Indeed, FDA-mandated trials for most drugs are small, involving a few thousand patients, compared to the masses consuming a cheap-zyrtec after it has been approved. That means that some rare side effects will be discovered only after the drug has been taken by hundreds of thousands or millions of patients. Expanding the testing process to require more and larger clinical trials might uncover a few more side effects, but would also delay the introduction of valuable new therapies - as it is, drug development often takes more than a decade.
This confronts the agency with a speed-safety tradeoff: ensuring safer drugs entails a longer wait, and hence higher morbidity and mortality for patients in need of new treatments. The agency must thus balance speed of approval with safety. The FDA, although not perfect, at least has access to the right expertise to make science-based decisions on whether the existing speed-safety tradeoff is in the best interests of society. Courts and juries - who only see injured plaintiffs - are poorly positioned to second-guess those balanced decisions and will focus too much on liability rather than innovation.
Wednesday, October 22, 2008
Wednesday, October 8, 2008
Viagra- analogue
Grow-your-own Viagra craze hits Britain's garden centres
A chance discovery by a Berkshire allotment-holder that a plant widely available in garden centres has the same effect on men as Viagra has been confirmed by experts at one of the world's leading botanical institutions.
The plant is winter-flowering heather, and botanists at the Royal Botanic Gardens, Edinburgh, many of them heather experts who have recognised the source of its active ingredient, now expect it to be the next must-have plant in British gardens. Demand is already high. Nurseries and garden centres in some areas are having trouble finding sufficient supplies as word spreads of the plant's unexpected properties.
A spokesman for Wyevale Garden Centres, which has 106 UK branches, said: "At first, it was just a trickle of inquiries, but now stores are virtually being besieged each weekend. We have had men buying dozens of the plants and, at one store in Croydon, there were men old enough to know better fighting over the last remaining trays."
The latest gardening craze was triggered by a discovery by a 55-year-old furniture restorer, Michael Ford, on his allotment. He was always experimenting with drinks made from different plants and one day he tried an infusion from his winter-flowering heather. He said: "The effect was almost immediate. I had to stay in my potting shed for an hour or so before I could decently walk down the street."
He then contacted the Royal Botanic Gardens, Edinburgh, famous for their work with the heather family, to see if they could offer an explanation. They could. Botanist Alan Bennell said: "This first surfaced when East European chemists reported finding a Viagra-type chemical in the floral tissues of winter-flowering heaths. They were able to isolate measurable amounts of material that is an analogue of the active principle in Viagra."
Winter-flowering heather, he explained, belongs to the genus Erica, a close relative of our own native heather. He said: "As yet, the active ingredient has not been found in these British forms, but it is proving to be most concentrated in many of the widely available hybrids sold as winter-flowering heather in garden centres. Particularly potent are forms of Erica carnea, the Alpine heather, whose range extends into the Balkans.
"The work of these biochemists and physiologists - much of it disrupted and lost during the ravages of war - is now coming to light."
From the limited amount of information available, it is suggested the Viagra-analogue is best extracted by steeping the detached small flowers in neat alcohol. An infusion of about 20g of flowers in 100ml of fluid liberates the active principle. A quality full-strength vodka (at least 40 per cent) is also effective. Mr Bennell added: "There is some confusion whether oral consumption or topical application is more effective."
But not everyone is happy about this new discovery. One woman shopping at a Wyvales in Dorking yesterday said: "It's amazing. My husband has never shown any interest in gardening before, but now he's out there night and day fussing over his heathers. Frankly, I preferred it when he left the garden to me and wasn't so frisky."
A chance discovery by a Berkshire allotment-holder that a plant widely available in garden centres has the same effect on men as Viagra has been confirmed by experts at one of the world's leading botanical institutions.
The plant is winter-flowering heather, and botanists at the Royal Botanic Gardens, Edinburgh, many of them heather experts who have recognised the source of its active ingredient, now expect it to be the next must-have plant in British gardens. Demand is already high. Nurseries and garden centres in some areas are having trouble finding sufficient supplies as word spreads of the plant's unexpected properties.
A spokesman for Wyevale Garden Centres, which has 106 UK branches, said: "At first, it was just a trickle of inquiries, but now stores are virtually being besieged each weekend. We have had men buying dozens of the plants and, at one store in Croydon, there were men old enough to know better fighting over the last remaining trays."
The latest gardening craze was triggered by a discovery by a 55-year-old furniture restorer, Michael Ford, on his allotment. He was always experimenting with drinks made from different plants and one day he tried an infusion from his winter-flowering heather. He said: "The effect was almost immediate. I had to stay in my potting shed for an hour or so before I could decently walk down the street."
He then contacted the Royal Botanic Gardens, Edinburgh, famous for their work with the heather family, to see if they could offer an explanation. They could. Botanist Alan Bennell said: "This first surfaced when East European chemists reported finding a Viagra-type chemical in the floral tissues of winter-flowering heaths. They were able to isolate measurable amounts of material that is an analogue of the active principle in Viagra."
Winter-flowering heather, he explained, belongs to the genus Erica, a close relative of our own native heather. He said: "As yet, the active ingredient has not been found in these British forms, but it is proving to be most concentrated in many of the widely available hybrids sold as winter-flowering heather in garden centres. Particularly potent are forms of Erica carnea, the Alpine heather, whose range extends into the Balkans.
"The work of these biochemists and physiologists - much of it disrupted and lost during the ravages of war - is now coming to light."
From the limited amount of information available, it is suggested the Viagra-analogue is best extracted by steeping the detached small flowers in neat alcohol. An infusion of about 20g of flowers in 100ml of fluid liberates the active principle. A quality full-strength vodka (at least 40 per cent) is also effective. Mr Bennell added: "There is some confusion whether oral consumption or topical application is more effective."
But not everyone is happy about this new discovery. One woman shopping at a Wyvales in Dorking yesterday said: "It's amazing. My husband has never shown any interest in gardening before, but now he's out there night and day fussing over his heathers. Frankly, I preferred it when he left the garden to me and wasn't so frisky."
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