At 66, Peter was in pretty good shape. Running and calisthenics were a part of his daily routine for 28 years in the Marines. But he’d slacked off a bit since his retirement and by last summer his cholesterol had crept up to a point where his doctor put him on a statin drug. That’s when his health took a steep dive.

In six weeks, Peter lost 20 pounds, most of it muscle. His biceps went from 16 inches to 14 inches. The pants that used to be snug were now baggy. His face turned ashen. His muscles were sore, he felt weak, he had trouble walking. He went back to see his doctor, who took him off the medication.

Peter’s doctor was surprised at his reaction. He’d been taking Zocor, one of the older statins, considered relatively safe. Another statin, Baycol, was taken off the market in 2001 when it was linked to a sometimes fatal muscle-wasting condition, rhabdomyolysis—but the condition is rare in Zocor-takers. And when symptoms do show up, they usually disappear quickly when the patient stops taking the drug. But five months later, Peter still hasn’t fully recovered.
Peter didn’t want his last name used, for fear of damaging his relationship with his VA doctor. He’s happy with the care he gets, but the doc may have jumped the gun on prescribing the medication. For someone with two risk factors, as Peter has, the national cholesterol guidelines call for drugs only when levels of LDL—the “bad” cholesterol—are 160 or higher. Peter’s blood pressure was high and his father had had bypass surgery; his LDL was 156. Going strictly by the guidelines, his doctor should have urged Peter to first try bringing his cholesterol down with more exercise and dietary changes.

When an individual doctor oversteps guidelines, it’s one thing. What’s more disturbing is that the guidelines themselves may be skewed toward overprescribing statins. Dr. John Abramson, a family practitioner who teaches primary care at Harvard Medical School, says that when you look at the data on which the guidelines are supposedly based, the evidence simply isn’t there. Follow the money and you see the problem: Eight of the nine experts who wrote the guidelines had financial ties to statin manufacturers.

It’s a pervasive problem, says Abramson, not just with statins, but with all prescription drugs. The pharmaceutical companies drive medicine at every level: in the research lab, in the medical journal, at the regulatory agency and in the doctor’s office. Abramson dissects the system in his book, Overdosed America: The Broken Promise of American Medicine, published last fall.

Abramson’s timing could only have been better if the publishing date had been nine days later. That’s when the blockbuster arthritis drug Vioxx was pulled from the market with the announcement that it increased the risk of heart attack and stroke. At the same time, it was revealed that the FDA knew about the risk for four years and had ignored it. “The book came out to a resounding thud on September 21,” says Abramson. “And on September 30, when Vioxx was recalled, I suddenly found myself on CBS Evening News, CNN Headline News, Lou Dobbs, the Today show and CNN’s American Morning. So what seemed like it was too bad to be true suddenly gained credibility on September 30.”

• • • •

THE VIOXX RECALL set off a chain of events that have raised serious questions about how the drug companies influence medical decisions, corroborating many of the contentions in Abramson’s book. Senate hearings have been held, in which FDA drug safety officer David Graham said that conflicts of interest made the agency incapable of protecting the public from unsafe drugs. The Journal of the American Medical Association called for an independent agency to monitor drug safety, again citing FDA conflicts of interest. A previously buried survey by the Department of Health and Human Services was unearthed, in which a significant minority of FDA scientists said they’d been pressured to recommend approval of new drugs despite their reservations about safety or efficacy.

Also, a recently published study on arthritis medication highlights the role of physicians: It showed that doctors had been prescribing new drugs like Vioxx to patients who could have gotten the same relief from older, cheaper drugs with a known track record for safety.

The legalization of consumer-directed advertising has fueled the overprescribing of drugs. People watch a persuasive TV pitch for something touted as a new miracle drug, go to the doctor’s office and demand it. At the same time, drug manufacturers send their reps to doctors’ offices with free samples and a blizzard of literature. Manufacturers also sponsor continuing education and grand round visits from experts who give glowing reports of whatever drug they’re being paid to push. Hit from both sides—patients and drug makers—docs feel that prescribing the latest pharmaceuticals is all part of giving the best state-of-the-art care.

Dr. Joel Sklar, chief of cardiology at Marin General, says drug company influence used to be even more shameless. “I’m young enough that I wasn’t around during the real boondoggle era—the whole business of taking doctors out to dinner at fancy restaurants and weekends in the desert—that’s gone. So the level it’s at now is, they come to the office, we listen to them. We like to think we’re smart enough that we’re not actually influenced and I like to think it’s true. But no question, it’s an issue.” Visiting professors who conduct grand rounds announce right off the bat who’s sponsoring them, he says, and add a reminder when they get to their spiel about the sponsor’s drug. “The question is whether that level of transparency is good enough to outweigh the bias. But it’s a lot like lobbying. Face time counts.”

Even if doctors can manage to maintain a healthy skepticism about drug company influence, when it comes to the reliability of the major medical journals, their faith borders on religious. “I think if doctors stopped believing in those sources as legitimate,” says Abramson, “they would become paralyzed.”

Abramson’s own disillusionment came from applying the research skills he’d learned as a Robert Wood Johnson Fellow to his analysis of some studies published in JAMA and The New England Journal of Medicine. He remembers his partner’s reaction when he told him that these highly respected journals had misrepresented the data. “Honest to God, he looked at me like I was having a psychotic break. I mean, if I had said, ‘Jesus is in my gas tank and the CIA’s going to press the button if I don’t wink twice,’ he would have had the same look on his face.”

Abramson, who describes himself as a “child of the late ’60s,” is clearly more willing than most physicians to question authority, and probably a bit more idealistic. He grew up in a middle-class suburb near Boston and graduated college in 1970. While he was attending Dartmouth Medical School, he spent two summers working in a clinic in rural West Virginia. He loved it. After med school, he spent two years practicing in Appalachia before hanging his shingle in the tiny town of Hamilton, Massachusetts.

• • • •

ABRAMSON’S FAITH IN the system was shaken the first time four years ago, when he read a study in the NEJM concluding that a statin drug marketed as Pravachol reduced the risk of stroke. When he looked at the details of the data he realized that the only patients in the study who benefited from the drug were men under the age of 70. In the general population, half of all men who have strokes are 71 or older, and half of all women are at least 79. And among the patients in the study who were older than 70, Pravachol increased the rate of stroke by 21 percent.

Busy doctors don’t often give the studies published in the journals such careful scrutiny. They consider themselves conscientious when they read the titles and summaries. Without poring over the details, they would come away from the Pravachol article thinking it was good for all their patients—a dangerous misunderstanding.

As Abramson delved further into the literature, he found that a lot of the standard assumptions about cholesterol and heart disease were questionable. It’s become a given, for instance, that a high cholesterol count means an increased risk of death from heart disease for everyone. But the famous study that served as the basis for calculating cholesterol risk—the Framingham Heart Study—actually shows there is no such correlation after the age of 60—in fact, for people over 50, the risk of death from causes other than heart disease increases with lower cholesterol levels.

Michael Lerner, co-founder of Bolinas-based Commonweal and the Collaborative on Health and the Environment, thinks the questions raised by Abramson merit more examination. “I’m not saying that Abramson, in quoting one study, is necessarily right about the risk/reward ratios of statins,” he says, weighing each word. “But I am saying that—given the enormous financial stakes of the pharmaceutical industry in the prescription of statin drugs and given their enormous power both in the medical community and the FDA—that these are questions that need serious, independent evaluation. And that’s what interests me. I’m concerned that the pharmaceutical industry in the United States right now is seriously out of whack.”

Abramson has been out to Bolinas to talk with Lerner about how his network might take on an examination of the issue. While Lerner’s organizations are headquartered on a nearly inaccessible bluff overlooking the Pacific, miles from the nearest freeway, his collaborative consists of 1,400 organizations and individuals scattered across the country and its work is known throughout the world. Focusing on the link between the environment and human health, CHE’s groups are studying cancer, learning and developmental disabilities, infertility and electromagnetic fields. Lerner says they’ve been considering for some time whether to start a group on pharmaceuticals and health. His interest became personal recently when he landed in the emergency room with a bad reaction to a statin drug.

He’d been on Lipitor for 18 months, after a heart attack. He never experienced any soreness or weakness in his muscles, but one night he was hit with an intense bout of nausea and vomiting. At 2 in the morning a friend drove him across the county and he checked into Marin General Hospital. “A very wonderful and insightful cardiologist who was on call that night looked at my liver enzymes, asked me if I was on a statin and Niaspan [a time-released niacin medication] and told me, that’s it, get off them.”

Since cholesterol is produced in the liver and statins work by limiting that action, it’s not surprising that the drugs can affect liver function. Adding niacin increases the risk, but also gives statins an added boost at reducing cholesterol, so the two drugs are often prescribed together. Doctors routinely monitor their patients’ liver function to catch any abnormalities. Lerner’s reaction came up suddenly, in between screenings.

• • • •

LERNER HAS NO qualms about the care he received. In his case, prescribing Lipitor was perfectly appropriate, and may even have saved his life. It’s when people who don’t have existing heart disease are put on statins that has Lerner concerned. “The people who are most likely to benefit from statins are people who have already had a heart attack and the goal is to prevent a second one. And I was in that group. So I am grateful that Lipitor was prescribed for me, and if I had not developed liver toxicity, I would probably be taking it to this day.”

Still, Lerner hasn’t gone back on the medication, although his liver has since recovered. He’s chosen instead to participate in two cardiac rehabilitation programs—one with Dr. Dean Ornish, the other with Dr. Mark Wexman. They both prescribe four lines of attack: a very low-fat diet, exercise, stress reduction using either yoga or tai chi, and participation in a support group.

Ornish ran a small study, published in both JAMA and The Lancet, which showed impressive results: Patients with heart disease who followed the program reduced their LDL by 40 percent after one year; after five years, they had 2.5 times fewer cardiac events than patients who didn’t follow it. Lerner has been sticking to the program religiously.

Of course, not everyone is as motivated as Lerner. “Lifestyle change” programs take work. The appeal of statins is that they’re so easy. Pop a pill once a day and your cholesterol comes down. Patients like the quick fix, and so do doctors. With a borderline patient like Peter—two risk factors and an LDL level just a few points shy of the guidelines-recommended medication trigger—a statin prescription is a surefire way to reduce his cholesterol.

Since he was forced to go off his medication, Peter has lowered his fat intake a bit and upped his exercise regimen. But there’s only so much he’s willing to do. He doesn’t want to change what he eats, so he limits his fats by eating less of everything. He doesn’t belong to a support group. He says he doesn’t have the patience for yoga.

And he’s had his share of stress. During his two tours in Vietnam as a helicopter pilot, he was shot down twice. He finally left the military two years short of 30 after being passed over twice for promotion. His 26-year marriage ended in divorce. Now he’s in his 60s, living alone. He knows he could benefit from a stress reduction program. In fact, he’s become involved in the alternative health community in recent years. His life took a dramatic shift after his divorce. He spent three years in India living near an ashram and going there every day for meditation. He learned therapeutic massage there and, since settling in Marin, he’s been practicing at a chiropractic clinic and receiving referrals from the Stress Management Center in Larkspur.

He was sheepish when the owner of the center, Robin Gueth, noticed he looked ill last fall and he had to admit he’d been taking Zocor. He knew she disapproved of statins. Gueth’s father died of kidney failure a year and a half ago after being put on one statin drug after another for a year. Sitting cross-legged on the floor of her yoga studio, her voice rises in anger as she talks about what she’s seen the drugs do to men she knows. “I’ve had it with this! If I see one more 50-year-old man come in and tell me he’s feeling out of shape and lethargic and I find out he’s started taking Lipitor and his liver screens are off, I’m just going to lose it. The amount of medication they’re taking into their bodies is having side effects, they feel like dirt and don’t know why. And I don’t want to see them, God forbid, leave us because nobody recognized the symptoms until it was too late.”

Dr. Sklar, on the other hand, hopes that people who need statins don’t get scared off. “Not everybody needs an LDL of 70 and not everybody should take a statin, but if you’ve got heart disease, you shouldn’t be saying, ‘Oh, my God, these drugs are the devil’s spawn.’ “ He’s afraid that, in the wake of all the bad publicity about statins and other drugs, some useful medications could be yanked from the market. He worries in particular about Crestor, a newer drug that has shown a much higher rate of rhabdomyolysis and kidney failure than other statins. “It has a higher incidence of risk because it’s more potent,” he says. “If a drug has advantages over other drugs in certain situations and a known higher risk, I don’t think it should be taken off the market. The patient should have the choice. I’m for full disclosure, and let people decide.”

Full disclosure would be a good start, Abramson agrees. Beyond that, he would like to see an independent oversight board set up to evaluate research and develop clinical guidelines. “Let’s have reasonable people who have no ax to grind look at all the scientific evidence and see which drugs work and in what situations and let’s just find out the truth,” he says. “At heart, I think this is a question of whether democracy can work, or whether the marketplace can so bias information to serve commercial ends that we’re unable to make informed decisions as citizens. Because if we can’t have good information then we can’t make good decisions, in medicine or in any other arena of our public lives.”

On March 2, 7:30-9pm, Lee Lipsenthal, M.D., former director of the Dean Ornish Clinic and incoming president of the American Board of Holistic Medicine, will answer questions about heart health, medications and alternatives. The event is free at the Stress Management Center of Marin, 1165 Magnolia Ave., Larkspur, 415/461-2288.