FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

* Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
* Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
* There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
* Women should monitor their breast implants and contact their doctor if they notice any changes.
* Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.


The FDA published its literature review in a document posted on FDA's website site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses."

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

For more information:

ALCL and Breast Implants

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Breast Implant Consumer Information

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063717.htm

ALCL and Breast Implants Consumer Article

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm

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FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)

/PRNewswire/ -- The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. 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.

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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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Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public

/PRNewswire/ -- Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.

Sarah Janssen, MD, PhD, staff scientist, Natural Resources Defense Council: "Just as you rely on your doctor for medical advice, FDA must rely on the advice of scientific experts. Dozens of independent scientists, including the Director of NIEHS, have recommended avoiding BPA exposure. FDA should heed their guidance and ban BPA in food packaging."

Janet Nudelman, Breast Cancer Fund: "Scientific evidence shows there's no safe level of BPA exposure. The FDA should immediately ban BPA in polycarbonate food containers and require labeling of cans containing BPA."

Urvashi Rangan, PhD, toxicologist with Consumers Union, whose recent study revealing BPA in canned foods was cited by Senators Schumer and Gillibrand: "Consumers can't know how much BPA is in any can of food. The current safety limit for BPA is outdated, using traditional toxicology that doesn't apply to BPA and other endocrine disruptors. BPA has demonstrated adverse effects at very low doses."

"Restrictions on BPA are in place in Connecticut, Minnesota, Chicago, three New York counties, and legislation has been introduced in 21 states," according to Sarah Uhl from Coalition for a Safe and Healthy Connecticut.

Bobbi Chase Wilding of Clean New York is pregnant: "Women of child bearing age and babies are put in danger because this toxic chemical is in products we use. Recent studies find BPA in the bodies of pregnant women and health care providers. FDA must protect us and not delay."

Mike Schade, Center for Health, Environment & Justice. says, "Some local and state governments have banned sales of BPA-contaminated products, and retailers are taking them off their shelves. The FDA needs to act now."

"As we celebrate the Christmas season, we are reminded of Jesus' commitment to those in poverty. We hope that the FDA will take measures to ensure that canned food is BPA-free through the use of safe alternatives in the future," says Chloe Schwabe from the National Council of Churches.

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Study raises concerns about outdoor second-hand smoke

Indoor smoking bans have forced smokers at bars and restaurants onto outdoor patios, but a new University of Georgia study in collaboration with the Centers for Disease Control and Prevention suggests that these outdoor smoking areas might be creating a new health hazard.

The study, thought to be the first to assess levels of a nicotine byproduct known as cotinine in nonsmokers exposed to second-hand smoke outdoors, found levels up to 162 percent greater than in the control group. The results appear in the November issue of the Journal of Occupational and Environmental Hygiene.

“Indoor smoking bans have helped to create more of these outdoor environments where people are exposed to secondhand smoke,” said study co-author Luke Naeher, associate professor in the UGA College of Public Health. “We know from our previous study that there are measurable airborne levels of secondhand smoke in these environments, and we know from this study that we can measure internal exposure.

“Secondhand smoke contains several known carcinogens and the current thinking is that there is no safe level of exposure,” he added. “So the levels that we are seeing are a potential public health issue.”

Athens-Clarke County, Ga., enacted an indoor smoking ban in 2005, providing Naeher and his colleagues and ideal environment for their study. The team recruited 20 non-smoking adults and placed them in one of three environments: outside bars, outside restaurants and, for the control group, outside the UGA main library. Immediately before and after the six-hour study period, the volunteers gave a saliva sample that was tested for levels of cotinine, a byproduct of nicotine and a commonly used marker of tobacco exposure.

The team found an average increase in cotinine of 162 percent for the volunteers stationed at outdoor seating and standing areas at bars, a 102 percent increase for those outside of restaurants and a 16 percent increase for the control group near the library.

Naeher acknowledges that an exposure of six-hours is greater than what an average patron would experience but said that employees can be exposed for even longer periods.

“Anyone who works in that environment—waitresses, waiters or bouncers—may be there for up to six hours or longer,” Naeher said. “Across the country, a large number of people are occupationally exposed to second-hand smoke in this way.”

Studies that measured health outcomes following indoor smoking bans have credited the bans with lowering rates of heart attacks and respiratory illness, but Naeher said that the health impacts of outdoor second-hand smoke are still unknown.

In Naeher’s study, cotinine levels in the volunteers at the bar setting saw their levels increase from an average pre-exposure level of 0.069 ng/ml (nanograms per milliliter) to an average post-exposure level of 0.182 ng/ml. The maximum value observed, however, was 0.959 ng/ml. To put that number into context, a widely cited study has determined that an average cotinine level of 0.4 ng/ml increases lung cancer deaths by 1 for every 1,000 people and increases heart disease deaths by 1 for every 100 people.

Still, the researchers caution that it’s too early to draw policy conclusions from their findings. Cotinine is a marker of exposure to tobacco, Naeher said, but is not a carcinogen. The team is currently planning a study that would measure levels of a molecule known as NNAL, which is a marker of tobacco exposure and a known carcinogen, in people exposed to second-hand smoke outdoors.

“Our study suggests that there is reason to be concerned about second-hand smoke levels outdoors,” said study co-author Gideon St. Helen, who is pursuing his Ph.D. through the university’s Interdisciplinary Toxicology Program, “and our findings are an incentive for us to do further studies to see what the effects of those levels are.”

The study was funded by the Northeast (Georgia) Health District, the Athens (Georgia) Community Wellness Council and the Athens Tobacco Prevention Coalition.

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FDA Statement on Vibrio Vulnificus in Raw Oysters

/PRNewswire/ -- Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months. The intent of this change in policy, which would affect about 25% of the total annual harvest, would be to substantially reduce the number of Americans who suffer severe and painful illness and death from the Vibrio vulnificus bacteria. The FDA's announced change in policy was modeled on a successful California initiative that was implemented in 2003.

As a public health agency, the FDA is committed to identifying reasonable and workable approaches to reduce unnecessary suffering and death from preventable causes. The FDA staff work every day with state and local counterparts around the country to stop outbreaks of all types of infectious disease. Illnesses from bacteria like Vibrio vulnificus are particularly important to prevent because they can cause loss of skin, kidney failure, amputations, excruciating pain, and death.

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011. These are legitimate concerns.

It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal. Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.

While this study is ongoing, the FDA will continue to reach out to state authorities and the Gulf Coast industry to discuss their concerns about the agency's policy and measures the industry is pursuing to make oysters safer. The FDA is committed to assisting local farmers in the implementation of post-harvest processing through all possible means.

The agency looks forward to working with Gulf Coast officials and industry to accomplish the goal of protecting consumers from Vibrio vulnificus in a manner that is feasible and minimizes impacts on the oyster industry.

Some actions that the FDA will undertake over the next weeks and months include:

#1. Continuing to discuss future collaboration with the Interstate Shellfish Sanitation Conference to address Vibrio vulnificus in the region, including discussing the scope of needed studies, and meeting with the Board in March 2010.

#2. Working in conjunction with the National Marine Fisheries Service, the FDA will offer technical assistance to facilitate implementation of post-harvest processing or equally effective alternatives, including:

1. Validation of processing parameters that can be applied to post-harvest
processes to achieve non-detectable levels of Vibrio vulnificus, while
also preserving acceptable taste and texture, and ensuring that this
information is in the public domain so that all processors can use it.
2. Studying alternatives to post-harvest processing, including off-shore
relaying in which oysters are harvested and moved to salty waters where
the high salinity kills Vibrio vulnificus.
3. Providing technical assistance to firms in development of their
post-harvest processing processes and HACCP plans.


#3. The FDA will work with other federal agencies, such as the USDA and the National Oceanic and Atmospheric Administration in the Department of Commerce to review what types of grants and other forms of economic assistance may be available to support establishment of processing cooperatives or other mechanisms to ensure widespread access to post-harvest processing facilities.

#4. As USTR and the oyster industry work to foster wider access to international markets that are now closed because of concerns about Vibrio vulnificus, FDA's new approach should provide public health and science data to support the safety of these products for human consumption in the U.S. and abroad.

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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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Cap and Trade Legislation Would Increase Uninsured by Millions

/PRNewswire/ -- The U.S. Senate can increase the number of Americans with health insurance by tens of millions -- at zero cost to taxpayers -- by rejecting cap-and-trade legislation passed by the U.S. House, according to an analysis just released by The National Center for Public Policy Research.

In June, the House of Representatives approved the American Clean Energy and Security Act, commonly referred to as the Waxman-Markey bill, which seeks to reduce U.S. greenhouse gas emissions by more than 80 percent by 2050.

The National Center for Public Policy Research contends Waxman-Markey would increase energy prices, slow the economy and result in higher unemployment. This, in turn, the group says, would increase the number of uninsured.

"For every one percentage point increase in unemployment, 1.1 million Americans lose their health insurance coverage," said David A. Ridenour, Vice President of The National Center for Public Policy Research. "With the Waxman-Markey legislation projected to cost an average of 1.15 million jobs annually between 2012 and 2030, this could translate into tens of millions of Americans losing their health insurance coverage. The best health care reform is doing nothing at all - at least on cap-and-trade."

Loss of health insurance coverage is only one of the negative health consequences that would result from a Waxman-Markey-style bill, according to Ridenour.

"The stress and loss of self-esteem that accompanies job loss can lead to unhealthy lifestyles, including substance abuse and poor eating habits," said Ridenour. "The unemployed are more likely to be diagnosed for hypertension, heart disease, diabetes and stroke, and because discretionary income drops with the loss of a job, so too do routine screenings that might prevent late-stage diseases."

Ridenour cites a study by Kate Strully of the State University of New York at Albany showing that involuntarily unemployed factory workers are 83 percent more likely to develop a new health problem than those who keep their job.

Ridenour's analysis is available at http://www.nationalcenter.org/NPA577.html.

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Misleading the Public on Health Care with Spoken Words

TT Note: Perhaps the public and Congress should read the bill. Then, we would know when someone is trying to mislead us with eloquent words. Listening to the words last night makes one wonder what bill has he seen? Certainly, it's one that no one else has!

President Obama Misleads Public on Health Care for Illegal Aliens; Illegal Aliens Would Benefit Under H.R. 3200

/PRNewswire/ -- "The reforms I'm proposing would not apply to those who are here illegally," President Obama said in a carefully worded statement to a Joint Session of Congress and the American public last night. The problem, notes the Federation for American Immigration Reform (FAIR), is that the health care reforms proposed in H.R. 3200, America's Affordable Health Care Act of 2009, clearly would benefit illegal aliens.

"Perhaps the reforms that President Obama advocates would not cover illegal aliens, but those are not the reforms currently under consideration by Congress," commented Dan Stein, president of FAIR. "H.R. 3200, the legislation that the House will be voting on, would allow illegal aliens to benefit from the government-financed public option, and includes no verification provisions to prevent illegal aliens from receiving taxpayer subsidies to purchase private health insurance."

President Obama's assertion that illegal alien would not be covered under AAHCA is directly contradicted by an August 25 report, Treatment of Noncitizens in H.R. 3200, issued by the Congressional Research Service. The nonpartisan research arm of Congress concluded, "H.R. 3200 does not contain any restrictions on noncitizens - whether legally or illegal present, or in the United States temporarily or permanently - participating in the [Health Insurance] Exchange."

Once in the Exchange, participants are free to enroll in the government run health insurance program. This public option, established under H.R. 3200, would be heavily or entirely subsidized by the American taxpayers. While illegal aliens are barred from receiving "affordability credits" to help pay for private insurance, CRS noted the absence of any mechanism in the bill to verify citizenship or legal residency.

"There is no reason why the controversy over whether illegal aliens will be eligible for massive health care subsidies should persist," said Stein. "The president, congressional leaders, and the public all agree they should not. The authors of H.R. 3200 can easily remove the ambiguities from the House bill, and Senate leaders can include specific language barring illegal aliens from all nonemergency benefits in the bill that is being written in that chamber.

"President Obama himself can also play an important role in seeing to it that his wishes are carried out by publicly urging leaders of both houses to include clear, unambiguous language in their legislation that would preclude illegal aliens from coverage under his health care reform proposal," Stein continued. "FAIR stands ready to work with the White House and congressional leaders to develop legislative language that would make sure that President Obama's pledge to the American people is fulfilled."

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American Life League: Bishops Must Choose Between Christ-Centered Care and Obamacare

/PRNewswire/ -- As Obama prepares to address the nation Wednesday on his health care plan, American Life League challenged the nation's Catholic bishops to be prepared to shut down Catholic health care and make it clear that they prefer this action to compromising with the intrinsic evils currently contained in various Obamacare proposals.

"Obama speaks tonight. Christ speaks always. When it comes to health care reform which road will our Catholic bishops take?" the group asked in a Washington Times ad.

The ad highlighted six principled positions Catholic-supported health care must include: opposition to abortion, contraception, sterilization, human embryonic stem cell therapy, euthanasia and assisted suicide.

Judie Brown, president of American Life League, the country's largest grassroots Catholic pro-life organization, said the ad addressed a critical question from the nation's lay Catholic faithful: Why are the bishops largely remaining silent in opposition to the deadly provisions contained in Obamacare proposals?

"The president has laid before us a government mandate to subsidize a culture of death and impose it on Catholic health care," Brown said. "We desperately need our bishops to lead the fight against this plan so diametrically opposed to the Faith - yet their silence speaks their approval."

The ad quotes Joseph Cardinal Ratzinger (now Pope Benedict XVI) who in 1997 said:

"The words of the Bible and of the Church fathers rang in my ears, those sharp condemnations of shepherds who are like mute dogs; in order to avoid conflicts, they let the poison spread. Peace is not the first civic duty, and a bishop whose only concern is not to have any problems and to gloss over as many conflicts as possible is an image I find repulsive."

"For the American bishops, the choice is simple," Brown said. "Embrace Obamacare and sell the soul of the Church to government bureaucrats and politicians or embrace the Faith and be prepared to shut down Catholic health care rather than participate in intrinsic evil. We ask the bishops to unite behind Christ and His teachings now while there is still time to have a positive effect on the road ahead."

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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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Coca-Cola Sued Over Deceptive VitaminWater Claims

/PRNewswire/ -- A class action lawsuit was filed late yesterday in the United States District Court for the Northern District of California against the Coca-Cola Company alleging that Coca-Cola has used deceptive advertising in marketing its VitaminWater line of beverages. The plaintiff is represented by Whatley Drake & Kallas, LLC ("WDK"), Reese Richman LLP, and the Center for Science in the Public Interest (CSPI).

The complaint alleges that Coca-Cola deceived consumers by marketing VitaminWater as a healthy alternative to soft drinks formulated to provide a host of health benefits including reducing the risk of certain diseases, promoting healthy joints, and supporting optimal immune function. Contrary to Coca-Cola's claims of health benefits, the complaint alleges that the 33 grams of sugar in each bottle of VitaminWater may contribute to serious health problems, such as obesity and diabetes.

"Consumers are increasingly health-conscious, with more and more people avoiding soft drinks in favor of healthier alternatives," said WDK attorney Patrick Sheehan. "Coca-Cola has taken advantage of that trend -- and of consumers -- by purposefully misrepresenting their product as 'healthy' when in fact it is essentially sugar water with a few added vitamins. Consumers should not have to look beyond the misleading claims on VitaminWater labels in order to discover the truth on an ingredients list."

VitaminWater does not name Coca-Cola anywhere on its packaging or labeling, instead marketing these purportedly healthy drinks without any reference to the soft drink manufacturer that produces them.

"It's clear that Coca-Cola has attempted to market an alternative to its soda products in a way that deliberately deceives consumers," continued Sheehan. "Whatley Drake & Kallas is proud to be playing a role in protecting those consumers through this class action suit filed on their behalf."

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Obesity Comes With a Price Tag

(BUSINESS WIRE)--There are hard dollars-and-cents costs to being overweight or obese, according to Humana (NYSE: HUM), one of the nation’s largest health benefits companies.

Specifically, Humana estimates these costs at the following for 2009:

* $19.39 in added health care costs for every overweight pound;
* $1,037.64 for every overweight individual;
* $127 billion added to the national health care bill.

Overweight people are more prone to heart disease, stroke, diabetes — even some kinds of cancers. Chronic diseases that are a result of weighing too much are an ever-increasing part of America’s health care bill.

Carol McCall — a research actuary at Humana — culled through national health care data and the data from Humana’s members, and here is what she found.

Like butter and sugar, obesity has a cost per pound

On average, the annual per-pound cost of being overweight — that is, the added cost per added pound of the overweight and the obese — is $19.39. The cost increases with age.

For 25-year-olds, it averages $10.25 for every overweight pound. By age 64, it increases to $26.32. (On average, overweight people are 29 pounds overweight; the obese are 82 pounds overweight.)

For someone age 25, the added annual health care cost is $209 for the overweight and $960 for the obese. By age 64, this grows to $610 extra for the overweight and $2,300 for the obese.

Why this impacts the national healthcare crisis

There are more than 122 million overweight and obese Americans between the ages of 20 and 65. On average, their additional health care costs are $534 per year for an overweight person and $1,614 for an obese person. Those costs add up to a $127 billion crisis. The increase in obesity prevalence – going from 23 percent to 33 percent between 1994 and 2004 – added $34 billion to the annual health care bill.

A person who is 25 and obese today, and remains obese until they’re 65, will average $179,000 more in health care costs (in 2009 dollars, assuming health care inflation of 4 percent a year) over those 40 years.

A new way to look at and to count calories

Maintaining all of those extra pounds requires Americans to take in 23 trillion calories a year. That’s the equivalent of 46 billion Big Macs, 114 billion Krispy Kreme donuts or 152 billion bags of chips.

These calories have the same energy as the following:

* 10 1,000-megawatt power stations generating for a year
* 788 million gallons of gasoline
* 10 million tons of coal
* 96 trillion AA alkaline batteries

There is a way to get out of this national problem

The good news is that Humana’s data also indicates that just a small change – a reduction of 276 calories a day for the overweight – makes a big difference. Cutting that little from each day’s intake would start moving millions of Americans from the category of overweight to healthy. That means people don’t have to re-engineer their lives to get on a healthier path. Incremental change — giving up one soft drink and walking an extra 2,500 steps each day, for example — will do the job.

“If obesity were eliminated, or even significantly reduced,” says McCall, “the money saved would be significant. It could pay for food for the poor, health insurance for the uninsured or millions of college educations every year.”

Dr. Jonathan Lord, Humana’s Chief Innovation Officer — who oversees Humana’s efforts to reduce health care costs by engaging people in healthy behaviors — put it this way: “In this time of financial crisis, it’s now clear that Americans can improve the economy as well as their own health prospects by giving up a few pounds.”

“Riding a bike and taking a walk in the park burn calories,” Dr. Lord says, “but those activities are also fun. Life is so hectic and we are so dependent on cars that many of us have forgotten that.”

Humana’s Innovation Center is full of teams trying to find new ways to engage people in their health. The company believes that the key to success is to meet people where they are: at school, playing video games, on cell phones, walking or riding bikes in the park.

Humana, for example, created the Freewheelin bike-sharing program, which debuted at the Democratic and Republican national conventions last summer. In less than two weeks, 7,523 rides were taken, 42,000 miles were ridden, 1.3 million calories were burned – and participants who hadn’t been on a bike in years raved about the experience. Now, Humana is partnering in B-cycle, a new company it created to sell bike-sharing programs to cities and universities.

Humana also is partnering in Sensei, a cell phone application to support people in making better nutritional choices and in physical activity. And the company has also pioneered several very successful pedometer programs in England and in this country.

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Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies

Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies; More Than Half of States Score 7 or Lower Out of 10 in Readiness Rankings

/PRNewswire-USNewswire/ -- Trust for America's Health (TFAH) and the Robert Wood Johnson Foundation (RWJF) today released the sixth annual Ready or Not? Protecting the Public's Health from Diseases, Disasters, and Bioterrorism report, which finds that progress made to better protect the country from disease outbreaks, natural disasters, and bioterrorism is now at risk, due to budget cuts and the economic crisis. In addition, the report concludes that major gaps remain in many critical areas of preparedness, including surge capacity, rapid disease detection, and food safety.

The report contains state-by-state health preparedness scores based on 10 key indicators to assess health emergency preparedness capabilities. More than half of states and D.C. achieved a score of seven or less out of 10 key indicators. Louisiana, New Hampshire, North Carolina, Virginia, and Wisconsin scored the highest with 10 out of 10. Arizona, Connecticut, Florida, Maryland, Montana, and Nebraska tied for the lowest score with five out of 10.

Over the past six years, the Ready or Not? report has documented steady progress toward improved public health preparedness. This year however, TFAH found that cuts in federal funding for state and local preparedness since 2005, coupled with the cuts states are making to their budgets in response to the economic crisis, put that progress at risk.

"The economic crisis could result in a serious rollback of the progress we've made since September 11, 2001 and Hurricane Katrina to better prepare the nation for emergencies," said Jeff Levi, PhD, Executive Director of TFAH. "The 25 percent cut in federal support to protect Americans from diseases, disasters, and bioterrorism is already hurting state response capabilities. The cuts to state budgets in the next few years could lead to a disaster for the nation's disaster preparedness."

Some serious 2008 health emergencies include a Salmonella outbreak in jalapeno and Serrano peppers that sickened 1,442 people in 43 states, the largest beef recall in history in February, Hurricanes Gustav and Ike, severe flooding in the Midwest, major wildfires in California in June and November, and a ricin scare in Las Vegas.

Among the key findings:

Budget Cuts: Federal funding for state and local preparedness has been cut more than 25 percent from fiscal year (FY) 2005, and states are no longer receiving any supplemental funding for pandemic flu preparedness, despite increased responsibilities.

-- In addition to the federal decreases, 11 states and D.C. cut their
public health budgets in the past year. In the coming year, according
to the Center on Budget and Policy and Priorities, 33 states are
facing shortfalls in their 2009 budgets and 16 states are already
projecting shortfalls to their 2010 budgets.

Rapid Disease Detection: Since September 11, 2001, the country has made significant progress in improving disease detection capabilities, but major gaps still remain.

-- Only six states do not have a disease surveillance system compatible
with the U.S. Centers for Disease Control and Prevention's (CDC)
National Electronic Disease Surveillance System.
-- Twenty-four states and D.C. lack the capacity to deliver and receive
lab specimens, such as suspected bioterror agents or new disease
outbreak samples, on a 24/7 basis.
-- Only three state public health laboratories are not able to meet the
expectations of their state's pandemic flu plans.

Food Safety: America's food safety system has not been fundamentally modernized in more than 100 years.

-- Twenty states and D.C. did not meet or exceed the national average
rate for being able to identify the pathogens responsible for food
borne disease outbreaks in their states.

Surge Capacity: Many states do not have mechanisms in place to support and protect the community assistance that is often required during a major emergency.

-- Twenty-six states do not have laws that reduce or limit liability for
businesses and non-profit organizations that help during a public
health emergency.
-- Only eight states do not have laws that limit or reduce liability
exposure for health care workers who volunteer during a public health
emergency.
-- Seventeen states do not have State Medical Reserve Corps Coordinators.

Vaccine and Medication Supplies and Distribution: Ensuring the public can quickly and safely receive medications during a major health emergency is one of the most serious challenges facing public health officials.

-- Sixteen states have purchased less than half of their share of
federally-subsidized antivirals to use during a pandemic flu outbreak.
-- Every state now has an adequate plan for distributing emergency
vaccines, antidotes, and medical supplies from the Strategic National
Stockpile, according to the CDC. In 2005, only seven states had
adequate plans. The CDC changed to a different grading system in
2007. However, questions still remain about the contents of the
federal stockpile.

"States are being asked to do more with less, jeopardizing our safety, security, and health," said Risa Lavizzo-Mourey, M.D., M.B.A., president and CEO of the Robert Wood Johnson Foundation. "We all have a stake in strengthening America's public health system, because it is our first line of defense against health emergencies."

The report also offers a series of recommendations for improving preparedness, including:

-- Restoring Full Funding. At a minimum, federal, state, and local
funding for public health emergency preparedness capabilities should
be restored to FY 2005 levels.
-- Strengthening Leadership and Accountability. The next administration
must clarify the public health emergency preparedness roles and
responsibilities at the U.S. Department of Health and Human Services
and U.S. Department of Homeland Security.
-- Enhancing Surge Capacity and the Public Health Workforce. Federal,
state, and local governments and health care providers must better
address altered standards of care, alternative care sites, legal
concerns to protect community assistance, and surge workforce issues.
-- Modernizing Technology and Equipment. Communications and surveillance
systems and laboratories need increased resources for modernization.
-- Improving Community Engagement. Additional measures must be taken to
engage communities in emergency planning and to improve protections
for at-risk communities.
-- Incorporating Preparedness into Health Care Reform and Creating an
Emergency Health Benefit. This is needed to contain the spread of
disease by providing care to the uninsured and underinsured Americans
during major disasters and disease outbreaks.

Score Summary:

For the state-by-state scoring, states received one point for achieving an indicator or zero points if they did not achieve the indicator. Zero is the lowest possible overall score, 10 is the highest. The data for the indicators are from publicly available sources or were provided from public officials. More information on each indicator is available in the full report on TFAH's Web site at www.healthyamericans.org and RWJF's Web site at www.rwjf.org. The report was supported by a grant from RWJF.

10 out of 10: Louisiana, New Hampshire, North Carolina, Virginia, Wisconsin

9 out of 10: Alabama, Indiana, Michigan, Pennsylvania, South Carolina, Tennessee, Vermont,

8 out of 10: Arkansas, Delaware, Georgia, Hawaii, Iowa, Minnesota, North Dakota, Ohio, South Dakota, Washington

7 out of 10: California, Colorado, D.C., Illinois, Kentucky, Missouri, New Jersey, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Utah, West Virginia, Wyoming

6 out of 10: Alaska, Idaho, Kansas, Maine, Massachusetts, Mississippi, Nevada, Texas

5 out of 10: Arizona, Connecticut, Florida, Maryland, Nebraska, Montana

A five minute video about the report is available at: http://healthyamericans.org/reports/bioterror08/video/

Trust for America's Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. www.healthyamericans.org

The Robert Wood Johnson Foundation focuses on the pressing health and health care issues facing our country. As the nation's largest philanthropy devoted exclusively to improving the health and health care of all Americans, the Foundation works with a diverse group of organizations and individuals to identify solutions and achieve comprehensive, meaningful and timely change. For more than 35 years the Foundation has brought experience, commitment, and a rigorous, balanced approach to the problems that affect the health and health care of those it serves. Helping Americans lead healthier lives and get the care they need -- the Foundation expects to make a difference in our lifetime. For more information, visit www.rwjf.org.

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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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Oh crud, now they're going after caffeine...

Toxic Note: I hate posting this one. However, I am now heading off to search for some way to increase my serotonin (aside from exercising) so I can keep imbibing my caffeine. At least I now have an excuse for gaining weight. It's not 'cause I sit in front of the computer for most of the day, it's because I'm chugging caffeine while I'm sitting. I am a very happy person, not depressed in the least. Therefore, I declare the following partially bunk. Caffeine as an excuse for weight gain I can live with...

Caffeine Plays Critical Role in Obesity and Depression, Says Researcher Phoenix Gilman

ATLANTA, Dec. 20 /PRNewswire/ -- The #1 most socially accepted, legalized drug is caffeine. Both young and old consume it daily - and at an alarming rate - be it in their lattes, energy drinks, ice teas, sodas, etc. Yet caffeine is highly addictive and it drastically depletes serotonin, a major neurotransmitter that governs critical aspects of the brain's ability to function properly.
Obesity is a frightening epidemic. Antidepressants are the most prescribed pharmaceutical drug. As such, researcher and international author Phoenix Gilman is urgently trying to inform others, through her book and interviews nationwide, that caffeine is contributing significantly to our health crisis.

Gilman says, "Caffeine, along with many other things, depletes serotonin. Side effects of low serotonin are numerous, ranging from carbohydrate cravings, binge eating, obesity, to anxiety, ADD, depression, alcoholism and suicidal behavior - not forgetting, insomnia, PMS, migraines, increased risks for type 2 diabetes, high blood pressure, heart disease and certain cancers. Shockingly, no one in the media is talking about this clinically proven research, research that has the potential to help millions live healthier. And though I'm thrilled to hear CA is considering labeling caffeine as a toxic substance, the awareness needs to go far beyond that."

About the author: Entrepreneur Phoenix Gilman is an internationally respected author and weight loss/wellness expert with 30 years of experience, from personal trainer and sports nutritionist, to researcher, product developer, consumer activist and speaker. Fed up with the misinformation and marketing scams running rampant within the diet, food and pharmaceutical industries, she vowed to make a difference. Her book, "DIET FAILURE ... THE NAKED TRUTH: The Brain Chemistry Key to Losing Weight and Achieving Extraordinary Health" is the result.

Her research has been recognized by many, including the Centers for Disease Control, Forbes.com, Focus Atlanta (CW television network), Citizens Commission on Human Rights and best-selling authors Michael Murray, ND, co- author of the Encyclopedia of Natural Medicine, and Diana Schwarzbein, MD, author of The Schwarzbein Principle. Phoenix has done over 200 interviews nationwide, from radio, print, to TV.