2009: Year in Review
A look back at 2009 and ahead at 2010
2009 was a year of evolutionary, not revolutionary, change in the world of diabetes. In diabetes, true breakthroughs are rare, but progress should never be taken for granted, and that is how 2009 should be remembered. There were no game changers in terms of products or research, but we made progress on therapies and technologies that could benefit patients for years to come, and we believe that 2010 is going to be a very important year on the regulatory front.
But oddly, perhaps the most significant change in the world of diabetes in 2009 may have occurred on the political front. The broad outlines of health care reform have the potential to significantly change the way people with diabetes are insured, diagnosed, and managed. Hopefully, many more people will be covered and insurers will no longer be able to use "pre-existing conditions" – a dreaded phrase for any person with diabetes – as a reason to deny coverage. If that holds true, 2009 will have been a breakthrough year indeed.
Otherwise, we have broken down 2009 into Drugs, Devices, Scientific Studies, and Coming in 2010:
Drug Progress in 2009 – Full Speed Ahead!
- Obesity drugs come step into light: Today, there are very few drugs that are available that help people lose weight. The few weight loss drugs that are approved have significant side effects and produce relatively little weight loss. This may be why many obese people are electing to have weight loss (bariatric) surgery in spite of its cost and nontrivial risk. Finally, however, big things seem to be happening in the world of weight loss drugs. In December 2009, two companies submitted new drug applications (NDAs) for weight loss drugs, and the FDA will give feedback on both drugs in 2010. The two drugs are lorcaserin (developed by Arena Pharmaceuticals) and Qnexa (developed by Vivus). A third weight loss drug, Contrave (developed by Orexigen), will be submitted in early in 2010 and will likely receive feedback that year as well.
Given obesity's role in type 2 diabetes, an increase in pharmaceutical weight loss options could yield obvious benefits. In the past, weight loss drugs have had limited success – they were shown either to be unsafe or to have such adverse side effects that they were difficult to take. Efficacy (how well the drugs worked) was a major problem as well. We believe that obesity drugs will not catch on unless they prompt weight loss of at least 10% and don't cause major side effects. Losing weight could lower the rate of type 2 diabetes and other co-morbidities (high cholesterol, high blood pressure, and sleep apnea, to name a few), and we believe insurance companies will be more likely to pay for weight loss drugs if and when these benefits are shown in studies and published.
- Onglyza approved in U.S. and Europe: Onglyza (saxagliptin), which works in the same way that Merck's Januvia (sitagliptin) does, was approved in the U.S. and Europe this year. These drugs are called DPP-IV inhibitors, are taken orally and have few side effects – the pills are taken once daily and don't cause hypoglycemia or weight gain. (This last point is important – over the past few years, the medical community has expressed its growing skepticism of diabetes drugs in development that prompt weight gain and today we believe that a company couldn't get a drug approved for diabetes that caused substantial weight gain – a very big difference from even a decade ago.) Although Onglyza, manufactured by BMS and AstraZeneca, is nearly identical in efficacy to Januvia (and Novartis' Galvus in the EU), its presence will help build awareness of DPP-IV inhibitors. While the glycemic improvement from these drugs used in monotherapy (i.e., not in combination but used alone) is not as dramatic as with many other diabetes drugs, they can offer remarkable A1C improvement when used in combination with metformin and can be particularly useful for people who have been recently diagnosed.
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I hate to even suggest this, but what if the cure never comes? What if long-term clinical human trials go on indefinitely into the future with no hope in sight? What if cinnamon is just cinnamon? What if cactus juice is just cactus juice and reptile saliva just reptile saliva? And what if the BCG drug is a vaccine for tuberculosis and nothing more? I have this terrible feeling I’ll be an old man with a long grey wizard’s beard and a walking cane made out of...