RISK-AVERSE BUREAUCRACY AND PUFFED-UP DO-GOODERS HURT MS SUFFERERS

Now they have no drug to help them. How many of them were asked if they were willing to take a small risk to get help for their suffering?

Anna Peabody's dreams of motherhood and marriage -- and merely walking upright -- came alive with the arrival of Tysabri.

Multiple sclerosis patients such as she had waited years for the drug, the first promising treatment in nearly a decade. Early last year, Cambridge biotech giant Biogen Idec Inc. said Tysabri warded off MS more powerfully than even the most optimistic predictions. Peabody, 19, thought the drug ''would change everything."

Just one year of data from test patients was enough to wow federal regulators. They approved Tysabri a year ahead of schedule, without public discussion or debate, and before planned clinical tests were completed. But there were concerns: Some scientists thought the drug would leave patients vulnerable to deadly infections. At the time, Biogen Idec's vice president of medical research, Al Sandrock, declared: ''No multiple sclerosis drug currently on the market has been approved with less than two years worth of data."

But in a tragic flash, it all unraveled. Two test patients contracted a rare infection. One died. Last week, Biogen Idec and its partner, Elan Corp., pulled the drug from the market.

Tysabri's precipitous rise and fall has called into question the FDA's decision to quickly and quietly approve a potentially risky drug, criticism that comes on the heels of recent controversies over its handling of painkillers and antidepressant drugs.

''They should take as much time as they need to make sure the drugs are safe and effective," said Arthur Levin, director of the Center for Medical Consumers, an advocacy group. Quick approval, he said, ''increases the risk that we're going to discover really serious threats to the public health later on after a drug has been approved."

What I would really LOVE now is for the complacent Mr Levin to get MS

More here

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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.

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