Do read it all -- and do note that he gives much-deserved credit to PM for the plant sterols theory as to a plausible mechanism of action. . . .
Here's a snippet:
. . . .I wrote this piece for two main reasons: one reason is that I think this case (and the fiasco surrounding Vioxx) is an important reminder not to be so eager to take a new drug just because it’s new and has a cute ad. FDA approval is no guarantee that a drug is safe, and some relatively rare but certainly very significant side effects only become noticed during what is called post-marketing surveillance. The other reason is as a teaser for my upcoming, first ever book review: Reasonable Rx: Solving the Drug Price Crisis, by Finkelstein and Temin. . . .
Do go read. Now.
6 comments:
Condor,
I have to compliment you again.
One minor point. The author refers to "rare...side effects".
The cancers were 4.1% vs. 2.1% for placebo for a marginal difference of 2% i.e. 1 in 50 people. Rare is a qualitative term, not quantitative, although quite a while back FDA did use certain definitions from the USP when they included the term rare side effect in labeling decisions. They were if I remember correctly:
frequent >= 1 in 100
common <1 in 100 to >=1 in 1000
uncommon <1 in 1000 to >=1 in 10000
Rare < 1 in 10000
by these definitions the potential risk for cancer is not rare but is a frequent.
You can't advise your patients on every side effect however if I were a practicing physician or pharmacist I would counsel my all of my patients about the potential risk of cancers being so high. I believe that not to do so would be failing in my duty to warn the patient.
Salmon
I agree -- I think it worth quoting, even if the author soft-pedals some of we all, here assembled have already seen. Wider exposure of the meme is a good thing, right?
Thanks, Salmon!
Agreed and I understood your meme. I just wanted to highlight that even so the potential risk is being soft pedaled.
It's one thing for someone to say well even if it does double my risk of cancer I'll still take the drug if the doubling is from 1 in 200,000 to 1 in 100,000. It's something else if the doubling is from 1 in 50 to 1 in 25.
If the drug works and drops your risk from cardiovascular death from 1 in 500 to 1 in 100 it's worth it in the first case but not in the second. Unfortunately, as I've pointed out before FDA doesn't typically do these sort of analyses. In fact FDA's guidance on quantitative risk assessment indicates that it's the financial impact on the company that has to be included in a quantitative assessment. How messed up is that
Salmon
I think you guys may be misconstruing what Dr. Loeb is saying in that sentence. I think his use of the word "rare" is not meant to refer specifically to the possible cancer risk from ezetimibe, but to adverse events that show up after approval in general. In any case, when reading a blog post you have to make allowances for the nature of blog posts. They are generally not polished pieces of writing where every word is weighed carefully, but rather tend to be written somewhat in haste. If you asked him, I don't think Dr. Loeb would classify the excess cancer cases and deaths in SEAS as "rare."
Thank you both -- I think Marilyn's gets at wheat I was aiming for, in a much more precise way.
And I still agree, Salmon, I would not take a "from 1 in 50, to a 1 in 25" risk lightly.
Thanks for keeping this spinning while I was (mostly) off the grid yesterday afternoon.
As one with minimal formal medical training compared with others, I still can state with clarity and confidence that the assessment of this JH Oncologist that he is completely accurate with in particular his statemet about newer medications in particular.
If one examines, say over the past two decades, the medications approved by those who are no less than the employees of the pharmaceutical industry, the FDA, one can do nothing but conclude that many newer medications either are rather impotent regarding efficacy, or, more concerning and frightening, are in fact quite toxic. We have been betrayed as public citizens by the administration created to protect the American Citizens. Mr Upton Sinclair's efforts are being proven to be benign presently
Nothing is being done about this danger if not waste regarding this process of bringing new medications to others due perhaps to the monetary damage that may occur to shareholders and earnings of those corporations in the pharmaceutical industry.
Now, maybe I'm not informed completely, but I ask with great desperation the following: Is the apathetic immobility of our government regarding this issue of the atrophied U.S. Health Care System that progressively deteriorates because of potential financial alterations that may occur because financial gain is viewed as more important than the health and well being of us? Would we as U.S. citizens not sacrifice financial gain in order to assure the safety of others?
If I am wrong on what I believe, then my country can add another member to its population that is failing to cope with an insane designed government that ostrasizes those who do not strive for prosperity at any cost.
Post a Comment