Court rules out terminally ill for tests
Tue, 07 Aug 2007 20:44:59 GMTBy MATT APUZZO, Associated Press Writer
WASHINGTON - Terminally ill patients do not have a constitutional right to be treated with experimental drugs, even if they likely will be dead before the medicine is approved, a federal appeals court said Tuesday.
The ruling by the U.S. Court of Appeals for the District of Columbia Circuit overturned last year's decision by a smaller panel of the same court, which held that terminally ill patients may not be denied access to potentially lifesaving drugs.
The full court disagreed, saying in an 8-2 ruling that it would not create a constitutional right for patients to assume "any level of risk" without regard to medical testing.
"Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."
Food and Drug Administration approval of drugs generally requires extensive testing that can involve years of trials and thousands of patients.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.
FDA spokeswoman Susan Cruzan said the agency was pleased with the decision, which she said considered the public's safety and the need for access to experimental drugs.
Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs' daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.
"What the opinion by Judge Griffith is saying is, 'We don't want to risk one life or a few lives, even at the expense of the lives of hundreds or thousands of people,'" Burroughs said. "The logic of that escapes me."
In a sharply worded dissent, Judge Judith W. Rogers called the ruling "startling." She said courts have established the right "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body even if it results in one's own death or the death of a fetus."
"But the right to try to save one's life is left out in the cold despite its textual anchor in the right to life," Rogers wrote.
Rogers was joined by Chief Judge Douglas H. Ginsburg. The case cut across party lines, with conservative and liberal judges taking both sides of the dispute.
The court noted that there are government programs that provide access to experimental drugs in certain situations. It said the matter is not closed and said Congress might be a better venue than the courts to address the issue.
Burroughs said he expects such legislation to be introduced this session. Both the Senate and House have considered such legislation but it languished in committee.
Seafood from China wasnt screened
Tue, 07 Aug 2007 20:33:05 GMTBy JUSTIN PRITCHARD and ADAM GOLDMAN, Associated Press Writers
At least 1 million pounds of suspect Chinese seafood landed on American store shelves and dinner plates despite a Food and Drug Administration order that the shipments first be screened for banned drugs or chemicals, an Associated Press investigation found.
The frozen shrimp, catfish and eel arrived at U.S. ports under an "import alert," which meant the FDA was supposed to hold every shipment until it had passed a laboratory test.
But that was not what happened, according to an AP check of shipments since last fall. One of every four shipments the AP reviewed got through without being stopped and tested. The seafood, valued at $2.5 million, was equal to the amount 66,000 Americans eat in a year.
FDA officials stuck the pond-raised seafood on their watch list because of worries it contained suspected carcinogens or antibiotics not approved for seafood.
No illnesses have been reported, but the episode raises serious questions about the FDA's ability to police the safety of America's food imports.
"The system is outdated and it doesn't work well. They pretend it does, but it doesn't," said Carl R. Nielsen, who oversaw import inspections at the agency until he left in 2005 to start a consulting firm. "You can't make the assumption that these would be isolated instances."
If the system cannot stop known risks, Nielsen said, how can it protect against hidden dangers, such as the ingredients from China that made toothpaste potentially poisonous and killed dozens of pets earlier this year?
China is America's biggest foreign source of seafood, the 1.06 billion pounds it supplied in 2006 accounting for 16 percent of all seafood Americans buy.
President Bush has asked a Cabinet-level panel to recommend better imported food safety safeguards. Chinese officials have promised to inspect fish farms closely for the use of drugs and chemicals, even as they called the FDA's testing mandate illegal under world trade rules.
FDA officials acknowledged that some shipments slip through import alerts, but said overall they work.
"Any time you introduce a human element into something, I don't think you can necessarily guarantee 100 percent," said Michael Chappell, the official responsible for field inspections and labs.
Normally, the FDA inspects just 1 percent of the cargo it oversees. When goods land under an import alert, however, they are considered guilty until proven innocent: All shipments are supposed to be held until private tests that cost importers thousands of dollars show the seafood is clean. Sometimes, the FDA double-checks those tests in its own labs. Products can be detained for months, irking importers.
However, a shipment can escape inspection if, for example, a company uses a name or address not on an import alert, Chappell said. That appears to be what happened in one case AP found.
Also, FDA workers who must review hundreds of shipments that flash across a computer screen each day may miss some tagged for testing.
The agency has about 450 budgeted positions for screening approximately 20 million shipments annually of such things as fish, fruit and medical devices. At a congressional hearing last month, FDA employees doubted whether they have the resources to do the job.
Last summer, FDA labs began accumulating evidence that 15 percent of farm-raised shrimp, eel and catfish contained dangerous or unapproved substances. The agency started throwing individual companies on its watch list, and ultimately issued a sweeping mandate that all shrimp, eel and catfish raised on Chinese farms be stopped and tested.
Federal food safety officials said that while the seafood poses no immediate danger, long-term exposure could increase the risk of cancer or undermine the effectiveness of drugs used to fight outbreaks of disease.
The FDA did not tell shoppers to throw away what they had bought; agency officials said they simply had to get control over what China was sending.
Seafood that clears the ports enters a vast distribution system that includes restaurants, wholesalers and brand-name packagers.
The Chinese government and U.S. importers say the FDA overreacted. It would be impossible, importers say, for a person to eat enough seafood to be affected by the trace levels that FDA found of substances such as the antifungal chemical malachite green and the antibiotic Cipro.
The AP reviewed 4,300 manifests of seafood shipments from China compiled by Piers Reports, a company that tracks import-export data, and found 211 shipments that arrived under import alert since last fall.
FDA officials refused to identify exactly which shipments were tested, saying they were too busy to do so.
So the AP contacted importers directly, talking to 15 companies responsible for 112 of the 211 shipments. Eleven said their products were tested; four said the FDA did not bother to stop a total of 28 shipments weighing 1.1 million pounds. Virtually all the shipments entered through ports in the Southeast, including Tampa, Fla., Miami and Savannah, Ga.
The importer with the most cases was Florida-based Tampa Bay Fisheries.
Chief executive Robbie Paterson said 23 shipments of breaded or dusted frozen shrimp delivered between October and May were not inspected. In rare cases, the FDA removes from its watch list companies that have passed five straight tests. Paterson said he assumed that was why Tampa Bay's shipments went through.
Not so: Tampa Bay's shrimp supplier — the Fuqing City Dongyi Trading Co. — was on the watch list.
Three other companies said a total of five shipments of catfish, eel or shrimp were not stopped and tested.
Like many others in the importing business interviewed for this story, Paterson said he believed that import alerts were completely effective and that Chinese seafood poses no health risk.
FDA officials "are diligently doing the inspections as they see fit," Paterson said.
The expanded testing mandate has rattled China. U.S. importers said they are being told that the government is holding back shipments until tests show they will pass U.S. muster. The disruption has yet to result in any substantial price increases in the United States.
"I don't really know why they conducted the special test on our products," said a woman who identified herself as Miss Lin, a spokeswoman for Shantou Red Garden Foodstuff, which the FDA placed on its watch list in April after finding its dusted shrimp contained nitrofurans, an antibiotic that may cause cancer. "We've been exporting products to the U.S. for many years and we respect their standards and we meet their standards."
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Associated Press Writer Christopher Bodeen in Shanghai, China, contributed to this report.
Woman has pencil removed from head
Tue, 07 Aug 2007 16:30:53 GMTBy KRISTEN ALLEN, Associated Press Writer
BERLIN - After being plagued for 55 years with the torment of a pencil lodged in her head, a German woman has finally had it removed.
Margaret Wegner, now 59, was 4 years old when she fell while carrying the 3.15 inch-long pencil, which went through her cheek and into her brain.
"It bored right through the skin and disappeared into my head," Wegner told Germany's best-selling newspaper, Bild. "It hurt like crazy."
At the time the technology did not exist to safely remove the pencil, so Wegner had to live with it — and the chronic headaches and nosebleeds that it brought — for the next five-and-a-half decades.
But on Friday, Dr. Hans Behrbohm, an ear, nose and throat specialist at Berlin's Park-Klinik Weissensee, was able to use modern techniques to identify the exact location of the pencil so that he could accurately determine that the risks of removing it, and then take most of it out.
The operation was particularly difficult because of the way the pencil had shifted as Wegner grew, Behrbohm told The Associated Press on Tuesday.
"This was something unique because the trauma was so old," said Behrbohm, who has also operated to remove bullets from the brains of shooting victims, and glass from the brains of people involved in car accidents.
Though a 0.79-inch piece of the pencil could not be removed, Behrbohm said it does not present a danger.
And now Wegner, the wife of German boxing coach Ulli Wegner, will no longer have the headaches and nosebleeds, and her sense of smell should also return soon, Behrbohm said.
"She shouldn't suffer any longer," he said.
Roberts says cancer surgery went well
Tue, 07 Aug 2007 15:17:41 GMTNEW YORK - ABC "Good Morning America" anchor Robin Roberts says messages of support from her fans helped her get through breast cancer surgery last Friday.
"I am incredibly grateful that my surgery went well Friday," Roberts said in a posting on ABC News' Web site. "Thanks for all the prayers — I owe you big time!"
Roberts, 46, told "GMA" viewers last Tuesday that she had cancer, which she discovered through self-examination.
Her mother and sisters traveled from the Mississippi Gulf Coast and New Orleans to be with her for the operation. The former college basketball star and sportscaster grew up in Pass Christian, Miss.
"My family read many of your e-mails while I was in surgery," said Roberts, who has been an anchor at "GMA" since 2005. "It brought them such comfort. My big sis, Sally-Ann, marked all the survivor stories with a big S."
She said her co-anchor, Diane Sawyer, had visited her in the hospital.
"I woke up in the recovery room with sweet Diane gently tugging on my big toe," she said in a posting Monday. "As you can imagine, I am still quite sore from the procedure and need to take some time for my body to heal."
Roberts left the hospital on the day of her surgery.
"Right now the best medicine for me is to be at home surrounded by family and loved ones," she said. "I expect to get the final test results later this week, which will determine the course of my treatment."
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System leaves some children unvaccinated
Tue, 07 Aug 2007 20:02:35 GMTBy CARLA K. JOHNSON, Associated Press Writer
CHICAGO - For children whose health insurance doesn't cover newly recommended shots, it's better to have no insurance at all, a new study suggests.
Free vaccines are available to children who are uninsured or qualify for public insurance.
But many states can't afford to help children with inadequate private insurance that doesn't cover new, expensive shots and even some older shots, the study found. That puts more than a million children at risk, researchers said.
Illinois, for example, doesn't provide vaccines against chickenpox, pneumonia, hepatitis A, human papillomavirus and rotavirus to children with insufficient private insurance. Parents would have to pay $400 out of pocket for those vaccines.
"Health insurance plans are not necessarily keeping up with the new vaccines, posing significant ethical dilemmas to public health clinics," said the study's lead author Dr. Grace Lee of Harvard Medical School.
The study of the nation's patchwork system of paying for immunizations appears in Wednesday's Journal of the American Medical Association.
Childhood shots have become a $1 billion-a-year endeavor for government since the discovery of polio vaccine 55 years ago. The per-child cost grew more than sevenfold from $155 in 1995 to $900 for boys and $1,200 for girls this year. Costs in the private sector are higher.
Lee and her colleagues surveyed states to find out which shots they provide and to whom. Program managers from 48 states responded. Lee wouldn't say which states participated because researchers promised anonymity.
Sixteen of the states require health insurers to cover all recommended vaccines.
About 55 million employees and their dependents get coverage through self-insured companies that are exempt from state mandates. Those people are the most likely to be underinsured for vaccines, said vaccine policy expert Dr. Matthew Davis of the University of Michigan.
According to the research, 17 states reported they were unable to give a vaccine for meningitis to children with inadequate private insurance, even if they were seen in public health clinics. And eight states don't give pneumococcal shots to underinsured infants and toddlers.
A handful of states don't provide shots for chickenpox and hepatitis A to the underinsured. Two states don't provide Tdap, the combined booster shot for tetanus, diphtheria and pertussis for 11- to 12-year-olds.
More than 1 million insured children are unable to get the meningococcal vaccine leaving them vulnerable to potentially deadly infection, the researchers estimated.
The survey did not ask about two vaccines recommended last year: an oral vaccine for infants against rotavirus, a common cause of childhood diarrhea and vomiting, and a vaccine for girls against human papillomavirus, which can cause cervical cancer.
Workers covered by plans marketed by Aetna and other insurance companies generally are covered for childhood vaccines, although they may have to pay co-payments or satisfy deductibles, said Mohit Ghose, a spokesman for American's Health Insurance Plans.
As costs rise, it may be necessary to decide at a national level which vaccines are most important, Davis said. He was not involved in the new study, but wrote an accompanying editorial in the journal.
Officials at the U.S. Centers for Disease Control and Prevention oppose prioritizing vaccines and instead favor better coverage by insurers and more government funding as a safety net, said CDC immunizations director Dr. Lance Rodewald.
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Choline may increase odds of polyps study
Tue, 07 Aug 2007 20:12:55 GMTBy Ishani Ganguli
WASHINGTON - The essential nutrient choline -- found in red meat, poultry, eggs and milk -- may increase the risk of colon polyps, at least for women, U.S. researchers said on Tuesday.
The findings were the opposite of what they expected, said Eunyoung Cho, the epidemiologist at Harvard's Brigham and Women's Hospital in Boston, who led the study.
Because choline is involved in similar processes as folate, a vitamin known to protect against genetic changes that can lead to cancer, researchers had thought choline might also have a protective effect.
But it turns out that choline actually may be encouraging the growth of polyps, Cho said in a telephone interview. That's because choline also helps form the outer coating of cells, said Cho, whose work appears in the Journal of the National Cancer Institute.
Cho and colleagues analyzed the diet and colon health of nearly 40,000 female nurses whom they followed since 1984.
Women who ate the most choline -- based on food questionnaires filled out every two years -- were 45 percent more likely to develop polyps than those who consumed the smallest amount.
Choline has a number of important functions in the body, including roles in brain development and memory function. Less is known about its association with cancer.
Researchers said other nutrients found in choline-rich foods may explain the increased polyp risk.
&;We know that red meat intake has been associated with increased risk of colorectal cancer. We are concerned that there may be other components in red meat and animal-based food that may be responsible for this association,&; Cho said.
Colorectal adenomas -- the type of polyps studied -- are found in up to 40 percent of adults over 50. Fewer than 5 percent of them turn cancerous, experts said.
&;It's probably too early to worry about choline,&; added Cho, who is now looking for a similar association in men.
The average choline intake in this study was lower than the Institute of Medicine's daily recommendation of 425 mg.
