Gaining the Public Trust - Applied Clinical Trials

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Gaining the Public TrustMedicine and clinical trials--time for a paradigm shift?

Source: Applied Clinical Trials

Medicine and clinical trials--time for a paradigm shift?
The pharmaceutical industry is under siege again with the recent discovery of high cardiac risk and the use of COX-2 inhibitors. The authors of a New York Times story noted that exposure of these drug risks was the "clearest instance yet of how medicine and marketing can turn hope into hype" (12/19/04).

At a time when profits in the pharmaceutical industry are down, generic drugs are gaining ground, drug importation is looming, and blockbuster drugs are on a downward spiral, the industry needs to take a step back and weigh the consequences of the loss of public confidence. Perhaps it is time for a paradigm shift in the way the science of drug discovery is communicated.

Industry leaders from Europe, Japan, and the United States are finally responding to the public by promising to improve disclosure of clinical trial information via clinical trial registries and databases. Again, it has been mentioned that the registries will be on a volunteer basis, and some questions still remain about what information will be put forth and how the registry/databases will be coordinated. It will be interesting to see how all of this is implemented in the coming year. This month, ACT columnists Wechsler and O'Donnell further explore the registry and database issue.

The need for an increase in the transparency of clinical trials was recently discussed at a public forum on "Bio-pharmaceuticals and The Public Trust" (Fordham University Center for Ethics Education Summit, 1/10/05). The panel represented government, the pharmaceutical industry, and litigators involved in clinical trial issues. The speakers acknowledged the need to restore public confidence in the pharmaceutical industry and government. The forum is a starting point in the public trust arena. Let us hope that actions will follow the concerns and ideas expressed.

There appear to be some thought leaders on the horizon who understand this need for change and communication. Plaudits to the individual pharmaceutical companies that have recently announced they will soon have publically available registries that include disclosure of clinical trial results of postmarketed products.

The entire staff of ACT would like to express our deepest sympathy to those who have lost so much due to the December 2004 tsunami. The number of people who have died in this disaster is difficult to comprehend, and almost beyond one's imagination and belief. We applaud those governments who have jumped in to aid the survivors, as well as the individuals and companies who are donating money and supplies to those who are now so much in need.

It is unfortunate that a disaster of this magnitude has to remind us that we are all responsible for each other, and all creatures that walk this earth. It is going to take a long time to rebuild. We urge our readers to continue to contribute in whatever way you can. The International Federation of Red Cross and Red Crescent Societies is one way to help--visit www.redcross.org for more information.

Toby Jane Hindin, EdD
Editor-in-Chief
email: thindin@advanstar.com
www.actmagazine.com

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