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Custom-made meds may pose deadly threat

March 11th, 2009    Posted by: Adam C

While going through menopause, Marcia Sticka developed miserable hot flashes and night sweats, dry skin, a short temper, and an uncharacteristic lack of energy. No more: Every day for the past three years, she’s rubbed a low, precisely measured dose of the hormone testosterone onto her inner thighs, and she feels great.

“It really helped the hot flashes and night sweats, I’m not cranky all the time, and I wake up raring to go,” says Sticka, 57, of Hillsboro, Ore.

Sticka is one of millions of people benefiting from compounding — when pharmacists prepare drugs in doses, forms, and combinations not available from manufacturers. In this case, the standard prescription testosterone gel (Androgel) is suitable only for men, delivering several times the daily dose Sticka’s doctor prescribed.

More than 30 million prescription drugs are compounded each year, and they’re a godsend for people with needs that off-the-shelf pharmaceuticals can’t meet. But these drugs have recently come under attack. Critics are concerned that some compounders are acting like drug manufacturers, doctors, or both — but without the same safeguards. There’s good reason to be worried: Compounded drugs are blamed for a host of serious side effects, including three recent deaths. Even if this is the first you’ve heard of compounding, you shouldn’t feel immune to its potentially negative consequences. As the practice becomes more widespread (over the past decade, it’s burgeoned into at least a $5 billion business), it has the potential to affect millions.

Lifesaver or risky business?
All of the nearly 200,000 pharmacists in this country are licensed to compound, and about 5,000 make it a specialty. At their best, compounding pharmacists occupy a respected, time-honored position in the medical system. From modifying the strength of a medication to altering the form or flavor so it’s easier to swallow, they fill a vital need if you can’t take commercial, one-size-fits-all prescription drugs.

The problem is the changing nature of compounding. Traditionally, it involves a sacrosanct “triad relationship” between a patient with a special need (such as Sticka), a physician who writes her a prescription, and a pharmacist who tailors the drugs.

But lately some shady prescription drug manufacturers are calling themselves compounders to get around the FDA’s stringent oversight of pharmaceuticals. Even some corner drugstore types — in an effort to drum up new business and boost profits — seem to be overstepping their bounds in a way that puts consumers at risk.

Compounding goes awry
Though compounders aren’t supposed to make anything unless they receive a specific prescription, many are producing, stockpiling, and marketing large quantities of Rx drugs — creating what’s being dubbed a “shadow drug industry.” However, unlike drugs made by the pharmaceutical industry, compounded medicines aren’t regulated by the FDA. This lack of oversight is accepted when pharmacists make drugs for a single patient. But these large-scale compounders often employ poor manufacturing processes that can result in products without the required strength, quality, or purity — meaning an error could endanger many.

This worst-case scenario happened to Margrit Long of Portland, Ore., who sought relief from chronic back pain. Her doctor suggested injections of colchicine, a drug used in pill form to treat gout, and prescribed off-label in injection form for back pain. The doctor got the medication from ApothéCure, a Dallas pharmacy that promotes its compounded injectables. The strong anti-inflammatory action of the shots seemed to help with Long’s pain for several years — until March 2007, when an injection killed her. The problem: a measurement error by the person mixing the prescription, which meant that Long and at least two others were fatally injected with eight times the intended amount of colchicine. ApothéCure ultimately recalled more than 3,500 vials of the drug distributed nationwide.

Errors don’t have to be reported
Precisely how many other compounding errors there are isn’t known. That’s because — unlike commercial drug manufacturers — pharmacies in most states aren’t required to report adverse events associated with compounded drugs to the FDA or state pharmacy boards. But the one state that tests random samples of drugs has uncovered problems. When Missouri’s board of pharmacy spot-checked compounded prescriptions in 2007, 51 of 213 prescriptions tested were more than 10 percent off in the dose of active ingredients, one had only one-fifth of the amount needed, and another had 4 1/2 times the prescribed dose.

Horror stories like Long’s aren’t the exclusive domain of large-scale compounders: Local compounding pharmacists can be overconfident in their ability to make what patients and physicians need. In 2001, Doc’s Pharmacy in Walnut Creek, Calif., began compounding a steroid that the manufacturer had temporarily stopped making. But the reputable pharmacy was unable to create a sterile compound, and within a few months, three people treated with the contaminated injections died of meningitis. This outcome shouldn’t be that surprising, considering that just 1 in 5 schools of pharmacy offers a special course on compounding sterile medications. Only 13 percent of pharmacy school deans felt that their students graduated with adequate training in compounding sterile preparations, according to a 2005 survey. Yet all pharmacists are licensed to compound.

Pharmacists as physicians?
Some compounders veer toward practicing medicine themselves, dispensing advice directly to customers on the best drug for their ills. This is especially true when it comes to “bioidenticals.” These prescription hormones, frequently used to treat perimenopausal discomfort, are synthesized to be molecularly identical to specific human hormones. It’s okay for compounders to make up prescriptions for various combinations of hormones, but compounders frequently promote bioidenticals as natural, risk free, and able to prevent or cure a host of medical conditions. The truth: Bioidenticals are created in a laboratory, often by manipulating plant hormones, and there’s no proof they have fewer or different risks than other hormones or offer any specific health benefits.

But that’s not what many hear. At some pharmacies, you can go to a lecture on the benefits of bioidenticals, schedule an individual consultation to review your symptoms, take hormone tests that the pharmacist analyzes, and have a customized bioidentical hormone prescription recommended and sent to your physician’s office for a signature. If your doctor’s not amenable, the pharmacy helps you find a physician who is.

Read the entire article at http://www.msnbc.msn.com/id/29532018/

Live Longer Easily!

February 24th, 2009    Posted by: admin

At the end of a residential cul-de-sac in Dartmouth, Nova Scotia, a driveway winds up a hill to the headquarters of Ocean Nutrition, a complex of buildings of mid-century vintage overlooking the tall-masted schooners and gray-hulled Canadian Navy destroyers in Halifax Harbour.

Down the road, semi-trailers loaded with drums of oily yellow liquid pull up outside a newly built factory. Inside cavernous galvanized-steel hangars, the oil is blended with deionized water in 6,500-gallon tanks. The resulting slurry of micro-encapsulated oil is then pumped through a five-story spray-drier to remove the moisture.

The final product is a fine-grained beige substance that looks like flour but is, in fact, a triumph of technology: smelly fish oil, transformed by industry into a tasteless, odorless powder. It will be used to spike everything from infant formula in China to the Wonder Bread and Tropicana orange juice on our supermarket shelves.

Ocean Nutrition is not manufacturing some Soylent Green for the new millennium.

After seven years and $50 million of research, the company’s 45 technicians and 14 Ph.D.s have found a high-tech way of getting a crucial set of nutrients back into our bodies — compounds that, thanks to the industrialization of agriculture over the past half century, have been thoroughly stripped from our food supply without, until recently, it being realized by anyone.

Now, an ever-growing body of research is showing that the epidemic of diseases associated with the Western diet — cancer, heart disease, depression, and much more — might be curtailed simply by restoring something we never should have removed from our diets in the first place: omega-3 fatty acids.

The great mistake
We are, it is often — and accurately — said, what we eat. Recent diet trends, from Atkins to South Beach, have put the emphasis on upping our intake of protein or cutting out carbohydrates. Meanwhile, cholesterol, saturated fats, and trans fats have been stigmatized, leading to the belief that waging a total war on fat is the best way to get a slimmer waistline and a longer life. But fats are as crucial to a healthy body as protein is; they end up holstered into the heart, protecting organs, and building the cells of the brain, an organ that is itself 60 percent fat. The key to good health lies not in ruthlessly striking fat from our diets, but in eating the best possible fats for our bodies. And a growing chorus of nutritionists agrees that those fats are omega-3s.

Certainly, you’ve read headlines trumpeting the ability of omega-3 fatty acids to boost brain function and protect against coronary heart disease. Hedging your bets, you may already have tweaked your diet, substituting beef or poultry for salmon or some other oily fish a few times a week. But, as a jaded observer of food trends, you may have wondered whether the new “heart-healthy” fats touted on the packaging of eggs, margarine, spaghetti, and frozen waffles are just a marketing ploy — the latest in a long line of miracle nutrients that, a few months or years hence, will prove to be nothing more than hype.

Lose the skepticism. This isn’t the next oat bran.

Omega-3 molecules are a by-product of the happy meeting of sunlight, water, and carbon dioxide in the chloroplasts of terrestrial plants and marine algae. Not long ago, these fatty acids were an inescapable component of our diet. Back in the early 1900s — long before the arrival of bovine growth hormone and patented transgenic seeds — American family farms were perfect factories for producing omega-3s.

Bucolic, sun-drenched pastures supported a complex array of grasses, and cattle used their sensitive tongues to pick and choose the ripest patches of clover, millet, and sweet grass; their rumens then turned the cellulose that humans can’t digest into foods that we can: milk, butter, cheese, and, eventually, beef, all of them rich in omega-3s. Cattle used to spend four to five carefree years grazing on grass, but now they are fattened on grain in feedlots and reach slaughter weight in about a year, all the while pumped full of antibiotics to fight off the diseases caused by the close quarters of factory farms.

Likewise, a few generations ago, chickens roamed those same farms, foraging on grasses, purslane, and grubs, providing humans with drumsticks, breasts, and eggs that were rich in grass-derived omega-3s. Today, most American chickens are now a single hybrid breed — the Cornish — and are raised in cages, treated with antibiotics, and stuffed full of corn.

Our animal fats were once derived from leafy greens, and now our livestock are fattened with corn, soybeans, and other seed oils. (Even the majority of the salmon, catfish, and shrimp in our supermarkets are raised on farms and fattened with soy-enriched pellets.) So not only have good fats been stricken from our diets, but these cheap, widely available seed oils are the source of another, far less healthy family of fatty acids called omega-6s, which compete with omega-3s for space in our cell membranes. Omega-6s are essentially more rigid fatty acids that give our cells structure, while omega-3s are more fluid and help our bodies fight inflammation. Our ancestors ate a ratio of dietary omega-6s to omega-3s of approximately 1:1. The Western diet (the modern American and European eating pattern characterized by high intakes of red meat, sugar, and refined carbohydrates) has a ratio of about 20:1.

“The shift from a food chain with green plants at its base to one based on seeds may be the most far reaching of all,” writes Michael Pollan in his prescriptive manifesto In Defense of Food. “From leaves to seeds: It’s almost, if not quite, A Theory of Everything.”

Read the entire article at http://www.msnbc.msn.com/id/29104695/

New Calcium Study

February 23rd, 2009    Posted by: Adam C

CHICAGO - A study in nearly half a million older men and women bolsters evidence that diets rich in calcium may help protect against some cancers.

The benefits were mostly associated with foods high in calcium, rather than calcium tablets.

Previous studies have produced conflicting results. The new research involved food questionnaires from participants and a follow-up check of records for cancer cases during the subsequent seven years. This research method is less rigorous than some previous but smaller studies.

But because of its huge size — 492,810 people and more than 50,000 cancers — the new study presents powerful evidence favoring the idea that calcium may somehow keep cells from becoming cancerous, said University of North Carolina nutrition expert John Anderson, who was not involved in the study.

The study was run jointly by the National Institutes of Health and AARP. The results appear in Monday’s Archives of Internal Medicine.

National Cancer Institute researcher Yikyung Park, the study’s lead author, called the results strong but said more studies are needed to confirm the findings.

Duke University nutrition researcher Denise Snyder said the results support the idea that food rather than supplements is the best source for nutrients.

Participants were AARP members aged 50 to 71 who began the study in the mid-1990s. A total of 36,965 men and 16,605 women were later diagnosed with cancer. There were more than 10 different kinds of cancer, the most common being prostate, breast, lung and colorectal.

Compared with people who got little calcium, those who consumed the most had the lowest chances of getting colon cancer. Those in that highest category got on average 1,530 milligrams a day among men and 1,881 milligrams daily among women. The recommended amount for older people is 1,200 milligrams, and getting much more than that didn’t result in any greater protection. Adults can get that amount from four cups of milk or calcium-fortified orange juice.

Men who got the most calcium from food were about 30 percent less likely to get cancer of the esophagus, about 20 percent less likely to get head and neck cancer and 16 percent less likely to get colon cancer, when compared to men who got low amounts of calcium.

Among women, those who got the most food-based calcium were 28 percent less likely to get colon cancer than low-calcium women.

In men, calcium supplements only seemed to help protect against colon cancer; for women, supplements meant a lower risk for liver cancer, which is rare.

Some previous studies have linked diets high in calcium with prostate cancer but the current study found no such risk.

Adults who ate the most calcium also tended to be healthier overall than the others.

Northwestern University preventive medicine instructor Patricia Sheean called the results impressive. But she noted that all those in the study, AARP members, may have been healthier and wealthier than the general U.S. population so it’s not clear if the results would apply to the wider population.

I found this article at http://www.msnbc.msn.com/id/29353337/

This week’s Healthcare News

February 23rd, 2009    Posted by: Adam C

Listen up Germophobes!

February 19th, 2009    Posted by: Adam C

At least once a day, Lisa Pisano feels the itch. The 30-year-old fashion publicist goes to the reception desk of her New York City office to accept a delivery of clothing samples from a designer. The courier hands over the garments, swings his messenger bag forward on his hip, fishes inside for a clipboard and hands her a pen. And then she feels it: a tickle at the back of her mind. A little rush of disquiet. Oh, my God, she thinks. Where has that pen been?

She imagines the possibilities: tucked behind the courier’s ear. Clutched by a stranger’s hand, which that day had probably touched a bathroom door or a subway handrail. She thinks about the millions of people in New York, eating, scratching, rubbing their noses, picking up bacteria and then leaving it on that handrail, and then on the person’s hands, and then on the courier’s pen, and then on her hand, her face, her lungs, her… Ick.

Pisano has always been germ-conscious — she wipes off her purse if it’s been resting on the floor and swabs her keyboard, phone and mouse with disinfecting wipes — but the pen problem pushes her over the edge every time.

One day, on the way to work, she spotted her salvation in an office-supply store window: a pen made of antibacterial plastic. She bought a handful and now, whenever the messengers buzz for her, she carries one to the door. Her co-workers tease her. She ignores them. “I’m known in the office for being a little nutty about my pens,” she says, laughing but not apologizing. “If you take my pen, I’m coming after you.”

Admit it: You’ve got something in your own life that makes you go ick. Ask any group of women what they do to protect themselves from germs, and the stories will pour out: We open the bathroom door with elbows, punch the elevator buttons with knuckles, carry wet wipes to disinfect the ATM — and we wonder whether we’re going a little too far. Even the doctors we turn to for reassurance aren’t immune. “I’m extremely aware of the potential for being ‘contaminated,’ in and out of my office,” says Susan Biali, M.D., a 37-year-old physician in Vancouver, British Columbia. “I wouldn’t touch the magazines in the waiting room if you paid me!”

When Self.com polled readers about their germophobia, more than three quarters said they flush public toilets with their foot, and 63 percent avoid handrails on subways, buses and escalators — all unnecessary precautions, experts say. Almost 1 in 10 say they avoid shaking hands, behavior that may flirt with full-fledged obsession, when your efforts to sanitize your life begin to stymie your day-to-day functioning.

Germophobia, of course, is not listed in the Diagnostic and Statistical Manual of Mental Disorders. But mental-health professionals agree that, in vulnerable people, extreme germ awareness can be both a symptom of and a catalyst for a variety of anxiety ailments for which women are already more prone — including obsessive-compulsive disorder, which often features repetitive hand washing and fear of contamination. Ironically, hands that are dry and cracked from overwashing are more likely to pick up an infection through openings in the skin, says Joshua Fox, M.D., a spokesman in New York City for the American Academy of Dermatology.

Read the entire article at http://www.msnbc.msn.com/id/29166897/

This Week in Healthcare

February 16th, 2009    Posted by: Adam C

Cure for the common cold??

February 13th, 2009    Posted by: Adam C

Snifflers of the world rejoice: Scientists are one step closer to finding effective treatments for the common cold now that researchers have deciphered the genetic code of the ubiquitous virus.

While a full-blown cure for the common cold is not expected anytime soon, the mapping of the human rhinovirus’s genetic blueprint will help scientists better understand and combat this highly contagious pathogen. In the meantime, there are always ways to help keep yourself from succumbing to the coughs and congestion.

Researchers from the University of Maryland School of Medicine in Baltimore and the University of Wisconsin-Madison cracked the cold’s code by sequencing the genomes of all 99 known strains of rhinovirus. This allowed the team to determine how all the strains were related to one another, creating a viral family tree of sorts.

The work, detailed in the Feb. 13 issue of the journal Science, confirmed some ideas about the nature of the human rhinovirus while providing a few surprises.

“We know a lot about the common cold virus,” said study co-author Ann Palmenberg of the University of Wisconsin-Madison, “but we didn’t know how their genomes encoded all that information. Now we do, and all kinds of new things are falling out.”

Read the entire article at http://www.msnbc.msn.com/id/29165133/

Spur the Economy and Stay Healthy too!

February 6th, 2009    Posted by: admin

NEW YORK - It is the dusking of the Age of Aquarius.

And as the generation that wouldn’t trust anyone over 30 enters their 60’s, the fitness industry is singing “You’ve Got a Friend” to all 77.5 million of them.

“Baby boomers are a booming population. Their numbers are expected to increase by about 25 percent in the next eight years,” said Kara Thompson, of the International Health, Racquet and Sportsclub Association (IHRSA).

Boomers span ages 43 to 61, approximately. With the U.S. Administration on Aging reporting that 77 percent of all financial assets in the United States are held by those 50 and older, it’s like the poet said: “You don’t need a weatherman to know which way the wind blows.”

Thompson said an a survey by IHRSA, which promotes fitness through education and sports club membership, showed that gym membership among the 55+ group in the United States jumped from 1.5 million in 1987 to 9.9 million in 2007.

“It is estimated that in this year alone, Boomers will spend over $70 billion on ways to stave off the aging process,” she added.

As we age, tendons and muscles shorten, bones lose calcium and lungs lose elasticity, writes Dr. Vonda Wright, in her new book, “Fitness After 40.”

But that’s just the bad news.

“Only 30 percent of aging is genetic,” Wright, who specializes in sports medicine, explained. “That means that 70 percent of how we age is determined by the decisions we make.”

Strong spirit, weakened flesh
Boomers have grown up with fitness. Charles Atlas extolled body building in their comic books. Jack La Lane performed jumping jacks on their black and white TVs, and Jane Fonda exercised on their VCRs.

So with the spirit still strong but the flesh somewhat weakened, what’s the Woodstock generation to do now?

Wright is specific: “We need 30 minutes of brisk aerobic exercise three to five times a week that gets our heart rates up to at least 70 percent of maximum, daily stretching, three days a week of resistance training and daily balance training.” she said.

Fitness centers have heeded the call.

Curves is the leader of the pack. The Texas-based chain of health clubs was founded in 1995 to bring 30-minute circuit training to women of a certain age.

“These women have the most purchasing power of any segment of the population. They don’t want to sit their golden years out on the sidelines — more than any other generation they want to stay young and fit,” said Becky Frusher, spokeswoman for Curves, adding that it has 10,000 locations in 70 countries around the world.

As more and more over-50’s turn up in fitness classes everywhere, teachers and administrators are happily accommodating them.

Programs geared to seniors
At a Bally Total Fitness Center in Brooklyn, New York, instructor Kathy Rubinstein leads a group of mostly baby boomers through her strength class.

“My classes aren’t meant for any special age group, but I give variations of the workout. I show them the high impact move and then the low impact move,” Rubinstein said.

“I think it’s fair to make the workout beneficial for all age groups, so they’re not intimidated from taking my classes,” she added.

So what can boomers look forward to further down that long and winding road?

Several fitness-club chains in the United States, including Gold’s Gym, Bally’s, and the YMCA, offer programs specially geared to seniors. The biggest, Silver Sneakers, is in all 50 states and 9,000 locations. It is even covered by some Medicare-based health plans.

“It’s an awesome class and a lot of fun for that age group,” said Rubinstein, who is 31.

The times, it seems, are still a-changin’.

Weekly News

February 5th, 2009    Posted by: admin

Study: MS linked to vitamin D deficiency

February 5th, 2009    Posted by: admin

LONDON - A certain genetic variant combined with a vitamin D deficiency when young may increase a person’s chances of developing multiple sclerosis later in life, British researchers said Thursday.

The finding suggests that giving vitamin D supplements to pregnant women and young children could reduce the risk of getting the disease, they reported in the journal PLoS Genetics.

It also bolsters previous evidence implicating the so-called “sunshine” vitamin in the autoimmune disease, which affects 2.5 million people worldwide.

“Vitamin D is a safe and relatively cheap supplement with substantial potential health benefits,” Sreeram Ramagopalan, a University of Oxford researcher, who worked on the study, said in a statement.

“There is accumulating evidence that it can reduce the risk of developing cancer and offer protection from other autoimmune diseases.”

Multiple sclerosis is a disease of the nervous system caused by damage to the myelin sheath that protects nerve cells. It can cause symptoms ranging from vague tingling to blindness and paralysis.

Vitamin D, made when skin is exposed to sunlight and found in fatty fish like salmon, is added to milk and other foods in many countries. Evidence suggests it helps lower blood pressure, reduce inflammation and boost the immune system.

“We have known for a long time that genes and environment determine multiple sclerosis risk,” George Ebers, a researcher at the University of Oxford, who worked on the study, said in a statement.

“Here we show that the main environmental risk candidate — vitamin D — and the main gene region are directly linked and interact.

The researchers found that proteins activated by vitamin D bind to a particular DNA sequence lying next to the DRB1 variant, which in effect switches the gene on. Too little vitamin D may cause the gene to malfunction, they said.

Read the entire article at http://www.msnbc.msn.com/id/29035920/