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Sunday, April 10, 2011

THE RETURN OF DISEASE?

Antibiotics have been one of the greatest success stories in medicine but barely 70 years after antibiotics were introduced, the World Health Organisation has warned the world could soon face a future without them. The world is heading towards a post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated. Drug resistance was a natural process, but had been vastly accelerated by misuse. "Modern medicine can't function without effective antibiotics," says Derek Butler, chairman of the MRSA Action UK charity "If we lose these magic bullets, medicine will be set back over 80 years."

About half of current antibiotic production is used in agriculture, to promote growth and prevent disease, as well as to treat sick animals. With such massive use, drug resistant microbes generated in animals can be later transferred to humans.

"In addition, veterinarians in some countries earn at least 40 per cent of their income from the sale of drugs, creating a strong disincentive to limit their use," said WHO's director-general, Dr Margaret Chan.

"Irrational and inappropriate use of antimicrobials is by far the biggest driver of drug resistance. This includes overuse, when drugs are dispensed too liberally, sometimes to 'be on the safe side', sometimes in response to patient demand, but often for doctors and pharmacists to make more money." This includes underuse, especially when economic hardship encourages patients to stop treatment as soon as they feel better, rather than complete the treatment course needed to fully kill the pathogen.

She said. "No action today means no cure tomorrow. At a time of multiple calamities in the world, we cannot allow the loss of essential medicines - essential cures for many millions of people - to become the next global crisis."

Last year in Europe more than 25,000 people died of bacterial infections that were resistant to antibiotics. An estimated 440,000 new cases of tuberculosis resistant to several types of drugs were reported last year in nearly 60 countries. TB already kills around 5,000 people a day. MRSA, or methicillin-resistant Staphylococcus aureus, alone is estimated to kill 19,000 people each year in the United States -- far more than HIV and AIDS.

ou might think all that adds up to a great business opportunity for the pharmaceuticals industry. But in the past 40 years only two new classes of antibiotics have won marketing approval, while the total number of antibacterial agents approved for sale has dived. Why are the drugs firms so quiet? For many years, making antibiotics was a bread-and-butter activity for the drugs industry. Today it has shrunk to a neglected Cinderella business reflecting the skewed economics that can drive pharmaceutical development.Drug manufacture almost inevitably depends on the pharmaceutical industry and unfortunately there are problems with the present business model. It's very hard to make the commercial sums work. The drugs industry has seen dwindling returns on all its R&D in recent years, resulting in a wave of high-profile laboratory closures (To take a drug from discovery to market is estimated to cost £700m) , cost-cutting measures that have been cheered by the stock market. The payback on antibiotics has been even more dismal than in other diseases. There are two main reasons for this. First and foremost antibiotics, when they work, tend to cure people. Patients take small quantities for several days, a few weeks at most. That's not a very attractive revenue flow. By contrast, a patient on a cholesterol-lowering heart medicine will keep using the pills, and contributing to drug industry profits, for the rest of his or her life. Second, even if a new antibiotic is approved for sale, its use is likely to be reserved for serious infections once again, minimizing the sales opportunity. To cap it all, most existing antibiotics have been around for decades and are widely available as cheap generics, setting a very low bar for prices.

Colin McKay, from the European Federation of the Pharmaceutical Industries and Associations, said: "It is very difficult to make economically viable models for antibiotics.With heart medication or anti-depressants a lot of people take them for a long time so you can make money back. An antibiotic that works is unlikely to be used for more than a couple of weeks... If you are in the business of antibacterials, I think you just have to accept that is the way it is.Will it be as profitable as a really great cardiovascular drug? Probably not."

European Medicines Agency outgoing Executive Director Thomas Lonngren said drug manufacturers were failing to put their research dollars into key areas of unmet medical need. "It's an issue where commercial consideration doesn't really match the public health need." He went on to warn that, while it was not the job of regulators to tell commercial companies where to invest, they might in future need to advise politicians and the public at large about such research deficiencies.

The global market for all prescription drugs grew by more than 40 percent over the last five years, the value of sales of antibiotics shrank to $14.4 billion in 2010 from $16.1 billion in 2005 projected to fall to $12.0 billion in 2015. A long list of big drug companies have decided to end their antibiotic research, including Roche Holding AG, Bristol-Myers Squibb Co and Eli Lilly & Co.

In capitalism
fixing the system, the experts argue, requires a mixture of "push" and "pull" incentives - "push" measures to lower the cost of developing new antibiotics, and "pull" factors to increase the commercial rewards for successful products. The drug companies seek financial incentives such as tax breaks, patent extensions or government commitments to buy future drug. Ultimately, under capitalism antibiotics may no longer be a cheap tratment. Rather, they would become premium-priced products along the lines of targeted cancer therapies, which can cost tens of thousands of dollars a year for each patient. It would price out many in the developing world. Right now the drug companies are in a very powerful position in setting social and political agendas.

In socialism the solution will be sought without the commercial pressures of today and without the drive for profit it would be possible to behave in a responsible manner. Capitalism’s peculiar and illogical ways of working conspires against solving the anti-biotic resistance problem.

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