Censorship Issue Stalls Research on Heart Device : Science: University, government funding agencies at odds on what can be said to the press about ongoing projects.
Stanford University was all set to research a new artificial heart device until it learned that the government wanted to control what the public is told about the project, and when.
Stanford refused to accept the rule, and now the two sides are dueling in court over the government’s right to stop professors from talking or writing about research they conduct with public money.
It boils down to a clash of First Amendment free speech rights against the government’s power to control activities it funds. It touches on the same conflict addressed by the U.S. Supreme Court in its May 23 ruling that the government may bar counselors from discussing abortion at federally funded family planning clinics.
“We consider this a classic prior restraint on speech,” Stanford attorney David Stewart said last month, when he asked U.S. District Judge Harold H. Greene to throw out the rule on the heart research contract.
“Free communication amongst scholars and scientists is one of the many things the framers (of the Constitution) wanted to protect,” Stewart said. “We worry about executive agencies taking the right to control speech.”
But the government worries that testing of the heart device would be delayed if Greene orders the research returned to Stanford from St. Louis University, which was awarded the contract after Stanford refused to agree to the rule barring disclosure of research results.
The new heart device, still in development, is intended as a long-term solution for patients who now sometimes wait in vain for a suitable transplant heart.
The patient would keep his or her diseased heart and the Left Ventricular Assist Device would be implanted to boost the left side’s ability to pump blood at the correct pressure level.
Similar devices have been used on a short-term basis for patients awaiting transplants. The new version would be fully contained inside the body--except for the battery pack, worn in a vest, that would transmit electricity to the device through the skin.
The 5-year research project organized by the National Heart, Lung and Blood Institute, an arm of the National Institutes of Health, will involve two research institutes that each implant the heart device into 10 patients. A third research contractor will coordinate the resulting data, and the work could begin in about a year.
The heart institute offered Stanford a $1.5-million contract that would have allowed its premier artificial heart researcher, Dr. Philip Oyer, to conduct the implants.
But university officials objected to a “confidentiality of information” clause that said the institute must approve any release of “preliminary unvalidated findings” that could harm the public or the federal agency.
That amounts to censorship, contends Stanford, which says the rule is vague enough that it is uncertain how far the policy would extend.
“If the government is going to insist on approval of a publication that comes from a researcher, that’s not in keeping with fundamental academic principles,” Oyer said in an interview recently.
Oyer said he was concerned that if he disagreed with the majority view of the research results, he might be barred from airing his opinion.
The government said the rule--usually used only when multiple researchers are involved in a project--is necessary to preserve the integrity of the research. The project was divided between two researchers on purpose, and the idea is to look at both their findings and release the combined result, court papers said.
“It gives peace of mind to everybody in the project to know that the government is not going to allow preliminary unvalidated findings to be issued,” government attorney John Cleary told Greene last month. “We think the regulation works.”
One aim, Cleary said, is to avoid raising false hopes among the public by releasing early results that may turn out to be incorrect.
“These people have decisions to make about transplantation, about alternative cures and remedies, about what to believe from their doctor or not to believe,” Cleary said.
Stewart argued, however, that false hopes inevitably are raised in medical research and that the heart device wouldn’t be available, in any case, to everyone who wanted to try one.
Both sides contend that the Supreme Court’s opinion on abortion counseling supports their position.
The government noted that the Supreme Court opinion states, “When the government appropriates public funds to establish a program it is entitled to define the limits of that program,” and that speech is among the things that may be limited.
But Stanford cited the opinion’s statement that government funding does not guarantee a federal right to control speech. For example, the high court said, “The university is a traditional sphere of free expression so fundamental to the functioning of our society” that the First Amendment’s vagueness rule bars efforts to control academic speech by attaching conditions to the spending of government money.
The government said the rule on research grants is not vague, adding that universities have been accepting it for about a dozen years. Even Stanford did in a few cases--an oversight, according to university attorney Iris M. Brest.
Harvard University filed a brief to support Stanford, saying, “Scholars must be free to publish what they and they alone believe the results of their research to be.”
