Sunday, December 19, 2004


Add Another Drug to the Watch-Out List...and Quit Calling them "SIDE" Effects Already!

I'm about to propose something novel today. Ready?

Instead of drug companies being forced to list "side effects" or "adverse reactions" to drugs they produce and market, they should be forced to call them exactly what they are: EFFECTS and REACTIONS. When Merck pulled Vioxx off the market a few weeks back because it increased the risk of heart attacks, that risk wasn't a "side effect." It was an EFFECT about as big and as troubling as effects come. Now the drug Celebrex has been linked to similar heart problems, but Pfizer, the company that makes it, says Celebrex is staying on the market because some people can still be helped by it.

The front page of Sunday New York Times featured an article about a family whose young child has been diagnosed with a rare liver disorder that required chemotherapy, an umbilical cord blood transplant and follow-up drug treatments. A photo showed the baby with dark hair growing all over her face and chin, with this caption: "Her hair growth is a drug side effect." As much as I empathasize with the struggles the parents are going through, excuse me, and I beg to differ! That hair is an EFFECT of the drug being given to that little baby to prevent transplant rejection.

A heart attack that results from taking a pain-killer such as Vioxx or Celebrex is an EFFECT of those drugs, not a "side" effect.

Four-hour-long erections from Levitra that require immediate treatment are EFFECTS of Levitra, not side effects...and it's time that drug companies start taking responsibility for the problems their drugs are causing.

Sleepiness, disturbed thinking, changes in eating patterns and lack of sexual arousal are not common "side effects" of anti-depressants, they're clearly EFFECTS of anti-depressants, and it's time we quit fooling ourselves otherwise.

I'm a subscriber (literally and figuratively) to the "seven-year rule" proposed by Dr. Sidney Wolfe (M.D.) and the folks at Public Citizen Health Research Group: In their opinion (published again in the Dec. 04 newletter of "Worst Pills/Best Pills"): "You should wait at least seven years from the date of release to take any new drug unless it is one of those rare "breakthrough drugs" that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven months of release. Also, warnings about serious new adverse reactions have been added to the labeling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug's release."

Hear, hear! And what that warning fails to mention is that most "clinical trials" of drugs before their release are performed on otherwise healthy adults...people with no underlying diseases and no chronic health problems. Until the last decade or so, many drugs weren't even tested on women because of the possibility the drugs would interfere with fetal development in case the woman got pregnant during the tests.

Surgery sucks? Indeed. Drugs can suck, please, please, please try to take as few drugs as possible and look for as many health alternatives as possible. Because they're out there. You just might not find out about them from your doctor. Or surgeon. Or "health-care professional."

Merry Christmas and happy holidays, everyone!

UPDATE 12/20: One day after I posted this rant, Pfizer announced it would pull all advertising for Celebrex, and the FDA announced it would reconsider the use of all Cox-2 inhibitors, the class of pain-relieving drug to which Celebrex (and Vioxx and Bextra) belong.

UPDATE 12/21: The National Institutes of Health has now stopped a study that was supposed to determine whether Celebrex or naproxen (the main ingredient in over-the-counter Aleve) would reduce the risk of Alzheimer's disease...until they noticed that BOTH groups of patients taking the drugs had an increased risk of heart attack and stroke.

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