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Mandatory public clinical drug trial registry needed to help ensure prescription drug safety, IOM panel told

Monday, June 27, 2005

Mandatory public clinical drug trial registry needed to help ensure prescription drug safety, IOM panel told

Consumers Union statement for today’s public hearing

(Washington, D.C.) — Consumers Union, which supports a mandatory clinical drug trial registry to help ensure doctors and patients know the latest information about a drug’s side effects, today issued the following statement to the Institute of Medicine. The IOM’s Board on Health Science Policy is studying ways to improve clinical trial registries by holding a public hearing today.

Consumers Union, the nonprofit, independent publisher of Consumer Reports with 6 million print and on-line subscribers, supports the earliest possible public registration of all clinical trials that offer information on the safety and effectiveness of pharmaceuticals.

Consumers Union is deeply concerned that public confidence and faith in the drug approval and safety process has been severely damaged by a number of recent, high-profile cases. We believe that the Food and Drug Administration needs a number of additional authorities and resources to give more emphasis to safety in the process of pre- and post- market approval of pharmaceuticals.

A key part of restoring public confidence in the drug safety process is to require that information about (and obtained from) clinical trials on pharmaceuticals be registered and made public. Though in some case it may not be necessary to register and disclose results from Phase I and some Phase II trials, we urge the Institute to err on the side of more public information, not less.

For those who have volunteered to assist in these trials, often at danger to themselves, we owe it to these individuals to learn and gain from their experience.

It is essential that the goals, specifications, and endpoints of clinical trials be registered and made public. It is a scandal that in some recent cases only portions of clinical trials that made a drug look good were made public, and portions that revealed danger and unacceptable risk — or lack of effectiveness — were hidden.

Consumers Union has endorsed legislation in this area, S. 430 (by Senators Dodd and Grassley), and we have attached a summary of that legislation. We urge the Institute and the Board to make an early endorsement of the provisions in S. 430, so that Congress is encouraged to act this year — and not delay while valuable safety and effectiveness information continues to be hidden.

We also urge the NIH, which hosts the website, to make the necessary changes now to allow researchers to place clinical trial results in that database. This will allow researchers and drug trial sponsors to post results on a database that uses uniform and consistent reporting fields and search mechanisms and will allow for the broadest possible public access.

Contact: Susan Herold, 202-462-6262