“That’s way over the top,” said Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center. “When you are doing research, you have to make sure that people understand it’s promising, that you’re making no guarantee of benefit. That’s getting very close to guaranteeing a benefit. That language is irresponsible.”
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Five ethicists and researchers who reviewed Chung’s comments at the Globe’s request said they appeared to violate ethical standards requiring that researchers convey a balanced message about clinical trials to possible research subjects.
“It’s inappropriate, and I would argue unethical, to approach people about a research study that hasn’t been approved and to say the potential benefits outweigh the risks,” Grodin said.
“That was definitely overselling,” O’Sullivan said. “There needed to be, ‘We hope there will be fewer side effects. We hope it will be more effective, but we don’t know that.’ ”
Chung made little mention of side effects. After prompting by an audience member’s question, he said, “The important point to make about this combination therapy is that it has been very well tolerated . . . and we believe that the side effect profile described in those [earlier] trials will be something we will be able to manage effectively in this group of patients.”
Hohmann said Chung’s comments were not “hyperbolic.”
“I think it’s enthusiastic but justified based on these drugs, which are really looking very good,” she said.
Chung, too, defended his comments. “This is not a hard sell. This is simply a restatement of facts in an informational setting.”
Indeed, he said, he felt it was his responsibility to alert the patients to the drug combination’s promise so they could, if they wished, access it before approval, which he said could come as early as next year.
He also noted that the evening’s promotional materials — which called the combination he hopes to test “wonder drugs” — were the work of the Patients Speak; neither he nor Mass. General officials reviewed the materials.
The FDA, which enforces laws governing clinical research trials, declined to comment on Chung’s presentation. But agency spokeswoman Michelle Bolek pointed to laws that bar investigators from representing “in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.”
Some ethicists questioned Chung’s timing, saying he should have held off on taking names and contact information of interested patients until he had secured approval from the Partners Human Research Committee. That panel did not approve Chung’s study until a month after the Exeter presentation.
FDA guidelines note that institutional review boards — widely known by the acronym IRB — should review the “methods and material that investigators propose to use to recruit subjects.”
“In his capacity as an educator and a doctor, he may want to educate people broadly about what’s going on in hepatitis C and how there is a sea change afoot in hepatitis C drug treatment options,” said Dr. Timothy Lahey, cochairman of the Dartmouth-Hitchcock Medical Center Ethics Committee.
“But he would have to be very careful not to actively recruit anyone to a specific study without IRB approval or to overstate the expected potency of an experimental regimen.”
And taking names, some ethicists said, clearly constituted recruitment.
“If you are taking names so you can contact them, that’s recruiting,” said Lisa Bero, a University of California, San Francisco specialist in clinical trial ethics.
Chung and Hohmann disagreed. “This is simply collecting names and contact information for when [the study] is ready to rock,” Hohmann said.
She compared Chung’s presentation to notices about upcoming trials placed by researchers and institutions on the Internet. Those are permitted, under FDA guidelines, so long as they are restricted to basic information, such as the study’s title, purpose, protocol, eligibility criteria, and study site.
Chung said he notified Hohmann before the meeting in Exeter and advised her that he planned to discuss the upcoming trial.
Some ethicists said Chung’s recruitment methods reflected real-world pressures and demands on researchers.
“I have a little sympathy,” Annas said. “It’s hard to recruit people for a study. The key thing is, did he tell people clearly that this is research?”
At root, Chung said, “I was responding to what I perceived and I felt was a very strong, intense need for information on behalf of an aggrieved group of patients who were confused and had nowhere to turn.”Continued...