This blog has continued researching and reporting on potential Exubera inhaled insulin risks for more than two years.

Pfizer’s and Nektar’s announcements this morning that 6 of the 4,740 patients using Exubera in clinical studies developed lung cancer confirms what this blogger has been saying all along:

That it was foolish of the FDA to rush into conditionally approving the inhaled insulin without first completing long-term safety studies of the diabetes drug.

During that time, we’ve examined studies, concerns by endocrinologists and pulmonologists about the drug, and caution by diabetics.
Nektar announced today that it “ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis” citing lung cancer developed by patients in Exubera safety studies.

Pfizer appeared to suggest that any diabetics who developed lung cancer while on Exubera might be at fault, since “all patients who developed lung cancer had a prior history of cigarette smoking.”
Not surprisingly, the drugmaker pooh-poohed the cancer findings, claiming there “were too few cases to determine whether the development of lung cancer is related to the use of Exubera.” Citing financial reasons, Pfizer already opted to yank Exubera from its product line last fall.

Novo-Nordisk and Pfizer reportedly settled their patent litigation this week over Pfizer’s failed Exubera inhaled insulin and Novo’s AERx insulin that the Danish drugmaker has been developing with Aradigm Corp.

The litigation started just before Pfizer brought Exubera to market (after considerable delays), and continued for just over a year.

Novo claimed that Exubera infringed on a host of patents that it had for inhaled insulin. In its answer to the lawsuit, Pfizer stressed that the real reason behind Novo’s suit was “to preserve indefinitely the inhaled insulin market for Novo.”

Although the settlement agreement was reported late Monday, terms of the deal were not made public.

Pfizer announced that it was pulling Exubera from the market on October 18, 2007. Given that Pfizer originally paid Sanofi-Aventis $1.3 billion to acquire exclusive worldwide rights to market the first FDA-approved inhaled diabetes drug, yet only generated $4 million in Exubera sales for Q2 2007, it is no surprise that the drugmaker opted to stop spending money on lawyers fees when it no longer had a product to justify the litigation expense.

According to Michael Krensavage, a pharmaceutical equity analyst at Raymond James Financial, Inc. (NYSE:RJF), the launch of Exubera inhaled insulin for diabetics “has been one of the most spectular flops in the pharmaceutical industry.”

Krensavage made this analysis when interviewed about Pfizer, Inc.’s (NYSE:PFE) difficulty in launching and maintaining profitable new drugs in a highly competitive market.  “No matter how you look at it,” Krensavage concluded, Pfizer’s drug research and development efforts have yielded “a disappointing pipeline.”
Pfizer’s 8K report to shareholders disclosed Exubera’s continued market failure. “Sales of Exubera continue to be disappointing, with $4 million of worldwide revenues in the second quarter of 2007.”
Generating only $4 million in revenue on a diabetes drug for which Pfizer paid Sanofi-Aventis $1.3 billion in January 2006 is an abysmal failure, there may still be a silver-lining for diabetics.

By sticking to proven diabetes medications that do not have unknown pulmonary and related risks for diabetics that are the subject of long-term FDA-mandated drug safety studies (as a condition of the drug’s approval), endocrinologists appear likely to give their patients trusted choices for managing their care.

Even given reported the Avandia heart attack risks for Type 2 diabetics, Pfizer doesn’t seem to have convinced endocrinologists that Exubera is a better diabetes drug.

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).

Since the New England Journal of Medicine published an article warning about Avandia heart attack risks for Type 2 diabetics on the GlaxoSmithKline rosiglitazone class of medicine, it is likely that a fair number of diabetics may be switching off the GlaxoSmithKline diabetes drug.
The FDA also announced that diabetics using Avandia haave a 43-percent greater risks of heart attack risks than those not taking it.

This raises an important question: are the dangers of using Avandia less than, equal to, or greater than the risks of using Exubera inhaled insulin?

Could Avandia and Exubera both become like Vioxx and other COX-2 inhibitors:  Drugs  approved by the FDA that were found to be too risky for patients to use safely?
It’s still too early to know whether Exubera sales will be benefit from potential Avandia risks.