The big question with insulin in the news now is how come we have generic sulfonylureas and metformin, but no generic insulin? After all, insulin has been on the market since 1922, while the first sulf came out years later, in 1957. Glucophage, the first brand of metformin approved in the U.S., came out more recently yet, in 1995.
The current (June-July 2007) issue of Diabetes Health covers the question in Linda von Wartburg’s three-page article, “Why does Insulin Cost more than Ever?” The magazine also has the whole article online. For even more detailed coverage, diabetes blogger Scott Strumello has a four-page article at “Diabetes Thought.”
The problem in a nutshell is that insulin is a biotech drug, sometimes known as a biologic or a biopharmaceutical. The Food and Drug Administration says that it lacks the express legal authority to approve generic versions of this type of drug, which the pharmaceutical industry produces from living cell cultures, rather than synthesizing them chemically. Unlike those other drugs, the FDA can’t approved generic versions even after all patents expire.
However, in February a bipartisan group of senators and representatives introduced a bill that, if and when it becomes law, would give the FDA the authority that it needs to approve generic biotech drugs, including insulin. In the Senate, this is S. 623, “Access to Life-Saving Medicine Act.” In the House of Representatives, it is H.R. 1038.
Everyone who has type 1 diabetes relies totally on insulin. Even about one-third of people who are diagnosed with type 2 diabetes use it.
Insulin is certainly more expensive that it would be if generics were available. But I have to wonder if all the hypos that type 2s suffer on insulin are really necessary.
Doctors usually prescribe insulin for type 2s when orals fail, and they have at least two good reasons for avoiding insulin until then. Hypos are one, and weight gain is another.
The United King Prospective Diabetes Study (UKPDS) is the longest randomized, controlled study ever of people with type 2 diabetes. One part of that study tracked 2,078 people newly diagnosed with type 2 diabetes for six years. This part compared how well they did on insulin, suflonylureas, and metformin. It turned out that people in two subgroups using insulin gained 22 or 23 pounds in that time. Most of the weight gain came in the first year.
The experience of 9,546 members of Kaiser Permanente Northwest, one of the country’s largest health maintenance organizations, is similar. Those who started insulin between 1996 and 2002 and continued to use it for at least a year without adding any other diabetes medication, gained an average of 7 pounds.
The medical profession is beginning to recognize this double bind. “Faced with an obese patient with failing glucose control, clinicians must decide whether a further reduction in average glucose level by 10 mg/dl to 20 mg/dl, is worth another 10 pounds of weight gain,” writes Richard Comi, M.D., in an editorial, “Treatment of Type 2 Diabetes Mellitus: A Weighty Enigma,” in the October 2005 issue of the Annals of Internal Medicine. He goes on to note that even the new inhaled insulin is associated with the typical weight gain when people with type 2 diabetes start taking it.