Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine, uses the terms “the Vioxx moment” and “the Avandia moment” in his September 2007 “From the Editor” column. He describes these as “the moment when a safety signal has been detected on a drug, and no one yet knows for certain whether it is real or not – the moment when pharma companies and FDA alike set themselves up for a kick in the teeth.”  In other words, do we tell people that someone died while taking our drug, or should we wait to see if anyone else dies?

Obviously, when a drug makes the body more likely to have a heart attack, disclosure is imperative – up front – so patients and doctors can discuss and weigh the risks of drugs, disease and other life issues they already face.  Some drugs treat serious, life-threatening diseases, but also have potentially serious side effects.  For some patients these drugs should never be used.  For others, those same drugs are a godsend because the patient would otherwise have had no chance at all of survival.

I worked with GSK a number of years ago to market Avandia, a drug that treats certain symptoms of type 2 diabetes. We were very careful to include all of the important risk information in the marketing pieces we created.  Our direct mail packages were large fulfillment mailers designed to provide patients with more information about Avandia, including all of the FDA-approved important safety information – with several points about heart failure as a possible side effect.

At the time, I felt very good about marketing a product like Avandia, because I believed that it was providing a vital benefit to many people with type 2 diabetes who could not control their blood sugar through other options.  Today, after the addition of a black-box warning to the Avandia packaging, I still believe that the drug is right for some patients and not right for others.  As always, that is for the doctors to decide.

As marketers, it is our responsibility to ensure we do everything we can to be truthful. While the goal is to sell more product, it should not be at the cost of public faith in medicine, nor at the cost of lives.  We must ensure that we include ALL of the safety information in a clear format that everyone can understand.

Print and online media generally afford the space for longer disclosures of safety information.  But with TV we may find ourselves foolishly searching for ways to shorten the fair balance while staying within FDA regulations.  In the end, if the safety information is not clear, and someone misses an important, life-changing piece of information, you have failed.

My advice: stick with integrity.  Do it right the first time.  Continue to elevate a positive profile for the pharmaceutical industry.  And help healthcare providers, and their patients, make the right medical decisions based on ALL of the necessary information.