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Aug. 28, 2013

Note: The U.S. Department of Health and Human Services called police to break up the press conference that Public Citizen held in front of the HHS entrance today. A blog post about the incident, with pictures and video, is posted on our Citizen Vox blog.

HHS Must Stop Ongoing Unethical Trials on Premature Infants, Strengthen Ethical Standards for Human Research

‘I Would Not Have Let My Baby in the Trial Had I Known of the Dangers,’ Parent Says

WASHINGTON, D.C. – The federal government should halt all ongoing trials involving premature infants that are being conducted by the National Institutes of Health (NIH)–funded Neonatal Research Network until it can be determined that parents have been adequately informed of the dangers, Public Citizen said today at a press conference held outside the U.S. Department of Health and Human Services (HHS). In addition, HHS should strengthen – not weaken, as critics are pushing for – ethical and regulatory standards for human research.

“The fact that HHS is having a public discussion about this indicates that an enormous amount of pressure is being brought to bear by people who are trying to weaken the current standards of research with human subjects,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “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. We cannot let that happen.”

Publicity generated by Public Citizen over an unethical trial, known as the SUPPORT study, prompted HHS to convene the unusual public forum at its headquarters. The meeting is designed to solicit comments from experts and the public about what risks should be disclosed to participants when research is focused on the so-called “standard of care” treatment given patients for a particular condition.

Since Public Citizen publicized the lack of adequate informed consent in the SUPPORT study, a controversy has raged in the scientific community over what kind of consent is needed in certain kinds of clinical trials.

In the SUPPORT study, which took place from 2005-2009 and was funded by the NIH, 1,316 premature infants were exposed to an increased risk of blindness, brain injury and death as researchers tested two experimental approaches for managing oxygen therapy.

The Office for Human Research Protections (OHRP), an office within HHS, determined earlier this year that the consent forms had significant deficiencies. In June, 45 experts signed a letter published in The New England Journal of Medicine denouncing the use of “seriously deficient” consent forms in the SUPPORT study that violated requirements for clinical trials.

Carrie and Shawn Pratt, parents of a baby enrolled in the trial, came from their home in Kingwood, West Virginia to speak at the HHS meeting. They were accompanied by Dagen, now 6, who required surgery early in life for an eye disease known as retinopathy of prematurity and suffers from cerebral palsy.

“The SUPPORT study looked good on paper,” Carrie Pratt said. “We were told that it wouldn’t hurt Dagen in any way. We were shocked to learn that the care she received was based not on what she needed but on what some protocol dictated. Had we known of the risks, we never would have agreed to have her be in the trial.”

“The SUPPORT study may represent the tip of the iceberg with the problems in contemporary medical research,” said Alice Dreger, Ph.D., professor of clinical medical humanities and bioethics at the Feinberg School of Medicine at Northwestern University, who spoke at the press conference. “Here, as so many times in the history of American medical research, the consent process failed.”

Added George Annas, JD, MPH, the William Fairfield Warren Distinguished Professor and Chair in the Department of Health Law, Bioethics & Human Rights at the Boston University School of Public Health, “A patient has a right to a physician who is duty-bound to protect their health interests. The research subject does not. … At a minimum, the doctrine of informed consent requires the disclosure of any risks that could cause a reasonable person to reject the proposed medical treatment or research project.”

Last week, Public Citizen publicized the existence of another, similar trial that also poses known serious risks to premature babies, but researchers are not fully informing the parents about those risks when seeking consent. Called the Transfusion of Prematures (TOP) trial, it is designed to determine which of two strategies for treating anemia with blood transfusions is more likely to result in death or neurologic injury in extremely premature infants who develop anemia (low blood hemoglobin, which is found in red blood cells and carries oxygen to the body). The trial is just beginning.

Public Citizen is calling for: 1) HHS to immediate halt the TOP trial and direct OHRP to open an investigation into the trial; 2) OHRP to develop a plan to contact the parents of subjects already enrolled in the trial and provide them with full information about the risks, purpose and nature of the research; 3) an independent investigation of the HHS system for review and oversight of HHS-funded human subject research; and 4) a suspension of any other similar studies currently being funded by NIH or any other HHS agency.

It is unclear how much input HHS really wants; many people in Washington, D.C., are out of town in August because that is when Congress is out of session. In addition, HHS chose to hold the meeting on the 50th anniversary of the March on Washington.

Read statements and testimony from today's meeting.

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