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Inhalable Insulin Medical Breakthrough

Inhalable Insulin Medical Breakthrough

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Inhalable Insulin

 In January of 2006 the Food and Drug Administration approved the first version of an inhaled form of insulin, which would give millions of adult diabetics an alternative to some of the injections they now endure. This is the first new way to get that hormone into the body since it was discovered in 1921. The Food and Drug Administration said the Pfizer Inc. insulin, will be marketed as "Exubera." In addition, the FDA recommended in January that smokers and people with some types of lung disease, including asthma, avoid using the product.

Listening to the media reports at that time, it gave the impression that it would be a truly revolutionary development for those with type 2 diabetes. The hearsay was for people with diabetics to accept that their diabetic troubles would be significantly reduced. However, not all diabetics are overjoyed at the promotion of Exubera, some have been quiet vocal stating that the hype promotes "complete ignorance about what diabetes actually is."

It's estimated that approximately 5 million take the insulin shots, but a high proportion inject themselves too few times during the day because the shots are considered inconvenient. Pfizer is hoping that the inhaled insulin will overcome some of that resistance, helping diabetics ward off a slew of medical problems that afflict those who don't control their disease. Patients involved in the Exubera trials told researchers they prefer them to needles by a wide margin, according to studies sponsored by Pfizer.

Paul Matelis, 56, a comptroller for a real estate title company in Miami, wasn't getting adequate control of his blood sugar seven years ago when he heard about inhaled insulin.

I really didn't think it was going to work," he recalled. "I said, 'How can this stuff come through my lungs?

But he took the plunge, becoming one of the first people to enroll in human tests. The first morning, he ate a huge breakfast of "steak, eggs, jelly, waffles" than showed up at the doctor's office with sky-high blood sugar. He took a puff of insulin powder into his lungs, then watched in amazement as his blood sugar fell. He has been on the product continuously for seven years without a problem, he said.

However, in late October of 2006, a report from Datamonitor suggests that Exubera does not meet the requirements needed to fuel a multibillion-dollar market. Datamonitor has been quoted as saying in Datamonitor's opinion, Pfizer / Nektar's Exubera is unlikely to revolutionize insulin therapy as some might expect.

A Pfizer spokesperson says that Exubera does have an important role to play for patients for whom insulin was the best way of glycemic control. A Datamonitor analyst disagrees, stating this concerns only a small patient subset with a marginal commercial potential.

The report also said that the introduction of inhalable insulins has added a set of further potential side effects to insulin; such as the unknown risk of carcinogenicity and long-term lung damage in addition to hypoglycemia and weight gain. Particularly, there is concern about the potential effect of insulin, on the pulmonary vasculature (blood vessels and how they are carried throughout the lungs), such as pulmonary hypotension (increase in blood pressure) and pulmonary edema (swelling and/or fluid accumulation in the lungs). The Pfizer spokesperson said that the findings from clinical trials showed that there is a low risk for potential effect on lung functions.

The report also suggests that cost of therapy will also be a key issue for patients, and any inhalant that does not get reimbursement approval will simply not sell. Exubera, for example, has already been denied full reimbursement coverage by UK and German authorities. More specifically, Exubera can be reimbursed for particular types of diabetic patients, including Haemophiliacs (a desease that impairs the body's ability to control bleeding) and people with needle-phobia. But, the issue is that the restrictive reimbursement guidelines will put patients off.

Mohamed Shakir, head of endocrinology at Howard University Hospital, said Exubera could be particularly important in a city like Washington. There's a big racial disparity in diabetes, with blacks, Hispanics and native Americans more likely to contract the disease and less likely to receive adequate care. Mohamed Shakir said low income people are not as willing to understand and research the disease and take control of their illness. He said he hopes Pfizer will price Exubera fairly, and he looks forward to offering it to newly diagnosed diabetics. Mohamed Shakir said The fear of the needles - we are going to eliminate it. That will be a big plus.

Although the introduction of new antidiabetics is definitely good news for diabetic patients, present and future, none of the new drugs will be the answer to the growing diabetes problem. Lifestyle changes»» and education is still the key for a continuance of healthy maintenance. After all, the overweight child of today is the middle-aged diabetic of tomorrow.


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