FDA relents from midodrine withdrawal plan

NEW YORK – Federal regulators have backed off a plan to remove a Shire PLC low blood-pressure treatment from the market after warning in August that the drug has not been proven effective.
Food and Drug Administration representative Sandy Walsh said in an emailed statement that the agency will continue to allow access to ProAmatine, also known as midodrine, "while the necessary data is collected and the legal issues get sorted out."
Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.
Last month, the FDA proposed withdrawing the drug from the market and giving Shire, which is based in Ireland, an opportunity to schedule a hearing to discuss the matter. It had approved ProAmatine in 1996 based on promising early results in treating low blood pressure. But a mandatory follow-up study to actually prove the long-term benefits of the drug was never conducted.
Shire acquired the drug when it bought Roberts Pharmaceuticals in 2000. Shire spokeswoman Jessica Mann said the drugmaker did conduct follow-up trials and submitted data in 2005 that it believes showed its effectiveness. The company plans to continue to work with the FDA.
Shire had said it was planning to withdraw the drug from the market by Sept. 30. But the company no longer intends to do so.
"It's our goal to do what we can to ensure that this treatment is still available to patients," Mann said.
The FDA's letter marked the first time it threatened to pull a drug off the market due to missing follow-up data, though it has long held that power. FDA spokeswoman Sandy Walsh said in an e-mail the issue "continues to evolve," and that it will know more in the coming weeks.
Copies of the letter also were sent to five generic drugmakers who make the drug, including Mylan Inc. and Novartis AG unit Sandoz Inc. The generic versions would also be subject to a market withdrawal, unless their manufacturers complete the study requested by the FDA.

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WHO wants faster, more flu vaccine production

HONG KONG – The vaccine used to contain the recent swine flu pandemic was effective, but health authorities will need to ramp up the speed and volume of production during the next global outbreak, a World Health Organization official said Monday.
The WHO declared last month that the swine flu pandemic that started in June 2009 was over, after it killed about 18,600 people worldwide, far less than the worse-case scenarios in which authorities said millions could die.
The widespread use of vaccines was critical in limiting the number of casualties, with studies showing they offered protection in up to 95 percent of cases, WHO official David Wood said at a news conference on the sidelines of an influenza conference in Hong Kong.
Some 350 million doses of the vaccine were administered worldwide, according to WHO figures.
"That gives us considerable hope for the future, for the future pandemics, that the technologies that we have to actually make the vaccines are" effective, said Wood, the quality and safety team co-ordinator for the WHO's immunization and vaccines department.
But while vaccines became available six months after the H1N1 virus strain behind the pandemic was identified in April 2009, that was still too late for some countries, he said. In the case of the U.S., vaccination started on Oct. 5, 2009 — weeks after a second wave of cases hit as schools resumed, U.S. Centers for Disease Control and Prevention flu expert Nancy Cox told reporters.
The WHO is studying ways to make vaccines more quickly, Wood said without offering specifics, adding that technological breakthroughs will also speed up the process.
"In the short term, we'll be able to make some gains of weeks that Nancy was talking about that can make all the difference. In the longer term, we may even have these new technologies that shorten our lag more significantly, so I'm quite optimistic," Wood said.
The WHO official also said the global healthy body is working on increasing global production capacity beyond the centers of Europe, America and China, targeting countries like India, Indonesia, Thailand, Brazil and Mexico.
The WHO was accused by some of hyping the pandemic, prompting excessive buying of vaccines and antiviral drugs that enriched drug companies. Asked about such accusations, Wood said the organization only advised countries to vaccinate high-risk groups, like health care workers and pregnant women.
"I believe that the recommendations that came from the organization were proportionate to the risks that we had at the time," he said.

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Expert warns of complacency after swine flu fizzle

HONG KONG – A leading virus expert urged health authorities around the world Sunday to stay vigilant even though the recent swine flu pandemic was less deadly than expected, warning that bird flu could spark the next global outbreak.
A World Health Organization official also defended the U.N.'s health body against accusations that it wasted governments' money and enriched pharmaceutical companies with its strong warnings during the swine flu outbreak's early days last year.
WHO declared the swine flu pandemic over last month. The latest death toll is just over 18,600 — far below the millions that were once predicted. The head of the global health body has credited good preparation and luck, since the H1N1 swine flu virus didn't mutate as some had feared.
But speaking to reporters on the sidelines of an influenza conference in Hong Kong, researcher Robert Webster warned against complacency.
"We may think we can relax and influenza is no longer a problem. I want to assure you that that is not the case," said Webster, chairman of the virology and molecular biology department at St. Jude Children's Research Hospital in Memphis, Tennessee.
Webster predicted that the next pandemic could be sparked by a virus that spreads from water fowl to pigs and then onto humans — such as the H5N1 strain of bird flu, which has killed 300 people over the past seven years. He noted that after several years of decline, the number of bird flu cases in humans increased in 2009, lifted by an uptick of cases in Egypt.
"H5N1 can kill 61 percent of humans infected, but it doesn't know how to spread from human to human. But don't trust it because it could acquire that capacity. So we must stay vigilant," he said.
Sylvie Briand, head of WHO's global influenza program, said its surveillance has shown that the bird flu strain isn't capable now of jumping between humans except in rare cases of close personal contact, but echoing Webster, warned: "These are viruses that are evolving. They are changing all the time."
Both experts said it was difficult to predict when — or if — bird flu might set off a new pandemic.
"We don't understand enough about the virus to make predictions," Webster said.
University of Hong Kong microbiologist Malik Peiris said scientists are closely monitoring mutations by influenza viruses — including bird flu viruses — but it's hard to determine which mutations are most likely to spread among humans.
Briand also defended WHO against accusations that it hyped the swine flu pandemic, saying it was acting with limited information when the virus first surfaced and adjusted its response when it became clear the outbreak wasn't as serious as expected.
WHO received at least $170 million from member states to deal with the outbreak, some of which was invested in immunization programs long after the virus strain was known to provoke only mild illness in most of those infected. Governments spent many times that amount buying vaccines and antiviral medicines that are now being junked.
European legislators have repeatedly accused WHO of overstating the danger of swine flu and playing into the hands of the pharmaceutical industry, which has earned millions from the outbreak since it began in April 2009.
"We prepared for the worst and hoped for the best. And as the information became available, there was adaptation of the plan and adaptation of the recommendations in order to really tailor the response to the reality," Briand said. "But it took some time."

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Cholera kills 41 in Central African nation of Chad

N'DJAMENA, Chad – Health officials in Chad say an outbreak of cholera in the Central African nation has killed at least 41 people.
Mahamat Mamadou Adji said Friday that there have been nearly 600 confirmed cases of the fast-moving infection that causes diarrhea in victims, leading to severe dehydration.
The outbreak in Chad come as officials in the neighboring countries of Nigeria and Cameroon also have expressed concern about cholera deaths.
In Nigeria, health officials say more than 350 people have been killed in only three months.
Cholera is highly contagious yet easily preventable with clean water and sanitation. But Nigerian health officials say in many areas, wells remain uncovered, allowing tainted water to flow into the communities' drinking water supplies.

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Lack of Sleep May Be Linked to Childhood Obesity

MONDAY, Sept. 6 (HealthDay News) -- Infants and preschoolers who don't get enough sleep at night are at increased risk for later childhood obesity, a new study suggests.
The researchers also found that daytime naps are not an adequate substitute for lost nighttime sleep in terms of preventing obesity.
The study included 1,930 U.S. children, ages 1 month to 13 years, who were divided into two groups -- younger (ages 1 month to 59 months) and older (ages 5 to 13 years). Data on the children was collected at the start of the study (baseline) in 1997 and again in 2002 (follow-up).
At the follow-up, 33 percent of the younger children and 36 percent of the older children were overweight or obese. Among the younger children, lack of sufficient nighttime sleep at baseline was associated with increased risk for later overweight or obesity.
Among the older children, the amount of sleep at baseline was not associated with weight at follow-up. However, a lack of nighttime sleep at follow-up was associated with increased risk of a shift from normal weight to overweight and from overweight to obesity, the study found.
The findings "suggest that there is a critical window prior to age 5 years when nighttime sleep may be important for subsequent obesity status," wrote Janice F. Bell of the University of Washington in Seattle, and Frederick J. Zimmerman of the University of California, Los Angeles.
"Sleep duration is a modifiable risk factor with potentially important implications for obesity prevention and treatment," the authors concluded. "Insufficient nighttime sleep among infants and preschool-aged children appears to be a lasting risk factor for subsequent obesity, while contemporaneous sleep appears to be important to weight status in adolescents. Napping had no effects on the development of obesity and is not a substitute for sufficient nighttime sleep," they added.
The study is published in the September issue of the journal Archives of Pediatrics & Adolescent Medicine.
More information
The Nemours Foundation has more about children and sleep.

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Keep Health in Mind When Planning School Day Menus

MONDAY, Sept. 6 (HealthDay News) -- As parents prepare for their children's return to school, they need to remember that healthy meals and snacks are essential for learning.
"Parents can make the school day easier for their children by providing nutritious and yummy breakfasts, lunches and snacks that promote optimal learning. Everyone is in a rush in the morning, but it only takes a few minutes on Sunday to plan healthy meals to fuel your child's week," Karin Richards, director of the Exercise Science and Wellness Management program, and director of Health Sciences at the University of the Sciences in Philadelphia, said in a university news release.
Richards offered the following advice for parents as they plan breakfast, lunch and snacks for their school-age children:
Include at least three types of foods into each meal, making sure to include some type of protein and complex carbohydrates, such as whole wheat bagels or pasta. The complex carbohydrates will provide energy while the protein will satisfy your child's appetite for a longer period of time.
Bring your child to the market with you and let him or her choose one fruit or vegetable each week. Encourage kids to try new and interesting produce such as kiwi, papaya and edamame.
Monitor portion size. Three to four ounces of meat (about the size of your palm) is plenty. Adjust the amount based on your child's age and activity level.
Add more vegetables into your child's diet, even if you have to sneak them in. For example, try zucchini bread, veggies with low-fat dip, or shred carrots into tomato sauce and soups.
For beverages, suggest low-fat milk or water. If you child prefers juice, make sure it's 100 percent juice.
More information
The Nemours Foundation has more about children and healthy eating.

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