Archives for: May 2004
STUDY: Deceptive Marketing
JOURNAL: FDA and FTC
ABSTRACT: The Federal Trade Commission has charged the marketers of a dietary supplement called Coral Calcium Supreme with making false and unsubstantiated claims about the product's health benefits.
COMMENTARY: FTC alleges that Kevin Trudeau; Robert Barefoot; Shop America (USA), LLC; and Deonna Enterprises, Inc., violated the FTC Act by claiming, falsely and without substantiation, that Coral Calcium Supreme can treat or cure cancer and other diseases, such as multiple sclerosis and heart disease.
The FTC charges that these and other claims go far beyond existing scientific evidence regarding the recognized health benefits of calcium.
The FTC also is suing Trudeau, who has promoted items in infomercials
for years, for allegedly violating a 1998 court order that prohibits him
from making unproven product claims. The lawsuit says the coral calcium
ads and promotions for pain-relieving product called Biotape violate that order.
STUDY: Stay away from NSAIDS on a regular basis
JOURNAL: Hypertension 2002;40:604-8.
AUTHORS: Dedier J, Stampfer MJ, Hankinson SE
ABSTRACT: ASA, acetaminophen and ibuprofen are the most commonly used medications among adults, according to a national survey of US households.
Short-term prospective studies suggest that NSAIDs can cause acute elevations of blood pressure, and ASA and acetaminophen can influence prostaglandin homeostasis.
COMMENTARY: Short-term prospective studies suggest that NSAIDs can cause acute elevations of blood pressure, and ASA and acetaminophen can influence prostaglandin homeostasis.
The Nova Scotia Heart Health study has shown that 21% of women aged 35–64 years have hypertension, thus, even small elevations in blood pressure caused by nonnarcotic analgesic use could result in cardiovascular morbidity and mortality.
STUDY: Arthroscopic procedures for arthritis no better than placebo, study finds
JOURNAL: New England Journal of Medicine
AUTHORS: Dr. Bruce Moseley
ABSTRACT: A type of knee surgery performed on more than 300,000 Americans each year to ease arthritis pain is worthless, government researchers say.
The provocative study compared arthroscopic knee surgery for osteoarthritis to a sham procedure and found no difference in the outcome.
COMMENTARY: THE ARTHROSCOPIC operation is done to clear out debris or repair damaged cartilage in osteoarthritis, the painful, steadily worsening, wear and tear on joints that affects 12 percent of senior citizens.
In a type of study only rarely conducted, some patients got a real knee operation, while others underwent sham surgery.
At every point over the next two years, those who had the fake surgery could climb stairs and walk slightly faster on average than those who had gotten real operations.
The study shows that all of the benefit that people receive is from a placebo effect.
Patients have benefited more from a relatively new treatment — injections of a synthetic version of fluid inside the knee that acts as a shock absorber and lubricant.
STUDY: Medication mistakes are fairly common in hospitals
JOURNAL: Annals of Internal Medicine
AUTHORS: Dr. Jay Brooks
ABSTRACT: It was every patient's nightmare.
A 68-year-old, non-diabetic woman who had just had elective bypass surgery was given insulin instead of the anticoagulant heparin to flush her arteries
COMMENTARY: The insulin sent the woman's blood sugar plummeting; she fell into a coma and died seven weeks later, when her family decided to stop life support.
Medication mistakes are fairly common in hospitals, but most of them are not life-threatening, says an article in Annals of Internal Medicine, the second in a series examining medical errors.
Although the medication-dispensing process varies widely not only between facilities but also within them, errors can occur at any of a number of points, the article says.
In many hospitals, most prescriptions are handwritten by the doctor, and then typed into a computer by a low-paid clerk who may or may not have trouble reading the handwriting. The typed information is then transmitted to the pharmacy, where a technician begins the process of dispensing.
"If it's a pill, that's pretty simple," says Dr. Jay Brooks, chief of hematology/oncology at the clinic. "But if it's a mixture in a bag of fluids, it's more complicated because you have the actual mixing, then the proper labeling, then it has to go back to the floor" where you have to assume the nurse or other staff member who actually administers the medicine follows proper instructions.
"You can see that this whole process is fraught with possible errors," Brooks adds.
In the case of the 68-year-old bypass patient, several factors contributed to the fatal error, including a failure to store the medications properly -- the heparin and insulin vials were on top of a medication cart and, apparently, mistaking the two drugs is common.
"Both of these drugs are used frequently, and the vials they're kept in look somewhat similar, and the medications are often not kept in secure places because it's more expedient," says Dr. David Bates, lead author of the study and the chief of general internal medicine at Brigham and Women's Hospital in Boston.
Most hospitals have many checks to help ensure errors aren't happening. Often the nurse on the floor will double-check with what the clerk typed in the computer. The pharmacist will call the doctor if he feels a request seems strange. If Brooks is writing an out-of-the-ordinary prescription, he will often attach the journal article that explains the request or he'll call the pharmacist directly.
A number of hospitals have started implementing bar coding like that found in supermarkets, Bates says. Unfortunately, manufacturers do not routinely provide drugs with bar codes, so the hospitals and clinics have to do it themselves at considerable expense.
Bar coding would help, Bates adds, but other things might help more.
"The single most beneficial change in terms of medication process is to get physicians to order medications using the computer, so that the orders can be checked for allergies and other problems," he says.
This would not have altered the fate of the 68-year-old woman, but it would help with more common types of errors: If patients have adverse reactions to drugs or they receive the wrong dosage.
Some common sense advice would be to double-check your meds. There are some handy books available that have pictures of pills along with information so that you can make sure that what is in the bottle matches what’s on the label.
STUDY: Busiest radiologists--those who had evaluated the most mammograms--did not necessarily do the best job at identifying signs of breast cancer.
JOURNAL: Journal of the National Institute of Cancer 2003;95:250-252.
AUTHORS: Dr. Craig A. Beam
ABSTRACT: Conflicting information on what factors determine radiologists' accuracy in reading mammograms may have some women wondering what they can do to ensure a correct diagnosis.
COMMENTARY: There are a number of steps women can take to boost the accuracy of the breast cancer screening test.
First and foremost, women should attempt to go to the same breast cancer screening clinic year after year.
If that is not possible, women should obtain the X-rays from their previous mammograms for comparison sake.
For younger women, they should avoid getting a mammogram while they are menstruating because the breast tissue undergoes changes during this time that can affect mammogram accuracy.
Younger women are better off scheduling mammograms during the follicular phase of their cycle--the first and second week after the first day of their period.
It is also important to stay as still as possible during a mammogram.
Women need to be warned that when getting a mammogram, it can hurt...but despite the unpleasantness they need to hold really, really still to avoid motion artifacts on the X-ray.
Plus, the more the breast is compressed the better the image and the less radiation required.
Older women who are taking hormone replacement therapy should be aware that the treatment may reduce the accuracy of mammography by increasing breast density.
STUDY: Honey prevents bacterial growth
JOURNAL: Journal of Wound, Ostomy, and Continence Nursing (2002;29:295–300).
ABSTRACT: Topical application of honey is beneficial in the treatment of wounds and burns.
COMMENTARY: Honey is a highly concentrated sugar solution produced by honey bees, primarily from the nectar of plants. It is composed of carbohydrates (sugars), water, enzymes, amino acids, pigments, pollen, wax, and other trace constituents from both bees and plants.
Honey has been used in the treatment of burns and wounds for many centuries, with documents describing this use dating back to 1700 BC.
A number of properties inherent to honey might contribute to its ability to fight infection and promote healing. Its high sugar content allows it to draw infection and fluid from wounds by a process called “osmosis.”
Honey prevents bacterial growth through its acidic pH and through the work of an enzyme that produces small amounts of hydrogen peroxide. Its ability to keep the area around a wound moist and protected promotes fast healing and prevents scarring.
Honeys also contain components from the specific plants used by the bees in their production, and it is speculated that some of these components might further add to the antibacterial and wound-healing effects of certain honeys.
The process of pasteurization, used to sterilize commercial honeys, destroys the enzyme involved in the production of hydrogen peroxide, rendering these honeys less antibacterial. Raw honeys maintain their enzymes, and honeys produced for therapeutic use are sterilized through an irradiation process that does not damage their constituents.
There are currently two therapeutic honeys available: Medihoney of Australia and Active Manuka Honey of New Zealand. Both are derived from bees using the flowers of tea trees (Leptospermum spp.) as their source.
A number of studies have confirmed the antibacterial effects of honey in test tubes. One study found that different honeys had different levels of activity against specific bacteria. Studies on humans have reported that honey used as a wound dressing reduced infection, inflammation, pain, and odor, and promoted easy removal of dead tissue and rapid healing with little scarring.
Fifty-nine people with chronic wounds and ulcers participated in one preliminary study described in this review. The group included people with diabetic ulcers, burns, traumatic ulcers, gangrene, and other types of wounds. All had been treated with commercial wound dressings and antibiotics for periods of between one month and two years without results.
Although 51 of the 59 wounds had been infected prior to honey treatment, all were free of infection within one week of starting honey dressing applications. In addition, inflammation and odor were markedly reduced and healing rapidly ensued.
JOURNAL: Ann Intern Med 2003;138. www.annals.org<br />
AUTHORS: Dr. Bent
ABSTRACT: Compared with other herbal products, ephedra is far more likely to cause adverse effects.
COMMENTARY: Based on an analysis of reports to the American Association of Poison Control Centers, Dr. Stephen Bent and his colleagues discovered that products with ephedra accounted for 64% of the herb-related adverse reactions in 2001.
This finding is remarkable, the authors note, given that less than 1% of herbal products sold that year contained ephedra.
Although awareness of the potential dangers of ephedra is growing among consumers, many still purchase ephedra-containing products.
Using data from case reports alone, it has been difficult to definitively link ephedra with various adverse effects, Dr. Bent said. But the finding that ephedra is linked to far more side effects than other herbs adds support to the theory that the substance can be dangerous, he said.
How ephedra stacked up against other products varied from herb to herb, Dr. Bent and his colleagues note -- but in all cases, it outnumbered other products in adverse reactions by a factor of at least 100.
My Comment is that Ephedra has always been the whipping boy of the herbal industry. Used properly I have never had a problem with it. It is the abuse of it that causes the issue. Like everything else I don't see alcohol or tobacco being banned and these two items cause far greater adverse outcomes.