Is a signature enough?

GlaxoSmithKline’s diabetes drug, Avandia has been under intense scrutiny recently. According to a study by cardiologist, Dr. Steven Nissen and Kathy Wolski, published in the New England Journal of Medicine, the drug increases the risk of heart attack by 43% and increases the risk of dying from cardiovascular causes by 64%.

In Europe, the European Medicines Agency has banned its use. In the US, however, the FDA has decided to keep Avandia available to patients. The FDA argues study data is not strong enough to remove it from the market. It currently requires restricted access under a risk evaluation and mitigation strategy (REMS). As such, patients currently taking Avandia who feel they are benefiting from the drug may continue taking it upon signing a consent form acknowledging the potential risks associated with the drug. The strategy only allows new patients to take the medication if it is truly the only option available to them to control their glucose levels, and again, upon signing a consent form.

"Patients will only be allowed to use [Avandia] if they acknowledge and document the risk of this drug," said Dr. Joshua Sharfstein, FDA principal deputy commissioner.

In essence, the FDA has pushed the responsibility of determining if risk outweighs reward to the patient and their doctor. We would argue the signing of the consent form shifts much of this responsibility to the patient, relinquishing the doctor and the manufacturer of liability. They were told the risks, they signed the form, what happens next is on the patient.

In a case where your risks include heart attack, stroke or even death, is simply signing a written consent enough? Shouldn’t there also be a check for actual understanding? A panelist on the FDA advisory committee, a researcher from Duke, Ruth Day, suggested patients should be required to take a quiz to check for understanding.

We would agree. Here is the reality: A patient sits in an exam room as a doctor rattles off a laundry list of “potential risks.” The eyes glaze over a little, there is a lot of nodding and affirmative responses. A doctor whom they trust implicitly says “sign here” and voila, consent is given. Is that true understanding? Especially in patients for whom English is not their first language, how do you know they really understand? Would it be wrong to make the patient run it back?

Taking this medication can cause which of the following side effects?
a) purple fingernails
b) bulging eyeballs
c) heart attack, stroke or possibly death
d) all of the above?

If doctors and the FDA are going to put the responsibility of the risk of death onto the patient, shouldn’t they be responsible for ensuring patients fully and clearly understand that responsibility?