In recent years, efforts to combat drug-resistant bacteria have focused on
the immediate goal of reducing rates of hospital-acquired infections. But
now global health officials face an approaching crisis: the number of
different antibiotics available to treat such infections when they do occur
is dwindling because pharmaceutical companies have neglected to invest in
the development of new types of drugs.
Bacterial and parasitic diseases are the second-leading cause of death
worldwide, according to a report on antibiotic research released Sept. 17 by
the London School of Economics and Political Science , with 175,000
deaths attributed to hospital-acquired infections each year in Europe alone.
And due to the emergence of drug-resistant “superbugs,” such as
Methicillin-resistant Staphylococcus aureus , traditional antibiotics
such as penicillin and its derivatives are becoming obsolete. New
antibiotics are desperately needed, but the amount of money being spent on
the research and development of these drugs is woefully inadequate. “The
issue is quite dreadful,” says Elias Mossialos, a professor of Health Policy
at LSE and author of the report. “When you look down the pipeline, there are
only a handful of new antibiotics in development, and all in the early
stages.”
There are several reasons why it’s not cost-effective for the major
pharmaceutical companies to invest more in antibiotic research, the report
found. The course of antibiotic treatment is typically short because the
drugs help patients get better quickly, and doctors tend to curtail the
number of prescriptions they write so as to avoid patients developing
resistance to the drugs. And when resistance to a certain antibiotic
inevitable develops, the drug becomes largely obsolete.
But the report pointed out ways to incentivize pharmaceutical companies to invest more in
antibiotic research. One solution would be for governments
to offer drug companies an extension on patents for new antibiotics and perhaps
even allow companies to transfer the extension to a different therapeutic
category. This would help major pharmaceutical
companies protect their monopolies on
lucrative “blockbuster” drugs.
Governments could also offer companies rewards such as vouchers for
accelerated regulatory approval of new antibiotics. These, too, could be
transferred internally to cover different drugs or even sold to other drug
companies, the report said.
Such incentives, which health economists calls “pull” mechanisms because
they help pull a drug onto market once it has been discovered, would
particularly help big drug companies, which have the capital to invest in
early-stage research and development. For small- and medium-size biotech
companies, which do not have the same abundance of capital, the report advocates more tax credits and government or NGO loans and grants
to help support early-stage research and help “push” new drugs onto the market. The LSE report recommends the European
Union and the U.S. implement a hybrid of “pull” and “push” mechanisms to
encourage antibiotic development, with bonus incentives linked to the drugs’
efficacy.
Sweden, which took over the rotating presidency of the E.U. in July, is
taking the lead on pushing for legislation on antibiotic development in
Europe and the U.S. Otto Cars, head of the Swedish Strategic Programme
Against Antibiotic Resistance, which advises the Swedish government, says
Sweden will lobby for the E.U. to pass an incentives package for antibiotic
research by the end of the year. Swedish leaders will also meet with U.S.
officials in December to push for legislation there. “Physicians and the
scientific community have been warning about this for years, but the
political reaction has been very weak,” Cars told TIME. “We are working to bridge the gap.”
One of the few pharmaceutical companies concentrating on antibiotic
development is Switzerland-based Basilea Pharmaceutica Ltd., which was
founded in 2000 when Roche abandoned antibiotic development. Basilea
recently began selling a new antibiotic called Ceftobiprole, which is
effective against MRSA and other superbugs, in Canada, Ukraine and
Switzerland. Basilea CEO Anthony Man said there is
“no one-size-fits-all” incentive program to encourage companies to invest in
antibiotic research. But he said major pharmaceutical companies and smaller,
boutique firms both need to be lured back to the field.
“We simply do not have enough companies working on this area. There should
be a basket of different solutions available from governments and NGOs that
companies could choose from depending on the maturity of the R&D project in
their pipeline,” he said.
David Payne, head of GlaxoSmithKline’s Antibacterial Discovery Performance
Unit, says that incentives would certainly help his research team, which is
one of the few left in major pharmaceutical firms that continue to develop
new classes of antibiotics. “A lot of people don’t appreciate that in big
companies it’s a pretty competitive environment for funding for each of the
therapeutic areas. Incentives would offer a way for us to accelerate our
program and increase our probability of success.”
But both Man and Payne also acknowledged that there are scientific obstacles
to antibiotic research that cannot be solved by incentives alone. A deadly
new class of antibiotic-resistant bacteria — so-called “gram-negative”
bacteria — have a protective layer that has largely stymied drug developers.
“[Drug-resistant bacteria] have multiple defense mechanisms to new drugs,” says Man. “There are difficult technical challenges.”
To Cars, the scientific challenges are more worrying than the financial
obstacles. “Even if we got the incentives right, there’s a knowledge gap
that needs to be filled,” he says. “The pharmaceutical companies have
already picked the low-hanging fruit and developed drugs for the ‘easy’
bacteria. We are facing a rapidly spreading pandemic. And we are running out
of ammunition. We need to do something now.”
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