Last fall, US Food and Drug Administration (FDA) safety expert David J. Graham, MD, sat down before a Senate committee and blew the whistle on his bosses. Although the risks of the arthritis pain pill Vioxx had long been evident, he pointed out that the agency ignored repeated warnings of increased heart attacks and strokes in those who took it. Eventually, its own manufacturer, Merck, withdrew the drug. Vioxx, however, was just the latest drug to "strike out" as far as Dr. Graham was concerned. He cautioned senators that the FDA's failure to take action on this medicine was part of a broader, systemic failure to address drug safety, and that the agency as it stands now is incapable of protecting the public from another drug disaster. In particular, he pointed to four more potential problem drugs that are "on deck" for a public hanging...
*Accutane (isotretinoin), an acne treatment (Roche Pharmaceuticals)
*Crestor (rosuvastatin), a cholesterol-fighting statin drug (AstraZeneca)
*Meridia (sibutramine), a weight-loss drug (Abbott Laboratories)
*Serevent (salmeterol xinafoate), an asthma drug (GlaxoSmithKline).
To get the lowdown on these drugs and find safer alternatives to them, I spoke with Jay S. Cohen, MD, associate professor (voluntary) of family and preventive medicine at the University of California in San Diego and author of What You Must Know About Statin Drugs and Their Natural Alternatives, and Mark A. Stengler, ND, a naturopathic physician in private practice at the La Jolla Whole Health Clinic in California and author of The Natural Physician's Healing Therapies.
ACCUTANE FOR ACNE
Most women know that Accutane, which is a vitamin A analog, causes birth defects and that women who are even thinking about getting pregnant should not take it. What you may not know is that FDA MedWatch received 147 reports of people taking Accutane who committed suicide, attempted suicide or were hospitalized for severe depression between 1982 and 2000. The family of 15-year-old Charles Bishop has filed a $70 million lawsuit, contending that Accutane brought on the teen's dramatic suicide. In January 2002, he stole a plane and crashed it into a Tampa skyscraper. The ninth grader was taking flying lessons, but was too young for a pilot's license.
Natural alternatives: Dr. Stengler recommends zinc as a natural alternative to Accutane. Research demonstrates that this important nutrient helps reduce acne. Take 25 mg twice daily along with 3 mg of copper. Caution: Supplemental zinc at doses of more than 100 mg daily may increase risk for prostate cancer. Topically, some people swear by naturally antibacterial tea tree oil. Apply a drop directly to pimples.
Safer drug alternatives: For mild to moderate acne, a recent study in The Lancet (December 18-25, 2004) reports that over-the-counter topical products containing benzoyl peroxide (such as Clearasil) are usually as effective as topical or oral antibiotics at a fraction of their cost.
CRESTOR FOR CHOLESTEROL REDUCTION
While manufacturer AstraZeneca touts Crestor's strength, Dr. Cohen cautions that more is not necessarily better when it comes to drugs. In December 2004, the FDA called AstraZeneca's newspaper ads defending the safety of Crestor "false and misleading." The health advocacy group Public Citizen has called for the withdrawal of this powerful statin, which has been linked to muscle aches, joint pain, abdominal discomfort, cognitive impairment, nerve injury, kidney toxicity and liver damage or failure.
Natural alternatives: According to Dr. Cohen, many people can get their cholesterol under control simply with regular exercise and a healthy diet (eating more fruits, vegetables, soy and fish and less saturated fat). He also notes that there are many natural cholesterol-lowering alternatives, including red yeast rice (which contains compounds similar to lovastatin, the lower-priced generic form of Mevacor)... policosanol (a safe, natural substance found in citrus peels)... and guggulipid (an Ayurvedic medicine used for centuries in India). These supplements should be used under medical supervision.
Safer drug alternatives: When it comes to statins, you want the mildest drug that works for you, says Dr. Cohen. He points out that less potent statins, such as Mevacor, Lescol (fluvastatin sodium) and Pravachol (pravastatin), are strong enough for most people and have a better track record for safety. If these fail to do the trick, Lipitor and Zocor are strong enough for most people who need greater protection.
MERIDIA FOR WEIGHT LOSS
Public Citizen has called for the withdrawal of Meridia since 2002, after studies indicated that it had little impact on weight loss and caused serious side effects, such as increased blood pressure and heart rate. According to Public Citizen, "Meridia has been implicated in the deaths of 29 users in three years from apparent cardiac complications." ( www.drugintel.com/drugs/meridia.htm)
Natural alternatives: A good natural alternative to Meridia is conjugated linoleic acid (CLA), says Dr. Stengler. Studies show that this supplement helps to significantly reduce body fat. Take 1,000 mg twice daily on an empty stomach. To read about the one and only proven effective way to lose weight -- eat less and exercise more -- see Daily Health News, January 22, 2004.
Safer drug alternatives: Obesity drugs typically have unpleasant -- often dangerous -- side effects, such as diarrhea and elevated blood pressure. Recent studies suggest that a new drug in development may help people lose weight, control cholesterol and even quit smoking. Only time will tell if Acomplia (rimonabant) will be approved by the FDA and live up to its potential. Be watchful, however, of jumping on the new-drug bandwagon. All too often the dangerous side effects are not discovered until long-term use has been studied.
SEREVENT FOR ASTHMA
This is a case of a drug causing adverse effects similar to those it is supposed to prevent! In August 2003, after a study demonstrated a small increased risk for life-threatening asthma attacks and deaths in people using Serevent, the FDA added a new black box warning to its label and assumed it had done its job.
Natural alternatives: Vitamin C (1,000 mg) with bioflavonoids (500 mg) twice daily may help relieve asthma related to allergies, says Dr. Stengler. For exercise-induced asthma, he adds that lycopene can be helpful. In one double-blind trial, more than half of people with exercise-induced asthma had significantly fewer asthma symptoms after taking capsules containing 30 mg of lycopene per day for one week compared with when they took a placebo.
Safer drug alternatives: Before turning to stronger and more problematic medicines, it is wise to consider safer and less-toxic alternatives. Serevent is made by the same manufacturer (GlaxoSmithKline) as Ventolin (albuterol). When its patent for albuterol expired in 1995 and the drug became available generically, the pharmaceutical giant introduced a "new and improved" medicine, Serevent. Yet albuterol has a better safety record than Serevent, and is not associated with the same potentially fatal adverse effects.
With a dizzying array of health-care choices and unease over how much the FDA is looking out for us and how much it is looking out for the welfare of pharmaceutical companies, what's a consumer to do? For the majority of disorders, Dr. Cohen recommends that you begin by looking at lifestyle adjustments, such as nutrition. If that is not enough to get the condition under control, work with a trained professional to apply natural therapies. If all else fails, then test pharmaceuticals. When it comes to drugs, do your homework and act as your own advocate. Don't assume that the drug you see advertised most frequently on TV is the right drug for you. To choose the safest and most effective medicine, Dr. Cohen advises that you stick with those that have the longest proven track record for safety. Don't use a new drug unless there's a specific need for it, he warns. And to avoid side effects, always ask your doctor to prescribe the lowest possible effective dose of any drug.