FEEBLE ATTEMPT TO UNBLOCK THE FDA BARRIERS TO NEW DRUGS

Saying "No" to everything would of course be the ideal bureaucratic strategy. There lieth safety for the bureaucrats! They can't quite go that far but they do their best

Drugmakers may be able to hone in on their most promising compounds more quickly under relaxed U.S. guidelines for human testing that apply more modern scientific techniques and ease manufacturing requirements. The Food and Drug Administration guidelines, released yesterday, let companies make microscopic amounts of compounds and give them to less than a dozen people before animal studies are complete. Researchers would then use imaging tests to track the drugs' effects before undertaking larger and longer human studies.

The move is designed to overcome one of the most formidable hurdles in drug development: taking promising compounds from the laboratory to successful human studies.

The FDA approved 20 new breakthrough drugs in 2005, the second-lowest number in more than a decade. While the revolution in human-genome research created insights into the biology underlying disease, the advances haven't been exploited to simplify and speed drug testing. Drug development "is expensive and too often uses technologies of the last century to evaluate cutting-edge, 21st century treatments," FDA acting director Andrew von Eschenbach said in a conference call. The rules enable researchers to "more rapidly establish whether a new compound truly has a clinical benefit for people."

Nine of 10 experimental drugs that begin full-scale human studies ultimately fail, Health and Human Services Secretary Mike Leavitt said in a statement. The initiative is designed to improve those odds. Companies are bringing fewer breakthrough drugs to pharmacy shelves, while their spending on research and development skyrockets.

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GOVERNMENT REGULATION DOES NOT WORK ANYWAY

It sure did not in this case. An approved drug was actually very harmful

A drug commonly used to prevent pregnant women from going into labour too early actually has the opposite effect, a trial has shown. The antibiotic metronidazole is given to about one in every 200 women to treat a condition called bacterial vaginosis. This is linked to pre-term delivery, so the assumption has been that treating it reduces the risks of having a baby too early. A new trial supported by Tommy's, the baby charity, suggests that this is mistaken. [A charity had to put them right!]

The trial identified 900 women over a period of 4+ years who were believed to be at risk of early delivery. At 23 to 24 weeks' gestation, the women were given a week's course of either the drug or a placebo. In the placebo group, 39 per cent of the women went on to have pre-term babies. But in the drug group, 62 per cent did, Andrew Shennan and colleagues report in the British Journal of Obstetrics and Gynaecology.

In Britain about one in 20 pregnant women is screened for bacterial vaginosis, and one in 10 of the tests records a positive result. That means that one in 200 pregnant women is BV-positive and at high-risk of having a pre-term baby. Given that there are about 700,000 births each year in Britain, Tommy's estimates that 1,000 babies may be being born prematurely every year because of the drug.

Metronidazole has been used for years after studies in the 1980s suggested that it was beneficial. "There is no doubt that bacterial vaginosis is associated with pre-term birth," Professor Sherman said. "It is not really an infection, but an excess growth of certain bacteria in the vagina that may in fact be normal for some women. Getting rid of this by using metronidazole may not be helpful because it allows other bacteria in." It is also possible, the team suggests, that dying bacteria may result in an inflammatory response that increases the risk of premature labour.

Professor Shennan said that the drug also increased the risks of seriously early births, which frequently produced babies that would later suffer severe abnormalities. "Clinicians and high-risk pregnant women should be aware of this research so that we can avoid the escalation of pre-term birth and save more babies' lives."

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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