New bipolar disorder treatments tested
Sun, 02 Sep 2007 18:15:46 GMTBy MALCOLM RITTER, AP Science Writer
NEW YORK - Scientists are testing seasickness patches and other surprising options in a challenging search for new ways to treat the crushing depression and uncontrolled mania of bipolar disorder.
Also called manic-depression, it's an illness that can rip careers and marriages apart and drive people to suicide. And it's so complex and mysterious that researchers haven't developed a medication specifically for it since lithium, more than half a century ago.
Yet bipolar appears in various forms and severity in about 1 in every 25 American adults at some point in their lives, according to a major study published in May.
Current medicines help, but often fall short.
They "certainly reduce symptoms but don't do a good enough job," said Dr. Husseini Manji of the National Institute of Mental Health. "Many patients are helped, but they're not well."
Nobody knows yet whether the latest crop of possible treatments will pan out. Besides the motion sickness patch, unusual choices include a drug that treats Lou Gehrig's disease and a device that produces an electric field around the brain. Even the breast cancer drug tamoxifen has been tested.
Some of these approaches were identified by logic, and others by pure chance. Scientists already have early evidence that someday they may prove useful against bipolar.
The disorder's classic feature is episodes of mania, which are periods of boosted energy and restlessness that can run for a week or more.
"You have so much energy, you have so many great ideas" said Tamara, 26, a Pittsburgh resident who was diagnosed several years ago. She asked that her last name not be used.
"You feel like you're thinking so clear, you've got the answer for everybody. You need to tell them, you need to phone all your friends... It's so hard to sleep. You keep thinking of all sorts of things."
But mania can also bring extreme irritability. Tamara's energetic charisma made her the life of the party, but "if somebody spilled a drink on me, I would just explode," she recalled. "It's like all your emotions are just completely intensified."
She got into fights and experienced road rage. She made bad decisions, plagiarizing a college paper and behaving promiscuously.
"A lot of things sound like a good idea when you're manic," she said, "and they're really not."
During manic episodes many people even get hallucinations or delusions, and Tamara experienced those too. "I was convinced I could hear other people's thoughts, or at least know what they were," she recalled. "I thought everybody was saying bad things about me."
The other side of the bipolar coin is episodes of depression that last a week or more. For Tamara, depression was life turning gray.
"Nothing is interesting. You're bored with everything... Nothing sounds fun anymore. All you want to do is sleep. I slept days and days away."
In her senior year of college, thoughts of suicide frightened her into seeking help.
Doctors currently treat bipolar with a variety of drugs including lithium, anticonvulsant medications that can stabilize mood, and antipsychotics. Psychological therapy and patient education greatly boost the effectiveness of the drugs.
Tamara takes lithium and another drug, and says, "I'm doing fine right now."
She's lucky. Bipolar disorder is hard to treat chiefly because the depressive episodes are more severe and more resistant to therapy than ordinary "unipolar" depression, notes Dr. Andrea Fagiolini, an associate professor of psychiatry at the University of Pittsburgh.
What's more, many patients can't tolerate current bipolar medications because of side effects like weight gain, sleepiness, tremor, and the sense of feeling "drugged," Fagiolini said. .
A study of treated patients published last year found that about 60 percent got well for at least eight weeks, but only half of that group remained well when followed for up to two years. And this was with very good therapy, noted Dr. Andrew Nierenberg, professor of psychiatry at Harvard Medical School.
"That means there's a lot of room for improvement," Nierenberg said. "That's why we need new treatments."
But there's a basic problem. Just as heart attacks come from chronic heart disease, the manic and depressive episodes come from an underlying chronic brain disease. And "we just don't really understand what's behind the illness," said Dr. Gary Sachs, who directs bipolar research at Harvard's Massachusetts General Hospital.
That mystery and the complexity of the disorder have discouraged scientists from trying to develop drugs for bipolar, Manji said. Not since lithium, developed more than 50 years ago, have they developed a drug specifically for bipolar, Manji said.
Like lithium, some of the latest crop of early candidate drugs revealed their potential simply by chance.
Take the experience of NIMH researchers Maura Furey and Dr. Wayne Drevets with the drug scopolamine, which is normally used to keep people from getting seasick or carsick. Several years ago, they were studying whether scopolamine could improve memory and attention in depressed people. So they gave the drug intravenously to depressed patients, trying to find the right dose for a brain-imaging study.
But then they noticed an odd thing. These patients started feeling less depressed the night after the injections, a remarkable thing since most antidepressants take weeks to kick in.
"Some patients would say it was the best night of sleep they'd had in many years, and the next morning they woke up feeling a substantial lifting of their depression," Drevets said. "In many cases that improvement persisted for weeks or even months."
Drevets and Furey quickly changed their research focus to test the drug's effect on depression itself. And in October 2006 they published an encouraging, though preliminary, result with a small group of depressed patients, some of whom had bipolar.
Now Furey is leading a study using scopolamine skin patches — like those travelers wear to prevent motion sickness — to treat depression in bipolar disorder as well as ordinary depression. For now, people shouldn't try patch treatment for depression on their own, she said.
A similar bit of serendipity showed up at McLean Hospital in Belmont, Mass., in 2001. Depressed bipolar patients who were getting their brains scanned for a study of brain chemistry suddenly felt a lot better. Alerted by a research assistant, scientists started taking a closer look. And in 2004, they published their conclusion that the electric fields produced by the brain scans might lift depression. It's still not clear how.
Follow-up studies have had inconsistent results. But researchers have now built a device that resembles a hair-salon dryer to produce electric fields. They plan to start testing it this fall.
Apart from luck, researchers have taken advantage of the few insights they have into bipolar disease to develop potential treatments.
That's the story with riluzole, now used to treat the paralyzing disorder Lou Gehrig's disease, also known as ALS or amyotrophic lateral sclerosis. Scientists found that a drug that's effective against depression in bipolar disorder boosts the abundance of a certain protein in rat brain cells, and that riluzole does too. So the researchers tried riluzole in a small number of depressed bipolar patients, and in some patients the symptoms virtually disappeared, Manji said.
So riluzole, which is distributed by Sanofi-Aventis, might become a treatment for bipolar disorder, he said.
Similar research used an off-the-shelf drug to get a lead for developing a new medication. Studies in rats showed that lithium and another anti-mania drug hamper the effect of a particular enzyme in the brain. That suggested that other drugs that hamper that enzyme might work against mania too, Manji said.
The best available candidate: tamoxifen, used to fight breast cancer. And sure enough, Manji's recent study in a small group of bipolar patients found that tamoxifen quickly quelled mania. Other studies have found similar results, he said.
That shows the value of blocking the enzyme, and now Manji is trying to develop other drugs that will do that, perhaps for use in emergency rooms. He wants to avoid tamoxifen itself because of concern about long-term side effects, since his work requires a higher dose than women use to stave off breast cancer for years.
Scientists say the real key to unlocking the mysteries of bipolar disorder — and thereby exposing targets for drugs — lies in a new generation of research into DNA.
In recent months, scientific journals have begun to publish the early results of a revolution in DNA analysis: the ability to scan entire genomes in detail to find genetic variants that predispose people to particular diseases. Some of the new work is implicating dozens of variants in bipolar disorder.
Such work can expose the hidden biological underpinnings of disease, and so tip off researchers to unsuspected targets for intervening.
"We've been stumbling in the dark for most of our history" of bipolar research, said gene expert Dr. Francis McMahon of NIMH. But "these kinds of studies ... will really give us the chance to reason from biological insights back to the patient."
Sachs, of Harvard, agreed: "I think these whole-genome scans will in fact be the important bridge to better treatments."
And not just in some far-distant future. The new gene studies, Sachs said, help give "a great potential to advance the field in our lifetimes and treat people who are living now."
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On the Net:
Bipolar information: http://www.nimh.nih.gov/healthinformation/bipolarmenu.cfm
National Alliance on Mental Illness: http://www.nami.org
Depression and Bipolar Support Alliance: http://www.ndmda.org
Disease treatment studies: http://www.clinicaltrials.gov
Picture boards speak in health crisis
Sun, 02 Sep 2007 19:27:02 GMTBy LINDA A. JOHNSON, Associated Press Writer
TRENTON, N.J. - With more ill and injured people needing emergency care but do not speak English, hospitals, clinics and rescue squads are turning to picture boards to bridge the communication gap with easily understood images.
The large, double-sided panels let patients point to icons showing their problem — such as pain, a burn, breathing trouble or a fall — as well as the part of the body that is affected. They also can point to their native language in a list so an appropriate interpreter can be located.
"They ought to be in every ambulance, in every hospital, in every clinic," said Dr. Fred M. Jacobs, head of New Jersey's health department. "Communication barriers lead to adverse impacts on quality, misunderstandings and even medical errors."
His department is partnering with the state's hospital association to distribute thousands of the boards to all New Jersey hospitals, rescue squads and public health clinics.
Use of the panels is likely to spread under a new U.S. Department of Health and Human Services program aimed at helping hospitals to determine their patients' communication needs and to find tools to meet those needs. At least nine state hospital associations have signed on: New Jersey, New York, Pennsylvania, Kentucky, Missouri, Oklahoma, Rhode Island, Utah and Washington.
At University Hospital in Newark, up to 15 percent of patients speak Spanish, Portuguese or another language besides English, said triage nurse Robert Cagadoc. Since getting the picture boards last month, he's used them a couple times every shift to help patients arriving in the emergency department.
They help "big time," he said Friday.
According to the American Hospital Association, up to 23 million U.S. residents have limited English proficiency, and a recent survey found 48 percent of hospitals encounter patients with limited English skills daily.
Hospitals are required by federal law to provide interpreters as needed for patients, so they generally subscribe to commercial services provided by telephone or, as New Jersey hospitals are now doing, train bilingual staff members.
The boards also are helpful for patients who are deaf, hard of hearing or mute, or who cannot speak because they have had a stroke or have a breathing tube down their throat.
The boards originated in Florida after Hurricane Andrew in 1992. They sold by Servision Inc., mainly through licensed distributors. Servision founder Michael Weston said he came up with the idea after serving as director of the greater Miami Red Cross and seeing how many people didn't get needed help after Andrew because of communication difficulties. Originally just laminated cardboard, today they are made of a nearly indestructible synthetic.
They gradually caught on through word of mouth among health groups in various states.
"You'll probably find boards in virtually every state in the country at this point," Weston said.
New York City started using the icon panels shortly before the Sept. 11, 2001, attacks and some were used by emergency responders that day, said Elizabeth A. Davis, who had ordered customized versions in her job as a special-needs adviser in the city's Office of Emergency Management. She now distributes Weston's boards through her consulting company, EAD & Associates.
"They're not a silver bullet that solves every single communication problem," but they get the process started, Davis said.
The Metropolitan Chicago Health-care Council has distributed at leased 5,000 copies of the boards to nursing homes and every hospital in the state, used them successfully in disaster drills and is ordering 2,000 more, said spokesman Patrick Finnegan.
"When I found this thing, I was like a kid in a candy store because this is exactly what you need," he said.
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On the Net:
Picture board supplier: http://www.eadassociates.com/products.html
New study Drugcoated stents not so bad
Sun, 02 Sep 2007 16:21:57 GMTBy MARIA CHENG, AP Medical Writer
VIENNA, Austria - Drug-coated heart stents may not increase the risk of blood clots as much as previously thought, according to research presented Sunday at a meeting of cardiologists.
Nearly 6 million people worldwide have the devices, which are implanted into the heart during an angioplasty to prevent new clogs from forming in arteries.
Last year, research suggested that the devices were responsible for an increased number of fatal blood clots. But on Sunday, Dr. Stefan James of the Uppsala Clinical Research Centre in Sweden presented follow-up results from last year's study to the European Society of Cardiology conference, which runs until Wednesday in Vienna.
With more patients and an extra year of data, the numbers tell a different story.
After four years of tracking patients with the drug-coated stents, James said the results showed no significant difference between patients who received the drug stents and those who received bare metal ones: Patients with drug stents had only a 1 percent increased chance of dying.
In December, James told a Food and Drug Administration safety hearing that research from the first three years of the study indicated that patients with drug-emitting stents had an 18 percent increased chance of dying compared to patients with bare metal stents.
Those results were later published in the New England Journal of Medicine, and sales for the device have plummeted worldwide, with the U.S. market expected to shrink by about $1 billion.
The FDA never restricted the stents' use but suggested doctors only recommend them in certain cases. Johnson & Johnson, a major stent-maker, recently cut 5,000 jobs in response to declining sales.
In August, Britain's health advisory watchdog proposed striking the drug stents from the list of medical devices it would pay for. Drug-coated stents typically cost about $2,300 compared to the approximately $700 for bare metal stents.
Experts are not entirely sure what might explain the research reversal, but more selective stent use might help explain the change, they said.
In the last year, use of drug stents has dropped dramatically. James said that in Sweden only about 15 percent of eligible patients now receive them, compared to nearly 60 percent in previous years. And in the U.S., use has dropped from more than 90 percent of eligible heart patients to about 70 percent.
"There's probably more awareness among doctors that drug-eluting stents aren't for everyone," said Dr. Bob Bonow, chief of cardiology at Northwestern University and a spokesman for the American Heart Association.
Bonow said that doctors implanting the devices are probably paying more attention to ensuring that patients who get a drug stent also take anti-clotting medication for at least six months.
Newer drug stents are also better than earlier versions, some of which had to be recalled.
Other experts said the backlash against drug-coated stents was an overreaction.
"There is a risk that the stents could cause a clot, but we understand better how to manage that risk," said Dr. Eckhart Fleck, director of cardiology at the German Heart Institute in Berlin and a spokesman for the European Society of Cardiology.
"In some patients, drug-eluting stents do exactly what they're supposed to do," Bonow said. The stents leak drugs to prevent the growth of tissue that would reclog arteries.
James said that while patients should be reassured by his research, doctors should still pay close attention to their use.
"The risk is not eliminated," he said. "We haven't solved the clot problem yet."
James said he has no ties to pharmaceutical companies and no conflict of interest. Sweden's government funded the study.
FDA approves new smallpox vaccine
Sun, 02 Sep 2007 04:07:08 GMTBy JOHN HEILPRIN, Associated Press Writer
WASHINGTON - The approval of a new vaccine against smallpox was announced Saturday by the Food and Drug Administration, which says the shots could be made quickly if the virtually extinct virus reappears.
The vaccine, ACAM2000, is intended to innoculate people at high risk of exposure to smallpox, a highly contagious disease. The FDA said the vaccine also could be used to protect individuals and populations during a bioterrorist attack.
"The licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon," said Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research.
Goodman said the vaccine is made using modern cell culture technology that would allow for speedy manufacturing if large quantities were needed quickly.
ACAM2000 is made by Acambis Inc. of Cambridge, England and Cambridge, Mass. The federal Centers for Disease Control and Prevention already has stockpiled 192.5 million doses of the vaccine.
The U.S. ended routine vaccination against smallpox in 1971, and world health authorities declared the disease eradicated from the wild in 1980. The last known case was reported in Somalia in 1977.
But after the terrorist attacks of Sept. 11, 2001, concern arose that smallpox and other infections could be engineered as weapons. That led to the stockpiling of certain vaccines in case they ever are needed — and to vaccinate some military personnel and health care workers.
Only two approved U.S. and Russian labs keep known stockpiles of smallpox, which the CDC considers among the greatest potential threats to public health.
"Smallpox could be a particularly dangerous biological threat to us that would kill or debilitate a high percentage of the population," said Dr. W. Craig Vanderwagen, a rear admiral and assistant secretary for preparedness and response at the Department of Health and Human Services.
Smallpox is caused by the variola virus, which spreads through close contact with infected individuals or contaminated objects. There is no FDA-approved treatment for it.
The new vaccine is derived from the nation's old smallpox vaccine, called Dryvax, which is no longer made, although there are leftover supplies. ACAM2000 is made using a pox virus called vaccinia, which is related to but different from the virus that causes smallpox.
It contains live vaccinia virus, the FDA said, and works by causing a mild infection that stimulates an immune response that effectively protects against smallpox without actually causing the disease.
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On the Net:
FDA: http://www.fda.gov
Acambis: http://www.acambis.com
