By TANALEE SMITH, Associated Press Writer
SYDNEY, Australia - An Australian doctor proposed Monday that the government pay up to $47,000 for kidney donations to overcome a chronic shortage.
The suggestion touched off debate around the country on the idea, which critics say will end in the poor selling their organs to the rich.
Kidney specialist Gavin Carney said allowing the sale of organs would save thousands of lives and billions of dollars in care for patients on transplant waiting lists. He also said it would stop people from buying organs on the black market in developing countries, where they pursue risky, unregulated surgeries.
Australia has one of the lowest rates of organ donation in the developed world, about 10 donors per 1 million people, according to a federal health task force.
“We’ve tried everything to drum up support for organ donation and the rates have not risen in 10 years,” Carney was quoted as saying in Fairfax newspapers. “People just don’t seem to be willing to give their organs away for free. … Let’s pay people some money for a new car or a house deposit and those waiting lists will be halved within about five years.”
Carney, a professor at the Australian National University, could not immediately be reached by The Associated Press.
Carney’s proposal was immediately criticized by transplant groups, who fear it would exploit poor people.
The idea was dismissed by Health Minister Nicola Roxon, who said Australians would not be allowed to market their organs. “But we do know that we need urgent action in this area of organ donation,” Roxon told Australia Broadcasting Corp. radio.
Rather than paying people for organs, Roxon said her ministry would act on some of the recommendations of a federal task force that recently completed a review of the organ donation system. She did not specify its recommendations.
The task force attributed Australia’s low organ donor rate to a decrease in road accidents and strokes, lack of public awareness, and poor identification of donors in hospitals, among other factors. In comparison, Germany has 15 donors per 1 million people, the Netherlands has 25, the United States 27, and Spain 35, it said.
Selling or buying organs is illegal in Australia, as in most countries, and carries a penalty of six months in jail and a fine of up to $4,130.
More than 1,800 people are waiting for kidney transplants in the country but only 343 kidneys were donated last year, Fairfax reported. Transplant Australia, a national charity and organ support group, said the average wait for a kidney transplant is four years.
The group’s chief executive Chris Thomas said his organization rejects paying for organs and instead is working with the government to change the donation system. He said Carney’s proposal would leave poor people vulnerable.
“It really focuses on the poor and people who are least able to pay for things in society. They get attracted to these types of things,” he told ABC Radio. “We’d reject that.”
Kidney Health Australia also rejected Carney’s proposal, saying it would be open to “many ethical issues and abuse.”
“In my opinion it is inappropriate for the Australian medical system to consider, and is counter to the Australian culture which promises an equitable approach in all things,” KHA medical director Tim Mathew told The Associated Press. “The commercial trade in organs is not something we can support.”
Carney said the suggestion that paid donation would exploit poor people was “a red herring,” telling ABC radio that government regulation of organ commercialization would ensure high ethical standards and medical safeguards.
“I don’t support (illegal trade),” Carney said. “But I also do not agree with the fact that we should let people just rot on dialysis until they have been on dialysis so long they are untransplantable.”
Last week, health officials in the Philippines announced that foreigners will be banned from receiving kidneys for transplant there in an attempt to crack down on a thriving black market in organs sold by poor people.
NEW YORK (Reuters Life!) - Got a passion for buying sneakers? It could be a good sign, with a poll finding that people who buy three pairs of sneakers or more a year are far more likely to be a leadership type than other people.
Mindset Media, a media company that examines personality traits of different consumers, found that people who buy more than three pairs of sneakers a year are 61 percent more likely to have the qualities of a modern leader.
These qualities were defined as having ideas and vision, and a style with others that is both inclusive and decisive.
The survey of 7,500 people, using market research group Nielsen’s online panel, found multi-sneaker buyers were 50 percent more likely to be very assertive and 47 percent more likely to be spontaneous.
Lauren Arvonio, a spokeswoman for Mindset Media, said sneaker buyers were more likely to fly by the seat of their pants.
“It is often said you can tell a lot about a person by the shoes they wear, and now we have some hard data to back that up,” Arvonio told Reuters.
“What is interesting is that these personality traits held true across the board, regardless of age, income, or gender.”
Previous Mindset Media surveys found that people who pay their credit card bills off each month were more likely to be “highly deliberate,” thinking through their actions, but also less modest than others, likely to brag about their habits.
Hybrid car owners were found to be 78 percent more likely to be highly creative than other people and less dogmatic.
(Writing by Belinda Goldsmith, Editing by Patricia Reaney)
By Matthew Herper
CHICAGO -
Merck and Schering-Plough had hoped new results presented Sunday would ease worries about the usefulness of their cholesterol drugs, Zetia and Vytorin. Instead, for many researchers, anxiety about the medicines is deepening.
The companies’ share prices have fallen 25% since part of the data was released in January. They counted on the full release of the study, called ENHANCE, to restore investor confidence in their $5.2 billion cholesterol franchise. The opposite is now likely.
“It’s going to temper the use of these drugs, there’s no doubt in my mind,” says Douglas Weaver, a cardiologist at Henry Ford Hospital and the president of the American College of Cardiology, which is meeting in Chicago this weekend. Says Harlan Krumholtz, of Yale University, a member of an expert panel that will discuss the drugs at the ACC meeting: “The burden of proof is on the companies to prove Zetia and Vytorin are safe and effective. They have not done that yet.”
The New England Journal of Medicine, which published ENHANCE Sunday at 1 p.m. Eastern, took the unusual step of printing not one but two editorials about the study, both recommending doctors only turn to Zetia and Vytorin after they had exhausted all other options. Another study, by Krumholtz, found the drugs–which are much more expensive than rival generics–are prescribed four times more often in the U.S. than in Canada, where direct consumer advertising is banned.
Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ) disagreed with the contention that use of Zetia and Vytorin should be limited. “What we do not agree with is that it should be used as a second- or third-line therapy,” says Enrico Veltri, the Schering-Plough vice-president in charge of heart disease drugs. “We don’t think it needs to be a last resort.”
More than a dozen cardiologists reviewed the New England Journal publications for Forbes. The vast majority expected use of Zetia and Vytorin would decline following the release of the data.
Zetia is approved for lowering cholesterol, but there is no evidence it prevents heart attacks and saves lives like the statin drugs, including Lipitor and Zocor. Guidelines from the ACC and the American Heart Association say that Zetia should only be used in patients who can’t get their cholesterol down far enough with statins. Vytorin is a combination of Zetia and Zocor.
“The willingness of U.S. physicians to so rapidly adopt an unproven therapy is worrisome,” says Paul Ridker, a cardiologist at the Brigham and Woman’s Hospital in Boston. “The questions patients with high cholesterol should ask their physicians is simple: Will the drug you are giving me lower my risk of heart attack or stroke? If not, why are you prescribing it?”
In the artery study, doctors gave 720 patients with a genetic disease that causes high cholesterol either the Vytorin combination pill or just the Zocor component. Researchers then used ultrasound devices to measure the thickness of the arteries in their neck and leg. Atherosclerosis, the disease that leads to heart attacks and strokes, causes arteries to thicken, so the patients on Vytorin should have had skinnier artery walls than those on Zocor alone because of their lower cholesterol levels. They didn’t.
Instead, the arteries of patients on Zocor became 0.006 millimeters thicker, compared with 0.01 millimeters for Vytorin. The difference is so small as to be unimportant, says John Kastelein, the University of the Netherlands doctor who led the trial. “This is a zero trial,” he says, that neither shows harm nor benefit.
In the New England Journal and in an interview, Kastelein argued part of the reason for the decline was that these patients have been treated with statins for decades, and now their arteries are almost as thin, given their genetic illness. “It was a failure of us as investigators,” says Evan Stein of the Metabolic Research Laboratories in Cincinnati, who worked on the ENHANCE study. He says the problem was “somewhat akin to trying to show one antibiotic is better than another, or even placebo, but selecting a population with no infection.”
But Kastelein himself says he’s not certain this accounts entirely for the surprising result. He will continue to prescribe the drug to his patients, who all suffer from the genetic illness familial hypercholesterolemia and desperately need their cholesterol lowered, but he wants more evidence about how Zetia works before a big study of the drugs benefits concludes in 2012, at least a year later than originally expected.
“I need to be convinced that this drug indeed confers vascular benefit,” Kastelein says. He calls on Merck and Schering to fund more molecular biology, chemistry and imaging studies of Zetia. “What we need now is some really good science.”
William Boden of the University of Buffalo says the idea that the arteries were thin does not explain away worries about Zetia’s effectiveness against heart attack-causing atherosclerosis. “There’s not a hint of things moving in the right direction,” says Boden. He predicts “a significant dampening of enthusiasm” for Zetia and Vytorin until the companies have data to show whether they affect heart attacks and strokes.
Either the imaging technique doesn’t predict whether drugs prevent heart attacks and strokes, or Zetia isn’t going to prevent heart attacks and strokes, says Prediman K. Shah, a researcher who studies cholesterol at Cedars-Sinai Medical Center. “I’m confused,” he says, because reducing low-density lipoprotein (LDL), or bad cholesterol, is such a cornerstone of cardiology. But he is reluctant to apply “magic” properties to statins. “I’m going to give up medicine if it turns out that a statin is the only way to get an LDL reduction that reduces events,” he says.
Some researchers now wonder whether Zetia may have subtle, negative effects that counteract its LDL-lowering ability. Paul Thompson, director of cardiology at Hartford Hospital, says he will still use Zetia when statins aren’t enough to lower cholesterol. But now there are questions about the drug that weren’t being asked before. “What other things was it doing that you didn’t know about?” wonders Thompson. “That is the issue.”
Allen Taylor, chief of cardiology at Walter Reed Army Medical Center and co-author of one of the editorials, says he worries that Zetia “does things its not intended to do,” affecting the way Zetia works. “It’s uncomfortable because it’s a widely used drug, and there’s a lot of conjecture.”
For some, the data in ENHANCE are just too weak to draw any conclusions. Eric Topol of Scripps Health says his concerns would be the same whatever the outcome of the study. Says Elliott Antman of Harvard University: “It provides very limited information about one way of looking at the problem of atherosclerosis.” Adds Valentin Fuster, dean of academic affairs at Mt. Sinai and past president of the AHA: “This study doesn’t have power. This study doesn’t tell me much because I don’t have confidence in what is happening.”
An immediate result could be that doctors turn more quickly to drugs that lower particles of fat in the blood called triglycerides or raise “good cholesterol” (HDL) instead of just cutting LDL, says Howard Weintraub, a preventative cardiologist at New York University. That would favor the Niaspan and Tricor brands sold by Abbott Laboratories (nyse: ABT - news - people ), and also Lipitor from Pfizer (nyse: PFE - news - people ) and Crestor from AstraZeneca (nyse: AZN - news - people ), statins that also have some effect on triglyceride and HDL.
But those drugs have side effects that make them difficult to take, says Robert Califf of Duke University, who is helping to run the biggest Vytorin study. Tricor is linked to kidney problems; niacin can cause flushing. Some older cholesterol-lowering drugs, called resins, can cause constipation. But he says that if people are using Zetia or Vytorin on patients who could instead tolerate a higher dose of a statin, that’s a problem, because statins have proven benefits and Zetia doesn’t.
“The unpardonable sin is using [Zetia] instead of a statin when somebody can take a statin,” says Califf. “This study should remind people that shouldn’t be done.”
Complicating matters for Merck and Schering is the fact that the companies delayed the release of the ENHANCE trial data by more than a year, releasing it only after inquiries from Forbes. That delay prompted two congressional investigations and ignited a firestorm of media controversy. Kastelein says if he had been in full control of the study, results would have been presented last March. Now doctors are left to ask when they will get more answers about a drug that has become widely used because it cut cholesterol, caused no obvious side effects and was heavily advertised. It won’t happen fast.
One study, called SEAS, is expected in November. But it compares Vytorin with placebo, so it could just show the benefit of Zocor, and is in an odd population: people with a heart artery defect. Another, called SHARP, compares Vytorin, Zocor and placebo in patients with kidney disease. But whereas 4,000 patients get Vytorin and another 4,000 get placebo, only 1,000 get Zocor. So that study might not show researchers if Zetia confers an additional benefit either.
The best hope for a clear answer comes from a study called IMPROVE-IT, which was originally expected in 2011. On Friday, Merck said the researchers running the study enrolled another 8,000 patients, bringing the total number in the study to 18,000 and delaying results by a year. The benefits of cutting LDL may be more subtle than they expected, they say, and they want to make sure they get a clear answer. It took two years for the companies to decide to conduct that study. Many cardiologists now say the Food and Drug Administration should have delayed approve Zetia until plans for the trial were already under way.
“It’s a very good study, it’s just that it got started too late,” says Roger Blumenthal, a preventative cardiologist at Johns Hopkins University, who sees a role for Zetia because of the many patients who get side effects on statins. “That’s where the mistake was. That’s not going to happen again. That definitely is what we’ve learned from this whole debacle.”
[Source: forbes.com]
By DARRIN MORTENSON
Could Prime Minister Nouri al-Maliki’s attempts to re-establish control over Basra backfire? There is a growing possibility that it could become a wider intra-Shi’ite war, drawing in the forces loyal to radical cleric Moqtada al-Sadr, whose ceasefire has been key to the success of the U.S. “surge”? If so, the consequences for American military strategy in Iraq in an all-important political year will be grave.
Maliki’s government targeted Basra because it could. Unlike many other southern cities where fighting has escalated in recent weeks, Maliki has built an independent power base among the security forces there. But Tuesday’s sweep of Basra could turn sour in other southern cities where the central government’s power is weak. Indeed, many Shi’ites are seeing this not just as an example of the Shi’ite Maliki taking on other Shi’ites (including Sadrists) but of America backing the Prime Minister up in a de facto Shi’a civil war. Iraqi government forces have attacked Shi’ite militias and gangs in at least seven major southern Iraq cities in the past two weeks. And America has been there to support Maliki’s troops every time.
In response, Sadr loyalists have already taken to the streets in Baghdad, where U.S. troops will have to deal with the backlash. U.S. officials have so far shied away from blaming Sadr for the recent rise of violence (including an Easter attack on the Green Zone), mostly because Sadr’s ceasefire has been key to the success of the surge. (General David Petraeus has pointed the finger at Iran instead.) But as clashes increase, they may not be able to dance around it for much longer.
The violence is escalating as Patraeus, the architect of the nine-month military “surge” involving some 30,000 extra troops in Iraq, prepares for a scheduled Apr. 8 and 9 report to congress on his progress in Iraq. They also come as he and Defense Secretary Robert Gates waffle over whether to withdraw five combat brigades by July, reducing troop levels down from about 158,000 to 140,000 - the pre-surge peak. If the fighting spreads to other southern cities and attacks by Shi’ite militias increase, intra-Shiite violence may be the wrench that jams the whole works of a meaningful reduction of troops.
While the focus this weekend on attacks on Baghdad has now turned towards Basra, violence has surged for weeks throughout the Shi’ite south, where Americans have suffered fresh losses in old haunts in the cities of Nasiriyah, Hilla and Diwaniyah. Meanwhile, the Shi’ite infighting in Basra has forced British forces to stall the planned withdrawal of some 1,500 troops. Some 4,000 British troops have been hunkered down at the Basra airport after turning the city over to Iraqi forces last year. So far they have not been drawn from their base into this week’s fighting there.
If the U.S. decides to actively go after the Shi’ite forces in the south, it would mean reopening a southern front where American forces once fought some of the Iraq war’s fiercest battles against Sadr but now have only a shadow presence. That would involve draining the concentration of surge troops around Baghdad and the Sunni triangle. It might even require more troop extensions or additional deployments to hold ground and maintain modest gains. Moving against the Shi’ite strongholds could then open opportunities for the Sunni fighters of al-Qaeda to strike Iraqi and U.S. targets in the Sunni triangle as the American heat turns south.
This week’s violence in Baghdad and Basra followed several days of bloodshed in the Shi’ite city of Kut, some 100 miles southeast of the capital, where Sadr loyalists clashed with police forces largely controlled by their Shi’ite rivals, the Badr Corps militants of the Supreme Islamic Council of Iraq, and with government troops affiliated with Maliki’s Da’awa party.
“This was expected. It was just a matter of timing,” said Vali Nasr, Tufts University scholar and author of the bestselling book, The Shi’a Revival: How Conflicts within Islam Will Shape the Future. “The ceasefire and the surge allowed everyone to regroup and rearm. There is still the Shi’a-Sunni conflict. There is still the Sadr-Badr conflict. The surge and the ceasefire merely kept them apart, but there has never been a real political settlement,” he said. “No, the big battle for Iraq hasn’t been fought yet. The future of Iraq has not been determined.” Nasr said the question now remains just how deep U.S. forces will get sucked into a Shi’ite civil war.
Sadr’s ceasefire did allow U.S. forces to concentrate on hunting al-Qaeda in Baghdad, Mosul and Diyala without having an open front in the south. But it also allowed the cleric to rearm, clean his own house and retake the reins of his splintering movement. However, Sadr’s devoted rank and file seem to be itching for a fight now as the Iraqi government and their American backers take sides with rival factions and continue to crack down on Sadr’s Jaish al Mahdi, or JAM. “Sadr has had an interest in making sure everyone knows he’s still around,” Nasr said. “He’s not going to go down without a fight.”
The conveniently quiet arrangement between Sadr and the U.S. is now being challenged from within and from without. “There are all kinds of groups who would be interested in dragging [Sadr] into positions and into conflicts that he doesn’t want to be in,” said Anthony Cordesman, a top Iraq analyst for the Center for Strategic and International Studies in Washington. Cordesman warns against jumping to conclusions that the south is rising up. He says it’s more likely that the recent violence is a sign that the many Shi’ite factions that have broken from Sadr’s movement are seeking to prove their mettle, and that al-Qaeda cells are seeking new ways to strike as they are forced out of more and more areas by U.S. and Iraqi forces.
Cordesman echoes Army Lt. Gen Ray Odierno, who, after leading U.S. forces in Iraq for the past 15 months, recently reported that Sadr seemed to be softening and his movement becoming more of a faith-based political movement than a militia waiting to kill Americans or take power by force. That said, Odierno expressed concern over the growing Shi’ite rivalries. “I worry about intra-Shi’a violence a bit,” he said upon returning to the Pentagon earlier this month. “That could, you know, spiral out of control.” View this article on Time.com
Samantha Power, a Barack Obama foreign policy advisor and Harvard professor who helped focus the world’s attention on genocide, apparently has a little trouble with personal diplomacy. In an interview with the Scotsman published today, Power described Hillary Clinton as a “monster” and used an expletive to describe the Obama campaign’s losing effort in Ohio — comments for which she is already apologizing.
The money quote: “You just look at her and think, ‘Ergh.’ But if you are poor and she is telling you some story about how Obama is going to take your job away, maybe it will be more effective. The amount of deceit she has put forward is really unattractive.”
And: “In Ohio, they are obsessed and Hillary is going to town on it, because she knows Ohio’s the only place they can win. She is a monster, too -– that is off the record -– she is stooping to anything.”
Imagine the meeting this morning among the Obama communications advisors. Power, a Pulitzer Prize-winning journalist, already has drawn lightning over her views on the Mideast, though she has picked up some defenders too.
And there will probably be some chatter this morning about Power’s saying that the “monster” comment was off the record. But Power should know better. Off-the-record status is something agreed to between interviewer and interviewee, not something decreed by the person being interviewed because he or she uttered something problematic.
And in this case, Power’s “frankness” might not rise to the level of Obama’s “problem from hell,” but it’s not exactly the kind of distraction the campaign needs at this point.
– Scott Martelle
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