Monday, January 27, 2014

Fwd: qotd: Bayer designs its products for the market, not for poor people

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-------- Original Message --------
Subject: qotd: Bayer designs its products for the market, not for poor
people
Date: Mon, 27 Jan 2014 13:47:41 -0800
From: Don McCanne <don@mccanne.org>
To: Quote-of-the-Day <quote-of-the-day@mccanne.org>



Financial Times
FT Global Pharmaceuticals & Biotechnology Conference 2013
December 3, 2013
Buffering the Pharma Brand: Restoring Reputation, Rebuilding Trust (A
panel discussion)

With recent surveys revealing pharmaceutical companies now ranking in
trust perceptions below producers of spirits and tobacco, and physicians
basing prescribing decisions as much on brands as on products, the need
for pharmaceutical companies to understand and address the factors
contributing to poor reputation has never been greater. How can pharma
companies restore reputation and increase trust?

Marijn Dekkers, Chairman of the Board of Management, Bayer:

India for us was an unusual situation. Our patent was not questioned. I
mean, other companies patents are questioned. In our case. the Indian
government said, "No, no, your patent is valid." - and this is a product
for kidney and liver cancer - "Your patent is valid. We just think that
you charge too much, and because you charge too much you have to do a
mandatory license to a generic company in India that is now going to
make this drug and sell it, and on that low price that they will sell it
for, you will get six percent royalty." And that was a government
decision. So, we had a patent, but somebody else is allowed to make this
product, and because there is not enough access to this product for poor
Indians. I don't know if you have ever been to India. There are a lot of
poor Indians obviously, and the hospitals aren't that close by (laughs)
where they live. So we found that this was extremely politically
motivated and essentially, I would say, theft of the Indian government
of a capability of a company that has patented and therefore a patent
right. So, now is this going to have a big effect on our business model?
No, because we did not develop this product for the Indian market -
let's be honest - we developed this product for Western patients who can
afford this product, quite honestly. It is an expensive product, being
an oncology product. But, you know, the risk in these situations is
always spillover. A generic Indian company is now going to sell this
product, in South Africa, and then in New Zealand, you never know how
this is going to spill over. That puts the whole industry, and the
patent right of an industry, at risk.

https://www.ft-live.com/ft-events/ft-global-pharmaceuticals-biotechnology-conference-2013/sessions/buffering-the-pharma-brand-restoring-reputation-rebuilding-trust-panel

****

Mail Online
January 24, 2014
'We didn't make this medicine for Indians… we made it for western
patients who can afford it': Pharmaceutical chief tries to stop India
replicating its cancer treatment
By Daily Mail Reporter

The CEO of phamaceutical giant Bayer has sparked fury after announcing
one of the firm's drugs was for 'western patients who can afford it'.

Marijn Dekkers made the inflammatory comments after the Indian company
Natco Pharma Ltd. were granted a government licence to produce a copy of
Bayer's cancer drug Nexavar which they will sell for 97 per cent less
than the original product.

Under Indian law the government grants compulsory licenses to domestic
firms to produce copies of drugs if the original isn't available locally
at a reasonable price, regardless of whether they are under patent.

Mr Deekers, who has previously described India's patent laws as
'essentially theft', said: 'We did not develop this medicine for
Indians. We developed it for western patients who can afford it.'

Nexavar, which is also known as Sorafenib, has been approved for the
treatment of kidney cancer, advanced liver cancer (hepatocellular
carcinoma), and thyroid cancers that are resistant to radioactive iodine
treatment.

Currently a kidney cancer patient would pay $96,000 (£58,000) for a
year's course of the Bayer-made drug. However the cost of the Natco
version would be around $2,800 (£1,700).

http://www.dailymail.co.uk/news/article-2545360/Pharmaceutical-chief-tries-stop-India-replicating-cancer-treatment.html

****

Forbes
December 5, 2013
Does Pharma Only Develop Drugs For Those Who Can Pay?
By John LaMattina

At the Financial Times Global Pharmaceutical & Biotech Conference this
week, Bayer AG CEO, Marijn Dekkers, is reported to have said that Bayer
didn't develop its cancer drug, Nexavar (sorafenib) for India but for
Western patients that can afford it. That's a pretty provocative
comment. At a time when Pharma's reputation is suffering, Dekkers'
comment does not help matters. Rather, it reinforces the notion that Big
Pharma is only interested in profits and those in need are out of luck
when it comes to life saving medicines.

Reader Comments:

Marijn Dekkers:

John,

You write that I could have been more circumspect with my remarks.

I regret that what was a quick response from me within the framework of
a panel discussion at the recent FT Pharma conference has come across in
a different way as it was meant by myself. It could not be more opposite
to what I want and we do at Bayer.

Let me confirm that Bayer as a company wants to improve people's health
and quality of life with innovative therapies and we would like all
people to share the fruits of medical progress, regardless of their
origins or income.

However, I was particularly frustrated by the Indian government's
decision, to not protect a patent on Nexavar that was given to us by the
Indian patent authority. This was a unique event against Bayer's
intellectual property. But as you know best, the protection of our IP is
so vital to our ability to fund and advance new innovations to help
address some of the worst diseases in the world such as cancer.

I am very passionate about our ability to innovate and in the open and
candid discussion at the conference, as I was expressing my fundamental
frustrations, I should have made this more clear.

However, I remain firm that there is no excuse for any country to weaken
the intellectual property rights. Without new medicines people in
developing countries – as well as those in the more prosperous countries
– ultimately will all suffer. Bayer, like any other private company,
needs a sufficient return on investment to allow for future research and
therefore innovation. Generic manufacturers have a critical role to play
– but generic companies do not invest in researching and developing and
therefore don't ever bring any new innovative cures and treatments. Not
for the developing nor the developed markets!

Marijn Dekkers
Chairman of the Board of Management of Bayer AG

And…

davidstuarthill:

Dr David Hill
Chief Executive
World Innovation Foundation

It should be quite clear now that big pharma is 'only' interested in
vast profits and basically has no empathy with humankind other than it
being an immense cash-cow for them. Their actions and out-of-court
settlements speak volumes and where history cannot lie.

For the major drug companies throughout the world are continually being
found out for criminal and fraudulent activity in order to sell their
pharmaceuticals. Not me saying this but the world's media coverage and
the out-of-court agreements that they have settled and where in the past
5 years alone fines in excess of $17 billion have been agreed between
authorities and the big drug companies. These include but where they are
not a fully exhaustive list of examples,
$2.2 billion and $2.5 billion by J&J (2013),
£3 billion by GSK (2012),
$762 million by Amgen (2012),
$1.5 billion by Abbott (2012),
$95 million by Boehringer Ingelheim (2012),
$109 million by Sanofi-Aventis (2012),
$950 million by Merck (2011),
$520 million by AstraZeneca (2010),
$750 million by GSK (2010),
$423 million by Novartis (2010),
$460 million by Allergan (2010),
$2.3 billion by Pfizer (2009),
$1.42 billion by Eli Lilly (2009)
and $425 million by Cephalon (2008) – Source for all from the US
'Department of Justice' and reinforced by Wikipedia listing. Note also
that all of these actions had criminal activity as part of their
respective settlements. But because these huge global concerns make so
much money out of selling drugs, these fines have apparently now become
an in-built expense in the corporate cost of their drugs. Indeed in
GSK's 2012 case in the USA, nearly $30 billion was sold and where it was
estimate that even after the $3 billion fine was deducted, a profit of
$11 billion was made.

Therefore it certainly appears that the accepted corporate environment
that these giant corporations have structured internally for themselves
has created these illegal activities and where it is of their own making
and not predominantly the countries that they operate within – but I
have to say though, that it does help if there is government and
internal corruption to boot. But possibly the biggest sadness to date
has to come out yet in India where over 20,000 of the poorest children
in the world (between the ages of 10 and 14) have been used as human
guinea pigs for Big Pharma – http://www.bbc.co.uk/news/magazine-20136654
. Indeed over the past seven years, nearly 2,000 trials have taken place
in the country and the number of deaths increased from 288 in 2008 to
637 in 2009 to 668 in 2010, before falling to 438 deaths in 2011, the
latest figures available. Therefore the drive for corporate profits has
a very dark side to it and everyone should be fully aware of this fact.
Apparently this is not a problem for big pharma and where vast profits
and greed rise above human life itself. Governments just have to get to
grips with these huge corporations and fine then not just a small
percentage of their profits but all the estimated total profit. That is
the only way that they will ever alter their corporate mind-set and
strategic blue-print.

http://www.forbes.com/sites/johnlamattina/2013/12/05/does-pharma-only-develop-drugs-for-those-who-can-pay/

About The World Innovation Foundation:
http://www.thewif.org.uk/wif.php?xy=1440&pl=macintel

****

NICE (National Institute for Health and Care Excellence)
Results for Sorafenib (Nexavar):

NICE does not recommend sorafenib for people with advanced
hepatocellular carcinoma. Sorafenib does not provide enough benefit to
patients to justify its high cost, even when special considerations were
applied, so NICE did not recommend it.

Bevacizumab, sorafenib and temsirolimus are not recommended as first
drug treatments for people with advanced and/or metastatic renal cell
carcinoma. Sorafenib and sunitinib are not recommended as second drug
treatments for people with advanced and/or metastatic renal cell carcinoma.

http://www.nice.org.uk/Search.do?x=-987&y=-75&searchText=Sorafenib&newsearch=true

****

Médecins Sans Frontières (Doctors Without Borders)
January 23, 2014
MSF response to Bayer CEO statement that medicines developed only for
western patients
By Dr Manica Balasegaram, Executive Director, Médecins Sans Frontières
Access Campaign

The Bayer CEO going on record to say that they did not develop a cancer
medicine for Indians but only for 'western patients who can afford it'
sums up everything that is wrong with the multinational pharmaceutical
industry. Bayer is effectively admitting that the drugs they develop are
deliberately going to be rationed to the wealthiest patients.

This is a side-effect of the way drugs are developed today.
Pharmaceutical companies are singularly focused on profit and so
aggressively push for patents and high drug prices. Diseases that don't
promise a profit are neglected, and patients who can't afford to pay are
cut out of the picture. Drug companies claim to care about global health
needs, but their track record says otherwise.

It doesn't have to be this way. Medical innovation can be incentivised
differently, and research paid for in ways that deliver drugs but
without high prices that exclude millions of people from access.
Instead of being part of the problem, drug companies should work to be
part of the solution and change the dire state of medical research and
development today.

http://www.msfaccess.org/content/msf-response-bayer-ceo-statement-medicines-developed-only-western-patients


Comment: Bayer Chairman Marijn Dekkers wants to be honest with us when
he tells us that Nexavar (sorafenib), an expensive drug for certain
liver and kidney cancers, was developed for Western patients who can
afford it, but not for poor people such as much of the population of
India. Should markets be the controlling factor?

Today's New York Times reviewed the 2014 Rolls-Royce Wraith, a
spectacular two-door sedan available for $372,324, with the $12,925
option of a headliner with 1,340 LEDs that provides the ambiance of a
night sky filled with stars. Transportation is an important public
policy issue, but, I dare say, the sale of a Rolls-Royce should be left
to market dynamics.
http://www.nytimes.com/2014/01/26/automobiles/autoreviews/the-ecstasy-of-excess-the-agony-of-the-sticker.html

What about health care? Should it be left to markets? Let's look at the
corporate market mentality in the case of Bayer's Nexavar. It was not
developed for all patients with hepatocellular or renal cell carcinoma;
it was developed only for those who could afford it. It was developed
for private markets, not for public health. It was intended that it be
priced near the maximum that the market would bear, rather than being
priced based on costs plus fair profits. The fear and grief of cancer
patients are used to leverage higher market prices for oncology drugs.
Thus the price of Nexavar was set at $96,000 - a price at which Bayer
decided that there was a large enough market of wealthy individuals with
these cancers who would willingly pay that amount.

Should the government intervene when drug pricing prevents access for
most patients? India thinks so. Bayer could, but won't, produce the
drugs for a much fairer price (since they didn't design it for the poor
people of India). So India is licensing generics, while honoring Bayer's
patent by giving them a six percent royalty for nothing other than
owning the patent.

In the United States, we have decided to leave much of the pricing of
drugs to the market, except for government programs such as the VA and
Medicaid. Although insurers and pharmacy benefit managers do some
negotiating, they are still part of the marketplace, and they are very
weak negotiators at that. Thus we pay much higher prices for
prescription drugs than do all other nations.

There is another point to be made when using the example of Nexavar.
England's NICE evaluates the benefits and costs of various therapeutic
measures, and they have decided that this drug is not recommended for
either advanced hepatocellular carcinoma or advanced renal cell
carcinoma. So why would anyone want to be treated with this medication?
One report submitted to NICE showed that Nexavar "on average improves
overall survival by 83 days" for hepatocellular carcinoma with Grade A
liver function, but "available evidence does not indicate that it delays
symptom progression or improves quality of life." Prolonging life at
well over $1000 per day might be worth it to some even if symptoms
progress anyway and quality of life does not improve.
http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0009/65295/FullReport-hta14Suppl1-03.pdf

The British and the Indians seem to understand the issues better. Maybe
someday we will too, but not until we get a better grasp on the proper
role of markets and the government. Markets will get you a Rolls-Royce
or 83 days of poor quality life, if you can afford it. The government
would get all of us the health care that we really need, if only we
would change our politics to make it happen.

But that Rolls… with its 624 horsepower 6.6-liter twin-turbo V12, you
can go from a standstill to 60 miles per hour in only 4.4 seconds… an
American dream! (Forget about the American nightmare of our health care
system.)

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