Again, Januvia is one of the most searched-for terms on this site — which is interesting, because it's an oral drug for controlling Type 2 diabetes with which I have no personal experience. But there's a "perfect storm" surrounding Januvia that encapsulates many of the controversial themes running through diabetes care:
Show Me the Money
If you recall, Januvia is an oral DPP-4 inhibitor that lowers blood sugar by inhibiting glucagon release, versus the GLP-1 receptor drugs like Byetta, which are taken by injection and work to lower your blood sugar in three ways: enhancing insulin secretion, suppressing glucgon release, and gastric emptying.
They both effectively lower blood sugar, right? So you'd assume everyone would jump on Januvia, which you can swallow (no needles necessary) and also costs less.
From Forbes: "The dramatic increase in cost (of diabetes drugs) is due to the high cost of commonly prescribed newer drugs. For example, sitagliptin (Januvia) costs $160 per prescription and exenatide (Byetta) costs $210 per prescription. That's eight to 11 times higher than older, generic drugs such as metformin..."
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And indeed, Merck has been selling its brains out on this drug, recently reporting that third-quarter Januvia sales doubled to $379 million.
Right now, you can even find a discussion on CafePharma of how aggressive sales targets are putting Merck drug reps under some ugly pressure to increase prescriptions of Januvia.
Who Does it Better?
A medical comparison of Januvia versus Byetta published by Medscape last fall actually showed proof that exenatide works better:
Average A1c reduction with oral DPP inhibitors is only 0.6% to 0.8% and they are "weight neutral," whereas the GLP-1receptor drugs showed average A1c reductions of 1%, and "modest weight loss and improved glycemic control with a trajectory for up to 3 years."
Despite the safety concerns over pancreatitis in some isolated cases of Byetta users, the ADA has now changed its guidelines for treating Type 2 diabetes and recommended Byetta over Januvia.
What Side Effects?
Meanwhile, with its major competitor stalled at the FDA, Merck is enjoying a US monopoly of the DPP-4 market right now, and it's clearly riding this wave while the surf's still up.
But Januvia may be dangerous. Last summer, a watchdog site called Worst Pills, Bad Pills issued a warning that diabetics should not take Januvia until 2014:
"Long-term safety is unknown, and The FDA medical officer for sitagliptin wrote that sitagliptin's effect on lowering HbA1c was "fairly modest." The drug was not as effective as the older diabetes drug glipizide."
Yipes! And patients continue to report uncomfortable side effects like muscle pain, skin rashes, heart burn, nausea, high blood pressure, anxiety and more.
In the Patient Product Reviews area at DiabeticConnect.com, one commenter summed it up very well: "Taking Januvia is a mixed bag. Definitely helps with my numbers overall but the safety profile is very dubious."
What's Politics Got to Do With It?
Patient advocate and blogger Jenny over at Diabetes Update explains that the "dubious state" of diabetes and other drugs is one reason why this election matters so much.
"In an atmosphere of deregulation, the FDA is in a bad state. The current FDA drug testing criteria are a joke. They do not require that a drug be shown to be more effective than an existing drug. All they ask is that a drug be more effective than no drug at all...
The companies selling expensive and unproven new drugs like Avandia, Januvia and Byetta have been marketing these incredibly expensive drugs to PCPs claiming — based on flawed evidence — that they cause beta cell mass to rejuvenate. These claims have been debunked for the glitazone drugs like Avandia and Actos — though they were marketed to doctors on that premise for almost a decade. These claims will probably be debunked in time for Januvia and Byetta, too, as the evidence supporting these claims is seriously flawed. But meanwhile millions of people will buy and use them, even though these drugs may be doing them harm."
In fact, the jury's still out on how much harm versus good these drugs do, because as anyone in healthcare knows, only time will tell. But what we CAN DO right now — today! — is cast our vote for "regulators who are familiar with and respectful of the principles that drive science." Well said, Jenny!