Stumbles and false starts mared the past 12 months for diabetes care in the U.S. It began with the report that one of the nation’s most highly prescribed diabetes medications, Avandia, could possibly increase the risk of heart attacks. While the drug avoided being formally withdrawn from the market, its use was severely restricted by the addition of new and stringent FDA warnings. According to the pharmaceutical grape vine, the writing of prescriptions for Avandia dropped off a cliff after this action and has yet to recover.

Another drug related to diabetic care receiving substantial negative publicity recently is Zetia. Zetia has been a popular medication used to reduce cholesterol levels. High cholesterol must be strictly controlled in diabetics to reduce heart attack risk. According to newly released results from the Enhance Study, Zetia was ineffective at preventing narrowing of the arteries (arteriosclerosis) which is the process thought to cause heart attacks. Dr. Nissan who gained a degree of fame leading the attack on Avandia, was one of the first to publically advise doctors to stop using Zetia (and Vytorin which contains Zetia) to treat high cholesterol. These negative comments where widely published in the media and echoed by the various interested parties. Eventually these findings were mostly brushed off as irrelevant by the experts, but the publicity surrounding the Enhance Study has left many doctors and the general public wondering if taking Zetia and Vytorin is still worthwhile.

Two other medications with potential use in diabetic treatment failed in their attempts to reach the U.S. market. Galvus (marketed by Novartis) was to become one of the first of a new type of medication for lowering elevated blood sugar in diabetes, but was denied approval by the FDA due to safety concerns. The FDA also rejected another promising drug, Ramonabant, a weight loss drug shown to improve various metabolic problems in diabetics, over safety issues.

In an unprecedented development Pfizer Pharmaceuticals, the sole marketer of the first non-injectable form of insulin, Exubera, abruptly ceased distribution of this product for economic reasons. Exubera is inhaled through a large and cumbersome device and during its brief public exposure, did not achieve the anticipated acceptance needed for profitability. Pfizer’s actions left those who were being treated successfully with Exubera, with no alternative but to resume their old methods of insulin administration.

Part 2. of this review of the year in Diabetes care will follow soon.

Gary Pepper M.D. FACP

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