This is not going to be pleasant

This is not going to be pleasant

Based on the briefing documents released by the FDA, it appears that AstraZeneca (NYSE:AZN) is facing an uphill battle in their fight to prevent the agency from making major label changes to Onglyza. As we noted yesterday any changes to the label could not only hurt future sales but cast a wide shadow over Januvia as we await more data from Merck (NYSE:MRK). Given the popularity of DPP4’s any major label changes or worse a Black Box warning could send the diabetes drug market into frenzy.

The question becomes should these changes become a reality what will physicians do? Will they begin taking their patients off DPP4’s and if so which drug will serve as a replacement? Given that Januvia is the most commonly prescribed DPP4 and the data is not yet available for Januvia, how will they advise their patients?

Diabetic Investor is equally curious how Merck will respond to what the FDA does. Yes they can state the data on Januvia is not yet available but this provides little comfort to physicians or patients. As we noted yesterday should the FDA come down hard on Onglyza, Januvia will be guilty by association. This may be unfair, especially since the data on Januvia remains unknown, but it is realistic.

We sense that no matter what happens with Onglyza Merck will be forced into a position of explaining the differences between how Januvia works compared to Onglyza. While both are DPP4’s they don’t work exactly the same way. However these differences may not be enough to put physicians at ease.

Sadly we anticipate another battle over how the analysis was done, which data sets were included, who was on the panel and so on. This is what drives everyone crazy. Now we can’t blame Merck or AstraZeneca for taking this approach as billions of dollars are stake. And as we noted yesterday not just sales but also for fending off future class action lawsuits.

Even worse may be how the FDA is viewed when this is all over. Will they be seen as having done their job or given the popularity of DPP4’s will they be thrown under the bus for not catching this while the drugs were under review? We shudder to think what new rules the FDA would impose on drug makers if they are taken out to the woodshed as they were with Avandia.

What this situation should make abundantly clear is just how much regulatory risk has increased since the Avandia controversy. Is it any wonder why companies are not developing innovative new therapy options? Isn’t more cost effective to go with the devil you know than the one you don’t. Yet this meeting shows that even a strategy of developing me-too copycat drugs isn’t safe.

As always lost in this debate is how it impacts patients. While it may seem ludicrous today metformin the most popular of all diabetes drugs , the gold-standard almost did not become a reality, that the FDA almost decided not to approve this widely prescribed drug. Think for a moment what diabetes would be like without metformin.  While patients with diabetes don’t necessarily need more drugs they do need better drugs. The only way this happens is for drug companies to take chances, to take risks.

However today the risk reward scales are way out of whack. The FDA and so-called patient advocates like Dr. Nissen (sorry about the misspelling yesterday Steve) seem to live in some sort of fantasy land where drugs are not just effective but free from any adverse events. This just isn’t going to happen no matter what rules the FDA puts in place.

Back when the Avandia controversy was raging Diabetic Investor hoped that some good may come out of it, that some balance would be found between the risk of drugs and the risk of poorly controlled diabetes. That some perspective be brought to this debate. A debate which seems to rage with almost every diabetes therapy. Lantus and cancer, GLP-1’s and pancreatitis are two of the more recent.

Sadly no balance has come as the system continues to be out of whack. The fact is patients with diabetes aren’t stupid, they like most normal people understand that while it would be great if drugs didn’t have any adverse events this is just not realistic. The same goes for physicians and just about anyone who isn’t a zealot like the good doctor. Heck we’d even venture to guess that the people FDA feel this way.

Yet thanks to the crusading cardiologist patients with diabetes once again won’t be able to get a simple answer to what they see as a simple question – “Is this medication safe?” Thanks Steve we certainly hope you’re happy for the carnage that you have created. Like Dr. Frankenstein the life you thought you were saving was actually a monster in disguise that would create untold long lasting damage.