tag:blogger.com,1999:blog-9143719926358099859.post6623858244858471785..comments2023-10-26T08:08:43.486-07:00Comments on Dr. Mintz' Blog: Eli Lilly terminates inhaled insulin programDr. Matthew Mintzhttp://www.blogger.com/profile/01058182168282244996noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-9143719926358099859.post-92028071987912764012008-10-24T13:55:00.000-07:002008-10-24T13:55:00.000-07:00I am one who participated in the Pfizer study and ...I am one who participated in the Pfizer study and can't say enough good things about their product. It was very predictable and as long as the appliance was maintained, it worked perfectly. I truly think Pfizer made a big mistake in not trying different avenues to offer the inhale. As far as the FDA (fat dumb arrogant), they should be pulling this same kind of pressure on the drugs that are causing serious problems, not those that can make life easier for us diabetics.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9143719926358099859.post-79995784035445524142008-08-02T17:23:00.000-07:002008-08-02T17:23:00.000-07:00I am not aware that Mankind has dropped the projec...I am not aware that Mankind has dropped the project. In addition, the home page of their website (http://www.mannkindcorp.com/) has a picture of their inhaled insulin device displayed prominently. Thus, it would appear they are still committed to their product.Dr. Matthew Mintzhttps://www.blogger.com/profile/01058182168282244996noreply@blogger.comtag:blogger.com,1999:blog-9143719926358099859.post-82121869715947897562008-08-01T13:36:00.000-07:002008-08-01T13:36:00.000-07:00Is mannkind corporation inhaled insulin trials sti...Is mannkind corporation inhaled insulin trials still alive? Will they seek FDA approval?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9143719926358099859.post-43810424215177694802008-03-09T18:25:00.000-07:002008-03-09T18:25:00.000-07:00Yes, business is business, but my point is that th...Yes, business is business, but my point is that things have gotten trickier. It is likely true that some products in the past may have been pushed too quickly (Vioxx), but I think the pendulum may have shifted too far in the other direction. Since there is no public data on the Lilly product, other than they said it was safe, I will use Exubera as an example. Exubera was delayed for about 2 years because the FDA was concerned about declines in lung function. There was a small, but not very meaningful declince in the lungh function of patients taking Exubera. After two years of looking at hunderds of patients, the studies showed that this mostly inconsequential decrease in lung function was seen soon after starting the medication, didn't get worse, and resolved after stopping the medication. However, when the FDA approved Exubera, one of the caveats was listing that patients should all get lung function testing before starting Exubera. Unlike an EKG machine, most primary care physicians do not have lung function testing machines in their office (though they should), thus requiring a referral to a testing center that had this or to a pulmonologist. This caveat caused physicians to question the safety of the drug, and remained a barrier to starting Exubera on a patient, which is likely one reason the product was not as successful as Pfizer thought it would be. It is very possible or even likely that the Lily product had the same lung function issue, and though their drug was possibly equally as safe as Exubera, Lily didn't see that a big enough profit would be made if they anticipated the FDA would apply these same restrictions.Dr. Matthew Mintzhttps://www.blogger.com/profile/01058182168282244996noreply@blogger.comtag:blogger.com,1999:blog-9143719926358099859.post-66471832835254938902008-03-09T17:21:00.000-07:002008-03-09T17:21:00.000-07:00"The political and heightened media scrutiny of th..."The political and heightened media scrutiny of the FDA and drug companies may be in part to blame for a needed drug not coming to market."<BR/>Ridiculous. Do you think Eli Lilly will not field new products due to scrutiny? They would go out of business. Either the safety was not there or the required profit margin was not there. Business is business.Anonymousnoreply@blogger.com