June 14, 2006

Polyheme Take 10

USATODAY.com isn't the place to find what is the dead center front page story about the ethical issues associated with the trial of Polyheme. The story is riddled with therapeutic misconception, with one of those People Magazine stories as the lead, the sort of story that reminds you that the plural of 'anecdote' is not 'data':
[subtitle:]On the brink of death, Hilary Williams couldn't consent to getting the experimental blood substitute that she believes saved her life

As Hilary Williams hung from her seat belt in the overturned wreckage of her truck — legs broken, colon ruptured and lung bruised — blood oozed from torn arteries and veins.

Hilary, 27, and her sister, Holly, 25, who was injured less severely in the crash, waited half an hour for medical help to arrive. By the time an air ambulance reached them at the crash site, about 45 miles south of Memphis, it was midday onMarch 15. Hilary's face was pale, her lips were blue, her faint pulse was fast, and her blood pressure was 55/0. She was in shock.

Because she was close to death, she instantly became eligible for enrollment in a controversial clinical trial. But because she was in no shape to consider the risks, the flight nurses did not have to obtain her consent before giving her an experimental blood substitute.

Within moments, fluid the color of merlot was dripping into her veins. Hilary, a singer/songwriter and the daughter of country singer Hank Williams Jr., became one of thousands of people across the nation who, while fighting for their lives over the past 10 years, unknowingly became test subjects in medical trials.

With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection.

Although the study that included Hilary Williams has brought criticism, she believes the infusion of blood substitute helped save her. “I thought I was going blind,” she says as she recovers in Nashville. “Everything was dark. My eyes were open but I couldn't see anything. I felt at peace. I kept wanting to fall asleep, but a truck driver who stopped kept telling me to wake up and to hang on.”

Ultimately the piece goes to the real issues:
The study in which Williams was enrolled is the most widespread use yet of PolyHeme. The trial has raised concern among some ethicists and alarm in Congress, where Sen. Charles Grassley, R-Iowa, chairman of the Finance Committee, is conducting an investigation.

Grassley is concerned that people who live in the 19 states where PolyHeme is being tested have had inadequate notice about the trial. The FDA requires that community input be sought in the regions around test sites. “It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential ‘guinea pig,' without providing a practical, informative warning to the public,” Grassley wrote in a letter to the FDA in February.

“This study raises significant ethical issues,” says King, who co-wrote an article in the current edition of The American Journal of Bioethics that faults the PolyHeme trial for withholding available treatments, namely blood transfusions, from patients.

In the trial, PolyHeme is appropriately given to patients without their consent in ambulances, she says, where blood is not available. But some patients, including Williams, also get the blood substitute for up to 12 hours in the hospital, where blood is available.

King says some patients who die from their injuries therefore will perish while “being denied an available treatment.” Though she favors the concept of waived-consent trials, she says PolyHeme could be tested on the battlefield or during elective surgeries in which “you could get prior consent.”

Steven Gould, chief executive of Northfield Laboratories, stands behind the PolyHeme trial. He says it is too complex to be performed on a battlefield and elective surgery is not the crisis situation best suited for the study of PolyHeme. Of King's comments, he says, “We have different points of view, but that is what this is all about.”

Amid the controversy, some cities stopped enrolling patients while the data-monitoring board reviewed preliminary findings.

It looked like the Polyheme story had died down but it is back and with a very new spin: people are dying, it is claimed - one anecdote at a time - because they aren't receiving this blood substitute.

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