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Diabetics who keep their blood sugar tightly controlled run the risk of having traffic accidents due to low blood sugar, Canadian researchers report.

Controlling blood sugar is the cornerstone of managing diabetes. By keeping blood sugar under control, diabetics can ward off many of the complications associated with the condition, including heart and kidney disease. However, blood sugar that is too low — known as hypoglycemia — can cause dizziness and loss of consciousness, the researchers say.

“Diabetes is a common disease that may impair an adult’s ability to drive,” said lead researcher Dr. Donald A. Redelmeier, a professor of medicine at the University of Toronto.

Worldwide, Redelmeier said, diabetics are required to produce proof of good blood-sugar control to keep their driver’s license. The United States, United Kingdom, Canada, Germany, Holland, Australia and other countries all have such laws, but they’re “based on theory rather than science,” he said.

And contrary to the prevailing theory, people with good blood-sugar control were found to have a higher risk for crashing, Redelmeier said of his study’s results. The risk was substantial, accounting for almost 50 percent of the accidents, he said.

The accidents were mostly related to severe hypoglycemia in association with strict blood sugar control, he noted. The findings were published online Dec. 8 in PLoS Medicine.

For the study, Redelmeier’s team collected data on 795 diabetic drivers. They found that one in 14 of the drivers had been involved in car accidents. Those with low blood sugar were more likely to have had an accident than were diabetics whose blood sugar was not as well controlled.

Moreover, the risk for having a car accident increased fourfold if the person had a history of hypoglycemia, the researchers found.

“This finding calls into question laws that restrict driver’s licenses on the basis of this measure of diabetes control,” Redelmeier said.

The study could be the first step in getting driving laws changed, he added. His research group, Redelmeier said, was the first to identify driving and talking on cell phones as a hazard, which led to laws restricting the use of cell phones while driving.

Dr. Luigi F. Meneghini, an associate professor of clinical medicine and director of clinical operations for the division of endocrinology, diabetes and metabolism at the University of Miami Miller School of Medicine, agreed that the study “brings up the risk of driving while you have diabetes.”

People taking medication to lower their blood sugar need to be aware of any symptoms of an oncoming hypoglycemic episode, Meneghini said. And older people, who he said often aren’t aware that a hypoglycemic episode is starting, should check their blood sugar more often.

“They should certainly check their blood sugar before they get into a car,” he said. “If they have low blood sugar, treat the low blood sugar and wait until their blood sugar is in a safe range before getting behind the wheel.”

Redelmeier said he advises diabetics not to drive if they feel dizzy or have other symptoms of hypoglycemia. In addition, he urges people to always have food available to boost the blood sugar should a hypoglycemic episode start.

Seniors enrolled in private, standalone Medicare prescription drugs plans (PDP) could encounter significant changes this open enrollment period, which begins Sunday.

Monthly premiums will rise 11 percent to $38.94, on average, according to an analysis published by the Henry J. Kaiser Family Foundation. That’s up 50 percent from 2006, the first year that Medicare Part D drug benefits were offered.

“But these changes vary considerably by plan,” added Jack Hoadley, a research professor in the Health Policy Institute at Georgetown University in Washington, D.C., and one of the report’s authors. “Just among the five most popular plans, the premium for one is up by 22 percent for 2010, while the premium for another is down by 3 percent,” he said.

So is Medicare Part D still a good buy? It all depends, experts say.

“The general advice is you do have to look beyond the premium and look at what’s covered, what your expenses are for the course of the year and whether it works for you with the drugs that you take,” said Paul Precht, director of policy and communications in the Washington, D.C., office of the Medicare Rights Center, a nonprofit consumer counseling and advocacy group.

Seniors can access Part D one of two ways. If they’re in traditional Medicare, they can select a private PDP from a wide array of options. Or, if they are enrolled in a Medicare Advantage plan, like an HMO or PPO, with prescription drug coverage, they can receive Part D benefits through that plan.

Of the nearly 27 million Medicare beneficiaries in Part D, two-thirds are enrolled in standalone PDPs, according to the Kaiser Family Foundation analysis, which examines changes in the PDP marketplace.

With dozens of PDPs from which choose in every region, sifting through the various options can be a pain. For 2010, a total of 1,576 plans will be offered nationwide — 113 fewer choices. Yet seniors will still have anywhere from 41 to 55 alternatives from which to choose in every region.

“I think it’s a good trend that the number of plans is going down. I do think there is a thing as too much choice,” said David Lipschutz, staff attorney for California Health Advocates, a nonprofit Medicare advocacy and education outfit.

Seniors will get little relief, however, from cost-sharing requirements. Sixty percent of PDPs, up from 45 percent in 2009, will require an annual deductible in 2010, for example. The maximum deductible that a plan may charge is $310.

Plan coverage of costs incurred in connection with Part D’s infamous “doughnut hole” is getting stingier, too. In 2010, many beneficiaries will have to foot the bill for the coverage gap, which begins after the enrollee has incurred $2,830 in drug spending. Coverage resumes for drug costs above $6,440.

The House of Representatives on Nov. 7 passed a sweeping health reform bill that provides gap relief beginning in 2010 and eliminates the gap by 2019. However, the Senate must act before any health reform legislation is enacted.

There are also changes in store for seniors in “benchmark” plans, which offer basic Part D coverage to individuals who qualify for a premium. Of the 7.9 million getting extra financial help, 2.2 million must switch plans or pay a portion of their premium. If they want to stay in their current plan, their share of the premium will run roughly $8 to $10 a month, Precht said.

Part D experts urge seniors to take time during the open enrollment period to consider all of their options.

“It pays to do your homework,” Lipschutz said. “The plan you’re in now could change significantly next year, not only premium-wise but also the drugs it covers, the cost-sharing it charges for the drugs, the rules it imposes on accessing those drugs, [and] the pharmacy it contracts with.”

Nicotine patches and gum seem to be safe and effective in pregnant women, according to a new study.

Such patches and gum have been shown to help non-pregnant adults stop smoking, study co-author Dr. Geeta K. Swamy told Reuters Health. However, women and their obstetricians have been uncertain about their safety and effectiveness during pregnancy.

Dr. Swamy, from Duke University Medical Center in Durham, North Carolina, and colleagues took another look at data on pregnant smokers who had participated in a study comparing psychological treatments with nicotine patches or gum to help them quit.

Adding nicotine patches or gum tripled the number of women who quit, from 8 percent to 24 percent.

Almost a third - 31 percent — of the women who used the patch or gum had pregnancy complications, compared to 17 percent of the women who did not use it.

However, there was a much higher risk of such complications in black women, those with complications in previous pregnancies, and use of painkillers. The use of the patch did not seem to have a direct effect, the researchers note.

Based on the findings, although the patch is not “absolutely safe,” it may still be worth using in heavy smokers, given the known association between smoking and bad pregnancy outcomes, particularly premature birth and low birth weight, they conclude.

When it comes to teaching healthy behaviors, boys’ high school team sports might be doing more harm than thought.

New research suggests that for teenage boys, participation in team sports may encourage unruly behavior such as fighting and binge drinking.

Girls, on the other hand, seem to behave better in organized sports, said the lead researcher, Susan Connor, manager of the injury prevention program at Rainbow Babies & Children’s Hospital in Cleveland.

“The research raises more questions than it answers,” said Connor, who was to present her findings at the American Public Health Association’s annual meeting, in Philadelphia, which concludes Wednesday. “We were looking at a broad database, so we do not know why team sports may affect boys differently or how they affect them. That’s a topic for further research.”

Connor and her team studied the responses of more than 13,000 U.S. high school students who took part in the 2007 Youth Risk Behavioral Study, an assessment of adolescent high-risk behaviors conducted by the federal Centers for Disease Control and Prevention.

According to Connor’s findings, roughly 60 percent of the male respondents said they had played in at least one team sport in the past year. For girls, the participation rate was 48 percent.

The data did not specify which sports the teenagers participated in, although the top high school sports in the 2000 U.S. Census included basketball, football, baseball, soccer, track and field, and cross-country running.

For boys, the study found that participation in team sports correlated with an increased likelihood of fighting, drinking and binge drinking. Rates of depression and smoking, however, seemed to decline.

The findings were different for girls. White girls who were active in team sports reported lower levels of fighting, depression, smoking, marijuana use and unhealthy weight-loss practices, Connor and her colleagues found. Black high school girls reported increased levels of binge drinking.

“I think the issue is more socio-economic than race,” said Connor, who added that more research is needed to explore the slight behavior differences between black and white female high school athletes.

Connor stopped short of offering explanations for the apparent negative aspects of boys’ team sports. One possibility, she said, is that there is a culture in male sports that creates a climate of poor behavior.

“There are certainly health benefits in playing team sports,” said Connor. “But there is also this misconception, which is very widespread, that sports are all good. As a parent, you can’t assume your kid is protected. Sports are what you and your child make of it.”

Robert Regal, a psychologist in private practice in Valhalla, N.Y., agreed with Connor’s findings. Part of the problem, he said, is that boys’ teams may inherently attract athletes who are aggressive and highly competitive, leading to unruly behavior once they join a team.

“There are pre-existing expectations for both male and female athletes,” he said. “To be a female athlete means not having the same kind of hyper-aggressive, big-man-on-campus image. For guys, team sports are played with a great deal of expectation for success. It’s written into the team ethic.

“I’d be curious to see the behaviors of the top girls’ teams, the ones that win the state championships. I suspect they mirror the behaviors of the boys,” Regal added.

A urinary tract infection occurs when certain bacteria invade the urinary tract. Symptoms may include itching, burning, and painful urination.

The National Women’s Health Information Center lists these common causes of urinary tract infections in women:
Wiping from back to front after a bowel movement.
Having sex.
Holding urine for too long.
Being diabetic.
Having a kidney stone or other factor that makes it difficult to urinate.
Producing less estrogen, such as after menopause.
Having recently had a catheter inserted.

Merck and Co’s failed AIDS vaccine may not have worked, but it probably did not raise the risk of infection either, doctors said Tuesday.

Data analyzed after the large clinical trial was stopped in 2007 contradict earlier findings that suggested some groups, such as uncircumcised men, may have been more vulnerable to infection if they got the vaccine, Dr. Susan Buchbinder of the San Francisco Department of Public Health told an AIDS vaccine conference.

Merck’s STEP trial involved 3,000 people in South America, the United States, Canada and Australia. Researchers were not only dismayed that it appeared to do no good, but may have harmed some of the volunteers.

“With ongoing follow-up, the trend in the wrong direction is diminishing,” Buchbinder said in an interview. “Either they were at risk, and that has gone away, or they were never at increased risk. It was never significant.”

Researchers working to produce AIDS vaccines are in Paris this week to pore over the results of the latest experiments.

Of particular interest is a trial in Thailand that has just shown it may be possible to make a vaccine to prevent AIDS; the first hint of success in the 25 years since the pandemic began.

Buchbinder said researchers who worked on the Merck vaccine continue to monitor participants from the trial and are drawing insights from it even now. Lessons learned will be crucial in the making of AIDS vaccines.

STILL LEARNING

Twenty-nine people in the STEP trial who were infected showed a slight decrease in their viral load — a measure of virus in the blood — for a short time, she said.

“The bigger picture issue is that we see some clues here and some clues there about ways where the vaccine may be providing some protection. Overall it didn’t protect, but can we learn something about places where the vaccine may have provided even small amounts of protection so that we can build on those,” she said.

The vaccine aimed to fight AIDS by encouraging so-called cell-mediated immunity, jump-starting T-cells to tackle the virus and stop or slow the progress of the human immunodeficiency virus. It used a weakened virus called adenovirus-5 as a “vector” to transport the vaccine into the body.

Buchbinder said the STEP study also showed the importance of studying the effects of such vectors on the immune system.

“We never understood the complexity of the immune response against the vector and we think that is a very important thing to understand. Animal studies can’t address that because adenovirus 5 does not normally infect non-human primates,” she said.

“These efficacy trials are really moving science forward,” Buchbinder added.

“With each step we are learning more information that we couldn’t get any other way …. We don’t know what it is going to take to make a safe and effective vaccine. Each of these studies, particularly larger trials in humans, help shine a light on issues that we didn’t know or understand before.”

Hooked on cocaine or cigarettes? The U.S. government wants drug companies to make a vaccine for that.

Convinced of the need for new and better treatments for addiction, the government is focusing its efforts on vaccine development as a new way to treat and possibly prevent addiction to a range of addictive substances.

“It’s a perspective that is very different from what we’ve operated on in the past,” Dr. Nora Volkow, director of the National Institute on Drug Abuse told reporters this week at the Society for Neuroscience meeting in Chicago.

Volkow said the agency intends to piggyback on the frenetic investment by drug companies in vaccine development, spurred by the need for new products and the runaway success of products like Merck’s Gardasil vaccine to prevent the virus that causes cervical cancer.

“There is an enormous amount of research and development in vaccines for cancers and a wide variety of disorders,” she said. “We can take advantage of those developments.”

But first Volkow has to tempt drug companies to develop the vaccines by funding costly clinical trials.

Earlier this month, her agency, part of the National Institutes of Health, awarded Nabi Biopharmaceuticals a $10 million grant — the agency’s largest ever — for a late-stage clinical trial of Nabi’s vaccine for nicotine addiction called NicVAX.

Volkow said she did her homework before backing the Nabi vaccine to ensure it was significantly different from other products. “Nonetheless, when you are investing in something at this level, it can be very risky,” she said.

The vaccine is meant to stimulate the immune system to make antibodies against nicotine, blocking its rewarding effects and helping to prevent relapse in smokers trying to quit.

TOUGH MARKET

A similar anti-smoking vaccine by Cytos Biotechnology and Swiss drugmaker Novartis last week missed its main goal in a midstage study, leading some analysts to question whether it can make it to market.

“They are still looking at it but it has been very problematic,” said Robert Wasserman, director of investment research at the investment banking firm Dawson James in Florida.

“Vaccines are really tough,” he said. “It’s not for the faint of heart.”

Still, if it works, a nicotine vaccine could have a huge impact, Volkow said. “It’s an international problem that kills 5 million individuals every year across the world,” she said.

The global market for smoking cessation is expected to reach $4.6 billion by 2016, and vaccines could account for $2 billion in sales, according to independent market research firm Datamonitor.

Volkow said the same methods for making a nicotine vaccine could be used for other illicit substances.

Her agency backed a study released this month of an anti-cocaine vaccine that helped block the high felt by 38 percent of addicts who took it.

The vaccine was developed by Dr. Thomas Kosten of Baylor College of Medicine in Houston, who used a similar approach to make a nicotine vaccine now being tested in Europe by private equity firm Celtic Pharma.

Volkow said drumming up drug company interest in vaccines for illicit drugs is a harder sell because of liability concerns, and the fact that drug abusers are stigmatized.

“Unfortunately, when it comes to treatments for drug addiction … most of the investment goes to the government,” she said.

Newborn babies shouldn’t be expected to sleep through the night. Their bodies are so tiny that they should be awakened if they haven’t eaten for at least five hours, the Nemours Foundation says.

But there are things that new parents can do to help ensure a safe night’s rest for their little one. The foundation offers these suggestions:
Put baby to sleep on his or her back to reduce the risk of sudden infant death syndrome (SIDS).
Don’t let baby sleep with plush bedding, blankets or pillows.
Remove stuffed animals from baby’s crib when it’s bedtime.
Each night, alternate which side of his or her head your baby sleeps on, to prevent development of a “flat spot” on a favored side of the head.

As if migraine sufferers didn’t already have enough pain, new research has found that they may also be more prone to hangover headaches.

U.S. researchers studied the effects of alcohol on a group of rats that experience recurrent migraines as well as a group of control rats that don’t get the headaches. The study authors found that the rats with migraines experienced more pain four to six hours after ingesting alcohol than the control rats.

“Our results suggest that dehydration or impurities in alcohol are not responsible for hangover headache,” Michael Oshinsky, an assistant professor of neurology at Jefferson Medical College of Thomas Jefferson University, and a member of the Jefferson Headache Center team, said in a university news release.

“Since these rats were sufficiently hydrated and the alcohol they received contained no impurities, the alcohol itself or a metabolite must be causing the hangover-like headache. These data confirm the clinical observation that people with migraine are more susceptible to alcohol-induced headaches,” Oshinsky added.