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The first one showing that cheaper, generic heart pills work just as well as expensive appeared in the prestigious "Journal of the American Medical Association". The second one showing that Pfizer's [PFE
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] Lipitor works better than Merck's [MRK
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] Zocor, now generic, appeared in the less influential "Mayo Clinic Proceedings." It was also publicized in a PFE press release that came out the morning after the JAMA study, which had received a certain amount of media attention.
The post touched a nerve. In an unscientific poll on my blog, a good number of readers voted overwhelmingly that they think the timing of the Pfizer release was deliberate versus coincidental. But the vast majority of people who sent emails accused me of ginning up a story where none exists. Here's a sample:
Peter DeVilbiss: "The conclusions that Mike Huckman reaches in his erroneous article are so juvenile and idiotic...."
Anonymous offered his/her version of the poll: "Was Mike Huckman's confusion about these two studies: 1. A Coincidence? 2. Deliberate? 3. Uninformed?"
Brendan Kempin: "Your attempts at sensationalizing this press release must mean that you either do not understand the difference between the studies being quoted or you are just shamelessly trying to generate a story on a slow news day."
Tim Brown: "Mike Huckman is a hack. He should do his homework before implying he knows anything about therapeutics, lest he make such an a** out of himself again."
Dr. Stephen Stefani took the other side: "What a dumba** study," he wrote referring to the Pfizer clinical trial. "This study demonstrates nothing. I feel JAMA has it right."
Terry Hiers: "They (Pfizer) know up front that nobody will challenge them with a study to refute it. Lipitor is 10 times more expensive."
And Al Mandell wrote to commend the position taken on the JAMA study by PhRMA, the industry's lobbying group: "As a scientist in the pharmaceutical industry, the PhRMA statement is right on. Without the stong R&D efforts from the world's major pharmaceutical companies there will be no new drugs period. So if everyone would like cures for diseases such as cancer, macular degeneration, Alzheimer's, etc, support of the major drug companies is imperative. Hopefully, this point is not lost on the lay people of the world."
As I've mentioned here before, I have been on 10 mg of Lipitor daily for the past few years. My insurance company and pharmacy benefit manager have sent me letters and emails in the past to switch to generic Zocor, but I continue to pay the higher co-pay for the brand-name drug.
USC: Beat the Bruins!
UPDATE — Pfizer Weighs In:
And Friday afternoon I received this email about the statin-study "coincidence" from Pfizer spokesman Ray Kerins:
"Your thesis that there may be a coincidence between the timing of these two separate and distinct studies in two reputable peer-reviewed publications is wholly unsubstantiated. It is important to set the record straight for your readers.
Here are the facts:
The observational analysis published in Mayo Clinic Proceedings compares treatment of Lipitor with Zocor (branded name for simvastatin) in a managed care population with no history of cardiovascular disease and showed a significant benefit for patients taking Lipitor as demonstrated by a 13 percent reduction in the relative risk of experiencing a cardiovascular event compared with patients taking Zocor therapy. This “real world” study was conducted prior to the availability of generic simvastatin. Lipitor and simvastatin have different active ingredients and are not therapeutically equivalent.
On the other hand, the JAMA study evaluated the appropriateness of generic substitution (i.e., replacing a brand-name drug with a generic drug that is bioequivalent and has the same active ingredient – example is Zocor to simvastatin) rather than therapeutic substitution (i.e., replacing a brand-name drug with a generic alternative within the same class that is NOT bioequivalent and has a different active ingredient – example is Lipitor to simvastatin).
Therefore, one cannot draw any conclusion about the clinical equivalence of a brand-name drug and a generic alternative with a different active ingredient (i.e., therapeutic substitution) from the JAMA study.
Lastly, Pfizer had no knowledge of the publication date for the JAMA study and did not control the publication date of the observational study in Mayo Clinic Proceedings."
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