Battle of the Brains – Orlando

The weather wasn’t the only thing hot in Orlando. Take the Dr. David Orloff (Medpace Exec Director, Regulatory Affairs; Former FDA) and Dr. Steven Nissen (Chair, Cardiovascular , Cleveland Clinic) debate over the new FDA standards of novel diabetes drugs at the ADA’s 70th Scientific Session as an example.

2 opposite views with a common thread – increased safety and efficacy for diabetes drugs. But what is the best way to deliver better drugs and minimize the CV risk in doing so?

Nissen’s support of the one-size-fits-all stems from his meta-analysis of GSK’s Avandia (rosiglitazone) which showed 43% increase in relative risk for Myocardial Infarction. Nissen criticizes placebo-endpoint studies and calls the industry’s “glucosecentricity” for expediated approvals and paved the way for drugs like Avandia.

Orloff, however, takes a more nuanced approach citing Nassim Nicholas Taleb’s “Black Swan Theory” on the biases that ensues from a rare and uncertain event. Dr. Orloff expresses the need for customizable and agent specific review to curtail development time and save the patient money in the long run.

Orloff, an expert at crafting clinical development plans, has been the thought leader in the CV and diabetes spaces for years.

You can gain a better understanding of the new FDA guidelines here: http://www.medpace.com/AboutUs/NewsAndEvents/OnDemand/OrloffPodcast.aspx
OR can meet with Dr Orloff at the CBI Obesity and Diabetes Summit in Arlington, VA July 20-21.

Is this the first step by the regs towards standardization across CV related indications? Is obesity, cholesterol, and blood pressure next? We shall see…