HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, July 26, 2008

The Dangerous Art of the Tattoo

US News reports that since tattoo inks are not approved by the FDA, no one knows exactly what is in all the many commercial and homemade brands.  Chemists have turned up some unhealthy surprises like mercury, lead, and antifreeze.  However, some experts remain skeptical that the inks can be harmful and even if questionable, the amount injected is probably so small that harm is not an issue.  Bernadine Healy M.D. writes,

TattooTattoos are fast becoming a mark of the 21st century, with one quarter or more of those under the age of 30 adorning their skin with at least one. Whether driven by the urge for personal expression or just plain youthful impulsiveness, most people get tattooed without a clue about the health implications of this invasive skin-puncturing procedure. I'd suggest that all tattooing require a signed consent form outlining risks—the most obvious one being a major case of remorse.

Upwards of 50 percent of those who get tattoos later wish they hadn't. Their regrets become medical when they visit a dermatologist to have the tattoos removed, which is both painful and expensive. In the July issue of the Archives of Dermatology, researchers at Texas Tech University Health Sciences Center report on what's behind the change of heart: moving on from the past, problems wearing clothes, embarrassment, and concerns that tattoos could adversely affect job or career.

But tattooing is designed to last forever, delivering permanent ink deep under the epidermis. The skin reacts by protectively encapsulating the alien clumps of pigment in dense fibrous tissue while a few nearby lymph nodes collect what migrates out. For a long time, removal meant surgical excision or deep abrasion of the skin, invariably causing scarring and sometimes the need for skin grafting. In the preferred approach now, the tattoo gradually fades away under many months of laser treatments tailored to the wavelength of the pigments. Sounds easy. But with disruption, the fading tattoo becomes more like a toxic chemical dump.

Chemists from several laboratories, including the government's National Center for Toxicological Research, have identified low levels of carcinogens in tattoo ink. But the laser removal process, which demolishes the pigment by scorching it with heat, triggers chemical reactions that generate carcinogenic and mu-tation-inducing breakdown products, which are then absorbed by the body. Recently, German scientists reported that concentrations of toxic molecules from red and yellow pigments increased up to 70-fold after laser irradiation. And the bigger the tattoo, the greater the toxic release. This can only make one wonder whether it's better to let the sleeping paint lie, walled off by the body's own protective devices. Only time and a lot more study will tell.

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July 26, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunscreen Safety Is Called Into Question

The New York Times reports on a study from the Environmental Working Group that has found that four out of five sunscreens offer inadequate protection from the sun or contain ingredients that may pose a health risk.  However, dermatologists are skeptical of these findings claiming the study lacks scientific rigor and is based on an arbitrary rating system without any accepted scientific standard.  Tara Parker-Pope writes,

SunscreenFor years, dermatologists have told us sunscreen protects skin. Now, many people are questioning that advice after an environmental group challenged the safety of many popular brands.

“Patients are confused,” said Dr. Darrell S. Rigel, a clinical professor of dermatology at New York University who is a skin cancer researcher. “I’ve had patients come in and ask, ‘Am I harming myself by using it?’ I’ve spent a lot of time talking to people about it.”

The latest report comes from the Environmental Working Group, which claims that in an investigation of nearly 1,000 sunscreen products, four out of five offer inadequate protection from the sun or contain ingredients that may pose a health risk.

But dermatologists who reviewed the group’s research say the biggest problem is that it lacks scientific rigor. In particular, they are critical of a sunscreen rating system that they say is arbitrary and without basis in any accepted scientific standard.

“What they are doing is developing their own system for evaluating things,” said Dr. Warwick L. Morison, professor of dermatology at Johns Hopkins and chairman of the Skin Cancer Foundation’s photobiology committee, which tests sunscreens for safety and effectiveness. “Using this scale to say a sunscreen offers good protection or bad protection is junk science.”

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July 26, 2008 | Permalink | Comments (0) | TrackBack (0)

California Becomes First State to Ban Trans Fats

The Washington Post reports that California will become the first state to sign into law a measure banning trans fats.  The measure will phase out trans fats in restaurants beginning in 2010 and from baked goods by 2011.  Jane Black writes,

Nutrition_factsCalifornia became the first state in the country to ban artery-clogging trans fats yesterday when Gov. Arnold Schwarzenegger signed into law a measure to phase them out in restaurants beginning in 2010 and from baked goods by 2011.

"California is a leader in promoting health and nutrition, and I am pleased to continue that tradition by being the first state in the nation to phase out trans fats," Schwarzenegger (R) said.

Trans fatty acids, or trans fats, are commonly found in partially hydrogenated oils, which became popular at fast-food restaurants and bakeries because they have a longer shelf life than other oils.

But a series of studies over the past decade has shown that trans fats can lower "good cholesterol" (high-density lipoproteins) and raise "bad cholesterol" (low-density lipoproteins), which can contribute to heart disease and other ailments.

Researchers at the Harvard University School of Public Health estimate that artificial trans fats cause 50,000 premature heart-attack deaths every year.

Violators of the California law will incur fines of $25 to $1,000. Food sold in manufacturer-sealed packaging will be exempt.

"Trans fat is generally recognized as the single most harmful fat in the food supply on a gram-per-gram basis," said Michael Jacobson, executive director of Center for Science in the Public Interest, a Washington-based health advocacy group that has called for trans fat labeling since the 1990s. "This is a historic day."

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July 26, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, July 25, 2008

Congress Sends Bush Expanded Global AIDS Program

The Washington Post reports that Congress has approved an expansion of the global AIDS bill, which would approve $48 billion over the next five years for HIV/AIDS, tuberculosis and malaria programs in Africa and other afflicted areas of the world. It also would approve $2 billion for American Indian health, water and law enforcement programs.  Richard Cowen writes,

Red_ribbonThe Congress on Thursday approved a large expansion of a program to fight AIDS and other diseases raging in Africa and elsewhere, sending the measure to President George W. Bush, who is expected to sign it into law.

By a vote of 303-115, the House of Representatives passed the bill authorizing $48 billion over the next five years to help treat and prevent AIDS, tuberculosis and malaria. That is up sharply from the $15 billion Congress initially funded for the first five years of the program that began in 2003.

The Senate passed an identical bill on July 16.

Despite authorizing the funds, Congress must still pass separate legislation to deliver the money. It is unclear whether that will occur in this election year as Democrats and Republicans wrangle over the budget.

House Foreign Affairs Committee Chairman Howard Berman, a California Democrat, said expanding the program "will allow us to significantly boost the health care workforce" in countries hard-hit by AIDS "and to increase the number of HIV-positive individuals receiving life-saving medicine."

Bush had requested $30 billion for 2009 to 2013, but has signaled a willingness to go along with the $48 billion for a signature program of his presidency.

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July 25, 2008 | Permalink | Comments (1) | TrackBack (0)

Tomato Industry Seeks Compensation

The Wall Street Journal reports that the tomato industry has introduced legislation that would give tomato growers and shippers $100 million to compensate for losses they incurred as a result of the salmonella outbreak.  Jane Zhang and Lauren Etter write,

Tomato_industryFederal health officials haven't cleared tomatoes as a cause of the salmonella outbreak that has sickened more than 1,270 nationwide, but the tomato industry has -- and it is asking taxpayers to compensate them for their loss.

Rep. Tim Mahoney, a Democrat from Florida, a big tomato producer in the U.S., introduced legislation Wednesday night that would give the nation's tomato growers and shippers $100 million to compensate for losses they incurred in the outbreak. The Agriculture Department would decide who qualifies, much like the way disaster assistance is carried out.

At the same time, Congress has scheduled at least three hearings next week on the salmonella outbreak and why it took so long to figure out what caused it.

The sought-after amount is based on an estimate from Florida growers and includes crops abandoned in the field, products thrown out by retailers and tomatoes forced to be sold as low as $5 a box, compared with as much as $20 in a normal market, said Reggie Brown, executive vice president of the Florida Tomato Growers Exchange, a cooperative of tomato farmers. The Agriculture Department hasn't released a firm estimate of the cost to farmers or distributors.

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July 25, 2008 | Permalink | Comments (0) | TrackBack (0)

In Surprise Move, EPA Bans Carbofuran Residue on Food

The Washington Post reports that the EPA has announced that it will no longer allow residue of the toxic pesticide carbofuran on domestic or imported foods as a result of the safety risks posed to toddlers.  Juliet Eilperin writes,

Pesticide_carbofuranThe Environmental Protection Agency announced yesterday that it will no longer allow residue of the toxic pesticide carbofuran on domestic or imported food, a decision that would effectively remove the chemical from the U.S. market.

EPA officials said they made the decision -- which surprised environmentalists as well as the pesticide's sole U.S. manufacturer -- on the grounds that the chemical residue poses an unacceptable safety risk to toddlers.

"This is a product that we don't believe meets our high standards for the general population, particularly for small children who are more sensitive," said James Gulliford, EPA associate administrator for the office of prevention, pesticides and toxic substances. "While there is little exposure today [to the pesticide], we don't think there's a need, a reason for any exposure."

A million pounds of carbofuran are applied each year in the United States, affecting less than 1 percent of the nation's farmed acres, according to the EPA, but it is used more heavily in developing countries on crops including rice, bananas, coffee and sugar cane. The EPA had indicated earlier this year that it would not apply the ban to imported food, but yesterday it said it will.

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July 25, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, July 24, 2008

Billionaires Back Antismoking Effort

The New York Times reports that Bill Gates and Mayor Michael R. Bloomberg have agreed to spend $500 million in an anti-smoking campaign to stop people around the world from smoking.  Donald G. McNeil Jr. writes,

No_smokingBill Gates and Mayor Michael R. Bloomberg announced on Wednesday that they would spend $500 million to stop people around the world from smoking.

The World Health Organization estimates that tobacco will kill up to a billion people in the 21st century, 10 times as many as it killed in the 20th.

This time, most are expected to be in poor countries like Bangladesh and middle-income countries like Russia. In an effort to cut that number, Mr. Bloomberg’s foundation plans to commit $250 million over four years on top of a $125 million gift he announced two years ago. The Bill and Melinda Gates Foundation is allocating $125 million over five years.

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July 24, 2008 | Permalink | Comments (0) | TrackBack (0)

Gene May Help ID Statin Side Effect Risk

CNN reports that genetic variations may predict patients who will get muscle pain and weakness as a side effect from taking cholesterol-lowering statin drugs.  CNN writes,

ZocorScientists may have found a way to test for and possibly avoid the most serious side effect of cholesterol-lowering statin drugs, one of the top-selling medicines in the world.

In rare cases, statins can cause muscle pain and weakness. Researchers have identified a genetic variation that seems to predict more than half of these cases. People on statins who have the variant were about five to 17 times more likely to develop muscle problems, a serious side effect that can lead to muscle breakdown, kidney failure and death.

The finding raises hope that a test could be developed to screen heart patients to find out who is at greatest risk. Normally, muscle weakness caused by statins affects 1 out of 10,000 patients a year.

"It could become a very simple check," said Rory Collins of the University of Oxford, who co-authored the study published in Thursday's New England Journal of Medicine.

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July 24, 2008 | Permalink | Comments (0) | TrackBack (0)

F.D.A. Urges Genetic Test Before Giving AIDS Drug

The New York Times reports that the FDA is urging doctors to use a genetic test to screen patients before prescribing the drug abacavir, which is widely used for HIV infections and AIDS.  Andrew Pollack writes,

Genetic_testing5Seeking to prevent life-threatening side effects, the Food and Drug Administration is urging doctors to use a genetic test to screen patients before prescribing a drug widely used for H.I.V. infection and AIDS.

In an advisory it is expected to issue Thursday, the agency says that patients with a particular variation in an immune system gene should not be given the drug abacavir because they are at a far higher risk of a severe allergic reaction to the drug.

Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.

The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.

The labels of several other drugs, like the blood thinner warfarin and the cancer drug irinotecan, also recommend tests aimed at avoiding side effects or helping to adjust the dose.

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July 24, 2008 | Permalink | Comments (0) | TrackBack (0)

Cancer Expert Warns Employees on Cell Phones

CNN reports that although there are no published studies or definitive data, one cancer doctor is warning that cell phones are more than likely to cause cancer.  CNN writes,

Cell_phone2The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer.

The warning from Dr. Ronald B. Herberman, director of the University of Pittsburgh Cancer Institute, is contrary to numerous studies that don't find a link between cancer and cell phone use, and a public lack of worry by the U.S. Food and Drug Administration.

Herberman is basing his alarm on early unpublished data. He says it takes too long to get answers from science, and he believes that people should take action now, especially when it comes to children.

"Really at the heart of my concern is that we shouldn't wait for a definitive study to come out but err on the side of being safe rather than sorry later," Herberman said.

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July 24, 2008 | Permalink | Comments (2) | TrackBack (0)

Medical Genetics Pioneer, Victor McKusick, Dies at 86

The Los Angeles Times and The New York Times reports on the recent death of Victor McKusick, a doctor that linked specific diseases to specific genes, established one of the nation's first departments of medical genetics, and was one of the first to propose sequencing the human genome.  Thomas H. Maugh II for the Los Angeles Times writes,

MckusickDr. Victor A. McKusick, the Johns Hopkins University physician who is widely regarded as the father of medical genetics, died Tuesday at his home in Baltimore. He was 86 and died of complications from cancer.

McKusick was a pioneer in linking diseases to specific genes and began the first database of gene functions, a repository that now includes more than 18,000 human genes.

The two-week course in genetics taught by McKusick and his colleagues every summer in Bar Harbor, Maine, became the best-known and most respected course in the subject, bringing in more than 4,000 students, doctors and researchers from all over the country and introducing them to an entirely new way of addressing illnesses.

"Today we have lost a legend," said Dr. Edward D. Miller, dean of the Johns Hopkins medical faculty and chief executive of Johns Hopkins Medicine. "His influence and legacy reach around the world."

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July 24, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 23, 2008

A Government Threat to Birth Control

US News reports that Sen. Hillary Clinton and other advocates of women's rights say a planned regulation could cut access to contraception.  Deborah Katz writes,

Birth_control A new set of health laws that could be proposed by the government sometime in the next few weeks has women's health activists steaming. If the laws are implemented, they claim, women will have a harder time getting access to contraception.

The legislation, a draft of which was leaked last week to the New York Times, stokes the debate over when human life begins by taking the position that birth control that prevents the implantation of a fertilized egg actually results in abortion. It would prohibit federally funded medical facilities—including teaching hospitals and Planned Parenthood clinics—from refusing to hire doctors who don't want to dispense birth control pills and other types of contraception that may cause the expulsion of a fertilized egg. (It's already illegal to discriminate against doctors who refuse to perform abortions.) The new laws would also override state laws that require hospitals to offer emergency contraception to rape victims and those that require employers to provide contraceptives along with other prescriptions.

Late last week, Sen. Hillary Clinton called the planned rules (which could be imposed without congressional approval) "damaging" and a "dire threat to women" and warned that contraceptive coverage would "disappear overnight" if enacted. Dozens of organizations, including the American College of Obstetricians and Gynecologists and Planned Parenthood, have also voiced their objection, especially to the government's definition of the onset of pregnancy.

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July 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Veto Seems More Likely in Battle Over Tobacco Bill

The New York Times reports on the tobacco legislation pending in Congress that will give the FDA regulatory authority over tobacco.  Stephanie Saul writes, 

TobaccoIn its sharpest criticism yet of the tobacco legislation pending in Congress, the Bush administration has said it “strongly” opposes the effort to give the Food and Drug Administration regulatory authority over tobacco.

The criticism came Monday in a letter by Michael O. Leavitt, the secretary of health and human services, which some saw as a signal that a veto would be likely if the legislation cleared the House and Senate.

The letter was sent to Joe L. Barton of Texas, the highest-ranking Republican member of the House Energy and Commerce Committee, which approved the bill in April. Mr. Barton voted against the bill.

The White House and the F.D.A. commissioner, Dr. Andrew C. von Eschenbach, have previously raised concerns about the legislation. The letter provided the strongest indication yet that the administration would try to block the bill.

The proposal has broad support in the House but, in the Senate, it is believed to be three votes short of a majority sufficient to override a veto. The House could vote on the measure as early as this month.

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July 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Health Plan From Obama Spurs Debate

Writing for the New York Times, Kevin Sack questions whether Barack Obama's health plan can really lower health care costs enough to bring down premiums by $2,500 for the typical family.  Sack writes,

Barack_obamaIt is one of the most audacious promises in a campaign that has been thick with them.

In speech after speech, Senator Barack Obama has vowed that he will lower the country’s health care costs enough to “bring down premiums by $2,500 for the typical family.” Moreover, Mr. Obama, the presumptive Democratic nominee, has promised that his health plan will be in place “by the end of my first term as president of the United States.”

Whether Mr. Obama can deliver is a matter of considerable dispute among health analysts and economists. While there is consensus that the American health care system is bloated with waste, eliminating enough to save $2,500 per family would require simultaneous and synergistic solutions to a host of problems that have proved intractable for decades.

Even if the next president and Congress can muster the political will, analysts question whether significant savings would materialize in as little as four years, or even in 10. But as Mr. Obama confronts an electorate that is deeply unsettled by escalating health costs, he is offering a precise “chicken in every pot” guarantee based on numbers that are largely unknowable. Furthermore, it is not completely clear what he is promising.

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July 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Salmonella Outbreak Exposes Food-Safety Flaws

The Wall Street Journal continues coverage on the salmonella outbreak and reports on problems in the US food-safety system.  Jane Zhang and Janet Adamy write,

Jalapeno3The twisting road that led federal investigators to announce Monday that they found a single contaminated jalapeno pepper grown in Mexico and sitting at a distribution center in McAllen, Texas -- the smoking gun in the continuing salmonella outbreak long blamed on tomatoes -- has exposed problems in the U.S. food-safety system.

After weeks of trying to get to the bottom of the outbreak, it occurred to investigators in late June that they had to look beyond fresh tomatoes. In at least two large clusters of illnesses, tomatoes weren't a factor, and cases kept piling up after the government had warned consumers to avoid eating fresh tomatoes.

Hurdles to the probe ranged from poor record-keeping for tracking fresh produce to some overwhelmed state health departments to the fact that jalapenos had never before been implicated in a salmonella outbreak.

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July 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Viagra Helpful to Women on Antidepressants, Study Finds

The Los Angeles Times reports on a study that finds viagra may be helpful to women whose sexual performance had flagged as a side effect of taking antidrepressants.  Denise Gellene writes,

ViagraThe long search for the female equivalent of Viagra has led researchers to . . . Viagra.

In a small study of 98 women published today, the little blue pill helped women whose sexual performance had flagged as a side effect of taking antidepressants, known as SSRIs -- a very specific finding that could open a new use for the male impotence drug.

The report in the Journal of the American Medical Assn. is one of the few to find some benefit for women despite nearly a decade of searching by its maker, Pfizer Inc.

More than 6 million women in the U.S. suffer from major depression. Antidepressants are the most common treatment for the mood disorder, and while they can be quite beneficial, they often have debilitating sexual side effects.

Doctors said the study, which was funded with a grant from Pfizer, could foster broader experimentation with Viagra for women, although they added that the drug was unlikely to become the blockbuster phenomenon it is among men. Its effectiveness in women is limited compared with men, and Pfizer has said it does not plan to develop the drug for female disorders.

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July 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, July 22, 2008

FDA Finds Salmonella Strain in Jalapeño Pepper

The New York Times reports that the strain blamed for the salmonella outbreak shows up in a Mexican-grown pepper found in a Texas distribution plant. Officials warn against eating fresh jalapeños.  Bina Venkataraman writes,

Jalapeno2Federal food officials have matched a bacterial strain found on fresh jalapeños in a Texas distribution plant with the strain responsible for what has become the nation’s largest food-borne outbreak in the past decade.

The strain found on the jalapeños, Salmonella Saintpaul, was a genetic match to the strain found in lab tests of many of the 1,251 people who have become sick from salmonella poisoning over the past three months.

It was the first time officials had found the strain on fresh produce. But the discovery still does not tell investigators whether the contamination occurred in Mexico, where the peppers were grown, or at the distribution center in McAllen, Tex. The contamination might have also occurred somewhere in between, Dr. David Acheson of the Food and Drug Administration said Monday in a conference call with reporters.

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July 22, 2008 | Permalink | Comments (0) | TrackBack (0)

Epilepsy Drug Topamax Linked to Birth Defects

The Los Angeles Times reports on a study of 203 pregnant women that finds a connection to an anti-epilepsy drug, topiramate, that raises the risk of birth defects.  Experts caution that the group is too small to draw definitive results. Still, they say they aren't surprised.  Thomas H. Maugh II writes,

TopomaxA widely used anti-epilepsy drug called topiramate raises the risk of birth defects as much as 14-fold when taken by pregnant women, especially in combination with another drug called valproate, British researchers reported today.

Experts were quick to caution, however, that the study involved only 203 women, and thus significant statistical uncertainty remained about the research.

"You can't make any definitive statements from the data," said Dr. Kimford J. Meador of the University of Florida in Gainesville, who was not involved in the study.

But the results are not surprising, experts added, because topiramate -- sold by Johnson & Johnson under the brand name Topamax -- has been shown to cause similar defects in animals.

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July 22, 2008 | Permalink | Comments (0) | TrackBack (0)

Better Health for $10 a Person

Writing for Time magazine, Lauran Neergaard suggests that investing $10 a year or leading a healthy lifestyle could cut health care costs by more than $16 billion annually.  Neergaard writes,

Ten_dollarsInvesting just $10 per person — roughly the price of a six-pack of beer and some chips — could greatly fuel community programs that get couch potatoes moving, prevent smoking and improve nutrition, researchers say.

How much health does $10 a person buy? Invest that every year, and within five years the nation could cut health care costs by more than $16 billion annually, concludes a new analysis by the nonprofit Trust for America's Health and a team of public-health research groups.

If the big dollars have your eyes glazing, the overall point is simple: Obesity — from poor nutrition and inactivity — and smoking are blamed for much of the heart disease, cancer, diabetes and lung diseases that are the nation's leading public health problems, fueling the $2 trillion annually spent on health care.

Yet small improvements can add up. Research suggests, for example, that walking 30 minutes a day and dropping just 15 pounds can cut in half the risk that someone with pre-diabetes will get the full-blown disease. The question is how to educate and persuade people to take such steps.

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July 22, 2008 | Permalink | Comments (0) | TrackBack (0)

The Empowered Patient: Don't become the victim of a surgical error

CNN gives a few tips about what patients should do in the process of going through sugery to avoid error and mistake.  Elizabeth Cohen writes,

Hospital_patient2I thought my husband was crazy.  When our 2-year-old daughter had hernia surgery, he insisted on seeing the surgeon minutes before to remind him that the hernia was on her right side, not her left.

The nurses weren't happy; it wasn't protocol to have the surgeon meet with parents immediately before a procedure.

"Maybe this is overkill," I said to my husband. "He knows what side the hernia's on. He's already seen her twice in his office. Plus, we've told the pre-op nurses 10 times it's on the right side."

But experts tell me my husband was right on. Mistakes do happen, no matter how great the surgeon, and it behooves you to help them get it right. Witness these headlines: Minnesota doctors remove the healthy kidney of a cancer patient while leaving the diseased one behind; California doctors remove the appendix of the wrong patient; one of the most experienced surgeons in a Boston, Massachusetts, hospital operates on the wrong side of a patient. All of these mistakes happened in the past year.

Solid numbers are hard to come by, because most states don't require doctors to report surgical errors. To make sure you're not the next victim, you might have to get pushy, like my husband did.

"You need to be that thorn in their side," said Dr. Samuel Seiden, an anesthesiologist who's co-author of a study on surgical errors. "You will catch things. You might also frustrate the nurses, but you have to look out for yourself."

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July 22, 2008 | Permalink | Comments (0) | TrackBack (0)