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Wednesday, October 5, 2011
Thursday, July 14, 2011
Anxiety, Depression in Pregnancy May Raise Kids' Asthma Risk
FRIDAY, July 8 (HealthDay News) -- Children of women who experience anxiety and depression during pregnancy may be at greater risk for asthma, according to new research.
The study of 279 inner-city black and Hispanic women adds weight to research previously conducted among white families that found children are particularly susceptible to asthma-related risks during the prenatal period.
The findings are published in the July issue of Annals of Allergy, Asthma & Immunology.
"Approximately 70 percent of mothers who said they experienced high levels of anxiety or depression while they were pregnant reported their child had wheezed before age 5," study lead author Marilyn Reyes, a researcher at the Columbia Center for Children's Environmental Health in New York City, said in a news release from the American College of Allergy, Asthma and Immunology.
"Understanding how maternal depression affects a child's respiratory health is important in developing effective interventions," Reyes added.
The research team said common asthma symptoms include:
The study of 279 inner-city black and Hispanic women adds weight to research previously conducted among white families that found children are particularly susceptible to asthma-related risks during the prenatal period.
The findings are published in the July issue of Annals of Allergy, Asthma & Immunology.
"Approximately 70 percent of mothers who said they experienced high levels of anxiety or depression while they were pregnant reported their child had wheezed before age 5," study lead author Marilyn Reyes, a researcher at the Columbia Center for Children's Environmental Health in New York City, said in a news release from the American College of Allergy, Asthma and Immunology.
"Understanding how maternal depression affects a child's respiratory health is important in developing effective interventions," Reyes added.
The research team said common asthma symptoms include:
- Coughing, particularly during the night
- Wheezing or whistling while breathing
- Difficulty breathing that causes the skin around the ribs or neck to sink in
- Frequent chest colds
The study authors noted that children who experience any of these symptoms on a regular basis could have asthma and should see an allergist.
"The symptoms of pediatric asthma can range from a nagging cough that lingers for days or weeks to sudden and scary breathing emergencies," allergist Dr. Rachel Miller, study senior author, said in the news release. "With the right treatment, your child can sleep through the night, avoid missing time from day care or preschool, and breathe easy."
"The symptoms of pediatric asthma can range from a nagging cough that lingers for days or weeks to sudden and scary breathing emergencies," allergist Dr. Rachel Miller, study senior author, said in the news release. "With the right treatment, your child can sleep through the night, avoid missing time from day care or preschool, and breathe easy."
Friday, June 3, 2011
Cell Phones Might Cause Brain Cancer
May 31, 2011 -- The expert panel that evaluates cancer risks today said that cell phones might possibly cause brain cancer.
The announcement comes from the International Agency for Research on Cancer (IARC). Like the World Health Organization, the American Cancer Society relies on IARC for evaluation of cancer risks.
"After reviewing all the evidence available, the IARC working group classified radiofrequency electromagnetic fields as possibly carcinogenic to humans," panel chairman Jonathan Samet, MD, chair of preventive medicine at the USC Keck School of Medicine, said at a news teleconference. "We reached this conclusion based on a review of human evidence showing increased risk of glioma, a malignant type of brain cancer, in association with wireless phone use."
In finding cell phones to be "possibly carcinogenic," the IARC means that heavy cell phone use might -- or might not -- cause a specific form of brain cancer called glioma. The finding means that research is urgently needed to find out whether cell phones actually cause cancer, and how they might do it.
The IARC estimates that some 5 billion people worldwide have mobile phones. Lifetime exposure to the magnetic fields created by the phones -- particularly when they are held tightly against the head -- rapidly is increasing.
Children are at particular risk, not only because their skulls are thinner but also because their lifetime exposure to cell phones likely will be greater than the exposure of current adults.
The announcement comes from the International Agency for Research on Cancer (IARC). Like the World Health Organization, the American Cancer Society relies on IARC for evaluation of cancer risks.
"After reviewing all the evidence available, the IARC working group classified radiofrequency electromagnetic fields as possibly carcinogenic to humans," panel chairman Jonathan Samet, MD, chair of preventive medicine at the USC Keck School of Medicine, said at a news teleconference. "We reached this conclusion based on a review of human evidence showing increased risk of glioma, a malignant type of brain cancer, in association with wireless phone use."
In finding cell phones to be "possibly carcinogenic," the IARC means that heavy cell phone use might -- or might not -- cause a specific form of brain cancer called glioma. The finding means that research is urgently needed to find out whether cell phones actually cause cancer, and how they might do it.
The IARC estimates that some 5 billion people worldwide have mobile phones. Lifetime exposure to the magnetic fields created by the phones -- particularly when they are held tightly against the head -- rapidly is increasing.
Children are at particular risk, not only because their skulls are thinner but also because their lifetime exposure to cell phones likely will be greater than the exposure of current adults.
Putting Possible Cancer Risk in Perspective
It's important to put the possible risk into context. Kurt Straif, MD, PhD, MPH, head of the IARC Monographs Program, notes that the IARC currently lists some 240 agents as "possibly carcinogenic," including dry cleaning fluid and some commonly used pesticides.
While the IARC doesn't make recommendations to consumers, Straif noted that there are precautions people can take.
"Some of the highest exposures come from using mobile phones for voice calls. If you text, or use hands-free devices, you lower exposure by at least [10-fold]," Straif said at the news conference. "So this is left to consumers to consider whether this level of evidence is enough for them to take such precautions."
Otis W. Brawley, MD, chief medical officer for the American Cancer Society, notes that the IARC is a highly credible group. But Brawley echoes Straif's advice: People who are worried can reduce their risk.
"On the other hand, if someone is of the opinion that the absence of strong scientific evidence on the harms of cell phone use is reassuring, they may take different actions, and it would be hard to criticize that," Brawley says in a news release.
John Walls, vice president for public affairs at CTIA, the trade group representing the wireless communications industry, notes that the IARC findings do not mean cell phones cause cancer -- and that the limited evidence on which the findings are based are far from conclusive.
"Based on previous assessments of the scientific evidence, the Federal Communications Commission has concluded that '[t]here's no scientific evidence that proves that wireless phone usage can lead to cancer.' The Food and Drug Administration has also stated that '[t]he weight of scientific evidence has not linked cell phones with any health problems,'" Walls notes in a news release.
Samet and colleagues will publish a summary of their findings in the July 1 issue of The Lancet, which is still in press.
SOURCES: IARC, news teleconference, May 31, 2011American Cancer Society, news release.News release, CTIA-The Wireless Association.International Agency for Research on Cancer web site.News release, International Agency for Research on Cancer.Jonathan Samet, MD, chair of preventive medicine, USC Keck School of Medicine.Kurt Straif, MD, PhD, MPH, head, International Agency for Research on Cancer Monographs Program. ©2011 WebMD, LLC. All Rights Reserved.
It's important to put the possible risk into context. Kurt Straif, MD, PhD, MPH, head of the IARC Monographs Program, notes that the IARC currently lists some 240 agents as "possibly carcinogenic," including dry cleaning fluid and some commonly used pesticides.
While the IARC doesn't make recommendations to consumers, Straif noted that there are precautions people can take.
"Some of the highest exposures come from using mobile phones for voice calls. If you text, or use hands-free devices, you lower exposure by at least [10-fold]," Straif said at the news conference. "So this is left to consumers to consider whether this level of evidence is enough for them to take such precautions."
Otis W. Brawley, MD, chief medical officer for the American Cancer Society, notes that the IARC is a highly credible group. But Brawley echoes Straif's advice: People who are worried can reduce their risk.
"On the other hand, if someone is of the opinion that the absence of strong scientific evidence on the harms of cell phone use is reassuring, they may take different actions, and it would be hard to criticize that," Brawley says in a news release.
John Walls, vice president for public affairs at CTIA, the trade group representing the wireless communications industry, notes that the IARC findings do not mean cell phones cause cancer -- and that the limited evidence on which the findings are based are far from conclusive.
"Based on previous assessments of the scientific evidence, the Federal Communications Commission has concluded that '[t]here's no scientific evidence that proves that wireless phone usage can lead to cancer.' The Food and Drug Administration has also stated that '[t]he weight of scientific evidence has not linked cell phones with any health problems,'" Walls notes in a news release.
Samet and colleagues will publish a summary of their findings in the July 1 issue of The Lancet, which is still in press.
SOURCES: IARC, news teleconference, May 31, 2011American Cancer Society, news release.News release, CTIA-The Wireless Association.International Agency for Research on Cancer web site.News release, International Agency for Research on Cancer.Jonathan Samet, MD, chair of preventive medicine, USC Keck School of Medicine.Kurt Straif, MD, PhD, MPH, head, International Agency for Research on Cancer Monographs Program. ©2011 WebMD, LLC. All Rights Reserved.
Eating Meat May Raise Colon Cancer Risk
Study Suggests Eating Less Red Meat and Processed Meat May Cut Chances of Getting Colon Cancer.
May 23, 2011 -- Red meat and processed meat may increase the risk of developing colon cancer, according to a new report from the American Institute for Cancer Research (AICR) and the World Cancer Research Fund.
The report, which builds on the two groups' 2007 Continuous Update Project, points to solid evidence that eating less red meat and avoiding processed meat altogether can slash colon cancer risk.
When this advice is combined with other diet and lifestyle changes -- such as consuming less alcohol, boosting fiber intake, exercising, and maintaining a healthy body weight -- it could prevent 45% of all colon cancer cases, or more than 64,000 cases of colon cancer each year, the report states.
Colorectal cancer is the third most common type of cancer diagnosed in the U.S., excluding skin cancers, according to the American Cancer Society.
"The good news is that we have some control over our colon cancer risk," says Elisa Bandera, MD, PhD, an associate professor of epidemiology, Cancer Institute of New Jersey, New Brunswick. Bandera was a member of the expert panel that analyzed all of the available literature on colon cancer risk, diet, exercise, and weight.
Eating less than 18 ounces per week of red meat, such as beef, lamb, or pork, shows very little increase in colon cancer risk, the report states.
People who eat 3.5 ounces or red meat every day (24.5 ounces per week) will have a 17% increased risk of colon cancer compared to someone who eats no red meat, according to the report. People who eat 7 ounces per day (49 ounces per week) will have a 34% increased risk.
People who eat 3.5 ounces of processed meat a day will have a 36% increased risk of developing colon cancer compared with people who avoid all processed meat, according to the report. The more processed meat eaten, the higher your risk for developing colorectal cancer.
The report, which builds on the two groups' 2007 Continuous Update Project, points to solid evidence that eating less red meat and avoiding processed meat altogether can slash colon cancer risk.
When this advice is combined with other diet and lifestyle changes -- such as consuming less alcohol, boosting fiber intake, exercising, and maintaining a healthy body weight -- it could prevent 45% of all colon cancer cases, or more than 64,000 cases of colon cancer each year, the report states.
Colorectal cancer is the third most common type of cancer diagnosed in the U.S., excluding skin cancers, according to the American Cancer Society.
"The good news is that we have some control over our colon cancer risk," says Elisa Bandera, MD, PhD, an associate professor of epidemiology, Cancer Institute of New Jersey, New Brunswick. Bandera was a member of the expert panel that analyzed all of the available literature on colon cancer risk, diet, exercise, and weight.
Eating less than 18 ounces per week of red meat, such as beef, lamb, or pork, shows very little increase in colon cancer risk, the report states.
People who eat 3.5 ounces or red meat every day (24.5 ounces per week) will have a 17% increased risk of colon cancer compared to someone who eats no red meat, according to the report. People who eat 7 ounces per day (49 ounces per week) will have a 34% increased risk.
People who eat 3.5 ounces of processed meat a day will have a 36% increased risk of developing colon cancer compared with people who avoid all processed meat, according to the report. The more processed meat eaten, the higher your risk for developing colorectal cancer.
Why Meat May Raise Colon Cancer Risk
Exactly how red and/or processed meat increases risk for colon cancer isn't clear, but there are several theories. Some research suggests that chemicals called heterocyclicamines,which are produced when meat is cooked at high temperature, may play a role. Processed meats are made by smoking, curing, salting, and or adding preservatives such as nitrates. The body converts nitrates into nitrosamines, which are known to increase risk of cancer.
"It appears that red meat -- and maybe processed meat even more -- has some relationship with colon cancer risk," says panel member Steven H Zeisel, MD, PhD, theKenan Distinguished Professor of nutrition and pediatrics at the University of North Carolina, Chapel Hill.
"A betting person would say there is risk associated with the consumption of red meat and processed meat," he says. "Moderating the amount of red meat you take in is reasonable based on this data. And trying to cut back and substitute other types of meat or vegetables would be a good idea for someone who wants to reduce risk of colon cancer."
Exactly how red and/or processed meat increases risk for colon cancer isn't clear, but there are several theories. Some research suggests that chemicals called heterocyclicamines,which are produced when meat is cooked at high temperature, may play a role. Processed meats are made by smoking, curing, salting, and or adding preservatives such as nitrates. The body converts nitrates into nitrosamines, which are known to increase risk of cancer.
"It appears that red meat -- and maybe processed meat even more -- has some relationship with colon cancer risk," says panel member Steven H Zeisel, MD, PhD, theKenan Distinguished Professor of nutrition and pediatrics at the University of North Carolina, Chapel Hill.
"A betting person would say there is risk associated with the consumption of red meat and processed meat," he says. "Moderating the amount of red meat you take in is reasonable based on this data. And trying to cut back and substitute other types of meat or vegetables would be a good idea for someone who wants to reduce risk of colon cancer."
Diet and Lifestyle Changes
Drinking alcohol may increase colon cancer risk, according to the report. The report also states that excess belly fat may raise colorectal cancer risk, but staying lean, eating more fiber, and engaging in regular physical activity can help lower this risk.
"If you limit consumption of red meat, you have more room on your plate for good things like whole grains and vegetables," Bandera says. Some simple substitutes can help. "Choosing brown rice instead of white rice is a good way of increasing fiber."
Alice Bender, MS, RD, of the AICR, says the new report is especially important to people with a family history of colorectal cancer.
"If you have family history, it's more important than ever to follow these guidelines because they offer potentially some extra protection," she says.
Drinking alcohol may increase colon cancer risk, according to the report. The report also states that excess belly fat may raise colorectal cancer risk, but staying lean, eating more fiber, and engaging in regular physical activity can help lower this risk.
"If you limit consumption of red meat, you have more room on your plate for good things like whole grains and vegetables," Bandera says. Some simple substitutes can help. "Choosing brown rice instead of white rice is a good way of increasing fiber."
Alice Bender, MS, RD, of the AICR, says the new report is especially important to people with a family history of colorectal cancer.
"If you have family history, it's more important than ever to follow these guidelines because they offer potentially some extra protection," she says.
National Cattlemen's Beef Association Weighs In
"Americans should continue to build healthier diets with beef, knowing the scientific evidence to support the role of nutrient-rich, lean beef in a healthy, balanced diet is strong," says Shalene McNeill, PhD, RD, executive director of Human Nutrition Research at the National Cattlemen's Beef Association.
"Nothing in this update should change the way Americans consume beef," she says. " In fact, Americans are consuming beef well within WCRF's [World Cancer Research Fund] 500 gram (18 ounces) per week recommendation. As a scientist, registered dietitian, and a mother, I will continue to recommend lean beef to Americans trying to build a healthier plate because of the unique package of nutrients and enjoyment it brings to a healthy diet."
SOURCES: Elisa Bandera, MD, PhD, associate professor, epidemiology, Cancer Institute of New Jersey, New Brunswick.Steven H Zeisel, MD, PhD, Kenan Distinguished Professor ofnutrition and pediatrics, University of North Carolina, Chapel Hill.Alice Bender, MS, RD, American Institute for Cancer Research, Washington, D.C.World Cancer Research Fund/American Institute for Cancer Research: "Continuous Update Project Report," May 23, 2011.Shalene McNeill, PhD, RD, executive director of Human Nutrition Research, National Cattlemen's Beef Association. ©2011 WebMD, LLC. All Rights Reserved.
"Americans should continue to build healthier diets with beef, knowing the scientific evidence to support the role of nutrient-rich, lean beef in a healthy, balanced diet is strong," says Shalene McNeill, PhD, RD, executive director of Human Nutrition Research at the National Cattlemen's Beef Association.
"Nothing in this update should change the way Americans consume beef," she says. " In fact, Americans are consuming beef well within WCRF's [World Cancer Research Fund] 500 gram (18 ounces) per week recommendation. As a scientist, registered dietitian, and a mother, I will continue to recommend lean beef to Americans trying to build a healthier plate because of the unique package of nutrients and enjoyment it brings to a healthy diet."
SOURCES: Elisa Bandera, MD, PhD, associate professor, epidemiology, Cancer Institute of New Jersey, New Brunswick.Steven H Zeisel, MD, PhD, Kenan Distinguished Professor ofnutrition and pediatrics, University of North Carolina, Chapel Hill.Alice Bender, MS, RD, American Institute for Cancer Research, Washington, D.C.World Cancer Research Fund/American Institute for Cancer Research: "Continuous Update Project Report," May 23, 2011.Shalene McNeill, PhD, RD, executive director of Human Nutrition Research, National Cattlemen's Beef Association. ©2011 WebMD, LLC. All Rights Reserved.
Monday, January 10, 2011
Infant Organ Donors Could Help Meet Transplant Needs
The organs of about 8% of infants who suffer cardiac death in newborn intensive care units (NICUs) would be eligible for donation and could help save the lives of other infants and young children, according to a new study.
Children younger than 1 year old account for about 100 of the more than 200,000 people in the United States on an organ transplant waiting list. But currently, infants and young children who need an organ transplant can only receive an organ from an older child or part of an adult organ.
In addition to the challenge of fitting a larger organ into an infant's body, demand for adult organs exceeds supply, noted Dr. Richard Parad, a neonatologist in the newborn medicine department at Brigham and Women's Hospital (BWH), and his colleagues at Children's Hospital Boston and Beth Israel Deaconess Medical Center.
"A key motivation behind this study was our inability to act, under current guidelines, on the direct requests from parents faced with the loss of their newborn who turned to us wanting their child to be an organ donor," Parad said in a BWH news release.
These parents want some good to come from their tragic loss, he added.
In this study, the researchers analyzed 192 deaths that occurred in the NICUs of three academic medical centers between 2005 and 2007. Eligibility for organ donation was based on criteria developed with transplantation surgeons and the New England Organ Bank.
Of the 192 infants who died, 14 livers, 18 kidneys and 10 hearts may have been eligible for donation, the researchers concluded.
The researchers said their main objective was to provide data regarding the availability of infant donors. "Further investigation into this potential falls to those in the fields of transplant medicine and ethics. We feel we owe it to the families who request organ donation to be part of the conversation by investigating the size of the potential donor population," study co-author Dr. Anne Hansen, of Children's Hospital Boston, said in the news release.
In addition to the challenge of fitting a larger organ into an infant's body, demand for adult organs exceeds supply, noted Dr. Richard Parad, a neonatologist in the newborn medicine department at Brigham and Women's Hospital (BWH), and his colleagues at Children's Hospital Boston and Beth Israel Deaconess Medical Center.
"A key motivation behind this study was our inability to act, under current guidelines, on the direct requests from parents faced with the loss of their newborn who turned to us wanting their child to be an organ donor," Parad said in a BWH news release.
These parents want some good to come from their tragic loss, he added.
In this study, the researchers analyzed 192 deaths that occurred in the NICUs of three academic medical centers between 2005 and 2007. Eligibility for organ donation was based on criteria developed with transplantation surgeons and the New England Organ Bank.
Of the 192 infants who died, 14 livers, 18 kidneys and 10 hearts may have been eligible for donation, the researchers concluded.
The researchers said their main objective was to provide data regarding the availability of infant donors. "Further investigation into this potential falls to those in the fields of transplant medicine and ethics. We feel we owe it to the families who request organ donation to be part of the conversation by investigating the size of the potential donor population," study co-author Dr. Anne Hansen, of Children's Hospital Boston, said in the news release.
Monday, November 29, 2010
Paracetamol links to allergy/asthma in young children, study suggests
Links between early paracetamol use and the development of allergies and asthma in five and six year old children have been confirmed by health researchers at the University of Otago, Wellington.
The report by Professor Julian Crane is based on the New Zealand Asthma and Allergy Cohort Study. It investigated the use of paracetamol by 505 infants in Christchurch, and 914 five and six year olds in Wellington and Christchurch to see if they developed any signs of asthma or allergic sensitivity. The study has recently been published in Clinical and Experimental Allergy.
“The major finding is that children who used paracetamol before the age of 15 months (90%) were more than three times as likely to become sensitized to allergens and twice as likely to develop symptoms of asthma at six years old than children not using paracetamol,” says Professor Crane.
“However at present we don’t know why this might be so. We need clinical trials to see whether these associations are causal or not, and to clarify the use of this common medication.”
The research also found that by six years 95% of the study sample were using paracetamol and there was a significant increased risk for current asthma and wheeze. However the findings depended on how much paracetamol was being used, with the risk greater for those with severe asthma symptoms.
“The results at this stage are supportive of a role for paracetamol in asthma and allergic disease,” says Professor Crane.
However there may be many different mechanisms operating in the links between paracetamol and allergy/asthma researchers say. For instance it has been shown that fever in infancy may reduce allergy in childhood, and that paracetamol may affect antigen processing in the immune system early in life, or may be linked to free radical damage and enhancement of allergic inflammation and bronchospasm.
The University of Otago study concludes that although direct causation between paracetamol and allergy/asthma has not been established, neither has paracetamol been shown to have a beneficial effect on disease outcomes when used against fever, and guidelines for its use are unclear.
Provided by University of Otago
The report by Professor Julian Crane is based on the New Zealand Asthma and Allergy Cohort Study. It investigated the use of paracetamol by 505 infants in Christchurch, and 914 five and six year olds in Wellington and Christchurch to see if they developed any signs of asthma or allergic sensitivity. The study has recently been published in Clinical and Experimental Allergy.
“The major finding is that children who used paracetamol before the age of 15 months (90%) were more than three times as likely to become sensitized to allergens and twice as likely to develop symptoms of asthma at six years old than children not using paracetamol,” says Professor Crane.
“However at present we don’t know why this might be so. We need clinical trials to see whether these associations are causal or not, and to clarify the use of this common medication.”
The research also found that by six years 95% of the study sample were using paracetamol and there was a significant increased risk for current asthma and wheeze. However the findings depended on how much paracetamol was being used, with the risk greater for those with severe asthma symptoms.
“The results at this stage are supportive of a role for paracetamol in asthma and allergic disease,” says Professor Crane.
However there may be many different mechanisms operating in the links between paracetamol and allergy/asthma researchers say. For instance it has been shown that fever in infancy may reduce allergy in childhood, and that paracetamol may affect antigen processing in the immune system early in life, or may be linked to free radical damage and enhancement of allergic inflammation and bronchospasm.
The University of Otago study concludes that although direct causation between paracetamol and allergy/asthma has not been established, neither has paracetamol been shown to have a beneficial effect on disease outcomes when used against fever, and guidelines for its use are unclear.
Provided by University of Otago
Botox Shots Approved for Migraine
The Food and Drug Administration approved Botox, the anti-wrinkle shot from Allergan, as a treatment to prevent chronic migraines, a little more than a month after the company agreed to pay $600 million to settle allegations that it had illegally marketed the drug for unapproved uses like headaches for years.
Allergan says sales of Botox for chronic migraine and other medical uses will eclipse sales of the drug as a wrinkle smoother. The agency’s decision endorses doctors’ use of Botox to treat patients who suffer from a severe form of migraine involving headaches on at least 15 days a month. Britain’s drug agency approved Botox for the same use this summer.
Botox is already approved by the F.D.A. to treat uncontrolled blinking; crossed eyes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. It also is approved for cosmetic purposes — to smooth lines between the eyebrows.
Botox had worldwide sales last year of about $1.3 billion, divided equally between medical and cosmetic uses.
But Allergan said sales of Botox for chronic migraine and other medical uses would soon eclipse sales of the drug as a wrinkle smoother. Allergan is also studying the drug for a variety of new medical uses, including overactive bladder, said Dr. Scott M. Whitcup, the company’s executive vice president for research and development.
“For the business, Botox has been an incredible medication. We call it our pipeline in a vial,” Dr. Whitcup said. “People still think about it as a cosmetic product, but the therapeutic indications in the next five years will far surpass its cosmetic use.”
Industry analysts have forecast worldwide sales of the drug for the severe migraine condition at $250 million to more than $1 billion annually by 2015.
Unlike the occasional headache, the chronic migraine condition is often accompanied by nausea, vomiting, dizziness, intense sensitivity to light and noise, and moderate to severe pain.
The audience for Botox headache shots could be significant because some chronic migraine patients do not improve when they take the pills that are now the standard treatment, neurologists said. Treatments include pills like Topamax, taken daily to prevent migraine, and the triptan family of drugs, taken to ease an existing migraine.
Botox is a purified form of botulinum toxin, a nerve poison produced by the bacteria that causes botulism. Injections of Botox typically act to temporarily blunt nerve signals to certain muscles or glands. Researchers are still exploring how the drug works on migraines. Dr. Whitcup said one theory was that it blocked pain signals from reaching nerve endings.
A Botox migraine treatment generally involves a total of 31 injections in seven areas — including the forehead, temples, the back of the head, the neck and shoulders. To treat the chronic condition, injections are given about every three months.
Industry analysts estimated that the migraine treatment would cost $1,000 to $2,000, depending on the amount of the drug used and the physician’s fee. Some private insurers are likely to cover the migraine treatment now that it has received F.D.A. approval, analysts said, although patients may have to cover a significant co-payment.
“The cost is prohibitive for some,” Randall Stanicky, a vice president for global research at Goldman Sachs, said in an interview earlier this year. “But given the debilitating challenges of having migraines more than 15 days a month, if Botox can cut down on that, it’s clearly going to be a big opportunity.”
Other analysts have expressed skepticism that doctors and patients would embrace the drug, arguing that Botox has a marginal effect on headaches compared with a placebo.
“The true drug effect is minimal,” Corey Davis, an analyst at Jefferies & Company, said in an interview earlier this year.
Patients in one study financed by Allergan, for example, typically experienced about five fewer headache episodes a month than they had before the study — no matter whether they had injections of Botox or a placebo.
After Allergan reviewed the results of that first study, the company changed the primary end point — the scientific goal post — on a second study so that it would focus on the drug’s effect on the number of headache days rather than the number of headache episodes that a person experienced each month. Dr. Whitcup said it was easier for patients to remember how many headache days as opposed to how many headache episodes they had every month.
The second study reported that patients who received Botox injections typically experienced about 2.3 fewer headache days than the placebo group, a statistically significant difference. But the placebo group also experienced considerable improvement — a common feature in pain studies — raising questions among some doctors about the magnitude of the Botox effect.
Dr. Whitcup said Botox had consistently beaten the placebo at different time points in the study and that patients had reported an improvement in their daily functioning and quality of life.
Although the F.D.A. approved the drug for the chronic condition, the agency said in its statement Friday that Botox had not been shown to work for the occasional headache or migraine.
Common side effects were neck pain and headaches. But neurologists point to a more welcome side effect for some — fewer wrinkles.
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