Exubera

Exubera is an inhalable insulin treatment for diabetes produced by Pfizer. [1] It Was approved for use by the U.S. Food and Drug Administration in late January 2006. [2]

Announcing its approval the FDA also stated that "Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly. Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth. Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended after the first 6 months of treatment and every year thereafter, even if there are no pulmonary symptoms." [3]

Pfizer's media ket on the day of the announcement also included a video news release [4] produced by MultiVu [Pfizer's media ket on the day of the announcement also included a video news release produced by MultiVu[5]

Problems highlighted by the FDA

"FDA scientists who reviewed Exubera's new drug application identified a number of potential safety risks with the drug, including respiratory problems and hypoglycemia, but the advisory panel determined the health risks shouldn't prevent the product from being approved. For example, a large number of clinical trial participants reported experiencing cough when taking Exubera, but the panel found the severity of the coughing problems were generally mild." (Learner & Niven, 2005)

"One panel member noted that Exubera's clinical data appear to show "a little bit of a signal of lung cancer risk," but she acknowledged the signs are faint and would require a large clinical study to confirm." (Learner & Niven, 2005)

"Panel members did caution, however, that Pfizer and sanofi-aventis shouldn't overstate the convenience of the Exubera, which, in most cases, would decrease the number of a patient's injections but not eliminate injections altogether." (Learner & Niven, 2005)

"Educating" Doctors Ahead of Advertising Blitz

In February 2006 PR Week reported that Pfizer was working with the PR firm Weber Shandwick to launch Exubera. PR Week reported that "there would be a heavy educational focus" on doctors. Rebecca Hamm, Pfizer's director of PR, said that while Pfizer wouldn't rund direct-to-consumer advertising during the first six months after approval it would concentrate on, in PR Weeks's words, "educating doctors about a drug's risks and benefits ahead of a consumer launch." [6]

Other SourceWatch Resources

• Drug industry

External links

• Neal Learner & Michael Niven, Exubera's Benefits Outweigh Its Risks, Say FDA Advisers, Drug Industry Daily, Vol. 4, No. 177, 9 September, 2005.
• U.S. Food and Drug Administration, "FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes", Media Release, January 27, 2006.
• Pfizer, "Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults", Media Release, January 27, 2006.
• Beth Herskovits, "Pfizer selects WS for Exubera work", PR Week, February 2, 2006. (sub req'd).