Archive for July, 2008

Success seen with tailored diabetes education

Washington -- Diabetes education that is tailored to a specific population goes a long way toward improving blood sugar control among those with type 2 diabetes, according to a review published July 15 by TheCochrane Library.

Such targeted education has long been encouraged by the American Medical Association and many other medical groups. Still, knowing that the bottom-line result -- better control over A1c levels is being achieved -- is welcome news.

The research team from Cardiff University in the United Kingdom was assembled by the Cochrane Collaboration, an international, nonprofit organization that reviews health interventions, to examine 11 randomized controlled trials involving 1,603 people.

Researchers found that the use of community-based health advocates, the delivery of information within same-gender groups, or the adaptation of dietary and lifestyle advice to fit a particular community's needs were effective tools in the effort to gain control of the disease.

Diabetes is a problem throughout the world and, with rising obesity rates, is expected to become even more pervasive. Nearly 8% of the U.S. population already has type 2 diabetes, and the rate is increasing especially sharply for members of minority populations, according to the Centers for Disease Control and Prevention and others.

Type 2 diabetes is a particular problem for members of minority ethnic groups who move from poorer nations to high-income countries where they confront many physical, communication and cultural barriers that make it difficult to access health care effectively, said the researchers.

Hispanics, blacks, and Asian and Pacific Islanders all experience higher rates of diabetes than do whites. Among those younger than 20, American Indians have the highest rate of type 2 diabetes among all groups, according to the CDC.

Making programs appropriate

"With such a large proportion of the U.S. population composed of minority groups, which are only going to increase over time, and with diabetes being more prevalent among those groups, it makes sense to step back and see if culturally appropriate programs work," said Leonard Jack Jr., PhD, professor in the behavioral and community health sciences program at Louisiana State University Health Sciences Center in New Orleans. "I was happy to see that they do work."

Jack coordinated the development of the American Assn. of Diabetes Educators' 2007 position statement on Cultural Sensitivity and Diabetes Education. Among the recommendations: "Practice active listening, which may permit identification of what is meaningful to people."

Nearly 8% of the U.S. population has been diagnosed with type 2 diabetes.

In findings from their review, the Cochrane researchers noted improvements in blood-sugar control within three months of the start of education programs that were deemed culturally appropriate. The benefit still was seen when the six-month trial period ended. But one year later, the benefits had not been retained, indicating the need for a refresher course.

"That is predictable," said John B. Buse, MD, PhD, president for medicine and science at the American Diabetes Assn. "It's remarkable how often people fall off the wagon, despite how well they understand. People need coaching to sustain something like diabetes management, to sustain physical activity and watch their diet."

The findings aren't shockingly new but bear repeating, said Dr. Buse, who also is professor of medicine at the University of North Carolina School of Medicine in Chapel Hill. "If you talk to people about foods that are not a part of what they normally eat, they are not likely to follow suggestions," he said. "If you suggest joining a health club and they can't afford a health club, that's not going to be very effective."

The Cochrane researchers also cautioned that all minority communities are not the same, and that programs should be developed in partnership with a community.

They defined culturally appropriate health education as any type of diabetes education that has been specifically tailored to the cultural needs of a target minority group.

Although education in general is key to the successful management of diabetes, it's not enough, said Michele Heisler, MD, MPH, associate professor of internal medicine at the University of Michigan in Ann Arbor. "You need to be motivated to do something, you have to have the confidence that you can do something, and the social support as well," she said.

"Culturally appropriate education is much more likely to tap into and resonate with people's lifestyles and values," she added.

Lifestyle issues contribute to weight gain in teen girls

Teen girls who want to lose weight may need to consider how much they sleep, drink and surf the Internet, according to a study published online July 10 in the Journal of Pediatrics.

Researchers analyzed data from 4,427 girls ages 14 to 21 who were participating in the Growing Up Today Study, a cohort of children of subjects from the Nurses' Health Study II. An average weight gain of four pounds per year was associated with getting less than five hours of sleep a night, drinking more than two servings of alcohol per week and surfing the Internet for recreation for an hour or more at a time. Coffee did not appear to play a role. However, the authors noted that the caloric content of many coffee drinks has increased since this population was surveyed in 2000 and 2001. The other worry is the cumulative effect of these additional pounds as these lifestyle issues become hard-to-break habits.

"These particular factors are potentially very important with regard to excess weight gain because as girls get older, they spend more time on the Internet while getting less sleep, drinking more coffee and, possibly, also beginning to consume alcohol," said Catherine Berkey, ScD, lead author and a lecturer in medicine at Harvard Medical School in Boston.

Experts praised the paper for attempting to quantify the many lifestyle factors that may contribute to weight gain among adolescent girls.

"This study makes perfect sense," said Ellen Rome, MD, MPH, head of adolescent medicine at the Cleveland Clinic.

Most suspect these behaviors are connected to weight because they play a role in sedentary behavior and excess calorie consumption. For example, teens who spend a lot of time in front of computers would have, before the Internet, been sitting in front of a TV. Therefore, adolescent medicine specialists are calling for physicians to ask about total screen time rather than just television hours.

Alcohol consumption, lack of sleep and long Internet sessions are associated with weight gain in teen girls.

"The Internet is the new watching television for this particular generation of adolescents and young adults," said James Farrow, MD, professor of pediatrics and medicine and director of the student health service at Tulane University in New Orleans. "It's a sedentary way of socializing instead of playing a sport or something like that, and I would not be surprised if they were eating at the same time they were on the Internet."

Alcohol provides significant liquid calories and can lead to sleep disturbances. This lack of sleep quality, in turn, can lead to metabolic issues that can add pounds. The resulting daytime sleepiness may mean that teens will not have the energy to participate in physical activity.

"It becomes a vicious cycle. Alcohol can significantly disrupt [one's] sleep cycle, and if they're more sleepy during the day, they're not going to be as active," said Tonya Chaffee, MD, MPH, associate clinical professor of pediatrics at the University of California, San Francisco.

Those who work with adolescents also would like to see more analysis of how these factors may affect the weight of teen boys, and of the impact of all caffeinated drinks, not just coffee.

Vaccine-autism link unsupported by science, but theory lives on

At the Autism One conference in Chicago on Memorial Day weekend, hundreds of parents and clinicians gathered to hear a keynote by Jenny McCarthy, an actress and the mother of an autistic child, who has publicly associated her child's illness with vaccines. Many conference sessions were dedicated to doubts about immunizations. And, even when it wasn't the focus, the notion that some aspect of vaccines may play a role in autism was evident.

As the number of children diagnosed with autism has increased, so has the number of national support groups like this one. Parents often turn to these organizations for help in finding an explanation for their child's condition.

"Is the vaccine association real? Yes, I think it is. The future is going to see some major advances in our understanding of vaccine strategies that are safer for many, many more children," said Dr. Andrew Wakefield, who was among the conference's most well-known speakers. He also is the executive director of Thoughtful House Center for Children in Austin, Texas. He is not licensed to practice medicine in that state.

Dr. Wakefield was lead researcher for the controversial 1998 paper published in The Lancet, which linked the measles, mumps and rubella vaccine with gastrointestinal disease and developmental regression in 12 children.

His Autism One speech outlined his side of the story regarding some of the fallout from that paper -- specifically, the United Kingdom's General Medical Council hearings, which will continue through August. At these proceedings, the council is considering allegations of misconduct surrounding his research. The charges could result in the removal of his right to practice medicine in his home country. It also is reviewing the contributions of two co-authors on the 1998 paper. Dr. Wakefield denies the charges of any wrongdoing. His speech received a standing ovation.

Two different perspectives

Day in and day out, physicians spend time refuting the theory that vaccines play a role in the development of autism. The idea has been extremely tough to put to rest, even though significant scientific efforts, numerous studies and multiple evidence reviews have found no link.

"Scientific data overwhelmingly shows that there is no connection between vaccines and autism," said AMA Trustee Edward L. Langston, MD. "Autism is a heart-wrenching condition, and the upheaval felt by parents whose children have been diagnosed with autism is understandable -- as is their search for answers. We need more research to investigate the actual causes of autism."

More U.S. measles cases were detected in the first 4 months of 2008 than in the same period for any year since 2001.

But those on the other side of the issue say the studies dismissing the relationship are not conclusive. They wonder about the impartiality of the Centers for Disease Control and Prevention, which has carried out many of the investigations but promotes vaccine uptake as a part of its mission to improve public health.

In addition, people in this camp want biological rather than epidemiological studies and resent being labeled "anti-vaccine." They say they are seeking safe vaccines for all children, including the ones they suspect may have been harmed because of a genetic predisposition.

"I don't feel that vaccines cause or have caused autism, but I do believe that many of our children have problems with toxins, the metals that they may be exposed to, and the things we add to vaccines," said Nancy O'Hara, MD, a pediatrician from Wilton, Conn., who presented data on this subject at the Defeat Autism Now clinicians' seminar, which preceded the Autism One convention. "These children cannot detoxify as well as neurotypical children. ... We need a more individualized approach to giving vaccines, and to look at these genetically predisposed children in a different way."

Some also argue that, even though thimerosal has been removed from most vaccines, there's still enough to cause problems. And if thimerosal is not to blame -- because that's never been proven -- then something about vaccines is causing autism.

Every so often, a small study such as the one conducted by Dr. Wakefield comes along to buttress that belief. In this case, the momentum has held, even though 10 of the 13 authors on the 1998 paper published a statement in The Lancet in 2004 retracting the original interpretation that their data indicated a causal link between MMR and autism, and Dr. Wakefield faces significant professional scrutiny.

To many, such retractions and medical board inquests are part of a conspiracy. "It's a witch hunt," said Mayer Eisenstein, MD, JD, MPH, a lawyer and medical director of Homefirst Health Services in Chicago, who presented a session on vaccination at the Autism One meeting. "These combination vaccines cannot be right."

Rebuilding trust

This degree of staying power is why those who work on vaccine issues speak of the need not only to investigate possible adverse events but also to rebuild public trust surrounding the entire enterprise. A special article published in the July Pediatrics called for more public engagement in immunization issues and education on the complexity of the vaccine safety system. The article also urged that more time be allowed to build understanding about the rationale behind new vaccines before promoting them, and that reliance on mandates to force parental compliance be reduced.

"It's quite clear that the issues are really complex and don't lend themselves to sound bites," said Louis Z. Cooper, MD, lead author and professor emeritus in the Dept. of Pediatrics at Columbia University's College of Physicians and Surgeons in New York. He also is a former president of the American Academy of Pediatrics, although he was speaking personally.

The steps outlined in that article are needed because, experts say, despite all the science supporting vaccine safety, this confidence has not necessarily been conveyed to the public. A Web search on the word "vaccines" will turn up many sites that question such assertions. Moreover, the general public has a tendency to internalize the horrors of individual cases -- whether about a child down the block, the experience of a friend-of-a-friend-of-a-friend or a personal story found on the Internet -- rather than respond to population studies.

"It's very difficult to communicate good science to the public, and it's very easy to scare people. It's very hard to unscare them," said Paul A. Offit, MD, chief of infectious diseases at Children's Hospital of Philadelphia. He is also the co-inventor of one of the rotavirus vaccines.

There's no question that the seeming impossibility of putting this theory to rest has done damage. In June, the United Kingdom's Health Protection Agency declared measles endemic for the first time since 1994 and announced the first death from the disease since 2006. In May, the CDC announced that more measles cases have been detected in the U.S. this year than in any year since 2001.

FDA requires black-box warnings for fluoroquinolones

Washington -- The Food and Drug Administration has notified the makers of fluoroquinolone antimicrobials that they need to place boxed warnings on the labels of seven drugs in this class because they pose a risk for tendinitis and tendon rupture.

The FDA said a medication guide to inform patients also is necessary.

These medicines need the black-box warnings, the strongest issued by the agency, due to continued reports of tendon injuries associated with their use despite existing, but less prominent, label warnings, explained Edward Cox, MD, director of FDA's Office of Antimicrobial Products, at a July 8 press briefing.

Bayer Healthcare, which makes Cipro -- one of the most well-known fluoroquinolones -- said in a statement that it was implementing the changes and preparing the revised warning text.

Tendon ruptures are relatively rare. They occur spontaneously, often from sports injuries, at an estimated annual rate of six to as many as 37 per 100,000 people, according to recent studies. The use of fluoroquinolones increases the likelihood of a rupture by three to four times that rate, said FDA officials.

The tears or ruptures may occur in the Achilles, shoulder, hand or other tendons, sometimes with a dramatic pop or snap.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs ... particularly for certain patient populations," said Dr. Cox.

Those most at risk

The risk increases for patients older than 60, those taking corticosteroids, and patients who have received kidney, heart or lung transplants, said Renata Albrecht, MD, director of the FDA's Division of Special Pathogen and Transplant Products.

Patients who experience pain, swelling, inflammation of a tendon or tendon rupture should stop taking the medications and call their physicians, she added.

Fluoroquinolones use increases the likelihood of a tendon rupture by 3 to 4 times.

The manufacturers also have been told to develop a risk evaluation and mitigation strategy, or REMS, to ensure that the benefits of the drugs outweigh the risks. Under the FDA Amendments Act of 2007, the agency may require manufacturers to submit REMS when a drug first comes on the market, or later if the FDA becomes aware of new safety data about the drug.

A Bayer spokeswoman noted that the fluoroquinolones the company sells have been reported in clinical trials to provide "significant benefits over standard therapy."

The heightened warnings come two years after a petition was filed by the Washington, D.C.-based watchdog group Public Citizen and Illinois Attorney General Lisa Madigan that asked the FDA to require the black-box label warnings, a medication guide for patients and a "Dear Doctor" letter from manufacturers detailing the tendon risks. The FDA agreed with the first two requests but did not address the third.

"As the only state to petition the FDA to require additional product labeling information, we are pleased with the FDA's decision that will better inform patients and medical providers of the potential risks these drugs pose," said a spokeswoman for Madigan.

Public Citizen, which also filed a lawsuit in January because the FDA had not yet responded to the petition, welcomed the agency's actions, but wants more. "The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture," said Sidney Wolfe, MD, director of the Public Citizen's Health Research Group.

When asked why the FDA hadn't required a letter to doctors, Dr. Cox said the agency would be "happy to work with" manufacturers interested in sending such a communication.

Expect the thrill of victory, the agony of bad air at the Olympics

With the 2008 Beijing Olympics around the corner, health experts warn that a once-in-a-lifetime trip to the games requires travelers to see beyond the excitement of the athletic contests to factors that could undermine their well-being.

In this context, the potential for rare infectious diseases is not the primary concern. Rather, the health problems that could be experienced by the 600,000 foreign visitors and athletes expected to travel to China next month are more likely to result from poor air quality, a common cold virus, inexperienced drivers and animal bites, according to a paper published this month and physicians advising Olympic guests.

"Using common sense while in Beijing can keep you healthy," said Nina Marano, DVM, MPH, chief of the Travelers' Health and Animal Importation Branch at the Centers for Disease Control and Prevention. "Wash your hands, watch your step and don't pet stray dogs."

The advice is based on findings published in the July American Journal of Tropical Medicine and Hygiene analyzing data from the GeoSentinel Surveillance Network run by the International Society of Travel Medicine and the CDC. This report documented that, over the past decade, travelers to China were far more likely than those going to India or Southeast Asia to experience respiratory issues. Sprains and strains along with bites from dogs, cats and monkeys were commonly reported. No cases of malaria, dengue, leishmaniasis or Japanese encephalitis were noted.

"We had thought we would find more exotic diseases. We need to tell people about dog bites. People need to consider respiratory illness and injuries," said Phyllis Kozarsky, MD, one of the paper's authors and a CDC expert consultant.

In addition, although the H5N1 avian influenza virus has long been problematic in the region's poultry, experts do not expect it to be an issue for these travelers.

China has the world's 2nd-highest rate of human rabies.

"H5N1 is probably basically embedded in southern China. I'm not sure they're ever going to eliminate it," said Richard V. Lee, MD, professor of medicine at the State University of New York at Buffalo. "The advice there is don't go to wet markets and don't kiss chickens." Wet markets usually sell live animals along with fruits and vegetables.

But experts are particularly concerned about other respiratory illnesses, particularly those that are not infectious in origin. Many believe that, despite efforts made by officials to reduce pollution, anyone with asthma or other lung problems making this Olympic journey should be prepared for a flare-up. Additionally, indoor air quality is problematic because so much of the population smokes. In China, people can light up almost anywhere indoors.

"The air pollution can be just dreadful, and, oftentimes, it's not just in the ambient air. It's in the inside air as well," Dr. Lee said.

Look both ways

Physicians tracking the possible health risks associated with the games are eyeing certain other injuries and illnesses as reason for anxiety, too. New construction has been carried out rapidly but not necessarily to high safety standards. The city also has experienced a rapid increase in car ownership, meaning many drivers have not been on the road long.

"It seems that half the nation just recently traded in their bicycles for cars," said Gregory Juckett, MD, MPH, professor of family medicine and director of the West Virginia University International Travel Clinic in Morgantown. "I have been to China three times and have narrowly escaped rogue buses and other assorted vehicles each time. It's every man for himself." Dr. Juckett also is president of the West Virginia Academy of Family Physicians, although he was speaking personally.

Another threat is rabies. About 140,000 animal bites were reported in Beijing in 2006, and the country has the second-highest rate of human rabies in the world. Physicians are calling for extreme caution when dealing with any animal. But with the vaccine in short supply and lower rates of this disease in urban areas, pre-exposure immunization is not viewed as necessary, particularly for those not venturing far out of Beijing.

"People will see monkeys and think they are something they want to play with without realizing that it's a health danger," said Dr. Kozarsky, also a professor of medicine and infectious diseases at Emory University in Atlanta.

Physicians for the athletes, though, expect to be kept most busy with complaints that become more important in the midst of competition.

"Athletes think, 'This is my big chance.' That scratchy throat that they would not normally go to the doctor for turns into a great concern," said Kristine Karlson, MD, a physician for the U.S. Olympic team. Among the athletes she will be treating are those participating in rowing, kayaking and the triathlon. "We give out large doses of reassurance and do lots of cheerleading." She also is a family and sports medicine physician at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

In general, experts are advising that visitors avoid drinking the water, carry medications for travelers' diarrhea and be vaccinated against hepatitis A. Additional precautions are necessary if any part of the trip involves travel to a rural area.