[Ip-health] Richard Bergström of EFPIA: industry may be prepared to accept" delinking of research costs and drug pricing

Jamie Love james.love at keionline.org
Wed Nov 23 07:30:56 PST 2011


Richard Bergström, is the Director General of the European Federation of
Pharmaceutical Industries and Associations (EFPIA).

In a recent article in the Bulletin of the World Health Organization on the
topic of new antibiotics, Bergström, says the R&D pharma industry "may be
prepared to accept" delinking of research costs and drug pricing."  Here
are some quotes, followed by the full text of the article.  Jamie


------------------------------------
*  Referring to “the twin challenges of conserving the effectiveness of
existing antibacterial drugs and developing new ones”, authors of the
British Medical Journal article Anthony So, Melissa Furlong and Andreas
Heddini of Swedish-based nongovernmental organization, ReAct, write that
“delinking research and development costs from drug pricing and the return
that drug companies receive on investment could correct misaligned economic
incentives”.

*  This delinking of research costs and drug pricing is something that
industry may be prepared to accept, according to Richard Bergström,
director-general of LIF, the trade association for the research-based
pharmaceutical industry in Sweden.

*   “Incentives that separate the financial return from the use of a
product are the only way to change this behaviour,” said Bergström at a
conference held at Uppsala University in September 2010. “Intelligent pull
incentives, such as advance commitments and prizes, provide financial
rewards to the developer that are not based on the volume of use of the
novel antibiotic. With the right set-up, pharma companies will have no
incentive to drive use. Maybe they will not do any promotion at all. Use
would be agreed with public policy-makers, purchasers and national health
systems.”

---------------------------------


http://www.who.int/bulletin/volumes/89/2/11-030211/en/index.html


Bulletin of the World Health Organization
Race against time to develop new antibiotics


The second part of a series of three news features on antimicrobial
resistance looks at how the antibiotics pipeline is drying up while
resistance to existing drugs is increasing. Theresa Braine reports.

Bulletin of the World Health Organization 2011;89:88–89.
doi:10.2471/BLT.11.030211

Within a few days of scraping his leg in a scooter accident in 2009,
nine-year-old Brock Wade was in hospital fighting for his life with a
methicillin-resistant Staphylococcus aureus (MRSA) infection. Once the
infection – caused by one of the bacteria most often resistant to
antibiotics – had been diagnosed, doctors put him on five different
antibiotics. “After a month in the hospital, and against all odds, Brock
recovered and was well enough to come home,” says his mother Rhonda
Bailey-Wade on the web site of the Infectious Diseases Society of America
(IDSA).

Scenarios such as this IDSA case study are increasingly being played out
all over the world. But not all the thousands of patients that contract
drug-resistant bacterial infections every year are as lucky as Brock. And
the problem looks set to get worse. While infectious agents are becoming
more and more resistant to the medicines that are currently in use, not
enough drugs are being developed to combat them.


Courtesy of Infectious Diseases Society of America
Young Brock Wade spent a month in hospital fighting an antibiotic-resistant
infection.
“MRSA continues to be a major cause of community-acquired antibiotic
resistant infections,” says Dr Brad Spellberg, one of the authors of the
2004 IDSA report Bad bugs, no drugs. “However, because companies in the
late 1980s and early 1990s recognized the threat of MRSA, starting in 2000
we did get new MRSA drugs. Right now, we have reasonable antibiotics to
treat MRSA. As resistance catches up with them, in the future we will have
problems again.”

There are many reasons. One is scientific. “The low-hanging fruit has been
picked,” says Spellberg. “But the concept that we’ve exhausted the pantry
is ridiculous. Now we have to dig deeper, think harder and more cleverly.”

Another reason is commercial. Antibiotics, in particular, have a poor
return on investment because they are taken for a short period of time and
cure their target disease. In contrast, drugs that treat chronic illness,
such as high blood pressure, are taken daily for the rest of a patient’s
life. “Companies have figured out that they make a lot more money selling
the latter drugs than they do selling antibiotics,” Spellberg says,
highlighting the lack of incentive for companies to develop antibiotics.

That’s why many companies have stopped developing antibiotics altogether.
Only five major pharmaceutical companies – albeit five of the biggest –
GlaxoSmithKline, Novartis, AstraZeneca, Merck and Pfizer, still had active
antibacterial discovery programmes in 2008, according to an article
published in the journal Clinical Infectious Diseases in January 2009.

Adding to the grim picture, a comprehensive study of antibiotic
development, covering innovative, small firms, as well as pharma giants,
found in 2008 that only 15 antibiotics of 167 under development had a new
mechanism of action with the potential to meet the challenge of multidrug
resistance. Most of those were in the early phases of development,
according to the study entitled The bacterial challenge: time to react.

But there is hope. “Given that the antibiotics we have available today were
discovered as growth byproducts of bacteria that we can culture, and that
we’ve cultured less than 1% of the bacteria on our planet, there are many
potential solutions out there,” Spellberg says.


WHO/Chadin Tephaval
Checking vials of biological samples at Thailand’s National Institute of
Health in Bangkok.
A variety of biological solutions have yet to be fully explored, such as
phage therapy and the potential use of the lytic enzymes found in mucus and
saliva to kill pathogens (as described by researchers in an article
published in October 2010 in the Institute of Physics’ journal Physical
Biology).

Another example is that of researchers at GlaxoSmithKline who recently
described a novel class of antibacterial agents that target type IIA
topoisomerases. The article was published in Nature in August 2010. “This
investigational compound class has activity against a broad spectrum of
Gram-positive and Gram-negative bacteria,” says Dr Mick Gwyn, the study’s
lead author and a researcher in antibacterial drug discovery at
GlaxoSmithKline.

Antimicrobial resistance is the inevitable consequence of prescribing
antibiotics. “Whatever infections we treat, the bacteria that are part of
our normal flora are always exposed to these antibiotics,” says Dr Hajo
Grundmann, chair of infectious diseases and epidemiology at the University
of Groningen and head of the Department of Bacteriology at the National
Institute of Public Health in the Netherlands. “Simply by surviving the
onslaught of antibiotics, they are developing more clever ways to overcome
the most sophisticated and advanced antibiotics.”

There are no global data on the number of cases, including fatal ones, of
resistant bacterial infections. According to the 2008 study, every year at
least 25 000 patients in the European Union alone die from an infection
caused by multidrug-resistant bacteria and estimated additional health-care
costs and productivity losses are at least 1.5 billion Euros.

Some of the most resistant infections are caused by Gram-negative
Acinetobacter, and by certain strains of Klebsiella and Pseudomonas
species, according to Spellberg. These bacteria cause a variety of
illnesses ranging from hospital-acquired pneumonia, bloodstream infections,
urinary tract infections from catheters, abdominal infections and even
meningitis in people who have had head and spine procedures, for example,
epidurals during labour.

“Anywhere in the body can be hit by these bugs. And the issue is that
without effective antibiotics the death rate is much higher,” says
Spellberg.


WHO/Chadin Tephaval
A laboratory technician at Thailand’s National Institute of Health in
Bangkok.
The outbreak of resistant strains of Escherichia coli (E. coli) – a common
cause of food poisoning – carrying a gene called NDM1 (New Delhi
metallo-β-lactamase) in India in 2010, which spread to other countries, is
a case in point. Until recently such completely resistant bacteria have
only been found in hospitals, Spellberg says, but “now we’re starting to
see virtually or totally pan-resistant bacteria spilling into the
community”.

The solution may lie not only in scientific discovery but also in the
economic incentives for developing drugs. “I think that Congress
understands that this is now a market failure and that economic incentives
are needed to correct the market failure,” he says.

Public–private partnerships could provide one solution, according to a May
2010 commentary in the British Medical Journal, such as the GlaxoSmithKline
research partnerships with the Wellcome Trust and with the United States
Defence Threat Reduction Agency.

Referring to “the twin challenges of conserving the effectiveness of
existing antibacterial drugs and developing new ones”, authors of the
British Medical Journal article Anthony So, Melissa Furlong and Andreas
Heddini of Swedish-based nongovernmental organization, ReAct, write that
“delinking research and development costs from drug pricing and the return
that drug companies receive on investment could correct misaligned economic
incentives”.

This delinking of research costs and drug pricing is something that
industry may be prepared to accept, according to Richard Bergström,
director-general of LIF, the trade association for the research-based
pharmaceutical industry in Sweden.

“Incentives that separate the financial return from the use of a product
are the only way to change this behaviour,” said Bergström at a conference
held at Uppsala University in September 2010. “Intelligent pull incentives,
such as advance commitments and prizes, provide financial rewards to the
developer that are not based on the volume of use of the novel antibiotic.
With the right set-up, pharma companies will have no incentive to drive
use. Maybe they will not do any promotion at all. Use would be agreed with
public policy-makers, purchasers and national health systems.”

Bergström called for a “global compact” similar to the one used for the
United Nations programme for good governance and sustainable development
enshrined in Millennium Development Goal 7. This agreement “could focus on
the agreed and gradual introduction – and responsible marketing and use of
– new agents”.

“A global compact would require that not only industry but also
governments, physicians and pharmacists join forces to preserve the new
medicines that our children and grandchildren need,” said Bergström. “No
single tool will solve the problem. What is really needed is a collection
of incentives that address the multiple obstacles to success.”

This year the World Health Organization is devoting World Health Day on 7
April to raising awareness around the issue of antimicrobial resistance.
More information is available at: http://www.who.int/world-health-day

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
using my MaxRoam number: +447937390810
twitter.com/jamie_love



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