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Senin, 13 April 2009

America's uninsured haven't shown collective power

WASHINGTON – If the uninsured were a political lobbying group, they'd have more members than AARP. The National Mall couldn't hold them if they decided to march on Washington.

But going without health insurance is still seen as a personal issue, a misfortune for many and a choice for some. People who lose coverage often struggle alone instead of turning their frustration into political action.

Illegal immigrants rallied in Washington during past immigration debates, but the uninsured linger in the background as Congress struggles with a health care overhaul that seems to have the best odds in years of passing.

That isolation could have profound repercussions.

Lawmakers already face tough choices to come up with the hundreds of billions it would cost to guarantee coverage for all. The lack of a vocal constituency won't help. Congress might decide to cover the uninsured slowly, in stages.

The uninsured "do not provide political benefit for the aid you give them," said Robert Blendon, a professor of health policy and political analysis at the Harvard School of Public Health. "That's one of the dilemmas in getting all this money. If I'm in Congress, and I help out farmers, they'll help me out politically. But if I help out the uninsured, they are not likely to help members of Congress get re-elected."

The number of uninsured has grown to an estimated 50 million people because of the recession. Even so, advocates in the halls of Congress are rarely the uninsured themselves. The most visible are groups that represent people who have insurance, usually union members and older people. In the last election, only 10 percent of registered voters said they were uninsured.

The grass-roots group Health Care for America Now plans to bring as many as 15,000 people to Washington this year to lobby Congress for guaranteed coverage. Campaign director Richard Kirsch expects most to have health insurance.

"We would never want to organize the uninsured by themselves because Americans see the problem as affordability, and that is the key thing," he said.

Besides, added Kirsch, the uninsured are too busy scrambling to make ends meet. Many are self-employed; others are holding two or three part-time jobs. "They may not have a lot of time to be activists," he said.

Vicki and Lyle White of Summerfield, Fla., know about such predicaments. They lost their health insurance because Lyle had to retire early after a heart attack left him unable to do his job as a custodian at Disney World. Vicki, 60, sells real estate. Her income has plunged due to the housing collapse.

"We didn't realize that after he had the heart attack no one would want to insure him," said Vicki. The one bright spot is that Lyle, 64, has qualified for Medicare disability benefits and expects to be getting his card in July.

But for now, the Whites have to pay out of pocket for Lyle's visits to the cardiologist and his medications. The bills came to about $5,000 last year. That put a strain on their limited budget because they are still making payments on their house and car.

"I never thought when we got to this age that we would be in such a mess," said Vicki, who has been married to Lyle for 43 years. "We didn't think we would have a heart attack and it would change our life forever."

While her own health is "pretty good," Vicki said she suffers chronic sinus infections and hasn't had a checkup since 2007. "I have just learned to live with it," she said.

The Whites' example shows how the lack of guaranteed health care access undermines middle-class families and puts them at risk, but that many of the uninsured eventually do find coverage. Lyle White has qualified for Medicare, even if the couple must still find a plan for Vicki.

Research shows that nearly half of those who lose coverage find other health insurance in four months or less. That may be another reason the uninsured have not organized an advocacy group. At least until this recession, many have been able to fix the situation themselves.

"The uninsured are a moving target," said Cathy Schoen, a vice president of the Commonwealth Fund, a research group that studies the problems of health care costs and coverage.

But even if gaps in coverage are only temporary, they can be dangerous. "Whenever you are uninsured, you are at risk," said Schoen. "People don't plan very well when they are going to get sick or injured."

Indeed, the Institute of Medicine, which provides scientific advice to the government, has found that a lack of health insurance increases the chances of bad outcomes for people with a range of common ailments, from diabetes and high blood pressure to cancer and stroke. Uninsured patients don't get needed follow-up care, skip taking prescription medicines and put off seeking help when they develop new symptoms.

Such evidence strengthens the case for getting everybody covered right away, Schoen said. But she acknowledges the politics may get tough. "It certainly has been a concern out of our history that unorganized voices aren't heard," she said.

___

On the Net:

White House: http://www.whitehouse.gov/agenda/health_care/

Health Care for America Now: http://www.healthcareforamericanow.org/

Commonwealth Fund: http://www.commonwealthfund.org/

Institute of Medicine: http://tinyurl.com/dm8gnn


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7th surgery shows face transplants gaining ground

Five years ago, it was the stuff of science fiction: Replace someone's face with one from a dead donor. But on Thursday, Boston doctors performed the world's seventh such transplant — less than a week after one in France — and plans are in the works for more.

"Society is allowing us to do this. I think you're going to see more and more," especially in soldiers disfigured in recent wars, said Dr. Frank Papay, a surgeon who helped perform the nation's first face transplant, in December at the Cleveland Clinic.

Some of the successes have been dazzling. People who couldn't eat, speak normally, or go out in public now can walk the streets without being recognized as someone who got a new face.

Even so, face transplants are likely to remain uncommon, used on only the most severely disfigured, because of the big risks and lifelong need to take medicines to prevent rejection.

"It's not going to be like some people imagine — routine, like people getting a facelift, or cosmetic surgery," said Stuart Finder, director of the Center for Healthcare Ethics at Cedars-Sinai Medical Center in Los Angeles.

"We have what appears to be success," he noted, but there is always the chance that some patients may experience serious rejection problems or refuse to stay on the required lifetime of drugs.

Boston doctors stressed the care and psychological screening they required before performing the nation's second face transplant on Thursday. The operation, at Harvard-affiliated Brigham and Women's Hospital, was on a man who suffered traumatic facial injuries from a freak accident.

Face transplants go far beyond the transfer of skin and facial features, using things like bone and cartilage for reconstruction. The team led by plastic surgeon Dr. Bohdan Pomahac replaced the man's nose, palate, upper lip, and some skin, muscles and nerves with those of a dead donor.

The hospital would not identify the recipient or donor, but the donor's family members released a statement saying they hope the procedure convinces others to donate.

"The fact that we are able to give this gift was a tremendous comfort in our time of grief," the statement said.

At a news conference on Friday, Pomahac said: "There is no risk of recognizing the donor on the new patient. There's a 60 percent chance the patient will look how he used to look."

In a phone interview earlier Friday, Pomahac (pronounced POE-ma-hawk) said the man's injury occurred some years ago, and it left him with "no teeth, no palate, no nose, no lip."

"It was difficult for him to speak, to eat, to drink. It certainly caused a lot of social problems," Pomahac said.

The man had been Pomahac's patient for a long time, and doctors decided to pursue a face transplant because previous attempts to treat him left him still badly deformed. It took three months to find a suitable donor, who also provided some organs for transplant in other patients, Pomahac said.

The 17-hour operation began at 1:15 a.m. Thursday, with the recipient and the donor in operating rooms across the hall from each other. The patient was still recovering from anesthesia on Friday.

"He's still not fully awake so he has not seen himself. We have not really had a meaningful conversation so far," Pomahac said.

"He was incredibly motivated to go forward with it," and was extensively evaluated psychologically by doctors in and outside of Brigham, Pomahac said. "We really made sure that nothing was left to chance."

The seven primary surgeons and other assistants all donated their time and services, Pomahac said.

"We are essentially making a lifelong commitment to help him," the surgeon said.

Pomahac was born in Ostrava in the Czech Republic, and graduated from Palacky University School of Medicine in Olomouc, Czech Republic. He came to Brigham for a surgical research internship in 1996 and now, at 38, is associate director of its burn center, where he treats trauma and plastic surgery cases.

The Boston hospital's board approved Pomahac's plans to offer face transplants a year ago.

The world's first transplant in 2005 was led by Dr. Jean-Michel Dubernard in Amiens, France, who treated Isabelle Dinoire, a woman who had been mauled by a dog and grotesquely disfigured. Dinoire's appearance today is virtually normal.

The first U.S. face transplant, and the most extensive operation so far, was done in December by doctors at Cleveland Clinic. They replaced 80 percent of a woman's face with that of a female cadaver. The woman's identity has not been revealed, nor the circumstances that led to the transplant.

The woman left the hospital in February, and is doing "phenomenally well," Papay said. "Her speech is improved so everyone can understand her now, and she has a great outlook on life. She's very comfortable with the way she looks now and she's very happy."

The early successes are encouraging, but should not lead to over-exuberance, and extending the operation too fast, said Finder, the Los Angeles ethicist.

"This is still very new and hence requires a hyper-vigilance about helping patients understand what they're getting into," he said.

People who have received other transplants — organs, hands — have sometimes discovered they traded one set of problems for another, and get sick of taking the medicines needed to maintain the transplant. At least one hand transplant recipient later had the hand amputated for this reason.

Pomahac originally was considering only people who had already received a kidney or other organ transplant, because they already would be on immune-suppressing medicines and would therefore have a low risk of rejecting a new face.

"I still think that's the best group of patients but we have enlarged the protocol" to include others with severe facial deformities, he said.

"It's really in its infancy in terms of knowing what will happen," he added. "Each of the cases is its own unique story."

Eventually, surgeons hope to form waiting lists of face transplant candidates "just like for any other organ," Pomahac said.

___

Associated Press writer Russell Contreras in Boston contributed to this story.


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Report: Ethanol raises cost of nutrition programs

WASHINGTON – Food stamps and child nutrition programs are expected to cost up to $900 million more this year because of increased ethanol use.

Higher use of the corn-based fuel additive accounted for about 10 percent to 15 percent of the rise in food prices between April 2007 and April 2008, according to the nonpartisan Congressional Budget Office. That could mean the government will have to spend more on food programs for the needy during the current budget year, which ends Sept. 30. It estimated the additional cost at up to $900 million.

The CBO said other factors, such as skyrocketing energy costs, have had an even greater effect than ethanol on food prices. CBO economists estimate that increased costs for food programs overall due to higher food prices will be about $5.3 billion this budget year.

Ethanol's impact on future food prices is uncertain, the report says, because an increased supply of corn has the potential to eventually lower food prices.

Roughly one-quarter of corn grown in the United States is now used to produce ethanol and overall consumption of ethanol in the country hit a record high last year, exceeding 9 billion gallons, according to the CBO. It took nearly 3 billion bushels of corn to produce ethanol in the United States last year — an increase of almost a billion bushels over 2007.

The demand for ethanol was one factor that increased corn prices, leading to higher animal feed and ingredient costs for farmers, ranchers and food manufacturers. Some of that cost is eventually passed on to consumers, since corn is used in so many food products.

Several of those affected groups have banded together to oppose tax breaks and federal mandates for the fuel. They said Thursday that the report shows the unintended consequences of ethanol.

"As startling as these figures are, they do not even tell the story of the toll higher food prices have taken on working families, nor the impact higher feed prices have had on farmers in animal agriculture who have seen staggering losses and job cuts and liquidation of livestock herds," the Grocery Manufacturers Association, American Meat Institute, National Turkey Federation and National Council of Chain Restaurants said in a statement.

Supporters of ethanol disagreed, saying the report was good news.

"The report released by the Congressional Budget Office confirms what we've known for some time: The impact of ethanol production on food prices is minimal and that energy was the main driver in the rise of food prices," said Tom Buis, CEO of Growth Energy, an ethanol industry group.

Ethanol producers asked the Environmental Protection Agency last month to increase the amount of ethanol that refiners can blend with gasoline from a maximum of 10 percent to 15 percent, which could boost the demand for ethanol by as much as 6 billion gallons a year. They said raising that cap would create thousands of new jobs.

Agriculture Secretary Tom Vilsack has said he believes the administration could move quickly to raise the cap to at least 12 percent or 13 percent, but the EPA has not yet decided.

The report also looked at ethanol's effects on greenhouse gas emissions, concluding that over time ethanol's benefits over gasoline could diminish. The report says the use of ethanol reduced gasoline consumption by about 4 percent last year and reduced the gases blamed for global warming from the burning of gasoline by less than 1 percent. But the clearing of cropland and forests to produce more ethanol could more than offset those reductions.


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Minggu, 05 April 2009

Doctor in hepatitis B case has license suspended

NEWARK, N.J. – State regulators on Friday temporarily suspended the medical license of a doctor who health officials suspect is linked to a hepatitis B outbreak.

Nearly 3,000 of Dr. Parvez Dara's patients have been warned to get tested after five cancer patients tested positive for the disease, which is transmitted through exposure to infected blood and can cause serious liver damage.

On Friday, the state presented evidence about the conditions at the oncologist's Toms River office. Investigators said they found blood on the floor of a room where chemotherapy was administered, blood in a bin where blood vials were stored, open medication vials and unsterile saline and gauze.

Inspectors also cited problems with cross-contamination of pens, refrigerators and countertops; use of contaminated gloves; and misuse of antiseptics, among other health code violations.

"This was not a one-time episode," Deputy Attorney General Siobhen Krier told regulators. "This is a case of egregious, bad medical judgment displayed over a long period of time."

A special committee of the state Board of Medical Examiners issued the suspension, effective immediately, on an emergency basis. The full board will consider whether to continue the suspension on Wednesday.

During the hearing Friday, Krier said Dara had a history of health code violations dating to 2002 and posed "a clear and imminent danger to the public."

Since 2002, Dara has paid nearly $56,000 in fines for infection control health code violations, court records show.

Dara said he only used sterile supplies and equipment and took steps correct the violations. He questioned whether the patients may have contracted the disease some other way, such as from a hospital or from surgery, and suggested some may have been latent carriers — meaning they had the virus but it was dormant — until they began receiving chemotherapy, which can suppress the body's immune system.

"It's not that rare," Dara said.

In making its decision, the committee said Dara showed "a significant and gross deficiency in judgment" and that that could not be remedied by changing office practices.

"Dr. Dara's own testimony has not persuaded the committee that he has an appreciation for the gravity of multiple breaches of basic infection control practices," the committee said in its order to suspend Dara's license.

Dara did express sympathy for his patients: "This is hurting them so much more than it's hurting me."

A March 28 letter was sent to his patients warning them of the risk and suggesting they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.

Dara, originally from Pakistan, has been practicing at his Toms River office for 23 years. He estimated that he sees between 45 and 60 patients a day, with about a dozen receiving chemotherapy each day.

His attorney, Robert Conroy, argued to the board that there was no direct evidence the hepatitis cases were linked to Dara's office. He characterized the state's investigation as sloppy and said the fact that the outbreak investigation is ongoing should have precluded regulators from drawing any conclusions.

"There's no proof," he said. "This is a rush to judgment ... before they get test results back."

Conroy said Dara plans to immediately appeal the decision.
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Kraft Foods offers salmonella timeline

FRESNO, Calif. – Kraft Foods Inc., the company whose testing led to the nationwide pistachio recall, said Friday it first heard there was salmonella in its trail mix in late 2007, but could not trace the possible source to tainted nuts from California until two weeks ago.
Workers at one of Kraft's manufacturers in Illinois turned up a contaminated batch of fruits and nuts in December 2007. Then, in September of last year, another positive sample appeared.

Only after thousands of tests could the company pinpoint the source for the second positive test as California-based Setton Pistachio of Terra Bella, Inc., said Kraft spokeswoman Susan Davison.

Last week, the food products giant recalled or destroyed all suspect foods, and notified its suppliers and the Food and Drug Administration, which on Monday issued a sweeping national warning against eating the nuts.

"If we did detect salmonella, of course we would never ship our products," Davison said. "We conducted extensive testing of all our food, and we were just unable to zero in until March that pistachios were the root cause."

On Friday, Lee Cohen, a production manager for Setton's sister company in New York, said Kraft did not tell Setton until recently that they had detected salmonella-tainted pistachios last year. The company later retracted his statement without explanation.

Setton, the second-largest pistachio processor in the nation, sells its nuts to Kraft and 35 other wholesalers across the country, which use them in everything from ice cream to cake mixes. As FDA officials scour its records and swab its factory, the plant has temporarily shut down after recalling more than 2 million pounds of nuts.

No pistachio-related illnesses have been reported.

Also Friday, the FDA sent out a letter to the pistachio industry reminding nut processors to follow good manufacturing practices to protect consumers, something food safety experts called welcome guidance.

Dr. David Acheson, FDA's assistant commissioner for food safety, said Kraft first told the administration about the problems last week.

Neither federal nor state laws require food manufacturers to test the safety of their products or to report any findings of contamination, though many do if they plan to recall a product, Acheson said.

"If they find problems in a product prior to shipment, they'll pull it back and destroy it," Acheson said. "I wouldn't call that a good manufacturing practice, but that is clearly a good public health practice."

Kraft finally determined pistachios caused last year's problem in March, when their manufacturer in Illinois detected salmonella for the third time — this time in the nuts, the only common ingredient between the second and third batch of trail mix, Davison said. Kraft has not traced the source for the first positive salmonella test in 2007.

Salmonella, the most common cause of food-borne illness, causes diarrhea, fever and cramps. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.

Roasting is supposed to kill the bacteria in nuts, but problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.

Setton Pistachio officials suspect the roasted pistachios sold to Kraft Foods may have become mixed at the plant with raw nuts that could have contained traces of the bacteria.

Cohen, the production official at Setton International Foods Inc. in Commack, N.Y., said Friday that Setton Pistacio's internal tests had detected salmonella on some of its raw pistachios in the past, but said all tainted pistachios were later roasted. He did not specify when those tests were performed.

"We have found salmonella on raw pistachios, but that doesn't mean anything because those nuts are coming straight from the orchards where you could have had a very small localized contamination from birds," Cohen said. "Those nuts never hit the marketplace."

More than a dozen other companies that got their nuts from the California plant have recalled their pistachio products this week for fear of possible contamination. On Friday, Setton International announced it was also voluntarily recalling about 118,000 pounds of pistachio products.

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CDC: Rocket fuel chemical found in baby formula

ATLANTA – Traces of a chemical used in rocket fuel were found in samples of powdered baby formula, and could exceed what's considered a safe dose for adults if mixed with water also contaminated with the ingredient, a government study has found.

The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. It was published last month, but the Environmental Working Group — a Washington, D.C.-based advocacy organization — issued a press release Thursday drawing attention to it.

The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites.

No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. The thyroid helps set the body's metabolism. Thyroid problems can impact fetal and infant brain development.

However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.

The U.S. Food and Drug Administration, aware of the debate over perchlorate in food and water, has not recommended that people alter their diet or eating habits because of the chemical.

The study itself sheds little light on how dangerous the perchlorate in baby formula is. "This wasn't a study of health effects," said Dr. Joshua Schier, one of the authors.

The largest amounts of the chemical were in formulas derived from cow's milk, the study said.

The researchers would not disclose the brands of formula they studied. Only a few samples were studied, so it's hard to know if the perchlorate levels would be found in all containers of those brands, a CDC spokesman said.

"This study provides no data on potential health effects of perchlorate. Health authorities continue to emphasize that infant formula is safe," said Haley Curtis Stevens of the International Formula Council, which represent formula manufacturers.

Earlier this year, the U.S. Environmental Protection Agency said it was considering setting new limits on the amount of perchlorate that would be acceptable in drinking water. A few states have already set their own limits.

The agency issued a statement Friday saying perchlorate exposure is a serious issue and "a top priority" for EPA Administrator Lisa Jackson. EPA officials expect to announce a decision soon about future steps in dealing with the chemical.

The EPA has checked nearly 4,000 public water supplies serving 10,000 people or more. About 160 of the water systems had detectable levels of perchlorate, and 31 had levels high enough to exceed a new safety level the EPA is considering.

___

CDC: http://www.cdc.gov/

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Kamis, 02 April 2009

NJ warns nearly 3,000 to get tested for hep B

TRENTON, N.J. – New Jersey officials have advised nearly 3,000 people who share a doctor to get tested after five cancer patients who visited the physician were found to have hepatitis B.
Two cases of hepatitis B were confirmed in late February as connected with the office of Dr. Parvez Dara, an oncologist with offices in Toms River and Manchester, near the Jersey Shore, Marilyn Riley, spokeswoman for the state Health Department, said Thursday.
Health officials recently learned of three more cases, all in Toms River, in which the patients were also under Dara's care.
"These were older adults who didn't have other risk factors, so that is what raised a red flag," Riley said.
Ocean County decided to send a letter to all Dara's patients dating to 2002. The March 28 letter warns them of the risk and suggests they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Linda Bradford of Bayville said she's worried about her husband's health after hearing news of the outbreak.
"The first thing I did was call my husband," Bradford told WCBS-TV. "I was terrified. Oh my God, what's going on here?"
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles. Dara's office treats patients with blood disorders and cancer, some of whom receive chemotherapy there.
"The evidence that's available suggests the infections could be linked to the method the clinical staff used to administer injectable medications," such as chemotherapy, Riley said. "There's no evidence to suggest the medications were a problem."
Dara faces suspension of his medical license in connection with the outbreak and for other alleged health code violations. A hearing is scheduled for Friday before the state Board of Medical Examiners.
Until then, he is performing only patient consultations, not procedures, said his lawyer, Robert Conroy. Neither of Dara's offices were open Thursday.
According to a report by the state epidemiology division, Dara has infection control violations dating to 2002, including violations of standards of the federal Occupational Safety and Health Administration.
Conroy said that there is no proof the patients got the disease from Dara's office and that other factors aren't being considered. All five patients were also seen at Community Medical Center in Toms River, he said.
Health officials said they ruled the hospital out as a possible source of the infection.
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles.
Conroy said three patients were found to have dormant hepatitis infections that might have been noticed only after they started cancer treatments, which can suppress the body's immune system.
Because the patients live in the same area, he said, there could be another possible source.
"Absent any evidence, it is just as likely that those patients were infected (at) ... a common eatery," he wrote in a letter to the Medical Examiners Board.
Meanwhile, Conroy said Dara has received only support from his patients.
"The doctor has never felt more appreciated by his patients than he does right now," he said.
Ocean County Health Department spokesman Edward Rumen said no new cases have been reported since the alert was issued.
___
Associated Press writer Bruce Shipkowski in Toms River contributed to this report.

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House approves FDA regulation of tobacco products

WASHINGTON – Anti-smoking forces won a long-awaited victory Thursday as the House passed legislation that would give the federal government key controls over the tobacco industry for the first time.
The measure, passed 298-112, gives the Food and Drug Administration authority to regulate — but not ban — cigarettes and other tobacco products.
The Senate could take up its version of the bill later this month, and supporters are confident they can overcome opposition from tobacco-state senators. The White House supports the legislation, a shift from the Bush administration which threatened to veto a House-passed measure last year.
President Barack Obama has spoken publicly about his own struggles to kick a smoking habit.
"This is truly a historic day in the fight against tobacco, and I am proud that we have taken such decisive action," said Energy and Commerce Committee Chairman Henry Waxman, D-Calif., the bill's sponsor. "Today we have moved to place the regulation of tobacco under FDA in order to protect the public health, and now we all can breathe a little easier."
Waxman and his Senate counterpart, Sen. Edward Kennedy, D-Mass., have promoted legislation giving the FDA regulatory powers over tobacco products since the Supreme Court in 2000 ruled that the agency did not have that authority.
That ruling came after years of lawsuits and debate on the issue, including Waxman's memorable 1994 hearing where the heads of big tobacco companies testified that nicotine was not addictive.
Waxman's Family Smoking Prevention and Tobacco Control Act wouldn't let the FDA ban nicotine or tobacco outright, but the agency would be able to regulate the contents of tobacco products, make their ingredients public, prohibit flavoring, require much larger warning labels and strictly control or prohibit marketing campaigns, especially those geared toward children.
Kennedy plans to introduce his version of the bill after Congress returns from its April recess. Sen. Richard Burr, R-N.C., is expected to lead the opposition, but supporters are confident they can clear the 60-vote threshold needed to break a filibuster.
"FDA regulation of cigarettes — the most lethal of all consumer products — is long overdue," Kennedy said Thursday. "I am confident that the Senate will approve it expeditiously."
Opponents from tobacco-growing states such as top-producing North Carolina argued that the FDA had proven through food safety failures that it's not up to the job. They also said that instead of unrealistically trying to get smokers to quit or prevent them from starting, lawmakers should ensure they have other options, like smokeless tobacco.
That was the aim of an alternate bill offered by Rep. Steve Buyer, R-Ind., who would leave the FDA out and create a different agency within the Health and Human Services Department. His proposal failed on a 284-142 vote.
"Effectively giving FDA stamp of approval on cigarettes will improperly lead people to believe that these products are safe, and they really aren't," Buyer said. "We want to move people from smoking down the continuum of risk to eventually quitting."
Major public health groups, including the American Lung Association and the American Medical Association, wrote to lawmakers asking them to oppose Buyer's bill, contending it would leave tobacco companies without meaningful regulation and able to make untested claims about the health effects of their products.
Buyer pointed out that Waxman's bill is supported by the nation's largest tobacco company, Marlboro maker Philip Morris USA. Officials at rival tobacco companies contend the Waxman bill could cement Philip Morris' market advantage.
Lorillard Tobacco Co. said in a statement that among other problems, Waxman's bill "leads to an industry monopoly by locking in the huge market share of our largest competitor while eliminating our ability to communicate with our adult smokers."
___
The bill is H.R. 1256.
On the Net:
Congress: http://thomas.loc.gov/

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NY county ban on baby bottle chemical is official

NEW YORK – A suburban New York county has adopted the nation's first ban on the chemical found in plastic baby bottles and sippy cups.
The measure banning the sale of baby bottles containing BPA was signed by Suffolk County Executive Steve Levy on Thursday after county legislators passed it last month.
Several states including California, Oregon and Hawaii are considering bans the chemical formally known as bisphenol A, but Suffolk County, on Long Island, is the first place in the nation to enact one.
Canada announced in October it was banning BPA in baby bottles, becoming the first country to restrict sale of the chemical, which is commonly used in the lining of food cans, eyeglass lenses and hundreds of household items.
The Suffolk County ban will take effect within 90 days of being filed with New York's secretary of state and applies to empty beverage containers used by children ages 3 and younger.
Baby bottles frequently contain BPA, which is used to harden plastic and make it shatterproof.
Some scientists believe that long-term exposure to BPA is harmful to humans, but the European Union and the U.S. Food and Drug Administration say the chemical is safe.
"While the U.S. Food and Drug Administration stands by, Suffolk County is taking measures to protect their most vulnerable population from the potential harm of BPA exposure," said Urvashi Rangan, a senior scientist and policy analyst at Consumers Union, the nonprofit that publishes Consumer Reports magazine.
Levy, the Suffolk County executive, said children's exposure to potentially harmful products should be minimized.
"Of all the things a parent must worry about," he said, "whether or not their child is being harmed by a baby bottle should not be one of them."

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1 in 5 Medicare patients readmitted within month

NEW YORK – One in five Medicare patients end up back in the hospital within a month of discharge, a large study found, and that practice costs billions of dollars a year. The findings suggest patients aren't told enough about how to take care of themselves and stay healthy before they go home, the researchers said. A few simple things — like making a doctor's appointment for departing patients — can help, they said.
The study found that a surprising half of the non-surgery patients who returned within a month hadn't even seen a doctor between hospital stays.
"Hospitals put more effort into the admission process than they do into the discharge process," said Dr. Eric Coleman, one of the study's authors from the University of Colorado in Denver.
Coleman, who runs a program to improve "hand-offs" between health care systems, said patients often have a honeymoon notion about how things will be once they're home. Then when they become confused about how to take their medicine or run into other problems, they head back to the hospital because they don't know where to turn, he said.
The issue of hospital readmissions and their cost has come under scrutiny in recent years. And it's getting attention now because President Barack Obama's budget calls for reducing spending on Medicare readmissions to pay for health care reform.
For their study, reported in Thursday's New England Journal of Medicine, the researchers looked at Medicare records from late 2003 through 2004. They found that about 20 percent of 11.9 million patients were readmitted to the hospital within a month of discharge; about a third were back in the hospital within three months.
About half of the patients hospitalized for ailments didn't see a doctor before they landed back in the hospital within a month.
Patients with heart failure and pneumonia had the most readmissions overall; among surgical procedures, heart stents and major hip and knee surgery had the highest returns.
About 10 percent of all readmissions were probably planned, such as putting in a stent, the researchers said. They estimated that the cost of unplanned return visits in 2004 was $17.4 billion.
"It's a big hunk of money and it's a big hunk of misery," said another study author, Dr. Stephen Jencks, an independent consultant who worked for the Centers for Medicare and Medicaid Services.
Besides making follow-up doctor appointments, Jencks said hospitals should give patients a list of all their medications, explain what to do at home and where to call if they run into problems. He said the hospitals should also call the patient within two days and make sure that the patient's doctor knows they were in the hospital.
He said the goal is to keep patients from getting really sick again, not to keep them out of the hospital if they do.
The differences in readmission rates among states suggests that improvements can be made, he said. Iowa had the lowest rate with 13 percent, while Washington, D.C., had the highest at 23 percent.
Dr. Brian Jack at Boston Medical Center tells the story of a patient who didn't understand that the blood pressure medicine that the hospital told her to take was the same as the one she had at home — just with different names. She took both and returned to the hospital with kidney failure. Jack and his colleagues tested a new checklist that nurses used when they sent patients home. The patients who used the checklist had 30 percent fewer visits to the emergency room or return hospital stays over the next month, compared to patients who didn't use it, they found.
"There are not too many things that improve health and save money," said Jack, who was not involved in the new research.
In 2007, a panel that advises Congress on Medicare suggested ways to cut hospital readmissions. One recommendation was to change how Medicare pays hospitals and to cut payments to those with high rates — an approach included in Obama's budget proposal.
Currently, hospitals get the same payment for each hospital stay and critics say there's no incentive to reduce readmissions.
___
On the Net:
New England Journal: http://www.nejm.org
Care Transitions: http://www.caretransitions.org/
Project Red: http://www.bu.edu/fammed/projectred

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Selasa, 31 Maret 2009

Pistachio warning could signal food safety shift

TERRA BELLA, Calif. – It could take weeks before health officials know exactly which pistachio products may be tainted with salmonella, but they've already issued a sweeping warning to avoid eating the nuts or foods containing them.
The move appears to indicate a shift in how the government handles food safety issues — from waiting until contaminated foods surface one-by-one and risking that more people fall ill to jumping on the problem right away, even if the message is vague.
Officials wouldn't say if the approach was in response to any perceived mishandling of the massive peanut recall that started last year, only that they're trying to keep people from getting sick as new details surface about the California plant at the center of the pistachio scare.
"What's different here is that we are being very proactive and are putting out a broad message with the goal of trying to minimize the likelihood of consumer exposure," said Dr. David Acheson, FDA's assistant commissioner for food safety. "The only logical advice to consumers is to say 'OK consumers, put pistachios on hold while we work this out. We don't want you exposed, we don't want you getting salmonella.'"
Dr. Joshua Sharfstein, the president's new acting commissioner who started Monday, made it clear staff needed to move quickly, Acheson said.
The agency announced Monday that Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, recalled more than 2 million pounds of its roasted pistachios.
Suspect nuts were shipped as far away as Norway and Mexico, Acheson said Tuesday. One week after authorities first learned of the problem, they still had little idea what products were at risk, he said.
As federal health inspectors take swabs inside the plant to try to identify a salmonella source, a whole range of products from nut bars to ice cream and cake mixes remain in limbo on grocery shelves.
Company officials said Tuesday they suspected their roasted pistachios may have been contaminated by salmonella-tainted raw nuts they were processed with at the hulking facility.
Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-exposed to bacteria.
The firm sells its California-grown pistachios to giants of the food industry such as Kraft Foods Inc., as well as 36 wholesalers across the country.
"We care about our business and our customers greatly," said Lee Cohen, the production manager for Setton International Foods Inc., a sister company to Setton Pistachios. "We've never had an illness complaint before but obviously this affects the whole industry. It's not good."
California supplies 99.99 percent of the U.S. pistachio market, according to the California Pistachio Board.
"What's scary is that it's after the nuts have been processed that this stuff is getting into it, so it really makes you wonder," said Marcia Rowland, an avid pistachio eater in Apopka, Fla.
The FDA learned about the problem March 24, when Kraft notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day and expanded the recall to include any Planters and Back to Nature products that contain pistachios Tuesday.
Kraft spokeswoman Laurie Guzzinati said her company's auditors visited the plant early last week, and "observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination."
She said she didn't know specifically what they saw.
Federal inspectors last visited the plant in 2003, and the California Department of Public Health was there last year, Acheson said. Federal officials made note of several problems — an open door into one of the nut rooms, and an employee wearing street clothes that weren't adequately covered — but nothing that posed a food safety threat, he said.
Acheson said management corrected the problems that day, and said he did not have access to California inspectors' records.
Cohen said the plant had never had an illness complaint, followed industry health guidelines and had its huge metal silos and warehouse inspected regularly, but refused to provide additional details or records. Several plaques on the firm's office walls showed the firm won industry awards for food safety excellence.
No illness have been tied to contaminated pistachios. Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn't been confirmed, Acheson said.
While consumer advocates praised the government's swift action, they said the pistachio recall illustrated that more oversight was needed.
"It is encouraging that this response was so quick, but we need to move to a system that focuses on prevention through the entire food production process," said Jeff Levi, executive director of Trust for America's Health.
Two California legislators introduced a bill Tuesday that would require periodic testing of food at food processing facilities and mandate processors to report to state authorities within 24 hours any positive test result for a dangerous contaminant.
"We shouldn't be reacting to the next crisis, we should be preventing the next crisis," said Assemblyman Mike Feuer, D-Los Angeles.
___
Associated Press writers Tracie Cone in Fresno and Samantha Young in Sacramento contributed to this report.
___
On the Net:
http://us.rd.yahoo.com/dailynews/ap/ap_on_re_us/storytext/salmonella_pistachios/31503103/SIG=10s3n7kvf/*http://www.settonfarms.com
http://www.fda.gov/

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FDA cracks down on unapproved narcotic painkillers


WASHINGTON – The government ordered 14 unapproved narcotic painkillers off the market Tuesday, prescription versions of potent morphine, hydromorphone and oxycodone. The Food and Drug Administration told nine manufacturers to quit distributing the drugs within 90 days — but insisted there are plenty of legal versions of the painkillers being sold for patients who need relief.
"There will be no shortage for consumers," said Deborah Autor, director of FDA's drug compliance office.
The move is part of the FDA's years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. Many entered the market decades ago, before federal law required such approval. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled.
Tuesday, the FDA targeted unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Most are generic.
To help consumers tell if they have an approved or unapproved version, the FDA posted both lists on its Web site: http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm.
Manufacturers receiving warning letters Tuesday are: Boehringer Ingelheim Roxane Inc. of Columbus, Ohio; Cody Laboratories Inc. of Cody, Wyo.; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Co. Inc. of Philadelphia; Lehigh Valley Technologies Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care inc. of Tulsa; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of Newport, Ky.
The largest, Boehringer, didn't immediately return a call seeking comment.
Even FDA-approved versions of these painkillers pose a risk of serious side effects, but the unapproved products add an extra problem: Regulators haven't checked that those versions work as well and are as pure as their approved competitors.
Companies that don't heed the FDA's deadline could face big penalties: The government once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order, Autor noted.

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St. Louis hospital to study birth defect


ST. LOUIS – A top children's hospital wants to improve the survival rate of infants born with a birth defect that many families have never heard of until their child is diagnosed.
Dr. Brad Warner, surgeon-in-chief of St. Louis Children's Hospital, said Tuesday that he and others plan research to better understand the condition, known as CDH, or Congenital Diaphragmatic Hernia. One in 2,000 babies is diagnosed with the disease, doctors say. Half of those don't live to their first birthday.
The condition occurs when the diaphragm, which separates the chest cavity from the abdomen, does not completely form in the womb. The contents of the belly migrate to the chest, which keeps the lungs from developing properly.
Eight babies at the St. Louis hospital died last year from the condition.
Doctors at St. Louis Children's Hospital say they're part of a national database registry to collect and track information on children with the condition. They plan to recruit faculty candidates that are able to explore fetal surgery intervention and are working to collect DNA for analysis.
Treatment for the birth defect varies.
Many are stillborn. Babies who die from the birth defect usually have insufficient lung tissue to survive, or develop hypertension in the blood vessels of the lungs. Medications to lower blood pressure in the lungs lower the baby's overall blood pressure, which can be problematic.
Of those who live, some are in distress from the moment the umbilical cord is clamped; others are OK for their initial hours of life, then get worse. A third group, which is the most uncommon, initially looks good, but later exhibits signs, such as bowel sounds in the chest, that reveal the condition.
In some cases, doctors have performed surgery on pregnant women and their fetuses to try to address problems before a baby is born, but those procedures have risks. Children with CDH can grow up to be healthy adults.
Doctors say they hope to better understand predictors of good and bad outcomes for babies with the condition, as well as how to address the many complications that can arise.
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On the Net:
Breath of Hope: http://www.breathofhopeinc.com/

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Study: Plavix plus aspirin helps prevent strokes


ORLANDO, Fla. – Taking the blood thinner Plavix along with aspirin helped prevent strokes and heart attacks in people with a common heartbeat abnormality that puts them at high risk of these problems, doctors reported Tuesday.
The treatment is for atrial fibrillation, a rhythm disorder that 2.2 million Americans have. It occurs when the upper parts of the heart quiver instead of beating properly. This allows blood to pool and form clots that can travel to the brain, causing a stroke.
The usual treatment is the blood thinner warfarin, sold as Coumadin and in generic form. But finding the right dose is tricky — too little and patients can have a stroke; too much and they can have life-threatening bleeding. Patients on the drug must go to the doctor often for blood tests to monitor their dose.
For these reasons, as many as half of patients take aspirin instead of warfarin, even though aspirin is much less effective at preventing strokes.
Dr. Stuart Connolly of McMaster University in Hamilton, Ontario, led a study testing whether adding clopidogrel, sold as Plavix by French-based Sanofi-Aventis SA, could help.
The study involved 7,554 patients in the United States and 32 other countries who were not able or chose not to take warfarin. All were treated with aspirin; half also were given Plavix.
After nearly four years of followup, the dual drug treatment lowered a combined measure — heart attacks, heart-related deaths, strokes and blood clots — by 11 percent. There were 924 of these problems in patients on aspirin alone but only 832 in those also getting Plavix.
However, the combination treatment raised the risk of serious bleeding — 251 cases versus 162 for those on aspirin alone.
Doing the math, patients still come out ahead on the combination, Connolly said. For every 1,000 patients treated for three years, it would prevent 28 strokes and six heart attacks, and lead to 20 bleeding cases. Bleeding often is treated with transfusions and is not as likely to prove fatal.
"For the first time in 20 years, there's a new treatment for atrial fibrillation," Connolly said.
Results were presented Tuesday at an American College of Cardiology conference and published online by the New England Journal of Medicine.
The study was sponsored by Sanofi, and Connolly and other authors have consulted for the company. Plavix costs about $4 a day.
"Warfarin was, and remains, first-line therapy — this does not change that," said Dr. Richard Page, cardiology chief at the University of Washington School of Medicine in Seattle and an American Heart Association spokesman.
But for those who can't tolerate it, the Plavix-aspirin combo gives a better option than aspirin alone, he said. Page has consulted for Sanofi in the past.
On Saturday, other doctors at the cardiology conference reported on another potential treatment for atrial fibrillation — an experimental heart device called the Watchman aimed at preventing clots from reaching the brain. A federal Food and Drug Administration panel meets to consider it on April 23.
___
On the Net:
Cardiology meeting: http://www.acc.org
Medical journal: http://www.nejm.org

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Stop-smoking lines flooded as tobacco tax rises

WASHINGTON – Calling your state stop-smoking hot line for help kicking the habit? Expect a wait: Smokers are flooding the lines in a panic over an increase in the tobacco tax.
Denver-based National Jewish Health received triple the usual number of calls Monday for a March day to quit lines it runs in six states: Colorado, Idaho, Iowa, Montana, New Mexico and Ohio.
The calls — 2,317 on Monday — had steadily increased all month as smokers began dealing with a big price hit in a sour economy. Not only does the per-pack federal tax climb from 39 cents to $1.01 on Wednesday, but the major cigarette makers raised prices several weeks ago in anticipation.
Quit lines around the country are feeling the surge, according to an informal survey by the Campaign for Tobacco-Free Kids that found a missed opportunity as cash-strapped states struggled to meet demand.
Michigan's quit line itself had to quit — working, that is. It ran out of money in mid-March after logging more than 65,000 callers in five days. Besides counseling and tips, Michigan's hot line offered free nicotine patches, gum or lozenges. The giveaway program in 2008 generated only about 20,000 calls in six weeks, the campaign noted.
Arkansas quit general advertising of the quit line to keep up with calls that rose from about 500 a week in January to more than 2,000 a week in mid-March, the campaign said. And Indiana and Oklahoma were receiving record-level weekly calls.
Price surges typically spur would-be quitters to take the plunge. Not all will be successful. The tobacco-free kids group estimates that about 1 million adults will quit as a result of the tax increase.
Consumers can dial 1-800-QUIT-NOW to be directed to their state hot lines.
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Campaign for Tobacco-Free Kids: http://www.tobaccofreekids.org/index.php

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