The Department of Homeland Security (DHS) descended on a press conference being conducted by Public Citizen outside the Washington offices of the U.S. Department of Health and Human Services (HHS) yesterday.
With sirens blaring, about ten black DHS SUVs raced up to the HHS building, participants in the news conference said.
The end result of all the commotion and disruption? The doctors, scientists, parents and at least one disabled child picked up their belongings and moved about 70 feet from the steps of the HHS building onto the sidewalk as the armed DHS police "guarded" the building. Meanwhile, HHS employees lounged on the steps nearby eating their lunch.
It's OK, apparently, for federal workers to sit on the steps doing nothing but not for others to venture onto public property to air concerns and grievances.
Tests on infants
The news conference involved tests being conducted on premature infants under grants from the National Institutes of Health (NIH). Public Citizens wants the tests halted until it can be determined that parents have been adequately informed of the dangers. The group also wants HHS to strengthen ethical and regulatory standards for research carried out on humans.
HHS convened an unusual public forum on the topic yesterday and Public Citizen says it fears the agency is trying to drum up support for weakening existing standards.
“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.
Publicity generated by Public Citizen over what it says was 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.
Risk of blindness, death
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, Public Citizen said.
Carrie and Shawn Pratt, parents of a baby enrolled in the trial, came from their home in Kingwood, W.Va. 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 who now 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.”
"It is unclear how much input HHS really wants," Public Citizen said in a statement. "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."