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.

After scoring a $1.3 billion deal selling Pfizer all of its rights to market Exubera inhaled insulin, Sanofi-Aventis probably laughed all the way to the bank when Pfizer pulled the ridiculously unprofitable diabetes drug from the market.

That’s why Sanofi’s latest ad campaign for injectable insulin has a timely “I told you so” quality to it. Some of that deal money appears to be well spent on these direct-to-consumer (DTC) pieces.

Sanofi’s Go Insulin campaign is a push for the French drugmaker’s injectable basal insulin Lantus. Although not the subject of this ad campaign, the pharmaceutical companies new FDA-approved Apidra fast-acting insulin may also get a boost from this ad series.

Two Type-2 diabetics tell their stories though video about how using injectable insulin has helped them control their diabetes using recommended Hemoglobin A1C targets as guidelines.

Greg, a 45-year-old delicatessen and real estate owner in Virginia describes how his initial treatment taking pills after being diagnosed with diabetes was not effectively helping him cope with the disease. He’s a husband and father with an attitude that shows he tries to tackle things.
Loretha Huff, a Chicago resident, describes how she dealt with managing her diabetes when she was diagnozed at age 35. Taking pills to manage her blood sugar was not effective, so she worked with her doctor to switch to Lantus injectable insulin.

She says that “injecting yourself wasn’t as bad as I thought it was going to be,” and expalins how her Hemoglobin A1C’s have come under better control. With a positive can-do attitude, Loretha’s story seems likely to strike a chord with folks who have concerns about taking insulin injections and eating right. Loretha’s positive, up-beat approach to managing her diabetes seems likely to help Sanofi with its sales of Lantus.

Significantly, Sanofi created special areas on it’s Go Insulin web site focusing on:

• The Importance of Insulin
• Insulin Myths and Realities

These explainer pieces argue that taking insulin doesn’t mean that you’ve failed at treating your diabetes, and that it’s just what you might need to do to control your Hemoglobin A1C levels.

One Pfizer employee recently disclosed alleged problems at Pfizer’s Exubera inhaled insulin manufacturing plant in Terre Haute, Inc.:

The person disclosed that:

“[T]here are several issues with [Exubera’s] manufacturing process…lets just say it’s not efficient or effective. As for the powder processing, they still have agreements with Nektar to produce a certain % of the powder used. This product will be lackluster at best. If things don’t get better in 6 months I see a bleak future for that site and the drug.”

That doesn’t sound well for Pfizer’s Terre Haute, Indiana employees.

In a startling revelation, the San Jose Mercury News revealed today that Nektar CEO Howard Robin told financial analysts that Exubera “is not strategically relevant to the future success of” the company.
Some analysts have called Exubera “a spectacular flop,” and that more than a few diabetes doctors are hesitant to prescribe the drug.

“I see it as my job to talk people out of (using) it,”  Dr. John Buse (inset, left), the president-elect of the American Diabetes Association (’ADA’) told one New Jersey newspaper.

Buse is on a mission: to convince diabetics that Exubera is not worth the inhaled insulin’s potential safety risks.

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).