The Center for Executive Medicine

Studies Could Ease Fears of Medicines for ADHD

2011-12-23T17:55:00.000-06:00

Ritalin, Adderall and other drugs widely used to treat attention disorders didn't increase the risk of serious heart problems in a major study published Monday that could help ease concerns about the heart-related safety of the medicines.

The drugs, including Shire PLC's Adderall, Johnson & Johnson's Concerta, and Novartis AG's Ritalin, as well as generic versions, are associated with modest increases in blood pressure and heart rate. They are also known to be highly effective in managing ADHD symptoms, with more than 80% of patients responding to the medicines, researchers say.

The findings, from an analysis involving nearly 500,000 adults, come on the heels of a separate study that reached a similar conclusion about the medications' effect in 1.2 million children and young adults. The results don't completely exonerate the drugs, which have other side effects that include a slowing of growth in children and anxiety. But researchers and doctors who treat the condition—known formally as attention deficit-hyperactivity disorder, or ADHD—said that together the reports should generally allay worries about heart risk that have stirred confusion among doctors and patients for several years.

"We don't see any evidence they're increasing risk," said Laura A. Habel, a research scientist at Kaiser Permanente at the big health plan's Northern California operation in Oakland and lead author of the latest study. But she added that the study didn't go as far as to prove the drugs are safe.

About 2.7 million children are prescribed medicines for ADHD, mostly to help control impulsive behavior and an inability to focus and pay attention. More than 1.5 million adults also take the drugs, researchers said. Growth in the medications' use among adults has outpaced that in children during the past decade.

Fears about potential heart risk for ADHD medicines were sparked in 2005 by reports of about a dozen deaths from sudden cardiac arrest among young users of Adderall. The reports prompted the Canadian government to temporarily remove Adderall from the market, though it later lifted the suspension after it was determined that the patients who had died had heart defects or other underlying heart disease.

In the U.S., the Food and Drug Administration held advisory panels to discuss the matter in 2006. The agency subsequently required an update to product labeling to mention cardiac risk. The American Heart Association in 2008 urged that children being considered for ADHD drugs undergo a thorough heart exam, possibly including an electrocardiogram, before taking the medicines.

"Many patients and families stopped using the medicine," said Victor Fornari, director of child/adolescent psychiatry at North Shore-LIJ Health System in New Hyde Park, N.Y. The issue of whether the drugs cause heart problems still "comes up every single day" in discussions with parents of children with ADHD and adult patients, he said.

At the Mayo Clinic, in Rochester, Minn., cardiologist Michael Ackerman said he knows of students who stopped taking the medicines and went from "high-functioning, straight-A students to F students" after doctors became concerned that the drugs "could kill their patients."

Both doctors, who weren't involved with the research, said they hope the new findings provide reassurance to doctors, patients and parents of children with ADHD that the risk of the medicines, especially in otherwise healthy people, is very low.

"The consequences of failure to treat ADHD far outweigh the risk of untreated ADHD," Dr. Fornari said. Children with untreated ADHD usually don't do well in school and adults often can't function in the workplace.

Both the new study, published online Monday by the Journal of the American Medical Association, and the earlier one, published last month by the New England Journal of Medicine, were funded by the FDA and other U.S. agencies to get a clearer picture of the risk associated with the medicines after the 2006 advisory panel hearings.

The study in JAMA compared about 150,000 adult users of ADHD medications between 25 and 64 years old to nearly 300,000 nonusers. Researchers reviewed medical records from four health insurance plans to look at the number of serious cardiovascular events such as sudden cardiac death, heart attack and stroke among both groups.

The study found there were 1,357 heart attacks, 296 cases of sudden cardiac death, and 575 cases of stroke among all patients. The rate was similar among users and nonusers of ADHD drugs, which suggests the drugs didn't increase risk of developing serious cardiovascular problems.

The earlier study, by the same research team, reached a similar conclusion among patients 2 to 24 years old.

Patients evaluated in the studies weren't randomized and the average duration of treatment was relatively short, prompting researchers to say that a potential for increased risk associated with the medicines was possible.

"Even though we can't rule out increased risk," said William Cooper, a pediatrician at Vanderbilt University, Nashville, Tenn., and lead author of the earlier paper, "the absolute magnitude would be low because the [serious] events are so rare."

Despite the findings, the FDA said Monday that patients treated with ADHD medications should continue to be monitored for changes in heart rate or blood pressure as well as for other side effects that include decreased appetite, weight loss and trouble sleeping. The agency also said the drugs "should not be used by patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic."

Mason Turner, regional director of mental health outpatient operations for Kaiser Permanente Northern California, said that with low doses, careful monitoring of blood pressure and other measures, and consultation with a cardiologist, even patients with heart risk who also have significant ADHD symptoms can be effectively treated with the medicines.

Dr. Turner also said strategies that don't involve taking drugs can help some patients. Among these are educating patients to better organize their lives or to ask at school or work for assistance in helping with detailed assignments and projects. That "can mean the difference between doing well or doing poorly," he said.

By Jennifer Corbett and Ron Wilson, The Wall Street Journal

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

Vitamins and Other Supplements: An Update

2011-10-23T06:11:00.000-05:00

We are often asked about various vitamins and supplements and when important information becomes available, we try to make blog posts to update everyone. We’ve also decided to summarize some of our thoughts about supplements and this is the result of that effort. As always, the opinions expressed here are general recommendations and we always encourage a conversation with your physician before you make any changes to previously recommended treatments.

Multivitamins

There is general agreement among physicians that a well-balanced diet provides adequate vitamins and minerals required to maintain health and prevent diseases. Over half of Americans report that they regularly take dietary supplements in an effort to improve their health. Unfortunately, no studies have documented any benefit from multivitamin supplementation in healthy adults and safety concerns have been raised.

Specific vitamins and supplements

We do not recommend routine supplementation with vitamins A, C, E, folic acid or beta-carotene.

Taking antioxidant vitamins (such as vitamin C and vitamin E) has been promoted as beneficial in prevention of colds, heart attack, stroke and cancer. Unfortunately, none of these illnesses are prevented by taking vitamins. And worse yet, evidence has accumulated that antioxidant vitamins can be harmful.

A remarkable study from Norway published in the New England Journal of Medicine in 2006 rebuffed prior theories that heart attacks could be prevented by antioxidant vitamins and was among the first to raise concerns that these might actually increase heart attack and stroke risk.

Supplemental beta-carotene, vitamin A and vitamin E may increase risk of death according to a recent JAMA review.

A study published in the Proceedings of the National Academy of Sciences demonstrated that taking supplemental vitamin C and vitamin E eliminated one of the major benefits of exercise in healthy men (in this case, the body’s ability to respond to insulin). We described this study in detail in a prior post.

There is no evidence that vitamin E is effective in preventing Alzheimer’s disease or other types of dementia.

A recent review of 67 studies (involving over 230,000 participants) concluded that vitamin C (alone or in combination with other vitamins) did not lower mortality. The same review concluded that vitamin E supplementation (as well as supplementation with vitamin A and beta-carotene) may increase mortality significantly.

A recent study published in the Archives of Internal Medicine also concluded that the “more is better” approach is not necessarily the best. They concluded that for adult women, multivitamins, vitamin B₆, folic acid, iron, magnesium, zinc and copper all increased mortality in and that calcium supplementation decreased overall risk.

A study published in the Journal of the American Medical Association this month also concluded that men who took 400 IU of vitamin E were 17% more likely to develop prostate cancer over 7 years than were those who did not take vitamin E. An earlier study concluded that vitamin E supplementation increased the risk of death in men.

Earlier studies in smokers found that beta-carotene supplements increased lung cancer risk and the trace mineral selenium has been linked to an increased risk of non-melanoma skin cancer in women and men.

The exceptions

Deficiencies of vitamins B₁₂ and D are linked to many health problems and when low levels are found in lab testing, we often recommend supplementation. Also, most American adults should probably take a calcium supplement.

It is very clear that vitamin D is important for bone health (to prevent osteoporosis). Recently, data have suggested that adequate vitamin D levels may also decrease the risk of falling, and prevent colon polyps and cancer and heart attack and may facilitate weight loss in those who are overweight. We’ve reviewed this data and while it’s unlikely that vitamin D is magic, it does seem to be important. Over-the-counter vitamin D supplementation is reasonable for average-risk patients who have a mild vitamin D insufficiency, but a much higher dose (prescription strength) supplement is probably more appropriate in patients at risk for osteoporosis or those with severe deficiency.

Low levels of vitamin B12 can cause anemia and damage to the brain and nerve cells. Symptoms of nerve damage may be present before anemia. They can include numbness or tingling in the fingers and toes, poor balance and coordination, forgetfulness, depression, confusion, difficulty thinking and concentrating, impaired judgment and poor control of impulses, a decreased ability to sense vibration, ringing in the ears (tinnitus), and dementia, a decline in mental abilities that is severe enough to interfere with daily life.

The Bottom Line

With the few exceptions above, vitamin supplements are unnecessary and potentially harmful. A well-balanced diet coupled with daily exercise is the closest thing to a magic pill for good health.

Written by: Drs. Martin, Schrader and Yates

Marilyn Monroe

2011-10-22T06:15:00.000-05:00

"It's not true that I had nothing on. I had the radio on."
-- Marilyn Monroe

Parents Urged Again to Limit TV for Youngest

2011-10-21T05:12:00.000-05:00

Parents of infants and toddlers should limit the time their children spend in front of televisions, computers, self-described educational games and even grown-up shows playing in the background, the American Academy of Pediatrics warned on Tuesday. Video screen time provides no educational benefits for children under age 2 and leaves less room for activities that do, like interacting with other people and playing, the group said.

The recommendation, announced at the group’s annual convention in Boston, is less stringent than its first such warning, in 1999, which called on parents of young children to all but ban television watching for children under 2 and to fill out a “media history” for doctor’s office visits. But it also makes clear that there is no such thing as an educational program for such young children, and that leaving the TV on as background noise, as many households do, distracts both children and adults.

“We felt it was time to revisit this issue because video screens are everywhere now, and the message is much more relevant today that it was a decade ago,” said Dr. Ari Brown, a pediatrician in Austin, Tex., and the lead author of the academy’s policy, which appears in the current issue of the journal Pediatrics.

Dr. Brown said the new policy was less restrictive because “the Academy took a lot of flak for the first one, from parents, from industry, and even from pediatricians asking, ‘What planet do you live on?’ ” The recommendations are an attempt to be more realistic, given that, between TVs, computers, iPads and smartphones, households may have 10 or more screens.

The worry that electronic entertainment is harmful to development goes back at least to the advent of radio and has steadily escalated through the age of “Gilligan’s Island” and 24-hour cable TV to today, when nearly every child old enough to speak is plugged in to something while their parents juggle iPads and texts. So far, there is no evidence that exposure to any of these gadgets causes long-term developmental problems, experts say.

Still, recent research makes it clear that young children learn a lot more efficiently from real interactions — with people and things — than from situations appearing on video screens. “We know that some learning can take place from media” for school-age children, said Georgene Troseth, a psychologist at Peabody College at Vanderbilt University, “but it’s a lot lower, and it takes a lot longer.”

Unlike school-age children, infants and toddlers “just have no idea what’s going on” no matter how well done a video is, Dr. Troseth said.

The new report strongly warns parents against putting a TV in a very young child’s room and advises them to be mindful of how much their own use of media is distracting from playtime. In some surveys between 40 and 60 percent of households report having a TV on for much of the day — which distracts both children and adults, research suggests.

“What we know from recent research on language development is that the more language that comes in — from real people — the more language the child understands and produces later on,” said Kathryn Hirsh-Pasek, a professor of psychology at Temple University.

After the academy’s recommendation was announced, the video industry said parents, not professional organizations, were the best judges. Dan Hewitt, a spokesman for the Entertainment Software Association, said in an e-mail that the group has a “long and recognized record of educating parents about video game content and emphasizing the importance of parental awareness and engagement.”

“We believe that parents should be actively involved in determining the media diets of their children,” he said.

Few parents of small children trying to get through a day can resist plunking the youngsters down in front of the screen now and then, if only so they can take a shower — or check their e-mail.

“We try very hard not to do that, but because both me and my husband work, if we’re at home and have to take a work call, then yes, I’ll try to put her in front of ‘Sesame Street’ for an hour,” Kristin Gagnier, a postgraduate student in Philadelphia, said of her 2-year-old daughter. “But she only stays engaged for about 20 minutes.”

In one survey, 90 percent of parents said their children under 2 watched some from of media, whether a TV show like “Yo Gabba Gabba!” or a favorite iPhone app. While some studies find correlations between overall media exposure and problems with attention and language, no one has determined for certain which comes first.

The new report from the pediatrics association estimates that for every hour a child under 2 spends in front of a screen, he or she spends about 50 minutes less interacting with a parent, and about 10 percent less time in creative play. It recommends that doctors discuss setting “media limits” for babies and toddlers with parents, though it does not specify how much time is too much.

“As always, the children who are most at risk are exactly the very many children in our society who have the fewest resources,” Alison Gopnik, a psychologist at the University of California, said in an e-mail.

Published: October 18, 2011 - New York Times online

By BENEDICT CAREY

Clear Minds

2011-10-19T09:22:00.001-05:00

"Compelling ideas come into clear minds."

-- Bill O'Reilly

An Easier Colonoscopy Prep

2011-10-15T04:30:00.000-05:00

Overall, the lifetime risk of developing colorectal cancer is about 1 in 20 (5.1%). The American Cancer Society estimates that there will be almost 150,000 colorectal cancers diagnosed in the United States annually and that approximately 50,000 deaths will result.

What makes this particularly disturbing is that colon cancer is almost entirely preventable when appropriate screening tests are done. Guidelines from professional societies vary but they generally recommend that average-risk adults should begin colorectal cancer screening at age 50 years, utilizing one of several options for screening, among which is colonoscopy. For patients with relatives who have had colon cancer or polyps, earlier screening is recommended.

We have reviewed the data regarding colorectal cancer and screening risks and benefits and we strongly recommend screening using colonoscopy beginning at age 40 rather than 50. Colonoscopy is a very safe procedure and complications are very rare. When polyps are found, they can almost always be removed immediately (during the colonoscopy procedure).

In our experience, the largest barrier to colon cancer screening with colonoscopy is the preparation required. The traditional colonoscopy prep requires that you drink 64 ounces of liquid in two hours and while most patients have no trouble with this, some find it difficult. Fortunately, there is a new product called Suprep which is a much smaller volume to drink. So, for those of you who've been putting this off (and you know who you are), it's time to act!

If you’ve questions about this, please contact us. We’re happy to discuss this important issue further and to help make arrangements to protect you from this devastating disease.

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

Predicting the Future

2011-10-11T13:54:00.000-05:00

"The best way to predict the future is to invent it."
-- Alan Kay

"I never think of the future - it comes soon enough."
-- Albert Einstein (1879 - 1955)

"Prediction is very difficult, especially about the future."
-- Niels Bohr (1885 - 1962)

"Predicting the future is easy. It's trying to figure out what's going on now that's hard."
-- Fritz Dressler

It's Time for Flu Vaccine

2011-10-09T05:30:00.000-05:00

There has been a great deal of information in the media concerning the influenza vaccine in the last few years, stemming from the H1N1 virus. This will continue to be an important topic in the next 6 months as we enter flu season. Many people are anxious to receive the latest vaccine to prevent infection. Although vaccination is encouraged by doctors, there are concerns that vaccination too early may cause problems. The outbreak of the seasonal influenza virus generally occurs at the end of October or early November. The disease has a peak in February and generally is gone by spring (though in Texas we see cases often into April). This means there is a risk of infection lasting 6-7 months.

Considering the flu season is about 7 months, it’s important to give the vaccine early enough to cover the initial outbreak, but not so early that the effects wear off before the season has run its course. This generally means giving the vaccine in October. An ounce of prevention is worth a pound of cure - if the prevention is given at the right time.

Written by: Michael C. Martin, MD

Steve Jobs (1955 - 2011)

2011-10-08T05:00:00.000-05:00

“Why join the navy if you can be a pirate?”
-- Steve Jobs, 1982

"When you’re a carpenter making a beautiful chest of drawers, you’re not going to use a piece of plywood on the back, even though it faces the wall and nobody will ever see it. You’ll know it’s there, so you’re going to use a beautiful piece of wood on the back. For you to sleep well at night, the aesthetic, the quality, has to be carried all the way through.”
-- Steve Jobs, 1985

“Being the richest man in the cemetery doesn’t matter to me … Going to bed at night saying we’ve done something wonderful… that’s what matters to me.”
-- Steve Jobs, 1993

“I am saddened, not by Microsoft’s success — I have no problem with their success. They’ve earned their success, for the most part. I have a problem with the fact that they just make really third-rate products.”
-- Steve Jobs, 1996

"It's really hard to design products by focus groups. A lot of times, people don't know what they want until you show it to them."
-- Steve Jobs, 1998

“Your work is going to fill a large part of your life, and the only way to be truly satisfied is to do what you believe is great work. And the only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t settle. As with all matters of the heart, you’ll know when you find it. And, like any great relationship, it just gets better and better as the years roll on. So keep looking until you find it. Don’t settle.”
-- Steve Jobs, 2005

“Remembering that I’ll be dead soon is the most important tool I’ve ever encountered to help me make the big choices in life. Because almost everything — all external expectations, all pride, all fear of embarrassment or failure — these things just fall away in the face of death, leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart...Stay hungry. Stay foolish.”
-- Steve Jobs, 2005

“No one wants to die. Even people who want to go to heaven don’t want to die to get there. And yet death is the destination we all share. No one has ever escaped it. And that is as it should be, because Death is very likely the single best invention of Life. It is Life’s change agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away. Sorry to be so dramatic, but it is quite true."
-- Steve Jobs, 2005

More Controversy about PSA Screening for Prostate Cancer

2011-10-07T09:22:00.001-05:00

The Wall Street Journal (and others) report that the U.S. Preventive Services Task Force will recommend against screening for prostate cancer using the PSA blood test having apparently concluded that more harm than benefit results from testing.

This recommendation will certainly be controversial. This is the same panel that recently recommended that women not do breast self examination and that screening mammography not be offered to women between ages 40 and 50. Those recommendations have not been widely adopted.

Here are a few of the articles discussing this change:

Panel Faults Widely Used Prostate-Cancer Test
By JENNIFER CORBETT DOOREN And THOMAS M. BURTON
Published: October 7, 2011 - Wall Street Journal online

A key federal advisory panel is poised to recommend that healthy men shouldn't be screened with a widely used blood test for prostate cancer, indicating that the test offers more harm than benefit.

The U.S. Preventive Services Task Force will recommend a "D" rating for prostate specific antigen, or PSA, testing, said a person familiar with the draft document. A "D" rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. It also is a recommendation to "discourage use" of test or treatment.

The task force is set to make its proposal Tuesday, and then allow for a four-week comment period before issuing a final recommendation.

The task force is an influential group whose recommendations can influence coverage decisions by the federal Medicare program and other insurers.

The scientific findings behind the recommendation are scheduled to be published Monday by the Annals of Internal Medicine. A copy of the paper was obtained by the newsletter Cancer Letter, which posted the paper on its website Thursday night.

The paper concluded that after about 10 years, PSA screening "results in small or no reduction" in death from prostate cancer but is "associated with harms," including biopsies, other tests and treatments, "some of which may be unnecessary."

Virginia A. Moyer, who chairs the task force,declined to comment on what the updated advisory would be. She noted that the current guidance is that the evidence is insufficient to recommend for or against screening in men younger than 75. That recommendation was last updated in August 2008. "New evidence has become available, and we had to reconsider our statement," Dr. Moyer said.

The new report is the latest in a long-running controversy over the value of PSA screening. Advocates say the test, when given regularly to men age 50 and over, facilitates the discovery of the cancer at an early stage, improving the chances of successful treatment. Critics say the test has a significant rate of false positives—apparent detection of cancer that isn't confirmed with further tests—or that it identifies so-called indolent tumors that are ultimately of little health consequence. This leads to unnecessary biopsies and cancer treatments.

Because such interventions can lead to infections, impotence and incontinence, critics say the risks of testing often outweigh the benefit.

U.S. Panel Says No to Prostate Screening for Healthy Men
By GARDINER HARRIS
Published: October 6, 2011 - New York Times online
Healthy men should no longer receive a P.S.A. blood test to screen for prostate cancer because the test does not save lives over all and often leads to more tests and treatments that needlessly cause pain, impotence and incontinence in many, a key government health panel has decided.

The draft recommendation, by the United States Preventive Services Task Force and due for official release next week, is based on the results of five well-controlled clinical trials and could substantially change the care given to men 50 and older. There are 44 million such men in the United States, and 33 million of them have already had a P.S.A. test — sometimes without their knowledge — during routine physicals.

The task force’s recommendations are followed by most medical groups. Two years ago the task force recommended that women in their 40s should no longer get routine mammograms, setting off a firestorm of controversy. The recommendation to avoid the P.S.A. test is even more forceful and applies to healthy men of all ages.

“Unfortunately, the evidence now shows that this test does not save men’s lives,” said Dr. Virginia Moyer, a professor of pediatrics at Baylor College of Medicine and chairwoman of the task force. “This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does.”

But advocates for those with prostate cancer promised to fight the recommendation. Baseball’s Joe Torre, the financier Michael Milken and Rudolph W. Giuliani, the former New York City mayor, are among tens of thousands of men who believe a P.S.A. test saved their lives.

The task force can also expect resistance from some drug makers and doctors. Treating men with high P.S.A. levels has become a lucrative business. Some in Congress have criticized previous decisions by the task force as akin to rationing, although the task force does not consider cost in its recommendations.

“We’re disappointed,” said Thomas Kirk, of Us TOO, the nation’s largest advocacy group for prostate cancer survivors. “The bottom line is that this is the best test we have, and the answer can’t be, ‘Don’t get tested.’ ”

But that is exactly what the task force is recommending. There is no evidence that a digital rectal exam or ultrasound are effective, either. “There are no reliable signs or symptoms of prostate cancer,” said Dr. Timothy J. Wilt, a member of the task force and a professor of medicine at the University of Minnesota. Frequency and urgency of urinating are poor indicators of disease, since the cause is often benign.

The P.S.A. test, routinely given to men 50 and older, measures a protein — prostate-specific antigen — that is released by prostate cells, and there is little doubt that it helps identify the presence of cancerous cells in the prostate. But a vast majority of men with such cells never suffer ill effects because their cancer is usually slow-growing. Even for men who do have fast-growing cancer, the P.S.A. test may not save them since there is no proven benefit to earlier treatment of such invasive disease.

As the P.S.A. test has grown in popularity, the devastating consequences of the biopsies and treatments that often flow from the test have become increasingly apparent. From 1986 through 2005, one million men received surgery, radiation therapy or both who would not have been treated without a P.S.A. test, according to the task force. Among them, at least 5,000 died soon after surgery and 10,000 to 70,000 suffered serious complications. Half had persistent blood in their semen, and 200,000 to 300,000 suffered impotence, incontinence or both. As a result of these complications, the man who developed the test, Dr. Richard J. Ablin, has called its widespread use a “public health disaster.”

One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis. The disease is rare before age 50, and most deaths occur after age 75.

Not knowing what is going on with one’s prostate may be the best course, since few men live happily with the knowledge that one of their organs is cancerous. Autopsy studies show that a third of men ages 40 to 60 have prostate cancer, a share that grows to three-fourths after age 85.

P.S.A. testing is most common in men over 70, and it is in that group that it is the most dangerous since such men usually have cancerous prostate cells but benefit the least from surgery and radiation. Some doctors treat patients who have high P.S.A. levels with drugs that block male hormones, although there is no convincing evidence that these drugs are helpful in localized prostate cancer and they often result in impotence, breast enlargement and hot flashes.

Of the trials conducted to assess the value of P.S.A. testing, the two largest were conducted in Europe and the United States. Both “demonstrate that if any benefit does exist, it is very small after 10 years,” according to the task force’s draft recommendation statement.

The European trial had 182,000 men from seven countries who either got P.S.A. testing or did not. When measured across all of the men in the study, P.S.A. testing did not cut death rates in nine years of follow-up. But in men ages 55 to 69, there was a very slight improvement in mortality. The American trial, with 76,693 men, found that P.S.A. testing did not cut death rates after 10 years.

Dr. Eric Klein of the Cleveland Clinic, an expert in prostate cancer, said he disagreed with the task force’s recommendations. Citing the European trial, he said “I think there’s a substantial amount of evidence from randomized clinical trials that show that among younger men, under 65, screening saves lives.”

The task force’s recommendations apply only to healthy men without symptoms. The group did not consider whether the test is appropriate in men who already have suspicious symptoms or those who have already been treated for the disease. The recommendations will be open to public comment next week before they are finalized.

Recommendations of the task force often determine whether federal health programs like Medicare and private health plans envisioned under the health reform law pay fully for a test. But legislation already requires Medicare to pay for P.S.A. testing no matter what the task force recommends.

Still, the recommendations will most likely be greeted with trepidation by the Obama administration, which has faced charges from Republicans that it supports rationing of health care services, which have been politically effective, regardless of the facts.

After the task force’s recommendation against routine mammograms for women under 50, Health and Human Services Secretary Kathleen Sibelius announced that the government would continue to pay for the test for women in their 40s. On Thursday, the administration announced with great fanfare that as a result of the health reform law, more people with Medicare were getting free preventive services like mammograms.

Dr. Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence in Britain, said he was given a P.S.A. test several years ago without his knowledge. He then had a biopsy, which turned out to be negative. But if cancer had been detected, he would have faced an awful choice, he said: “Would I want to have it removed, or would I have gone for watchful waiting with all the anxieties of that?” He said he no longer gets the test.

But Dan Zenka, a spokesman for the Prostate Cancer Foundation, said a high P.S.A. test result eventually led him to have his prostate removed, a procedure that led to the discovery that cancer had spread to his lymph nodes. His organization supports widespread P.S.A. testing. “I can tell you it saved my life,” he said.

Answering Questions About the P.S.A. Test
By TARA PARKER-POPE
Published: October 6, 2011 - New York Times online

News that an influential panel of experts is advising healthy men not to be screened for prostate cancer with a widely used test is certain to cause confusion and anxiety among men and their doctors, and reignites a debate about the benefits and risks of screening tests.

The recommendations, to be officially announced on Tuesday by the United States Preventive Services Task Force, affect more than 44 million men age 50 and older who typically are candidates for a simple blood screen call the prostate-specific antigen (P.S.A.) test.

The panel, which already recommends against P.S.A. screening for men age 75 and older, will cite recent research suggesting that the testing does not save lives but does lead to unnecessary treatments that can cause impotence, incontinence and a number of other complications.

Here are some answers to common questions about P.S.A. testing and what the task force recommendations mean for men.

Will the new recommendations prevent me from getting a P.S.A. test if I want one?

No. Whether to be screened for prostate cancer is still a decision that each man must make for himself with the advice of a doctor he trusts. But now that the independent panel has taken a stand, many doctors who were ambivalent or opposed to P.S.A. testing may be more willing to express their own doubts about the test and to advise patients against it.

What if I have a family history of prostate cancer or worrisome symptoms? Should I still be checked for cancer?

The panel’s advice is based on studies of healthy men. Men who have symptoms related to prostate health should always be seen by a doctor; the task force did not address whether P.S.A. testing is appropriate for them. And men with a strong family history of prostate cancer may have more to gain from screening than men at low risk, so they also should discuss the issue with their physician.

In addition, a man who already has prostate cancer that has been diagnosed or treated is likely to continue to undergo P.S.A. testing, which can help doctors determine whether cancer has returned or is spreading.

What do other groups say about P.S.A. testing?

Most major medical groups have not taken a stand against routine P.S.A. screening and say it is a decision a man should discuss with his doctor. The American Cancer Society suggests that the conversation start at age 50 for most men, earlier for African-Americans and men with a strong family history of prostate cancer.

The American Urological Association recommends that P.S.A. screening be offered to men 40 or older. Most organizations discourage prostate cancer screening for men with less than 10 years life expectancy.

Why not get screened? Isn’t it always better to find cancer early?

The argument against P.S.A. testing is that prostate cancer is typically so slow growing that most men would be just fine if they never knew it was there. But once cancer is detected, it is psychologically difficult for a man to do nothing.

As a result, tens of thousands of men each year are left impotent and incontinent as a result of aggressive treatment for a cancer that would never have caused them harm. But it is impossible to tell which men have comparatively benign cancer and which men have aggressive cancer. As a result, many doctors believe the overall benefits of screening outweigh the negatives.

How much weight do the task force recommendations carry?

The task force is an independent panel of experts in prevention and primary care appointed by the federal Department of Health and Human Services. While the group only makes recommendations, a change by the task force often prompts other organizations to review their guidelines and can influence how insurance companies reimburse for certain services.

But the influence of the panel is often determined by how controversial its recommendations are. Two years ago, for instance, the task force concluded that healthy women under age 50 should no longer get annual mammograms. That recommendation was met with strong resistance by many cancer organizations, women and their doctors, many of whom continue to ignore it.

And even though the panel has already recommended that men over age 75 not undergo P.S.A. testing, many men and their doctors continue the practice. Earlier this year, the Journal of Clinical Oncology reported that men ages 80 to 85 are being screened as often as those 30 years younger. The task force’s advice is not necessarily the final word.

Painful Shingles Can Strike More Than Once

2011-02-24T15:21:00.001-06:00

Having shingles can be a miserable experience. Now, to make matters worse, the long-held notion that people can only get shingles once in their lives appears to be false, according to a study in the journal Mayo Clinic Proceedings this month.

It's estimated that 1 in 3 Americans will get shingles at some point, with one million new cases reported a year in the U.S. It typically starts with itching, tingling or numbness, then develops into a painful rash that blisters. It often hits people who are elderly or already suffering from another illness or trauma, and the residual nerve pain can last for months.

The incidence rate has been rising around the world, in all age groups, though it isn't clear why, says Rafael Harpaz, a medical epidemiologist in the Centers for Disease Control and Prevention's division of viral diseases. More than half of cases occur in people over age 60, when the risk of complications also rises steeply. Women are slightly more likely to contract shingles than men.

The CDC has urged all Americans age 60 and older to get the shingles vaccine—whether they've had shingles or not. But supplies of the vaccine are on back order in some areas. Merck & Co., the only company that makes it, has encountered frequent supply problems since the vaccine was approved in 2006.

Shingles is caused by the Varicella zoster virus, or VZV, the same virus that causes chicken pox, and it only strikes people who have had chicken pox in the past. Like other herpes viruses, VZV never fully leaves peoples' bodies. It can lie dormant for decades in the nerve roots in the spinal column, until it suddenly replicates and travels down the nerves to cause shingles. This frequently creates a striped rash that follows the pattern of nerves on the back or chest.

Exactly what prompts the virus to wake up is unknown, but it seems to occur when the immune system, which has kept it in check for years, becomes weakened due to age, illness or treatments such as chemotherapy. Emotional stress can cause recurrences of other herpes viruses, and the CDC is investigating whether it can spark shingles as well.

For the new study on shingles recurrence, researchers at the Olmsted Medical Center in Rochester, Minn., examined medical records of nearly 1,700 patients who had a documented case of shingles between 1996 and 2001. They found that more than 5% of them were treated for a second episode within an average of eight years—about the same rate as would typically experience a first case.

That a recurrence is so common is more of a surprise to virologists and other scientists than primary-care physicians, who have seen it in their practices, says Barbara Yawn, director of research at the Olmsted center and the study's lead author. "I've gotten calls and emails from some saying, 'Thank you. Now they will believe us.'"

The Olmsted researchers found the people most likely to have a recurrence were patients whose pain had lasted more than 30 days with their first shingles episode.

It's possible that some subgroups of the virus are more prone to recurrence, says Dr. Yawn. In their next study, her team is monitoring new episodes of shingles and the CDC will analyze samples of those that recur to look for genetic patterns. The earlier studies were funded in part by Merck and the National Institutes of Health, while the new study is funded by the CDC.

Some shingles cases are mild, causing only a minor rash. But some patients develop sharp, stabbing nerve pain that can make the affected area extremely sensitive. "Sometimes people say they can't stand to have anything touch the rash area, even clothes," Dr. Yawn says.

In some cases, the nerve pain is the only symptom for days. Patients have been hospitalized with what was thought to be heart disease or appendicitis until the telltale shingles rash appeared. "Sometimes the rash never develops—that really confuses doctors," says the CDC's Dr. Harpaz.

Nerve pain that lingers for more than a month is called postherpetic neuralgia, or PHN, and it can last for years in some patients. While antiviral medications can shorten the duration and severity of shingles episodes, PHN is harder to treat. Some patients get limited relief from opiates, antiseizure medications and antidepressants, but many elderly people can't tolerate the side effects.

In rare cases, shingles has other serious consequences. Blisters can become infected. A rash on the face can spread shingles into eyes, which can lead to loss of vision, sometimes permanent. A rash around the ear can cause a complication known as Ramsey Hunt syndrome, which can include deafness and weakness of the facial muscles.

A big unknown is whether people who got the chicken-pox vaccine as children will be susceptible to shingles in later years or protected from it—or even vulnerable to full-blown chicken pox if their immunity has weakened. Since the chicken-pox vaccine was only approved in 1996, it will be several decades before the first generation of Americans to be widely vaccinated reaches the typical shingles years.

"It's quite plausible that rates will come down dramatically as those kids become older adults," says Dr. Harpaz, though he notes that some people who got the chicken-pox vaccine may unknowingly harbor the actual virus because the vaccine doesn't prevent 100% of cases, and some people may have had a mild, unnoticeable case before they were vaccinated.

The shingles vaccine, known as Zostavax, doesn't eliminate all cases. Studies show that it cuts the risk of shingles by about half in people over age 60. The cases that do occur in vaccinated people tend to be milder.

If it's possible to get shingles more than once, why does a vaccine work at all? Eddy Bresnitz, Merck's medical director for adult vaccines, says that unlike most vaccines, which prime a person's immune system to ward off a virus the first time it invades, Zostavax boosts the immune system's ability to keep the preexisting herpes infection in check, even though it never fully disappears.

To date, less than 11% of Americans over age 60 have had the shingles vaccine, partly because the shortages have frustrated public-awareness efforts and partly because of cost. Zostavax, which ranges from $140 to $400, is one of the most expensive of adult vaccines, and only some Medicare Part D plans cover it.

Dr. Bresnitz says Merck is building a new plant in North Carolina and expects to have more Zostavax available in coming years. It uses the same raw materials as the chicken-pox vaccine for children, to which Merck gives first priority. Side effects are usually limited to mild irritation and tenderness around the injection site.

Public-health experts urge Americans over 60 not to wait until they are very old or ailing to get the vaccine. Once people have compromised immune systems, they are no longer eligible, due to the risk that the vaccine could cause shingles rather than prevent it.

By Melinda Beck, The Wall Street Journal

From Dr. Yates: We've discussed this vaccine and recommend that our patients over the age of 50 consider being vaccinated earlier than the recommendation from the CDC, particularly if they've had shingles previously. Certainly, with a few exceptions, anyone over age 60 should be vaccinated and we can arrange vaccination in our office.

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

The Autism Vaccine Hoax - The Wall Street Journal.

2011-01-11T04:58:00.002-06:00

Twelve years late, the media and medical community may finally be digging a grave for one of the more damaging medical scares in history. We're speaking of the vaccines-cause-autism panic, the burial of which cannot come too soon.

The British Medical Journal this week published an article and editorial explaining that the 1998 study that provoked the vaccine scare was an "elaborate fraud." That study, published in the (once) respected journal "The Lancet," was by British doctor Andrew Wakefield and other researchers, who claimed that the widely used measles, mumps and rubella vaccine was linked to autism. Around the same time, U.S. parents and opportunistic lawyers latched on to a related theory that vaccination shots containing a mercury compound called thimerosal caused autism.

Despite broad evidence even in the 1990s that these claims were unfounded, the medical community was slow to push back. Nervous public-health groups inspired a panic by rushing to get thimerosal out of vaccines. The Lancet stuck by its article, the media sensationalized the story, and Congress joined the cause celebre. Maine Senators Olympia Snowe and Susan Collins went so far as to kill a vaccine liability provision so that parents could bring thimerosal suits. Indiana Republican Dan Burton was especially irresponsible in raising public fears.

By 2004, Britain's immunization rates had dropped to a low of 80%; the rates have recovered only slightly. The Centers for Disease Control says that in the U.S. 40% of parents have delayed or declined at least one of their children's shots. This has led to the needless re-emergence of once-conquered diseases.

Measles is now endemic in England and Wales. California recently suffered a whooping cough outbreak that sickened 7,800 people and killed 10 babies. As Paul Offit, the chief of infectious diseases at the Children's Hospital of Philadelphia and one of the few who stood up against the autism scare, writes in his new book "Deadly Choices," the victims of this "war on science" are children.

Researchers have all the while continued to churn out studies disproving the vaccine-autism link. Vaccine courts have struck down thimerosal claims. Yet it is only recently that professional journals and media have rediscovered a responsibility gene.

It took the Lancet until last year to offer a full retraction of the 1998 study, and that came only after Britain's medical regulator had ruled that Mr. Wakefield had acted "dishonestly and irresponsibly." The British Medical Journal's article is the first in-depth look at Mr. Wakefield's abuses. By journalist Brian Deer—who has investigated Mr. Wakefield for years—the article reports that the doctor grossly misrepresented the cases of 12 children to support his theory, and that he worked with plaintiffs attorneys to exploit the panic for financial gain.

This is a start, but the health community and media have a long way to go to restore public trust in immunizations. They also bear some responsibility for the dollars that have been diverted from research into finding the real causes of the terrible affliction that is autism. Let's hope they now broadcast the vaccine truth as much as they encouraged the vaccine panic.

From The Wall Street Journal

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

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

2010-12-27T06:09:00.002-06:00

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!

2010-12-24T05:25:00.001-06:00

"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

2010-12-19T05:21:00.001-06:00

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

2010-12-17T05:03:00.003-06:00

"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

2010-12-15T05:49:00.006-06:00

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

2010-12-13T04:35:00.002-06:00

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

2010-12-10T05:15:00.002-06:00

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

2010-12-08T05:08:00.002-06:00

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

-- Winston Churchill

Meet Dr. Michael Martin

2010-12-07T04:55:00.002-06:00

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

2010-12-02T04:11:00.001-06:00

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

2010-11-29T06:56:00.002-06:00

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

2010-11-27T05:14:00.002-06:00

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

-- Anonymous

U.K. bans doctor who linked autism to vaccine

2010-11-26T05:05:00.004-06:00

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