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Inhaled Insulin Associated with Excess of Lung Cancer Cases  

The FDA has warned that more cases of lung cancers have been reported in patients treated with the inhaled insulin Exubera than in controls in clinical trials.

The warning is another blow to the star-crossed Exubera, which was hailed as the only new method of delivering insulin in 80 years when it was approved in 2006 (See: FDA Okays Inhaled Insulin for Type 1 and 2 Diabetes).

However, less than two years later, Pfizer, the drug's maker, said it was phasing the drug out because patients and doctors had been slow to accept it (See: Citing Lack of Acceptance, Pfizer Pulls Plug on Inhaled Insulin).

Some patients continue to use Exubera, especially those on Pfizer's extended transition program, initiated when the company pulled the plug on the medication.

In the clinical trials, the FDA said, there have been six newly diagnosed cases of primary lung cancers among Exubera patients and only one among controls treated with comparator medications. . . .

The FDA said there have been "too few cases to determine whether the emergence of these events is related to Exubera" and the agency pointed out that all patients diagnosed with lung cancer had a history of cigarette smoking.

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• MannKind ends partner talks on inhaled insulin  

MannKind Corp said on Thursday it was suspending talks with potential partners for its experimental form of inhaled insulin due to negative market sentiment about such products, given possible cancer risks of Pfizer Inc's Exubera product.

MannKind's experimental form of inhaled insulin, Technosphere Insulin, is begin tested in a broad group of patients with diabetes, but data from late-stage trials of the medicine have not yet been obtained.

"At this time, we believe that we will be unable to achieve an appropriate valuation for Technosphere Insulin until Phase 3 data are available that confirm our belief in the safety and efficacy" of the product, MannKind said in a release.

Shares of MannKind plunged 60 percent to $2.35 on Wednesday after Pfizer and its former partner, Nektar Therapeutics, said six of the 4,740 patients given Exubera in clinical trials developed lung cancer. That compared with one of the 4,292 patients in the same trials who did not receive Exubera.

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MannKind shares rise; co. says inhaled insulin treatment is well tolerated 

Shares of MannKind Corp. (NASDAQ:MNKD) rose in early trading Thursday, after the company said its inhaled insulin treatment has a strong safety profile with no indication of carcinogenic potential.

The shares rose 4.3% to $2.43.

The stock sank dramatically Wednesday as investors and analysts reacted to the news that competitor Nektar Therapeutics (NASDAQ:NKTR) has suspended all further research on an inhaled insulin product, a treatment that MannKind is also developing.

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MannKind Being Its Own "Man" About Inhalable Insulin  

I haven't seen a note to subscribers from him about this latest development, but I bet David Kliff who writes "The Diabetic Investor" is saying, "I told you so." From the get-go Kliff, a type 2 insulin-dependent diabetic, has been kind of a voice in the wilderness, poo-pooing the idea of inhalable insulin and trying to tell anyone who would listen that diabetics don't fear or dislike needles as much as some people might think.

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Abbott: No Lung-Cancer Signals In Inhaled-Insulin Trials 

Abbott Laboratories (ABT) has seen "no signals of lung cancer" in patient trials of its experimental inhaled insulin, a company spokesman said Thursday.

Abbott's disclosure comes a day after Pfizer Inc. (PFE) warned that a small number of users of its inhaled insulin, Exubera, developed lung cancer, though it wasn't able to determine whether Exubera was the cause. Pfizer decided last year to stop marketing Exubera due to disappointing market performance since it was approved in 2006; the company is working with doctors to switch patients from Exubera to other therapies.

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MannKind Addresses Pfizer's Announcement Regarding Exubera 

MannKind Corporation (Nasdaq: MNKD) released the following statement in response to the announcement by Pfizer Inc. that over the course of Exubera's clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, although Pfizer concluded that there were too few cases to determine whether this observation was related to Exubera. According to Pfizer's "Dear Doctor" letter, Exubera remains a safe and effective medication. It is important to note that each of the patients affected had a history of cigarette smoking, a known, major risk factor for lung cancer. Although the sugar-based Exubera formulation did have a small but statistically significant impact on pulmonary function, we are not aware of any specific carcinogenicity studies of Exubera to evaluate the potential of cancer risk.

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Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients 

Nektar Therapeutics (Nasdaq: NKTR) announced today that it has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. All new incidences of lung cancer were in patients that are former smokers.

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Lung Capacity Declines Faster With Diabetes  

Diabetes, the leading cause of heart disease, stroke, blindness, kidney failure and non-traumatic amputations, can also cause the lungs to deteriorate quicker than they normally do with age, a new study shows.

Although everyone experiences a decline in lung function as they grow older, research published in the April issue of Diabetes Care concluded that the lungs of people with type 2 diabetes deteriorate more quickly than normal.

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• NICOTINE AND TYPE 2 DIABETES (PDF) ($$) 

ToxSci Advance Access published on March 18, 2008. doi:10.1093/toxsci/kfn050

Borowitz and Isom Toxicol. Sci..2008; 0: kfn050v1-kfn050

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William F. Buckley, Jr. 

In a column published December 3, 2007, Buckley commented on the cause of his emphysema:[38]

Half a year ago my wife died, technically from an infection, but manifestly, at least in part, from a body weakened by 60 years of nonstop smoking. I stayed off the cigarettes but went to the idiocy of cigars inhaled, and suffer now from emphysema, which seems determined to outpace heart disease as a human killer. Stick me in a confessional and ask the question: Sir, if you had the authority, would you forbid smoking in America? You'd get a solemn and contrite, Yes.

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Remembering Bill [Kathryn Jean Lopez] 

As you can imagine, it's an emotional day here. I half expect an e-mail from him asking me for Laura Ingraham's number to thank her for her kind words about him on her show today (the kind of thing this humble man would always do). We're already getting some beautiful tributes from readers, Right and Left. We'll share as many as we can over the coming days.

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• William F. Buckley Jr. Is Dead at 82  

William F. Buckley Jr., who marshaled polysyllabic exuberance, famously arched eyebrows and a refined, perspicacious mind to elevate conservatism to the center of American political discourse, died Wednesday at his home in Stamford, Conn.

Mr Buckley, 82, suffered from diabetes and emphysema, his son Christopher said, although the exact cause of death was not immediately known. He was found at his desk in the study of his home, his son said.

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Educational Disparities in Rates of Smoking Among Diabetic Adults: The Translating Research Into Action for Diabetes Study  

Conclusions. Approximately half of poorly educated young adults with diabetes smoke, magnifying the health risk associated with early-onset diabetes. Targeted public health interventions for smoking prevention and cessation among young, poorly educated people with diabetes are needed.

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Active Smoking and the Risk of Type 2 Diabetes: A Systematic Review and Meta-analysis 

Conclusion

Active smoking is associated with an increased risk of type 2 diabetes. Future research should attempt to establish whether this association is causal and to clarify its mechanisms.

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Active Smoking and the Risk of Type 2 Diabetes: A Systematic Review and Meta-analysis 

Conclusion

Active smoking is associated with an increased risk of type 2 diabetes. Future research should attempt to establish whether this association is causal and to clarify its mechanisms.

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