FDA Approves Drug for Chronic Constipation
The drug Amitiza (lubiprostone) has been approved for treatment of chronic constipation in adults with no known cause for the condition, the U.S. Food and Drug Administration said Tuesday.
This drug, the first of its chemical type, will be available as capsules to treat chronic idiopathic constipation, defined as infrequent or difficult passage of stool. It's one of the most common disorders suffered by Americans. It affects women more often than men and is more common in people older than 65. Abdominal pain and discomfort, bloating, straining, and hard stools are symptoms of the condition.
Amitiza increases intestinal fluid secretion, which helps ease passage of stool and alleviate symptoms associated with chronic idiopathic constipation, the FDA said.
The agency's approval is based on two clinical trials of the drug that concluded that taking the drug was associated with higher frequency of bowel movements. Side effects included headache, nausea, diarrhea, abdominal pain, and distention.
The drug is taken twice a day with food, the FDA said.
European Union Approves Tamiflu for Children
The anti-influenza drug Tamiflu, regarded as a potential defense against bird flu, has received European Union approval for use as a preventative measure in children ages 1 to 12, the Financial Times reported.
Last December, the United States gave the same kind of approval for Tamiflu, which is being stockpiled around the world in anticipation of a global flu pandemic. The antiviral drug is made by Swiss company Roche.
Children are three times as likely as adults to get influenza and those under 2 with influenza are twice as likely to be hospitalized as people over the age of 65, the company said.
"The influenza season is just starting in the northern hemisphere and Roche plans to make Tamiflu available to prevent influenza in very young children who are particularly vulnerable during an outbreak of the disease," William Burns, Roche chief executive, told the Financial Times.
Moderate Exercise Boosts Depressed People
A single session of moderate-intensity exercise -- such as a 30-minute walk -- improves important mood markers of depression, says a U.S. study of people with major depressive disorder.
The 40 study volunteers, aged 18 to 55, were divided into two groups to compare the effects of 30 minutes of quiet rest to 30 minutes of treadmill walking at 60 percent to 70 percent of maximum heart rate, the Washington Post reported.
Following their 30 minutes of rest or exercise, both groups reported reductions in negative feelings such as anger, tension and depression. However, only the people in the exercise group reported improvements in the positive mood markers vigor and well-being. The beneficial effects of exercise were most evident five and 30 minutes after exercise, the Post reported.
The exercise-induced boost in vigor and well-being was likely the result of "perceived accomplishment" among those who used the treadmill, said study lead researcher John B. Bartholomew, associate professor, department of kinesiology and health education, at the University of Texas at Austin.
The study was published in the journal Medicine & Science in Sport & Exercise.
Teflon Chemical a 'Likely' Carcinogen: EPA Panel
A chemical used to make Teflon and other nonstick products should be regarded as a "likely" carcinogen, according to a draft report by an independent scientific review panel that advises the U.S. Environmental Protection Agency.
The panel's conclusions, released Monday, contradict an EPA draft risk assessment that determined that animal studies provided only "suggestive evidence" that perfluorooctanoic acid (PFOA) and its salts are potential human carcinogens, the Associated Press reported.
"The predominant panel view was the descriptor 'likely to be carcinogenic' was more consistent with currently available data, while a few panel members reached the conclusion that the current evidence fails to exceed the descriptor 'suggestive,' of carcinogenicity," the panel wrote.
The conclusion was challenged by Delaware-based DuPont, the only North American producer of PFOA.
"We disagree with the panel's recommendation on the cancer classification, and we continue to support the EPA's draft risk assessment," Robert Rickard, DuPont's director of health and environmental sciences, told the AP.
Half of U.S. Kids Don't Have Regular Dental Checkups
Only about half of all American children between 2 and 17 years old regularly get a dental checkup at least once a year, says a new Agency for Healthcare Research and Quality report.
The analysis of 2003 data found that 32 million children (49 percent) did not usually get annual dental checkups. Hispanic and black children were far less likely to usually have annual dental checkups (34 percent and 42 percent, respectively) than non-Hispanic white children (59.5 percent).
The report also found that health care professionals often fail to inform parents about the importance of routine dental checkups.
Parental education and income also had an impact. Children in households where at least one parent attended college were almost twice as likely to have an annual checkup than children whose parents were, at most, high school graduates (60.9 percent vs. 33.2 percent).
When children did not get necessary dental care, or there was a delay in getting that care, lack of money was the main reason 56 percent of the time.
160 Human Bird Flu Infections To Date: WHO
The number of people worldwide who have been infected with the deadly H5N1 strain of bird flu now stands at 160 people, and 85 people have died from the disease, the World Health Organization (WHO) said Tuesday.
The figures were updated after laboratory tests confirmed that at least 12 people in Turkey were infected by the virus. Samples from nine other people in Turkey are currently being tested to verify the presence of the H5N1 virus, the Associated Press reported.
Until human cases began appearing in Turkey earlier this year, all human cases of bird flu had been limited to eastern Asia. The virus appeared in poultry in Asia in 2003 and has since spread to poultry in eastern Europe and the Middle East.
The first human case of bird flu in Iraq was confirmed this week after the death of a 15-year-old girl in the northern area of the country. The WHO is sending a team to that area of Iraq to investigate possible bird flu cases, the AP reported.
Food Fact:
Soy to the world.
Think soy is boring? Edamame just might change your mind. Baby green soybeans are unlike tofu or soy milk in taste, look and feel, but are just as packed with protein and protective soy isoflavones. Edamame are sold frozen in the pod or shucked. Cook for 7 or 8 minutes in boiling water until tender. Serve plain as a snack or add to stir-fries, bean salads or vegetables mixes. A 1/4-cup serving contains about 110 calories and 9 grams of protein.
Fitness Tip of the day:
Eat your veggies.
Listen to your mom; veggies will enhance your workout. Most veggies contain pantothenic acid, an essential nutrient that helps you stay fit and alert. This essential part of your diet contributes to the production of amino acids, helps metabolize fat and assists in the manufacture of neurotransmitters, the chemicals that carry messages in the brain.
FAQ of the day:
Can I take a pill to get the benefits of soy food?
In order to get the benefits of soy, a supplement alone won't do. You'll need to eat soy food, for both soy protein and soy isoflavones, to get the full range of health benefits. Pills will just give you the isoflavones. Only soy foods like tofu, tempeh, soy milk and soy protein powder provide both.
Tuesday, January 31, 2006
Monday, January 30, 2006
Health Headlines - January 30
Health Indicators Decline for Older Americans
Five of seven health care indicators for Americans 50 and older declined over a one-year period at the same time that the age group saw a drop in family income, according to the annual "State of 50+ America" report released Monday by AARP.
"The AARP report found health care costs are staggering for more Americans. The percentage of 50+ households which can not even afford medical care they need today is growing," John Rother, AARP director of policy and strategy, said in a prepared statement.
"Economists are reporting a growing economy. But AARP has found that real family income has not increased since the late 1990s for mid-life and older Americans, and over the last year family income for the age group has declined," Rother said.
Real median family income for 50+ households decreased 1.5 percent over the most recent one-year period. The report also said that 50.1 percent of Americans age 62 and older received more than half their 2004 income from sources other than Social Security. That's a slight increase over the previous year.
The report also said that 47 percent of Americans 50 and older reported their health as excellent or very good in 2004, a slight decline from 47.5 percent in 2003. The number of people 50 and older who said they weren't overweight or obese declined from 39.7 percent in 1998 to 35 percent in 2004.
More than half (55 percent) of Americans 50 and older said their housing costs accounted for a larger share of their budget in 2004 than five years ago.
Single Gene Determines Earwax Type
A single gene called ABCC11 determines whether a person has wet or dry earwax and earwax type could even be related to attractiveness, says an international study in the journal Nature Genetics.
Researchers analyzed the genes of people from 33 populations across the world and concluded that ethnicity determines which form of the ABCC11 gene a person has, BBC News reported.
Up to 95 percent of East Asians have dry earwax, compared with no more than 3 percent of people of African or European origin.
The study also noted that earwax type could related to attractiveness due to a link with body odor glands. Wet earwax has been linked to armpit odor, BBC News reported.
While the scientists identified the gene responsible for determining the type of earwax, they said the exact purpose of earwax is unclear.
COX-2 Inhibitors Reduce Breast Cancer Risk: Study
Controversial COX-2 inhibitors, used mainly as arthritis drugs, may reduce the risk of breast cancer, says an Ohio State University study in the journal BMC Cancer.
The study of 323 breast cancer patients and 649 healthy women found that those who took COX-2 inhibitors for at least two years had a 71 percent reduced risk of breast cancer, The Times of London reported.
Ibuprofen and naproxen were also effective. Women who took those drugs had a 63 percent lower risk of breast cancer.
The COX-2 inhibitors in this study included Vioxx and Celebrex. The study was partly funded by drug company Pfizer, which makes Celebrex. The remainder of the funding came from the U.S. National Cancer Institute, The Times reported.
Vioxx was withdrawn from the U.S. market because it was linked with heart disease. Celebrex is still on the market.
First Iraqi Bird Flu Case Confirmed
The H5N1 strain of bird flu caused the death of a 15-year-old girl in northern Iraq earlier this month, Iraqi Kurdistan and United Nations officials said Monday. It's the first known human bird flu case in the country, the Associated Press reported.
Blood samples from the girl, who died January 17 after contracting a severe lung infection, were tested at the U.S. Navy Medical Research Unit in Cairo, Egypt. Thirty other samples from northern Iraq are being tested at the unit.
The girl's uncle died January 27. Both lived in the same house near Ranya, located near a reservoir that's a stopover for migratory birds from Turkey, which is currently trying to halt a bird flu outbreak.
In other news, Turkish Cypriot authorities said they've quarantined a 10-kilometer area around a village where H5N1 was found in a dead bird. A large number of birds in the quarantine area have been slaughtered, the Voice of America reported.
Greek Cypriot officials said they've taken steps to prevent the bird flu virus from spreading into their area of Cyprus.
Analytical Couples Linked to Autistic Children
Highly analytical couples such as scientists, engineers and mathematicians may be more likely than other couples to have autistic children, says a University of Cambridge researcher.
In a paper in the journal Archives of Disease of Childhood, Prof. Simon Baron-Cohen said the gene that makes some people analytical may also impair their social and communication skills, BBC News reported.
Autism is characterized by social and communication difficulties.
Baron-Cohen noted that scientists and other "systemizers" are skilled at analyzing systems to figure out how they function but tend to be less interested in social skills and can exhibit obsession with detail and other behaviors associated with autism.
Since systemizers tend to be attracted to each other, they're more likely to pass "autism" genes and behaviors onto their children, Baron-Cohen suggested.
Some experts argue that the rise in autism in linked to increased awareness of the condition, BBC News reported.
Food Fact:
Slice of heaven?
Is pizza healthy any way you slice it? No, but you can make it so. To make healthy pizza, you've got to attack the fat. Instead of full-fat mozzarella, sausage and pepperoni, increase the variety and quantity of vegetables and use a small amount of flavorful cheese, such as feta or Parmesan. Given the amount of pizza Americans eat, any choice to cut calories helps; collectively, we eat about 100 acres of pizza each day, which works out to 46 slices of pizza for every man, woman and child over the course of a year.
Fitness Tip of the day:
Set reasonable goals.
Want to lose 30 pounds or have killer abs? Great, but remember: Every long journey starts with one step. By focusing on smaller, incremental targets unrelated to results -- say, following through on a promise to walk a little every day at lunch for a week -- you'll feel a sense of achievement early and more often. Big goals take time to reach, and focusing on them too soon may do more harm than good.
FAQ of the day:
Can soy save me from prostate cancer?
Soy's isoflavones exhibit several cancer-protective effects, but one relates directly to reducing prostate cancer risk. Isoflavones inhibit an enzyme that converts testosterone into an active form (dehydrosterone) associated with prostate cancer risk. Dehydrotestosterone, made primarily in the prostate, regulates the prostate cell's growth. Soy isoflavones have little effect on testosterone itself.
Five of seven health care indicators for Americans 50 and older declined over a one-year period at the same time that the age group saw a drop in family income, according to the annual "State of 50+ America" report released Monday by AARP.
"The AARP report found health care costs are staggering for more Americans. The percentage of 50+ households which can not even afford medical care they need today is growing," John Rother, AARP director of policy and strategy, said in a prepared statement.
"Economists are reporting a growing economy. But AARP has found that real family income has not increased since the late 1990s for mid-life and older Americans, and over the last year family income for the age group has declined," Rother said.
Real median family income for 50+ households decreased 1.5 percent over the most recent one-year period. The report also said that 50.1 percent of Americans age 62 and older received more than half their 2004 income from sources other than Social Security. That's a slight increase over the previous year.
The report also said that 47 percent of Americans 50 and older reported their health as excellent or very good in 2004, a slight decline from 47.5 percent in 2003. The number of people 50 and older who said they weren't overweight or obese declined from 39.7 percent in 1998 to 35 percent in 2004.
More than half (55 percent) of Americans 50 and older said their housing costs accounted for a larger share of their budget in 2004 than five years ago.
Single Gene Determines Earwax Type
A single gene called ABCC11 determines whether a person has wet or dry earwax and earwax type could even be related to attractiveness, says an international study in the journal Nature Genetics.
Researchers analyzed the genes of people from 33 populations across the world and concluded that ethnicity determines which form of the ABCC11 gene a person has, BBC News reported.
Up to 95 percent of East Asians have dry earwax, compared with no more than 3 percent of people of African or European origin.
The study also noted that earwax type could related to attractiveness due to a link with body odor glands. Wet earwax has been linked to armpit odor, BBC News reported.
While the scientists identified the gene responsible for determining the type of earwax, they said the exact purpose of earwax is unclear.
COX-2 Inhibitors Reduce Breast Cancer Risk: Study
Controversial COX-2 inhibitors, used mainly as arthritis drugs, may reduce the risk of breast cancer, says an Ohio State University study in the journal BMC Cancer.
The study of 323 breast cancer patients and 649 healthy women found that those who took COX-2 inhibitors for at least two years had a 71 percent reduced risk of breast cancer, The Times of London reported.
Ibuprofen and naproxen were also effective. Women who took those drugs had a 63 percent lower risk of breast cancer.
The COX-2 inhibitors in this study included Vioxx and Celebrex. The study was partly funded by drug company Pfizer, which makes Celebrex. The remainder of the funding came from the U.S. National Cancer Institute, The Times reported.
Vioxx was withdrawn from the U.S. market because it was linked with heart disease. Celebrex is still on the market.
First Iraqi Bird Flu Case Confirmed
The H5N1 strain of bird flu caused the death of a 15-year-old girl in northern Iraq earlier this month, Iraqi Kurdistan and United Nations officials said Monday. It's the first known human bird flu case in the country, the Associated Press reported.
Blood samples from the girl, who died January 17 after contracting a severe lung infection, were tested at the U.S. Navy Medical Research Unit in Cairo, Egypt. Thirty other samples from northern Iraq are being tested at the unit.
The girl's uncle died January 27. Both lived in the same house near Ranya, located near a reservoir that's a stopover for migratory birds from Turkey, which is currently trying to halt a bird flu outbreak.
In other news, Turkish Cypriot authorities said they've quarantined a 10-kilometer area around a village where H5N1 was found in a dead bird. A large number of birds in the quarantine area have been slaughtered, the Voice of America reported.
Greek Cypriot officials said they've taken steps to prevent the bird flu virus from spreading into their area of Cyprus.
Analytical Couples Linked to Autistic Children
Highly analytical couples such as scientists, engineers and mathematicians may be more likely than other couples to have autistic children, says a University of Cambridge researcher.
In a paper in the journal Archives of Disease of Childhood, Prof. Simon Baron-Cohen said the gene that makes some people analytical may also impair their social and communication skills, BBC News reported.
Autism is characterized by social and communication difficulties.
Baron-Cohen noted that scientists and other "systemizers" are skilled at analyzing systems to figure out how they function but tend to be less interested in social skills and can exhibit obsession with detail and other behaviors associated with autism.
Since systemizers tend to be attracted to each other, they're more likely to pass "autism" genes and behaviors onto their children, Baron-Cohen suggested.
Some experts argue that the rise in autism in linked to increased awareness of the condition, BBC News reported.
Food Fact:
Slice of heaven?
Is pizza healthy any way you slice it? No, but you can make it so. To make healthy pizza, you've got to attack the fat. Instead of full-fat mozzarella, sausage and pepperoni, increase the variety and quantity of vegetables and use a small amount of flavorful cheese, such as feta or Parmesan. Given the amount of pizza Americans eat, any choice to cut calories helps; collectively, we eat about 100 acres of pizza each day, which works out to 46 slices of pizza for every man, woman and child over the course of a year.
Fitness Tip of the day:
Set reasonable goals.
Want to lose 30 pounds or have killer abs? Great, but remember: Every long journey starts with one step. By focusing on smaller, incremental targets unrelated to results -- say, following through on a promise to walk a little every day at lunch for a week -- you'll feel a sense of achievement early and more often. Big goals take time to reach, and focusing on them too soon may do more harm than good.
FAQ of the day:
Can soy save me from prostate cancer?
Soy's isoflavones exhibit several cancer-protective effects, but one relates directly to reducing prostate cancer risk. Isoflavones inhibit an enzyme that converts testosterone into an active form (dehydrosterone) associated with prostate cancer risk. Dehydrotestosterone, made primarily in the prostate, regulates the prostate cell's growth. Soy isoflavones have little effect on testosterone itself.
Sunday, January 29, 2006
Health Headlines - January 29
Company Recalls 500,000 Baby Teethers
At least a half million liquid-filled baby teethers distributed in the United States and Canada have been recalled because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no illnesses have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza told the wire service Friday.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen has been given the government's blessing, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey told the wire service on Friday. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina; Ranexa allows the heart to pump more efficiently without the need for more oxygen, the AP reported.
Current drugs for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. Ranexa relaxes contracted heart muscle, Dr. Louis Lange, chairman and chief executive officer of CV Therapeutics, told the AP. That returns blood flow to normal levels, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration has warned.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported Thursday.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Texas Attorney Must Turn Over Damaging Guidant Documents
A Texas attorney has been ordered by the U.S. Justice Department to hand over documents indicating the company continued selling some of its heart defibrillators after knowing they could malfunction, the Associated Press reported Saturday.
As part of the government's investigation into the Indianapolis-based company, attorney Bob Hilliard must relinquish notes and PowerPoint slides he obtained during preparations for an upcoming product liability trial in Texas, according to the AP.
Included in the documents are notes from Fred McCoy, president of Guidant's cardiac rhythm management division, that show the company decided to keep selling defibrillators McCoy described as having sporadic "life-threatening" defects.
Guidant spokesman Steve Tragash declined to comment, and Assistant U.S. Attorney Robert Lewis did not return a phone call seeking comment on the subpoena, the AP reported.
Hilliard represents about 70 patients who are suing Guidant. The first trial, scheduled to begin Feb. 20, involves two patients with faulty defibrillators.
In the last six months, Guidant has recalled or issued safety advisories for about 88,000 defibrillators, and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices.
Illinois Pharmacists Sue Drug Store Chain Over Morning-After Pill Policy
Four Illinois pharmacists have sued Walgreen Drug Stores, claiming they were fired illegally after they refused to sign a pledge promising to dispense the morning-after birth-control pill, the Associated Press reported Friday.
Walgreen Co. is accused of violating the Illinois Health Care Right of Conscience Act, according to the AP. The American Center for Law and Justice, a public-interest group founded by evangelist Pat Robertson, is representing the pharmacists.
A new state rule requires pharmacies that sell federally approved contraceptives to fill prescriptions for emergency birth control "without delay" if they have the medication in stock. The rule is being challenged in federal court.
In response, Deerfield-based Walgreen asked its pharmacists to promise in writing that they would fill prescriptions for contraceptives such as the morning-after pill. The plaintiffs were suspended indefinitely without pay when they refused to sign the pledge in November.
"It couldn't be any clearer," ACLJ senior counsel Francis J. Manion told the wire service. "In punishing these pharmacists for asserting a right protected by the Conscience Act, Walgreens broke the law."
Walgreen spokesman Michael Polzin said the company had no legal choice but to comply with the new regulations.
Food Fact:
Kernels of wisdom.
The secret to tastier corn: Know exactly how long to cook it. Sweet and tender corn should be cooked in boiling water for no more than 1 or 2 minutes. For best flavor, cook corn the same day it's picked. It's naturally tasty - try it without butter to avoid added fat.There's nothing better than eating corn-on-the-cob on a summer's night. It's good for the soul and the body too. One ear's worth of kernels contains 85 calories and 3 grams fiber. Yellow corn contains lutein, a plant pigment that helps protect your eyes from macular degeneration. Hominy is corn that has been treated with an alkali to remove the hulls. The process boosts the availability of the niacin in corn as a nutrient.
Fitness Tip of the day:
Find the right activity.
Answers to three questions will tell you if your exercise program is right for you. Try different activities, and ask yourself : Do I look forward to this? Do I enjoy doing it? Do I feel good afterward? If you answer yes to all three, it's an activity you'll probably keep doing. Remember, no exercise program will work for long if you have to force yourself to do it.
FAQ of the day:
Do I need more soy if I'm menopausal?
There's some evidence that soy's isoflavones may help reduce hot flashes. More important is the benefit that soy foods rich in soy protein and isoflavones have on osteoporosis and heart disease. Like estrogen itself, soy's isoflavones help keep bones strong. You may want to take a soy protein isolate powder containing isoflavones daily to help prevent osteoporosis and lower blood cholesterol. With diet and exercise, you can greatly reduce your risk of heart disease after menopause, even without hormone replacement therapy.
At least a half million liquid-filled baby teethers distributed in the United States and Canada have been recalled because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no illnesses have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza told the wire service Friday.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen has been given the government's blessing, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey told the wire service on Friday. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina; Ranexa allows the heart to pump more efficiently without the need for more oxygen, the AP reported.
Current drugs for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. Ranexa relaxes contracted heart muscle, Dr. Louis Lange, chairman and chief executive officer of CV Therapeutics, told the AP. That returns blood flow to normal levels, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration has warned.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported Thursday.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Texas Attorney Must Turn Over Damaging Guidant Documents
A Texas attorney has been ordered by the U.S. Justice Department to hand over documents indicating the company continued selling some of its heart defibrillators after knowing they could malfunction, the Associated Press reported Saturday.
As part of the government's investigation into the Indianapolis-based company, attorney Bob Hilliard must relinquish notes and PowerPoint slides he obtained during preparations for an upcoming product liability trial in Texas, according to the AP.
Included in the documents are notes from Fred McCoy, president of Guidant's cardiac rhythm management division, that show the company decided to keep selling defibrillators McCoy described as having sporadic "life-threatening" defects.
Guidant spokesman Steve Tragash declined to comment, and Assistant U.S. Attorney Robert Lewis did not return a phone call seeking comment on the subpoena, the AP reported.
Hilliard represents about 70 patients who are suing Guidant. The first trial, scheduled to begin Feb. 20, involves two patients with faulty defibrillators.
In the last six months, Guidant has recalled or issued safety advisories for about 88,000 defibrillators, and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices.
Illinois Pharmacists Sue Drug Store Chain Over Morning-After Pill Policy
Four Illinois pharmacists have sued Walgreen Drug Stores, claiming they were fired illegally after they refused to sign a pledge promising to dispense the morning-after birth-control pill, the Associated Press reported Friday.
Walgreen Co. is accused of violating the Illinois Health Care Right of Conscience Act, according to the AP. The American Center for Law and Justice, a public-interest group founded by evangelist Pat Robertson, is representing the pharmacists.
A new state rule requires pharmacies that sell federally approved contraceptives to fill prescriptions for emergency birth control "without delay" if they have the medication in stock. The rule is being challenged in federal court.
In response, Deerfield-based Walgreen asked its pharmacists to promise in writing that they would fill prescriptions for contraceptives such as the morning-after pill. The plaintiffs were suspended indefinitely without pay when they refused to sign the pledge in November.
"It couldn't be any clearer," ACLJ senior counsel Francis J. Manion told the wire service. "In punishing these pharmacists for asserting a right protected by the Conscience Act, Walgreens broke the law."
Walgreen spokesman Michael Polzin said the company had no legal choice but to comply with the new regulations.
Food Fact:
Kernels of wisdom.
The secret to tastier corn: Know exactly how long to cook it. Sweet and tender corn should be cooked in boiling water for no more than 1 or 2 minutes. For best flavor, cook corn the same day it's picked. It's naturally tasty - try it without butter to avoid added fat.There's nothing better than eating corn-on-the-cob on a summer's night. It's good for the soul and the body too. One ear's worth of kernels contains 85 calories and 3 grams fiber. Yellow corn contains lutein, a plant pigment that helps protect your eyes from macular degeneration. Hominy is corn that has been treated with an alkali to remove the hulls. The process boosts the availability of the niacin in corn as a nutrient.
Fitness Tip of the day:
Find the right activity.
Answers to three questions will tell you if your exercise program is right for you. Try different activities, and ask yourself : Do I look forward to this? Do I enjoy doing it? Do I feel good afterward? If you answer yes to all three, it's an activity you'll probably keep doing. Remember, no exercise program will work for long if you have to force yourself to do it.
FAQ of the day:
Do I need more soy if I'm menopausal?
There's some evidence that soy's isoflavones may help reduce hot flashes. More important is the benefit that soy foods rich in soy protein and isoflavones have on osteoporosis and heart disease. Like estrogen itself, soy's isoflavones help keep bones strong. You may want to take a soy protein isolate powder containing isoflavones daily to help prevent osteoporosis and lower blood cholesterol. With diet and exercise, you can greatly reduce your risk of heart disease after menopause, even without hormone replacement therapy.
Saturday, January 28, 2006
Health Headlines - January 28
FDA Approves Inhaled Insulin for Diabetes
Exubera, the first inhaled insulin treatment for diabetes, won approval from U.S. regulatory officials on Friday.
The long-awaited action by the U.S. Food and Drug Administration means millions of people with both type 1 and type 2 diabetes may have the option of avoiding the needles and countless injections that have marked their lives so far.
"This is the first new insulin delivery option introduced since the discovery of this drug in 1920s," said Dr. Steve Galson, director of the FDA Center for Drug Evaluation and Research. "There are more than 5 million Americans who take insulin injections every day, and Exubera may be an option for many of these patients. It will not replace all injectable insulin. . . It's a very highly innovative product that has the potential to improve the quality of life of millions of Americans with diabetes."
"This is highly positive. It will be a major advance for individuals with diabetes, both children and adults," said Dr. Robert Rapaport, director of the division of pediatric endocrinology at Mount Sinai School of Medicine in New York City. "I think there will be some longstanding questions about its ultimate safety because it's the first inhaled medication that will be used like this. But, assuming the safety profile will be good, it will be a major advance."
Added Dr. Stuart Weiss, an assistant clinical professor of medicine at New York University School of Medicine: "There are still some questions as to lung function and diffusion capacity, and smokers can't use it. There are all sorts of things to be concerned about. It's going to take a few years to see whether or not it's as safe as all that."
The announcement follows European regulators' approval of Exubera on Thursday. A U.S. Food and Drug Administration advisory panel recommended approval of the drug in the United States on Sept. 8.
Type 2 diabetes has become a global epidemic, affecting some 12 million people in the United States alone. The condition, which develops when the pancreas does not produce enough insulin or the body cannot use the hormone efficiently, is strongly associated with overweight and obesity. While some people can manage their type 2 diabetes through diet and exercise, others must rely on insulin injections.
Type 1 diabetes, in which the body's insulin-producing capabilities are limited or non-existent, is not linked to body weight.
Insulin is the hormone that converts blood sugar, called glucose, into energy for cells in the body.
If left uncontrolled, either type of diabetes can lead to a multitude of complications, including amputations, blindness, kidney disease, heart attack and strokes.
The first commercial insulin hit the market in the 1920s. Since then, the gold standard for treatment of type 1 diabetes and more advanced type 2 diabetes has been insulin, injected before meals.
In the intervening years, new types of insulin formulations and devices have made the process more efficient.
"Needles are way, way smaller, syringes are easier to use, pen devices are very discreet, all sorts of delivery devices are very impressive," Weiss said. But the premise has remained the same -- delivery by injection.
Exubera, on the other hand, is a dry powder formulation of insulin inhaled into the lungs through the mouth. Like injectable insulin, it is administered before meals using a small, hand-held device.
Studies on safety and effectiveness were done on more than 2,500 adults with type 1 and type 2 diabetes. The drug, manufactured by Pfizer Inc., was as effective as injectable insulin for control of blood sugar, the company stated. Pfizer apparently delayed Exubera's application for U.S. approval for three years to finish safety studies.
"Because this is a new way to deliver insulin to patients, it has been extensively studied with respect to safety and efficacy," said Dr. Robert Meyer, director of the FDA Office of Drug Evaluation II, which oversees the division of Metabolic and Endocrine Drugs. "We have a large amount of data from the clinical trials speaking to the safety of this product overall, and safety in the lungs as well. In addition, there are ongoing, continuing trials to monitor safety that will be reported after approval."
"We feel that there is an extensive and reasonable safety database to allow us to make a determination of efficacy and safety for patients without underlying lung disease and who do not smoke," Meyer said.
In those clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by injection. Peak insulin levels were achieved at 49 minutes, on average, with Exubera, compared to 105 minutes, on average, with regular insulin, the FDA said.
Prescriptions for Exubera will be accompanied by a "Medication Guide" containing FDA-approved information written especially for patients, the agency said.
Like any insulin product, low blood sugar is a side effect of Exubera and diabetics should carefully monitor their blood sugar regularly. Other side effects associated with Exubera in clinical trials included cough, shortness of breath, sore throat and dry mouth, the FDA said.
Exubera shouldn't be used by smokers or someone who quit smoking within the last six months. The drug is also not recommended in people with asthma, bronchitis or emphysema. Baseline tests for lung function are recommended before beginning treatment, and should be repeated every six to 12 months, according to the FDA.
Inhaled insulin is unlikely to completely replace injectable insulin. But, for many people, it may greatly improve glucose control.
"It's very hard to predict what the impact will be," Weiss said. "A lot of people who need to be on insulin are not on insulin. For that type 2 diabetic who is afraid of needles or will not take a shot, this is an ideal product. The problem is it doesn't address the root cause of diabetes. It could become another treatment that will cause people to overeat and under-exercise."
Exubera is also unlikely to be the only inhaled insulin on the market for long. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions.
Company Recalls 500,000 Baby Teethers
At least a half million liquid-filled baby teethers distributed in the United States and Canada were recalled on Friday because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to manufacturer The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no cases of illness have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza said.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen was given the government's blessing on Friday, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey said. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina. Ranexa allows the heart to pump more efficiently without the need for more oxygen, the company said.
Current drugs used for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. In contrast, Ranexa relaxes contracted heart muscle, Dr. Louis Lange, the chairman and chief executive officer of CV Therapeutics, told the AP. That restores normal blood flow, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Chronic Wasting Disease Prions Found in Deer Muscle Meat
The haunch and leg meat, and possibly other muscle meat, of deer with chronic wasting disease contains the infectious prions that spread that disease, says a U.S. study published Friday in the journal Science.
This finding contradicts assurances from state and federal health officials that people eating deer won't be exposed to the disease as long as they don't consume or touch a deer's brain, spinal cord or other nervous tissues. It was believed that these were the only locations where the infectious prions were located, The New York Times reported.
Chronic wasting disease is similar to mad cow disease. To date, there is no evidence that chronic wasting disease has been passed to humans. The disease afflicts deer and elk in 11 states and in two Canadian provinces.
In states where the disease is found, officials routinely caution hunters to freeze deer and elk meat while the animal's head is tested for prions.
"This study is very important. It's frightening that there should be so many prions in the muscle meat of deer," Stanely Prusiner of the University of California, San Francisco, told the newspaper. Prsuiner won the 1997 Nobel in medicine for his research on prions.
Sharp Increase in Children's Asthma Rates
In some parts of North America, children's asthma rates are four times higher than they were 20 years ago, says a report released Friday by the Commission for Environmental Cooperation, which was set up under the North American Free Trade Agreement.
The report cited a number of possible factors, other than heredity, that may influence increased rates of asthma. They include outdoor air pollution, and smoke in homes from secondhand cigarette smoke and wood or charcoal fires, CBC News reported.
A tendency toward allergies and the presence of pet dander, dust mite antigens, molds, pesticides, gases or aerosol in homes and schools may also play a role.
"The air children breathe is an important source of exposure to substances that may potentially harm their health," the report said. "Exposures in early childhood when the lungs and immune systems are not fully developed raise concerns that children may respond more adversely than adults would."
There was some good news in the report. In recent years, there's been a decline in rates of lead contamination and water-related sicknesses among children in Canada, Mexico and the United States, CBC News reported.
Food Fact:
Juice vs. fruit.
A piece of fresh fruit has one key advantage over a glass of juice. When you eat an orange, an apple or a grapefruit, you're getting fiber, which isn't there in a glass of juice. Not only does fiber play a major role against diabetes and heart disease, but it fills you up with fewer calories, helping you control your weight. Fruit juices also tend to be high in added sugar. Citrus fruits in particular are loaded with antioxidant, cancer-preventing compounds, and they're bursting with vitamin C, folate and potassium.
Fitness Tip of the day:
Less is more.
Surprise! A few short exercise sessions a day can be as valuable as one longer session. The key to making exercise a habit is to fit it comfortably into your schedule. If you can't find a 30-minute block of time, try three 10-minute stints over the course of the day.
FAQ of the day:
Should I buy fat-free soy milk?
It's not a good idea; fat-free soy milk lacks the beneficial soy isoflavones. If you're concerned about the calories in whole soy milk, switch to 1%.
Exubera, the first inhaled insulin treatment for diabetes, won approval from U.S. regulatory officials on Friday.
The long-awaited action by the U.S. Food and Drug Administration means millions of people with both type 1 and type 2 diabetes may have the option of avoiding the needles and countless injections that have marked their lives so far.
"This is the first new insulin delivery option introduced since the discovery of this drug in 1920s," said Dr. Steve Galson, director of the FDA Center for Drug Evaluation and Research. "There are more than 5 million Americans who take insulin injections every day, and Exubera may be an option for many of these patients. It will not replace all injectable insulin. . . It's a very highly innovative product that has the potential to improve the quality of life of millions of Americans with diabetes."
"This is highly positive. It will be a major advance for individuals with diabetes, both children and adults," said Dr. Robert Rapaport, director of the division of pediatric endocrinology at Mount Sinai School of Medicine in New York City. "I think there will be some longstanding questions about its ultimate safety because it's the first inhaled medication that will be used like this. But, assuming the safety profile will be good, it will be a major advance."
Added Dr. Stuart Weiss, an assistant clinical professor of medicine at New York University School of Medicine: "There are still some questions as to lung function and diffusion capacity, and smokers can't use it. There are all sorts of things to be concerned about. It's going to take a few years to see whether or not it's as safe as all that."
The announcement follows European regulators' approval of Exubera on Thursday. A U.S. Food and Drug Administration advisory panel recommended approval of the drug in the United States on Sept. 8.
Type 2 diabetes has become a global epidemic, affecting some 12 million people in the United States alone. The condition, which develops when the pancreas does not produce enough insulin or the body cannot use the hormone efficiently, is strongly associated with overweight and obesity. While some people can manage their type 2 diabetes through diet and exercise, others must rely on insulin injections.
Type 1 diabetes, in which the body's insulin-producing capabilities are limited or non-existent, is not linked to body weight.
Insulin is the hormone that converts blood sugar, called glucose, into energy for cells in the body.
If left uncontrolled, either type of diabetes can lead to a multitude of complications, including amputations, blindness, kidney disease, heart attack and strokes.
The first commercial insulin hit the market in the 1920s. Since then, the gold standard for treatment of type 1 diabetes and more advanced type 2 diabetes has been insulin, injected before meals.
In the intervening years, new types of insulin formulations and devices have made the process more efficient.
"Needles are way, way smaller, syringes are easier to use, pen devices are very discreet, all sorts of delivery devices are very impressive," Weiss said. But the premise has remained the same -- delivery by injection.
Exubera, on the other hand, is a dry powder formulation of insulin inhaled into the lungs through the mouth. Like injectable insulin, it is administered before meals using a small, hand-held device.
Studies on safety and effectiveness were done on more than 2,500 adults with type 1 and type 2 diabetes. The drug, manufactured by Pfizer Inc., was as effective as injectable insulin for control of blood sugar, the company stated. Pfizer apparently delayed Exubera's application for U.S. approval for three years to finish safety studies.
"Because this is a new way to deliver insulin to patients, it has been extensively studied with respect to safety and efficacy," said Dr. Robert Meyer, director of the FDA Office of Drug Evaluation II, which oversees the division of Metabolic and Endocrine Drugs. "We have a large amount of data from the clinical trials speaking to the safety of this product overall, and safety in the lungs as well. In addition, there are ongoing, continuing trials to monitor safety that will be reported after approval."
"We feel that there is an extensive and reasonable safety database to allow us to make a determination of efficacy and safety for patients without underlying lung disease and who do not smoke," Meyer said.
In those clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by injection. Peak insulin levels were achieved at 49 minutes, on average, with Exubera, compared to 105 minutes, on average, with regular insulin, the FDA said.
Prescriptions for Exubera will be accompanied by a "Medication Guide" containing FDA-approved information written especially for patients, the agency said.
Like any insulin product, low blood sugar is a side effect of Exubera and diabetics should carefully monitor their blood sugar regularly. Other side effects associated with Exubera in clinical trials included cough, shortness of breath, sore throat and dry mouth, the FDA said.
Exubera shouldn't be used by smokers or someone who quit smoking within the last six months. The drug is also not recommended in people with asthma, bronchitis or emphysema. Baseline tests for lung function are recommended before beginning treatment, and should be repeated every six to 12 months, according to the FDA.
Inhaled insulin is unlikely to completely replace injectable insulin. But, for many people, it may greatly improve glucose control.
"It's very hard to predict what the impact will be," Weiss said. "A lot of people who need to be on insulin are not on insulin. For that type 2 diabetic who is afraid of needles or will not take a shot, this is an ideal product. The problem is it doesn't address the root cause of diabetes. It could become another treatment that will cause people to overeat and under-exercise."
Exubera is also unlikely to be the only inhaled insulin on the market for long. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions.
Company Recalls 500,000 Baby Teethers
At least a half million liquid-filled baby teethers distributed in the United States and Canada were recalled on Friday because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to manufacturer The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no cases of illness have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza said.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen was given the government's blessing on Friday, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey said. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina. Ranexa allows the heart to pump more efficiently without the need for more oxygen, the company said.
Current drugs used for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. In contrast, Ranexa relaxes contracted heart muscle, Dr. Louis Lange, the chairman and chief executive officer of CV Therapeutics, told the AP. That restores normal blood flow, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Chronic Wasting Disease Prions Found in Deer Muscle Meat
The haunch and leg meat, and possibly other muscle meat, of deer with chronic wasting disease contains the infectious prions that spread that disease, says a U.S. study published Friday in the journal Science.
This finding contradicts assurances from state and federal health officials that people eating deer won't be exposed to the disease as long as they don't consume or touch a deer's brain, spinal cord or other nervous tissues. It was believed that these were the only locations where the infectious prions were located, The New York Times reported.
Chronic wasting disease is similar to mad cow disease. To date, there is no evidence that chronic wasting disease has been passed to humans. The disease afflicts deer and elk in 11 states and in two Canadian provinces.
In states where the disease is found, officials routinely caution hunters to freeze deer and elk meat while the animal's head is tested for prions.
"This study is very important. It's frightening that there should be so many prions in the muscle meat of deer," Stanely Prusiner of the University of California, San Francisco, told the newspaper. Prsuiner won the 1997 Nobel in medicine for his research on prions.
Sharp Increase in Children's Asthma Rates
In some parts of North America, children's asthma rates are four times higher than they were 20 years ago, says a report released Friday by the Commission for Environmental Cooperation, which was set up under the North American Free Trade Agreement.
The report cited a number of possible factors, other than heredity, that may influence increased rates of asthma. They include outdoor air pollution, and smoke in homes from secondhand cigarette smoke and wood or charcoal fires, CBC News reported.
A tendency toward allergies and the presence of pet dander, dust mite antigens, molds, pesticides, gases or aerosol in homes and schools may also play a role.
"The air children breathe is an important source of exposure to substances that may potentially harm their health," the report said. "Exposures in early childhood when the lungs and immune systems are not fully developed raise concerns that children may respond more adversely than adults would."
There was some good news in the report. In recent years, there's been a decline in rates of lead contamination and water-related sicknesses among children in Canada, Mexico and the United States, CBC News reported.
Food Fact:
Juice vs. fruit.
A piece of fresh fruit has one key advantage over a glass of juice. When you eat an orange, an apple or a grapefruit, you're getting fiber, which isn't there in a glass of juice. Not only does fiber play a major role against diabetes and heart disease, but it fills you up with fewer calories, helping you control your weight. Fruit juices also tend to be high in added sugar. Citrus fruits in particular are loaded with antioxidant, cancer-preventing compounds, and they're bursting with vitamin C, folate and potassium.
Fitness Tip of the day:
Less is more.
Surprise! A few short exercise sessions a day can be as valuable as one longer session. The key to making exercise a habit is to fit it comfortably into your schedule. If you can't find a 30-minute block of time, try three 10-minute stints over the course of the day.
FAQ of the day:
Should I buy fat-free soy milk?
It's not a good idea; fat-free soy milk lacks the beneficial soy isoflavones. If you're concerned about the calories in whole soy milk, switch to 1%.
Friday, January 27, 2006
Health Headlines - January 27
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a new conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
California Declares Secondhand Smoke a Toxic Pollutant
California officials voted Thursday to become the first state to declare secondhand smoke a toxic air pollutant, which puts it in the same category as arsenic, benzene and diesel exhaust.
The unanimous vote by the California Air Resources Board was based on a September report that concluded that young women exposed to secondhand smoke have a 68 percent to 120 percent increased risk of breast cancer, the Associated Press reported.
Secondhand smoke was also linked to other kinds of cancer, asthma, heart disease, premature births, and health problems in children. The report was based on the findings of 1,000 studies of the effects of secondhand smoke.
"If people are serious about breast cancer, they have to deal with secondhand smoke. That's what this is all about," Stanton Glantz, director of the Center for Tobacco Control, Research and Education at the University of California, San Francisco, told the AP.
He called the report, by scientists at California's Office of Environmental Health Hazard Assessment, "a seminal, international document. It's impossible to underestimate what a big deal this is."
EPA Not Collecting Full Data on Lead in Drinking Water: Report
The U.S. Environmental Agency has been dragging its feet in forcing states to collect and report required data on lead levels in drinking water, according to a Washington Post report.
The Government Accountability Office (GAO) study, being released Friday, also found that the EPA has little information on lead levels in drinking water in schools and childcare facilities.
The EPA database doesn't have data on recent test results on more than 30 percent of community water systems in the United States and is missing data on more than 70 percent of water systems, the Post reported.
The lack of proper data, "may be undermining the intended level of public health protection," the GAO noted.
Growing Number of Drug Treatment Patients Started Using at Young Age
A growing number of Americans in treatment for drug abuse began using at least one of their problem drugs before they were 13 years old, according to a report released Thursday by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
In 2003, 14 percent of people (162,708 people) admitted for treatment began using drugs prior to age 13, compared with 12 percent (114,462 people) in 1993, the report said.
The number of patients who started using marijuana before age 13 increased from 20 percent in 1993 to 23 percent in 2003. The number of patients who began using opiates before age 13 increased from 4 percent in 1993 to 5 percent in 2003. Opiates include heroin and prescription pain killers.
The percentage of patient who used cocaine before age 13 declined from 5 percent to 4 percent, and there was also a decline in those who used stimulants (such as methamphetamine) -- from 10 percent to 9 percent.
"Age at first use is an important predictor of the potential for serious substance abuse problems later in life. The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak with their children early and often about the dangers of drug use," Charles Curie, SAMHSA administrator, said in a prepared statement.
Hospitals Need Better Records to Prevent Drug Errors: Alert
U.S. hospitals need to improve their record-keeping and communication in order to prevent drug errors that often occur when patients are discharged or transferred, says an alert issued Wednesday by the Joint Commission on Accreditation of Healthcare Organizations.
Among the recommended improvements: medications and proper doses should be listed in a highly visible location on patient medical charts; that information should be communicated to doctors, nurses and patients during transfers between one hospital unit and another; discharged patients should be given an accurate list of their required medications and instructions for use, the Associated Press reported.
The alert was sent to more than 15,000 hospitals and healthcare organizations in the United States.
Poor record keeping means that patients being transferred or discharged are at risk of getting double doses of drugs, the wrong medication, or incompatible drugs, the commission noted.
It's estimated that medication errors result in the deaths of more than 7,000 hospitalized patients each year in the United States, the AP reported. According to the commission, breakdowns in communication were responsible for 63 percent of reported drug errors that caused death or serious injury.
Pregnancy Increases Snoring
Women are twice as likely than normal to snore during the late stages of pregnancy because their airways tend to be narrower, says an Edinburgh University study.
Researchers found that 41 of 100 pregnant women snored, compared with 17 of 100 non-pregnant women. The increased snoring among pregnant women may be linked with weight gain and pressure on the trachea and lungs caused by the distended abdomen, BBC News reported.
The study also found that women snorers had, on average, a one-centimeter greater neck circumference than non-snorers.
The researchers noted that as pregnant women's airways narrow, their blood pressure increases. High blood pressure is linked to pre-eclampsia. So this study supports previous data that pregnant women who snore have a greater risk of pre-eclampsia, the study authors said.
The findings appear in the European Respiratory Journal.
Food Fact:
A touch of cinnamon.
For diabetes control, a dash of cinnamon may have a surprisingly sweet payoff. Researchers have found it may enhance insulin's ability to metabolize glucose. It's estimated that as little as 1/4 tsp. cinnamon may have a positive effect on blood sugar. Cinnamon is also rich in catechins, which are potentially health-protective, although the catechins in cinnamon are not as well studied as those found in tea. If your cinnamon has been sitting on the shelf for more than a year, toss it out. As with most spices, its flavor goes flat with time.
Fitness Tip of the day:
Patience pays.
If you don't get results right away, don't quit -- buff takes time. When you start an exercise program, don't expect changes overnight. It may be a couple of weeks before you see improvements. Although changes may seem subtle at first, stick with it. Even small amounts of exercise will start you on the road to a better body.
FAQ of the day:
Is tofu a good source of calcium?
Many kinds of tofu are excellent sources of calcium, but not all. If tofu is processed with calcium sulfate -- as most are -- it will have about 260mg of calcium per cup. This calcium is as absorbable by the body as the calcium in milk. But tofu processed with nigiri will have little calcium. Similarly, calcium-fortified soy milk contains 300mg of calcium, the same as a cup of milk, but not all soy milks are fortified. Read the label to be sure.
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a new conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
California Declares Secondhand Smoke a Toxic Pollutant
California officials voted Thursday to become the first state to declare secondhand smoke a toxic air pollutant, which puts it in the same category as arsenic, benzene and diesel exhaust.
The unanimous vote by the California Air Resources Board was based on a September report that concluded that young women exposed to secondhand smoke have a 68 percent to 120 percent increased risk of breast cancer, the Associated Press reported.
Secondhand smoke was also linked to other kinds of cancer, asthma, heart disease, premature births, and health problems in children. The report was based on the findings of 1,000 studies of the effects of secondhand smoke.
"If people are serious about breast cancer, they have to deal with secondhand smoke. That's what this is all about," Stanton Glantz, director of the Center for Tobacco Control, Research and Education at the University of California, San Francisco, told the AP.
He called the report, by scientists at California's Office of Environmental Health Hazard Assessment, "a seminal, international document. It's impossible to underestimate what a big deal this is."
EPA Not Collecting Full Data on Lead in Drinking Water: Report
The U.S. Environmental Agency has been dragging its feet in forcing states to collect and report required data on lead levels in drinking water, according to a Washington Post report.
The Government Accountability Office (GAO) study, being released Friday, also found that the EPA has little information on lead levels in drinking water in schools and childcare facilities.
The EPA database doesn't have data on recent test results on more than 30 percent of community water systems in the United States and is missing data on more than 70 percent of water systems, the Post reported.
The lack of proper data, "may be undermining the intended level of public health protection," the GAO noted.
Growing Number of Drug Treatment Patients Started Using at Young Age
A growing number of Americans in treatment for drug abuse began using at least one of their problem drugs before they were 13 years old, according to a report released Thursday by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
In 2003, 14 percent of people (162,708 people) admitted for treatment began using drugs prior to age 13, compared with 12 percent (114,462 people) in 1993, the report said.
The number of patients who started using marijuana before age 13 increased from 20 percent in 1993 to 23 percent in 2003. The number of patients who began using opiates before age 13 increased from 4 percent in 1993 to 5 percent in 2003. Opiates include heroin and prescription pain killers.
The percentage of patient who used cocaine before age 13 declined from 5 percent to 4 percent, and there was also a decline in those who used stimulants (such as methamphetamine) -- from 10 percent to 9 percent.
"Age at first use is an important predictor of the potential for serious substance abuse problems later in life. The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak with their children early and often about the dangers of drug use," Charles Curie, SAMHSA administrator, said in a prepared statement.
Hospitals Need Better Records to Prevent Drug Errors: Alert
U.S. hospitals need to improve their record-keeping and communication in order to prevent drug errors that often occur when patients are discharged or transferred, says an alert issued Wednesday by the Joint Commission on Accreditation of Healthcare Organizations.
Among the recommended improvements: medications and proper doses should be listed in a highly visible location on patient medical charts; that information should be communicated to doctors, nurses and patients during transfers between one hospital unit and another; discharged patients should be given an accurate list of their required medications and instructions for use, the Associated Press reported.
The alert was sent to more than 15,000 hospitals and healthcare organizations in the United States.
Poor record keeping means that patients being transferred or discharged are at risk of getting double doses of drugs, the wrong medication, or incompatible drugs, the commission noted.
It's estimated that medication errors result in the deaths of more than 7,000 hospitalized patients each year in the United States, the AP reported. According to the commission, breakdowns in communication were responsible for 63 percent of reported drug errors that caused death or serious injury.
Pregnancy Increases Snoring
Women are twice as likely than normal to snore during the late stages of pregnancy because their airways tend to be narrower, says an Edinburgh University study.
Researchers found that 41 of 100 pregnant women snored, compared with 17 of 100 non-pregnant women. The increased snoring among pregnant women may be linked with weight gain and pressure on the trachea and lungs caused by the distended abdomen, BBC News reported.
The study also found that women snorers had, on average, a one-centimeter greater neck circumference than non-snorers.
The researchers noted that as pregnant women's airways narrow, their blood pressure increases. High blood pressure is linked to pre-eclampsia. So this study supports previous data that pregnant women who snore have a greater risk of pre-eclampsia, the study authors said.
The findings appear in the European Respiratory Journal.
Food Fact:
A touch of cinnamon.
For diabetes control, a dash of cinnamon may have a surprisingly sweet payoff. Researchers have found it may enhance insulin's ability to metabolize glucose. It's estimated that as little as 1/4 tsp. cinnamon may have a positive effect on blood sugar. Cinnamon is also rich in catechins, which are potentially health-protective, although the catechins in cinnamon are not as well studied as those found in tea. If your cinnamon has been sitting on the shelf for more than a year, toss it out. As with most spices, its flavor goes flat with time.
Fitness Tip of the day:
Patience pays.
If you don't get results right away, don't quit -- buff takes time. When you start an exercise program, don't expect changes overnight. It may be a couple of weeks before you see improvements. Although changes may seem subtle at first, stick with it. Even small amounts of exercise will start you on the road to a better body.
FAQ of the day:
Is tofu a good source of calcium?
Many kinds of tofu are excellent sources of calcium, but not all. If tofu is processed with calcium sulfate -- as most are -- it will have about 260mg of calcium per cup. This calcium is as absorbable by the body as the calcium in milk. But tofu processed with nigiri will have little calcium. Similarly, calcium-fortified soy milk contains 300mg of calcium, the same as a cup of milk, but not all soy milks are fortified. Read the label to be sure.
Thursday, January 26, 2006
Health Headlines - January 26
Growing Number of Drug Treatment Patients Started Using at Young Age
A growing number of Americans in treatment for drug abuse began using at least one of their problem drugs before they were 13 years old, according to a report released Thursday by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
In 2003, 14 percent of people (162,708 people) admitted for treatment began using drugs prior to age 13, compared with 12 percent (114,462 people) in 1993, the report said.
The number of patients who started using marijuana before age 13 increased from 20 percent in 1993 to 23 percent in 2003. The number of patients who began using opiates before age 13 increased from 4 percent in 1993 to 5 percent in 2003. Opiates include heroin and prescription pain killers.
The percentage of patient who used cocaine before age 13 declined from 5 percent to 4 percent, and there was also a decline in those who used stimulants (such as methamphetamine) -- from 10 percent to 9 percent.
"Age at first use is an important predictor of the potential for serious substance abuse problems later in life. The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak with their children early and often about the dangers of drug use," Charles Curie, SAMHSA administrator, said in a prepared statement.
Hospitals Need Better Records to Prevent Drug Errors: Alert
U.S. hospitals need to improve their record-keeping and communication in order to prevent drug errors that often occur when patients are discharged or transferred, says an alert issued Wednesday by the Joint Commission on Accreditation of Healthcare Organizations.
Among the recommended improvements: medications and proper doses should be listed in a highly visible location on patient medical charts; that information should be communicated to doctors, nurses and patients during transfers between one hospital unit and another; discharged patients should be given an accurate list of their required medications and instructions for use, the Associated Press reported.
The alert was sent to more than 15,000 hospitals and healthcare organizations in the United States.
Poor record keeping means that patients being transferred or discharged are at risk of getting double doses of drugs, the wrong medication, or incompatible drugs, the commission noted.
It's estimated that medication errors result in the deaths of more than 7,000 hospitalized patients each year in the United States, the AP reported. According to the commission, breakdowns in communication were responsible for 63 percent of reported drug errors that caused death or serious injury.
Pregnancy Increases Snoring
Women are twice as likely than normal to snore during the late stages of pregnancy because their airways tend to be narrower, says an Edinburgh University study.
Researchers found that 41 of 100 pregnant women snored, compared with 17 of 100 non-pregnant women. The increased snoring among pregnant women may be linked with weight gain and pressure on the trachea and lungs caused by the distended abdomen, BBC News reported.
The study also found that women snorers had, on average, a one-centimeter greater neck circumference than non-snorers.
The researchers noted that as pregnant women's airways narrow, their blood pressure increases. High blood pressure is linked to pre-eclampsia. So this study supports previous data that pregnant women who snore have a greater risk of pre-eclampsia, the study authors said.
The findings appear in the European Respiratory Journal.
Slow Start for U.S. Health Savings Plans
So far, there's little proof that consumer-directed health savings plans advocated by the White House as a way to control rising medical costs are helping many people deal with the high price of health care, The New York Times reported.
For the most part, employers and workers have been slow to embrace health savings plans, designed to lower businesses' health care expenses and give individuals more control of their medical spending.
The early results seem to confirm the forecasts of those who criticized the health savings plans from the outset. These plans are increasing people's out-of-pocket health costs, which may make them less likely to seek routine preventive care that may head off major health problems later on, The Times reported.
"The savings accounts are not designed to help people pay for health care; they are designed to help employers unload their health care costs," said Pat Schoeni, executive director of the National Coalition on Health Care, which is lobbying for better, more affordable health care in the United States.
Bird Flu Vaccine Trials to Begin in Spring
Clinical trials to test a vaccine against the deadly H5N1 bird flu virus may begin as soon as April, according to an executive with drug maker GlaxoSmithKline.
David Stout, president of pharmaceutical operations, said the vaccine would be tested with two different boosters and initial results should be available about three months later, the Associated Press reported.
The clinical trials are designed to test the safety of the vaccine and to establish the dosage and schedule for core compounds. Production of the vaccine could begin by the end of the year.
Within the next few weeks, Glaxo will start production of its traditional flu vaccine for the next flu season.
"If a pandemic breaks out, we would be able to stop production of the traditional flu vaccine and start production of the pandemic vaccine. We could start production on a risk basis (without regulatory approval) if that was necessary," Stout told the AP.
Skeptics Question New Chinese HIV/AIDS Estimates
A new estimate puts the number of HIV/AIDS cases in China at 650,000, down from the official figures of 840,000 released in 2003 by the Chinese government.
The new tally, conducted with the World Health Organization and the United Nations AIDS program, may suggest a positive trend. However, some experts said they doubted the new figure was any more reliable than past estimates, The New York Times reported.
Even Chinese and International health officials who endorsed the new lower count warned that the rate of HIV infection in China is still increasing. There were 70,000 new cases in 2005.
Drug users and prostitutes are responsible for the majority of HIV transmissions in China, but this new report noted that the disease is spreading from those high-risk groups into the general population. That means an increased risk of broader infection in the country, The Times reported.
One critic of the new report said it's difficult to get an accurate count because many people in China are reluctant to reveal that they have HIV/AIDS.
"Frankly, in all of my experience, the quality of data and the accuracy of the information here is not high enough to have confidence in this new estimate," Odilon Couzin, of Hong Kong-based advocacy group China AIDS Info, told the Times.
Food Fact:
Broccoli vs. cancer.
The veggie's green pigment makes it a potent disease-fighter. Substances called isothiocyanates, found in cruciferous vegetables such as broccoli, stimulate our bodies to break down potential carcinogens. Plus, ounce for ounce, broccoli contains as much calcium as milk. Vegetables in the crucifer family range widely in color, shape and flavor, from squat purple turnips to lanky, leafy nappa cabbage. Most crucifers are strong-flavored and require an assertive seasoning to bring out their best.
Fitness Tip of the day:
Buddy up!
Struggling to stick to your exercise program? Try working out with a partner. Adding a social aspect to your workout helps keep you both motivated and makes sessions more fun. Training with a friend provides mutual support for keeping a regular schedule and pushes you harder to meet your goals.
FAQ of the day:
Will carbs make me fat?
It certainly hasn't worked that way for traditional Asian societies, where carbohydrates can make up as much as 80% of the diet and obesity is rare. Excess calories from any source will lead to weight gain. As for carbohydrates, the key for weight control is to limit consumption of refined grains and sugars, which pack a lot of calories in a portion, and emphasize whole grains rich in fiber, and whole fruits and vegetables, which are very low in calories.
A growing number of Americans in treatment for drug abuse began using at least one of their problem drugs before they were 13 years old, according to a report released Thursday by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
In 2003, 14 percent of people (162,708 people) admitted for treatment began using drugs prior to age 13, compared with 12 percent (114,462 people) in 1993, the report said.
The number of patients who started using marijuana before age 13 increased from 20 percent in 1993 to 23 percent in 2003. The number of patients who began using opiates before age 13 increased from 4 percent in 1993 to 5 percent in 2003. Opiates include heroin and prescription pain killers.
The percentage of patient who used cocaine before age 13 declined from 5 percent to 4 percent, and there was also a decline in those who used stimulants (such as methamphetamine) -- from 10 percent to 9 percent.
"Age at first use is an important predictor of the potential for serious substance abuse problems later in life. The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak with their children early and often about the dangers of drug use," Charles Curie, SAMHSA administrator, said in a prepared statement.
Hospitals Need Better Records to Prevent Drug Errors: Alert
U.S. hospitals need to improve their record-keeping and communication in order to prevent drug errors that often occur when patients are discharged or transferred, says an alert issued Wednesday by the Joint Commission on Accreditation of Healthcare Organizations.
Among the recommended improvements: medications and proper doses should be listed in a highly visible location on patient medical charts; that information should be communicated to doctors, nurses and patients during transfers between one hospital unit and another; discharged patients should be given an accurate list of their required medications and instructions for use, the Associated Press reported.
The alert was sent to more than 15,000 hospitals and healthcare organizations in the United States.
Poor record keeping means that patients being transferred or discharged are at risk of getting double doses of drugs, the wrong medication, or incompatible drugs, the commission noted.
It's estimated that medication errors result in the deaths of more than 7,000 hospitalized patients each year in the United States, the AP reported. According to the commission, breakdowns in communication were responsible for 63 percent of reported drug errors that caused death or serious injury.
Pregnancy Increases Snoring
Women are twice as likely than normal to snore during the late stages of pregnancy because their airways tend to be narrower, says an Edinburgh University study.
Researchers found that 41 of 100 pregnant women snored, compared with 17 of 100 non-pregnant women. The increased snoring among pregnant women may be linked with weight gain and pressure on the trachea and lungs caused by the distended abdomen, BBC News reported.
The study also found that women snorers had, on average, a one-centimeter greater neck circumference than non-snorers.
The researchers noted that as pregnant women's airways narrow, their blood pressure increases. High blood pressure is linked to pre-eclampsia. So this study supports previous data that pregnant women who snore have a greater risk of pre-eclampsia, the study authors said.
The findings appear in the European Respiratory Journal.
Slow Start for U.S. Health Savings Plans
So far, there's little proof that consumer-directed health savings plans advocated by the White House as a way to control rising medical costs are helping many people deal with the high price of health care, The New York Times reported.
For the most part, employers and workers have been slow to embrace health savings plans, designed to lower businesses' health care expenses and give individuals more control of their medical spending.
The early results seem to confirm the forecasts of those who criticized the health savings plans from the outset. These plans are increasing people's out-of-pocket health costs, which may make them less likely to seek routine preventive care that may head off major health problems later on, The Times reported.
"The savings accounts are not designed to help people pay for health care; they are designed to help employers unload their health care costs," said Pat Schoeni, executive director of the National Coalition on Health Care, which is lobbying for better, more affordable health care in the United States.
Bird Flu Vaccine Trials to Begin in Spring
Clinical trials to test a vaccine against the deadly H5N1 bird flu virus may begin as soon as April, according to an executive with drug maker GlaxoSmithKline.
David Stout, president of pharmaceutical operations, said the vaccine would be tested with two different boosters and initial results should be available about three months later, the Associated Press reported.
The clinical trials are designed to test the safety of the vaccine and to establish the dosage and schedule for core compounds. Production of the vaccine could begin by the end of the year.
Within the next few weeks, Glaxo will start production of its traditional flu vaccine for the next flu season.
"If a pandemic breaks out, we would be able to stop production of the traditional flu vaccine and start production of the pandemic vaccine. We could start production on a risk basis (without regulatory approval) if that was necessary," Stout told the AP.
Skeptics Question New Chinese HIV/AIDS Estimates
A new estimate puts the number of HIV/AIDS cases in China at 650,000, down from the official figures of 840,000 released in 2003 by the Chinese government.
The new tally, conducted with the World Health Organization and the United Nations AIDS program, may suggest a positive trend. However, some experts said they doubted the new figure was any more reliable than past estimates, The New York Times reported.
Even Chinese and International health officials who endorsed the new lower count warned that the rate of HIV infection in China is still increasing. There were 70,000 new cases in 2005.
Drug users and prostitutes are responsible for the majority of HIV transmissions in China, but this new report noted that the disease is spreading from those high-risk groups into the general population. That means an increased risk of broader infection in the country, The Times reported.
One critic of the new report said it's difficult to get an accurate count because many people in China are reluctant to reveal that they have HIV/AIDS.
"Frankly, in all of my experience, the quality of data and the accuracy of the information here is not high enough to have confidence in this new estimate," Odilon Couzin, of Hong Kong-based advocacy group China AIDS Info, told the Times.
Food Fact:
Broccoli vs. cancer.
The veggie's green pigment makes it a potent disease-fighter. Substances called isothiocyanates, found in cruciferous vegetables such as broccoli, stimulate our bodies to break down potential carcinogens. Plus, ounce for ounce, broccoli contains as much calcium as milk. Vegetables in the crucifer family range widely in color, shape and flavor, from squat purple turnips to lanky, leafy nappa cabbage. Most crucifers are strong-flavored and require an assertive seasoning to bring out their best.
Fitness Tip of the day:
Buddy up!
Struggling to stick to your exercise program? Try working out with a partner. Adding a social aspect to your workout helps keep you both motivated and makes sessions more fun. Training with a friend provides mutual support for keeping a regular schedule and pushes you harder to meet your goals.
FAQ of the day:
Will carbs make me fat?
It certainly hasn't worked that way for traditional Asian societies, where carbohydrates can make up as much as 80% of the diet and obesity is rare. Excess calories from any source will lead to weight gain. As for carbohydrates, the key for weight control is to limit consumption of refined grains and sugars, which pack a lot of calories in a portion, and emphasize whole grains rich in fiber, and whole fruits and vegetables, which are very low in calories.
Wednesday, January 25, 2006
Health Headlines - January 25
States to be Fully Reimbursed for Medicare Drug Costs
The U.S. federal government said Tuesday that states will be fully reimbursed for prescription drug payments they made that should have been covered by the new Medicare program.
Dozens of states are spending millions of dollars a day to help low-income people unable to get their prescription drugs under the program, which took effect Jan. 1.
Tuesday's announcement by the Bush administration was made in response to the political uproar over the problems plaguing the new Medicare drug program, The New York Times reported.
The federal government will use its influence to ensure that private insurers under contract to Medicare reimburse states for the cost of drug claims that the insurers should have paid.
The federal government will also reimburse states that have paid more for drugs than what the private plans would repay them and will also cover administrative costs incurred by states, the Times reported.
Through Feb. 15, states will be reimbursed for prescription drugs provided to low-income Medicare beneficiaries. The reimbursement program would end Feb. 15 because problems with the new drug program will be corrected by then, federal officials said.
Drug Companies Will Boost Flu Vaccine Production
Drug companies in the United States plan to boost flu vaccine production to as many as 120 million doses for next year's flu season, an amount that far surpasses the record of 95 million doses produced in 2002, the Associated Press reported.
The move is in response to expected rising demand for flu shots caused by public fears about bird flu, increased government reimbursement for flu shots, and indications that the federal government may eventually recommend flu shots for nearly all people in the United States.
The plans for increased production could mean there will be no more of the flu vaccine shortages that have occurred in the United States for the past three autumns, the AP reported.
"We and other manufacturers are making the investments to ensure that there will be sustainable supplies going forward," Andrew MacKnight, executive director of vaccine supply for GlaxoSmithKline, said Tuesday at a flu vaccine summit meeting in Atlanta.
The planned boost in flu vaccine production is good news, said a spokesman for the U.S. Centers for Disease Control and Prevention.
Jury Selection Made for Fourth Vioxx Trial
A jury of 10 men and two women was selected Tuesday to hear the fourth Vioxx trail in the United States.
The case involves a lawsuit filed in Texas by the family of 71-year-old Leonel Garza, who suffered a fatal heart attack in 2001, after taking Vioxx for 17 days. The jury will have to decide whether the drug played a role in his death or whether he died as the result of 23 years of heart disease.
The jury selection was made late Tuesday after attorneys spent a long day questioning prospective jurors, the Associated Press reported. Several jurors were dismissed because they knew the plaintiffs or had experienced recent deaths in their families.
"The dispute is a very simple one. It is whether Vioxx played any role whatsoever in the death of Leonel Garza," defense attorney Richard Josephson said.
David Hockema, the plaintiff's lawyer, said Garza was the last person who should have been given Vioxx, given his heart condition, the AP reported.
Critics Denounce EPA Criteria for Pesticide Tests on Humans
Some members of Congress are harshly critical of how the U.S. Environmental Protection Agency is establishing the first-ever guidelines for human pesticide testing, the Associated Press reported.
The EPA won't allow intentional pesticide dosing studies of children and pregnant women, according to Susan Hazen, the agency's principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances.
Nonetheless, the EPA's rules are being denounced by three California Democrats -- Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis -- who have seen the final draft of the EPA criteria, the AP said.
Boxer said the EPA rule still allows tests on pregnant women and children as long as pesticide companies can convince the EPA that they didn't intend to submit the results of those studies when they began them.
"The fact that the EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
Magnetic Method Tracks Organ Rejection
Magnetic tracking of immune cells may eventually prove an effective way of checking for signs of rejection in transplanted organs, concludes a study led by researchers at Carnegie Mellon University.
The scientists found that it was possible to tag immune cells with iron oxide and then use magnetic resonance imaging (MRI) to track the cells. Accumulation of immune cells in a transplanted organ can indicate whether the body is rejecting it, the Associated Press reported.
The findings appear in the latest issue of the journal Proceedings of the National Academy of Sciences.
For this study, the scientists tagged immune cells called macrophages with iron oxide particles. The immune cells were then injected into mice that had undergone heart transplants three days earlier.
MRI was used to track the immune cells and observe what happened as the mice rejected the new hearts.
UCI Transplant Program Rejected Many Kidneys: Report
Even though as many as 150 people were on a waiting list, the kidney transplant program at the University of California, Irvine Medical Center turned down numerous kidneys over the last five years, the Los Angeles Times reported.
A Times analysis of UCI data found that many patients on the waiting list would have had a much better chance of receiving a kidney if they'd gone to other hospitals.
The review showed that between July 2000 and June 2005, the UCI Medical Center accepted only 8.7 percent of the kidneys offered for its patients. That's far lower than the median annual acceptance rate of 25.9 percent to 31.2 percent across the United States over the same period.
During those five years, about 35 patients died while waiting for kidney transplants at UCI. It's not clear how many kidneys were offered for those patients or whether they would have survived if they had received a new kidney, the Times reported.
The problems uncovered by the Times echo troubles that led to the closure of UCI Medical Center's liver transplant program in November 2005.
Food Fact:
Balanced diet?
Eat more blueberries, and you may be less prone to falls. Researchers at Tufts University fed antioxidant-rich extracts of blueberries, strawberries or spinach to rats for eight months -- and those that received blueberry extracts displayed better balance when walking over small rods. Similarly, the deep blue color of this all-American berry comes from anthocyanin, a powerful plant pigment believed to reduce some of the cognitive problems associated with aging.
Fitness Tip of the day:
Lift weights, lose weight.
Marilyn Monroe knew it, and you should, too: For good health and a great shape, dumbbells are a girl's best friend. Dieters who lift weights and eat well lose more body fat, and feel stronger and more flexible. Lifting weights as you diet makes it easier to shed pounds; increased muscle mass will boost your metabolic rate over time, allowing you to burn calories even at rest. It also gives your muscles a tight, firm appearance.
FAQ of the day:
Is a "plant-based" diet the same as "vegetarian"?
Nutritionists use the term "plant-based" for a diet that gets most of its calories from plant foods, but may include some animal foods. In some parts of the world, what nutritionists have called plant-based diets will include red meat like beef or pork, but eaten rarely, or in very small amounts. Vegan diets, which include no foods of animal origin, are plant-based by definition. So are lacto-ovo-vegetarian diets, which include dairy foods and eggs, as well as diets that include fish, shellfish and poultry. Population studies have demonstrated a significant link between plant-based foods (whole grains, vegetables, fruits, beans, soy) and a reduced risk of developing cancer and coronary heart disease.
The U.S. federal government said Tuesday that states will be fully reimbursed for prescription drug payments they made that should have been covered by the new Medicare program.
Dozens of states are spending millions of dollars a day to help low-income people unable to get their prescription drugs under the program, which took effect Jan. 1.
Tuesday's announcement by the Bush administration was made in response to the political uproar over the problems plaguing the new Medicare drug program, The New York Times reported.
The federal government will use its influence to ensure that private insurers under contract to Medicare reimburse states for the cost of drug claims that the insurers should have paid.
The federal government will also reimburse states that have paid more for drugs than what the private plans would repay them and will also cover administrative costs incurred by states, the Times reported.
Through Feb. 15, states will be reimbursed for prescription drugs provided to low-income Medicare beneficiaries. The reimbursement program would end Feb. 15 because problems with the new drug program will be corrected by then, federal officials said.
Drug Companies Will Boost Flu Vaccine Production
Drug companies in the United States plan to boost flu vaccine production to as many as 120 million doses for next year's flu season, an amount that far surpasses the record of 95 million doses produced in 2002, the Associated Press reported.
The move is in response to expected rising demand for flu shots caused by public fears about bird flu, increased government reimbursement for flu shots, and indications that the federal government may eventually recommend flu shots for nearly all people in the United States.
The plans for increased production could mean there will be no more of the flu vaccine shortages that have occurred in the United States for the past three autumns, the AP reported.
"We and other manufacturers are making the investments to ensure that there will be sustainable supplies going forward," Andrew MacKnight, executive director of vaccine supply for GlaxoSmithKline, said Tuesday at a flu vaccine summit meeting in Atlanta.
The planned boost in flu vaccine production is good news, said a spokesman for the U.S. Centers for Disease Control and Prevention.
Jury Selection Made for Fourth Vioxx Trial
A jury of 10 men and two women was selected Tuesday to hear the fourth Vioxx trail in the United States.
The case involves a lawsuit filed in Texas by the family of 71-year-old Leonel Garza, who suffered a fatal heart attack in 2001, after taking Vioxx for 17 days. The jury will have to decide whether the drug played a role in his death or whether he died as the result of 23 years of heart disease.
The jury selection was made late Tuesday after attorneys spent a long day questioning prospective jurors, the Associated Press reported. Several jurors were dismissed because they knew the plaintiffs or had experienced recent deaths in their families.
"The dispute is a very simple one. It is whether Vioxx played any role whatsoever in the death of Leonel Garza," defense attorney Richard Josephson said.
David Hockema, the plaintiff's lawyer, said Garza was the last person who should have been given Vioxx, given his heart condition, the AP reported.
Critics Denounce EPA Criteria for Pesticide Tests on Humans
Some members of Congress are harshly critical of how the U.S. Environmental Protection Agency is establishing the first-ever guidelines for human pesticide testing, the Associated Press reported.
The EPA won't allow intentional pesticide dosing studies of children and pregnant women, according to Susan Hazen, the agency's principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances.
Nonetheless, the EPA's rules are being denounced by three California Democrats -- Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis -- who have seen the final draft of the EPA criteria, the AP said.
Boxer said the EPA rule still allows tests on pregnant women and children as long as pesticide companies can convince the EPA that they didn't intend to submit the results of those studies when they began them.
"The fact that the EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
Magnetic Method Tracks Organ Rejection
Magnetic tracking of immune cells may eventually prove an effective way of checking for signs of rejection in transplanted organs, concludes a study led by researchers at Carnegie Mellon University.
The scientists found that it was possible to tag immune cells with iron oxide and then use magnetic resonance imaging (MRI) to track the cells. Accumulation of immune cells in a transplanted organ can indicate whether the body is rejecting it, the Associated Press reported.
The findings appear in the latest issue of the journal Proceedings of the National Academy of Sciences.
For this study, the scientists tagged immune cells called macrophages with iron oxide particles. The immune cells were then injected into mice that had undergone heart transplants three days earlier.
MRI was used to track the immune cells and observe what happened as the mice rejected the new hearts.
UCI Transplant Program Rejected Many Kidneys: Report
Even though as many as 150 people were on a waiting list, the kidney transplant program at the University of California, Irvine Medical Center turned down numerous kidneys over the last five years, the Los Angeles Times reported.
A Times analysis of UCI data found that many patients on the waiting list would have had a much better chance of receiving a kidney if they'd gone to other hospitals.
The review showed that between July 2000 and June 2005, the UCI Medical Center accepted only 8.7 percent of the kidneys offered for its patients. That's far lower than the median annual acceptance rate of 25.9 percent to 31.2 percent across the United States over the same period.
During those five years, about 35 patients died while waiting for kidney transplants at UCI. It's not clear how many kidneys were offered for those patients or whether they would have survived if they had received a new kidney, the Times reported.
The problems uncovered by the Times echo troubles that led to the closure of UCI Medical Center's liver transplant program in November 2005.
Food Fact:
Balanced diet?
Eat more blueberries, and you may be less prone to falls. Researchers at Tufts University fed antioxidant-rich extracts of blueberries, strawberries or spinach to rats for eight months -- and those that received blueberry extracts displayed better balance when walking over small rods. Similarly, the deep blue color of this all-American berry comes from anthocyanin, a powerful plant pigment believed to reduce some of the cognitive problems associated with aging.
Fitness Tip of the day:
Lift weights, lose weight.
Marilyn Monroe knew it, and you should, too: For good health and a great shape, dumbbells are a girl's best friend. Dieters who lift weights and eat well lose more body fat, and feel stronger and more flexible. Lifting weights as you diet makes it easier to shed pounds; increased muscle mass will boost your metabolic rate over time, allowing you to burn calories even at rest. It also gives your muscles a tight, firm appearance.
FAQ of the day:
Is a "plant-based" diet the same as "vegetarian"?
Nutritionists use the term "plant-based" for a diet that gets most of its calories from plant foods, but may include some animal foods. In some parts of the world, what nutritionists have called plant-based diets will include red meat like beef or pork, but eaten rarely, or in very small amounts. Vegan diets, which include no foods of animal origin, are plant-based by definition. So are lacto-ovo-vegetarian diets, which include dairy foods and eggs, as well as diets that include fish, shellfish and poultry. Population studies have demonstrated a significant link between plant-based foods (whole grains, vegetables, fruits, beans, soy) and a reduced risk of developing cancer and coronary heart disease.
Tuesday, January 24, 2006
Health Headlines - January 24
Critics Denounce EPA Criteria for Pesticide Tests on Humans
Some members of Congress are harshly critical of how the U.S. Environmental Protection Agency is establishing the first-ever guidelines for human pesticide testing, the Associated Press reported.
The EPA won't allow intentional pesticide dosing studies of children and pregnant women, according to Susan Hazen, the agency's principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances.
Nonetheless, the EPA's rules are being denounced by three California Democrats -- Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis -- who have seen the final draft of the EPA criteria, the AP said.
Boxer said the EPA rule still allows tests on pregnant women and children as long as pesticide companies can convince the EPA that they didn't intend to submit the results of those studies when they began them.
"The fact that the EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
Magnetic Method Tracks Organ Rejection
Magnetic tracking of immune cells may eventually prove an effective way of checking for signs of rejection in transplanted organs, concludes a study led by researchers at Carnegie Mellon University.
The scientists found that it was possible to tag immune cells with iron oxide and then use magnetic resonance imaging (MRI) to track the cells. Accumulation of immune cells in a transplanted organ can indicate whether the body is rejecting it, the Associated Press reported.
The findings appear in the latest issue of the journal Proceedings of the National Academy of Sciences.
For this study, the scientists tagged immune cells called macrophages with iron oxide particles. The immune cells were then injected into mice that had undergone heart transplants three days earlier.
MRI was used to track the immune cells and observe what happened as the mice rejected the new hearts.
UCI Transplant Program Rejected Many Kidneys
Even though 150 people at a time were on a waiting list, the kidney transplant program at the University of California, Irvine Medical Center turned down numerous kidneys over the last five years, the Los Angeles Times reported.
A Times analysis of UCI data also found that many patients on the hospital's waiting list would have had a much better chance of receiving a kidney if they'd gone to other hospitals.
The review showed that between July 2000 and June 2005, the UCI Medical Center accepted only 8.7 percent of the kidneys offered for its patients. That's far lower than the median annual acceptance rate of 25.9 percent to 31.2 percent across the United States over the same period.
During those five years, about 35 patients died while waiting for kidney transplants at UCI. It's not clear how many kidneys were offered for those patients or whether they would have survived if they had received a new kidney, the Times reported.
The problems uncovered by the Times echo troubles that led to the closure of UCI Medical Center's liver transplant program in November 2005.
Lawsuit Alleges Medtronic Gave Illegal Payments to Doctors
U.S. medical device maker Medtronic paid tens of millions of dollars to surgeons in the form of consulting contracts in recent years, and some of these payments were made to gain or keep the doctors' business, a lawsuit filed against the company alleges.
The suit, launched by a former Medtronic employee who turned whistle-blower, accuses the company of giving spine surgeons "excessive enumeration, unlawful perquisites and bribes in other forms for purchasing goods and medical devices," The New York Times reported.
For example, Medtronic allegedly paid a Wisconsin surgeon $400,000 a year for a consulting contract that required him to work just eight days. And a doctor in Virginia reportedly was paid nearly $700,000 in consulting fees for the first nine months of 2005, The Times said.
Internal company documents filed with the lawsuit reveal that Medtronic paid at least $50 million to doctors over about four years, through June or later in 2005, the newspaper said. Such payments are illegal when they're linked to a doctor's use of a particular product. Federal law prohibits payments and other benefits to doctors if the payments are meant to induce doctors to use a company's products.
Doctors named in the lawsuit who were reached for comment said the payments they received from Medtronic were appropriate and fair compensation for the work they did. Medtronic declined direct comment on the accusations.
FDA Panel Recommends Approval of OTC Fat-Blocking Drug
A U.S. Food and Drug Administration advisory panel voted 11-3 Monday to recommend approving over-the-counter sales of a nonprescription form of the fat-blocking pill orlistat.
If the full FDA follows the committee's recommendation, the OTC drug could be available within the next few months and would be the first such weight-loss pill to win FDA approval, the Associated Press reported.
Drugmaker GlaxoSmithKline said it would instruct people to use the OTC version of orlistat -- marketed as Alli -- for only six months at a time as part of an overall diet and exercise program.
When taken with meals, orlistat blocks absorption of about 25 percent of any fat consumed, and that fat is then passed out of the body in stools. In clinical trials of the drug, about half of the participants suffered gastrointestinal side effects such as fecal incontinence, gas, and oily discharge.
The FDA advisory panel said that, if Alli is approved for sale in the U.S., Glaxo should conduct follow-up studies and rework the label in order to ensure proper use of the drug, the AP reported.
Glaxo's application was opposed by the watchdog group Public Citizen. Group spokesman Dr. Sidney Wolfe called it a, "desperate attempt to revive this barely effective drug by an OTC switch."
Childhood Heart Repairs May Begin to Fail in Adulthood
Many adults who had childhood surgery to repair lethal heart defects are unaware that those repairs may start to fail as they approach middle age, experts warn.
These patients believe they were cured and don't bother to get cardiac checkups. In addition, few cardiologists outside of children's hospitals know how to monitor these kinds of heart conditions, the Associated Press reported.
Open-heart surgery to repair heart defects in babies and young children only became common in the 1970s. Doctors have started to notice a disturbing trend among survivors of those surgeries as they reach adulthood.
Evidence suggests that about 20 years after childhood heart surgery, there's increasing risk for serious problems, including enlarged hearts, irregular heartbeats, heart failure, and even sudden death, the AP reported.
If these problems are detected at an early stage, they are treatable or even preventable. However, many of these patients suffer major heart damage by the time a doctor makes the connection between a repaired heart and an adulthood illness, said Dr. Roberta Williams of the American College of Cardiology.
Food Fact:
Go bananas.
Smart bakers have a bunch of tricks for cutting fat using this versatile fruit. Mash very ripe bananas into a puree, and you can use it to replace half to 3/4 of the fat in your favorite muffin or quick bread recipe. As if that alone wasn't enough of a heart-healthy improvement, bananas are chock full of potassium, which helps regulate blood pressure. Just be aware they're a little high in calories and sugar compared to most other fruits -- a medium-sized banana has about 110 calories, a "super-sized" one may have twice that.
Fitness Tip of the day:
Lobby cardio.
If you're running late on a business trip and can't get to the gym, "hallway laps" can fill the exercise gap. Lace up your sneakers and jog in the halls at times when you won't disturb other guests. Or, take the stairs -- walk to a room on the 15th floor and you won't need to reserve a stair climber in the gym. Even if it's twice as difficult to squeeze in exercise as during a normal workday, on a business trip it's twice as important. A workout on the road boosts your energy, creativity and effectiveness.
FAQ of the day:
Is grilling safe?
Grilling, broiling and barbecuing creates compounds in meat that may increase risk of cancers of the stomach, colon and rectum. Some stem from burning fat, while others are inside highly heated meat. Char-broiled foods are the worst offenders. You can substantially reduce the levels of these potential carcinogens by marinating the meat beforehand, and then cooking it on a cooler part of the grill. If any meat gets charred, scrape it off before serving. This advice also applies to chicken and fish.
Some members of Congress are harshly critical of how the U.S. Environmental Protection Agency is establishing the first-ever guidelines for human pesticide testing, the Associated Press reported.
The EPA won't allow intentional pesticide dosing studies of children and pregnant women, according to Susan Hazen, the agency's principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances.
Nonetheless, the EPA's rules are being denounced by three California Democrats -- Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis -- who have seen the final draft of the EPA criteria, the AP said.
Boxer said the EPA rule still allows tests on pregnant women and children as long as pesticide companies can convince the EPA that they didn't intend to submit the results of those studies when they began them.
"The fact that the EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
Magnetic Method Tracks Organ Rejection
Magnetic tracking of immune cells may eventually prove an effective way of checking for signs of rejection in transplanted organs, concludes a study led by researchers at Carnegie Mellon University.
The scientists found that it was possible to tag immune cells with iron oxide and then use magnetic resonance imaging (MRI) to track the cells. Accumulation of immune cells in a transplanted organ can indicate whether the body is rejecting it, the Associated Press reported.
The findings appear in the latest issue of the journal Proceedings of the National Academy of Sciences.
For this study, the scientists tagged immune cells called macrophages with iron oxide particles. The immune cells were then injected into mice that had undergone heart transplants three days earlier.
MRI was used to track the immune cells and observe what happened as the mice rejected the new hearts.
UCI Transplant Program Rejected Many Kidneys
Even though 150 people at a time were on a waiting list, the kidney transplant program at the University of California, Irvine Medical Center turned down numerous kidneys over the last five years, the Los Angeles Times reported.
A Times analysis of UCI data also found that many patients on the hospital's waiting list would have had a much better chance of receiving a kidney if they'd gone to other hospitals.
The review showed that between July 2000 and June 2005, the UCI Medical Center accepted only 8.7 percent of the kidneys offered for its patients. That's far lower than the median annual acceptance rate of 25.9 percent to 31.2 percent across the United States over the same period.
During those five years, about 35 patients died while waiting for kidney transplants at UCI. It's not clear how many kidneys were offered for those patients or whether they would have survived if they had received a new kidney, the Times reported.
The problems uncovered by the Times echo troubles that led to the closure of UCI Medical Center's liver transplant program in November 2005.
Lawsuit Alleges Medtronic Gave Illegal Payments to Doctors
U.S. medical device maker Medtronic paid tens of millions of dollars to surgeons in the form of consulting contracts in recent years, and some of these payments were made to gain or keep the doctors' business, a lawsuit filed against the company alleges.
The suit, launched by a former Medtronic employee who turned whistle-blower, accuses the company of giving spine surgeons "excessive enumeration, unlawful perquisites and bribes in other forms for purchasing goods and medical devices," The New York Times reported.
For example, Medtronic allegedly paid a Wisconsin surgeon $400,000 a year for a consulting contract that required him to work just eight days. And a doctor in Virginia reportedly was paid nearly $700,000 in consulting fees for the first nine months of 2005, The Times said.
Internal company documents filed with the lawsuit reveal that Medtronic paid at least $50 million to doctors over about four years, through June or later in 2005, the newspaper said. Such payments are illegal when they're linked to a doctor's use of a particular product. Federal law prohibits payments and other benefits to doctors if the payments are meant to induce doctors to use a company's products.
Doctors named in the lawsuit who were reached for comment said the payments they received from Medtronic were appropriate and fair compensation for the work they did. Medtronic declined direct comment on the accusations.
FDA Panel Recommends Approval of OTC Fat-Blocking Drug
A U.S. Food and Drug Administration advisory panel voted 11-3 Monday to recommend approving over-the-counter sales of a nonprescription form of the fat-blocking pill orlistat.
If the full FDA follows the committee's recommendation, the OTC drug could be available within the next few months and would be the first such weight-loss pill to win FDA approval, the Associated Press reported.
Drugmaker GlaxoSmithKline said it would instruct people to use the OTC version of orlistat -- marketed as Alli -- for only six months at a time as part of an overall diet and exercise program.
When taken with meals, orlistat blocks absorption of about 25 percent of any fat consumed, and that fat is then passed out of the body in stools. In clinical trials of the drug, about half of the participants suffered gastrointestinal side effects such as fecal incontinence, gas, and oily discharge.
The FDA advisory panel said that, if Alli is approved for sale in the U.S., Glaxo should conduct follow-up studies and rework the label in order to ensure proper use of the drug, the AP reported.
Glaxo's application was opposed by the watchdog group Public Citizen. Group spokesman Dr. Sidney Wolfe called it a, "desperate attempt to revive this barely effective drug by an OTC switch."
Childhood Heart Repairs May Begin to Fail in Adulthood
Many adults who had childhood surgery to repair lethal heart defects are unaware that those repairs may start to fail as they approach middle age, experts warn.
These patients believe they were cured and don't bother to get cardiac checkups. In addition, few cardiologists outside of children's hospitals know how to monitor these kinds of heart conditions, the Associated Press reported.
Open-heart surgery to repair heart defects in babies and young children only became common in the 1970s. Doctors have started to notice a disturbing trend among survivors of those surgeries as they reach adulthood.
Evidence suggests that about 20 years after childhood heart surgery, there's increasing risk for serious problems, including enlarged hearts, irregular heartbeats, heart failure, and even sudden death, the AP reported.
If these problems are detected at an early stage, they are treatable or even preventable. However, many of these patients suffer major heart damage by the time a doctor makes the connection between a repaired heart and an adulthood illness, said Dr. Roberta Williams of the American College of Cardiology.
Food Fact:
Go bananas.
Smart bakers have a bunch of tricks for cutting fat using this versatile fruit. Mash very ripe bananas into a puree, and you can use it to replace half to 3/4 of the fat in your favorite muffin or quick bread recipe. As if that alone wasn't enough of a heart-healthy improvement, bananas are chock full of potassium, which helps regulate blood pressure. Just be aware they're a little high in calories and sugar compared to most other fruits -- a medium-sized banana has about 110 calories, a "super-sized" one may have twice that.
Fitness Tip of the day:
Lobby cardio.
If you're running late on a business trip and can't get to the gym, "hallway laps" can fill the exercise gap. Lace up your sneakers and jog in the halls at times when you won't disturb other guests. Or, take the stairs -- walk to a room on the 15th floor and you won't need to reserve a stair climber in the gym. Even if it's twice as difficult to squeeze in exercise as during a normal workday, on a business trip it's twice as important. A workout on the road boosts your energy, creativity and effectiveness.
FAQ of the day:
Is grilling safe?
Grilling, broiling and barbecuing creates compounds in meat that may increase risk of cancers of the stomach, colon and rectum. Some stem from burning fat, while others are inside highly heated meat. Char-broiled foods are the worst offenders. You can substantially reduce the levels of these potential carcinogens by marinating the meat beforehand, and then cooking it on a cooler part of the grill. If any meat gets charred, scrape it off before serving. This advice also applies to chicken and fish.
Monday, January 23, 2006
Health Headlines - January 23
Poor Planning Doomed Medicare Drug Plan Launch, Critics Charge
Earlier this month, a Medicaid recipient on four different heart medications was denied coverage for her life-saving prescriptions by her pharmacy in New York City.
Ideally, the woman should have been automatically transitioned from Medicaid-based coverage to Medicare's new drug benefit plan, which launched Jan. 1. Instead, her pharmacist told her he could no longer find any record of her in the system.
Desperate, she contacted the Medicare Rights Center, a nonprofit group that advocates on behalf of seniors and the disabled covered by the plan.
"There's literally hundreds of cases like just this in our office, right now," said Robert Hayes, the group's president.
Contacting Medicare's regional office in lower Manhattan, Hayes struggled to untangle the bureaucratic logjams that are preventing this patient and hundreds like her from getting the drugs they need.
"The response I got was, 'Well, give us their names,' " Hayes said. "But, they had had those names for eight or nine days."
A worker at the center said the outcome of the heart patient's case remains uncertain.
Tens of thousands of Medicare and Medicaid patients across the country have been encountering scenes like these ever since the roll-out of Medicare's Part D drug benefit, which was designed to provide cash-strapped seniors with low-cost medications through link ups with private insurers.
The biggest glitch? "Dual eligibles" -- Medicaid recipients like the woman above who also qualify for the new drug benefit -- were auto-enrolled by the agency into a private Part D plan. But some also went ahead and chose another plan in the run-up to the Jan. 1 deadline. The result? Data regarding their choice of a private plan made it into the system, but information as to their ongoing status as an eligible Medicaid/Medicare recipient did not.
Another problem: Beneficiaries switched to a new plan only to realize that it did not cover a brand-name drug they were taking. Under Part D rules, the new plan was required to cover the drug for a 30-day period, but this didn't always happen.
Scrambling, officials in 20 states passed short-term, emergency measures to pay pharmacists with state funds so that locked-out enrollees could get their drugs. And on Jan. 15, the White House ordered insurers to supply all beneficiaries in need with a 30-day supply of medications, no matter what. That measure might be extended if deemed necessary, federal officials said.
Medicare's critics say it just didn't have to be this way.
"It didn't have to be such a hassle," said Bill Vaughan, a health lobbyist and senior policy analyst at Washington, D.C.-based Consumers Union, which publishes Consumer Reports. He criticized the federal government for what he called its "breathtaking arrogance" in rushing the plan to the public.
Vaughan pointed to a 2004 study from the government's own Medicare Payment Advisory Commission, which found that transferring large numbers of patient files from one large insurer to another can take an average of six months.
"But here you have people in Part D signing up beginning on Nov. 15th for a program that starts Jan. 1 -- with some people even signing up Dec. 31st. And you expect them to get a prescription by January 2nd? It just won't work," Vaughan said.
A Medicare spokesman said that his agency was hamstrung by the law that created Part D. "You have to remember that Congress created the Part D program to begin January 1, 2006," Peter Ashkenaz said from his Washington, D.C. office. "So we put all the contingencies in place to handle as much as we did."
And he added that enrollment in the new plan has been high.
"Enrollment numbers issued earlier this week showed that we've got about 24 million people who are now receiving Part D drug coverage," Ashkenaz said in an interview Friday. "Roughly 20 million of them are receiving them through Part D plans -- stand alone plans, Medicare advantage plans or employer programs. We saw enrollment rise from a million the first couple of weeks to 3.6 million as of the 13th of January."
According to Ashkenaz, the biggest modification of Medicare in its 40-year history was bound to encounter a bump or two, and he said that millions of beneficiaries are getting their drugs just as easily as before.
He also noted that the new system does have a built-in "safety net."
"If a beneficiary is found not to be in a plan, the pharmacist has the ability to sign that 'dual-eligible' up to a plan right there at the counter -- it's a plan offered by Wellpoint, the only national plan that's authorized to receive auto-enrollments from low-income beneficiaries," he said.
Still, Hayes believes more could have been done. He said he personally warned Mark McClellan, Administrator of the federal Centers for Medicare and Medicaid Services, that the launch as planned couldn't go smoothly. Early last year, he said, "I was sitting in McClellan's office and I said, 'Look, even if you get this transition 99 percent right for the people losing Medicaid coverage, you're still going to have 64,000 people without drug coverage come Jan. 1.' And [McClellan] said 'No, we have everything under control.' "
The emergency relief now offered by the states provides beneficiaries with some form of safety net, Hayes said, though it's "a little late, and a little chaotic."
Ashkenaz' response: "Look, we are concerned if even a single beneficiary doesn't get the drugs they need. But we have the fallback system with Wellpoint, and we're working through the data systems to ensure that beneficiaries are able to get those drugs."
Others contend the system could have been designed better. New York City-based "information designer" Leslie Smolan works with big business to smooth out complex logistical bottlenecks.
She blamed the current Medicare problems on the fact that patient information remains split among the agency, doctors, pharmacies and insurance plans -- each with its own computer system and "language."
Better, centralized design that allowed every player in the process to share the same codes, programming and language would have prevented a lot of pain for the public, Smolan said. So would have more "beta testing" of the plan itself. "It's what any business creating any kind of product would do -- make sure it works, then roll it out," she said. "Now, it's just damage control."
But Ashkenaz said most of its partners have worked hard to merge their systems with Medicare's. "I talked to a 500-bed nursing home yesterday that said, 'We began preparing for Part D a year ago. We made sure then that our pharmacy was going to be able to talk to all of the plans.' "
Experts on both sides stressed that most of those who've enrolled have managed to get their medications without a problem, and Vaughan noted that the country has seen these types of first-year jitters during other major program launches.
In 1974, he noted, the federal government merged welfare programs for the aged, disabled and blind into what is now Social Security.
"In the first couple weeks, the system was so screwed up, The New York Times ran pictures of mounted police defending Social Security offices from people throwing bricks at the windows," he said.
"So, we've been here before," Vaughan noted. "This will get better and the system will shake out."
Heart Tests, Treatments May Be Overused
Doctors are using more and more tests and procedures to help detect and treat heart disease, even though the incidence of the illness isn't rising all that much, new studies show.
"I do believe that some of it is being done needlessly," said F. Lee Lucas, associate director of the Maine Medical Center's Outcomes Research and Evaluation, and lead author of a report in the Jan. 24 issue of Circulation.
Looking at Medicare records, Lucas and her colleagues found that from 1993 to 2001, U.S. doctors charted a nearly three-fold increase in the number of imaging stress tests ordered and more than a seven-fold increase in the use of coronary stents, the flexible tubes used to open narrow blood vessels in the heart.
"However, heart attack, by contrast, has not been increasing in any dramatic way," Lucas said. "So, we do not believe that the large increase in cardiac procedures reflects an underlying increase in coronary heart disease."
A report in the same journal on a study led by physicians at the University of Toronto found that annual costs for cardiac tests and bypass surgery nearly doubled in Canada between 1992 and 2001, outstripping "both demographic shifts and changes in the prevalence of coronary artery disease."
"The proliferation of cardiac testing challenges the sustainability of Medicare in Canada, especially given uncertainty as to whether the accompanying incremental rise in total expenditures translates into significant outcome benefits in the population," the researchers wrote.
In the United States, there has been a slight decrease in bypass surgery, Lucas said. "The rate has leveled off and will stay leveled off," she said.
But other procedures -- such as the insertion of catheters, flexible tubes used to open arteries, and stents, metal tubes designed to keep arteries open -- are being done more often, Lucas said.
"My basic feeling is that the rate of catheterization and coronary procedures such as stenting continues to increase," she said. "Some analyses show more than a linear increase. The trend is accelerating. Although this paper doesn't say so, I don't expect to see any leveling off based on what we see in the data."
The belief that many procedures are being done needlessly comes from a related study by the Maine group, Lucas said. "What we were able to show was that in areas where the rate is higher, the extra procedures are not targeted at the people who need them most," she said. "People get them equally, despite their risk."
The American Heart Association and the American College of Cardiology have separated patients into several classes, Lucas noted. "Class three includes those in whom the procedures are contraindicated, such as the terminally ill, who do not derive benefit from the procedure," she said. "What we showed is that the rate at which cardiac catherizations are being given is higher among all the subgroups, including those for whom it is contraindicated."
However, these two studies don't show whether the procedures are overused or done on patients who don't really need them, said Dr. Sidney C. Smith Jr., professor of medicine at the University of North Carolina and a spokesman for the American Heart Association.
"Nothing in either paper deals directly with appropriateness," Smith said, adding, "We need to be sure that we use these procedures appropriately and that all who might benefit from them receive them."
Until further studies are done to determine whether too many procedures are being done, prevention still should be key, he said.
"Cardiovascular disease is largely preventable," Smith said. "The issue can be resolved by better and increased use of preventive measures -- exercise, control of blood pressure, control of lipid abnormalities, weight loss when necessary. We wouldn't have to worry about the need for extensive procedures if these measures were taken by more people."
FDA Panel Approves OTC Weight-Loss Pill
A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final FDA approval before it can sell the nonprescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults as use as a weight-loss aid. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts. Currently, the FDA has not approved any nonprescription weight-loss drugs for sale.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills. Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.
However, the pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
Black Currants May Help Thwart Alzheimer's
Compounds in black currants may help protect against Alzheimer's disease, according to a study in the current issue of Chemistry & Industry magazine.
Researchers found that these compounds -- anthocyanins and polyphenolics -- had a strong protective effect in cultured neuronal cells. Darker black currants contain more anthocyanins and are likely to be more potent.
"These compounds also work in hippocampal cells taken straight from the brain," researcher James Joseph of Tufts University said in a prepared statement. He said these protective effects will likely be reproduced in the human body and that these compounds may prevent or significantly delay the onset of Alzheimer's.
While previous research found that compounds in black currants acted as antioxidants, this is the first study to demonstrate that they may help protect brain cells. Exactly how they do this remains unclear, the study said.
"We have evidence that the compounds protect against Alzheimer's by influencing the early gene expression in learning and memory, which influences cell signaling pathways that help neuronal cells communicate with each other," Joseph said.
Health Tip: Using a Nebulizer
For some people with respiratory problems, nebulizers are as essential as breathing.
In fact, these devices are used to treat asthma and other conditions that make it difficult to breathe. They deliver a stream of medicated air through a mask or tube to help open the airways to the lungs.
Different medications are used in nebulizers. Many have side effects such as headache, dizziness or even chest pain, but all of them are designed to help breathing.
According the National Library of Medicine, nebulizer medicines should be stored in a safe place, at room temperature, and away from children. Some medications should not be exposed to light until they're actually used.
If asthma symptoms become worse and the nebulizer medication becomes less effective, it's important to call a doctor because the patient's condition may be getting worse.
Health Tip: Keeping the Kids Safe Around the Car
Most people worry about their children's safety in cars.
But another critical place to be concerned about safety is around cars, according to a study by the U.S. Centers for Disease Control and Prevention.
A CDC reports concludes that children left unattended in or around motor vehicles can be injured or killed by slow-moving cars, cars rolling backward in driveways and parking lots, cars set in motion by the child, and children getting trapped in the car's trunk.
Some automobile companies are now equipping cars with sensors that can detect some of these unseen obstacles.
The best advice: When the kids are involved, be alert.
Food Fact:
Guac shock.
Think avocados are too lush and buttery to be good for you? Think again. Yes, avocados are high in fat, but it's the heart-healthy kind. Even "good" fat is highly caloric, so you have to keep portions under control, but in moderation as part of a diet low in saturated fat, avocados can help reduce bad cholesterol. To determine ripeness, press gently on the avocado's skin. If the flesh yields slightly, the avocado is ready to eat that day. Store avocados at room temperature, never in the refrigerator.
Fitness Tip of the day:
Dyna-band on the run.
Next time you head out on a business trip, pack a Dyna-band and a jump rope -- small items with big rewards. When time or the weather doesn't permit a gym visit or running, you can work up a sweat in your room with resistance training and cardio exercise using these two compact helpers. Nothing boosts your energy, creativity and effectiveness on the road like a workout.
FAQ of the day:
What exactly is considered "red" meat?
Contrary to what some advertisements may dub "the other white meat," scientists define red meat as the meat from land mammals such as cattle, pigs and lamb. That means beef, lamb and, yes, pork.
Earlier this month, a Medicaid recipient on four different heart medications was denied coverage for her life-saving prescriptions by her pharmacy in New York City.
Ideally, the woman should have been automatically transitioned from Medicaid-based coverage to Medicare's new drug benefit plan, which launched Jan. 1. Instead, her pharmacist told her he could no longer find any record of her in the system.
Desperate, she contacted the Medicare Rights Center, a nonprofit group that advocates on behalf of seniors and the disabled covered by the plan.
"There's literally hundreds of cases like just this in our office, right now," said Robert Hayes, the group's president.
Contacting Medicare's regional office in lower Manhattan, Hayes struggled to untangle the bureaucratic logjams that are preventing this patient and hundreds like her from getting the drugs they need.
"The response I got was, 'Well, give us their names,' " Hayes said. "But, they had had those names for eight or nine days."
A worker at the center said the outcome of the heart patient's case remains uncertain.
Tens of thousands of Medicare and Medicaid patients across the country have been encountering scenes like these ever since the roll-out of Medicare's Part D drug benefit, which was designed to provide cash-strapped seniors with low-cost medications through link ups with private insurers.
The biggest glitch? "Dual eligibles" -- Medicaid recipients like the woman above who also qualify for the new drug benefit -- were auto-enrolled by the agency into a private Part D plan. But some also went ahead and chose another plan in the run-up to the Jan. 1 deadline. The result? Data regarding their choice of a private plan made it into the system, but information as to their ongoing status as an eligible Medicaid/Medicare recipient did not.
Another problem: Beneficiaries switched to a new plan only to realize that it did not cover a brand-name drug they were taking. Under Part D rules, the new plan was required to cover the drug for a 30-day period, but this didn't always happen.
Scrambling, officials in 20 states passed short-term, emergency measures to pay pharmacists with state funds so that locked-out enrollees could get their drugs. And on Jan. 15, the White House ordered insurers to supply all beneficiaries in need with a 30-day supply of medications, no matter what. That measure might be extended if deemed necessary, federal officials said.
Medicare's critics say it just didn't have to be this way.
"It didn't have to be such a hassle," said Bill Vaughan, a health lobbyist and senior policy analyst at Washington, D.C.-based Consumers Union, which publishes Consumer Reports. He criticized the federal government for what he called its "breathtaking arrogance" in rushing the plan to the public.
Vaughan pointed to a 2004 study from the government's own Medicare Payment Advisory Commission, which found that transferring large numbers of patient files from one large insurer to another can take an average of six months.
"But here you have people in Part D signing up beginning on Nov. 15th for a program that starts Jan. 1 -- with some people even signing up Dec. 31st. And you expect them to get a prescription by January 2nd? It just won't work," Vaughan said.
A Medicare spokesman said that his agency was hamstrung by the law that created Part D. "You have to remember that Congress created the Part D program to begin January 1, 2006," Peter Ashkenaz said from his Washington, D.C. office. "So we put all the contingencies in place to handle as much as we did."
And he added that enrollment in the new plan has been high.
"Enrollment numbers issued earlier this week showed that we've got about 24 million people who are now receiving Part D drug coverage," Ashkenaz said in an interview Friday. "Roughly 20 million of them are receiving them through Part D plans -- stand alone plans, Medicare advantage plans or employer programs. We saw enrollment rise from a million the first couple of weeks to 3.6 million as of the 13th of January."
According to Ashkenaz, the biggest modification of Medicare in its 40-year history was bound to encounter a bump or two, and he said that millions of beneficiaries are getting their drugs just as easily as before.
He also noted that the new system does have a built-in "safety net."
"If a beneficiary is found not to be in a plan, the pharmacist has the ability to sign that 'dual-eligible' up to a plan right there at the counter -- it's a plan offered by Wellpoint, the only national plan that's authorized to receive auto-enrollments from low-income beneficiaries," he said.
Still, Hayes believes more could have been done. He said he personally warned Mark McClellan, Administrator of the federal Centers for Medicare and Medicaid Services, that the launch as planned couldn't go smoothly. Early last year, he said, "I was sitting in McClellan's office and I said, 'Look, even if you get this transition 99 percent right for the people losing Medicaid coverage, you're still going to have 64,000 people without drug coverage come Jan. 1.' And [McClellan] said 'No, we have everything under control.' "
The emergency relief now offered by the states provides beneficiaries with some form of safety net, Hayes said, though it's "a little late, and a little chaotic."
Ashkenaz' response: "Look, we are concerned if even a single beneficiary doesn't get the drugs they need. But we have the fallback system with Wellpoint, and we're working through the data systems to ensure that beneficiaries are able to get those drugs."
Others contend the system could have been designed better. New York City-based "information designer" Leslie Smolan works with big business to smooth out complex logistical bottlenecks.
She blamed the current Medicare problems on the fact that patient information remains split among the agency, doctors, pharmacies and insurance plans -- each with its own computer system and "language."
Better, centralized design that allowed every player in the process to share the same codes, programming and language would have prevented a lot of pain for the public, Smolan said. So would have more "beta testing" of the plan itself. "It's what any business creating any kind of product would do -- make sure it works, then roll it out," she said. "Now, it's just damage control."
But Ashkenaz said most of its partners have worked hard to merge their systems with Medicare's. "I talked to a 500-bed nursing home yesterday that said, 'We began preparing for Part D a year ago. We made sure then that our pharmacy was going to be able to talk to all of the plans.' "
Experts on both sides stressed that most of those who've enrolled have managed to get their medications without a problem, and Vaughan noted that the country has seen these types of first-year jitters during other major program launches.
In 1974, he noted, the federal government merged welfare programs for the aged, disabled and blind into what is now Social Security.
"In the first couple weeks, the system was so screwed up, The New York Times ran pictures of mounted police defending Social Security offices from people throwing bricks at the windows," he said.
"So, we've been here before," Vaughan noted. "This will get better and the system will shake out."
Heart Tests, Treatments May Be Overused
Doctors are using more and more tests and procedures to help detect and treat heart disease, even though the incidence of the illness isn't rising all that much, new studies show.
"I do believe that some of it is being done needlessly," said F. Lee Lucas, associate director of the Maine Medical Center's Outcomes Research and Evaluation, and lead author of a report in the Jan. 24 issue of Circulation.
Looking at Medicare records, Lucas and her colleagues found that from 1993 to 2001, U.S. doctors charted a nearly three-fold increase in the number of imaging stress tests ordered and more than a seven-fold increase in the use of coronary stents, the flexible tubes used to open narrow blood vessels in the heart.
"However, heart attack, by contrast, has not been increasing in any dramatic way," Lucas said. "So, we do not believe that the large increase in cardiac procedures reflects an underlying increase in coronary heart disease."
A report in the same journal on a study led by physicians at the University of Toronto found that annual costs for cardiac tests and bypass surgery nearly doubled in Canada between 1992 and 2001, outstripping "both demographic shifts and changes in the prevalence of coronary artery disease."
"The proliferation of cardiac testing challenges the sustainability of Medicare in Canada, especially given uncertainty as to whether the accompanying incremental rise in total expenditures translates into significant outcome benefits in the population," the researchers wrote.
In the United States, there has been a slight decrease in bypass surgery, Lucas said. "The rate has leveled off and will stay leveled off," she said.
But other procedures -- such as the insertion of catheters, flexible tubes used to open arteries, and stents, metal tubes designed to keep arteries open -- are being done more often, Lucas said.
"My basic feeling is that the rate of catheterization and coronary procedures such as stenting continues to increase," she said. "Some analyses show more than a linear increase. The trend is accelerating. Although this paper doesn't say so, I don't expect to see any leveling off based on what we see in the data."
The belief that many procedures are being done needlessly comes from a related study by the Maine group, Lucas said. "What we were able to show was that in areas where the rate is higher, the extra procedures are not targeted at the people who need them most," she said. "People get them equally, despite their risk."
The American Heart Association and the American College of Cardiology have separated patients into several classes, Lucas noted. "Class three includes those in whom the procedures are contraindicated, such as the terminally ill, who do not derive benefit from the procedure," she said. "What we showed is that the rate at which cardiac catherizations are being given is higher among all the subgroups, including those for whom it is contraindicated."
However, these two studies don't show whether the procedures are overused or done on patients who don't really need them, said Dr. Sidney C. Smith Jr., professor of medicine at the University of North Carolina and a spokesman for the American Heart Association.
"Nothing in either paper deals directly with appropriateness," Smith said, adding, "We need to be sure that we use these procedures appropriately and that all who might benefit from them receive them."
Until further studies are done to determine whether too many procedures are being done, prevention still should be key, he said.
"Cardiovascular disease is largely preventable," Smith said. "The issue can be resolved by better and increased use of preventive measures -- exercise, control of blood pressure, control of lipid abnormalities, weight loss when necessary. We wouldn't have to worry about the need for extensive procedures if these measures were taken by more people."
FDA Panel Approves OTC Weight-Loss Pill
A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final FDA approval before it can sell the nonprescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults as use as a weight-loss aid. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts. Currently, the FDA has not approved any nonprescription weight-loss drugs for sale.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills. Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.
However, the pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
Black Currants May Help Thwart Alzheimer's
Compounds in black currants may help protect against Alzheimer's disease, according to a study in the current issue of Chemistry & Industry magazine.
Researchers found that these compounds -- anthocyanins and polyphenolics -- had a strong protective effect in cultured neuronal cells. Darker black currants contain more anthocyanins and are likely to be more potent.
"These compounds also work in hippocampal cells taken straight from the brain," researcher James Joseph of Tufts University said in a prepared statement. He said these protective effects will likely be reproduced in the human body and that these compounds may prevent or significantly delay the onset of Alzheimer's.
While previous research found that compounds in black currants acted as antioxidants, this is the first study to demonstrate that they may help protect brain cells. Exactly how they do this remains unclear, the study said.
"We have evidence that the compounds protect against Alzheimer's by influencing the early gene expression in learning and memory, which influences cell signaling pathways that help neuronal cells communicate with each other," Joseph said.
Health Tip: Using a Nebulizer
For some people with respiratory problems, nebulizers are as essential as breathing.
In fact, these devices are used to treat asthma and other conditions that make it difficult to breathe. They deliver a stream of medicated air through a mask or tube to help open the airways to the lungs.
Different medications are used in nebulizers. Many have side effects such as headache, dizziness or even chest pain, but all of them are designed to help breathing.
According the National Library of Medicine, nebulizer medicines should be stored in a safe place, at room temperature, and away from children. Some medications should not be exposed to light until they're actually used.
If asthma symptoms become worse and the nebulizer medication becomes less effective, it's important to call a doctor because the patient's condition may be getting worse.
Health Tip: Keeping the Kids Safe Around the Car
Most people worry about their children's safety in cars.
But another critical place to be concerned about safety is around cars, according to a study by the U.S. Centers for Disease Control and Prevention.
A CDC reports concludes that children left unattended in or around motor vehicles can be injured or killed by slow-moving cars, cars rolling backward in driveways and parking lots, cars set in motion by the child, and children getting trapped in the car's trunk.
Some automobile companies are now equipping cars with sensors that can detect some of these unseen obstacles.
The best advice: When the kids are involved, be alert.
Food Fact:
Guac shock.
Think avocados are too lush and buttery to be good for you? Think again. Yes, avocados are high in fat, but it's the heart-healthy kind. Even "good" fat is highly caloric, so you have to keep portions under control, but in moderation as part of a diet low in saturated fat, avocados can help reduce bad cholesterol. To determine ripeness, press gently on the avocado's skin. If the flesh yields slightly, the avocado is ready to eat that day. Store avocados at room temperature, never in the refrigerator.
Fitness Tip of the day:
Dyna-band on the run.
Next time you head out on a business trip, pack a Dyna-band and a jump rope -- small items with big rewards. When time or the weather doesn't permit a gym visit or running, you can work up a sweat in your room with resistance training and cardio exercise using these two compact helpers. Nothing boosts your energy, creativity and effectiveness on the road like a workout.
FAQ of the day:
What exactly is considered "red" meat?
Contrary to what some advertisements may dub "the other white meat," scientists define red meat as the meat from land mammals such as cattle, pigs and lamb. That means beef, lamb and, yes, pork.
Sunday, January 22, 2006
Health Headlines - January 22
FDA Delays Decision on Morning-After Pill
There was still no word as the weekend began on whether the U.S. Food and Drug Administration would approve over-the-counter sales of levonorgestrel, the so-called "morning-after" birth control pill.
Barr Pharmaceuticals, the firm that markets the pill under the name Plan B, issued a news release saying the FDA had delayed its decision, which was expected Friday. Barr said it was still hopeful that the federal agency would approve the pill for non-prescription sales and that the delay came because FDA officials hadn't completed their review in time to meet the Jan. 21 deadline, the Associated Press quotes the company news release as saying.
The FDA rejected Barr's bid for OTC sales in May 2004, saying it didn't have enough evidence of the drug's safety among younger teenagers to allow unregulated use in that age group. Barr's new plan, submitted two months later, would restrict over-the-counter use to women 16 and older, and would still require a prescription for younger girls.
When it became apparent that the FDA would not meet its deadline, a federal lawsuit was filed in New York against the government, AP reports. The Center for Reproductive Rights filed suit against the FDA, saying that it didn't follow its own procedures or mandates, beginning when it first denied the application in May 2004.
Alzheimer's Drug Maker Announces Death Increase In Clinical Trials
U.S. government officials have been notified that two clinical trials involving a prescription drug that treats mild cases of Alzheimer's disease resulted in triple the number of deaths than those in the control group.
The New York Times reports that Johnson & Johnson, which developed Reminyl -- approved in 69 countries to treat mild-to-moderate cases of Alzheimer's disease -- notified the U.S. Food and Drug Administration Friday as well a regulators in Canada and Europe about the clinical trial results.
The trials were taking place in 16 countries using 2,000 people to determine whether Reminyl could also be used to treat people with mild cognitive impairment, a type of memory lapse that some believe could be a precursor to Alzheimer's, the newspaper reports. During the two year trial period, 15 patients taking Reminyl died, as opposed to five who were taking a placebo, according to the Times.
But a Johnson & Johnson spokeswoman, Carol Goodrich, told the newspaper that the investigators didn't believe there was a connection between the deaths and Reminyl. There could have been a number of reasons for the deaths, many of which were heart attacks or strokes, she maintained. Johnson & Johnson said the number of deaths was low for the elderly population participating in the trials.
Representatives of both the FDA and Health Canada -- that country's government health agency -- told the Times they were investigatig the results of the clinical trial! s.
Final Medicare Drug Benefit Provisions Unveiled
The U.S. Medicare program released final regulations Friday for establishing the long-awaited senior prescription drug benefit, to take effect in 2006.
Under the sweeping Medicare Modernization Act signed by President Bush in 2003, the new provisions begin the shift from the temporary drug discount cards now in use to broad-based drug coverage for all beneficiaries, according to a statement from Medicare's parent agency, the U.S. Department of Health and Human Services.
HHS says the new rules, affecting 41 million elderly and disabled Americans, include provisions to:
Give beneficiaries a choice of at least two drug plans that will cover a wide range of both brand names and generics.
Give relief to 9 million low-income beneficiaries by waiving any premiums and deductibles.
Ensure that people who qualify for participation in both Medicare and Medicaid are automatically enrolled in the drug plan if they fail to sign up by the December 2005 deadline.
Once the drug benefit takes effect, it's expected to save U.S. states an estimated $8 billion annually over the first five years, the statement said.
Anti-Bacterial Chemical Found in U.S. Waterways
An anti-microbial chemical used in hand soaps and other cleaning products appears to be present in about 60 percent of the 85 U.S. streams, rivers and other water resources investigated by researchers at Johns Hopkins University, according to a statement from the college's Bloomberg School of Public Health.
Triclocarban has been used for some 50 years, but rarely has been monitored for its effects on the environment, scientists led by Prof. Rolf U. Halden said. If the results were confirmed nationwide, it would mean triclocarban is the fifth most frequent contaminant among 96 pharmaceuticals, personal care products and organic wastewater contaminants evaluated, the school's statement said.
Triclocarban is often difficult to detect, noted Halden's team, which predicted the chemical's concentrations based on actual test results of similar contaminants found in the same cleaning products. The researchers said their results suggested that triclocarban contamination is "greatly underreported" nationwide.
Results of the study are published in the online edition of Environmental Science & Technology, a peer-reviewed journal of the American Chemical Society.
Jan. 24 is Most Depressing Day of Year: Psychologist
If a British psychologist's assessment is correct, next Monday will be the most depressing day of 2005 for many people.
Dr. Cliff Arnall, who specializes in seasonal disorders at the University of Cardiff in Wales, has devised a formula that accounts for such factors as weather, time since Christmas, monetary debt and motivational levels, reports MSNBC.
"Following the initial thrill of New Year's celebrations and changing over a new leaf, reality starts to sink in," Arnall told the network. "The realization coincides with the dark [winter] clouds rolling in and the obligation to pay off Christmas credit card bills."
Arnall devised the formula at the request of a British travel agency, which had asked him to estimate when people were most likely to seek respite from a long, harsh winter.
Japanese Government Ponders Iressa Ban
The Japanese government is considering banning the controversial lung cancer drug Iressa following a report that links the drug to 588 deaths in that country, more than four times the number of deaths previously believed to have been caused by the drug.
A spokesperson for Japan's Ministry of Health and Welfare told The Times of London that the report's findings raise the possibility that Iressa would be withdrawn from the Japanese market.
Along with the 588 deaths, the report concluded that 1,473 patients suffered serious side effects after taking Iressa. A full version of the report, compiled by a panel of scientists, is due in March.
The findings are part of an emergency investigation into the safety and efficacy of Iressa ordered last year after drug maker AstraZeneca said a clinical trial of Iressa showed the drug was no more effective than a placebo in prolonging the lives of lung cancer patients, The Times reported.
Japan accounts for more than 40 percent of total worldwide sale of Iressa.
Food Fact:
Asparagus tips.
Spear 25 on your fork to barely reach 100 calories? That's not all... This true dieter's delight is plentiful and inexpensive in spring. Asparagus is a great source of folic acid, and a good source of vitamins A and C. When buying asparagus, choose firm, bright green spears with tight tips. Wrap in plastic and store for up to 4 days in the refrigerator. If stems are thick, peel the outermost layer with a vegetable peeler. Steam or boil until just tender, about 3 minutes. Resist butter sauces or oil-rich vinaigrettes, which ruin the nutritional profile.
Fitness Tip of the day:
Be a road scholar.
It's easy to find out where you can work out on a business trip, if you know where to look online. Before you leave, go to a travel or city guide Web site for your destination and research the parks, community centers, tracks and fitness centers where you can get a little exercise. Nothing boosts your energy, creativity and effectiveness on the road like a workout. Bonus: Explore the local jogging paths, and you'll get a taste of city life you'll never find in a hotel or pitch meeting.
FAQ of the day:
How much red meat is too much?
If you choose to include red meat in your diet, you can greatly reduce your risk of chronic disease by limiting how much and how often you eat it. In population studies, individuals who say that they eat red meat "less than once a week" are generally at significantly lower risk of heart disease and cancer than people who eat red meat several times a week. A good goal: No more than once a month. You don't have to reach this goal overnight; work your way down to once a week, then once every two weeks, then once a month. Take it one day at a time; try fish, chicken, beans or soy tonight!
There was still no word as the weekend began on whether the U.S. Food and Drug Administration would approve over-the-counter sales of levonorgestrel, the so-called "morning-after" birth control pill.
Barr Pharmaceuticals, the firm that markets the pill under the name Plan B, issued a news release saying the FDA had delayed its decision, which was expected Friday. Barr said it was still hopeful that the federal agency would approve the pill for non-prescription sales and that the delay came because FDA officials hadn't completed their review in time to meet the Jan. 21 deadline, the Associated Press quotes the company news release as saying.
The FDA rejected Barr's bid for OTC sales in May 2004, saying it didn't have enough evidence of the drug's safety among younger teenagers to allow unregulated use in that age group. Barr's new plan, submitted two months later, would restrict over-the-counter use to women 16 and older, and would still require a prescription for younger girls.
When it became apparent that the FDA would not meet its deadline, a federal lawsuit was filed in New York against the government, AP reports. The Center for Reproductive Rights filed suit against the FDA, saying that it didn't follow its own procedures or mandates, beginning when it first denied the application in May 2004.
Alzheimer's Drug Maker Announces Death Increase In Clinical Trials
U.S. government officials have been notified that two clinical trials involving a prescription drug that treats mild cases of Alzheimer's disease resulted in triple the number of deaths than those in the control group.
The New York Times reports that Johnson & Johnson, which developed Reminyl -- approved in 69 countries to treat mild-to-moderate cases of Alzheimer's disease -- notified the U.S. Food and Drug Administration Friday as well a regulators in Canada and Europe about the clinical trial results.
The trials were taking place in 16 countries using 2,000 people to determine whether Reminyl could also be used to treat people with mild cognitive impairment, a type of memory lapse that some believe could be a precursor to Alzheimer's, the newspaper reports. During the two year trial period, 15 patients taking Reminyl died, as opposed to five who were taking a placebo, according to the Times.
But a Johnson & Johnson spokeswoman, Carol Goodrich, told the newspaper that the investigators didn't believe there was a connection between the deaths and Reminyl. There could have been a number of reasons for the deaths, many of which were heart attacks or strokes, she maintained. Johnson & Johnson said the number of deaths was low for the elderly population participating in the trials.
Representatives of both the FDA and Health Canada -- that country's government health agency -- told the Times they were investigatig the results of the clinical trial! s.
Final Medicare Drug Benefit Provisions Unveiled
The U.S. Medicare program released final regulations Friday for establishing the long-awaited senior prescription drug benefit, to take effect in 2006.
Under the sweeping Medicare Modernization Act signed by President Bush in 2003, the new provisions begin the shift from the temporary drug discount cards now in use to broad-based drug coverage for all beneficiaries, according to a statement from Medicare's parent agency, the U.S. Department of Health and Human Services.
HHS says the new rules, affecting 41 million elderly and disabled Americans, include provisions to:
Give beneficiaries a choice of at least two drug plans that will cover a wide range of both brand names and generics.
Give relief to 9 million low-income beneficiaries by waiving any premiums and deductibles.
Ensure that people who qualify for participation in both Medicare and Medicaid are automatically enrolled in the drug plan if they fail to sign up by the December 2005 deadline.
Once the drug benefit takes effect, it's expected to save U.S. states an estimated $8 billion annually over the first five years, the statement said.
Anti-Bacterial Chemical Found in U.S. Waterways
An anti-microbial chemical used in hand soaps and other cleaning products appears to be present in about 60 percent of the 85 U.S. streams, rivers and other water resources investigated by researchers at Johns Hopkins University, according to a statement from the college's Bloomberg School of Public Health.
Triclocarban has been used for some 50 years, but rarely has been monitored for its effects on the environment, scientists led by Prof. Rolf U. Halden said. If the results were confirmed nationwide, it would mean triclocarban is the fifth most frequent contaminant among 96 pharmaceuticals, personal care products and organic wastewater contaminants evaluated, the school's statement said.
Triclocarban is often difficult to detect, noted Halden's team, which predicted the chemical's concentrations based on actual test results of similar contaminants found in the same cleaning products. The researchers said their results suggested that triclocarban contamination is "greatly underreported" nationwide.
Results of the study are published in the online edition of Environmental Science & Technology, a peer-reviewed journal of the American Chemical Society.
Jan. 24 is Most Depressing Day of Year: Psychologist
If a British psychologist's assessment is correct, next Monday will be the most depressing day of 2005 for many people.
Dr. Cliff Arnall, who specializes in seasonal disorders at the University of Cardiff in Wales, has devised a formula that accounts for such factors as weather, time since Christmas, monetary debt and motivational levels, reports MSNBC.
"Following the initial thrill of New Year's celebrations and changing over a new leaf, reality starts to sink in," Arnall told the network. "The realization coincides with the dark [winter] clouds rolling in and the obligation to pay off Christmas credit card bills."
Arnall devised the formula at the request of a British travel agency, which had asked him to estimate when people were most likely to seek respite from a long, harsh winter.
Japanese Government Ponders Iressa Ban
The Japanese government is considering banning the controversial lung cancer drug Iressa following a report that links the drug to 588 deaths in that country, more than four times the number of deaths previously believed to have been caused by the drug.
A spokesperson for Japan's Ministry of Health and Welfare told The Times of London that the report's findings raise the possibility that Iressa would be withdrawn from the Japanese market.
Along with the 588 deaths, the report concluded that 1,473 patients suffered serious side effects after taking Iressa. A full version of the report, compiled by a panel of scientists, is due in March.
The findings are part of an emergency investigation into the safety and efficacy of Iressa ordered last year after drug maker AstraZeneca said a clinical trial of Iressa showed the drug was no more effective than a placebo in prolonging the lives of lung cancer patients, The Times reported.
Japan accounts for more than 40 percent of total worldwide sale of Iressa.
Food Fact:
Asparagus tips.
Spear 25 on your fork to barely reach 100 calories? That's not all... This true dieter's delight is plentiful and inexpensive in spring. Asparagus is a great source of folic acid, and a good source of vitamins A and C. When buying asparagus, choose firm, bright green spears with tight tips. Wrap in plastic and store for up to 4 days in the refrigerator. If stems are thick, peel the outermost layer with a vegetable peeler. Steam or boil until just tender, about 3 minutes. Resist butter sauces or oil-rich vinaigrettes, which ruin the nutritional profile.
Fitness Tip of the day:
Be a road scholar.
It's easy to find out where you can work out on a business trip, if you know where to look online. Before you leave, go to a travel or city guide Web site for your destination and research the parks, community centers, tracks and fitness centers where you can get a little exercise. Nothing boosts your energy, creativity and effectiveness on the road like a workout. Bonus: Explore the local jogging paths, and you'll get a taste of city life you'll never find in a hotel or pitch meeting.
FAQ of the day:
How much red meat is too much?
If you choose to include red meat in your diet, you can greatly reduce your risk of chronic disease by limiting how much and how often you eat it. In population studies, individuals who say that they eat red meat "less than once a week" are generally at significantly lower risk of heart disease and cancer than people who eat red meat several times a week. A good goal: No more than once a month. You don't have to reach this goal overnight; work your way down to once a week, then once every two weeks, then once a month. Take it one day at a time; try fish, chicken, beans or soy tonight!
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