PharmExec Blog

Unlikely European Allies Target Superbugs

The annual worldwide antibiotic awareness event—celebrated in Europe on November 15—generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers. But it was perhaps most compellingly marked by a plangent call for better medicines from an unusual source.
First, the statistics. Superbugs are on the way to a victory. Antibiotic resistance is now threatening those hitherto reliable last-resort carbapenems. The proportion of Klebsiella pneumoniae bloodstream infections resistant to carbapenems has increased over the last three years to above 5% in 5 countries, mostly in the south of Europe. And a new concern is the emergence and spread of carbapenem-resistant Acinetobacter species, which is above 25% in eight of 18 countries reporting data.
Now the reassurance. “I cannot stress enough how seriously we take the challenge posed by antimicrobial resistance,” European Commissioner for Research and Innovation, Máire Geoghegan-Quinn, said in a statement accompanying the figures. She also listed some of the research that the European Union is undertaking both to minimise resistance and to develop new medicines.
And now the expressions of urgency from industry and the research community. Barry Eisenstein, Head of Scientific Affairs at Cubist, speaking on behalf of the European drug industry at a meeting early this month at the European Medicines Agency, said: “The greatest risk is being unprepared!” He added: “We’ve now spent several years talking about how to resolve this… We need greater trial feasibility and regulatory predictability.”
But the message that carried the sharpest tone came from Médecins sans Frontières, an organization not famous for espousing the concerns of the medicines industry. “People with drug-resistant tuberculosis and their medical providers call for urgent change,” ran the headline of a major campaign launched in mid-month, focused particularly on developing countries.  Warning that current treatments can cause deafness, psychosis, vomiting, loss of vision, it is calling for “the international community to deliver universal access to testing and treatment, more effective and tolerable medicines, and the financial support necessary to achieve these goals.”
A manifesto at the heart of the campaign says: “We, the medical staff who provide medical care for people with drug-resistant tuberculosis, find it unacceptable that the only treatment options that we can offer people cause so much suffering, especially when the chance of cure is so low. We have no choice but to juggle combinations of largely ineffective and toxic drugs.”
A spreading epidemic is driving resistance and making success even harder, says MSF. “We want to save many more lives, but we desperately need shorter, safer and more effective treatment to do so.”
The campaigners make clear their hostility to some drug industry practices in derogatory references to use of intellectual property rights. But they also say: “New drugs must be developed specifically to treat DR-TB, while research must continue into combinations using new and existing drugs to respond to the wide range of drug resistance. Research and development must be financed to rapidly develop not only effective and safe new drugs, but also easy-to-use, accurate and affordable diagnostics, as well as development of a vaccine to prevent the spread of TB.”
When opposed parties start saying the same thing about the core problem, even while disagreeing about related issues, there is a good chance that they are both right, and that the discussion is moving towards a useful conclusion. Will the MSF intervention trigger new impetus to the challenges that Europe and the world face in anti-infective therapy?

By Peter O’Donnell.

The annual worldwide antibiotic awareness event — celebrated in Europe on November 15 — generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers. But it was perhaps most compellingly marked by a plangent call for better medicines from an unusual source.

First, the statistics. Superbugs are on the way to a victory. Antibiotic resistance is now threatening those hitherto reliable last-resort carbapenems. The proportion of Klebsiella pneumoniae bloodstream infections resistant to carbapenems has increased over the last three years to above 5% in 5 countries, mostly in the south of Europe. And a new concern is the emergence and spread of carbapenem-resistant Acinetobacter species, which is above 25% in eight of 18 countries reporting data.

Now the reassurance. “I cannot stress enough how seriously we take the challenge posed by antimicrobial resistance,” European Commissioner for Research and Innovation, Máire Geoghegan-Quinn, said in a statement accompanying the figures. She also listed some of the research that the European Union is undertaking both to minimise resistance and to develop new medicines.

And now the expressions of urgency from industry and the research community. Barry Eisenstein, Head of Scientific Affairs at Cubist, speaking on behalf of the European drug industry at a meeting early this month at the European Medicines Agency, said: “The greatest risk is being unprepared!” He added: “We’ve now spent several years talking about how to resolve this… We need greater trial feasibility and regulatory predictability.”

But the message that carried the sharpest tone came from Médecins sans Frontières, an organization not famous for espousing the concerns of the medicines industry. “People with drug-resistant tuberculosis and their medical providers call for urgent change,” ran the headline of a major campaign launched in mid-month, focused particularly on developing countries.  Warning that current treatments can cause deafness, psychosis, vomiting, loss of vision, it is calling for “the international community to deliver universal access to testing and treatment, more effective and tolerable medicines, and the financial support necessary to achieve these goals.”

A manifesto at the heart of the campaign says: “We, the medical staff who provide medical care for people with drug-resistant tuberculosis, find it unacceptable that the only treatment options that we can offer people cause so much suffering, especially when the chance of cure is so low. We have no choice but to juggle combinations of largely ineffective and toxic drugs.”

A spreading epidemic is driving resistance and making success even harder, says MSF. “We want to save many more lives, but we desperately need shorter, safer and more effective treatment to do so.”

The campaigners make clear their hostility to some drug industry practices in derogatory references to use of intellectual property rights. But they also say: “New drugs must be developed specifically to treat DR-TB, while research must continue into combinations using new and existing drugs to respond to the wide range of drug resistance. Research and development must be financed to rapidly develop not only effective and safe new drugs, but also easy-to-use, accurate and affordable diagnostics, as well as development of a vaccine to prevent the spread of TB.”

When opposed parties start saying the same thing about the core problem, even while disagreeing about related issues, there is a good chance that they are both right, and that the discussion is moving towards a useful conclusion. Will the MSF intervention trigger new impetus to the challenges that Europe and the world face in anti-infective therapy?

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