"Dumbest quote of the year"

Jun/28/2008 06:48

"If you start putting a greater emphasis on doing [testing] premarket, you greatly increase the cost of clinical trials, which may lead companies to rethink developing new drugs in this area," said Alan Goldhammer, deputy vice president at Pharmaceutical Research and Manufacturers of America. Of all the dumb things to say this has to rank up at the top. Mr Goldhammer is talking about the the Food and Drug Administration considering tougher standards for new and current diabetes drugs.

We all know that there are risks in taking prescription drugs, especially new ones, but would consumers and insurers agree to pay more for products that were better tested? This centers around current and new diabetes drugs on the market as two new major studies indicate that aggressively lowering blood-sugar levels doesn't reduce diabetes patients' chances of having heart attacks.

So it comes down to dollars and cents again rather than patients health. Pharma companies are saying that this will add costs to the drug and therefore they may not have the financial resources to bring new as many new drugs to market. But "All you have to do is read about the number of overweight people and those with Type 2 diabetes to know this is a potential gold mine for industry. Who's abandoning this area?" said the analyst, Ira Loss of Washington Analysis. DUH !

Again the drug companies are not thinking about what is best for the patient here. They are thinking that every clinical study may keep the drug off the market longer and as thus prohibit ROI for all the money they have allocated to develop the drug. Surely there has to be a way to reach a compromise here that both protects the patients and the allows the drug companies to recoup their money.

Is it time to go back and revisit the business model? Uhh, YES! Basically it comes down to this: if we invest $700-$900 million on a drug can we make back our money and keep shareholders happy before the drug comes off patent? Costs for drug development are rising there is no doubt that and no way to decrease these costs in an era of transparency and eMails trails. Rather than look to do an end run around the development costs however shouldn’t pharmaceutical companies be changing their business models? This does not mean paying a couple of hundred million for small biotech companies it means forming an alliance with key influencers within the industry, the FDA and in Congress so that they understand the challenges and can work together for the common good of patients rather than the Wall Street analysts.

Most of all it requires new leadership and new thinking, something that has been lacking in the pharma industry for quite a long time.