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A Future of Doubt: For Diabetes Sufferers, History Forces us to Question the Future

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Recently the U.S. Food and Drug Administration denied approval of Takeda’s newest diabetes drug alogliptin. Citing a need for more research and data, alogliptin’s denial brings to light the stark reality of what has developed into a series of stumbling blocks for diabetes drug development.

In 2007, studies revealed that GlaxoSmithKline’s popular diabetes drug Avandia increased the risk of heart attack, cardiovascular disease, stroke and death. Consequently, this led to the FDA requiring Avandia to use a black box warning to alert consumers of the risks. These warnings were still not enough.

By late 2011, Avandia was no longer available through retail pharmacies. And then came Actos.

Waiting one day after Avandia received restrictions from the FDA, Takeda began a new advertising campaign for its diabetes product Actos.

Boasting taglines such as “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack of stroke,” diabetes sufferers quickly shifted from Avandia to Actos.

What Takeda failed to mention initially though was their diabetes drug carried its own risks – it was linked to bladder cancer in long term users.

Just last year, independent researchers discovered that Actos users have a 40% higher chance of developing cancer after they have taken the drug for longer than a year. The FDA issued a warning regarding this link between bladder cancer and Actos users and continues to review the data Following the FDA warning, a few Eurpoean markets (France, Germany, and Luxembourg) took the additional step of suspending use of Actos.

Around this same time, MannKind’s Afrezza, an inhalable form of insulin, was denied approval by the FDA as well. Without additional clinical studies and at least one trial comparing the new inhaler with an earlier version, Afrezza will never hit the market.

Furthermore, Afrezza wasn’t the only diabetic medication whose market potential was rightfully stunted by the FDA in the last year. AstraZeneca and Bristol-Myers Squibb’s drug dapagliflozin was denied approval because of significant concerns about breast and bladder cancers seen in patients taking the drug.

A month after dapagliflozin was denied, major manufacturer Merck received an FDA warning for failing to conduct timely and complete post marketing studies on drugs Januvia and Janumet. The FDA stressed that Merck’s studies were insufficient to deter worries about the possibility of pancreatic cancer in the medication’s prescribers.

Even as recently as May 31, 2012, medications for diabetics are being pushed for approval by manufacturers. Janssen Research & Development recently submitted a New Drug Application to the FDA for a once-daily, oral drug for type-2 diabetes called canagliflozin. Like its predecessors, all we can do is wait and hope for better results than what the past has presented.

So that brings us back to diabetics and their pursuit for a drug to help with their suffering that doesn’t set them up for new injuries. What are diabetics supposed to do? What drugs can they safely turn towards to alleviate their struggles?

Sadly, it appears there is no clear answer at this time. Given the history of diabetes drugs, diabetics have to seriously question and monitor the release of new diabetes medications such as Takeda’s hopeful alogliptin, especially when the FDA is already requesting additional research.

Today’s diabetic must be informed. If you are a diabetic, your focus should remain on your health. It is always advisable to discuss any risks and concerns with your physician, for history has shown us, with respect to Avandia and Actos, that we can no longer trust just the studies pharmaceutical companies conduct.

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  1. terry kotta says:
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    that lawyer speak hold in court ?

    “Afrezza … whose market potential was rightfully stunted ”

    Afrezza is INSULIN . Perhaps you should ask a diabetic client if they heard of INSULIN. Its not even hexameric, zinc stabilized insulin. Its’ INSULIN. As in just like pancreatic.