Why Big Pharma now outsources its clinical trials overseas

In New Delhi, 49 babies died at the All India Institute of Medical Sciences (a public hospital renowned for providing low-cost treatment to the poor) while they were taking part in pharmaceutical clinical trials over a 30-month period. These babies had been given a variety of new drugs being studied to treat conditions like zinc deficiency, high blood pressure or a brain inflammation called chronic focal encephalitis. The head of the pediatrics department at the All India Institute claimed that “none of the deaths was due to the medication or interventions used in clinical trials.”

The blood-pressure drugs had never before been given to anyone under 18. Yet of the children enrolled in these studies, two-thirds of them were infants less than one year old.

As recently as 1990, only 271 drug trials were being conducted in foreign countries on drugs intended for North American use. But by 2008, that number had risen to 6,485—an increase of more than 2,000%Continue reading

Viagra goes generic: then what?

Jim Edwards asks a question that many Big Pharma watchers are asking, too: “What will happen when Viagra goes generic?”  The BNET pharmaceutical writer and former managing editor of Adweek offers this best guess in an AccessRx column:

“When the drug giant Pfizer loses its patent protection for its erectile dysfunction drug Viagra, any drug company will be able to make and sell a cheap generic version of the blockbuster drug. Doctors and lawyers believe that the expiration of Pfizer’s monopoly on the drug will be good news for patients, as it will force competition between Pfizer’s Viagra and the new generic versions, dramatically driving down the price not only of Viagra but also of Eli Lilly’s Cialis and Bayer’s Levitra.

“However, increased options and cheaper prices for patients will lead to some confusion in the marketplace as Pfizer defends the reputation of its original brand and pharmacies become flooded with copycat pills, many of which may be made in China Continue reading