Drug Co Reps Say Clinical Trial Data Should Remain Secret


Two out of three of the panel participants at today’s Food and Drug Administration (FDA) transparency hearing discussing whether data for unapproved drugs and medical devices should be made available to the public were pharmaceutical industry representatives.

As we reported in our investigation, Heart of the Matter, drug and medical device companies lobbied Congress to keep data secret for government-regulated clinical trials for products that don’t make it to market.

Now the issue is before the agencies. An audience of about 75 people listened as the panel members discussed detailed case studies about whether and when the FDA or companies should make data available to the public. (The hearings were available via livestream here.)  For the most part, drug industry representatives stuck to the same arguments they made to Congress–that such data are proprietary and should remain secret.

Heather Nigro serves as regulatory affairs manager for pharmaceutical firm Covidien, a subsidiary of Tyco International, which has reported spending $1.3 million on lobbying so far in 2009. At the hearing, she stated that if a drug is withdrawn for safety reasons, then volunteer subjects should be notified, but that the data collected on the drug should not be made public.

Ekopimo Ibia, director of global medical and regulatory policy for Merck, a drug company that has reported spending $4.6 million on lobbying in 2009 alone, also testified.

Diana Zuckerman, director of the National Research Center for Women and Families, the sole consumer group representative, argued strongly in favor of transparency and disclosure. “When people participate in clinical trials…they are participating for the public good,” she said. She said that clinical testing data should be made public to contribute to a body of science that would be helpful to everybody.

(additional reporting by Josh Heath)