Studies Could Ease Fears of Medicines for ADHD

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

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

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

Parents Urged Again to Limit TV for Youngest

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

"Compelling ideas come into clear minds."

-- Bill O'Reilly

An Easier Colonoscopy Prep

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

"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

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)

“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

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

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