Panel OKs insulin that can be inhaled

WASHINGTON (AP) — Millions of people with diabetes may have an alternative to some or all of their daily needles if the government adopts an advisory panel's recommendation to approve the first insulin that can be inhaled.

Federal health advisers on Thursday scrutinized the drug and inhaler device, questioning developers about the long-term effects of distributing insulin to the body through the lungs, rather than directly into the blood stream.

Proponents of the drug, Exubera, and the associated inhaler say many diabetics who refuse to take all their injections will be more inclined to use an inhaler.

"I take four shots a day and the fourth one is hardest one,'' Rebecca Wilkes Killion of Bowie, Md., the patient representative on the advisory panel, said during a hearing Thursday on the drug.

"I'm tired of it. If I could get myself down to one I'd be thrilled. A lot of people resist it because they are afraid of the needles,'' she said.

The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee twice voted 7-2 to recommend that the agency approve the drug and inhaler device for sale in the United States. The separate votes were for each of the two major types of diabetes.

The FDA usually follows the recommendations of its advisory committees, but is not required to.

The insulin, developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics, is promoted it as a convenient alternative to the injections millions of diabetics must take several times daily.

Advisers who voted to recommend inhaled insulin said the benefits outweighed certain problems, most notably whether the effects of the drug on people with lung disease had been fully studied.

Other advisers expressed concern it would be difficult to train doctors and people with diabetes in the proper use and maintenance of the inhaler device. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics now must rely on.

Committee members did not recommend specific restrictions on the drug. But Dr. David Orloff, director of the FDA division that would oversee the drug, said the drug probably would not be available to smokers. They would be at risk for a dangerous drop in blood sugar because they absorb much more inhaled insulin in their lungs that do nonsmokers.

The FDA advisers also worried that the drug had not been adequately tested on people who do not smoke but are regularly exposed to secondhand smoke.

The companies proposed to conduct studies on the long-term effects of the drug until 2019.

"We understand the need to assess the long-term effects on pulmonary function,'' said Dr. Neville Jackson of Pfizer.

During drug trials, researchers found that inhaled insulin generally was as effective as injections in controlling blood sugar levels. Some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.

It is estimated that more than 18 million people in the U.S. have diabetes, although some do not know it. The number of people with diabetes is believed to have tripled in the past quarter-century.

Most have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes this can be treated with pills instead of injections.

Fewer than 10 percent have Type 1, a disorder in which the immune system attacks insulin-producing cells in the pancreas. This is sometimes called juvenile diabetes.

An FDA medical officer questioned whether inhaled insulin could provide a precise enough dose to treat people with Type 1 diabetes.

Inhaled insulin could be used to manage blood sugar levels for people with either type of diabetes who need insulin injections before meals.

The drug would not replace longer-acting insulin injections some diabetics, particularly those with Type 1 diabetes, need to take in the morning or before bed, according to FDA documents.

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This is going to make it harder for me to get my smack needles.

The public bathrooms in Santa Cruz have your smack needles for free. So call yer buddy Buggy.

Vanguard Health Care:



Oh yeah. Come to daddy.

This is such positive news for Type 1 diabetics. Hopefully the government will get on board for approval.

As long as it doesn't prevent pregnancy, that shouldn't be a problem.

God, I hope that they will let ambulances carry this stuff. It will be sooo much easier to give it this way then trying to stick a tube into somebody's mouth.