Question for ''The Doctor'' ( Young, of course )

[andrea]

Dear dr Young,
watching what is going on with Bayer's drug for colesterol I'm asking my self how many years they
have 'lost' in animal's trials for, at the end, come up with a drug that 'appears' to be very dengerus o even mortal for a lot of people. What I meand is how can we be sure that this long waiting that we all are carring on, for testing the safetly and efficacy of all this new therapy, is really necessary if result is something lake that ? Of course the question could be in the opposit sense. Will it be the time-trial ever enought to avoid any risks ?

[Wise Young]

Andrea

The Bayer anti-cholesterol drug simply reminds us that every drug has its risks and benefits. Very few drugs are completely beneficial and risk-free. If Bayer, for example, had known from animal or other studies that there may be risks involved and warned clinicians of these risks, they could have avoided this fiasco. Worse still, they may have pushed the development of the drug too fast and ignored warning signs. As it turns out, this is the worst case scenario for a company... the complete withdrawal of a drug that actually might be useful for some patients who have serious cholesterol control problems. They not only have lost probably the $500 million or more that they have invested in the development and marketing of this drug but may lose twice that much in lawsuits. I have always told drug companies that truth is the only path to profit. Incomplete data, wishful thinking, and over-marketing a drug beyond its efficacy and safety parameters will eventually lead to trouble.

The spinal cord injury community is now grappling with the problem of evaluating the benefits and risks of multiple therapies that are becoming available, distinguishing between hype and hope, trying to guess what the next year will bring. Many people are trying now to decided whether they should participate in some of the first generation therapies. Most will wait. A few will go ahead.

I am so grateful for the generosity of people like Bilby and Birde, Teddy and Ed Lancaster, and others who are sharing their experiences with us on these forums. They are heroes in the true sense. They are undertaking the risk so that the community would benefit from the knowledge.

Wise.