The Battle Intensifies

The Battle Intensifies

It’s appropriate that during an election year several companies have resorted to negative campaign tactics. As the diabetes market continues to explode and controversy surrounds many drugs used to treat type 2 diabetes the battle for market leadership is intensifying. Today at the EASD in Rome, Merck (NYSE:MRK), Novartis (NYSE:NVS), Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) all released study data touting the benefits of their particular therapy option.

Given the controversy surrounding pancreatitis and Byetta usage it should be noted that all of the drugs studied came with their own set of adverse events. This is not unusual, unless you’re the FDA and believe that drugs should have absolutely no adverse events.

A reoccurring theme of all the studies was how patients using their particular drug did not experience any significant weight gain. That is of course until you look at the studies from Amylin and Lilly on Byetta. While not every patient taking Byetta experiences weight loss, the weight loss capabilities of Byetta are well documented. The same is true for Liraglutide from Novo Nordisk (NYSE:NVO). While the weight loss for Liraglutide may not be as robust as Byetta, still both drugs have performed well compared to other treatment options which are weight neutral at best and are more likely to cause weight gain.

Last summer everyone was up in arms over the possibility that Avandia may lead to an increase in adverse cardiovascular events. Many called for new standards to approve drugs. Many of these “experts” said it was no longer acceptable to approve a drug based just on its ability to lower A1C levels. These “experts” said the FDA should begin looking more closely at secondary endpoints such as the drugs cardiovascular profile. According to the ADA

  • Heart disease and stroke account for about 65% of deaths in people with diabetes.
  • Adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes.
  • The risk for stroke is 2 to 4 times higher and the risk of death from stroke is 2.8 times higher among people with diabetes.

Given these statistics this increased focus on cardiovascular profile of a drug candidate made perfect sense. That is of course, you’re the FDA who for reasons they only understand, focuses on an issue like pancreatitis. As serious as pancreatitis is, the incidence in patients with diabetes pales in comparison to the risk of adverse cardiovascular events. The fact is a patient with diabetes is at higher risk of experiencing a heart attack or stroke than developing pancreatitis.

There are many who claim that Diabetic Investor is being unduly critical of the FDA and that the agency is merely following the rules set by Congress. To some extent this is accurate as our elected officials are more concerned about their 15 minutes in the spotlight rather than understanding the real world implications of the rules they make the agency follow. This is hardly unusual as the members are exempted from many of the laws everyone else is asked to follow.

That being said, the FDA does bear the responsibility for following their stated mission to use evidence based medicine. Walk into any physician’s office and ask them which is a greater risk for their patients with diabetes, pancreatitis or heart attack. Look at the incidence rate for both conditions. Which adverse event is a greater burden to our healthcare and carries a greater economic cost. Finally and most importantly which event carries the ultimate risk of death?

Back during the Avandia controversy Diabetic Investor hoped that finally there would be some reform instituted. The FDA based on their public statements made at the time welcomed and even encouraged reform. While more funding for the FDA is desperately needed just throwing money at the problem won’t solve anything if Congress fails to do their part. The reality is even though this is an election year history tells us as unhappy as voters are with Congress most members will be reelected.

Until the rules the FDA are made to follow are changed nothing will change. Some balance is needed so that patients and physicians can evaluate the risk reward profile of the medications available to them. Perspective is needed as well. The fact is diabetes is growing at epidemic rates. The burden to our healthcare system and economy is growing. Nearly two-thirds of patients with diabetes are not under control which will only lead to more problems in the future. If we continue along our present path disaster awaits and lives will be lost unnecessarily.

With this set of circumstances patients with diabetes and the physicians that treat them need more weapons in their arsenal not less. As Machiavelli stated; “States are ruined because they do not modify their institutions to suit the changes of the times.”