Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

Child support claim rankles sperm donor to lesbian couple






KANSAS CITY, Kansas (Reuters) – A Kansas man who donated sperm to a lesbian couple so they could have a child said on Wednesday he is shocked the state is now trying to make him pay child support.


William Marotta, 46, donated sperm to Jennifer Schreiner and Angela Bauer under a written agreement that he would not be considered the father of the child nor liable for child support. A daughter, now 3, was born to Schreiner.






But in October, the state of Kansas filed a petition seeking to have Marotta declared the father of the child and financially responsible for her after the couple encountered money difficulties.


Marotta will ask the court in a hearing January 8 to dismiss the claim, which centers on a state law that the sperm must be donated through a licensed physician in order for the father to be free of any later financial obligations. Marotta gave a container of semen to the couple, who found him on Craigslist, instead of donating through a doctor or clinic.


The case is seen as having repercussions for other sperm donors. Sperm banks routinely provide sperm to people who want to conceive a child on the understanding that the donors are not responsible for the children.


Kansas is seeking child support from Marotta, including about $ 6,000 in medical expenses related to the child’s birth, according to its petition.


“This was totally unexpected,” Marotta said in a phone interview. “The very first thing that went through my mind was that no good deed goes unpunished.”


The case has attracted national attention. Shannon Minter, legal director for the National Center for Lesbian Rights, said Wednesday “it is unfortunate and unfair” that Kansas is seeking money from a sperm donor.


“It certainly might have a negative effect on other men’s willingness to help couples who need a donor, which would be harmful to everyone,” Minter said.


“I also think it undermines everyone’s respect for the law when you see it operate so arbitrarily.”


Kansas officials are required under the law to determine the father of a child when someone seeks state benefits, said Angela de Rocha, spokeswoman for the Department for Children and Families. The couple was compelled to provide that information, which led to investigation of the sperm donation.


Marotta should be declared the father and subject to financial claims because he donated the sperm directly to the women and not through a physician, as required by Kansas law, the state’s petition states.


Marotta said he’s had virtually no contact with the child, but that he and Schreiner have remained cordial. He said she was pressured by the state to provide his name as the sperm donor.


“To me, ethics need to override rules,” he said.


Lawyers for Marotta argue that he had no parental rights because of his agreement with the couple and cannot be held financially responsible.


They cite a 2007 case in which the Kansas Supreme Court ruled against a sperm donor seeking parental rights because he did not have any such agreement with the mother, lawyers for Marotta said.


“So now, we are flipping the argument around,” Marotta attorney Ben Swinnen said Wednesday.


If the father had no legal parental rights in the 2007 case, Marotta should be declared to have no parental obligations in the current case, Swinnen said.


Marotta, a race car mechanic, responded to an ad on Craigslist from someone offering to pay $ 50 for sperm donations, but he made the donation for free. Marotta said he and his wife have no children of their own but have fostered a daughter. Marotta said he was simply trying to help a couple wanting a child.


(Editing by James B. Kelleher and Lisa Shumaker)


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Senate’s “fiscal cliff” bill packed with sweeteners






WASHINGTON (Reuters) – The Senate packed an eclectic mix of handouts and takebacks into its last-minute deal to avoid the “fiscal cliff,” including a measure to repeal part of President Barack Obama‘s signature healthcare overhaul and a string of special interest tax breaks.


At the center of the 157-page bill adopted early Tuesday are provisions to raise taxes on the wealthiest households and to make permanent Bush-era tax cuts for the middle class. The bill now goes to the Republican-controlled House of Representatives.






But senators also extended higher rum excise taxes to Puerto Rico and the U.S. Virgin Islands and provided tax breaks to a wide range of other groups and interests, including motorsports entertainment complexes and mine rescue teams.


Among the other sweeteners:


* special expensing rules for certain film and TV productions


* tax-exempt financing for New York Liberty Zone, an area around the site of the World Trade Center.


* extension of American Samoa economic development credit


Congressional lawmakers often insert pet projects and other unrelated provisions into major “must do” bills in the last days of a legislative session, when it is more likely that quick passage will occur.


Green energy was another big winner in the bill. Roughly a dozen provisions would extend credits and incentives for plug-in electric vehicles, energy-efficient appliances, biodiesel and renewable diesel, and other alternative energy initiatives.


The legislation also would kill the part of Obama’s 2010 Affordable Care Act designed to let millions of elderly and disabled people get help at home rather than be placed in institutional care, which tends to be more expensive.


Democrats acknowledge that the insurance initiative known as the Community Living Assistance Services and Support program, or CLASS, is financially flawed but they had argued it should be fixed rather than ended.


The House voted to repeal that provision 11 months ago.


Also tucked in the bill, known as the American Taxpayer Relief Act of 2012, are measures to avert the so-called “dairy cliff” – a steep increase in milk prices that would otherwise take place this year.


The measures would extend farm subsidy programs and prevent dairy subsidies from reverting to 1949 levels, which would have meant retail milk prices could have doubled to about $ 7 per gallon.


One thing lawmakers did not slide into the legislation: a raise for themselves. The Senate bill says members of Congress will get no cost-of-living adjustment in their pay for fiscal year 2013.


(Reporting by Jim Wolf; Editing by Karey Wutkowski and Paul Simao)


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Texas judge OKs ban on Planned Parenthood funding






AUSTIN, Texas (AP) — Texas can cut off funding to Planned Parenthood‘s family planning programs for poor women, a state judge ruled Monday, requiring thousands to find new state-approved doctors for their annual exams, cancer screenings and birth control.


Judge Gary Harger said that Texas may exclude otherwise qualified doctors and clinics from receiving state funding if they advocate for abortion rights.






Texas has long banned the use of state funds for abortion, but had continued to reimburse Planned Parenthood clinics for providing basic health care to poor women through the state’s Women’s Health Program. The program provides preventive care to 110,000 poor women a year, and Planned Parenthood clinics were treating 48,000 of them.


Planned Parenthood’s lawsuit to stop the rule will still go forward, but the judge decided Monday that the ban may go into effect for now. In seeking a temporary restraining order, Planned Parenthood wanted its patients to be able to see their current doctors until a final decision was made.


“We are pleased the court rejected Planned Parenthood’s latest attempt to skirt state law,” attorney general spokeswoman Lauren Bean said. “The Texas Attorney General’s office will continue to defend the Texas Legislature‘s decision to prohibit abortion providers and their affiliates from receiving taxpayer dollars through the Women’s Health Program.”


Ken Lambrecht, president and CEO of Planned Parenthood of Greater Texas, said he brought the lawsuit on behalf of poor women who depend on its clinics.


“It is shocking that once again Texas officials are letting politics jeopardize health care access for women,” Lambrecht said. “Our doors remain open today and always to Texas women in need. We only wish Texas politicians shared this commitment to Texas women, their health, and their well-being.”


Planned Parenthood has brought three lawsuits over Texas’ so-called “affiliate rule,” claiming it violates the constitutional rights of doctors and patients while also contradicting existing state law.


Republican lawmakers who passed the affiliate rule last year have argued that Texas is an anti-abortion state, and therefore should cut off funds to groups that support abortion rights. Gov. Rick Perry, who vehemently opposes abortion, has pledged to do everything legally possible to shut down Planned Parenthood in Texas and welcomed the court’s ruling.


“Today’s ruling finally clears the way for thousands of low-income Texas women to access much-needed care, while at the same time respecting the values and laws of our state,” Perry said. “I applaud all those who stand ready to help these women live healthy lives without sending taxpayer money to abortion providers and their affiliates.”


The Texas Health and Human Services Commission has spent the last nine months preparing to implement the affiliate rule. But federal officials warned it violated the Social Security Act and cut off federal funds for the Women’s Health Program, prompting the commission to start a new program using only state money.


State officials have also scrambled to sign up new doctors and clinics to replace Planned Parenthood. Women who previously went to Planned Parenthood clinics will now have to use the agency’s web site to find a new state-approved doctor. HHSC officials acknowledged Monday they are unsure whether the new doctors can pick up Planned Parenthood’s caseload in all parts of the state.


Any capacity issues will become clear in the next few weeks as women try to make appointments with new clinics and doctors, with problems anticipated in South Texas and other impoverished areas. Texas already suffers from a shortage of primary care physicians willing to take on new patients who rely on state-funded health care.


Linda Edwards Gockel, a spokesman for the Texas Health and Human Services Commission, said Monday that the new state program will launch as planned on Tuesday.


“We have more than 3,500 doctors, clinics and other providers in the program and will be able to continue to provide women with family planning services while fully complying with state law,” she said. “We welcome Planned Parenthood’s help in referring patients to providers in the new program.”


Democratic lawmakers continued to question whether women will have to wait longer for appointments and services.


“I vehemently disagree with the state’s efforts to blacklist a qualified provider and, thereby, interfere with a woman’s right to choose her own provider,” said state Rep. Donna Howard, D-Austin. “I will be submitting a letter to the Texas Health and Human Services Commission, requesting a list of approved providers to gauge the outreach of the new program, and ensure that all qualified women throughout the state have access to its services.”


Another hearing is scheduled with a different judge for Jan. 11, where Planned Parenthood will again ask for an injunction to receive state funding.


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New Year’s Resolutions For Better Health






New Year’s resolutions are typically so singular, self-focused and private. How about making a resolution or two this year that has benefits beyond yourself? Here are some suggestions with lots of links to get you started.


You can help stop the spread of disease. Resolve to get up-to-date on your vaccines. While children have a full slate of vaccines, many adults don’t realize they have regular immunization obligations, too. Getting flu, pertussis, human papillomavirus and other vaccines can protect you and help stop the spread of diseases that harm others. Here’s a great guide to adult immunizations from the federal government. If the cost of vaccines is an issue, check into free or low-cost immunizations through your county’s public health department. Here’s a guide to finding your local office. Volunteer with an organization that needs your help. A group called Catchafire matches professionals who wish to volunteer their skills to organizations that need the help — including many important health organizations. The idea is to give great organizations access to top talent while respecting the professionals’ schedules and making their volunteer work meaningful. Here’s the link. Influence a healthier food climate. Americans spend about half of their food budgets eating out. So we had better demand thorough nutritional information about what we’re getting. Under healthcare reform, many restaurant chains will soon carry nutritional information. But the law has loopholes. If you don’t see the information you’re looking for on salt, fat, calories or other nutrients, ask the restaurant’s manager where you can find it. Nutritional information should be easy to access. Until it is, speak up and ask for it. Do your part to keep down healthcare costs. The Affordable Care Act will bring many consumers into the insurance healthcare system for the first time. But that doesn’t mean we can ignore the cost of care. Rising healthcare costs remain a huge issue that could drag down the economy and bedevil some reform efforts. You can help by being a wise healthcare consumer. Read your insurance policy and know what it does and doesn’t cover. Take advantage of free preventive care services and screening tests under the ACA. Shop around for prescriptions to find the cheapest prices. Ask your doctor for generic equivalents. Finally, use your health savings account if your employer offers one. These accounts provide incentives for using your money wisely, shopping around to find the best healthcare prices and weighing the costs and benefits of certain drugs, tests or procedures.  Here’s a guide to understanding how HSAs work. Be responsible about the prescription drugs you store at home. You can reduce your own risk of addiction and lower the risk for others, too, if you are careful about medications kept in your home. This year marked a turning point in the nation’s epidemic of prescription-drug abuse and addiction.  Admissions to addiction treatment centers for use of narcotic painkillers rose 569 percent in the past decade, according to the federal government. More people now die from drug overdoses than from traffic accidents. More than six million Americans abuse prescription drugs, and more than 70 percent of addicts get their drugs through family or friends or by raiding a home medicine cabinet. Dispose of unused medications. The Drug Enforcement Agency operates a National Prescription Drug Take-Back Day a few times a year (the next one is in April), that makes it easy to dispose of dangerous substance.  Go through your home today and collect unused medications. You can take them to a pharmacy for disposal or even flush them down the toilet. Some drugs carry disposal instructions on the label. Here’s information on how to dispose of prescription medications. Be a safe driver. One of the biggest safety issues on the nation’s roads these days is driver distraction. A large share of the distractions come from talking on a hand-held cell phone or text messaging while driving. You’re 23 times more likely to crash if you text while driving. Most states now prohibit texting while driving, but there are still many people who do it while knowing it’s unsafe. Break yourself of this terrible habit. The federal government has a website that provides people with information and tools to discourage distracted driving. Included in this package is a simple pledge sheet you can print out, sign and post on your refrigerator door or bathroom to help you make the commitment. There are a couple of other things you can do, too. Speak out if the driver you’re riding with is distracted. Encourage family and friends to drive phone-free. Run a race for the greater good. Who doesn’t love a good 5K walk or run? You benefit from the exercise and, if you choose a charity race, others reap rewards, too. There are thousands of charity races each year. Pick one and invite your friends to participate with you. Here’s a website to help you find a race.  Apply for a grant. There’s money out there for doing good. Saucony’s Run for Good Foundation aims at preventing child obesity by promoting running as part of a healthy lifestyle for kids. The foundation issues grant money to organizations that want to organize a kids’ running group. You can find information on how to apply at the foundation website. Sign a petition. Concerned about flame retardants in consumer products? Gun safety? Funding for research to fight a particular disease? There’s probably a petition for that. It’s an easy way to make your voice heard. Both change.org and thepetitionsite.com are good places to look to find a petition close to your heart.






Question: What resolutions can you make to help others? Tell us what you think in the comments.



Shari Roan is an award-winning health writer based in Southern California. She is the author of three books on health and science subjects.


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FDA approves Bristol Myers, Pfizer’s anti-clotting drug Eliquis






(Reuters) – U.S. health regulators approved clot prevention drug Eliquis, developed by Bristol Myers-Squibb Co and Pfizer Inc, for treatment in patients with atrial fibrillation, or irregular heartbeats.


The drug, also known as apixaban, was approved by European health regulators last month.






Eliquis belongs to a new class of medicines designed to replace decades-old warfarin for preventing blood clots in heart patients, or after a hip- or knee-replacement surgery.


Eliquis would compete against approved blood clot preventers such as Xarelto from Johnson & Johnson and Bayer, and Pradaxa from Boehringer Ingelheim.


Treating atrial fibrillation, which greatly raises the risk of strokes, is considered by far the largest and most important use for these new drugs.


The oral tablet Eliquis, like Xarelto, works by inhibiting a protein called Factor Xa that plays a critical role in blood clotting. Pradaxa has a slightly different mechanism of action.


However, Eliquis should not be taken by patients with prosthetic heart valves or those with atrial fibrillation caused by a heart valve problem, the U.S. Food and Drug Administration said in a statement.


About 5.8 million people in the United States suffer from atrial fibrillation, the most common form of heart arrhythmia, or irregular heartbeat.


Bristol-Myers shares were up 2 percent at $ 32.48 and Pfizer shares were up 10 cents at $ 24.99 in extended trading.


(Reporting by Prateek Kumar; Editing by Sreejiraj Eluvangal)


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Surival Rates Similar for Two Types of Abdominal Aneurysm Repairs






Less-invasive surgery isn’t necessarily better than an open procedure to repair a potentially fatal abdominal aortic aneurysm. That’s the conclusion of researchers at the Johns Hopkins University School of Medicine, who found similar survival rates for both types of procedures.


The medical community was enthusiastic about a new, less-invasive procedure assumed to be safer and better than traditional open surgery, according to Medical News Today. The researchers followed patients for up to nine years. Surprisingly, they found that after four years, survival rates for the two types of surgery were very similar.






An aneurysm is a bulge resembling a balloon in an artery. When the artery’s wall has been weakened by genetic issues, trauma, or certain medical problems, the pressure of blood against it can cause an aneurysm. Aneurysms in the aorta claim the lives of around 13,000 Americans a year, says the National Heart Lung and Blood Institute. Most deaths occur after the rupture of an aneurysm or a split in the aorta’s wall.


An abdominal aortic aneurysm occurs when the aorta — the body’s largest blood vessel — balloons in the abdomen due to pressure on the wall. If it ruptures, massive bleeding can be quickly fatal. This type of aneurysm ranks 14th among leading causes of death for Americans between 60 and 85.


Treatment depends on an aneurysm’s size and location. The traditional surgery for an abdominal aortic aneurysm utilizes a large, open cut. The more recent type of repair is an endovascular embolization, in which the surgeon uses a stent to prop open the blood vessel or reinforce its wall, according to PubMed Health.


While the survival rate was higher after two years in patients in the Hopkins study who had undergone endovascular repair, by the four-year mark, rates were nearly the same. Among elderly patients considered bad risks for an open surgery, individuals didn’t fare better with the newer technique. The team found no increased survival in patients at least 70 years old who had undergone the less-invasive procedure. Any benefits occurred in younger individuals.


Study leader Julie A. Freischlag, M.D., says the results raise an issue over who should undergo aneurysm repair. Even when older patients underwent repairs, their lives weren’t prolonged. She says the issue is whether they should have either procedure, since they’re already dying of diseases associated with old age.


My father lived, largely symptom-free, for years with an abdominal aortic aneurysm . Citing a weak heart, surgeons declined to repair it. When he experienced sudden pain, my mother took him to the emergency room. He survived an open repair procedure but died after 16 days in intensive care of an infection at the surgical site. Although he was 71, we wonder if an endovascular embolization would have provided a different outcome, at least for four years after surgery.


Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.


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Few tests done at toxic sites after superstorm






OLD BRIDGE, N.J. (AP) — For more than a month, the U.S. Environmental Protection Agency has said that the recent superstorm didn’t cause significant problems at any of the 247 Superfund toxic waste sites it’s monitoring in New York and New Jersey.


But in many cases, no actual tests of soil or water are being conducted, just visual inspections.






The EPA conducted a handful of tests right after the storm, but couldn’t provide details or locations of any recent testing when asked last week. New Jersey officials point out that federally designated Superfund sites are EPA’s responsibility.


The 1980 Superfund law gave EPA the power to order cleanups of abandoned, spilled and illegally dumped hazardous wastes that threaten human health or the environment. The sites can involve long-term or short-term cleanups.


Jeff Tittel, executive director of the Sierra Club in New Jersey, says officials haven’t done enough to ensure there is no contamination from Superfund sites. He’s worried toxins could leach into groundwater and the ocean.


“It’s really serious and I think the EPA and the state of New Jersey have not done due diligence to make sure these sites have not created problems,” Tittel said.


The EPA said last month that none of the Superfund sites it monitors in New York or New Jersey sustained significant damage, but that it has done follow-up sampling at the Gowanus Canal site in Brooklyn, the Newtown Creek site on the border of Queens and Brooklyn, and the Raritan Bay Slag site, all of which flooded during the storm.


But last week, EPA spokeswoman Stacy Kika didn’t respond to questions about whether any soil or water tests have been done at the other 243 Superfund sites. The agency hasn’t said exactly how many of the sites flooded.


“Currently, we do not believe that any sites were impacted in ways that would pose a threat to nearby communities,” EPA said in a statement.


Politicians have been asking similar questions, too. On Nov. 29, U.S. Sen. Frank Lautenberg, D-N.J., wrote to the EPA to ask for “an additional assessment” of Sandy’s impact on Superfund sites in the state.


Elevated levels of lead, antimony, arsenic and copper have been found at the Raritan Bay Slag site, a Superfund site since 2009. Blast furnaces dumped lead at the site in the late 1960s and early 1970s, and lead slag was also used there to construct a seawall and jetty.


The EPA found lead levels as high as 142,000 parts per million were found at Raritan Bay in 2007. Natural soil levels for lead range from 50 to 400 parts per million.


The EPA took four samples from the site after Superstorm Sandy: two from a fenced-off beach area and two from a nearby public playground. One of the beach samples tested above the recreational limit for lead. In early November, the EPA said it was taking additional samples “to get a more detailed picture of how the material might have shifted” and will “take appropriate steps to prevent public exposure” at the site, according to a bulletin posted on its website. But six weeks later, the agency couldn’t provide more details of what has been found.


The Newtown Creek site, with pesticides, metals, PCBs and volatile organic compounds, and the Gowanus Canal site, heavily contaminated with PCBs, heavy metals, volatile organics and coal tar wastes, were added to the Superfund list in 2010.


Some say the lead at the Raritan Bay site can disperse easily.


Gabriel Fillippeli, director of the Center for Urban Health at Indiana University-Purdue University Indianapolis, said lead tends to stay in the soil once it is deposited but can be moved around by stormwaters or winds. Arsenic, which has been found in the surface water at the site, can leach into the water table, Fillippeli said.


“My concern is twofold. One is, a storm like that surely moved some of that material physically to other places, I would think,” Fillippeli said. “If they don’t cap that or seal it or clean it up, arsenic will continue to make its way slowly into groundwater and lead will be distributed around the neighborhood.”


The lack of testing has left some residents with lingering worries.


The Raritan Bay Slag site sits on the beach overlooking a placid harbor with a view of Staten Island. On a recent foggy morning, workers were hauling out debris, and some nearby residents wondered whether the superstorm increased or spread the amount of pollution at the site.


“I think it brought a lot of crud in from what’s out there,” said Elise Pelletier, whose small bungalow sits on a hill overlooking the Raritan Bay Slag site. “You don’t know what came in from the water.” Her street did not flood because it is up high, but she worries about a park below where people go fishing and walk their dogs. She would like to see more testing done.


Thomas Burke, an associate dean at the Johns Hopkins School of Public Health, says both federal and state officials generally have a good handle on the major Superfund sites, which often use caps and walls to contain pollution.


“They are designed to hold up,” Burke said of such structures, but added that “you always have to be concerned that an unusual event can spread things around in the environment.” Burke noted that the storm brought in a “tremendous amount” of water, raising the possibility that groundwater plumes could have changed.


“There really have to be evaluations” of communities near the Superfund sites, he said. “It’s important to take a look.”


Officials in both New York and New Jersey note they’ve also been monitoring less toxic sites known as brownfields and haven’t found major problems. The New York DEC said in a statement that brownfields in that state “were not significantly impacted” and that they don’t plan further tests for storm impacts.


Larry Ragonese, a spokesman for the New Jersey Department of Environmental Protection, said the agency has done visual inspections of major brownfield sites and also alerted towns and cities to be on the lookout for problems. Ragonese said they just aren’t getting calls voicing such concerns.


Back at the Raritan Bay slag site, some residents want more information. And they want the toxic soil, which has sat here for years, out.


Pat Churchill, who was walking her dog in the park along the water, said she’s still worried.


“There are unanswered questions. You can’t tell me this is all contained. It has to move around,” Churchill said.


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Mother loses UK legal fight to stop son’s cancer radiotherapy






LONDON (Reuters) – A mother in Britain, who was so desperate to stop her cancer-stricken son having to undergo conventional medical treatment that she went into hiding with him, lost a court battle on Friday to prevent him receiving radiotherapy.


The case of Sally Roberts, 37, a New Zealander living in Brighton, southern England, and the plight of her seven-year-old son has made headlines in Britain.






Roberts wants to try alternative treatments first, including immunotherapy and photodynamic therapy for her son Neon. She has been told the boy needs treatment fast but fears the side-effects of conventional medicine.


Doctors treating the boy had warned that without radiotherapy he could die within three months


Judge David Bodey told the High Court in London the life-saving radiotherapy treatment could start against the mother’s wishes, the Press Association reported.


“The mother has been through a terrible time. This sort of thing is every parent’s nightmare,” the judge said.


“But I am worried that her judgment has gone awry on the question of the seriousness of the threat which Neon faces.”


The story of the sick blue-eyed blonde boy came to public attention earlier this month when Roberts prompted a nationwide police hunt by going into hiding with Neon for four days to stop him from undergoing the treatment.


The mother’s relentless battle in court also cast a light on the dilemmas parents can face when dealing with the illness of a loved one, considering the short-term and long-term risks of a treatment and handling conflicting medical information available at the click of a mouse.


Roberts said in court she had researched on the Internet her son’s condition – a fast-growing, high-grade brain tumor called medulloblastoma – and sought advice from specialists around the world because she did not trust British experts.


She feared radiotherapy would stunt the boy’s growth, reduce his IQ, damage his thyroid and potentially leave him infertile.


Earlier this week, a judge ruled that Neon could undergo emergency surgery to remove a tumor which had resisted an initial operation in October, despite opposition from his mother, who found he appeared to be recovering after what she said was a “heartbreaking” stay in hospital.


“EXPERIMENTAL AND UNPROVEN”


Surgeons said Neon’s operation on Wednesday had been successful but that radiotherapy was needed to ensure no residual tumor was left behind.


Neon’s father Ben, who lives in London and is separated from Roberts, has sided with his son’s doctors.


But his wife suggested exploring several alternative treatments, including immunotherapy, which mainly consists of stimulating the body’s immune system to fight cancerous cells, and photodynamic therapy, which uses a photosensitizing agent and a source of light to kill malignant cells.


The hospital treating Neon slammed “experimental and unproven” methods which entered “unchartered territory”. The hospital, which cannot be named, also questioned the credentials of some of the private specialists contacted by Roberts’s team.


The court heard that at least one of these could not even correctly spell medulloblastoma.


Radiotherapy is used to prevent cancer from spreading or striking back after surgery but it can damage nerve tissue and healthy brain cells.


Long-term side effects tend to be more common in children, whose nervous systems are still developing.


(Reporting by Natalie Huet; Editing by Sophie Hares)


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Number of new drugs picks up in Europe and U.S.






LONDON (Reuters) – The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries.


European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 – the highest level in eight years.






The sector badly needs a pick-up in productivity as companies try to refill their medicine chests after a wave of patient expiries that have peaked this year, depriving leading U.S. and European drug companies of more than $ 30 billion of revenue.


“It bodes well,” said Standard & Poor’s (S&P) analyst Olaf Toelke, who predicts that strong pipelines will allow most large drugmakers to emerge unscathed from the spike in sales losses.


“It shows that companies are addressing the need to find new drugs to replace those facing patent expiration. They have done their homework and it looks as if the industry will be at least stable in future and not fall off the threatened patent cliff.”


The U.S. Food and Drug Administration (FDA), gatekeeper to the world’s biggest pharmaceuticals market, still has just over a week to add more approvals to this year’s tally – and there are signs that the number will increase further.


Three new products for leukemia, anthrax and Cushing’s disease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone, and the FDA is scheduled to hand down decisions on a further four drugs before the end of the month.


FEWER GENERICS


A green light for all these would take the 2012 tally of new molecular entities (NMEs) approved by the agency’s Center for Drug Evaluation and Research to 38 – two more than the 2004 total of 36.


The European Medicines Agency painted a different picture of improving productivity by announcing that its work program for the year ahead included a forecast for 54 new drug applications, up from 52 in 2012, 48 in 2011 and 34 in 2010. These figures exclude medicines designated for “orphan”, or rare, diseases.


Significantly, the London-based agency is also expecting a sharp drop in the number of applications from companies to sell generic versions of drugs, to 20 in 2013 from 39 in 2012, given the slowdown in patent expiries next year.


Major U.S. drug companies will lose a total of about $ 21 billion in revenue this year from lucrative medicines coming off patent, while the hit for European businesses is about $ 10 billion, according to S&P.


This year’s expiries have included Sanofi and Bristol-Myers Squibb’s heart drug Plavix and AstraZeneca’s antipsychotic Seroquel.


Winning approval from regulators, however, is only part of the battle for drugmakers.


Investors will also be watching closely to see how the new drugs perform commercially once they reach the market, since securing payment for innovative medicines is an increasingly tough fight – especially in austerity-hit Europe.


An analysis by Deloitte and Thomson Reuters this month found that while new drug approvals were increasing, this was offset by lower expected revenues from many individual products.


(Editing by David Goodman)


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Inherited colon cancer risk tied to certain foods






NEW YORK (Reuters Health) – Among people who have a genetic susceptibility to colon cancer, those whose diets are heavy in junk food have an even higher risk, according to a new study.


“These patients have this very high risk because of this (genetic) mutation they have, but it might be that they could reduce the number of (tumors) by having a more healthy lifestyle,” said Akke Botma, the lead author of the study.






Botma’s study is just the first to find a link between certain foods and a higher colon cancer risk in this group, and it can’t prove that the diet is to blame.


All of the people in the study had Lynch syndrome, a genetic disorder that predisposes people to cancer at younger ages and that affects up to one in 660 people.


In Western countries, colorectal and endometrial cancers are the dominant cancers to turn up in people with the syndrome, while in Asia it’s mostly stomach cancer, Botma said.


Up to 70 percent of people with Lynch syndrome will develop colon cancer. Among people without Lynch syndrome, such cancers are thought to be influenced by diet, particularly alcohol and red and processed meat, the authors note in their study, published in the journal Cancer.


Botma and her colleagues at Wageningen University in the Netherlands contacted 486 people with Lynch syndrome from a national database of families with inherited risks for cancer.


At the beginning of the study they surveyed the participants about what they ate, and they ranked each person on whether he ate low, medium or high amounts of foods within four dietary categories.


The food groups included one that was dominated by fruits, vegetables and whole grains; another that was high in meat and coffee; a third dietary group that resembled a Mediterranean diet – fish, leafy greens, pasta, sauces and wine; and a fourth group that was heavy on fried snacks, fast food and diet soda.


Botma and her colleagues found that, over 20 months of follow up, 56 of the participants — or 12 percent — screened positive for tumors in the colon, a precursor to cancer.


Of the four dietary groupings, only the junk food category showed any link with a different risk for developing colon tumors.


Of the 160 people who scored low on the junk food diet, 17 developed tumors, while 18 out of the 160 people who ate the most junk food developed tumors.


The numbers initially seemed similar, but after taking into account smoking and other risk factors, the researchers determined that those in the high junk food group were twice as likely to develop colon tumors.


HOW TO MANAGE RISKS?


“It’s hard to say why” junk food is linked with a greater risk for these tumors, said Dr. Mala Pande, an instructor at the University of Texas MD Anderson Cancer Center in Houston who was not involved in the research.


She said some researchers have suggested that high fat might have something to do with it, but it’s impossible to conclude that from this study.


Although the findings are too preliminary to be used in making dietary recommendations to people with Lynch Syndrome, the study was valuable in launching research into the possible role of certain foods on cancer risk, said Christopher Amos, a professor at the Geisel School of Medicine at Dartmouth College.


“People with Lynch Syndrome are at higher risk, and we’d really like to know how to manage their risks better,” Amos, who was not part of the study, told Reuters Health.


Certain foods have been shown to be linked with different types of cancer, but many of those studies contradict each other and sow confusion (see Reuters Health report of December 5, 2012 here: http://reut.rs/YPuDcs).


Amos said the new study is a good start, but “it would be nice to confirm (it) with additional findings.”


SOURCE: http://bit.ly/SG85JD Cancer, online December 17, 2012.


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Boehner opens door to tax hikes, shifts U.S. fiscal cliff talks






WASHINGTON (Reuters) – U.S. House of Representatives Speaker John Boehner‘s offer to accept a tax rate increase for the wealthiest Americans knocks down a key Republican road block to a deal resolving the year-end “fiscal cliff.”


The question now boils down to what President Barack Obama offers in return. Such major questions, still unanswered so close to the end of the year suggest, however, that no spending and tax agreement is imminent.






A source familiar with the Obama-Boehner talks confirmed that Boehner proposed extending low tax rates for everyone who has less than $ 1 million in net annual income, meaning tax rates would rise on all above that line.


Under current law, the 35 percent top tax rate is scheduled to expire on January 1, and would automatically go to 39.6 percent. Boehner’s proposal would allow that rate to rise as scheduled at a threshold of $ 1 million – putting it back to where it was during the Clinton administration.


The White House has not accepted the proposal and the source could not confirm any additional talks were held on Sunday between Obama and Boehner.


With just over two weeks before the fiscal cliff’s $ 600 billion in automatic tax hikes and spending cuts are triggered, threatening a new recession, there is little time to craft a comprehensive deal that will satisfy both Democrats and Republicans.


Until the latest Republican offer, made on Friday, Boehner had insisted on extending all of the Bush era’s lower tax rates, resisting Obama’s demand to let the marginal rates rise on income above $ 250,000. A rising chorus of business executives also had urged Republicans to agree to this.


Some lawmakers and congressional aides had predicted that Republicans, once serious negotiations began, might try to raise the $ 250,000 threshold, say to $ 500,000 or $ 1 million. They also speculated that Republicans, if forced into a tax rate hike on the upper-income groups, might seek a smaller increase, say to around 37 percent.


Although the White House has not accepted Boehner’s gambit, it could push negotiations away from entrenched, ideological positions.


“Boehner has now accepted the premise of higher rates. So now we’re just arguing over details. I think it’s a significant step,” said Greg Valliere, chief political strategist at Potomac Research Group.


A framework deal spelling out tax revenue and spending cut targets to be finalized in the new year could be possible, Valliere said.


“Boehner’s offer to allow tax rates to go up for taxpayers earning over $ 1 million fundamentally transforms fiscal cliff negotiations,” added Sean West, U.S. policy analyst at Eurasia Group, a political risk consultancy.


In a note to clients, West wrote that it signals, significantly, that Boehner ultimately believes a deal to avoid the cliff is still possible.


“The political burden is now shifted back to the president, who must be willing to take on his party in order to get a deal Boehner can ultimately pass. We do not think the president will overreach: Obama will work with Boehner to get to a deal.”


There are still several critical elements to a deal besides a tax rate increase on the wealthy, including Republican demands to cut spending on social programs.


Changes to the expensive Medicare and Medicaid health care programs for the elderly and the poor could be central to any deal, which must also include an increase in the federal debt limit needed by the end of February.


DEMANDS SOCIAL PROGRAM CUTS


Boehner conditioned his tax rate increase offer on Obama’s agreement to cuts in social program spending, often called entitlements.


Many Republican lawmakers want to raise the eligibility age for Medicare to 67 from 65. They also want to link Medicare to the income of recipients, making wealthier retirees pay more for their care.


Currently, Medicare does have some means testing, charging higher premiums for coverage of doctors visits and prescription drugs to individuals earning more than $ 85,000 and married couples earning more than $ 170,000. Only about 5 percent of recipients pay these higher premiums.


Thus far, Obama has offered only about $ 400 billion in 10-year entitlement savings, mostly through small adjustments in reining in health care costs – not fundamental changes such as raising the eligibility age.


And just as Boehner faces opposition in his own party to raising any tax rates, Obama faces opposition to cuts to Medicare, Medicaid and Social Security from Democrats, who pledged in election campaigns they would protect these programs.


A major bloc of congressional Democrats has already signaled they will not accept major cutbacks in Medicare as part of any fiscal cliff deal.


House Minority Leader Nancy Pelosi of California and Maryland Representative Chris Van Hollen of Maryland are among the high ranking Democrats in the House who have come out forcefully in recent days against raising the age for eligibility for Medicare to 67 years of age.


“Given the level of savings that is being talked about from Medicare, you can’t get it all from providers and drug makers,” said Paul Heldman, an analyst at Potomac Research, which tracks Washington policy for investors.


“So opponents of raising the eligibility age have reason to believe beneficiaries will take some sort of hit if a mega-deal is cut,” he said.


If Republicans are not successful in securing entitlement program cuts in exchange for a tax-rate increase on the wealthy, they are adamant about using a debt-limit increase as leverage to overhaul Social Security and Medicare.


The U.S. Treasury expects to reach its $ 16.4 trillion statutory debt cap by year-end, and will exhaust its remaining borrowing capacity around mid-February, risking a potential default.


Louisiana Republican Representative John Fleming, a member of the conservative Tea Party caucus who has never voted to increase the debt ceiling, said he would support a debt limit hike if it were part of a deal to make Medicare and Social Security sustainable.


The pace of activity could pick up the coming week.


House Republicans were told to prepare for a possible weekend session next week, potentially interrupting travel plans for the long Christmas holiday weekend.


House Majority Leader Eric Cantor scheduled “possible legislation related to expiring provisions of law,” a reference to the expiring tax cuts, for the end of the week, portending a weekend session. Cantor has said the House would meet through the Christmas holidays and beyond.


(This story was fixed to correct current top tax rate to 35 percent from 36 percent)


(Additional reporting by Thomas Ferraro, Richard Cowan and Kim Dixon; Editing by Fred Barbash, Todd Eastham and Jackie Frank)


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Clinton sustains concussion; Benghazi testimony postponed






WASHINGTON (Reuters) – Secretary of State Hillary Clinton, who canceled an overseas trip last weekend because of illness, suffered a concussion after fainting due to dehydration, prompting the postponement of her scheduled congressional testimony on the attack on a U.S. mission in Libya, officials said on Saturday.


“While suffering from a stomach virus, Secretary Clinton became dehydrated and fainted, sustaining a concussion,” State Department spokesman Philippe Reines said in a statement.






“She has been recovering at home and will continue to be monitored regularly by her doctors,” Reines said, adding that she would work from home and stay in regular contact with other top officials.


Clinton, 65, fell ill with a stomach virus last weekend and was forced to cancel a planned trip to the Middle East and North Africa. The virus also hit other members of her staff, who were returning with her from a European trip, and was described as uncomfortable, but not medically serious.


Clinton’s doctors, Lisa Bardack of the Mt. Kisco Medical Group and Gigi El-Bayoumi of George Washington University, issued a statement saying that Clinton fainted as a result of “extreme dehydration” due to the virus.


“Over the course of this week we evaluated her and ultimately determined she had also sustained a concussion,” the doctors said in their statement, which was distributed by the State Department.


“We recommended that the secretary continue to rest and avoid any strenuous activity, and strongly advised her to cancel all work events for the coming week. We will continue to monitor her progress as she makes a full recovery.”


Clinton has often been cited as a potential Democratic candidate for the U.S. presidency in 2016 and frequently refers to her general good health. She said in an interview with ABC broadcast on Wednesday that she has “incredible stamina and energy.”


She has maintained a punishing schedule in her final weeks as the top U.S. diplomat, a position she intends to leave toward the end of January when U.S. President Barack Obama is sworn in for a second term.


Obama telephoned Clinton to wish her well, White House spokesman Tommy Vietor said.


BENGHAZI TESTIMONY NEXT WEEK


Clinton had been expected to testify on December 20 before the House of Representatives and Senate foreign affairs committees on a report on the deadly attack on the U.S. diplomatic post in Benghazi, Libya, in September that killed the U.S. ambassador and three other Americans and raised questions about security at far-flung posts.


Jodi Seth, a spokeswoman for Senate Foreign Relations Committee head John Kerry, said that given her condition, Clinton’s testimony would be postponed, but did not say until when. Seth said the planned hearings would be held with other senior officials appearing in Clinton’s place.


The Republican chair of the House of Representatives Foreign Affairs Committee, Ileana Ros-Lehtinen, issued a statement saying she was sorry to hear of Clinton’s ill health, but it was “unfortunate” she would be unable to testify before the committee next week.


“We still don’t have information from the Obama Administration on what went so tragically wrong in Benghazi that resulted in the deaths of four patriotic Americans,” Ros-Lehtinen said.


“We have been combing through classified and unclassified documents and have tough questions about State Department threat assessments and decision-making on Benghazi. This requires a public appearance by the Secretary of State herself.”


Ros-Lehtinen’s statement said William Burns and Thomas Nides, deputy secretaries of state, would provide testimony in Clinton’s place.


REPUBLICAN CRITICISM


Republicans have criticized the Democratic Obama administration for its early public explanations of the attack.


Much of the criticism focused on U.S. Ambassador to the United Nations Susan Rice, who on Thursday said she was withdrawing her name from consideration to replace Clinton as secretary of state to avoid a potentially disruptive confirmation process.


Clinton has appointed a special panel known as an accountability review board to assess both the Benghazi incident and the official response to it.


The board’s report, which will contain both classified and unclassified sections, is expected to be complete next week and Clinton has promised to be as transparent as possible with Congress in sharing its findings.


Clinton, whose husband, Bill Clinton, was president from 1993 to 2001 and who herself came tantalizingly close to winning the Democratic presidential nomination four years ago, has used her star power to promote U.S. interests around the world since Obama named her to lead the State Department in 2009.


She has consistently been rated as the most popular member of Obama’s Cabinet, leading to speculation she might mount another White House bid in 2016, although she herself has played down suggestions that she still hopes to become president.


“I’ve said I really don’t believe that that’s something I will do again. I am so grateful I had the experience of doing it before,” Clinton told ABC’s Barbara Walters in the interview broadcast on Wednesday.


“I just want to see what else is out there. I’ve been doing … this incredibly important and … satisfying work here in Washington, as I say, for 20 years. I want to get out and spend some time looking at what else I can do to contribute.”


(Reporting by Andrew Quinn and Lisa Lambert; Editing by Will Dunham, David Brunnstrom and Mohammad Zargham)


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Lundbeck’s alcohol dependency drug wins EU green light






LONDON (Reuters) – A novel drug to fight alcohol dependency was given a green light by European regulators on Friday, providing a boost to Danish drugmaker Lundbeck at a time when its top product faces a big drop in sales.


The European Medicines Agency (EMA) said on Friday it recommended approval of Selincro in conjunction with counseling for the reduction of alcohol consumption in adults dependent on drink.






Recommendations from the EMA are normally endorsed by the European Commission within two or three months, implying the drug could be launched in Europe early next year.


That is good news for Lundbeck, which needs new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States and Japan, which is now coming off patent.


Alcohol abuse is theoretically a vast market, although it is unclear whether doctors will be ready to prescribe a drug as a treatment and whether Lundbeck has the marketing muscle to make a big impact.


Lundbeck Chief Executive Ulf Wiinberg told Reuters last week that Selincro was “a bit of a joker in our portfolio” because of uncertainty as to how it will be used in practice.


The drug, which blocks the action of opioid receptors in the brain, was licensed to Lundbeck from Finland’s Biotie Therapies and shares in Biotie jumped as much as 16 percent on the news, while Lundbeck rose around 1 percent.


“Clearly, the news is a much-needed boost to sentiment for the (Lundbeck) shares,” said Deutsche Bank analyst Tim Race.


“However, we suspect the market will refrain from pricing-in significant upside from the drug given uncertainties in reimbursement and Lundbeck’s ability to penetrate this market without a major partner.”


Race said current consensus forecasts suggested modest sales of 540 million Danish crowns ($ 95 million) in 2016.


More important for Lundbeck will be the verdict from regulators in North America and Europe late next year on a new antidepressant being developed with Japanese partner Takeda Pharmaceutical that analysts see as a potential $ 1-2 billion-a-year seller.


Developing new treatments for depression has proved an uphill battle for drugmakers in recent times but vortioxetine has produced encouraging clinical trial results and its unique mode of action and flexible dosing could make it a winner.


Another approval prospect for next year is Abilify Maintena, a once-monthly version of schizophrenia drug Abilify that Lundbeck is working on with Otsuka.


Further out, Lundbeck is also developing a drug for the symptoms of Alzheimer’s that will be ready to go into final-stage clinical testing next year and could be partnered with a larger drug company.


(Reporting by Ben Hirschler; Editing by Chris Wickham and Mark Potter)


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Doctors Fight Leukemia With HIV






Dec 10, 2012 7:33pm



7ad18  ht whitehead mi 121210 wblog Doctors Fight Leukemia With HIV

Image credit: Christine Chardo Photography for The Tiny Sparrow Foundation







By Ann Reynolds:


In April, Emma Brooke Whitehead’s leukemia seemed unbeatable.


Emma, a 6-year-old from Phillipsburg, Pa., had been fighting the disease for nearly two years and doctors at Children’s Hospital of Philadelphia said there were no standard treatments left.  So they took a gamble on a new, potentially groundbreaking treatment — using HIV.


They removed millions of Emma’s disease-fighting white blood cells and used genetically altered HIV — a virus that easily gets into human immune systems — to turn Emma’s cells into a kind of immunological “directed missile,” specifically programmed to destroy the leukemia cells.  The cells were then returned to Emma’s body.


“All of the things that make the HIV virus able to cause disease have been removed from this particular virus whose only purpose is to put a gene into a cell,” said Dr. Stephan Grupp, a pediatric oncologist at CHOP who uses HIV to infiltrate the immune system. “There is no danger of infection and there is no longer the HIV virus.”


Kari Whitehead, Emma’s mother, said that initially after the treatment Emma became very ill — she had a fever as high as 105 degrees — and doctors warned the family that she might not make it through the night.


Grupp then gave the second grader a rheumatoid arthritis drug “off label.”  In arthritis, the drug was meant to block a specific part of the body’s immune reaction, part caused by white blood cells called T cells.  In Emma’s case, it blocked the side effect of the cancer treatment. In just 12 hours, she stabilized.


“She was the first child in the world they tried it on and they told us they didn’t know what to expect,” Whitehead told ABC News. “They do feel now that the arthritis drug that they used will keep the kids in the future from getting any where close to that [sick].”


Grupp says that Emma, now eight months past her treatment, is in complete remission.


“She has no leukemia in her body for any test that we can do — even the most sensitive tests,” he said. “We need to see that the remission goes on for a couple of years before we think about whether she is cured or not. It is too soon to say.”


He said that the treatment is being tried experimentally at two hospitals and was intended for childhood leukemia that has returned and no longer responds to chemotherapy. He said doctors hoped the T cell treatment would eventually replace bone marrow transplants.


“This treatment was really her [Emma's] only chance,” Grupp said. “She has been treated with extended chemotherapy and she wasn’t getting any better. … For me, it’s incredible.”


Whitehead said Emma, now 7, looked and felt “amazing” and had reunited with her dog Lucy.


“There is a big difference,” she said. “She has a ton of energy. She’s back with her class. She was even able to play a little bit of soccer. So she’s doing wonderful right now.”



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Booze, smokes on agenda for quirky gov’t group












BELTSVILLE, Md. (AP) — Deep in a secure laboratory just outside Washington sits the federal government‘s heaviest smoker.


It is a half-ton hulk of a machine, all brushed aluminum and gasping smoke holes, like a retrofit of equipment used on an Industrial Revolution production line. It can smoke 20 cigarettes at once and conclude which are unsafe because they are counterfeit and which are unsafe merely because they are cigarettes.












Down the hall, a chemist tests shiny flecks from a bottle of Goldschlager, the spicy cinnamon schnapps, to make sure they’re real gold. A government agent was sent out to stores to buy it and hundreds of other alcoholic drinks randomly chosen for analysis.


Back at headquarters in downtown Washington, a staffer prepares for a meeting of the Tequila Working Group — a committee created to mollify Mexico and keep bulk tequila flowing north across the border.


These are the proud scientists, rule-makers and trade ambassadors of the Alcohol and Tobacco Tax and Trade Bureau, one of the federal government’s least-known and most peculiar corners.


The bureau, known as TTB, collects taxes on booze and smokes and tells the companies that produce them how to do business — from approving beer can labels to deciding how much air a gin bottle can contain between lid and liquor.


It decides which valleys in Oregon and California can slap their names on wine labels, what grapes can go into wine and which new alcoholic drinks are safe to import.


The bureau is one example of the specialized government offices threatened by Washington’s current zeal for cost-cutting. Obama administration officials weighed eliminating it during the fiscal stalemate of 2011, according to news reports at the time. Its officials were called to the White House budget office to justify their existence — or risk having their duties split between the Internal Revenue Service and the Food and Drug Administration.


The White House ultimately left the bureau’s $ 100 million budget in place for this year — perhaps because it spends far less money to collect each tax dollar than its counterpart, the IRS. But officials there remain hyper-aware of their vulnerability as Republicans and Democrats look to squeeze savings from unlikely places.


If they look closely, the belt-tighteners will discover an agency whose responsibilities often appear to conflict — a regulator that protects its industry from rules it deems unfair, a tax collector that sometimes cuts its companies a break.


Some of its decisions are open to negotiation. A tequila-like liquor with a scorpion floating in it made scientists balk until the producer convinced them that the scorpions are farm-raised and non-toxic.


In other words, this may be the only federal agency that responds favorably to receiving scorpion candy in the mail — an edible tool for persuading scientists that the arthropods were fit for human consumption.


If labs, rules and taxes weren’t enough for the bureau’s 500-odd employees, they also have law enforcement authority. TTB investigators can send people to jail for things like removing alcohol from the production line and reselling it before it has been taxed by authorities.


With all these responsibilities, it’s no surprise the agency’s priorities sometimes clash. The bureau gives companies a wide berth on some rules and taxes, officials and experts say, mainly because of its small size and history of collaborating with business. It has granted millions in tax givebacks because of concerns that companies will sue and tie up government resources.


“Because we’re regulated by such a friendly agency, and because enforcement isn’t huge, there’s a level of non-compliance that’s sort of acceptable,” says Rachel Dumas Rey, president of Compli, a California company that helps wineries comply with Treasury policy.


Agency officials say they use scant resources where they can make the most difference, generally on the biggest producers or companies where there is an indication of wrongdoing.


Yet last July, the bureau slashed a tax bill for the multinational agribusiness conglomerate Cargill from $ 839,370 to $ 63,000. Cargill failed to report or pay taxes on about 23,000 gallons of nearly pure industrial alcohol that leaked from a rail car, violating several U.S. laws, according to documents on the bureau’s website.


Since 2010, under similar deals with alcohol and tobacco companies, the agency has forgiven more than $ 25.4 million; the total amount is unclear because some public documents do not list the size of the tax bill or penalty that is being reduced. Nine companies persuaded the agency to slash their bills by more than 95 percent, including Procter & Gamble’s Olay subsidiary, which uses alcohol in its skin care products.


Tom Hogue, a spokesman for the bureau and former explosives inspector, says it only agrees to reduce companies’ tax bills “if we are satisfied that the (remaining) penalty is commensurate with the violation and is sufficient to deter future illegal conduct.” In cases where settlements are granted, Hogue says, “they allow us to use our resources to counter non-compliance, instead of tying them up in court.”


When the alcohol and tobacco bureau was split from the Bureau of Alcohol, Tobacco and Firearms, it held on to the former agency’s tax collection duties, including for firearms and ammunition. It’s still the government’s third-biggest revenue collector, after the IRS and Customs and Border Protection. It took in $ 23.5 billion in federal taxes on alcohol, tobacco, weapons and ammo in the fiscal year ended Sept. 30, 2011, the most recent data available. That amounts to $ 468 for every dollar the agency spent collecting taxes — more than twice the IRS’ ratio, officials note.


The bureau also works with government trade officials to protect and expand international markets for American alcohol and tobacco. Its expertise is crucial in negotiating with Europeans about wine labeling, or standing up to countries that refuse to recognize American “straight bourbon” for what the government says it is: corn whiskey stored in charred new oak containers for at least two years.


In this role, the agency has come to the rescue over the years of whiskey lovers in China, Colombia and Brazil. Those countries’ governments tried to ban booze containing too much fusel alcohol, the pungent byproduct of fermentation that gives some whiskey its spicy, solvent-like aroma. Working through international trade groups, armed with data from TTB scientists, U.S. officials spent years convincing them to reverse their policies and allow the importation of whiskey that meets American standards. That was a win for American alcohol producers.


Sometimes, to protect U.S. producers, the bureau erects trade barriers of its own. Under a proposal by the bureau last spring, anything labeled Pisco must have originated in Chile and Peru. (Pisco is a South American grape brandy whose signature cocktail, the Pisco Sour, is so celebrated that it has its own official Peruvian holiday.)


Aspiring Pisco producers in Bolivia, in the U.S. government’s eyes, can take a hike.


This is no accident: It’s the result of a trade agreement that compels Chile and Peru, in exchange for the Pisco rule, to make sure any bourbon sold there is from the U.S. and meets this country’s standards.



The U.S. is the only nation with an alcohol regulator based in its Treasury Department. Treasury was the federal government’s monitor of products seen as sinful or illicit even before Prohibition began in 1919.


When the government first tried to crack down on cocaine and heroin in 1914, it did so by enacting steep taxes. For a time, marijuana also was controlled by imposing taxes so high, it was hoped, that people might lose interest.


After Prohibition was repealed in 1933, the government tried to keep a handle on the alcohol industry by writing production standards for alcohol directly into the tax code. That’s where wine’s alcohol content is limited to 24 percent.


The government uses taxes to control social phenomena, explains Bill Foster, who ran the bureau’s headquarters before retiring this summer.


“Tobacco and alcohol are two of those commodities,” Foster says.


The taxes are collected directly from producers and manufacturers, which pass those costs along to consumers. Liquor producers generally pay a flat rate of $ 13.50 per proof gallon — a gallon of liquid that is one-half alcohol by volume. Small cigars and cigarettes are taxed at a rate of $ 50.33 per 1,000 sticks.



The current Alcohol Tobacco Tax and Trade Bureau was split from the Bureau of Alcohol, Tobacco and Firearms in 2003. ATF was moved to the Justice Department, where it focuses on firearms, explosives and violent crime.


Officials who regulate and tax alcohol and tobacco remained at Treasury, where they continue to ensure that wine doesn’t contain pesticides and absinthe is free of thujone, the psychoactive ingredient — now banned — that gave it its hallucinogenic reputation.


That’s how Dr. Abdul Mabud found himself overseeing 26 chemists at a lab in Beltsville, Md., that tests hundreds of bottles, cigarettes and perfumes every year.


One afternoon, Mabud holds aloft a jar of pure, clear alcohol containing a coiled king cobra, its hood flared and forked tongue extended. Surrounding it are smaller green snakes that appear to be biting each other’s tails.


The snake liquor was submitted for consideration as an import from east Asia, where snakes are believed to increase virility.


“With that much snake in there, it’s probably not a beverage,” Mabud says, explaining why the shelves of America’s liquor stores and supermarkets are free of giant, gin-soaked snakes.


Mabud traces his lab’s history to 1886, when Congress passed steep taxes on margarine — at the time, an upstart competitor to the nation’s dairy products. The 1886 law aimed to prevent crooked margarine-pushers from selling their product as butter. Treasury’s first food-quality lab was set up to preserve butter’s integrity.


Today, the bureau owns some of the most sophisticated equipment available, including the smoking machine, which can be set to inhale in at least three ways, depending on how long and hard the smoker being simulated prefers to puff: light, medium and Canadian. The last one is when the perforations around the cigarette’s filter are blocked and the machine takes bigger, more frequent puffs. It was invented by the Canadian government, and does not necessarily reflect the actual smoking habits of Canadians, says Dawit Bezabeh, chief of the bureau’s tobacco lab.


“That’s the worst-case scenario,” he says.



Officials are less chatty about a third agency priority: The diplomatically sensitive work of promoting the international alcohol and tobacco trade.


The bureau helps strike deals with other countries that have liquor industries, like the one with Peru and Chile over Pisco. The idea is to protect U.S. alcohol and tobacco producers from unfair competition. Jim Beam’s prices might be easily undercut, for example, if an overseas firm was allowed to label something as bourbon even though it was aged in a cask that is neither charred nor oak nor new.


That’s how the Tequila Working Group was born. Citing safety concerns, Mexico had threatened to stop exporting bulk tequila — a commodity that supports 500 U.S. bottling jobs. After the bureau agreed in 2006 to regular meetings with Mexico’s tequila industry, Mexico backed down. The jobs were saved.


Until the early 2000s, the U.S. negotiated wine-making standards as part of a European wine trade group. As the American wine industry blossomed, officials began to believe that the group was favoring European wineries, for example, by refusing to endorse American agricultural methods. Every member of the group had veto power, and France was willing to use it.


The U.S. escaped Europe’s dominance by joining with other oenological up-and-comers like Australia, Argentina, Canada, Chile, New Zealand and South Africa to form the World Wine Trade Group. The group encourages countries to accept each other’s wine-making methods.



Its complicated history helps explain why the bureau looks and acts different from most government offices. As a tax-collecting agency, it wants to see its industries thrive. As a consumer-protection outfit tasked with keeping antifreeze-spiked wine off the market, the bureau must rein in dangerous, sloppy practices by industry members.


If other government agencies ran that way, the Consumer Product Safety Commission would be promoting U.S. baby crib makers at the same time it evaluated their products as potential death traps.


“There’s some peril with that kind of approach,” says Jeff Bumgarner, a professor of criminal justice at the University of Minnesota who studies the history of federal law enforcement. “The trade part of your mission is one of support and standing up the industries, and the tax collection part and the regulatory part and the compliance part is one of holding those industries in check.”


That basic conflict leaves the U.S. government with an alcohol regulator that recently hosted industry executives at conferences to educate them about the bureau’s rules and encourage “voluntary compliance,” then months later raided a Native American reservation that was suspected of harboring cigarette tax evaders.


Critics say the bureau’s close relationship with industry makes it less likely to take a hard line against violators.


Foster sees it another way. He says agents and officials like him are more effective overseers of the industry because they started out working on the distillery floor, measuring batches of liquor and handing producers their tax bills.


“It gave us all a significant understanding of how the industry operates and what their challenges were,” he says.


Agency officials say they are making the most of limited resources, and doing better than most federal departments. And their workload is increasing steadily. The alcohol and tobacco bureau is responsible, for example, for approving every label to be used on an alcohol product in the U.S. As the number of microbrewers and microdistilleries explodes, the work of reviewing those labels is becoming a heavier lift.


The bureau now regulates more than 56,000 companies, an increase of 27 percent since 2007. In that time, its core budget rose only 8 percent.



Like any government office, the agency has had its share of hiccups. Agawam grapes were known on U.S. wine labels as Agwam grapes until the bureau corrected its spelling error in rules published last year.


Vintners with leftover Agwam labels were given until October to stop using them.


___


Daniel Wagner can be reached at www.twitter.com/wagnerreports.


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Could Medicaid Benefits Get Pushed Off the Fiscal Cliff?












Medicaid provides benefits to more than 60 million Americans, including millions of children, who might not otherwise be able to afford medical care. This sizable government program has been sheltered from large federal cuts but is now vulnerable because of the ongoing talks in Washington to close the budget gap and avoid the fiscal cliff.Sharp cuts to Medicaid would hobble health care reform and hamper efforts to reduce overall health care spending, argues Sara Rosenbuam, a professor of health law and policy at the George Washington University School of Public Health and Health Services in Washington, DC, in an essay published online December 5 in the New England Journal of Medicine.Medicaid is relatively protected from automatic budget cuts by the Budget Control Act. The program is insulated from the across-the-board spending reduction known as sequestration which is set to take effect if Congress and the president fail to reach a compromise by the end of the year.However, there are still many ways Medicaid–and with it, some of the Affordable Care Act’s promised health care reform changes–could lose ground during the budgetary negotiations. Medicaid is a tempting target: a massive federal program that is only set to grow. Initially, the Affordable Care Act extended its coverage to some 20 million people as states expand eligibility to those who had not previously qualified but who have trouble obtaining private insurance. But in June, the U.S. Supreme Court undercut this provision, ruling that states were not required to extend additional eligibility.Rosenbaum argues that reducing coverage would mean that many millions will continue to go without medical coverage, continuing the shift of expenses on to insurers and other patients. The Congressional Budget Office has estimated that insuring people through Medicaid costs 50 percent less per person than subsidizing private insurance from a state-run health insurance exchange. “The problem is that Medicaid’s cost is driven by high enrollment, not excessive per capita spending,” Rosenbaum notes. “As a result, there’s very little money to wring out of Medicaid without shaking its structure in ways that reduce basic coverage.”Medicaid is an effective and efficient investment in health care for large numbers of people, she writes. For example, “much of the health care that Medicaid beneficiaries receive is furnished through safety-net providers such as community health centers, which are highly efficient and accustomed to operating on tight budgets.”One proposal to help trim the federal budget, as outlined by the House Budget Committee, run by Paul Ryan, would remove all of the Affordable Care Act’s Medicaid expansions in states and instead give out set grants for states to provide coverage for some qualifying residents. This option is estimated to save some $ 2 trillion in the next 10 years, but, Rosenbaum argues, it is based on “an arbitrary limit” rather than actual, changing needs. “Recent and ongoing demographic shifts…and recent tragedies, such as Hurricane Sandy, underscore the way in which uncontrollable events can cause unexpected surges in the need for government assistance,” she writes.”Such blunt force strategies would leave many poor and disabled Americans without the basic services they need to stay healthy,” Rosenbaum said in a prepared statement. Instead, she suggests redoubling efforts to increase the program’s efficiency, looking to reduce costs of caring for the most expensive patients, such as those that require long-term institutional care and use both Medicaid and Medicare.Other proposals limit states’ abilities to generate funds for Medicaid by levying taxes on hospitals or pharmacies. They also seek to reduce states’ abilities to use Medicaid funds to invest in public hospitals and other centers that care for beneficiaries. “Changing the rules would destabilize these institutions at the very time when expanded insurance coverage is creating greater demand for care,” Rosenbaum writes.But Medicaid is a plump and tempting budgetary target. And unlike Medicare, which provides coverage for seniors, Medicaid does not enjoy the same level of vocal (and financial) support. As Rosenbaum notes, often “Medicaid beneficiaries lack political clout.”


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Diabetes may be linked to hearing loss: study












(Reuters) – Diabetes has already been tied to an increased risk of kidney and cardiovascular troubles, nerve damage and vision loss, and now a Japanese study finds diabetics to be more than twice as likely as those without the disease to have hearing impairment.


In a review of past research on the issue, published in the Journal of Clinical Endocrinology and Metabolism, scientists found that younger diabetics were at even higher risk than older adults, though they could not explain why.












“Current meta-analysis suggests that the higher prevalence of hearing impairment in diabetic patients compared with nondiabetic patients was consistent regardless of age,” wrote lead researcher Chika Horikawa, at Niigata University Faculty of Medicine, and colleagues.


It’s not the first time researchers have found a link between diabetes and hearing loss. In 2008, researchers from the U.S. National Institutes of Health (NIH) saw similar patterns in a sample of more than 11,000 people, with people with diabetes twice as likely to have hearing loss as those without.


It’s thought that high blood sugar levels brought on by diabetes may lead to hearing loss by damaging blood vessels in the ears, said Horikawa.


Horikawa and colleagues collected information from 13 previous studies examining the link between diabetes and hearing loss and published between 1977 and 2011. Together, the data covered 7,377 diabetes and 12,817 people without the condition.


Overall, Horikawa‘s team found that diabetics were 2.15 times as likely as people without the disease to have hearing loss. But when the results were broken down by age, people under 60 had 2.61 times the risk while people over 60 hand 1.58 times higher risk.


Some experts caution that this kind of study does not prove that diabetes is directly responsible for the greater hearing loss rates.


“It doesn’t definitively answer the question, but it continues to raise an important point that patients might ask about,” said Steven Smith, a diabetes specialist at the Mayo Clinic in Rochester, Minnesota.


The researchers note that future studies that take more factors into account, such as age and noisy environment, are needed to clarify the link between diabetes and hearing loss.


Still, Horikawa told Reuters Health in an email, people should recognize that diabetics may be at risk for hearing loss based on their results.


“Furthermore, these results propose that diabetic patients are screened for hearing impairment from (an) earlier age compared with non-diabetics,” said Horikawa, adding that hearing loss has also been linked to an increased risk of depression and dementia. SOURCE: http:.//bit.ly/RIVeeW


(Reporting from New York by Andrew Seaman at Reuters Health; editing by Elaine Lies)


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