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FDA Panel Greenlights Diabetes Inhaler

September 9, 2005

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Relief could be at hand for millions of diabetics who must be injected daily with insulin. A Food and Drug Administration advisory panel has recommended approval of a new insulin delivery system in which the substance would be inhaled rather than injected with needles.

But consumer advocates complained that at least three of the committee's nine members had direct ties to Pfizer, the product's manufacturer, or its technological partner, Nektar Therapeutics. One other member -- the acting chairman -- holds stock in Pfizer, according to the Center for Science in the Public Interest.

The panel voted 7-2 to approve Exubera for treatment of both juvenile and adult-onset diabetes. The FDA is expected to follow the recommendation.

Exubera is a joint project of Pfizer, Nektar Therpeutics, and Sanofi-Aventis. It is one of several therapies under development to spare diabetes patients daily insulin injections.

Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device, has been studied in more than 3,500 patients, some for over seven years. The companies seek approval to market Exubera for adult patients with type 1 and type 2 diabetes. Exubera is currently also under review by the European Medicines Evaluation Agency.

According to the FDA presentation, the data behind Pfizer's claim that insulin inhalers will be safe and effective for people with Type I diabetes is unclear. Yet the ease and desirability of switching to an inhaler from subcutaneous injections will make this product extremely attractive to millions of Americans suffering from diabetes, whether Type I or Type II.

That's why it is critical that the advice given the FDA by its advisory committees be free from conflicts of interest or even the appearance of conflict of interest, CSPI said.

"The public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval," said Merrill Goozner, director of the Integrity in Science project at CSPI.

Members of the committee questioned the developers about the long-term effectiveness of distributing insulin through the lungs instead of directly through the blood system. Proponents said Exubera would be more effective, since many diabetes sufferers will be more likely to strictly follow their treatment regimen if their treatment is less painful.

The seven committee members who voted to recommend the inhaled form of insulin said they did so in the belief that the benefits of the new therapy outweigh potential problems. The two votes against approval came from committee members who expressed concern about difficulties in training physicians and patients in the use of the inhaler.

But CSPI said the committee members' potential conflicts of interest should not be ignored.

Dr. Talmadge E. King of San Francisco General Hospital has consulted with Nektar in the recent past. He was granted a complete waiver to participate in the meeting. Dr. Dara P. Schuster of Ohio State University has consulted and spoken on behalf of Pfizer. He also was granted a complete waiver. Dr. Nelson Watts, usually the committee's chairman, was allowed to participate in the meeting without a vote despite earning $5,000 to $10,000 a year for serving on Pfizer's speakers bureau. And Dr. Paul Woolf, who chaired the meeting, was granted a "de minimus" waiver for owning under $25,000 in stock in Pfizer.

People suffering from diabetes have been dreaming of the possibility of inhaled insulin, ever since insulin injections were introduced more than 75 years ago.

Results from Phase 2 trials of the inhaler were presented at the June, 1998, American Diabetes Association Convention in Chicago. These studies involved 70 people with Type 1 diabetes and 51 people with Type 2 diabetes. Researchers found blood sugar control was equivalent when inhaled Regular insulin was compared to injected Regular taken before each meal.

In the past, the FDA has claimed that it cannot find suitable expertise without ties to industry and that all of the most qualified people have such ties. Yet every medical school in the country has experts who both practice and conduct research in the fields of endocrinology and pulmonary medicine (relevant here because they were considering the safety of the chronic use of inhalers).

"It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer," said Goozner.

Because of the FDA's use of conflicted scientists on its advisory panels, the House of Representatives in June voted to require the FDA to end the practice and seek out unconflicted advice. The Senate should pass a similar measure next week when it considers the FDA appropriations bill.

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