North Observer

4 Comments

    • ON: Sat Apr 12th 01:14 AM
      Commented on:
      Mannkind Slammed: No Guarantees in Drug Safety
      capgain
      by the way, if you're trying to work out those numbers yourself, you will need to show a 'statistically significant DIFFERENCE' between the fraction of 6/4720 and the national average of ~80/100000; taking into account demographic and geographic variations.
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    • ON: Sat Apr 12th 00:50 AM
      Commented on:
      Mannkind Slammed: No Guarantees in Drug Safety
      capgain
      you guess some right and you guess some wrong. I am a player but I am also commited to long term investment. I have been with MNKD for over 8 years. Regarding the 6 subjects, I don't know if they were all long term smokers....I don't believe that information was disclosed, and correct me if I'm wrong. I would share your concern if all 6 were long term smokers and all developed lung cancer following use of the product. Reason being is that the product would appear to show specific and synergistic effect to the use of cigarette smoke (Which I believe has more carcinogens than the chemical in the product - insulin)!. Even with cigarette smoking, including second hand data, all we prove is a "CASUAL" relationship. I dare any scientist in the world to show statistical significance of the cancer in those 6 subjects to the use of that product, only if there were non smokers amongst them. Again, if the incidence was observed ONLY in smokers, then I agree that a statistical significance may in fact be there.
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    • ON: Fri Apr 11th 02:35 AM
      Commented on:
      Mannkind Slammed: No Guarantees in Drug Safety
      I have a few more questions. Is the 6 out of 4,740 fraction higher the national average? To answer that question, I would like to know the answers to the following questions:
      1- Do the 4,740 subjects represent a true cross section of the population?
      2- Were the geographic variations taken into account in determining the significance of that fraction...we know cancer shows geographic variations. For example, other than smoking, what fraction lives in 'smoggy' urban centers?

      It is true that too much of any drug can be toxic....even too much oxygen is. But in these trials, I doubt that who are running them allow the subjects to inhale toxic levels of a trusted compound like insulin. Let's take the case of penicillin. Unlike insulin, this chemical is produced by a microorganism. A significant fraction of the population is allergic to it, in some cases fatal, yet it has been in use for over 50 years.

      My point is that it was careless of Pfizer to release such 'unqualified' data. At the present time, Mannkind Corp is the only remaining player in the inhaled insulin business. When the product gets the FDA approval, which I have a feeling will be in the next few months, Mannkind will have no competitors. With the negative publicity of Pfizer'a own product, they will not be able to go back into the market.
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    • ON: Fri Apr 11th 01:47 AM
      Commented on:
      Mannkind Slammed: No Guarantees in Drug Safety
      I really don't understand what the fuss is all about! The numbers provided by Pfizer were 6 cases of lung cancer in 4,740 subjects. This translates to approximately 0.1%. The national average of the incidence of lung/bronchus cancers falls between 0.06 and 0.08%. In African Americans, the rate is approximately 0.1%. In smokers, which I understand were amongst the 6 reported by Pfizer, the incidence of lung/bronchus cancers is 23 times (men) or 13 times (women) higher. I am not an epidemiologist or a statistician, but it's obvious that the 6 out of 4,740 is NOT as alarming as it is made to be. (numbers taken from the CDC Fact Sheet, 2006 and the 2004 Surgeon General's report).
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