Side Effects

That is the name of a movie I saw a few weeks ago. It comes to mind now because the next issue of The Medical Letter (April 15) will include an article on an FDA warning about a possible side effect of salmon calcitonin, which is used to treat osteoporosis. In the movie, a possible side effect of a new drug that was zealously promoted by a presumed-to-be-evil pharmaceutical manufacturer is a central part of the plot. I will say no more about the movie so as not to spoil it for anyone.

Salmon calcitonin is not a new drug. It has been around since the 1980’s. Our most recent Treatment Guidelines issue on Drugs for Osteoporosis described modest benefits and little risk. We did not mention that a study published in 2000 found a small (1.5 times) increase in the incidence of cancer in patients who took the drug. Others were more concerned, and this year two FDA advisory committees held a joint meeting to discuss the results of 21 meta-analyses of the possible carcinogenicity of salmon calcitonin. They found a similar increase in the incidence of cancer (1.6 times) in patients who took the drug. No particular type of cancer predominated, and no one could think of a plausible mechanism by which salmon calcitonin could cause cancer. The advisory committees voted (12-9) that the benefits of the drug did not outweigh the risks.

The FDA does not have to accept the judgment of its advisory committees, but it usually does. The world will keep turning if salmon calcitonin disappears from the osteoporosis armamentarium, even though some clinicians and some patients will miss it.  What I keep coming back to is that penicillin and aspirin probably would not be approved by the FDA in today’s climate, and if they were, they would probably be removed from the market after a few patients bled to death or had anaphylactic reactions. It seems to be difficult for the government, the media, and the public to accept the fact that drugs have side effects.

Anyway, go see the movie. It’s pretty good.

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Comments

  1. Randall Rowlett MD says:

    It seems difficult for humans to overcome our predisposition to binary thinking: each thing is pronounced either “good for you” or “bad for you” without any consideration of individual variation, dosage, rate of absorption, drug-drug interactions, comorbid conditions, changes in metabolism with age, etc. People want to believe that some things are “safe” – forgetting that too much water or oxygen can kill you.

  2. Robert Fuentes, MD, FACP says:

    Is the movie Carnage? Fantastic, extremely well made, well acted movie. Much more enjoyable than trying to explain the true risk of cancer to a patient who does not want to take a basal insulin, injectable incretin, or a thiazoladinedione.

  3. Nessuno says:

    Apples, oranges, aircraft carriers. This seems to be the thinking associated with recent blogging here about side effects. Penicillin’s benefit to risk ratio weighs heavily in favor of benefit. Is there any rational individual prepared to make the same quantitative assertion about salmon calcitonin, especially when there are non-pharmacologic approaches that provide similar or better benefits? Certainly not the FDA advisory committee who were far from unanimous in their assessment.

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