2010-03-12T18:54:13-06:00 ExpressionEngine Copyright (c) 2010, Staff tag:therochesterdemocrat.com,2010:ee/index.php/51.58064 2010-03-12T18:53:12-06:00 2010-03-12T18:54:13-06:00

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2010-03-12T18:53:12-06:00 Staff editor@TheRochesterDemocrat.com Research





LONDON (AP) - Women who took the birth control pill beginning in the late 1960s lived longer than those never on the pill, a new study says.

British researchers observed more than 46,000 women for nearly four decades from 1968. They compared the number of deaths in women on the pill to those who never took it.

In the study, women on the pill generally took it for almost four years. Experts concluded the pill cut women's risk of dying from bowel cancer by 38 percent and from any other diseases by about 12 percent.

The research was published Friday in the British medical journal, BMJ.

Slightly higher death rates were found among women under 30 on the pill, but that began to be reversed by age 50.

Doctors aren't sure exactly why the pill may lower death rates. It contains synthetic hormones to suppress ovulation, which may have some role in preventing certain diseases.

Previous studies have found the pill does not raise the risk of dying. It also may protect against ovarian and endometrial cancer, but slightly increase the chances of breast and cervical cancer. It may also be that women on the pill are somehow healthier than those that aren't.

Because the study only observed women on the pill compared with those who weren't, researchers weren't able to make any hypotheses about cause and effect.

"In the longer term, the health benefits of the contraceptive pill outweigh any risks," Richard Anderson, a gynecologist at the University of Edinburgh, said in a statement. Anderson was not connected to the BMJ study.

But he said the findings might not be projected to women using modern contraceptive pills, which may have a different risks than earlier products. The risks may also be higher depending on when women start taking the pill and how long they are on it.

"Many women, especially those who used the first generation of oral contraceptives many years ago, are likely to be reassured by our results," Philip Hannaford of the University of Aberdeen in Scotland, the study's lead researcher, said in a statement.

Hannaford and colleagues said the pill's risks and benefits may vary worldwide, depending on how it is used and each patient's health risks.

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On the Net:

http://www.bmj.com


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.58048 2010-03-12T12:01:22-06:00 2010-03-12T12:02:23-06:00

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2010-03-12T12:01:22-06:00 Staff editor@TheRochesterDemocrat.com Environment




CHICAGO (AP) - Too much cancer screening, too many heart tests, too many cesarean sections. A spate of recent reports suggest that too many Americans - maybe even President Barack Obama - are being overtreated.

Is it doctors practicing defensive medicine? Or are patients so accustomed to a culture of medical technology that they insist on extensive tests and treatments?

A combination of both is at work, but now new evidence and guidelines are recommending a step back and more thorough doctor-patient conversations about risks and benefits.

As a medical journal editorial said this week about Obama's recent checkup, Americans including the commander in chief need to realize that "more care is not necessarily better care."

Obama's exam included prostate cancer screening and a virtual colonoscopy. The PSA test for prostate cancer is not routinely recommended for any age and colon screening is not routinely recommended for patients younger than 50. Obama is 48.

Earlier colon cancer screening is sometimes recommended for high-risk groups - which a White House spokesman noted includes blacks. Doctors disagree on whether a virtual colonoscopy is the best method. But it's less invasive than traditional colonoscopies and doesn't require sedation - or the possible temporary transfer of presidential power, the White House said.

The colon exam exposed him to radiation "while likely providing no benefit to his care," Dr. Rita Redberg, editor of Archives of Internal Medicine, wrote in an online editorial. Obama's experience "is multiplied many times over" at a huge financial cost to society, and to patients exposed to potential harms but no benefits.

"People have come to equate tests with good care and prevention," Redberg, a cardiologist with the University of California at San Francisco, said in an interview Thursday. "Prevention is all the things your mother told you - eat right, exercise, get enough sleep, don't smoke - and we've made it into getting a new test."

This week alone, a New England Journal of Medicine study suggested that too many patients are getting angiograms - invasive imaging tests for heart disease - who don't really need them; and specialists convened by the National Institutes of Health said doctors are too often demanding repeat cesarean deliveries for pregnant women after a first C-section.

Last week, the American Cancer Society cast more doubt on routine PSA tests for prostate cancer. And a few months ago, other groups recommended against routine mammograms for women in their 40s, and for fewer Pap tests looking for cervical cancer.

Experts dispute how much routine cancer screening saves lives. It also sometimes detects cancers that are too slow-growing to cause harm, or has false-positive results leading to invasive but needless procedures - and some risks. Treatment for prostate cancer that may be too slow-growing to be life-threatening can mean incontinence and impotence. Angiograms carry a slight risk for stroke or heart attack.

Not all doctors and advocacy groups agree with the criticism of screening. Many argue that it can improve survival chances and that saving even a few lives is worth the cost of routinely testing tens of thousands of people.

Dr. Peter Pronovost, a Johns Hopkins University patient safety expert, said routine testing is often based on bad science, or on guidelines that quickly become outdated as new science emerges.

The recent shift in focus reflects evolving research on the benefits and risks of screening.

While some patients clearly do benefit from screening, others clearly do not, said Dr. Richard Wender, former president of the American Cancer Society.

These include very old patients, who may unrealistically fear cancer and demand a screening test, when their risks are far higher of dying from something else, Wender said.

"Sometimes it's kind of the path of least resistance just to order the test," he said.

Doctors also often order tests or procedures to protect themselves against lawsuits - so-called defensive medicine - and also because the fee-for-service system compensates them for it, said Dr. Gilbert Welch, a Dartmouth University internist and health outcomes researcher.

Some doctors think "it's always a good thing to look for things to be wrong," Welch said. It also has become much easier to order tests - with the click of a mouse instead of filling out forms, and both can lead to overuse, he said.

While many patients also demand routine tests, they're often bolstered by advertisements, medical information online - and by doctors, too, Welch said.

"To some extent we've taught them to demand these things," he said. "We've systematically exaggerated the benefits of early diagnosis," which doesn't always improve survival. "We don't always tell people there might actually be downsides" to testing.

Jennifer Traig, an Ann Arbor, Mich., author of a book about hypochondria, says patients like her often think, "I'm getting better care if we're checking for more things."

Traig has had many costly high-tech tests, including an MRI and several heart-imaging tests, for symptoms that turned out to be nothing. She thinks doctors were right to order those tests, but that counseling could have prevented her from "wasting resources" and getting tests it turned out she didn't need.

Patients seeking screening information have several online resources, including the National Institutes of Health, ; the American Cancer Society, ; and a nonprofit advocacy group called the Foundation for Informed Medical Decision Making, .http://bit.ly/a8c7P0http://bit.ly/9w0flihttp://www.informedmedicaldecisions.org

The new guidance from the cancer society last week on PSA testing, echoing others' advice on mammograms, is for doctors and patients to thoroughly discuss testing, including a patient's individual disease risks, general pros and cons of testing and possible harms it may cause.

Dr. Bruce Minsky, a University of Chicago cancer specialist who still favors routine mammograms for women in their 40s, said that emphasis is a positive trend.

"That to me is one of the greatest benefits," he said. "It enhances that communication between the physician and patient."

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On the Net:

The National Institutes of Health: http://bit.ly/a8c7P0

The American Cancer Society: http://bit.ly/9w0fli

Foundation for Informed Medical Decision Making: .http://www.informedmedicaldecisions.org

]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.58014 2010-03-11T01:43:11-06:00 2010-03-11T01:44:12-06:00

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2010-03-11T01:43:11-06:00 Staff editor@TheRochesterDemocrat.com Disease




WASHINGTON (AP) - Children inherit about 30 mutated genes from each parent, fewer than had been thought, but enough in at least one case to pass on inherited illnesses, according to a first detailed look at the blueprint for human life in a family.

And a separate study of an individual genome located the cause of another inherited disease.

The blueprint for life, called DNA, contains about 22,000 genes, and researchers calculated the number of changes by analyzing the genes of a mother, father, and their son and daughter.

The result, reported in Thursday's online edition of the journal Science, found that the children had about 30 mutations from each parent for a total of 60 changes passed along to the offspring.

Scientists previously had thought a child had about 75 mutated genes from the parents.

The rate of mutations probably will vary somewhat, depending on the age of the parents, said co-author Lynn B. Jorde, chairman of the Department of Human Genetics at the University of Utah School of Medicine.

Most mutations are thought to be unimportant, but the rate at which things change is considered critical, helping explain the gradual development of changes.

Genomic studies can help researchers find ways to identify individual genes or mutations that can lead to inherited disease.

Jorde and the senior author, David J. Galas, of the Institute of Systems Biology in Seattle studied a family in which the parents had no genetic abnormalities, but each carried recessive genes that resulted in their son and daughter being born with two extremely rare conditions - Miller's syndrome and primary ciliary dyskinesia.

Miller's syndrome, which causes facial and limb malformations, has been diagnosed in only two families in the world. PCD is a condition in which the tiny hair-like structures that are supposed to move mucus out of airways in the lungs do not function. The chances of having PCD are estimated at one in 10,000.

Jorde said the odds of someone having both PCD and Miller's syndrome are less than one in 10 billion.

"We were very pleased and a little surprised at how much additional information can come from examining the full genomes of the same family," Galas said in a statement.

"Comparing the sequences of unrelated individuals is useful, but for a family the results are more accurate. We can now see all the genetic variations, including rare ones, and can construct the inheritance of every piece of the chromosomes, which is critical to understanding the traits important to health and disease," he said.

The family was not named in the report.

Meanwhile, a separate report in the New England Journal of Medicine disclosed that Dr. James Lupski of Baylor College of Medicine had sequenced his own complete genome and identified the gene involved in his form of Charcot-Marie-Tooth syndrome, which affects the function of nerves in the body's limbs, hands and feet.

Lupski, vice chairman of molecular and human genetics, said the work "demonstrates that the technology is robust enough that we can find disease genes by determining the whole genome sequence. We can start to use this technology to interpret the clinical information in the context of the sequence - of the hand of cards you have been dealt."

"Isn't that the goal or dream of personalized genomic medicine?" he said in a statement.

Lupski said he has known for 40 years that he had a disease caused by recessive genes. Now he knows the gene at fault.

And Lupski and colleagues found that having a single copy of the recessive mutation is susceptible to carpal tunnel syndrome, which usually affects people who perform repetitive motions that compress a nerve where it crosses the wrist.

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On the Net:

Science: http://www.sciencemag.org

New England Journal of Medicine: http://www.nejm.org


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.57750 2010-03-02T00:14:21-06:00 2010-03-02T00:15:22-06:00

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2010-03-02T00:14:21-06:00 Staff editor@TheRochesterDemocrat.com Death & Dying



CHICAGO (AP) - It's a situation too agonizing to contemplate - a child dying and in pain. Now a small but provocative study suggests that doctors may be giving fatal morphine doses to a few children dying of cancer, to end their suffering at their parents' request.

A handful of parents told researchers that they had asked doctors to hasten their children's deaths - and that doctors complied, using high doses of the powerful painkiller.

The lead author of the study and several other physicians said they doubt doctors are engaged in active mercy killing. Instead, they speculate the parents interviewed for the study mistakenly believed that doctors had followed their wishes.

A more likely scenario is that doctors increased morphine doses to ease pain, and that the children's subsequent deaths were only coincidental, said lead author Dr. Joanne Wolfe, a palliative pain specialist at Dana-Farber Cancer Institute and Children's Hospital in Boston.

The American Medical Association, American Academy of Pediatrics and most other mainstream doctor groups oppose mercy-killing but say withholding life-prolonging treatment for dying patients can be ethical.

Dr. Douglas Diekema, a medical ethicist at Seattle Children's Hospital, said the study results are not surprising.

"I have no doubt that in a small number of cases, some physicians might cooperate with a parent's desire to see a child's suffering ended. This might include giving a drug for sedation or pain control that also suppresses the drive to breathe.

"Most physicians don't intentionally push that drug to the point of stopping a child's breathing, but some may be comfortable not intervening if a child stops breathing in the course of treating him or her for discomfort," Diekema said.

The study was published Monday in the March edition of Archives of Pediatrics & Adolescent Medicine. It was based on interviews with parents of 141 children who had died of cancer and were treated at three hospitals, in Boston and Minnesota.

Among parents studied, one in eight, or 13 percent, said they had considered asking about ending their child's life, and 9 percent said they had that discussion with caregivers. Parents of five children said they had explicitly requested euthanasia for their dying children, and parents of three said it had been carried out, with morphine.

"If there was absolutely no other option, and the patient is suffering, then why wouldn't you" hasten death? said David Reilly, a Boston-area man whose 5-year-old son died of cancer 11 years ago.

Reilly was not part of the study, but Wolfe, the study author, treated his son. The boy had soft-tissue tumors that threatened to spread to his throat and choke him.

"I remember thinking what a horrible, horrible way to go," Reilly said. He recalls asking Wolfe if his son began to suffer, '"Can we just get it over with quickly?'" Wolfe told him no.

Wolfe said in an interview that euthanasia "is going beyond a moral stance that I hold for myself in terms of controlling when a person dies."

She said she could not comment when asked if she knew of any cases occurring at her hospitals, which both were involved in the study.

The third hospital was Children's Hospitals and Clinics of St. Paul, Minn. Dr. Susan Sencer, a cancer specialist there who did not take part in the study, said in a text message that doctors will often tell parents this when dying children are suffering: "'To alleviate pain and suffering we may need to increase the narcotics; increasing the narcotics may result in respiratory depression, which may hasten death,' so that they are aware of the trade-off."

Wolfe said the study highlights the challenges of treating dying children: Parents cannot tolerate seeing their children suffer and do not know about all the legal options for pain relief, which can include sedating children into unconsciousness. Also, many doctors are uncomfortable discussing such issues.

Dr. Melanie Brown, a palliative care specialist at the University of Chicago's Comer Children's Hospital, said she's never had parents ask her to end their child's life, but the general topic has come up.

She said when parents mention the idea, "What they're talking about is ending the pain."

Learning ahead of time about options other than euthanasia can help make these deaths more comfortable for children and their parents, she said.

Dr. Walter Robinson, an ethicist and associate pediatrics professor at Vanderbilt University, said many doctors lack expertise in treating dying children's pain, and many also worry about using opiates including morphine to treat children's pain because there's an unreasonable fear of addiction.

"The lesson we should learn from the paper is the need for expert pain control. That ought to be available in every children's hospital and to every child with a life-limiting illness," Robinson said.

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On the Net:

Archives: http://www.archpediatrics.com

Palliative care: http://www.childrenshospice.org

]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.57558 2010-02-23T15:19:51-06:00 2010-02-23T15:21:52-06:00

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2010-02-23T15:19:51-06:00 Staff editor@TheRochesterDemocrat.com Cancer


By AMY HARMON
NY TIMES
Published: February 23, 2010


For the melanoma patients who signed on to try a drug known as PLX4032, the clinical trial was a last resort. Their bodies were riddled with tumors, leaving them almost certainly just months to live.

But a few weeks after taking their first dose, nearly all of them began to recover.

Lee Reyes, 30, of Fresno, Calif., who had begun using a feeding tube because of a growth pressing against his throat, bit into a cinnamon roll.

Nothing, he told his mother, had ever tasted as good.

Rita Quigley, who had been grateful just to find herself breathing each morning since learning she had the virulent skin cancer, went shopping for new clothes with her daughters at a mall in Huntsville, Ala.

Randy Williams, 46, who drove 600 miles from his home in Jonesboro, Ark., to the M.D. Anderson Cancer Center in Houston to get the experimental drug, rolled out of bed. “Something’s working,” he thought, “because nothing’s hurting.”

It was a sweet moment, in autumn 2008, for Dr. Keith Flaherty, the University of Pennsylvania oncologist leading the drug’s first clinical trial. A new kind of cancer therapy, it was tailored to a particular genetic mutation that was driving the disease, and after six years of disappointments his faith in the promise of such a “targeted” approach finally seemed borne out. His collaborators at five other major cancer centers, melanoma clinicians who had tested dozens of potential therapies for their patients with no success, were equally elated.

In a kind of “pinch me” exercise, the six doctors sent one another “before and after” CT scans of their patients.

One was of Mark Bunting, 52, an airline pilot in Sandy, Utah. His initial scan in early October showed the cancer in his bones, an incursion considered virtually impossible to reverse. After two months on the drug, it had all but disappeared.

“Holy Cow!” Dr. Flaherty typed in reply to the slide from Dr. Antoni Ribas at the University of California, Los Angeles, that Dec. 17.

“Are you sure it is the same patient??” added Dr. Jeffrey A. Sosman at the Vanderbilt-Ingram Cancer Center in Nashville.

From New York, Dr. Paul B. Chapman of Memorial Sloan-Kettering Cancer Center, perhaps the most determined skeptic of the group, acknowledged, “This looks impressive.”

The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time.

Throughout the fall, the only two patients on the trial whose tumors continued to grow were the ones who did not have the particular gene mutation for which the drug had been designed. They were removed from the trial. By late December, tumors in the 11 patients who did have the mutation had shrunk. Those involved in the trial held their collective breath waiting to see how long the remissions would last.

It was a far cry from where they had been a year earlier, when a previous incarnation of the drug had no effect. Urged on by Dr. Flaherty and Dr. Chapman, the companies that owned it had spent months devising a new formulation that could be absorbed at higher doses.

But the new drug, still in the earliest phase of testing, had to pass several more hurdles before federal regulators would determine whether it was safe and effective enough for widespread use.

In December, as the doctors added more patients to the Phase 1 trial, looking for the highest dose they could give without intolerable side effects, they scrambled to prepare slides with graphs and statistics to convince the Food and Drug Administration that the drug should be tested in a larger Phase 2 trial. The agency required a summary of any and all side effects — there had been only a few — and any deaths of patients on the study; thankfully, there had been none since the drug was reformulated. In a matter of days they needed to submit their findings for a prestigious meeting of clinical oncologists in June.

First, though, Dr. Flaherty, 39, needed to respond to a desperate phone message from a patient named Christopher Nelson. It came the day after Christmas.

“Dr. Flaherty,” the message said, “I need to get onto your trial.”

Hoping for a Match

The doctor had expected the call.

Mr. Nelson, 42, and his wife, Sharlene, had come to see him just before Thanksgiving. They were planning to travel to Bethesda, Md., so Mr. Nelson could enroll in a trial for a different melanoma drug. But the couple, from Jackson, N.J., had learned of Dr. Flaherty’s trial, and wanted to cover all their bases.

He liked them: Sharlene, a real estate broker who peppered him with questions, and Chris, a furniture installer around his own age with a penchant for low-stakes poker and the Grateful Dead. Both were quick to make light of a grim situation.

“I’ve gained the 60 pounds he’s lost from the cancer,” Mrs. Nelson observed. “Stress eating.”

They had met after high school, at Levitz, the furniture store where they both worked. Like Dr. Flaherty, they had two children.

“He was never sick a day in his life,” Mrs. Nelson told Dr. Flaherty. “Never had a headache, never took a sick day. I mean, can’t you give me the common cold first? It had to be cancer?”

The trial in Bethesda, run by the National Cancer Institute, involved coaxing immune cells to grow in a test tube in a procedure that worked for only a small fraction of patients, Dr. Flaherty knew.

But there would be no point in Mr. Nelson taking PLX4032 if his tumor did not carry the right mutation. For now, the doctor had a slot for only one more patient on the trial, and he and his collaborators had agreed it was almost unethical to give the drug to people without that mutation.

He wished, not for the first time, that he could snap his fingers and know the genetic profile of his patient’s cancer cells. But getting a hospital that had operated on a patient months earlier to retrieve a tumor sample from storage could take days or weeks; the test for the gene mutation could take even longer. To speed the process, Mr. Nelson drove his tumor sample himself from Robert Wood Johnson University Hospital in New Brunswick, N.J., where it had been removed from his lymph nodes, to the laboratory at the University of Pennsylvania.

Dr. Flaherty agreed that while they waited, Mr. Nelson should proceed with the trial in Bethesda, which first required the removal of his tumor-laden spleen. Either way, that needed to go.

Mrs. Nelson thought her husband had died when she saw the stricken look on the face of the surgeon after the operation. Normally 2 pounds, the spleen had weighed 10. Mr. Nelson’s liver was so enlarged that maneuvering around it had been almost impossible. And then, on Dec. 23, Mr. Nelson learned that the doctors running the trial had been unable to grow his immune cells.

On the phone, Dr. Flaherty assured him he would let them know his genetic status as soon as he found out. “If it’s positive,” Dr. Flaherty told him, “the spot is yours.”

Checking, Checking

No one knows just what causes the single change in a single gene in a single cell that fuels a malignant melanoma.

Randy Williams, now in recovery, had gone over in his mind a million times the day he fell asleep in the sun at the lake when he was 16. His feet were so badly burned, he could not walk for a week. Twenty years later, a mole inside the arch of his left foot turned cancerous.

Was that it? Was that the moment his fate was set? Because melanoma has been linked to sunburn, especially in childhood, many of the trial’s participants relived such memories. Almost certainly, each had accumulated mutations in many other genes, at other moments, over the course of their lives. Some may have inherited a gene that was already damaged.

Once unleashed, however, any cancer seemed to rely on the protein made by a particular mutated gene to fuel its wild growth. In all of the PLX patients, that gene was B-RAF. And whatever the cause, they came to consider themselves, so far as it was possible with what has always been a virtually untreatable cancer, charmed.

At least they had a chance. The patients took pills the size of large vitamins, twice a day. Some gulped them down with water. Others spooned them up with applesauce.

To get to the mandatory doctor’s appointments where patients were given precisely one month’s supply, Mr. Williams, a contractor with two teenage children, drove all night with his brother in a pickup truck. One young woman hopped “corporate angel” flights on private jets whose owners donated empty seats.

Mark Bunting used his pilot privileges to commute to Los Angeles to see his oncologist. “He says,” Mr. Bunting told friends as his tumors melted away last fall, “that I’m the leader of the pack.”

For some patients and their family members, though, the sudden reprieve was almost as disorienting as the diagnosis.

Mr. Bunting, for one, could not convince his wife, Trish, that it was for real.

A former flight attendant, she had coped with her husband’s cancer by confronting it head-on. She organized a family trip to Disney World, so their young children would have the memory. She entered nursing school, so she would have a means of supporting herself.

As if to drive home the point, on her first day, a teacher had illustrated a lesson on cell growth with a picture of melanoma that had metastasized. “Here’s when I think of one of my favorite Carole King songs: ‘It’s Too Late,’ ” the teacher said.

Now, even as Ms. Bunting watched the color seep back into her husband’s gray skin, even as they celebrated a Christmas she never thought he would live to see, she found herself unable to shake the need to prepare for his death. “You need to sit and write down stuff for me,” she told her husband. “I need to know who I call for this, I need to know where things are.”

“But I’m doing better!” he pleaded. “Can’t you see?”

In Oklahoma City, Kerri Adams, 30, just tried not to jinx it. She did not look up anything about the drug, the gene or the cancer on the Internet or anywhere else. Single and employed as an analyst at a local utility company, she attended church with her mother and ate dinner with friends. But when they coaxed her to meet new people, she demurred. The future seemed too uncertain.

Mr. Williams, back full time at his contracting business with his brother, climbed ladders, lifted weights and fixed up his Corvette.

The tumors on his legs that had constantly oozed blood dried up and then disappeared. Yet every day, he ran his fingers over the spots where they used to be, checking, checking, checking.

“I don’t think I’ll ever believe,” he said, “that it’s not coming back.”

A Doctor’s Struggle

Still waiting to hear if he would be eligible for Dr. Flaherty’s trial, Mr. Nelson managed to get to a Portuguese restaurant with the rest of the family for his son’s 16th birthday in January 2009, but he could not eat.

One morning a few weeks later, the pain in his stomach was so overwhelming that he told his wife they needed to go to the emergency room, where he was admitted and hooked up to intravenous morphine for the pain.

“There’s nothing we can do for him,” the doctor told her. “You should think about getting hospice.”

Frantically, Mrs. Nelson left a message for Dr. Flaherty. She wanted to order an ambulance, an airlift, whatever it took to get her husband to Philadelphia.

He called back immediately. The test had finally come back, he said.

Mr. Nelson had the mutation.

“Is my husband going to be able to get on this drug?” she demanded. “I need to know because there’s no waiting.”

First, she would need to wean him from the auto-drip morphine, Dr. Flaherty told her gently. To qualify for the trial, he needed to be able to walk in. And the last spot on the trial had to be filled within a week.

Mr. Nelson, who had not eaten in days, threw up the morphine pills the first several times he tried to get them down. But he went home the day before Valentine’s Day.

“Honey,” his wife told him, “you don’t have to get me anything.”

At home, Mr. Nelson called her on her cellphone as she waited in a long pharmacy line to pick up the morphine. The pain was breaking through.

“Hurry,” he said.

Mrs. Nelson drove to Philadelphia a few days later, her husband sprawled in the back seat. At the cancer center, she pushed him in a wheelchair into the waiting room of the melanoma clinic. When the nurse called his name, he struggled to his feet and walked in to see the doctor.

Dr. Flaherty looked at him. He did not need the required blood test to tell that his numbers were off the charts. Mr. Nelson’s eyes were yellow, a sign that his liver was at the edge of failure. He had, at the most, the doctor thought, a month to live.

Maryann Redlinger, the clinical trial nurse, was not one to mince words.

“Are you out of your mind?” she asked Dr. Flaherty when he told her he wanted to put Mr. Nelson on the trial. A death on a trial was a black mark. No matter how good the other numbers were, it would count against them.

If his decision delayed by even a few months the approval of a drug that could help tens of thousands of patients, surely it would be unethical. But there might be a benefit in seeing what the drug could do for a patient like Mr. Nelson. This was the kind of patient who came to him all the time.

And how could he deny Chris Nelson a drug that, he knew in his gut, would give him extra time?

“He has two kids at home, Maryann,” he said. “Do you want to tell him he can’t get it? Go ahead, you call him up and tell him no.”

Dialing Back

The side effects struck at the 1,120-milligram dose.

Many patients had been taking the reformulated drug for five months with no signs of relapsing. The doctors had hoped that by pushing up the dose they could shut down the cancer more effectively. Some patients were taking as many as 28 pills a day.

Ms. Adams, in Oklahoma City, woke up one morning covered in a rash. Frightened that she would be dropped from the trial, she tried to ignore it. But at work, her boss was horrified and insisted that she call the doctor. Another woman’s hand swelled up, and she could not make a fist. A Philadelphia patient had horrible nausea and diarrhea, and Mr. Bunting’s joints grew so stiff that he had to hand jars to his wife to remove the lids, even when they had already been opened.

Maybe the drug, designed to turn off only the defective B-RAF protein, was, at high doses, also affecting its role in healthy cells. Or perhaps it was interfering with other proteins the body needed to function properly. On their next conference call, the doctors agreed that they had to dial back the dose.

As the side effects began to subside, many of the patients began to believe they had beaten their cancer. One evening, Mr. Bunting performed what had become his pill-taking ritual as his wife puttered around the kitchen.

He liked the water to be room temperature, so he heated it in the microwave and added cold from the tap. He burped, and some powder from the pills came out of his mouth just as she turned to look.

They both laughed.

One Step Forward ...

When Mr. Nelson strolled into the University of Pennsylvania for a scheduled day of blood work and monitoring in mid-March, Ms. Redlinger greeted him as if he had risen from the dead.

Gazing out the window of the clinic room, he spied a hot dog stand.

“Dirty water dogs,” he exclaimed.

“Can you get me one?” he asked his wife’s sister. “Actually, two?”

“Chris is feeling better,” the nurse told Dr. Flaherty casually when she saw him.

“What do you mean?” he pressed.

“Well, he’s off pain meds,” she said.

Dr. Flaherty was not scheduled to see Mr. Nelson until three weeks later. But between appointments that day, the doctor found time to visit his patient. In Mr. Nelson’s room, he broke into a wide smile, a tension he had not realized he was holding seeping out of him.

He had never seen a melanoma patient who had been that sick improve that much. He was not sure he had ever seen a melanoma patient that sick who improved at all.

Mrs. Nelson hugged him. In the weeks that followed, Mr. Nelson gained 17 pounds. One morning a friend drove him to Atlantic City, where for a $35 buy-in, they played his favorite game, Texas hold ’em, all day. The drug had made him sensitive to the sun, and he burned his skin cleaning the pool one afternoon, even with strong sunblock. Mrs. Nelson bought an umbrella, and he spent much of the spring sitting underneath it.

“Today’s a nice day,” he said over the phone to a friend in early May. “There’s a cloud, and the sun is behind it.”

In mid-May, right before he was to fly to Orlando, Fla., to present the trial’s data, Dr. Flaherty received a message on his BlackBerry as he was walking on campus.

The first patient to respond in the trial, Elmer Bucksbaum, had been admitted to the hospital. The cancer had spread to his brain.

Dr. Flaherty stopped walking.

The drug, Dr. Flaherty knew, was powerless in the brain. But had the drug held off the cancer elsewhere in Mr. Bucksbaum’s body? Or would other patients, too, begin to relapse?

Mr. Bucksbaum died a few days later.

Dr. Flaherty called his family and offered his condolences. It had been not quite eight months.



]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.57508 2010-02-22T12:16:13-06:00 2010-02-22T12:18:14-06:00

{summary}

2010-02-22T12:16:13-06:00 Staff editor@TheRochesterDemocrat.com Disease



By MARILYNN MARCHIONE
Associated Press
Feb 21, 12:33 PM (ET)


Some of mankind's most devastating inherited diseases appear to be declining, and a few have nearly disappeared, because more people are using genetic testing to decide whether to have children.

Births of babies with cystic fibrosis, Tay-Sachs and other less familiar disorders seem to have dropped since testing came into wider use, The Associated Press found from interviews with numerous geneticists and other experts and a review of the limited research available.

Many of these diseases are little known and few statistics are kept. But their effects - ranging from blood disorders to muscle decline - can be disabling and often fatal during childhood.

Now, more women are being tested as part of routine prenatal care, and many end pregnancies when diseases are found. One study in California found that prenatal screening reduced by half the number of babies born with the severest form of cystic fibrosis because many parents chose abortion.

More couples with no family history of inherited diseases are getting tested before starting families to see if they carry mutations that put a baby at risk. And a growing number are screening embryos and using only those without problem genes.

The cost of testing is falling, and the number of companies offering it is rising. A 2008 federal law banning gene-based discrimination by insurers and employers has eased fears.

Genetic testing pushes hot-button issues: abortion, embryo destruction and worries about eugenics - selective breeding to rid a population of unwanted traits. Yet it is touching a growing number of people:

- In suburban Cleveland, Beth and Thad Meese were stunned to learn during her second pregnancy that they carry genes that can cause cystic fibrosis. Tests show the baby won't have the disease, but they have decided against having a third child or to screen embryos if they do. "I feel like we got lucky" and should not tempt fate again, she said.

- In Boston, Harvard psychologist and author Steven Pinker and his wife, novelist Rebecca Goldstein, learned last year that they carry genes that cause a serious neurological disease, familial dysautonomia. Too old to have children, they shared the news with younger relatives, who are being tested to see if they, too, have the gene. "There's a tendency psychologically to think these are very rare and what are the chances that two people could both have rare genes," Pinker said. "Not only can it happen, but it happened to me."

- In the Canadian city of Vancouver, Jeff and Megan Carroll screened embryos to have two children free of the Huntington's disease gene Jeff has. "I felt very strongly that I didn't want to pass on this," he said. Huntington's "is done killing people in my family when I am gone."

Although genetic testing can raise moral dilemmas, at least one conservative religious group - Orthodox Jews - has found ethically acceptable ways to use it to lessen diseases that have plagued its populations.

"I am a Holocaust survivor. I was born in the middle of the second World War. I hope that I am not a suspect for practicing eugenics. We are trying to have healthy children," said Rabbi Josef Ekstein of New York, who founded a group that tests couples and discourages matches when both carry problem genes.

Some diseases - sickle cell, cystic fibrosis, Tay-Sachs, thalassemia, spinal muscle atrophy - occur when people inherit two bad genes, one from each parent. The genes can pass quietly for generations until two carriers mate; then children have a one-in-four chance of getting the disease.

(Down syndrome is the best known disorder for which prenatal testing has long been available, but it's caused by an extra chromosome during abnormal cell division - not genes inherited from the parents.)

Statistics for inherited diseases are hard to come by - birth certificates often don't list them, and they sometimes aren't diagnosed for months or years after birth. Yet, there's little doubt that testing has put a dent in many.

"We're definitely seeing decreased rates of certain genetic disorders as a result of carrier screening," said Dr. Wendy Chung, clinical genetics chief at Columbia University. In five years, she has seen only one case of Tay-Sachs, a neurological disease that used to be more common in Ashkenazi, or Eastern European Jews. Children with the disease lack a key enzyme; they lose mental and physical abilities and usually die by age 4.

In the last decade, only about a dozen new cases of Tay-Sachs occurred each year in the United States, said Dr. Michael Kuback, a professor at the University of California at San Diego who tracks the disease.

Ekstein, the rabbi, lost four children to it before founding Dor Yeshorim, a Brooklyn-based group that recruits Jews to be tested. Using confidential PIN numbers, they call a hotline to see if a prospective mate would be a risky match. The group has 300,000 members and tests for nine diseases, including cystic fibrosis.

"In the Orthodox Ashkenazi community around the world, we virtually have wiped out the diseases we screen for," said the group's development director, Allan Binder.

One is familial dysautonomia. Since 2004, only a few children worldwide have been born with it each year, and it soon may cease to exist because of genetic screening, said Dr. Barron Lerner, a Columbia University medical historian. The disease causes faulty nerve development, floppy muscles, digestive and other problems, and kills many by young adulthood.

Fragile X syndrome, the leading cause of mental impairment in boys, may decline because carrier testing for parents and prenatal testing of fetuses is now available for it, said Barbara Biesecker, director of the genetic counseling program at the National Institutes of Health.

Lots of eyes are on cystic fibrosis, a disease that causes sticky mucus buildup in the lungs, digestive problems and death in young adulthood. More than 10 million Americans - one in 25 to 29 whites, who are more at risk for it than blacks - carry a gene mutation for it. In 2001, the American College of Obstetricians and Gynecologists and other groups recommended that white pregnant women be offered testing for mutations. Tests on partners and fetuses often followed, and an unknown number of abortions.

The impact showed up two years later in Massachusetts, one of the few states testing newborns for the disease at the time. Births of babies with cystic fibrosis dropped, from 29 in 2000 to only 10 in 2003, ticking up to 15 in 2006, said Dr. Richard Parad, a Brigham and Women's Hospital physician who helped set up the screening program.

In California, Kaiser Permanente, a large health maintenance organization, offered prenatal screening. From 2006 through 2008, 87 couples with cystic fibrosis mutations agreed to have fetuses tested, and 23 were found to have the disease. Sixteen of the 17 fetuses projected to have the severest type of disease were aborted, as were four of the six fetuses projected to have less severe disease.

Comparisons to couples not given prenatal screening suggested that screening had cut births of babies with severe disease in half, researchers reported at a genetics conference in 2008. Studies in Canada, Italy, Australia and in Europe also found that cases dropped after screening began.

The Cystic Fibrosis Foundation's registry, which tracks voluntarily reported cases, shows a steady rise in recent years. But that is because more states have started testing all newborns, discovering cases that previously went unreported, some researchers believe. In December, Texas became the final state to add such testing; the first reliable national estimate of cases is expected in a couple of years.

Beth Meese, the Cleveland nurse who discovered from prenatal tests that she and her husband are carriers, wishes they had been screened before pregnancy. By the time they learned of their risk, they had seen an ultrasound and decided to have the baby no matter what its tests showed.

"We saw the baby, saw it moving," she said. "It makes that decision that much more difficult to make."

Gene testing hasn't led to declines in all diseases. Sickle cell, a blood disorder that causes anemia and pain and raises the risk of stroke, has not dropped. It mostly afflicts blacks; gene carriers are said to have sickle cell "trait," which sounds harmless.

"Now we're actually learning that it's not as benign as we thought it was," and that carriers have higher risks for certain medical problems, said Dr. Lanetta Jordan, a Florida physician and chief medical officer of the Sickle Cell Disease Association of America.

Newborn screening is finding more sickle cell carriers and cases, but this doesn't seem to affect parents' future family plans, Jordan said.

Gene testing also has had little impact on Huntington's disease, a progressive, fatal neurological disorder. Unlike many other inherited diseses, only one bad copy of a gene is needed to cause Hungtington's, and symptoms don't usually appear until middle age, after many have already had children.

Fewer than 15 percent of people in families with a history of it agree to be tested, said Kimberly Quaid, an Indiana University genetics researcher.

"They just prefer to live their life and hope for the best," she said.

Jeff Carroll, the Canadian who, with his wife, screened embryos because he carries the Huntington's gene, said it is "unconscionable" to procreate without taking steps to prevent passing on the disease. "Having my test result has immensely improved my life. I was able to make reproduction decisions that ended HD in my family," and to launch a career as a biologist researching the disease, he said.

The number of fertility treatments that include embryo screening has been on the rise in recent years, with nearly 5,200 screenings in 2006, according to the Society for Assisted Reproductive Technology. Carrier testing also is rising. A California company, Counsyl, sells a $349 saliva test for genes for more than 100 inherited disorders. Several thousand people used it over the last year, the company reports.

Eliminating disease is a noble goal but also "should give us pause," Lerner, the Columbia historian, wrote recently in the New England Journal of Medicine.

"If a society is so willing to screen aggressively to find these genes and then to potentially to have to abort the fetuses, what does that say about the value of the lives of those people living with the diseases?" he asked.

It's a touchy issue. The Cystic Fibrosis Foundation points out that the disease varies greatly in severity, and life expectancy with it is now 37 years.

Diseases like familial dysautonomia and Tay-Sachs, which kill before school age, are easier cases. If one of those vanishes, "thank God," said Rabbi Ekstein of the Jewish testing group. "It gives me a very good feeling that we are a part of such life-saving efforts."

---

On the Net:

March of Dimes: http://www.marchofdimes.com/pnhec/4439.asp

National Human Genome Research Institute: http://www.genome.gov/19516567

American College of Medical Genetics: http://www.acmg.net


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.57468 2010-02-20T13:24:19-06:00 2010-02-20T13:25:20-06:00

{summary}

2010-02-20T13:24:19-06:00 Staff editor@TheRochesterDemocrat.com Drug News


By GARDINER HARRIS
NY TIMES
February 20, 2010


Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.’s drug center, wrote that “there are multiple conflicting opinions” about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

“I await the recommendations of the advisory committee,” the agency’s commissioner, Dr. Margaret Hamburg, said Friday night. “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

“Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

In response, GlaxoSmithKline said that it disagreed with the Senate investigation’s conclusions. The company said that it could not comment on internal F.D.A. documents but that “the official ruling from F.D.A. is that Avandia remain on the market.”

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.’s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia’s use by precisely such patients, the reports note.

“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable,” one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company’s patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.

Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.

“It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Mr. Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”

The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems — including 304 deaths — reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.

But companies say that such reports do not offer proof of a problem and that highlighting them can scare patients away from needed treatment, so they often argue that more certainty is needed before alarms are raised. GlaxoSmithKline said a “vast majority” of the recent reports regarding Avandia was related to litigation.

The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company’s Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study — called the Record trial — to examine Avandia’s heart risks because hints of these problems appeared in the company’s earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials — called Dream and Adopt — were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company’s Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies “disquieting.” Negotiations with agency officials about how and whether to alert the public continued.

Meanwhile, the company continued to market and advertise Avandia aggressively. The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.

In 1999, for instance, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania.

GlaxoSmithKline said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.”


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.57080 2010-02-04T21:17:12-06:00 2010-02-04T21:18:13-06:00

{summary}

2010-02-04T21:17:12-06:00 Staff editor@TheRochesterDemocrat.com Health Initiatives





NEW YORK (AP) - It's the mystery under the kitchen sink.

Exactly what's in floor cleaner? What's stain remover made of? And what effects, if any, might they have on human health or the environment?

Environmental advocates want to know, and they asked a court Wednesday to use a 1971 New York state law to force such manufacturers and Procter & Gamble and Colgate-Palmolive to reveal just what makes up such household staples as Ajax, Ivory soap and Tide.

The cleanser industry - which recently ramped up voluntary efforts to unveil product ingredients - says that the legal case is unwarranted, and that fears about health risks are misinformed.

But groups including the American Lung Association and the Sierra Club want the public to know more.

Members "want access to the information so they can determine the kind of chemicals that they are introducing into their homes and whether there are any risks associated with them," Keri Powell, an attorney for the environmental firm Earthjustice, told a state judge at a hearing Wednesday.

A victory in the New York case would require companies to report their contents only to the state. But the advocates hope it will fuel nationwide reform of regulations on chemicals in cleaners and other products.

The case comes amid growing concerns about potential toxins lurking in consumer goods, from the heavy metal cadmium in jewelry to the chemical bisphenol A in baby bottles. While lawyers argued the cleaning-products case in New York, a Senate subcommittee in Washington held a hearing to examine current science on the public's exposure to toxic chemicals.

Some studies have linked cleaning product components to asthma, antibiotic resistance, hormone changes and other health problems. The industry's major trade group, the Soap and Detergent Association, assails the research as flawed, says the products are safe if used correctly and notes that cleaning can itself help stop the spread of disease.

Federal environmental laws don't require most household cleaning products to list their ingredients, though there are congressional proposals to change that. The Consumer Product Safety Commission requires hazard warning labels on some cleansers, and the National Institutes of Health offer some health and safety information for hundreds of cleaning products, drawn from data gathered for industrial use.

Cleanser industry groups unveiled their own ingredient-listing initiative last month, offering information on participating manufacturers' Web sites. New York-based Colgate-Palmolive Co., Cincinnati-based Procter & Gamble Co. and several other industry heavyweights are participating.

"We think we've done it in a meaningful way that provides more information than ever before," Soap and Detergent Association spokesman Brian Sansoni said.

Environmental advocates welcome the disclosures but say they are too selective and vague - some components can be listed simply as "fragrance" or "dye," for instance.

"We must be careful about exposures for all household chemicals," said Joseph A. Gardella Jr., a Sierra Club member from Buffalo.

The activists say only regulation can insure full disclosure, and they hope the New York law can serve as a model.

The law and subsequent regulations authorized the state Department of Environmental Conservation to make manufacturers detail household cleaning products' ingredients, as well as any company-led research on the products' health and environmental effects.

"No consumer wishing to purchase a detergent for washing clothes or dishes or for cleansing the human body, can realistically gauge the detrimental effects of such products unless informed as to the ingredient of the product," then-Gov. Nelson Rockefeller wrote when he signed the law.

The DEC, and the companies fighting the lawsuit, say the law allows but doesn't require the agency to collect the data. The companies have said in legal papers they would make the disclosures if required but haven't been officially asked.

"The DEC has never enforced these regulations," John J. Kuster, a lawyer for New York-based Colgate-Palmolive, told the judge Wednesday.

The companies - also including Church & Dwight Co. Inc., Procter & Gamble and Reckitt-Benckiser Inc. - asked a state Supreme Court judge to dismiss the case. There's no definite timeframe for a ruling.

Reckitt-Benckiser, a British company with its U.S. headquarters in Parsippany, N.J., makes products including Lysol and Woolite. Princeton, N.J.-based Church & Dwight makes Arm & Hammer cleaners, among other items.

Some other companies have sent ingredient lists to the DEC since Earthjustice and other organizations began asking in 2008. The agency is looking at ways to publicize the information for consumers who want it, spokeswoman Maureen Wren said.


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56519 2010-01-12T13:12:28-06:00 2010-01-12T13:13:29-06:00

{summary}

2010-01-12T13:12:28-06:00 Staff editor@TheRochesterDemocrat.com Imports





LOS ANGELES (AP) - Federal and state watchdogs opened a new front Monday in the campaign to keep poisons out of Chinese imports, launching inquiries into high levels of cadmium in children's jewelry while Walmart pulled many suspect items from its store shelves.

A day after The Associated Press documented the contamination in an investigative report, the top U.S. consumer safety regulator warned Asian manufacturers not to substitute other toxins for lead in children's charm bracelets and pendants.

Regulators and lawmakers reacted swiftly to the AP report, which found that some Chinese manufacturers have been using cadmium, sometimes at extraordinarily high levels. Congress clamped down on lead in those products in 2008, but cadmium is even more harmful.

Melissa Hill, a spokeswoman for Wal-Mart Stores Inc., called the AP findings "troubling." She said the company, which is the world's largest retailer, had a special responsibility "to take swift action, and we are doing so."

Members of Congress voiced anger about the imports. Sen. Bill Nelson, a Florida Democrat, said he's reviewing the law that regulates such substances to decide if a fix is needed.

"Parents will be outraged to learn certain jewelry makers overseas thought they could pull a fast one at the expense of our kids' safety," said Democratic Sen. Mark Pryor of Arkansas, who has championed stronger rules for children's products.

Cadmium, which is known to cause cancer, is a soft, whitish metal that occurs naturally in soil. It's perhaps best known as half of rechargeable nickel-cadmium batteries, but also is used in pigments, electroplating and plastic.

Cadmium is attractive to Chinese manufacturers because it is cheap and easy to work with. But, like lead, it can hinder brain development in the very young, recent research shows.

In Hong Kong, Vincent Tan, the director for compliance at the Jetta Co., a toy manufacturer, said he would support a cadmium ban "if scientific evidence supports that it is leaching and causing hazards for children."

Companies like Jetta - which has made electronic and plastic toys for U.S. companies like Hasbro Inc. and Mattel Inc., but does not produce children's jewelry - do not use cadmium in paint. But the metal may be present in alloys it uses. The company doesn't have much experience testing for it, said Tan.

In taped remarks to be delivered Tuesday in Hong Kong, the chairwoman of the U.S. Consumer Product Safety Commission urged other countries to ensure that manufacturers do not substitute cadmium, antimony or barium in place of lead in children's products.

"All of us should be committed to keeping hazardous or toxic levels of heavy metals out of ... toys and children's products," Inez Tenenbaum said in a transcript of remarks to an international toy safety conference.

Tenenbaum singled out cadmium for special vigilance and said: "Voluntary efforts will only take us so far."

The commission immediately said it was opening an investigation into the AP's findings, promising to "take action as quickly as possible to protect the safety of children."

Connecticut Attorney General Richard Blumenthal also said Monday that his office would investigate cadmium content in some products, particularly costume jewelry.

Blumenthal would not say whether he's investigating particular merchants. Rather than "singling out any stores, we're interested in any retail outlets that sell jewelry that may have cadmium," he said.

New York state Sen. James S. Alesi said he will introduce legislation to ban the sale of cadmium in jewelry in his state. "We must act immediately to keep this contaminated jewelry out of the hands of children and reduce their exposure to toxic substances," said Alesi, a Republican.

Lab tests were conducted for the AP on 103 pieces of low-price children's jewelry such as charm bracelets and pendants purchased around the country. Virtually all were imported from China.

Twelve items had cadmium levels of at least 10 percent by weight. One piece had a startling 91 percent, and others contained more than 80 percent. The government has no restrictions on cadmium in jewelry.

Children can be exposed by sucking or biting such jewelry. But without direct exposure, most people do not experience its worst effects: cancer, kidneys that leak vital protein and bones that spontaneously snap.

The worrisome results came in tests of bracelet charms sold at Walmart stores, at the jewelry chain Claire's and at a Dollar N More store. High amounts of cadmium also were detected in "The Princess and The Frog" movie-themed pendants.

Eighty-nine items were free of cadmium.

U.S.-based trade groups, as well as distributors and sellers of the jewelry containing cadmium, said their products meet safety standards. Cadmium is regulated in painted toys but not in jewelry.

A cadmium specialist with the Beijing office of Asian Metal Ltd., a market research and consultancy firm, said products with cadmium are normally directed to the Chinese domestic market.

"This is just the latest example of the need for stronger consumer safety laws in this country, especially for products manufactured and marketed for children, and shows yet again why products from China should be subject to additional scrutiny," said Rep. Rosa L. DeLauro, a Connecticut Democrat.

"Between children's jewelry, tainted milk and contaminated pet food, China has a long record of producing unsafe products, and the U.S. should continue to be wary of all products arriving from China."

A 2008 law imposed limits on lead in children's products and sent factories rushing for substitutes. About the same time, cadmium prices dropped, in part because nickel-cadmium batteries are swiftly being replaced with newer designs.

In her speech, Tenenbaum praised manufacturers for largely abandoning lead in their goods. The tests run for the AP found little lead.

The jewelry testing was conducted by chemistry professor Jeff Weidenhamer of Ashland University in Ohio, who over the past few years has provided the government with results showing high lead content in products that were later recalled.

His testing of children's jewelry for AP also showed that some items easily shed cadmium, elevating concerns about exposure to children.

"Clearly it seems like for a metal as toxic as cadmium, somebody ought to be watching out to make sure there aren't high levels in items that could end up in the hands of kids," Weidenhamer said.

"There's nothing positive that you can say about this metal. It's a poison," said Bruce A. Fowler, a cadmium specialist and toxicologist with the U.S. Centers for Disease Control and Prevention. On the agency's priority list of 275 most hazardous substances in the environment, cadmium ranks No. 7.

If the cadmium-laden jewelry were industrial garbage, it could qualify as hazardous waste. But since there are no cadmium restrictions on jewelry, such items are sold legally. The federal government has never recalled an item for cadmium, though it has fielded scattered complaints for at least two years. The CPSC cited "an upward trend" in reports of products containing cadmium.

Private-sector testing confirms this. Two laboratories that analyze more than a thousand children's products each year checked their data at AP's request. Both said their findings of cadmium above 300 parts per million in an item - the current federal limit for lead - increased from about 0.5 percent of tests in 2007 to about 2.2 percent of tests in 2009.

However, Sheila A. Millar, a lawyer for the Fashion Jewelry Trade Association, said members had not noticed "widespread substitution" with cadmium. She said jewelry makers these days often opt for zinc, which is a safer substitute.

Some children's advocates weren't reassured.

"If they're going to substitute one chemical for another ... they need to have some indications it's a safe thing to have in a product that a child is going to use," said Nancy Cowles, director of Kids in Danger, a Chicago-based nonprofit that advocates for safety in children's products. "With cadmium, we've known for years it's unsafe."


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56500 2010-01-11T19:09:14-06:00 2010-01-11T19:10:15-06:00

{summary}

2010-01-11T19:09:14-06:00 Staff editor@TheRochesterDemocrat.com Products




LOS ANGELES (AP) - The top U.S. consumer product regulator is warning Asian manufacturers not to substitute other toxic substances for lead in children's items, a message that follows the launch of a government investigation into Chinese-made jewelry that lab tests showed was laden with the heavy metal cadmium.

Inez Tenenbaum, chairman of the Consumer Product Safety Commission, said in taped remarks to be delivered Tuesday in Hong Kong that her agency would be strenuously guarding against attempts to swap one health hazard for another, now that lead is barred under U.S. law in children's toys and jewelry.

"I would highly encourage all of you to ensure that toy manufacturers and children's product manufacturers in your country are not substituting cadmium, antimony, barium, in place of lead," Tenenbaum tells an audience of children's products manufacturers, exporters and regulators, according to a transcript. "All of us should be committed to keeping hazardous or toxic levels of heavy metals out of ... toys and children's products."

The speech follows an Associated Press investigative report that documented how some Chinese manufacturers have been substituting cadmium for lead in cheap charm bracelets and pendants being sold throughout the United States.

In lab testing for the AP, the most contaminated piece of children's jewelry contained 91 percent cadmium by weight. The cadmium content of other trinkets, all purchased at national and regional chains or franchises, tested at 89 percent, 86 percent and 84 percent by weight. Few of the items contained much lead.

The testing also showed that some items easily shed the heavy metal, raising additional concerns about the levels of exposure to children.

The CPSC reacted within hours of the AP report Sunday, announcing an investigation while promising to "take action as quickly as possible to protect the safety of children." CPSC spokesman Scott Wolfson said the agency would study the test results, attempt to buy the contaminated products and "take appropriate action."

Tenenbaum acknowledged media coverage of cadmium contamination in the speech to a toy safety conference organized by Asia-Pacific Economic Cooperation, a forum of governments in the region.

She aptly predicted that heavy metals, "especially cadmium, are going to attract attention in the United States from consumer advocates, the media and parents." She promised the agency would continue to post information on its Web site, Web-based interactive training seminars to provide practical information for industry compliance.

Tenebaum's remarks about cadmium substitution departed from her overall upbeat tone, which praised manufacturers for in most cases abandoning the use of lead in their products.

The jewelry testing was conducted by chemistry professor Jeff Weidenhamer of Ashland University in Ohio, who over the past few years has provided the CPSC with results showing high lead content in products that were later recalled. Wolfson acknowledged the agency had worked closely with Weidenhamer.

Cadmium is a known carcinogen. Like lead, it can hinder brain development in the very young, according to recent research.

Children don't have to swallow an item to be exposed - they can get persistent, low-level doses by regularly sucking or biting jewelry with a high cadmium content.

To gauge cadmium's prevalence in children's jewelry, the AP organized lab testing of 103 items bought in New York, Ohio, Texas and California. All but one were purchased in November or December. The results: 12 percent of the pieces of jewelry contained at least 10 percent cadmium.

Some of the most troubling test results were for bracelet charms sold at Walmart, at the jewelry chain Claire's and at a dollar store. High amounts of cadmium also were detected in "The Princess and The Frog" movie-themed pendants.

"There's nothing positive that you can say about this metal. It's a poison," said Bruce A. Fowler, a cadmium specialist and toxicologist with the U.S. Centers for Disease Control and Prevention. On the CDC's priority list of 275 most hazardous substances in the environment, cadmium ranks No. 7.

Jewelry industry veterans in China say cadmium has been used in domestic products there for years. Zinc, the metal most cited as a replacement for lead in imported jewelry being sold in the United States, is a much safer and nontoxic alternative. But the jewelry tests conducted for AP, along with test findings showing a growing presence of cadmium in other children's products, demonstrate that the safety threat from cadmium is being exported.

A patchwork of federal consumer protection regulations does nothing to keep these nuggets of cadmium from U.S. store shelves. If the products were painted toys, they would face a recall. If they were industrial garbage, they could qualify as hazardous waste. But since there are no cadmium restrictions on jewelry, such items are sold legally.

The CPSC has never recalled an item for cadmium - even though it has received scattered complaints based on private test results for at least the past two years.

There is no definitive explanation for why children's jewelry manufacturers, virtually all from China in the items tested, are turning to cadmium. But a reasonable double whammy looms: With lead heavily regulated under the Consumer Product Safety Improvement Act of 2008, factories scrambled for substitutes, just as cadmium prices plummeted.

That law set a new, stringent standard for lead in children's products: Only the very smallest amount is permissible - no more than 0.03 percent of the total content. The statute has led manufacturers to drastically reduce lead in toys and jewelry.

The law also contained the first explicit regulation of cadmium, though the standards are significantly less strict than lead and apply only to painted toys, not jewelry.

To determine how much cadmium a child could be exposed to, items are bathed in a solution that mimics stomach acid to see how much of the toxin would leach out after being swallowed.

Weidenhamer's lab work for AP assessed how much cadmium was in each item. Overall, 12 of the 103 items each contained at least 10 percent cadmium. Two others contained lower amounts, while the other 89 were clean.

Ten of the items with the highest cadmium content were then run through the stomach acid test to see how much would escape. Although that test is used only in regulation of toys, AP used it to see what hazard an item could pose because unlike the regulations, a child's body doesn't distinguish between cadmium leached from jewelry and cadmium leached from a toy.

"Clearly it seems like for a metal as toxic as cadmium, somebody ought to be watching out to make sure there aren't high levels in items that could end up in the hands of kids," said Weidenhamer.

His test results include:

- Three flip flop bracelet charms sold at Walmart contained between 84 and 86 percent cadmium. The charms fared the worst of any item on the stomach acid test; one shed more cadmium in 24 hours than what World Health Organization guidelines deem a safe exposure over 60 weeks for a 33-pound child.

The bracelet was purchased in August 2008. The company that imported them, Florida-based Sulyn Industries, stopped selling the item to Wal-Mart Corp. in November 2008, the firm's president said. Wal-Mart would not comment on whether the charms are still on store shelves, or how many have been sold.

Sulyn's president, Harry Dickens, said the charms were subjected to testing standards imposed by both Wal-Mart and federal regulation - but were not tested for cadmium.

In separate written statements, Dickens and Wal-Mart said they consider safety a very high priority. "We consistently seek to sell only those products that meet safety and regulatory standards," Wal-Mart said. "Currently there is no required cadmium standard for children's jewelry."

As was the case with every importer or retailer that responded to AP's request for comment on the tests, neither Sulyn nor Wal-Mart would address whether the results concerned them or if the products should be recalled.

- Four charms from two "Rudolph the Red-Nosed Reindeer" bracelets sold at a Dollar N More store in Rochester, N.Y., were measured at between 82 and 91 percent cadmium. The charms also fared poorly on the stomach acid test. Two other charms from the same bracelets were subjected to a leaching test which recreates how much cadmium would be released in a landfill and ultimately contaminate groundwater. Based on those results, if the charms were waste from manufacturing, they would have had to be specially handled and disposed of under U.S. environmental law. The company that imported the Rudolph charms, Buy-Rite Designs, Inc. of Freehold, N.J., has gone out of business.

- Two charms on a "Best Friends" bracelet bought at Claire's, a jewelry chain with nearly 3,000 stores in North America and Europe, consisted of 89 and 91 percent cadmium. The charms also leached alarming amounts in the simulated stomach test. Informed of the results, Claire's issued a statement pointing out that children's jewelry is not required to pass a cadmium leaching test.

"Claire's has its products tested by independent accredited third-party laboratories approved by the Consumer Product Safety Commission in compliance with the commission's standards, and has passing test results for the bracelet using these standards," the statement said. Those standards scrutinize lead content, not cadmium.

- Pendants from four "The Princess and The Frog" necklaces bought at Walmart ranged between 25 and 35 percent cadmium, though none failed the stomach acid test nor the landfill leaching test. The Walt Disney Co., which produced the popular animated movie, said in a statement that test results provided by the manufacturer, Rhode Island-based FAF Inc., showed the item complied with all applicable safety standards.

An official at FAF's headquarters did not respond to multiple requests for comment when informed of Weidenhamer's results; a woman at the company's office in southern China who would not give her name said FAF products "might naturally contain some very small amounts of cadmium. We measure it in parts per million because the content is so small, for instance one part per million." However, the tests conducted for AP showed the pendants contained between 246,000 and 346,000 parts per million of cadmium.

"It comes down to the following: Cadmium causes cancer. How much cadmium do you want your child eating?" said Michael R. Harbut, a doctor who has treated adult victims of cadmium poisoning and is director of the environmental cancer program at the Karmanos Cancer Institute in Detroit. "In my view, the answer should be none."

Xu Hongli, a cadmium specialist with the Beijing office of Asian Metal Ltd., a market research and consultancy firm, said test results showing high cadmium levels in some Chinese-made metal jewelry did not surprise her. Using cadmium alloys has been "a relatively common practice" among manufacturers in the eastern cities of Yiwu and Qingdao and the southern province of Sichuan, Xu said.

"Some of their products contain 90 percent cadmium or higher," she acknowledged. "Usually, though, they are more careful with export products."

She said she thought that manufacturers were becoming aware of cadmium's dangers, and are using it less, "But it will still take a while for them to completely shift away from using it."

The CPSC has received dozens of incident reports of cadmium in products over the past few years, said Gib Mullan, the agency's director of compliance and field operations. Though the CPSC has authority to go after a product deemed a public danger under the Federal Hazardous Substances Act - the law used in lead-related recalls several years ago - there have been no enforcement actions.

"We are a small agency so we can't do everything we think would be a good idea. We have to try to pick our spots," Mullan said. At most, the agency can investigate 10 percent of the tens of thousands of reports filed by the public each year, he said.

With the help of an outside firm, the CPSC has started a scientific literature review of cadmium and other heavy metals, including how the substances fare in leaching tests, according to spokesman Wolfson. "If there has a been a shift in manufacturing to the use of cadmium, CPSC will take appropriate action."

Meanwhile, the CPSC's Mullan cites "a trend upward" in cadmium reports the agency has received - and private-sector testing AP reviewed shows cadmium is showing up more frequently.

Two outfits that analyze more than a thousand children's products each year checked their data at AP's request. Both said their findings of cadmium above 300 parts per million in an item - the current federal limit for lead - increased from about 0.5 percent of tests in 2007 to about 2.2 percent of tests in 2009. Those tests were conducted using a technology called XRF, a handheld gun that bounces X-rays off an item to estimate how much lead, cadmium or other elements it contains. While the results are not as exact as lab testing, the CPSC regularly uses XRF in its product screening.

Much of the increase found by the Michigan-based HealthyStuff.org came in toys with polyvinyl chloride plastic, according to Jeff Gearhart, the group's research director. Both lead and cadmium can be used to fortify PVC against the sun's rays. Data collected by a Washington-based company called Essco Safety Check led its president, Seth Goldberg, to suspect that substitution of cadmium for lead partly explains the increase he's seen.

Rick Locker, general counsel for the Toy Industry Association of America, and Sheila A. Millar, a lawyer representing the Fashion Jewelry Trade Association, said their industries make products that are safe and insisted cadmium is not widely used.

Millar said jewelry makers often opt for zinc these days. "While FJTA can only speak to the experience of its members," Millar wrote in an e-mail, "widespread substitution of cadmium is not something they see."

---

The AP National Investigative Team can be reached at investigate(at)ap.org


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56499 2010-01-11T19:07:55-06:00 2010-01-11T19:07:56-06:00

{summary}

2010-01-11T19:07:55-06:00 Staff editor@TheRochesterDemocrat.com Mental Health



WASHINGTON (AP) - The suicide rate among 18- to 29-year-old men who've left the military has gone up significantly, the government said Monday.

The rate for these veterans went up 26 percent from 2005 to 2007, according to preliminary data from the Veterans Affairs Department. It's assumed that most of the veterans in this age group served in Iraq or Afghanistan.

If there is a bright spot in the data, it's that in 2007 veterans in the group who used VA health care were less likely to commit suicide than those who did not. That's a change from 2005.

The military in recent years has struggled as well with an increase in suicides, with the Army seeing a record number last year. While the military frequently releases such data, it has been more difficult to track suicide information on veterans once they've left active duty.

The VA calculated the numbers using Centers for Disease Control and Prevention numbers from 16 states. In 2005, the rate per 100,000 veterans among men ages 18-29 was 44.99, compared with 56.77 in 2007, the VA said. It did not release data for other population groups.

The VA and the military have sought to more aggressively tackle the problem in recent years with measures ranging from a suicide hot line to educational campaigns.

At a conference on Monday in Washington dedicated to addressing the issue, VA Secretary Eric Shinseki said his agency needs to do a better job understanding what led to each suicide. He said he'd also like to see more stringent protocol put into place at VA facilities about how to handle a potentially suicide veteran, similar to what's done with someone who's having a heart attack.

He noted that of the 30,000 suicides each year in America, about 20 percent are committed by veterans.

"Why do we know so much about suicides but still know so little about how to prevent them?" Shinseki said. "Simple question but we continue to be challenged."

---__

On the Net:

Conference Web site: http://www.dcoe.health.mil/training/upcomingconferences.aspx

Psychological Health and Traumatic Brain Injury Information and Resources: http://www.dcoe.health.mil/

Real Warriors campaign: http://www.realwarriors.net/

National Suicide Prevention Lifeline: 1-800-273-TALK (8255).


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56495 2010-01-11T14:17:58-06:00 2010-01-11T14:18:59-06:00

{summary}

2010-01-11T14:17:58-06:00 Staff editor@TheRochesterDemocrat.com Cardio-Vascular


By WILLIAM NEUMAN
NY Times


First New York City required restaurants to cut out trans fat. Then it made restaurant chains post calorie counts on their menus. Now it wants to protect people from another health scourge: salt.

On Monday, the Bloomberg administration plans to unveil a broad new health initiative aimed at encouraging food manufacturers and restaurant chains across the country to curtail the amount of salt in their products.

The plan, for which the city claims support from health agencies in other cities and states, sets a goal of reducing the amount of salt in packaged and restaurant food by 25 percent over the next five years.

Public health experts say that would reduce the incidence of high blood pressure and should help prevent some of the strokes and heart attacks associated with that condition. The plan is voluntary for food companies and involves no legislation. It allows companies to cut salt gradually over five years so the change is not so noticeable to consumers.

“We all consume way too much salt, and most of the salt we consume is in the food when we buy it,” said Dr. Thomas Farley, the city health commissioner, whose department is leading the effort. Eighty percent of the salt in Americans’ diets comes from packaged or restaurant food. Dr. Farley said reducing salt from those sources would save lives.

Since taking office, Mayor Michael R. Bloomberg, who just began his third term, has gained a reputation as an advocate for healthy living, initiating prominent campaigns against smoking and harmful trans fats. To combat obesity, he has campaigned for calorie labeling on restaurant menus and warned consumers about sugary soft drinks.

The city’s salt campaign is in some ways more ambitious and less certain of success than the ones it waged against smoking and obesity. For one thing, the changes it prescribes require cooperation on a national scale, city officials said, because major food companies cannot be expected to alter their products for just the New York market.

And removing salt from many products can be complicated. Salt plays many roles in food, enhancing flavor, preventing spoilage and improving shelf life. It helps bread to rise and brown.

The city’s campaign against salt resembles its push to cut trans fat from restaurant foods, which began with a call for voluntary compliance. When that did not work, the city passed a law to force restaurants to eliminate trans fat.

But city officials said it would be difficult to legislate sodium reduction.

“There’s not an easy regulatory fix,” said Geoffrey Cowley, an associate health commissioner. “You would have to micromanage so many targets for so many different products.”

He said officials hoped the campaign would work through public pressure. Companies that complied would benefit from good publicity.

The city has been discussing the program with the food industry since late 2008, yet only a few companies appear ready to jump on board. One of those is A.& P., the supermarket chain.

“We think it’s a very realistic set of criteria that our suppliers can adhere to,” said Douglas A. Palmer, vice president for store brands at A.& P.

He said the company expected to embrace the city’s salt reduction goals for the hundreds of store brand products it sells under labels like America’s Choice and Smart Price in 435 supermarkets throughout the Northeast and Mid-Atlantic regions. In Manhattan, the chain operates under the name Food Emporium.

Subway, the fast food sandwich chain, also said it expected to commit to the city’s salt guidelines at its nearly 23,000 stores across the country.

Lanette R. Kovachi, Subway’s corporate dietitian, said the company has reduced salt in stores in several other countries, including Britain and Australia, in response to government programs there.

“We view these as achievable goals,” she said.

The company’s best-selling item, a six-inch turkey sandwich, is already below the city’s five-year average target for lunch meat sandwiches in restaurants. But the chain also has a six-inch spicy Italian sub whose salt content is well above the city’s goals.

On Monday, after a year of consultations with industry, the city will release preliminary targets for sodium content. After a review, the city will unveil final targets in the spring and ask companies to commit to the program.

The system proposed by the city is complex, with reductions ranging from 10 to 40 percent for 61 classes of packaged foods and 25 classes of restaurant foods.

It would measure the average salt content of a company’s entire line of a particular type of product, like canned vegetables, breakfast cereals or frozen dinners, adjusted to give greater weight to products with the highest sales. That would allow companies to maintain a range of sodium levels but would create incentive to cut back on salt in the most popular items.

While most food companies say they agree at least with the goal of reducing salt, some medical researchers have questioned the scientific basis for the initiative, saying insufficient research had been done on possible effects. While agreeing that reducing salt is likely to lower average blood pressure, they say it can lead to other physiological changes, some of which may be associated with heart problems.

An elaborate clinical trial could weigh the pluses and minuses of cutting salt in a large group of people. But that would cost millions, and it has not been done.

Dr. Michael H. Alderman, a professor at the Albert Einstein College of Medicine, said the city’s initiative, if successful in reducing salt, would amount to an uncontrolled experiment with the public’s health.

“I’m always worried about unintended consequences,” he said.

The federal government recommends that sodium intake from salt be limited to 1,500 to 2,300 milligrams a day, with the latter figure equaling about a teaspoon. But the average adult in this country consumes about 3,400 milligrams a day.

Several major companies, including some that have been leaders in reducing salt, said they would not join the city initiative.

“One of the things we want to bring across to New York City is that sodium reduction does not always follow a prescribed time or prescribed progress,” said Chor-San Khoo, vice president for global nutrition and health at the Campbell Soup Company. “There’s no one size fits all.”

Campbell has already made significant reductions in the amount of salt in many of its products, including many canned soups, V8 beverages and Pepperidge Farm breads.

“We will continue to reduce sodium as long as there’s consumer acceptance in the marketplace,” Ms. Khoo said.

ConAgra, which makes a wide array of products, including Hunt’s canned tomato products and Chef Boyardee packaged meals, said it would continue with previously announced plans to cut the sodium in its portfolio of products by 20 percent by 2015.

“We don’t have plans to join other organizations’ pledges,” the company said.


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56487 2010-01-11T02:22:45-06:00 2010-01-11T02:24:46-06:00

{summary}

2010-01-11T02:22:45-06:00 Staff editor@TheRochesterDemocrat.com Child Health, Imports





LOS ANGELES (AP) - Barred from using lead in child jewelry because of its toxicity, some Chinese manufacturers have been substituting the more dangerous heavy metal cadmium in sparkling charm bracelets and shiny pendants being sold throughout the United States, an Associated Press investigation shows.

The most contaminated piece analyzed in lab testing performed for the AP contained a startling 91 percent cadmium by weight. The cadmium content of other contaminated trinkets, all purchased at national and regional chains or franchises, tested at 89 percent, 86 percent and 84 percent by weight. The testing also showed that some items easily shed the heavy metal, raising additional concerns about the levels of exposure to children.

A spokesman for the U.S. Consumer Product Safety Commission, which regulates children's products, said Sunday that the agency "is opening an investigation" and "will take action as quickly as possible to protect the safety of children."

Cadmium is a known carcinogen. Like lead, it can hinder brain development in the very young, according to recent research.

Children don't have to swallow an item to be exposed - they can get persistent, low-level doses by regularly sucking or biting jewelry with a high cadmium content.

To gauge cadmium's prevalence in children's jewelry, the AP organized lab testing of 103 items bought in New York, Ohio, Texas and California. All but one were purchased in November or December.

The results: 12 percent of the pieces of jewelry contained at least 10 percent cadmium.

Some of the most troubling test results were for bracelet charms sold at Walmart, at the jewelry chain Claire's and at a dollar store. High amounts of cadmium also were detected in "The Princess and The Frog" movie-themed pendants.

"There's nothing positive that you can say about this metal. It's a poison," said Bruce A. Fowler, a cadmium specialist and toxicologist with the U.S. Centers for Disease Control and Prevention. On the CDC's priority list of 275 most hazardous substances in the environment, cadmium ranks No. 7.

Jewelry industry veterans in China say cadmium has been used in domestic products there for years. Zinc, the metal most cited as a replacement for lead in imported jewelry being sold in the United States, is a much safer and nontoxic alternative. But the jewelry tests conducted for AP, along with test findings showing a growing presence of cadmium in other children's products, demonstrate that the safety threat from cadmium is being exported.

A patchwork of federal consumer protection regulations does nothing to keep these nuggets of cadmium from U.S. store shelves. If the products were painted toys, they would face a recall. If they were industrial garbage, they could qualify as hazardous waste. But since there are no cadmium restrictions on jewelry, such items are sold legally.

The CPSC has cracked down on the dangers posed by lead and products known to have killed children, such as cribs, it has never recalled an item for cadmium - even though it has received scattered complaints based on private test results for at least the past two years.

There is no definitive explanation for why children's jewelry manufacturers, virtually all from China in the items tested, are turning to cadmium. But a reasonable double whammy looms: With lead heavily regulated under the Consumer Product Safety Improvement Act of 2008, factories scrambled for substitutes, just as cadmium prices plummeted.

That law set a new, stringent standard for lead in children's products: Only the very smallest amount is permissible - no more than 0.03 percent of the total content. The statute has led manufacturers to drastically reduce lead in toys and jewelry.

The law also contained the first explicit regulation of cadmium, though the standards are significantly less strict than lead and apply only to painted toys, not jewelry.

To determine how much cadmium a child could be exposed to, items are bathed in a solution that mimics stomach acid to see how much of the toxin would leach out after being swallowed.

The jewelry testing for AP was conducted by chemistry professor Jeff Weidenhamer of Ashland University in Ohio, who over the past few years has provided the CPSC with results showing high lead content in products that were later recalled. His lab work for AP assessed how much cadmium was in each item. Overall, 12 of the 103 items each contained at least 10 percent cadmium. Two others contained lower amounts, while the other 89 were clean.

Ten of the items with the highest cadmium content were then run through the stomach acid test to see how much would escape. Although that test is used only in regulation of toys, AP used it to see what hazard an item could pose because unlike the regulations, a child's body doesn't distinguish between cadmium leached from jewelry and cadmium leached from a toy.

"Clearly it seems like for a metal as toxic as cadmium, somebody ought to be watching out to make sure there aren't high levels in items that could end up in the hands of kids," said Weidenhamer.

The CPSC reacted swiftly to the AP story. Agency spokesman Scott Wolfson said: "CPSC will open an investigation into the products tested by Professor Weindenhamer, who we have worked closely with before." He said CPSC would study Weidenhamer's results, attempt to buy the contaminated products content and "take appropriate action as quickly as possible."

Weidenhamer's test results include:

- Three flip flop bracelet charms sold at Walmart contained between 84 and 86 percent cadmium. The charms fared the worst of any item on the stomach acid test; one shed more cadmium in 24 hours than what World Health Organization guidelines deem a safe exposure over 60 weeks for a 33-pound child.

The bracelet was purchased in August 2008. The company that imported them, Florida-based Sulyn Industries, stopped selling the item to Wal-Mart Corp. in November 2008, the firm's president said. Wal-Mart would not comment on whether the charms are still on store shelves, or how many have been sold.

Sulyn's president, Harry Dickens, said the charms were subjected to testing standards imposed by both Wal-Mart and federal regulation - but were not tested for cadmium.

In separate written statements, Dickens and Wal-Mart said they consider safety a very high priority. "We consistently seek to sell only those products that meet safety and regulatory standards," Wal-Mart said. "Currently there is no required cadmium standard for children's jewelry."

As was the case with every importer or retailer that responded to AP's request for comment on the tests, neither Sulyn nor Wal-Mart would address whether the results concerned them or if the products should be recalled.

- Four charms from two "Rudolph the Red-Nosed Reindeer" bracelets sold at a Dollar N More store in Rochester, N.Y., were measured at between 82 and 91 percent cadmium. The charms also fared poorly on the stomach acid test. Two other charms from the same bracelets were subjected to a leaching test which recreates how much cadmium would be released in a landfill and ultimately contaminate groundwater. Based on those results, if the charms were waste from manufacturing, they would have had to be specially handled and disposed of under U.S. environmental law. The company that imported the Rudolph charms, Buy-Rite Designs, Inc. of Freehold, N.J., has gone out of business.

- Two charms on a "Best Friends" bracelet bought at Claire's, a jewelry chain with nearly 3,000 stores in North America and Europe, consisted of 89 and 91 percent cadmium. The charms also leached alarming amounts in the simulated stomach test. Informed of the results, Claire's issued a statement pointing out that children's jewelry is not required to pass a cadmium leaching test.

"Claire's has its products tested by independent accredited third-party laboratories approved by the Consumer Product Safety Commission in compliance with the commission's standards, and has passing test results for the bracelet using these standards," the statement said. Those standards scrutinize lead content, not cadmium.

- Pendants from four "The Princess and The Frog" necklaces bought at Walmart ranged between 25 and 35 percent cadmium, though none failed the stomach acid test nor the landfill leaching test. The Walt Disney Co., which produced the popular animated movie, said in a statement that test results provided by the manufacturer, Rhode Island-based FAF Inc., showed the item complied with all applicable safety standards.

An official at FAF's headquarters did not respond to multiple requests for comment when informed of Weidenhamer's results; a woman at the company's office in southern China who would not give her name said FAF products "might naturally contain some very small amounts of cadmium. We measure it in parts per million because the content is so small, for instance one part per million." However, the tests conducted for AP showed the pendants contained between 246,000 and 346,000 parts per million of cadmium.

"It comes down to the following: Cadmium causes cancer. How much cadmium do you want your child eating?" said Michael R. Harbut, a doctor who has treated adult victims of cadmium poisoning and is director of the environmental cancer program at the Karmanos Cancer Institute in Detroit. "In my view, the answer should be none."

Xu Hongli, a cadmium specialist with the Beijing office of Asian Metal Ltd., a market research and consultancy firm, said test results showing high cadmium levels in some Chinese-made metal jewelry did not surprise her. Using cadmium alloys has been "a relatively common practice" among manufacturers in the eastern cities of Yiwu and Qingdao and the southern province of Sichuan, Xu said.

"Some of their products contain 90 percent cadmium or higher," she acknowledged. "Usually, though, they are more careful with export products."

She said she thought that manufacturers were becoming aware of cadmium's dangers, and are using it less, "But it will still take a while for them to completely shift away from using it."

The CPSC has received dozens of incident reports of cadmium in products over the past few years, said Gib Mullan, the agency's director of compliance and field operations. Though the CPSC has authority to go after a product deemed a public danger under the Federal Hazardous Substances Act - the law used in lead-related recalls several years ago - there have been no enforcement actions.

"We are a small agency so we can't do everything we think would be a good idea. We have to try to pick our spots," Mullan said. At most, the agency can investigate 10 percent of the tens of thousands of reports filed by the public each year, he said.

With the help of an outside firm, the CPSC has started a scientific literature review of cadmium and other heavy metals, including how the substances fare in leaching tests, according to spokesman Wolfson. "If there has a been a shift in manufacturing to the use of cadmium, CPSC will take appropriate action."

Meanwhile, the CPSC's Mullan cites "a trend upward" in cadmium reports the agency has received - and private-sector testing AP reviewed shows cadmium is showing up more frequently.

Two outfits that analyze more than a thousand children's products each year checked their data at AP's request. Both said their findings of cadmium above 300 parts per million in an item - the current federal limit for lead - increased from about 0.5 percent of tests in 2007 to about 2.2 percent of tests in 2009. Those tests were conducted using a technology called XRF, a handheld gun that bounces X-rays off an item to estimate how much lead, cadmium or other elements it contains. While the results are not as exact as lab testing, the CPSC regularly uses XRF in its product screening.

Much of the increase found by the Michigan-based HealthyStuff.org came in toys with polyvinyl chloride plastic, according to Jeff Gearhart, the group's research director. Both lead and cadmium can be used to fortify PVC against the sun's rays. Data collected by a Washington-based company called Essco Safety Check led its president, Seth Goldberg, to suspect that substitution of cadmium for lead partly explains the increase he's seen.

Rick Locker, general counsel for the Toy Industry Association of America, and Sheila A. Millar, a lawyer representing the Fashion Jewelry Trade Association, said their industries make products that are safe and insisted cadmium is not widely used.

Millar said jewelry makers often opt for zinc these days. "While FJTA can only speak to the experience of its members," Millar wrote in an e-mail, "widespread substitution of cadmium is not something they see."

---

The AP National Investigative Team can be reached at investigate(at)ap.org


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56354 2010-01-05T14:14:59-06:00 2010-01-05T14:17:00-06:00

{summary}

2010-01-05T14:14:59-06:00 Staff editor@TheRochesterDemocrat.com Mental Health


By BARBARA STRAUCH
NY TIMES
Published: January 5, 2010


I LOVE reading history, and the shelves in my living room are lined with fat, fact-filled books. There’s “The Hemingses of Monticello,” about the family of Thomas Jefferson’s slave mistress; there’s “House of Cards,” about the fall of Bear Stearns; there’s “Titan,” about John D. Rockefeller Sr.

The problem is, as much as I’ve enjoyed these books, I don’t really remember reading any of them. Certainly I know the main points. But didn’t I, after underlining all those interesting parts, retain anything else? It’s maddening and, sorry to say, not all that unusual for a brain at middle age: I don’t just forget whole books, but movies I just saw, breakfasts I just ate, and the names, oh, the names are awful. Who are you?

Brains in middle age, which, with increased life spans, now stretches from the 40s to late 60s, also get more easily distracted. Start boiling water for pasta, go answer the doorbell and — whoosh — all thoughts of boiling water disappear. Indeed, aging brains, even in the middle years, fall into what’s called the default mode, during which the mind wanders off and begin daydreaming.

Given all this, the question arises, can an old brain learn, and then remember what it learns? Put another way, is this a brain that should be in school?

As it happens, yes. While it’s tempting to focus on the flaws in older brains, that inducement overlooks how capable they’ve become. Over the past several years, scientists have looked deeper into how brains age and confirmed that they continue to develop through and beyond middle age.

Many longheld views, including the one that 40 percent of brain cells are lost, have been overturned. What is stuffed into your head may not have vanished but has simply been squirreled away in the folds of your neurons.

One explanation for how this occurs comes from Deborah M. Burke, a professor of psychology at Pomona College in California. Dr. Burke has done research on “tots,” those tip-of-the-tongue times when you know something but can’t quite call it to mind. Dr. Burke’s research shows that such incidents increase in part because neural connections, which receive, process and transmit information, can weaken with disuse or age.

But she also finds that if you are primed with sounds that are close to those you’re trying to remember — say someone talks about cherry pits as you try to recall Brad Pitt’s name — suddenly the lost name will pop into mind. The similarity in sounds can jump-start a limp brain connection. (It also sometimes works to silently run through the alphabet until landing on the first letter of the wayward word.)

This association often happens automatically, and goes unnoticed. Not long ago I started reading “The Prize,” a history of the oil business. When I got to the part about Rockefeller’s early days as an oil refinery owner, I realized, hey, I already know this from having read “Titan.” The material was still in my head; it just needed a little prodding to emerge.

Recently, researchers have found even more positive news. The brain, as it traverses middle age, gets better at recognizing the central idea, the big picture. If kept in good shape, the brain can continue to build pathways that help its owner recognize patterns and, as a consequence, see significance and even solutions much faster than a young person can.

The trick is finding ways to keep brain connections in good condition and to grow more of them.

“The brain is plastic and continues to change, not in getting bigger but allowing for greater complexity and deeper understanding,” says Kathleen Taylor, a professor at St. Mary’s College of California, who has studied ways to teach adults effectively. “As adults we may not always learn quite as fast, but we are set up for this next developmental step.”

Educators say that, for adults, one way to nudge neurons in the right direction is to challenge the very assumptions they have worked so hard to accumulate while young. With a brain already full of well-connected pathways, adult learners should “jiggle their synapses a bit” by confronting thoughts that are contrary to their own, says Dr. Taylor, who is 66.

Teaching new facts should not be the focus of adult education, she says. Instead, continued brain development and a richer form of learning may require that you “bump up against people and ideas” that are different. In a history class, that might mean reading multiple viewpoints, and then prying open brain networks by reflecting on how what was learned has changed your view of the world.

“There’s a place for information,” Dr. Taylor says. “We need to know stuff. But we need to move beyond that and challenge our perception of the world. If you always hang around with those you agree with and read things that agree with what you already know, you’re not going to wrestle with your established brain connections.”

Such stretching is exactly what scientists say best keeps a brain in tune: get out of the comfort zone to push and nourish your brain. Do anything from learning a foreign language to taking a different route to work.

“As adults we have these well-trodden paths in our synapses,” Dr. Taylor says. “We have to crack the cognitive egg and scramble it up. And if you learn something this way, when you think of it again you’ll have an overlay of complexity you didn’t have before — and help your brain keep developing as well.”

Jack Mezirow, a professor emeritus at Columbia Teachers College, has proposed that adults learn best if presented with what he calls a “disorienting dilemma,” or something that “helps you critically reflect on the assumptions you’ve acquired.”

Dr. Mezirow developed this concept 30 years ago after he studied women who had gone back to school. The women took this bold step only after having many conversations that helped them “challenge their own ingrained perceptions of that time when women could not do what men could do.”

Such new discovery, Dr. Mezirow says, is the “essential thing in adult learning.”

“As adults we have all those brain pathways built up, and we need to look at our insights critically,” he says. “This is the best way for adults to learn. And if we do it, we can remain sharp.”

And so I wonder, was my cognitive egg scrambled by reading that book on Thomas Jefferson? Did I, by exploring the flaws in a man I admire, create a suitably disorienting dilemma? Have I, as a result, shaken up and fed a brain cell or two?

And perhaps it doesn’t matter that I can’t, at times, recall the given name of the slave with whom Jefferson had all those children. After all, I can Google a simple name.

Sally.

Barbara Strauch is The Times’s health editor; her book “The Secret Life of the Grown-Up Brain” will be published in April.


]]> tag:therochesterdemocrat.com,2010:ee/index.php/51.56338 2010-01-05T05:17:03-06:00 2010-01-05T05:19:04-06:00

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2010-01-05T05:17:03-06:00 Staff editor@TheRochesterDemocrat.com Health Spending





WASHINGTON (AP) - The recession dramatically slowed U.S. health care spending to $2.3 trillion in 2008, but it still grew much faster than the economy as a whole, accounting for more than 16 percent of the nation's economic output, says a new federal analysis.

The eye-popping figure of $2.3 trillion - that's $7,681 per person - underscores the challenges confronting President Barack Obama and lawmakers seeking to overhaul the system. Obama has repeatedly cited spiraling health costs as one of the main reasons Congress needs to pass his health plan, and administration officials said the findings highlighted the need for quick action.

"This report contains some welcome news and yet another warning sign," said Jonathan Blum, a top official at the government's Centers for Medicare and Medicaid Services. "Health care spending as a percentage of GDP (gross domestic product) is rising at an unsustainable rate. It is clear that we need health insurance reform now."

However, health care experts question whether there are significant cost-containment measures in the legislation passed by House and Senate Democrats before Christmas - and Republicans insist there aren't. The new report could provide fodder for both sides as lawmakers work to reconcile the House and Senate legislation into a final bill in coming weeks.

"I agree we need reform, but both the House and Senate Democrat bills make the problem worse by increasing the cost of health care," said Rep. Dave Camp of Michigan, top Republican on the House Ways and Means Committee. "They spend $1 trillion we don't have and bend the curve the wrong way."

Republicans cited earlier analyses by the Centers for Medicare and Medicaid that found the sweeping overhaul legislation that seeks to extend coverage to more than 30 million uninsured Americans over the next decade would lead to increased health care costs. Democrats counter that the bills begin to slow cost increases over time.

However, some cost-saving measures Democrats proposed were blocked or turned into pilot projects after lobbying by doctors, hospitals or other interest groups. One major attempt to bring down health costs is a tax on high-value insurance plans included in the Senate bill but opposed in the House; it's likely to survive in some form though exactly how remains to be seen.

The new analysis by economists at the Centers for Medicare and Medicaid appears Tuesday in the journal Health Affairs. It found that total national health spending grew 4.4 percent in 2008, the slowest rate of increase since CMS began tracking health spending in 1960. By contrast, the growth rate in 2007 was 6 percent. The study seeks to measure all public and private health expenditures.

Still, the growth of health costs was higher than the overall growth in gross domestic product, which stood at 2.6 percent in 2008 before adjusting for inflation.

Health spending reached 16.2 percent of the gross domestic product in 2008, up from 15.9 percent in 2007. That added up to $2.3 trillion and far higher per-person expenditures than other industrialized countries, although the higher spending is generally not matched by better health outcomes, studies have found.

Even with the high spending, the recession made itself felt throughout the health care sector in 2008, with slowdowns in out-of-pocket spending, private insurance premiums and hospital spending - the latter largely because of loss of revenue from hospitals' investment incomes.

The slowdown in health insurance premium costs might seem counterintuitive, given the complaints of increased health care costs coming from individuals and businesses large and small. Part of the reason is because of the jobs lost in the recession, forcing people off the insurance roles and shrinking the overall cost of premiums nationally. Enrollment in private health insurance declined from 196.4 million in 2007 to 195.4 million in 2008, the report said.

"Health care spending is usually somewhat insulated from the immediate impact of a downturn in the economy. But this recession has exerted considerable influence on the health care sector," said CMS statistician Micah Hartman, a lead author on the report.

Medicare, the federal health insurance program for people 65 and older, was the only area where the rate of spending growth in 2008 was greater than in 2007. That's partly because Medicare recipients are largely out of the workforce and therefore more insulated from the recession. Medicare hospital spending grew, and more patients shifted into privately run Medicare Advantage plans, which offer better benefits than traditional fee-for-service Medicare but also cost the government more.

The recession also had the effect of shifting a greater share of health spending onto the federal government as the passage of the economic stimulus bill last year sent billions to states to help them with their share of Medicaid costs, including some retroactive costs. Medicaid enrollment in 2008 rose along with unemployment, but overall spending on Medicaid services slowed anyway as cash-strapped states scrimped on costs.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.56197 2009-12-29T23:27:48-06:00 2009-12-29T23:28:49-06:00

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2009-12-29T23:27:48-06:00 Staff editor@TheRochesterDemocrat.com Over The Counter Remedies



Dec 29, 4:25 PM (ET)


NEW YORK (AP) - Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

According to a statement posted to the Food and Drug Administration Web site late Monday, the New Brunswick, N.J., company is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.

Johnson & Johnson had recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea.

The health care company said the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.

To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The recall only affects the specific lots cited. All other Tylenol Arthritis pain products remain available.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

J&J's McNeil consumer health care division sells a range of over-the-counter medicines, including cold reliever Sudafed and the antacid Mylanta. The unit posted $16 billion in sales in 2008, according to J&J's annual report.

Consumers seeking a refund or replacement can call J&J at 1-888-222-6036.

Company shares rose 38 cents to $65.32 in morning trading Tuesday.


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2009-12-29T13:00:43-06:00 Staff editor@TheRochesterDemocrat.com Flu, Pandemic





GENEVA (AP) - It is too early to declare that the swine flu pandemic has peaked worldwide and many more people could become sick with the virus this winter, the head of the World Health Organization said in an interview published Tuesday.

The swine flu outbreak has peaked in the United States, Canada and some other countries in the northern hemisphere, Dr. Margaret Chan, she told the Geneva daily Le Temps.

"It is too early to assert that we have passed the peak of the flu A pandemic at worldwide level," she said. "Not all the countries are there yet. Winter is still long," said Chan.

Africa and some poor countries in Asia have not seen a surge in the number of swine flu cases, which could be due to weak reporting or because the full outbreak there may be yet to come, she told the newspaper.

Over 11,500 people are known to have died from the disease since the outbreak began in April, according to WHO. Between 250,000 and 500,000 people die from regular flu each year.

When the U.N. health agency declared swine flu to be a pandemic in June, it described it as "moderate."

While most people recover from the illness without needing medical treatment, officials are also continuing to see severe cases in people under 65 - people who are not usually at risk during regular flu seasons.

But since flu viruses constantly evolve, experts have feared swine flu could mutate into a more dangerous form.

"WHO has adopted a very cautious attitude, even more so because this has been the first pandemic since four decades," said Chan, who was scheduled to brief reporters Tuesday.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.56133 2009-12-26T11:20:30-06:00 2009-12-26T11:23:31-06:00

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2009-12-26T11:20:30-06:00 Staff editor@TheRochesterDemocrat.com Health Initiatives


by Rupa Shenoy,
Minnesota Public Radio
December 22, 2009


St. Paul, Minn. — Medical experts call diabetes a growing epidemic. About one in three people will get the disease, approximately 24 million people already have it.

Many people can prevent diabetes with simple lifestyle changes, but Medicare and most private insurance programs don't pay for prevention efforts.

That gap could be plugged by legislation included in the health care reform bill working it's way through the U.S. Senate.

A year ago, Suzanne Rosenberger got her lunches at fast food restaurants. Today, her lunch is in a tote bag she brought from home.

"My lunch is actually in my closet," she said. "Two bananas and three tangerines. That's my lunch."

Rosenberger's transition from burgers and fries to fruit began last spring. Blood tests showed she had an elevated level of glucose, a form of sugar the body uses for energy.

People with diabetes don't break glucose down properly, and the disease can lead to other health problems like a heart attack or stroke.

A person's risk of developing diabetes is much higher after age 45. Rosenberger, an office manager at an auto body repair shop, is 48.

The doctor told her she was pre-diabetic, meaning she would get the disease if she didn't lose weight.

"I really was scared when I heard the word diabetic," she said. "Back when I was very little I remember my aunt that was such a wonderful woman and had both legs amputated...and that scared me to death."

Rosenberger, who is uninsured, struggled to change her lifestyle on her own until a state program referred her to a class at the East St. Paul YMCA.

Rosenberger was one of five people who took the 16-week course.

They learned to do 30 minutes of exercise a day, like a brisk walk after lunch. They counted up calories and figured out where they had to cut down. They talked about how to eat well while eating out or at parties, and they discussed getting back on the wagon if they fall off.

Rosenberger lost 18 pounds.

"The structure of the class really made you aware of how much you're putting in your mouth, what you're putting in your mouth, and to be active," she said. "I was able to start feeling better... I wasn't as dizzy or disorientated. [I] was jumping back into clothing I had stuffed into the closet. Loved that."

Rosenberger's YMCA class was part of a pilot program based on a National Institutes of Health study. The study showed some weight loss and exercise cut participants' risk of developing diabetes in half.

The pilot program was tested in a handful of states. It showed the NIH study's results could be duplicated on the community level at little cost.

That sounds simple, but it hadn't been done before.

"Everybody talks about prevention being important but there really hasn't been many dollars allocated to prevention," said Dr. Richard Bergenstal, executive director of the International Diabetes Center in St Louis Park, Minn. "Because it's a long term problem and everyone wants to fix something in the short term."

Bergenstal, who is also president-elect of the American Diabetes Association, said to change health care in a significant way, policy-makers need hard data.

"We have all the evidence we need now to say it can be accomplished, it can be sustained, and now we can show that we can do it on a community level in a cost effective way," he said. "So the time is right to finally implement a prevention strategy for diabetes."

New legislation would fund the pilot program in more states. It would be a step toward taking the programs everywhere.

Sen. Al Franken, D-Minn., is one of two sponsors for the Diabetes Prevention Act.

"To me, this is just a no-brainer," Franken said. "If we can intervene before these Americans develop full blown diabetes we'll save billions of dollars and not incidentally avoid the burden of diabetes for millions in our country. It's really a win-win."

A University of Chicago study published this month predicts spending on diabetes will jump from $45 billion now to $171 billion in the next 25 years.

Bergenstal said the community-based prevention programs will cost about $300 per person annually.

"I really this think this could be a big step for our country -- for preventing one of the most costly diseases that's out there today - diabetes."

And it could happen soon. Franken has tacked the Diabetes Prevention Act on as an amendment to the Senate's health care reform bill, in an effort to get it passed quickly.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.56099 2009-12-23T14:23:17-06:00 2009-12-23T14:25:18-06:00

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2009-12-23T14:23:17-06:00 Staff editor@TheRochesterDemocrat.com Cancer





BOSTON (AP) - Teresa Heinz says she is being treated for breast cancer discovered through mammography and argues that younger women should continue undergoing the tests despite a federal panel's recent recommendation to reduce their frequency.

The 71-year-old wife of the 2004 Democratic presidential nominee, Sen. John Kerry, of Massachusetts, told The Associated Press that the cost of mammography is far lower than the physical and personal tolls women ages 40 to 60 face if their cancer goes undetected early and they later have to be treated with aggressive chemotherapy.

"Chemotherapy is serious. It also costs a lot of money. It's very painful. And it's very destructive of people's - most people's - lives for a while, anyway. So why put people through that instead of just having a test that's done, and it's done?" Heinz told the AP during an interview this week. "So that's why I was so upset about that decision of this panel."

She recalled nurses in a hospital where she was receiving a magnetic resonance imaging procedure, or MRI, being "so livid" when they heard the U.S. Preventive Services Task Force recommend last month that women start receiving mammograms at age 50, rather than the long-standing practice of 40.

"They said, 'We've taken all these years to teach women to do preventive mammograms, and now look at this,'" Heinz said.

President Barack Obama's administration later backed off the recommendation amid criticism from many medical and women's groups. It said the government's policies "remain unchanged."

Kerry helped launch Obama on the national political stage by giving the then-Illinois senator the keynote speaking role at the 2004 Democratic National Convention.

Heinz - the widow of Sen. John Heinz, heir to the Heinz ketchup fortune - said she found out in late September that she had cancer in her left breast after having her annual mammogram.

In early October, she underwent lumpectomies on both breasts at a Washington hospital after doctors also discovered what they thought was a benign growth on her right breast.

That diagnosis was initially confirmed in postoperative pathology, but two other doctors later found it to be malignant. In November, Heinz had another pair of lumpectomies performed at Massachusetts General Hospital.

Doctors also inserted titanium clips in the tissue of both breasts during the operations, and next month she will receive five days of targeted radiation aimed at improving her odds of a successful treatment to 95 percent.

Heinz said she is undecided about follow-up medicinal treatments that could raise her survival odds to 99 percent, given her age and the potential side effects.

Her surgeon at Massachusetts General Hospital was the one she recommended to Elizabeth Edwards, who found out she had breast cancer just as her husband, former Sen. John Edwards, of North Carolina, was concluding his stint as Kerry's vice presidential running mate.

Heinz said she has not spoken with Elizabeth Edwards about her own cancer bout.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55921 2009-12-16T01:57:26-06:00 2009-12-16T02:00:27-06:00

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2009-12-16T01:57:26-06:00 Staff editor@TheRochesterDemocrat.com Flu, Immunization Massive Recall Is No Reason for Concern, Infectious Disease Experts Say


By TODD NEALE and DAN CHILDS
ABC News Medical Unit in Collaboration with MedPage Today
Dec. 15, 2009


No big deal. That's what infectious disease experts are saying about drugmaker Sanofi Pasteur's recall of about 800,000 pediatric doses of its vaccine against pandemic H1N1 influenza because of low potency. The recall was announced by the U.S. Centers for Disease Control and Prevention on Tuesday.

"It is a pain the neck, but not a major crisis," said Dr. William Schaffner, chair of Vanderbilt University School of Medicine's Department of Preventive Medicine in Nashville, Tenn. "This should not discourage people from being vaccinated."

But the recall is hardly a shot in the arm for a swine flu vaccination effort that has in recent months been plagued by delays and supply shortages.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55486 2009-11-24T22:26:31-06:00 2009-11-24T22:27:32-06:00

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2009-11-24T22:26:31-06:00 Staff editor@TheRochesterDemocrat.com Toys





WASHINGTON (AP) - Holiday shoppers should look out for toy hazards such as small parts, loud sounds, soft plastics and lead contamination, consumer advocates warned Tuesday.

These dangers were highlighted by the U.S. Public Interest Research Group in its 24th annual "Trouble in Toyland" report, the first since sweeping consumer safety legislation went into effect earlier this year.

"This is definitely a time when people are going to be thinking about making purchases for the holidays, so we want people to be aware of these hazards," said Elizabeth Hitchcock, public health advocate for U.S. PIRG.

The organization focused on four hazards: small parts that can choke children younger than 3-years-old, loud toys that can cause hearing damage, lead-tainted toys and soft plastic toys that contain chemicals called phthalates.

Hitchcock encouraged parents to use , specially designed for use with mobile phones, to look up toy hazards while they are shopping.http://toysafety.mobi

The Toy Industry Association responded with a statement warning parents not to be "needlessly" frightened by these types of reports, which "often ignore or misinterpret the facts."

Government safety officials assured shoppers that toys are safer this year than in previous holiday seasons.

"We feel that parents should have more confidence this year for toys than past years because we are enforcing the new Consumer Product Safety Improvement Act," Consumer Product Safety Commission Chairwoman Inez Tenenbaum said in an interview.

Choking is the number one cause of toy-related deaths and injuries, according to the report. Hitchcock said not all toys bear the required choking warnings and that if a toy can fit into a toilet paper tube it is too small for children under three.

The group is also concerned about toys that just barely meet CPSC standards on small parts. U.S. PIRG encouraged the agency to make the choking standards more strict.

"We looked at choking hazards and found some toys that violate that standard and some toys that make the case for expanding that standard," Hitchcock said.

U.S. PIRG also focused on loud toys, because nearly 15 percent of children between 6 and 17 years old show signs of hearing loss. The CPSC recently adopted new standards addressing this risk. Hitchcock said her group wanted to alert the CPSC that it was finding problems in this area.

In addition to toys such as play cell phones that are intended to be held next to the child's ear, Hitchcock noted that most noisemaking toys may pose risks because they are often held only as far away as the child's arm length.

Tenenbaum responded that her agency will continue to monitor the new standards for noisy toys. "But at this point we have really focused on lead, phthalates and just the overall safety of a product," she said.

The report does warn against lead contamination and phthalates, both of which were subject to tougher standards in the Consumer Protection Safety Improvement Act passed last year.

The group found violations of the new lead paint standards, as well as a cell phone charm that contained 71 percent lead by weight.

Lead poisoning can cause irreversible learning disabilities, behavioral problems and, at very high levels, seizures, coma and death.

U.S. PIRG found two children's products that contain phthalates, a lunch bag and a purse. These chemicals are widely used to make plastic products softer and can cause health problems.

"Protecting the safety of children is a shared responsibility and a year-round priority the Toy Industry Association, Inc. and its members," the association statement said. "Consumers have every reason to trust the safety of the three billion toys sold in America each year."

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On the Net:

http://www.uspirg.org/issues/toy-safety

]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55469 2009-11-24T01:42:06-06:00 2009-11-24T01:43:07-06:00

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2009-11-24T01:42:06-06:00 Staff editor@TheRochesterDemocrat.com Public Health Service





WEST PALM BEACH, Fla. (AP) - The federal government said Monday that it has found a "strong association" between problematic imported Chinese drywall and corrosion of pipes and wires, a conclusion that supports complaints by thousands of homeowners over the last year.

In its second report on the potentially defective building materials, the U.S. Consumer Product Safety Commission said its investigation also has found a "possible" link between health problems reported by homeowners and higher-than-normal levels of hydrogen sulfide gas emitted from the wallboard coupled with formaldehyde, which is commonly found in new houses.

The commission, along with the Environmental Protection Agency and the Centers for Disease Control and Prevention, continues to study the potential health effects, and the long-term implications of the corrosion.

"We can say that we believe that there's a number of different chemicals that when brought together can be related to some of these irritant health effects that we've been getting reports of," said CPSC spokesman Scott Wolfson. "But we're still working toward that exact nexus."

The commission said it can now move forward with additional studies to identify effective remediation of the problem and potential assistance from the federal government. However, Warren Friedman of the U.S. Department of Housing and Urban Development said it's too soon to discuss specifics of any financial assistance homeowners could get.

The Formaldehyde Council, a trade group, said there is no scientific evidence to support the theory that the two chemicals can combine to sicken people.

Betsy Natz, the group's executive director, called it "irresponsible to speculate that formaldehyde and hydrogen sulfide can act in a synergistic ... manner to cause irritant effects in human beings at the low levels found in the CPSC study."

The CPSC has spent more than $3.5 million on the studies, and has received more than 2,000 homeowner complaints from 32 states, Washington, D.C., and Puerto Rico, in what is now the largest consumer product investigation in U.S. history. Most of the complaints have come from Florida, Louisiana, and Virginia. Wolfson said the CPSC has committed nearly 15 percent of its staff to the issue.

The results released Monday came, in part, from a 51-home indoor air quality study.

However, officials cautioned that not all Chinese drywall is necessarily problematic and that homes with American-made drywall also are being studied.

"Not all drywall is alike," said Jack McCarthy, president of Environmental Health & Engineering Inc., the firm hired by the government to perform the air quality tests. "It depends on what it's made of, not necessarily the country where it came from."

Added Wolfson: "We are not limited in the scope of our investigation to just Chinese drywall."

The commission released its first report on the drywall last month, noting further studies were needed before it could consider a recall, ban or other action.

Thousands of homeowners who bought new houses built with the imported Chinese building product are finding their lives in limbo as hundreds of lawsuits against builders, contractors, suppliers and manufacturers wind through the courts.

During the height of the U.S. housing boom, with building materials in short supply, American construction companies imported millions of pounds of Chinese-made drywall because it was abundant and cheap. An Associated Press analysis of shipping records found that more than 500 million pounds of Chinese gypsum board was imported between 2004 and 2008 - enough to have built tens of thousands of homes.

They are heavily concentrated in the Southeast, especially Florida and areas of Louisiana and Mississippi hit hard by Hurricane Katrina.

The suspect building materials have previously been found by state and federal agencies to emit "volatile sulfur compounds" and produce a rotten-egg odor. Homeowners complain the fumes are corroding copper pipes, destroying TVs and air conditioners, blackening jewelry and silverware, and making them sick.

The federal government says China is assisting with the investigation.

---

On The Net:

http://www.cpsc.gov/info/drywall/index.html


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55411 2009-11-20T21:12:51-06:00 2009-11-20T21:12:52-06:00

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2009-11-20T21:12:51-06:00 Staff editor@TheRochesterDemocrat.com Cancer




WASHINGTON (AP) - First mammograms. Now - in an apparent coincidence - Pap smears.

New guidelines by the American College of Obstetricians and Gynecologists say most women in their 20s can have a Pap smear every two years instead of annually to catch slow-growing cervical cancer.

The change comes amid a separate debate over when regular mammograms to detect breast cancer should begin, in the 40s or the 50s. The timing of the Pap guidelines is coincidence, said ACOG, which began reviewing its recommendations in late 2007 and published the update Friday in the journal Obstetrics & Gynecology.

While the two sets of recommendations are unrelated, they come at a time of intense debate over health-care reform. Mammograms in particular have drawn broad attention in Congress, reflecting a more than decade-long debate in the cancer community about how best to perform mammograms.

Republicans sought to connect the mammogram recommendations to the health-care overhaul, contending that such findings are the way that medical rationing starts.

Under the pending legislation, "nothing would prohibit the federal government from deciding if tests, treatments and procedures are too expensive, and therefore, unnecessary," Sens. Jon Kyl of Arizona, the Republican Whip, and Tom Coburn of Oklahoma, a physician, said in a joint statement.

But the Pap guidelines promise to be far less controversial as doctors for years have been told to perform fewer Paps among many women over 30, to cut back on unneeded care for the least at risk - and there's growing understanding that over-treating younger women is an issue, too.

"The tradition of doing a Pap test every year has not been supported by recent scientific evidence," said Dr. Alan Waxman of the University of New Mexico, who headed ACOG's review.

The guidelines also say:

_Routine Paps should start at age 21. Previously, ACOG had urged a first Pap either within three years of first sexual intercourse or at age 21.

_Women 30 and older should wait three years between Paps once they've had three consecutive clear tests. Other national guidelines have long recommended the three-year interval; ACOG had previously backed a two- to three-year wait.

_Higher-risk women, such as those with HIV, other immune-weakening conditions or previous cervical abnormalities, need more frequent screening.

Paps can spot pre-cancerous changes in the cervix in time to prevent invasive cancer, and widespread use has halved cervical cancer rates in the U.S. in recent decades. About 11,270 new cases will be diagnosed this year, and about 4,070 women will die from it, according to American Cancer Society estimates. Half of women diagnosed with cervical cancer have never had a Pap, and another 10 percent haven't had one in five years.

Cervical cancer is caused by certain strains of the extremely common sexually transmitted virus called HPV, for human papillomavirus. There is a new HPV vaccine that should cut cervical cancer in the future; ACOG's guidelines say for now vaccinated women should follow the same Pap guidelines as the unvaccinated.

But the updated guidelines reflect better understanding of HPV. Infection is high among sexually active teens and young adults. Women's bodies very often fight off an HPV infection on their own without lasting harm, although it can take a year or two. The younger the woman, the more likely that HPV is going to be transient.

Moreover, ACOG cited studies showing no increased risk of cancer developing in women in their 20s if they extended Pap screening from every year to every two years.

As for adolescents, ACOG said cervical cancer in teens is rare - one or two cases per million 15- to 19-year-olds - while HPV-caused cervical abnormalities usually go away on their own. Treating them unnecessarily increases the girls' risk of premature labor years later, and preterm birth is a growing national problem.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55342 2009-11-17T01:30:06-06:00 2009-11-17T01:32:07-06:00

{summary}

2009-11-17T01:30:06-06:00 Staff editor@TheRochesterDemocrat.com Testing





NEW YORK (AP) - Most women don't need a mammogram in their 40s and should get one every two years starting at 50, a government task force said Monday. It's a major reversal that conflicts with the American Cancer Society's long-standing position.

Also, the task force said breast self-exams do no good and women shouldn't be taught to do them.

For most of the past two decades, the cancer society has been recommending annual mammograms beginning at 40.

But the government panel of doctors and scientists concluded that getting screened for breast cancer so early and so often leads to too many false alarms and unneeded biopsies without substantially improving women's odds of survival.

"The benefits are less and the harms are greater when screening starts in the 40s," said Dr. Diana Petitti, vice chair of the panel.

The new guidelines were issued by the U.S. Preventive Services Task Force, whose stance influences coverage of screening tests by Medicare and many insurance companies.

But Susan Pisano, a spokeswoman for America's Health Insurance Plans, an industry group, said insurance coverage isn't likely to change because of the new guidelines. No changes are planned in Medicare coverage either, said Dori Salcido, spokeswoman for the Health and Human Services department.

Experts expect the task force revisions to be hotly debated, and to cause confusion for women and their doctors.

"Our concern is that as a result of that confusion, women may elect not to get screened at all. And that, to me, would be a serious problem," said Dr. Len Lichtenfeld, the cancer society's deputy chief medical officer.

The guidelines are for the general population, not those at high risk of breast cancer because of family history or gene mutations that would justify having mammograms sooner or more often.

The new advice says:

_Most women in their 40s should not routinely get mammograms.

_Women 50 to 74 should get a mammogram every other year until they turn 75, after which the risks and benefits are unknown. (The task force's previous guidelines had no upper limit and called for exams every year or two.)

_The value of breast exams by doctors is unknown. And breast self-exams are of no value.

Medical groups such as the cancer society have been backing off promoting breast self-exams in recent years because of scant evidence of their effectiveness. Decades ago, the practice was so heavily promoted that organizations distributed cards that could be hung in the shower demonstrating the circular motion women should use to feel for lumps in their breasts.

The guidelines and research supporting them were released Monday and are being published in Tuesday's issue of the Annals of Internal Medicine.

The new advice was sharply challenged by the cancer society.

"This is one screening test I recommend unequivocally, and would recommend to any woman 40 and over," the society's chief medical officer, Dr. Otis Brawley, said in a statement.

The task force advice is based on its conclusion that screening 1,300 women in their 50s to save one life is worth it, but that screening 1,900 women in their 40s to save a life is not, Brawley wrote.

That stance "is essentially telling women that mammography at age 40 to 49 saves lives, just not enough of them," he said. The cancer society feels the benefits outweigh the harms for women in both groups.

International guidelines also call for screening to start at age 50; the World Health Organization recommends the test every two years, Britain says every three years.

Breast cancer is the most common cancer and the second leading cause of cancer deaths in American women. More than 192,000 new cases and 40,000 deaths from the disease are expected in the U.S. this year.

Mammograms can find cancer early, and two-thirds of women over 40 report having had the test in the previous two years. But how much they cut the risk of dying of the disease, and at what cost in terms of unneeded biopsies, expense and worry, have been debated.

In most women, tumors are slow-growing, and that likelihood increases with age. So there is little risk by extending the time between mammograms, some researchers say. Even for the minority of women with aggressive, fast-growing tumors, annual screening will make little difference in survival odds.

The new guidelines balance these risks and benefits, scientists say.

The probability of dying of breast cancer after age 40 is 3 percent, they calculate. Getting a mammogram every other year from ages 50 to 69 lowers that risk by about 16 percent.

"It's an average of five lives saved per thousand women screened," said Georgetown University researcher Dr. Jeanne Mandelblatt.

Starting at age 40 would prevent one additional death but also lead to 470 false alarms for every 1,000 women screened. Continuing mammograms through age 79 prevents three additional deaths but raises the number of women treated for breast cancers that would not threaten their lives.

"You save more lives because breast cancer is more common, but you diagnose tumors in women who were destined to die of something else. The overdiagnosis increases in older women," Mandelblatt said.

She led six teams around the world who used federal data on cancer and mammography to develop mathematical models of what would happen if women were screened at different ages and time intervals. Their conclusions helped shape the new guidelines.

Several medical groups say they are sticking to their guidelines that call for routine screening starting at 40.

"Screening isn't perfect. But it's the best thing we have. And it works," said Dr. Carol Lee, a spokeswoman for the American College of Radiology. She suggested that cutting health care costs may have played a role in the decision, but Petitti said the task force does not consider cost or insurance in its review.

The American College of Obstetricians and Gynecologists also has qualms. The organization's Dr. Hal Lawrence said there is still significant benefit to women in their 40s, adding: "We think that women deserve that benefit."

But Dr. Amy Abernethy of the Duke Comprehensive Cancer Center agreed with the task force's changes.

"Overall, I think it really took courage for them to do this," she said. "It does ask us as doctors to change what we do and how we communicate with patients. That's no small undertaking."

Abernethy, who is 41, said she got her first mammogram the day after her 40th birthday, even though she wasn't convinced it was needed. Now she doesn't plan to have another mammogram until she is 50.

Barbara Brenner, executive director of the San Francisco-based Breast Cancer Action, said the group was "thrilled" with the revisions. The advocacy group doesn't support screening before menopause, and will be changing its suggested interval from yearly to every two years, she said.

Mammograms, like all medical interventions, have risks and benefits, she said.

"Women are entitled to know what they are and to make their best decisions," she said. "These guidelines will help that conversation."

---

Medical Writer Marilynn Marchione reported from Milwaukee.

---

On the Net:

Government advice: http://www.ahrq.gov/clinic/uspstf/uspsbrca.htm

]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55234 2009-11-12T00:31:47-06:00 2009-11-12T00:31:48-06:00

{summary}

2009-11-12T00:31:47-06:00 Staff editor@TheRochesterDemocrat.com Human Genome





WASHINGTON (AP) - Chimps, our nearest relative, don't talk. We do. Now scientists have pinpointed a mutation in a gene that might help explain the difference. The mutation seems to have helped humans develop speech and language. It's probably not the only gene involved, but researchers found the gene looks and acts differently in chimps and humans, according to a study published online Wednesday by the journal Nature.

Lab tests showed that the human version regulated more than 100 other genes differently from the chimp version. This particular gene - called FOXP2 - mutated around the time humans developed the ability to talk.

"It's really playing a major role in chimp-human differences," said the study's author, Daniel Geschwind, a professor of neurology, psychiatry and human genetics at the University of California, Los Angeles. "You mutate this gene in humans and you get a speech and language disorder."

This tells you "what may be happening in the brain," he said.

Frances Vargha-Khadem, head of developmental cognitive neuroscience at the University College London, who wasn't part of the research, said the study "is very much in line with what we had always suspected."

Vargha-Khadem has studied people with other inherited mutations in the gene and their speech and language problems. People with a certain mutation have subtle physical differences in the lower part of the jaw, the tongue and roof of the mouth, and she suspects chimps do, too.

That physical part is important because "you can't produce the dance unless you have the feet to do the dance," she said.

Eventually, work on this gene and others could potentially lead to genetic treatments for people with certain developmental difficulties, such as autism, because it gives future researchers targets, Geschwind said.

Other outside experts warned of making too much of this finding.

While finding the molecular differences is good, it is too early and unclear to weigh what it means for language and cognitive evolution, said Marc Hauser, a professor of human evolutionary biology at Harvard University.

"I would be extremely skeptical about drawing inferences," Hauser wrote in an e-mail.

And the key question is not how, but "why did we get language," said Derek Bickerton, a linguistics professor at the University of Hawaii. He wrote the book "Adam's Tongue: How Humans Made Language, How Language Made Humans."

Just because humans developed the ability for language, that doesn't mean it would happen automatically, Bickerton said.

"Every other species gets along just fine without it," Bickerton wrote in an e-mail. "We must have had some need that other species didn't have."

---

On the Net

Nature: http://www.nature.com/nature

]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55085 2009-11-05T12:12:46-06:00 2009-11-05T12:14:47-06:00

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2009-11-05T12:12:46-06:00 Staff editor@TheRochesterDemocrat.com Flu, Immunization


By DONALD G. McNEIL Jr.
NY TIMES
Published: November 4, 2009


Even though the regular flu season has yet to start, the nation is facing a severe shortage of seasonal flu vaccine as well as swine flu vaccine.

Federal officials and independent flu experts have said the situation was unavoidable, given that the global swine flu pandemic had raised demand for all flu shots far beyond what manufacturers can make in a year.

The shortage does not mean there will be an increase in seasonal flu deaths, which average about 36,000 a year. The same amount of vaccine was made this year as last, and there is no reason to believe any of the three strains of seasonal flu will be worse this winter. In parts of the Southern Hemisphere, swine flu seemed to “crowd out” seasonal flu this winter, experts said, but whether it will do so here is impossible to predict.

Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, told a House subcommittee on Wednesday that officials were “very frustrated” by the shortages but unable to prevent them.

Dr. Anthony S. Fauci, director of the National Institute for Allergy and Infectious Diseases, said it showed “the inexorable connection between preparedness for pandemic flu and preparedness for seasonal flu.”

In New York, the shortage is so acute that the city health department on Wednesday asked doctors to stop giving seasonal vaccines to healthy adults under 65.

“Some additional supplies of vaccine are expected during November,” said Dr. Thomas Farley, the city’s health commissioner. “But the demand may continue to exceed the supply.”

Shortages are being reported across the country. Based on recent telephone surveys and health insurer billing data, the C.D.C. believes that up to 85 million Americans have already had seasonal flu shots, said David Daigle, a C.D.C. spokesman. Last year at this time, only about 61 million had.

Last year was the previous record: 113 million doses of vaccine were made and about 103 million Americans took them. This year, from February to May, manufacturers had grown virtually the same amount — 114 million doses — before they were asked to switch to swine flu vaccine. They have shipped about 90 million doses of seasonal flu vaccine, Mr. Daigle said.

Unless there is a sudden loss of interest, a shortage seems inevitable even after the remaining 24 million doses are shipped. Exactly when shipping will finish is unknown. One company that had problems growing one of the three seasonal flu strains has not even filled its vials yet, said a flu expert who spoke on condition of anonymity.

A sudden drop in demand seems unlikely. In New York, children and teenagers have had 258,000 doses, twice the number given last year, and frustrated parents are looking for more. The city’s public clinics have already vaccinated more people than they did all last year, the health department said.

“Most of my colleagues in Manhattan ran out of injectable vaccine two or more weeks ago and are faced with dwindling stocks of FluMist,” said Dr. Mark Horowitz, a family practitioner with offices near Wall Street and Carnegie Hall. “And none of the manufacturers are going to retool to make more.”

The University of Minnesota, which last year set the record — 11,810 — for most seasonal flu shots given in one day, had to cancel this year’s clinic because it could not get vaccine, said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy there.

The current problems began years ago, experts said, when vaccine companies started abandoning the American market.

Vaccines, which involve living viruses, are much harder to make than most drugs. Profits are lower and unused flu vaccine expires after a few months. Also, vaccines are primarily intended for children, and Americans frequently sue when a child is injured.

Little was done to lure companies back until bioterrorism fears emerged after the anthrax attacks of 2001 and the H5N1 avian flu virus, which kills about 60 percent of humans infected with it, emerged in 2003, Dr. Fauci said.

In 2004, only two companies were licensed to sell flu vaccine in the United States; now there are five, but only one, Sanofi-Pasteur, has a domestic plant. The others — GlaxoSmithKline, Novartis, CSL Ltd. and Medimmune — use plants in England, Germany and Australia.

The drawback of relying on foreign plants was made clear recently when the Australian government pressured CSL to keep its vaccine at home instead of fulfilling its contract for 36 million doses of swine flu vaccine for the United States.

Bush administration officials repeatedly pressed Congress for money for vaccine technology, sometimes as part of bioterrorism-preparedness budgets, but never got as much as they asked for, said William Hall, a spokesman for the Department of Health and Human Services.

Trying to place blame for the current shortages “is inappropriate,” said Dr. William Schaffner, director of preventive medicine at Vanderbilt University medical school. “It was decisions by the manufacturers, and it was only recently, after the bioterrorism threat, that people woke up and started trying to reverse that.”

Although the government itself ordered and paid for all this year’s swine flu vaccine, about 90 percent of each year’s seasonal vaccine is made for the private sector.

Some of it is ordered directly by pharmacies, hospitals and other big users, and some is ordered by distributors who sell to individual doctors.

There is no way for vaccine makers to make more seasonal vaccine now, several experts said. They have already committed their factories to making nearly 200 million doses of swine flu vaccine for the United States and unknown amounts for other markets. It is growing in eggs much more slowly than was predicted.

They are under pressure to make more to donate or sell to the World Health Organization. Even optimistic predictions say the world’s poorest countries will get only 10 percent of the vaccine they need by winter’s end.

Also, it takes longer to make seasonal vaccine because it contains three strains.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.55083 2009-11-05T12:05:20-06:00 2009-11-05T12:07:21-06:00

{summary}

2009-11-05T12:05:20-06:00 Staff editor@TheRochesterDemocrat.com Flu





DES MOINES, Iowa (AP) - A 13-year-old Iowa cat has been infected with H1N1 flu, veterinary and federal officials said Wednesday in what is believed to be the first case of the H1N1 virus in a feline in the United States.

The domestic shorthaired cat was treated last week at Iowa State University College of Veterinary Medicine in Ames and has recovered, officials said. The virus also has been confirmed in two ferrets - one in Oregon and the other in Nebraska - but they died.

"We've known certainly it's possible this could happen," said Centers for Disease Control and Prevention spokesman Tom Skinner. "This may be the first instance where we have documentation that transmission occurred involving cats or dogs."

The veterinarian who treated the cat, Dr. Brett Sponseller, said two of the three people in the cat's Iowa home had flu-like symptoms before the cat became ill. The case was confirmed at both Iowa State and the U.S. Department of Agriculture.

Other influenza strains have been known to cross species, but Sponseller cautioned against drawing too many conclusions from the cat including whether other pets could also get the swine flu.

"It's well documented in influenza in general, but this is the first highly suspected case of H1N1 going from humans into a cat," he said.

The indoor cat was lethargic, had a loss of appetite and appeared to have trouble breathing after it became infected, Sponseller said. Its owners declined to comment.

Officials said pet owners should take the same precautions against spreading swine flu to pets as they would with humans.

Getting children vaccinated for swine flu can also help prevent the illness from spreading to pets. There is no H1N1 flu vaccine for pets.

Dr. Ann Garvey, Iowa's state health veterinarian, said it is not yet known how sick cats or other pets could get from swine flu.

"Because we haven't seen that many cases, it's difficult to give a blanket assessment on how sick it can make an animal," she said.

]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.54979 2009-10-30T12:37:22-06:00 2009-10-30T12:38:23-06:00

{summary}

2009-10-30T12:37:22-06:00 Staff editor@TheRochesterDemocrat.com Flu





LOS ANGELES (AP) - It was bound to happen: Some people who aren't at high risk for swine flu complications got the much-in-demand vaccine.

Sometimes they were healthy adults or senior citizens instead of kids, pregnant women and people with health problems.

Before Los Angeles County health officials stepped up screening at their flu clinics, Natalie Thompson sailed through the long line and got the vaccine along with her 8-year-old son, even though she's not in one of the priority groups.

"If I can get it, I'm not gonna say no," said Thompson, 35, of Hollywood Hills.

Another mom, Katy Radparvar, didn't say no either.

"Our doctor doesn't have it yet," said the 41-year-old woman who was vaccinated along with her three children at a public health vaccination site in suburban Encino last week.

Public health officials don't want to be vaccine police. Many don't turn anyone away who wants the vaccine, though some locations are tougher than others.

"For many this is a frustrating process and we really sympathize with those who show up at a clinic and can't get vaccinated," said Los Angeles County public health director Dr. Jonathan Fielding.

Across the country, thousands have waited in line and many have been turned away, as manufacturers have trickled out the slow-to-produce vaccine. Things are improving, and now about 25 million doses are available, the government says.

Aware of scant supplies up front, Santa Barbara County clinics administered their 4,400 shots to pregnant women only. San Diego County is only immunizing those on the priority list, but is taking the word of residents.

Nevada is using the honor system with vaccinations offered on a first-come, first-served basis to those who identify themselves as at-risk for the H1N1 virus.

"We really are hoping people go on the honor system and let us immunize people in the priority groups," Southern Nevada Health District spokeswoman Stephanie Bethel said. "I think, for the most part, it's working."

In Oregon, Portland metro area officials say pregnant women and children are moved to the front of the lines and inoculated before the general public.

"We assertively asked those who were not in the priority group to move to the end of the line, so when we ran out of vaccine, those people who were left were those who were not at risk," said health officer Dr. Gary Oxman. "And people have responded well to it."

The vaccine shortfall prompted Wisconsin state health officials this week to remind local health agencies "to strongly encourage" announcements about the limited vaccine supply and the focus on vaccinating high-risk groups first.

Robert M. Pestronk, executive director of the National Association of County and City Health Officials, said local health departments are doing the best they can under challenging conditions.

"Despite those best efforts, it doesn't surprise me that people who are not in high priority groups are appearing at clinics for vaccination," he said. "It's difficult to restrict vaccine simply to the priority groups."

One of the doctors who helped draw up guidelines for vaccine priority groups also isn't surprised at how things are unfolding.

The government's vaccine advisory panel "did not expect vaccine police to be set up around the country," said Dr. William Schaffner, a flu specialist at Vanderbilt University Medical Center, who is on the panel.

If vaccine demand is low in some locations, it makes sense for non-priority groups to get it instead of wasting the supply.

"I don't consider it a problem," said Schaffner. "I consider it more of a problem if vaccine is left unused."

That's what happened in the 2004-05 flu season when there was a shortage of seasonal flu vaccine. Many older healthy people refused to get the shot so that those who had health problems would have access to vaccine.

"One of the things that was learned was to be careful about turning people away because we might end up with a lot of vaccine at the end of the year," said Dr. Anne Schuchat of the Centers for Disease Control and Prevention But right now, there aren't many vaccine leftovers to be found. Every morning, Anne Jenkins of Shreveport, La., makes a round of calls to ask doctors and health clinics if they have the injectable swine flu vaccine. She is 23 weeks pregnant.

After seeing four elderly women requesting swine flu vaccine - to no avail - at a local military treatment facility she thought to herself, "you're not on the list."

Though local officials tell Jenkins the vaccine won't be available until mid-November, she's ready to compete for her dose when it arrives.

"You feel the animal instinct come out," she said.


]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.54898 2009-10-26T14:04:23-06:00 2009-10-26T14:06:24-06:00

{summary}

2009-10-26T14:04:23-06:00 Staff editor@TheRochesterDemocrat.com Flu




WASHINGTON (AP) - Health and Human Services Secretary Kathleen Sebelius said Monday the swine flu vaccine "is coming out the door as fast as it comes off the production line."

But at the same time, she acknowledged delays in getting a sufficient supply for all those demanding it.

"We were relying on the manufacturers to give us their numbers and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy," Sebelius said in one interview. "We do have a vaccine that works," she said. Sebelius said the immune response is working faster than officials anticipated.

Appearing Monday morning on nationally broadcast news shows, she said officials now have a supply of about 16.5 million doses of the vaccine, while conceding that's millions of doses below the amount needed.

Sebelius said she couldn't predict just how widespread the virus will be. Roughly a thousand people have died from it so far in the United States. But she also said officials do not believe there is yet any cause to close down schools and cease other daily activities.

President Barack Obama declared a health emergency over the weekend to give hospitals and health professionals more leeway from federal regulations to respond to the illness. And on Sunday, Senate Republican Leader Mitch McConnell of Kentucky said Congress would be happy to provide additional support and money on a bipartisan basis, if the need arises.

Said Sebelius: "If we had found the virus a little earlier we could have started a little earlier."

Asked what advice she would give to people who have waited futilely in line for shots, the secretary replied, "I want them to come back."

"I hope that people aren't discouraged," she said. "I know it's frustrating to wait in line and particularly if you end up with no vaccine. We wish this could have been smoother, that we had a larger supply. We knew it would come in waves."

Sebelius sought to assure people that eventually there will be enough supplies "for everyone."

Dr. Anne Schuchat, who heads the Immunization and Respiratory Diseases Division of the Centers for Disease Control and Prevention, said it's hard to predict how long the H1N1 wave will continue, so even getting vaccinated a few months from now - when vaccine supplies are more plentiful - won't be too late.

"It wouldn't be too late," she said. "We don't know how long this increase will go on. ... We might see another wave after the first of the year. I think it's important for people to take steps to protect themselves."

Sebelius appeared on ABC's "Good Morning America," CBS's "The Early Show" and NBC's "Today" show. Schuchat was interviewed on CNN.

]]> tag:therochesterdemocrat.com,2009:ee/index.php/51.54861 2009-10-24T20:56:37-06:00 2009-10-24T21:02:38-06:00

{summary}

2009-10-24T20:56:37-06:00 Staff editor@TheRochesterDemocrat.com Genetic Engineering



Oct. 24 (Bloomberg) -- Eight-year-old Corey Haas stared skyward four days after he had been to the doctor and noticed for the first time in his life that the sun hurt his eyes.

He had undergone experimental gene therapy to correct an inherited defect that left him with little vision and likely to go blind as an adult. The experiment, described today in the journal Lancet, worked.

The youngster from Hadley, New York, was the seventh of 12 people with the condition known as Leber’s congenital amaurosis to have a gene injected into one eye. All of the patients improved. The success of the experiment is a major boost for the field of gene therapy, which began 20 years ago and has had few clear successes in that time, said Ronald Crystal, a gene therapy researcher who wasn’t involved in the study.

“This is the most successful gene therapy trial yet in terms of showing improvement in human disease,” said Crystal, a professor of medicine at Weill Cornell Medical College in New York. “I think the field is now turning around.”

A number of companies are developing gene therapies and 320 trials are under way or cleared to begin by U.S. regulators, said Karen Riley, a U.S. Food and Drug Administration spokeswoman. Genzyme Corp. of Cambridge, Massachusetts, will begin a human trial using gene therapy next year to treat macular degeneration, the leading form of age-related vision loss, said John Lacey, a Genzyme spokesman, in a telephone interview yesterday.

Impaired at Birth

About 2,000 people in the U.S. have Leber’s and five children are born with the condition each year, according to researchers at Children’s Hospital of Philadelphia, where the study was conducted.

Leber’s causes impaired vision from birth as a result of defects in one of several genes. The patients in this study had mutations disabling a gene called RPE65 that produces a protein essential to vision, said Katherine High, a pediatrician and gene therapy researcher at the University of Pennsylvania.

“Normally when light strikes the retina, your eyes convert the light signals into electrical signals,” High said in an Oct. 22 telephone interview. “If it can’t do that, the system runs down.”

The first sign that Corey had a problem came during infancy when he failed to make eye contact during feeding, said his father Ethan Haas. As a toddler, he bumped into things, Haas recalled. There was one other unusual sign.

‘Craving Light’

“He was constantly staring at lights,” Haas said. “His eyes were basically craving light.”

Corey wore glasses starting at 10 months and he was diagnosed at 6 with Leber’s. He learned to read using large- print books and started getting lessons in reading Braille and using a white cane after doctors said he’d be blind by his 40s or sooner.

When the family’s eye doctor told them about the Children’s Hospital study, they jumped at the chance and went to Philadelphia in September 2008.

In a 90-minute procedure, the missing gene was injected into Corey’s eye, carried on a virus. The so-called adeno- associated virus used largely stays out of the patient’s DNA, making it safer, High said.

Troubled Chapter

Gene therapy has had a difficult history, with its most troubled chapter occurring at the University of Pennsylvania in 1999, when 18-year-old Jesse Gelsinger died within hours of being injected. The therapy, which used a different gene-bearing virus than the one Corey and his fellow subjects got, sparked a massive immune response, killing Gelsinger.

The current study drew extra scrutiny because of the school’s previous experience, said Jean Bennett, the study’s senior author.

“We and other people who are involved in human gene therapy studies had to go through many extra layers of security,” Bennett said in an e-mail today. “The net result, however, is that the Gelsinger case served to ratchet up the level of protection of human subjects to the level that it should be.”

In the study, four children and eight adults had the gene injected into one eye. That allows researchers to compare changes in the two eyes and leaves one protected if something goes wrong, High said.

“Every patient improved and the children improved most of all,” High said.

Children Helped Most

Patients improved on standard vision tests such as reading eye charts and their pupils had a much greater response when light was shined in their eyes, she said.

“The main reason children did well is that there’s more retinal material still there to rescue,” High said.
“The best results were in the youngest patients who had more cells still present.”

None of the patients suffered serious adverse events. Some had minor immune reactions after the injections that disappeared within days, High said.

The results help demonstrate the potential of gene therapy, said Cornell’s Crystal, who last year showed that gene therapy may help patients with a rare brain disorder.

“This is one of several examples where the field has been able to demonstrate that gene therapy can be effective,” he said. “That was the promise of gene therapy when it was first developing in the late 1980s. Now 20 years on, we’re seeing the fruits of all the hard work.”

For Corey Haas, the benefits are simple.

“I can see colors a lot better now,” he said by telephone on Oct. 22. “I can navigate better on my bike.”



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