Info Service on Health Issues (Jun13/02)
UK to call for G8 action against superbugs
The prevailing sentiment in the global health community is that the world is on the brink of a public health catastrophe in view of soaring rates of potentially lethal infections. Public health programmes are under increasing threat due to unbridled antimicrobial resistance. While health care providers grapple with increasing ineffectiveness of ‘drugs-of-last-resort’ and the pipeline for antimicrobial innovation remains dry, governments are beginning to seek coordinated international action to tackle antimicrobial resistance. This mailing informs on the latest move by Britain in efforts to arrest the problem.
With best wishes
UK to call for G8 action against superbugs
By Shila Kaur, Penang, 13 June 2013
In a move seen as the strongest to date by any country in the world to arrest the alarming rates of lethal infections, Britain will urge the G8 to take action against antimicrobial resistance through co-ordinated international action. Britain’s science Minister, David Willets has come out strongly with a proposal for far-reaching measures aimed at clamping down on the overuse of antibiotics by hospital doctors and GPs as well as in animal husbandry and fisheries in Britain.
According to a 11 June 2013 news report in The Guardian, Willet’s proposal includes getting consensus on ways to increase new drug innovation, fast track approval and delivery to patients as well as strong cross-border surveillance for emerging strains. Willets made this announcement ahead of a meeting today (Wednesday 12 June 2013) of science ministers at the Royal Society in London. (see appended ‘UK raises alarm on deadly rise of superbugs’ The Guardian, Tuesday 11 June 2013)
The meeting will be briefed by England’s chief medical officer, Dame Sally Davies, who has asked for antibiotic resistance to be added to the UK government’s national risk register, a move that makes it easy to flag the issue internationally. She has already rallied international experts and chief medical officers in other countries to push the EU and World Health Organization to beef up their action plans. This was evidenced by a jointly organized meeting on Antibiotic Resistance by the delegations of Sweden and Britain, held on 21 May 2013 on the sidelines of the recently convened 66th World Health Assembly in Geneva. (see TWN Info Service on Health Issues, May13/09,
30 May 2013)
WHO has warned that underlying factors that accelerate the emergence and spread of AMR include: lack of a comprehensive and coordinated response; weak or absent antimicrobial resistance surveillance and monitoring systems; inadequate systems to ensure quality and uninterrupted supply of medicines; inappropriate use of antimicrobial medicines, including in animal husbandry; poor infection prevention and control practices; and insufficient diagnostic, prevention and therapeutic tools.
Britain’s proposals which are seen as far-reaching include stimulating the development of new drugs through public-private partnerships, restricting the use of antibiotics in farm animals and medical practice, cross-border surveillance and national antibiotics education programmes. The government is expected to make public its antimicrobial resistance strategy next month which will show case plans to slow down the emergence and spread of antimicrobial resistant strains, maintain the effectiveness of existing drugs and bolster support for researchers.
Britain’s announcement may prove to be the rallying call for other countries as it comes in the wake of an earlier report published by the Infectious Diseases Society of America (IDSA) on 17 April 2013 which showed that since 1998, only four antibiotics have been produced by the world’s 11 biggest drug companies – and today, only four Big Pharma companies are still working on antibiotics at all.
According to that report, in 2010 IDSA launched a ‘10 x 20’ campaign calling for 10 new antibiotics by the end of the decade. However only two new antibiotics were approved in the US since 2009. The report cited high cost/benefit ratios and FDA rules as factors hindering interest in drug innovation. While a handful of smaller pharma companies have continued to invest in antimicrobial drug innovation their numbers are small and insufficient. Without government partnership and support for approval measures and finances, the brain drain from antibiotic research will continue.
A study by MPHonline.org reported that superbugs are responsible for US$20 billion a year in excess US healthcare costs, plus US$35 billion in lost wages and other societal costs from the almost eight million days that infected patients spend in the hospital. Other bacterial strains cause an estimated 3.6 million cases of food poisoning each year, according to the US Centres on Disease Control and Prevention. The symptoms can range from diarrhoea to kidney failure, paralysis and even death. Salmonella-caused illnesses alone kill 400 people a year and cause 23,000 hospitalizations in the US.
According to doctors in Britain, some 80% of gonorrhoea is now resistant to the frontline antibiotic tetracycline. There is serious concern about the rise of resistance to powerful antibiotics of last resort – carbapenems. Apart from this, there is threat of increasing use of drugs in animal husbandry. Increasing evidence also points towards the evolution of strains of dangerous bacteria, including MRSA, E coli and salmonella that are resistant to some of the strongest antibiotics. While farms in the UK and other EU countries are not supposed to use antibiotics, there is a lack of monitoring information on how these drugs are actually used in practice.
In the US antibiotics are routinely used in animal feed - where up to 80% of antibiotics are used for animals – and in Latin America and other regions because they help animals gain weight faster.
In view of the above Britain’s proposal for increased public-private partnership to stimulate drug innovation will be closely watched by the global health community. Detractors of the fast track regulatory approval process, advocated by IDSA, to make antibiotic development more profitable for Big Pharma, favour smaller pharma companies’ focus exclusively on superbugs and other resistant bacteria. Whether it is partnering with Big or small Pharma, Britain will be test case of sorts with regards to antibiotics innovation.
It has also been intimated that Britain will eventually push for a UN treaty that would ban antibiotics in food production such as fish and fruit farming, streamline the regulatory process for licensing new drugs and commit nations to educational drives that instil more prudent usage of the drugs.
What is clear is that in blazing the trail, Britain is impressing on the global health community, the urgency of the current state of AMR.
UK raises alarm on deadly rise of superbugs
Britain to call for G8 action against spread of drug-resistant bacteria by clamping down on overuse of antibiotics
Ian Sample, Fiona Harvey and Denis Campbell
The Guardian, Tuesday 11 June 2013
Britain is to urge the G8 to take action against the spread of drug-resistant microbes as medical and veterinary experts warn that co-ordinated international action is needed to prevent soaring rates of potentially lethal infections turning into a public health catastrophe.
David Willetts, the science minister, will propose far-reaching measures that would clamp down on the overuse of antibiotics by GPs and hospital doctors. He will also try to restrict usage on farms and fisheries, where the drugs are blended with feed to boost yields.
Willetts will push for a consensus on ways to ramp up the discovery of new drugs to fight bacteria, speed their approval and delivery to patients, and strengthen cross-border surveillance for emerging resistant strains.
"Across the G8, we should regard the spread of antibiotic resistance as a global challenge that is up there with climate change, water stress and environmental damage, and there are genuine policy consequences that follow from that," Willetts told the Guardian ahead of Wednesday's meeting of science ministers at the Royal Society in London.
Drug-resistance is an inevitable consequence of antibiotics. The drugs wipe out susceptible infections but leave resistant organisms behind. The survivors multiply and, in time, can become immune to even the strongest antibiotics. Though improved surveillance and hygiene has reduced levels of life-threatening MRSA and C difficile "superbugs" in hospitals, resistant strains are on the rise.
In Britain, doctors see ever more resistant strains of TB, E coli and Klebsiella, which causes pneumonia. Some 80% of gonorrhoea is now resistant to the frontline antibiotic tetracycline. Of serious concern is the rise of resistance to powerful drugs called carbapenems, the antibiotics of last resort. The first few cases were detected in Britain in 2003, but since then the numbers have soared to 217 cases in the first six months of 2011.
Willetts has asked England's chief medical officer, Dame Sally Davies, to brief the meeting after she warned in a March report that untreatable infections posed a "catastrophic threat" to the population.
Davies has asked for antibiotic resistance to be added to the government's national risk register, a move that makes the issue easier to raise abroad.
Davies has already briefed senior figures in Whitehall on the threat and has rallied international experts and chief medical officers in other countries to push the EU and World Health Organisation to beef up their action plans. Ultimately, she seeks a UN treaty that would ban antibiotics in food production, such as fish farming and fruit growing, streamline the regulatory process for licensing new drugs, and commit nations to educational drives that instil more prudent usage of the drugs."The soaring number of antibiotic-resistant infections poses such a great threat to society that in 20 years' time we could be taken back to a 19th century environment where everyday infections kill us as a result of routine operations," Davies said.
The government is to publish its antimicrobial resistance strategy next month. It will set out plans to slow the emergence and spread of drug-resistant bugs, maintain the effectiveness of existing drugs and bolster support for researchers.
The G8 meeting is seen as an opportunity to urge other nations to follow suit. "We can't tackle the problem on our own and urgently need coordinated international action," Davies said.
New research published by the Guardian also reveals that GPs in some areas are almost three times more likely than elsewhere to prescribe antibiotics. Keith Ridge, NHS England's chief pharmaceutical officer, said he was aware of this worryingly wide variation and keen to see if lessons from hospitals' improved prescription of antibiotics could now be applied to England's 8,500 GP practices.
Davies said: "Our proposals are far-reaching, including stimulating development of new drugs through some sort of public-private partnership, cutting down the antibiotics given to farm animals and used in medical practice, making infection surveillance go across borders, and getting countries to sign up to their own education programmes."
Dr Clare Gerada, chair of the Royal College of GPs, said some GPs were over-prescribing antibiotics to patients simply because they were overworked, increasing the long-term risks.
"I'm not blaming them. I've been there myself, at the end of a very busy clinic. If you're running over time and have a queue of patients waiting, sometimes the least worst option is to give a prescription, even though you know that medically it's of little value," she said.
In the past, drug resistance was countered by a steady flow of new antibiotics on to the market. Over the past 60 years, the pharmaceutical industry released three generations of drugs, starting with natural penicillins, then synthetic penicillins, and most recently the carbapenems. But the supply has dried up. The number of new drugs in the pipeline is at an all-time low as research was shelved in favour of more profitable drugs in the 1990s, coupled with the difficulties in discovering new medication.
Meanwhile, other experts are warning that increasing use of the drugs on farms poses a threat to people. Recent studies have shown that the overuse of antibiotics in intensive livestock farming could lead to the evolution of strains of dangerous bacteria, including MRSA, E coli and salmonella, that are resistant to some of the strongest antibiotics. An increasing body of evidence shows they can spread from farms to farm workers and their families as well as to consumers through affected meat.
Farms in the UK are not supposed to use antibiotics routinely, as happens in many non-EU countries, but the Guardian has uncovered clear problems with this regime as the current monitoring of usage does not give government regulators enough information to decide how the drugs are used in practice.
Antibiotics are routinely dumped into animal feed in the US – where 80% of antibiotics are used for animals – and Latin America and other regions because they help animals put on weight faster.
Zac Goldsmith, the Conservative MP who has tabled a motion in parliament for stronger regulation, said dealing with antibiotics on farms was as urgent as changing prescribing practices and hygiene in hospitals. "We need to phase out the routine use of antibiotics on intensive farms altogether, starting with those most important in human medicine."
John Rex, vice-president and medical director for infection at Astra Zeneca, said necessary changes were planned for the regulatory process too. "The idea that we as a society should wait for these cases before we start drug development is a non-starter. Bacterial infections can kill you in a couple of days, We are now treating young women with complicated urinary tract infections with intravenous antibiotics, not a pill. We are seeing strains of gonorrhoea for which we have no antibiotics, not just a small number, not just one, but zero," he said.
This summer, the European Medicines Agency will overturn this system by allowing trials of antibiotics to be done differently. Trials will no longer need to recruit people with the same infection in the same place.
Instead, they can pool people with infections at any body area, such as the lungs, stomach, or skin, as long as they are caused by the same bug. The shift means trials can be run much faster, said Rex. The US Food and Drug Administration is expected to make similar changes to its guidelines.