No dose for the dose – a warning

by JoelLane 27. February 2013 14:58

gonorrhoea bacteria The lack of new antibiotics is exposing the UK population to serious risk from untreatable gonorrhoea, the Health Protection Agency (HPA) has warned.

The Agency’s Gonorrhoea Resistance Action Plan aims to maximise the effectiveness of existing treatments after a year in which new diagnoses rose by 25%.

The increasing prevalence of antibiotic-resistant strains draws attention to the lack of new therapies, a problem highlighted by GSK’s Andrew Witty in 2012.

The action plan, developed by the HPA’s Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP), places emphasis on data collection, rapid detection of treatment failures, and actions to reduce infection rates.

The GRASP data show that new gonorrhoea diagnoses rose by 25% in 2011 to nearly 21,000. Men who have sex with men made up a third of new infections, compared to a quarter in 2010.

With treatment failures occurring worldwide and no new antibiotics in the pipeline, England’s Chief Medical Officer recently argued that antibiotic resistance should be considered a civil emergency on a par with terrorism.

Professor Cathy Ison, lead author of the action plan, said: “Ensuring treatment-resistant gonorrhoea strains do not persist and spread remains a major public health concern. The GRASP Action Plan sets out practical, measurable actions to extend the useful life of the current recommended therapies in England and Wales.”

Current fears that the transfer of sexual health services to the council-funded public health system will see cuts in these services has intensified concern about the likely spread of untreatable gonorrhoea.

Andrew Witty, CEO of GSK, commented in 2012 that by the time a viable commercial model for new antibiotics existed, it would be too late to avert a serious pandemic. “The market has failed,” he concluded.

Antibiotic Action, a new UK-led initiative to encourage global investment in the development of new antibiotics, is working to establish an all-party Parliamentary Group that can address the issue.

Professor Laura Piddock, Director of Antibiotic Action, commented: “The GRASP Action Plan is a good example of why we need new drugs, and begs the question why they are not being developed for this infection. Government must act now to avert this and similar crises that threaten the health of our nation.”

Antibiotic cupboard is bare, says Chief Medical Officer

by JoelLane 24. January 2013 14:08

Prof. Dame Sally Davies, CMO web The ‘empty’ antibiotic pipeline threatens a future of mass death from antibiotic-resistant infections, the UK Chief Medical Officer has said.

Professor Dame Sally Davies told a Parliamentary committee that the pharmaceutical industry has no solutions to the growing problem of antibiotic resistance.

Overuse of antibiotics, especially in the developing world, and the combined impact of sex tourism and medical tourism were globalising the most serious health threats, the committee heard.

Antibiotic resistance has been recognised as a problem in Europe for decades, with the power of the standard antibiotics to fight disease steadily waning.

However, the massive current use of antibiotics in countries such as India, where private drug supply is deregulated, has caused a proliferation of drug-resistant infections that are spreading through the developed world.

Professor Davies warned: “The apocalyptic scenario is that when I need a new hip in 20 years I’ll die from a routine infection because we’ve run out of antibiotics.”

Antibiotic-resistant strains of tuberculosis and gonorrhoea are spreading globally, she said. Meanwhile, the pharmaceutical industry is failing to develop new antibiotics because there is no urgent need for them – but when there is, it may be too late to prevent a lethal pandemic.

GSK’s CEO, Andrew Witty, made the same point last year and warned that “the market has failed” to address the danger. He called for global collaboration between health systems and industry.

“There is a broken market model for making new antibiotics, so it's an empty pipeline, so as they become resistant, these bugs... there will not be new antibiotics to come,” said Professor Davies.

Antibiotic resistance is growing public health threat

by JoelLane 19. November 2012 16:20

ecoli Overuse of antibiotics for minor infections is leading to the prevalence of deadly ‘superbugs’, experts have warned.

According to the European Centre for Disease Prevention and Control (ECDPC), antibiotic-resistant bacterial infections kill 25,000 people in the EU each year.

Bacterial diseases that are becoming harder to treat include E. coli (pictured), K. pneumoniae and gonorrhoea.

Noting the lack of new antibiotics and the waning effect of existing ones, the ECDPC called for major investment in antibiotic R&D.

Speaking on the fifth European Antibiotic Awareness Day, NHS Chief Medical Officer Prof. Dame Sally Davies said: “Antibiotics are losing their effectiveness at a rate that is both alarming and irreversible – similar to global warming.

“I urge patients and prescribers to think about the drugs they are requesting and dispensing. The more you use an antibiotic, the more bacteria become resistant to it.”

The inappropriate prescribing of antibiotics for viral infections has been identified as a major cause of antibiotic resistance.

Overuse of antibiotics is a historic medical problem, and at present is a major issue in India’s health system.

New ECDC data shows a significant rise over the last four years of resistance to multiple antibiotics in K. pneumoniae and E. coli in the EU. These are normally harmless gut bacteria, but certain strands can cause lethal infections.

The last-line antibiotics, carbapenems, that are the only way to treat ‘superbug’ infections are used much more widely than five years ago, the ECDC noted – while carbapenem-resistant K. pneumoniae strains are common and increasing.

Robert-Jan Smits, Director General for Research & Innovation at the European Commission, said the rise in antibiotic resistance makes a “dedicated research effort” necessary.

UK incidence of drug-resistant gonorrhoea soars

by JoelLane 31. May 2012 13:46

Pf clinical news The spread of drug-resistant strains of gonorrhoea led to a 25% rise in newly diagnosed cases of the disease in England in 2011.

With some European patients showing full resistance to first-line treatments, the Health Protection Agency has warned that gonorrhea may become “a very difficult infection to treat”.

The growing medical crisis highlights the need for new and more specific antibiotics that was noted by GSK’s Andrew Witty in March.

Gonorrhoea is a bacterial infection that can lead to infertility if not effectively treated with antibiotics.

Professor Cathy Ison, a gonorrhoea expert at the HPA, said that drug resistance had been dealt with in the past by the use of a new drug – but now there isn’t one.

Dr Gwenda Hughes, Head of Sexually Transmitted Infection Surveillance at the HPA, warned: “We are worried that in the next five years, or some point in the future, that this is going to be a very difficult infection to treat.”

Sexual health will shortly become the responsibility of local authorities rather than the NHS, though medication will remain essential to the treatment of sexually transmitted infections.

Companies join forces to tackle antibiotic resistance

by IainBate 24. May 2012 12:05

Pharma Industry News A host of pharmaceutical and biotechnology companies will join forces alongside public research organisations and scientific experts to address the rising threat from antibiotic resistance.

Companies including GSK, AstraZeneca, Janssen and Sanofi will partner in a new £180 million research programme to boost the discovery and development of new antibiotics.

Patrick Vallance, President, Pharmaceuticals R&D at GSK said the agreement “signals a new model of collaboration” to develop treatments to tackle infections such as MRSA.

NewDrugs4BadBugs is supported by the Innovative Medicines Initiative (IMI) – who will jointly fund the first project with contributions from the pharma and biotech companies involved.

The objective of the collaboration is to improve the underlying scientific understanding of antibiotic resistance and design and implement clinical trials that see novel drug candidates clinically developed.

Currently, the WHO describes the pipeline of future antibiotics to counter emerging resistant bacteria as “virtually dry”.

Antibiotic resistance is increasingly becoming a worldwide health threat with new ‘superbugs’ evolving around the globe.

However, despite the urgent need for effective counteraction, research has diminished over the past 15 years with few companies remaining active in this area due to difficulties in finding new agents and regulatory complexities.

Martin Mackay, President, R&D, at AstraZeneca commented: “It is time to tackle this issue in a different way, sharing information and expertise among public and private partners – collaboration of this type is critical if we are to speed up the discovery of these medicines to improve patient health.”

FDA plans to make more drugs OTC

by JoelLane 9. March 2012 11:43

Pf industry news The Food and Drug Administration (FDA) is considering making medications for some long-term conditions available without prescription.

The US regulatory agency will hold a public meeting to discuss whether to reclassify drugs for high blood pressure, high cholesterol, asthma and migraine in order to ease patient access.

The FDA is also considering ways to accelerate the approval of drugs for Alzheimer’s disease and rare conditions, and to improve the targeting of antibiotics to specific patient groups.

FDA Commissioner Margaret Hamburg commented: “As the science is unfolding in new and exciting ways that will give us new tools, I think we are in a position to do things differently than we have historically.”

The shifting of some long-term condition medications to OTC status would require drug companies to carry out consumer use studies in order to show that customers are able to use the medicines correctly.

Despite this hurdle, the new policy could create a new OTC market opportunity for ‘blockbuster’ branded drugs such as Lipitor, which is facing a major drop in sales due to patent expiry.

This could create a new medical model for long-term condition management where the patient consults with a pharmacist rather than a doctor.

According to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, the FDA intends to expand its accelerated approval programme – currently limited to AIDS and cancer drugs – to drugs for Alzheimer’s disease and rare conditions.

Woodcock also said that in order to counter the spread of antibiotic resistance, which has “reached crisis proportions”, the FDA plans to allow companies to test new antibiotics on smaller patient groups, and to restrict prescribing to more closely defined patient populations.

These changes, which have implications for many pharmaceutical companies selling into the US market, are intended to address urgent unmet medical needs in the US population.

HPA calls for better antibiotic use

by JoelLane 21. November 2011 15:53

Pf NHS News Antibiotics are still over-prescribed and over-used in the UK, increasing the risk of antibiotic resistance, a new survey from the Health Protection Agency (HPA) has found.

The HPA survey of 1800 people in England found that a quarter of people wrongly believe antibiotics work on coughs and colds, and that 97% are prescribed antibiotics on request.

In addition, 10% of people keep leftover antibiotics – and half of these self-medicate with them. These numbers are significant as 30% of the population use antibiotics in a year.

Experts have warned that overuse and misuse of antibiotics, combined with failure of the pharma industry to develop new ones, could lead to a rise in drug-resistant infections – which currently cause 25,000 deaths in Europe each year.

The HPA said that doctors must resist patient demands for antibiotics to treat viral infections such as coughs and colds. In addition, patients must not use leftover medication.

“There is evidence that the more antibiotics you have, the more likely you are to develop resistance,” said the HPA’s Dr Cliodna McNulty.

“Despite many years of public health campaigns advising people that antibiotics don’t work against coughs, colds and flu, our research results show that these myths prevail.”

The Department of Health has issued fresh guidance on antibiotic prescribing, urging doctors and nurses to “think twice”.

Professor Laura Piddock of the University of Birmingham’s School of Immunity and Infection also warned: “The demise of antibacterial drug discovery brings the spectre of untreatable infections.”

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