Beyond Precaution

Published September 1, 2004

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 count rose from 146 to 230 within two months of his starting on the Atkins diet, which he says clogged his arteries so badly that within two years he needed the blood vessels 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. Spitzer wants the company to “disgorge all profits” related to the drug’s use in children. Paxil had sales of $3 billion last year alone.

Knowledge Gap

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 3 percent to 6 percent, all other risks aside. And that’s over 10 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.

Risk vs. Harm

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. Yet Spitzer is as confused as the Atkins dieter when it comes to the difference between risk and harm.

The options available for treating depressed children are few and far between. The alternative to the newer antidepressants, such as Paxil, is to use the older, tricyclic antidepressants. 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 among young people in the United States. This has not been a problem with drugs such as Paxil.

The problem with Paxil lies in three unpublished studies submitted to the Food and Drug Administration by GlaxoSmithKline, PLC 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 a placebo, and its use was associated with a slightly higher incidence of “emotional liability” (3.2 percent with Paxil compared to 1.5 percent with placebo).

The papers made no attempt to distinguish the types of emotional liability to which the young persons were made more susceptible–whether they were throwing tantrums or crying easily or attempting suicide. And despite that lack of distinction, the attorney general of one of the nation’s most populous states has accused the drug maker of fraud. In addition, the attorney general ignored the fact that there is always a very strong placebo effect when it comes to treating depression, especially in children.

It is also important to bear in mind that the older, more dangerous, antidepressants are likewise no better than placebos. And of critical significance is the fact that not one child in any of the studies committed suicide. Finally, the attorney general failed to consider the fact that the suicide rate among U.S. children has dropped while the number being treated with drugs like Paxil has increased. If there is a whiff of risk, we should be seeing evidence of a real and present danger.

However, having widely adopted the precautionary principle–the idea that avoiding theoretical risks is a paramount concern for public policy–we have taken the inevitable next step. Risk no longer means the possibility of harm. Risk in itself is harm.

Sydney Smith ([email protected]) is a family physician in private practice since 1991. An earlier version of this article appeared on June 24, 2004 on TechCentralStation. (