FDA Approval of Insulin System is…Sweet…All Hail “Exubera”:

A newly approved system of insulin delivery into the blood streams of diabetes patients via the inhalation of a fine insulin powder through a plastic device could reduce or eliminate the need for insulin injections for millions of diabetic patients. A stock analyst says Exubera could eventually see sales of $1 billion a year.Now let’s have a look at the ten-year studies. Oh, there aren’t any. Okay, let’s look at the five-year studies. Pfizer, the largest drug company in the world, will be compelled by the FDA to do studies for five years with 5,000 patients… after the drug reaches the market.You probably know that there is an alarm bell ringing on diabetes, especially the rise of Type 2 diabetes in young people. A growing number of children and adolescents are being diagnosed with Type 2 diabetes, which used to be seen only in adults. About 2,000 new cases of Type 2 diabetes are diagnosed every day, leading to a threefold increase in the past 40 years. One in five people over age 65 has Type 2 diabetes. Or, as the boards of Pfizer and Nektar Therapeutics might say right now, “Market share, baby!” Nektar invented Exubera and licenses it to Pfizer. When word of Pfizer’s upcoming Exubera announcement leaked out, Pfizer stock gained 4 percent. Nektar’s stock also went up. There are still unresolved safety issues with Exubera. Patients with asthma or pulmonary disease should not use it until further studies (which we don’t have yet from the largest drug company in the world) prove the drug is safe for these patients. All involved already cop to the drug’s tendency to cause a slight decrease in breathing capacity. The FDA is not FEMA and Exubera arrives after at least two different companies spent decades working on an inhaled insulin system. But in June of last year, CNN/ Money reported that analysts were predicting that the FDA would spend two more years evaluating Exubera because of the lack of long-term tests establishing whether it would cause respiratory problems for smokers, as well as its effects on children. However, last Friday the announcement of Exubera’s FDA approval was all over the media.After Vioxx, one might reasonably assume that the FDA had entered a new era of cautiousness, even if the drug involved is being marketed by, say, the largest drug company in the world. If so, that would be yet another in a series of phases for the FDA that began in the early 1990’s when pressure from AIDS patients for new drugs and malarkey from congressional Republicans (Newt Gingrich: “The FDA is the leading job killer in America”) caused the FDA to speed up review procedures.But then the FDA started to look like a girlfriend to big drug companies, as one drug after another (Rezulin, Lotronex, Vioxx) had to be recalled. Several of those quietly returned to the market. Annie Applebaum of the Washington Post wrote about the cycles of the FDA last April and observed, “Even the arcane world of pharmaceutical regulation is afflicted by highly emotional mood swings.”Good point, except that my own mother is a potential Exubera customer. I would love it if she didn’t have to endure injections before meals in restaurants and all the complicated fuss that goes with hypodermic needles. But what do I know for certain about Exubera? So far, the only thing written in stone seems to be its potential to make money. Should my mother wait five years and see? She might. I know she has more patience than, say, the largest drug company in the world. This Week’s “Know Your News” Quiz1) Skater Michelle Kwan will get a shot at (a) winning Olympic gold. (b) endorsing Jack Daniels. (c) “Skating with the Stars” with Carrot Top.2) The renovated Getty villa has (a) a video arcade for kids. (b) been booked until July 31. (c) pre-Colombian condom machines.3) Police say two homeless car thieves (a) stole 600 cars last year alone. (b) use the moniker “Ride Daddies.” (c) can hook you up with some rims.Answer Key1) a. “Quadruple Lutz: She nails it!”2) b. “Dude, the statues are naked!”3) a. “Now we can drive to the Getty…”