NEW YORK (Reuters Health) - In older people with mild cognitive impairment, having a drink now and then -- up to an average of one drink of alcohol each day -- may delay progression to dementia, new research suggests.
"While many studies have assessed alcohol consumption and cognitive function in the elderly, this is the first study to look at how alcohol consumption affects the rate of progression of mild cognitive impairment to dementia," study authors Dr. Vincenzo Solfrizzi and Dr. Francesco Panza, from the University of Bari in Italy, said in a statement.
In the study, reported in the medical journal Neurology, the researchers assessed the occurrence of mild cognitive impairment in 1445 subjects and the progression to dementia in 121 patients with mild cognitive impairment.
The participants were between 65 and 84 years of age at the start of the study, and they were followed for 3.5 years. Alcohol use was assessed starting the year before the survey.
Drinking was not associated the development of mild cognitive impairment, according to the report. However, once mild impairment occurred, subjects who had up to one drink per day of alcohol had an 85 percent reduced risk of dementia compared with those who abstained.
The benefit was seen with both alcohol in general and with wine in particular.
Having more than one drink a day, however, offered no protection against dementia compared with abstaining, the report indicates.
"The mechanism responsible for why low alcohol consumption appears to protect against the progression to dementia isn't known. However, it is possible that the arrangement of blood vessels in the brain may play a role," Solfrizzi and Panza conclude.
SOURCE: Neurology, May 22, 2007.
Tuesday, May 22, 2007
Monday, May 21, 2007
FDA issues safety alert on diabetes drug
The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday.
The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the
New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.
The company downplayed the report of heart risks, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr. Lawson McCartney who leads Glaxo's diabetes drug development, said the company is not seeing "anything like" the problems reported in the medical journal.
"We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine," McCartney said.
The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research.
Some data suggests "that there is a potentially significant increase in the risk" but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.
FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control.
Worried patients should not quit Avandia on their own and should discuss concerns with their doctors, wrote Drs. Bruce Psaty and Curt Furberg in an editorial in the New England Journal. Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.
However, to the extent that the new analysis shows valid risks, the drug "represents a major failure of the drug-use and drug-approval processes in the United States," they said.
When the drug was approved, "evidence was at best mixed" on its benefit, wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct in the case involving
Vioxx. The popular arthritis medicine sold by Merck & Co. was taken off the market in 2004 when heart problems came to light after it had been taken by millions of people
Several experts said Avandia was another example of the FDA failing to detect a safety problem early enough.
Glaxo's shares trading in the United States fell $3.85, or 6.6 percent, to $53.89 in afternoon trading.
The report on the diabetes drug's risks follow Glaxo's $2.5 million settlement of a lawsuit filed by former New York Attorney General Eliot Spitzer over the release of data on the safety and effectiveness of its drugs. Spitzer, now New York governor, accused Glaxo of fraudulently withholding some results of studies that had examined the safety of prescribing the antidepressant Paxil to children.
GlaxoSmithKline disputed that it attempted to mislead anyone, and said it has always been in favor of widespread disclosure of clinical trial results.
The company's clinical trials registry (http://ctr.gsk.co.uk) is available to the public, although the reports within it are highly technical and may appear incomprehensible to an untrained reader.
The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the
New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.
The company downplayed the report of heart risks, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr. Lawson McCartney who leads Glaxo's diabetes drug development, said the company is not seeing "anything like" the problems reported in the medical journal.
"We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine," McCartney said.
The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research.
Some data suggests "that there is a potentially significant increase in the risk" but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.
FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control.
Worried patients should not quit Avandia on their own and should discuss concerns with their doctors, wrote Drs. Bruce Psaty and Curt Furberg in an editorial in the New England Journal. Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.
However, to the extent that the new analysis shows valid risks, the drug "represents a major failure of the drug-use and drug-approval processes in the United States," they said.
When the drug was approved, "evidence was at best mixed" on its benefit, wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct in the case involving
Vioxx. The popular arthritis medicine sold by Merck & Co. was taken off the market in 2004 when heart problems came to light after it had been taken by millions of people
Several experts said Avandia was another example of the FDA failing to detect a safety problem early enough.
Glaxo's shares trading in the United States fell $3.85, or 6.6 percent, to $53.89 in afternoon trading.
The report on the diabetes drug's risks follow Glaxo's $2.5 million settlement of a lawsuit filed by former New York Attorney General Eliot Spitzer over the release of data on the safety and effectiveness of its drugs. Spitzer, now New York governor, accused Glaxo of fraudulently withholding some results of studies that had examined the safety of prescribing the antidepressant Paxil to children.
GlaxoSmithKline disputed that it attempted to mislead anyone, and said it has always been in favor of widespread disclosure of clinical trial results.
The company's clinical trials registry (http://ctr.gsk.co.uk) is available to the public, although the reports within it are highly technical and may appear incomprehensible to an untrained reader.
Tuesday, May 15, 2007
U.S. healthcare expensive, inefficient: report
WASHINGTON (Reuters) - Americans get the poorest health care and yet pay the most compared to five other rich countries, according to a report released on Tuesday.
Germany, Britain, Australia and Canada all provide better care for less money, the Commonwealth Fund report found.
"The U.S. health care system ranks last compared with five other nations on measures of quality, access, efficiency, equity, and outcomes," the non-profit group which studies health care issues said in a statement.
Canada rates second worst out of the five overall. Germany scored highest, followed by Britain, Australia and New Zealand.
"The United States is not getting value for the money that is spent on health care," Commonwealth Fund president Karen Davis said in a telephone interview.
The group has consistently found that the United States, the only one of the six nations that does not provide universal health care, scores more poorly than the others on many measures of health care.
Congress,
President George W. Bush' name=c1> SEARCHNews News Photos Images Web' name=c3> President George W. Bush, many employers and insurers have all agreed in recent months to overhaul the U.S. health care system -- an uncoordinated conglomeration of employer-funded care, private health insurance and government programs.
The current system leaves about 45 million people with no insurance at all, according to U.S. government estimates from 2005, and many studies have shown most of these people do not receive preventive services that not only keep them healthier, but reduce long-term costs.
Davis said the fund's researchers looked at hard data for the report.
"It is pretty indisputable that we spend twice what other countries spend on average," she said.
Per capita health spending in the United States in 2004 was $6,102, twice that of Germany, which spent $3,005. Canada spent $3,165, New Zealand $2,083 and Australia $2,876, while Britain spent $2,546 per person.
KEY MEASURES
"We focus primarily on measures that are sensitive to medical care making a difference -- infant mortality and healthy lives at age 60," Davis said. "Those are pretty key measures, like how long you live and whether you are going to die before age 75."
Measures of other aspects of care such as cataract surgery or hip replacements is harder to come by, she said.
They also looked at convenience and again found the United States lacking -- with a few exceptions.
"We include measures such as waiting more than four months for elective, non-emergency surgery. The United States doesn't do as well as Germany but it does a lot better than the other countries on waiting time for surgery," Davis said.
"We looked at the time it takes to get in to see your own doctor ... (or) once you go to the emergency room do you sit there for more than two hours, and truthfully, we don't do well on those measures," Davis said.
According to the report, 61 percent of U.S. patients said it was somewhat or very difficult to get care on nights or weekends, compared with 25 percent to 59 percent in other countries.
"The area where the U.S. health care system performs best is preventive care, an area that has been monitored closely for over a decade by managed care plans," the report reads.
The United States had the fewest patients -- 84 percent -- reporting that they have a regular doctor.
And U.S. doctors are the least wired, with the lowest percentage using electronic medical records or receiving electronic updates on recommended treatments.
Germany, Britain, Australia and Canada all provide better care for less money, the Commonwealth Fund report found.
"The U.S. health care system ranks last compared with five other nations on measures of quality, access, efficiency, equity, and outcomes," the non-profit group which studies health care issues said in a statement.
Canada rates second worst out of the five overall. Germany scored highest, followed by Britain, Australia and New Zealand.
"The United States is not getting value for the money that is spent on health care," Commonwealth Fund president Karen Davis said in a telephone interview.
The group has consistently found that the United States, the only one of the six nations that does not provide universal health care, scores more poorly than the others on many measures of health care.
Congress,
President George W. Bush' name=c1> SEARCHNews News Photos Images Web' name=c3> President George W. Bush, many employers and insurers have all agreed in recent months to overhaul the U.S. health care system -- an uncoordinated conglomeration of employer-funded care, private health insurance and government programs.
The current system leaves about 45 million people with no insurance at all, according to U.S. government estimates from 2005, and many studies have shown most of these people do not receive preventive services that not only keep them healthier, but reduce long-term costs.
Davis said the fund's researchers looked at hard data for the report.
"It is pretty indisputable that we spend twice what other countries spend on average," she said.
Per capita health spending in the United States in 2004 was $6,102, twice that of Germany, which spent $3,005. Canada spent $3,165, New Zealand $2,083 and Australia $2,876, while Britain spent $2,546 per person.
KEY MEASURES
"We focus primarily on measures that are sensitive to medical care making a difference -- infant mortality and healthy lives at age 60," Davis said. "Those are pretty key measures, like how long you live and whether you are going to die before age 75."
Measures of other aspects of care such as cataract surgery or hip replacements is harder to come by, she said.
They also looked at convenience and again found the United States lacking -- with a few exceptions.
"We include measures such as waiting more than four months for elective, non-emergency surgery. The United States doesn't do as well as Germany but it does a lot better than the other countries on waiting time for surgery," Davis said.
"We looked at the time it takes to get in to see your own doctor ... (or) once you go to the emergency room do you sit there for more than two hours, and truthfully, we don't do well on those measures," Davis said.
According to the report, 61 percent of U.S. patients said it was somewhat or very difficult to get care on nights or weekends, compared with 25 percent to 59 percent in other countries.
"The area where the U.S. health care system performs best is preventive care, an area that has been monitored closely for over a decade by managed care plans," the report reads.
The United States had the fewest patients -- 84 percent -- reporting that they have a regular doctor.
And U.S. doctors are the least wired, with the lowest percentage using electronic medical records or receiving electronic updates on recommended treatments.
Monday, May 14, 2007
Blood pressure rising around the globe
WASHINGTON - The numbers are a shock: Almost 1 billion people worldwide have high blood pressure, and over half a billion more will harbor this silent killer by 2025. It's not just a problem for the ever-fattening Western world. Even in parts of Africa, high blood pressure is becoming common.
That translates into millions of deaths from heart disease alone. Yet hypertension doesn't command the attention of, say, bird flu, which so far has killed fewer than 200 people.
"Hypertension has gone a bit out of fashion," says Dr. Jan Ostergren of Sweden's Karolinska University Hospital, who co-authored a first-of-its-kind analysis of the global impact of high blood pressure.
The idea: to rev up world governments to fight bad blood pressure just as countries have banded together in the past to fight infectious diseases.
International heart specialists welcome the push.
"Even in the U.S., the majority of people with high blood pressure are not treated adequately," says Dr. Sidney Smith of the University of North Carolina at Chapel Hill, who advises the World Heart Federation. "Look at China, look at Africa, go around the world. It is a major risk factor."
And the dangers go well beyond the heart. High blood pressure is a leading cause of strokes and kidney failure. It also plays a role in blindness and even dementia.
Patients seldom notice symptoms until organs already have been damaged.
Yet treating high blood pressure before that happens is a medical best-buy. Improving diet and exercise can help. When that's not enough, blood pressure drugs are among the oldest and thus cheapest on the market — 21 cents a day for a leading diuretic.
Ostergren joined experts from the London School of Economics and the State University of New York to assemble two teams of specialists and map what they call the coming crisis of hypertension: 1.56 billion people are expected to have it by 2025.
With funding from drug maker Novartis Pharma AG, they're providing copies to governments and health officials around the globe; a briefing in Washington is set for Thursday.
The report essentially calls for a cultural change. Consider: In the U.S., commiserating over blood pressure readings is an accepted dinner-table topic. Because black Americans are at especially high risk — roughly 40 percent are affected — hypertension has become a sermon topic at majority-black churches, and post-service screenings aren't uncommon. The government even advertises about the condition.
That adds up to an openness about blood pressure not seen in much of the world, says report co-author Dr. Michael Weber of SUNY's Downstate College of Medicine.
In some regions, "it's sort of an insult to your manhood if you have to take a blood-pressure medicine," Weber says, citing estimates that hypertension affects about one in three adults in Mexico, Paraguay and Venezuela.
"We need to break those barriers as well and make it perfectly fashionable. We need to get role models in those countries to say, 'You know what? I've got high blood pressure.'"
The U.S. still needs to improve, too, Weber hastens to add. High blood pressure affects nearly one in three adult Americans as well, or 72 million people. About a third have their condition well-controlled, not nearly enough but better than other countries that track treatment, the report found.
Normal blood pressure is measured at less than 120 over 80. Anyone can get high blood pressure, a level of 140 over 90 or more. But being overweight and inactive, and eating too much salt, all increase the risk. So does getting older.
The world's population is aging and fattening, fueling a continued increase in blood pressure problems. Remarkably, the report cites worse hypertension rates in much of Western Europe than in the U.S., despite cultural similarities: 38 percent in England, Sweden and Italy; 45 percent in Spain; 55 percent in Germany.
But the biggest jump is expected in developing countries and nations rapidly moving to more Western-style economies, the report warns. In parts of India, studies suggest one in three urban adults has high blood pressure, while it's still rare in rural areas with more traditional lifestyles. More than a quarter of adults in China have hypertension. So do one in four in Ghana and South Africa.
Treatment is difficult, because patients often quit their medicine, not understanding it's necessary even when they feel good. Also, doctors may be reluctant to prescribe the two- or three-drug combinations that half of patients wind up needing.
For poorer countries, the tab for even low-cost diuretics is an issue — not to mention public education about sticking to treatment, notes Smith, the World Heart Federation adviser, who was not involved in the new report.
But fighting bad blood pressure could mean that developing countries avoid epidemics of full-blown heart disease, which they definitely can't afford, Smith stresses. World health and economic groups already are brainstorming strategies to help, such as whether industries that move into poor countries should be required to screen their workers for high blood pressure.
That translates into millions of deaths from heart disease alone. Yet hypertension doesn't command the attention of, say, bird flu, which so far has killed fewer than 200 people.
"Hypertension has gone a bit out of fashion," says Dr. Jan Ostergren of Sweden's Karolinska University Hospital, who co-authored a first-of-its-kind analysis of the global impact of high blood pressure.
The idea: to rev up world governments to fight bad blood pressure just as countries have banded together in the past to fight infectious diseases.
International heart specialists welcome the push.
"Even in the U.S., the majority of people with high blood pressure are not treated adequately," says Dr. Sidney Smith of the University of North Carolina at Chapel Hill, who advises the World Heart Federation. "Look at China, look at Africa, go around the world. It is a major risk factor."
And the dangers go well beyond the heart. High blood pressure is a leading cause of strokes and kidney failure. It also plays a role in blindness and even dementia.
Patients seldom notice symptoms until organs already have been damaged.
Yet treating high blood pressure before that happens is a medical best-buy. Improving diet and exercise can help. When that's not enough, blood pressure drugs are among the oldest and thus cheapest on the market — 21 cents a day for a leading diuretic.
Ostergren joined experts from the London School of Economics and the State University of New York to assemble two teams of specialists and map what they call the coming crisis of hypertension: 1.56 billion people are expected to have it by 2025.
With funding from drug maker Novartis Pharma AG, they're providing copies to governments and health officials around the globe; a briefing in Washington is set for Thursday.
The report essentially calls for a cultural change. Consider: In the U.S., commiserating over blood pressure readings is an accepted dinner-table topic. Because black Americans are at especially high risk — roughly 40 percent are affected — hypertension has become a sermon topic at majority-black churches, and post-service screenings aren't uncommon. The government even advertises about the condition.
That adds up to an openness about blood pressure not seen in much of the world, says report co-author Dr. Michael Weber of SUNY's Downstate College of Medicine.
In some regions, "it's sort of an insult to your manhood if you have to take a blood-pressure medicine," Weber says, citing estimates that hypertension affects about one in three adults in Mexico, Paraguay and Venezuela.
"We need to break those barriers as well and make it perfectly fashionable. We need to get role models in those countries to say, 'You know what? I've got high blood pressure.'"
The U.S. still needs to improve, too, Weber hastens to add. High blood pressure affects nearly one in three adult Americans as well, or 72 million people. About a third have their condition well-controlled, not nearly enough but better than other countries that track treatment, the report found.
Normal blood pressure is measured at less than 120 over 80. Anyone can get high blood pressure, a level of 140 over 90 or more. But being overweight and inactive, and eating too much salt, all increase the risk. So does getting older.
The world's population is aging and fattening, fueling a continued increase in blood pressure problems. Remarkably, the report cites worse hypertension rates in much of Western Europe than in the U.S., despite cultural similarities: 38 percent in England, Sweden and Italy; 45 percent in Spain; 55 percent in Germany.
But the biggest jump is expected in developing countries and nations rapidly moving to more Western-style economies, the report warns. In parts of India, studies suggest one in three urban adults has high blood pressure, while it's still rare in rural areas with more traditional lifestyles. More than a quarter of adults in China have hypertension. So do one in four in Ghana and South Africa.
Treatment is difficult, because patients often quit their medicine, not understanding it's necessary even when they feel good. Also, doctors may be reluctant to prescribe the two- or three-drug combinations that half of patients wind up needing.
For poorer countries, the tab for even low-cost diuretics is an issue — not to mention public education about sticking to treatment, notes Smith, the World Heart Federation adviser, who was not involved in the new report.
But fighting bad blood pressure could mean that developing countries avoid epidemics of full-blown heart disease, which they definitely can't afford, Smith stresses. World health and economic groups already are brainstorming strategies to help, such as whether industries that move into poor countries should be required to screen their workers for high blood pressure.
Saturday, May 5, 2007
Honey could save diabetics from amputation
MADISON, United States (AFP) - Spreading honey on a diabetic ulcer could prevent the need to amputate an infected foot, researchers say.
A doctor at the University of Wisconsin who helped about half a dozen of her diabetic patients avoid amputation has launched a controlled trial to promote the widespread use of honey therapy.
The therapy involves squeezing a thick layer of honey onto the wound after dead skin and bacteria have been removed.
The honey kills bacteria because it is acidic and avoids the complication of bacterial resistance found with standard antibiotics, Jennifer Eddy, a professor at the University's School of Medicine and Public Health, told AFP.
"This is a tremendously important issue for world health," Eddy said.
Diabetics typically have poor circulation and decreased ability to fight infection and ulcers can be hard to treat. An amputation is performed every 30 seconds somewhere in the world, Eddy said.
"If we can prove that honey promotes healing in diabetic ulcers, we can offer new hopes for many patients, not to mention the cost benefit, and the issue of bacterial resistance. The possibilities are tremendous."
Honey therapy is already used to treat bed sores in New Zealand and as an alternative form of medicine in Europe, but has largely been relegated to history books in the United States.
Eddy first heard of it in medical school when a professor commented that of all the ancient remedies, honey actually seemed to work when he tried it out in the laboratory.
She tried honey therapy as a last resort six years ago with a 79-year-old diabetic patient who had developed foot wounds resistant to standard treatments.
"I tried it only after everything else had failed and... we had essentially sent him home to die," she said. "All antibiotics were stopped when we started honey, and his wounds rapidly healed."
Eddy hopes to have the trial completed and the results published by 2008 or 2009.
A doctor at the University of Wisconsin who helped about half a dozen of her diabetic patients avoid amputation has launched a controlled trial to promote the widespread use of honey therapy.
The therapy involves squeezing a thick layer of honey onto the wound after dead skin and bacteria have been removed.
The honey kills bacteria because it is acidic and avoids the complication of bacterial resistance found with standard antibiotics, Jennifer Eddy, a professor at the University's School of Medicine and Public Health, told AFP.
"This is a tremendously important issue for world health," Eddy said.
Diabetics typically have poor circulation and decreased ability to fight infection and ulcers can be hard to treat. An amputation is performed every 30 seconds somewhere in the world, Eddy said.
"If we can prove that honey promotes healing in diabetic ulcers, we can offer new hopes for many patients, not to mention the cost benefit, and the issue of bacterial resistance. The possibilities are tremendous."
Honey therapy is already used to treat bed sores in New Zealand and as an alternative form of medicine in Europe, but has largely been relegated to history books in the United States.
Eddy first heard of it in medical school when a professor commented that of all the ancient remedies, honey actually seemed to work when he tried it out in the laboratory.
She tried honey therapy as a last resort six years ago with a 79-year-old diabetic patient who had developed foot wounds resistant to standard treatments.
"I tried it only after everything else had failed and... we had essentially sent him home to die," she said. "All antibiotics were stopped when we started honey, and his wounds rapidly healed."
Eddy hopes to have the trial completed and the results published by 2008 or 2009.
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