Kelly Close if you don’t know is a tireless diabetes advocate and on the front lines of diabetes information and its dissemination. A highly respected financial analyst, as well as someone who’s lived with type 1 diabetes for more than 25 years, Kelly runs Close Concerns and keeps an eagle eye on research, product development, pharma and the FDA.diaTribe is her free every other month e-newsletter.
The July issue had a message from Kelly I wanted to pass along. Given the FDA’s risk-averse policy to new drugs and devices, many products that could help the many linger and languish. Kelly’s inviting any and all of us to chime in to the FDA at their public hearing August 11th. Here’s the article below and here’s the plea: please email us on what you would like the FDA to know at:
We want our diabetes treatments to be effective, but we also want them to be safe, and it is up to the FDA to decide if the benefits of a given medication outweigh the risks. Our concern, is that the pendulum has swung too far in favor of caution and safety at the expense of innovation. Much-needed new products are being delayed or even shelved entirely. the good news is theta FDA will be considering these risk-benefit tradeoffs at a meeting in August, and you have a chance to make your voice heard.
Determining whether a new diabetes drug should be approved has never been easy, but the turning point in this debate occurred in 2007, when Avandia was implicated for apparently increasing the risk of heart attacks. The FDA revised its guidelines so that drug companies would need to demonstrate cardiovascular safety before approval, adding huge costs to the process ($100 – $300 million). The FDA tried to ease this burden by allowing the companies to submit so-called interim data, or data midway through the cardiovascular (CV) trial that demonstrated safety, and the companies could complete the trial after the d rug was approved.
Unfortunately, that hasn’t worked out too well. Once the drug has been approved, participants want that drug and are motivated to abandon the trial. It’s logical behavior, but it negates the very costly study.
The result? Companies are giving up on diabetes. Bristol-Myers Squibb left diabetes entirely in 2013, and Genentech is out too. The cardio trials can delay drugs (like degludec) and follow up drugs (IDegLira) for years. Takeda said it won’t develop its once-weekly DPP-4 inhibitor in the US because trials are too expensive, while delays with Sanofi’s GLP-1 agonist Lyxumia slowed development of entire new classes of diabetes drugs.
In sum, there are benefits to the trials, but we believe we are sacrificing innovation at the altar of safety. (And by the way, Avandia was ultimately found to be safe).
The FDA is holding a public hearing on August 11 to discuss how to address interim data in trials. This is a real opportunity for our community to make our voices heard. Registration to attend is open until July 28; those who can’t make it to Silver Spring, Maryland, can submit a comment right here at Kelly@diaTribe.org. Every comment submitted before July 28 will be considered, but you can submit all the way up to October 10. We would love to thank the FDA for giving patients and families and healthcare providers the option to comment.
When our response is ready, we’ll tweet it and make it widely available – we’re working on it now! This issue is complex, and it’s only part of a much larger question about how we should handle drug development and approval. But for now, let’s tell the FDA that the status quo isn’t working. We also look so forward to following up November 3 in a conversation with FDA – read our new now next for more on this!