Understood. And thanks for the kind words. And I continue to appreciate your observations.

all best
ed

Please understand, I’m glad you posted the piece. I appreciate the larger legal implications which you higlighted. I didn’t see that in Ms. Pettypiece’s story which seemed to be more about leveraging a presentation at ACC into increase sales of a product we should regard with some suspicion. I wasn’t at the ACC and didn’t see the data, but it seems that Dr. Solomon is reaching in the quote in the second paragraph above.

My interpretation would be simply: “the higher the dose, the greater the risk.” We don’t know the lowest safe dose of celecoxib. It may be zero milligrams.

My compliments on your site. It rivals the “Pink Sheets” of olden days, but much less expensive. The bonus is no need for a stupid distribution list stapled to the front of it to save a buck or two.

I appreciate your thoughtful comment. And you raise a good question. One thing I would like to note, however, is that I decided to post this item not merely because it popped up at the ACC, but because the issue concerning the high doses was fought in court just a few months ago, which I noted.

Thanks for stopping by,
ed

The original study methods permited identification of the low risks of upper GI bleeding. Though the absolute risks were very small, the design and size of the study allowed comparison of the risks between the different treatments. These methods could have been (and yet can be) adapted to answer the question of heart attack and other CV risks. However, Pfizer was so impressed with the original published reports that Dr. Mamdani got a plum job offer in International Outcomes Research. I understand from the nice folks at ICES in Toronto that he is no longer at Pfizer - don’t know if that is true or not.

In my experience, PhRMA companies don’t usually ask questions which don’t have relatively certain answers. If an unexpected result is found, you can be fairly sure the results won’t be public until the damage control plan is in place.

It is sad that now we know the predictable outcome that higher doses are more risky than lower doses. We actually already knew this from the discontinued colon cancer prevention trial. Sadder still is that we treat it as news simply because it is at the ACC. I can’t see how this gives us any assurances of safety (absolute or relative) of lower doses of celecoxib.

We are left with this question: Given all of the available, reasonable treatments are the cardiovascular risks of celecoxib lower, equal to or higher than any of the other agents?

The folks in Ontario could help us find an answer - even if it is with administrative data. This could have happened a long time ago if Pfizer had really wanted to know. They had the guy who could have done it with a few changes in some SAS code.

Or do we?