Pharmaceutical Executive-07-01-2006

Jeffrey Kindler holds two blue, diamond-shaped pills in the palm of his hand. One is authentic Viagra, manufactured by Pfizer. The other is counterfeit, maybe bought by an undercover Pfizer investigator, or intercepted when smugglers crossed a border, or perhaps seized in a raid on an illegal Chinese factory. Kindler challenges visitors and fellow employees to tell the difference between the two pills. Neither looks in any obvious way "fake," and no one among the journalists, corporate communications employees, or even security specialists gathered in Pfizer's global security operations center cares to hazard a guess.

Figuring out the right drug for each manifestation of the disease is going to be critical. Because then patients know they're getting something that works.

I needed to eat. I even wanted to eat. Instead, I sat in front of my hospital lunch tray, unable to face up to a carton of red Jell-O. When you think of it, that's a situation most of us face (minus the Jell-O) every day in business.

Pharma companies fear CMS' new Medicare policy will routinely require post-approval studies in order to gain reimbursement for new drugs. CMS says it is expanding payment for "promising but not persuasive" drugs.

Electronic data capture (EDC) is an emerging paradigm for gathering information in clinical trials. Ask anyone who has sorted through stacks of accumulated paper at the end of a study, and they'll say EDC is the wave of the future. But while many companies are on board with the technological benefits, enthusiasm wanes when it comes to actual implementation. Even some of EDC's biggest champions admit to its obstacles: "It's a disruptive technology that doesn't give immediate returns," says James Tiede, vice president of integrated data services, global clinical operations at Johnson & Johnson.

RFID is not ready for prime time anywhere. Certainly not in the US. There is no way RFID gives you end-to-end control of the product.

California has proposed legislation for a pilot program to reinforce access to treatment for mentally ill offenders. This is a step in the right direction, but it should be the subject of national policy, not a localized effort.