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.

Less than a week after Pfizer decided to stop selling Exubera inhaled insulin, the Chairman of rival drug developer Alkermes cautioned that it’s AIR inhaled insulin could also affect diabetics’ lung function.

Richard Pops, Chairman of Cambridge, Mass.-based Alkeremes, told Reuters that the inhaled insulin that the company is jointly developing with Eli Lilly & Co., may also have the potential for pulmonary risks for diabetics using the drug.

Pops explained that his company is “assuming that pulmonary insulins in that regard are all pretty much the same,” but added a caveat that the 2-year long AIR insulin drug safety trials have not been completed yet.

This blog has long-reported on concerns by doctors and diabetics about Exubera’s known and unknown pulmonary risks. The fact that a competing drug developer openly acknowledged similar concerns is significant.

It’s official: Pfizer’s Exubera inhaled insulin experiment is over.

Sales of the diabetes drug were a complete failure. Some might even think of them as non-existent, considering that Pfizer paid Sanofi-Aventis $1.3 billion to acquire exclusive worldwide rights to market the insulin, yet only generated $4 million in sales for Q2 2007.  The company’s website for the drug acknowledged that “too few patients are taking Exubera.”

Pfizer CEO Jeffrey Kindler told shareholders in an October 18, 2007 company press release that, “[d]espite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.”

It cost Pfizer a whopping $2.8 billion in pre-tax charges to stop Exubera sales, according to an SEC filing that the company made.

According to Pfizer CFO Frank D’Amelio, the drugmaker had approximately $661 million of Exubera inventory.  That’s a staggering amount of unsold insulin.

Although Pfizer’s website for Exubera emphasized that the company’s decision to stop selling the diabetes drug “was not based on any safety problems with Exubera” and that it remains “a safe and effective medicine,” that conclusion remains subject to debate among some endocrinologists and diabetics.

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.

It looks like Pfizer may have spent some big bucks on a ’survey,’ that — surprise, surprise — appears to have achieved results designed to get more doctors to write prescriptions for the drugmaker’s Exubera inhaled insulin.

The new survey titled “Reimbursement of Inhaled Insulins: Safety and Efficacy Concerns vs. Improved Patient Compliance,” was done by Physician & Payer Forum, a primary research service of Decision Resources, a pharmaceutical consultant and advisory company.

Guess who the company’s clients are? Drug companies like Pfizer!

Decision Resources boasts that its:

“client base is diverse - including large pharmaceutical companies, emerging biotechnology concerns, financial services, managed care organizations, and medical device manufacturers who turn to Decision Resources to help shape their strategy and master their chosen markets.” (emphasis added)

That means the company’s recent press release extolling praise for its new statistical look at Exubera inhaled insulin prescriptions could be viewed by some cynics as essentially an advertorial.

It paints a rosy sales outlook for Exubera, something that Pfizer certainly hasn’t felt since it bought exclusive worldwide rights from sanofi-aventis for $1.3 billion in 2006 to launch the drug. Critics have called the company’s acquisition of these rights little more than the purchase of a ‘billion-dollar bong.’

Saying that their survey shows “54 percent of primary care physicians and 41 percent of endocrinologist say they will increase the number of prescriptions they write for insulin generally,” they also allege that half of the seventeen (17) managed care pharmacy directors that they surveyed think that Exubera will help diabetic patients start using insulin earlier than they othewise might using injectable insulin.

How is asking just 17 managed care pharamcy directors about Exubera noteworthy? On the contrary, it’s such a miniscule number that it appears statistically insignificant.
Why is that significant? Because there have been widespread reports that physicians remain reluctant to presecribe Exubera for their newly diagnosed and existing diabetic patients.

For roughly a year, Pfizer’s Exubera sales were so poor that it wasn’t even reporting them to shareholders in its SEC filings. In February it was revealed that Exubera sales were $110M for 2006, the first year that the drug received FDA approval.

that offers access to high volume-prescribing physicians, specialists, and managed care organization representatives in the United States; analysis of events and survey participants’ responses to them; insight into prescribing patterns; and an examination of the implications of events and issues for the pharmaceutical market.