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Pharmacies Sue FDA Over Compounding Limits

December 2004

LE Magazine December 2004
Pharmacies Sue FDA Over Compounding Limits

A coalition of pharmacies from Texas, Arizona, Alabama, Wisconsin, California, and Col-orado filed suit against the Food and Drug Administration in September, claiming that the agency is illegally enforcing an arbitrary regulation that is out of its jurisdiction. The suit accuses the FDA of conducting unlawful inspections, illegal interventions, and intimidation of law-abiding pharmacies.

At issue is the centuries-old practice of compounding medications from bulk ingredients. In this process, a pharmacist combines, mixes, or alters the administration of ingredients to prepare a medication, prescribed by a physician or veterinarian, that is tailored to an individual patient’s needs. Compounding protection laws were enacted in 1962 to ensure the best health care for patients and pets.

The FDA has no legal authority over pharmacies, whether or not they prepare compound preparations. Last year, however, the FDA issued a compliance policy guideline that made the use of bulk ingredients in the preparation of medications illegal. The agency has since waged an aggressive inspection campaign to enforce the guideline.

Ten compounding pharmacies have petitioned a US District Court in Texas to be able to continue filling prescriptions from doctors and veterinarians using pure “bulk ingredients” that are manufactured in facilities that are registered, inspected, and approved by the FDA.

“If the FDA is successful, this would deprive veterinarians and physicians of critical treatment options that relieve the suffering of their patients and improve their health,” said Steven F. Hotze, MD, president of Premier Pharmacy in Katy, TX.

Compounded drugs typically offer superior treatment options because they are tailored to the individual patient. Moreover, restrictions on compounded medications prevent many prescription drugs from being offered at more affordable prices. The FDA’s illegal actions work to the benefit of large pharmaceutical companies, which continually lobby the agency in efforts to stifle competition and keep prices high.

—Stephen Laifer

Whey Cuts Weight Gain, Improves Insulin Sensitivity

Whey protein, a mixture of some of the proteins found naturally in milk, reduces weight gain and increases insulin sensitivity, according to a study conducted by Australian researchers.*

Whey is a highly bioavailable source of protein that is known to promote immune health and to raise levels of the antioxidant glutathione. A high-protein diet has been known to help reduce body weight and to improve insulin sensitivity, but scientists previously had not known whether those outcomes were affected by the type of dietary protein consumed.

Scientists at the University of Adelaide in Australia examined the effects of both whey protein and red-meat protein on mice. Insulin-resistant rats were fed a high-fat diet for nine weeks. They were then switched to a diet containing either 80 or 320 grams of protein per kilogram of body weight, provided by either whey protein concentrate or red meat, for six weeks. The rats were then analyzed for energy intake, body fat, body weight, plasma insulin, and insulin sensitivity.

High dietary protein reduced energy intake by the rats, as well as visceral, subcutaneous, and carcass fat. Increasing the dietary concentration of whey protein concentrate, but not red-meat protein, also reduced body weight gain and plasma insulin concentration, and increased insulin sensitivity.

These findings support the conclusion that a high-protein diet reduces energy intake and reduces body fat in mice. Whey protein, the researchers concluded, is more effective than red meat in reducing body weight gain and increasing insulin sensitivity. These data are highly significant for the millions of overweight and obese Americans who experience associated problems such as insulin resistance.

—Elizabeth Wagner, ND


* Belobrajdic DP, McIntosh GH, Owens JA. A high-whey-protein diet reduces body weight gain and alters insulin sensitivity relative to red meat in wistar rats. J Nutr. 2004 Jun;134(6):1454-8.

Tea Drinking Tied to Reduced Hypertension Risk

Tea is the second most consumed beverage in the world, second only to water. The most common cardiovascular disease among adults worldwide is hypertension, or high blood pressure. A recently published research study from Taiwan suggests that habitual tea drinkers may significantly reduce their risk of hypertension.*

Researchers compared the incidence of hypertension in habitual tea drinkers to that in nonhabitual tea drinkers. The samples were adjusted to account for age, sex, socioeconomic status, family history of hypertension, body mass index, waist-hip ratio, and lifestyle and dietary factors.

The tea-drinking group was found to be generally more obese, to smoke and drink alcohol more, and to exercise less than the non-drinking group. With these characteristics, one would thus logically assume the tea drinkers to show a higher incidence of hypertension. In fact, however, habitual tea drinkers who ingested 120-599 mL of tea daily exhibited a 46% reduction in hypertension compared to nonhabitual drinkers. Even more striking was the 65% reduction in hypertension in those who ingested over 600 mL of tea daily compared to nonhabitual drinkers. Habitual tea consumption for periods of more than one year was not associated with a further reduction of hypertension risk.

The researchers did not identify a mechanism to explain the results, though theoretical arguments were advanced concerning caffeine, theanine (a neurotransmitter), and the antioxidant effect from tea polyphenols that could cause vasodilatation. The study results, however, conclusively demonstrated that habitual moderate-strength green or oolong tea consumption of 120 mL or more daily for one year significantly reduces the risk of developing hypertension in Chinese adults.

—Steve Otto, MD


* Yang Y, Lu F, Wu J, Wu C, Chang C. The pro- tective effect of habitual tea consumption on hypertension. Arch Intern Med. 2004 Jul 26;164(14):1534-40.

Blood Test May Detect Aortic Atherosclerosis

Scientists at the Mayo Clinic have found that a simple blood test measuring C-reactive protein may help to ascertain risk for aortic atherosclerosis.* Although common in the elderly and the most significant risk factor for stroke, aortic atherosclerosis is generally an undiagnosed disease.

Atherosclerosis is a systemic disease involving the heart, brain, aorta, and peripheral arteries. Of deaths attributable to it, approximately 70% are due to heart attacks, 17% to strokes, and 10% occur after rupture of an aortic aneurysm. Some 700,000 strokes occur in the US each year, usually without warning. Symptoms appear after the stroke has occurred. In the US, stroke-related deaths rank behind only those attributed to heart disease and cancer, and the associated disability of survivors is life altering.

Blood tests have not been used to diagnose aortic atherosclerosis or to stratify risk. Although not currently used as routine screening tests, transesophageal echocardiography, a noninvasive ultrasound test performed in the office, and magnetic resonance imaging are available and can identify clinically significant plaques.

Researchers at the Mayo Clinic in Rochester, MN, report that a simple blood test can raise suspicions of aortic atherosclerosis. In their study, 386 men and women with an average age of 66 underwent trans-esophageal echocardiography. Nearly 70% of the subjects were shown to have atherosclerotic plaques in the aorta, and 25% of the plaques were categorized as “severe.” C-reactive protein, a systemic biomarker of inflammation and an established risk factor for cardiovascular disease, was measured in all subjects and found to be independently associated with severe plaques, but not insignificant plaques, in both those with and without known cardiovascular disease.

Given the role of aortic atherosclerosis in stroke, it may be prudent to consider further testing in those with elevated C-reactive protein to detect and possibly treat existing disease.

—Linda M. Smith, RN


* Agmon Y, Khandheria BK, Meissner I, et al. C-reactive protein and atheroscle- rosis of the thoracic aorta: a population- based transesophageal echocardiographic study. Arch Intern Med. 2004 Sep 13;164(16):1781-7.