Consumer Health Digest #02-29
Your Weekly Update of News and Reviews
July 16, 2002
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
Hormone-replacement trial arouses concern. The Women's Health Initiative (WHI) has stopped part of a large study designed to assess the benefits and risks of hormone replacement therapy (HRT) with a combination of estrogen and progesterone. The arm of the study that was stopped included more than 16,000 women aged 50-79 years whose uterus was intact when the study began. The researchers examined the balance of risks and benefits related to coronary heart disease, breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes.
After an average of 5.2 years of follow-up, the data showed increases in the risk of breast cancer, heart disease, and stroke, but decreased risk of colon and rectal cancer, uterine cancer, hip fracture, and death from other causes. However, there was no change in the the overall risk of cancer, dying from breast cancer, or dying from any other cause; and comparable increased risks were not seen in an estrogen-only portion of the WHI study, which is still ongoing. The researchers concluded that combined estrogen-progestin HRT (a) should not be used on a population-wide basis for postmenopausal women and (b) should not be started or continued for the purpose of preventing coronary heart disease in apparently healthy women. They also concluded that the risks should be considered when choosing among the drugs available to prevent osteoporosis. [Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative Randomized Controlled Trial. JAMA 288:321-333, 2002] An accompanying editorial concluded:
- Although the WHI trial results are reported primarily in terms of relative risk, the absolute risk of harm to an individual woman is very small: Among 10,000 women taking the drug for a year, there will be 7 more coronary heart disease events, 8 more invasive breast cancers, 8 more strokes, and 8 more pulmonary emboli, but 6 fewer colorectal cancers and 5 fewer hip fractures. When counting all events over the 5.2 years of the trial, the excess number of events in the active drug group was 100 per 10 000 (or 1 in 100 women). This is still a small risk, but it demonstrates that risks from the drug add up over time.
- The purpose of healthy women taking long-term estrogen/progestin therapy is to preserve health and prevent disease. This study provides strong evidence that the opposite is happening for important aspects of women's health, even if the absolute risk is low. Given these results, clinicians should stop prescribing this combination (1 daily tablet containing 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate) for long-term use. Other regimens may have different results, but the 3 studies reported to date in the United States with other regimens have all found an increased risk of breast cancer.
- This study and many others show that HRT protects against osteoporosis. There are alternative preventive strategies, at least one of which also lowers the risk of breast cancer, although cardiovascular its effects are not clear.
- The WHI trial does not specifically address whether short-term HRT should be used for managing menopausal symptoms, but it suggests that short-term use has risks for cardiovascular disease. The possibility of these small absolute risks should be balanced against the severity of symptoms and benefit of treatment. [Fletcher SW, Colditz GA. Failure of estrogen plus progestin therapy for prevention. JAMA 288:366-368, 2002]
What should women do? Most important, they should realize that the goal of good medical care is to live as long and healthfully as possible and not just to avoid a particular disease. Although this WHI report raises legitimate concerns, it does not show excess deaths among users of the combined HRT treatment. Since cardiovascular disease is the leading cause of death, it is important that cardiovascular risk factors be assessed and managed. With respect to HRT, women should review their individual circumstances with a knowledgeable physician to determine whether HRT makes sense for them ias part of an overall strategy to optimize their health and reduce the risk of health problems and premature death.
"Male menopause" advocate barred from Internet prescribing. Malcolm Carruthers, a London physician who prescribed male hormones over the Internet has been censured by the British General Medical Council (GMC) for serious professional misconduct. Carruthers' Web site included a questionnaire with which men could test themselves for possible "male menopause" ("andropause"). If their score was 10 or more, the site recommended "AndroScreen" testing, which cost from £70 (about US$100) to £575.00 ($800), depending on what was included. The test was constructed so that many people with normal hormone levels would be advised to undergo unnecessary hormone testing. The misconduct involved (a) diagnosing and recommending high-dose testosterone injections for male menopause in a 70 year old patient with Alzheimer's disease without ever seeing him or his records and (b) improperly criticizing the patient's local physician who believed that the prescribed dose was too high. [Dyer O. Exponent of "male menopause" censured by GMC. British Medical Journal 325:65, 2002] Carruthers, who authored The Testosterone Revolution, chairs the Andropause Society, a group campaigning for wider recognition of a "male menopause." The prevailing scientific viewpoint is that Carruthers' concept is not valid. [Jacobs HS. The male menopause—does it exist? (negative view). British Medical Journal 320:858-861, 2000]
Study finds no link between cardiovascular death rates and
vitamin use. The Physicians Health Study has found that taking
vitamin E, vitamin C, or multivitamins was not associated with
a significant decrease in death rates from cardiovascular disease.
The study included 83,639 male physicians in the United States
who had no history of heart disease at baseline and were followed
for an average of 5.5 years. [Muntwyler J and others. Vitamin
supplement use in a low-risk population of US male physicians
and subsequent cardiovascular mortality Archives of Internal
Medicine 162:1472-1476, 2002]
Diet pills containing fenfluramine cause liver failure. The governments of China and Singapore have outlawed the marketing of diet pills found to contain fenfluramine as an undeclared ingredient. The pills, marketed as Slim 10 in Singapore, and "First Generation Yuzhitang Diet Capsules in China, have been linked to several deaths and more than 30 other cases of serious illness in China, Singapore, and Japan. Fenfluramine was banned in the United States in 1997.
French antismoking ad draws huge response. The Associated Press has reported that half a million people telephoned a toll-free number in response to a television ad which stated that a commonly consumed product had been found to contain traces of cyanuric acid, mercury, acetone. and ammonia. The product, which the ad did not identify, was the cigarette. The National Health Institute for Prevention and Education, which sponsored the ad, said it was intended to wake people up to the dangers of cigarette smoking.
Rise in cigarette tax evasion predicted. Knowledgeable observers have predicted that the recent rise in cigarette taxes (17 states have acted this year) will lead to more aggressive smuggling and bolder use of the Internet as a tax-evading tobacco shop. Smuggling is encouraged by the low taxes in the tobacco-producing states of Virginia (2.5¢ per pack), Kentucky (3¢), North Carolina (5¢), and South Carolina (7¢). The Bureau of Alcohol, Tobacco and Firearms Control has said that large-scare organized crime gangs as well as isolated individuals are involved in smuggling operations. In addition, the number of Internet cigarette outlets has increased considerably during the past two years; and some American Indians claim that their Internet sales should be tax-free. [Crary D. Cigarette taxes might fuel smuggling, tax evasion. Associated Press, July 14, 2002] In December 2001, Rep. Martin Meehan (D-MA) introduced the Tobacco Free Internet for Kids Act, which would ban Internet tobacco sales to minors, require Internet tobacco vendors to verify the purchaser's identity and age, and use shipping methods that require purchasers to sign for delivery and show photo identification.
This page was posted on July 16, 2002.