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Tamiflu limits flu effects in chronically ill kids

Tue, Aug 11, 2009

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Using oseltamivir, marketed as Tamiflu, early in the course of the flu reduces complications and hospitalizations in children and adolescents with chronic medical conditions such as asthma, according to a new study.

Using anonymous data from MarketsSan databases (Thomson Reuters, Cambridge, Massachusetts), Dr. Pedro A. Piedra from Baylor College of Medicine, Houston and colleagues studied 1634 children prescribed oseltamivir and 3721 who received no antiviral drugs. Chronic conditions among the children included chronic lung disease, asthma, diabetes, HIV infection, cancer and transplants.

In the 14 days following influenza diagnosis, children treated with oseltamivir had about a rate of breathing-related illnesses (other than pneumonia) about one-quarter less than that of those not treated with antiviral medication, the authors report. Among the 1634 children with flu, there were 324 cases of such illnesses in those treated with oseltamivir; there were 885 cases among the 3721 who did not receive the treatment.

The rate of ear infections and its complications was also about a third less, compared with children not treated with antiviral medication, the authors report. Among the 1634 children with flu, there were 46 cases of such illnesses in those treated with oseltamivir; there were 184 cases among the 3721 who did not receive the treatment.

Children treated with oseltamivir were only one third as likely to require hospitalization for any reason as children not treated with antiviral medication. There were a total of 58 hospitalizations among both groups.

The results were similar for the 30 days following the influenza diagnosis, the researchers note, but the risk reductions were somewhat smaller.

The study, Piedra told Reuters Health via email, will be helpful in determining the best uses of oseltamivir for flu strains including H1N1, also known as swine flu.

Piedra has been a consultant to Tamiflu manufacturer Roche, and to other companies, and one of his co-authors is a Roche employee.

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Health Tip: Staying Safe on the Playground

Mon, Aug 10, 2009

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Playgrounds are great sources of fun for children - as long as they’re safe.

The U.S. National Safety Council says parents should inspect playgrounds before their children use them for the following safety features:

  • A soft ground surface such as mulch, sand, wood chips, rubber mats or shredded tires, instead of concrete, grass or dirt.
  • Soft swing seats, and swings that are set apart from other playground equipment. Look for full-bucket seats rather than partial ones that children could slide out of.
  • Slides that are firmly anchored to the ground with sturdy handrails and traction on the stairs. A bar at the top of every slide should force children to sit down.
  • Seesaws that are spring-loaded, instead of adjustable seesaws with chains.
  • Climbing equipment that is well secured and has sturdy handrails and steps.
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Europe fast tracking swine flu vaccine

Sun, Jul 26, 2009

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LONDON – In a drive to inoculate people against swine flu before winter, many European governments say they will fast-track the testing of a vaccine, arousing concern among some experts about safety and proper doses.

The European Medicines Agency, the EU’s top drug regulatory body, is accelerating the approval process for swine flu vaccine, and countries such as Britain, Greece, France and Sweden say they’ll start using the vaccine after it’s greenlighted — possibly within weeks.

In an interview with The Associated Press, Dr. Keiji Fukuda, the World Health Organization’s flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe’s approach outright.

“One of the things which cannot be compromised is the safety of vaccines,” he said Friday. “There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”

Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

But European officials won’t know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.

“Everybody is doing the best they can in a situation which is far from ideal,” said Martin Harvey-Allchurch, a spokesman for the European Medicines Agency. “With the winter flu season approaching, we need to make sure the vaccine is available.”

In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, to ensure the immune system produces enough antibodies to fight the infection.

But to ensure swine flu vaccine is available as soon as possible, the European Medicines Agency is allowing companies to skip testing in large numbers of people before the vaccine is approved.

The main issue is probably that without thorough testing it’s difficult to gauge the effective dosage — meaning Europeans might get too weak a vaccine. It’s unlikely the vaccine would endanger anyone, but until it is used in large numbers of people, no one will know for sure.

Europeans appear ready to use the vaccine widely before conducting any big studies to prove it is safe and effective. Neither the vaccine makers nor the European Medicines Agency would specify what basic safety tests are being done.

The U.S. is taking a more cautious approach: the government called Wednesday for several thousand volunteers to be injected with the swine flu vaccine in tests beginning in August to assess the vaccine’s safety. American officials said results should be ready by the time the U.S. plans to roll out a vaccination campaign in October.

Results from the U.S. tests will be of limited use to Europe, since countries like Britain plan to start vaccinating as early as August — before any American trial data is available. The vaccines used in the U.S. will also be different from those in Europe.

Some experts favor urgent action.

“The consequences of not having a vaccine if this virus gets worse are very high,” said Leonard Marcus, a public health expert at Harvard University. “If (regulatory authorities) took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost.”

But critics say dangers lurk in any strategy to vaccinate without robust testing.

Scant information exists on flu vaccines with adjuvants, a component used to stretch the active ingredient that is commonly found in European flu vaccines. There are no licensed flu vaccines with the ingredient in the U.S.

There is also limited or no data on the safety and effectiveness of vaccines with adjuvants in children under 3 and pregnant women — two of the most vulnerable groups in a pandemic — a global outbreak.

Mass swine flu vaccination campaigns will also take place in the shadow of the 1976 swine flu disaster, when hundreds of people in the U.S. developed Guillain-Barre syndrome, a paralyzing disorder, after being vaccinated.

Experts don’t know why that happened, but say modern vaccine production techniques have improved since 1976. To avoid a similar episode, some say comprehensive testing before the vaccine is rolled out is essential.

“I can’t see any possible excuse to not test it for safety before it’s given to anyone,” said George Annas, a bioethics expert at Boston University.

If the vaccine turns out to have dangerous side effects, it could generate a public backlash, particularly in a country like Britain, where many people remain suspicious of vaccines because of unsubstantiated allegations linking the measles, mumps and rubella vaccine to autism. That could lead to millions of people refusing vaccination.

When the bird flu crisis hit several years ago, the European Medicines Agency designed a special protocol to approve a vaccine for use in a pandemic as soon as possible.

The agency let companies submit data for a “mock-up” vaccine, using H5N1 bird flu. The idea was to do most of the testing before the global epidemic hit so when it did, drugmakers could insert the pandemic virus into the vaccine at the last minute.

When the first swine flu vaccine doses are ready, the European Medicines Agency will approve them largely based on data from the bird flu vaccine, since both will have the same basic ingredients.

If the agency thinks the bird flu data predicts how the swine flu virus will work, they will approve it, said spokesman Harvey-Allchurch.

The agency will then require regular reporting of the vaccine’s effects as it is being administered — monitoring that is normally done beforehand.

WHO’s Fukuda said everyone involved in making the vaccine, from manufacturers to regulatory agencies, is looking at what steps can be taken to streamline the process.

“But there is no one who disagrees that one of the absolutes is that there can’t be any question whether the vaccine is safe or not,” he said.

WHO reported that the swine flu viruses aren’t producing enough of a key vaccine ingredient, which may limit how much vaccine is available. Its laboratory network is now working to produce a new set of viruses that it hopes will work better.

Drugmakers including Baxter International, GlaxoSmithKline PLC, Novartis and Sanofi-Pasteur, however, insist they will be able to start shipping the first batches of vaccine soon.

British health officials have repeatedly said they will start vaccinating in August, as soon as the vaccine is approved. Other European countries, including Greece, France, Sweden, say they will use the vaccine after it gets the green light from the European agency, but none other than Britain expect to start the shots next month.

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Depression Poses Pregnancy Risks

Sun, Jul 19, 2009

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SUNDAY, July 19 (HealthDay News) — Thanks to high-profile celebrities like Brooke Shields, postpartum depression is out of the closet and discussed as something to recognize and treat.

But less well known is depression during pregnancy — a common problem as well, and one that also can be risky for the unborn baby, experts now know.

A depressed woman, for instance, is more likely to give birth early, increasing health risks for the baby.

Depression during pregnancy is more common than most people believe, agree Dr. De-Kun Li, a reproductive perinatal epidemiologist in the research division at Kaiser Permanente in Oakland, Calif., and Dr. Diana Dell, a psychiatrist and obstetrician-gynecologist at Duke University Medical Center in Durham, N.C.

One or two of every 10 pregnant women have symptoms of major depression, according to the March of Dimes. Those who have had a bout of depression before are more likely to get it again. And Li said that others might have depressive symptoms — short of clinical depression but still bothersome and unhealthy.

In his recent study of 791 pregnant women, Li found that 44 percent had depressive symptoms, about half of them severe, during pregnancy. “It wasn’t necessarily clinical depression,” he said, but a mood noticeably low.

Li tracked the women through delivery and found that those with depressive symptoms had nearly twice the risk of delivering a baby early, before 37 weeks.

Early delivery, by itself, is associated with health risks, he said. “Premature delivery is the No. 1 cause of infant mortality,” he said. His findings were published in the January 2009 issue of Human Reproduction.

“We don’t know the mechanism” of why depression and early delivery are linked, Li said. But what’s certain is that “depression is not a benign condition,” he said. “It can be harmful to your baby.”

What about antidepressant use during pregnancy?

“What I tell patients who see me in consultation [for depression] is that moms need to be well in pregnancy,” Dell said.

That may or may not mean taking antidepressants, she said. There have been no head-to-head comparisons of antidepressants during pregnancy to determine which are safest, she said, making it difficult to know, if medication is needed, which to choose.

In 2008, the American College of Obstetricians and Gynecologists updated its bulletin, “Use of Psychiatric Medications During Pregnancy and Lactation.” In it, the group notes that more than 500,000 pregnancies in the United States each year involve women who have psychiatric illnesses — depression, but other illnesses as well — that occurred before the pregnancy or emerge with it.

In the bulletin, the college experts offer a number of recommendations, including the suggestion that pregnant women avoid the antidepressant paroxetine (Paxil). In 2005, the U.S. Food and Drug Administration issued a warning about Paxil based on studies that found that it might increase the risk of birth defects.

Other reports have found that babies born to women who are taking a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor) could have breathing or feeding problems, according to the March of Dimes.

The bulletin recommends that treatment with antidepressants be individualized.

Antidepressants, though, aren’t the only option to treat depression during pregnancy, Dell said. Other options include talk or cognitive therapy. Some women might find help through a support group, according to the March of Dimes. And, if a woman has the type of depression known as seasonal affective disorder, which returns in the fall and winter when less light is available, light therapy might help, according to the March of Dimes.

What is crucially important, Li and Dell agree, is for a woman who is pregnant and thinks she is depressed to alert her physician. Together, they can weigh the pros and cons of treatment and decide what would be best for her and the baby.

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Statins Might Stave Off Alzheimer’s

Wed, Jul 1, 2009

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TUESDAY, June 30 (HealthDay News) — Treatment with a cholesterol-lowering drug might protect against Alzheimer’s disease, new research suggests.

Scientists have long known that nerve cells in people with Alzheimer’s die prematurely because they are strongly overstimulated, a process called excitotoxicity.

Theorizing that the cholesterol drug lovastatin might ward off cell death, researchers at the University of Groningen, The Netherlands, conducted animal experiments in which they administered lovastatin (Altoprev, Mevacor) to overstimulated nerve cells. Lovastatin is a first-generation member of a class of drugs, statins, that has revolutionized the treatment of high cholesterol.

Lovastatin did indeed prevent cell death and, just as important, blocked the loss of memory that accompanies excitotoxicity, according to the lead scientist on the project, Amalia Dolga. Earlier, Dolga had shown that statins seem to stimulate the protective capacity of tumor necrosis factor, a key player in the brain’s immune response. In addition, some researchers have speculated that high cholesterol might be a risk factor for Alzheimer’s, suggesting that lowering cholesterol could be beneficial.

The findings are in the June issue of the Journal of Alzheimer’s Disease.

Alzheimer’s disease affects more than 5 million people in the United States. The degenerative disease attacks brain cells and ruins memory and thinking. It is the leading cause of dementia and the seventh-leading cause of death in the United States, according to the Alzheimer’s Association.

No cure has been found, but treatments have been shown to improve a person’s quality of life.

More information

The Alzheimer’s Association has more on Alzheimer’s disease.

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