October 26

Just Say No – Forbes

Just Say No – Forbes

Tue, 16 Nov 2004

When Mrs. Nancy Reagan coined the phrase, Just Say No, she was referring to illicit drug pushers. The current Forbes cover story–Just Say No–refers to the prescription drug industry. "In a perverse kind of symbiosis, the cascade of disease and medical complications growing out of America’s excesses and lack of fitness triggers more demand for more drugs."

The drug industry assisted by the medical community and the media – which are financially dependent on industry–have deluded the American public into spending $216 billion on prescription drugs–a dozen prescriptions for every man, woman and child.

Forbes gets to the heart of the issue by asking what few in the media have:

What health benefits has this spending bought?

Cholesterol-lowering drugs cost us $13.9 billion a year reducing their risk of heart attacks by 35%; whereas patients with heart disease who go on a Mediterranean diet reduce their risk of future heart attacks and cardiac death by up to 70%.

Do you really need all those prescription pills you are popping?

Health care professionals and common sense tell us that millions of people are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise, are more effective for most ailments and a lot cheaper. Cholesterol, hypertension, osteopenia (thinning bones), anxiety-depression, chronic pain, insomnia, and heart burn can all be treated effectively without debilitating adverse side-effects by a healthy diet, exercise, stress reduction, and short-term cognitive behavior modification.

In many cases, the drugs are making people sicker and drug dependent: that’s a prescription for increasing profits – not improving health.

Although SSRI antidepressants have mostly failed to show a clinically significant benefit over placebo in clinical trials; although they are linked to severe adverse effects – including, mania, increased suicide, sexual dysfunction, and severe withdrawal effects–according to a poll by Harris Interactive, 80% of people who seek treatment for depression are prescribed drugs.

Forbes foresees "a backlash building against the cost, risk and side effects of medication, and it’s bad news for the pharmaceutical industry."

"Let the Un-Drugging of America begin."

Contact: Vera Hassner Sharav


Just Say No
Robert Langreth, 11.29.04

Do you really need all those prescriptions pills you are popping? Maybe not. There’s a backlash building against the cost, risk and side effects of medication, and it’s bad news for the pharmaceutical industry.

Wesley Miller was a walking medicine cabinet after undergoing triple-bypass surgery in 1994. By late 2001 he was on 16 drugs, including Lipitor for high cholesterol, Glucotrol for diabetes and three pills to lower his blood pressure. He couldn’t walk from his front doorstep to the mailbox without doubling over in chest pain. At one point tests showed the blockages were back and that his arteries were too damaged to risk another operation. He thought he might die.

But Miller, now 65, a former hospital food-service director in West Virginia, discovered a lifesaver–not more drugs but a program of daily exercise, stress reduction, group support and a diet very low in fat and high in vegetables and whole grains. After seven weeks on this low-tech form of medicine, recommended by his doctor and designed by California health guru Dr. Dean Ornish, Wes Miller started to get better. The angina attacks faded. In eight months he lost 40 pounds. His blood pressure eased off, his cholesterol level fell from 243 to 110, and his blood sugar normalized. Today the only drugs he takes are a daily aspirin and one pill for hypertension. He regrets that he didn’t sign on sooner. “It has totally changed my life and given me reason to live again,” he says.

Let the Un-Drugging of America begin. The pharmaceutical industry, despite a golden age of biology that has unraveled mysteries of the genetic code and yielded miracle drugs that save thousands of lives, may be on the brink of a backlash. Millions of us are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise–harped on by physicians for decades–are more effective and a lot cheaper.

The results of pill dependence are insidious and devastating: billions of dollars in ever-higher drug costs; millions of people enduring sometimes highly toxic side effects; and close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the elderly, one major study estimates. And every few years comes the ultimate medical catastrophe: a miracle cure that turns out to be toxic.

The latest involves Merck & Co.’s Vioxx, withdrawn from the market in September because the painkiller boosted heart attack risk. Estimates of the number of injured patients range from 30,000 to 100,000. Merck dismisses the high numbers, but it likely faces one of the biggest liabilities in drug history. This comes on top of new evidence that Prozac, Paxil and other antidepressants cause suicidal thoughts in children and recent findings that hormone replacement therapy, touted for decades as a panacea for menopause, could increase the risk of heart attacks, strokes, breast cancer and dementia.

In the wake of the Vioxx debacle, a broader backlash could scare some patients into a wholesale retreat, hurting drug sales (and drug stock prices). Some opponents of the drug business say it’s high time America went through withdrawal. “We have this idea that we can pop a pill and solve everything. It is craziness,” says pharmacologist James Wright of the University of British Columbia. “People are dying from taking too many drugs at too high doses for mild conditions where they have little chance of benefit.”

Dr. John Abramson, a Harvard Medical School instructor and author of Overdosed America: The Broken Promise of American Medicine, adds: “We have this exaggerated belief in biomedicine, in the same way that primitive society believed in folk cures.” He blames drugmakers for exaggerating the benefits and minimizing the side effects of patented medicines, and he urges the medical establishment to emphasize cleaner living.

But Big Pharma argues the opposite case: that the real problem is undermedication. For great numbers of people, better diet and more exercise simply aren’t enough, this argument goes. A Rand Corp. study a year ago found significant undertreatment of diabetes, heart disease, asthma and stroke. Congress last year extended Medicare coverage to drugs in part because of such concerns.

And yet America, which leads the world in developing new drugs, ranks a mediocre 29th in life expectancy. Demographics have something to do with this, but another reason is that we are fatter and more out of shape than ever before. A fourth of Americans are obese (i.e., at least 30 to 40 pounds over their recommended weight). Thirteen million people live with heart disease. Another 18 million have diabetes, which could soar to 30 million in 25 years, despite new designer drugs.

In a perverse kind of symbiosis, the cascade of disease and medical complications growing out of America’s excesses and lack of fitness triggers more demand for more drugs. In the U.S. employers, government and consumers spent $216 billion on prescription drugs last year (or 2% of the U.S. economy), up 11.5% in a year, says IMS Health. That paid for 3.4 billion prescriptions, a dozen for every man, woman and child in this country.

This penchant for chemicals, stoked in part by $3.2 billion a year that drugmakers spend on ads to reach consumers (part of a $25 billion marketing budget), distracts doctors and patients from the lifestyle changes that could have far greater impact. Decades of nagging from doctors have failed to get people off the sofa and into the gym. “Physicians are somewhat hardened,” says Cleveland Clinic cardiologist Eric Topol. “There is a sense that we have tried [to preach better lifestyle], but patients don’t do it.”

Epidemiological studies have found that bad living–smoking, drinking too much alcohol, feasting on cheeseburgers–is responsible for 80% of one’s risk of heart disease and almost all of the risk of diabetes. Cleaning up your act would do more to reduce that risk than popping a plethora of new pills. Quit smoking by age 40 and you can add nine years of life; stop by 50 and you can buy six years. Walking briskly three hours a week adds six years of life, if you start at age 45.

Heart patients who go on a Mediterranean diet reduce their risk of future heart attacks and cardiac death by up to 70%; cholesterol-lowering drugs cost us $13.9 billion a year and lower the risk only half as much. Shedding a few pounds and exercising lowers the chances of developing diabetes by 58% in those at risk; Bristol-Myers Squibb’s Glucophage and similar drugs are taken by 6.5 million patients. In a test of its power as a prophylactic it reduced the incidence of the disease by only 31%.

This is the inherent bias in a system of medical benefits that reimburses employees for drugs and hospital visits but (usually) doesn’t subsidize their trips to the gym. “People say diet and exercise have failed, but the system never gave diet and exercise a chance. Doctors don’t learn about it in medical school, while every day pharmaceutical reps are pounding into their heads the benefits of drugs,” says Timothy Church, a preventive medicine researcher at the Cooper Institute in Dallas. “If corporations spent just a tiny fraction of what they spend on drugs on lifestyle modification, we could save hundreds of millions in health costs.”

“Eat your broccoli, dear.” That advice is a century old. What makes it more relevant now?The very fact that the drug industry has come up with so many genuine lifesavers like antibiotics or cancer drugs for which there is no lifestyle substitute. Since drug interactions are always a risk, you would be better off living a clean life, avoiding the drugs that can be avoided and saving room in your bloodstream for the lifesavers.

Are Americans prepared to jump on the treadmill? “Human nature is working against us,” says Gary Palmer, a vice president at Pfizer, which makes Lipitor. He’s right. But that doesn’t mean you shouldn’t try. Herewith are specifics on drug avoidance, in seven categories.

High Cholesterol

Lipitor and other statins can be lifesaving for anyone with proven heart disease–a market of 13 million patients. Federal guidelines now recommend the drugs for up to 24 million more Americans who don’t have heart disease but risk getting it in the future. Abramson and other critics argue that the rush to give cholesterol drugs to just about everyone goes beyond the evidence and could pose unknown future side effects. In healthy women the drugs don’t appear to save lives at all, and the evidence they prevent heart disease is weak: Statin takers have only a slightly better chance of avoiding heart disease than women on a placebo, according to a recent analysis. Pfizer’s Palmer, a cardiologist, counters: “If my mother had high cholesterol, I wouldn’t want her to wait until she had a heart attack to get treated.”

Lipitor will reduce your bad cholesterol by 40% to 50%–but what happens if you don’t want to take the drug for the rest of your life? Making some fairly radical changes in your diet can reduce bad cholesterol by up to 30% in only four weeks, a recent University of Toronto study found. The Toronto team designed a vegetarian diet that augmented a standard low-fat regimen with foods that in lab studies have shown an ability to lower cholesterol levels, including soy protein (activates cholesterol receptors); oats and other soluble fibers (helps the body process cholesterol-containing bile); almonds and so-called plant sterols found in vegetables and plant oils (inhibit cholesterol absorption from the gut). Patients on this vegetarian diet for four weeks reduced their bad cholesterol levels just as much as a control group on Merck’s Mevacor.

“People thought the most you could do with diet was 10% or 15%. We basically doubled that,” says University of Toronto nutrition researcher Cyril Kendall. The next test: whether patients are willing to stay on such a radical diet over the long haul.

James Anderson of the University of Kentucky is working with food companies to put the Toronto study’s ingredients into a twice-a-day cereal bar, so people could reduce their cholesterol without having to completely give up meat. He says up to one-half of the people told to take statins could avoid the drugs by consuming such a product. “People are nervous about taking statins; they want to get as much mileage as possible from diet and exercise,” Anderson says.

Meanwhile, eating a Mediterranean diet high in fruits, vegetables, nuts, beans and omega-three fatty acids (found in fatty fish) may cut your risk of heart attack at least as much as Lipitor does, even without lowering your cholesterol much. A 2002 study in India compared the effects of a Mediterranean diet with a standard low-fat diet in 1,000 heart patients, most of whom had untreated high cholesterol. Two years later those who ate the Mediterranean diet had half the risk of heart attack and sudden cardiac death compared with those who stayed on the regular low-fat diet, even though their cholesterol declined only a modest 14%. In general each additional serving of fruit or vegetables that’s added to your daily diet decreases the risk of heart disease by four percentage points.


Diet and exercise can lower blood pressure significantly. One trial of 412 people with slightly elevated blood pressure found that a diet high in potassium, with just one-third the salt used in standard American fare, could reduce blood pressure by up to 11.5 points (millimeters of mercury) in 30 days; the diet was especially effective in African-Americans. The improvement is equivalent to what can be achieved with a single drug.

Even some people on meds for years may be able to go off them and maintain normal blood pressure with minimal lifestyle changes. In one study of 8,000 patients who took a holiday from their blood-pressure meds, 20% to 25% of them had no return to elevated levels, say researchers at the Baker Medical Research Institute in Melbourne, Australia. This may be because some people were erroneously put on the drugs, or because years of drug therapy healed heart damage, or simply because taking people off the pills motivates them to clean up their behavior.

“We propose that a period of drug withdrawal should be considered as part of ongoing management of hypertensive patients,” says cardiovascular epidemiologist Christopher Reid. This may make particular sense around retirement age, he says, when people are likely to have more free time to start an exercise program.

Thinning Bones

If you are one of the 8 million American women who have osteoporosis (brittle bones), one option is taking Merck’s Fosamax. It builds bone density by 5% to 10% in the spine and hip and cuts in half the risk of a debilitating hip fracture. But the drug also is approved for treating a vastly larger swath of 34 million Americans with slightly thin bones (osteopenia). Even some experts who have helped test Fosamax say this broader group is being overtreated.

“Osteopenia is not a disease. It is a term that was invented and arbitrarily defined by a group of men ten years ago,” says San Francisco epidemiologist Steven Cummings, who has helped test Fosamax and other osteoporosis drugs. “It creates the impression [among younger woman] that you need a drug, even when it doesn’t make any medical or biological sense.” In reality, the absolute risk of a hip fracture for an average 60-year-old woman with mild osteopenia is very small, one-tenth of one percent a year; for any nonspine fracture, the risk is two percent a year. And there is no direct evidence that Fosamax prevents hip or wrist fractures in this broader group. Dr. Bess Dawson-Hughes, president of the National Osteoporosis Foundation, counters that it would be a mistake to exclude all women with osteopenia from treatment, since most fractures occur in this group. She says it’s implausible that the drugs would have no fracture effect on women with osteopenia.

Calcium and vitamin D, by contrast, are essential to maintaining the bones and can be had by adjusting your diet. An exercise regimen also can keep up bone density and let a person avoid getting on the drugs. In one recent study researchers in Germany tested the effects of three hours a week of strength training, jumping and high-impact aerobics on 50 postmenopausal women at risk for osteoporosis. After three years, those in the exercise therapy group had maintained their bone density, unlike the small control group that was inactive. Patients in the exercise group reported lower cholesterol levels and less back pain than those in the control group. The German researchers now hope to compare exercise with drug therapy in a larger, longer-term trial; but so far no one is willing to fund it.

Anxiety and Depression

The 1990s made pill-popping for happiness an acceptable therapeutic alternative for millions of even mildly depressed patients. Now 80% of people who seek treatment for depression try drugs, while only half have tried talk therapy, according to a poll by Harris Interactive. Prozac and its successors were an ideal solution for employers wary of paying the bill for a lifetime of 45-minute sessions for long-winded Woody Allens. “Psychotherapy just can’t compete with drug company advertising. We get crushed,” says Michael Otto, a clinical psychologist at Boston University.

But the drug lineup finally has a potent alternative: a newly emerging style of therapy of shorter and intentionally finite duration, with less hand-wringing about past hurts and more coaching on how to cope. Known as cognitive behavioral therapy, this approach has been rigorously studied and has had startling success in a variety of applications.

The new therapy replaces open-ended, classic psychoanalysis with a course of 12 to 20 sessions aimed at breaking distorted thinking patterns common in anxiety and depression and teaching coping skills so patients can retake control of their lives. Patient trials in panic disorder, obsessive compulsive disorder, social anxiety disorder and adult depression have found that cognitive behavioral therapy is as effective as drugs in the medium term and good at preventing relapse once drugs are stopped, says Otto; combining drugs and therapy may be even more effective. (Psychiatrists say drugs tend to be better for severe cases and dispute that CBT helps prevent relapses of major depression.)

Unlike Prozac, Paxil and Zoloft, psychotherapy doesn’t cause sexual dysfunction. “Drugs just mask the problem; this teaches you to condition yourself to get over your fears,” says Robert MacNeill, a 62-year-old contractor. Until he tried cognitive behavioral therapy, panic attacks made him unable to travel more than an hour’s drive from his home in Hingham, Mass.; now the attacks are much less frequent and he flies all over the world. One big downside, besides the time commitment: Few therapists have been trained in these newer techniques.

Chronic Pain

As estimated 26 million Americans have chronic pain in the lower back, and roughly 15% end up on narcotics, with an increasing number taking potent remedies such as Purdue Pharma’s OxyContin. Their use in these patients is controversial, as there are few studies documenting their effectiveness over the long term; side effects include nausea, constipation and dependence. (A Purdue Pharma official says the drugs “work extremely well” for some back patients.) Moreover, chronic pain conditions are a far murkier beast compared with acute pain from an injury. “Chronic pain is in many ways a central sensitization of pain producing pathways in the brain,” says James Rainville, a Harvard prof and chief of physical rehabilitation at New England Baptist Hospital. This allows pain signals to be created long after the original injury healed. Patients with back pain used to be told to stay in bed. Today researchers preach the opposite: exercise. Few studies have compared exercise to drug treatment, but two randomized trials have shown that vigorous exercise combined with cognitive treatment is just as good as spinal fusion surgery, with fewer complications. Strength training, aerobic exercise and stretching can prevent muscles from withering, reduce disability and even reduce pain intensity by 10% to 50%, Rainville says. In a recent 84-patient study published in the Spine Journal, Rainville found half of the patients in the study on narcotics were able to stop taking them after six weeks of exercise therapy.

Surprisingly, psychological therapy can also help treat various sorts of chronic pain, including back pain. At least six controlled studies show that cognitive behavior therapy can improve symptoms and lessen disability somewhat.


Sleep-starved Americans shelled out $1.3 billion for Sanofi-Aventis’ sleeping pill Ambien last year. The short-acting pill is popular because it eliminates the hangover associated with older medicines. Ambien and pills like it are approved only for short-term use; few clinical studies have bothered to document their safety beyond three months of usage. Yet “every week I see patients who have been on them for years,” says Dr. Gregg Jacobs, sleep medicine expert at Harvard MedicalSchool. “Be wary. We have no idea what the long-term side effects are.” Known short-term effects include diarrhea and dizziness, which may increase the risk of falls in the elderly.

Cognitive behavioral therapy could help here, too. Five sessions with a psychologist may fix the problem by teaching relaxation techniques, using behavior modification to boost the association between bedtime and sleep, and counseling to get overwrought patients to realize that their insomnia has less of an impact on the next day than they think. “People with insomnia catastrophize and make matters worse,” says New York psychologist Arthur Spielman. “They think, ŒMy immune system is going to fail, I won’t be able to function and I will lose my job.'”

Most drug trials compare the drug to a placebo. Harvard’s Jacobs put Ambien to the test in a rare head-to-head trial versus cognitive behavioral therapy in a small number of patients with insomnia (63 in total). The result: the new therapy worked as well as the drug in the short term and was clearly better than Ambien in the long term. Both therapies helped people get to sleep 25 to 30 minutes faster in the short term, but Ambien’s effects faded when patients stopped taking it; the therapy patients still were sleeping better a full year later. Sanofi-Aventis says the study was too small to offer any real conclusions about the relative merits of the therapies. But will Sanofi conduct any studies comparing Ambien to therapy? The company says that no decision has been made yet.

One myth is that adults need eight or more hours of sleep each night. It turns out that people who sleep nine hours or more have a slightly higher mortality rate than those who sleep just six or seven, according to a giant study conducted by the University of California, San Diego; it involved looking at the records of 1.1 million Americans.


Treating stomach acid is big business in the U.S., where patients spend $13 billion a year on 92 million prescriptions for Nexium (“the new purple pill”), Prilosec and other proton pump inhibitors. These drugs are amazingly effective at suppressing acid. But stomach acid is a defense against bacteria, and a big new study found that acid suppression may have a surprising downside: more infections.

In one of the first studies to address this issue, Netherlands epidemiologist Robert Laheij culled medical records of 365,000 patients and found that people taking proton pump inhibitors had a 90% higher risk of getting pneumonia than a control group not taking the drugs. The higher the dose, the greater the pneumonia risk, his team reported in the Oct. 27 Journal of the American Medical Association. The absolute risk to any one person is minute, but it translates into tens of thousands of excess cases of pneumonia in this country each year because of the drugs. AstraZeneca says that it has not found any evidence of pneumonia risk in studies it has conducted in more than 100,000 patients who were taking its drugs, Prilosec and Nexium. It sees no reason to look further into the matter.

Laheij says patients should stop gobbling Prilosec like candy, especially those who are susceptible to pneumonia complications (the elderly and people with asthma or weakened immune systems). Lifestyle changes, while no cure, may reduce the severity of symptoms of acid reflux. Obese patients are up to six times as likely as trim patients to report chronic heartburn, says a study in the Journal of the American Medical Association. Smoking and heavy drinking also are thought to play a role.

Lose weight, stop smoking and cut down on booze–it’s always the same advice, alas, and it’s never very much fun. But for many of us, the pharmaceutical alternative is no longer the clear-cut choice it once might have seemed; and for some of us, drugs may be the wrong choice altogether. It’s time to start thinking harder about when to just say no.

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