The Byetta Fallout- The Impact of the FDA decision goes beyond Amylin

The Byetta Fallout- The Impact of the FDA decision goes beyond Amylin

Once again a decision by the FDA is having wide spread impact on the diabetes sector. Yesterday the FDA issued a warning for Byetta over the possible risk of pancreatitis, according to the FDA there were six reported cases of severe pancreatitis, two of which resulted in deaths. The FDA did not mention in their warning that the agency considered this event to be “a rare and uncommon event” which they did when they answered questions asked by Diabetic Investor.

As expected the mainstream media has done exactly what Diabetic Investor expected implying that Byetta usage causes pancreatitis. Looking over the various press reports there is no mention that there are nearly one million patients taking Byetta or that patients with diabetes are at an increased risk of pancreatitis no matter what therapy they are on.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Incidence (annual) of Acute Pancreatitis: 80,000 cases occur in the USA ; 17 per 100,000 new cases

Incidence Rate: approx 1 in 3,400 or 0.03% or 80,000 people in USA
Prevalence of Acute Pancreatitis: About 80,000 cases occur in the United States each year; some 20 percent of them are severe.

Incidence of Acute Pancreatitis: 17 new per 100,000 people

Yet the FDA felt it was necessary to issue a warning when only six patients out of a population of one million Byetta users developed pancreatitis. Do your own math but any way you calculate it Byetta users are at lower risk than the general population in developing pancreatitis. This is especially significant when every credible expert acknowledges that patients with diabetes are at an increased risk for pancreatitis just because they have diabetes.

While Diabetic Investor can excuse the mainstream media for going for the sensational headlines, there is absolutely no excuse for the over the top action from the FDA. There action is unparalleled when they acknowledge this is a “rare and uncommon event.” Unfortunately it’s investors, patients and physicians who are paying for the FDA’s overly dramatic action. So far today:

Amylin down over 5%
Novo Nordisk (NYSE:NVO) down nearly 5%
Lilly (NYSE:LLY) down almost 1%
Alkermes (NASDAQ:ALKS) down almost 2%

Just what does the FDA expect patients and physicians to do know? Put patients on Januvia? Ask any respectable endocrinologist or diabetologiests who isn’t on Merck’s (NYSE:MRK) payroll and they will tell you that Januvia performance is average at best. There’s a reason the drug has gained the nickname Junknuvia . Try as they might Merck reps don’t have a leg to stand on when comparing Januvia to Byetta – Byetta has superior glucose control, a superior cardiovascular profile and proven ability to help patient’s lose weight.

Why not just put patients on insulin? As effective as insulin therapy can be primary care physicians are not equipped to deal with the patient education required. Ask any primary care provider why they don’t prescribe more insulin therapy and the answer may just surprise you. No it’s not fear of injections, its fear of hypoglycemia, a serious possibly life threatening event. Unlike oral medications or Byetta which can delivered with little or no monitoring, proper dosing of insulin requires a patient to be educated. Something that PCP’s aren’t paid to do and even if they were they don’t have the time or infrastructure to do.

That leaves metformin and sulfonylureas as the only medications available to treat the type 2 diabetes epidemic. Two drugs available as generics yet each with its own set of limitations.

One has to openly wonder if the FDA has a clue to what they are doing. Did they learn nothing from the Avandia controversy? Are they blind to the widely reported fact that many patients stop taking any medications at all as a result of the Avandia controversy? Can they really be that dense and not realize that the mainstream media won’t bother to investigate the details and just go with the most sensational headlines they can?

Based on their actions one could make a serious argument this agency which is supposed to help the public is intentionally taking way the most effective weapons physicians have to fight the diabetes epidemic. This would be like the International Olympic Committee asking athletes to wear running shoes that were used back in the 1900’s or swimsuits used back in the 1960’s. Let’s see Mr. Bolt or the amazing Mr. Phelps set world records using these antiquated tools. It would come as no surprise to Diabetic Investor if the agency started advising physicians to use leaches to treat diabetes.

Sadly unlike the companies trying to help the millions of patients with diabetes who are accountable to their shareholders, patients and physicians, these bureaucrats are accountable to no one. As we learned from the Avandia controversy our elected officials love face time on television and seeing their names in the newspaper. Yet when it comes to really helping the public all we get is more of the same, lots of hot air and not much else.

Back when the Avandia controversy was in full swing Diabetic Investor wondered if this time we would see more than just the usual bluster and actually see some real reform. After Rezulin and Vioxx, just to name a few notables FDA blunders, many believed Avandia would be the straw that broke the camel’s back. When the FDA’s own report concluded reforms were necessary it seemed like reform was a lock.

Looking at this sad state Diabetic Investor agrees with Boies Penrose the former Pennsylvania senator; “Public office …. Is the last refuge of the incompetent.”

David Kliff
Diabetic Investor
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224-715-3761 mobile