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Clinical Studies: The Role of Informed Consent
by admin on: November 16th, 2011

Whenever a pharmaceutical company has a new drug in development, clinical trials are run during which patients receive the drug as part of a closely monitored therapy. However, before registering for an experiment, the patients (and often their caregivers) undergo a process that is referred to as ???informed consent.??? Generally speaking, this process involves informing the patient about the procedure, or experimental drug, so that the patient is in a position to decide whether he or she wants to participate in the study. All patients learn about what the therapy may do and are warned that the therapy, or drug, may not help their condition.

While everyone hopes that these clinical trials will benefit patients, sometimes patients end up worse than they started. In August 2010, Eli Lily discontinued two clinical trials after results indicated that their new Alzheimer???s drug, Semagacestat, was making patients worse. In a statement (available on Eli Lily???s website), the company stated that cognition and the ability of patients to complete activities consistent with ???daily life??? worsened while receiving this drug. In addition, there was data indicating that patients taking Semagacestat had an increased risk for developing skin cancer. Semagacestat was among the first types of drugs developed to inhibit gamma secretase, which is an enzyme required to make the protein beta amyloid. This protein accumulates as plaque in the brain of patients that suffer from Alzheimer???s disease.

Currently, Eli Lily and other pharmaceutical companies, such as Elan, are testing drugs that are mechanistically similar to Semagacestat but will, hopefully, target the beta anyloid protien more specifically. Yet this still begs the question: What do you tell these patients when describing the potential effects of these products? While one would hope that these new drugs have a better safety profile, certain disease states (Alzheimer???s disease included) make people desperate for a ???cure??? and each patient, and their family, have the opportunity to weigh the benefits against the risks because of informed consent.

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