Showing posts with label risks. Show all posts
Showing posts with label risks. Show all posts

Friday, March 04, 2011

FDA: Risk of oral birth defects in children born to mothers taking topiramate

New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.

Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry2, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

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Saturday, November 20, 2010

Darvon and Darvocet: Risks Outweigh the Benefits





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Monday, August 16, 2010

Independent Toxicologists Issue Warning: We Object to the Claim That Chemical Dispersants Have A Low Potential For Accumulating in Marine Life and Do Not Pose an Environmental Health Concern

/PRNewswire/ -- Attorney Stuart H. Smith, representing the United Commercial Fishermen's Association, the Louisiana Environmental Action Network, public and private entities, and citizens harmed by the BP oil catastrophe, today issued this statement:

"Independent analysis by toxicologists dispute FDA claims made in the last few days that chemical dispersants used by BP during the oil catastrophe may not accumulate in marine animals.

"In fact, in a full report by Dr. Bill Sawyer released today, there is a grave problem caused by dispersants, due to the fact that these were used in deep waters and on such a vast scale.

"Studies of other spills show that the toxic components of crude oil 'bio-accumulate' into the food chain and become highly toxic to marine reproduction, even when dispersants are applied at the surface and the chemical toxins may be sufficiently diluted over time to pose only minimal risks.

"However, BP's use of dispersants deep underwater in the Gulf, and on such a vast scale, represents the first time dispersants have been used in this manner. The greatly-reduced biodegradation in the DEEPWATER HORIZON case, resulting from lack of sunlight, extreme cold temperatures at 5,000 feet, and other environmental factors significantly reduce the rate at which the dispersed crude components are degraded.

"Eight months would be required to remove 96 percent of the petroleum under ideal conditions, thus we can only assume what remains in the Gulf waters will be a 'toxic soup' of chemicals for the foreseeable future, due to the worst-case scenario which has unfolded.

"The most potentially dangerous of the components in the Gulf's toxic soup are 'polynuclear aromatic hydrocarbons' (PAHs), dangerous cancer-causing chemicals which slowly break down after being ingested by marine life, persist in marine organisms and can be passed to both humans and other wildlife through consumption.

"PAHs are not contained within the dispersants used, but rather, have been extracted from the BP crude and suspended in the water column via dispersant use.

"It must also be noted that the deep water National Oceanic and Atmospheric Administration Weatherbird analyses and our own near shore water, tunicate and beach samples have revealed a consistent pattern of dispersant-induced C19-C36 hydrocarbons and PAHs. Unfortunately, these specific PAHs are of the most toxic variety."

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Wednesday, May 26, 2010

Report: 15 National Parks, Other Natural Areas Most at Risk From BP Oil Blowout Identified

/PRNewswire/ -- From Padre Island National Seashore in Texas to the Everglades National Park in Florida, the 15 national parks, wildlife refuges and state parks in Gulf states most threatened by the ongoing BP oil blowout are identified in a new report from the Natural Resources Defense Council (NRDC) and the Rocky Mountain Climate Organization (RMCO).

The new NRDC/RMCO report, "Special Places at Risk in the Gulf: Effects of the BP Oil Catastrophe," lists the following 15 top national and state parks and wildlife areas at risk to contamination because of the BP oil blowout:

1. Aransas National Wildlife Refuge, Texas
2. Bon Secour National Wildlife Refuge, Alabama
3. Breton National Wildlife Refuge, Louisiana
4. Delta National Wildlife Refuge, Louisiana
5. Dry Tortugas National Park, Florida
6. Everglades National Park, Florida
7. Lower Suwanee National Wildlife Refuge, Florida
8. Grand Bay National Wildlife Refuge, Mississippi and Alabama
9. Gulf Islands National Seashore, Mississippi and Florida
10. John Pennekamp Coral Reef State Park, Florida
11. Key West National Wildlife Refuge, Florida
12. Padre Island National Seashore, Texas
13. Pass a Loutre Wildlife Management Area, Louisiana
14. Rockefeller Wildlife Refuge, Louisiana
15. St. Marks National Wildlife Refuge, Florida


Theo Spencer, senior advocate, Climate Center, Natural Resources Defense Council, said: "This could become America's greatest environmental disaster. Oil contamination from the explosion of BP's drilling rig threatens precious natural resources and livelihoods across the Gulf of Mexico and beyond. By highlighting special places that belong to all Americans, this report sheds light on one stark aspect of the BP disaster: our country's dangerous over-dependence on fossil fuels. That dependence threatens part of America's 'Best Idea,' some National Parks and other protected places with unique natural resources in a region of great natural value."

Stephen Saunders, president, Rocky Mountain Climate Organization, said: "The 15 special places highlighted in our report were chosen to include the best examples of the full range of both the protected public areas and the resources within them that are vulnerable to contamination by the BP disaster. Because the potential reach of this catastrophe is so broad, our list certainly cannot include more than a tiny fraction of what is at stake as oil continues to gush into and spread around the Gulf."

Julie Wraithmell, wildlife policy coordinator, Florida Audubon, said: "For Gulf Coast states, our coastal areas are our lifeblood, ecologically and economically. Blindingly white sand beaches where marine turtles and diminutive snowy plovers nest; vast seagrass meadows flush with redfish and trout; mangrove islands blanketed with nesting pelicans; vibrant coral reefs and cool, clear coastal springs; oyster bars and vast marshes, nurseries for the seafood that feeds a nation. These habitats were already under tremendous pressure when the Deepwater Horizon accident brought oil to our shores. It is our job now to do all we can to protect and restore our coastal wealth, and find a way forward with renewable energy policies so that as Americans we can all tell our children, 'Never again,' and know we can keep our promise."

Enid Sisskin, PhD, University of West Florida and board member of several local and regional environmental organizations, including the Gulf Coast Environmental Defense, the Southern Alliance for Clean Energy, and the Florida Conservation Alliance, said: "For years, the fear of the environmental catastrophe such as we are now seeing, has united Floridians in opposition to drilling near our coasts. Now we all realize that there is no place far enough away that we can be certain that the pollution and other environmentally damaging effects of drilling will spare our shores. This disaster will affect our environment and economy for many years to come."

Captain Louis Skrmetta, of Gulfport, Mississippi, a third generation ferry pilot and CEO of Ship Island Excursions, the official passenger ferry service for the National Park Service and Gulf Islands National Seashore in Mississippi, said, "Gulf Islands National Seashore is the Yosemite, Canyonlands, and Grand Teton of the Central Gulf Coast region. These resilient white sand islands have experienced more than a hundred major hurricanes, and each time the eco-system endured. The BP catastrophe is occurring approximately 40 miles south of the Mississippi islands, and for the first time our national seashore and its magnificent natural recourses are truly endangered and could be transformed into a 'dead zone.' We need a miracle."

For the full report, go to www.rockymountainclimate.org on the Web.

METHODOLOGY


The list of 15 sites included in "Special Places at Risk in the Gulf: Effects of the BP Oil Catastrophe" was chosen to include the best examples of the full range of both the protected coastal public areas and the resources within them that are vulnerable to contamination by the BP disaster. Because the potential reach of this catastrophe is so broad, our list certainly cannot include more than a tiny fraction of what is at stake as oil continues to gush into and spread around the Gulf. But by highlighting some of these special places and what they protect, this report may shed some light on the amazing environment of the Gulf of Mexico that now threatened by the BP oil disaster.

This list does not reflect any judgment or opinion on where the oil from the BP oil blowout may go and which areas may be most affected. Instead, the list reflects the judgment of government agencies and scientists that the oil may go anywhere in the Gulf (and potentially even beyond the Gulf, a possibility which we have not addressed in this report.) For example, the National Park Service has identified eight units of the national park system that are potentially vulnerable to the oil. Those eight units encircle the entire Gulf, and include Jean Lafitte National Historical Park and Preserve, in and around New Orleans, Louisiana; Gulf Islands National Seashore, with units in both Mississippi and northwestern Florida; De Soto National Memorial, on the Manatee River at Bradenton, Florida; Big Cypress National Preserve and Everglades, Biscayne, and Dry Tortugas national parks, all in south Florida; and Padre Island National Seashore, on the coast of south Texas.

As this is being written, it still is not clear how much oil has already escaped from the BP blowout, when the gush of oil will be stopped, where the Gulf's currents and winds will take the oil, and what may happen if one or more hurricanes enters the Gulf this year.

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Thursday, May 06, 2010

President's Cancer Panel Report Finds True Burden of Environmentally Induced Cancer Greatly Underestimated

/PRNewswire/ -- Even with the growing body of evidence linking environmental exposures to cancer in recent years, a report released today by the President's Cancer Panel finds that the true burden of environmentally-induced cancer is greatly underestimated. The Panel's report, "Reducing Environmental Cancer Risk: What We Can Do Now," concludes that while environmental exposure is not a new front on the war on cancer, the grievous harm from this group of carcinogens has not been addressed adequately by the National Cancer Program.

"There remains a great deal to be done to identify the many existing but unrecognized environmental carcinogens and eliminate those that are known from our daily lives - our workplaces, schools and homes," said LaSalle D. Leffall, Jr., M.D., chair of the Panel. "The increasing number of known or suspected environmental carcinogens compels us to action, even though we may currently lack irrefutable proof of harm," he added.

Key Findings

With nearly 80,000 chemicals on the market in the US, many of which are used by millions of Americans in their daily lives and are un- or under-studied and largely unregulated, the report finds that exposure to potential environmental carcinogens is widespread. Yet, the public remains unaware of many of these carcinogens as well as their own level of exposure, especially to many common environmental carcinogens such as radon, formaldehyde and benzene.

In addition to environmental carcinogens, the report found that while improved imaging technologies have facilitated great strides in diagnosing and treating diseases, including cancer, some of these technologies also carry risks from increased radiation exposures. Many health care professionals, as well as the public, are unaware of the radiation dose associated with various tests or the total radiation dose and related increased cancer risk individuals may accumulate over a lifetime.

In addition, the report found that health care providers often fail to consider occupational and environmental factors when diagnosing patient illness. Physicians and other medical professionals ask infrequently about patient workplace and home environments when taking a medical history, thereby missing out on information that could be invaluable in discovering underlying causes of disease.

The report also recognizes the United States military as a major source of toxic occupational and environmental exposures that can increase cancer risk. Information is available about some military activities that have directly or indirectly exposed military and civilian personnel to carcinogens and contaminated soil and water in numerous locations in the United States and abroad, such as radiation exposure due to nuclear weapons testing. Nearly 900 Superfund sites are abandoned military facilities or facilities that produced materials and products for, or otherwise supported, military needs. In some cases, these contaminants have spread far beyond their points of origin because they have been transported by wind currents or have leached into drinking water supplies.

The Panel concluded that Federal responses to the plight of affected individuals have been unsatisfactory, and that those affected lack knowledge about the extent of their exposure or potential health problems they may face.

Recommendations

The Panel recommends concrete actions that government; industry; research, health care, and advocacy communities; and individuals can take to reduce cancer risk related to environmental contaminants, excess radiation and other harmful exposures. Key recommendations include -

-- Increase, broaden and improve research regarding environmental
contaminants and human health.
-- Raise consumer awareness of environmental cancer risks and improve
understanding and reporting of known exposures.
-- Increase awareness of environmental cancer risks and effects of
exposure among health care providers.
-- Enhance efforts to eliminate unnecessary radiation-emitting medical
tests, and to ensure that radiation doses are as low as reasonably
achievable without sacrificing quality.
-- Aggressively address the toxic environmental exposures the US military
has caused, and improve response to associated health problems among
both military personnel and civilians.


Additional recommendations that are underscored in the report include those related to the needs for a comprehensive and cohesive policy agenda on the issue, stronger regulation and safer alternatives to many currently used chemicals, among other highlights.

The Panel concluded, "Just as there are many opportunities for harmful environmental exposures, ample opportunities also exist for intervention, change, and prevention to protect the health of current and future generations and reduce the national burden of cancer."

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Wednesday, April 21, 2010

Tuna Surprise: Over One Third of Mercury Exposure From This Fish, New Study Finds

/PRNewswire/ -- A new study ranking exposure risks from methylmercury finds that tuna accounts for over one third of total mercury exposure from seafood consumption in the United States. These key findings were published in a peer-reviewed paper by Dr. Edward Groth III, "Ranking the contributions of commercial fish and shellfish varieties to mercury exposure in the United States: Implications for risk communication," and appearing in the April 2010 issue of Environmental Research.

"Canned tuna is the number one fish product consumed in the U.S. today at just under 3 pounds per capita per year," said Michael Bender, director of the Mercury Policy Project. "Based on these new findings, tuna is also the number one mercury exposure risk."

Tuna contributes 37% of the total mercury in the seafood supply -- almost six times as much as the combined total of the four highest mercury-laden fish: swordfish, shark, king mackerel and Gulf tilefish, according to the study.

"Eating tuna can be a toxic gamble, especially for pregnant women, mothers, babies and children," said Buffy Martin Tarbox, Campaign Coordinator for GotMercury.org, based in Forest Knolls, CA.

Groth's paper explains seafood varieties differ by over 120-fold in average mercury content, so which fish you choose drives your mercury exposure. For anyone who eats fish twice a week or more -- not just mothers-to-be -- choosing low-mercury fish is an important health strategy.

"Unfortunately," Groth notes, "most consumers have no idea which fish are high in mercury and should be avoided, or which are low in mercury and are safe to consume."

Canned "light" tuna, the most popular fish in the American diet, has an above-average mercury level, and some "light" tuna has even higher levels. Canned albacore (white) tuna and tuna steaks have still higher average mercury levels. "Women who are trying to minimize their mercury exposure should avoid all forms of tuna," says Groth.

Dr. Groth's study also found that two-thirds of the seafood supply and nine of the 11 most consumed fish and shellfish are low or very low in mercury. So if consumers know what to pick, they can easily find low-mercury alternatives.

To view an abstract of Dr. Groth's paper and also his chart grouping 51 fish varieties into six categories by mercury content, visit: www.mercurypolicy.org

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Wednesday, April 14, 2010

The Health Risks of Smokeless Tobacco Use Deserve Congressional Attention, Advocates Say

/PRNewswire/ -- Oral Health America (OHA) participated in a congressional hearing today on the use of smokeless tobacco by young people, the effects it has on oral health, and the impact of its use by professional baseball players. The hearing, "Smokeless Tobacco: Impact on the Health of our Nation's Youth and Use in Major League Baseball," was held by Chairman of the House Energy and Commerce Committee Henry Waxman (D-CA) and Health Subcommittee Chairman Frank Pallone, Jr. (D-NJ). Speakers included OHA's former NSTEP® (National Spit Tobacco Education Program) Chairman, Joe Garagiola, and Gruen Von Behrens, an oral cancer survivor and member of the NSTEP speaker's bureau.

"I wish to thank the Committee for bringing this important, but overlooked health issue to the table. Smokeless tobacco is not harmless," Mr. Von Behrens said at the hearing. "It has ruined my life."

Mr. Von Behrens first started using smokeless tobacco at the age of 13 to fit in with his peers. As a high school baseball star at the age of 17, he was diagnosed with cancer and has since undergone 34 surgeries in the past 15 years. He now travels throughout the country and has shared his story with over 2 million young people and collegiate and professional athletes.

OHA established the NSTEP program in 1994 to reduce the use of spit tobacco and help break baseball's association with it. NSTEP reaches up to 325,000 Little League players every year with its relationship with Little League Baseball and Softball and its presence at the Little League World Series each August.

"We applaud the committee's attention to this serious health issue today, and maintain our ongoing commitment to providing educational outreach to young baseball and softball players throughout the country," said Beth Truett, President and CEO, Oral Health America.

Oral Health America's mission is to change lives by connecting communities with resources to increase access to oral health care, education and advocacy for all Americans, especially those most vulnerable. For more information, visit www.oralhealthamerica.org.

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Tuesday, November 17, 2009

Smoking Causes Blindness

/PRNewswire/ -- AMD Alliance International strongly urges all smokers to participate in the Great American Smokeout on November 19 to save their eyes and protect their vision from the debilitating effects of macular degeneration.

Research has demonstrated that age-related macular degeneration (AMD), a progressive disease that causes the loss of central vision, is two to three times as frequent among tobacco smokers, and the risk is dose dependent(1, 2). In other words, the more you smoke, the greater the risk and the faster the progression of the disease. For patients with certain genetic backgrounds, regular heavy smoking can increase the risk of AMD a stunning 144-fold(3).

AMD is the leading cause of blindness among those older than 50.

"We salute the American Cancer Society and its efforts on behalf of the Great American Smokeout," said David Herman, Chairman of the global AMD Alliance International. "And we add vision loss to the list of significant and debilitating health risks that are caused by smoking. If you quit today, you can immediately begin lowering your risk of losing your sight to macular degeneration."

In addition to quitting smoking and maintaining a healthy diet and lifestyle, AMD Alliance International recommends regular visits to the eye doctor to check for onset of macular degeneration.

For more information about how to prevent, treat and manage AMD, please visit AMD Alliance International at www.amdalliance.org.

Notes:

1) Seddon JM et al. A prospective study of cigarette smoking and age-related macular degeneration in women. JAMA 1996 Oct 9 276 1141-1146.

2) Christen WG et al. A prospective study of cigarette smoking and risk of age-related macular degeneration in men. JAMA 1996 Oct 9 276 1147-1151.

3) DeAngelis, Margaret M. et al. Cigarette Smoking, CFH, APOE, ELOVL4, and Risk of Neovascular Age-Related Macular Degeneration. Archives of Ophthalmology January 2007 125 49-54.

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Thursday, November 05, 2009

FDA Warns Consumers on Sexual Enhancement Products

The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.

Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.

Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.

In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

The FDA remains committed to stopping the illegal marketing of unapproved drugs and will continue to protect the public with vigorous law enforcement and criminal prosecution of violators.

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Friday, October 30, 2009

Study Examines Mercury in Vaccines

/PRNewswire/ -- The injectable, multi-dose H1N1 vaccine contains the mercury-based preservative thimerosol to reduce risks of bacterial contamination. The presence of thimerosol has once again raised concerns whether there are risks posed to children when the tiny amount of mercury contained in thimerosol is included in a vaccine. In a recent issue of the Journal of Pediatrics, however, a team of scientists supported by the National Institutes of Health reported findings that should alleviate those concerns. The researchers, led by author Michael E. Pichichero, MD, Director of the Rochester General Research Institute, Rochester General Hospital, Rochester, NY evaluated levels of mercury in the blood of the smallest children -- prematurely born and low birth weight infants after they received a dose of a childhood vaccine containing thimerosol. They found the levels of mercury were exceedingly low.

The issue of administering vaccines containing mercury has been controversial because at very high levels mercury is known to cause organ damage (brain/kidneys). Consequently in 2001, as a precaution, at the prompting of the American Academy of Pediatrics, the Centers for Disease Control, and the Food and Drug Administration, the use of thimerosol in childhood vaccines was reduced or eliminated. However, after examining the evidence the Institute of Medicine issued an opinion that an association between thimerosol exposure and autism was not supported by the evidence. Nevertheless the contention that mercury in vaccines causes autism continues to be debated. The newly released multi-dose, injectable H1N1 Influenza vaccines contain the preservative thimerosol and thimerosol is 50% ethyl mercury, which has sparked a renewed debate on the safety of administering this new influenza vaccine.

The purpose of the study was to find out how much mercury from a vaccine containing thimerosol stays in a child's body," said Dr. Pichichero. "What we found was that blood mercury levels before vaccination were often detectable, even at a level similar to many children after the vaccination. By just breathing the air, mothers were passing to their unborn infants some slight amounts of mercury. The mothers did not eat fish that contains mercury, so in the United States and other countries where fish is consumed by pregnant women the levels of mercury would be presumably even higher. After the babies were given vaccines containing thimerosol, their blood levels of mercury did rise to very low levels and then fell rapidly to baseline levels by day ten after the vaccination."

Since thimerosol has been largely removed from vaccines in the US since 2001, this study of 72 newborn infants was conducted at the Hospital Durand in Buenos Aires, Argentina. In Argentina, like many countries of the world, vaccines are purchased through sources supported by the World Health Organization and the WHO has rejected the notion that thimerosol in vaccines is unsafe. This is the third and final study by Dr. Pichichero and his colleagues that tested mercury levels following the injection of vaccines containing thimerosol. Previous studies were conducted on term newborns, and on 2-and 6-month old infants. In those studies, the researchers also found the mercury levels in the vaccinated children were very low and quickly returned to pre-vaccine levels, usually within three to seven days. In 1999, when the first concerns about thimerosol in vaccines was raised, it was presumed that the ethyl mercury in thimerosol would behave in the same manner as methyl mercury in fish after ingested. The three NIH-supported studies clearly refuted that idea.

Dr. Pichichero and colleagues concluded that with this latest data, it is time to recognize that the risk of exposure to thimerosol in vaccines is minimal to non-existent. "The H1N1 vaccine is safe and should be given to those at risk as recommended by the US Centers for Disease Control," Dr. Pichichero said.

Rochester General Research Institute is part of the Rochester General Health System (RGHS) in Rochester, NY. The Research Institute is focused on clinical and translational research in the areas of infectious diseases and immunology, cardiovascular diseases, cancer, and innovations in
biotechnology. The Rochester General Research Institute has alliances with the Rochester Institute of Technology, the Cleveland Clinic and Roswell Park Cancer Institute.

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California Office of Environmental Health Hazard Assessment Review Verifies Safety of Synthetic Turf

/PRNewswire/ -- Representing the latest convincing data on the safety of synthetic turf, the California Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, released a report last week dated July 2009 which indicated there is a negligible human health risk from inhaling the air above synthetic turf. The OEHHA summary also stated "it is unlikely that the new generation of artificial turf is itself a source of MRSA."

OEHHA searched the available literature related to the safety of new generation artificial turf fields, those which contained crumb rubber infill. They analyzed whether these fields emitted levels of chemicals or particulates into the air that are a health risk when inhaled, and also any potential risk factors for MRSA infection. Based on the data from two 2009 New York studies and a 2006 report of indoor fields, they found that "Both reports concluded that these fields did not constitute a serious public health concern, since cancer or non-cancer health effects were unlikely to result from these low-level exposures." Other key findings included:

-- Analyzing the chemicals detected above the fields in New York, OEHHA
noted that "many of these occurred at similar concentrations in the
air sampled upwind of the fields" - which suggests that the source of
these chemicals was not from the turf fields.


-- Cancer risks are negligible, lower than many common human activities.
OEHHA created a test scenario to determine the exposure and health
risks of an athlete playing on an artificial turf field from age five
until age 55 for nearly 100 chemicals. The results showed an exposure
to five chemicals with a lifetime cancer risk above one in one
million, which is considered a negligible risk. As OEHHA explains
"these estimated risks are low compared to many common human
activities." To give context, their website states that the cancer
risk of breathing California air (in 2000) due to diesel particles was
540 in one million.


-- Synthetic turf is not a source of MRSA. OEHHA stated that "It seems
unlikely that the new generation of artificial turf is itself a source
of MRSA, since MRSA has not been detected in any artificial turf
field." That conclusion is consistent with the findings of the Penn
State January 2009 study conducted on the lifespan of staph on grass
and synthetic turf, which was sponsored by the STC and the
Pennsylvania Turfgrass Council.

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Monday, August 31, 2009

Cell Phones and Health: Is There a Brain Cancer Connection?

TT Note: I remember an uncle of mine suggesting that my brand new cell phone would cause brain cancer. His bold statement was made in 1991. Wonder what the evidence shows now?

/PRNewswire/ -- Are cell phones safe? Mounting concerns about the cancer risks of cell phone radiation, especially for children, will bring experts to Washington for a groundbreaking international conference on September 13-15. The goal of the conference is to propose a U.S. research agenda.

The latest scientific evidence on cell phones and human health and public policy implications will be presented by such respected experts as Dr. Ronald B. Herberman, Director Emeritus, University of Pittsburgh Cancer Institute; Dr. Siegal Sadetzki, Tel Aviv Medical University, Israel's key researcher on cancer and cell phones; Dr. Margaret Offermann, national research deputy at the American Cancer Society; and Professor Frank Barnes, chairman of the 2008 National Academy of Sciences report on research needed on cell phones and other personal wireless devices.

Key members of Congress are expected to attend. Senator Arlen Specter (D-PA) is planning to independently chair a Senate hearing on cell phones and health on Monday, September 14 on Capitol Hill.

Dr. Devra L. Davis, Professor of Public Health at the University of Pittsburgh and primary organizer of the conference, reports: "Deeply troubling findings have been reported outside the U.S., where cell phones have been widely used for longer periods of time. These findings show a doubled risk of brain cancer. Many governments, including France, Finland, China and Russia, even advise that children not use cell phones."

Says co-organizer Dr. Dariusz Leszczynski, Research Professor at the Finnish Radiation and Nuclear Safety Authority, "People want to believe that cell phones are safe, but at this point we cannot make that judgment. Some scientific evidence suggests that cell phones might be harmful. Given the current uncertainty, we have to develop precautionary measures to reduce potential risks while the new research is planned and carried out."

Sponsored by the National Institute of Environmental Health Sciences; University of Pittsburgh; National Research Center for Women & Families; The International Commission for Electromagnetic Safety; The Flow Fund Circle, and the Environmental Health Trust, the conference will be held at the historic Credit Union House, 4th and Maryland Ave. NE, near the U.S. Capitol.

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Wednesday, July 29, 2009

Researchers Skew Data?

TT Note: Some researchers have long been known to use selection bias so their studies will show the results they want. Not all researchers do this. It would be nice if we didn't use our bias history as we make deductions now. Hey, didn't I just do that?

I thought this article was interesting. Perhaps the possibility of an increased breast cancer risk will make some women think twice or three times.....

Study: Turkish Women with Abortions Have Statistically Significant 66% Increase in Breast Cancer Risk / Researchers Likely Underestimated the Risk, Reports Scientist

/Standard Newswire/ -- I guess they didn't get the 'memo' from the U.S. National Cancer Institute (NCI), which declared back in 2003 that the non-existence of the ABC (abortion-breast cancer) link had been 'established'"! - Professor Joel Brind, Breast Cancer Prevention Institute

A retrospective study conducted by Dr. Vahit Ozmen and his colleagues at the Istanbul Medical Faculty and Magee-Women's hospital reported a statistically significant 66% increase in breast cancer risk among women who'd had any abortions.

According to Joel Brind, professor of endocrinology at Baruch College, City University of New York and a director at the Breast Cancer Prevention Institute, Ozmen's team most likely underestimated the breast cancer risk associated with abortion because of a flaw known as "selection bias."

Selection bias would also explain their team's unusual findings - significantly decreased risks for
women who use oral contraceptives (OCs) and hormone replacement therapy (HRT). The World
Health Organization and the NCI acknowledge that use of combined (estrogen + progestin) OCs and combined HRT increase risk.

Selection bias is a flaw in the study because only hospital or clinic patients were selected as study
subjects, and they were therefore not representative of the general population. According to Brind's hypothesis, a disproportionate number of "modern" women were likely represented among the controls, a group more likely to use HRT and OCs, have abortions and visit the hospital often for minor complaints. By contrast, a disproportionate number of "traditional" women were represented among the patients; women less likely to use HRT and OCs, have abortions and visit the hospital (except in cases of serious illness, like breast cancer).

To their credit, Dr. Ozmen et al. did acknowledge the likelihood of selection bias in their study, although they were not specific in attributing any effects on their results to it.

Brind's analysis of Ozmen's research can be read
here:
www.abortionbreastcancer.com/download/
BrindTurkishStudy.pdf (http://rs6.net/tn.jsp?et=1102652862893&s=13633&e=001xxmgfXy49dLCmcC1PHAHANLDqnoIurCPs85rTzPiEBdoGHzu_EyXBIgnNH6qacd9SJ5QxORxBoh97fV4PkI-sbJB_X2k8X7e1s_XwZjyXK4aFgn8S6TxYCLwmx_bhI2ytTImi5kWc-Lp_jZ-Y0-h-PM2aTTHWIqx-W-PgaUWj_Q=)

"Although the NCI, the nation's largest funder of cancer-research, and others have worked feverishly to suppress the ABC link by publishing fraudulent research and even leaning on scientists whose studies have shown risk increases among women who have abortions, honest research occasionally escapes the NCI's purview," declared Karen Malec, president of the Coalition on Abortion/Breast Cancer.

The Coalition on Abortion/Breast Cancer is an international women's organization founded to protect the health and save the lives of women by educating and providing information on abortion as a risk factor for breast cancer.

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Wednesday, January 07, 2009

Credit Analyst Warns of Trap for Credit Card Customers

/PRNewswire/ -- "Many people will have their credit scores lowered this year if they're not watchful, know what to do and take action," said Eddie Johansson, president of Credit Security Group, a leading nationwide credit score analysis and rescoring firm.

Credit scores are used by lenders to determine credit risk. Lower scores result in loss of credit and higher interest rates. Financial analysts predict cuts up to $2 trillion in credit card account lines over the next 18 months.

"This will have very bad consequences for consumers who are not prepared," said Johansson, speaking recently about credit scores at the Texas Bankers Association's Financial Literacy Summit.

Analysts predict many card companies will be canceling unused cards and lowering limits this year. According to Johansson, "This is how the trap will be set: you have a $4,000 balance on a card that the company lowers your limit from $10,000 to $5000. You don't know it, but your credit score has just taken a hit -- and it's only beginning." Johansson says credit companies constantly monitor your credit score, which causes the trap to spring.

"Another company lowers your limit and increases your interest rate, 'due to decreased credit score.' This lowers your credit score further. Another company cancels an unused card. The cycle snowballs with other cards, and then the same ones over again. If you are planning a major credit move -- say, refinancing your house for lower rates, your lower credit score hurts your chances of refinancing and greatly increases the interest rate offered."

Johansson points out that the consumer here has done nothing different, hasn't gone into more debt, hasn't missed any payments. Yet, his rates have gone up and his ability to use credit has been damaged -- while he was unaware. And once ensnared it's difficult to get out. "This is why it's a trap," Johansson said.

"You can prevent this from happening to you," he said, "if you know how."

"The critical piece of this trap is your credit score," said Johansson. "It's what keeps the snowball rolling. Your credit score is also the sole measure used to determine your credit risk and interest rates in the future. You should carefully guard it as it comes under attack this year," he said.

With the amount of credit reduction projected, almost everyone will lose some credit availability, Johansson said. "You can't control credit card companies reducing the amount of credit in the system, but you can make sure it does not hurt your credit score - and this is critical to maintaining your ability to manage your finances in addition to saving you thousands of dollars in fees and interest payments."

Johansson gives specific advice on what to do. The key is in your credit scores -- knowing how the scoring system works and how to avoid hits to your score. In brief, the steps are:

1) Keep your balances low on existing cards.

2) Remember it's the balance/limit ratio that counts -- not the balance amount. If a credit card company lowers your limit, immediately lower your balance if necessary to stay under eight percent. Try to keep all cards under the eight percent guideline.

3) Charge small amounts on your old, unused credit cards. This makes them active which increases the limit portion of your balance/limit ratio.

4) Avoid opening new lines of credit if at all possible. Use new credit sparingly and for your best advantage.

5) Don't price-shop where the seller pulls your credit score. This includes homes and cars among other products and services. If you're not sure, make sure -- tell them not to pull your credit report.

6) Whatever it takes, avoid any negative events on your credit report.

7) Monitor your credit reports; be alert for any changes. Correct inaccurate information in your report, or hire a professional to do so. Besides keeping your score from decreasing, many people increase their scores by correcting their data at the credit bureaus.

More detailed information on these steps and what to do can be found at the Credit Security Group web site, http://www.creditsecuritygroup.com/ .

Johansson said that consumers' lack of knowledge about the credit systems is especially costly to them in these times and there is a great deal of misinformation. "Common sense and credit sense are not the same thing."

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Friday, September 26, 2008

Hopkins Experts: Call for Warning Labels on Energy Drinks about Caffeine

TT Note: This just brings the subject up to the surface. Are energy drinks "spunky" due to the caffeine levels? Thoughts to ponder.

Johns Hopkins scientists who have spent decades researching the effects of caffeine report that a slew of caffeinated energy drinks now on the market should carry prominent labels that note caffeine doses and warn of potential health risks for consumers.

"The caffeine content of energy drinks varies over a 10-fold range, with some containing the equivalent of 14 cans of Coca-Cola, yet the caffeine amounts are often unlabeled and few include warnings about the potential health risks of caffeine intoxication," says Roland Griffiths, Ph.D., one of the authors of the article that appears in the journal Drug and Alcohol Dependence this month.

The market for these drinks stands at an estimated $5.4 billion in the United States and is expanding at a rate of 55 percent annually. Advertising campaigns, which principally target teens and young adults, promote the performance-enhancing and stimulant effects of energy drinks and appear to glorify drug use.

Without adequate, prominent labeling; consumers most likely won't realize whether they are getting a little or a lot of caffeine. "It's like drinking a serving of an alcoholic beverage and not knowing if its beer or scotch," says Griffiths.

Caffeine intoxication, a recognized clinical syndrome included in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization's International Classification of Diseases, is marked by nervousness, anxiety, restlessness, insomnia, gastrointestinal upset, tremors, rapid heartbeats (tachycardia), psychomotor agitation (restlessness and pacing) and in rare cases, death.

Reports to U.S. poison control centers of caffeine abuse showed bad reactions to the energy drinks. In a 2007 survey of 496 college students, 51 percent reported consuming at least one energy drink during the last month. Of these energy drink users, 29 percent reported "weekly jolt and crash episodes," and 19 percent reported heart palpitations from drinking energy drinks. This same survey revealed that 27 percent of the students surveyed said they mixed energy drinks and alcohol at least once in the past month. "Alcohol adds another level of danger," says Griffiths, "because caffeine in high doses can give users a false sense of alertness that provides incentive to drive a car or in other ways put themselves in danger."

A regular 12-ounce cola drink has about 35 milligrams of caffeine, and a 6-ounce cup of brewed coffee has 80 to 150 milligrams of caffeine. Because many energy drinks are marketed as "dietary supplements," the limit that the Food and Drug Administration requires on the caffeine content of soft drinks (71 milligrams per 12-ounce can) does not apply. The caffeine content of energy drinks varies from 50 to more than 500 milligrams.

"It's notable that over-the-counter caffeine-containing products require warning labels, yet energy drinks do not," says Chad Reissig, Ph.D., one of the study's authors.

Griffiths notes that most of the drinks advertise their products as performance enhancers and stimulants - a marketing strategy that may put young people at risk for abusing even stronger stimulants such as the prescription drugs amphetamine and methylphenidate (Ritalin). A 2008 study of 1,253 college students found that energy drink consumption significantly predicted subsequent non-medical prescription stimulant use, raising the concern that energy drinks might serve as "gateway" products to more serious drugs of abuse. Potentially feeding that "transition" market, Griffiths says, are other energy drinks with alluring names such as the powdered energy drink additive "Blow" (which is sold in "vials" and resembles cocaine powder) and the "Cocaine" energy drink. Both of these products use the language of the illegal drug trade.

Griffiths and colleagues are currently collecting case reports of intoxication from energy drinks in children and adolescents. If readers are interested in learning more, go to http://www.bpru.org/energydrinks/ .

Eric C Strain, M.D., from Johns Hopkins also contributed to this study.

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