Judge blocks U.S. sale of Plavix
Tue, 19 Jun 2007 19:54:35 GMTBy LARRY NEUMEISTER, Associated Press Writer
NEW YORK - A Canadian company's cheap generic version of the blood thinner Plavix has been blocked from the U.S. market until at least 2011.
U.S. District Judge Sidney H. Stein said Tuesday that Apotex Inc. had failed to prove during a three-week trial in New York City earlier this year that the patent protecting Plavix from competitors was invalid.
Plavix, used by 48 million Americans, is Bristol-Myers Squibb Co.'s best selling product. It is the world's second best selling drug after Pfizer Inc.'s cholesterol-lowering agent Lipitor.
The ruling also was a victory for the French patent-holder, Sanofi-Aventis, which sells Plavix in the United States through Bristol-Myers.
"We're pleased that our intellectual property rights have been maintained," said Bristol-Myers spokesman Tony Plohoros.
Robert L. Baechtold, a lawyer for Bristol-Myers and Sanofi, said Stein delivered a "carefully thought out and well reasoned decision."
Apotex said it would file an immediate appeal with the Federal Circuit in Washington. A win would allow the company to "once again make possible billions of dollars in savings for the public," said Chief Executive Barry Sherman.
Apotex's drug sells for about $124 for 30 pills, compared with $148 for a month's supply for the branded version.
Shares of Bristol-Myers surged $1.21, or 4 percent, to $31.52 in afternoon trading on Tuesday, while Sanofi-Aventis' U.S. shares rose 21 cents to $41.56.
Last year, Stein had granted a request by Sanofi-Aventis to stop Apotex from producing the generic drug, which had gained a majority of market share after its launch last summer. The judge had allowed Apotex to continue selling a six-month supply of product that it already had shipped to U.S. distributors.
Sherman said the issues in the case were "extremely similar" to those in a dispute over a patent for a blood pressure medication, Norvasc. Earlier this year, a federal appeals court cleared the way for Apotex to sell a cheaper generic version of the blood pressure drug.
The judge, however, rejected Apotex's claims that his findings in the Plavix case were similar to the overturned Norvasc ruling.
Sherman said Apotex will pursue the Plavix case "full bore and work relentlessly" to invalidate the patent covering clopidogrel bisulfate, the active ingredient in Plavix. Sanofi obtained the patent in July 1989, naming two employees as inventors.
In Tuesday's opinion, Stein said Sanofi had shown it was likely to suffer irreparable price erosion, loss of goodwill and a negative impact on the amount of research devoted to developing other medical uses for Plavix if sales of the generic version were allowed.
The judge rejected claims by Apotex that the patent protecting sales of Plavix contains disclosures that were obvious to a person of ordinary skill who studies prior pharmaceutical discoveries.
The judge said damages will be set in an amount to be determined at future proceedings.
Can motion sensors predict dementia
Tue, 19 Jun 2007 03:13:13 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Tiny motion sensors are attached to the walls, doorways and even the refrigerator of Elaine Bloomquist's home, tracking the seemingly healthy 86-year-old's daily activity.
It's like spying in the name of science — with her permission — to see if round-the-clock tracking of elderly people's movements can provide early clues of impending Alzheimer's disease.
"Now it takes years to determine if someone's developing dementia," laments Dr. Jeffrey Kaye of Oregon Health & Science University, which is placing the monitors in 300 homes of Portland-area octogenarians as part of a $7 million federally funded project.
The goal: Shave off that time by spotting subtle changes in mobility and behavior that Alzheimer's specialists are convinced precede the disease's telltale memory loss.
Early predictors may be as simple as variations in speed while people walk their hallways, or getting slower at dressing or typing. Also under study are in-home interactive "kiosks" that administer monthly memory and cognition tests, computer keyboards bugged to track typing speed, and pill boxes that record when seniors forget to take their medicines.
More than 5 million Americans, and 26 million people worldwide, have Alzheimer's, and cases are projected to skyrocket as the population ages. Today's medications only temporarily alleviate symptoms. Researchers are desperately hunting new ones that might at least slow the relentless brain decay if taken very early in the disease, before serious memory problems become obvious.
So dozens of early diagnosis methods also are under study, from tests of blood and spinal fluid to MRI scans of people's brains. Even if some pan out, they're expensive tests that would require lots of doctor intervention, when getting someone to visit a physician for suspicion of dementia is a huge hurdle. And during routine checkups, even doctors easily can miss the signs.
Bloomquist, of Milwaukee, Ore., knows the conundrum all too well. She volunteered for Kaye's research because her husband died of Alzheimer's, as did his parents and her own mother.
"It's hard to know when people begin Alzheimer's," she reflects. "Alzheimer people do very well socially for short periods of time. If it's just a casual conversation, they rise to the occasion."
Measuring how people fare at home — on bad days as well as good ones, not just when they're doing their best for the doctor — may spot changes that signal someone's at high risk long before they're actually demented, Kaye told the Alzheimer's Association's international dementia-prevention meeting last week.
"If you only assess them every once-in-a-blue-moon, you really are at a loss to know what they are like on a typical day," Kaye explains.
High-tech monitors under study:
_Researchers at New York's Mount Sinai School of Medicine are heading a study that ultimately plans to recruit 600 people over age 75 to help test in-home "kiosks" that turn on automatically to administer monthly cognitive exams. A video of a smiling scientist appears on-screen to talk participants through such classic tests as reading a string of words and then, minutes later, repeating how many they recall, or seeing how quickly they complete connect-the-dot patterns.
_An Oregon pilot study of the motion sensors tracked 14 participants in their upper 80s for almost a year. Half had "mild cognitive impairment," an Alzheimer's precursor, and half were healthy. Impaired participants showed much greater variation in such day-to-day activities as walking speed, especially in the afternoons.
Why? The theory is that as Alzheimer's begins destroying brain cells, signals to nerves may become inconsistent — like static on a radio — well before memories become irretrievable. One day, signals to walk fire fine. The next, those signals are fuzzy and people hesitate, creating wildly varying activity patterns.
The pilot study prompted a first-of-its-kind grant from the National Institutes of Health to extend the monitoring study to 300 homes; 112 are being monitored already, mostly in retirement communities like Bloomquist's. They're given weekly health questionnaires to make sure an injury or other illness that affects activity doesn't skew the results.
_In addition, participants receive computer training so they can play brain-targeted computer games and take online memory and cognition tests. The keyboards are rigged to let researchers track changes in typing speed and Internet use that could indicate confusion.
_Finally, a souped-up pill dispenser called the MedTracker is added to some of the studies, wirelessly recording when drugs are forgotten or taken late.
Electronics giants already sell various medical warning technologies for the elderly, including dementia patients, such as pill boxes that sound reminder alarms at dose time. And the Alzheimer's Association and Intel Corp. are jointly funding research into how to use television, cell phones and other everyday technology to do such things as guide dementia patients through daily activities.
The next step of companies selling early symptom monitoring isn't far off, and unbiased data on what really helps will be crucial, Kaye warns.
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EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Stroke drug may also help with frostbite
Tue, 19 Jun 2007 02:00:13 GMTBy DOUG ALDEN, Associated Press Writer
SALT LAKE CITY - An anti-clotting drug used to treat strokes and heart attacks can also restore blood flow to frostbitten fingers and limbs, greatly reducing the need for amputation, according to a new study.
Doctors at the University of Utah who conducted the research on a small sample of patients hope it marks the start of a move beyond the traditional — and limited — treatment for frostbite.
"What it does is help to rescue that tissue that is damaged but not yet dead," said Dr. Stephen Morris, one of the authors of the study, which was released Monday in the Archives of Surgery medical journal.
Patients who received the thrombolytic therapy at the university's burn center were more likely to keep their frostbitten fingers and toes than patients who went without the drug.
All patients had similar degrees of frostbite.
Thrombolytic therapy is not new, but has been difficult to study because not every frostbite victim is a candidate. For instance, people already on blood thinners or someone who has suffered a head injury would be at risk for serious complications from the anti-clotting drug.
Dr. John Twomey, burn director at the Hennepin County Medical Center in Minneapolis, first tried the therapy on a patient about 20 years ago and has treated 18 other patients with it since.
Twomey, whose early findings are mentioned in the Utah study, said the treatment for frostbite has been limited to warming the affected tissue and waiting to see how much would survive.
"We saw all these frostbitten patients come in, and there was absolutely nothing we could do to alter their disease," Twomey said. "That was pretty discouraging and disheartening to see that happening, and it happened repeatedly."
In the Utah study, six patients who were treated with a drug called tissue plasminogen activator, or tPA, within 24 hours of injury were compared with 25 other patients who did not receive the drug, and one patient who got the anti-clotting drug later than the 24-hour window.
Among the patients who received tPA within 24 hours, only six of 59 frostbitten fingers or toes were removed, or about 10 percent. In the other group, 97 of 234 affected digits were amputated, or about 41 percent.
The sample used for the study was small and taken only from one geographic area. The study was also based only on the one anti-clotting drug. Those are just a few of the variables that leave questions to be answered by future research.
But for some, the findings may offer a chance at avoiding amputation.
"For the injured tissue, there's still hope," said Dr. Amalia Cochran, another of the University of Utah authors.
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On the Net:
The Archives of Surgery: http://www.archsurg.com
University of Utah burn center: http://uuhsc.utah.edu/burncenter/
Skipping insulin for weight risky
Tue, 19 Jun 2007 02:00:35 GMTBy JIM ELLIS, Associated Press Writer
Like many teenage girls, Lee Ann Thill was obsessed with her appearance. A diabetic, she was already suffering from bulimia — forcing herself to throw up to lose weight. But it wasn't enough, and she'd recently put on 20 pounds.
Then one day at a camp for diabetic teens, she heard counselors chew out two girls for practicing "diabulimia" — not taking their insulin so they could lose weight, one of the consequences of uncontrolled diabetes.
Don't you realize you could die if you skip your insulin? the counselor scolded. Don't you know you could fall into a coma or damage your kidneys or your eyes?
But that's not what registered with Thill, who has Type 1, or juvenile diabetes. Instead, she focused on this: Skipping insulin equals weight loss. For the next 17 years, diabulimia was her compulsion.
"I took just enough insulin to function," said Thill, now 34, of Magnolia, N.J.
Today, she worries about the long-term damage that may have come from her weight obsession. At 25, a blood vessel hemorrhage in her eye required surgery. At 28, doctors told her she had damaged kidneys.
"I'm fearful for the future," Thill said. "I feel very strongly that had I taken care of myself, I could have lived as long as anyone without diabetes. I don't think that's going to happen now."
Diabulimia is usually practiced by teenage girls and young women, and it may be growing more common as the secret is exchanged on Internet bulletin boards for diabetics and those with eating disorders. One expert who has studied the phenomenon estimates that 450,000 Type 1 diabetic women in the United States — one-third of the total — have skipped or shortchanged their insulin to lose weight and are risking a coma and an early death.
"People who do this behavior wind up with severe diabetic complications much earlier," said Ann Goebel-Fabbri, a clinical psychologist at the Joslin Diabetes Center in Boston.
The American Diabetes Association has long known about insulin omission as a tactic to lose weight. But "diabulimia" is a term that has only cropped up in recent years and is not a recognized medical condition, said Barbara Anderson, a pediatrics professor at Baylor College of Medicine in Houston.
Type 1 diabetes is a disorder in which the body's own immune system attacks insulin-producing cells in the pancreas. People with this disease produce little or no insulin, so they take shots of the hormone daily.
It differs from Type 2, the form associated with obesity and which accounts for about 90 to 95 percent of all diabetes.
Insulin is vital for delivering glucose from the bloodstream to the body's cells. Without insulin, cells starve even while the bloodstream becomes burdened with too much glucose.
When Type 1 diabetics skip or reduce their insulin, they risk falling into a coma or even dying. Blindness, amputations and kidney failure are some of the long-term complications that can develop.
Warning signs for diabulimia include a change in eating habits — typically someone who eats more but still loses weight — low energy and high blood-sugar levels, Goebel-Fabbri said. Frequent urination is another signal. When sugars are high, the kidneys work overtime to filter the excess glucose from the blood.
This purging of sugar from the body through the kidneys is similar to someone with bulimia, who binges and then purges, or vomits, Anderson said.
Studies show that women with Type 1 diabetes are twice as likely to develop an eating disorder. Ironically, good diabetes management, which requires a preoccupation with food, counting carbohydrates and following a diet, may lead some to form an unhealthy association with food, Goebel-Fabbri said.
Jacq Allan, 26, of London, is a diabulimic. When recently interviewed, she said she had not taken her insulin shots for two weeks and rarely takes them regularly. She weighs 42 pounds less than she did a year ago.
Allan is stuck between two fears: taking insulin, which may lead to weight gain, and the damage her destructive compulsion is doing to her body.
"I'm terrified of insulin," Allan said. "Every morning I wake up and think maybe I should go to the hospital."
Diagnosed with Type 1 diabetes nearly three years ago, Allan said she can feel the constant, sky-high sugar in her blood. Her list of ailments — chest pain, heart palpitations, muscle cramps, bacterial infections and lower back pain — are not the usual health problems of a twenty-something.
"I'm constantly worried that my eyes are going to go, but they seem relatively OK for the moment," she said. "I always wonder if this will be the day that some major organ fails. I kind of want something to happen because then maybe I'll stop."
Gwen Malnassy, 21, of Santa Monica, Calif., detailed her struggle with diabulimia for three years in a diary she posted on the Internet.
"If you don't think it will happen to you, don't fool yourself," writes Malnassy, diagnosed with diabetes at 9, in her final entry 11 months ago. "I believed the same."
Doctors diagnosed Malnassy with both anorexia and bulimia at 13, she said.
"I would look at magazines and think that if I looked like the models, I would have more friends and be more popular," Malnassy said in a recent interview.
She began withholding insulin at 17 after learning of the practice during a doctor's visit and continued withholding insulin off and on until last year.
Malnassy continues in her online diary: "I will say it again. Reach out; get help. Do not fall; do not let the disorder consume you. It's a miserable way to exist."
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On the Net:
http://care.diabetesjournals.org/cgi/content/abstract/22/12/1956
Obese pregnant women can safely lose weight
Tue, 19 Jun 2007 16:52:55 GMTBy Amy Norton
NEW YORK - Obese pregnant women can avoid weight gain or even lose some weight without harming their babies, a small study suggests.
In fact, researchers found, obese women who maintained their weight or shed pounds during pregnancy were more likely to have a normal-weight newborn than those who gained pregnancy pounds.
The notion that it's all right for obese women to avoid weight gain during pregnancy is fairly controversial, said Dr. Raul Artal, an obstetrician at St. Louis University and the lead author of the new study.
In the U.S., he told Reuters Health, most obstetricians follow guidelines devised in 1990 that recommend obese women gain about 13 pounds during pregnancy. That's far less than the 25 to 35 pounds recommended for normal-weight women, but still a substantial amount of weight for women who are already heavy.
Those guidelines deserve a second look, Artal argued. For obese women, he said, weight maintenance or even modest weight loss may not only do no harm to mother and child, but might benefit them.
For their study, Artal and his colleagues followed 96 obese pregnant with gestational diabetes -- a form of diabetes that emerges during pregnancy.
Fifty-seven of the women enrolled in a diet program, while the rest began a diet-and-exercise program. Both groups received help devising a healthy, lower-calorie eating plan, while women in the exercise group had supervised, moderate workouts, such as treadmill walking, once a week. Exercisers were also encouraged to walk or perform other low-impact activities on their own every day.
In the end, Artal's team found, women who dieted and exercised gained less weight than women who only changed their eating habits.
Moreover, women who shed pounds or maintained their weight -- regardless of the group they were in -- were less likely to have a larger-than-normal newborn. There was no evidence that weight loss increased the risk of pregnancy complications or harmed fetal growth, the researchers report in the journal Applied Physiology, Nutrition, and Metabolism.
Because it's so difficult for obese women to shed pounds gained during pregnancy, Artal said, preventing the weight gain could bring longer-term health benefits.
&;Pregnancy is not a state of confinement,&; he said, and overweight women should not be afraid of moderate physical activity. &;All we're talking about is a brief walk after each meal,&; Artal noted.
That said, he advised that pregnant women still talk to their doctors before taking up an exercise routine, to make sure they have no conditions that preclude physical activity. Women should also get advice from a nutritionist on how to make healthy diet changes.
SOURCE: Applied Physiology, Nutrition, and Metabolism, June 2007.
