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Selling Sickness

Posted by medconsumers on January 1, 2006

BOOKS WE LIKE

Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients (New York: Nation Books, 2005)

We are being manipulated by the pharmaceutical industry. The we in this case includes the general public, doctors, researchers, consumer advocacy groups, federal health officials, and politicians. The pharmaceutical industry exerts its influence over virtually all aspects of the medical care system. It sets a lion’s share of the research agenda; has a strong say in the ever-changing definitions of normal; controls most of the average doctor’s postgraduate pharmacological education; and is changing the way we think about illness in order to sell more drugs. Just to name a few.

With predictable regularity, one “silent epidemic” after another—high blood pressure, high cholesterol, bone loss, depression—is promoted either directly with “educational” advertising or indirectly through media stories inspired by the press releases of multi-national pharmaceutical giants that stand to profit from our fears. And the industry isn’t above creating a few diseases of its own. Shyness is now a social anxiety disorder; whereas menopause has long been a hormone-deficiency disease. Both, of course, have prolonged drug therapy as the solution.

More often the pharmaceutical industry has a hand in broadening the definition of illness so that more and more people can be funneled into long-term drug therapy. In the not-so-distant past, for example, one did not have osteoporosis until a fracture had occurred; now the diagnosis can be applied to anyone who shows more bone loss than the average 35-year-old (on a bone density test). How this particular diagnostic change occurred can be traced to a World Health Organization meeting funded by producers of drugs that stop bone loss.

In “Selling Sickness,” Ray Moynihan, a journalist, and Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, British Columbia, carefully document pharmaceutical industry tactics in hyping awareness of and selling drugs for ten common conditions. Moynihan and Cassels do not dispute the fact that conditions like hypertension and osteoporosis can in fact lead to heart attacks and hip fractures, respectively, in some people. And others like depression and irritable bowel syndrome cause undeniable suffering.

Moynihan and Cassels object to industry-influenced expanding definitions of illness that turn millions of healthy people into lifelong patients. Too often thresholds for normal blood pressure and cholesterol are lowered, resulting in the same effect. Too often the normal travails of life or afflictions of aging are “medicalized.” Moynihan and Cassels found that 90% of the experts who sit on committees that set disease definitions and treatment guidelines for their peers have a conflict of interest because of financial ties to the drug industry.

For many doctors, the bulk of their information about new drugs comes from the materials supplied by the ubiquitous drug salespeople who regularly visit doctors at their offices armed with gifts and detailed information about their prescribing practices. (The Wall Street Journal once reported that there are 7,000 salespeople in the U.S. solely selling the cholesterol-lowering drug, Lipitor.) Moynihan and Cassels report how two Canadian health professionals are working to counter industry tactics by bringing unbiased information directly to doctors as well as the general public.

Bob Rangno, a physician, and James McCormick, a doctor of pharmacy—both members of Therapeutics Initiative at the University of British Columbia—travel the province delivering the same lecture. As recounted in “Selling Sickness,” they explain to a group of retirees that high blood pressure is not a disease in itself. Rather, it is one factor that can raise their risk of a future heart attack or stroke. Then Rangno and McCormick go on to demonstrate how easy it is to mislead with statistics, a common drug industry tactic. Their powerpoint slide shows the following questions based on study results:

Would you take a drug every day for five years if it…

A) lowered your chance of having a heart attack by 33%?

B) lowered your chances of having a heart attack from 3% down to 2%, a difference of 1%?

C) saved one person in a hundred from having a heart attack but there is no way to know in advance who that one person will be?

Rangno and McCormick ask the audience how many would take the drug based on question A, and about 80-90% raised their hands. Only about 20% indicated that they would take the drug based on questions B and C.

Then Rangno and McCormick reveal that all three questions are based on exactly the same study results. They explain that if a person’s risk of having a heart attack is 3% to start with, taking an antihypertensive drug to reduce that by 33% would bring that risk down to 2%. The 1% difference explains the one in a hundred who will benefit from the drug. “Advertisements to doctors and patients will claim, for example, that a drug offers a 33% reduction in the risk of heart attack without explaining that in actual fact you may have to take the medicine for five years in order to lower risks from 3% to 2%.” The surprised reactions they elicited from this audience of senior citizens, say Rangno and McCormick who have given this lecture numerous times, is no different from those expressed by an audience of physicians.

Industry’s marketing strategies are illustrated aptly in the chapter on female sexual dysfunction. To show how “new disease markets” are created, Moynihan and Cassels cite a business report, intended only for drug company marketing executives and potential investors, that “outlines how companies are ‘expanding the patient pool’ by using marketing campaigns to change public perceptions about what used to be considered normal life.”

Companies that make erectile dysfunction drugs are expanding their market to include women. But activists are fighting back. Chief among them is psychologist Dr. Leonore Tiefer, New York University School of Medicine, who is said to have documented the fact that for almost every key meeting where this new condition was being defined, the funding came directly from the pharmaceutical companies. She attends many of these meetings objecting to the narrow focus on genitalia and voicing another view of women’s sexual difficulties, which she acknowledges are widespread. “Women’s sexual problems and satisfactions have far more to do with relationship difficulties, life stress, and cultural expectations than with clitoral blood flow or testosterone levels.”

Tiefer’s five-year campaign of activism, which has had a strong impact on public debate via the media, merits imitation, say Moynihan and Cassel, “Her colorful campaign could well become a guide for others looking to expose and combat corporate attempts to inappropriately widen the boundaries of human illness.”±

Maryann Napoli, Center for Medical Consumers © January 2006

Posted in Book Reviews, Conflict of Interest, Drug ads, Heart, Women's Health | Tagged: , , , | Comments Off

Radiation-Induced Heart Damage on the Decline

Posted by medconsumers on May 1, 2005

Radiation therapy now has a lower risk of fatal heart damage to women with breast cancer than it did for women treated in the past. The cardiac harm, however, does not show up until ten or more years after treatment, so it remains unclear whether this adverse effect has been completely eliminated by modern improvements in radiation techniques. These findings were published last month in the JNCI (Journal of the National Cancer Institute, 3/16/05).

As of 2002, about 42% of American women newly diagnosed with breast cancer had the cancerous breast tumor surgically removed (lumpectomy) followed by six weeks of radiation therapy. This has been a valid choice ever since 1985 when a major nationwide clinical trial found that mastectomy (breast removal), lumpectomy plus radiation therapy, and lumpectomy alone all had the same survival rate. Lumpectomy alone, however, was—and still is—rarely offered to women. This is because the same large clinical trial found, in 1993, that the radiation therapy decreased the rate of breast cancer recurrence, though it did not reduce the death rate. Worse, as women treated with radiation were followed beyond ten years, they showed a higher death rate then the women whose breasts were not irradiated.

Obviously, this was not expected. Researchers began to speculate that the anticipated decrease in breast cancer mortality was being offset by an increase in treatment-related deaths. By the early 1990s, researchers knew that there were more cardiac deaths among breast cancer patients given radiation therapy than those whose breasts had not been irradiated. A 1994 analysis showed a 62% increase in heart-related deaths among women treated with radiation. Researchers also knew that women with left-sided breast cancer had higher rates of radiation exposure and higher rates of cardiovascular mortality.

To determine whether the multiple improvements in breast radiation techniques had overcome this hazard, a Texas research team assessed the data from 12 cancer registries around the country. Altogether the registries included 27,283 women with early-stage breast cancer who had been treated with radiation therapy between 1973 and 2000. (Radiation therapy after a mastectomy was the standard breast cancer treatment until the mid-1970s; and it continues to be used in certain circumstances.) Half of the women had left-sided breast cancer, and half had right-sided breast cancer. These registries are broadly representative of the way breast cancer patients are treated across the country.

The researchers, led by Sharon H. Giordano, MD, MPH, University of Texas M.D. Anderson Cancer Center, Houston , found that the risk of death from heart disease decreased over time. For the women diagnosed between 1973 and 1979, the heart disease mortality rate at 15 years was 13% for those with left-sided breast cancer and 10% for those with right-sided breast cancer. For the women diagnosed in the late 1980s, it was nearly 6% and nearly 5%.

Dr. Giordano and colleagues concluded that, due to advances in radiation techniques, the risk of cardiac death associated with radiation after breast cancer “has substantially decreased over time.” Given that radiation-induced heart damage takes many years to develop, the researchers added this caution. “Whether the risk of ischemic heart disease mortality resulting from radiotherapy has been entirely eliminated cannot be determined definitely from this study. Continued follow-up of the women diagnosed and treated in the late 1980s will be necessary to answer this question.”

Where does this leave the woman diagnosed today? If radiation therapy doesn’t prolong life, wouldn’t it be safer to forego this treatment, just have a lumpectomy, and take the small risk of recurrence? “Not quite true,” answered Jack Cuzick, PhD, author of the editorial that accompanied the study. In an e-mail interview, Dr. Cuzick explained, “Recent trials are showing a reduction in breast cancer deaths [in women given radiation therapy], and little effect on other causes of death, so for women at high risk of recurrence and breast cancer death, for example, those with node-positive breast cancer, radiotherapy is a pretty good option.” But, Dr. Cuzick cautioned that there is still uncertainty about the value of radiation therapy for women whose breast cancer death risk is low, for example, those with tumors under 1 cm or ductal carcinoma in situ.

Maryann Napoli, Center for Medical Consumers ©
May 2005

Posted in Cancer, Heart, Women's Health | Tagged: , , , | Comments Off

Antibiotics Before Dental Procedures

Posted by medconsumers on April 1, 2005

Should People with Heart Valve Problems Take Antibiotics Before Invasive Dental Procedures?

People with heart valve problems are told to take antibiotics before certain dental procedures in order to prevent bacterial endocarditis. This disease can be triggered by bacteria disrupted by tooth scaling, dental implantation, and other invasive procedures. The bacteria goes into the bloodstream and become lodged in the innermost layers of the damaged heart valves. It is potentially fatal and can be well underway before symptoms ever appear. To treat after the fact might very well be too late. But antibiotic therapy in itself can cause harm. And some researchers have questioned the universal preventive antibiotics recommendation because bacterial endocarditis is an uncommon disease.

For a 2004 Cochrane* review entitled, “Penicillins for the prophylaxis of bacterial endocarditis in dentistry,” R. Oliver and colleagues searched the published medical literature to find studies that proved the benefits of preventive antibiotics outweigh the harm for high-risk people facing an invasive dental procedure. All that could be found was one case-control study conducted in The Netherlands, and its results are inconclusive.

The Cochrane reviewers also found a population study published in 2000 in the American cardiac journal, Circulation that quantified the risk of bacterial endocarditis and the risk of taking antibiotics. It estimated that people taking penicillin were five times more likely to die from an allergic reaction to this antibiotic than from endocarditis.

The Cochrane authors concluded: “There is no evidence about whether penicillin prophylaxis is effective against bacterial endocarditis in people at risk who are about to undergo an invasive dental procedure. There is a lack of evidence to support published guidelines in this area. It is not clear whether potential harms and costs of penicillin administration outweigh any beneficial effect. Ethically practitioners need to discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.”

*The abstracts from all Cochrane reviews are available at www.thecochranelibrary.com . See “Penicillins for the prophylaxis of bacterial endocarditis in dentistry”.

Maryann Napoli, Center for Medical Consumers ©
April 2005

Posted in Drugs, Heart | Tagged: , , , | Comments Off

Drugs For High Blood Pressure: Which Are Best?

Posted by medconsumers on April 1, 2005

Drugs that lower high blood pressure are the cornerstone of preventive medicine. Clearly they have prevented many a heart attack or stroke, but it’s getting harder and harder for doctors to know who should get what drug… and who should not be treated at all. Every few years a committee of hypertension experts (often with strong ties to the pharmaceutical industry) lowers the threshold for the definition of normal hypertension, steadily expanding the pool of people who should be on drugs.

And every few years a study produces the bad news that a certain anti-hypertensive drug or drug combination kills more people than other drugs or drug combinations. Last December, for example, a study reported that an older, supposedly tried and true beta-blocker drug called atenolol (some brand names: Tenoretic, Apo-Atenolol) had caused more strokes and cardiac deaths than other commonly prescribed anti-hypertensives.

Many people have high blood pressure but no heart disease, and as a group they are less likely to have a large benefit from drug therapy than the people with heart disease. There are exceptions, of course, such as diabetics. And some people with high blood pressure gain nothing at all from drug therapy. A 2003 Cochrane* review of all anti-hypertensive drug trials that included women found that white women under the age of 55 years showed no benefit, nor were they harmed by the drugs.

To complicate things further, there is a wide range of anti-hypertensive drugs on the market. To keep them all straight, researchers refer to them by their drug classes, for example, ACE inhibitors, calcium channel blockers, etc. Altogether there are six drug classes and within each, multiple brand names [see below].

Last month, the British journal The Lancet published a commentary by three scientists who questioned the excessive focus on high blood pressure when there are many other risk factors—smoking, family history, diabetes, etc.—that determine who will die of heart disease. Instead, they argue for changing the focus to the prevention of blood-pressure-related diseases. “…clear evidence now shows that several blood-pressure-lowering drugs reduce the risks of major vascular events [e.g. stroke] in a broad range of non-hypertensive individuals with high-risk disorders, such as cerebrovascular disease, diabetes, or coronary heart disease.”

The Lancet commentary makes sense given the fact that studies show some anti-hypertensives (ACE inhibitors) can produce cardiovascular benefits while making only modest reductions in blood pressure. Conversely, other drugs (calcium channel blockers) are good at lowering blood pressure without doing much for the odds of having a heart attack or stroke.

How would you know whether you are taking the right drug or drug combination for your particular circumstances? Is your doctor able to keep up with all the new information—and, again, how would you know?

In 2002, a major anti-hypertensive drug trial rocked the international medical establishment with findings that challenged widely held beliefs. It found that diuretics, the oldest and cheapest anti-hypertensive drug class, are just as effective and, in some circumstances, better than the newer, expensive drugs. But just when it appeared that, at last, there is definitive anti-hypertensive drug news, the same study made it clear that many people with hypertension need another drug in addition to a diuretic.

This 2002 landmark trial, known as the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), included over 33,000 men and women over age 55 years with mild to moderate hypertension who were at high risk for developing heart disease (e.g. 36% had diabetes). The ALLHAT had randomly assigned participants to take daily doses of a calcium channel blocker, an alpha blocker, an ACE inhibitor, or a diuretic.

Whenever a drug failed to control blood pressure, the study participants were put on a second or third additional drug selected from the other three. In other words, everyone in this study was on anti-hypertensive drugs, often two or three on a daily basis. The ALLHAT participants were broadly representative of the U.S. population in terms of race, gender, socioeconomic status, and geographical region.

Here are some of the ALLHAT findings:

  • A diuretic should be the first-choice treatment for high blood pressure;
  • the total or overall mortality—that is, the deaths from all causes—was the same for all treatments;
  • calcium-channel-blocker drugs increased the incidence of heart failure;
  • participants taking the alpha-blocker (doxazosin) were stopped prior to the intended conclusion of ALLHAT because they showed a significantly increased rate of angina, stroke, and congestive heart failure;
  • whether they were treated with a diuretic, ACE inhibitor, or an alpha blocker, the occurrences of heart-related death, and non-fatal heart attack were virtually identical.

Because most anti-hypertensive drug trials have combined the results for men and women, some researchers have pointed out that this might inflate drug therapy’s benefit to women who typically do not have heart attacks or heart-related fatalities until they are much older than men. Also, there might be gender-differences in harms associated with drugs that would show up as non-cardiac deaths.

A 2003 Cochrane review of all trials that included women concluded that in white women over 55 years, drugs reduced the rate of fatal and non-fatal cerebrovascular “events” (e.g., stroke, trans ischemic attacks), and fatal and non-fatal cardiovascular events, but they do not reduce the cardiovascular or overall mortality. Black women of any age , however, benefited on all counts (except overall mortality) from drug therapy because their cardiovascular risk is higher to begin with. Black women tend to develop hypertension earlier in life than white women. In the trials included in this Cochrane review, they also were more likely to be smokers and diabetics than white women.

Another attempt to clarify things was an all-woman study published at the end of 2004 in JAMA, the Journal of the American Medical Association. A research team led by S. Wassertheil-Smoller evaluated different drug combinations in over 30,000 older women—50 to 79 years—with hypertension but no heart disease or diabetes. They had been followed for almost six years. This is what researchers call an observational study because it looked at the different ways women with hypertension are treated in “the real world” as opposed to a clinical trial based at an academic medical center where researchers determine the treatments and assign them randomly to participants.

Here are some of the findings:

  • Of the women taking only a diuretic, this drug was equal to or superior to other drugs taken singly in preventing cardiovascular disease complications;
  • of the women taking only one drug: those on a calcium channel blocker had a higher rate of death from heart disease than those taking only a diuretic;
  • the women who took only a calcium channel blocker had a higher rate of death from heart disease compared with those who took a diuretic plus a beta-blocker;
  • and women taking a diuretic plus a calcium channel blocker had a greater rate of cardiovascular death than those on a diuretic plus a beta blocker or a diuretic plus an ACE inhibitor.

Who has hypertension?
In all the anti-hypertensive drug studies described in this article, the definitions of hypertension were roughly similar. Study participants were diagnosed as having high blood pressure when they had a systolic that is higher than 140 mm HG (millimeters of mercury) or a diastolic more than 90 mm Hg.

Bottom Line:
Diuretics are the first-choice drug for men and women. While it would seem reasonable to conclude that the calcium channel blocker should be avoided, hypertension researchers see it as a “drug of last resort”. The ALLHAT did not include low-risk people with hypertension—that is, healthy adults whose only risk for heart disease is high blood pressure. When trials show a reduction in cardiovascular deaths but not in overall deaths, this suggests that the heart-related survival benefit may be canceled by treatment-related deaths. Anti-hypertensive drug trials follow people five or six years, at most, whereas people are expected to take these drugs for life.

Many heart disease researchers believe that physicians should not focus solely on high blood pressure when deciding drug therapy. Instead, a person’s entire risk profile should be taken into consideration. And finally, this from the authors of the all-woman study: “An important question is whether it is the blood pressure lowering effect of anti-hypertensive drug therapy that is the critical element in preventing cardiovascular disease sequelae or whether particular drug classes offer benefits beyond their effects in lowering blood pressure.”

*Abstracts generated by The Cochrane Collaboration are available at www.thecochranelibrary.com , see “Pharmacotherapy for Hypertension in Women of Different Races”.

Read our 2009 article: “No benefit to reducing blood pressure below 140/90.”

Box insert

Six Anti-Hypertensive Drug Classes and Brand-Named Members

Alpha Blockers or Alpha-Adrenergic Blockers
Cardura, Minipress, Hytrin, Doxaloc, Apa-Doxazosin, Gen-Doxazosin, Med-Doxazosin

ACE (angiotensin-converting enzyme) Inhibitors
Lotensin, Benicar, Capoten, Vasotec, Monopril, Prinivil, Zestril, Univasc, Aceon, Accupril Altace, Renormax, Mavik

Angiotensin-2-Receptor Antagonists, also known as ARBs
Atacand, Teveten, Avapro, Cozaar, Micardis, Diovan

Beta Blockers (beta-adrenergic-blocking drugs)
Sectral, Atenolol, Tenormin, Kerlone, Zebeta, Ziac, Cartrol, Coreg, Normodyne, Trandate, Lopressor, Corgard, Levatol, Visken, Inderal, Blocadren

Calcium Blockers or Calcium-Channel-Blocking Drugs
Norvasc, Vascor, Cardizem, Tiazac, Plendil, DynaCirc, Cardene, Adalat CC, Procardia XL, Nimotop, Sular, Calan, Isoptin, Verelan

Thiazide Diuretics
Naturetin, Aquatag, Exna, Marazide, Diuril, Anhydron, Esidrix, HydroDiuril, Diucardin, Saluron, Enduron, Aquatensen, Renese, Metahydrin, Naqua

Maryann Napoli, Center for Medical Consumers ©
April 2005

Posted in Heart, hypertension, Men's Health, Women's Health | Tagged: , , , | Comments Off

C-Reactive Protein Testing Not For Everyone

Posted by medconsumers on February 1, 2005

The upbeat cardiac news last month involved a protein in the blood called C-reactive protein, or CRP. High levels are a sign of inflammation within the artery walls, which some researchers see as an important predictor of heart disease. All they lacked was the proof that reducing a high CRP level would also reduce the risk. As the story played out in the media, two studies that appeared in the same issue of The New England Journal of Medicine have produced the strongest evidence to date. They purportedly showed that lowering CRP levels with statin-drug therapy can lower the rate of heart attacks in people with severe heart disease.

The findings are likely to encourage widespread use of the CRP test. And this, in turn, will greatly expand the market for statins, a drug class that includes Lipitor, Mevacor, Zocor, Pravachol and Crestor. Both studies deserve scrutiny because they are destined to lead to a broader use of statins by people for whom the drugs may cause more harm than good. Both were funded by companies that make statin drugs, and the lead authors of each study, like most cardiovascular research physicians, have strong financial ties to the cardiac drug industry.

First of all, the participants in both studies had severe heart disease. And the CRP test has yet to be proven useful to people in the early stages of heart disease or to healthy people who are at risk for developing heart disease. The lead author of one study, Paul Ridker, MD, of Brigham and Women’s Hospital in Boston , was quoted extensively in the media with variations on his comment to The New York Times: “What we now have is hard clinical evidence that reducing CRP is as least as important as lowering cholesterol.” Keep in mind that half of all heart attacks occur in people with normal cholesterol levels.

In both studies the participants had been randomly assigned to take either daily high-dose Lipitor (80 mg) or a lower dose of Pravachol (40 mg). Both measured the effect of reducing CRP levels. In the study headed by Dr. Ridker, there was a higher reduction in heart attacks and strokes among people taking high-dose Lipitor. In the other study led by Steven Nissen, MD, of the Cleveland Clinic, the participants on high-dose Lipitor showed (on ultrasound) greater reductions in the rate of atherosclerosis progression.

There are several reasons to be skeptical about Dr. Ridker’s study, according to John Abramson, MD, author of Overdosed America and a clinical instructor at Harvard Medical School . After careful review of this study, Dr. Abramson said that he remains unconvinced that the researchers proved that reduced CRP levels account for the reduced incidence of heart attack and stroke.

High CRP levels may merely be an indicator that a person is at higher risk for another heart attack or stroke, he explained in a telephone interview. What’s more, Dr. Abramson drew attention to the high percentage of the study participants who smoked. “36% of these people were smokers—if the goal is really to reduce heart disease, then it doesn’t make sense to focus attention exclusively on CRP without addressing smoking cessation and other lifestyle modifications like exercise that are at least as effective as statin therapy,” he said. “Not only does current smoking raise the CRP levels, but the risk remains elevated for 10 to 14 years after people stop smoking.” The Ridker study did not identify how many of the participants were former smokers. Ironically, the relationship between high CRP levels and smoking had already been established in an earlier study conducted by the same research team, according to Dr. Abramson, who added, “CRP might simply be a measure of smoking status.”

Statin drugs work when given appropriately, explained Dr. Abramson, referring to the fact that all the study participants had recently been hospitalized either for a heart attack or unstable angina. “After these people had been treated with statins for a month, however, those whose CRP levels remained high appeared to be at higher risk of having another heart attack or stroke, but we don’t have evidence that additional treatment—with even more drugs—will further reduce their risk.”

Whether it is appropriate to prescribe statins to women is another unknown. Heart disease trials now include women, but they are underrepresented, reaching no more than one-third of all participants (the new studies are no exception). What’s more, most clinical trials have not separated the findings that apply to women. This makes it difficult to know one way or another whether statins are safe and effective for half the human race. At least one researcher is paying attention, Beatrice Golomb, MD, PhD, assistant professor of medicine, University of California at San Diego . “No study that has released gender-specific information has shown a survival benefit to statin use in women,” said Dr. Golomb in a telephone interview, making it clear that she was referring to all the major statin trials that included women with and without heart disease. And there is no conclusive evidence that statins spare women without heart disease a non-fatal heart attack or stroke.

“Another group that should also be careful about taking high-dose Lipitor on the basis of the new findings includes everyone over the age of 65 years,” observed Dr. Abramson. “It is important to remember that the earlier version of this study [published last year] showed no difference — whether the participants in this age group took high-dose Lipitor or lower dose Pravachol.”

High doses of statins used in the new studies should be a concern for everyone, according to Dr. Golomb, who has been documenting the serious adverse reactions to this drug class. “There is reason to be concerned about 80 mg. because the benefit of statins is dose dependent, and so are the harms,” she said, “There is more potential for serious adverse reactions.” Dr. Golomb is also the principal investigator of the University of California San Diego Statin Study . People typically take statins for life; yet the statin trials lasted no more than five years.

“What matters is not just whether the person has a heart attack or not,” she continued, “What matters is the over-all complications and over-all mortality, yet in most cases, the drug companies have not released the non-cardiac data.” Dr. Golomb explained that the few statin trials that have done so, either showed the benefits and harms of the drug were even or there was “a trend toward harm”—that is, more women died in the statin group then in the placebo group, but this was not statistically significant.

All government-funded trials, Dr. Golomb continued, are obligated to make their serious adverse events data available to the public. This includes hospitalizations, prolonged hospitalizations and deaths from all causes. “But the reality is that all the major statin trials are funded by drug companies, and there is no obligation to release this critical information,” Dr. Golomb said, adding that she wrote each drug company that has failed to release its data and was turned down. “They [the drug companies] claim it’s irrelevant.”

To Dr. Abramson, lifestyle changes are the forgotten element in the rush to drug therapy: “We know that people over 65, who don’t smoke, eat a Mediterranean-style diet, exercise regularly, drink moderately, have a death rate reduced by two-thirds that of people the same age who don’t maintain these healthy habits.”

Maryann Napoli, Center for Medical Consumers ©
February 2005

Posted in Heart | Tagged: , , , | Comments Off

Vitamin D Deficiency: Cause Of Many Ailments

Posted by medconsumers on January 1, 2005

The Institute of Medicine brought experts together recently to explore the question of whether the RDA or recommended daily allowance, of vitamin D has been set too low. The impetus for the occasion was the mounting evidence for this vitamin’s role in preventing common cancers, autoimmune diseases, type 1 diabetes, heart disease, and osteoporosis. Furthermore, studies have shown that vitamin D deficiency is common in the U.S. Because the typical symptoms are aching bones and muscle discomfort, vitamin D deficiency is often misdiagnosed as fibromyalgia or chronic fatigue syndrome, according to Michael F. Holick, MD, PhD, of the Boston University School of Medicine.

Dr. Holick has conducted a review of all vitamin D studies, which was published in the December 2004 issue of the American Journal of Clinical Nutrition. Vitamin D has become the vitamin of the moment, possibly because researchers in this field want to raise the RDA again. And Dr. Holick’s review, which was funded by the U.S. National Institutes of Health, certainly supports the move.

For most Americans, sunlight provides the lion’s share of our vitamin D requirements because we eat few foods that naturally contain vitamin D, such as cod liver oil and oily fish (salmon, sardines, and mackerel). But many Americans do not meet the minimum requirement of sun exposure. What’s more, vitamin D deficiency is more pronounced among people living at higher latitudes, such as the New England States, especially in winter.

Dr. Holick and colleagues conducted a 2002 study at the Boston Medical Center , which found that, by the end of the winter, 32% of students and doctors, aged 18 to 29 years, were vitamin D deficient. Winter isn’t the only problem because, year-round, many people spend a lot of time indoors or slather themselves with sunscreen when they do go outside. So it was not too surprising that another study conducted in Boston found a high degree of D deficiency in white (30%), Hispanic (42%) and black (84%) elderly people at the end of August. Another study found that 38% of nursing home residents were vitamin D deficient.

Much of the sun avoidance and excessive sunscreen use is attributed to public education campaigns by dermatologists warning about skin cancers. It should be noted, however, that the most deadly form of skin cancer, melanoma, is not entirely related to sun exposure. In fact, Dr. Holick describes the sunlight-melanoma link as baffling because the disease rarely occurs on the face and hands. Instead, melanoma is more likely to appear on areas of the body that are not as exposed to the sun.

Obesity is yet another cause of vitamin D deficiency, according to Dr. Holick, who found that even when dietary vitamin D intake and sun exposure are adequate, the vitamin becomes unavailable because it becomes stored in the large amount of body fat. Aging skin requires more sun exposure. A 70-year-old exposed to the same amount of sunlight as a 20-year-old will only make 25% of the vitamin D that the young person can make. Breastfed infants are deficient in vitamin D because human milk is deficient in vitamin D. Dr. Holick offered this explanation for why deficiencies are widely overlooked: During the standard blood work-up, doctors tend to focus on the blood calcium levels, and if they are normal, doctors incorrectly assume their patients are getting enough D.

Why the seemingly sudden interest in vitamin D when intriguing research goes back over a half century? In 1949, a researcher published his observation that people who live at higher latitudes, such as New Hampshire , Vermont , and Massachusetts , had a higher incidence of cancer deaths, compared with people living in southern states, such as Texas , Georgia , and Alabama.

In a telephone interview, Dr. Holick was asked why other researchers didn’t pick up on this study and look further. “It was an interesting observation, but people didn’t take epidemiology seriously,” he answered. “Little attention was paid to it until the 1980s when other researchers reported that colon and breast cancer rates were higher for those living at higher latitudes in the U.S. ” Even then, the finding was not taken seriously until researchers understood the mechanism for how the breast, colon, and prostate activate vitamin D and use it to regulate cell growth, which Dr. Holick explained as a process that is, “keeping cell growth in check and possibly preventing the cell from becoming autonomous and developing into an unregulated cancer cell.”

After the paper explaining the mechanism was published in the British journal The Lancet, much more research attention began to be paid to vitamin D. And after 1999, many more observational studies were published showing a link between vitamin D deficiency and several chronic diseases. For example, there are higher rates of multiple sclerosis in people who live at higher latitudes; and another study showed vitamin D intake is inversely associated with rheumatoid arthritis.

In a 2001 study published in The Lancet, children treated with 2,000 IU daily of vitamin D from their first birthday onward had an 80% decreased risk of developing type 1 diabetes throughout the next 20 years. And in the last few years, several studies have been published indicating a link between schizophrenia and decreased exposure to sunlight. Dr. Holick’s review states that animal studies have successfully shown that type 1 diabetes, rheumatoid arthritis, and multiple sclerosis can be prevented using mice prone to these diseases.

To Dr. Holick, who is an endocrinologist, it is clear from studies like these (and many more that go unmentioned in this article for lack of space) that vitamin D should no longer be thought of only as the nutrient necessary for the prevention of rickets in young children. He said that his work has been instrumental in the vitamin D fortification of several common foods, including milk products, bread, and orange juice.

In the telephone interview, Dr. Holick was asked whether an increase in the RDA for vitamin D was imminent, given the fact that the Institute of Medicine , a division of the National Academy of Science, recently held a meeting on the topic. “No, it usually takes 10 to 15 years to change an RDA,” he answered. “A huge bureaucratic system is involved.” In the meantime, he and other vitamin D researchers recommend a minimum of 1,000 IU vitamin D daily. This increase, he explained, will maximize the absorption of calcium.

As for the risk of overdose, Dr Holick said, “You’d have to take 10,000 to 20,000 IU daily to approach toxicity.” Is the type of vitamin D important? “Multivitamins usually have D 2 which comes from yeast, but it’s probably only 20-40% as effective as D 3 ,” which, he believes is better and longer lasting.

Then there’s the question of what constitutes an adequate amount of sunlight: “Five to ten minutes of exposure of the arms and legs or the hands, arms and face two or three times a week,” stated Dr. Holick, adding a way of determining the right timing, “25% of the time that it would take to cause a light pinkness to the skin.”

For More Information:
Read Dr. Holick’s book, co-authored with Mark Jenkins and written for the general public, The UV Advantage ( New York : Simon & Schuster/ibooks , 2003).

Maryann Napoli, Center for Medical Consumers ©
January 2005

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Overdosed America

Posted by medconsumers on December 1, 2004

New Book: Overdosed America-the Broken Promise of American Medicine

No, this isn’t another book about Americans popping too many pills and paying exorbitant prices for them. Its far more worrisome premise is summed up in the long subtitle: How the Pharmaceutical Companies Distort Medical Knowledge, Mislead Doctors, and Compromise Your Health. Author John Abramson, MD, is troubled by the commercial influences that pervade all aspects of American medical care. The pharmaceutical industry’s influence can be seen in everything from the sponsoring of continuing medical education to the latest treatment guidelines that make an ever-expanding number of Americans candidates for life-long drug therapy.

A Harvard Medical School faculty member, Dr. Abramson writes that he thoroughly enjoyed practicing family medicine for over 20 years. But he had become increasingly disturbed by the new brand of medical consumerism, typified by the middle-aged male patient who came in demanding an expensive, widely advertised prescription drug (Celebrex). No amount of explaining about cheaper, safer and equally effective alternatives could change his patient’s mind.

It is not only his patients who get a skewed view of new drugs, observed Dr. Abramson, his fellow physicians were influenced by the same promotional campaigns, often masquerading as education. Whereas taxpayers once funded most medical research, the pharmaceutical industry now pays the lion’s share. By now, many Americans know that the pharmaceutical industry has one of the highest profit margins of the Fortune 500 companies. How many know that the industry spends more money on marketing (from advertising to free drug samples for doctors) than on research?

Dr. Abramson left his practice to spend the next two and a half years doing what most practicing doctors have little time to do—“researching the research.” He found that drug companies have been known to: design clinical trials in such a way that ensures their products will come out on top; withhold the trials that show negative results; focus attention on the benefits while giving short shrift to the harms; and ‘spin’ equivocal results in a way that puts their drugs in a favorable light.

What’s more, the people selected for clinical trials are often unrepresentative of the majority for whom the drug will ultimately be prescribed. Cancer drugs are offered as an example. “Nearly two-thirds of all cancer patients are 65 or older,” observes Dr. Abramson, “but only one-quarter of the people in cancer studies have reached 65.” Many of the articles published in medical journals, even the most prestigious ones, he found, are little more than infomercials for the drug.

In time, Dr. Abramson began to detect the frequent use of overblown statistics guaranteed to scare people into a life-long drug regimen. Two years ago, The New England Journal of Medicine published a study about a new, inexpensive blood test that measures blood levels of inflammation in the body called C-reactive protein, or CRP, which supposedly can predict a person’s risk of heart disease. The study followed 28,000 women over eight years and found that those with the highest CRP levels were more than twice as likely to develop heart disease. The study’s authors concluded that identifying people with elevated CRP would allow “optimal targeting of statin therapy.” In other words, a way to identify future customers for cholesterol-lowering drugs.

What’s wrong with this picture? asks Dr. Abramson after the largely uncritical media picked up the CRP story and ran with it as “ground-breaking” and “extremely important.” A closer look at the statistics from this study showed that the 28,000 female participants were less than 55 years old and healthy. Their risk of heart attack, stroke, etc. was quite small. For “every 1000 women with the highest CRP levels, there was only slightly more than one (1.3) additional episode of cardiovascular disease each year than among the 1000 women with the lowest CRP levels.” In other words, the twice-as-likely-to-develop-heart-disease statistic boiled down to a doubling of odds that were tiny to begin with.

With the relentless focus on drugs, Dr. Abramson suggests that doctors and the general public tend to overlook the considerable body of research showing that regular exercise, smoking cessation, and a healthy diet trump nearly every medical intervention as the best way to keep heart disease at bay.

Americans tend to have faith in the latest high-tech medical care, but a large Medicare study challenged some common assumptions. Areas of the country with higher concentrations of specialists have both higher health care costs and worse health care outcomes.

“The public needs access to independent expert opinion that can counterbalance the enormous influence that the medical industry wields over our beliefs about the best approach to health and medical care,” writes Dr. Abramson. (Full disclosure: The Center for Medical Consumers is mentioned twice in this book as one of the rare sources of unbiased information.) A new national public body with the independence and expertise of the Institute of Medicine , he suggests, is the only way that will ever be accomplished.

Maryann Napoli December 2004

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Cardiologists Poised to Give Everyone Lipitor

Posted by medconsumers on April 1, 2004

The findings were considered to be so important that The New England Journal of Medicine made the study freely available on its Web site one month earlier than the April 8 publication date. Two cholesterol-lowering statin drugs—Lipitor (atorvastatin) and Pravachol (pravastatin)—were compared in a clinical trial that involved 4,162 people who had been hospitalized for a sudden attack of chest pain due to heart disease. Lipitor proved to be more effective at reducing the rate of deaths from heart disease, heart-related problems and the need for procedures, such as bypass surgery and angioplasty. Once the news caught media attention, the reporting made the benefit appear larger than it is.

Some of the participants, all of whom had heart disease and low levels of LDL, the so-called bad cholesterol, benefited from even further reductions in their LDL with Lipitor. The finding is widely expected to lead to a lowering of what constitutes the ideal level of LDL. Currently, people are told to keep their LDL below 100 mg.

The participants had been randomly assigned to take either a higher than normal dose of Lipitor (80 mg) or the standard 40 mg dose of Pravachol each day. Because of the high stakes, drug companies rarely pit their drug against a competitor in a clinical trial. Bristol-Myers Squibb, maker of Pravachol, lost big time by sponsoring this trial. It was designed to prove that Pravachol, which had been losing market share, is just as good as the more costly high dose Lipitor.

At the time this trial was planned, Pravachol’s highest dose was 40 mg. The study is known by the catchy name of Prove It, or Pravastatin or Atorvastatin Evaluation and Infection Therapy.

Here are the differences in outcomes in the Prove It trial: After two years, the people on Pravachol had a combined rate of heart attack, bypass surgery, angioplasty, stroke and death of 26.3% compared with 22.4% for people on Lipitor. The death rate from heart disease was 1.1% for the Lipitor group compared to 1.4% for the Pravachol group. The rate of death from any cause was 2.2% for people on Lipitor and 3.2% for people on Pravachol.

These 1- 3% differences in favor of Lipitor have cardiologists across the country quite excited and ready to raise the statin dose and lower the threshold for safe LDL levels. The Prove It results would be exciting if we had the full picture on high-dose Lipitor. As is often the case, the serious adverse effects experienced by the study participants taking Lipitor were not reported.

Christopher P. Cannon, MD, who led the Prove It trial, was asked about this information gap. “We do plan a separate full publication of all the safety data soon…the journal only allows a certain amount of space for only one paper,” he responded by e-mail. “There were more liver function test abnormalities with Lipitor at 80 mg, but these were all transient and were resolved when the dose was stopped or reduced.” Still, adverse reactions caused nearly one out of every three participants to stop the drug. 3% more people in the Lipitor group stopped taking the drug. Besides liver failure, muscle pain is a known consequence of high-dose statin therapy.

Dr. Cannon said that his study found Lipitor to be better than Pravachol for both men and women, though women represented only 22% of the participants (911). The above-quoted statistics apply to all participants, and the researcher did not break things down to show how large the benefits are to women, or whether they have a higher rate of serious adverse reactions.

90% of participants were white and the rest were not specified. This leaves an information gap for everyone else. Earlier studies have shown that Asians, for example, are at a higher risk for severe muscle damage if they take any statin at daily doses of 80 mg. For unknown reasons, the drug tends to remain in the body longer in Asians, which raises their odds of this and other adverse effects. Dr. Cannon and colleagues suggest that their findings point to the need for 62 mg as the new LDL threshold for people with “established coronary heart disease.”

Judging from the media reports of Prove It trial, many cardiologists seem poised to extend its results to people without heart disease. None of the physicians quoted in the media warned that this would amount to a dangerous experiment. In all the previous clinical trials that involved people without heart disease, statin drugs were administered in doses no higher than 40 mg. Only one prevention trial involved people taking Lipitor. None lasted more than seven years.

Interestingly, the new results have revived an old controversy about whether the benefits of statins are due to their cholesterol lowering, anti-inflammatory or some other effects. “Unfortunately, we do not know the precise mechanism of action responsible for atorvastatin’s [Lipitor's] superiority,” wrote Eric J. Topol, MD, of the Cleveland Clinic in an accompanying editorial. Dr. Topol believes that “only a fraction of the patients who should be treated with a statin are actually receiving such therapy.” He sees cost as the biggest stumbling block. Lipitor, at the recommended starting dose of 10 mg, is about $900 per year. At the 80-mg dose used in the Prove It trial, Lipitor costs about $1,400 per year.

What you can do
Here are several non-drug ways to reduce your odds of having a heart attack.

  • Cut trans fatty acids from your diet because they have long been known to be damaging to the heart. Trans fatty acids are formed during the hydrogenation of either vegetable or fish oils. They are used extensively in processed foods to ensure a longer shelf life. Certain foods like donuts, potato chips and other snack foods are particularly high in trans fatty acids. Look for the words “partially hydrogenated oil” or “shortening” on the ingredients list.
  • Take niacin supplements. The Coronary Drug Project followed 3,908 men taking a placebo or niacin therapy for nine years. The niacin group had a lower rate of non-fatal heart attacks and an 11% lower rate of all-cause mortality than the men in the placebo group. A recent survey of the various types of niacin on the market found that immediate-release niacin is the least expensive and safest version to purchase (and the no-flush niacin products are useless, see HealthFacts January 2004).
  • Add heart healthy foods with omega-3 fatty acids and folic acid to your diet. Omega-3 fats can be found in fish, omega-3-enriched eggs, walnuts and flax seeds. Folic acid is in green vegetables, beans, wheat germ and certain fruits and vegetables.

Maryann Napoli, April 2004

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The Women and Heart Disease Awareness Campaign

Posted by medconsumers on March 1, 2004

The Women and Heart Disease Awareness Campaign: Awareness + Fear + Drugs

Heart disease is the number one killer of women.

½ million women in the U.S. die each year of cardiovascular disease—higher than the number of men and the next seven causes of death in women.

An American woman dies every two minutes of heart disease.

They’re scaring us with statistics again. These statistics were quoted recently in the media because February was American Heart Month aimed at increasing women’s awareness of their risk of developing heart disease. The campaign was launched by First Lady Laura Bush who encouraged women to wear a red dress on February 6 while the fashion industry announced that it would send a traveling fashion show with models wearing red dresses to five major cities—all in the cause of giving “women a personal and urgent wake-up call about their risk for heart disease.”

Apparently, women are woefully unaware of heart disease. A survey cited by the campaign found that only 9% of women, aged 45 to 64 years, named heart disease as the condition they most fear, while 61% named breast cancer. In a major effort to raise the fear level, the heart disease awareness campaign is following the path of the breast cancer awareness campaign, which in its early days told women that one in eight would get breast cancer. This statistic successfully raised fears, especially when no one explained that breast cancer is overwhelmingly a disease of older women and that one in eight women get breast cancer only if they live to be 90. Breast cancer is the leading cause of death for women, aged 40-44 years. As intended, this particular statistic got many women in their 40s to make a mammography appointment. It seemed to be in no one’s interest to explain that women in this age group do not have a high rate of death from anything.

Here we go again. Yet another disease awareness campaign, complete with its own pin—a tiny red dress. The first thing to be skeptical about in any disease awareness campaign are the statistics showing how widespread the problem is. Yes, heart disease is the number one killer of women, but the critical issue is the number of women who die prematurely of heart disease. Taken from that perspective, heart-related annual deaths drop from the above-quoted ½ million to 50,000 women under the age of 65 years. Or put another way, nearly 80% of the heart-related deaths in women occur over the age of 75.

After age 50, women begin to develop and die of heart disease at a rate equal to that of men. This statistic is only somewhat accurate because it fails to convey the fact that women are a good 15 years older by the time equality kicks in. No doubt, women in early middle age would not be scared enough if they were told that the average age for a first heart attack is about 70 years .

The next thing to be skeptical about in any disease awareness campaign is the sponsor. Ask yourself who profits from raising fear of a particular disease—and then follow the money. American Heart Month was sponsored by two government agencies: the National Heart, Lung and Blood Institute (NHLBI) and the National Institutes of Health. That’s what the Web site says. But who funds the campaign? You’ll find the answer on the NHLBI Web site, which lists another sponsoring organization called WomenHeart: National Coalition for Women with Heart Disease. The corporate funders of this group include PHARMA, the trade association for the pharmaceutical industry, and ten companies that make heart drugs or devices. (Breast Cancer Awareness Month is funded by AstraZeneca, makers of the world’s best-selling anti-breast cancer drug, tamoxifen.)

One might ask what could be possibly be the downside of a campaign that encourages healthy symptom-free women between the ages of 40 and 60 years to ask their doctors about their personal risk factors for heart disease. Here’s one: It is in the pharmaceutical industry’s interest to make women and doctors think that heart disease occurs right after menopause when estrogen levels decline—that’s a big reason why estrogen “replacement” therapy became so widely prescribed to women in early middle age as a heart disease preventive.

Now the pharmaceutical industry needs another drug that healthy women can take for the rest of their lives, and there are plenty of choices, ranging from aspirin to cholesterol-lowering drugs. Women are underrepresented in the statin and aspirin clinical trials, making up less than one-third of all participants. This leaves a crucial unanswered question: Do the benefits outweigh the risks of these drugs for healthy but high-risk women?

Increased awareness of any disease inevitably results in drawing broad boundaries around who is at high risk. Heart disease awareness is likely to funnel healthy women to inappropriate and inaccurate testing that, in turn, will lead to inappropriate lifelong drug therapy. That’s why you see so many drug company-sponsored ads that do not mention a drug but simply tell consumers to ask their doctors about having a cholesterol-screening test or a bone-density test.

What’s more, the standard non-pharmacologic recommendations to high-risk women are already well known: lose excess weight; get blood pressure* under control; exercise regularly; stop smoking; etc. Following these recommendations “will reduce the risk of heart disease as well as the risk of diabetes which is also a risk for heart disease,” said Judith Walsh, MD, associate professor of clinical medicine at the Women’s Health Clinic Research Center, University of California at San Francisco, in a telephone interview. “The heart disease awareness campaign should focus women on a healthy lifestyle,” she said.

Asked about the likely possibility that doctors may instead focus on cholesterol testing, Dr. Walsh responded, “The issue with cholesterol is that it is a number that needs to be interpreted within the context of other heart disease risk factors. If a woman is young and otherwise healthy and has a high cholesterol, her overall risk for heart disease is still very very low,” she said, “but as a woman gets older—reaching her 70s—and has high blood pressure and diabetes and then has high cholesterol—that’s different.”

A pharmaceutical industry-fueled awareness campaign is not likely to give more than lip service to lifestyle changes; nor will it look at factors outside the medical care system’s purview. Arguably, poverty is an important risk for premature deaths from heart disease, one that goes unmentioned in the awareness campaign. Conversely, low rates of heart disease are associated with white women and women of affluence. A traveling fashion show might very well be targeting the wrong group of women.

*A Cochrane review of all trials in which women with hypertension had been randomly assigned to a drug or a placebo came to this conclusion: drug treatment for white women with high blood pressure between the ages of 30 and 54 years provides no benefit or harm.

Maryann Napoli
March 2004

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Second Thoughts about Aspirin a Day to Prevent Heart Attacks

Posted by medconsumers on January 1, 2004

A baby aspirin a day keeps a heart attack away. This widely accepted health practice was seriously undermined at an advisory committee meeting of the Food and Drug Administration (FDA, held in December 2003. The FDA advisory committee voted overwhelmingly to reject a petition from the Bayer Corp. to approve aspirin for reducing the risk of a first heart attack.

Though an estimated 20 million Americans already take low-dose aspirin daily to prevent a heart attack, this is an off-label use—that is, the aspirin manufacturers have not received FDA approval for this particular indication. FDA approval is required, however, once an aspirin manufacturer plans to advertise the drug for this use. And once approval is granted, the drug’s packet insert must be rewritten to inform consumers of the new indication.

Bayer’s petition made the FDA Cardiovascular and Renal Drugs Advisory Committee take a critical look at the five trials (One trial compared aspirin with vitamin E) in which people without heart disease took either aspirin or a placebo (a dummy pill). Altogether there were more than 55,000 participants at anywhere from low to high risk for a heart attack. Here is what the cardiologists and other experts on the committee found in the way of benefit: Aspirin produced about a 32% reduction in non-fatal heart attacks. [Translation: An estimated 3% of all moderate-risk people will have a heart attack in the next five years. Daily low-dose aspirin therapy will reduce their odds to about 2%.] The benefit is given in terms of a five-year period because the trials lasted four to seven years.

Several things troubled the FDA committee members about the results of these trials: Aspirin did not have any mortality reduction benefit; nor did it reduce the odds of having an ischemic stroke, which is, arguably, the most feared consequence of heart disease. Yet aspirin has the potential for causing another, less common type of stroke called hemorrhagic stroke, which is a rupture of a blood vessel in the brain.

One committee member who voted to reject Bayer’s petition is Steven Nissen, MD, Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center. In a telephone interview, Dr. Nissen explained, “The data [from the five trials] were terribly weak.” You always have to weigh the trade- offs , he said, referring to hemorrhagic stroke as the major concern.

But the aforementioned 32% reduction in non-fatal heart attacks applies to the combined total of all the study participants, most of whom were men with differing levels of risk. The committee hit a snag once it came to individuals. Dr. Nissen said that he and other committee members were concerned that daily aspirin, if taken by people at a low enough risk, could cause more harm than good. Asked to define “low enough risk,” he explained that there was too much uncertainty to answer the question. “No one in the world can answer the question of who benefits and who doesn’t, and if there is no answer, then how could I vote to approve?” he asked.

The fact that women were underrepresented in the five trials (only 20% of all participants) also troubled Dr. Nissen. “It may be that the risks exceed the benefit for women,” he said, “but we simply don’t know—there is not enough data.” Still, Dr. Nissen was careful to stress that he was not against aspirin therapy for everyone, suggesting that people talk over the decision with their physicians. The FDA advisory committee “took a lot of heat,” said Dr. Nissen, referring to its decision to turn down Bayer’s petition and thus reject the prevailing medical view that aspirin therapy is good for just about everyone. “We were called flat earthers ,” he said.

The FDA is not obligated to follow the decisions made by its advisory committees, but the agency usually does. The committee’s decision, though entirely appropriate, illustrates how the current system works against consumers who want to become fully informed before they go on lifelong drug therapy. Approval would have meant a rewrite of the drug’s packet insert to include the new indication. And this, in turn, would have compelled the advisory committee to identify the appropriate group of people for whom the benefit of aspirin therapy clearly outweighs the risks. The evidence from the five trials did not provide the answer; therefore, 20 million people will continue to take daily aspirin without knowing anything about the uncertainties of the supporting research.

The advisory committee’s concerns can be contrasted with the practice guidelines aimed at physicians and published in 2002 by the U.S. Preventive Services Task Force. The Task Force concluded that the number of “cardiac events” prevented by aspirin therapy far exceeded the number of hemorrhagic strokes caused by aspirin therapy. This, too, is based on the combined results of the same five trials. When the Task Force tried to break things down for individuals, it came up with this estimation for moderate-risk men and women: “For 1,000 patients with a 3% risk of having a heart attack in the next five years, aspirin would prevent eight heart attacks but would cause one hemorrhagic stroke and three major gastrointestinal bleeding events.”

Where it concerns low-risk people, the Task Force is in agreement with the FDA advisory committee: MMMM
“…patients at low risk for coronary heart disease probably do not benefit from and may even be harmed by aspirin because the risk for adverse events may exceed the benefits…” (Annals of Internal Medicine, 1/15/02).

For More Information:

  • Go to www.med-decisions.com to see one method used by the Task Force to identify different levels of risk for a heart attack. The Task Force used an additional assessment tool based on the risk information from the Framingham Heart Study, which has since become outdated.
  • The transcript of the December 8-9, 2003 meeting of the Cardiovascular and Renal Drugs Advisory Committee is likely to be posted on the Internet in February or March. Go to www.fda.gov and click into “Advisory Committees.” Then go to this specific committee and its meeting date.

Maryann Napoli
January 2004

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