[Ip-health] BMJ MSF's Manica Balasegaram: Drugs for the poor, drugs for the rich--why the current research and development model doesn't deliver

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Fri Feb 14 02:32:13 PST 2014


BMJ
Manica Balasegaram: Drugs for the poor, drugs for the rich--why the current
research and development model doesn't deliver
13 Feb, 14 | by BMJ
http://blogs.bmj.com/bmj/2014/02/13/manica-balasegaram-drugs-for-the-poor-drugs-for-the-rich-why-the-current-research-and-development-model-doesnt-deliver/

The past month has seen the reputation of "Big Pharma" dented more than
usual. The CEO of German pharmaceutical company Bayer, Marijn Dekkers, was
reported as saying that the company didn't develop a cancer drug for the
Indian market, but rather "for Western patients who can afford it." The
comment summed up the attitude of the pharmaceutical companies towards the
poor and succinctly described what is wrong with today's research and
development (R&D) system.

In a similar vein, last month British/Swedish pharma company AstraZeneca
announced it was pulling out of all early stage R&D for malaria,
tuberculosis (TB), and neglected tropical diseases--all diseases of the
developing world. Instead, the company stated it will focus efforts on
drugs for cancer, diabetes, and high blood pressure, all diseases that
affect rich countries, with potentially plenty of people to pay the high
prices on new drugs.

This system of R&D--which increasingly relies on patents, market monopolies,
and high prices of drugs to recoup costs--is broken. We are seeing a
complete lack of R&D into areas of real need, especially in diseases that
affect the poor. The effects of this system on patients in developing
countries is something that I--as someone who has worked as a doctor in some
of the most remote areas in the world with Médecins Sans Frontières
(MSF)--have witnessed for years.

The pharmaceutical industry touts the need for strong intellectual property
(IP) protections and patents as a means to secure funding for R&D needs.
They say that without 20 year plus patent terms and the ability to have
patents granted on even minor modifications on existing drugs--known as
"evergreening"--we simply wouldn't have innovation. And yet, incredibly, the
industry is pulling out and stopping innovation in the areas of the
greatest need.

This trend is not new. Pfizer stopped R&D into all anti-infective drugs in
2012; in the same year, barely a third of the estimated funding needed for
TB drug development was met. The need for new TB drugs and new regimens to
treat TB--especially drug-resistant forms of TB--is increasing worldwide,
including in some parts of Europe and countries such as South Africa and
India.

The lack of R&D for new drugs doesn't only affect developing countries;
wealthy countries are also faced with a huge gap in medical innovation.
With the numbers of cases of antibiotic resistance on the rise in many
parts of the world--including in western hospitals--there are, worryingly,
few new antibiotics being developed. We are fast approaching the point, if
we're not there already, where people will develop infections that are
resistant to all existing antibiotics, and we'll have nothing effective
with which to treat them.

The problem is simply this: pharmaceutical companies like Pfizer,
AstraZeneca, and Bayer lack the incentives to develop drugs like
antibiotics that are only taken for a short period of time, or against
diseases that primarily affect the poor. With an obligation to
shareholders, pharma companies develop those drugs that will most enable
them to achieve high sales in targeted lucrative markets. Typically, these
drugs are for diseases that affect mostly people in wealthy countries who
can afford--for the most part--to pay the high prices that come with a R&D
system which relies on patent monopolies to recoup costs.

Increasingly, we're seeing not only the unavailability of drugs for medical
needs, but also unaffordability when drugs are priced out of the reach of
most people. The drugs that are developed today are priced so highly that
even people in the USA, UK, and the EU--the very markets that Big Pharma are
targeting--are unable to afford price tags such as US$84 000 for the new
hepatitis C drug sofosbuvir, or cancer drugs priced at over $100 000. We
have to ask ourselves--if the drugs being developed are priced so highly
that no one can afford them, is society actually benefiting?

The pharmaceutical industry's response to criticism over high prices is
that it costs a lot to develop these drugs. While this is undoubtedly true,
there are two important points of clarification: first, a lot of the R&D
behind successful new drugs is heavily subsidised by the tax
payer--globally, about half of all R&D is paid for from the public purse and
by philanthropic organisations. In effect, we're paying twice for new
drugs. Secondly, there is a lack of transparency from the pharmaceutical
industry-- so we don't really know how much it costs, and how much this can
vary.

The industry often throws around the figure of $1 billion as the cost. Yet
this figure is often questioned, even by one of their own; last year, GSK's
Andrew Witty called the $1 billion figure "a myth." Other organisations
have proved that it's possible to develop new drugs for significantly less
than $1 billion, and have no patents or high prices attached. For example,
a non profit public private partnership used-up front funding to develop an
artemisinin based combination therapy for malaria, which has no patent, is
priced at less than US$1 and has seen over 250 million treatments used in
31 African countries. The private public partnership Drugs for Neglected
Diseases initiative has estimated that development of a new chemical entity
can cost as little as $50 million per successfully developed drug; with
attrition and failure rates taken into account, it's still as little as
$200 million.

Pharma has a vision for R&D--tough intellectual property rights and patents
on new medicines, and high prices. But clearly, this approach doesn't
entirely work to deliver public health benefits. Our vision for R&D
involves an overhaul of the current system. New drugs should be developed
according to actual medical needs in a system that does not exclusively
rely on patents and high prices to recoup costs. There are other ways to
pay for R&D and alternative business models that can be used. It is
essential these are further developed to ensure that innovators are
sufficiently and transparently rewarded for developing useful products. It
is possible to develop drugs for neglected diseases and diseases that
affect the developing world. It is possible to develop new antibiotics and
drugs where we aren't forced to pay more than $100,000 for each patient
treated. The system is broken; it's time we fixed it--for the benefit of
everyone, including the pharmaceutical industry.

Manica Balasegaram is the executive director of the Médecins Sans
Frontières (MSF) Access Campaign. Previously he was head of the
Leishmaniasis Clinical Program for Drugs for Neglected Diseases initiative
(DNDi) and has worked in MSF medical projects in Uganda, Sudan, Democratic
Republic of Congo, Ethiopia, India, and Bangladesh.



Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan

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