WASHINGTON (Reuters) - More than 40 million people in the United States say they cannot afford adequate heath care and go without drugs, eyeglasses or dental treatment, according to a federal report released on Monday.
The latest look at the state of U.S. health care also shows that while death rates from cancer and heart disease have dropped in recent years, just as many Americans are dying in car crashes. Read more..
http://www.reuters.com/article/healthNews/idUSN0343703420071203
1.31.2008
Public Outcry Keeps Hormone Milk Labels in PA
At a time when consumers can look at labels to find whether their food has less salt, is Kosher or trans-fat-free, the Pennsylvania Agriculture Department thought, when it came to labels on dairy products, less was more.
In October, Pennsylvania became the first state to ban the practice of labeling milk as free from Monsanto’s artificial growth hormone rBST also known as rbGH (synthetic or recombinant bovine growth hormone).
The labels were too confusing since milk already has naturally occurring hormones and it might be difficult to verify whether “coming from cows not treated with rBST” was actually true according to the state agriculture secretary, Dennis Wolff who issued notice of the ban.
But on the eve of the February 1 deadline for label changes, a bombardment of consumer emails, letters and calls into Governor Edward Rendell's office convinced him to intervene and reverse the labeling prohibition.
http://www.injuryboard.com/national-news/public-outcry-keeps-hormone-milk-labels-in-pa.aspx?googleid=29144
In October, Pennsylvania became the first state to ban the practice of labeling milk as free from Monsanto’s artificial growth hormone rBST also known as rbGH (synthetic or recombinant bovine growth hormone).
The labels were too confusing since milk already has naturally occurring hormones and it might be difficult to verify whether “coming from cows not treated with rBST” was actually true according to the state agriculture secretary, Dennis Wolff who issued notice of the ban.
But on the eve of the February 1 deadline for label changes, a bombardment of consumer emails, letters and calls into Governor Edward Rendell's office convinced him to intervene and reverse the labeling prohibition.
http://www.injuryboard.com/national-news/public-outcry-keeps-hormone-milk-labels-in-pa.aspx?googleid=29144
Unfavorable drug studies don't get into print: report
BOSTON (Reuters) - Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.
"Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.
The idea that unfavorable test results are quietly tucked away so nobody will see them -- sometimes call the "file drawer effect" -- has been around for years.
The Turner team used a U.S. Food and Drug Administration registry in which companies are supposed to log details of their drug tests before the experiments are begun.
"It tells you where they placed their bets before they saw the data," Turner said in a telephone interview.
"Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the authors.
For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print.
There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published. A fourth study, ruled questionable by the FDA, was written and published to make it appear that the drug worked. Read more..
http://news.yahoo.com/s/nm/20080117/us_nm/drugs_studies_dc
"Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.
The idea that unfavorable test results are quietly tucked away so nobody will see them -- sometimes call the "file drawer effect" -- has been around for years.
The Turner team used a U.S. Food and Drug Administration registry in which companies are supposed to log details of their drug tests before the experiments are begun.
"It tells you where they placed their bets before they saw the data," Turner said in a telephone interview.
"Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the authors.
For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print.
There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published. A fourth study, ruled questionable by the FDA, was written and published to make it appear that the drug worked. Read more..
http://news.yahoo.com/s/nm/20080117/us_nm/drugs_studies_dc
1.26.2008
Japan says Tamiflu/psychiatric link unclear
The announcement comes after an investigation following earlier reports of abnormal behaviour and self harming in younger patients who had taken the Roche-manufactured flu drug.
Since 2005, there have been more than 100 reports of abnormal behaviour in people taking Tamiflu (oseltamivir), including eight deaths.
According to the Health Ministry report, almost 60 per cent of people showing abnormal behaviour had taken the drug. Read more..
http://www.in-pharmatechnologist.com/news/ng.asp?n=82101-roche-chugai-tamiflu-abnormal-behaviour-h-n-influenza
Since 2005, there have been more than 100 reports of abnormal behaviour in people taking Tamiflu (oseltamivir), including eight deaths.
According to the Health Ministry report, almost 60 per cent of people showing abnormal behaviour had taken the drug. Read more..
http://www.in-pharmatechnologist.com/news/ng.asp?n=82101-roche-chugai-tamiflu-abnormal-behaviour-h-n-influenza
Invisible RFID Ink Safe For Cattle And People, Company Says
The process developed by Somark involves a geometric array of micro-needles and an ink capsule, which is used to 'tattoo' an animal. The ink can be detected from 4 feet away.
Read more..
http://www.informationweek.com/news/showArticle.jhtml?articleID=196802844
Read more..
http://www.informationweek.com/news/showArticle.jhtml?articleID=196802844
1.25.2008
Toothpaste Woes: Fluoride's Dark Side
Parents don't let your children swallow their toothpaste. Seems like an odd thing to say but young children can ingest almost half of the toothpaste that is put onto their toothbrushes at every brushing. Did you know that about half a tube of toothpaste can have enough fluoride in it to kill your child? Did you even know that fluoride is a toxic element? Did you know it is slightly more toxic than Lead (Pb)? Read more..
http://www.reuters.com/article/blogBurst/health?type=healthNews&w1=B7ovpm21IaDoL40ZFnNfGe&w2=B8kvecPa11hc9lKHEnu7ZUN&src=blogBurst_healthNews&bbPostId=B4LZKn90LO9WCz7SjYxePDb2fCzETkFnXODJt4CzBtBvxwmOMQG&bbParentWidgetId=B8kvecPa11hc9lKHEnu7ZUN
http://www.reuters.com/article/blogBurst/health?type=healthNews&w1=B7ovpm21IaDoL40ZFnNfGe&w2=B8kvecPa11hc9lKHEnu7ZUN&src=blogBurst_healthNews&bbPostId=B4LZKn90LO9WCz7SjYxePDb2fCzETkFnXODJt4CzBtBvxwmOMQG&bbParentWidgetId=B8kvecPa11hc9lKHEnu7ZUN
Study: The Pill protects against cancer
LONDON - Women on the birth control pill are protected from ovarian cancer, even decades after they stop taking it, scientists said. British researchers found that women taking the pill for 15 years halved their chances of developing ovarian cancer, and that the risk remained low more than 30 years later, though protection weakened over time. The findings were published Friday in The Lancet.
"Not only does the pill prevent pregnancy, but in the long term, you actually get less cancer as well," said Valerie Beral, the study's lead author and director of the Cancer Research UK Epidemiology Unit at Oxford University. "It's a nice bonus." The study was paid for by Cancer Research UK and Britain's Medical Research Council. Read more..
http://news.yahoo.com/s/ap/20080125/ap_on_he_me/ovarian_cancer
"Not only does the pill prevent pregnancy, but in the long term, you actually get less cancer as well," said Valerie Beral, the study's lead author and director of the Cancer Research UK Epidemiology Unit at Oxford University. "It's a nice bonus." The study was paid for by Cancer Research UK and Britain's Medical Research Council. Read more..
http://news.yahoo.com/s/ap/20080125/ap_on_he_me/ovarian_cancer
1.24.2008
Study shows how ultrafine particles in air pollution may cause heart disease
A new academic study led by UCLA researchers has revealed that the smallest particles from vehicle emissions may be the most damaging components of air pollution in triggering plaque buildup in the arteries, which can lead to heart attack and stroke. The findings appear in the Jan. 17 online edition of the journal Circulation Research.
The scientists identified a way in which pollutant particles may promote hardening of the arteries — by inactivating the protective qualities of high density lipoprotein (HDL) cholesterol, known as "good" cholesterol.
Nanoparticles are the size of a virus or molecule — less than 0.18 micrometers, or about one-thousandth the size of a human hair. The EPA currently regulates fine particles, which are the next size up, at 2.5 micrometers, but doesn't monitor particles in the nano or ultrafine range. These particles are too small to capture in a filter, so new technology must be developed to track their contribution to adverse health effects.
"We hope our findings offer insight into the impact of nano-sized air pollutant particles and help explore ways for stricter air quality regulatory guidelines," said Nel, principal investigator and a researcher at UCLA's California NanoSystems Institute. Read more..
http://www.nanotech-now.com/news.cgi?story_id=27536
The scientists identified a way in which pollutant particles may promote hardening of the arteries — by inactivating the protective qualities of high density lipoprotein (HDL) cholesterol, known as "good" cholesterol.
Nanoparticles are the size of a virus or molecule — less than 0.18 micrometers, or about one-thousandth the size of a human hair. The EPA currently regulates fine particles, which are the next size up, at 2.5 micrometers, but doesn't monitor particles in the nano or ultrafine range. These particles are too small to capture in a filter, so new technology must be developed to track their contribution to adverse health effects.
"We hope our findings offer insight into the impact of nano-sized air pollutant particles and help explore ways for stricter air quality regulatory guidelines," said Nel, principal investigator and a researcher at UCLA's California NanoSystems Institute. Read more..
http://www.nanotech-now.com/news.cgi?story_id=27536
Nanotech's health, environment impacts worry scientists
The new findings are in stark contrast to controversies sparked by the advent of technologies of the past such as nuclear power and genetically modified foods, which scientists perceived as having lower risks than did the public.
Nanotechnology rests on science's newfound ability to manipulate matter at the smallest scale, on the order of molecules and atoms. The field has enormous potential to develop applications ranging from new antimicrobial materials and tiny probes to sample individual cells in human patients to vastly more powerful computers and lasers. Already products with nanotechnology built in include such things as golf clubs, tennis rackets and antimicrobial food storage containers.
At the root of the information disconnect, explains Scheufele, who conducted the survey with Elizabeth Corley at Arizona State University, is that nanotechnology is only now starting to emerge on the nation's policy agenda. Amplifying the problem is that the news media have paid scant attention to nanotechnology and its implications. Read more..
http://www.enn.com/sci-tech/article/25828
Nanotechnology rests on science's newfound ability to manipulate matter at the smallest scale, on the order of molecules and atoms. The field has enormous potential to develop applications ranging from new antimicrobial materials and tiny probes to sample individual cells in human patients to vastly more powerful computers and lasers. Already products with nanotechnology built in include such things as golf clubs, tennis rackets and antimicrobial food storage containers.
At the root of the information disconnect, explains Scheufele, who conducted the survey with Elizabeth Corley at Arizona State University, is that nanotechnology is only now starting to emerge on the nation's policy agenda. Amplifying the problem is that the news media have paid scant attention to nanotechnology and its implications. Read more..
http://www.enn.com/sci-tech/article/25828
'Second Thoughts about Fluoride,' Reports Scientific American
NEW YORK, Jan. 2 /PRNewswire-USNewswire/ -- "Some recent studies suggest that
over-consumption of fluoride can raise the risks of disorders affecting teeth,
bones, the brain and the thyroid gland," reports Scientific American editors
(January 2008). "Scientific attitudes toward fluoridation may be starting to
shift," writes author Dan Fagin.
"Fluoride, the most consumed drug in the USA, is deliberately added to 2/3 of
public water supplies theoretically to reduce tooth decay, but with no
scientifically-valid evidence proving safety or effectiveness," says lawyer
Paul Beeber, President, New York State Coalition Opposed to Fluoridation.
Fagin, award-wining environmental reporter and Director of New York
University's Science, Health and Environmental Reporting Program, writes,
"There is no universally accepted optimal level for daily intake of fluoride."
Some researchers even wonder whether the 1 mg/L added into drinking water is
too much, reports Fagin.
After 3 years of scrutinizing hundreds of studies, a National Research Council
(NRC) committee "concluded that fluoride can subtly alter endocrine function,
especially in the thyroid -- the gland that produces hormones regulating
growth and metabolism," reports Fagin. Read more..
http://www.reuters.com/article/pressRelease/idUS108377%2B02-Jan-2008%2BPRN20080102
over-consumption of fluoride can raise the risks of disorders affecting teeth,
bones, the brain and the thyroid gland," reports Scientific American editors
(January 2008). "Scientific attitudes toward fluoridation may be starting to
shift," writes author Dan Fagin.
"Fluoride, the most consumed drug in the USA, is deliberately added to 2/3 of
public water supplies theoretically to reduce tooth decay, but with no
scientifically-valid evidence proving safety or effectiveness," says lawyer
Paul Beeber, President, New York State Coalition Opposed to Fluoridation.
Fagin, award-wining environmental reporter and Director of New York
University's Science, Health and Environmental Reporting Program, writes,
"There is no universally accepted optimal level for daily intake of fluoride."
Some researchers even wonder whether the 1 mg/L added into drinking water is
too much, reports Fagin.
After 3 years of scrutinizing hundreds of studies, a National Research Council
(NRC) committee "concluded that fluoride can subtly alter endocrine function,
especially in the thyroid -- the gland that produces hormones regulating
growth and metabolism," reports Fagin. Read more..
http://www.reuters.com/article/pressRelease/idUS108377%2B02-Jan-2008%2BPRN20080102
1.21.2008
Merck's Prospects Brighten
Prospects for Merck & Co.'s $4.85 billion Vioxx settlement grew more promising, with participation outpacing expectations and the parties agreeing on amendments that resolve a major sticking point and make payouts more attractive to holdout plaintiffs.
The parties announced Friday that more than 57,100 claimants out of an estimated 60,100 -- in excess of 95% -- registered their cases by the Jan. 15 deadline, far more than the minimum required to keep the deal alive. Read more..
http://online.wsj.com/article/SB120067727704100917.html?mod=health_home_stories
The parties announced Friday that more than 57,100 claimants out of an estimated 60,100 -- in excess of 95% -- registered their cases by the Jan. 15 deadline, far more than the minimum required to keep the deal alive. Read more..
http://online.wsj.com/article/SB120067727704100917.html?mod=health_home_stories
Cloned food and milk
The FDA says it's safe to eat cloned meat and drink milk from cloned cows. What I find interesting is that no matter what the FDA or any other public or private agency says about edibles from cloned animals, ultimately it will be you, the consumer, who determines the success or failure of cloned food in the marketplace. Read more..
http://www.cnn.com/HEALTH/blogs/paging.dr.gupta/2008/01/cloned-food-and-milk.html
http://www.cnn.com/HEALTH/blogs/paging.dr.gupta/2008/01/cloned-food-and-milk.html
Drug firms 'bury' poor trial results
Drug companies are placing depressed patients at risk by not publishing negative results from clinical trials and distorting the evidence doctors use to decide which drugs to prescribe.
New research published in The New England Journal of Medicine found nearly a third of the 74 industry-sponsored studies of antidepressants they examined were not published, most of which showed negative outcomes for the drug involved. Not only were positive results 12 times more likely to be published, but negative results were often written so as to convey a favourable outcome.
Researchers warn that selective reporting of clinical trials can lead to misrepresentation of the benefits and risks of a drug and could mislead healthcare professionals into believing some drugs are more effective and less harmful than they actually are, which could place patients at risk.
The published articles suggest 94 per cent of the trials conducted had positive results, whereas analysis by the FDA found only half were favourable.
New research published in The New England Journal of Medicine found nearly a third of the 74 industry-sponsored studies of antidepressants they examined were not published, most of which showed negative outcomes for the drug involved. Not only were positive results 12 times more likely to be published, but negative results were often written so as to convey a favourable outcome.
Researchers warn that selective reporting of clinical trials can lead to misrepresentation of the benefits and risks of a drug and could mislead healthcare professionals into believing some drugs are more effective and less harmful than they actually are, which could place patients at risk.
The published articles suggest 94 per cent of the trials conducted had positive results, whereas analysis by the FDA found only half were favourable.
Doctors often prescribe placebos: study
A significant number of doctors in the United States prescribe placebos to their patients, a new study suggests.
A study of 200 doctors in the Chicago area found that nearly half had, at some point, written prescriptions for interventions they did not expect would have a physical effect.
The findings are reported in the January issue of the Journal of General Internal Medicine.
Rachel Sherman, a medical student at the University of Chicago, sent questionnaires to 466 internists at three Chicago-area academic medical centres. About half of them responded.
And 45 per cent of those who filled out the forms said they had prescribed a placebo at some time. Of those:
* 34 per cent said they presented a placebo as "a substance that may help and will not hurt."
* 19 per cent told their patients "it is medication."
* Nine per cent said "it is medicine with no specific effect."
Only four per cent of doctors admitted to their patients that they had prescribed a placebo.
About 12 per cent of the doctors surveyed said they felt the prescription of placebos should be prohibited.
Placebo means "to please somebody" in Latin, Dr. Peter Lin, a Toronto-based general practitioner told CBC's Metro Morning on Monday.
"If I give you a pill and I say that you're going to get better, people get better," he said.
Lin says that previous studies involving placebos have shown that when patients were given what they thought were painkillers — but instead were given placebos — their brains produced endorphins, natural painkillers, which essentially produced the same physical effects as the drugs.
"It's not an imagined improvement," says Lin. "It's an actual improvement. There is a huge mind-body connection that we need to explore."
Lin said the only caveat is that doctors need to prescribe placebos in an ethical manner. He says physicians who are just trying to get rid of patients who repeatedly ask them for some form of medication by prescribing placebos are doing them a disservice.
However, he says, if the doctor has checked out a patient and found them healthy but still seeking a treatment they don't require, placebos can meet that need.
"If we can get patients to feel better, that's good," Lin says.
A study of 200 doctors in the Chicago area found that nearly half had, at some point, written prescriptions for interventions they did not expect would have a physical effect.
The findings are reported in the January issue of the Journal of General Internal Medicine.
Rachel Sherman, a medical student at the University of Chicago, sent questionnaires to 466 internists at three Chicago-area academic medical centres. About half of them responded.
And 45 per cent of those who filled out the forms said they had prescribed a placebo at some time. Of those:
* 34 per cent said they presented a placebo as "a substance that may help and will not hurt."
* 19 per cent told their patients "it is medication."
* Nine per cent said "it is medicine with no specific effect."
Only four per cent of doctors admitted to their patients that they had prescribed a placebo.
About 12 per cent of the doctors surveyed said they felt the prescription of placebos should be prohibited.
Placebo means "to please somebody" in Latin, Dr. Peter Lin, a Toronto-based general practitioner told CBC's Metro Morning on Monday.
"If I give you a pill and I say that you're going to get better, people get better," he said.
Lin says that previous studies involving placebos have shown that when patients were given what they thought were painkillers — but instead were given placebos — their brains produced endorphins, natural painkillers, which essentially produced the same physical effects as the drugs.
"It's not an imagined improvement," says Lin. "It's an actual improvement. There is a huge mind-body connection that we need to explore."
Lin said the only caveat is that doctors need to prescribe placebos in an ethical manner. He says physicians who are just trying to get rid of patients who repeatedly ask them for some form of medication by prescribing placebos are doing them a disservice.
However, he says, if the doctor has checked out a patient and found them healthy but still seeking a treatment they don't require, placebos can meet that need.
"If we can get patients to feel better, that's good," Lin says.
1.19.2008
USDA Recommends That Food From Clones Stay Off the Market
The U.S. Department of Agriculture yesterday asked U.S. farmers to keep their cloned animals off the market indefinitely even as Food and Drug Administration officials announced that food from cloned livestock is safe to eat.
Bruce I. Knight, the USDA's undersecretary for marketing and regulatory programs, requested an ongoing "voluntary moratorium" to buy time for "an acceptance process" that Knight said consumers in the United States and abroad will need, "given the emotional nature of this issue."
Yet even as the two agencies sought a unified message -- that food from clones is safe for people but perhaps dangerous to U.S. markets and trade relations -- evidence surfaced suggesting that Americans and others are probably already eating meat from the offspring of clones.
Executives from the nation's major cattle cloning companies conceded yesterday that they have not been able to keep track of how many offspring of clones have entered the food supply, despite a years-old request by the FDA to keep them off the market pending completion of the agency's safety report.
At least one Kansas cattle producer also disclosed yesterday that he has openly sold semen from prize-winning clones to many U.S. meat producers in the past few years, and that he is certain he is not alone. Read more..
http://www.washingtonpost.com/wp-dyn/content/article/2008/01/15/AR2008011501555.html
Bruce I. Knight, the USDA's undersecretary for marketing and regulatory programs, requested an ongoing "voluntary moratorium" to buy time for "an acceptance process" that Knight said consumers in the United States and abroad will need, "given the emotional nature of this issue."
Yet even as the two agencies sought a unified message -- that food from clones is safe for people but perhaps dangerous to U.S. markets and trade relations -- evidence surfaced suggesting that Americans and others are probably already eating meat from the offspring of clones.
Executives from the nation's major cattle cloning companies conceded yesterday that they have not been able to keep track of how many offspring of clones have entered the food supply, despite a years-old request by the FDA to keep them off the market pending completion of the agency's safety report.
At least one Kansas cattle producer also disclosed yesterday that he has openly sold semen from prize-winning clones to many U.S. meat producers in the past few years, and that he is certain he is not alone. Read more..
http://www.washingtonpost.com/wp-dyn/content/article/2008/01/15/AR2008011501555.html
Experts Call for Shift in AIDS Policy
LONDON (Jan. 18) - In the two decades since AIDS began sweeping the globe, it has often been labeled as the biggest threat to international health.
But with revised numbers downsizing the pandemic — along with an admission that AIDS peaked in the late 1990s — some AIDS experts are now wondering if it might be wise to shift some of the billions of dollars of AIDS money to basic health problems like clean water, family planning or diarrhea. Read more..
http://news.aol.com/health/story/_a/experts-call-for-shift-in-aids-policy/20080118170209990002?ncid=NWS00010000000001
But with revised numbers downsizing the pandemic — along with an admission that AIDS peaked in the late 1990s — some AIDS experts are now wondering if it might be wise to shift some of the billions of dollars of AIDS money to basic health problems like clean water, family planning or diarrhea. Read more..
http://news.aol.com/health/story/_a/experts-call-for-shift-in-aids-policy/20080118170209990002?ncid=NWS00010000000001
1.18.2008
GSK Announces Trial To Compare Effectiveness Of Gardasil And Cervarix
GlaxoSmithKline has revealed that it will be conducting a clinical trial to determine whether its human papilloma virus vaccine Cervarix is more effective than rival Merck's HPV vaccine Gardasil, according to Philadelphia Inquirer.
GSK said that it will be focusing on the effectiveness of both the drugs on HPV strains 16, 18, 31 and 45. Brian Lortie, GSK's vice president for Cervarix operations, said his company is confident that Cervarix will prove to be the more effective vaccine among the two.
"We're quite confident Cervarix has a stronger immune response and broader protection than Gardasil", he said. Reacting to the news of the trial, officials at Merck released a statement saying that the study is limited to only immune response which can never reveal the true efficacy data of a drug.
The trial can further dent Gardasil's reputation, which due to its high cost ($360 for three doses) has not been widely prescribed. Gardasil is the most expensive vaccine on CDC's list of recommended childhood vaccines which has seen many of the private insurance companies not making adequate reimbursement to cover physicians' costs to purchase, store and administer the vaccine.
Merck has already said that it will be offering the vaccine for free to low-income women aged between 19 to 26 years and are not insured. New Hampshire and South Dakota are also thinking of offering the vaccine at no cost to women who are under 18 years of age.
Independent clinical trials have proved that both Gardasil and Cervarix are 100 percent effective in preventing the infection of strains 16 and 18 of HPV, which cause around 70 percent of known cervical cancer cases. Gardasil was approved by the Food and Drug Administration (FDA) last year with CDC's Advisory Committee on Immunization Practices saying that girls aged 11 and 12 should be given the vaccine.
A study published in the April 2006 online edition of the Lancet said that Cervarix successfully prevented the infection of HPV strains 31 and 45. Strains 16 and 18 along with 31 and 45 account for nearly 80 percent of cervical cancer cases. Meanwhile Merck has claimed that Gardasil is 99 percent effective in preventing strains 6 and 11, which when combined with strains 16 and 18 are responsible for 90 percent of genital wart cases.
http://www.vaccinerx.com/news/cervical-cancer/gsk-announces-trial-to-compare-effectiveness-of-gardasil-and-cervarix-20070124-62-56.html
GSK said that it will be focusing on the effectiveness of both the drugs on HPV strains 16, 18, 31 and 45. Brian Lortie, GSK's vice president for Cervarix operations, said his company is confident that Cervarix will prove to be the more effective vaccine among the two.
"We're quite confident Cervarix has a stronger immune response and broader protection than Gardasil", he said. Reacting to the news of the trial, officials at Merck released a statement saying that the study is limited to only immune response which can never reveal the true efficacy data of a drug.
The trial can further dent Gardasil's reputation, which due to its high cost ($360 for three doses) has not been widely prescribed. Gardasil is the most expensive vaccine on CDC's list of recommended childhood vaccines which has seen many of the private insurance companies not making adequate reimbursement to cover physicians' costs to purchase, store and administer the vaccine.
Merck has already said that it will be offering the vaccine for free to low-income women aged between 19 to 26 years and are not insured. New Hampshire and South Dakota are also thinking of offering the vaccine at no cost to women who are under 18 years of age.
Independent clinical trials have proved that both Gardasil and Cervarix are 100 percent effective in preventing the infection of strains 16 and 18 of HPV, which cause around 70 percent of known cervical cancer cases. Gardasil was approved by the Food and Drug Administration (FDA) last year with CDC's Advisory Committee on Immunization Practices saying that girls aged 11 and 12 should be given the vaccine.
A study published in the April 2006 online edition of the Lancet said that Cervarix successfully prevented the infection of HPV strains 31 and 45. Strains 16 and 18 along with 31 and 45 account for nearly 80 percent of cervical cancer cases. Meanwhile Merck has claimed that Gardasil is 99 percent effective in preventing strains 6 and 11, which when combined with strains 16 and 18 are responsible for 90 percent of genital wart cases.
http://www.vaccinerx.com/news/cervical-cancer/gsk-announces-trial-to-compare-effectiveness-of-gardasil-and-cervarix-20070124-62-56.html
Merck's Cervical Cancer Vaccine, Gardasil®, Added To The Cdc Vaccines For Children Contract
Merck & Co., Inc. today announced that the U.S. Centers for Disease Control and Prevention (CDC) has added Merck's cervical cancer vaccine, GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the CDC's Vaccines for Children (VFC) contract for girls and women aged 9 to 18. GARDASIL was approved on June 8 by the Food and Drug Administration (FDA) for use in girls and women ages 9 to 26 years. GARDASIL is the world's first and only vaccine available for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.
"The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL."
Health insurers covering approximately 94 percent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse GARDASIL. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians' offices, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC program has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC's Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend GARDASIL to the VFC program. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete. Read more..
http://www.medicalnewstoday.com/articles/55737.php
"The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL."
Health insurers covering approximately 94 percent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse GARDASIL. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians' offices, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC program has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC's Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend GARDASIL to the VFC program. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete. Read more..
http://www.medicalnewstoday.com/articles/55737.php
CDC Purchasing 10 Million Doses of Gardasil
The Centers for Disease Control and Prevention’s (CDC) latest round of acquisitions under its Vaccines for Children program includes the purchase of 10 million doses of Merck’s human papillomavirus (HPV) vaccine Gardasil, according to CDC solicitation documents.
The agency’s planned purchase is the same as its 2007 procurement.
Merck is the only FDA-approved manufacturer of quadrivalent HPV, which is called for in the procurement specifications. Gardasil (HPV quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) protects against four different strains of the virus, unlike GlaxoSmithKline’s (GSK) Cervarix (HPV, AS04 adjuvant-adsorbed).
Cervarix, approved in Europe, provides 100 percent protection against strains 16 and 18 only, according to the company. Although GSK has indicated that the product provides broader protection against cancer-causing HPV strains, the firm’s marketing authorization from the European Medicines Agency only references strains 16 and 18.
The FDA recently issued a complete response letter for Cervarix, requesting more information about the product. Results from a head-to-head trial comparing Cervarix with Gardasil could be available later this year.
The anticipated performance period of the contract starts April 1 and continues through March 31, 2009. Only measles, mumps and rubella and Hib vaccines are subject to statutory price ceilings. Bids close Jan. 28. The solicitation can be accessed at fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc.
http://www.fdanews.com/newsletter/article?artueId=11210icleId=103084&iss
The agency’s planned purchase is the same as its 2007 procurement.
Merck is the only FDA-approved manufacturer of quadrivalent HPV, which is called for in the procurement specifications. Gardasil (HPV quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) protects against four different strains of the virus, unlike GlaxoSmithKline’s (GSK) Cervarix (HPV, AS04 adjuvant-adsorbed).
Cervarix, approved in Europe, provides 100 percent protection against strains 16 and 18 only, according to the company. Although GSK has indicated that the product provides broader protection against cancer-causing HPV strains, the firm’s marketing authorization from the European Medicines Agency only references strains 16 and 18.
The FDA recently issued a complete response letter for Cervarix, requesting more information about the product. Results from a head-to-head trial comparing Cervarix with Gardasil could be available later this year.
The anticipated performance period of the contract starts April 1 and continues through March 31, 2009. Only measles, mumps and rubella and Hib vaccines are subject to statutory price ceilings. Bids close Jan. 28. The solicitation can be accessed at fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc.
http://www.fdanews.com/newsletter/article?artueId=11210icleId=103084&iss
1.17.2008
FDA and HPV -- when did they know the truth?
What I have done is read all 68 pages of this document. What I am going to show you is that the FDA knew back in 2003 that a HPV is not the actual cause of cervical cancer. The actual cause is a "persistent HPV infection that may act as a tumor promoter in cancer induction [8-11]. Read more....
http://www.renewamerica.us/columns/janak/071212
http://www.renewamerica.us/columns/janak/071212
Making Water From Thin Air
A company that developed technology capable of creating water out of thin air nearly anywhere in the world is now under contract to nourish U.S. soldiers serving in Iraq.
The water-harvesting technology was originally the brainchild of the Pentagon's Defense Advanced Research Projects Agency, which sought ways to ensure sustainable water supplies for U.S. combat troops deployed in arid regions like Iraq.
"The program focused on creating water from the atmosphere using low-energy systems that could reduce the overall logistics burden for deployed forces and provide potable water within the reach of the war fighter any place, any time," said Darpa spokeswoman Jan Walker.
To achieve this end, Darpa gave millions to research companies like LexCarb and Sciperio to create a contraption that could capture water in the Mesopotamian desert.
But it was another company, Aqua Sciences, that developed a product on its own and was first to put a product on the market that can operate in harsh climates.
"People have been trying to figure out how to do this for years, and we just came out of left field in response to Darpa," said Abe Sher, chief executive officer of Aqua Sciences. "The atmosphere is a river full of water, even in the desert. It won't work absolutely everywhere, but it works virtually everywhere."
Sher said he is "not at liberty" to disclose details of the government contracts, except that Aqua Sciences won two highly competitive bids with "some very sophisticated companies."
He also declined to comment on how the technology actually works.
"This is our secret sauce," Sher said. "Like Kentucky Fried Chicken, it tastes good, but we won't tell you what's in it."
He did, however, provide a hint: Think of rice used in saltshakers that acts as a magnet to extract water and keeps salt from clumping.
"We figured out how to tap it in a very unique and proprietary way," Sher said. "We figured out how to mimic nature, using natural salt to extract water and act as a natural decontamination.
"Think of the Dead Sea, where nothing grows around it because the salt dehydrates everything. It's kind of like that."
The 20-foot machine can churn out 600 gallons of water a day without using or producing toxic materials and byproducts. The machine was displayed on Capitol Hill last week where a half-dozen lawmakers and some staffers stopped by for a drink.
"It was very interesting to see the technology in action and learn about its possible implementation in natural disasters," said Rep. E. Clay Shaw Jr., a Republican from Florida whose hurricane-prone district includes Fort Lauderdale.
"It was delicious," Shaw said.
Jason Rowe, chief of staff to Rep. Tom Feeney, another Florida Republican, called the technology "pretty impressive."
"I was pretty blown away by the things it's able to do," Rowe said. "The fact that this technology is not tied to humidity like others are makes it an attractive alternative for military bases in the Mideast where humidity is not really an option.
"It seems like it's a cheaper alternative to trucking in bottled water, which has a shelf life," said Rowe, who described himself as a fiscal hawk.
Once deployed, the machines could reduce the cost of logistical support for supplying water to the troops in Iraq by billions of dollars, said Stuart Roy, spokesman of the DCI Group, Aqua Sciences' public affairs firm.
The cost to transport water by C-17 cargo planes, then truck it to the troops, runs $30 a gallon. The cost, including the machines from Aqua Sciences, will be reduced to 30 cents a gallon, Roy said.
Several systems on the market can create water through condensation, but the process requires a high level of humidity.
Aqua Sciences' machines only require 14 percent humidity, Roy said. "That's why this technology is superior and why they are getting the contracts."
http://www.wired.com/science/discoveries/news/2006/10/71898
The water-harvesting technology was originally the brainchild of the Pentagon's Defense Advanced Research Projects Agency, which sought ways to ensure sustainable water supplies for U.S. combat troops deployed in arid regions like Iraq.
"The program focused on creating water from the atmosphere using low-energy systems that could reduce the overall logistics burden for deployed forces and provide potable water within the reach of the war fighter any place, any time," said Darpa spokeswoman Jan Walker.
To achieve this end, Darpa gave millions to research companies like LexCarb and Sciperio to create a contraption that could capture water in the Mesopotamian desert.
But it was another company, Aqua Sciences, that developed a product on its own and was first to put a product on the market that can operate in harsh climates.
"People have been trying to figure out how to do this for years, and we just came out of left field in response to Darpa," said Abe Sher, chief executive officer of Aqua Sciences. "The atmosphere is a river full of water, even in the desert. It won't work absolutely everywhere, but it works virtually everywhere."
Sher said he is "not at liberty" to disclose details of the government contracts, except that Aqua Sciences won two highly competitive bids with "some very sophisticated companies."
He also declined to comment on how the technology actually works.
"This is our secret sauce," Sher said. "Like Kentucky Fried Chicken, it tastes good, but we won't tell you what's in it."
He did, however, provide a hint: Think of rice used in saltshakers that acts as a magnet to extract water and keeps salt from clumping.
"We figured out how to tap it in a very unique and proprietary way," Sher said. "We figured out how to mimic nature, using natural salt to extract water and act as a natural decontamination.
"Think of the Dead Sea, where nothing grows around it because the salt dehydrates everything. It's kind of like that."
The 20-foot machine can churn out 600 gallons of water a day without using or producing toxic materials and byproducts. The machine was displayed on Capitol Hill last week where a half-dozen lawmakers and some staffers stopped by for a drink.
"It was very interesting to see the technology in action and learn about its possible implementation in natural disasters," said Rep. E. Clay Shaw Jr., a Republican from Florida whose hurricane-prone district includes Fort Lauderdale.
"It was delicious," Shaw said.
Jason Rowe, chief of staff to Rep. Tom Feeney, another Florida Republican, called the technology "pretty impressive."
"I was pretty blown away by the things it's able to do," Rowe said. "The fact that this technology is not tied to humidity like others are makes it an attractive alternative for military bases in the Mideast where humidity is not really an option.
"It seems like it's a cheaper alternative to trucking in bottled water, which has a shelf life," said Rowe, who described himself as a fiscal hawk.
Once deployed, the machines could reduce the cost of logistical support for supplying water to the troops in Iraq by billions of dollars, said Stuart Roy, spokesman of the DCI Group, Aqua Sciences' public affairs firm.
The cost to transport water by C-17 cargo planes, then truck it to the troops, runs $30 a gallon. The cost, including the machines from Aqua Sciences, will be reduced to 30 cents a gallon, Roy said.
Several systems on the market can create water through condensation, but the process requires a high level of humidity.
Aqua Sciences' machines only require 14 percent humidity, Roy said. "That's why this technology is superior and why they are getting the contracts."
http://www.wired.com/science/discoveries/news/2006/10/71898
1.16.2008
FDA Announces Plan to Eliminate Vitamin Companies
(NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
http://www.newstarget.com/022499.html
http://www.newstarget.com/022499.html
1.05.2008
Merk drug company vaccines admits injecting cancer viruses
This stunning censored interview conducted by medical historian Edward Shorter for WGBH public television (Boston) and Blackwell Science was cut from The Health Century due to its huge liability--the admission that Merck drug company vaccines have traditionally been injecting cancer viruses (SV40 and others) in people worldwide.
This segment of In Lies We Trust: The CIA, Hollywood & Bioterrorism, produced and freely contributed by consumer protector and public health expert, Dr. Leonard Horowitz, features the world's leading vaccine expert, Dr. Maurice Hilleman, who explains why Merck's vaccines have spread AIDS, leukemia, and other horrific plagues worldwide. Click on link to watch...
http://www.liveleak.com/view?i=327_1195303011
This segment of In Lies We Trust: The CIA, Hollywood & Bioterrorism, produced and freely contributed by consumer protector and public health expert, Dr. Leonard Horowitz, features the world's leading vaccine expert, Dr. Maurice Hilleman, who explains why Merck's vaccines have spread AIDS, leukemia, and other horrific plagues worldwide. Click on link to watch...
http://www.liveleak.com/view?i=327_1195303011
1.04.2008
Did IBM Knowingly Dump Chemicals In New York State From 1924 To 2002
NEW YORK (Reuters) - Neighbors of a former IBM (IBM.N) plant in New York state sued the company on Thursday, saying it released chemicals into the air, ground and water for nearly 80 years that caused birth defects and cancer.
Some 90 residents of the upstate New York towns of Endicott and Union say that from 1924 to 2002, IBM dumped chemicals including trichloroethylene and tetrachloroethylene near the Endicott plant where the computer giant was born.
They seek unspecified damages, according to the suit filed in Broome County Superior Court.
"IBM will defend itself vigorously against these claims that have no merit in science," company spokesman Michael Maloney said.
The lawsuit is the first of several planned against IBM by nearly 1,000 people who say they have been harmed by the chemicals, lawyers for the plaintiffs said.
IBM began at Endicott, where it built everything from typewriters to mainframe computers. It sold the plant in 2002.
(Reporting by Dan Wilchins in New York and Philipp Gollner in San Francisco; Editing by Daniel Trotta and Xavier Briand)
http://news.yahoo.com/s/nm/20080103/bs_nm/ibm_lawsuit_dc
Some 90 residents of the upstate New York towns of Endicott and Union say that from 1924 to 2002, IBM dumped chemicals including trichloroethylene and tetrachloroethylene near the Endicott plant where the computer giant was born.
They seek unspecified damages, according to the suit filed in Broome County Superior Court.
"IBM will defend itself vigorously against these claims that have no merit in science," company spokesman Michael Maloney said.
The lawsuit is the first of several planned against IBM by nearly 1,000 people who say they have been harmed by the chemicals, lawyers for the plaintiffs said.
IBM began at Endicott, where it built everything from typewriters to mainframe computers. It sold the plant in 2002.
(Reporting by Dan Wilchins in New York and Philipp Gollner in San Francisco; Editing by Daniel Trotta and Xavier Briand)
http://news.yahoo.com/s/nm/20080103/bs_nm/ibm_lawsuit_dc
1.03.2008
Gardasil Causing Pain and Fainting?
Health officials have touted the Gardasil vaccine as an important new protection against a cancer-causing sexually transmitted virus. In recent months, they've also noted reports of pain and fainting from the shot.
During its first year of use, reports of girls fainting from vaccinations climbed, but it's not clear whether the pain of the cervical cancer vaccine was the reason for the reaction.
Officials at Merck & Co., which makes the vaccine, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.
Meanwhile, U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006.
But it's not clear that Gardasil's sting is related to the fainting increase, said Dr. Barbara Slade, an immunization safety specialist at the U.S. Centers for Disease Control and Prevention.
http://news.yahoo.com/s/ap/20080103/ap_on_he_me/painful_shot
During its first year of use, reports of girls fainting from vaccinations climbed, but it's not clear whether the pain of the cervical cancer vaccine was the reason for the reaction.
Officials at Merck & Co., which makes the vaccine, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.
Meanwhile, U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006.
But it's not clear that Gardasil's sting is related to the fainting increase, said Dr. Barbara Slade, an immunization safety specialist at the U.S. Centers for Disease Control and Prevention.
http://news.yahoo.com/s/ap/20080103/ap_on_he_me/painful_shot
1.02.2008
Researchers work on cocaine vaccine
HOUSTON - Two Baylor College of Medicine researchers in Houston are working on a cocaine vaccine they hope will become the first-ever medication to treat people hooked on the drug. "For people who have a desire to stop using, the vaccine should be very useful," said Dr. Tom Kosten, a psychiatry professor who is being assisted in the research by his wife, Therese, a psychologist and neuroscientist. "At some point, most users will give in to temptation and relapse, but those for whom the vaccine is effective won't get high and will lose interest."
he vaccine, currently in clinical trials, stimulates the immune system to attack the real thing when it's taken.
The immune system — unable to recognize cocaine and other drug molecules because they are so small — can't make antibodies to attack them.
To help the immune system distinguish the drug, Kosten attached inactivated cocaine to the outside of inactivated cholera proteins.
In response, the immune system not only makes antibodies to the combination, which is harmless, but also recognizes the potent naked drug when it's ingested. The antibodies bind to the cocaine and prevent it from reaching the brain, where it normally would generate the highs that are so addictive.
"It's a very clever idea," says David Eagleman, a Baylor neuroscientist. "Scientists have spent the last few decades figuring out reward pathways in the brain and how drugs like cocaine hijack the system. It turns out those pathways are difficult to rewire once they've seen the drug. But the vaccine just circumvents all that."
Kosten asked the Food and Drug Administration in December to green-light a multi-institutional trial to begin in the spring and is awaiting a response.
Approval would mark a breakthrough in the treatment of cocaine addiction, which now mostly involves psychiatric counseling and 12-step programs. It presumably would be the final clinical hurdle before the vaccine — more than a decade in the making — might be approved for treatment. But one expert warns against expecting too much.
"Addiction vaccines are a promising advance, but it's unlikely any treatment in this field will work for everyone," said Dr. David Gorelick, a senior investigator at the National Institute on Drug Abuse. "Still, if they prove successful, they will give those working in drug addiction an important option."
http://news.yahoo.com/s/ap/20080102/ap_on_sc/cocaine_vaccine
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