Dr Ahmed El Hakim, the Senior Manager of Pfizer’s (NYSE:PFE) Middle East Arab Group, recently defended the drug company’s lackluster worldwide Exubera inhaled insulin sales.

Downplaying the diabetes drug’s widely known poor worldwide launch, El Hakim explained to ArabianBusiness.com that “this is the price you pay as an innovator - the concept [of using inhaled insulin] has not yet been established, and while we are now establishing the concept of using this convenient therapy, sales have not been up to the expectations of many people.”

A study published in the World Health Organization’s journal, the Eastern Mediterranean Health Journal, concluded that diabetes was a growing problem in Saudi Arabia, citing the following factors:

• A high prevalence of obesity;
• A diet rich in carbohydrates (e.g., bread, dates, sugar, and potatoes);
• Lack of exercise; and
• Genetic factors

At the time the study was reported in 1998, it found that there was more than a 300% increase in Type 2 diabetics older than 30 in Central Saudi Arabia, from 6% in 1982 to more than 18.22% in 1998.  Pfizer’s El Hakim told a reporter that the country’s now approximately 25% of Saudis are diabetics.
That’s a huge potential market for the pharmaceutical company’s diabetes and cardiovascular drugs.

A Worcester, Mass. newspaper, interviewed a senior endocrinologist at the Joslin Diabetes Center in Boston about the potential problems and pitfalls of oral insulin delivery.

Dr. Richard A. Jackson (inset, left) explained that “a chief concern in developing oral insulin products is ensuring dosage accuracy. Insulin levels are especially sensitive,” and experience has proven that injecting insulin subcutaneously using needles delivers accurate dosing.

“Small variances in the dosing and the speed of absorption is more important for insulin than other things. If absorption through the mouth varies by 15 percent, that’s a lot,” he said.

Guess what? This concern should apply to Pfizer’s Exubera inhaled insulin, as well as other potential oral insulin delivery products currently in the pipeline undergoing clinical trials.
These include Canadian-based Generex Biotechnology Corp.’s Oral-lyn, Mannkind’s Technosphere inhaled insulin, and the Alkermes / Eli Lilly & Co. AIR inhaled insulin — all of which are undergoing clinical trials.
Dr. Jackson emphasized that a critical issues is “whether [orally delivered insulin products] can achieve the accuracy and be consistent about how much is absorbed in the mouth.”

U.S. Department of Veterans Affairs (’V.A.’) has some fascinating conditions associated with the agency’s formulary list for approving health plan members’ use of Pfizer’s Exubera inhaled insulin.

Both of these conditions must be met:

• Doctor’s must have experience in managing diabetic patients on insulin
• Patient must have baseline spirometry and diffusing capacity for carbon monoxide (DLCO)

Also, the insured diabetic patient must either:

• Have severe persistent injection site problems such as lipohypertrophy, or
• Work in an environment that does not allow needles (e.g. prison guard)

In effect, it appears that the V.A.’s forumulary committee concluded that Exubera is generally not more effective than subcutaneous injectable insulin for either Type 1 or Type diabetics, and that working in a place where needles aren’t allowed would limit coverage of the diabetes drug to a relatively small class of insured patients.

You can read the V.A.’s full explanation of conditions associated with Exubera forumulary coverage by clicking here.

Exubera inhaled insulin drugmaker Pfizer, Inc. (NYSE:PFE) is expected to release the results of 2 scientific studies involving the diabetes drug at the American Diabetes Assocaition’s Scientific Sessions annual conference in Chicago this week.

The company and, researchers that it supports, are expected to present research findings involving ’stop-and-go’ Exubera usage over a 2-year period involving Type 1 and Type 2 diabetics. The findings concern pulmonary risks and safety issues (i.e., lung function) that remain an ongoing concern of many doctors and diabetics regarding the inhaled insulin.

It will be interesting to see how doctors view the results that Pfizer presents at the ADA sessions, particularly when Dr. John Buse, the orginzation’s president-elect, stated that he sees his job as “talk[ing] people out of (using)” Exubera.

Pfizer’s Exubera sales remain lackluster according to news reports and numerous online posts from anonymous drug sales reps from the company.

The ADA Scientific Sessions are supported, in part, by a grant from the embattled maker of Avandia, the diabetes drug from GlaxoSmithKline that the FDA ordered to carr a ‘black-box warning’ due to widely reported excessive risks of heart attacks and related safety and personal injury issues.

Endocrinologist Dr. John Buse (inset, below), the president-elect of the American Diabetes Association (’ADA’) says he’s on a mission: to convince diabetics that Exubera is not worth the inhaled insulin’s potential safety risks.

“I see it as my job to talk people out of (using) it,” Buse recently told the Abury Park Press in New Jersey.

It’s refreshing to see the head of an organization devoted to representing the best interests of diabetics make an objective, unbiased analysis of Pfizer’s Exubera. Buse is aware of the long-term studies being conducted on Exubera safety — the very studies upon which the FDA ultimately conditioned approval of the diabetes drug.

Exactly one year ago Exubera-Risks.com asked: “Is Two Years a Sufficient Long-Term Exubera Safety Study?“  The answer has not changed: it still appears to be a resounding “No.”

That’s because the conditions attached to the FDA’s approval of Pfizer, Inc. (Pfizer, Inc.) and Nektar Therapeutics’ inhaled insulin mandated a signficant number of prospective safety studies over 5 and 7 year periods to study changes in lung function for Type 1 and Type 2 diabetics using Exubera, and insulin antibody formation examing the relative risk of development of allergic and immune disorders in users of the inhaled insulin.

The results of those FDA-mandated Exubera long-term safety studies are not due for at least another 7 - 9 years (December 31, 2013 and December 31, 2015).