Patients in study who knew they were taking placebo still felt better

Doctors surprised that sugar pills had effect anyway

Take two sugar pills and call me in the morning. That could become the new mantra of doctors everywhere if a new Beth Israel Deaconess Medical Center study showing the power of the placebo holds water in the real world.

The researchers got some astounding results when they gave placebos — gelatin capsules filled with nondigestible cellulose — to patients suffering from irritable bowel syndrome for three weeks. Nearly 60 percent reported an improvement in their symptoms compared with 35 percent of the patients who took nothing beyond their usual treatments.

But here is the kicker: The placebo takers knew they were popping the equivalent of sugar pills, yet they still said they experienced less abdominal pain, constipation, or loose stools during the study.

In previous studies demonstrating the placebo effect, patients were told they would be given a medication or a sugar pill, that there was a possibility they could be on a real drug.

“There are some things going on that we don’t quite understand,’’ said study author Dr. Ted Kaptchuk, an associate professor of medicine at Harvard Medical School. “We know that placebos represent some kind of self-healing capacity; it could be that taking a pill triggers a sort of unconscious conditioning in our body to begin the healing process.’’

It could also be that the patients were simply helped by seeing doctors who were sympathetic to their symptoms. After all, 35 percent of the study participants who did nothing other than check in with the doctor during the study reported an improvement in their symptoms.

Kaptchuk emphasizes that placebos work best for conditions during which people appraise how they’re feeling; think mood disorders like depression or chronic pain conditions like IBS, fibromyalgia, and osteoarthritis. These are subjective measurements, not objective lab findings that can be quantitatively measured. “I don’t think placebos will improve cholesterol or hypertension,’’ he said, “or shrink a tumor.’’

But they can make people feel better — at least in this small study of 80 volunteers, all of whom were eager to participate in a mind-body experiment. That’s how the study was described in an advertisement to recruit participants, so it might have been biased in favor of those who believe in the placebo effect.

Kaptchuk said the findings need to be replicated in a larger experiment, which he and his colleagues are now planning. Most likely, the high effectiveness rate — better than some prescription medications for irritable bowel syndrome — will drop somewhat with a larger pool of individuals.

If placebos turn out to help even when patients know the pills are fake, it would surmount an ethical dilemma for physicians. Some doctors lie to patients, making them think a placebo is real medication to foster belief in the pill’s healing power. The American Medical Association and others discourage this practice, because it denies patients informed consent.

“We were looking for an honest strategy for dispensing placebos to patients, and I think we showed it can work,’’ Kaptchuk said. Perhaps that will get doctors to stop giving what he calls “impure’’ placebos to patients, such as antibiotics for a cold or vitamins for tension headaches.

About half of 679 American physicians surveyed in a 2008 British Medical Journal study that Kaptchuk co-authored reported giving placebos to their patients, with the vast majority dispensing something other than a sugar pill. Ninety-five percent of doctors who prescribed placebos told their patients they were prescribing “medicine.’’

By Deborah Kotz, The Boston Globe

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Merry Christmas!

"There has been only one Christmas - the rest are anniversaries."
-W.J. Camero

"The Supreme Court has ruled that they cannot have a nativity scene in Washington, D.C. This wasn't for any religious reasons.  They couldn't find three wise men and a virgin."
-Jay Leno

"There is a remarkable breakdown of taste and intelligence at Christmastime. Mature, responsible grown men wear neckties made of holly leaves and drink alcoholic beverages with raw egg yolks and cottage cheese in them."
-P.J. O'Rourke.

"I stopped believing in Santa Claus when I was six.  Mother took me to see him in a department store and he asked for my autograph."
-Shirley Temple

Getting Fit Without the Pain

Athletes over 50 usually hire a physical therapist after a problem, often an injury if not surgery.

But more older people are starting to hire physical therapists before they get hurt to fill the role of personal trainer.

Before he began training for a marathon, 62-year-old veteran runner Joseph Goldberg consulted with a physical therapist about the shin splints that had developed whenever he'd run more than eight miles at a stretch. She diagnosed an imbalanced gait, ordered custom orthotics for him to wear in his shoes and prescribed exercises to strengthen his hips, a corrective proven to reduce leg-related ailments. "I finished the marathon without injury," says Mr. Goldberg, a Virginia attorney.

By fitness-training standards, physical therapists who specialize in sports medicine are extraordinarily highly educated in the science of preserving, restoring and improving human function. Most have master's degrees, and the profession is pushing its members to obtain doctorates as a matter of course by 2020.

But while physical therapists have become fixtures on the sidelines of professional and college sports, their health-preserving skills are little known among recreational athletes. "We're the best-kept secret in sports medicine," says James Glinn, a physical therapist who runs a set of clinics called Movement for Life, based in San Luis Obispo, Calif.

Word is getting out, as Jane Esparza can attest. The owner of a speakers bureau, Ms. Esparza encountered intensifying levels of knee pain as she entered her 50s. Her doctor told her that losing weight and getting fit would help.

But the trainers she interviewed paid less attention to her knee pain than to her excess weight. All of them, she says in an email, responded with some variation of "We'll whip you into shape."

Then she learned about a fitness clinic near her Virginia home called Body Dynamics, run by Jennifer Gamboa, who holds a doctorate in physical therapy. Following a thorough study of Ms. Esparza's needs and limitations, a Body Dynamics physical therapist worked one-on-one with her for eight weeks, leading her through exercise routines that improved fitness and built confidence without straining her knees. Then she was handed over to a Body Dynamics personal trainer, who continued the regimen that the physical therapist had crafted, with an easy-does-it emphasis.

After 18 months, "I've lost weight," Ms. Esparza says. "My blood pressure has gone down. My cholesterol has improved. I breathe better. My strength and balance are improved. And the pain I lived with daily in my knees has greatly improved. Some days I'm almost pain free."

"What physical therapists are very good at is identifying barriers to exercise-knee injuries, chronic ankle pain-and building a program around them that creates incremental improvements," Dr. Gamboa says. Half of people who start an exercise program drop out within six months, partly because of "fear, discomfort and lack of confidence," she says.

Physical therapists often charge far more than $100 an hour, well above the cost of a personal trainer. Insurance companies tend not to cover the cost of physical therapy without a physician's referral; referrals are often limited to patients recovering from injuries, accidents or surgery. After receiving a fitness program from a physical therapist, many patients will, like Ms. Esparza, hire a personal trainer to implement it. But prevention is where many physical therapists say their profession could make the most difference.

A large percentage of aging athletes eventually suffer sprains, strains, overuse injuries and joint pain, and as part of their recovery they go to a physical therapist who focuses on resolving inflammation, restoring flexibility and developing a more-efficient and balanced program.

A proactive visit to a physical therapist can reveal the muscle imbalances and inefficient movement patterns that cause injury. The therapist can provide a regime that corrects those problems while enhancing endurance, balance, strength and weight control.

The American College of Sports Medicine says that it has certified hundreds of physical therapists and that it has no official position on whether injured athletes should seek help first from a physician or physical therapist.

Even so, fitness trainers shouldn't attempt to treat, and certainly shouldn't ignore, sports injuries, says Diane Buchta, spokeswoman for IDEA, a trainer organization. "We must refer those clients to a physician," she adds.Of course, many personal trainers specialize in treating the aging population. But the credentials of personal trainers can range from doctorate-level academic degrees to little or no certification at all. To address that problem, officials at IDEA recently established FitnessConnect, an online directory of more than 100,000 trainers with verified credentials.The American College of Sports Medicine says that it has certified hundreds of physical therapists and that it has no official position on whether injured athletes should seek help first from a physician or physical therapist.

Physical therapy "is largely built on the sciences of anatomy, biomechanics, exercise science and movement analysis," Carl DeRosa, a doctor of physical therapy at Northern Arizona University. That combination, he says, provides "a comprehensive and efficient 'start-to-finish' service to recreational athletes."

In five states, a physician's referral is required for patient visits to a physical therapist. Elsewhere such restrictions have been eliminated, and physical therapists are allowed to diagnose and treat conditions involving impaired movement. Not all physical therapists are sports-medicine specialists, however. The Find-A-PT link on the Web site of the physical therapy association lists 15 specialties other than sports medicine, including wound management, wheelchair mobility and hand rehabilitation.

By Kevin Helliker, The Wall Street Journal

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Oops

"I think there is a world market for maybe five computers."
-- Thomas Watson, Chmn, IBM, 1943

"This telephone has too many shortcomings to be seriously considered as a means of communication. The device is inherently of no value to us."
-- Western Union Internal Memo, 1876

"There is no reason why anyone would want a computer in their home."
-- Ken Olson, Founder, Digital Equipment Corporation, 1977

Firms Feel Pain From Health Law

Big employers faced with incorporating the first round of health-care changes next month are grappling with how to comply with the long list of new rules.

Many companies are hiring consultants to help sort though the mountain of new mandates, which include extending dependent coverage to children up to age 26, and may eventually result in covering more employees. Some are also considering changes to their plans—including pushing costs to workers.

There is also some concern about how to digest the sheer volume of paperwork.

"There's administrative burden just to try and understand the 2,400 pages of the document," says Jenn Mann, vice president of human resources at software maker SAS Institute Inc.

As a result of the reform, SAS is doubling its legal and consultant expenses for 2011, says Ms. Mann. She declined to provide a dollar amount, and SAS wouldn't say what it currently spends on health-care overall.

SAS is also taking steps now to prepare for changes that take effect in future years. In 2018, a tax kicks in on employers with plans whose costs exceed certain levels. If SAS doesn't adjust its health plans, it estimates the tax will cost it approximately $20 million a year, says Ms. Mann.

To help get under the threshold level, in January SAS is eliminating its higher-cost indemnity plan and is also doubling co-pays to $20 from $10, she says. The company may still have to shift more costs to employees to avoid the tax, she says.

The U.S. Department of Health and Human Services says the health-care act "lowers costs for American businesses. The law provides small business tax credits, reimburses employers from some of their highest early retiree costs and cuts the hidden tax they often pay to provide care for the uninsured."

A survey conducted by Ernst & Young in August and September of 381 executives found that 31% are most concerned about the cost of compliance with the law, while 16% were most concerned about their overall readiness to comply with the law.

Borders Group Inc. has increased health-care-related consulting by around 20% to help it understand the law, says Rosalind Thompson, senior vice president of human resources.

Borders' 16,500 part-time employees in the U.S. are offered health coverage through a type of plan known as a "mini-med," which offers limited coverage.

Such plans may be more likely to run afoul of the law's requirements that insurers spend a high portion of premiums on medical care rather than administrative expenses. Those plans won a reprieve in November that loosened the requirements for 2011, but Borders says it's still waiting for guidance on how the rules will apply afterwards.

Ms. Thompson says Borders is also figuring out how to respond to the difference between how the law defines full-time and how Borders does. Borders considers employees who work 32 hours per week full-time, but under the new federal health law, employees who work 30 or more hours would be considered full-time.

Under that definition, Borders would have to cover more employees on its more expensive health-care plan.

"We'll have to do something different with part-time employees ... but until guidelines are fleshed out we don't know what," she says. The company says it's unsure whether it will reduce some employees' hours.

Borders is a member of the National Retail Federation and other groups that lobby on the company's behalf, and hopes those efforts will yield some concessions, Ms. Thompson says, though she wouldn't elaborate.

Neil Trautwein, vice president of the National Retail Federation, says the group has "a lot of concerns about the penalty mandates" and opposes "changing the definition of a full-time employee."

Furniture manufacturer Leggett & Platt Inc. is considering shifting costs to employees as it expects to have to bring more employees and dependents onto its plan.

John Moore, vice president of human resources, says that complying with the first round of changes next year will raise health-care costs by 2% for the company.

For instance, the Carthage, Mo., based company next year expects to cover more dependents after having to extend coverage to children up to 26 years of age, says Mr. Moore.

In 2014, the bill requires most people to have health insurance. Mr. Moore says he worries that will cause many of Leggett's employees who have opted out of the company's health coverage to sign up, raising Leggett's costs. Thirteen percent of Leggett's eligible employees "opt out" or elect not to have health coverage; many are young or dropped out of the plan to save money.

Mr. Moore says the company may consider increasing employee co-pays or implementing high-deductible plans in order to compensate.

Ryder System Inc. has increased its use of outside consultants by as much as 20% since March to help guide its response to the bill, says Gregory Greene, executive vice president and chief administrative officer of the truck rental company.

Until recently, the Miami-based company covered children until the age of 19 and full-time students up to 23 years of age, says Mr. Greene. Next year, it will have to cover dependents up to age 26 and remove a lifetime limit on claims.

Ryder doesn't expect big additional costs from those changes, but worries about future changes as regulators continue to flesh out some aspects of the law.

"The most concerning part is not knowing," says Mr. Greene.

From The Wall Street Journal by Dana Mattioli

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Automated External Defibrillators - No Longer Just for Hospitals

About a decade ago, American Airlines and other decided to equip their airplanes with Automated External Defibrillators (AEDs).   Since that time, casinos, airports, shopping centers, schools, churches, sports venues and just about every airline in the world have followed and in public places,  you're likely to see AEDs widely distributed.  

AEDs are computerized devices designed to be simple to use and provide defibrillation (an electrical shock) only when appropriate.  They can be used by non-medical personnel because you don't need to know how to read an EKG to use the device safely.  

By 2003, AEDs had been proven to decrease the risk of death from sudden cardiac arrest (usually due to heart attack) in airplanes and casinos. 

In late 2003, the Public Access to Defibrillation (PAD) trial was presented at the American Heart Association annual meeting.  Almost 20,000 non-medical volunteers had been randomly assigned to one of two groups.   Volunteers in the first group were trained to call 911 and begin CPR.  In the second group, training included 911, CPR and AED use.  Both public places and private residences were included in the study, though the majority of events occurred in the former.  Over 21 months, survival to hospital discharge was 54% higher with responders in the AED-trained group. 

In 2007, the Resuscitation Outcomes Trial (ROC) demonstrated a 2-fold increase in survival with AED vs. EMS based defibrillation.  

More recently, the Home AED Trial (HAT) showed a 33% decrease in mortality from sudden cardiac events with home AEDs. The result was not statistically significant, probably because the overall number of events was very small (likely a testament to the preventive benefit of aspirin and medications to treat elevated blood pressure and cholesterol).  

The bottom line is that you cannot get on a major commercial airliner, visit a Vegas casino, or attend a high school football game without an AED being nearby.  For patients at high risk (those who have known or suspected coronary disease or risk factors for coronary disease) or for whom the cost of the device (about $1,500 each - and not covered by insurance) is not prohibitive, an AED at home and work may be reasonable.  There are several brands, and multiple models of AEDs.   We prefer (and keep in our office) the Phillips HeartStart professional model.  We can provide these to patients who wish to purchase them.  Linda in our office is American Red Cross certified to teach both CPR and AED use and will teach you, your family or your office staff how to use the device.  Let Sherri know if you'd like more specific information about the device or training.

Written / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Triple That Vitamin D Intake, Panel Prescribes

A long-awaited report from the Institute of Medicine to be released Tuesday triples the recommended amount of vitamin D most Americans should take every day to 600 international units from 200 IUs set in 1997.

That's far lower than many doctors and major medical groups have been advocating—and it could dampen some of the enthusiasm that's been building for the sunshine vitamin in recent years.

Many doctors have added blood tests of vitamin D levels to annual physicals, and sales of vitamin D supplements have soared to $425 million last year from $40 million in 2001, according to the Nutrition Business Journal.

It's long been known that vitamin D is essential to maintaining strong bones. But hundreds of new studies have also linked low vitamin D levels to a higher risk of a slew of chronic health problems—heart disease, stroke, diabetes, prostate, breast and colon cancers, auto-immune diseases, infections, depression and cognitive decline. Studies have also suggested that many Americans are vitamin D deficient due to working and playing indoors and slathering on sunscreen.

The Institute of Medicine, an arm of the National Academy of Sciences that sets governmental nutrient levels, said there wasn't enough evidence to prove that low vitamin D causes such chronic diseases; it based its new recommendations on the levels needed to maintain strong bones alone.

"The evidence for bone health is compelling, consistent and gives strong evidence of cause and effect," said Patsy Brannon, a professor of nutritional sciences at Cornell University and member of the IOM panel. For the other health problems, she said, "there are relatively few randomized controlled trials, and even in the observational studies, the effects are inconsistent."

The new recommendations, which cover the U.S. and Canada, call for 600 IUs daily for infants through adults age 70 and 800 IUs after age 71. The IOM assumed that most people are getting minimal sun exposure, given rising concern over skin cancer and latitudes where the sun is too weak to create vitamin D on the skin much of the year. The panel also raised the acceptable upper limit of daily intake to 4,000 IUs for adults, from 2,000 previously.

Those levels do take into account vitamin D from food sources—but only a few, such as salmon and mackerel, contain much naturally. Milk fortified with vitamin D contains about 40 IUs per cup. Most Americans and Canadians need to get much of their vitamin D from supplements.

The IOM panel also issued new recommendations for daily calcium intake— ranging from 700 milligrams for children aged 1 to 3 up to 1,200 milligrams for women 51 and older. The main change from the 1997 recommendations was to lower the recommended level for men 50 to 70 to 1,000 from 1,200. The panel noted that teenage girls may not get enough calcium, and that postmenopausal women may get too much, running the risk of kidney stones.

The changes will impact the percentages of recommended daily allowances of vitamin D and calcium listed on food packages, as well as the composition of school-lunch menus and other federal nutrition programs.

The panel dismissed concerns that many Americans and Canadians are vitamin D deficient, noting that there is no scientifically validated level that's considered optimum. Even so, the panel concluded that for 97% of the population, a blood level of 20 nanograms of vitamin D per milliliter is sufficient.

Some vitamin D advocates took particular issue with that assumption. Several major medical groups, including the Endocrine Society and the International Osteoporsis Foundation, have concluded that a level of 30 ng/ml is necessary for optimal bone health.

"Randomized clinical trials have shown that in men and women 60 and older, you see fewer falls and fractures at the 30 ng/ml level," said Bess Dawson-Hughes, endocrinologist and director of the Bone Metabolism Laboratory at Tufts University. She also noted that while healthy people may reach that level taking 800 IUs per day, those who don't go outside, who use sunscreen religiously, have very dark skin or are taking some medications will need more.

Studies have also shown that at levels below 30 ng/ml, the body seeks calcium for everyday needs by leaching it from bones.

Dr. Brannon said the panel found such a wide range of blood levels considered optimal in various studies that it could not settle on a single threshold level. "I think the confusion is understandable. The committee is very concerned about the lack of evidence-based consensus guidelines for interpreting blood levels for vitamin D," said Dr. Brannon. "We strongly recommend that these be developed."

The panel was also concerned about what she called "emerging evidence of concern" about possible ill effects of too much vitamin D. Besides a risk of kidney and heart damage noted with vitamin D levels of 10,000 IUs per day, Dr. Brannon said the panel had seen higher death rates from pancreatic cancer, prostate cancer and other causes in men whose blood levels were above 50 ng/ml. The link is still tentative and may never be proven, she noted: "The difficulty is, you can't design a trial to look at adverse effects."

Other vitamin D advocates had guarded praise for the recommendations. "At least they recognized that there was a need to raise the daily intake level. That's a very important message," said Michael Holick, a professor of medicine at Boston University School of Medicine who testified before the committee in April.

He said that despite the paucity of randomized-controlled trials, the long list of chronic diseases associated with vitamin D does make sense, given that it is actually a hormone that affects virtually every organ in the human body and regulates as many as 2,000 genes.

For his part, Dr. Holick recommends that adults take 2,000 to 3,000 IUs per day—and notes that he had done studies giving subjects 50,000 IUs twice a month for six years and seen no harmful effects. "There is no downside to increasing your vitamin D intake, and there are more studies coming out almost on a weekly basis," he said.

One in particular may help settle whether vitamin D has long-term benefits beyond bone health: The National Institutes of Health has begun recruiting 20,000 men and women over age 60 for a nationwide clinical trial to study whether taking 2,000 IUs of vitamin D, or omega-3 fatty acids from fish oil, is any better than a placebo at lowering the risk of heart disease, cancer than other diseases.

In the meantime, some doctors say the IOM recommendations will not change their belief in testing patients' vitamin D levels and supplementing them as needed.

"I supplement patients who are deficient and they feel better. They come in and say, 'I've been much less achy and stiff or my mood's been better since I've been taking the vitamin D,' said Alan Pocinki, an internist in Washington D.C. Most of his patients are office workers, and 75% of them are below the 30 ng/ml level he considers necessary.

"Do we have the data to prove this conclusively? No. We don't have evidence for much of what we do in medicine, but if you wait for the evidence, you may be depriving your patients of beneficial treatments," Dr. Pocinki said.

By Melinda Beck, The Wall Street Journal

From Dr. Yates:  We've discussed this controversy.  Given the proven benefit of vitamin D in prevention of osteoporosis, as well as strong circumstantial evidence that vitamin D deficiency may increase the risk of heart disease, colon cancer and other common problems, we believe that testing vitamin D levels, and supplementing when necessary to maintain a level above 30 ng/ml is the most reasonable and prudent course.  Be sure to ask if you've any questions or concerns about your vitamin D level or supplement.

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

We're Optimists

"A pessimist sees the difficulty in every opportunity, an optimist sees the opportunity in every difficulty."

-- Winston Churchill

Meet Dr. Michael Martin

Good Morning!

For those of you whom I've not had the pleasure of meeting in person, I'd like to introduce myself. I'm Michael Martin, the new internist at the Center for Executive Medicine. There's been a lot going on in the office recently but now that Dr. Yates is back in business things are starting to take on a more normal appearance. I was pleased to have met some of you while Dr. Yates was out, and will be happy to see you in the future if there's anything you need. I may fill in from time to time if Dr. Yates or Dr. Schrader are out of town or unavailable so I will likely get to know many of you. Also, if you happen to be in the office I may just poke my head in the room to introduce myself and put a face to your name.

I'm a Texan through and through. I was born in Houston and raised in a small town in east Texas. I joined the military out of high school in an effort to see the world but God and country thought best to keep me close to home, so I never actually left the state during that time. I chased a pretty girl down to Beaumont, who later married me (after figuring out that she couldn't get rid of me) and then blessed me with twin boys. After receiving my bachelors at Lamar University I went to UT Houston for medical school. Then it was back to the northern border where I finished my residency in Internal Medicine at UT Southwestern. And that's a brief explanation of how I ended up here!

I'm very excited to be a part of the Center for Executive Medicine as I feel this is the way all medicine should be practiced. One of the problems in many doctor's offices is the lack of personal attention and interaction between the patients and physicians. I feel it creates a feeling of dissatisfaction among both patients and doctors. This is what drove me to the type of medicine practiced at the Center for Executive Medicine. Personal attention without looking at the clock leads to fewer errors, better health and a greater sense of satisfaction. Those are my goals each time we see you and if there is ever a time I don't meet those expectations, I'd like you to tell me about it.

I hope you all have a wonderful and blessed holiday season!

Michael Martin, MD

With Rise in Radiation Exposure, Experts Urge Caution on Tests

Advances in radiology have radically transformed medical practice, with CT scans and nuclear medicine exams providing physicians with the ability to quickly pinpoint internal bleeding, diagnose kidney stones or confirm appendicitis, assess thyroid function and identify and open blockages in the blood vessels to the heart.

The downside is that Americans are being exposed to record amounts of ionizing radiation, the most energetic and potentially hazardous form of radiation.

According to a new study, the per-capita dose of ionizing radiation from clinical imaging exams in the United States increased almost 600 percent from 1980 to 2006. In the past, natural background radiation was the leading source of human exposure; that has been displaced by diagnostic imaging procedures, the authors said.

"This is an absolutely sentinel event, a wake-up call," said Dr. Fred A. Mettler Jr., principal investigator for the study, by the National Council on Radiation Protection. "Medical exposure now dwarfs that of all other sources."

The study, financed by the federal government, is to be published by early next year. It found a particularly sharp rise in the number of CT scans - to 62 million in 2006, from 3 million in 1980. Though CTs make up only 12 percent of all medical radiation procedures, they deliver almost half of the estimated collective dose of radiation exposure in the United States. A CT scan exposes patients to far more radiation than a standard X-ray, and multislice CT scanners deliver higher doses of radiation than single-slice scanners.

Nuclear medicine exams increased to 18.1 million in 2006, from 6.4 million in 1980. They represent almost a quarter of the estimated collective radiation dose, with cardiac studies making up most of the dose.

X-rays have been classified as carcinogens by the World Health Organization, the Centers for Disease Control and Prevention and the National Institute of Environmental Health Sciences, because studies have shown that exposure causes leukemia and cancers of the thyroid, breast and lung.

Yet with the exception of mammography, scans remain largely unregulated. (The Food and Drug Administration regulates manufacturers of equipment but does not inspect facilities, which are licensed by states. Radiation doses for mammography are limited by federal law.) Radiation doses for the same procedure can vary drastically, as different machines in the hands of different practitioners deliver doses that vary by as much as a factor of 10, experts say.

Radiologists say they do not want to scare people away from having scans and exams when necessary, but they want patients - as well as physicians - to carefully evaluate the benefits and risks of each scan or exam, make sure the procedure is appropriate and keep track of cumulative exposure levels. Full-body CT scans should be avoided unless there is a good medical reason.

"We're not saying you shouldn't have X-rays or CT scans - they're wonderful, they've totally revolutionized the practice of medicine," said Dr. E. Stephen Amis Jr., a former president of the American College of Radiology who is chairman of radiology at Albert Einstein College of Medicine and Montefiore Medical Center in New York. "But if you go into the emergency room with recurrent pain and get a CT scan every time you show up, that's not good. Use a little common sense."

Studies of atomic bomb survivors in Japan found a statistically significant increase in cancer at high levels of exposure - 50 millisieverts, or mSv, about 16 times the current annual average for Americans from medical exams. But that figure is controversial; it is not clear that lower levels of radiation exposure are safe. Nor would it be unusual for a patient to exceed this level, according to a recent paper from the American College of Radiology.

"It is worth noting that many CT scans and nuclear medicine studies have effective dose estimates in the range of 10 to 25 mSv for a single study, and some patients have multiple studies; thus it would not be uncommon for a patient's estimated exposure to exceed 50 mSv," the paper said, adding that "the International Commission on Radiological Protections has reported that CT doses can indeed approach or exceed levels that have been shown to result in an increase in cancer."

A single CT scan of the abdomen, body or spine can expose a patient to 10 mSv, according to the American College of Radiology patient information Web site (www.radiologyinfo.org, see Safety). Mammography, on the other hand, delivers only 0.7 mSv, and a bone-density scan is only 0.01 mSv.

There are several steps patients can take to protect themselves, and they should not be shy about asking questions, doctors and other experts say.

"They can always inquire of the referring physician, 'Is this test necessary?' " said Richard Morin, chairman of the radiology college's quality and safety committee, adding that "exams are often done for reasons that are not quite appropriate."

Doctors should be familiar with the radiology college index of appropriateness criteria, which rates the imaging procedures for some 200 medical conditions. Dr. Morin suggests asking the doctor ordering the test about its rating for a given condition.  Scores range from 1 to 9, he said, and "if the number turns out to be 1 or 2, you should look for some other exam."

When undergoing a scan or exam, patients should try to use a facility accredited by the American College of Radiology. The accreditation, which is voluntary, means the machines are surveyed and calibrated to use the correct level of radiation and the technologists are certified. It also means the images are likely to be of higher quality, reducing the likelihood of having to repeat a procedure and suffer additional exposure.

Research studies closely regulate and monitor radiation doses, so participating in a research study may provide some protection, Dr. Morin said. Hospitalized patients are also often scanned routinely once a day when they are very ill, he said, and "it's not unreasonable for someone to ask, 'Do I really need this exam every day?' " Patients may also want to ask the radiologists or technicians whether the machines are routinely inspected by a medical physicist.

Women should tell the doctor or technician if they might be pregnant; generally, women, children and young people should try to avoid scans.

If patients are given a CD of their scan, along with the interpretation, they should hold onto it, to avoid having to repeat a procedure. People who are undergoing multiple studies may want to keep a record tracking all the radiological procedures they have had, and inform their physicians of their history, said Dr. Amis, of Albert Einstein.

"Patients should have a questioning demeanor when going in for any kind of health care," he said. "Unfortunately, the majority do not."

By RONI CARYN RABIN, THE NEW YORK TIMES

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Vitamin E Supplements to Prevent Stroke May Raise Stroke Risk, Study Says

Taking Vitamin E to Prevent Stroke May Be Harmful, Study Says

Taking vitamin E supplements doesn't reduce the risk of stroke, and may even be harmful, an analysis of previous research found.

The vitamin raised the risk of a severe type of stroke by 22 percent, while it lowered the risk of a milder kind by 10 percent, according to the study, published today in the British Medical Journal.

Exercise as well as medicines to lower blood pressure or cholesterol have a far greater effect on stroke prevention, the researchers, led by Markus Schuerks of Harvard Medical School, wrote in the study. 

About 13 percent of the U.S. population takes the supplement, they said. Previous studies of the vitamin's effectiveness have produced conflicting results, with some showing a protective effect and others seeing no effect and an increase in the risk of early death, the study said.

"Given the relatively small risk reduction of ischemic stroke and the generally more severe outcome of hemorrhagic stroke, indiscriminate widespread use of vitamin E should be cautioned against," the authors said.

The study pooled data from 9 previous trials involving a total of 118,756 patients, about half of whom took the supplement while the other half took a sugar pill. When the data were analyzed, the researchers found an increased risk of hemorrhagic stroke, and a smaller decrease in ischemic stroke.

The absolute risk is small, the study said. For every 1,250 subjects taking the supplement, one hemorrhagic stroke occurred, while one ischemic stroke was prevented for every 476 patients.

Oxygen Supply

Stroke occurs when a blood vessel carrying oxygen to the brain ruptures or is blocked by a blood clot or some other particle, cutting off the brain's supply of oxygen. Nerve cells then die, affecting the part of the body they control. These cells aren't replaced, leading to disability, according to the American Heart Association.

About 800,000 Americans suffer a stroke each year, and 137,000 of them die, according to the association.

Hemorrhagic stroke is caused when tissue is compressed by a hematoma, a collection of blood that has leaked out of a vessel. Ischemic stroke is seen when a loss of blood supply to part of the brain triggers a biochemical reaction that leads to cell death.

By Eva von Schaper, Bloomberg News

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Texas and Texans

"To make something happen, tell a Texan it can't be done."

-- Anonymous

U.K. bans doctor who linked autism to vaccine

Britain's top medical group ruled [in January this year] that a doctor who claimed autism was linked to a childhood vaccine can no longer practice in the U.K.

The General Medical Council also found Dr. Andrew Wakefield guilty of "serious professional misconduct" as it struck him from the country's medical register. The council was investigating how Wakefield and colleagues carried out their research, not the science behind it.

When the research was published a dozen years ago, British parents abandoned the measles vaccine in droves, leading to a resurgence of the disease. Vaccination rates have never recovered and there are outbreaks of measles in the U.K. every year.

In 1998, Wakefield and colleagues published a study alleging a link between autism and the vaccine for measles, mumps and rubella. Most of the study's authors renounced its conclusions and it was retracted by the journal in February.

Many other studies have been conducted since then and none have found a connection between autism and the vaccines. Wakefield moved to the U.S. several years ago and the ruling does not affect his right to practice medicine there or in other countries.

In 2005, Wakefield founded a nonprofit autism center in Austin, Texas, but quit earlier this year.

In January, Britain's medical council ruled that Wakefield and two other doctors acted unethically and showed a "callous disregard" for the children in their study. The medical body said Wakefield took blood samples from children at his son's birthday party, paying them 5 pounds (today worth $7.20) each.

In a statement then, Wakefield said the medical council's investigation was an effort to "discredit and silence" him to "shield the government from exposure on the (measles) vaccine scandal."

In [a recent] ruling, the medical council said Wakefield abused his position as a doctor and "brought the medical profession into disrepute."

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Happy Thanksgiving Humor

A lady was picking through the frozen turkeys at the grocery store, but couldn't find one big enough for her family. She asked the stock boy, 'Do these turkeys get any bigger?'

The stock boy answered, 'No ma'am, they're dead.'

What the Doctor Missed

Using Malpractice Claims to Help Physicians Avoid Diagnostic Mistakes, Delays

A doctor assumes a patient's recurrent cough is a respiratory infection and doesn't order a chest X-ray, missing a deadly lung cancer. A 40-year-old woman dies of a rare blood disease after her abnormal lab test falls through the cracks. A man dies from an obstructed bowel after different doctors treating him fail to share information about his acute abdominal pain.

Medical professionals are finding lessons in these and other past malpractice cases. By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, insurers and health-care providers are developing programs to avert mistakes. For example, some doctors are using electronic alerts and reminders to order tests, follow up on lab reports and close the loop with specialists to whom they refer patients.

Diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, studies of resolved claims show. Peter Pronovost, a patient-safety researcher at Johns Hopkins University, estimates that diagnostic errors kill 40,000 to 80,000 hospitalized patients annually, based on autopsy studies over the past four decades.

Studies of malpractice-claims data show that diagnostic errors often don't have a single cause. There are often at least three breakdowns that lead to missed or delayed diagnoses. Patients play a role as well: They may not seek care on a timely basis, fail to show up for tests or fail to follow instructions, such as not fasting before a blood test or not adequately emptying the bowels before a colonoscopy.

One concern is that using claims data to educate doctors will lead to more "defensive medicine," in which doctors order more tests and procedures than needed to protect themselves against malpractice suits. In a study in the June Archives of Internal Medicine, 91% of physicians surveyed reported that doctors practice defensive medicine; the majority of physicians also agreed that legal protections against unwarranted malpractice suits are needed to decrease the unnecessary use of diagnostic tests.

"Medicine is often a crapshoot and an odds game," and doctors can miss a diagnosis even if they adhere to guidelines on when to order a test, says Dr. Pronovost. Reducing diagnostic errors, he says, will require a focus on larger system failures, such as preventing lab results from getting lost and developing checklists to help doctors distinguish between, say, a "low-risk" headache and a "high-risk" headache.

Diagnostic mistakes most often involve cancer, with breast cancer the most commonly missed or delayed diagnosis. Last year, a jury awarded $2.5 million in a case brought by Barbara Glasow, who, before she died in May 2009, sued St. Luke's Hospital in Bethlehem, Pa., claiming the hospital and one of its doctors failed to diagnose her breast cancer in May 2004, when she came to see him for a lump on her chest. According to the suit, the doctor told her it was a cyst. By February 2005, it had broken in two and began to bleed. A biopsy determined that it was breast cancer. Her attorney, Steven Margolis, is pursuing the award, plus interest, totaling $2.9 million on behalf of her family. St. Luke's is appealing the case, and the hospital declined to comment.

Oakland, Calif.-based managed-care giant Kaiser Permanente also uses malpractice-claims data for educational purposes. But it relies on close tracking and follow-up of patients with abnormal test results to avoid missed diagnoses, says breast cancer surgeon Susan Kutner. Over the past 15 years it has identified 420,000 abnormal biopsies and 320,000 abnormal mammograms. As a result, 450 patients were found to have a new or recurrent cancer or an abnormal biopsy "who would not have been found if we did not bring them in proactively," Dr. Kutner says.

The Veterans Health Administration is developing programs to help doctors more closely follow up on abnormal lab results, which it delivers through an electronic medical record system. VA studies show that doctors are often overwhelmed by alerts and may not follow up, even when an alert says the test is abnormal. Hardeep Singh, chief of the health quality and policy program at the Houston VA research center, says its studies also show that if both a primary-care doctor and a specialist get test results, each assumes the other will follow up.

"Patients may think that if something was wrong, my doctor would have told me," says Dr. Singh. "But no news is not necessarily good news, and patients need to be empowered to follow up on their lab results and participate more actively in their care."

While malpractice claims represent only a fraction of all medical cases, "they are reflective of deeply rooted problems that are much more widespread in health care," says Robert Hanscom, vice president of loss prevention and patient safety for Crico/RMF, a malpractice insurer that covers Harvard University-affiliated hospitals and doctors. Mr. Hanscom says cases linked to diagnostic errors appear to be on the rise as primary care doctors, struggling with heavy case loads, take shortcuts or don't act on their patient's symptoms. Also hospitals are concerned about trial lawyers who may seek high monetary damages.

Of 1,137 malpractice cases between 2005 and 2009, diagnostic errors accounted for 26% of Crico/RMF's claims. But among the 456 "high severity" cases that resulted in serious patient harm or death, nearly half were diagnostic errors.

"People may show up with a series of symptoms or complaints that aren't taken seriously at the moment, or a physician...doesn't see the complaint as something new to be concerned about," says Ann Louise Puopolo, a nurse and patient-safety program director at Crico/RMF. For example, in missed or delayed colorectal cancer cases, patients often showed up with some kind of rectal bleeding, a usual sign that further testing is needed, but was not performed, says Ms. Puopolo.

Crico/RMF is offering continuing medical-education credits to doctors who study its analysis of the closed malpractice cases. And in a program it is co-sponsoring at Brigham and Women's Hospital in Boston, researchers are working with 16 primary-care practices in Massachusetts, using lessons from the claims to help them avoid common pitfalls like failing to consider that a patient with persistent symptoms might need a diagnostic test, and failing to follow up on abnormal test results when they come in.

"These errors may be less visible and dramatic than getting the wrong leg cut off, but a delay in diagnosis can adversely affect a patient's long-term outcome," says Gordon Schiff, associate director of patient-safety research at Brigham and Women's. Malpractice cases "let us drill down and learn deeper lessons, like what could have been done differently," Dr. Schiff says.

By Laura Landro, The Wall Street Journal

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

John Wayne

''Life's tough ... it's even tougher if you're stupid.''

-- John Wayne

‘You’ve Got Mail’ — But Not From Your Doctor!

Less Than 7% Are Emailing Patients

Doctors aren't exactly lining up to swap emails with their patients, as it turns out.

According to the Center for Studying Health System Change, only 6.7% of the 4,200-plus office-based physicians who responded to a 2008 national survey "routinely" emailed patients about clinical matters. Most just didn't have the technology available, but even among the doctors who had email access, only 19.5% regularly emailed with patients.

This survey didn't ask non-emailing physicians why they weren't trading LOLs and emoticons with their patients, but the CSHSC brief has a host of previously cited reasons: "lack of reimbursement, the potential for increased workload, maintaining data privacy and security, avoiding increased medical liability and the uncertain impact on care quality." (Given that list, it's hard to figure out why any physician would choose to email patients.)

Doctors working in practices the have already converted to electronic medical records were more likely to communicate with patients via email. So were physicians in HMOs or academic centers, compared to those in solo or two-doctor practices.

Given the reimbursement issue, it's not surprising that physicians on a fixed salary were more likely to communicate with patients than those with other compensation arrangements. (Aetna and Cigna are among the insurers reimbursing providers for communicating with patients via secure messaging.) Other options for compensation include a set per-patient fee paid to physicians for agreeing to coordinate care using email and other means or an annual fee paid directly by patients for email access privileges, the brief says.

Policy types "might more systematically explore whether email or other secure electronic communication with patients can deliver on its promise to enhance communication, increase patient engagement and satisfaction, improve patient outcomes and quality of care and boost efficiency," the brief says. If email does all (or some) of that, "expanding incentives to encourage email communication between physicians and patients might be a worthwhile investment."

By Katherine Hobson, The Wall Street Journal
Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Miss me?

What a summer!

The scary month of May (here's that story in case you missed it) gave way to a blur of June, July and August recovering. In September, I went back to work knowing that I'd need to do "something" in the future but had hoped to avoid surgery. In early October it became clear that to finally put an end to this mess, I would need more surgery, so back to the hospital I went. Apparently, I like to have my surgeries in pairs (though I don't recommend this strategy to others) because again, after the first surgery complications necessitated another. My body must also be in tune with the calendar because I also managed surgery on Mother's Day and twice the week of Ingrid's birthday. I may be in a little trouble for that.

November has been much better! I've been back to work this past week and today the last of the tubes was removed. Now I can focus on getting back my strength and endurance, getting caught up in the office, and spending some fun time with family. Several people have told me I should write a book. Don't know if anyone would read it but I did learn a lot - and much of what I already knew was reinforced. Like the value of having a physician who listens...stuff like that.

Recovery from the surgeries in October was painful and it took until last week to get off of all the pain medication. I was so excited to get back to work that I had trouble sleeping. I hate lying in bed (did a lot of that this summer too) so Wednesday morning I got up about 3:00, showered and went to the office. It was so quiet - and so nice to be back - I got a lot done early that morning. I sent a bunch of emails and got several responses that day asking why in the world I was working at 4:00 AM. It's great to be back!

While I was out of the office, Sherri, Dr. Schrader, our wonderful office staff and Dr. Martin - the latest addition to our practice (more on that later) kept the office humming and patients well cared for. Many patients sent cards or letters, visited me in the hospital, brought food to the house, helped Ingrid with errands and watching the kids...and some did all of these. One patient and his wife stood in line for 12 hours to get me a signed copy of George Bush's new book. Thank you all for being so generous and caring.

Seeing friends (patients) this week has been wonderful. I'm blessed that I get to take care of and advise such wonderful people. We've gotten the hospital bed out of our house, all the tubes are gone and we are packing up the medicines and paraphernalia. Getting that stuff out of the house and getting back to work some this week has made life feel much more normal.

So this Thanksgiving, the Yates family truly has many things for which to be thankful!

Posted by: Scott W. Yates, MD, MBA, MS, FACP

I Prefer Being the Doctor

Good morning!

On Tuesday May 4, I started my day with visits to two patients and then an early meeting at Presbyterian Hospital Plano. After the meeting, I went to the preop area. Later that morning, I had a relatively minor scheduled surgery. The surgeon is among the world's best in my estimation. Initially after surgery, everything seemed fine but within a couple of days, I knew there was something amiss.

That's when the month of May became unusual...and a planned one night stay in the hospital became three weeks.

Fortunately, the surgeon acted on what I told him I felt, and not based on the multiple normal scans. He kept me in the hospital and when I "crashed" that weekend, I was in the right place.

I don't remember much of the move to the ICU or the emergent surgery that followed. When I awoke, I found that the original five small holes in my abdomen from the original laparoscopic surgery had been joined by a foot-long incision and I remember trying unsuccessfully to write a note to ask my nurse questions while sedated and on the ventilator.

I've gradually improved and recently come home from the hospital. I cannot eat yet and have a nearly constant companion in the intravenous pump and feedings I carry in a backpack when out of bed. IV antibiotics and other medication have made our bedroom look like a pharmacy or chemistry lab.

We talk about the importance of great medical care. The importance of seeing kids grow up, running a business, hugging family. The past few weeks have been traumatic but these thoughts have never been far away.

Dr. Keith Schrader (my personal physician), Dr. Harry Meyers (surgeon), Dr. Mike Blackmon (critical care), Dr. Kunjan Thakor (infectious disease) and Dr. Trent Pettijohn (cardiology). Along with their partners, these incredible physicians saved my life.

Ingrid has been incredible. She's watched and absorbed everything, and added "nurse" to her already long list of jobs.

I cannot count the emails, cards and prayers from patients, family and friends. Quite a humbling experience.

I'm not sure when I will be back in the office but I hope it will be soon.  I miss being the doctor - I've had more than my share of time being a patient.

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP