Newswise — The number of cosmetic procedures performed in shopping malls, spas and walk-in clinics has risen dramatically in the past several years. Unfortunately, patients who choose to have these procedures performed in such locations may be forgoing safety for convenience of location and bargain prices. The American Academy of Dermatology (Academy) urges patients to select a board-certified physician for cosmetic surgery. The Academy recommends patients do their homework and consider a doctor’s training and credentials before they decide if a particular physician is the right choice for them.

Arielle N.B. Kauvar, MD, FAAD, clinical associate professor of dermatology at New York University School of Medicine, New York, NY, knows the risks involved when a cosmetic procedure is not performed by a qualified physician.

“Today, many non-physicians are performing various cosmetic procedures outside their scope of training in spas, shopping malls and walk-in clinics,” explains Dr. Kauvar. “While these locations may offer convenience, the limited training and supervision of the person performing the procedure, and the equipment available to handle complications or medical emergencies, can jeopardize the health and appearance of the patient.”

Some people may have medical problems or take medications that may increase the risks of side effects. Non-physicians may not be knowledgeable about these conditions.

In a 2007 survey by the American Society for Dermatologic Surgery (ASDS), 56 percent of dermatologic surgeons indicated that there had been an increase in the number of patients they had treated as the result of complications caused by a non-physician performing a cosmetic procedure. Burns, scarring and skin discoloration were some of the most common complications experienced by patients who had procedures performed by non-physicians.

“I have seen many cases of cosmetic procedures gone wrong. These procedures were performed by non-physicians without appropriate physician supervision,” said Dr. Kauvar. “In addition, staff members were not adequately trained in the procedure or knowledgeable about the risks and complications.”

To assist consumers in choosing a qualified dermatologist, the Academy recommends that before undergoing any cosmetic procedure, consumers should ask the following questions:

What are the doctor’s credentials? Is he/she a board-certified physician or other appropriately trained surgeon? What training does the staff have?

“Ask to see their credentials. Dermatologists are surgeons who have received extensive education and training and they safely perform thousands of cosmetic surgery procedures with excellent results for their patients,” explained Dr. Kauvar.

The education and training for dermatologists and dermatologic surgeons involves at least four years of postgraduate residency training in programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). This includes at least one year of training in internal medicine, pediatrics, general surgery, or another ACGME-approved broad-based program, followed by at least three years of intensive training in dermatology including dermatopathology and dermatologic surgery. To become board-certified, dermatologists also must pass a certifying examination given by the American Board of Dermatology, a member of the American Board of Medical Specialties.
Dermatologic surgeons also may participate in post-graduate surgical fellowships lasting one to two years. Beyond this, dermatologists and dermatologic surgeons engage in continuing medical education (CME) throughout their careers (in fact, almost every state requires a minimum number of CME hours per year for relicensure).

How many of these cosmetic surgery procedures has the physician performed? What results can be expected? Ask to see before and after photos of the physician’s previous patients.

“A physician should be up front and honest about the number of specific surgeries they have performed,“ stated Dr. Kauvar. “In addition, the physician you choose to perform your procedure should be willing to share before and after photos of cosmetic procedures he or she has performed, when available.”

How long is the recuperation period?

“With any cosmetic surgery, the results achieved largely depend not only on the skill and experience of the physician, but also on a patient’s general overall health, age, healing capacity, and the specific skin problem,” remarked Dr. Kauvar. A patient’s realistic expectations also help contribute to a positive outcome.

What are the risks?

“The risks involved in most cosmetic surgery procedures are minimal,” explained Dr. Kauvar. “However, there are inherent risks associated with any type of surgery, and these should be discussed with your physician during the initial consultation.”

Where is the cosmetic surgery usually performed?

“Because most cosmetic dermatologic procedures do not require general anesthesia, cosmetic surgery procedures are most often effectively and efficiently performed safely in the surgeon’s office, surgical suite, or outpatient surgical center,” stated Dr. Kauvar. “This venue offers a safe, cost-effective alternative to the hospital.”

What is the cost?

“As with any medical procedure, the cost will vary depending on the nature of the treatment,” explained Dr. Kauvar. “It is important to ask up front how much the procedure will cost and how payment is required.”

“The patient’s safety is the top priority for any physician,” noted Dr. Kauvar. “The overall care a patient receives from a physician in his or her office is unparalleled to the walk-in clinics found in shopping malls and spas. A well-informed patient and a board-certified physician are always the best prescription for a successful outcome.”
Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 15,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at
1-888-462-DERM (3376) or http://www.aad.org/.

Newswise — Why do some people experience a “placebo effect” that makes them feel better when they receive a sham treatment they believe to be real — while other people don’t respond at all to the same thing, or even feel worse?

A new study from the University of Michigan Health System may help explain why.

Using two different types of brain scans, U-M researchers have found that the extent to which a person responds to a placebo treatment is closely linked to how active a certain area of their brain becomes when they’re anticipating something beneficial.

Specifically, the research finds strong links between an individual’s response to a placebo “painkiller”, and the activity of the neurotransmitter known as dopamine in the area of the brain known as the nucleus accumbens. That’s a small region at the center of the brain that’s involved in our ability to experience pleasure and reward, and even to become addicted to the “high” caused by illicit drugs.

The new research, published in the July 19 issue of the journal Neuron, builds on research previously published by the same U-M team in 2005. That study was the first to show that just thinking a placebo “medicine” will relieve pain is enough to prompt the brain to release its own natural painkillers, called endorphins, and that this corresponds with a reduction in how much pain a person feels.

“Receptors for both endorphins and dopamine are clustered heavily in the nucleus accumbens. So, taken together, our studies delve directly into the mechanisms that underlie the placebo effect,” says senior author and U-M neuroscientist, psychiatrist and brain-imaging specialist Jon-Kar Zubieta, M.D., Ph.D. “This is a phenomenon that has great importance for how new therapies are studied, because many patients respond just as well to placebo as they do to an active treatment. Our results also suggest that placebo response may be part of a larger brain-resiliency mechanism.”

For the current study, Zubieta and his colleagues — led by neuroscience graduate student David J. Scott — combined information from two types of brain scan to come to their conclusions. They performed PET (positron emission tomography) scans on the brains of 14 healthy volunteers, and fMRI (functional magnetic resonance imaging) scans on those 14, and on 16 other healthy volunteers.

The PET scans focused on brain dopamine, looking at its activity as volunteers were told to expect, and then received, a painful injection of saline solution in their jaw muscle. They were then told to expect, and then received, an injection that they were told could either be a painkiller or a placebo. (Both were in fact placebos.) The fMRI scans looked at volunteers’ brains while they played a game. Before each round, they learned that a correct answer would win or lose an amount of money, up to $5.

The PET scans were made using 11C-raclopride, which combines a drug that binds preferentially to dopamine receptors with a short-lived radioactive form of carbon that can be “seen” on PET scans. Throughout the PET scanning session, volunteers were asked to rate their level of pain on a numerical scale, and to describe any emotions they were experiencing.

Before the painful injection began, but after the volunteers had been told it was coming, they were also asked to guess how much pain relief they’d get from the “painkiller” if they received it. Half the volunteers were women, all in the same stage of their monthly cycle to avoid differences in hormonal state that might affect tolerance of pain – another topic that Zubieta’s team has studied.

The PET scans and pain ratings revealed that as a group, the volunteers experienced significant pain relief from the placebo. But when researchers looked at each individual’s results, they found that only half of the volunteers reported less pain when they received the “painkiller” placebo.

These placebo responders, as they were dubbed, had significantly more dopamine activity in their left nucleus accumbens than the other volunteers, beginning when they were told the painkiller medicine was about to begin flowing into their jaws. It also turned out that these individuals had also all anticipated the “painkiller” would give good pain relief before they even received it.

Meanwhile, of the seven individuals who didn’t experience the placebo effect, four actually reported feeling more pain when the “painkiller” was delivered – a phenomenon that has been dubbed the “nocebo” effect and has been observed in other situations.

Just to make sure that the volunteers’ pain ratings weren’t affected by the fact that they always received painful injections followed by placebo “painkiller”, the researchers put a separate group of 18 male volunteers through the same experience twice, but no placebo was actually given, and actual PET scans were not done. Their pain and emotion ratings were significantly different from those of volunteers who received placebo.

“The results of these functional molecular imaging studies indicate that dopamine activity is activated in response to a placebo in a manner that’s proportional to the amount of benefit that the individual anticipates,” says Zubieta, who is the Phil F. Jenkins Professor of Depression in the U-M Medical School’s Department of Psychiatry and a member of U-M’s Molecular and Behavioral Neuroscience Institute, Depression Center and Department of Radiology.

The fMRI scans, which were performed on different days from the PET scans, revealed additional information about how individual expectations correlated with their placebo response. Each volunteer had an fMRI scan that looked at blood oxygenation throughout their brain, which allows researchers to spot areas where neurons (brain cells) are especially active as the individual performs a task or plays a game. In this case, the task was a very simple gambling game, in which subjects were scanned while expecting varying levels of a monetary reward or no reward.

As in the PET scans, the nucleus accumbens was a hotbed of activity as the volunteers were told how much money they could win or lose in the next round; as they waited for the round; and as they pressed the button and learned if they had succeeded in winning or avoiding losing money.

Then, the researchers compared the PET and fMRI scans for the volunteers who had had both types of scan. They also compared the ratings of anticipated placebo effect, the analgesia induced by the placebo during the pain studies, and the emotional changes associated with it. They found that those who expected a placebo to help them and got greater benefit from it (more analgesia, better emotional state) were also those who had the most activity in their nucleus accumbens during the anticipation of receiving a reward in the fMRI money game.

In addition to Zubieta and Scott, the study’s authors are Christian Stohler, DMD, formerly of the U-M School of Dentistry and now dean of the University of Maryland School of Dentistry; Christine Egnatuk and Heng Wang of the U-M MBNI; and Robert Koeppe, Ph.D., director of the PET Physics Section in the Nuclear Medicine division of the U-M Department of Radiology. The study was funded by the National Institutes of Health.

In response to a wide number of health problems caused by Chinese-made food products, China itself has now leveled charges of food contamination in US-made products.

On Monday, the official Xinhua news agency reported that Chinese inspectors found that a protein powder from a U.S. supplier contained too much selenium and was being sent back

Selenium is a trace mineral essential in small amounts, but too much of it can cause hair loss, stomach aches and other problems.

On the weekend China also suspended pork and poultry from some U.S. suppliers after finding salmonella-contaminated chicken and meat products with growth agents or other additives.

Chinese authorities have been very upset about the negative publicity in the overseas press about the health scares from Chinese-made goods.

The deaths of patients in Panama from toothpaste, deadly toxins in pet food ingredients and food laced with additives and antibiotics have increased public anxiety in the United States about the safety of China’s food exports.

In an editorial in the overseas edition of the People’s Daily, the ruling Communist Party’s official paper, said it was inevitable that the country’s rising exports would face tighter scrutiny from choosy foreign customers.

But it also blamed foreign forces seeking to undermine Chinese industry.

“In recent years those people churning out the theory of a China threat have grabbed hold of this issue and not let go, treating isolated cases as the whole and maliciously attacking ‘Made in China’,” the paper said.

China’s criticisms of foreign media and companies are unlikely to alter widespread U.S. public anxiety about foods, medical ingredients, toys and other goods made in China.

Last month, the U.S. Food and Drug Administration announced a temporary hold on imports of some Chinese seafood until suppliers could prove they were free of harmful residues.

Poorly regulated food and drug safety standards have been a problem for years in China and the Chinese government has moved in recent weeks to attack the problem, promising stricter oversight.

Last week, in an effort to show that it means business, China executed the former head of its Food and Drug Administration for corruptly approving unsafe drugs.

A daily pint of milk or a helping of dairy foods protect against the clustering of abnormal body chemistry known as the metabolic syndrome, suggests a study in the Journal of Epidemiology and Community Health. 

The syndrome has been linked to an increased risk of diabetes, coronary artery disease, and premature death.

The findings are based on a representative sample of 2,375 men aged between 45 and 59, all of whom were part of a long term study on health, known as the Caerphilly Prospective Study.

Two or more out of high blood glucose, insulin, blood fats, body fat, and blood pressure defined the presence of the metabolic syndrome in the men studied.

The men’s health was tracked over 20 years, during which time data from food questionnaires and weekly food diaries were used to assess how much milk and dairy foods the men consumed.

Around one in seven men (15%) had metabolic syndrome at entry into the study.

These men had almost double the risk of coronary artery heart disease and four times the risk of diabetes of those without the syndrome. They were also almost 50% more likely to die early.

But those who regularly drank milk and ate dairy products, such as yogurt and cheese, were significantly less likely to have the syndrome.

They were 62% less likely to have it if they drank a pint or more of milk every day, and 56% less likely to have it if they regularly ate other dairy produce.

And the more dairy produce the men consumed, the less likely were they to have the syndrome.

Milk consumption has plummeted in the UK over the past 25 years, amid concerns about its impact on health, say the authors. But dairy produce is part of a healthy diet and its consumption should be promoted, they conclude.

Newswise — Folate, or its synthetic form, folic acid, is good for brain health. But there’s concern that this brain booster could mask deficiencies in vitamin B-12, which can result in mental decline and other nerve problems. The July issue of Mayo Clinic Health Letter covers why it’s important to have enough of both.

Numerous studies have determined that high levels of folate intake, up to 800 micrograms (mcg) a day, may help ward off cognitive decline, possibly lower the risk of Alzheimer’s disease, and even improve mental sharpness in areas such as memory and mental processing speed.

Folate is also important during pregnancy for the developing fetus, which is why the Food and Drug Administration in 1998 mandated folic acid fortification of grain products sold in the United States.

Vitamin B-12 plays an essential role in red blood cell formation, cell metabolism and nerve function. Where there’s a deficiency, symptoms include persistent tingling in the hands and feet, confusion and forgetfulness.

An estimated 15 percent of older adults are deficient in vitamin B-12. This deficiency can be caused by age-related changes in the digestive tract, which blunt the body’s ability to digest and absorb vitamin B-12 from food. Vegetarians who avoid all animal products and people who have digestive diseases such as celiac disease or Crohn’s disease may also be at increased risk of vitamin B-12 deficiency.

While folic acid offers benefits, there are concerns about how it chemically reacts with vitamin B-12 within the body. It’s suspected that high folic acid intake can correct the anemia — but not the nerve and cognitive deterioration — that would normally occur with vitamin B-12 deficiency. Without the indication of anemia, vitamin B-12 deficiency may not be suspected and neurological deterioration may continue unabated.

More study is needed to fully explore the relationship between folate and vitamin B-12 and how it may affect brain health. Until then, the safest bet is to ensure intake of adequate amounts of both. Most older adults can do this by taking a multivitamin supplement that contains 100 percent of the recommended daily allowance of both folate and vitamin B-12. For folic acid, that’s 400 mcg a day and for vitamin B-12, it’s 2.4 mcg a day.

A healthy diet that includes daily servings of fortified breads, grains or cereals and a wide variety of fresh and natural foods such as fruits, vegetables, beans and nuts can boost daily intake of folate or folic acid to the higher levels that may benefit brain health.

Newswise — Eating about 30 calories a day of dark chocolate was associated with a lowering of blood pressure, without weight gain or other adverse effects, according to a study in the July 4 issue of JAMA.

Previous research has indicated that consumption of high amounts of cocoa-containing foods can lower blood pressure (BP), believed to be due to the action of the cocoa polyphenols (a group of chemical substances found in plants, some of which, such as the flavanols, are believed to be beneficial to health). “A particular concern is that the potential BP reduction contributed by the flavanols could be offset by the high sugar, fat and calorie intake with the cocoa products,” the authors write. The effect of low cocoa intake on BP is unclear.

Dirk Taubert, M.D., Ph.D., of University Hospital of Cologne, Germany, and colleagues assessed the effects of low regular amounts of cocoa on BP. The trial, conducted between January 2005 and December 2006, included 44 adults (age 56 through 73 years; 24 women, 20 men) with untreated upper-range prehypertension (BP 130/85 – 139/89) or stage 1 hypertension (BP 140/90 – 160/100). Participants were randomly assigned to receive for 18 weeks either 6.3 g (30 calories) per day of dark chocolate containing 30 mg polyphenols or matching polyphenol-free white chocolate.

The researchers found that from baseline to 18 weeks, dark chocolate intake reduced average systolic BP by −2.9 (1.6) mm Hg and diastolic BP by −1.9 (1.0) mm Hg without changes in body weight, plasma levels of lipids or glucose. Hypertension prevalence declined from 86 percent to 68 percent. Systolic and diastolic BP remained unchanged throughout the treatment period among those in the white chocolate group. Dark chocolate consumption resulted in the short-term appearance of cocoa phenols in plasma and increased vasodilatory S-nitrosoglutathione. There was no change in plasma biomarkers in the white chocolate group.

“Although the magnitude of the BP reduction was small, the effects are clinically noteworthy. On a population basis, it has been estimated that a 3-mm Hg reduction in systolic BP would reduce the relative risk of stroke mortality by 8 percent, of coronary artery disease mortality by 5 percent, and of all-cause mortality by 4 percent,” the authors write.

“The most intriguing finding of this study is that small amounts of commercial cocoa confectionary convey a similar BP-lowering potential compared with comprehensive dietary modifications that have proven efficacy to reduce cardiovascular event rate. Whereas long-term adherence to complex behavioral changes is often low and requires continuous counseling, adoption of small amounts of flavanol-rich cocoa into the habitual diet is a dietary modification that is easy to adhere to and therefore may be a promising behavioral approach to lower blood pressure in individuals with above-optimal blood pressure. Future studies should evaluate the effects of dark chocolate in other populations and evaluate long-term outcomes,” the authors conclude.

Newswise — Up to 73% of men with prostate cancer take nonprescription supplements and smaller numbers use diet, exercise, or both in the hope of improving their outcome. Most of these men also receive conventional therapy, but a few depend on lifestyle alone. The appeal of lifestyle therapy is obvious—but does it work? Experts don’t know, though research raises hope that it may have a beneficial impact, reports the July 2007 issue of Harvard Men’s Health Watch.

All of the 93 men who signed up for the trial had newly diagnosed low- to moderate-grade cancers that were localized to the prostate gland. Half were randomly assigned to a lifestyle program, and half got no advice on lifestyle changes. The program that researchers created included four elements: An ultra-low-fat vegan diet; supplements, including soy, fish oil, vitamins E and C, and selenium; an exercise program of walking 30 minutes six days a week; and stress reduction that included yoga-based stretching, breathing, and meditation for an hour a day.

At the end of a year, a small but significant difference was evident. The average PSA in the intensive lifestyle group fell, whereas the average PSA in the untreated men rose. The participants in the lifestyle group also showed favorable cancer-fighting changes in their blood.

Much more research is needed before lifestyle therapy can be recommended clinically. But, the Harvard Men’s Health Watch notes, men with prostate cancer may choose not to wait until science catches up with their disease. And since the lifestyle program studied is good for general health, its elements will make a reasonable addition to any prostate cancer program.

Newswise — Increasing intake of the omega-3 fatty acids DHA and EPA, found in popular fish-oil supplements, may protect against blindness resulting from abnormal blood vessel growth in the eye, according to a study published online by the journal Nature Medicine on June 24. The study was done in mice, but a clinical trial at Children’s Hospital Boston will soon begin testing the effects of omega-3 supplementation in premature babies, who are at risk for vision loss.

Abnormal vessel growth is the cause of retinopathy of prematurity, diabetic retinopathy in adults, and “wet” age-related macular degeneration, three leading causes of blindness. Retinopathy, affecting about 4 million diabetic patients and about 40,000 premature infants in the United States, is a two-step disease that begins with a loss of blood vessels in the retina (the nerve tissue at the back of the eye that sends visual signals to the brain). Because of the vessel loss, the retina becomes oxygen-starved and sends out alarm signals that spur new vessel growth. But the new vessels grow abnormally and are malformed, leaky and over-abundant. In the end stage of the disease, the abnormal vessels pull the retina away from its supporting layer, and this retinal detachment ultimately causes blindness.

The researchers, led by Lois Smith, MD, PhD, and Kip Connor, PhD, of Children’s Hospital Boston’s Department of Ophthalmology and Harvard Medical School, and John Paul SanGiovanni, ScD, of the National Eye Institute (NEI), National Institutes of Health, studied retinopathy in a mouse model, feeding the mice diets that emphasized either omega-3 fatty acids (comparable to a Japanese diet) or omega-6 fatty acids (comparable to a Western diet).

Mice on the omega-3 diet, rich in DHA (docosahexaenoic acid) and its precursor EPA (eicosapentaenoic acid), had less initial vessel loss in the retina than the omega-6-fed mice: the area with vessel loss was 40 to 50 percent smaller. As a result, the omega-3 group had a 40 to 50 percent decrease in pathological vessel growth.

“Our studies suggest that after initial loss, vessels re-grew more quickly and efficiently in the omega-3-fed mice,” says Connor, the study’s first author. “This increased the oxygen supply to retinal tissue, resulting in a dampening of the inflammatory ‘alarm’ signals that lead to pathologic vessel growth.”

Because omega-3 fatty acids are highly concentrated in the retina, a mere 2 percent change in dietary omega-3 intake was sufficient to decrease disease severity by 50 percent, the researchers note. Validating their findings, results were virtually identical in mice whose omega-3 fatty acid levels were increased through genetic means.

Omega-3 fatty acids like DHA and EPA are thought to dampen inflammation in the body. They are often lacking in Western diets; instead, omega-6 fatty acids predominate. The ideal omega-6:omega-3 ratio is thought to be 2:1 to 5:1, whereas typical Western diets have ratios of 10:1 or higher. Premature infants are especially lacking in omega-3 fatty acids, because they miss getting this nutrient from their mothers, a transfer that normally happens in the third trimester of pregnancy.

The researchers demonstrated that the omega-3-based diet suppressed production of TNF-alpha, reducing the inflammatory response in the retina, whereas the omega-6-based diet increased TNF-alpha production. The retinas of omega-3-fed mice also had increased production of the anti-inflammatory compounds neuroprotectinD1, resolvinD1 and resolvinE1. These compounds, derived from omega-3 fatty acids, also potently protected against pathological vessel growth, and they were not detected in the retinas of mice fed the omega-6 diet.

“If omega-3 fatty acids, or these anti-inflammatory mediators, are as effective in humans and they are in mice, simple supplementation could be a cost-effective intervention benefiting millions of people,” says Smith, the study’s senior investigator. “The cost of blindness is enormous.”

Aside from fish-oil supplements, the most widely available source of omega-3 fatty acids is coldwater oily fish (wild salmon, herry, mackerel, anchovies, sardines). The compounds can also be made synthetically from algae or other non-fish sources.

Paul A. Sieving, MD, PhD, director of the NEI, which provided funding for the study, said, “This study shows the benefit of dietary omega-3 fatty acids in protecting against the development and progression of retinal disease. It gives us a better understanding of the biological processes that lead to retinopathy and how to intervene to prevent or slow disease. It will be interesting to see if human clinical trials show similar beneficial effects.”

The clinical trial at Children’s Hospital Boston will follow premature newborns who are unable to feed and are receiving parenteral nutrition, with omega-3 fatty acids as part of their IV solution. The hope is that the omega-3 supplementation will allow the retina and its vessels to develop normally. “Once the retina is detached, there’s little you can do,” says Smith. “We want to give omega-3 right from the beginning to mimic what the infants would be getting from their mothers in utero, had they not been born prematurely.”

In addition to retinopathy, the researchers speculate that omega-3 fatty acids may help reduce vision loss in people with “wet” or neovascular phase of age-related macular degeneration (AMD), a disease that also involves abnormal vessel growth. This possibility is now being explored in a large, NEI-funded clinical trial called AREDS2, coordinated by Emily Chew and John Paul SanGiovanni, both co-authors of the animal study. (See www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 .)

Drugs that block the growth factor VEGF are also being studied in the end stages of retinopathy of prematurity and diabetic retinopathy, and have been approved for use in “wet” AMD, Smith notes. While injection of anti-VEGF compounds into the eye can block pathological vessel growth in the retina, omega-3 supplementation may reduce the need for repeated injections by preventing some patients from advancing to end-stage disease, she says.

The study was funded by the V. Kann Rasmussen Foundation, the National Eye Institute (NEI) of the National Institutes of Health, the Children’s Hospital Boston Mental Retardation and Developmental Disabilities Research Center, and a Research to Prevent Blindness Lew Wasserman Merit Award.

The U.S. Food and Drug Administration announced new rules requiring that dietary supplements are to be tested to ensure that they are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.   These standards are known as good manufacturing practices (cGMP) and are already used in food manufacturing.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Newswise — Slicing certain pills in half could slice a hefty amount off of America’s prescription drug costs. While only some types of pills can be split safely, the practice could be used by millions of Americans – including many of those who take popular cholesterol-lowering drugs.

Now, a new University of Michigan study adds more evidence that splitting a high-dose pill and swallowing half of it, rather than taking a whole low-dose pill each time, doesn’t change those medicines’ impact on cholesterol levels. It is also the first prospective randomized controlled trial of pill-splitting, and the first to look at the impact of out-of-pocket costs on patients’ willingness to take the time to split pills.

The study is published in the June issue of the American Journal of Managed Care by a team from the U-M Health System and the U-M College of Pharmacy.

“This study was done in part to see what the impact would be of having some of the cost savings go back to the patient,” says first author Hae Mi Choe, PharmD, CDE, clinical assistant professor in the College and a UMHS clinical pharmacist.

While the study did not find that out-of-pocket costs had an impact on the participants’ tendency to split and take their pills in the six-month study, most participants said that reduced co-pays would be needed to entice them to continue splitting pills.

The findings have already had an impact on one large employer’s prescription drug plan: U-M used them to justify a pill-splitting program that launched in early 2006. In its first full year, the program saved the University $195,000, and saved more than 500 employees and retirees a total of more than $25,000 in drug co-pay costs.

Pill-splitting relies on the fact that many medicines are manufactured in tablet formulations that contain different doses of the active ingredient. Some of the higher-dose tablets can be cut in half with a blade to produce two lower-dose tablets – for example, 80 milligram tablets can be cut to produce two 40-mg tablets.

Because drug manufacturers and wholesalers don’t usually charge twice the price for twice the dose, the cost of half of a high-dose pill is far lower than the cost of buying a whole pill containing the same dose of medicine. So, pill-splitting can save money for the insurance plan or pharmacy-benefit manager that buys the pills for a group of insured patients — and for the employer or government agency that pays for the plan.

But few prescription plans currently structure their benefits to encourage pill-splitting, by charging lower co-pays to patients who buy high-dose pills they intend to split.

Patients have been splitting pills on their own for years. Some do it without their doctors’ knowledge, to try to save money. But others do it with help from physicians who write prescriptions for a higher dose and instruct patients on how to make one month’s supply last two months. However, this can result in potentially dangerous confusion, and skew the patient’s and doctor’s records.

In recent years, pharmacists have worked to determine which tablets can be safely split, and which — such as drugs that exit the body quickly, or that have time-release coatings — cannot.

Cholesterol-lowering drugs called statins are among the most widely-used classes of medicines, with tens of millions of Americans taking the drugs. They’re also good candidates for splitting because they linger in the body for a relatively long time, and because small day-to-day dose fluctuations that can happen when pills are split don’t make a major difference in cholesterol levels.

The U-M study involved patients who were taking atorvastatin, pravastatin, or simvastatin, which are sold commercially as Lipitor, Pravachol, and Zocor or genetic simvastatin, respectively. The patients were all being treated by physicians at a single UMHS health center. They were also better educated and more likely to be white and female than the general U.S. adult population.

Two hundred eligible patients completed the initial survey regarding their perception on pill splitting, Of them, 111 patients agreed to participate in a 6-month trial of pill splitting in which half were randomized to receive a financial incentive of 50 percent reduction in their co-payment per refill and half did not.

All study participants were given two different pill-splitters to compare and to use for six months. They allowed the researchers to review their prescription information and cholesterol levels for a pre-study period as well as during the study. On average, the co-pay reduction was about $5 to $7 per month.

A total of 103 patients completed the entire six-month randomized study, and 109 completed the survey at the end. The patients who were randomly assigned to receive co-pay reductions were no more likely than the other patients to refill their prescriptions on time or to experience an increase in cholesterol levels.

The follow-up survey showed that 89 percent of all participants would be willing to continue splitting pills if they would receive a co-pay reduction, and 80 percent said that splitting pills had been “no big deal” for them. Most said it would take a 50-percent co-pay reduction to entice them to keep splitting, but 24 percent said they would only keep splitting if the out-of-pocket cost was zero. Few of the patients reported problem with splitting pills, or missing doses because they had to split.

Although the study didn’t show that