[Update, March 2013: I originally wrote this post in December 2012. Three months later, the FDA announced it “is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.” Several news agencies ran with the news, including AP and Bloomberg, as did some pharma industry bloggers. The JAMA Internal Medicine medical journal ran a column urging more research into the link between the drugs and pancreatic cancer, an article with a concerning, but perhaps harmless, revision after it was published. We think the latest attention and research makes the case against these drugs even stronger, and we’re moving forward in our own litigation.]
Diabetes is a global epidemic, affecting over 25 million Americans and ten times that worldwide. That also makes it an economic opportunity: the diabetes control medication market is worth more than $40 billion in the United States alone. There are thirteen types of approved Type 2 Diabetes medications on the market today (comprising over two dozens drugs), with another seven therapies in various stages of research and development. There’s big money to be made, if you’re a pharmaceutical company — hence the recent advertising push for Januvia, Byetta, and Victoza (the one Paula Deen endorses), relatively new entries to the overcrowded diabetes control market.
I’ve discussed before on this blog how one of the biggest public health problems in America is the pharmaceutical industry’s reliance on the “blockbuster” drugs that exceed $1 billion in annual sales. The whole industry, from research, to clinical trials, to physician education, is oriented around creating and promoting drugs that will become household names — to the exclusion of other useful medicines and to the detriment of patient safety. A year ago, I wrote about why Merck still didn’t admit Propecia caused persistent erectile dysfunction more than eight years after competent research showed the problem. The reason is quite simple: Propecia / Proscar was routinely bringing in more than half a billion dollars a year for Merck, and they wanted to keep it going for as long as possible.
Which brings us to Januvia, a drug that stock market analysts call a “real success story” for Merck. The Type 2 Diabetes market is huge, and Januvia (marketed as “Janumet” when mixed with metformin) has captured 75% of the dipeptidyl peptidase 4 (DPP-4) inhibitor market — for $4.6 billion in revenue in 2011 and likely topping $5 billion this year. It’s not hard to see why Januvia and other DPP-4 drugs have been successful and their sales are growing. They’re a one-a-day pill, not a shot, they haven’t been shown to cause weight gain, and they have a lower incidence of the nausea, abdominal pain, and digestive problems that characterize most diabetes treatments.
But there’s a big problem brewing.