Overdosed America (35 page)

Why the cold shoulder? Not only did the Lyon Diet Heart Study show that the Mediterranean diet was much more effective at reducing the risk of recurrent heart disease than the statins, but the decrease in risk came without lowering cholesterol levels. Giving the Lyon Diet Heart Study its due would have called into question the NCEP’s very mission of bringing LDL cholesterol to the public’s attention as the single most important culprit in heart disease. Given the amount of resources committed to educating people about lowering cholesterol compared with helping people eat a healthy diet, one might correctly surmise that drug companies have much more money to spend promoting the “scientific evidence” that supports lowering LDL cholesterol with statins than do the flaxseed, canola, olive, soybean, walnut, and vegetable farmers who would benefit from the widespread promotion of the Mediterranean diet.

The only reasonable conclusion from the best scientific evidence available is that taking a statin while ignoring routine exercise, a healthy diet, and the dangers of smoking may be good for drug company profits but is not good for your health. It’s not uncommon to hear doctors say that we should “just put statins in the water.” Wherever that phrase came from, it is certainly not from unbiased research. The narrow focus on cholesterol levels, statins, and cardiac tests and procedures has succeeded in drawing attention away from far more effective lifestyle changes that cost little more than a shift toward vegetables, whole grains, and unprocessed foods at the supermarket; and a pair of sneakers for a walk or jog around the park or a workout at the gym.

Stroke is the third leading cause of death in the United States. Between 1970 and 1990 the death rate from stroke declined even more quickly than the death rate from coronary heart disease. But then
progress in stroke mortality stalled
even more abruptly than it did with coronary heart disease.

Why? The risk factors for stroke are similar to the risk factors for heart disease, and the lack of progress after 1990 had an even greater effect. In October 2003, at the Centers for Disease Control and Prevention’s Third Annual Primary Care and Prevention Conference,
Dr. Wayne H. Giles
(an epidemiologist with the CDC) reported that compared with participating in regular exercise, a sedentary lifestyle increases the risk of stroke eightfold. Smoking increases the risk sixfold. High blood pressure increases the risk of stroke by two to four times. And diabetes doubles the risk of stroke.

It’s the same basic story: attention diverted from prevention to lucrative, but less effective, intervention. For example, you may have noticed that strokes today are sometimes called “brain attacks.” The name is actually quite fitting as a description of the problem. Eighty percent of strokes are caused by blockage of an artery that cuts off the supply of oxygen and nutrients to an area of the brain, causing the death of brain cells in much the same way that blockage of coronary arteries causes heart attacks. These are called “ischemic strokes.” (The other 20 percent of strokes, called “hemorrhagic strokes,” are caused by bleeding either within or just outside the brain.) The analogy also holds for the consequences of stroke, which can be as devastating as a severe heart attack. But the analogy does not hold quite so well for the benefit of emergency treatment, which is really what is behind the proposed name change.

The term “brain attack” was introduced into the lexicon by a marketing campaign sponsored by the biotech company Genentech. Genentech makes an expensive clot-busting drug,
Activase
(generic name, alteplase), that has been used, and perhaps overused, in the United States to treat heart attacks. It is now being pushed as a breakthrough in the treatment of ischemic strokes, at the cost of $2700 per patient treated. The term “brain attack” is designed to focus public attention on the urgency of getting stroke victims to the hospital as quickly as possible so that appropriate treatment (the term “lifesaving” was deleted because it wasn’t true) can be administered.

The results of a manufacturer-sponsored study show that when Activase is administered to 100 properly selected patients within three hours of the onset of stroke symptoms, 12 more patients have minimal or no disability three months later. In order to make sure that a stroke patient is more likely to be helped than harmed by Activase, within those three hours patients must have blood tests, a review of their medical history, a medical examination, and a CT scan to make sure that the symptoms are not being caused by a hemorrhagic stroke, in which case the clot-busting properties of Activase would make the stroke worse. In a paper published in the
British Medical Journal
in 1999, Danish researchers calculated that if all stroke victims got to the hospital in time (an admittedly unrealistic goal),
only one out of 25 would derive any benefit
from being given Activase. The Danish researchers concluded that “. . . treatment with alteplase [Activase] may benefit single patients but will have no impact on the general prognosis of stroke.. . . Before it is decided to offer this expensive, potentially harmful, and possibly only marginally effective treatment we suggest that another, much larger, European trial is needed to test the results of the U.S. trial.”

Nonetheless, the
2000 American Heart Association guidelines
for the treatment of acute stroke, published in its journal
Circulation,
upgraded the recommendation for the use of Activase in ischemic strokes from “optional” to “recommended.”
Dr. Rose Marie Robertson
, president of the AHA, described the nine experts who formulated these guidelines as “independent.” Each of the panelists had been required to file conflict-of-interest statements with the AHA, but no conflicts were reported in the American Heart Association’s guidelines published in
Circulation.
In a 2002 article published in the
British Medical Journal,
investigative journalist Jeanne Lenzer reported that the American Heart Association “will not release the conflict of interest statements for public inspection and verification.” However, a subsequent independent investigation reported that
six out of the eight experts
who supported the upgrade in the recommendations had financial ties to Genentech. In addition, contributions from Genentech to the AHA totaled $11 million between 1991 and 2001, including $2.5 million to help build the AHA’s new headquarters in Dallas.

This investigative work provides a rare look into the financial relationships among the American Heart Association, a drug manufacturer, and respected medical experts. Although there is no evidence of impropriety, one would expect that in the face of a decision as important and potentially controversial as its recommendation on the use of Activase for strokes, the American Heart Association would have gone out of its way to avoid even the hint of financial influence. The end result is that Activase, a very expensive therapy that can help fewer than 1 out of 25 stroke victims, is getting the majority of our medical attention regarding strokes, while exercise, not smoking, control of blood pressure, and prevention of diabetes are all far more effective ways to decrease the terrible toll of strokes and improve overall health at the same time.

Activase hasn’t been getting all of the attention. “Worried about having a stroke?” read the ads in widely circulated magazines and newspapers. They continue, “Pravachol is the only cholesterol lowering drug proven to help protect . . . against stroke.” The problem with these ads is that Pravachol has never been shown to prevent strokes in people who don’t already have heart disease. The manufacturer just publicly repeated the little slip it had made in the original
misleadingly titled NEJM article
“Pravastin and the Risk of Stroke,” which may have led busy readers to draw the same incorrect conclusion. But in this case the FDA was paying attention. These “false and misleading” ads
earned Bristol-Myers Squibb one of only five Warning Letters
sent to drug makers for advertising violations in 2003. The FDA seemed particularly irked because, the letter said, it had sent two less severe letters to Bristol-Myers Squibb for similar “overstated” and “unsubstantiated” claims in 2001.

If stroke prevention is the goal, lowering cholesterol with a statin drug is hardly the first strategy we should turn to. According to the data presented by Giles at the CDC conference, an elevated cholesterol level increases the risk of stroke one-eighth as much as diabetes, one-eighth to one-sixteenth as much as elevated blood pressure, and less than a thirtieth as much as a sedentary lifestyle.

With expensive therapies getting all the attention, the very effective and inexpensive basics of stroke prevention have been pushed aside. Engaging in routine exercise, not smoking,
eating fish at least once a week
, and controlling blood pressure (often with diuretics that cost less than $0.15 a day) would go a long way toward decreasing the amount of harm done by strokes in the United States.

The United States is in the midst of an
epidemic of type 2 diabetes
. In the past 12 years, the number of people with this disease increased by 78 percent, to more than 16 million, and the number is going up by 1.3 million each year.

There are two forms of diabetes. Type 1 starts abruptly, typically in childhood or adolescence. Its cause is unknown, but it is thought to involve an immune reaction against the cells in the pancreas that make the hormone insulin, perhaps triggered by a viral infection. The vast majority of Americans with diabetes (90 to 95 percent) have type 2. This has a more gradual onset, and is caused by slowly decreasing insulin production in the pancreas combined with decreasing sensitivity to the insulin that is produced. The risk factors for type 2 diabetes are excess body weight, lack of physical exercise, advancing age, and a family history of diabetes.

In the United States, deaths caused directly by high and low blood sugar are rare, but the complications of diabetes are responsible for more than 200,000 deaths and many other serious health problems each year. Almost half of the new cases of kidney failure in the United States are caused by diabetes. More than 80,000 diabetics undergo amputation of a foot or lower leg each year. Diabetes is the most common cause of blindness in American adults. Diabetics have twice the risk of stroke and two to four times the risk of developing heart disease. In 2002, the total cost of diabetes was $132 billion; $92 billion in direct medical costs and $40 billion in disability, work loss, and premature death.

Given the enormous toll of type 2 diabetes in terms of both human suffering and health care resources, one would expect that controlling this epidemic would be a top health priority. But most of what doctors and the public are hearing about diabetes recently has more to do with statin drugs. In April 2004, the
American College of Physicians issued clinical guidelines
recommending that all diabetics age 55 and older take a statin to protect against cardiovascular disease. One of the important studies upon which these guidelines are based is the widely publicized
Heart Protection Study
, which showed that treatment of diabetics with a statin drug decreases their relative risk of developing cardiovascular disease by 22 percent and the overall death rate by 13 percent. These sound like important reductions in risk and are the basis of the television advertisements recommending that diabetic viewers “talk to their doctor” about taking a statin. As with so many other studies, translating the relative risk reduction into the absolute risk reduction produces a different picture. More than 100 people with diabetes must be treated with a statin for a year to prevent a single cardiovascular complication.

Though drug therapy for diabetes is getting most of the attention, a number of recent studies show that changes in lifestyle offer much greater potential to control the number of new cases of diabetes and to decrease the health risks for people who already have diabetes. Data from the Nurses’ Health Study, published in NEJM in 2001, for example, show that
91 percent of the risk of developing type 2 diabetes
can be attributed to lifestyle factors such as being overweight, getting insufficient exercise, having a poor diet, and smoking. The study found that overweight women had 7.5 times the risk of developing diabetes as normal-weight women, and obese women had 20 times the risk. As a result of the childhood obesity epidemic, even young children in the United States are beginning to develop type 2 diabetes, a disease that until recently was seen only in adults.

Perhaps doctors don’t put much effort into encouraging patients to exercise and lose weight because they don’t believe their efforts will produce positive results. This conventional wisdom is not borne out by the scientific evidence. Two randomized studies, for example,
tested the effectiveness of counseling
for people at high risk of developing diabetes and came up with exactly the same results. Both studies found that overweight men and women at high risk of developing diabetes randomly assigned to receive exercise and weight loss counseling were 58 percent less likely to develop diabetes than the people randomized to receive no counseling. Among those who received counseling,
six fewer people out of 100
developed diabetes each year.

Why is there so little public awareness about the effectiveness of simple measures to prevent diabetes and its complications? A big clue is provided on the nonprofit American Diabetes Association’s website, in an announcement for a program called
“Make the Link! Diabetes, Heart Disease and Stroke,”
an initiative of the American Diabetes Association and the American College of Cardiology. The home page informs the reader that diabetes management involves more than just blood sugar control: “People with diabetes must also manage blood pressure and cholesterol and talk to their health provider to learn about other ways to reduce their chance for heart attacks and stroke.” There is no mention of the benefit of exercise or diet; for this you must access other web pages. However, the site does mention that the two nonprofit organizations participating in this educational initiative have
a number of “corporate partners,”
namely AstraZeneca, Aventis, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck, Merck/Schering-Plough, Monarch, Novartis, Pfizer, and Wyeth.