The Wall Street Journal recently wrote an article concerning the drug industries barrage of drug ads on T.V., radio and the internet.The frequency of these ads can eventually make even the most healthy human think a shaking foot or a night of twisting and turning in bed warrant a pill here or there.That is exactly what the billion dollar drug industry has in mind. The politicians who are considering action against the pharmaceutical industry are the same ones who in 1997 relaxed the rules governing drug ads.Investor’s Business Daily recently published two brief news articles in Trends and Innovations that stated over half of Americans are on meds. Another article’s title, “US Kids Prescribed More Drugs.” What is going on?
Clearly, the pharmaceutical industry has succeeded beyond their imagination in making the US a legal drug addicted society. However, our politicians are a direct recipient of this huge financial success. The pharmaceutical industry commits over $500,000,000 annually to the FDA and lobby efforts.
Read the briefs by Investor’s Business Daily:
Over Half of Americans on Meds
For the first time, more than half of insured Americans are taking prescription medications regularly for chronic health problems, a study by Medco health Solutions found. Blood pressure and cholesterol drugs are the most widely used medications. One in 4 children and teenagers, 52% of adult men, and two-thirds of women age 20 and older are taking prescription drugs regularly, according to the study, which examined 2.5 million customers from 2001 to 2007.
U.S. Kids Prescribed More Drugs
American children are 6 times more likely to take anti-psychotic drugs than U.K. children, a study by the University of London said. The number of U.S. kids who used the drugs rose by 96%, to 45 out of 10,000, from 1996 to 2001. In the UK the rate nearly doubled, to 7 out of 10,000, from 1992 to 2005. Experts say the drugs to treat autism and hyperactivity are being over-prescribed in both countries. In the U.S., direct ads for drugs are more common.
Read Alicia Mundy of the Wall Street Journal, drug ad article.
New Rules on Drug Ads Sought
WASHINGTON—Congressional Democrats are renewing pressure on the drug industry’s direct-to-consumer advertising amid growing tension over the marketing of several best-selling drugs. Last year, Democrats lost a fight over proposals to strengthen government regulation of TV commercials for prescription drugs. But recent controversies over the marketing of anticholesterol drugs Vytorin and Lipitor and of Procrit, which helps treat anemia, have given Democrats on the House Energy and Commerce Committee ammunition for a new battle. A subcommittee led by Michigan Democrat Bart Stupak has scheduled a hearing for Thursday with an agenda titled “Direct to Consumer Advertising: Marketing, Education or Deception?” Mr. Stupak says he wants to lay the groundwork for future legislation to tighten controls on drug marketing, including giving the Food and Drug Administration the right to force changes in TV drug ads before they are broadcast. Direct-to-consumer drug marketing brings in billions of dollars in sales for drug makers and for the television industry. In 1997, the government relaxed rules on TV and radio ads, allowing drug makers to shorten the warnings on side effects in their commercials; since then, pharmaceutical makers have spent about $14 billion on broadcast and cable TV ads for prescription drugs. Such advertising has become a major revenue stream for the TV industry. In 2007, drug makers spent more than $5 billion on direct-to-consumer ads, according to Nielsen Monitor-Plus; more than half of that was spent on television. The National Association of Broadcasters, a TV-industry lobbying group, and Pharmaceutical Research and Manufacturers of America, a drug-industry trade group, have beaten back several congressional efforts to toughen regulations on TV commercials for drugs. “The drug and TV and cable industries have formed a cabal here to protect their revenues,” said Gene Kimmelman of Consumers Union, an advocacy group that wants stricter limits on direct-to-consumer drug marketing. Ken Johnson, a PhRMA vice president, says consumer advertising for prescription drugs “brings patients into their doctors’ offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated.” The renewed debate about drug marketing was spurred in part by several recent high-profile campaigns. Merck & Co. and Schering-Plough Inc. have been criticized for heavily promoting the cholesterol drug Vytorin while failing to disclose a study that raised questions about the drug’s effectiveness. Committee members plan to question officials of Pfizer Inc. about ads for its cholesterol drug, Lipitor, which featured Robert Jarvik, the inventor of the artificial heart. Mr. Jarvik isn’t a practicing doctor, but he “appears to be giving medical advice,” according to the committee, which suggested that the ads are misleading. Pfizer and the joint venture between Merck and Schering-Plough have defended their ads as accurate. In an interview, Mr. Stupak said Procrit presents a particular problem. Procrit marketers Johnson & Johnson and its subsidiary Ortho Biotech continued to broadcast ads promoting Procrit as an antifatigue drug—a use for which the drug wasn’t approved—despite repeated requests from the FDA to the companies to revise their commercials. “They advertised this for seven years,” said Mr. Stupak, calling this a violation of off-label-use prohibitions. Mr. Stupak said political appointees leading the FDA’s legal advisory team effectively shut down the FDA’s marketing regulators during the current administration. The FDA’s letters to J&J and Ortho Biotech complaining about the Procrit TV commercials and print ads touting fatigue relief stopped in December 2001, shortly before the agency instituted a policy of routing warnings to companies through the FDA chief counsel’s office for review, Mr. Stupak said. The FDA didn’t respond to a request for comment. The company stopped running the Procrit TV ads in 2005, and the print ads stopped in 2006. Procrit was later linked to increased risk of tumor growth in certain patients, and a panel of experts advising the FDA questioned whether the drug was being overused in cancer patients. In a statement, a representative for Johnson & Johnson said the broadcast advertisements for Procrit, which ran from 1998 to 2005, “were accurate, substantiated by clinical research, and consistent with the FDA-approved label at the time they aired.”
Learn More on Healthy Living: Visit http://www.infinitehealthresources.com/
Tuesday, May 27, 2008
Sunday, May 18, 2008
Fast Food and Global Warming
Fast Food and Global Warming
There is always news about America’s beloved McDonald’s. I have written much and today will write a little more.My favorite daily financial paper, Investor’s Business Daily, always defends this global disease causing behemoth. Here is some news concerning America’s favorite past time, eating at McDonald’s. This company is indeed an incredible corporate titan. It’s earnings grow annually and the public is slowly dying from malnutrition and disease. Every low cost fast food chain is slowly disabling a significant portion of our society.McDonald’s is also contributing to global warming. There are over 5 billion cows in the world. That is up to 10,000 fold over the past 40 years. These 5 billion cows are increasing CO2 and methane gasses. The land required to feed these cows is enormous; millions of acres of forest must be cut down to allow grazing. Furthermore, the corn grown to feed these cows destroys millions more acres. Lastly, the gas emitted from these 5 billion cows is pure methane, trapping CO2 gasses in our atmosphere.My suggestion is McDonald’s, Burger King and the burger happy food chains, put aside 10% of their gross profits and dividends to treat the sick and fund green projects.Now, if we can just get Al Gore to spread this inconvenient truth, he would really be on to something.
Eat Healthy and Love Well. Find out more at www.infinitehealthresources.com
There is always news about America’s beloved McDonald’s. I have written much and today will write a little more.My favorite daily financial paper, Investor’s Business Daily, always defends this global disease causing behemoth. Here is some news concerning America’s favorite past time, eating at McDonald’s. This company is indeed an incredible corporate titan. It’s earnings grow annually and the public is slowly dying from malnutrition and disease. Every low cost fast food chain is slowly disabling a significant portion of our society.McDonald’s is also contributing to global warming. There are over 5 billion cows in the world. That is up to 10,000 fold over the past 40 years. These 5 billion cows are increasing CO2 and methane gasses. The land required to feed these cows is enormous; millions of acres of forest must be cut down to allow grazing. Furthermore, the corn grown to feed these cows destroys millions more acres. Lastly, the gas emitted from these 5 billion cows is pure methane, trapping CO2 gasses in our atmosphere.My suggestion is McDonald’s, Burger King and the burger happy food chains, put aside 10% of their gross profits and dividends to treat the sick and fund green projects.Now, if we can just get Al Gore to spread this inconvenient truth, he would really be on to something.
Eat Healthy and Love Well. Find out more at www.infinitehealthresources.com
More Problems With Plastics
U.S. News and World Report, May 19, 2008
”More Problems With Plastics”
By: Adam Voiland
Phthalates, a softening agent used in plastics may be responsible for countless diseases. This article in US News and World Report touches on the subject briefly. We at InfiniteHealthResources.com have been discussing the dangers of phthalates for several years. The astronomical rise in autism has the science community baffled. Surely our environment, diet and pharmaceutical industry may all contribute to this terrible epidemic.Please read this brief, but informative article. Much more detailed health info can be found at www.infinitehealthresources.com , click Health Center.More Problems With PlasticsLike BPA, chemicals called phthalates raise some concernsThe urethra is supposed to emerge at the tip of the penis, but in 1 out of every 300 baby boys, its opening is elsewhere—sometimes just underneath the head, or midway down the shaft, or even at the base of the scrotum. No one knows what causes the defect, called hypospadias, but studies have shown that widespread chemicals called phthalates can reproduce it in rodents. Phthalates are used widely as softening agents in certain plastics, notably PVC, and are also found in some cosmetics, pharmaceuticals, and a wide range of other products. Scientists classify these chemicals among the "endocrine disruptors," so known for their ability to alter the proper balance of hormones, which play a central role during development. "It's not just bisphenol A that we're concerned about," says Ted Schettler, the lead scientist at the Iowa-based advocacy group called the Science and Environmental Health Network, referring to another endocrine disruptor that has made headlines this spring.Widespread problem. Human exposure to hormone-disrupting synthetic chemicals, which can leach from a slew of consumer products, is continuous and widespread. The Centers for Disease Control and Prevention found in 2005 that most Americans have traces of hormone-disrupting chemicals in their body. An analysis of the data by the Environmental Working Group, an advocacy organization based in Washington, D.C., concluded that 84 percent of Americans have at least six different phthalates in their urine.Toxicologists have been studying the effects of various phthalates in animals for decades. Three in particular—diethylhexyl phthalate (DEHP), butyl benzyl phthalate (BBP), and dibutyl phthalate (DBP)—cause a constellation of reproductive defects that includes hypospadias, testicular cancer, reduced sperm quality, diminished penis size, and undescended testicles. The effects, in some cases, seem to extend beyond the male reproductive system. Studies in animals have linked allergic skin lesions and lung malformations to DEHP, which is the most widely produced of the phthalates. And pregnant rodents given high daily doses of DBP tend to lose their fetuses. Not everyone, however, thinks such adverse effects in animals justify concern among people. "Most of the exposures are at doses far higher than what we see in humans," says Marian Stanley, a spokesperson for the Phthalate Esters Panel, an industry group that represents phthalate manufacturers. Major scientific reviews from the National Toxicology Program have concluded the risk the chemicals pose to humans is minimal. Yet, the most concerned scientists counter that emerging evidence does suggest phthalates harm humans. Shanna Swan, an epidemiologist at the University of Rochester, has shown that baby boys born to women with elevated DBP and BBP levels tend to have somewhat demasculinized and slightly smaller genitals. Recent studies in adults have linked high exposure to certain phthalates to low sperm quality and abdominal obesity.Though these studies don't prove cause and effect, some people find the existing evidence alarming enough to act. Many European countries have banned phthalates in certain toys, and a number of American states are considering similar restrictions. Meanwhile, "phthalate-free" products are popping up in stores and on the Internet—just as bisphenol A (BPA)-free baby bottles and water bottles have. Industry groups say that many of the products people worry most about—including plastic wrap, water bottles, and food containers—do not contain any phthalates.Still, avoiding phthalates altogether is more difficult than avoiding BPA, since it's not clear which of the panoply of products containing them contribute most to exposure. The chemicals easily move from sources such as vinyl tiles or shower curtains, so phthalates routinely end up in the air, water, and dust.Pregnant women, children, and couples trying to conceive may have the most to gain from trying to avoid phthalates, scientists say. "The primary risk appears to be to the developing fetus," says Swan.
Learn more about Healthy Living. Visit InfiniteHealthResources.com.
”More Problems With Plastics”
By: Adam Voiland
Phthalates, a softening agent used in plastics may be responsible for countless diseases. This article in US News and World Report touches on the subject briefly. We at InfiniteHealthResources.com have been discussing the dangers of phthalates for several years. The astronomical rise in autism has the science community baffled. Surely our environment, diet and pharmaceutical industry may all contribute to this terrible epidemic.Please read this brief, but informative article. Much more detailed health info can be found at www.infinitehealthresources.com , click Health Center.More Problems With PlasticsLike BPA, chemicals called phthalates raise some concernsThe urethra is supposed to emerge at the tip of the penis, but in 1 out of every 300 baby boys, its opening is elsewhere—sometimes just underneath the head, or midway down the shaft, or even at the base of the scrotum. No one knows what causes the defect, called hypospadias, but studies have shown that widespread chemicals called phthalates can reproduce it in rodents. Phthalates are used widely as softening agents in certain plastics, notably PVC, and are also found in some cosmetics, pharmaceuticals, and a wide range of other products. Scientists classify these chemicals among the "endocrine disruptors," so known for their ability to alter the proper balance of hormones, which play a central role during development. "It's not just bisphenol A that we're concerned about," says Ted Schettler, the lead scientist at the Iowa-based advocacy group called the Science and Environmental Health Network, referring to another endocrine disruptor that has made headlines this spring.Widespread problem. Human exposure to hormone-disrupting synthetic chemicals, which can leach from a slew of consumer products, is continuous and widespread. The Centers for Disease Control and Prevention found in 2005 that most Americans have traces of hormone-disrupting chemicals in their body. An analysis of the data by the Environmental Working Group, an advocacy organization based in Washington, D.C., concluded that 84 percent of Americans have at least six different phthalates in their urine.Toxicologists have been studying the effects of various phthalates in animals for decades. Three in particular—diethylhexyl phthalate (DEHP), butyl benzyl phthalate (BBP), and dibutyl phthalate (DBP)—cause a constellation of reproductive defects that includes hypospadias, testicular cancer, reduced sperm quality, diminished penis size, and undescended testicles. The effects, in some cases, seem to extend beyond the male reproductive system. Studies in animals have linked allergic skin lesions and lung malformations to DEHP, which is the most widely produced of the phthalates. And pregnant rodents given high daily doses of DBP tend to lose their fetuses. Not everyone, however, thinks such adverse effects in animals justify concern among people. "Most of the exposures are at doses far higher than what we see in humans," says Marian Stanley, a spokesperson for the Phthalate Esters Panel, an industry group that represents phthalate manufacturers. Major scientific reviews from the National Toxicology Program have concluded the risk the chemicals pose to humans is minimal. Yet, the most concerned scientists counter that emerging evidence does suggest phthalates harm humans. Shanna Swan, an epidemiologist at the University of Rochester, has shown that baby boys born to women with elevated DBP and BBP levels tend to have somewhat demasculinized and slightly smaller genitals. Recent studies in adults have linked high exposure to certain phthalates to low sperm quality and abdominal obesity.Though these studies don't prove cause and effect, some people find the existing evidence alarming enough to act. Many European countries have banned phthalates in certain toys, and a number of American states are considering similar restrictions. Meanwhile, "phthalate-free" products are popping up in stores and on the Internet—just as bisphenol A (BPA)-free baby bottles and water bottles have. Industry groups say that many of the products people worry most about—including plastic wrap, water bottles, and food containers—do not contain any phthalates.Still, avoiding phthalates altogether is more difficult than avoiding BPA, since it's not clear which of the panoply of products containing them contribute most to exposure. The chemicals easily move from sources such as vinyl tiles or shower curtains, so phthalates routinely end up in the air, water, and dust.Pregnant women, children, and couples trying to conceive may have the most to gain from trying to avoid phthalates, scientists say. "The primary risk appears to be to the developing fetus," says Swan.
Learn more about Healthy Living. Visit InfiniteHealthResources.com.
Get Healthier and Happier
InfiniteHealthResources.com has produced many articles blasting the pharmaceutical industry and our medical community for its rampant abuse prescribing drugs.Well some good news finally. Much is written lately about the medical community realizing that medication is not the cure all that the drug industry would have you believe.
Get Healthier and Happier
You may need a lifestyle fix as well as antidepressants
By: Deborah Kotz, U.S. News and World Report
What has become abundantly clear in the antidepressant age—the drugs are now the most commonly prescribed medications in the country—is that depression is terribly difficult, if not impossible, to cure. Many primary-care doctors, who treat 80 percent of depressed people, labor under the assumption that a prescription is a panacea. But antidepressants completely alleviate symptoms in only about 35 to 40 percent of people compared with 15 to 20 percent of those who take a placebo—a fact not publicized in pharmaceutical ads. And about 70 percent of people who successfully beat one bout can expect to face another. "We just don't have one magical pill that will do the whole trick," says Madhukar Trivedi, a professor of psychiatry at the University of Texas Southwestern Medical Center in Dallas. He recently participated in the government-funded "Star*D" trial of more than 4,000 patients with difficult-to-treat depression, which showed success rates of antidepressants could be increased but that it sometimes took four tries of various drugs plus therapy. Even then, in 30 percent of those who completed the yearlong study, symptoms still lingered.Lifestyle culprits. Gradually, many mental-health practitioners are coming to believe that adjusting brain chemistry with medication isn't enough—that depression is a complex chronic disease, akin to diabetes, requiring lifestyle changes and ongoing monitoring to address underlying causes. As with diabetes, experts have begun to look for culprits in the 21st-century lifestyle. Might the isolating, sedentary, indoor computer culture explain, for example, why the disorder appears to be surging in young adults? Today's 20-somethings have a 1-in-4 lifetime risk of experiencing depression's hallmark black mood, joylessness, fatigue, and suicidal thoughts compared with the 1-in-10 risk of their grandparents' generation. Americans are 10 times as likely to have depression today as they were 60 years ago, a development that is not merely a result of increased awareness and diagnosis.There's certainly evidence that vigorous exercise has an effect on mood. Trivedi and others have shown that burning off 350 calories three times a week in sustained, sweat-inducing activity can reduce symptoms of depression about as effectively as antidepressants. Brain-imaging studies indicate that exercise stimulates the growth of neurons in certain brain regions damaged during depression. And animal studies have found that physical exertion increases the production of brain molecules that improve connections between nerve cells and act as a natural antidepressant. Sunlight or light-box exposure often helps people prone to seasonal affective disorder. And there's no doubt that getting a decent night's sleep can lift the spirits. Nutrition may play a role, too: It's fairly well established that those who eat the most fish have the lowest rates of depression.Realizing that primitive societies like the Kaluli of Papua New Guinea experience virtually no depression, Stephen Ilardi, an associate professor of psychology at the University of Kansas, is now testing a cave-man-esque approach to treatment with promising results. His 14-week Therapeutic Lifestyle Change program entails large doses of simulated hunter-gatherer living in people suffering from prolonged, unremitting depression. Participants sign up for 35 minutes of aerobic exercise (running, walking briskly, biking) three days a week, at least 30 minutes of daily sunlight or exposure from a light box that emits 10,000 lux, eight hours of sleep per night, and a daily fish oil supplement containing 1,000 mg of the fatty acid EPA and 500 mg of the fatty acid DHA.Brooders. They also get plenty of time surrounded by the "clan," in the form of frequent social gatherings with family members, Starbucks dates with friends, and volunteer work. "Hunter-gatherers almost never had time alone," says Ilardi; even a generation or two ago, people grew up supported by extended family and much more engaged with their community. Too much time in isolation, he says, means "opportunities to ruminate," the modern scourge. Studies indicate that brooders are far more likely than nonbrooders to develop depression. "I feel terrific now, but I'm really well plugged in with my old friends," says Russo, who regularly calls and E-mails former colleagues, occasionally traveling 70 miles to Philadelphia to meet them for lunch.Obsessive thinkers can learn to redirect themselves. Cognitive behavioral therapy, for example, teaches people to recognize when irrational negative thoughts are triggering a mood plunge and to reframe those thoughts in a rational way. Was that coworker really laughing at my outfit? Or just trying to be witty in front of the boss? A 2006 study published in the American Journal of Psychiatry found that people whose symptoms disappeared after cognitive behavioral therapy showed significant changes on MRI scans in two brain regions associated with depression. What's more, the therapy appears to be as effective as medication when used for resistant depression, according to findings from the Star*D trial."Drugs are quicker acting and take less work in the short run, but they only suppress the problem," says Michael Thase, a professor of psychiatry at the University of Pennsylvania School of Medicine who led the comparative study for Star*D. The therapy, he says, allows people to take action when their mood is dipping to prevent a full-blown relapse.
Happier—and Healthier
The mind-body link appears to work both ways
Far from being just a psychiatric disorder, depression wreaks havoc on the entire body by throwing the stress response out of whack. The amount of damage it causes takes a greater toll on health than chronic angina, arthritis, asthma, or diabetes, according to a September report from the World Health Organization. And a growing body of research indicates that it triggers certain diseases:
Heart disease. Under stress, blood produces more clotting factors to prepare for a wound, which can cause clots to form in the arteries—setting the stage for a heart attack or stroke. Increased stress hormones can also lead to inflammation in the heart.
Osteoporosis. Depression's link to high levels of the stress hormone cortisol may speed bone loss, raising the risk of fractures even in premenopausal women, according to one new study.
Diabetes. Increased cortisol also raises blood sugar levels, which new research suggests may cause diabetes in those over age 65. Inflammation may also play a role.
Cancer. Studies show that depressed folks have high levels of immune system chemicals called cytokines, which may hamper the body's ability to destroy malignant cells.
Get Healthier and Happier
You may need a lifestyle fix as well as antidepressants
By: Deborah Kotz, U.S. News and World Report
What has become abundantly clear in the antidepressant age—the drugs are now the most commonly prescribed medications in the country—is that depression is terribly difficult, if not impossible, to cure. Many primary-care doctors, who treat 80 percent of depressed people, labor under the assumption that a prescription is a panacea. But antidepressants completely alleviate symptoms in only about 35 to 40 percent of people compared with 15 to 20 percent of those who take a placebo—a fact not publicized in pharmaceutical ads. And about 70 percent of people who successfully beat one bout can expect to face another. "We just don't have one magical pill that will do the whole trick," says Madhukar Trivedi, a professor of psychiatry at the University of Texas Southwestern Medical Center in Dallas. He recently participated in the government-funded "Star*D" trial of more than 4,000 patients with difficult-to-treat depression, which showed success rates of antidepressants could be increased but that it sometimes took four tries of various drugs plus therapy. Even then, in 30 percent of those who completed the yearlong study, symptoms still lingered.Lifestyle culprits. Gradually, many mental-health practitioners are coming to believe that adjusting brain chemistry with medication isn't enough—that depression is a complex chronic disease, akin to diabetes, requiring lifestyle changes and ongoing monitoring to address underlying causes. As with diabetes, experts have begun to look for culprits in the 21st-century lifestyle. Might the isolating, sedentary, indoor computer culture explain, for example, why the disorder appears to be surging in young adults? Today's 20-somethings have a 1-in-4 lifetime risk of experiencing depression's hallmark black mood, joylessness, fatigue, and suicidal thoughts compared with the 1-in-10 risk of their grandparents' generation. Americans are 10 times as likely to have depression today as they were 60 years ago, a development that is not merely a result of increased awareness and diagnosis.There's certainly evidence that vigorous exercise has an effect on mood. Trivedi and others have shown that burning off 350 calories three times a week in sustained, sweat-inducing activity can reduce symptoms of depression about as effectively as antidepressants. Brain-imaging studies indicate that exercise stimulates the growth of neurons in certain brain regions damaged during depression. And animal studies have found that physical exertion increases the production of brain molecules that improve connections between nerve cells and act as a natural antidepressant. Sunlight or light-box exposure often helps people prone to seasonal affective disorder. And there's no doubt that getting a decent night's sleep can lift the spirits. Nutrition may play a role, too: It's fairly well established that those who eat the most fish have the lowest rates of depression.Realizing that primitive societies like the Kaluli of Papua New Guinea experience virtually no depression, Stephen Ilardi, an associate professor of psychology at the University of Kansas, is now testing a cave-man-esque approach to treatment with promising results. His 14-week Therapeutic Lifestyle Change program entails large doses of simulated hunter-gatherer living in people suffering from prolonged, unremitting depression. Participants sign up for 35 minutes of aerobic exercise (running, walking briskly, biking) three days a week, at least 30 minutes of daily sunlight or exposure from a light box that emits 10,000 lux, eight hours of sleep per night, and a daily fish oil supplement containing 1,000 mg of the fatty acid EPA and 500 mg of the fatty acid DHA.Brooders. They also get plenty of time surrounded by the "clan," in the form of frequent social gatherings with family members, Starbucks dates with friends, and volunteer work. "Hunter-gatherers almost never had time alone," says Ilardi; even a generation or two ago, people grew up supported by extended family and much more engaged with their community. Too much time in isolation, he says, means "opportunities to ruminate," the modern scourge. Studies indicate that brooders are far more likely than nonbrooders to develop depression. "I feel terrific now, but I'm really well plugged in with my old friends," says Russo, who regularly calls and E-mails former colleagues, occasionally traveling 70 miles to Philadelphia to meet them for lunch.Obsessive thinkers can learn to redirect themselves. Cognitive behavioral therapy, for example, teaches people to recognize when irrational negative thoughts are triggering a mood plunge and to reframe those thoughts in a rational way. Was that coworker really laughing at my outfit? Or just trying to be witty in front of the boss? A 2006 study published in the American Journal of Psychiatry found that people whose symptoms disappeared after cognitive behavioral therapy showed significant changes on MRI scans in two brain regions associated with depression. What's more, the therapy appears to be as effective as medication when used for resistant depression, according to findings from the Star*D trial."Drugs are quicker acting and take less work in the short run, but they only suppress the problem," says Michael Thase, a professor of psychiatry at the University of Pennsylvania School of Medicine who led the comparative study for Star*D. The therapy, he says, allows people to take action when their mood is dipping to prevent a full-blown relapse.
Happier—and Healthier
The mind-body link appears to work both ways
Far from being just a psychiatric disorder, depression wreaks havoc on the entire body by throwing the stress response out of whack. The amount of damage it causes takes a greater toll on health than chronic angina, arthritis, asthma, or diabetes, according to a September report from the World Health Organization. And a growing body of research indicates that it triggers certain diseases:
Heart disease. Under stress, blood produces more clotting factors to prepare for a wound, which can cause clots to form in the arteries—setting the stage for a heart attack or stroke. Increased stress hormones can also lead to inflammation in the heart.
Osteoporosis. Depression's link to high levels of the stress hormone cortisol may speed bone loss, raising the risk of fractures even in premenopausal women, according to one new study.
Diabetes. Increased cortisol also raises blood sugar levels, which new research suggests may cause diabetes in those over age 65. Inflammation may also play a role.
Cancer. Studies show that depressed folks have high levels of immune system chemicals called cytokines, which may hamper the body's ability to destroy malignant cells.
Sunday, April 13, 2008
Aquasana Healthy Water News 2008
Aquasana Healthy Water News Our quarterly newsletter on water related issues that affect you, our customer!
Infinite Health Resources is committed to bringing you up to date information on your drinking water wherever you may live. Feel free to contact us with any questions or product information.
Drugs in drinking water causes a frenzy with consumers.With all the media focus on the recent testing of major municipal water supplies and the realization that most, if not all, contain numerous prescription drugs and pharmaceuticals… our Aquasana call center has been overwhelmed. These compounds obviously pose significant health concerns and should not be ingested.
The question of the day is "Does Aquasana remove these pharmaceuticals?" While the answer is yes, it also calls for an explanation. There are no current test standards for "pharmaceutical" and therefore there are no certifications offered for the removal of these contaminants. However, most good quality home water filters will filter them out. According to the U.S. EPA, the vast majority of these compounds are Synthetic Organic Chemicals (SOCs) and/or Volatile Organic Chemicals (VOCs). Consumers should look for filters that are certified for VOCs, THMs and Chloroform as these are representative of the vast majority of prescription drugs. Aquasana is certified for all 3.
Drugs get into our water supplies from recycled waste water and livestock run-off. Standard municipal water treatment does not remove them and therefore they are in most tap water and should be removed at the point of use.
More on What's In Drinking Water.
Congratulations To Our Customers From Aquasana & Planet Earth!As most of you are probably already aware, there is a major backlash against bottled water use by the government and environmental groups. The damage to our planet and economy from bottled water use is now in the news almost daily. Cities like San Francisco, Los Angeles, Phoenix, Chicago, Las Vegas… and many more have "Banned Bottled Water" purchases by the city.
While those of us in the home water filtration industry have been striving for years to raise the awareness of this issue, it is now the target of the almighty media. Celebrities, city governments, environmentalists, journalists… are jumping on the "Ban the bottle" wagon by the hundreds. Articles bashing bottled water are popping up everywhere.
Two Growing Markets That Start at Your Tap By CLAUDIA H. DEUTSCHPublished: November 10, 2007Municipal water systems are aging. Environmentalists are castigating the makers of bottled water -- and the people who buy it -- for defiling the environment with plastic. All told, it is a great time to be selling water filters and reusable bottles.
Inc. Magazine, which tracks growth of private companies, recently cited Sun Water Systems, which sells high-end Aquasana filter systems, as one of the 10 fastest-growing consumer product companies in the country.
Read More...
Bottled water's environmental backlashBy Sandy BauersPosted on Sat, Nov. 3, 2007Philadelphia Enquirer INQUIRER STAFF WRITER
Bottled water, once an icon of a healthy lifestyle, has become a pariah, the environmentally incorrect humvee of beverages… The environmental impact of 60,000,000 plastic bottles being produced, transported and disposed of every day in the U.S. from bottled water use is staggering and serves little or no purpose…
Read More...
The facts are very clear
Bottled Water Production & Use In The U.S.:
· Uses 17 million barrels of oil per year to manufacture the plastic bottles.
· Causes the release of over 2.5 million TONs of CO2 gases from manufacturing the plastic.
· Uses over 10 million barrels of oil annually to transport or deliver bottles of water.
· It takes 3 times as much water to produce the bottle than it does to fill it.
· Causes over 60,000,000 plastic bottles a day to go into U.S. landfills!
All plastic bottles leach chemicals into the water at some level.Plastic was invented 144 years ago and over 98% of all plastic ever produced still exists today. It is estimated that it takes 300- 500 years for plastic to biodegrade. With the current growth in the use and disposal of plastic, it is only a matter of time until we choke our planet with a layer of plastic.
We are sending this information out to all of our Aquasana customers and contacts for 3 reasons:
One: To congratulate you on your decision to use home water filtration and to decrease your use of bottled water and plastic containers.
Two: To ask your help in spreading the "bottle your own" good word!
Three: Because it's good for our business! And the reality is, if it doesn't make financial sense, it most likely won't happen. The problem with most environmental causes is that they cost consumers money… this one saves money, time, energy… and a lot more!
Our "Bottle Your Own" Aquasana promotion has been our most successful ever. We are currently selling over 20,000 reusable glass bottles a month. A glance at the new "Bottles saved" counter on our home page at www.infinitehealthresources.comfinitehealthresources.com an actual, but staggering account of the millions of plastic bottles we are preventing with your help. And at the same time, we're offering higher quality water at a lower cost with more convenience! It just makes good sense.
"Home water filtration offers 10 times the quality at 1/10 the cost and NO plastic pollution!"
We are asking you to help us get the word out on this issue. We can literally wipe out the use of plastic water bottles in our lifetime and make a very positive impact on our environment in the process.
· Please pass this information on to your contacts.
· Ask your employer to switch from bottled water to water filtration.
· Proudly bottle your own with Aquasana and tell people about the benefits.
· Continue to use water filtration more and plastic bottles less!
It is rare that we get a chance to do a good thing for the environment that also is the best choice economically and for our health. It is a very clear fact that home water filtration offers better quality than bottled water, at a fraction of the cost, with far more convenience… and without the negative environmental impact.
Better for you and better for our planet, it truly is the right choice!Click here to view and purchase Aquasana Water Filter Products
Infinite Health Resources is committed to bringing you up to date information on your drinking water wherever you may live. Feel free to contact us with any questions or product information.
Drugs in drinking water causes a frenzy with consumers.With all the media focus on the recent testing of major municipal water supplies and the realization that most, if not all, contain numerous prescription drugs and pharmaceuticals… our Aquasana call center has been overwhelmed. These compounds obviously pose significant health concerns and should not be ingested.
The question of the day is "Does Aquasana remove these pharmaceuticals?" While the answer is yes, it also calls for an explanation. There are no current test standards for "pharmaceutical" and therefore there are no certifications offered for the removal of these contaminants. However, most good quality home water filters will filter them out. According to the U.S. EPA, the vast majority of these compounds are Synthetic Organic Chemicals (SOCs) and/or Volatile Organic Chemicals (VOCs). Consumers should look for filters that are certified for VOCs, THMs and Chloroform as these are representative of the vast majority of prescription drugs. Aquasana is certified for all 3.
Drugs get into our water supplies from recycled waste water and livestock run-off. Standard municipal water treatment does not remove them and therefore they are in most tap water and should be removed at the point of use.
More on What's In Drinking Water.
Congratulations To Our Customers From Aquasana & Planet Earth!As most of you are probably already aware, there is a major backlash against bottled water use by the government and environmental groups. The damage to our planet and economy from bottled water use is now in the news almost daily. Cities like San Francisco, Los Angeles, Phoenix, Chicago, Las Vegas… and many more have "Banned Bottled Water" purchases by the city.
While those of us in the home water filtration industry have been striving for years to raise the awareness of this issue, it is now the target of the almighty media. Celebrities, city governments, environmentalists, journalists… are jumping on the "Ban the bottle" wagon by the hundreds. Articles bashing bottled water are popping up everywhere.
Two Growing Markets That Start at Your Tap By CLAUDIA H. DEUTSCHPublished: November 10, 2007Municipal water systems are aging. Environmentalists are castigating the makers of bottled water -- and the people who buy it -- for defiling the environment with plastic. All told, it is a great time to be selling water filters and reusable bottles.
Inc. Magazine, which tracks growth of private companies, recently cited Sun Water Systems, which sells high-end Aquasana filter systems, as one of the 10 fastest-growing consumer product companies in the country.
Read More...
Bottled water's environmental backlashBy Sandy BauersPosted on Sat, Nov. 3, 2007Philadelphia Enquirer INQUIRER STAFF WRITER
Bottled water, once an icon of a healthy lifestyle, has become a pariah, the environmentally incorrect humvee of beverages… The environmental impact of 60,000,000 plastic bottles being produced, transported and disposed of every day in the U.S. from bottled water use is staggering and serves little or no purpose…
Read More...
The facts are very clear
Bottled Water Production & Use In The U.S.:
· Uses 17 million barrels of oil per year to manufacture the plastic bottles.
· Causes the release of over 2.5 million TONs of CO2 gases from manufacturing the plastic.
· Uses over 10 million barrels of oil annually to transport or deliver bottles of water.
· It takes 3 times as much water to produce the bottle than it does to fill it.
· Causes over 60,000,000 plastic bottles a day to go into U.S. landfills!
All plastic bottles leach chemicals into the water at some level.Plastic was invented 144 years ago and over 98% of all plastic ever produced still exists today. It is estimated that it takes 300- 500 years for plastic to biodegrade. With the current growth in the use and disposal of plastic, it is only a matter of time until we choke our planet with a layer of plastic.
We are sending this information out to all of our Aquasana customers and contacts for 3 reasons:
One: To congratulate you on your decision to use home water filtration and to decrease your use of bottled water and plastic containers.
Two: To ask your help in spreading the "bottle your own" good word!
Three: Because it's good for our business! And the reality is, if it doesn't make financial sense, it most likely won't happen. The problem with most environmental causes is that they cost consumers money… this one saves money, time, energy… and a lot more!
Our "Bottle Your Own" Aquasana promotion has been our most successful ever. We are currently selling over 20,000 reusable glass bottles a month. A glance at the new "Bottles saved" counter on our home page at www.infinitehealthresources.comfinitehealthresources.com an actual, but staggering account of the millions of plastic bottles we are preventing with your help. And at the same time, we're offering higher quality water at a lower cost with more convenience! It just makes good sense.
"Home water filtration offers 10 times the quality at 1/10 the cost and NO plastic pollution!"
We are asking you to help us get the word out on this issue. We can literally wipe out the use of plastic water bottles in our lifetime and make a very positive impact on our environment in the process.
· Please pass this information on to your contacts.
· Ask your employer to switch from bottled water to water filtration.
· Proudly bottle your own with Aquasana and tell people about the benefits.
· Continue to use water filtration more and plastic bottles less!
It is rare that we get a chance to do a good thing for the environment that also is the best choice economically and for our health. It is a very clear fact that home water filtration offers better quality than bottled water, at a fraction of the cost, with far more convenience… and without the negative environmental impact.
Better for you and better for our planet, it truly is the right choice!Click here to view and purchase Aquasana Water Filter Products
Saturday, February 23, 2008
GAO to Cite FDA Faults At Congressional Hearing - The Real FDA Scandal
Wall Street Journal – January 2008
GAO to Cite FDA Faults At Congressional Hearing
The Real FDA Scandal
We at Infinite Health Resources have long been critical of the FDA. On the other hand we also share FDA alerts and safety concerns on our website as this info becomes available from the FDA, which is weekly.
However, until the funding of the FDA is altered in some way to get Big Pharmaceuticals out of the nearly $500,000,000 it annually hands the FDA, we will continue to suffer adversely from much of their drug approval decision making.
In this global economy with imports from the world over. Much needed improvement in oversight is needed. This in our view is as threatening as securing our border from illegal immigration and possible terrorist infiltration.
Tainted food, toys and pet products have already been imported. These are just a few that were found. Surely there are more. More funding from the government to make sure a government agency, like the DFA, is operating sufficiently is long overdue.
This issue has not come to bare in our presidential campaign. Could those campaign dollars have anything to do with that? We wouldn’t bet the farm on it.
Read on:
GAO to Cite FDA Faults At Congressional Hearing
The Food and Drug Administration can’t keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign companies, according to congressional investigators.
In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found “weaknesses” in the agency’s over-sight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials’ own estimates, overseas makers of the riskiest products such as peacemakers, were examined only every 6 years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.
The GAO testimony on medical devices will be part of the hearing’s broader effort to high-light an issue that has turned up in reports and critiques over the past few years: concerns the FDA’s resources and technology aren’t enough to meet its regulatory responsibilities to oversee drugs, food and other products.
The subcommittee also is expected to discuss a separate, harshly worded report released in November by a group of the FDA’s own advisers that warned the agency needs substantial resources to deal with emerging scientific developments.
The report, from a subcommittee of the FDA’s outside Science Board that included members and advisers from industry as well as academia, said the agency “cannot even keep up with advances in science.” An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities – including food, drugs and medical devices – in 2006
The hearing also is expected to focus on the FDA’s oversight of food, an issue that has sparked concerns in the wake of recalls. The GAO will testify that the FDA’s plan to step up food regulation, unveiled last year, could help but the agency needs to issue more specifics. The FDA’s staff and resources haven’t kept up with the food-safety work load, the congressional investigators will say.
As the Bush administration comes close to releasing its proposed budget, the testimony will add weight to calls by some groups for a budget boost for the FDA.
An FDA spokeswoman said the agency will comment on the GAO testimony at the House hearing. She said the agency “appreciates the Science Board subcommittee’s efforts to draft a report” and will work with the full board on the issue.
Worries about the FDA’s fundings have been strong enough to spark a lobbying effort, first launched in 2006, that brought together industry and patient groups, as well as former agency officials. The money appreciated for the FDA by Congress for fiscal 2008, which ends October 1 was a bit more than 9% compared with the year before, according to Steven Grossman, deputy executive director of the Alliance for a stronger FDA.
The hearing also will highlight safety concerns that have been raised in several hearings by Michigan Democratic Representatives John Dingell and Bart Stupak, who are chairmen of the full Energy and Commerce panel and the Oversight and Investigations Subcommittee, respectively. Mr. Dingell has introduced a bill seeking to bolster inspections of imported food and drugs through new industry fees.
The medical-device testimony will say that FDA officials estimated U.S. markers of the highest risk products are examined, on average, every three years. Domestic manufacturers of moderate risk devices get inspected every five years. Overall, the GAO estimated, the FDA inspected about 27% of the registered U.S. manufacturers each year and about 5% of the foreign facilities.
In a statement, AdvaMed, a trade group that represents medical-device makers, said the industry “has an excellent safety record” and it supports “additional appropriations for FDA.”
The Real FDA Scandal
So Members of Congress and the press are working up another panic about the state of the Food and Drug Administration. The place is a mess all right, but as usual the most alarming news is receiving almost no attention.
Washington is responding to a series of investigations concluding that the FDA cannot "adequately" monitor America's food supply and medical products. One of the FDA's outside advisory panels, the Science Board, reports that the agency is in "a precarious position," in part because it is chronically underfunded. The Government Accountability Office chimes in that, at the FDA's current pace, it would take 13 years to inspect every foreign drug plant exporting to the U.S. and 1,900 years to inspect every overseas food factory.
That last factoid may be true, or not, but it does raise the question of whether such a crackdown is possible, never mind desirable. Monitoring 100% of foreign imports -- or 10%, or whatever -- would be so onerous that it might as well be a ban. Yet lapses like adulterated Chinese toothpaste are exceedingly rare, mainly because companies have every incentive to police themselves. (Ask Mattel about its toy import nightmare.)
Still, it's generally agreed that the FDA could use more cash, and the White House's 2009 budget requests a 5.7% increase. But what no one reports is that the Science Board says these shortfalls crop up because Congress hasn't increased FDA funding in proportion to its burgeoning regulatory demands. Over the last two decades, Congress has expanded the FDA's reach more than 127 times; it now oversees about 25 cents of every dollar spent in the U.S.
The Science Board's most important, and distressing, finding is that the FDA bureaucracy "cannot even keep up with the advances in science" -- and not solely due to a lack of funding. While "the world of drug discovery and development has undergone revolutionary change," the authors write, the FDA's "evaluation methods have remained largely unchanged over the last half-century." (Our emphasis.)
Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.
The observation comes on page three, which leads us to suspect that Congress's hand-wringers haven't even read the study. Here's a refresher: "The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities," the Science Board notes.
Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence "to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced" and "to support innovation in the industries and markets that it regulates."
The Science Board authors propose that the FDA "modernize current regulatory pathways," especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.
The FDA uses rigid statistical techniques to evaluate developmental drugs, even when the lives of terminally ill patients are at stake. Many advanced immunotherapies for cancer, for instance, are held hostage to the FDA's old models, which still insist on crude mortality rates and the large average effects detected in clinical trials. Better metrics would include improving the quality of life or slowing the progression of tumors, or focusing on targeted populations. The Science Board says that "there is an urgent need for developing . . . new statistical methods that are most appropriate for the data generated by new areas of science."
Take Junovan, a medicine for a rare pediatric bone cancer. Junovan's successes in a clinical trial were "only" demonstrated with a 94% level of statistical certainty, instead of the FDA-mandated 95%. Avastin, a revolutionary biologic currently used against lung and colorectal cancers, also looks like it will get a thumbs-down as a treatment for metastatic breast cancer. While the evidence shows that patients lived longer before their symptoms got worse, they didn't live longer on average. Refusing to consider "progression-free survival" as a drug benefit is not only unscientific, but morally hideous.
The real scandal is that these policies are the product of the FDA's institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it's so much easier to say, "spend more money."
Perhaps that's why the Science Board ends on a mordant, but all too accurate, note: "Finding: Recommendations of excellent FDA reviews are seldom followed."Read more at www.infinitehealthresources.com, click the Resource Center.
GAO to Cite FDA Faults At Congressional Hearing
The Real FDA Scandal
We at Infinite Health Resources have long been critical of the FDA. On the other hand we also share FDA alerts and safety concerns on our website as this info becomes available from the FDA, which is weekly.
However, until the funding of the FDA is altered in some way to get Big Pharmaceuticals out of the nearly $500,000,000 it annually hands the FDA, we will continue to suffer adversely from much of their drug approval decision making.
In this global economy with imports from the world over. Much needed improvement in oversight is needed. This in our view is as threatening as securing our border from illegal immigration and possible terrorist infiltration.
Tainted food, toys and pet products have already been imported. These are just a few that were found. Surely there are more. More funding from the government to make sure a government agency, like the DFA, is operating sufficiently is long overdue.
This issue has not come to bare in our presidential campaign. Could those campaign dollars have anything to do with that? We wouldn’t bet the farm on it.
Read on:
GAO to Cite FDA Faults At Congressional Hearing
The Food and Drug Administration can’t keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign companies, according to congressional investigators.
In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found “weaknesses” in the agency’s over-sight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials’ own estimates, overseas makers of the riskiest products such as peacemakers, were examined only every 6 years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.
The GAO testimony on medical devices will be part of the hearing’s broader effort to high-light an issue that has turned up in reports and critiques over the past few years: concerns the FDA’s resources and technology aren’t enough to meet its regulatory responsibilities to oversee drugs, food and other products.
The subcommittee also is expected to discuss a separate, harshly worded report released in November by a group of the FDA’s own advisers that warned the agency needs substantial resources to deal with emerging scientific developments.
The report, from a subcommittee of the FDA’s outside Science Board that included members and advisers from industry as well as academia, said the agency “cannot even keep up with advances in science.” An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities – including food, drugs and medical devices – in 2006
The hearing also is expected to focus on the FDA’s oversight of food, an issue that has sparked concerns in the wake of recalls. The GAO will testify that the FDA’s plan to step up food regulation, unveiled last year, could help but the agency needs to issue more specifics. The FDA’s staff and resources haven’t kept up with the food-safety work load, the congressional investigators will say.
As the Bush administration comes close to releasing its proposed budget, the testimony will add weight to calls by some groups for a budget boost for the FDA.
An FDA spokeswoman said the agency will comment on the GAO testimony at the House hearing. She said the agency “appreciates the Science Board subcommittee’s efforts to draft a report” and will work with the full board on the issue.
Worries about the FDA’s fundings have been strong enough to spark a lobbying effort, first launched in 2006, that brought together industry and patient groups, as well as former agency officials. The money appreciated for the FDA by Congress for fiscal 2008, which ends October 1 was a bit more than 9% compared with the year before, according to Steven Grossman, deputy executive director of the Alliance for a stronger FDA.
The hearing also will highlight safety concerns that have been raised in several hearings by Michigan Democratic Representatives John Dingell and Bart Stupak, who are chairmen of the full Energy and Commerce panel and the Oversight and Investigations Subcommittee, respectively. Mr. Dingell has introduced a bill seeking to bolster inspections of imported food and drugs through new industry fees.
The medical-device testimony will say that FDA officials estimated U.S. markers of the highest risk products are examined, on average, every three years. Domestic manufacturers of moderate risk devices get inspected every five years. Overall, the GAO estimated, the FDA inspected about 27% of the registered U.S. manufacturers each year and about 5% of the foreign facilities.
In a statement, AdvaMed, a trade group that represents medical-device makers, said the industry “has an excellent safety record” and it supports “additional appropriations for FDA.”
The Real FDA Scandal
So Members of Congress and the press are working up another panic about the state of the Food and Drug Administration. The place is a mess all right, but as usual the most alarming news is receiving almost no attention.
Washington is responding to a series of investigations concluding that the FDA cannot "adequately" monitor America's food supply and medical products. One of the FDA's outside advisory panels, the Science Board, reports that the agency is in "a precarious position," in part because it is chronically underfunded. The Government Accountability Office chimes in that, at the FDA's current pace, it would take 13 years to inspect every foreign drug plant exporting to the U.S. and 1,900 years to inspect every overseas food factory.
That last factoid may be true, or not, but it does raise the question of whether such a crackdown is possible, never mind desirable. Monitoring 100% of foreign imports -- or 10%, or whatever -- would be so onerous that it might as well be a ban. Yet lapses like adulterated Chinese toothpaste are exceedingly rare, mainly because companies have every incentive to police themselves. (Ask Mattel about its toy import nightmare.)
Still, it's generally agreed that the FDA could use more cash, and the White House's 2009 budget requests a 5.7% increase. But what no one reports is that the Science Board says these shortfalls crop up because Congress hasn't increased FDA funding in proportion to its burgeoning regulatory demands. Over the last two decades, Congress has expanded the FDA's reach more than 127 times; it now oversees about 25 cents of every dollar spent in the U.S.
The Science Board's most important, and distressing, finding is that the FDA bureaucracy "cannot even keep up with the advances in science" -- and not solely due to a lack of funding. While "the world of drug discovery and development has undergone revolutionary change," the authors write, the FDA's "evaluation methods have remained largely unchanged over the last half-century." (Our emphasis.)
Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.
The observation comes on page three, which leads us to suspect that Congress's hand-wringers haven't even read the study. Here's a refresher: "The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities," the Science Board notes.
Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence "to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced" and "to support innovation in the industries and markets that it regulates."
The Science Board authors propose that the FDA "modernize current regulatory pathways," especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.
The FDA uses rigid statistical techniques to evaluate developmental drugs, even when the lives of terminally ill patients are at stake. Many advanced immunotherapies for cancer, for instance, are held hostage to the FDA's old models, which still insist on crude mortality rates and the large average effects detected in clinical trials. Better metrics would include improving the quality of life or slowing the progression of tumors, or focusing on targeted populations. The Science Board says that "there is an urgent need for developing . . . new statistical methods that are most appropriate for the data generated by new areas of science."
Take Junovan, a medicine for a rare pediatric bone cancer. Junovan's successes in a clinical trial were "only" demonstrated with a 94% level of statistical certainty, instead of the FDA-mandated 95%. Avastin, a revolutionary biologic currently used against lung and colorectal cancers, also looks like it will get a thumbs-down as a treatment for metastatic breast cancer. While the evidence shows that patients lived longer before their symptoms got worse, they didn't live longer on average. Refusing to consider "progression-free survival" as a drug benefit is not only unscientific, but morally hideous.
The real scandal is that these policies are the product of the FDA's institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it's so much easier to say, "spend more money."
Perhaps that's why the Science Board ends on a mordant, but all too accurate, note: "Finding: Recommendations of excellent FDA reviews are seldom followed."Read more at www.infinitehealthresources.com, click the Resource Center.
Keep The Veggies Coming
US News and World Report December 2007
Keep The Veggies Coming
By Nancy Shute
This article hits it right on the mark when it comes to children developing healthy eating habits from infancy.
Remember the old saying, the apple doesn’t fall far from the tree, no pun intended.
When it comes to food, smoking, drinking, sports like fishing, tennis and on and on. Monkey see, monkey do. Well that certainly holds true for eating.
On my website, www.infinitehealthresources.com, The Resource Center, I have written hundreds of thousands of words related to this topic. I am no expert, however I have been blessed with 4 healthy children and they have been eating healthy veggy filled meals since solid foods were introduced into their lives. Here’s the secret. Shut up, sit down and eat. They will too. Talk to your spouse about how good this food is in front of your child. How good this food makes you feel. They will eat.
Now if your diet is hamburgers and fries or mac and cheese, you’re screwed. Period.
Read on and hear from the experts:
Want your kids to eat their veggies? Start offering them when they’re tiny babies, and don’t take a grimace to mean “No.”
That’s the advice of Julie Mennella, a biopsychologist and expert on food choices at the Monell Chemical Senses Center in Philadelphia. She recently had 45 mothers spoon-feed their babies pureed green beans once daily. Half the group also offered pureed peaches afterwards. At first, the babies who got peaches ate more peaches then beans; after eight days, both groups were eating green beans and had increased their consumption twofold. “They’ll wrinkle their noses,” Mennella says, “but they still continue to eat.”
The babies who were breast-fed also ate more peaches than formula-fed babies, perhaps because their mothers ate more fruit than non-breast-feeding moms. This echoes Mennella’s earlier research, in which babies born to women who drank carrot juice in the third trimester favored cereal made with carrot juice, as did babies whose mothers drank carrot juice while breast-feeding. “It’s really a fundamental feature of all mammals,” Mennella says. “It’s the first way we learn about foods and flavors.”
Sweets please. It’s clear that children favor what their parents eat, whether it’s muktuk in Alaska or dal in New Delhi. When it comes to eating vegetables, that’s a problem, since most adults don’t eat the recommended two servings of fruit and three servings of vegetables daily.All humans relish fat and sugar, because they’re the most concentrated sources of energy in a world where, until very recently, hunger and famine were threats to almost everyone. Now, alas, it’s easy to supersize the fats and carbs, and still hard to choose celery over cookies. Nutritionists are well aware that parents aren’t always the best role models when it comes to healthful eating, and schools have lately tried to do a better job of encouraging wise choices, by putting water in vending machines and fresh fruit in the lunch line. Congress is now considering a federal ban on the sale of candy, sodas, and salty fatty food in school vending machines and cafeterias.
The eat-your-vegetables war has escalated recently, fueled by two new books that encourage parents to sneak vegetables into treats like brownies and chocolate pudding. Deceptively Delicious by Jessica Seinfeld (wife of the comedian Jerry) and The Sneaky Chef by Missy Chase Lapine have evoked howls from chefs and nutritionists for suggesting that slipping pureed cauliflower into macaroni and cheese is a good idea. There are two big problems here. One, this sends kids the message that brownies are sustenance, not an occasional treat. And two, it never gives children the chance to learn to appreciate vegetables for their own merit.
“You can’t mask the flavor if the goal is to get kids to eat fruits and vegetables,” Mennella argues. All the research points to this common-sense realization: the earlier and broader a child’s experience with a wide variety of foods, the more healthful the diet. A new book, Food Flights by peditricians Laura Jana and Jennifer Shu, offers practical strategies that are much more appealing than vegetable subterfuge – like requiring a “no (more), thank you” bite to audition to new foods.
I, too, depair when the lunch bag comes home at the end of the day with carrots and apple unmunched. But I also have discovered that Mennella’s theory works too. If I ooh and ah over the deliciousness of spinach salad, my preschooler will smack her lips as she pops leaves into her mouth. She still thinks a Chicken Mcnugget is a culinary marvel, alas. But she also now takes joy in green things that crunch.
Learn more about healthy diets and great references at www.infinitehelathresources.com, click on The Resource Center.
Keep The Veggies Coming
By Nancy Shute
This article hits it right on the mark when it comes to children developing healthy eating habits from infancy.
Remember the old saying, the apple doesn’t fall far from the tree, no pun intended.
When it comes to food, smoking, drinking, sports like fishing, tennis and on and on. Monkey see, monkey do. Well that certainly holds true for eating.
On my website, www.infinitehealthresources.com, The Resource Center, I have written hundreds of thousands of words related to this topic. I am no expert, however I have been blessed with 4 healthy children and they have been eating healthy veggy filled meals since solid foods were introduced into their lives. Here’s the secret. Shut up, sit down and eat. They will too. Talk to your spouse about how good this food is in front of your child. How good this food makes you feel. They will eat.
Now if your diet is hamburgers and fries or mac and cheese, you’re screwed. Period.
Read on and hear from the experts:
Want your kids to eat their veggies? Start offering them when they’re tiny babies, and don’t take a grimace to mean “No.”
That’s the advice of Julie Mennella, a biopsychologist and expert on food choices at the Monell Chemical Senses Center in Philadelphia. She recently had 45 mothers spoon-feed their babies pureed green beans once daily. Half the group also offered pureed peaches afterwards. At first, the babies who got peaches ate more peaches then beans; after eight days, both groups were eating green beans and had increased their consumption twofold. “They’ll wrinkle their noses,” Mennella says, “but they still continue to eat.”
The babies who were breast-fed also ate more peaches than formula-fed babies, perhaps because their mothers ate more fruit than non-breast-feeding moms. This echoes Mennella’s earlier research, in which babies born to women who drank carrot juice in the third trimester favored cereal made with carrot juice, as did babies whose mothers drank carrot juice while breast-feeding. “It’s really a fundamental feature of all mammals,” Mennella says. “It’s the first way we learn about foods and flavors.”
Sweets please. It’s clear that children favor what their parents eat, whether it’s muktuk in Alaska or dal in New Delhi. When it comes to eating vegetables, that’s a problem, since most adults don’t eat the recommended two servings of fruit and three servings of vegetables daily.All humans relish fat and sugar, because they’re the most concentrated sources of energy in a world where, until very recently, hunger and famine were threats to almost everyone. Now, alas, it’s easy to supersize the fats and carbs, and still hard to choose celery over cookies. Nutritionists are well aware that parents aren’t always the best role models when it comes to healthful eating, and schools have lately tried to do a better job of encouraging wise choices, by putting water in vending machines and fresh fruit in the lunch line. Congress is now considering a federal ban on the sale of candy, sodas, and salty fatty food in school vending machines and cafeterias.
The eat-your-vegetables war has escalated recently, fueled by two new books that encourage parents to sneak vegetables into treats like brownies and chocolate pudding. Deceptively Delicious by Jessica Seinfeld (wife of the comedian Jerry) and The Sneaky Chef by Missy Chase Lapine have evoked howls from chefs and nutritionists for suggesting that slipping pureed cauliflower into macaroni and cheese is a good idea. There are two big problems here. One, this sends kids the message that brownies are sustenance, not an occasional treat. And two, it never gives children the chance to learn to appreciate vegetables for their own merit.
“You can’t mask the flavor if the goal is to get kids to eat fruits and vegetables,” Mennella argues. All the research points to this common-sense realization: the earlier and broader a child’s experience with a wide variety of foods, the more healthful the diet. A new book, Food Flights by peditricians Laura Jana and Jennifer Shu, offers practical strategies that are much more appealing than vegetable subterfuge – like requiring a “no (more), thank you” bite to audition to new foods.
I, too, depair when the lunch bag comes home at the end of the day with carrots and apple unmunched. But I also have discovered that Mennella’s theory works too. If I ooh and ah over the deliciousness of spinach salad, my preschooler will smack her lips as she pops leaves into her mouth. She still thinks a Chicken Mcnugget is a culinary marvel, alas. But she also now takes joy in green things that crunch.
Learn more about healthy diets and great references at www.infinitehelathresources.com, click on The Resource Center.
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