FDA: Problems with Genzyme study of Leukemia Drug
The AP reports (8/28, FindLaw) “Federal regulators are questioning whether Genzyme’s leukemia drug should be approved for older patients based on limited studies conducted by the biotech drug maker.” Genzyme has asked the FDA to approve the drug Colar for use by adults who are over 60 years of age, but are not healthy enough to undergo chemotherapy.
However, the FDA reviews have complained about several problems with the company’s study. One such issue is “the 112-patient study did not compare patient’s taking the drug to those taking a sham treatment, a practice commonly used to gauge a drug’s effect.” As a part of the continuing review process, the FDA will ask a panel of cancer experts to evaluate the drug in the near future.
As a medical malpractice lawyer, I advocate for thorough reviews before approving a drug. One special, but necessary consideration should be how the drug might react differently in elderly patients, and drugs such as this one that will be use primarily by older patients should take that into account during the review process.
Bookmark: 
