Thirty years ago, when the world faced the terrifying prospect of an untreatable disease known as AIDS, big drug makers scented an opportunity and raced to develop new medicines.

Today, as the world confronts another crisis, this time one of antibiotic resistance, the industry is doing the opposite. It is cutting research in a field that offers little scope for making money.

Antibiotics have become victims of their own success. Seen as cheap, routine treatments, they are overprescribed and taken haphazardly, creating "superbugs" they can no longer fight.

These "superbugs" are growing, but are not yet widespread, so the costly research needed to combat them is not worthwhile. Medical experts say this dilemma could return medicine to an era before Alexander Fleming discovered penicillin in 1928.

Fixing the problem will need both faster approval of last-resort drugs and new ways to guarantee rewards for companies, according to both industry leaders and public health officials who have been sounding the alarm.

Paul Stoffels, pharmaceuticals head at Johnson & Johnson, is better placed than many to understand the problems.

His company offered a rare glimmer of hope in December when it won regulatory approval for a new treatment for drug-resistant tuberculosis -- a growing issue in many countries.

Unfortunately for the world, it was a one-off and J&J is not currently developing any more antibiotics.

"The market for a new antibiotic is very small, the rewards are not there and so the capital is not flowing," he said in an interview in London.

"It's about the sheer amount of money people are prepared to pay for a drug. In cancer, people pay $30,000, $50,000 or $80,000 (per patient) for a drug, but for an antibiotic it is likely to be only a few hundred dollars."

On Monday, AstraZeneca, facing tough decisions about where to invest, said it would put less money in developing anti-infectives. "We have to make choices and we have to focus our investments where we think we can make a substantial difference," CEO Pascal Soriot told Reuters.

The regulatory bar for drug approval is a key consideration for any company weighing R&D investment.

For antibiotics is very high, partly due to a scandal over the approval of Sanofi's drug Ketek in 2004, which U.S. officials said later should be reserved for serious diseases due to the risk of side effects.

The head U.S. Food and Drug Administration's (FDA) drugs wing, Janet Woodcock, last year pledged a complete "reboot" of the approval process, aware of the stifling effect recent official caution has had on the development of new drugs.

The rapid approval of J&J's tuberculosis drug in December, based only on mid-stage Phase II data, may be a sign of a new flexibility at the FDA, which matters because the United States is the world's biggest drugs market.

The Generating Antibiotic Incentives Now (GAIN) Act, which came into effect in the U.S. last October, will also help by offering an extra five years of market exclusivity.

Still, the Infectious Diseases Society of America (IDSA)believes more legislation is needed to set out a clear path by which new antibiotics can be approved for a limited population after much smaller and faster clinical trials.

Just as in the early years of HIV, it argues, the world must accept riskier new drugs for incurable infections when there are no alternatives and patients' lives are on the line.

The European Medicines Agency is also working on new rules to encourage antibiotic development, while the European Union last year launched a novel public-private partnership to get governments and companies to share information and funding.

Fee instead of price?
Such public-private alliances across countries could start to change the conventional market model, according to Andrew Witty, CEO of GlaxoSmithKline, another of the few Big Pharma companies still actively researching antibiotics.

He favours greater sharing of research and has made an offer to England's chief medical officer Sally Davies to create new laboratories for developing research ideas brought in by others.

"I'm pretty sure that a classic model isn't going to solve this question and we need to be much more creative," Witty said.

New market approaches could include doing away with a price and instead having the healthcare system paying the inventor a fee per year as a reward for delivering a medicine, he said.

In some years, society would end up paying more in fees than it would in drug bills; in other years less. But at least companies would have an assured revenue stream.

Healthcare officials on both sides of the Atlantic are showing a willingness to do things differently after drawing attention to the antibiotic crisis this month.

Davies said the steady rise in resistance in the last five years represented a "ticking time bomb" that ranks alongside terrorism as a threat to the nation. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, called for an urgent fight-back against "nightmare bacteria".

 Rush for exit
The rush for the exit on antibiotic research has been dramatic.

Pfizer, once the leader in the field, closed its antibiotic R&D centre in Connecticut in 2011, to the dismay of many scientists. It now focuses anti-bacterial work on vaccines.

Others to have quit include Roche, Bristol-Myers Squibb and Eli Lilly, leaving only a handful of firms like GlaxoSmithKline, AstraZeneca and Merck & Co in the game. With basic research providing few new leads for drug targets, they are finding it tough.

Some smaller companies like Cubist Pharmaceuticals, Forest Laboratories, The Medicines Company and Optimer Pharmaceuticals are also active, hoping to capitalise on a niche left vacant by Big Pharma.

But Robert Guidos, public policy expert at the IDSA, fears minnows will struggle.

"Small companies rely on larger companies to help them get through Phase II and Phase III clinical development because it is so expensive," he said.

"The fewer large companies you have, the less help the smaller ones get and, as a result, few of the antibiotics now in early development are likely to make it across the finish line."

Since the 1980s, the number of new systemic antibiotics approved by the FDA has plunged from 16 in 1983-87 to just two in the last five years, according to the IDSA.

In the meantime, the "superbugs" are on the increase.

One of the best known is methicillin-resistant Staphylococcus aureus, or MRSA, which alone is estimated to kill some 20,000 people every year in the United States - far more than AIDS - and a similar number in Europe.

Others are spreading. Cases of totally drug resistant tuberculosis have appeared in recent years, as have untreatable strains of gonorrhoea, and a new wave of "super superbugs" with a mutation called New Delhi metallo-beta-lactamase (NDM 1), first seen in India, has now turned up across the globe.

As head of the company that developed AZT, the first HIV drug, GSK's Witty thinks the antibiotic problem can be cracked, given sufficient political will - but it won't happen overnight.

"This is a long cycle time business. Even if we get this absolutely brilliantly tuned up it is going to be a five to 10 year journey," he said.

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We've all had those fuzzy mornings where we've nearly brushed our teeth with Neosporin, but a new study presented at an annual meeting of epidemiologists has found that prison inmates are purposefully misusing over-the-counter topical antibiotics as grooming aids.

The study, which asked 822 inmates at two New York State prisons about their use of OTC antibiotics such as Bacitracin (an ingredient found in Neosporin), found that 29 percent of the men and 28 percent of the women had used the ointment for dry skin, 18 percent of men and 15 percent of women had used it as a lip balm, 8 percent of men and 3 percent of women had used it as hair gel and 6 percent of men had slathered the ointment onto their face as a shaving cream.

"I think one reason they used the antibiotic ointments in these ways is because they didn't know they shouldn't," says Carolyn Herzig, a PhD candidate in the Department of Epidemiology at the Mailman School of Public Health at Columbia University and lead author of the study. "Or it might be that they didn't have easy access to other products."

Misuse or overuse of antibiotics is worrisome because it can lead to strains of antimicrobial resistant pathogens resulting in the emergence of multi-drug resistant organisms such as MRSA, a strain of staph infection that's now resistant to methicillin, amoxicillin, penicillin, oxacillin, and many other antibiotics.

These pathogens are already a problem in prisons, and the "misuse of antibiotics in these facilities might exacerbate this issue," Herzig explains.

"We don't know specifically whether the overuse of topical antibiotics would lead to MRSA -- we don't have the data to demonstrate that -- but in many cases, in general, the overuse and misuse of antibiotics can lead to antibiotic resistance," says Herzig. "That's exactly what the concern is."

Herzig and her team of researchers tapped prison inmates as they were being admitted to two New York State maximum security prisons -- one men's and one women's. (The researcher declined to reveal the names of the prisons.)

"The question we asked was, 'Have you used antibiotic ointment in the past six months?'" she says. "They were entering the prison facilities from either jails or prisons or possibly, the community. If they served a sentence longer than six months, then they had used the ointments in other prisons or in county lockup. It's also possible that some of them used the ointments while they were not incarcerated but I would say the majority of them used them while incarcerated."

Medical personnel do dispense antibiotic ointments to inmates as needed; however, other items -- such as hair gel and shaving cream -- are harder to come by, Robin Campbell, press secretary for the New York City Department of Corrections (which includes Rikers Island and other Borough facilities), said in a statement. 

"Facility medical personnel dispense antibiotic creams and ointments, like foot gels, to inmates on an as needed basis," he said in an email. "Although inmates may purchase some personal hygiene products, like shampoo, toothpaste and deodorant, from the facility commissary, shaving cream, lip balm and hair gel are prohibited due to security concerns."

Antibiotic resistance concerns aside -- would a Neosporin-like cream even work as a beauty aid? "I think they probably worked as well as Vaseline," says Herzig. "And I really think if they'd had lotion or Vaseline, that's what they would have used."

The study's findings were presented this week at the 39th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology in San Antonio, Texas. Funded by the National Institute of Allergy and Infectious Diseases, the study was the first of its kind to report on the widespread misuse of topical antibiotics among inmates.

While Herzig says she's been unable to find any studies on the misuse of over-the-counter antibiotic ointments in everyday life, she is curious about inappropriate use of these products in normal populations.

"I've spent a lot of time looking at the literature to see if there's a comparable study that shows how people use these ointments in a community, but I haven't seen anything that reports that information," she says. "I suspect it is happening, though."

Melissa Rowton, a 41-year-old customer service trainer from Seattle, says she's used antibiotic ointments on blemishes before -- although she doesn't do it very often.

"I've used Neosporin for pimples and have a friend who swears by it," says Rowton. "It makes sense when they are often caused by bacteria. I wash and dry my face thoroughly and dab a small amount on any problem area before bed."

Herzig says none of the prisoners who answered the open-ended questionnaire indicated they'd used the antibiotic ointments in this way. However, in addition to using the topical antibiotics as hair gel, moisturizer and lip balm, many said they'd used the products in ways that were closer to their intended use.

"We got many reasons," she says. "Some used them for skin injuries, skin conditions including eczema and acne, fungal infection, or for new tattoos. We're not suggesting people should use antibiotics for all those reasons. But they're more appropriate than using them for lip balm or moisturizer."

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Attention, germaphobes. Exposure to the microscopic bugs is crucial for keeping kids healthy, according to new research in the prestigious journal Science. The study strongly supports a growing body of evidence that you need to put away the disinfectant and expose children to the real world of germs and microbes. 

Getty Images stock

We're meant to encounter some microbes and dirt when we're young. It's how we build our immune systems.

Scientists Richard S. Blumberg and Dennis L. Kasper and a team of researchers at Harvard Medical School showed that in mice exposure to germs in early life helped reduce the body’s inventory of invariant natural killer T (iNKT) cells. These cells help protect us against diseases like inflammatory bowel disease and asthma. But, if there are too many of them with too much time on their hands, they can actually cause these conditions. By exposing young mice to common microbes the scientists saw that the animals were protected from accumulating T cells -- and were healthier than those who were not.  

The scientists reached an admittedly geeky conclusion: “These results indicate that age-sensitive contact with commensal microbes is critical for establishing mucosal iNKT cell tolerance to later environmental exposures,” they wrote in the journal Science. In other words, exposing baby mice to common germs got their immune systems appropriately busy and able to not over-react when encountering nasty bugs and other biological stuff later in life.

This is a big deal.

The rapid rise in food allergies, asthma and other immunological diseases is due, at least in part, to our modern obsession with cleanliness, scientists increasingly believe. The 'hygiene hypothesis', first advanced in 1989 by the British epidemiologist David Strachan, contends that these diseases are becoming more common because young children are not exposed to them at an early age. We spend so effort trying to prevent exposure to germs with antibiotics, antibacterials and soaps that letting kids get dirty seems like a violation of basic parental duty.

Parents are constantly being told to make their kitchens spotless, to kill 99.9 per cent of the germs lurking in their bathrooms and to wash themselves and their babies all the time.

This world of purity sounds good but it does not fit how we are designed. We are meant to encounter some microbes and dirt when we are young. It is how we built our immune systems. We need a certain amount of grunginess as kids to be healthy adults. 

As the Harvard study shows, filth can be good -- at least in tiny amounts when you are very young.

Arthur Caplan, Ph.D., is a Professor in the Department of Medical Ethics and Health Policy at the University of Pennsylvania

By MyHealthNewsDaily Staff

Most people who have sinus infections should not be treated with antibiotics because the drugs are unlikely to help, according to new guidelines from infectious disease experts.

Although sinus infections are the fifth-leading reason for antibiotic prescriptions, 90 to 98 percent of cases are caused by viruses, which are not affected by antibiotics, according to the guidelines issued today (March 21) by the Infectious Diseases Society of America. Used inappropriately, antibiotics spur the development of drug-resistant superbugs, the IDSA says.

"There is no simple test that will easily and quickly determine whether a sinus infection is viral or bacterial, so many physicians prescribe antibiotics 'just in case,'" said Dr. Anthony Chow, professor emeritus of infectious diseases at the University of British Columbia, Vancouver and chairman of the guidelines panel.

"However, if the infection turns out to be viral — as most are — the antibiotics won't help and in fact can cause harm by increasing antibiotic resistance, exposing patients to drug side effects unnecessarily and adding cost," Chow said.

A study of 166 people with sinus infections published in February in the Journal of the American Medical association showed that those who took antibiotics saw no better improvement in their symptoms than those taking a placebo.

The new guidelines provide specific characteristics of the illness to help doctors distinguish between viral and bacterial sinus infections.

How to tell if it's bacterial
A sinus infection, properly called acute rhinosinusitis, is inflammation of the nasal and sinus passages that can cause uncomfortable pressure on either side of the nose, and last for weeks. Most sinus infections develop during or after a cold or other upper respiratory infection, but other factors such as allergens and environmental irritants may play a role.

According to the guidelines, a sinus infection is likely caused by bacteria, and should be treated with antibiotics, if any of these criteria are met:

• symptoms last for 10 days or more and are not improving (previous guidelines suggested waiting seven days)
• symptoms are severe, including fever of 102 degrees Fahrenheit or higher, nasal discharge and facial pain lasting three to four days in a row
• symptoms get worse, with new fever, headache or increased nasal discharge

For adults, 5 to 7 days is enough
The guidelines recommend treating bacterial sinus infections with amoxicillin-clavulanate, instead of the drug currently used, amoxicillin, because the addition of clavulanate helps to thwart the development of antibiotic resistance. The guidelines also recommend against using other commonly used antibiotics, due to increasing drug resistance.

While previous guidelines have recommended taking antibiotics for 10 days to two weeks, the new guidelines suggest five to seven days of antibiotics is long enough for the treatment of adults, and will not encourage bacterial resistance. The IDSA guidelines still recommend children receive antibiotic treatment for 10 days to two weeks.

Whether a sinus infection is bacterial or viral, decongestants and antihistamines are not helpful and may make symptoms worse, the guidelines say.

The voluntary guidelines are not intended to take the place of a doctor's judgment, but rather support the decision-making process, which must be made according to each patient's circumstances, the IDSA says.

The guidelines will be published in the April 15 issue of the journal Clinical Infectious Diseases.

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