Consent forms missing in lung-cancer study, report says

April 28th, 2011 by Charlie Belmore | Tags: Consent, Consent Forms

In medical experiments on human beings, every patient must sign an “informed consent” form acknowledging the risks, and researchers are required to keep track of those statements.

But the doctors who conducted a controversial, widely publicized lung-cancer study involving more than 50,000 patients at numerous hospitals were unable to locate 90 percent of the consent forms, according to a confidential review provided to The New York Times.

The finding casts further doubt on a clinical trial that made headlines in 2006, when it concluded that 80 percent of lung-cancer deaths could be prevented through widespread use of CT scans.

That trial, led by Dr. Claudia Henschke at Weill Cornell Medical College in New York City, drew criticism from skeptics of cancer screening; the criticism intensified when it was reported in March 2008 the research was being financed in part by $3.6 million in grants from the parent company of Liggett Group, a cigarette maker.

The confidential report on patient consent, dated Oct. 7, 2008, recommended the trial be stopped. But it continues, although not at Weill Cornell.

Several ethicists said the hospital was legally required to disclose the ethical problems documented by the secret review. That has not happened.

The confidential report was commissioned by Weill Cornell in 2008 after the article about the Liggett financing and other revelations about the study in a newsletter, The Cancer Letter.

The hospital hired four prominent professors from other universities to undertake an independent review of Henschke’s research, known as the International Early Lung Cancer Action Program, or I-Elcap.

In their report, the reviewers scolded Weill Cornell administrators for failing to supervise the research more closely, “especially knowing that scientific controversy has surrounded I-Elcap almost from its inception.”

One reviewer, Dr. David Carbone, a professor of medicine and cancer biology at Vanderbilt University in Nashville, Tenn., said in an interview that he and the other reviewers never found out “whether these consents were obtained and lost or whether they weren’t obtained at all.”

He said Henschke acted with the best of intentions, “but there’s no way for me to justify any of the problems” documented by the group’s review.

Henschke, who has since left Weill Cornell for Mount Sinai Medical Center, also in New York, declined to respond to the findings of the 2008 review. But in an email, she said the responsibility for keeping track of consent forms lay with all the hospitals where the experiments were done.

“I-Elcap is a non-federally funded academic consortium of independent, autonomous sites that share certain data,” she wrote. “Accountability and responsibility for human protection lie at the local level.”

But Henschke’s research has been supported by grants from the National Institutes of Health, and federal rules governing research conducted at multiple sites have long required the coordinating center either collect copies of patient-consent forms or ensure they are being kept appropriately.

“The responsible conduct of a study requires that informed-consent documents be kept on file,” said Dr. P. Pearl O’Rourke, director of human-research affairs at Partners HealthCare, part of Harvard University.

John Rodgers, a spokesman for Weill Cornell, wrote in an email that the medical school followed federal research regulations “and there were no issues regarding the safety of the research subjects.”

In November, a large federal study found that annual CT scans of current and former heavy smokers reduced their risk of death from lung cancer by 20 percent and seemed to reduce the risks of death from other causes.

Although the scale of the benefit was substantially less than Henschke said her research showed, the federal study was widely interpreted as confirming her longtime contention that CT screening can save lives from lung cancer, which kills more than 150,000 people each year in the United States. Most patients discover their disease too late for treatment, and 85 percent die from it.

Carbone, the reviewer, said he believed Henschke was so convinced CT screening would prove beneficial against lung cancer that she cut corners in her research.

“Claudia was so dedicated to this concept and underfunded in a lot of ways, so that there was no way for her to do it properly,” he said. “But the ends don’t always justify the means, and doing things wrong can really backfire.”

Health Care Adviser