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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