More reasons for doing nothing: untrustworthy studies

“Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong” says an article in the November, 2010 issue of The Atlantic. The article focuses on John Ionnidis, who is, among other things, the director of the Stanford Prevention Research Center at Stanford University School of Medicine. As a “meta-researcher,” he and his team apply rigorous statistical analysis to try to verify the evidence reported in medical journals.

After poring over journals to determine the credibility of medical research, he and his team found that as much as 90 percent of the information that doctors rely on is flawed. (Other meta-researchers are also finding disturbing high rates of error in medical literature.) “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” notes Ionnidis. For example, researchers can skew results by the ways in which they pose questions, recruit patients, select factors to measure, analyze the data, and present results.

The reason researchers distort results is primarily to increase the paper’s chance of getting published and to get themselves funded. (To stay afloat, researchers need to get their work published in well-regarded journals where rejection rates are high.) The papers that get published are those with eye-catching findings. As it turns out, when studied rigorously, the great majority of eye-catching findings collapse under the weight of contradictory data. And, of course, drug studies have added the corruptive force of financial conflict of interest by manipulating data to make their drugs look good.

As one of the doctors on Ionnidis’ team says, “When you look the papers up, you often find the drugs didn’t even work better than a placebo. And no one tested how they worked in combination with the other drugs. Just taking the patient off everything can improve their health right away.” 

Ionnidis found that even when a research error has been made known, the original results can persist for years or even decades. In looking at three prominent studies that had been soundly refuted, Ionnidis discovered that researchers continued to cite the original results as correct—in one case 12 years after the results were discredited. (Incidentally, here’s something I learned that was news to me: vitamin E—fish oil—does not help prevent cardiovascular disease.)

Doctors have been trained to order tests and prescribe whatever drugs they believe will affect an out-of-whack test number. They're not trained to study the research papers that helped make drugs they prescribe the standard of care—a time-consuming task. So the drug habits persist, helped by the fact that patients often don’t like it when they’re taken off their drugs. They find their prescriptions reassuring.

I highly recommend the article.

Next week: over-testing run amok--an example.

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The down side of blood pressure meds

Prior to the late 20^th century, physicians generally prescribed medicines only to patients with symptoms of disease. High blood pressure was the first condition for which regular treatment was started on people without symptoms. The treatment continues: people with no health complaints are given a diagnosis of hypertension and prescribed treatment based, usually, on unrealistic measurements (as I discussed in last week’s post). Thus, many healthy people who were never destined to develop symptoms or die from hypertension are needlessly treated.

Being unnecessarily treated for high blood pressure wouldn’t be bad if it weren’t for the side effects (not to mention cost and bother). Seventy percent of people over 70 take blood pressure medicine, which causes dizziness and is thus implicated in falls. In fact, a study performed in 2014 found that, among older people, the risk of serious injuries from falls was significantly higher for those who took hypertension drugs than those who did not. (As I mentioned in the cholesterol section, trips to the emergency room because of falls has increased by fifty percent in the last 10 years.)

Even more interesting is a thirty-year study of residents of a retirement home in California. It began in 1981, when residents completed surveys about their health and life styles. In 2003, researchers discovered the original records and also found that 1,900 of the original survey takers were still alive and in their 90’s or older. The researchers tested about 1,600 of this group. (You may have seen this on 60 Minutes.) Among other things, the study revealed that having high blood pressure seemed to benefit those who are over the age of 90. Not only that, they found that high blood pressure and high cholesterol reduces your chances of dementia.

A word about salt intake: My husband and I don’t worry about eating too much salt. Lots of studies have failed to find strong evidence that cutting salt intake reduces the risk for heart attacks, strokes or death in people with normal or high blood pressure. One study even found that the less sodium people consumed the greater their risk was of dying from heart disease. At any rate, our bodies strive to maintain a stable concentration of sodium in our blood: if we eat salt, we get thirsty and drink more water and retain more water.  In this case, our blood pressure might increase temporarily until our kidneys eliminate both salt and water. If we cut our salt intake, our bodies respond by releasing an enzyme and a hormone that increases blood pressure.

I just trust my body to work it out.

Next week: untrustworthy research studies.

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.

Who says your blood pressure is high?

My blood pressure is always “high” when measured in a medical facility—a phenomenon called the “white coat syndrome.” This happens with a lot of people. Because my blood pressure is high on such occasions (I think something in the neighborhood of 140 over something) I am urged to take blood pressure medicine. I’m having none of it. For one thing, my blood pressure fluctuates. For another, the definition of what constitutes “high” or “abnormal” blood pressure keeps getting lower.

Supposedly “normal” blood pressure is 120 (systolic) over 80 (diastolic). In fact, nobody really knows the demarcation between “normal” and “abnormal” blood pressure. The definition of what constitutes high blood pressure is regularly revised, constantly creeping lower over time. The new guidelines tell us that anyone with a systolic blood pressure of 120 to 139 (the top number) or a diastolic of 80 to 89 (the bottom number) “should be considered as hypertensive.”

By lowering the definition of what constitutes high blood pressures, you increase the pool of potential patients who are otherwise healthy, a boon for pharmaceutical companies: treatment for hypertension translates into a $40 billion global market in blood pressure medicines. What’s more, the guidelines were written by a panel riddled with major conflicts of interest. For example, nine of the eleven coauthors of the 2003 guidelines received speaker’s payments or research funding from, consulted for, or owned stocks in a long list of drug companies.

Not all physicians buy into the guidelines. For example, one cardiologist, Wake Forest University professor Curt Furberg, doesn't believe it’s a good idea to treat someone with a blood pressure of 160 who is otherwise healthy. The same goes for Dr. Matthew Kendrick, who argues that “almost everything written about treating blood pressure is wrong.” The US Preventive Services Task Force is now recommending that patients not be diagnosed as hypertensive based on measurements taken in a medical facility. (This means you need to measure yourself at home.)

Of course extremely high blood pressure, such as, say, 202/117 is abnormally high and should be treated. Blood pressure at these levels will likely cause symptoms, such as severe headache, as was the case for President Franklin D. Roosevelt, whose blood pressure before he died was 300/190. He died of a massive hemorrhage in his brain. So OK, severe high blood pressure indicates a need for treatment.

Next week: The down side of blood pressure meds.

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.

Stay away from statins

Cholesterol-lowering drugs are the top-selling drugs in the U.S., with $27.4 billion in sales projected for this year. In 2005, 29.7 million people were taking statins, the best-selling form of the drugs.

Because the National Cholesterol Education Committee has set the “desirable” level of total cholesterol to less than 200, high cholesterol can be diagnosed as a “disease” in half the population. (Most members of the Committee, by the way, have financial ties to the cholesterol-lowering drug manufacturers.) This is a dream come true for Henry Gadsen, a former chief executive of Merck. He told Fortune magazine that it had long been his dream to make drugs for healthy people so that Merck would be able to “sell to everyone.” Now they've done it: healthy people have been turned into patients.

Advertising hype to the contrary, the benefits of these drugs are minimal at best. For example, a 3-1/3-year study of Lipitor sponsored by its manufacturer revealed that only one person out of 100 appeared to have benefited from the drug, which means that in order for one person to benefit, 100 people had to take the drug. But in their advertisements, Pfizer casts this meager result in a more attention-getting light: “Lipitor reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease.” In smaller type, the ad says, “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”  This, of course, translates to a number needed to treat of 100 in order for one to benefit. Actually, the number needed to treat is probably higher, since those chosen for the trial were carefully selected people, such as those who smoke. (Compare this to the standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria: of 11 people given the antiobiotic, 10 will be cured.)

Studies have shown a small reduction in heart attacks for middle-aged men, but even for them, there was no overall reduction in total deaths. For those few who seem to benefit from statins, the reduction of heart attacks is unrelated to cholesterol levels (people with low cholesterol have just as many heart attacks as people with high cholesterol). Rather, the benefit is most likely tied to the reduction of arterial inflammation. 

Just keep me out of it. Though I’m an old lady with a cholesterol level of 258 (when last checked many years ago), I don’t take cholesterol-lowering medication (or any other, for that matter). I’m saving Medicare a few bucks and myself from being a sick person with muscle cramps.

Next week: questioning conventional "wisdom" about high blood pressure.

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.