Biogen CEO talks sense
I’m at the Harvard Business School alumni health care conference today and enjoyed the talk by Biogen CEO Jim Mullen. He made some key points about risk.
He wants us to regain perspective on risk. The “safe and effective” mantra doesn’t make sense. Actually drugs are inherently unsafe, even OTC products. Instead we should look at the risk of unforeseen outcomes (i.e., adverse events) versus the risk of forgoing therapy.
Naturally he offered the example of Biogen’s Tysabri, an effective drug against MS that can cause a deadly brain infection. From the FDA’s perspective, keeping the drug off the market was good because it meant avoiding harm, but patients looked at it differently: many wanted Tysabri back because they were willing to take the risk.
PS –I’ve recently been told of MS Patients for Choice, which is organizing patients to get their views across to the FDA,
One MS patient, a statistician, testified to an FDA advisory group that after “â€œwinning” the 1 in 1000 lottery and getting MS he was willing to take Tysabri and embrace the 999 in 1000 chance that he wouldn’t develop fatal complications.
I found myself in strong agreement with him.November 3, 2006