FDA backs drug that treats diabetes via the brain
LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) — People with Type 2 diabetes may soon get a very different treatment approach: A drug that helps control blood sugar via the brain — an idea sparked, surprisingly, by the metabolism of migrating birds.
The Food and Drug Administration approved Cycloset, maker VeroScience Inc. announced Wednesday. It’s a new version of an old drug called bromocriptine, used in higher doses to treat Parkinson’s disease and a few other conditions. But unlike its older parent, Cycloset is formulated to require a low, quick-acting dose taken just in the morning — no other time of day.
That timing provides a bump of activity in a brain chemical that seems to reset a body clock that in turn helps control metabolism in Type 2 diabetes, said VeroScience’s Anthony Cincotta, who led the drug’s development.
Company studies suggest that one morning dose helped lower the usual post-meal blood sugar rise at breakfast, lunch and dinner. Over six months, 35 percent of Cycloset users reached recommended average blood sugar levels, compared with 10 percent of diabetics given a dummy drug, Cincotta said.
Cycloset is the first drug to win FDA approval under new guidelines that require better evidence that diabetes treatments are heart-safe. Diabetics are at increased risk of heart disease. In a yearlong safety study involving 3,000 diabetics, those given Cycloset had 42 percent fewer heart attacks and other cardiovascular complications than those given a dummy drug.
Where do the birds come in? Years ago, Louisiana State University researchers were studying how migrating birds arrived at their destinations without being emaciated. They develop seasonal insulin resistance, the very condition that in people leads to Type 2 diabetes.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway.
The researchers discovered a biological clock — in the brain’s hypothalamus — that controlled when the metabolism change kicked in for the birds, and also in hibernating mammals. Different concentrations of certain brain chemicals, including dopamine, at different times of day dictated whether the bird metabolized like a fall bird or a summer bird, said Cincotta.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway in sensitivity to insulin, although Cycloset apparently did not affect weight.
Bromocriptine mimics dopamine: “We’re regulating the regulator,” Cincotta said.
Side effects include nausea and dizziness, sometimes because of blood pressure dips upon standing. Nursing women shouldn’t use it. Bromocriptine inhibits lactation, and although no link is proven, there have been reports of strokes in postpartum women using higher doses. The FDA said it also should be used cautiously with people taking blood pressuring-lowering medication.
It’s uncertain how soon sales can begin, or the drug’s cost: VeroScience, of Tiverton, R.I., is in negotiations with larger drug companies to find a distributor.
Copyright 2009 The Associated Press.
FDA panel supports Avastin for brain cancer
WASHINGTON (AP) — Preliminary studies of a blockbuster drug from Roche’s Genentech unit are strong enough to speed up its approval for brain cancer, federal cancer experts said Tuesday.
The company has asked the Food and Drug Administration to approve its blockbuster drug Avastin to treat patients with the deadliest form of brain tumor. The drug is already approved for patients with certain types of lung, breast and colon cancer.
The FDA’s panel of 10 outside experts unanimously voted that preliminary results in brain cancer patients warrant accelerated approval, according to an agency spokeswoman. The accelerated approval designation gives early market access to drugs that show promising early results. Companies must submit follow-up studies to stay on the market.
The FDA is not required to follow the advice of its panel, though it often does.
South San Francisco-based Genentech is now owned by drugmaker Roche, based in Basel, Switzerland.
Heading into the meeting, FDA’s drug reviewers said it was difficult to draw a clear connection between Avastin and tumor shrinkage seen in patient medical scans. Reviewers noted the difficulty of measuring tumor size via medical imaging.
But panelists were won over by two studies from Genentech showing between 20 and 25 percent of cancer patients responded to the treatment. The company also noted that “virtually no improvements have been made since the 1970s” in treatment for the cancer, known medically as recurring glioblastoma multiforme.
Avastin was Genentech’s top-selling product last year with revenue of $2.69 billion. However, sales growth has been slowing.
In the last quarter, U.S. sales of Avastin were $731 million, falling short of Wall Street forecasts for $740 million. Analysts said the drug is likely reaching a saturation point in the market and will need additional FDA approvals to continue growing.
Initially approved in 2004, Avastin was the first drug to fight cancer by choking off blood flow to tumors. Such “targeted therapies” were considered a significant advance beyond chemotherapy.
Copyright 2009 The Associated Press.
Richardson death revives debate on ski helmets
By MEGAN K. SCOTT
Associated Press Writer
NEW YORK (AP) — News that actress Natasha Richardson died of head injuries after falling on a ski slope has renewed debate over whether helmets should be mandatory for snowboarders and downhill skiers.
The 45-year-old actress was not wearing a helmet when she fell Monday at Mont Tremblant ski resort in Quebec. She died Wednesday in a New York hospital.
It’s unclear whether a helmet could have saved Richardson. But research shows wearing a helmet decreases the likelihood of having a head injury by 40 to 60 percent, said Dr. Robert Williams, associate professor of anesthesia and pediatrics at Fletcher Allen Health Care in Burlington, Vermont.
“There’s no downside at all to wearing a helmet,” he said.
In the United States, the National Ski Areas Association is not aware of any states that mandate helmets. But the association and its member resorts promote their use, and a growing number of skiers and snowboarders choose to wear them.
According to the group, nearly half of U.S. skiers and snowboarders wore helmets in the past two years, up from about 25 percent five years earlier. Sales of helmets have grown at a rate of about 9 percent each year since 2005-2006, according to SnowSports Industries America.
Quebec officials said Thursday that they are considering making helmets mandatory on ski slopes following Richardson’s accident. Emergency room doctors had been lobbying for the requirement, and Richardson’s death added impetus to the plans, said Jean-Pascal Bernier, a spokesman for the sports minister.
“By no means will a helmet save you 100 percent but it’s definitely a step in the right direction to try to prevent brain damage or something like that,” said Valerie Powell of the Canada Safety Council.
But the National Ski Areas Association, based in Lakewood, Colorado, stops short of calling for legislation.
The increase in helmet usage has not reduced the overall number of ski fatalities; more than half of the people involved in fatal accidents last season were wearing helmets at the time of the incident, according to information gathered by the group.
And ski and snowboarding-related deaths are relatively rare. During the 2004-2005 season, 45 fatalities occurred out of the 56.9 million skier/snowboarder days reported for the season, according to NSAA.
Helmets may be effective at preventing minor injuries, but they have not been shown to reduce fatalities, said Jasper Shealy, a professor emeritus at the Rochester Institute of Technology who has been studying skiing and snowboarding since 1970.
He encourages people to wear helmets, although he suspects they may give people a false sense of security to engage in risky stunts. Helmets work better at slow speeds, he said, when they can protect against injuries caused by collisions with solid objects.
Ski operators are among the most vocal opponents to mandated helmet use.
Alexis Boyer of the Quebec Ski Areas Association said 90 percent of youngsters under 12 already use helmets, but making that law would put operators in the position of having to police their guests, many of whom come from outside the province and country and may not be aware of the requirements.
Still, people tend to change their behavior as a result of high-profile deaths.
Andrea Fereshteh, 29, a writer at Duke University, said she started wearing a helmet after the ski-related deaths of Sonny Bono and Michael Kennedy. Both crashed into trees.
“It just became much more publicized about the need for helmets,” she said.
Richardson’s death is likely to hit home for skiers because she was on a beginner slope when she fell. Resort officials say she seemed fine immediately afterward and even refused to see a doctor but that she began complaining of a headache about an hour later and was rushed to hospital.
Scott Kerschbaumer, a former ski instructor who has never worn a helmet, considered Bono’s and Kennedy’s skiing deaths to be the result of high-speed, somewhat reckless behavior.
Richardson shows “that the most serious of injuries and even death can result from the most innocuous of falls while skiing.”
Kerschbaumer said he hadn’t wanted to wear a helmet because of vanity and comfort, but will now purchase one for himself and his 6-year-old son.
As a beginner skier, Latoicha Phillips Givens, 35, an attorney in Atlanta, thought she was safe skiing without one. She said she certainly is going to wear one now.
But Bill Douglass, 37, a social media strategist in New York City, said he doesn’t want to see people overreact.
“I think wearing a helmet when skiing is going too far,” he said. “Better to encourage people to focus on smarter safety measures like taking classes, learning how to stop properly, that kind of thing.”
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Associated Press Writer Rob Gillies in Toronto contributed to this report.
Copyright 2009 The Associated Press.
Lead raises questions about children’s books
By LEE LOGAN
Associated Press Writer
JEFFERSON CITY, Mo. (AP) — Could a vintage, dog-eared copy of “The Cat in the Hat” or “Where the Wild Things Are” be hazardous to your children?
Probably not, according to the nation’s premier medical sleuths, the Centers for Disease Control and Prevention.
But a new federal law banning more than minute levels of lead in most products intended for children 12 or younger — and a federal agency’s interpretation of the law — prompted at least two libraries last month to pull children’s books printed before 1986 from their shelves.
Lead poisoning has been linked to irreversible learning disabilities and behavioral problems, and lead was present in printer’s ink until a growing body of regulations banned it in 1986. The federal law, which took effect Feb. 10, was passed last summer after a string of recalls of toys.
The Consumer Product Safety Commission has interpreted the law to include books but has neither concluded that older books could be hazardous to children nor made any recommendations to libraries about quarantining such tomes, agency chief of staff Joe Martyak said Tuesday.
Still, the agency’s interpretation itself has been labeled alarmist by some librarians.
“We’re talking about tens of millions of copies of children’s books that are perfectly safe. I wish a reasonable, rational person would just say, ‘This is stupid. What are we doing?'” said Emily Sheketoff, executive director of the American Library Association’s Washington office.
A CPSC spokesman told The Associated Press in a recent interview that until more testing is done, the nation’s more than 116,000 public and school libraries should take steps to ensure that children are kept away from books printed before 1986.
After the spokesman’s comments appeared Tuesday in an AP story, Martyak said the spokesman “misspoke” about the agency’s stance on older books and younger children.
“We’re not urging libraries to take them off the shelves,” Martyak said. “It’s true the CPSC is investigating whether the ink contains unsafe levels of lead in children’s books printed before 1986.”
Jay Dempsey, a health communications specialist at the CDC, said lead-based ink in children’s books poses little danger.
“If that child were to actually start mouthing the book — as some children put everything in their mouths — that’s where the concern would be,” Dempsey said. “But on a scale of one to 10, this is like a 0.5 level of concern.”
The publishing and printing industries set up a Web site for book publishers last December to post the results of studies measuring the lead in books and their components, such as ink and paper. Those results show lead levels that were often undetectable and consistently below not only the new federal threshold, but the more stringent limit that goes into effect in August 2011.
Those findings were cited in a letter from the Association of American Publishers to the CPSC.
The American Library Association said it has no estimate of how many children’s books printed before 1986 are in circulation. But typically, libraries don’t have many, because youngsters are hard on books, librarians said.
“Frankly, most of our books have been well-used and well-appreciated,” said Rhoda Goldberg, director of the Harris County Public Library system in Houston. “They don’t last 24 years.”
Also, the lead is contained only in the type, not in the illustrations, according to Allan Adler, vice president for legal and governmental affairs for the Association of American Publishers.
Sheketoff said she heard of just two libraries that started to restrict access to children’s books last month amid publicity about the new law. One roped off the children’s section; the other covered children’s books with a tarp. Both libraries, which she declined to identify, stopped after being contacted by the association, she said.
“Communities would have a stroke if public libraries started throwing out hundreds and hundreds of books just because they came out before a certain copyright date,” said Margaret Todd, librarian for the Los Angeles County system, which has 89 branches and about 3 million children’s books. Todd said she expects the commission to develop reasonable standards that protect children.
Nathan Brown, a lawyer for the library association, said libraries should not even be subject to the law. He argued that Congress never wanted to regulate books and that libraries do not sell books and thus are not subject to the consumer products law.
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Associated Press Writer David A. Lieb contributed to this report.
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On the Net:
Safety Commission: http://www.cpsc.gov/index.html
Publishers Association study: http://www.rrd.com/cpsia
Copyright 2009 The Associated Press.
After football player death, Ky. seeks safety plan
By BRUCE SCHREINER
Associated Press Writer
FRANKFORT, Ky. (AP) — Kentucky House lawmakers unanimously passed a bill Friday to require the state’s high school coaches to complete first aid and sports safety training on athlete heat stroke and cold emergencies, a measure inspired by the death of a teenage football player at a sweltering summer practice.
National experts gave mixed reviews to Kentucky’s sports safety measure, which if signed into law by Gov. Steve Beshear would require every high school coaching staff to have at least one member with safety training roaming practice fields and game sidelines by the start of the next school year.
The measure, spurred on by the death of high school lineman Max Gilpin, cleared the House 93-0 Friday and the Senate 38-0 a day earlier.
“The intent is to give the coaches the tools they need to keep our students safe,” Democratic Rep. Joni Jenkins said after sponsoring the bill.
She said it was designed to give coaches greater know-how in averting any emergency and better skills to deal with one before trained medical help can be found.
“They’ll be able to recognize dangerous situations before they become tragic. And they’ll know to act immediately,” she said.
Beshear spokesman Jay Blanton said the governor will review the measure before deciding whether to sign it.
Gilpin, a sophomore at Pleasure Ridge Park High School in Louisville, died after collapsing in practice last August and arriving at a hospital with a 107-degree temperature, authorities said.
The 15-year-old’s coach, David Jason Stinson, has pleaded not guilty to reckless homicide in an unusual case of a coach being charged criminally with a player’s death.
Gilpin’s death certificate showed he died of septic shock, multiple organ failure and complications from heat stroke, three days after working out for two to three hours in temperatures that reportedly felt like 94 degrees. No autopsy was conducted.
The case alarmed Kentucky residents and sent shock waves through high school athletic programs nationwide after a rash of player deaths reported in high school programs around the country last year.
From 1995 through 2008, there were 39 heat stroke cases in all levels of football that resulted in death, according to a report compiled by Frederick Mueller at the University of North Carolina for the American Football Coaches Association in February 2009.
Mueller, a professor specializing in sport administration, said Friday that Kentucky’s proposal was a “good idea,” and said more states are now taking a closer look at athlete safety.
But Douglas J. Casa, director of athletic training education at the University of Connecticut, said that the concept is good but the bill doesn’t go far enough. “No course is going to properly prepare them (coaches) to deal with the emergencies they’re going to have to deal with on the field,” he said.
Casa said schools offering sports programs should be required to hire athletic trainers — something some say will be difficult because it requires more money.
Kentucky schools are not required to have certified athletic trainers, though the Kentucky High School Athletic Association strongly encourages them to hire trainers. The association issued a statement lauding the bill for putting an increased spotlight on safety and ensuring any risks to players are minimized.
Copyright 2009 The Associated Press.
The science of romance: Brains have a love circuit
By SETH BORENSTEIN
AP Science Writer
WASHINGTON (AP) — Like any young woman in love, Bianca Acevedo has exchanged valentine hearts with her fiance.
But the New York neuroscientist knows better. The source of love is in the head, not the heart.
She’s one of the researchers in a relatively new field focused on explaining the biology of romantic love. And the unpoetic explanation is that love mostly can be understood through brain images, hormones and genetics.
That seems to be the case for the newly in love, the long in love and the brokenhearted.
“It has a biological basis. We know some of the key players,” said Larry Young of the Yerkes National Primate Research Center at Emory University in Atlanta. There, he studies the brains of an unusual monogamous rodent to get a better clue about what goes on in the minds of people in love.
In humans, there are four tiny areas of the brain that some researchers say form a circuit of love. Acevedo, who works at the Albert Einstein College of Medicine in New York, is part of a team that has isolated those regions with the unromantic names of ventral tegmental area (VTA), the nucleus accumbens, the ventral pallidum and raphe nucleus.
The hot spot is the teardrop-shaped VTA. When people newly in love were put in a functional magnetic resonance imaging machine and shown pictures of their beloved, the VTA lit up. Same for people still madly in love after 20 years.
The VTA is part of a key reward system in the brain.
“These are cells that make dopamine and send it to different brain regions,” said Helen Fisher, a researcher and professor at Rutgers University. “This part of the system becomes activated because you’re trying to win life’s greatest prize — a mating partner.”
One of the research findings isn’t so complimentary: Love works chemically in the brain like a drug addiction.
“Romantic love is an addiction; a wonderful addiction when it is going well, a horrible one when it is going poorly,” Fisher said. “People kill for love. They die for love.”
The connection to addiction “sounds terrible,” Acevedo acknowledged. “Love is supposed to be something wonderful and grand, but it has its reasons. The reason I think is to keep us together.”
But sometimes love doesn’t keep us together. So the scientists studied the brains of the recently heartbroken and found additional activity in the nucleus accumbens, which is even more strongly associated with addiction.
“The brokenhearted show more evidence of what I’ll call craving,” said Lucy Brown, a neuroscientist also at Einstein medical college. “Similar to craving the drug cocaine.”
The team’s most recent brain scans were aimed at people married about 20 years who say they are still holding hands, lovey-dovey as newlyweds, a group that is a minority of married people. In these men and women, two more areas of the brain lit up, along with the VTA: the ventral pallidum and raphe nucleus.
The ventral pallidum is associated with attachment and hormones that decrease stress; the raphe nucleus pumps out serotonin, which “gives you a sense of calm,” Fisher said.
Those areas produce “a feeling of nothing wrong. It’s a lower-level happiness and it’s certainly rewarding,” Brown said.
The scientists say they study the brain in love just to understand how it works, as well as for more potentially practical uses.
The research could eventually lead to pills based on the brain hormones which, with therapy, might help troubled relationships, although there are ethical issues, Young said. His bonding research is primarily part of a larger effort aimed at understanding and possibly treating social-interaction conditions such as autism. And Fisher is studying brain chemistry that could explain why certain people are attracted to each other. She’s using it as part of a popular Internet matchmaking service for which she is the scientific adviser.
While the recent brain research is promising, University of Hawaii psychology professor Elaine Hatfield cautions that too much can be made of these studies alone. She said they need to be meshed with other work from traditional psychologists.
Brain researchers are limited because there is only so much they can do to humans without hurting them. That’s where the prairie vole — a chubby, short-tailed mouselike creature — comes in handy. Only 5 percent of mammals more or less bond for life, but prairie voles do, Young said.
Scientists studied voles to figure out what makes bonding possible. In females, the key bonding hormone is oxytocin, also produced in both voles and humans during childbirth, Young said. When scientists blocked oxytocin receptors, the female prairie voles didn’t bond.
In males, it’s vasopressin. Young put vasopressin receptors into the brains of meadow voles — a promiscuous cousin of the prairie voles — and “those guys who should never, ever bond with a female, bonded with a female.”
Researchers also uncovered a genetic variation in a few male prairie voles that are not monogamous — and found it in some human males, too.
Those men with the variation ranked lower on an emotional bonding scale, reported more marital problems, and their wives had more concerns about their level of attachment, said Hasse Walum, a biology researcher in Sweden. It was a small but noticeable difference, Walum said.
Scientists figure they now know better how to keep those love circuits lit and the chemicals flowing.
Young said that romantic love theoretically can be simulated with chemicals, but “if you really want, you know, to get the relationship spark back, then engage in the behavior that stimulates the release of these molecules and allow them to stimulate the emotions,” he said. That would be hugging, kissing, intimate contact.
“My wife tells me that flowers work as well. I don’t know for sure,” Young said. “As a scientist it’s hard to see how it stimulates the circuits, but I do know they seem to have an effect. And the absence of them seems to have an effect as well.”
Copyright 2009 The Associated Press.
Italian woman moved to hospital where she can die
ROME (AP) — A woman at the center of Italy’s right-to-die debate was transferred Tuesday to a hospital where she is to be allowed to die after 17 years in a vegetative state.
Eluana Englaro was moved to the northeastern city of Udine overnight, said family lawyer Vittorio Angiolini.
A small crowd of anti-euthanasia activists gathered outside the clinic in Lecco, where she had been cared for, seeking to prevent the ambulance from leaving, TV footage showed. Some were shouting “Eluana, Wake Up!”
Englaro has been in a vegetative state since a car accident in 1992, when she was 20. Her father has led a protracted court battle to disconnect her feeding tube, insisting it was her wish.
An Italian court in the summer granted his request, setting off a political storm in the Roman Catholic country.
Her father then sought to have her removed from the Catholic clinic in Lecco to Udine, in the region where the family is from. But the government issued a decree last month telling state hospitals that they must guarantee care for people in vegetative states, leading at least one hospital in Udine to refuse to take Englaro.
She was moved overnight to La Quiete, a private clinic.
Welfare Minister Maurizio Sacconi said the government is looking into the situation.
Italy does not allow euthanasia. Patients have a right to refuse treatment but there is no law that allows them to give advance directions on what treatment they wish to receive if they become unconscious.
The case has provoked the strong reaction of the Vatican, which is opposed to euthanasia. Pope Benedict XVI said this weekend that euthanasia is a “false solution” to suffering.
Cardinal Javier Lozano Barragan, the pope’s health minister, told La Repubblica that removing Englaro’s feeding tube “is tantamount to an abominable assassination and the church will always say that out loud.”
Copyright 2009 The Associated Press.
Air Force to train combat docs to use acupuncture
By KAMALA LANE
Associated Press Writer
WASHINGTON (AP) — Chief Warrant Officer James Brad Smith broke five ribs, punctured a lung and shattered bones in his hand and thigh after falling more than 20 feet from a Black Hawk helicopter in Baghdad last month.
While he was recovering at Walter Reed Army Medical Center in Washington, his doctor suggested he add acupuncture to his treatment to help with the pain.
On a recent morning, Col. Richard Niemtzow, an Air Force physician, carefully pushed a short needle into part of Smith’s outer ear. The soldier flinched, saying it felt like he “got clipped by something.” By the time three more of the tiny, gold alloy needles were arranged around the ear, though, the pain from his injuries began to ease.
“My ribs feel numb now and I feel it a little less in my hand,” Smith said, raising his injured arm. “The pain isn’t as sharp. It’s maybe 50 percent better.”
Acupuncture involves placing very thin needles at specific points on the body to try to control pain and reduce stress. There are only theories about how, why and even whether it might work.
Regardless, the ancient Chinese practice has been gradually catching on as a pain treatment for troops who come home wounded.
Now the Air Force, which runs the military’s only acupuncture clinic, is training doctors to take acupuncture to the war zones of Iraq and Afghanistan. A pilot program starting in March will prepare 44 Air Force, Navy and Army doctors to use acupuncture as part of emergency care in combat and in frontline hospitals, not just on bases back home.
They will learn “battlefield acupuncture,” a method Niemtzow developed in 2001 that’s derived from traditional ear acupuncture but uses the short needles to better fit under combat helmets so soldiers can continue their missions with the needles inserted to relieve pain. The needles are applied to five points on the outer ear. Niemtzow says most of his patients say their pain decreases within minutes.
The Navy has begun a similar pilot program to train its doctors at Camp Pendleton in California.
Niemtzow is chief of the acupuncture clinic at Andrews Air Force Base. He’s leading the new program after training many of about 50 active duty military physicians who practice acupuncture.
The U.S. military encountered acupuncture during the Vietnam War, when an Army surgeon wrote in a 1967 edition of Military Medicine magazine about local physicians who were allowed to practice at a U.S. Army surgical hospital and administered acupuncture to Vietnamese patients.
Niemtzow started offering acupuncture in 1995 at McGuire Air Force Base in New Jersey. Several years later, he became the first full-time military medical acupuncturist for the Navy, which also provides health care for the Marines.
Later, he established the acupuncture clinic at the Malcolm Grow Medical Center at Andrews, and he continued to expand acupuncture by treating patients at Walter Reed and other Air Force bases in the country and in Germany. Niemtzow and his colleague Col. Stephen Burns administer about a dozen forms of acupuncture — including one type that uses lasers — to soldiers and their families every week.
Col. Arnyce Pock, medical director for the Air Force Medical Corps, said acupuncture comes without the side effects that are common after taking traditional painkillers. Acupuncture also quickly treats pain.
“It allows troops to reduce the number of narcotics they take for pain, and have a better assessment of any underlying brain injury they may have,” Pock said. “When they’re on narcotics, you can’t do that because they’re feeling the effects of the drugs.”
Niemtzow cautions that while acupuncture can be effective, it’s not a cure-all.
“In some instances it doesn’t work,” he said. “But it can be another tool in one’s toolbox to be used in addition to painkillers to reduce the level of pain even further.”
Smith says the throbbing pain in his leg didn’t change with acupuncture treatment but that the pain levels in his arm and ribs were the lowest they’ve been since he was injured. He also said that he didn’t feel groggy afterward, a side-effect he usually experiences from the low-level morphine he takes.
Ultimately, Niemtzow would like troops to learn acupuncture so they can treat each other while out on missions. For now, the Air Force program is limited to training physicians.
He says it’s “remarkable” for the military, a “conservative institution,” to incorporate acupuncture.
“The history of military medicine is rich in development,” he said, “and a lot of people say that if the military is using it, then it must be good for the civilian world.”
Copyright 2009 The Associated Press.
Merck: New pill may work for MS
LONDON (AP) — German drugmaker Merck Serono is one step closer to releasing the first pill to treat multiple sclerosis, the company said Friday.
In a press statement, Merck said that patients taking cladribine tablets had a nearly 60 percent lower relapse rate than those on placebo pills. The two-year study included 1,326 MS patients who were randomly divided into three groups. Two groups received different doses of cladribine and one group received fake pills.
Patients on cladribine had up to a 60 percent reduced chance of having a relapse compared to patients on placebo. The study was paid for by Merck.
“This is promising news,” said Dr. Lee Dunster, head of research for the Multiple Sclerosis Society in the United Kingdom. Dunster was not linked to the Merck study. He said cladribine appeared to be twice as effective as current primary treatments for MS.
Multiple sclerosis is the most common neurological condition affecting young adults. It is the result of damage to myelin, the protective coating on nerve fibers of the central nervous system. When myelin is damaged, that interrupts the brain’s messaging system to other parts of the body.
Patients with MS often suffer from fatigue, muscle spams, problems with vision, speech, coordination, and the bladder. Relapses are often unpredictable and there is no known cure.
Current treatments for MS must be given by injections and have varying success rates.
Cladribine is already used to treat leukemia, but only for short periods of time. Doctors said more information was needed about the potential side effects from taking the drug in the long term, since multiple sclerosis is a lifelong condition.
Known side effects from cladribine include fatigue, an increased chance of infections, and anemia.
Merck has already asked American and European drug regulators to fast-track the drug to the market. In their press statement, Merck said they will submit cladribine for registration in the U.S. and Europe later this year.
Swiss pharmaceutical giant Novartis AG is also working on a pill to treat MS.
Though Merck’s study showed that cladribine reduced the relapse rate, Dunster said the real question was whether the drug slowed the disease’s progression. He expected that data to be released in the next few months.
“Relapses are not very nice things to have, but we are really looking to slow down the disease,” Dunster said. “For patients, it’s all about whether or not they will be able to kick around the ball with their kids in a few years.”
Copyright 2009 The Associated Press.