"The Daily Dose"

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.

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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/

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.

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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/

There’s no phone and no television. Only a screen offers privacy. But heart patient Edward Gray understands why the hospital put him in a cardiac unit hallway.

“They sent me up here to make room for other emergency patients,” Gray, 78, said last week from his bed in the hall of a New York area hospital. “This is the way things are in hospitals.”

It may not sound like ideal health care, but hospital officials nationwide are being urged to consider hallway medicine as a way to ease emergency department crowding, and some are trying it.
Leading the way is Stony Brook University Medical Center at Stony Brook, N.Y., where a study found that no harm was caused by moving emergency room patients to upper-floor hallways when they were ready for admission.

The study’s lead author says all hospitals should look at the program’s success.

“This is yet another battle cry for hospitals to get off their duffs and stop stacking people knee deep in the emergency department,” said Dr. Peter Viccellio, who is clinical director of the hospital’s emergency department.

He is to present the study’s findings Tuesday at a meeting of the American College of Emergency Physicians in Chicago.

Hospital-wide problem
Crowding is a hospital-wide problem that has been handed off to emergency departments, Viccellio said. His idea hands the problem back to the entire hospital.

Before the change, when his hospital filled up, patients were admitted but held in the ER in a common practice called boarding. On busy days, “things would grind to a halt and people would wait to be seen,” Viccellio said. Infectious patients would wait in the ER’s hallway for isolation rooms to open up elsewhere in the hospital.

Holding patients in ERs can cause deaths, doctors say. In a 2007 survey of nearly 1,500 emergency doctors, 13 percent said they personally experienced a patient dying as a result of boarding in the emergency department. The survey was conducted by the American College of Emergency Physicians.

The new study found slightly fewer deaths and intensive care unit admissions in the hallway patients compared to the standard bed patients. That was no surprise, Viccellio said, because the protocol calls for giving the first available rooms to the sickest patients. Intensive care patients never go to hallways.

The study is based on four years of Stony Brook’s experience with more than 2,000 patients admitted to hallways from the ER.

Other hospitals resist the idea, doctors say. Dr. Michael Carius, who heads the emergency department at Norwalk Hospital in Norwalk, Conn., would like it adopted at his hospital. But nurses and government regulators have resisted, citing safety issues, “as though the emergency department hallway is a safer environment,” he said in frustration.

“When you’re full of admitted patients, you’re no longer an emergency department, you’re just a holding area,” Carius said.

‘They could see the problem’
In Texas, all it took to convince nurses at Harris Methodist Fort Worth Hospital was a tour of the ER, said Barbara VanWart, emergency nurse manager.

“They could see the problem and help us make things happen because now it’s before their eyes,” VanWart said. The hospital started its hallway protocol in 2005.

Dr. Kirk Jensen of the nonprofit Institute for Healthcare Improvement in Cambridge, Mass., said the best reason to adopt the concept is the way it gets the whole hospital involved in finding rooms more quickly for admitted patients.

“It’s out of sight, out of mind, even if they know that patients are there in the emergency department,” Jensen said. With patients in their own hallways, “they get a lot more creative and aggressive with workflow practices.”

When Stony Brook began the hallway practice, the staff noticed “the miracle of the elevator,” said Carolyn Santora, who heads the hospital’s patient safety efforts. Somehow, rooms became available by the time hallway-bound emergency patients made it upstairs, she said.

Nurses hate seeing patients in their hallways, Santora said, and that’s fine with her.

“I want them to hate it. I want them to do everything to expedite flow to get the patient out of hallway.”

Gray, the hallway patient at Stony Brook, came to the ER with chest pains and was stabilized before being sent upstairs. He is a retired nurse and said hospital crowding deserves attention from lawmakers.

“I wish the $700 billion went for hospitals, roads and bridges and not to bail out those folks on Wall Street,” he said.

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PARIS - A 59-year-old woman has given birth to triplets at a Paris hospital after seeking fertility treatment in Vietnam, a hospital spokeswoman said on Monday.

News of the woman’s pregnancy has drawn widespread criticism in the French media since it was made public last week. It is illegal in France to provide fertility treatment to women who are no longer at an age when they can procreate naturally.

“On this particular point, scientific progress is not good for mankind,” said Andre Vingt-Trois, a Catholic archbishop, quoted by Monday’s Le Parisian newspaper.

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Food and milk from the offspring of cloned animals may already have entered the U.S. food supply, the Food and Drug Administration said on Monday, but it would be impossible to know because there is no difference between cloned and conventional products.

The FDA said in January meat and milk from cloned cattle, swine and goats and their offspring were as safe to eat as products obtained from traditional animals. Before then, farmers and ranchers had followed a voluntary moratorium that prevented the sale of clones and their offspring.

“It is theoretically possible” offspring from clones are in the food supply, said Siobhan DeLancey, an FDA spokeswoman. “I don’t know whether they are or not. I could imagine there are not very many of them.”

Proponents, including the Biotechnology Industry Organization, say cloned animals are safe and a way to create animals that produce more milk and better meat and are more disease-resistant. There are currently an estimated 600 cloned animals in the United States.

The small cloning industry and the FDA have maintained cloned animals and their offspring are as safe as their regular counterparts. Cloning animals involves taking the nuclei of cells from adults and fusing them into egg cells that are implanted into a surrogate mother.

U.S. Agriculture Department spokesman Keith Williams said ”there is no way to differentiate” between cloned animals, their offspring and conventionally bred animals, making it difficult to know if they are in the food supply.

Even as the FDA unveiled its final rule, USDA asked in January for the cloning industry to prolong the ban on selling products from cloned animals during a “transition” period expected to last at least several months. That ban would not extend to meat and milk from the clone’s offspring.

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WASHINGTON - Take the generic drug clonidine for high blood pressure? Double-check that you didn’t leave the drugstore with Klonopin for seizures, or the gout medicine colchicine.

Mixing up drug names because they look or sound alike — like this trio — is among the most common types of medical mistakes, and it can be deadly. Now new efforts are aiming to stem the confusion, and make patients more aware of the risk.

Nearly 1,500 commonly used drugs have names so similar to at least one other medication that they’ve already caused mix-ups, says a major study by the U.S. Pharmacopeia, which helps set drug standards and promote patient safety.

Last week the influential group opened a Web-based tool to let consumers and doctors easily check if they’re using or prescribing any of these error-prone drugs, and what they might confuse it with. Try to spell or pronounce a few on the site — http://www.usp.org/ — and it’s easy to see how mistakes can happen. Did you mean the painkiller Celebrex or the antidepressant Celexa?

Due out later this fall is a more patient-oriented Web site, a partnership of the nonprofit Institute for Safe Medication Practices and online health service iGuard.org, that will send users e-mail alerts about drug-name confusion.

And the Food and Drug Administration — which currently rejects more than a third of proposed names for new drugs because they’re too similar to old ones — is preparing a pilot program that would shift more responsibility to manufacturers to guard against name confusion. The goal is to spell out how to better test for potential mix-ups before companies seek approval to sell their products.

“There are so many new drugs approved each year, this problem can only get worse,” warns USP vice president Diane Cousins.

At least 1.5 million Americans are estimated to be harmed each year from a variety of medication errors, and name mix-ups are blamed for a quarter of them.

Rarely does a company change a drug’s name after it hits the market, although it’s happened twice since 2005. The Alzheimer’s drug Reminyl now is named Razadyne, after mix-ups, including two reported deaths, with the old diabetes drug Amaryl. The cholesterol pill Omacor is now named Lovaza, after mix-ups with blood-clotting Amicar.

Doctor’s penmanship only part of problem
Doctors’ notoriously bad handwriting isn’t the only culprit. A hurried pharmacist faced with alphabetized bottles on a shelf might grab the wrong one.

Nor are computerized prescriptions a panacea. A doctor who e-prescribes still can click the wrong row on the alphabetized screen, picking the bone drug Actonel instead of the diabetes drug Actos.

Phone or fax a prescription, and static or smudged ink can turn the epilepsy drug Lamictal into the antifungal pill Lamisil.

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