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As superbug problem mounts, drug companies slash antibiotics
research
By Guy Charron
11 September 2004
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Infectious disease specialists have drawn a causal link between
an alarming rise in the number of Quebec hospital patients becoming
infected with and dying from Clostridium difficilea
bacterium resistant to standard antibioticsand government
budget-cutting. As the World Socialist Web Site previously
reported, researchers studying the C. difficile pandemic
in Quebec have linked the bacterias spread to the unsanitary
environment created by decaying infrastructure, patient overcrowding,
and reduced staffing. [See Canada:
budget cuts have contributed to spread of super-bug]
Hospital-based infections and bacteria resistant to standard
antibioticsso-called superbugsare interlinked and
growing problems. In Quebec, more than 3,000 people died last
year as the result of infections they contracted while hospitalized,
making hospital-contracted infections the fourth most important
cause of death in Quebec. While many of the victims were persons
who were very old or already seriously ill, a significant number
succumbed to bacteria resistant to common antibiotics.
Since the early 1980s, the problem of superbugs has increasingly
preoccupied medical specialists and with good reason. It is estimated
that currently 20 percent of all bacterial infections in the US
involve microbes resistant to one or more antibiotics.
Media reports on the superbug phenomenon typically treat it
as exclusively a natural phenomenon. Bacteria that are resistant
to antibiotics or that have become resistant due to a mutation
survive antibiotic treatments, while the elimination of the non-resistant
strain facilitates the rapid proliferation of the superbug.
This explanation, based on the Darwinian principle of natural
selection, is certainly scientifically valid. But like the spread
of Quebecs C. difficile, the related general problem
of superbugs is also linked to social conditionspoverty,
the lack of basic hygiene, and the subordination of fundamental
health care concerns to the profit needs of big business.
An article published almost 10 years ago in one of the journals
of the American College of Physicians observed that in Asia, the
Middle East and Latin America, home to more than three quarters
of the worlds population, there is the greatest concentration
of antibiotic resistant bacteria, even though only 20 percent
of all antibiotics are consumed there.
The article asked, Why do countries that can afford so
little have so great a problem with resistance to antimicrobial
drugs? The situation appears to be due to a combination of a heavy
burden of bacterial infectious diseases; huge populations without
even the rudiments of primary health care; inappropriate use of
the available antimicrobial drugs; and rapid spread through crowding,
poor sanitation, and sexual contact. Self-prescribing is common
in most developing countries, and the effect is compounded by
a bewildering array of proprietary drugs containing irrational
mixtures of vitamins, stimulants, and
steroids and by the availability of drugs without prescription
for purchase in local pharmacies or open-air markets. Physicians,
when available, need to see as many patients as possible in the
shortest period of time with minimal, if any, laboratory or radiologic
support. They often feel compelled to prescribe antimicrobial
drugs to meet patient expectations. The pharmacies work on small
mark-ups. The amount of an antimicrobial purchased is often inadequate
to treat serious infections....
In some countries, the political systems are so corrupt,
the local business community so venal, and the physicians so disillusioned
that the situation seems hopeless.
Nevertheless, the author still held out hope that the spread
of superbugs could be reversed by the development of new antibiotics
and other antimicrobial drugs. However, the situation has changed
dramatically over the past decade. Despite the threat posed by
bacteria resistant to standard antibiotics, the major pharmaceutical
companies are withdrawing from research into antimicrobial drugs.
The number of new antimicrobial drugs approved by the FDA,
the US agency responsible for authorizing the marketing of pharmaceuticals,
has fallen significantly: 16 were approved between 1983 and 1987;
14 between 1988 and 1992; 10 between 1993 and 1997; and 10 more
in the last five-year period, 1998-2003. In 2003, the number of
new anti-infection agents submitted to the FDA for testing fell
by 10 percent from the year before, an indication that the long-term
trend is likely to continue.
In 2001, Eli Lilly and Bristol-Myers Squibb stopped work on
developing new antimicrobial drugs. Other major drug companies
are reported to be about to do likewise. A major conference of
microbiologists, doctors and pharmacists held in Chicago in September
2003 hosted a session devoted to discussing why the major drug
companies are withdrawing from antibiotics and antimicrobial research.
The session was titled Why Is Big Pharma Getting Out of
Anti-infective Drug Discovery?
Dr. Henry Masur, one of the session speakers, left no doubt
as to the impact of drug makers bottom-line on research
decisions that will ultimately affect the lives of masses of people:
The cost of drug development is astronomical, the market
is not nearly as enticing as markets that involve drugs that must
be taken for a lifetime rather than days or weeks, and there is
considerable pressure to reduce prices.
Nature, one of the worlds leading scientific journals,
summarized the Chicago session. Its summary read, in part: Big
drug companies are in the financial doldrums, and antibiotics
research is easy to cut, said Steven Projan, who directs such
work at Wyeths facility in Pearl River, New York. Natural
selection makes resistance inevitable, rendering any antibiotic
less profitable over time. New drugs that combat resistant bacteria
are often held in reserve by doctors to treat only the most stubborn
infectionsso they arent big earners. And unlike drugs
for chronic illnesses such as heart disease, antibiotics cure
people, eliminating their customers.
Antibiotic sales are valued at between $24 and $26 billion
per year and are expected to rise by 10 percent over the next
four years. Yet, because they can make larger profits by developing
other sorts of drugs, the pharmaceutical companies are cutting
back on antibacteria research.
To evaluate the quality of an investment, the pharmaceutical
industry uses an index called risk-adjusted net present value
or NPV. It takes into account several factors, including expected
sales, research costs and costs of the clinical tests needed to
get government approval for mass marketing. According
to the aforementioned Projan, antibiotics have an NPV of 100,
anti-cancer drugs 300, neurological drugs 720 and muscular-skeletal
1150.
The pharmaceutical companies have replied to the criticism
of their research decisions by complaining about the costs associated
with getting government approval to market new antibiotics. Their
standard refrain is that there is too much bureaucracy. FDA records
show, however, that since 1964 anti-infection agents have had
the highest approval rate of all classes of therapeutics and since
1982 the shortest or second shortest development time.
See Also:
Canada: budget cuts have contributed
to spread of super-bug
[30 August 2004]
The science and sociology
of SARS
Part 1: Viruses and the nature of present outbreak
[12 May 2003]
The science and sociology
of SARS
Part 2: Science, internationalism and the profit motive
[13 May 2003]
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