FDA panel set to weigh new female condom

WASHINGTON (Reuters) – A new, potentially less expensive version of the female condom faces U.S. regulatory review this week when a Food and Drug Administration advisory panel weighs whether they adequately prevent pregnancy, HIV and other sexually transmitted diseases.

The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost.

Male condoms, which come in a variety of brands and cost consumers between 50 cents and $2 a piece, are far more widely used than their female counterpart, which costs between $2.80 and $4.

Chicago-based Female Health is seeking FDA approval to market the new version. On Thursday, the agency will seek a recommendation from its panel of outside experts before later making its final decision.

"The whole idea is to increase access," said Mary Ann Leeper, an adviser and former president of the company.

But FDA regulatory staff questioned whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant.

Female Health said it did not conduct such studies because FC2 uses a new material but is otherwise similar to the version already on the U.S. market, the FDA staff said in documents released on Tuesday ahead of the panel meeting.

The company "asserts that such studies are not necessary. This is an important review issue," the staff wrote.

The company said it also looked at durability of the new material, a synthetic rubber called nitrile. The original condom uses polyurethane.

Both versions are comprised of a sheath with a closed ring on one end that is inserted near the cervix and an open ring on the outer end that stays outside the woman's body.

Conducting another trial would have taken five more years and cost millions of dollars, Female Health's Leeper said.

"The design is exactly the same, how you use it is exactly the same ... we just don't believe there is any more information required," she said.

FDA approval could help boost sales in the United States, which make up just 10 percent of the female condom's 34.7 million unit sales in 2008, according to Female Health Co.

"We haven't been able to market the product," Leeper said. But Female Health is seeking to partner with another company, perhaps a male condom manufacturer or a drugmaker invested in human immunodeficiency virus (HIV) awareness, she said.

Most of its U.S. sales are to aid agencies, including the U.S. Agency for International Development, which Leeper said needs FDA to approve FC2 before it can distribute it abroad.

The bulk of the condom's use is in other countries, particularly in Africa where public health agencies provide it to help prevent the spread of the HIV virus.

The female version gives women their own option for protection and allows them to insert a condom before intercourse. Most other countries have already adopted the newer version, the company has said.

It also offers other advantages over the male condom, according to the company, including greater protection by covering part of a woman's outer genitals.

Shares of Female Health Co. were up nearly 5 percent, or 13 cents, at $2.98 on the American Stock Exchange.

(Editing by Gerald E. McCormick, Derek Caney and Bernard Orr)

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New rule for health providers stirs objections

WASHINGTON – The Bush administration, in its final days, issued a federal rule Thursday reinforcing protections for doctors and other health care workers who refuse to participate in abortions and other procedures because of religious or moral objections.

Critics say the protections are so broad they limit a patient's right to get care and accurate information. For example, they fear the rule could make it possible for a pharmacy clerk to refuse to sell birth control pills without ramifications from an employer.

Under long-standing federal law, institutions may not discriminate against individuals who refuse to perform abortions or provide a referral for one. The administration's rule is intended to ensure that federal funds don't flow to providers who violate those laws, Health and Human Services officials said.

"Doctors and other health care providers should not be forced to choose between good professional standing and violating their conscience," said HHS Secretary Mike Leavitt.

The rule requires recipients of federal funding to certify their compliance with laws protecting conscience rights.

Despite multiple laws on the books protecting health providers, the administration argued that the rule was needed "to raise awareness of federal conscience protections and provide for their enforcement."

But many groups described the rule as a last-minute push designed to make it harder for women to get services such as contraception or counseling in the event they are pregnant and want to learn all of their options.

Several medical associations, more than 100 members of Congress, governors and 13 attorneys general were among the many thousands who wrote the department to protest the rule after it was proposed. Opponents didn't like the rule any better after it was finalized.

"In just a matter of months, the Bush administration has undone three decades of federal protections for both medical professionals and their patients," said Nancy Northup, president of the Center for Reproductive Rights. "It replaced them with a policy that seriously risks the health of millions of women, then tried to pass it off as benevolent."

Abortion opponents hailed the regulation because they said the lack of regulation had resulted in confusion and a lack of awareness.

"This is a huge victory for religious freedom and the First Amendment," said Tony Perkins, president of the Family Research Council.

The administration estimated the cost of complying with the rule at $43.6 million annually, which is spread throughout the hundreds of thousands of health providers subject to the rule — from hospitals and physician offices to medical schools and pharmacies.

Several lawmakers have promised to take up legislation that would overturn the rule once Congress reconvenes in January. Another option is for the Obama administration to issue new regulations that would trump it. The rule will take effect on Jan. 18, two days before Obama takes office.

Obama's transition team did not specifically address the rule Thursday, but spokesman Nick Shapiro issued a statement that said Obama "will review all eleventh-hour regulations and will address them once he is president."

While campaigning in August, Obama criticized the proposal: "This proposed regulation complicates, rather than clarifies the law. It raises troubling issues about access to basic health care for women, particularly access to contraceptives," he said.

The 127-page rule disputed concerns that the protections being proposed were too broad and would affect too many workers in the health care industry, not just doctors or nurses involved with an abortion or sterilization.

"These laws are intended to protect the conscience rights of all individuals participating in health care services, and research programs and activities receiving certain federal funds, or that are administered by the department," the rule said.

Opponents consistently described the rule as a last-minute effort that would reduce access to health care services, particularly access to birth control.

"Making birth control more — not less — accessible is the best way to prevent unintended pregnancies and reduce abortion," said Rep. Nita Lowey, D-N.Y.

Others said the rule would go so far as to protect providers who refuse to give rape victims emergency contraceptives.

The Planned Parenthood Federation of America said about 200,000 people submitted comments opposing the rule, including about 90,000 comments from its supporters.

"This midnight regulation, issued in the last days of the Bush administration, undermines this country's fragile health care system as well as patients' access to health care information and services," said the group's president, Cecile Richards.

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CLEVELAND – The nation's first face transplant is a big risk not just for the severely disfigured woman who received it, but also for the surgeon wh

CLEVELAND – Her injuries were ghastly: no nose, no palate, no way to eat or breathe normally, a face so hideous that children who saw her screamed and ran away. From the moment they met earlier this year, Dr. Maria Siemionow knew the severely disfigured woman would be the one — the first person in the U.S. to receive a face transplant.

"Our patient was called names and was humiliated. You need a face to face the world," said Siemionow, the Cleveland Clinic reconstructive surgeon who led the operation about two weeks ago.

During the 22-hour procedure, 80 percent of the patient's face was replaced with bone, muscles, nerves, skin, blood vessels and some teeth taken from a woman who had died hours earlier.

It was the fourth face transplant in the world, though the others were not as extensive as this one.

"I must tell you how happy she was when with both her hands she could go over her face and feel that she has a nose, feel that she has a jaw," Siemionow said. "She wants just to go out and be invisible in the crowd."

The patient's name and age were not released, nor were details on how she was injured, and she did not appear at a hospital news conference Wednesday. Surgeons said she was doing well and showing no signs of rejecting her new face. She was still sedated and unable to speak much, communicating mostly through writing, Siemionow said.

Doctors believe she will eventually be able to eat on her own, breathe normally instead of through a hole in her windpipe, and exhibit a full range of facial expressions, including smiling and frowning.

She is expected to spend weeks in the hospital, after which she will have to undergo periodic checkups for the rest of her life to watch for signs of rejection.

The transplant was fraught with ethical questions.

Unlike operations involving vital organs like hearts and livers, transplants of faces are done to improve quality of life — not extend it. Recipients run the risk of deadly complications and must take immune-suppressing drugs for the rest of their lives to prevent organ rejection, raising their odds of cancer and infections.

But the hospital's bioethics chief, Dr. Eric Kodish, said the circumstances and procedures followed for the donation and transplant were "beyond reproach."

"This is not cosmetic surgery in any conventional sense," Kodish said.

Over the past four years, Siemionow had considered dozens of desperate burn victims and other potential candidates for the operation, and practiced on animals and cadavers to perfect the technique. The woman selected was so badly injured that only her upper eyelids, forehead, lower lip and chin were left.

"She heard people calling her names, children just scared of her, running away from her. When she was on the street, people were turning their heads," Siemionow said.

Previous operations on the woman over several years at the Cleveland Clinic had made little improvement in her looks, doctors said.

"This patient exhausted all conventional means of reconstruction, and is the right patient," Siemionow said.

The donor's family gave specific permission for the face to be used. The removal of a dead person's face would rule out an open-casket funeral.

The recipient was not shown a picture of the donor, and in animal experiments, "the recipient never looks like the donor," especially when the injuries are severe, Siemionow said. That is because the underlying bone structure is different from person to person.

The hospital posted a statement from the woman's sibling on its Web site.

"We never thought for a moment that our sister would ever have a chance at a normal life again, after the trauma she endured," it says. "But thanks to the wonderful person that donated her organs to help another living human being, she has another chance to live a normal life. Our family cannot thank you enough."

After about three months waiting for a donor similar to the recipient in age, gender, tissue type and skin tone, Siemionow again asked her patient if she wanted to go through with it. "She said 'I'm ready. I've been waiting for this,'" the surgeon said.

Disfigured patients are stuck at home, "hiding from society" and afraid to go out, the surgeon said.

Many more like her exist, and a military grant to the clinic will let them explore the possibility of operating on soldiers left severely disfigured, Siemionow said.

The clinic is absorbing the roughly $200,000 cost of this first transplant because it is an experiment and part of research. They hope to offer more, but are taking this one case at a time for now, Siemionow said.

The world's first partial face transplant was performed in France in 2005 on a 38-year-old woman who had been mauled by her dog. Isabelle Dinoire received a new nose, chin and lips from a brain-dead donor. Apart from some rejection episodes, she has done well.

Two others have received partial face transplants since then — a Chinese farmer attacked by a bear and a European man disfigured by a genetic condition.

Leading plastic surgeons praised the operation. It's an example of a medical advance "that gives patients their lives back," Dr. John Canady, president of the American Society of Plastic Surgeons, said in a statement.

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Face transplant doctor waited long for this chance

CLEVELAND – The nation's first face transplant is a big risk not just for the severely disfigured woman who received it, but also for the surgeon who has made it the highlight of her career.

The Cleveland Clinic's Dr. Maria Siemionow has put her professional reputation on the line by doing a radical operation that some consider unethical but others praise as the only hope for people horribly disfigured by burns, trauma, cancer or violence.

She has spent more than a decade preparing for it, and fame is not her motivation, she said in an interview several years ago.

"I don't feel competition to do anything in life except with myself. I compete with myself," she said.

Which is no small matter for an overachiever fluent in five languages, who has made a reputation on several continents as a skilled hand microsurgeon.

Siemionow (pronounced SIM-en-now), 58, grew up in Poland. As a young girl, she had private classes in English, studied Russian and learned German in high school. She learned Spanish during two summers in Barcelona as an exchange student.

After medical school in Poznan, Poland, she trained in Belgium, Spain and Finland.

Working with Physicians for Peace in Turkey, she operated on many kids with burned hands.

"They looked like one big paddle," she said, and she would separate the fingers and graft skin between them.

Siemionow came to the United States in 1985 for a fellowship in hand surgery at Louisville, Ky., where the nation's first hand transplant was done in 1999. She has been at the Cleveland Clinic since 1995.

She has done hundreds, perhaps thousands of operations in 30 years. She knows that good results are only partly under the control of the surgeon.

"Many patients will think you've repaired their tendon and they don't have to exercise hundreds of times a day," and blame the surgeon when they end up with a stiff finger, she said.

These "learning experiences," as she calls them, taught her a lesson: "Be more critical in how you evaluate a patient."

It is why, after the hospital approved her plans, she spent more than three years selecting her first face transplant patient. She put candidates through formal interviews, looking for someone with a severe disformity, "not a little scar."

The person should be "psychologically stable but not happy," where the risks of the operation would clearly be outweighed by its potential benefit, she said in interviews. The person has to be strong enough psychologically, with good family support, to commit to taking anti-rejection drugs for the rest of their life.

Asked how much she want to know about a patient, she replied: "Everything possible. It's a commitment on both sides."

"She doesn't toot her own horn but she has done her homework," said Dr. Alan Lichtin, vice chairman of the hospital review board that approved the transplant plans.

Temperamentally, Siemionow seems ideal for the task. Her own hands are small and delicate, almost childlike. She dyes her hair blonde, likes to look sharp, and speaks of herself in confident but humble terms.

During surgery, "I like it quiet," she said. "I cannot read when there's music," preferring to give full attention to one task at a time.

Her husband is a biomedical engineer and her son is training to become an orthopedic surgeon.

In interviews over the last few years, she has talked of the many surgeries disfigured people have endured, and the poor quality of life many of them are left with.

"If you choose to be a surgeon, you are used to results that are not ideal but good," she said.

But with this landmark operation, she is clearly hoping for better.

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FDA raises the bar for new diabetes drugs

WASHINGTON – New drugs to treat an epidemic of diabetes will have to be screened more closely for heart risks, federal health officials said Wednesday.

The Food and Drug Administration's policy change should offer a greater assurance of safety to doctors and patients. But it will make it more costly and time-consuming for companies to develop drugs that lower blood sugars. Well over 100 such medications are in some stage of development.

"I think the FDA got this one right," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who raised the diabetes concern two years ago with a study indicating a popular new drug increased the risk of heart attacks. The medication, Avandia, remains on the market amid continuing debate. But such drugs will have to clear a higher bar in the future, the FDA said.

Some 23 million people in the U.S. have Type 2 diabetes, which is considered an epidemic among adults, and a concern with teenagers and even children. People with diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because of resistance to insulin. As the years go by, they are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Because heart attacks are a leading cause of death among diabetics, medications that lower blood sugars but also increase heart risks could easily do more harm than good.

That is particularly true when other treatments are available that do not appear to have heart risks, such as insulin injections or pills like metformin.

Dr. Mary Parks, head of the FDA division that oversees diabetes drugs, said the policy is intended to remove the uncertainty about new diabetes drugs. Separately, the FDA is working on new guidance for already approved diabetes drugs.

"The more we know about the safety profile, the better it is for physicians to make decisions," Parks said.

The policy sets out more rigorous standards for testing diabetes drugs, following recommendations from FDA advisers and critics such as Nissen.

"The idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need," Nissen. "This will raise the level of evidence available, and that is good for patients."

Currently, people selected to test a new medication are often younger and healthier than the patients who ultimately wind up being prescribed the drug. Under the new FDA policy, drug companies will have to test drugs on greater numbers of high-risk patients, such as the elderly, those with relatively advanced diabetes and those with kidney problems. The studies will have to take longer, which would allow for the emergence of subtle problems, such as gradual increases in blood pressure.

Drug companies will have to set up independent committees to monitor the rates of heart attacks, strokes, and heart-related deaths and hospitalizations linked to drugs in development.

Finally, the companies will have to conduct certain statistical analyses of the results, with an upper limit on how much risk is acceptable for a new drug.

But one bottom-line measure will not change: Diabetes drugs still will be judged on how well they lower blood sugars.

The FDA already sent letters to drugmakers describing the changes, Parks said. Makers of some 100 to 150 medications under development were notified.

"It is safe to assume that if we are going to be requiring a longer duration of trials, that it will add some years, some time to the clinical development process," added Parks.

That could turn into a drawback, said Scott Gottlieb, a former senior FDA official who is now a policy analyst at the business-oriented American Enterprise Institute.

"This is going to be hard risk to assess for and will add a lot of cost and time to development," Gottlieb said. "You are looking for small risks that only become manifest after prolonged use, so it may often take big, long term studies to uncover these things."

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FDA adds suicide warning to epilepsy drugs

WASHINGTON – Drugs used by millions of patients to control epileptic seizures must carry warnings about heightened risks of suicide, federal regulators said Tuesday.

The Food and Drug Administration announcement comes almost a year after the agency first said patients taking the drugs have a slightly higher risk for suicide than those taking dummy pills.

According to the new language, only about 1 in 500 patients face an increased risk of suicidal thoughts and behavior while taking the drugs. The new warning emphasizes that the risks are about the same among all antiseizure drugs.

The FDA advised patients to consult their doctor before making any changes to their treatment.

The agency is also requiring manufacturers to distribute pamphlets that describe the risks for patients.

"All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression," FDA said in a statement.

The new warnings apply to 21 medications, including blockbuster products like GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica.

The FDA stopped short of adding its sternest warning to the medications, as it had proposed earlier in the year.

In July a panel of outside experts recommended against adding the so-called "black box" warning, the strongest type available. Those experts and other physicians cautioned the agency that a boxed warning about suicide could alarm patients and cause them to stop taking their medications.

Anti-seizure drugs are used for a variety of illnesses besides epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.

London-based Glaxo said it supports the decision to add information about suicide risks to its medication. However, the company added in a statement that it "remains confident in the overall safety and efficacy profile of Lamictal based on our extensive clinical trial experience and the experience of more than 5 million people worldwide."

FDA said in January its analysis of nearly 200 studies of 11 different epilepsy drugs showed patients taking the treatments were more likely to have suicidal thoughts and behaviors.

Seizure drugs were the fifth best-selling class of drugs in the U.S. last year, with sales over $10 billion, according to pharmaceutical research firm IMS Health.

GlaxoSmithKline's Lamictal posted sales of $2.2 billion for 2007, while Pfizer's Lyrica had sales of $1.8 billion.

Shares of GlaxoSmithKline rose $1.54, or 4.2 percent, to $37.88. Shares of Johnson & Johnson rose $1.79, or 3 percent, to $59.60, while shares of Pfizer rose 73 cents, or 4.4 percent, to $17.36.

Pfizer said it would work with FDA to update labeling on Lyrica and Neurontin, an older drug which is approved to treat both epilepsy and nerve pain.

"Pfizer hopes that the labeling change will further facilitate important dialogue that should always occur between patients and their doctors."

Physician groups like the American Epilepsy Society pressured FDA in recent months to take a measured approach on the warnings, arguing they could cause more harm than good if patients stop taking the drugs.

Doctors have succeeded in curbing other FDA safety warnings in recent years. In 2004, regulators added a black box warning about suicide to antidepressant drugs. However, FDA scaled back the language last year after psychiatrists said it was causing patients to stop taking their medicines, putting them at even greater risk of suicide.

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Combo treatment for prostate cancer cuts deaths

LONDON – Treating advanced prostate cancer with radiation and hormone-blocking drugs cut the death rate in half in a study of Scandinavian men, researchers report. In the United States, the combination has been standard care since the 1990s. But in Europe, many doctors have avoided the combo treatment and used hormone drugs alone, thinking the pair would be too harsh for most patients.

"What this study shows is that men with prostate cancer do benefit from more aggressive therapy," said Dr. Howard Sandler, of Cedars-Sinai Medical Center in Los Angeles and a spokesman for the American Society of Clinical Oncology.

The Scandinavian rearchers tracked 875 men with advanced prostate cancer in Denmark, Norway and Sweden.

About half were given hormone-blocking drugs while the other half got the same treatment plus radiation. The drugs block production of testosterone, which feeds cancer cells.

After nearly eight years, 79 men in the hormone only group had died of prostate cancer, compared to 37 in the group that had hormone therapy plus radiation.

"It's not enough just to put patients on hormones," said Anders Widmark of Umea University in Sweden, one of the paper's authors. "To get a dramatic increase in survival, you have to add radiation. This should be the new standard."

The study was published online Tuesday by the British medical journal, Lancet. It was paid for by various Scandinavian cancer groups, Umea University and the makers of the drugs used in the study, Schering-Plough Corp. (Lupron), and Abbott Laboratories Inc. (Eulexin).

Adding radiation to patients' treatment did come at a cost. After five years, men receiving hormones and radiation reported higher rates of side effects including fatigue, insomnia, and sexual problems.

Prostate cancer is the most common cancer in men, and usually strikes after age 50.

While the combination treatment is recommended in U.S. guidelines, Sandler said not all patients get it. He said men who are being treated with hormones alone should talk to their doctor so see if radiation should be added.

"Combining hormones and radiotherapy should now be available to patients universally," said Chris Parker of the Institute of Cancer Research in Surrey, England.

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Associated Press writer Stephanie Nano in New York contributed to this report.

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Report: Young doctors still too tired for safety

WASHINGTON – Doctors-in-training are still too exhausted, says a new report that calls on hospitals to let them have a nap. Regulations that capped the working hours of bleary-eyed young doctors came just five years ago, limiting them to about 80 hours a week.
Tuesday, the prestigious Institute of Medicine recommended easing the workload a bit more: Anyone working the maximum 30-hour shift should get an uninterrupted five-hour break for sleep after 16 hours.
At issue is how to balance patient safety with the education of roughly 100,000 medical residents, doctors fresh out of medical school who spend the next three to seven years in on-the-job training for their specialty. The long hours are in some ways a badge of the profession; doctors can't simply clock out if a patient is in danger.
But sleep deprivation fogs the brain, a problem that can lead to serious medical mistakes. So in 2003, the Accreditation Council for Graduate Medical Education issued the first caps. Before then, residents in some specialties could average 110 hours a week.
The government asked the IOM to study the current caps. Violations of current limits are common and residents seldom complain, the committee found. While quality of life has improved, there's still a lot of burnout.
And despite one study that found residents made more errors while working longer shifts, patient safety depends on so many factors that it's impossible to tell yet if the caps helped that problem, the report said.
So it also recommends:
_Experienced physicians should more closely supervise residents.
_Better overlap of schedules during shift changes to reduce chances for error as one doctor hands patients' care over to the next.
_Increase mandatory days off each month, and extend hours off between shifts depending on how long the resident worked, during day or night.
The accreditation council didn't immediately say if it would follow the recommendations.

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Doctors separating joined twins in London

LONDON – British doctors conducted surgery to separate twins joined at the chest on Tuesday, hospital officials said.
Stephen Cox, a spokesman for the Great Ormond Street Hospital for Children in London, said the decision to separate Faith and Hope Williams was brought forward, after concerns developed Monday night. Cox would not specify what the concerns were.
The twins were born last week to Laura and Aled Williams. Doctors originally said they would have preferred to wait to separate the twins until they were older. The final decision to operate was made by the family.
The baby girls are joined at the abdomen. They are said to share a liver and intestines.
There was no word Tuesday night on how the operation went. The BBC said the hospital would provide an update Tuedsay morning.
"I would be optimistic about their chances," said Dr. Charles Stolar, pediatric surgeon in chief at Morgan Stanley Children's Hospital of New York-Presbyterian. Stolar is not connected to the British case, but has performed similar operations in the past.
"In general, this is a very fixable problem," he said.
But Stolar said that without knowing the details of the case, there could be other variables that could complicate the twins' prognosis.
Twins who share an abdomen usually share the liver, bile ducts from the liver, and various parts of the intestines. Conjoined twins occur about once in every 50,000 live births in the United States.
Twins joined at the chest are easier to separate than those joined elsewhere, like at the head. Last month, doctors in Cleveland decided it would have been too risky to separate 4-year-old twins born in Italy, connected at the head.
There are at least 40 doctors, nurses and other health professionals involved in the separation of the Williams twins in London.
During the surgery, doctors will have to divide the liver and ensure that each baby has enough intestinal tract to digest food. Doctors might also have to deal with other issues, such as if the kidneys are not distributed evenly or if they share part of the pelvis.
Lastly, doctors will need to close up the babies' abdomens, which may be tricky if there is not enough skin and muscle.
Depending on how complicated the surgery is, separated twins usually need to spend several weeks in the hospital as their recovery is monitored.
Stolar said that if there were no other complications — like heart or lung problems — then the babies would likely have few long-term problems, apart from not having belly buttons.
Hospital spokesman Cox said an update would be issued later, but didn't say when.
(This version CORRECTS Corrects that girls are joined at the abdomen stead breastbone to navel, corrects hospital name to Morgan Stanley Children's Hospital of New York-Presbyterian. UPDATES with briefing expected Wednesday.)

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1 in 5 young adults has personality disorder

CHICAGO – Almost one in five young American adults has a personality disorder that interferes with everyday life, and even more abuse alcohol or drugs, researchers reported Monday in the most extensive study of its kind. The disorders include problems such as obsessive or compulsive tendencies and anti-social behavior that can sometimes lead to violence. The study also found that fewer than 25 percent of college-aged Americans with mental problems get treatment.
One expert said personality disorders may be overdiagnosed. But others said the results were not surprising since previous, less rigorous evidence has suggested mental problems are common on college campuses and elsewhere. Experts praised the study's scope — face-to-face interviews about numerous disorders with more than 5,000 young people ages 19 to 25 — and said it spotlights a problem college administrators need to address. Study co-author Dr. Mark Olfson of Columbia University and New York State Psychiatric Institute called the widespread lack of treatment particularly worrisome. He said it should alert not only "students and parents, but also deans and people who run college mental health services about the need to extend access to treatment." Counting substance abuse, the study found that nearly half of young people surveyed have some sort of psychiatric condition, including students and non-students. Personality disorders were the second most common problem behind drug or alcohol abuse as a single category. The disorders include obsessive, anti-social and paranoid behaviors that are not mere quirks but actually interfere with ordinary functioning. The study authors noted that recent tragedies such as fatal shootings at Northern Illinois University and Virginia Tech have raised awareness about the prevalence of mental illness on college campuses. They also suggest that this age group might be particularly vulnerable. "For many, young adulthood is characterized by the pursuit of greater educational opportunities and employment prospects, development of personal relationships, and for some, parenthood," the authors said. These circumstances, they said, can result in stress that triggers the start or recurrence of psychiatric problems. The study was released Monday in Archives of General Psychiatry. It was based on interviews with 5,092 young adults in 2001 and 2002. Olfson said it took time to analzye the data, including weighting the results to extrapolate national numbers. But the authors said the results would probably hold true today. The study was funded with grants from the National Institutes of Health, the American Foundation for Suicide Prevention and the New York Psychiatric Institute. Dr. Sharon Hirsch, a University of Chicago psychiatrist not involved in the study, praised it for raising awareness about the problem and the high numbers of affected people who don't get help. Imagine if more than 75 percent of diabetic college students didn't get treatment, Hirsch said. "Just think about what would be happening on our college campuses." The results highlight the need for mental health services to be housed with other medical services on college campuses, to erase the stigma and make it more likely that people will seek help, she said. In the study, trained interviewers, but not psychiatrists, questioned participants about symptoms. They used an assessment tool similar to criteria doctors use to diagnose mental illness. Dr. Jerald Kay, a psychiatry professor at Wright State University and chairman of the American Psychiatric Association's college mental health committee, said the assessment tool is considered valid and more rigorous than self-reports of mental illness. He was not involved in the study. Personality disorders showed up in similar numbers among both students and non-students, including the most common one, obsessive compulsive personality disorder. About 8 percent of young adults in both groups had this illness, which can include an extreme preoccupation with details, rules, orderliness and perfectionism. Kay said the prevalence of personality disorders was higher than he would expect and questioned whether the condition might be overdiagnosed. All good students have a touch of "obsessional" personality that helps them work hard to achieve. But that's different from an obsessional disorder that makes people inflexible and controlling and interferes with their lives, he explained. Obsessive compulsive personality disorder differs from the better known OCD, or obsessive-compulsive disorder, which features repetitive actions such as hand-washing to avoid germs. OCD is thought to affect about 2 percent of the general population. The study didn't examine OCD separately but grouped it with all anxiety disorders, seen in about 12 percent of college-aged people in the survey. The overall rate of other disorders was also pretty similar among college students and non-students. Substance abuse, including drug addiction, alcoholism and other drinking that interferes with school or work, affected nearly one-third of those in both groups. Slightly more college students than non-students were problem drinkers — 20 percent versus 17 percent. And slightly more non-students had drug problems — nearly 7 percent versus 5 percent. In both groups, about 8 percent had phobias and 7 percent had depression. Bipolar disorder was slightly more common in non-students, affecting almost 5 percent versus about 3 percent of students.

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Depression leads to internal fat in 70-somethings

CHICAGO – Older people who are depressed are much more likely to develop a dangerous type of internal body fat — the kind that can lead to diabetes and heart disease — than people who are not depressed, a disturbing new study found.

The connection goes beyond obesity and suggests some biological link between a person's mental state and fat that collects around the internal organs, scientists said.

"For the depressed public, it should be another reason to take one's symptoms seriously and look for treatment," said study co-author Stephen Kritchevsky, director of the Sticht Center on Aging at Wake Forest University in Winston-Salem, N.C.

People with depression were twice as likely as others to gain visceral fat — the kind that surrounds internal organs and often shows up as belly fat. It raises the risk for heart disease and diabetes.

Previous research has linked depression with those same health problems. Some researchers believe depression triggers high levels of the stress hormone cortisol, which promotes visceral fat. The cortisol connection may explain the findings, Kritchevsky said.

The research, published in Monday's Archives of General Psychiatry, is the first large study to track people over time to see if those with depression were more likely to gain weight. Mostly federally funded, the study used data from 2,088 people in the ongoing Health, Aging and Body Composition study. That project is following healthy older Americans to find out how changes in bone, fat and lean body mass affect health.

The participants, all in their 70s, were recruited in and around Memphis, Tenn., and Pittsburgh in 1997 and 1998 and were followed for five years. Researchers screened for symptoms of depression at the start of the study and again at four follow-up visits.

They measured visceral fat with CT scans. They calculated body mass index, body fat percentage, waist size and the distance between the back and the biggest part of the belly.

There were 84 people with depression symptoms at the start of the study. They gained, on average, 9 square centimeters of visceral fat. In contrast, the 2,004 people who weren't depressed lost visceral fat — on average, 7 square centimeters.

That variation "could mean the difference between developing a cardiovascular disease or not," said lead author Nicole Vogelzangs of VU University Medical Center in Amsterdam, the Netherlands, in an e-mail.

Both groups, depressed and non-depressed, were overweight on average at the start of the study, with approximately the same average body mass index. When the researchers took into account other risk factors for obesity, including the depressed group's higher visceral fat levels in the beginning, they still found a connection between depression and visceral fat gain.

They also found a similar link to visceral fat gain in people with recurring depression over the years. Adjusting for antidepressant use didn't change the findings either.

Researchers didn't make adjustments for poor eating habits, but they found no link between depression and BMI or body fat percentage.

"Since such an increase in overall obesity was not clearly found, we believe a biological explanation is more likely" than poor diet, Vogelzangs said.

The researchers did find hints of a depression link with waist circumference and the back-to-belly measurement — two other gauges of visceral fat.

That suggests depression has a specific tie with fat gained around the organs in the abdomen. The good news is visceral fat is easier to lose than subcutaneous fat, Kritchevsky said.

Dr. David Baron of Philadelphia's Temple University School of Medicine praised the study, although he wanted to know more about the participants' family history of obesity. The connection between brain and body makes sense, he said.

"Depression is a physical illness," Baron said. "Maybe we should be even more aggressive in treating depression in this age group, whether through medication or talk therapy."

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On the Net: Archives of General Psychiatry: http://archpsyc.ama-assn.org/

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Asthma inhalers to go 'green' on Dec. 31

WASHINGTON – Last warning: Asthma inhalers go "green" on Dec. 31, forcing patients still using the old-fashioned kind to make a pricey and even confusing switch. The medicine inside these rescue inhalers — the albuterol that quickly opens airways during an asthma attack — isn't changing. But the chemicals used to puff that drug into your lungs are.

No more chlorofluorocarbons, or CFCs, that damage Earth's protective ozone layer. By year's end, all albuterol inhalers must be powered by the more eco-friendly chemical HFA, or hydrofluoroalkane.

The down side: The new inhalers cost more, $30 to $60 compared to as little as $5 or $10 for the disappearing generic CFC inhalers.

And patients face a learning curve. HFA inhalers must be used differently than the old-fashioned kind. The medicine feels and tastes different, sometimes alarming new users despite doctors' assurances that it works just as well.

"There's still significant confusion," says Dr. Harvey Leo of the University of Michigan's C.S. Mott Children's Hospital. "Patients will tell you, 'I don't feel the puff anymore.'"

Calls from parents unsure how to use the new inhalers, or even what they are, have increased in the past two months as more drugstores run out of CFC-powered inhalers and automatically switch people who'd been expecting a mere refill, he adds.

The change shouldn't be a surprise. The Food and Drug Administration has long warned it was coming, and lung specialists have spent the past year easing many of the nation's 20 million asthma patients — as well as millions of emphysema sufferers who also use albuterol to ease breathing — into it.

But industry figures show that in mid-November, 20 percent of all albuterol prescriptions still were being filled with CFC versions.

Some patients may purposefully be buying up cheaper CFC inhalers before the sales ban. But many patients don't see a lung specialist, or their prescription may not expire until next year so they haven't been seen recently enough to be told.

Reaching the last fraction "is, as you can imagine, a very difficult task," says Dr. Bidrul Chowdhury, FDA's pulmonary drugs chief. "How to get to somebody who is not tuned in?"

The CFC-free options: GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Teva Specialty Pharmaceuticals' ProAir HFA all contain albuterol. Also, Sepracor's Xopenex HFA contains the similar medication levalbuterol.

Albuterol inhalers are for emergencies, for quick relief of wheezing. Patients also need daily medication to control their asthma and prevent flare-ups. Someone who's using the albuterol inhaler more than a few times a month isn't well-controlled, and his or her doctor needs to determine why, stresses Dr. Paul Greenberger of Northwestern University, president-elect of the American Academy of Allergy, Asthma & Immunology.

Here's the rub: Recent research suggests only one in five children has their asthma under good control; no one knows how many adults do.

The last to go CFC-free will be the poor and uninsured whose asthma is less likely to be controlled, says Leo, who researches that issue at Michigan's Center for Managing Chronic Disease.

Albuterol manufacturers are providing free samples and posting coupons on their Web sites.

Still, specialists worry that some patients will try to save money with a decades-old nonprescription inhaler that contains a different drug, epinephrine, best known by the brand name Primatene Mist — inhalers that also contain ozone-harming CFCs. National asthma guidelines argue against such self-treatment as too risky and less effective than albuterol. The government will allow sale of those over-the-counter inhalers until December 2011 as manufacturers reformulate.

Leo has another concern: Only one of the new inhalers counts doses used. He's monitoring emergency-room statistics to see if cost-conscious patients trying to squeeze out last drops wind up using empty inhalers.

What do patients need to know as they switch?

_Expect a softer puff instead of the CFC version's cold blast of air in the back of the throat.

"They are getting their medicine," says Dr. David Rosenstreich of New York's Montefiore Medical Center. "They have to get used to it and be aware that it's working."

_The new inhalers clog more often because HFA makes the drug stickier. Clean the hole weekly, following the instructions unique to each brand.

_Never get the whole device wet.

The FDA says there's plenty of supply; it gave manufacturers several years to ramp up before the ban.

But don't wait until the last minute. When Eric Stoermer of Ann Arbor, Mich., made the switch in August, he waited a week for a new inhaler for his 11-year-old son Ethan. Their drugstore was temporarily out of stock.

"I ended up having to hunt around on an emergency basis," Stoermer says. "This is a bad thing to run out of."

___

EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Some doctors may give up vaccines because of cost

ATLANTA – About one in 10 doctors who vaccinate privately insured children are considering dropping that service largely because they are losing money when they do it, according to a new survey.

A second survey revealed startling differences between what doctors pay for vaccines and what private health insurers reimburse: For example, one in 10 doctors lost money on one recommended infant vaccine, but others made almost $40 per dose on the same shot.

The survey was revealing even to some doctors. "Many physicians really weren't aware and that they were getting reimbursed so little," said Dr. Gary Freed of the University of Michigan, a co-author of both articles published in the December issue of the journal Pediatrics.

The studies are the first to attach numbers to doctors' long-simmering complaints that they are only breaking even — or even losing money — when they give shots.

"It's a pleasure to see a real study to show we're not just making this up," said Dr. Herschel Lessin, a pediatrician in Hopewell Junction, N.Y. who said his practice's spending on vaccines has more than doubled from 2006 to 2007.

Experts say there's no evidence that significant numbers of doctors are quitting the vaccination business yet because of financial concerns.

But health officials are worried. Reimbursement concerns were behind an exodus of doctors from vaccine programs in the 1980s, which contributed to a terrible resurgence of measles in 1989-91 that caused 11,000 hospitalizations and 123 deaths.

This year, U.S. measles cases rose to the highest level in more than a decade, mainly because some parents are opting out of getting their kids vaccinated.

Health officials fear that problem, along with doctor's economic concerns, could set the stage for bigger outbreaks in the future.

"This is a very important wake-up call," said Dr. Lance Rodewald of the U.S. Centers for Disease Control and Prevention, referring to the two new studies.

The first study was based on a mail-in survey last year of nearly 1,300 pediatricians and family physicians; nearly 800 responded.

About half said they had delayed buying at least one vaccine because of the cost. Roughly one in five said they felt strongly that reimbursement for the purchase and administration of vaccines was not adequate.

The second survey asked doctors what they paid for vaccines and how much they were reimbursed by private insurers. It was answered by 76 doctors in five states, representing about 20 percent of those asked to participate. Many contracts prevent doctors from talking about their spending and reimbursement for vaccinations, Freed said.

One example of the disparity was a vaccine that protects against pneumococcal disease. The per-dose difference ranged from a $40 profit to an $11 loss. A chickenpox vaccine netted some doctors $35 but cost others nearly $30 per dose.

The survey examined the cost of the vaccines and the expense of storage and related medical supplies. But it didn't look at administrative fees and staff time.

The studies did not look at the 50 percent or more of vaccinations paid for by government, which generally provides free vaccines to doctors and covers administrative fees.

In New York state, some doctors actually do better financially with the government vaccine program than they do on the private market, with the government's administrative fee double or triple what some private insurers pay. But some business-savvy doctors can still make at least a small profit on vaccines in the private market, said Lessin, who is vice president of a 24-physician pediatric practice.

Most pediatricians are likely to keep giving vaccinations to kids, partly because of altruism and partly because giving shots drives business. "For us to give up vaccines would hurt our core business because that's why kids come in," Lessin said.

But family practice doctors — who are not as dependent on vaccinations for patients — may decide the shots are too much of a financial headache, he added.

Indeed, the new studies reflected that schism: Overall 11 percent of physicians have seriously considered stopping vaccinations for privately insured patients. But 21 percent of family doctors felt that way, compared with just 5 percent of pediatricians.

The financial problem has been getting worse in recent years, as more vaccines have come on the market, experts say. Some have been unusually expensive, including Gardasil, a vaccine for girls against cervical cancer which is given in three doses over six months and is priced at about $375 for the series.

A government advisory panel studying the financial burden of vaccines is expected to submit proposals for changes in reimbursement practices to federal health officials next year.

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Swiss approve pioneering legal heroin program

GENEVA – The world's most comprehensive legalized heroin program became permanent Sunday with overwhelming approval from Swiss voters who simultaneously rejected the decriminalization of marijuana.
The heroin program, started in 1994, is offered in 23 centers across Switzerland. It has helped eliminate scenes of large groups of drug users shooting up openly in parks that marred Swiss cities in the 1980s and 1990s and is credited with reducing crime and improving the health and daily lives of addicts.
The nearly 1,300 selected addicts, who have been unhelped by other therapies, visit one of the centers twice a day to receive the carefully measured dose of heroin produced by a government-approved laboratory.
They keep their paraphernalia in cups labeled with their names and use the equipment and clean needles to inject themselves — four at a time — under the supervision of a nurse, and also receive counseling from psychiatrists and social workers.
The aim is to help the addicts learn how to function in society.
The United States and the U.N. narcotics board have criticized the program as potentially fueling drug abuse, but it has attracted attention from governments as far away as Australia and Canada, which in recent years have started or are considering their own programs modeled on the system.
The Netherlands started a smaller program in 2006, and it serves nearly 600 patients. Britain has allowed individual doctors to prescribe heroin since the 1920s, but it has been running trials similar to the Swiss approach in recent years. Belgium, Germany, Spain and Canada have been running trial programs too.
Sixty-eight percent of the 2.26 million Swiss voters casting ballots approved making the heroin program permanent.
By contrast, around 63.2 percent of voters voted against the marijuana proposal, which was based on a separate citizens' initiative to decriminalize the consumption of marijuana and growing the plant for personal use.
Olivier Borer, 35, a musician from the northern town of Solothurn, said he welcomed the outcome in part because state action was required to help heroin addicts, but he said legalizing marijuana was a bad idea.
"I think it's very important to help these people, but not to facilitate the using of drugs," Borer said. "You can just see in the Netherlands how it's going. People just go there to smoke."
Sabina Geissbuehler-Strupler of the right-wing Swiss People's Party, which led the campaign against the heroin program, said she was disappointed in the vote.
"That is only damage limitation," she said. "Ninety-five percent of the addicts are not healed from the addiction."
Health insurance pays for the bulk of the program, which costs 26 million Swiss francs ($22 million) a year. All residents in Switzerland, which has a population of 7.5 million, are required to have health insurance, with the government paying insurance premiums for those who cannot afford it.
Parliament approved the heroin measure in a revision of Switzerland's narcotics law in March, but conservatives challenged the decision and forced a national referendum under Switzerland's system of direct democracy.
Jo Lang, a Green Party member of parliament from the central city of Zug, said he was disappointed in the failure of the marijuana measure because it means 600,000 people in Switzerland will be treated as criminals because they use cannabis.
"People have died from alcohol and heroin, but not from cannabis," Lang said.
The government, which opposed the marijuana proposal, said it feared that liberalizing cannabis could cause problems with neighboring countries.
On a separate issue, 52 percent of voters approved an initiative to eliminate the statute of limitations on pornographic crimes against children before the age of puberty.
The current Swiss statute of limitations on prosecuting pedophile pornography is 15 years. The initiative will result in a change in the constitution to remove that time limit.

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Global AIDS crisis overblown? Some dare to say so

LONDON – As World AIDS Day is marked on Monday, some experts are growing more outspoken in complaining that AIDS is eating up funding at the expense of more pressing health needs. They argue that the world has entered a post-AIDS era in which the disease's spread has largely been curbed in much of the world, Africa excepted.
"AIDS is a terrible humanitarian tragedy, but it's just one of many terrible humanitarian tragedies," said Jeremy Shiffman, who studies health spending at Syracuse University.
Roger England of Health Systems Workshop, a think tank based in the Caribbean island of Grenada, goes further. He argues that UNAIDS, the U.N. agency leading the fight against the disease, has outlived its purpose and should be disbanded. "The global HIV industry is too big and out of control. We have created a monster with too many vested interests and reputations at stake, ... too many relatively well paid HIV staff in affected countries, and too many rock stars with AIDS support as a fashion accessory," he wrote in the British Medical Journal in May. Paul de Lay, a director at UNAIDS, disagrees. It's valid to question AIDS' place in the world's priorities, he says, but insists the turnaround is very recent and it would be wrong to think the epidemic is under control. "We have an epidemic that has caused between 55 million and 60 million infections," de Lay said. "To suddenly pull the rug out from underneath that would be disastrous." U.N. officials roughly estimate that about 33 million people worldwide have HIV, the virus that causes AIDS. Scientists say infections peaked in the late 1990s and are unlikely to spark big epidemics beyond Africa. In developed countries, AIDS drugs have turned the once-fatal disease into a manageable illness. England argues that closing UNAIDS would free up its $200 million annual budget for other health problems such as pneumonia, which kills more children every year than AIDS, malaria and measles combined. "By putting more money into AIDS, we are implicitly saying it's OK for more kids to die of pneumonia," England said. His comments touch on the bigger complaint: that AIDS hogs money and may damage other health programs. By 2006, AIDS funding accounted for 80 percent of all American aid for health and population issues, according to the Global Health Council. In Ethiopia, Rwanda, Uganda and elsewhere, donations for HIV projects routinely outstrip the entire national health budgets. In a 2006 report, Rwandan officials noted a "gross misallocation of resources" in health: $47 million went to HIV, $18 million went to malaria, the country's biggest killer, and $1 million went to childhood illnesses. "There needs to be a rational system for how to apportion scarce funds," said Helen Epstein, an AIDS expert who has consulted for UNICEF, the World Bank, and others. AIDS advocates say their projects do more than curb the virus; their efforts strengthen other health programs by providing basic health services. But across Africa, about 1.5 million doctors and nurses are still needed, and hospitals regularly run out of basic medicines. Experts working on other health problems struggle to attract money and attention when competing with AIDS. "Diarrhea kills five times as many kids as AIDS," said John Oldfield, executive vice president of Water Advocates, a Washington, D.C.-based organization that promotes clean water and sanitation. "Everybody talks about AIDS at cocktail parties," Oldfield said. "But nobody wants to hear about diarrhea," he said. These competing claims on public money are likely to grow louder as the world financial meltdown threatens to deplete health dollars. "We cannot afford, in this time of crisis, to squander our investments," Dr. Margaret Chan, WHO's director-general, said in a recent statement. Some experts ask whether it makes sense to have UNAIDS, WHO, UNICEF, the World Bank, the Global Fund plus countless other AIDS organizations, all serving the same cause. "I do not want to see the cause of AIDS harmed," said Shiffman of Syracuse University. But "For AIDS to crowd out other issues is ethically unjust." De Lay argues that the solution is not to reshuffle resources but to boost them. "To take money away from AIDS and give it to diarrheal diseases or onchocerciasis (river blindness) or leishmaniasis (disfiguring parasites) doesn't make any sense," he said. "We'd just be doing a worse job in everything else."
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