Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, said he was not aware of physicians manipulating eligibility for clinical trials through transfusions. However, the letter raises a provocative issue that should be studied further, he said.
"This is something I have never heard of, never seen and I can't say how common it is," Lichtenfeld said. "I believe the authors have brought a very important issue to the attention of the oncology community and our patients."
If found to be commonplace, Lichtenfeld said the practice should stop. "Giving unnecessary transfusions is not the way we should be increasing access to new cancer drugs," he said.
Another layer to the issue that should be examined, Callum said, is how reasonable the "exclusion criteria" regarding participation in clinical trials are in the first place. The exclusion factors take into account a drug's toxicity and who is likely to be helped, she said.
"Exclusion criteria" are meant to protect patients by keeping people out who are too ill to metabolize a drug effectively, or too fragile to handle its side effects.
But drug companies want positive results, Callum noted, so there can be pressure to select healthier patients to make the drug look better.
If doctors are bypassing the exclusion criteria, it may be that they believe the criteria are unfairly leaving some very sick patients out of trials who could benefit, she said.
"We have to make sure exclusions are not selecting for the best patients that will make the drug look its best," Callum said.
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