Proactive Product Safety and Efficacy Surveillance Through Observational Research

I just read an article in PharmaVoice on the value of proactive pharmacoviligance . It was dated February 2011; I'm a bit behind on my reading.

However, I couldn't agree more. Manufacturers need to study their products closely post commercialization in order to understand how those products perform once they are used outside of the clinical setting. It is unrealistic to assume that patients and physicians will always have the exact same experiences observed in clinical trials. The world outside of the clinical trial is filled with comordities, concomitant medication, variable adherence, and more. Post-marketing surveillance studies can also serve as a way to catch concerns and address them before they become real issues like lawsuits and loss of approval.

Manufacturers should also want to preserve their products for potential future indications and to ensure that the right patients get the right treatment. I expect executives to would want to know how physician and patient experiences are going to impact the company's bottom line.

Let's face it, all safety and efficacy issues bubble to the surface eventually. We assume that executives would want to proactively manage their portfolios not just because it is good patient care, but because it is good business too.

We spend a good deal of time analyzing patient and physician experiences with pharmaceutical products. We get a real look at how patients and physicians use drugs and devices in real-world settings. We see safety and efficacy issues that definitely can pose potential problems for brands and for companies. We see misunderstandings that offer companies the opportunity to fix things at the source.

When we did our 10-year retrospective study on Avandia, we learned that problems were evident as early as 2004. GSK would have had time to change their label and marketing, instruct physicians, and educate patients. Maybe then in 2008 lawsuits would not have been the recourse patients/caregivers felt that they had to take. Maybe it didn't have to cost GSK so much in legal fees and consumer trust.

When we studied Actos earlier this year, we learned that Takeda faces some real problems with Actos that could impact approvals for future indications. Bladder cancer, bone fractures, and cardiovascular risks are not going away. We believe that Takeda needs to address these risks now for both their current diabetes patients as well as for new trials in different disease states..

So why isn't pharma being more proactive in pharmacoviligance as well as efficacy studies?

We believe that observational research and surveillance studies need to start as soon as a drug or device is in market. It is not only in the best interest of the patient but it is also ultimately in the best interest of the company and the industry. The contributors to the article I read were mostly from non-manufacturers like we are at Wool Labs.

How do we get more of the manufacturers on board?