At a recent meeting former FDA Commissioner David Kessler made the following observations:
"The model that we’ve based pharmaceutical development on for the past 10 years is simply not sustainable,” he said.
“The notion that there are going to be drugs that millions of people can take safely, the whole notion of the blockbuster, is what has gotten us into trouble.”
A whole economic discussion has to take place, he said, because Big Pharma can’t be sustained within this new framework.
He expects to see retrenching over the next few years, with companies focusing on more, less lucrative drugs targeted to individual patient segments.
Hat tip: On Pharma
"The model that we’ve based pharmaceutical development on for the past 10 years is simply not sustainable,” he said.
“The notion that there are going to be drugs that millions of people can take safely, the whole notion of the blockbuster, is what has gotten us into trouble.”
A whole economic discussion has to take place, he said, because Big Pharma can’t be sustained within this new framework.
He expects to see retrenching over the next few years, with companies focusing on more, less lucrative drugs targeted to individual patient segments.
Hat tip: On Pharma
1 comment:
Bravo David, this is an excellent idea which time has come. At this time all the big pharma cos. want the blockbuster, the mega drug. Most likely all the misconduct that is taking place (look at Pfizer's case of paying 480 million in fines, and others) stems from thier belief that every drug they make has the potential to be the big one. So what they do is use all kinds of "extras" including false claims, exaggerated claims, payoffs, excessive promotions etc. etc. to reach those unrealistic goals they set forthemselves.
"He know" heard once a claim from a top marketing person, in which he claimed that even a mediocre drug can become a blockbuster if ptomoted right. By right promotion he meant the type of promotion that got Pfizer to pay up. However the way they see it this is part and cost of doing their business and in the end it all pays off for them.
We are sure that David of FDA will try to change this approach which is designed to first assure huge profits for the big pharma and only secondly do good things for the people. He knows also saw his former Co. lock up a perfectly good and useful drug because the patient population was "too small" for the Co to put it on the market. The drug was superb almost a miracle but not enough patients, so forget it.
The drug was "locked up" for several years and only when somene found out that it can be used more widely, it was unlocked. In the meantime who knows how many people sufered or perished for this was a life saving medication for them.
Pharmaceutical business, although "business" is not like any other business and must be made to serve the population but not use the population to serve their purpose, as it looks today. No wonder, there is such distrust and unpopularity of them amongst the people worldwide.
Post a Comment