MDs balance pros cons of Super Xray
Tue, 06 Nov 2007 02:10:18 GMTBy MARILYNN MARCHIONE, AP Medical Writer
ORLANDO, Fla. - A type of "super X-ray" showed promise in its first big test as a potentially cheaper, faster and painless way to find out whether certain people with signs of heart disease actually have it and need treatment. The scans might eliminate the need for some of the 1.3 million cardiac catheterizations done each year in the United States to check for clogged arteries, said Dr. Julie Miller of Johns Hopkins University.
But the newer scans are controversial: Medicare and private insurers are debating whether to pay for them, and many heart specialists oppose them, partly because they supply a big dose of radiation. That raises the risk of cancer and might spur thousands of additional cases if the scans were widely used in the population, said Dr. Michael Lauer of the National Heart, Lung and Blood Institute.
Speaking at an American Heart Association conference where study results of the scan were presented Monday, he called on doctors not to use the scans until research proves they save lives.
"I think he went a little overboard" and was reacting to worries the scans would be used to screen people with no symptoms, rather than the more limited use tested in the study, said Miller, who led the research.
This new CT scan technology came on the market two years ago and is already used by many hospitals. Because it uses 64 detectors to produce and combine images, the scans are called "64-slice CT." The images are so detailed that one doctor described them as an almost surgical view.
In the new study, the scans were tested against the current gold standard method of checking a patient for heart disease: angiograms done in a cardiac catheterization lab. A tube is placed in a blood vessel in the groin and maneuvered near the heart, and a special dye is infused that makes the arteries show up on X-rays.
These can reveal who has blockages and needs treatment with bypass surgery or an artery-opening procedure called balloon angioplasty.
The new scans deliver 10 times more radiation to the patient than a standard angiogram. Though the technology has been in use, its accuracy hasn't been proved.
Miller's international study was the first direct comparison. It was funded by scanner maker Toshiba Medical Systems, and Miller has had research grants from the company.
Researchers started with 405 people suspected of having heart disease and eliminated about one-fourth because they had high amounts of calcium in their artery walls. This is common as people age and the arteries harden, and doctors worried that such findings could look like blockages and bias results.
The remaining 291 people were given the new CT scans, then standard angiograms.
Nine out of 10 patients with blockages were identified by the scans, as were 83 percent of those without blockages. The scans ruled out heart disease in half of the patients — people who could have been spared the pain, expense and risk of catheterization, Miller said.
The ability of the painless scans to rule out problems is "exciting," but questions remain about how they would do on a fuller range of patients, said Dr. Timothy Gardner, a Delaware cardiologist and heart association spokesman.
The association recently sent Medicare officials a letter opposing the scans for screening people with no heart disease symptoms, but saying they could be considered for those with symptoms or to check for heart defects, said Dr. Raymond Gibbons of the Mayo Clinic, a former heart association president.
Others said the study did not change their opposition to the new technology.
"I don't buy it," said Dr. Steven Nissen of the Cleveland Clinic, former president of the American College of Cardiology. "If you do a CT and you find anything, you've got to do a catheterization anyway."
Researchers also "cherry-picked" the kind of patients most likely to have heart disease to test in the study.
"It's not for the walking well" who worry they might have hidden problems, said Dr. W. Douglas Weaver, a Detroit heart specialist and president-elect of the College of Cardiology.
The new scans cost under $1,000; angiograms from catheterization cost $2,500 or more. Advanced scanners offering 128- and even 256-slice images are coming into use, so the issue will grow as images become more detailed.
The debate involves a turf war between cardiologists who do the current angiograms versus radiologists who do the new scans.
Also at the heart conference Monday:
_New research has doctors excited again that experimental drugs that boost good cholesterol can help cut the risk of heart attack.
New details on why Pfizer's failed drug torcetrapib raised the risk of death showed that its problems were unique and don't appear to apply to other medications being tested by Merck & Co. and Swiss drug maker Roche Holding AG.
"It looked very gloomy for this method of raising HDL. I am not gloomy for the prospects for this class anymore," said Nissen, who headed one of the stopped Pfizer experiments.
_Crestor, a statin drug that lowers bad cholesterol, did not cut the risk of death among elderly heart failure patients but helped some avoid hospitalization, according to a study sponsored by Crestor's maker, AstraZeneca PLC.
Statins are mostly prescribed to prevent heart attacks in people with clogged arteries. They are not typically prescribed to people who suffer from heart failure, which occurs when a weakened heart can no longer effectively pump blood.
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On the Net:
Heart Association: http://www.heart.org
Agency touts old medicine disposal idea
Tue, 06 Nov 2007 00:48:30 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - It's time to pooper-scoop your leftover medicine. Mixing cough syrup, Vicodin or Lipitor with cat litter is the new advice on getting rid of unused medications — preferably used cat litter.
It's a compromise, better for the environment than flushing — and one that renders dangerous medicines too yucky to try if children, pets or drug abusers stumble through the trash.
A government experiment is about to send that advice straight to thousands of patients who use potent painkillers, sleeping pills and other controlled substances. Why? Prescription drug abuse is on the rise, and research suggests more than half of people who misuse those drugs get them for free from a friend or relative.
In other words, having leftovers in the medicine cabinet is a risky idea. Anyone visiting your house could swipe them. So 6,300 pharmacies around the country have signed up for a pilot project with the Substance Abuse and Mental Health Services Administration.
When patients fill prescriptions for a list of abuse-prone medicines, from Ambien to Vicodin, the pharmacist also will hand over a flyer urging them to take the cat-litter step if they don't wind up using all their pills.
Not a cat owner? Old coffee grounds work, or doggie doo, even sawdust. Just seal the meds and the, er, goop in a plastic bag before tossing in the trash.
"We don't want to assert that this is a panacea for the larger problem," says SAMHSA's Dr. H. Westley Clark. "It just provides them with a caveat that these are not things you can just lay around."
But the concern isn't only about controlled substances. How to best dispose of any medicine, whether prescription or over-the-counter, is a growing issue.
Unfortunately, "we don't have a silver bullet," says Joe Starinchak of the U.S. Fish and Wildlife Service.
No one knows just how many unused drugs Americans dump each year, or how many are hoarded because patients simply don't know what to do with them or that they should dispose of them.
Once, patients were told to flush old drugs down the toilet. No more — do not flush unless you have one of the few prescriptions that the Food and Drug Administration specifically labels for flushing.
That's because antibiotics, hormones and other drugs are being found in waterways, raising worrisome questions about potential health and environmental effects. Already, studies have linked hormone exposure to fish abnormalities. Germs exposed to antibiotics in the environment may become more drug-resistant.
Some communities set aside "take-back" days to return leftover doses to pharmacies or other collection sites for hazardous-waste incineration. The Environmental Protection Agency recently funded a novel pilot program by the University of Maine to see if consumers will mail back unused drugs — a program that local officials estimate could cull up to 1.5 tons of medications.
But it's not clear if incineration is better for the environment than the slow seepage from a landfill, cautions the Fish and Wildlife Service's Starinchak.
Plus, take-back programs require legal oversight to make sure what's collected isn't then diverted for illegal use.
Starinchak calls the yucky-bag disposal method interim advice — the top recommendation until more research can determine the best way to balance the human health, environmental and legal issues.
So early next year, Fish and Wildlife will team with the American Pharmacists Association for a larger campaign called SMARxT Disposal. The campaign will spread this latest advice through even more drugstores, to purchasers of all types of medicine.
"There is a $64,000 question here: Whether people really will get rid of it," says Carol J. Boyd, director of the University of Michigan's Institute for Research on Women and Gender and a well-known specialist on drug diversion.
Say you're prescribed a week's worth of Vicodin for pain after a car crash, and you use only three days' worth. Most people would keep the rest, to avoid paying for more if they suffer serious pain for some other reason later. Boyd isn't sure how to counter that money issue.
But keeping the leftovers makes them accessible for misuse by children, other relatives or visitors. Stealing aside, Boyd's research uncovered that friends and family openly share these pills — "Use this, it helped me" — even with teens and college students, apparently not realizing there could be serious health consequences.
"The public needs to know this," Boyd says of the disposal advice. "What's not easy is, we don't know if it's working."
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EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Lack of sleep may lead to fatter kids
Tue, 06 Nov 2007 00:49:17 GMTBy CARLA K. JOHNSON, Associated Press Writer
CHICAGO - Here's another reason to get the kids to bed early: More sleep may lower their risk of becoming obese. Researchers have found that every additional hour per night a third-grader spends sleeping reduces the child's chances of being obese in sixth grade by 40 percent.
The less sleep they got, the more likely the children were to be obese in sixth grade, no matter what the child's weight was in third grade, said Dr. Julie Lumeng of the University of Michigan, who led the research.
If there was a magic number for the third-graders, it was nine hours, 45 minutes of sleep. Sleeping more than that lowered the risk significantly.
The study gives parents one more reason to enforce bedtimes, restrict caffeine and yank the TV from the bedroom. The study appears in the November issue of the journal Pediatrics.
Lack of sleep plays havoc with two hormones that are the "yin and yang of appetite regulation," said endocrinologist Eve Van Cauter of the University of Chicago, who was not involved in the new study.
In experiments by Van Cauter and others, sleep-deprived adults produced more ghrelin, a hormone that promotes hunger, and less leptin, a hormone that signals fullness.
Another explanation: Tired kids are less likely to exercise and more likely to sit on the couch and eat cookies, Lumeng said.
Dr. Stephen Sheldon, director of sleep medicine at Chicago's Children's Memorial Hospital, praised the study and called for more research. He said children's sleep may be disturbed by breathing problems — some caused by overweight, such as sleep apnea, and some caused by enlarged tonsils and adenoids.
"I'm not so sure we have enough information yet on cause and effect," said Sheldon, who was not involved in the study.
Researchers used data from an existing federal study and focused on 785 children with complete information on sleep, and height and weight in the third grade and sixth grade. The children lived in 10 U.S. cities.
Mothers were asked: "How much sleep does your child get each day ?" On average, the third-graders got about 9 1/2 hours sleep, but some slept as little as seven hours and others as much as 12 hours.
Of the children who slept 10 to 12 hours a day, about 12 percent were obese by sixth grade. Many more — 22 percent — were obese in sixth grade of those who slept less than nine hours a day.
The researchers took into account other risk factors for obesity, such as the children's body mass index in third grade, and still found the link between less sleep in third grade and obesity in sixth grade. They acknowledged that factors they did not account for, such as parents' weight or behavior, may have contributed to the risk.
Jodi Mindell of the Children's Hospital of Philadelphia's Sleep Center noted there are plenty of other reasons for encouraging good sleep habits, such as success in school.
"I don't want parents to think, 'If I get her to sleep, she's not going to be overweight,'" Mindell said. "I think this is a small piece in the picture."
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On the Net:
Pediatrics: http://www.aap.org
Faster heart care How one state did it
Tue, 06 Nov 2007 00:55:33 GMTBy MARILYNN MARCHIONE, AP Medical Writer
ORLANDO, Fla. - In an ideal world, every heart attack would end like Willard "Ziggy" Hill's. Within 90 minutes of arriving at a small community hospital in North Carolina, he was having a blocked artery reopened at Duke University Medical Center 25 miles away.
"It was like being a car in a pit stop at NASCAR," he said. "I thought 'I am in really good hands.'"
Two years ago, he might not have been. North Carolina was a bad place to have a heart attack, scoring below national norms of fast care. Now it may be one of the best.
The reason is the nation's most ambitious statewide project to redo how serious heart attacks are handled. Paramedics, doctors and 65 hospitals put aside powerful individual interests like money and control, and focused on giving faster care.
Why is this important? Drugs, devices and doctors do no good if they do not reach people quickly, before the heart suffers permanent damage.
Heart attacks happen when arteries are blocked, crimping a critical blood supply. The first choice of treatment is angioplasty, in which a tiny balloon is pushed into the vessel and inflated to flatten the clog.
However, many small hospitals lack specialized suites called catheterization labs needed for angioplasties. Instead, they sometimes give clot-dissolving drugs, which do not always work.
In the North Carolina project, 55 small hospitals agreed to send appropriate patients to 10 larger ones for angioplasty, even though it meant giving up thousands of dollars of revenue.
"If this is your Aunt Bess and she comes in to your emergency department and you offer her a level of care that's not the best, and you have to go to that funeral in that small community, that's what they think about — not cost," said Mayme Roettig, the nurse who coordinated the project.
Big hospitals also had room to improve, too, said Dr. Christopher Granger, the Duke cardiologist who led the project.
Statewide, "up to 40 percent who should get clot-busting drugs or angioplasty were not getting it, and when it was being given it was being given too slowly," he said.
He reported one-year results of the project Sunday at an American Heart Association meeting in Florida. They also were published online by the Journal of the American Medical Association.
Researchers compared the care of more than 2,000 patients before and after the project and found:
_More patients got care at top-tier heart hospitals, and more quickly than similar patients did before the project began. Helicopter transfers rose, and more paramedics diagnosed heart attacks from EKGs done in ambulances.
_The number of patients receiving angioplasty rose, and the portion of eligible patients not receiving artery-opening procedures dropped.
_Every single measure of time improved. Examples: the average time it took a small hospital to evaluate and refer patients to a larger one dropped from two hours to 71 minutes; average transfer times plunged more than half an hour.
"They did a magnificent job," said Dr. Harlan Krumholz, a Yale University cardiologist who is leading a national campaign to speed up heart attack care.
"This is a great example of where people in a state got together and said 'Gee, if I were a patient, what's the kind of care that I would want, and how can we deliver that?'"
The stories from North Carolina are dramatic.
Paramedics like 26-year-old Joshua Codispoti in rural Person County made judgment calls previously left to cardiologists. Last spring, he did an EKG in an ambulance, diagnosed a heart attack in a healthy-looking man in his 30s, and called a hotline to summon a team of specialists and ready a $2 million cath lab for angioplasty.
The team must be in the lab within 30 minutes, and the large hospitals must agree to take heart attack patients regardless of whether they have an open bed, said Duke cardiologist Dr. James Jollis.
Codispoti's patient was quickly evaluated at 50-bed Person Memorial Hospital and sent on to Duke. "I don't feel like we're giving up anything" by referring people for advanced care, said emergency room physician Dr. Kimberly Yarborough.
She hasn't given clot-dissolving drugs to a heart attack patient in nearly two years, since the project started.
Neighboring states also have benefited. Howard Campbell, 65, suffered a heart attack in May at his Lake Gaston home just across the Virginia-North Carolina state line.
"I was on my rec room floor having a heart attack at 1:30, and at 2:20 I was on a helicopter to Duke," he said.
When his wife arrived at 3:30, his procedure was already done.
"It was like we had rehearsed it — it just went so smoothly." Campbell said.
The project was funded by the hospitals, Blue Cross and Blue Shield of North Carolina, and the Doris Duke Foundation, which helped equip ambulances with EKGs. Doctors hope to expand it to the 35 state hospitals not currently participating.
Meanwhile, nearly 1,000 hospitals have joined a nationwide campaign that began a year ago to have hospitals give angioplasty treatment faster. Less than a third of patients get it within the recommended 90 minutes of arrival, and the risk of dying goes up 42 percent if care is delayed even half an hour longer.
"This has been a pretty spectacular effort," Krumholz said. "If you can get people in really quickly, you can almost abort the heart attack. It's such a different mindset than a few years ago when everybody said 'we're busy, we're doing the best we can.'"
Doctors will report first-year results early next year.
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On the Net:
Heart Association: http://www.americanheart.org/
JAMA: http://jama.ama-assn.org/
Hospital ratings: http://www.hospitalcompare.hhs.gov/
Australian researchers find hunger switch
Tue, 06 Nov 2007 02:15:50 GMTSYDNEY - Australian scientists have found how to switch hunger on and off using a molecule that targets the brain -- a discovery which could stop weight loss in terminally ill patients or produce weight loss in the morbidly obese.
The molecule, known as MIC-1, is produced by common cancers and targets receptors in the brain that switch off appetite. But Australian researchers found that by using antibodies against MIC-1 they were able to switch appetite back on.
When normal and obese mice were treated with MIC-1 they ate less and lost a lot of weight, suggesting that MIC-1 may also be used to treat severe obesity, said the Sydney researchers in a statement received on Tuesday.
&;This work has given us a better understanding of the part of the brain that regulates appetite,&; said Herbert Herzog, director of neuroscience research at the Garvan Institute in Sydney.
&;Our bodies send complex chemical signals to our brains, which interpret them and send back responses, in this case eat or don't eat. Our research indicated that MIC-1 is a previously unrecognized molecule sending a don't eat signal to the brain,&; Herzog said.
The researchers said it was hoped that in the near future, the MIC-1 findings will prevent a sizeable proportion of advanced cancer patients from &;literally wasting away.&;
Sam Breit at St Vincent's Centre for Immunology, who originally cloned the MIC-1 gene, said he believed the findings could have a significant impact on a range of appetite-related disorders.
&;Injecting mice with MIC-1 protein also made them stop eating, suggesting that it may be possible to use this to advantage for treating patients with severe obesity,&; he said.
The MIC-1 findings were published in the latest Nature Medicine magazine and the team of researchers led by St. Vincent's Hospital in Sydney hope to develop a human antibody and run clinical trials in the next few years.
Novacea ends latestage trial of prostate cancer drug
Mon, 05 Nov 2007 19:26:16 GMTBy Neetha Mahadevan
BANGALORE - Drugmaker Novacea Inc ended a late-stage trial of its prostate cancer drug Asentar, after a treatment arm containing the drug showed a higher death rate compared with the standard care, driving shares down more than 69 percent to a lifetime low.
South San Francisco-based Novacea also put its mid-stage trial for Asentar in advanced pancreatic cancer on hold, company spokesman Paul Laland said by phone.
The main goal of the prostate cancer trial was overall survival, which is the time from the date of randomization to the time of death from any cause.
The study compared the benefits of a weekly dose of Asentar in combination with Sanofi-Aventis' chemotherapy, Taxotere, to the current standard of care, which is Taxotere combined with a steroid, in the treatment of androgen-independent prostate cancer .
AIPC is a condition where prostate cancer cells do not depend on androgen for growth. Androgens are hormones responsible for male characteristics, and the development and function of male sexual organs.
&;We still believe Asentar has potential as a cancer treatment but we need to take the time to fully understand the reason for the unexpected outcome,&; Laland said.
To date, more than 900 of the planned total of 1,200 patients had been enrolled in this study.
The company said it suspended enrolment in other ongoing or planned trials for other indications, until further assessment of data.
The company, which is developing Asentar with Schering-Plough Corp, said the drug development alliance would continue.
&;We believe that this announcement casts uncertainty over the future of the company's Asentar partnership with SGP , though NOVC indicated that the product alliance will continue,&; Bear Stearns analyst Akhtar Samad said in a note to clients.
Samad downgraded Novacea to &;underperform&; from &;outperform.&;
Novacea shares fell $4.55 to $2.64 in late-afternoon trade, making it the biggest percentage loser on the Nasdaq. They hit a lifetime low of $2.21 earlier in the session.
Shares of Schering-Plough were trading down 1.97 percent at $29.37 on the New York Stock Exchange.
