Public Citizen Warns About Risks in Infant Clinical Trials

A prominent consumer watchdog group is raising concerns over serious risks associated with infant clinical trials, saying that some appear to have put babies in serious danger without fully informing the parents about the potential risks.

Public  issued a statement on August 28, calling on the U.S. Department of Health and Human Services (HHS) to strengthen the ethical standards for research on humans.

The group says parents should be better informed about the potential dangers of a trial involving infants before they agree to subject their child to the studies, indicating that some recent federally funded research has failed to live up to these standards.

Recent controversy surrounding infant clinical trials and questions about consent forms prompted the HHS to hold a Public Forum yesterday on the topic of ethical human research. The forum was designed to solicit comments from the public about what risks should be disclosed to participants of clinical trials.

Several experts offered testimony at the forum focusing on the inadequacies of consent forms, which often do not reveal to participants the serious risks, often including death.

“The debate goes to the heart of how research is conducted in the United States and could have far-reaching, negative implications if changes are made to weaken the ethical and regulatory standards by which trials are run,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.

Public Citizen attempted to hold a press conference outside of the HHS headquarters concerning the same topic. They called on industry leaders and parents to speak about informed consent and what risks should be disclosed to participants. A number of parents spoke out, saying that had they known of the risks involved in certain clinical trials they would not have allowed their children to participate.

During Public Citizen’s press conference, HHS security personnel asked the group to relocate and eventually forced them to move to a sidewalk area of public property, instead of government property, an area directly in front of the HHS building.

Controversial Studies

The recent push comes amid great controversy surrounding several clinical trials which are being criticized for severe deficiencies in proper informed consent ,including Public Citizen’s condemnation of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) in April. The trial exposed more than 1,300 infants to increased risk of blindness, brain injury and death during experimental approaches for managing oxygen therapy.

The Office for Human Research Protections (OHRP), a department within the HHS, concluded the consent forms used in the SUPPORT trial were deficient and violated requirements for clinical trials. Parents of the infants involved in the trial say the research was not conducted with the well being of the infants in mind.

Public Citizen also publicized the Transfusion of Prematures (TOP) trial just this month. The group alleges TOP also places premature infants at risk because researchers are failing to fully inform parents of the risks. The trial focuses on strategies for treating anemia with blood transfusions, offering severe risks which include neurological injury and death.

Nearly 2,000 infants are expected to participate in the trial which may also use deficient consent forms which do not advise parents of the risks. Public Citizen is calling on the HHS to stop recruiting for the trial immediately.

Public Citizen is calling on HHS to stop any current studies which may be funded by the National Institutes of Health or other HHS agencies. The group is also calling for an independent investigation of the HHS system concerning human research.

The requests follow a recent FDA push to encourage drug companies to conduct more studies focusing on the effects of drugs in children. The FDA said in a recent blog post they would use new authorities granted by Congress after the reauthorization of two laws concerning drug testing. The FDA said the laws will help the agency ensure more drug studies are conducted on pediatric patients. The agency says the process is long overdue considering many drugs currently used on children are intended for adults and have not been confirmed as safe for children.