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Health & Fitness (233)
It has led to a new specialty - "oncoplastic" surgery - combining oncology, which focuses on cancer treatment, and plastic surgery to restore appearance.
"Cosmetics is very important" and can help a woman recover psychologically as well as physically, said Dr. Deanna Attai, a Burbank, Calif., surgeon who is on the board of directors of the American Society of Breast Surgeons. Its annual meeting in Chicago earlier this month featured many of these new approaches.
More women are getting chemotherapy or hormone therapy before surgery to shrink large tumors enough to let them have a breast-conserving operation instead of a mastectomy. Fewer lymph nodes are being removed to check for cancer's spread, sparing women painful arm swelling for years afterward.
Newer ways to rebuild breasts have made mastectomy a more appealing option for some women. More of them are getting immediate reconstruction with an implant at the same time the cancer is removed rather than several operations that have been standard for many years. Skin and nipples increasingly are being preserved for more natural results.
Some doctors are experimenting with operating on breast tumors through incisions in the armpit to avoid breast scars. There's even a "Goldilocks" mastectomy for large-breasted women - not too much or too little removed, and using excess skin to create a "just right" natural implant.
Finally, doctors are testing a way to avoid surgery altogether, destroying small tumors by freezing them with a probe through the skin.
"Breast surgery has become more minimalistic," said Dr. Shawna Willey of Georgetown's Lombardi Comprehensive Cancer Center.
"Women have more options. It's much more complex decision-making."
Breast cancer is the most common cancer in women around the world. In the U.S. alone, about 230,000 new cases are diagnosed each year.
Most can be treated by just having the lump removed, but that requires radiation for weeks afterward to kill any stray cancer cells in the breast, plus frequent mammograms to watch for a recurrence.
Many women don't want the worry or the radiation, and choose mastectomy even though they could have less drastic surgery. Mastectomy rates have been rising. Federal law requires insurers to cover reconstruction for mastectomy patients, and many of the improvements in surgery are aimed at making it less disfiguring.
Here are some of the major trends:
Doctors used to think it wasn't good to start reconstruction until cancer treatment had ended - surgery, chemotherapy, radiation. Women would have a mastectomy, which usually involves taking the skin and the nipple along with all the breast tissue, followed by operations months later to rebuild the breast.
Reconstruction can use tissue from the back or belly, or an implant. The first operation often is to place a tissue expander, a balloon-like device that's gradually inflated to stretch the remaining skin and make room for the implant. A few months later, a second surgery is done to remove the expander and place the implant. Once that heals, a third operation is done to make a new nipple, followed by tattooing to make an areola, the darkened ring around it.
The new trend is immediate reconstruction, with the first steps started at the time of the mastectomy, either to place a tissue expander or an implant. In some cases, the whole thing can be done in one operation.
Nationally, about 25 to 30 percent of women get immediate reconstruction. At the Mayo Clinic, about half do, and at Georgetown, it's about 80 percent.
SPARING SKIN, NIPPLES
Doctors usually take the skin when they do a mastectomy to make sure they leave no cancer behind. But in the last decade they increasingly have left the skin in certain women with favorable tumor characteristics. Attai compares it to removing the inside of an orange while leaving the peel intact.
"We have learned over time that you can save skin" in many patients, Willey said. "Every single study has shown that it's safe."
Now they're going the next step: preserving the nipple, which is even more at risk of being involved in cancer than the skin is. Only about 5 percent of women get this now, but eligibility could be expanded if it proves safe. The breast surgery society has a registry on nipple-sparing mastectomies that will track such women for 10 years.
"You really have to pick patients carefully," because no one wants to compromise cancer control for cosmetic reasons, Attai said.
"The preliminary data are that nipple-sparing is quite good," but studies haven't been long enough to know for sure, Willey said. "It makes a huge difference in the cosmetic outcome. That makes the woman's breast recognizable to her."
Dr. Judy Boughey, a breast surgeon at the Mayo Clinic, said the new approach even has swayed patients' treatment choices.
"We're seeing women choosing the more invasive surgery, choosing the mastectomy," because of doctors' willingness to spare skin and nipples, she said.
It helped persuade Rose Ragona, a 51-year-old operations supervisor at O'Hare Airport in Chicago. She had both breasts removed on April 19 with the most modern approach: Immediate reconstruction, with preservation of her skin and nipples.
"To wake up and just see your breasts there helped me immensely," she said.
She chose to have both breasts removed to avoid radiation and future worry.
"I felt it was a safer road to go," she said. "I can't live the rest of my life in fear. Every time there's a lump I'm going to worry."
Attai, the California breast surgeon, is one of the researchers in a national study testing cryoablation. The technique uses a probe cooled with liquid nitrogen that turns tumors into ice balls of dead tissue that's gradually absorbed by the body. This has been done since 2004 for benign breast tumors and the clinical trial is aimed at seeing if it's safe for cancer treatment.
"The technology is amazing. This is done in the office under local anesthesia, a little skin puncture," Attai said.
In the study, women still have surgery at some point after the freezing treatment to make sure all the cancer is destroyed. If it proves safe and effective, it could eliminate surgery for certain cancer patients.
"I'd love to see the day when we can offer women with small breast tumors a completely non-operative approach, and I do think that's coming soon," Attai said.
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Where you live could make a huge difference in what you'll pay.
To try to keep premiums low, some states are allowing insurers to charge patients a hefty share of the cost for expensive medications used to treat cancer, multiple sclerosis, rheumatoid arthritis and other life-altering chronic diseases.
Such "specialty drugs" can cost thousands of dollars a month, and in California, patients would pay up to 30 percent of the cost. For one widely used cancer drug, Gleevec, the patient could pay more than $2,000 for a month's supply, says the Leukemia & Lymphoma Society.
New York is taking a different approach, setting flat dollar copayments for medications. The highest is $70, and it would apply to specialty drugs as well.
Critics fear most states will follow California's lead, and that could defeat the purpose of Obama's overhaul, because some of the sickest patients may be unable to afford their prescriptions.
"It's important that the benefit design not discriminate against people with chronic illness, and high copays do that," said Dan Mendelson, president of Avalere Health, a data analysis firm catering to the health care industry and government.
Avalere's research shows that 1 in 4 cancer patients walks away from the pharmacy counter empty-handed when facing a copay of $500 or more for a newly prescribed drug.
"You have to worry about a world where if you happen to contract cancer or multiple sclerosis, you are stuck with a really big bill," Mendelson said. "It's going to be very important for states to take a long, hard look at their benefit design."
Although the money for covering uninsured Americans is coming from Washington, the heath care law gives states broad leeway to tailor benefits, and the local approach can also allow disparities to emerge.
A spokesman for Covered California said state officials are trying to balance between two conflicting priorities: comprehensive coverage and affordable premiums.
"We are trying to keep the insurance affordable across the board," said Dana Howard, the group's spokesman. "This is just part of trying to manage the overall risk of the pool." Covered California is one of the new state marketplaces where people who don't get coverage on the job will be able to shop for private insurance starting this fall. Coverage takes effect Jan. 1.
Insurers are forecasting double-digit premium increases for individual policies, as people with health problems flock to buy coverage previously denied them. The Obama administration says the industry warnings are overblown, and that for many consumers, premium increases will be offset by tax credits to help buy insurance. And officials say it's important to realize that the law sets overall limits on patients' liability, even if those seem high to some people. Still, a full picture of costs and benefits isn't likely to come into focus until the fall.
Howard said California officials are aware of the concerns about drug costs and are trying to make medications more affordable.
Meanwhile, he said consumers will be protected because the law limits total out-of-pocket costs - the deductibles and copayments that policy holders are responsible for, apart from monthly premiums. In California, the annual out-of-pocket limit for an individual is $6,400, although it can be as low as $2,250 for low-income people. Once that limit is reached, insurance pays 100 percent.
That's still a lot of money, and such reassurances haven't dispelled the concerns.
"The intent of the Affordable Care Act is to make sure that all Americans have access to quality, affordable health care," said Brian Rosen, a senior vice president of the Leukemia & Lymphoma Society. He adds that there is a danger that the insurance marketplaces "will discriminate against the patients with the highest medical need. That would completely undermine the spirit of the ACA."
The group has been joined by Rep. Doris Matsui, D-Calif., in urging state officials to reconsider the policy. The high copays "could prevent many patients from receiving the lifesaving treatments they need because of prohibitively high cost," Matsui wrote to the state.
The problem with costly drugs is similar to another money issue with the health care law - a provision that could price millions of smokers out of coverage. Insurers are allowed to charge tobacco users buying an individual policy up to 50 percent higher premiums. For a 55-year-old smoker, the penalty could reach nearly $4,250 a year, on top of the standard premium. California is trying to override that problem by passing its own law. There's also pending state legislation to address some issues with prescription costs, but its prospects are unclear.
Meanwhile, leukemia patient Lisa Lusk worries about what will happen to her. A nursing assistant who lives near Fresno, Lusk is hoping to return to work in the next few months. When that happens, she expects to lose emergency coverage she's now getting through the state. And the medication Lusk takes to manage her chronic form of the disease costs more than $5,000 a month.
"I'm scared that when I get a job my copay may be more than $1,500 a month," said Lusk. "I'll just be working to pay for my medications."
Last week, the coronavirus related to SARS spread to France, where one patient who probably caught the disease in Dubai infected his hospital roommate. Officials are now trying to track down everyone who went on a tour group holiday to Dubai with the first patient as well as all contacts of the second patient. Since it was first spotted last year, the new coronavirus has infected 34 people, killing 18 of them. Nearly all had some connection to the Middle East.
The World Health Organization, however, says there is no reason to think the virus is restricted to the Middle East and has advised health officials worldwide to closely monitor any unusual respiratory cases.
At the same time, a new bird flu strain, H7N9, has been infecting people in China since at least March, causing 32 deaths out of 131 known cases.
WHO, which is closely monitoring the viruses, says both have the potential to cause a pandemic - a global epidemic - if they evolve into a form easily spread between people. Here's a crash course in what we know so far about them:
Q: How are humans getting infected by the new coronavirus?
A: Scientists don't exactly know. There is some suggestion the disease is jumping directly from animals like camels or goats to humans, but officials are also considering other sources, like a common environmental exposure. The new coronavirus is most closely related to a bat virus, but it's possible that bats are transmitting the disease via another source before humans catch it.
Q: Can the new coronavirus be spread from human to human?
A: In some circumstances, yes. There have been clusters of the disease in Saudi Arabia, Jordan, Britain and now France, where the virus has spread from person-to-person. Most of those infected were in very close contact, such as people taking care of a sick family member or health workers treating patients. There is no evidence the virus is spreading easily between people and all cases of human-to-human transmission have been limited so far.
Q: How are people catching the bird flu H7N9?
A: Some studies suggest the new bird flu is jumping directly to people from poultry at live bird markets. Cases have slowed down since Chinese authorities began shutting down such markets. But it's unclear exactly what kind of exposure is needed for humans to catch the virus and very few animals have tested positive for it. Unlike the last bird flu strain to cause global concern, H5N1, the new strain doesn't appear to make birds sick and may be spreading silently in poultry populations.
Q: What precautions can people take against these new viruses?
A: WHO is not advising people to avoid traveling to the Middle East or China but is urging people to practice good personal hygiene like regular hand-washing. "Until we know how and where humans are contracting these two diseases, we cannot control them," said Gregory Hartl, WHO spokesman.
Q: Which virus should we be more worried about?
A: It's impossible to know. "We really don't want to play the game of predicting which virus will be more deadly than the other," Hartl said. At the moment, both are worrisome since so little is known about how they are infecting humans and both appear to cause severe disease. "Any virus that has the ability to develop the capacity to spread from human to human is of great concern to WHO," he said.
The stakes are high for Christie, with medical professionals and campaign strategists alike suggesting there is no more serious barrier to his personal well-being and national ambitions than his weight.
It's not about politics, he said. It's about turning 50 and wanting to be around as his children grow up.
"This is a hell of a lot more important to me than running for president," Christie, a father of four, said at a news conference in Newark. "This is about my family's future."
Christie, who appeared thinner than he did earlier this year, said he decided around the time of his birthday in September to have the surgery and initially planned to have it done in November. But Superstorm Sandy's destruction in New Jersey pushed back the procedure until February. In the operation, a band was surgically placed around his stomach to restrict how much food he could eat.
Christie has not previously disclosed his weight, and he didn't on Tuesday. But it has been an issue throughout his political career. Comedians have often made fun of it, and in interviews with David Letterman, Oprah Winfrey, Barbara Walters and others, Christie has both joked about the issue and said solemnly that he was trying to shed pounds.
During a February appearance on "The Late Show with David Letterman," the governor pulled out a doughnut and said his girth was "fair game" for comedians.
Over the next few days, he was asked repeatedly about his weight. At one point, he said he had a plan. "Whether it's successful or not," he said, "you'll all be able to notice."
The next day, he responded angrily to comments from a former White House physician who said she hoped he would run for president but worried about him dying in office. The governor said the doctor should "shut up."
Ten days after that, on Feb. 16, Christie had the surgery. He said the operation lasted 40 minutes and he was home the same afternoon. He was back at work on Feb. 19 for a full day of events.
Christie, who is in the midst of a re-election campaign, said he has been eating less because he hasn't been as hungry. He also has been working out with a personal trainer.
He said he had told only a few top staffers - not his communications office or campaign staff - and his communications director was caught by surprise Monday when a New York Post reporter asked directly if he'd had the procedure. The Post first reported the surgery on Tuesday. Christie said he'd used an alias at the hospital.
Christie said he never intended to make a public announcement and that he was "not going to be the guy who writes a book" about losing weight. The Republican, who has been a fixture in the national media spotlight, said the scrum of reporters at his news conference was "silly" and "ridiculous" at a time when there are other things going on.
He said he tried other ways to lose weight for years, but none seemed to work.
"It's not a career issue for me; it's a long-term health issue for me," he said.
Still, it's a way to confront a significant hurdle in his indisputable quest to emerge as a key leader in the Republican Party. He's in the top tier of those considered potential contenders for the presidential nomination in 2016.
Weeks after the surgery, Christie launched an aggressive national fundraising tour, fueling speculation that he's laying the groundwork for a White House bid.
In a country facing an obesity epidemic, more than 220,000 stomach-reducing procedures of various types are performed each year. Gastric bypass, sometimes called stomach stapling, is the most common, where surgeons shrink the stomach's size and reroute food to the small intestine. Christie had gastric band surgery. It's best known by the brand name Lap-Band, and is a less invasive alternative in which an adjustable ring is placed over the top of the stomach and tightened to restrict how much food can enter.
The adjustable Lap-Band has been available in the U.S. since 2001 for the most obese patients, and in 2011 the Food and Drug Administration expanded approval to somewhat less obese patients.
Candidates for gastric banding must have a body mass index of between 30 and 40 - plus a weight-related medical condition, such as diabetes or high blood pressure - or a BMI of 40 and higher. They also must have previously attempted to lose weight through diet and exercise.
"If you eat appropriately and chew your food, it works nicely," said Dr. Christina Li, a bariatric doctor at Sinai Hospital of Baltimore. She said Christie has the resources to have people help him eat right and get exercise. While the band is removable, she said patients are told to adjust to having it for the rest of their lives.
Li said risks include infection, and that it does not work for all patients.
Dr. Jaime Ponce, who practices in Dalton, Ga., and is president of the American Society for Metabolic & Bariatric Surgery, said people who have the procedure Christie had often lose 1 to 2 pounds per week.
Christie's procedure was performed by Dr. George Fielding, head of NYU Medical Center's Weight Management Program, who did the same procedure for New York Jets coach Rex Ryan three years ago.
"It basically teaches you how to eat like a human," Ryan said of the device in an interview last week with The Associated Press. "The Lap-Band goes: `No, no. You're only going to eat this or that,' and it trains your body how to eat right," said Ryan, who said he has lost 115 pounds from his pre-surgery weight of 348.
Few significantly overweight presidential candidates have succeeded in the modern political era, when television became a major factor in shaping voter attitudes. There are disputed reports that President William Howard Taft couldn't fit in a White House bathtub a century ago, but only a handful of presidents since have been considered obese. President Bill Clinton struggled at times with his weight, but he was substantially slimmer than the New Jersey governor.
"This has nothing to do with politics," said Christie adviser Bill Palatucci. "He said that he's doing this for his family and that's the right reason."
Backers publicly argue that Christie answered any questions about his weight's political impact in 2009, when he beat Gov. Jon Corzine despite the Democrat's reference in an ad to Christie "throwing his weight around" to get out of traffic tickets. Supporters say Christie's openness about his struggle is part of an authenticity people admire in him.
The governor's allies, medical professionals and even history suggest that his weight presents both practical and political problems.
"Gov. Christie's weight is an issue the same way that any candidate or official's health is an issue," said Michael Dennehy, a New Hampshire-based Republican strategist and veteran of presidential politics. "Anyone running for president will need to comfort Americans with an overall healthy picture for their future."
Mulvihill reported from Haddonfield, N.J., and Peoples from Providence, R.I. AP Medical Writer Lauran Neergaard in Washington, AP writers Thomas Beaumont in Des Moines, Iowa, and AP Sports Writer Dennis Waszak in New York contributed to this report.
The company says that people who received 18 months of infusions with its drug, Gammagard, fared no better than others given infusions of a dummy solution.
Gammagard is immune globulin, natural antibodies culled from donated blood. Researchers thought these antibodies might help remove amyloid, the sticky plaque that clogs patients' brains, sapping memory and ability to think.
Patients with moderate disease and those with a gene that raises risk of Alzheimer's who were taking the higher of two doses in the study seemed to benefit, although the study was not big enough to say for sure.
"The study missed its primary endpoints, however we remain interested by the prespecified sub-group analyses" in groups that seemed to benefit, Ludwig Hantson, president of Baxter's BioScience business, said in a statement.
Gammagard is already sold to treat some blood disorders, and the results of the Alzheimer's study do not affect those uses. About 35 million people worldwide have dementia, and Alzheimer's is the most common type. In the U.S., about 5 million have Alzheimer's. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.
Excitement about Gammagard grew last summer, when researchers reported at a medical conference that the drug had stabilized Alzheimer's disease for as much as three years in four patients who had been receiving the highest dose of it for three years in the study. People typically go from diagnosis to death in about eight years, so to be stable for so long was considered remarkable.
The new results on the full group of study participants are disappointing, said the study's leader, Dr. Norman Relkin, head of a memory disorders program at New York-Presbyterian Hospital/Weill Cornell Medical Center.
"The bar was set very high" for the drug to show improvement, and "there does appear to be a signal" that it helped the two-thirds of patients in the study who had the apoE4 gene that raises the risk of developing Alzheimer's, as well as those with moderate versus mild disease, Relkin said.
No new side effects were seen in the study. About 5 percent of patients on the drug had a rash and decreases in hemoglobin, which carries oxygen in the blood. There were 17 serious reactions, 12 in the drug group and five in the placebo group.
Full results will be presented in July at an Alzheimer's conference in Boston.
Meanwhile, other studies are under way to test drugs earlier in the course of the disease. An experimental drug, Eli Lilly & Co.'s solanezumab, showed some promise in that setting in an earlier study.
Shares of Baxter fell $2.53, or 3.6 percent, to $67.78 in morning trading.
The FDA has regulated tanning beds and sun lamps for over 30 years, but for the first time ever the agency says those devices should not be used by people under age 18. The agency wants that warning on pamphlets, catalogues and websites that promote indoor tanning. And regulators are also proposing that manufacturers meet certain safety and design requirements, including timers and limits on radiation emitted.
The government action is aimed at curbing cases of melanoma, the deadliest form of skin cancer, which have been on the rise for about 30 years. An estimated 2.3 million U.S. teenagers tan indoors each year, and melanoma is the second most common form of cancer among young adults, according to the American Academy of Dermatology.
Recent studies have shown that the risk of melanoma is 75 percent higher in people who have been exposed to ultraviolet radiation from indoor tanning. While most cases are diagnosed in people in their 40s and 50s, the disease is linked to sun exposure at a young age.
Physician groups have been urging the U.S. government to take action on tanning beds for years, citing increases in the number of cases of skin cancer among people in their teens and 20s.
"As a dermatologist I see the consequences of indoor tanning. I have to diagnose too many young people with melanoma and see the grief that it causes to these families," said Dr. Mary Maloney of the American Academy of Dermatology, on a call with FDA officials. Maloney said the FDA action is an important first step, but that her group would continue to push for a ban on the sale and use of tanning beds for people under age 18.
Earlier this year, a study of Missouri tanning salons found that 65 percent of 250 businesses surveyed would accept children ages 10 to 12, often without parental permission. The study was conducted by dermatologists at the Washington University School of Medicine in St. Louis.
Currently the machines are classified as low-risk devices, in the same group as bandages and tongue depressors. The proposal would increase their classification to moderate-risk, or class II, devices. That would allow the FDA to review their safety and design before manufacturers begin selling them.
"They don't have to provide any data in advance before they go on the market, so we have no way of providing assurance that the tanning beds are performing up to specifications," said Dr. Jeffrey Shuren, FDA's director for medical devices.
Safety standards are important because recent studies show that many devices can cause sunburn even when used as directed. A 2009 study found that 58 percent of adolescents who tan indoors had sunburn exposure.
"If you get an indoor tan you shouldn't be burning," Shuren said.
The Indoor Tanning Association said it supported any changes that improve its customers' safety. But, in a statement, the group added that "we are concerned that these changes will burden our members with addition unnecessary governmental costs in an already difficult economic climate."
The FDA proposal would not place warnings on the devices themselves, but on related promotional material and websites. Some consumer advocates said those warnings might never actually reach users.
"The FDA is requiring that the labels and pamphlets include risk information about skin cancer, but consumers would not be required to see those labels or pamphlets - they are apparently only for the company buying the tanning bed," said Diana Zuckerman, of the National Research Center for Women and Families.
The agency said it will take comments on its proposal for 90 days before formulating a final regulation. Agency officials didn't give a timeframe for completion, but said it would be a priority.
TRENTON, N.J. (AP) - Men who are bashful about needing help in the bedroom no longer have to visit a drugstore to buy that little blue pill.
In a first for the drug industry, Pfizer Inc. says starting today it will sell begin selling erectile dysfunction pill Viagra directly to patients on its website.
Men still will need a prescription to buy the blue pill on viagra.com, but they won't have to face a pharmacist to get it filled.
Other drugmakers likely will watch closely, and could begin selling other medicines online.'