First things first: we have no idea how serious the risk of pancreatitis with Amylin's type 2 diabetes agent exenatide ( Byetta ) really is. Nor do we pretend to be able to guess how the brand will be affected commercially in the hypercompetitive diabetes market by the report of two deaths associated with the drug.

But this we do know: there seems to be a disconnect between the level of warning that FDA chose to issue for Byetta and the size of the financial market's reaction. And that disconnect underscores an ongoing, critical issue facing the entire pharmaceutical industry in the world of "Safety First" regulation: how to communicate a risk associated with a product without scaring patients that could benefit.

You have to give the Food & Drug Administration credit for diagnosing the problem. The agency is the first to admit that it simply doesn't know the best way to meet the public demand for transparency in regulatory actions--especially anything involving safety--without needlessly scaring patients, confusing providers, and sacrificing its ability to speak authoritatively on behalf of the public.

That, in a nutshell, is why the agency formed ¹ a new advisory committee on Risk Communication in the hopes of bringing a little science to the question of how best to warn consumers about emerging and inherently uncertain safety issues.

Based on what happened to Amylin Aug. 18, it's safe to say there is still a lot of work to do.

In case you missed it, FDA issued an ² update for health care professionals about the risk of pancreatitis associated with Byetta. FDA and the sponsors (Amylin and its partner Lilly) first alerted prescribers to the risk back in October, citing 30 reports of acute pancreatitis associated with the brand.

The update cites six new, more serious cases reported since then, involving what the agency describes as "hemorrhagic or necrotizing pancreatitis." All six cases led to hospitalization, and two patients died. In light of the apparently more serious reports, FDA says it is working with Amylin and Lilly on stronger warnings and advises discontinuation of Byetta when there are any signs of pancreatitis in the meantime.

Amylin's investors certainly think that's a big deal: the company's shares dropped 15% almost instantly on the news, stayed down to the close, and opened even lower today. You can't blame investors for being skittish. Byetta is a huge product for the biotech and has already been struggling a bit commercially. In this climate, the impact of even uncertain safety risks can be dramatic. (Remember ³ Vytorin?)

Last but not least, the issue certainly raises more questions about the regulatory prospects for Amylin's long-acting version of Byetta. (We have ⁴ written previously about why we think Byetta LAR could benefit from the focus on cardiovascular outcomes for type 2 diabetes products--but if there is some reason to suspect the long-acting version is worse for the pancreas, all bets are off.)

But here's the thing: FDA chose to disclose the new information about Byetta without much fanfare, simply posting the update on its "MedWatch" drug safety page, with a prominent link on the "What's New" column of the Center for Drug Evaluation & Research's home page. The agency did not issue a press release, a formal public health advisory, or host a media conference call, the way it does in other cases where it wants to amplify its warning.

In fact, we first heard about it from the ever vigilant David Kliff, whose Diabetic Investor issued a note at 1:45 pm--by which time the sell off was well underway. (For the record, our copy of the alert via FDA's email list serve arrived at 2:52 pm.)

In other words, Wall Street's reaction is driving coverage of this particular drug safety issue--not the public health judgment of the regulatory agency. Think about it: if Byetta happened to be sold by a privately held company, or exclusively by a global Big Pharma where it was not the exclusive focus of investor attention, the media coverage would certainly be much reduced.

Again, we don't claim to know the right outcome here. Maybe it's best if everyone stops using Byetta altogether. Maybe it's best that no one stop. But it seems safe to bet that more people will be aware of this risk than would have been without the Wall Street reaction--and that means the impact of the FDA warning will be larger than the agency might otherwise have anticipated.

You don't have to be an Amylin investor to think that may not be the best way for risk communication to work.

- Michael McCaughan (mmccaughan@windhover.com)

[Editor's note: This story appears courtesy of ⁵ IN VIVO Blog, a free online publication of F-D-C Report's sister company Windhover Information, offering biopharmaceutical and medical device business intelligence. Visit ⁶ www.windhover.com or call (203)838-4401 for subscription information.]

Miscommunicating Risk: The Byetta Disconnect

More from Archive

More from Pink Sheet