Vox Hunt: “My reputation grows with every failure.” – George Bernard Shaw

Failure is inevitable… Show us some failure.
Submitted by Connie.

So, Hannahbanana’s recent post and comment string and this vox-hunt had me thinking this morning.  Remember last fall, when we all had a good chuckle at Pfizer burning up three billion dollars with their failed inhaled insulin product, Exubera?  Well, the other week Pfizer issued a warning on the product citing that the use of Exubera may lead to lung cancer.  Whoa.

As it continues to follow-up patients that have taken the drug, it turns out that 6 of ~4700 patients have developed lung cancer compared to 1 in ~4300 that were treated by other methods.

Now six is not a big number, and in a clinical sense these results are not statistically significant, and the drug passed several years of toxicological studies (and incredibly rigorous pulmonary tox studies) in animals and was found to be clean, AND everyone that developed lung cancer had been a smoker, but yet, that number is a fairly big red flag.   Even more worrisome is that cancer is the sort of thing that might take a long time to show itself. 

Exubera is considered one of the biggest flops in modern pharmaceutical development history – predicted to make billions in sales just a few years ago, it’s only been used sporadically by a few thousand consumers.

Talk about a colossal failure.  Though in hindsight, Pfizer (and all of us) might be glad it wasn’t more popular.

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4 thoughts on “Vox Hunt: “My reputation grows with every failure.” – George Bernard Shaw

  1. Sort of an odd connection…are they sure that its connected or are they pulling it because it is a much bigger number than the control?
    I've never met a patient taking the medication, so i guess that says how well it caught on.
    I've just been thinking about how much better people do without multiple medications on board. Its a difficult thing,some of us need these things to keep going, but I get the sinking feeling that theres always some unexpected effects….

  2. Katie — Pfizer pulled the medicine last fall because of crappy sales. The data they found here was from standard follow-ups of patients that were part of their Phase-III clinical program.
    It would be very difficult to determine a causal relationship from these numbers (the numbers are too small to be statistically meaningful). One theory is that inhaling the insulin (which is structurally similar to certain growth factors) may have exacerbated lesions or proto-lesions into full blown cancer.
    With it already essentially being a "dead" product, Pfizer really just decided to pre-emptively pull the plug. Of course, they'll continute to monitor the folks that had taken it — so there should be more data in the future. It may turn out to be real or just an aberration.
    I told Hannah that I think pharmaceuticals can really save your life — or your quality of life. But with anything, there is a risk-benefit relationship that needs to be assessed — when you start AND while your taking the drugs.

  3. Katie — Pfizer pulled the medicine last fall because of crappy sales. The data they found here was from standard follow-ups of patients that were part of their Phase-III clinical program.
    It would be very difficult to determine a causal relationship from these numbers (the numbers are too small to be statistically meaningful). One theory is that inhaling the insulin (which is structurally similar to certain growth factors) may have exacerbated lesions or proto-lesions into full blown cancer.
    With it already essentially being a "dead" product, Pfizer really just decided to pre-emptively pull the plug. Of course, they'll continute to monitor the folks that had taken it — so there should be more data in the future. It may turn out to be real or just an aberration.
    I told Hannah that I think pharmaceuticals can really save your life — or your quality of life. But with anything, there is a risk-benefit relationship that needs to be assessed — when you start AND while your taking the drugs.

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