Sorry I came across as saying big pharma is good and that isn't what I meant or think.
I do think the simplistic cost profit analysis for any successful drug is unreasonable.
But I also heartily agree that the big pharma model of health care is broken. Where I differ from a lot of folks is that I think it is utterly broken - it cannot be fixed by any method that allows private enterprise to profit from health care. The problems always stem from the imperative that companies (by law) are required to maximise profit. That means they will always sacrifice humans for profit.
The only answer I can see as viable is to research and develop drugs and health care products under government funding and managed by scientists and clinicians (NOT businessmen (yes always men)). It won't be perfect but it will be better than the business does it.
That means paying more taxes.
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Bart Janssen, in reply to
I would like to add that the expensive research is no longer (in general) done by big Pharma
The cost for any drug is never the primary research, it is the cost of doing clinical trials. These are the trials developed after the thalidomide disaster. Those trials tend to cost 100 fold+ more than the primary research.
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James Freeman, in reply to
The real problem, and one that isn't being fixed, is the shareholder push to maximise profit.
Indeed, but it was not always so.
The chairman of the US company, Standard Oil, stated, in 1946, that the business of companies should be carried on ‘in such a way as to maintain an equitable and working balance among the claims of the various directly interested groups — stockholders, employees, customers and the public at large.’[1,2]
1. https://books.google.com.au/books?id=oS9EzyyJaagC&pg=PA59
2. http://www.austlii.edu.au/au/journals/SydLawRw/2007/23.htmlSadly, times have changed.
To add insult to injury Big Pharma, and Gilead in particular, are extraordinarily efficient in avoiding taxes [3]
3. Rubin R. Gilead avoids billions in U.S. Tax on its $1,000-a-Pill drug. Bloomberg; 2015 [updated 2015 Feb 27;]. Available at http://www.bloomberg.com/news/articles/2015-02-26/gilead-avoids-billions-in-u-s-taxes-on-its-1-000-a-pill-drug
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Bart Janssen, in reply to
Sadly, times have changed.
Sadly true.
Meanwhile none of that explains SDHBs behaviour, all it would take would be for them to admit they have been doing it wrong ... oh wait.
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