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Minyan Mailbag: Tysabri


C'mon people!


Note: Our goal in Minyanville is to remove intimidation from the financial markets and encourage an interactive dialogue among the Minyanship. We share this next discussion with that very intent.

This reaction to TYSABRI / ELAN is truly INSANE. This drug -- on its own -- has had no known significant side effects for over 2 YEARS -- neither has AVONEX when used on its own for 6 years. TYSABRI is a FABULOUS drug and has reduced the recurrence of relapsing flare ups in 66% of patients with multiple sclerosis -- which is FABULOUS. Now we have class action suits initiated.

This is CRAZY as studies have shown that even PLACEBOS{inert} used in double blind trials have caused life-threatening side effects -- cause not known. If this is not stopped soon -- NO drugs will ever be researched and developed. There is no such thing as a drug without side effects.

Minyan Dr. GM

Dear Dr. G:

I agree completely. I believe caution is warranted any time patients die from a drug, but I believe this is an overreaction. Manufacturers have lost their way, the FDA cannot see the forest for the trees, and these problems are exacerbated by a predatory legal climate.

As I've written previously, there is no such thing as a safe drug. Give a drug to enough patients and you will find one whose inherently unique body chemistry will react in unimagined ways. Peanuts, for goodness sake, kill people. There are people out there for whom sunlight is deadly. There are people out there for whom too little sunlight is deadly. It's no mystery that some people have bad reactions to active drugs.

The concept of a safe drug is obviously a fallacy. I don't mean to suggest we shouldn't take prudent, careful steps to determine the safety and efficacy of drugs. We have to reasonably determine both things so we can understand the risk/benefit analysis of the drugs we examine for approval.

We don't do a very good job of risk / benefit analysis in this country anymore. We seem to believe there is some nirvana - whether in the stock market or elsewhere - where we can discover a risk-free benefit. It doesn't exist just like "free lunches" don't exist. It's a societal affliction and one that has most recently manifested itself in how we look at the risk / benefit ratios for drugs. We need to take a step back in our quest for perfect safety lest we destroy the benefits possible from a whole generation of new drugs.

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