Vital Signs
Outcomes: Heeding Familiar Advice May Add Years to Your Life
By NICHOLAS BAKALAR
Published: January 22, 2008
Researchers have calculated just how many years you can add to your life by adopting healthy habits.
http://www.nytimes.com/2008/01/22/health/research/22outc.html?ex=1358658000&en=b32a513751e20341&ei=5124&partner=permalink&exprod=permalink
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050012
Sunday, January 27, 2008
More bad news about cola beverages
Really?
The Claim: Too Much Cola Can Cause Kidney Problems
By ANAHAD O’CONNOR
Published: January 22, 2008
When it comes to kidney problems, is there a difference between colas and other kinds of soda?
http://www.nytimes.com/2008/01/22/health/nutrition/22real.html?ex=1358658000&en=bfaaf54ba7f71c7a&ei=5124&partner=permalink&exprod=permalink
The Claim: Too Much Cola Can Cause Kidney Problems
By ANAHAD O’CONNOR
Published: January 22, 2008
When it comes to kidney problems, is there a difference between colas and other kinds of soda?
http://www.nytimes.com/2008/01/22/health/nutrition/22real.html?ex=1358658000&en=bfaaf54ba7f71c7a&ei=5124&partner=permalink&exprod=permalink
What’s Cholesterol Got to Do With It?
Driven by the fervor of the pharmaceutical industry relentlessly promoting the use of cholesterol lowering medications, doctors are advocating bringing down total cholesterol and LDL cholesterol to unaturally low levels. It is finally about time to reevaluate the key risk factors for heart disease.
Op-Ed Contributor
What’s Cholesterol Got to Do With It?
By GARY TAUBES
Published: January 27, 2008
The truth is, we’ve always had reason to question the idea that cholesterol is an agent of disease.
http://www.nytimes.com/2008/01/27/opinion/27taubes.html?ex=1359090000&en=8b0a1260ba521c07&ei=5124&partner=permalink&exprod=permalink
Op-Ed Contributor
What’s Cholesterol Got to Do With It?
By GARY TAUBES
Published: January 27, 2008
The truth is, we’ve always had reason to question the idea that cholesterol is an agent of disease.
http://www.nytimes.com/2008/01/27/opinion/27taubes.html?ex=1359090000&en=8b0a1260ba521c07&ei=5124&partner=permalink&exprod=permalink
Wednesday, January 23, 2008
High Mercury Levels Are Found in Tuna Sushi
By MARIAN BURROS
Published: January 23, 2008
Tests on sushi bought in Manhattan revealed mercury levels that exceed accepted safety standards.
http://www.nytimes.com/2008/01/23/dining/23sushi.html?ex=1358830800&en=48af12845334336a&ei=5124&partner=permalink&exprod=permalink
Published: January 23, 2008
Tests on sushi bought in Manhattan revealed mercury levels that exceed accepted safety standards.
http://www.nytimes.com/2008/01/23/dining/23sushi.html?ex=1358830800&en=48af12845334336a&ei=5124&partner=permalink&exprod=permalink
Monday, January 21, 2008
FDA Opens "Pandora's Box" by Approving Food from Clones for Sale
(January 15, 2008) Washington, DC - Today, the Center for Food Safety (CFS) condemned the Food and Drug Administration's (FDA) irresponsible determination that milk and meat from cloned animals are safe for sale to the public. In addition, the FDA is requiring no tracking system for clones or labeling of products produced from clones or their offspring. This action comes at a time when the U.S. Senate has voted twice to delay FDA's decision on cloned animals until additional safety and economic studies can be completed by the National Academy of Sciences and the United States Department of Agriculture (USDA).
"The FDA's bullheaded action today disregards the will of the public and the Senate - and opens a literal Pandora's Box," said Andrew Kimbrell, CFS Executive Director. "FDA based their decision on an incomplete and flawed review that relies on studies supplied by cloning companies that want to force cloning technology on American consumers. FDA's action has placed the interests of a handful of biotech firms above those of the public they are charged with protecting."
With FDA's release of their controversial risk assessment today, CFS joins dozens of other food industry, consumer, and animal welfare groups, as well as federal lawmakers in calling for swift action on the part of Congress to pass the 2007 Farm Bill containing provisions delaying FDA's release of clones into the food supply. The Farm Bill currently contains an amendment, advanced by Senator Barbara A. Mikulski (D-MD.) and co-sponsored by Senator Arlen Specter (R-PA), requiring a rigorous and careful review of the human health and economic impacts of allowing cloned food into America's food supply. The Senate overwhelmingly passed the bill by a vote of 79 to 14.
"The passage of this bill with the Mikulski-Specter amendment sends a strong message that the FDA has failed the public again by taking an inadequate and half-baked look at the safety of food products from cloned animals and their offspring," said Joseph Mendelson, CFS Legal Director. "The FDA's cavalier approach to cloned food and its potential impacts calls for the remedy of a truly rigorous scientific assessment, and Congress has now repeatedly called for such action."
The Farm Bill amendment addresses the gaps and inadequacies of the FDAs current risk assessment, and would go into effect before any food products from clones are marketed. The Farm Bill also directs the USDA to examine consumer acceptance of cloned foods and the likely impacts they could have on domestic and international markets. (Click here for more information on this amendment).
Additionally, the FDA is today issuing a guidance document for food producers; It fails to require any special procedures for tracking or handling food products from clones. It also fails to require labeling of any kind on food products from clones or their offspring, which deprives consumers of their right to know about the origins of their food.
Recently, two cloning companies - Viagen and Trans Ova, proposed the creation of a voluntary cloning registry program. While they advanced claims that the registry would provide consumer protection and transparency without regulation, clones and their progeny will still be dispersed through the food system without any tracking or labeling.
"The cloning industry's proposal is simply another attempt to force cloned milk and meat on consumers and the dairy industry by giving the public phony assurances," said Mendelson. "The proposal neither provides new studies on the safety of clones nor protects the consumers' right to know whether their food or dairy contains products from clones. Once clones are released into America's food supply without any traceability requirements, it will be difficult, if not impossible, to recall them."
Recent opinion polls show the majority of Americans do not want milk or meat from cloned animals in their food. A December 2006 poll by the Pew Initiative on Food and Biotechnology found that nearly two-thirds of U.S. consumers were uncomfortable with animal cloning. A national survey conducted this year by Consumers Union found that 89 percent of Americans want to see cloned foods labeled, while 69 percent said that they have concerns about cloned meat and dairy products in the food supply. A recent Gallup Poll reported that more than 60 percent of Americans believe that it is immoral to clone animals, while the Pew Initiative on Food and Biotechnology found that a similar percentage say that, despite FDA approval, they won't buy milk from cloned animals.
In its risk assessment of cloned food, the FDA claims to have evaluated extensive peer reviewed safety studies to support its conclusion, yet a recent report issued by CFS, Not Ready for Prime Time, shows the assessment only references three peer-reviewed food safety studies, all of which focus on the narrow issue of milk from cloned cows. What is even more disturbing is that these studies were partially funded by the same biotech firms that produce clones for profit.
"The FDA's bullheaded action today disregards the will of the public and the Senate - and opens a literal Pandora's Box," said Andrew Kimbrell, CFS Executive Director. "FDA based their decision on an incomplete and flawed review that relies on studies supplied by cloning companies that want to force cloning technology on American consumers. FDA's action has placed the interests of a handful of biotech firms above those of the public they are charged with protecting."
With FDA's release of their controversial risk assessment today, CFS joins dozens of other food industry, consumer, and animal welfare groups, as well as federal lawmakers in calling for swift action on the part of Congress to pass the 2007 Farm Bill containing provisions delaying FDA's release of clones into the food supply. The Farm Bill currently contains an amendment, advanced by Senator Barbara A. Mikulski (D-MD.) and co-sponsored by Senator Arlen Specter (R-PA), requiring a rigorous and careful review of the human health and economic impacts of allowing cloned food into America's food supply. The Senate overwhelmingly passed the bill by a vote of 79 to 14.
"The passage of this bill with the Mikulski-Specter amendment sends a strong message that the FDA has failed the public again by taking an inadequate and half-baked look at the safety of food products from cloned animals and their offspring," said Joseph Mendelson, CFS Legal Director. "The FDA's cavalier approach to cloned food and its potential impacts calls for the remedy of a truly rigorous scientific assessment, and Congress has now repeatedly called for such action."
The Farm Bill amendment addresses the gaps and inadequacies of the FDAs current risk assessment, and would go into effect before any food products from clones are marketed. The Farm Bill also directs the USDA to examine consumer acceptance of cloned foods and the likely impacts they could have on domestic and international markets. (Click here for more information on this amendment).
Additionally, the FDA is today issuing a guidance document for food producers; It fails to require any special procedures for tracking or handling food products from clones. It also fails to require labeling of any kind on food products from clones or their offspring, which deprives consumers of their right to know about the origins of their food.
Recently, two cloning companies - Viagen and Trans Ova, proposed the creation of a voluntary cloning registry program. While they advanced claims that the registry would provide consumer protection and transparency without regulation, clones and their progeny will still be dispersed through the food system without any tracking or labeling.
"The cloning industry's proposal is simply another attempt to force cloned milk and meat on consumers and the dairy industry by giving the public phony assurances," said Mendelson. "The proposal neither provides new studies on the safety of clones nor protects the consumers' right to know whether their food or dairy contains products from clones. Once clones are released into America's food supply without any traceability requirements, it will be difficult, if not impossible, to recall them."
Recent opinion polls show the majority of Americans do not want milk or meat from cloned animals in their food. A December 2006 poll by the Pew Initiative on Food and Biotechnology found that nearly two-thirds of U.S. consumers were uncomfortable with animal cloning. A national survey conducted this year by Consumers Union found that 89 percent of Americans want to see cloned foods labeled, while 69 percent said that they have concerns about cloned meat and dairy products in the food supply. A recent Gallup Poll reported that more than 60 percent of Americans believe that it is immoral to clone animals, while the Pew Initiative on Food and Biotechnology found that a similar percentage say that, despite FDA approval, they won't buy milk from cloned animals.
In its risk assessment of cloned food, the FDA claims to have evaluated extensive peer reviewed safety studies to support its conclusion, yet a recent report issued by CFS, Not Ready for Prime Time, shows the assessment only references three peer-reviewed food safety studies, all of which focus on the narrow issue of milk from cloned cows. What is even more disturbing is that these studies were partially funded by the same biotech firms that produce clones for profit.
New studies, different outcomes on caffeine, pregnancy
One study found that consuming 200 milligrams or more of caffeine per day doubled the risk of miscarriage.
USA TODAY
Most women know they shouldn't smoke or drink alcohol while pregnant. But what about caffeine?
Two new studies reach somewhat different conclusions about the connection between drinking caffeine and miscarriage risk, an inconsistency that dates back to the 1980s, when scientists began investigating the subject.
It's plausible that caffeine could trigger a miscarriage, a pregnancy loss before 20 weeks gestation. Caffeine crosses the placenta, but a fetus is not able to metabolize it. Caffeine might adversely affect cell development in the fetus and decrease blood flow in the placenta.
But some scientists have speculated that caffeine only appears to increase miscarriage risk because women with morning sickness, who are more likely to carry a pregnancy to term, avoid coffee and other drinks that contain it.
In both of the new studies, the authors say they took morning sickness into account, so their findings relate to caffeine and not to other characteristics of pregnant women who drink it.
In one study, in the American Journal of Obstetrics & Gynecology, Kaiser Permanente researchers analyzed information about caffeine drinking by 1,063 women early in their pregnancies.
Women who reported drinking less than 200 milligrams of caffeine per day (about two cups of regular coffee or five cans of caffeinated soda) were 40% more likely to miscarry than women who said they drank no caffeinated beverages. Those who drank 200 milligrams or more of caffeine per day had about twice the miscarriage risk as women who drank none.
"My suggestion is women who are pregnant and women who are trying to become pregnant should consider stopping caffeine entirely," co-author De-Kun Li says. If you must have that morning cup of coffee, he says, let it be your only one of the day.
Not so fast, says David Savitz, lead author of the other new study on the subject, in the January issue of Epidemiology. Savitz, a professor in community and preventive medicine at New York's Mount Sinai School of Medicine, found no link between miscarriage and caffeine consumption in the 2,407 pregnant women he studied.
Compared with women in other studies, though, Savitz says, his subjects were pretty light caffeine drinkers. The biggest consumers drank the equivalent of only about two cups of coffee a day, he says.
"It's really hard as a physician to translate this into clinical practice," says OB-GYN Tracy Flanagan, women's health director at Kaiser Permanente Northern California, who wasn't involved with Li's study. Flanagan advises pregnant women in their first trimester to limit their caffeine to two cups of coffee or five cans of soda a day. Better yet, she says, switch to decaffeinated beverages.
"Here is something that women can actively do" to reduce their miscarriage risk, Flanagan says.
After her first pregnancy ended in a miscarriage, self-described caffeine addict Tammy Plotkin-Oren of El Cerrito, Calif., swore off the stuff. Her sister, an OB-GYN, told her: "Is it going to ensure that you're not going to have another miscarriage? No." Coincidence or not, Plotkin-Oren, 35, went on to deliver three healthy daughters.
USA TODAY
Most women know they shouldn't smoke or drink alcohol while pregnant. But what about caffeine?
Two new studies reach somewhat different conclusions about the connection between drinking caffeine and miscarriage risk, an inconsistency that dates back to the 1980s, when scientists began investigating the subject.
It's plausible that caffeine could trigger a miscarriage, a pregnancy loss before 20 weeks gestation. Caffeine crosses the placenta, but a fetus is not able to metabolize it. Caffeine might adversely affect cell development in the fetus and decrease blood flow in the placenta.
But some scientists have speculated that caffeine only appears to increase miscarriage risk because women with morning sickness, who are more likely to carry a pregnancy to term, avoid coffee and other drinks that contain it.
In both of the new studies, the authors say they took morning sickness into account, so their findings relate to caffeine and not to other characteristics of pregnant women who drink it.
In one study, in the American Journal of Obstetrics & Gynecology, Kaiser Permanente researchers analyzed information about caffeine drinking by 1,063 women early in their pregnancies.
Women who reported drinking less than 200 milligrams of caffeine per day (about two cups of regular coffee or five cans of caffeinated soda) were 40% more likely to miscarry than women who said they drank no caffeinated beverages. Those who drank 200 milligrams or more of caffeine per day had about twice the miscarriage risk as women who drank none.
"My suggestion is women who are pregnant and women who are trying to become pregnant should consider stopping caffeine entirely," co-author De-Kun Li says. If you must have that morning cup of coffee, he says, let it be your only one of the day.
Not so fast, says David Savitz, lead author of the other new study on the subject, in the January issue of Epidemiology. Savitz, a professor in community and preventive medicine at New York's Mount Sinai School of Medicine, found no link between miscarriage and caffeine consumption in the 2,407 pregnant women he studied.
Compared with women in other studies, though, Savitz says, his subjects were pretty light caffeine drinkers. The biggest consumers drank the equivalent of only about two cups of coffee a day, he says.
"It's really hard as a physician to translate this into clinical practice," says OB-GYN Tracy Flanagan, women's health director at Kaiser Permanente Northern California, who wasn't involved with Li's study. Flanagan advises pregnant women in their first trimester to limit their caffeine to two cups of coffee or five cans of soda a day. Better yet, she says, switch to decaffeinated beverages.
"Here is something that women can actively do" to reduce their miscarriage risk, Flanagan says.
After her first pregnancy ended in a miscarriage, self-described caffeine addict Tammy Plotkin-Oren of El Cerrito, Calif., swore off the stuff. Her sister, an OB-GYN, told her: "Is it going to ensure that you're not going to have another miscarriage? No." Coincidence or not, Plotkin-Oren, 35, went on to deliver three healthy daughters.
Sunday, January 20, 2008
Study Reveals Doubt on Drug for Cholesterol
By ALEX BERENSON
Published: January 15, 2008
A clinical trial of Zetia, a widely used cholesterol drug, has raised questions about its effectiveness and the behavior of pharmaceutical companies that conducted the study.
http://www.nytimes.com/2008/01/15/business/15drug.html?ex=1358226000&en=dba4b9b6fb66e970&ei=5124&partner=permalink&exprod=permalink
Published: January 15, 2008
A clinical trial of Zetia, a widely used cholesterol drug, has raised questions about its effectiveness and the behavior of pharmaceutical companies that conducted the study.
http://www.nytimes.com/2008/01/15/business/15drug.html?ex=1358226000&en=dba4b9b6fb66e970&ei=5124&partner=permalink&exprod=permalink
Blueberries rate low on pesticide
By Shea Rarback
Concerns about pesticides can make the ''eat more fruit'' recommendation hard to swallow. I learned this from a reader who stopped eating blueberries when told they were high in pesticides. Here are the facts. In 2003 the Environmental Working Group tested and ranked 46 common fruits and vegetables for pesticide contamination. According to their findings, the produce with the highest amount of contamination, coined the dirty dozen, are peaches, strawberries, apples, spinach, nectarines, celery, pears, cherries, potatoes, bell peppers, raspberries and imported grapes. These would be the best choices for organic. Blueberries ranked No. 31.
Fruits and vegetables are great sources of naturally occurring disease-fighting compounds. They are low in fat and high in fiber. There might be small amounts of residue on produce but the benefits outweigh the risk and I encourage all to bring back the berries and at least four other servings of fruits and veggies daily.
Concerns about pesticides can make the ''eat more fruit'' recommendation hard to swallow. I learned this from a reader who stopped eating blueberries when told they were high in pesticides. Here are the facts. In 2003 the Environmental Working Group tested and ranked 46 common fruits and vegetables for pesticide contamination. According to their findings, the produce with the highest amount of contamination, coined the dirty dozen, are peaches, strawberries, apples, spinach, nectarines, celery, pears, cherries, potatoes, bell peppers, raspberries and imported grapes. These would be the best choices for organic. Blueberries ranked No. 31.
Fruits and vegetables are great sources of naturally occurring disease-fighting compounds. They are low in fat and high in fiber. There might be small amounts of residue on produce but the benefits outweigh the risk and I encourage all to bring back the berries and at least four other servings of fruits and veggies daily.
A cloned cheeseburger? Don't fire up the coals yet
It's going to take years for ranchers to raise the animals. And consumers may not have a taste for them.
http://www.latimes.com/features/health/la-fi-clonedmeat16jan16,1,6648168.story?track=crosspromo&coll=la-headlines-health&ctrack=1&cset=true
http://www.latimes.com/features/health/la-fi-clonedmeat16jan16,1,6648168.story?track=crosspromo&coll=la-headlines-health&ctrack=1&cset=true
Monday, January 14, 2008
Genetically Modified Foods: Just Say No!
Why are GMO foods banned in Europe and not in the United States?
http://blogs.webmd.com/integrative-medicine-wellness/2007/11/genetically-modified-foods-just-say-no.html
http://blogs.webmd.com/integrative-medicine-wellness/2007/11/genetically-modified-foods-just-say-no.html
Sunday, January 13, 2008
Fish-Oil Doses Can Be Hard To Swallow
By DAVID STIPP
SPECIAL TO THE WSJ
January 8, 2008; Page D1
It's no wonder that more Americans are gulping fish oil. Hardly a month goes by without a study suggesting that the omega-3 fatty acids in fish oil can fend off disease -- including heart attacks, strokes, Alzheimer's disease, depression, rheumatoid arthritis, asthma, psoriasis and even attention-deficit hyperactivity disorder.
The problem is, to get the health benefits seen in clinical trials, you probably need to take fistfuls of capsules.
"The kind of benefits seen in most of the clinical trials with omega-3 generally have involved much higher doses than you see recommended on supplement labels," says Charles Serhan, a Harvard Medical School expert on omega-3's activity. "But although a large number of studies have used industrial-level doses," he adds, "we don't have rigorous scientific evidence about what the doses should be."
Regardless of the recommended dose, the need to stockpile bottles of supplements may diminish as more foods are fortified with omega-3 and as research shows ways of enhancing the benefits with other therapies.
While most of the scientific data on the health effects of fish oil aren't definitive, the federal National Institutes of Health concluded after a massive review three years ago that consuming omega-3 fatty acids cuts the risk of death from heart attacks and other cardiovascular causes, can reduce the joint pain of rheumatoid arthritis and "appears" important for proper brain development and function.
Because of news like that, the market for fish-oil supplements is booming. U.S. omega-3 supplement sales reached an estimated $600 million last year, up 20% from a year earlier, says the Global Organization for EPA and DHA Omega-3s, a Salt Lake City trade group. (The two key omega-3 fatty acids are called EPA and DHA.) Omega-3 fatty acids now rank as the fifth-best-selling dietary supplement, behind multivitamins, calcium and vitamins C and E.
In trials aimed at lowering high blood levels of triglycerides, a contributor to heart disease, patients took four particularly potent capsules that contained a total of more than three grams of EPA and DHA a day. You would have to pop a daily dozen of the typical omega-3 capsules on the market to get that much -- four to six times the suggested daily "serving" usually specified on their labels. That many capsules could cost you more than $2 a day, and it is a lot more than you are likely to get from consuming fish: You would need more than six servings a day of tuna, or about three of salmon, to get that much EPA and DHA.
FISHTAILING
Clinical trials suggest that fish oil can fend off a variety of ailments, but the omega-3 doses used in the studies have varied widely.
• Heart disease: one gram or more
• Rheumatoid arthritis: two grams or more
• Brain health: one-half gram or moreFish may good for you, but you can get risky doses of mercury and other toxins by consuming lots of it. That is one reason the American Heart Association recommends that people who need to lower triglycerides to ward off heart attacks take omega-3 capsules. The suggested dose is two to four grams of EPA and DHA a day, which supplements can provide toxin-free. For healthy adults seeking merely to cut cardiac risks, the heart association says eating fatty fish, such as salmon, at least twice a week is probably enough.
But how much omega-3 should you take if you are trying to ease the joint inflammation of rheumatoid arthritis? Or ward off Alzheimer's disease? Or alleviate depression?
Unfortunately, there aren't enough clinical data to give firm answers. But the omega-3 literature affords hints. Results in various rheumatoid-arthritis trials indicate that you need to take more than two grams, perhaps 10 typical capsules, of omega-3 fatty acids a day to significantly curtail joint inflammation and pain.
For maintaining brain health, the overall data on omega-3's potential are inconclusive, according to the NIH. But a recent Dutch study showed that about 400 milligrams of EPA and DHA a day -- which you can get from two typical omega-3 capsules -- helped elderly men maintain mental acuity. The study found that the more omega-3 ingested, the greater the benefit.
In the depression data, two things stand out: EPA appears more effective than DHA. And about one gram of EPA seems optimal -- more isn't better.
All this suggests that you may have to take a half dozen or more typical omega-3 pills a day to get the kind of benefits observed in clinical trials with fish oil. But soon it may get easier to get such hefty doses without taking so many pills. A growing number of foods are fortified with omega-3, everything from yogurt to orange juice, including more than 1,200 such products launched in 2006 alone, according to the London-based market researcher Datamonitor. Such foods typically don't contain much omega-3 -- a fortified egg might contain half as much as a typical capsule. But as more fortified foods come to market, it will be easier to get omega-3 in your diet.
There is another reason popping fish-oil capsules by the fistful may be overkill. Many scientists believe omega-3's benefits flow primarily from its ability to damp low-level inflammation, which is thought to be a key culprit in just about every major scourge of aging, from clogged arteries to Alzheimer's. Studies over the past few years suggest that taking small doses of aspirin daily, which many people do to prevent heart attacks, magnifies the anti-inflammatory effect of taking fish oil.
Indeed, some of the most dramatic evidence of fish oil's heart benefits came from a 1999 Italian study in which patients who had recently had heart attacks showed a 45% reduction in subsequent "sudden cardiac death" when given modest fish-oil doses (the amount in about three typical omega-3 capsules). The supplements' striking effectiveness may well have been magnified by the fact that many of the patients were also taking aspirin daily.
Aspirin's effect on omega-3 isn't clear yet, though. So for now, big doses of the supplement probably are necessary to get the health benefits.
Omega-3 appears to be safe, even at the high doses used in clinical trials. But large doses can have side effects. Perhaps the best source on that issue is the prescribing information for Lovaza. Sold by GlaxoSmithKline PLC unit Reliant Pharmaceuticals Inc., Lovaza is prescribed for "very high" triglycerides.
In Lovaza's clinical trials, patients took four capsules a day with a total of 3.4 grams of EPA and DHA. The most common "adverse event," reported by about 5% of patients, was belching. Some 4% reported infections, compared with 2% on a placebo, but it's not clear whether fish oil caused the difference. While some research suggests that taking fish oil prolongs bleeding time, no bleeding problems were reported in the Lovaza trials.
There's no evidence Lovaza works better or is purer than high-end omega-3 dietary supplements -- such as those made by Nordic Naturals Inc., of Watsonville, Calif. -- which cost less than half as much as Lovaza does per gram of EPA and DHA.
A 2004 analysis of 44 kinds of omega-3 supplements by ConsumerLab.com1, based in Scarsdale, N.Y., found that none had unsafe levels of mercury or PCBs. And Lovaza wasn't used in most of the promising clinical trials with omega-3.
URL for this article:
http://online.wsj.com/article/SB119975627038373627.html
SPECIAL TO THE WSJ
January 8, 2008; Page D1
It's no wonder that more Americans are gulping fish oil. Hardly a month goes by without a study suggesting that the omega-3 fatty acids in fish oil can fend off disease -- including heart attacks, strokes, Alzheimer's disease, depression, rheumatoid arthritis, asthma, psoriasis and even attention-deficit hyperactivity disorder.
The problem is, to get the health benefits seen in clinical trials, you probably need to take fistfuls of capsules.
"The kind of benefits seen in most of the clinical trials with omega-3 generally have involved much higher doses than you see recommended on supplement labels," says Charles Serhan, a Harvard Medical School expert on omega-3's activity. "But although a large number of studies have used industrial-level doses," he adds, "we don't have rigorous scientific evidence about what the doses should be."
Regardless of the recommended dose, the need to stockpile bottles of supplements may diminish as more foods are fortified with omega-3 and as research shows ways of enhancing the benefits with other therapies.
While most of the scientific data on the health effects of fish oil aren't definitive, the federal National Institutes of Health concluded after a massive review three years ago that consuming omega-3 fatty acids cuts the risk of death from heart attacks and other cardiovascular causes, can reduce the joint pain of rheumatoid arthritis and "appears" important for proper brain development and function.
Because of news like that, the market for fish-oil supplements is booming. U.S. omega-3 supplement sales reached an estimated $600 million last year, up 20% from a year earlier, says the Global Organization for EPA and DHA Omega-3s, a Salt Lake City trade group. (The two key omega-3 fatty acids are called EPA and DHA.) Omega-3 fatty acids now rank as the fifth-best-selling dietary supplement, behind multivitamins, calcium and vitamins C and E.
In trials aimed at lowering high blood levels of triglycerides, a contributor to heart disease, patients took four particularly potent capsules that contained a total of more than three grams of EPA and DHA a day. You would have to pop a daily dozen of the typical omega-3 capsules on the market to get that much -- four to six times the suggested daily "serving" usually specified on their labels. That many capsules could cost you more than $2 a day, and it is a lot more than you are likely to get from consuming fish: You would need more than six servings a day of tuna, or about three of salmon, to get that much EPA and DHA.
FISHTAILING
Clinical trials suggest that fish oil can fend off a variety of ailments, but the omega-3 doses used in the studies have varied widely.
• Heart disease: one gram or more
• Rheumatoid arthritis: two grams or more
• Brain health: one-half gram or moreFish may good for you, but you can get risky doses of mercury and other toxins by consuming lots of it. That is one reason the American Heart Association recommends that people who need to lower triglycerides to ward off heart attacks take omega-3 capsules. The suggested dose is two to four grams of EPA and DHA a day, which supplements can provide toxin-free. For healthy adults seeking merely to cut cardiac risks, the heart association says eating fatty fish, such as salmon, at least twice a week is probably enough.
But how much omega-3 should you take if you are trying to ease the joint inflammation of rheumatoid arthritis? Or ward off Alzheimer's disease? Or alleviate depression?
Unfortunately, there aren't enough clinical data to give firm answers. But the omega-3 literature affords hints. Results in various rheumatoid-arthritis trials indicate that you need to take more than two grams, perhaps 10 typical capsules, of omega-3 fatty acids a day to significantly curtail joint inflammation and pain.
For maintaining brain health, the overall data on omega-3's potential are inconclusive, according to the NIH. But a recent Dutch study showed that about 400 milligrams of EPA and DHA a day -- which you can get from two typical omega-3 capsules -- helped elderly men maintain mental acuity. The study found that the more omega-3 ingested, the greater the benefit.
In the depression data, two things stand out: EPA appears more effective than DHA. And about one gram of EPA seems optimal -- more isn't better.
All this suggests that you may have to take a half dozen or more typical omega-3 pills a day to get the kind of benefits observed in clinical trials with fish oil. But soon it may get easier to get such hefty doses without taking so many pills. A growing number of foods are fortified with omega-3, everything from yogurt to orange juice, including more than 1,200 such products launched in 2006 alone, according to the London-based market researcher Datamonitor. Such foods typically don't contain much omega-3 -- a fortified egg might contain half as much as a typical capsule. But as more fortified foods come to market, it will be easier to get omega-3 in your diet.
There is another reason popping fish-oil capsules by the fistful may be overkill. Many scientists believe omega-3's benefits flow primarily from its ability to damp low-level inflammation, which is thought to be a key culprit in just about every major scourge of aging, from clogged arteries to Alzheimer's. Studies over the past few years suggest that taking small doses of aspirin daily, which many people do to prevent heart attacks, magnifies the anti-inflammatory effect of taking fish oil.
Indeed, some of the most dramatic evidence of fish oil's heart benefits came from a 1999 Italian study in which patients who had recently had heart attacks showed a 45% reduction in subsequent "sudden cardiac death" when given modest fish-oil doses (the amount in about three typical omega-3 capsules). The supplements' striking effectiveness may well have been magnified by the fact that many of the patients were also taking aspirin daily.
Aspirin's effect on omega-3 isn't clear yet, though. So for now, big doses of the supplement probably are necessary to get the health benefits.
Omega-3 appears to be safe, even at the high doses used in clinical trials. But large doses can have side effects. Perhaps the best source on that issue is the prescribing information for Lovaza. Sold by GlaxoSmithKline PLC unit Reliant Pharmaceuticals Inc., Lovaza is prescribed for "very high" triglycerides.
In Lovaza's clinical trials, patients took four capsules a day with a total of 3.4 grams of EPA and DHA. The most common "adverse event," reported by about 5% of patients, was belching. Some 4% reported infections, compared with 2% on a placebo, but it's not clear whether fish oil caused the difference. While some research suggests that taking fish oil prolongs bleeding time, no bleeding problems were reported in the Lovaza trials.
There's no evidence Lovaza works better or is purer than high-end omega-3 dietary supplements -- such as those made by Nordic Naturals Inc., of Watsonville, Calif. -- which cost less than half as much as Lovaza does per gram of EPA and DHA.
A 2004 analysis of 44 kinds of omega-3 supplements by ConsumerLab.com1, based in Scarsdale, N.Y., found that none had unsafe levels of mercury or PCBs. And Lovaza wasn't used in most of the promising clinical trials with omega-3.
URL for this article:
http://online.wsj.com/article/SB119975627038373627.html
Tuesday, January 8, 2008
On a Remote Path to Cures
By ANDREW DOWNIE
Published: January 1, 2008
Scouring remote regions for plants, oils and extracts can yield cures — and big profits — for pharmaceutical companies and indigenous tribes.
http://www.nytimes.com/2008/01/01/business/worldbusiness/01hunter.html?ex=1357016400&en=79f30970d7381269&ei=5124&partner=permalink&exprod=permalink
Published: January 1, 2008
Scouring remote regions for plants, oils and extracts can yield cures — and big profits — for pharmaceutical companies and indigenous tribes.
http://www.nytimes.com/2008/01/01/business/worldbusiness/01hunter.html?ex=1357016400&en=79f30970d7381269&ei=5124&partner=permalink&exprod=permalink
How dangerous are chemicals in ordinary products?
The (Possible) Perils of Being Thirsty While Being Green
By ALINA TUGEND
Published: January 5, 2008
I have the usual New Year’s resolutions — exercise more, lose weight, be a nicer person. I also hope to find out if I am inadvertently poisoning my children.
http://www.nytimes.com/2008/01/05/business/smallbusiness/05shortcuts.html?ex=1357448400&en=79df7579411f4b60&ei=5124&partner=permalink&exprod=permalink
Everyday Items, Complex Chemistry
By AMY SCHOENFELD
Published: December 22, 2007
Holiday shoppers may worry about whether the toys they buy contain lead, but some scientists are urging consumers to focus on the thousands of chemicals in everyday household items.
http://www.nytimes.com/2007/12/22/business/22chemicals.html?ex=1356066000&en=b42d1f7e4a74a77d&ei=5124&partner=permalink&exprod=permalink
By ALINA TUGEND
Published: January 5, 2008
I have the usual New Year’s resolutions — exercise more, lose weight, be a nicer person. I also hope to find out if I am inadvertently poisoning my children.
http://www.nytimes.com/2008/01/05/business/smallbusiness/05shortcuts.html?ex=1357448400&en=79df7579411f4b60&ei=5124&partner=permalink&exprod=permalink
Everyday Items, Complex Chemistry
By AMY SCHOENFELD
Published: December 22, 2007
Holiday shoppers may worry about whether the toys they buy contain lead, but some scientists are urging consumers to focus on the thousands of chemicals in everyday household items.
http://www.nytimes.com/2007/12/22/business/22chemicals.html?ex=1356066000&en=b42d1f7e4a74a77d&ei=5124&partner=permalink&exprod=permalink
Tame a Child's Cough With a Touch of Honey
By NICHOLAS BAKALAR
Published: December 11, 2007
A spoonful of honey might quiet a child's cough more effectively and safely than the most common over-the-counter cough medicine.
Researchers tested 105 children 2 to 18 with coughs from upper-respiratory infections, dividing them randomly into three groups. One received no treatment. The others received a remedy, but the researchers, parents and children did not know which it was: one or two teaspoons of buckwheat honey, depending on age, or an age-appropriate dose of honey-flavored dextromethorphan. The study was supported by a grant from the National Honey Board, an industry-backed agency of the Department of Agriculture.
Using questionnaires filled out by the parents, the scientists measured cough frequency and severity, and the effect on the children's and parents' sleep. By all measures, honey provided the greatest relief.
Honey, the authors wrote in the December issue of The Archives of Pediatric and Adolescent Medicine, has well-established antioxidant and antimicrobial effects, and it might be that sweet substances of any kind help dissolve mucus in the airways and soothe the back of the throat.
In October, a Food and Drug Administration advisory panel recommended a ban on over-the-counter cold medicine, including some brands containing dextromethorphan, intended for children under age 6.
Dr. Ian M. Paul, the lead author and an associate professor of pediatrics at Penn State, said that parents should consider honey ''as an alternative to cough medicine for children over age 1.'' In rare cases, honey can cause infantile botulism in children under 1.
Published: December 11, 2007
A spoonful of honey might quiet a child's cough more effectively and safely than the most common over-the-counter cough medicine.
Researchers tested 105 children 2 to 18 with coughs from upper-respiratory infections, dividing them randomly into three groups. One received no treatment. The others received a remedy, but the researchers, parents and children did not know which it was: one or two teaspoons of buckwheat honey, depending on age, or an age-appropriate dose of honey-flavored dextromethorphan. The study was supported by a grant from the National Honey Board, an industry-backed agency of the Department of Agriculture.
Using questionnaires filled out by the parents, the scientists measured cough frequency and severity, and the effect on the children's and parents' sleep. By all measures, honey provided the greatest relief.
Honey, the authors wrote in the December issue of The Archives of Pediatric and Adolescent Medicine, has well-established antioxidant and antimicrobial effects, and it might be that sweet substances of any kind help dissolve mucus in the airways and soothe the back of the throat.
In October, a Food and Drug Administration advisory panel recommended a ban on over-the-counter cold medicine, including some brands containing dextromethorphan, intended for children under age 6.
Dr. Ian M. Paul, the lead author and an associate professor of pediatrics at Penn State, said that parents should consider honey ''as an alternative to cough medicine for children over age 1.'' In rare cases, honey can cause infantile botulism in children under 1.
Nursing Homes Struggle To Kick Drug Habit
New Therapies Sought For Dementia Sufferers; Music and Massages
By LUCETTE LAGNADO December 20, 2007 WSJ
BROOKLYN, N.Y. -- It is lunchtime at Cobble Hill Health Center and Elizabeth Johnson is busy helping patients in the Alzheimer's unit -- tying plastic aprons around their waists, passing out salt and pepper shakers, paper cups, straws and little containers of milk.
"You have to sit and eat," Mrs. Johnson tells one resident. "There is a spoon if you need a spoon," she says to another.
In her print dress and coral lipstick, Mrs. Johnson, 71 years old, can almost pass for a staffer on some days, or even the manager she used to be at a local city hospital. In fact, she is a patient here, stricken with an advanced form of dementia that sometimes renders her confused, fretful -- even combative. Not long ago, Cobble Hill's staff would respond to Mrs. Johnson's unruly episodes by putting her on a powerful antipsychotic drug.
Use of a new generation of antipsychotic drugs to control the behavior of dementia patients has surged in recent years, despite the Food and Drug Administration's "black box" warning labels that these drugs can increase the risk of death for elderly dementia sufferers. About 30% of nursing-home residents are on antipsychotic drugs, according to the Centers for Medicare & Medicaid Services, most of them on newer ones called atypical antipsychotics.
Mrs. Johnson, however, is now part of an experiment at the Cobble Hill nursing home to wean patients off antipsychotics. In her case, the staff has figured out that when she becomes distraught, the best way to calm her down is to have her do what she loved to do when she was well: work. Simple tasks such as setting the table, they say, give Mrs. Johnson a renewed sense of purpose and calm.
The challenge of caring for rising numbers of seniors who suffer from dementia and the behavior problems that can stem from it has provoked a wrenching debate among nursing-home operators, regulators and families. There are few effective medicines to manage the outbursts of Alzheimer's patients -- behavior that can overwhelm family members trying to care for a loved one at home, and strain the resources of those trying to maintain order in nursing facilities.
Federal law strongly discourages nursing homes from physically tying down unruly patients. But federal health-care programs such as Medicaid do pay for drugs that may help calm aggressive behavior and agitation associated with Alzheimer's.
Medicaid in 2005 spent $5.4 billion on atypical antipsychotic medicines -- more than it spent on any other class of drugs, including antibiotics, AIDS drugs or medicines to treat high blood pressure. Atypical antipsychotics are approved for schizophrenia and bipolar disorder. But in what is known as "off label" use, doctors often prescribe the drugs to elderly people with dementia.
The widespread use of antipsychotics among the elderly has begun to draw criticism from regulators, researchers, lawmakers and some in the nursing-home industry. Sen. Charles Grassley, the ranking Republican on the Senate Finance Committee, this month asked several drug manufacturers for records on how they may have marketed these drugs for use in geriatric patients. He also has asked the Inspector General of the Department of Health and Human Services to investigate use of the drugs in nursing homes.
The $122 billion nursing-home industry has evolved toward large, often understaffed institutions. A law signed by President Reagan in 1987 sought to limit physical and chemical restraints in nursing homes. But in the late 1990s, with the introduction of new medicines called atypical antipsychotics, use of psychotropic drugs among the elderly began to creep up.
According to CMS, nearly 21% of nursing-home patients who don't have a psychosis diagnosis are on antipsychotic drugs. A 2005 study, published in the Archives of Internal Medicine, found antipsychotics were prescribed not only for psychosis, but for depression, confusion, memory loss and feelings of isolation, says the study's author Becky Briesacher.
Last year, CMS instituted new guidelines to limit the use of antipsychotics. Even so, under federal rules, it's still easier for nursing homes to get reimbursed for giving patients extra pills than it is for hiring extra staff.
An elderly person with Alzheimer's often isn't able to refuse antipsychotic drugs, says Cynthia Rudder, of the Long-Term Care Community Coalition, a New York patient-advocacy group. "You are basically quieting them against their will, and it is absolutely horrendous," she says.
Family members can object to the use of such drugs. But they risk having the facility threaten to discharge their relative on grounds that they pose a danger to themselves or others.
At CMS, officials stress the need to shift to smaller, less-rigid facilities as a way to reduce antipsychotic usage. Dennis Smith, director of the Center for Medicaid and State Operations, says nursing homes should seek "a different model" of care, so that when dealing with patients in distress, the solution isn't only "unlocking the drug cabinet." His agency is pursuing a twofold approach, offering alternatives to nursing homes -- such as the option to live in the community -- and trying to improve nursing homes by letting them know "they will be open to scrutiny."
Some nursing-home-industry officials agree change is needed. "We cannot treat people by simply throwing psychotropic drugs at them for our convenience," says Larry Minnix, president of the American Association of Homes and Services for the Aging. While there are "really good places where physicians and nurses monitor this carefully, that is the exception not the rule," he says.
Yet replacing drugs with approaches that require a more human touch is easier said than done. Staffing remains an issue: According to CMS, nursing-home patients, on average, receive a half-hour of care per day from a registered nurse, plus 48 minutes from a licensed practical nurse and two hours and 18 minutes from an aide.
There are some Alzheimer's patients for whom nonpharmacological approaches simply don't work, says William Thies, a vice president at the Alzheimer's Association in Chicago, and in these cases antipsychotics may be warranted. But the drugs need to be used very carefully, at the lowest dose and after ruling out a medical problem, says Dr. Thies, who has a doctorate in pharmacology.
Still some nursing homes are trying alternatives. At Providence Rest Nursing Home in the Bronx, distraught Alzheimer's patients are given massages and aromatherapy. Providence, a facility with 200 patients run by an order of nuns, has brought its overall reliance on antipsychotics down to 2% over the last few years -- and down to zero among patients who are not psychotic. At Bishop Wicke Care Center, a 120-bed facility in Shelton, Conn., the emphasis is on giving patients consistent caregivers -- avoiding staff turnover that can make life trying for residents. The home has also undertaken a project to get to know what patients were like when they were young, as a key to dealing with their angst.
At Cobble Hill in Brooklyn, the effort to wean Mrs. Johnson off antipsychotics is part of a broader effort by the facility's Chief Executive Officer Olga Lipschitz to make the facility more "homelike." Mrs. Lipschitz, who at 74 is the age of some of her patients, took over Cobble Hill in the 1970s following a scandal over conditions in New York nursing homes. "I have been at this for 35 years," she says. "Reform is constantly needed."
Some patients are responding well to alternative approaches. Others still need drugs.
After she retired, Mrs. Johnson lived on her own in Brooklyn. But she began to wander from her house. "Strangers were bringing her home," recalls her daughter, Shirlyn Breeden.
One day, a bruised Mrs. Johnson showed up at her church, unable to explain what had happened.
She was taken from one medical facility to another and given antipsychotics, her daughter says. Mrs. Johnson was on antipsychotics when transferred to Cobble Hill in May 2005 and the staff kept her on the medication. She was "combative with other residents at times," say her case notes.
"My mother thought this was her apartment and these strangers were living there. She would tell them to get their feet off the bed," Ms. Breeden recalls. "I would tell her, 'You're being mean to them,' but she would say, 'They know that you are not supposed to put your feet on the bed.'"
Ms. Breeden worried about her mom. "Her eyes were weak, she was incoherent, she couldn't complete a full sentence," she says. "That wasn't my mother -- she was never like that." Her mother was the kind of woman, she says, who never left the house without putting on lipstick.
The medication didn't halt her outbursts. Her daughter recalls a terrifying day when Mrs. Johnson moved her bed to block the door of her room, convinced strangers wanted to come in.
In 2005, Louis Mudannayake, Cobble Hill's medical director, decided the facility had too many patients on antipsychotic drugs.
"They were chemically 'shlogged,'" he says. "A patient who had had some quality of life earlier, who was able to interact and smile at her relatives and put a fork to her tuna fish, was no longer able to do that."
He began a chart-by-chart review of every patient on any type of antipsychotic. He formed a team -- including a psychiatrist, pharmacy consultant, a nurse, social worker, recreational therapist and nurse's aide -- that met roughly once a month. They determined which patients could be taken off the drugs and which ones could have doses reduced.
Initially, there was skepticism from the staff. Some nurses warned patients would run amok if taken off the drugs. Doctors balked, persuaded the drugs worked.
Ravi Amin, a psychiatrist who works at Cobble Hill and other facilities, says he has given orders at some of the other nursing homes to have a patient taken off antipsychotics only to find them countermanded by the unit nurse and the facility's on-site internist. "Doctors would be called to restart the medicine so that by the time I made the second visit, some patients were back on it," he says.
Mrs. Johnson had been on an antipsychotic called Seroquel for about a year and a half. In May, the team concluded she was a candidate for "environmental redirection." This meant that if she became upset, the staff wasn't to automatically reach for Seroquel, but try other ways to calm her.
Within a month, she was taken off the antipsychotic entirely.
"We began to give her little tasks -- pre-packaged spoons to give out, aprons to put on other residents," says Liza Long, a nurse who is the unit's community director. "She still thinks she's at work."
To her daughter, a telling change in Mrs. Johnson's life since stopping the antipsychotics is cosmetic: These days, she says, Mrs. Johnson rarely leaves her room without her lipstick on.
A spokesman for AstraZeneca Pharmaceuticals LP, maker of Seroquel, says "decisions about medical treatment are made by physicians" and the company doesn't recommend the drug "for uses other than its approved indications in schizophrenia and bipolar disorder." He says the boxed warning "contained in all labels for this class of drugs states there is 'increased mortality in elderly patients with dementia-related psychosis.'" He adds that the labels also state the drugs aren't approved for treatment of patients with dementia-related psychosis.
Some caretakers say that antipsychotics can be effective in helping an elderly loved one at home.
Serena Ferguson, 56, a physician, took care of her mother at home for years. In the throes of dementia, her mother would pace and wander and try to leave the apartment, she recalls. It was hard to get her to fall asleep and Dr. Ferguson had to place herself by the door to make sure her mom wouldn't slip out.
Dr. Ferguson says atypical antipsychotics were the only way to keep her mother safe at home. "They would calm her down," she says. "Those medications will make you drowsy, and she would go to sleep, and that is good, because I would go to sleep," she says.
Last year, her mother was admitted to Cobble Hill, where she remained on the antipsychotic drug Seroquel. But when the nursing home told her they wanted to wean her mom off the drug, Dr. Ferguson agreed.
Her mother has been off antipsychotics for about 11 months. Instead, she has been getting stimulation, her daughter says, including music and dancing.
When her 92-year-old mother, Mae, was young, she loved to go dancing at the Savoy Ballroom in Harlem. Mrs. Ferguson worked as a presser at a dry cleaner's to support herself and her only child.
On a recent Friday, Mrs. Ferguson sat motionless at the dining room table. She wasn't smiling; she had not eaten much.
Then a staffer put on a CD of Nat King Cole singing "Almost Like Being in Love." Mrs. Ferguson's eyes widened and she started to smile. With help from an aide, she rose and began swaying to the music, snapping her fingers. "Dance with me," she said to Dr. Mudannayake, the medical director. "I'd like to dance with all of you," she said to the staff.
Not all cases work out. Some patients relapse. Some receive reduced doses of antipsychotics, but show signs of distress. Others are taken off drugs and still suffer from symptoms of their brain disorder.
In 2003, the rate of antipsychotic use among Cobble Hill patients who didn't have a psychotic disorder was nearly 24%. Earlier this year, it had fallen to about 12%. But lately, the rate has crept up again, showing the constant struggle.
Sometimes little seems to work. After Cobble Hill patient Mary Goldman, a former college professor, suffered yet another stroke this year, she was no longer able to speak clearly. She began to scream uncontrollably, tugging at nurses. In an effort to calm her, the staff administered 75 milligrams of Seroquel, twice a day.
But Mrs. Goldman screamed even more loudly, sometimes for as long as an hour and a half, the medical director says.
When her case was reviewed earlier this year, the team recommended trying to taper her off the antipsychotic.
Now, Mrs. Goldman is off the drug. She still screams and cries out, her husband says, though not for as long. When his wife becomes distraught, he tries to soothe her by speaking gently, holding her arm, and stroking her hand.
"Sometimes it works and sometimes it doesn't," he says. "It does not diminish agitation completely but it does diminish it."
Lately, Cobble Hill has tried bringing books and magazines to Mrs. Goldman's bedside. "She is not really reading," says Dr. Mudannayake, "but they seem to comfort her and she yells and screams less."
Often she will merely fling them to the ground. Her husband bends down and picks them up.
By LUCETTE LAGNADO December 20, 2007 WSJ
BROOKLYN, N.Y. -- It is lunchtime at Cobble Hill Health Center and Elizabeth Johnson is busy helping patients in the Alzheimer's unit -- tying plastic aprons around their waists, passing out salt and pepper shakers, paper cups, straws and little containers of milk.
"You have to sit and eat," Mrs. Johnson tells one resident. "There is a spoon if you need a spoon," she says to another.
In her print dress and coral lipstick, Mrs. Johnson, 71 years old, can almost pass for a staffer on some days, or even the manager she used to be at a local city hospital. In fact, she is a patient here, stricken with an advanced form of dementia that sometimes renders her confused, fretful -- even combative. Not long ago, Cobble Hill's staff would respond to Mrs. Johnson's unruly episodes by putting her on a powerful antipsychotic drug.
Use of a new generation of antipsychotic drugs to control the behavior of dementia patients has surged in recent years, despite the Food and Drug Administration's "black box" warning labels that these drugs can increase the risk of death for elderly dementia sufferers. About 30% of nursing-home residents are on antipsychotic drugs, according to the Centers for Medicare & Medicaid Services, most of them on newer ones called atypical antipsychotics.
Mrs. Johnson, however, is now part of an experiment at the Cobble Hill nursing home to wean patients off antipsychotics. In her case, the staff has figured out that when she becomes distraught, the best way to calm her down is to have her do what she loved to do when she was well: work. Simple tasks such as setting the table, they say, give Mrs. Johnson a renewed sense of purpose and calm.
The challenge of caring for rising numbers of seniors who suffer from dementia and the behavior problems that can stem from it has provoked a wrenching debate among nursing-home operators, regulators and families. There are few effective medicines to manage the outbursts of Alzheimer's patients -- behavior that can overwhelm family members trying to care for a loved one at home, and strain the resources of those trying to maintain order in nursing facilities.
Federal law strongly discourages nursing homes from physically tying down unruly patients. But federal health-care programs such as Medicaid do pay for drugs that may help calm aggressive behavior and agitation associated with Alzheimer's.
Medicaid in 2005 spent $5.4 billion on atypical antipsychotic medicines -- more than it spent on any other class of drugs, including antibiotics, AIDS drugs or medicines to treat high blood pressure. Atypical antipsychotics are approved for schizophrenia and bipolar disorder. But in what is known as "off label" use, doctors often prescribe the drugs to elderly people with dementia.
The widespread use of antipsychotics among the elderly has begun to draw criticism from regulators, researchers, lawmakers and some in the nursing-home industry. Sen. Charles Grassley, the ranking Republican on the Senate Finance Committee, this month asked several drug manufacturers for records on how they may have marketed these drugs for use in geriatric patients. He also has asked the Inspector General of the Department of Health and Human Services to investigate use of the drugs in nursing homes.
The $122 billion nursing-home industry has evolved toward large, often understaffed institutions. A law signed by President Reagan in 1987 sought to limit physical and chemical restraints in nursing homes. But in the late 1990s, with the introduction of new medicines called atypical antipsychotics, use of psychotropic drugs among the elderly began to creep up.
According to CMS, nearly 21% of nursing-home patients who don't have a psychosis diagnosis are on antipsychotic drugs. A 2005 study, published in the Archives of Internal Medicine, found antipsychotics were prescribed not only for psychosis, but for depression, confusion, memory loss and feelings of isolation, says the study's author Becky Briesacher.
Last year, CMS instituted new guidelines to limit the use of antipsychotics. Even so, under federal rules, it's still easier for nursing homes to get reimbursed for giving patients extra pills than it is for hiring extra staff.
An elderly person with Alzheimer's often isn't able to refuse antipsychotic drugs, says Cynthia Rudder, of the Long-Term Care Community Coalition, a New York patient-advocacy group. "You are basically quieting them against their will, and it is absolutely horrendous," she says.
Family members can object to the use of such drugs. But they risk having the facility threaten to discharge their relative on grounds that they pose a danger to themselves or others.
At CMS, officials stress the need to shift to smaller, less-rigid facilities as a way to reduce antipsychotic usage. Dennis Smith, director of the Center for Medicaid and State Operations, says nursing homes should seek "a different model" of care, so that when dealing with patients in distress, the solution isn't only "unlocking the drug cabinet." His agency is pursuing a twofold approach, offering alternatives to nursing homes -- such as the option to live in the community -- and trying to improve nursing homes by letting them know "they will be open to scrutiny."
Some nursing-home-industry officials agree change is needed. "We cannot treat people by simply throwing psychotropic drugs at them for our convenience," says Larry Minnix, president of the American Association of Homes and Services for the Aging. While there are "really good places where physicians and nurses monitor this carefully, that is the exception not the rule," he says.
Yet replacing drugs with approaches that require a more human touch is easier said than done. Staffing remains an issue: According to CMS, nursing-home patients, on average, receive a half-hour of care per day from a registered nurse, plus 48 minutes from a licensed practical nurse and two hours and 18 minutes from an aide.
There are some Alzheimer's patients for whom nonpharmacological approaches simply don't work, says William Thies, a vice president at the Alzheimer's Association in Chicago, and in these cases antipsychotics may be warranted. But the drugs need to be used very carefully, at the lowest dose and after ruling out a medical problem, says Dr. Thies, who has a doctorate in pharmacology.
Still some nursing homes are trying alternatives. At Providence Rest Nursing Home in the Bronx, distraught Alzheimer's patients are given massages and aromatherapy. Providence, a facility with 200 patients run by an order of nuns, has brought its overall reliance on antipsychotics down to 2% over the last few years -- and down to zero among patients who are not psychotic. At Bishop Wicke Care Center, a 120-bed facility in Shelton, Conn., the emphasis is on giving patients consistent caregivers -- avoiding staff turnover that can make life trying for residents. The home has also undertaken a project to get to know what patients were like when they were young, as a key to dealing with their angst.
At Cobble Hill in Brooklyn, the effort to wean Mrs. Johnson off antipsychotics is part of a broader effort by the facility's Chief Executive Officer Olga Lipschitz to make the facility more "homelike." Mrs. Lipschitz, who at 74 is the age of some of her patients, took over Cobble Hill in the 1970s following a scandal over conditions in New York nursing homes. "I have been at this for 35 years," she says. "Reform is constantly needed."
Some patients are responding well to alternative approaches. Others still need drugs.
After she retired, Mrs. Johnson lived on her own in Brooklyn. But she began to wander from her house. "Strangers were bringing her home," recalls her daughter, Shirlyn Breeden.
One day, a bruised Mrs. Johnson showed up at her church, unable to explain what had happened.
She was taken from one medical facility to another and given antipsychotics, her daughter says. Mrs. Johnson was on antipsychotics when transferred to Cobble Hill in May 2005 and the staff kept her on the medication. She was "combative with other residents at times," say her case notes.
"My mother thought this was her apartment and these strangers were living there. She would tell them to get their feet off the bed," Ms. Breeden recalls. "I would tell her, 'You're being mean to them,' but she would say, 'They know that you are not supposed to put your feet on the bed.'"
Ms. Breeden worried about her mom. "Her eyes were weak, she was incoherent, she couldn't complete a full sentence," she says. "That wasn't my mother -- she was never like that." Her mother was the kind of woman, she says, who never left the house without putting on lipstick.
The medication didn't halt her outbursts. Her daughter recalls a terrifying day when Mrs. Johnson moved her bed to block the door of her room, convinced strangers wanted to come in.
In 2005, Louis Mudannayake, Cobble Hill's medical director, decided the facility had too many patients on antipsychotic drugs.
"They were chemically 'shlogged,'" he says. "A patient who had had some quality of life earlier, who was able to interact and smile at her relatives and put a fork to her tuna fish, was no longer able to do that."
He began a chart-by-chart review of every patient on any type of antipsychotic. He formed a team -- including a psychiatrist, pharmacy consultant, a nurse, social worker, recreational therapist and nurse's aide -- that met roughly once a month. They determined which patients could be taken off the drugs and which ones could have doses reduced.
Initially, there was skepticism from the staff. Some nurses warned patients would run amok if taken off the drugs. Doctors balked, persuaded the drugs worked.
Ravi Amin, a psychiatrist who works at Cobble Hill and other facilities, says he has given orders at some of the other nursing homes to have a patient taken off antipsychotics only to find them countermanded by the unit nurse and the facility's on-site internist. "Doctors would be called to restart the medicine so that by the time I made the second visit, some patients were back on it," he says.
Mrs. Johnson had been on an antipsychotic called Seroquel for about a year and a half. In May, the team concluded she was a candidate for "environmental redirection." This meant that if she became upset, the staff wasn't to automatically reach for Seroquel, but try other ways to calm her.
Within a month, she was taken off the antipsychotic entirely.
"We began to give her little tasks -- pre-packaged spoons to give out, aprons to put on other residents," says Liza Long, a nurse who is the unit's community director. "She still thinks she's at work."
To her daughter, a telling change in Mrs. Johnson's life since stopping the antipsychotics is cosmetic: These days, she says, Mrs. Johnson rarely leaves her room without her lipstick on.
A spokesman for AstraZeneca Pharmaceuticals LP, maker of Seroquel, says "decisions about medical treatment are made by physicians" and the company doesn't recommend the drug "for uses other than its approved indications in schizophrenia and bipolar disorder." He says the boxed warning "contained in all labels for this class of drugs states there is 'increased mortality in elderly patients with dementia-related psychosis.'" He adds that the labels also state the drugs aren't approved for treatment of patients with dementia-related psychosis.
Some caretakers say that antipsychotics can be effective in helping an elderly loved one at home.
Serena Ferguson, 56, a physician, took care of her mother at home for years. In the throes of dementia, her mother would pace and wander and try to leave the apartment, she recalls. It was hard to get her to fall asleep and Dr. Ferguson had to place herself by the door to make sure her mom wouldn't slip out.
Dr. Ferguson says atypical antipsychotics were the only way to keep her mother safe at home. "They would calm her down," she says. "Those medications will make you drowsy, and she would go to sleep, and that is good, because I would go to sleep," she says.
Last year, her mother was admitted to Cobble Hill, where she remained on the antipsychotic drug Seroquel. But when the nursing home told her they wanted to wean her mom off the drug, Dr. Ferguson agreed.
Her mother has been off antipsychotics for about 11 months. Instead, she has been getting stimulation, her daughter says, including music and dancing.
When her 92-year-old mother, Mae, was young, she loved to go dancing at the Savoy Ballroom in Harlem. Mrs. Ferguson worked as a presser at a dry cleaner's to support herself and her only child.
On a recent Friday, Mrs. Ferguson sat motionless at the dining room table. She wasn't smiling; she had not eaten much.
Then a staffer put on a CD of Nat King Cole singing "Almost Like Being in Love." Mrs. Ferguson's eyes widened and she started to smile. With help from an aide, she rose and began swaying to the music, snapping her fingers. "Dance with me," she said to Dr. Mudannayake, the medical director. "I'd like to dance with all of you," she said to the staff.
Not all cases work out. Some patients relapse. Some receive reduced doses of antipsychotics, but show signs of distress. Others are taken off drugs and still suffer from symptoms of their brain disorder.
In 2003, the rate of antipsychotic use among Cobble Hill patients who didn't have a psychotic disorder was nearly 24%. Earlier this year, it had fallen to about 12%. But lately, the rate has crept up again, showing the constant struggle.
Sometimes little seems to work. After Cobble Hill patient Mary Goldman, a former college professor, suffered yet another stroke this year, she was no longer able to speak clearly. She began to scream uncontrollably, tugging at nurses. In an effort to calm her, the staff administered 75 milligrams of Seroquel, twice a day.
But Mrs. Goldman screamed even more loudly, sometimes for as long as an hour and a half, the medical director says.
When her case was reviewed earlier this year, the team recommended trying to taper her off the antipsychotic.
Now, Mrs. Goldman is off the drug. She still screams and cries out, her husband says, though not for as long. When his wife becomes distraught, he tries to soothe her by speaking gently, holding her arm, and stroking her hand.
"Sometimes it works and sometimes it doesn't," he says. "It does not diminish agitation completely but it does diminish it."
Lately, Cobble Hill has tried bringing books and magazines to Mrs. Goldman's bedside. "She is not really reading," says Dr. Mudannayake, "but they seem to comfort her and she yells and screams less."
Often she will merely fling them to the ground. Her husband bends down and picks them up.
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