Doctors Do A Blood Transfusion For The Involvement Of Patients In Trials Of New Cancer Drugs.
Canadian researchers break they've noticed a alarming trend: Cancer doctors ordering unneeded blood transfusions so that critically ill patients can qualify for drug trials. In a letter published recently in the New England Journal of Medicine, the researchers circulate on three cases during the last year in Toronto hospitals in which physicians ordered blood transfusions that could present the patients appear healthier for the lone purpose of getting them into clinical trials for chemotherapy drugs neosizeplus men. The practice raises both medical and upright concerns, the authors say.
And "On the physician side, you want to do the best for your patients," said co-author Dr Jeannie Callum, concert-master of transfusion medicine and tissue banks at Sunnybrook Health Sciences Centre in Toronto. "If these patients have no other options progressive to them, you want to do everything you can to get them into a clinical trial. But the assiduous is put in a horrible position, which is, 'If you want in to the trial, you have to have the transfusion extender.design.' But the transfusion only carries risks to them".
A solely serious complication of blood transfusions is transfusion-related canny lung injury, which occurs in about one in 5000 transfusions and usually requires the patient to go on life support, said Callum. But apart from the potential for physical harm, enrolling very sick occupy in a clinical trial can also skew the study's results - making the drug perform worse than it might in patients whose bug was not as far along.
The unnecessary transfusions were discovered by the Toronto Transfusion Collaboration, a consortium of six big apple hospitals formed to carefully review all transfusions as a means of improving patient safety. At this point, it's unrealizable to know how often transfusions are ordered just to get patients into clinical trials. When she contacted colleagues around the period to find out if the practice is widespread, all replied that they didn't examine the reasons for ordering blood transfusions and so would have no way of knowing.
Dr J Leonard Lichtenfeld, spokesperson chief medical officer of the American Cancer Society, said he was not aware of physicians manipulating eligibility for clinical trials through transfusions. However, the dispatch raises a provocative issue that should be feigned further.
And "This is something I have never heard of, never seen and I can't say how routine it is. 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 discipline should stop. "Giving unnecessary transfusions is not the manner we should be increasing access to new cancer drugs".
Another layer to the issue that should be examined is how inexpensive the "exclusion criteria" regarding participation in clinical trials are in the first place. The denial factors take into account a drug's toxicity and who is likely to be helped. "Exclusion criteria" are meant to watch over patients by keeping people out who are too ill to metabolize a drug effectively, or too fragile to market its side effects.
But drug companies want positive results so there can be pressure to select healthier patients to win the drug look better. If doctors are bypassing the exclusion criteria, it may be that they accept the criteria are unfairly leaving some very sick patients out of trials who could benefit hormone. "We have to make secure exclusions are not selecting for the best patients that will make the drug look its best".
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