NEW YORK (AP) — When Dorothy Twinney first saw a Race for the Cure walk for breast cancer — “a sea of pink” traveling through her hometown of Plymouth, Mich. — she was so moved she sat in her car and wept.

This week, after watching The Susan G. Komen for the Cure breast cancer charity announce plans to cut funding to Planned Parenthood, then abandon those plans amid a public furor, Twinney decided she was done with the organization for which she raised thousands of dollars on three-day, 60-mile walks that left her feet bloodied and blistered, but her spirits high. 

“It just feels like it’s all tarnished now,” the 41-year-old mother of two said. “Honestly, I’m not sure what they can do to change that.”

At week’s end, many longtime Komen supporters were feeling similarly conflicted. Some, depending on where they stood on the hot-button issue of abortion, called it more of a betrayal. Those who supported Komen’s grants to Planned Parenthood for breast-cancer screenings called the initial move to cut them politically motivated; those opposed to the grants said the same thing about the reversal.

The outrage clearly stunned Komen, the country’s most widely known breast cancer organization. “I think (Komen) has been horrified to be so caught up in this culture war,” said Eric Scheidler, executive director of the Chicago-based Pro-Life Action League.

Many women described feeling caught in the middle when The Associated Press first reported on Tuesday that Komen had adopted criteria excluding Planned Parenthood from future breast screening grants because it was the subject of an investigation launched by a Florida congressman at the urging of anti-abortion groups. The grants totaled $680,000 in 2011.

Alyce Lee-Walker was one of them. A longtime Komen supporter, she’d never given money to Planned Parenthood. But when she learned of the funding cut, she immediately went online to donate $188 — the 88 signifying good luck in Chinese.

She didn’t stop there. The small business owner from Pinehurst, N.C., went about removing all the pink-ribbon stickers, a Komen symbol, that she’d affixed to her belongings.

“I took them off my personal car, the business car, off the doors in the office,” she said. And that pink chef’s knife she bought at Williams-Sonoma, with some of the proceeds going to Komen? “I’m done with that, too,” she said.

When she worked on Wall Street, Lee-Walker once prowled the trading floor soliciting donations “from anyone who loved a sister, mother, wife — or who was a fan of breasts,” she quips. She raised $15,000. But now, Komen’s reversal as well as its original move left her disgusted, she said: “It’s all political.”

Many shared that skepticism. “I’m wondering, is this really what they believe now, or is it just all the bad press that made them do it?” asked Mary Gauvin, a 27-year-old mother from Fort Drum, N.Y. “I doubt their motivation a bit.”

Gauvin, a supporter in the past of both Planned Parenthood and Komen, said that now, if a friend asked for sponsorship in a Race for the Cure event, she would offer to give money instead to the American Cancer Society.

Also switching allegiance was Suzanne Strempek Shea, a novelist and college writing teacher in Northhampton, Mass. “If someone asks me to sponsor them,” she said, “I’m going to say, ‘I wish you well, but I’m going to give the amount I’d have given you to Rays of Hope,” another breast cancer support group.

The issue was particularly painful to Shea, 51. She is a breast cancer survivor who discovered early warning signs at a Planned Parenthood breast screening (the group does screenings and refers some patients for mammograms).

“They found the cysts that led to the diagnosis. I don’t think people realize all the good they do,” Shea said. Horrified that a crucial women’s health issue had become entwined with the abortion debate, she said that despite the reversal, “I’m still angry.”

Even angrier about the reversal were anti-abortion advocates who’d applauded Komen’s original move.

“We were very happy to see (Komen) discontinue funding to Planned Parenthood,” said Tony Lauinger, state chairman for Oklahomans For Life. “For an entity … that’s trying to prevent breast cancer across the world, it’s directly counterproductive that the organization would be giving funds to Planned Parenthood, which is the largest provider of abortions in the country.”

Scheidler, of the Pro-Life Action League, sent out emails and social media messages Friday aimed at “tens of thousands” of abortion foes, urging them to withhold donations to Komen. Days earlier, when the original decision was reported, he’d urged people to donate to Komen.

Renee Wiesner, a mother of nine who opposes abortion, said she had been encouraged by Komen’s original decision.

“I had known about the grants, and that’s why I had avoided supporting Komen in the past,” said Wiesner, of Aurora, Ill. Now, she said, she will wait for the furor to die down before deciding where to contribute.

She said she suspected the reversal was simply a PR move by Komen:  “They need to keep a good public image if they want to be as successful as they’ve been.”

Not everyone was beating up on Komen. “They made a bad call, but they rethought their position,” said Katie Ferdinand, 46, of Basking Ridge, N.J. “I’d consider supporting them going forward.”

Before the reversal, Ferdinand had gone on Facebook and urged friends to join her in contributing to Planned Parenthood. The organization said it received $3 million between Tuesday evening and Friday afternoon, funds it said would be used to expand its breast health services, which now provide nearly 750,000 breast exams each year.

That made Planned Parenthood supporter Cindy Froggatt happy. “I am grateful to Komen for the unintended consequence of their misguided decision,” said Froggatt, of Philadelphia. She especially admired the actions of New York Mayor Michael Bloomberg, who himself made a $250,000 gift.

The controversy was rawest, it seemed, for breast cancer survivors, especially those, like Joyce Miller, who’d donated many hours of time to Komen. After her first breast cancer treatment, Miller spent an hour a day manning Komen’s phone lines, for nearly two years.

“I do not forgive them,” the 70-year-old Dallas woman said Friday, after the reversal. She said she was also thinking of her daughter, Twinney, the Michigan woman, who spent years on the breast cancer walks. “Those bloody feet,” Miller said. “The aching back!”

As for Twinney, she didn’t try to hold back the tears as she spoke of the years of fundraising, which included bartending stints to get cash together, and the three-day walks, buoyed by supporters including her two sons, who even agreed to dress in pink.

“Those weekends, on those walks, were some of the most special times of my life, next to the birth of my children,” she said. “You met the best people in the world. This organization began for such a special reason. And I am just so disappointed right now.”

___

Associated Press writers Carla K. Johnson in Chicago and Justin V. Juozapavicius in Tulsa, Okla., contributed to this report.

SATURDAY, Feb. 4 (HealthDay News) — Winter weather can be
challenging for some seniors, especially those with mobility or other
health issues.

But planning ahead, and enlisting the help of adult children, neighbors
or caregivers when needed, can help seniors stay safe and mobile during
the cold months.

“Snow and ice, cold temperatures and heating devices are all potential
safety hazards that result in a number of accidents every year. Minor
additions or changes to a senior’s home can minimize the risk of an
accident and create a dramatically safer environment,” Andrea Cohen, CEO
of HouseWorks, a Massachusetts-based private-pay home care business, said
in a company news release.

She offered a number of suggestions. If mobility, balance or other
health issues have made shoveling snow too taxing, make sure someone is
available to shovel snow and remove ice so that walkways are clear and
it’s safe to enter and exit the home.

Also, make sure that dryer vents and gutters are cleared.

Because cold weather and snow can limit a senior’s ability to get out
to take care of errands, it’s important to arrange to have someone
available to help with grocery shopping and to make sure the senior has
enough food and medication for several days, in case weather makes streets
impassable or affects electricity. Flashlights and batteries should be
readily available in case of a power outage.

Heating pads and space heaters are used by some seniors for extra
warmth, but these devices can be fire hazards if they’re not functioning
properly or if they’re left unattended. Check these items and repair or
remove any that might be unsafe. Fresh batteries should be placed in smoke
and carbon monoxide detectors in seniors’ homes.

Make sure important phone numbers — family members, health care
providers, food delivery — are posted in a convenient and visible
location, such as the refrigerator. The telephone needs to be easily
accessible and work when the power is out. It’s a good idea to provide
seniors with an easy-to-use charged mobile phone for emergencies.

If a senior lives far away from family members, arrange for a friend or
neighbor to check on them from time to time. Consider a medical alert
system that can ensure immediate response to a medical emergency.

A senior’s home might require safety modifications such as grab bars,
hand-held showers, or rearrangement of furniture and rugs.

More information

The AGS Foundation for Health in Aging offers

winter safety tips for seniors .

Copyright © 2012HealthDay. All rights reserved.

SATURDAY, Feb. 4 (HealthDay News) — All the food and beverages
served at Super Bowl parties can make it a challenging day for people who
made a New Year’s resolution to lose weight.

“We know January is the start of lots of new diets. But, then February
starts and the first weekend is Super Bowl Sunday, one of the biggest
eating days all year,” Alenka Ravnik-List, a registered dietitian and
diabetes program coordinator at the Mount Sinai Medical Center in New York
City, said in a center news release.

“Hours in front of the television can test our willpower. Too often
people with good intentions will fail,” she added.

However, by following a few rules you’ll be able to limit the impact
Super Bowl Sunday has on your diet plans, Ravnik-List said.

Start by making sure you eat breakfast on game day. Research has shown
that people who skip breakfast tend to eat more food than usual at the
next meal and munch on high-calorie snacks to ward off hunger. It’s also a
good idea to have a light lunch so you won’t be famished by the time the
game starts.

The game doesn’t begin until after 6 p.m., so that gives you plenty of
time to get out for some exercise that day. During half time, take a walk
around the block or toss a football around in the yard.

Use a medium-sized plate, about eight to nine inches wide, in order to
limit the amount of food you eat. Half the plate should be loaded with
colorful vegetables and the other half with lean protein and whole grain
starches. If you suspect your Super Bowl party hosts won’t offer
vegetables or other healthy snacks such as popcorn, bring your own,
Ravnik-List suggested.

If you drink alcoholic beverages, choose those with fewer calories and
carbohydrates, such as light beer, champagne or dry wine. For mixed
drinks, use sugar-free mixes such as diet soda, diet tonic, club soda or
seltzer.

Instead of chips, use nutritious choices such as broccoli, carrots,
celery and tomato grapes for dips. Try lighter versions of your favorite
dips. Don’t sit within an arm’s length of the chip and dip bowls or other
snacks that you can’t resist.

Limit what you eat during the actual football game. Try to eat only
during half-time and have a small snack after the first and third
quarters, Ravnik-List suggested.

More information

The American Academy of Family Physicians offers

nutrition advice .

Copyright © 2012HealthDay. All rights reserved.

(Reuters) – Allergan Inc, maker of wrinkle treatment Botox, eye drops and obesity treatments, said it will rely less on the United States for revenue in coming years as its products gain wider acceptance in Asia, particularly China.

The company on Thursday announced 6.4 percent earnings growth for the fourth-quarter of last year, but forecast lower-than-anticipated sales for 2012 as austerity measures in Europe keep a lid on demand and force the company to hold down prices.

Ian Bell, corporate vice-president and president for Asia-Pacific, was upbeat on growth prospects across Asia, with China appearing to be the main driver.

Bell told Reuters in an interview that cosmetic clinics were popping up in big hospitals in major Chinese cities, presenting an opportunities for Allergan’s aesthetics products.

He said sales of Botox for aesthetic use in China in 2011 were encouraging and Allergan was trialling its skin filler Juvederm, hoping to make it available in China in 2-3 years.

“China is going to grow very quickly over the next decade. We are starting somewhat late; Botox was only approved over a year ago and therefore levels of penetration are low,” he said.

“We have a big part of our portfolio that is privately paid, where healthcare reform is irrelevant,” said Bell, referring to China’s healthcare restructuring targeted at making more cheap drugs widely available.

“DOUBLE-DIGIT GROWTH”

Sales in Asia-Pacific grew 27 percent year on year in the third quarter of 2011, with “double-digit growth in Q4,” said an Allergan spokeswoman in Singapore.

“(Sales are) 60 percent the U.S. and 40 percent the rest of the world. The rest of the world is growing quicker than the U.S. right now and within those markets, Asia-Pacific is the fastest growing for us,” said Bell. “We see the trend continuing … and as for those percentages and our reliance on the U.S., we believe that over time it is going to diminish.”

Allergan obtained approvals in Asia in 2011 to use Botox to treat chronic migraines in Australia, Hong Kong, India, Malaysia, New Zealand, South Korea and Vietnam.

“The biggest market is Australia and we are now in negotiations with the authorities there to get it reimbursed. We hope to achieve that this year, so by end of 2012 we expect to be in a strong position to drive sales,” Bell said.

(Reporting by Tan Ee Lyn in SINGAPORE; Editing by Chris Lewis)

LONDON (Reuters) – In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn’t pay much attention.

A U.S. Food and Drug Administration (FDA) inspection had found some products manufactured by Poly Implant Prothese (PIP) were “adulterated,” the letter said. French regulators say they can’t be sure now if they even saw it on the FDA’s website.

In the following decade, substandard silicone implants made by PIP were implanted into hundreds of thousands of unwitting women around the world. The French government in December advised 30,000 women to have their implants removed, warning the devices had an unusually high rupture rate and may contain industrial-grade silicone.

The lack of transatlantic communication is just one problem highlighted by the scandal. The affair is rooted in an alleged fraud, in which PIP is suspected of duping inspectors and flouting safety rules.

But some doctors, regulators and even the medical devices industry itself say the affair also exposes Europe’s weak regulation system – one that allowed PIP to operate for longer than it could have under a more rigorous regime.

They point to an ad hoc system of product approval and a lack of vigilance once a device is on the market. And they say the process is so byzantine, no organization is truly taking responsibility for keeping the public safe.

“Unsafe at any speed – that’s one description I’d use for medical device regulation in Europe,” said Nick Freemantle of University College London, who has published studies on the way medical devices get to market.

Trish Groves, deputy editor of the British Medical Journal says there’s “definitely a risk other poor products will get through, because the system is so very weak.”

French health authorities acknowledged as much in a 175-page report on February 1. “Radical change” is needed in Europe to assure proper surveillance of medical devices, said the health department’s general director Jean-Yves Grall.

FDA ACTED SOONER

The FDA got onto PIP when the company sought approval to sell saline implants in the United States in 2000. The FDA rejected the application. Its warning letter cited PIP’s failure to investigate deflation problems with the implants, as well as a failure to report more than 120 complaints about them from customers in France and elsewhere.

“Given the serious nature of these violations … all devices manufactured by PIP … may be detained without physical examination upon entry to the United States until these violations are corrected,” said the letter, dated June 22, 2000.

The FDA believes its rigorous standards stopped U.S. patients from being exposed to the PIP implants, said William Maisel, deputy director and chief scientist for devices.

In the European Union, where more than 500,000 medical devices are sold, from dentures and wheelchairs to pacemakers and implants for breasts, buttocks and testicles, the system is both less thorough and more complex than the U.S. regime.

Medical devices are regulated under the Conformite Europeenne, or “CE mark,” system – sometimes known as the “kite mark” for its distinctive shape. The CE mark is also used for household gadgets like electric toasters or coffee machines and for children’s toys and mobile phones.

Getting a CE mark is tougher for devices like pacemakers or implants than for toys or toasters. But the badge of approval can still be gained with relatively few tests – certainly less scrutiny than the extensive clinical trials required for pharmaceuticals.

“CHALK AND CHEESE”

The EU and U.S. systems are as different as “chalk and cheese,” said Freemantle. In the United States, medical devices are tested by serious regulatory scientists at the FDA, in a process that resembles a new drug submission. Europe’s system, he said, is “more like an old-boy network.”

Because Europe has no centralized process for approving medical devices, manufacturers don’t go directly to a national or Europe-wide regulator. Instead, they seek a CE mark through any one of around 70 to 80 organizations known as Notified Bodies, which largely are private companies.

The Notified Bodies are scattered across all 27 EU member states and range from large companies to small firms with just one or two employees. All are authorized to give a stamp of approval to a new product. They are tasked with checking the product does what it’s supposed to, has been tested in a lab, or is similar to other devices on the market. And Notified Bodies can suggest to manufacturers that they contract out testing to small laboratories, who may themselves be authorized by a separate agency.

Scientists who published a review of the system in the European Heart Journal in May 2011 found that the fragmentary setup encourages manufacturers to shop around for countries or Notified Bodies most likely to offer hassle-free certification.

A 2010 survey of medical device manufacturers by researchers at Stanford University found that high-risk devices took an average of 54 months to get through the FDA to market, but just 11 months in Europe.

The medical technology industry says it recognizes Europe’s system is flawed.

John Brennan, director of regulatory and technical affairs at industry trade body Eucomed, which represents some 22,500 medical technology companies in Europe, said the system is constrained by “an excessive level of confidentiality, a lack of effective central coordination and the perceived lack of clinical data and involvement of authorities.”

The European Commission, which oversees the laws governing devices regulation, said the Notified Bodies’ quality looks uneven. It began working on new proposals to tighten the system long before the PIP scandal erupted, it said.

“The present legislation gives too great a margin of maneuver to organizations that certify medical devices,” said the Commission’s Director General for Health and Consumers, Paola Testori Coggi. The system is “imperfect” and has “a lot of space to improve.”

“SMOKESCREEN”

Once the Notified Body’s initial job is done and a product is on the market, it’s up to national regulators to keep a look out for problems and ensure the Notified Body is keeping tabs.

In the PIP case, that national regulator was the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), which has the power to take a medical device off the market. The Notified Body that gave PIP authorization to trade was a private German firm called TUV Rheinland.

AFSSAPS – already set for an overhaul following a scandal over diet pills which France withdrew in 2009 after they were blamed for at least 500 deaths – told Reuters that responsibility for checking medical devices like breast implants lies with the manufacturer.

It said the regulatory focus should be on TUV, whose inspectors would visit PIP’s headquarters once a year, assess standards, review paperwork and then report back to the company and German authorities in case of problems.

TUV said the implants themselves were tested by two French laboratories, which were in turn authorized by another French agency called COFRAC. Both labs confirmed they had tested PIP’s implants. One said its tests were only mechanical, such as rupture tests; the other said it had tested the implants’ contents for toxicity, but would not give details.

COFRAC, a government-funded non-profit body, said it was not responsible for the output of a lab and could not guarantee test results. COFRAC does not answer to AFSSAPS, but is audited internally and by peer review.

For its part, TUV was only responsible for auditing PIP’s manufacturing process, said spokesman Hartmut Mueller-Gerbes. TUV relied on PIP to disclose any operational alterations, such as a change in the kind of silicone it was using. If PIP said nothing, TUV would assume everything was unchanged. Audits were based on the assumption that a firm is responsible and liable, and would have too much to lose to cut corners, TUV said.

Germany’s Zentralstelle der Laender fuer Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, or ZLG, monitors TUV. It said inspections are announced a few weeks in advance, as stipulated in EU rules, and a wide range of documents are checked once a year.

PIP’s founder, Jean-Claude Mas, testified to police that PIP hid a paper trail documenting large purchases of non-authorized raw materials which may have aroused TUV’s suspicions.

It all adds up to what Richard Horton, editor of The Lancet medical journal, calls a “smokescreen of device regulation which is putting patients at risk.” The whole system is “based on the idea that you wait until something goes wrong before you take any serious action.”

“STRESS TEST”

It isn’t clear how AFSSAPS missed the warning from American regulators. AFSSAPS said it can’t be sure whether someone saw the letter. It watches the FDA’s site, but not systematically.

Jean-Claude Ghislain, its director of evaluation for medical devices, said AFSSAPS had not been informed by the FDA of its concerns over PIP in a “proactive” way. “We cannot check at every moment other countries’ health-authority websites.”

The FDA suggests the French could have been more attentive. “We don’t as a routine provide publically available information to other regulators, because it’s easier and more efficient for them to use the public website,” said the FDA’s Maisel.

His boss, FDA Commissioner Margaret Hamburg, said regulators on both sides of the Atlantic should see it as an opportunity to “look at our systems and see how we can strengthen them.”

The European Commission says it wants to reinforce rules and improve cooperation. It has written to French and German authorities, spokesman Frederic Vincent said, so they can explain “who did what and when.” When it gets the answers it needs, the Commission will conduct a “stress test” on the case to see what lessons can be learned.

Until the system is improved, “we’re sitting on a time bomb which could explode at any moment,” says The Lancet’s Horton. “No government anywhere in the EU can be sure that medical devices in their country are safe and effective.”

(Additional reporting by Alexandria Sage, Natalie Huet, Chine Labbe and Elena Berton in Paris, Ludwig Burger in Frankfurt, Anna Yukhananov in Washington and Ben Hirschler in London. Editing by Sara Ledwith and Simon Robinson)

(For pdf version: http://link.reuters.com/ten46s)