Thongs said to be harmful

The conclusions below are pure speculation: An attempt to hype some minor findings. Like many Australian men, I have worn little else on my feet for decades and, while not all of my bits work as well as they once did, my feet are fine. That could be me on the right below



American medical experts have put the toe into the great Australian tradition of wearing thongs, saying the iconic footwear is bad for the health. US researchers claim thongs - called "flip-flops" in America - can lead to leg pain among those who favour them. And the trusty, old faithful pair of thongs that have been "broken-in" were the most dangerous, a study presented at the annual meeting of the American College of Sports Medicine found last month.

The study's lead author, Justin Shroyer, said many people with lower leg pain could blame the so-called Aussie work boot. "It's apparent that individuals alter their gait while wearing flip-flops," Mr Shroyer said. "Based on this, we expected to find that flip-flops may be a cause of pain in the leg or foot."

Mr Shroyer said thongs should only be worn on rare occasions and be replaced every few months. "Flip-flops should only be worn casually and for shorter periods of time," he said. "They should also not be a primary footwear choice."

The study measured the way people walked, and the force with which their feet hit the ground in both running shoes and thongs. Researchers found those wearing thongs used less downward force while walking than they did while walking barefoot or in runners. That resulting change in gait may lead to lower leg pain, the researchers said.

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Hysteria over anti-smoking drug

The hysterics forget that smoking has Side Effects too -- like death

Patients and physicians want breakthrough medicines, and pharmaceutical companies spend years - and billions of dollars - researching and testing such medicines. But this is all becoming increasingly difficult amid the public's growing confusion about how drug development and safety monitoring actually work. Patients might rush to judgment, making medical decisions without consulting their doctors. We could also wind up with policies that reduce the availability of innovative new medicines in decades to come.

We should keep all that in mind following last month's release of a collection of adverse-event reports by the Institute for Safe Medication Practices (ISMP), a nonprofit group in Horsham, Pa. The report focused on Chantix, a medicine developed by Pfizer to help people quit smoking. Both the report and the subsequent media coverage of it revealed a lack of understanding about how pharmaceutical companies and regulators monitor drug safety. Missing was important context about the dangers of smoking, and how adverse-event reports are used to improve patient safety.

Chantix helps keep nicotine from reaching key receptors in the brain. It is designed to give smokers another option in their struggle to quit. Smoking is the leading cause of preventable disease and premature death globally, and it is estimated to cost more than $200 billion in annual health-related expenses and productivity losses in the U.S. alone.

Since its approval by U.S. regulators in May 2006, Chantix has been approved in more than 70 countries and prescribed to more than 6 million smokers world-wide. On May 21, the ISMP issued a statement accompanied by a tally of Chantix adverse-event reports collected by the FDA. The reports linked Chantix to conditions such as heart trouble, seizure and diabetes.

But contrary to some public perceptions, the information in the institute's report is not based on new or previously unknown data. In fact, the ISMP says it obtained the information from data published by the FDA for research purposes. What's more, Pfizer has been submitting adverse-event reports to the FDA ever since Chantix clinical trials first began, and has continued to do so since it went on sale in August 2006.

This is a system all pharmaceutical companies follow with prescription medicines. These reports have also been routinely submitted to regulatory authorities around the globe. The adverse-event reporting system is working as it should - gathering information that regulators and drug companies use to help communicate a medicine's safety profile.

After considering adverse-event reports and other factors, Pfizer updated Chantix product labeling in May 2007 to state that patients should use caution when driving or operating machinery until they determine how Chantix may affect them. In January, Pfizer updated the labeling to warn that certain neuro-psychiatric events had been reported by Chantix patients. In May, the warning was again updated to suggest patients stop taking Chantix if a depressed mood, agitation or other "changes in behavior that are not typical for them" are observed, including thoughts of suicide.

Label changes often crimp sales, as they have for Chantix. But they also show how drug companies and regulators strive to bring the latest information about the safe use of a medicine to the attention of patients and physicians.

The adverse-event reporting system is one of many tools used by drugmakers and regulators. After Chantix was approved, Pfizer began additional clinical studies in smokers with special health conditions.

The postmarketing adverse-event reporting system also has limitations. Reports may not tell us what other medications the person is taking, their general state of health or medical history. Nor do postmarketing adverse-events reports give us the rate of incidence for these events in the general population. For example, did the person report a depressed mood because they were undergoing nicotine withdrawal? Did they smoke because they were depressed - or was their depression caused by Chantix? As the ISMP report noted, "adverse event reports in themselves do not establish a causal link to the drug, only that an observer suspected a relationship."

We must rely on the most rigorous science, and our physicians, to help us make the best decisions for our health. Sensational media reporting sometimes risks creating a cascade of confusion that makes sensible medical choices difficult today, and that undermines the search for newer and better drugs for the future.

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