TCS Daily

Beyond Precaution

By Sydney Smith - June 22, 2004 12:00 AM

A 53 year old man recently sued the estate of deceased diet guru Dr. Robert Atkins. His grievance? He has coronary artery disease. The crux of his case is that his cholesterol went from 146 to 230 within two months of starting the Atkins diet, clogging his arteries so badly that within two years he needed his arteries roto-rooted.

At about the same time, New York's attorney general Eliot Spitzer charged drug company GlaxoSmithKline with fraud. The crux of his case is that the drug maker hid the fact that Paxil is not effective in children and that it makes them suicidal to boot. He wants the company to "disgorge all profits" related to the drug's use in children. Paxil had sales of $3 billion dollars last year alone.

Both cases are appalling examples of how distorted our understanding of risk, especially health risk, has become. In the first case, we have a middle-aged man with heart disease. This is not such an unusual condition for a middle-aged man, even one with normal cholesterol. High cholesterol is just one of many risk factors for heart disease, along with age and sex and smoking and diabetes and high blood pressure and being out of shape, and, well, you get the idea. Not one of these risk factors is a cause of heart disease in the same way that say, the cold virus is the cause of the common cold. They just contribute to the likelihood that a person will develop heart disease, in the same way that a good pedigree contributes to the likelihood that a racehorse will be a winner.

An increase in cholesterol level from 146 to 230 in a non-smoking 53 year old man, translates into an increase in the risk of heart disease from three percent to six percent, all other risks being minimal. And that's over ten years, not two. And yet, we've heard so much about the dangers of high cholesterol and the importance of taking drugs to lower it, that the perception has become that elevated cholesterol is the disease, and coronary artery disease its only symptom.

The second case is even more alarming. Here we have a government official who wields enormous power. With the flourish of a pen, he can damage reputations and bring the threat of financial ruin. Presumably he has experts at hand to advise him on the merits of a case before pursuing it. And yet, State Attorney General Spitzer is as confused as the Atkins dieter when it comes to the difference between risk and harm.

When it comes to treating depressed children, the options available are few and far between. The alternative to the newer anti-depressants, such as Paxil, is to use the older tricyclic anti-depressants. But these drugs are much more dangerous than the newer ones. If taken in an overdose they are lethal. In fact, they are the number one cause of fatality due to drug ingestion. This has not been a problem with drugs such as Paxil.

The problem with Paxil lies in three unpublished studies submitted to the FDA in an attempt to have the drug approved for the treatment of obsessive compulsive disorder in children. In these studies the drug was no more effective than placebo and its use was associated with a slightly higher incidence of "emotional lability" (3.2% with Paxil compared to 1.5% with placebo.) The papers made no attempt to distinguish the types of emotional lability -- whether it be throwing tantrums or crying easily or attempting suicide. And it's that lack of distinction that has the drug maker accused of fraud. Never mind that there is a very strong placebo effect when it comes to treating depression, especially in children. Never mind that the older, more dangerous, anti-depressants are also no better than placebo. Never mind that not one child in any of the studies committed suicide. And never mind that the suicide rate among children has dropped even as the number treated with drugs like Paxil has increased. If there's a whiff of risk, there must be a real and present danger.

Having widely adopted the precautionary principle, we have taken the inevitable next step beyond. Risk no longer means the possibility of harm. Risk is harm.

Sydney Smith is a family physician who has been in private practice since 1991. She is board certified by the American Board of Family Practice, and is a Fellow of the American Academy of Family Practice. She is the publisher of MedPundit.


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