Undisclosed Risks of Common Medical Treatments

Millions of tonsillectomies have been done, mostly to children. Were any of their parents told that tonsils are part of the immune system (taught in high school biology and known since the 1960s)? A Cochrane Review of tonsillectomies (the “highest standard” in evidence-based medicine) fails to mention that tonsils are part of the immune system. A recent study found tonsillectomies associated with a 50% increase in heart attacks. (I write about tonsillectomies here.)

Are tonsillectomies unusual? Several recent news stories suggest no, they aren’t. Failure to tell patients the full risks of medical treatment may be common:

1. Undisclosed risks of hernia surgery. From the Wall Street Journal: “More than 30% of patients may suffer from long-term chronic pain and restricted movement after surgery to fix a hernia . . . studies show.” The article says “many patients don’t consider” this risk — meaning they don’t know about it. A Berkeley surgeon named Eileen Consorti told me I should have surgery for a hernia I could not detect. I have previously written about her claim that evidence supported her recommendation when no such evidence existed — or, at least, no one including her has ever found it. I said I wanted to see the evidence because there were risks to surgery. She replied that none of her patients had died. I was shocked by the incompleteness of her answer. There are plenty of bad outcomes besides death — as the Wall Street Journal article shows.

2. Undisclosed risks of sleeping pills. A book called The Dark Side of Sleeping Pills by Daniel Kripke, a professor of psychiatry at UC San Diego, goes into great detail about risks of sleeping pills that few doctors tell their patients. For example, one study found that “patients who took sleeping pills died 4.6 times as often during follow-ups averaging 2.5 years [than matched patients who did not take sleeping pills]. Patients who took higher doses (averaging over 132 pills per year) died 5.3 times as often.” Insomnia alone was not associated with higher mortality. Tomorrow I will post Dr. Kripke’s answer to the question “why did you write this book?” Here is a website about the dangers of Ambien.

3. Undisclosed risks of anticholinergic drugs. From the NY Times: “After following more than 13,000 British men and women 65 or older for two years, researchers found that those taking more than one anticholinergic drug scored lower on tests of cognitive function than those who were not using any such drugs, and that the death rate for the heavy users during the course of the study was 68 percent higher. That finding, reported last July in The Journal of the American Geriatrics Society, stunned the investigators.” Anticholinergics are “very very common” said a researcher. They include many over-the-counter drugs, such as “allergy medications, antihistamines and Tylenol PM”.

4. Undisclosed risks of statins. A recent NY Times story says “the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin.” Prior to this official linkage, the reports of forgetfulness and confusion were mere anecdotes that evidence-based medicine proponents ignore and tell the rest of us to ignore.

5. Undisclosed risks of metal-on-metal hip replacements. They leak dangerous amounts of metal (e.g., cobalt) into the rest of the body. “Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark,” says a recent article in the BMJ. By 2007, the danger was so clear that a British regulatory committee said that patients must sign a form saying they’ve been warned. This didn’t happen — a surgeon told the BMJ that “surgeons were unaware of these discussions.” Other materials could have been used.

These six treatments (tonsillectomy, hernia surgery, sleeping pills, anticholinergic drugs, statins, and hip replacement) are so common they raise a scary question: What fraction of the risks are patients usually told?

The surgeon or drug company gets paid no matter what happens to you. Malpractice lawsuits are very rare on a per-patient basis — and no one will be sued for performing a tonsillectomy on a child who gets a lot of colds or prescribing sleeping pills to someone who has trouble sleeping. In a Freakonomics podcast, Steve Levitt said that doctors terrify him. And his father is a doctor. Given the undisclosed risks of common treatments, he is right to be terrified.

Thanks to Allan Jackson, Alex Chernavsky and Tim Beneke.