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Serbia marks World No Tobacco Day

May 31st, 2008 by Luis
Belgrade - A hearse with a sign Still smoking? See you soon might sound a bit morbid, but in Serbia where every second man and every third woman smoke, it might just be the right thing to make them stop. Serbia was Saturday marking World No Tobacco...

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FDA: Time for asthma patients to switch inhalers

May 31st, 2008 by Luis
WASHINGTON (AP) -- Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end - and the government is urging patients not to wait until the last minute to switch to newer alternatives.

Patients use inhalers to dispense airway-relaxing albuterol during asthma attacks.

Chemicals called chlorofluorocarbons, or CFCs, once were widely used to propel the drug into the lungs. But CFC-containing consumer products are being phased out because CFCs damage the Earth's protective ozone layer. As of Dec. 31, asthma inhalers with CFCs can no longer be made or sold in the U.S. Inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes.

The ozone layer shields the planet from harmful ultraviolet radiation.

Patients have been warned of the change for several years, but the Food and Drug Administration issued an advisory Friday saying anyone still using CFC inhalers should ask their doctor about switching now.

The FDA warns that patients will face a learning curve: HFA inhalers may taste and feel different. The spray may feel softer. Each must be primed and cleaned in a specific way to prevent clogs. And they tend to cost more.

CFC-free albuterol inhaler options include GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Teva Specialty Pharmaceuticals' ProAir HFA. Sepracor's Xopenex HFA is also CFC-free, but it contains levalbuterol, a similar medication.

The FDA said Armstrong Pharmaceuticals is the sole remaining maker of CFC inhalers and is expected to stop production even before the deadline. A spokesman for Armstrong's parent company wouldn't say when production would stop, but sales of remaining inventory will continue until Dec. 31.

© 2008 The Associated Press.

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FDA panel favors Glaxo, Ligand blood drug

May 31st, 2008 by Luis
WASHINGTON (AP) -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists.

A panel of 16 outside advisers voted unanimously in favor of Promacta at a meeting held in Chicago, said FDA spokeswoman Karen Riley. The drug is designed to treat an immune system disorder that causes the body to destroy its own platelets, which can cause excessive bleeding.

The decision sent shares of San Diego-based Ligand soaring $1.16, or 49.4 percent, to $3.51 on heavy volume. Shares of GlaxoSmithKline PLC rose 55 cents, or 1.3 percent, to $44.53.

Panel members noted that the companies have not provided long-term data on the drug, but said results from two, six-week studies appeared to show significant benefit. Long-term studies should be available by the end of the year, according to the companies.

British drugmaker Glaxo and partner Ligand want Promacta approved to treat patients' with chronic idiopathic thrombocytopenic purpura, which causes excessive bruising and bleeding. About 60,000 people in the U.S. have the disease, according to Glaxo.

The FDA has until June 19 to make a final decision on the drug. It is not required to follow the advice of its outside panel, though it often does.

The panel's opinion came as a surprise to Wall Street, since the FDA on Wednesday released its own negative review of the drug. That news walloped Ligand's shares, sending them to their lowest point in at least 10 years, $2.16, only to recover by day's end at $2.30, still down 36 percent. The company has been a Glaxo partner since 1997.

Agency reviewers said that the drug did not significantly lower bleeding compared with a placebo in two studies submitted by the companies.

FDA scientists also raised concerns about liver toxicity and the drug's safety in long-term use. Although the companies are seeking approval for short-term use, the FDA cautioned that doctors could continue prescribing the drug for extended periods of time.

Susquehanna Financial Group analyst Derek Jellinek faulted GlaxoSmithKline's clinical testing strategy for the critical FDA documents. While the company applied for short-term use for Promacta, GlaxoSmithKline instead studied patients with the chronic condition who need long-term treatment, he said in a note to investors Thursday.

That choice of chronic patients could complicate the company's dealings with the FDA, he said, "because the agency believes that short-term data may not immediately translate into long-term results."

Jellinek reaffirmed a "Positive" rating but lowered his price target to $7 from $8.

Friday's panel vote could put pressure on biotech giant Amgen, which is awaiting an approval decision on a similar drug called Nplate. The same FDA advisory panel that supported Promacta on Friday also unanimously supported Amgen's drug in March. The FDA is scheduled to make a decision on Nplate by July 23.

Amgen is seeking approval for long-term use of its drug, a company spokeswoman noted Friday, which would distinguish it from Promacta. Amgen also has conducted three years worth of studies on patients with the blood disorder, the longest of any company, she said.

Shares of Thousand Oaks, Calif.-based Amgen Inc. rose 61 cents, or 1.4 percent, to $44.03.

© 2008 The Associated Press.

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Report: UCLA gave transplant to Japanese gang boss

May 31st, 2008 by Luis
LOS ANGELES (AP) -- A Los Angeles hospital provided liver transplants to four Japanese gang figures, including one of Japan's most powerful gang bosses, over a period when several hundred area patients died while awaiting transplants, according to a published report.

The surgeries were performed at UCLA Medical Center by world-renowned liver surgeon Dr. Ronald W. Busuttil, executive chairman of UCLA's surgery department, the Los Angeles Times reported in a story posted on its Web site Thursday night. The Times cited a person familiar with the matter who spoke on condition of anonymity.

The surgeries were performed between 2000 and 2004, and in each of those years more than 100 patients died awaiting liver transplants in the greater Los Angeles region, according to the Times.

There is no indication UCLA or Busuttil knew any of the patients had ties to Japanese gangs, known as yakuza, the Times reported. The school and Busuttil said in statements they don't make moral judgments about patients, but treat them according to medical need.

U.S. transplant rules do not prohibit hospitals from performing transplants on foreign patients or those with criminal histories.

Tadamasa Goto, who had been barred from entering the United States because of his criminal history, was the most prominent transplant recipient. He leads a gang called the Goto-gumi, according to the Times.

With help from the FBI, Goto obtained a visa to enter America in 2001 in exchange for leads on potentially illegal activity in this country by Japanese criminal gangs, Jim Stern, retired chief of the FBI's Asian criminal enterprise unit in Washington, told the Times. The FBI did not help Goto arrange his surgery with UCLA.

The FBI didn't get much out of Goto, Stern said.

"I don't think Goto gave the bureau anything of significance," Stern said. Goto "came to the States and got a liver and was laughing back to where he came from. ... It defies logic."

Stern said he was not involved with the deal, and learned of it when he became unit chief in 2004. He said he continues to be troubled by it.

After the transplant, Goto was again barred from re-entering the U.S., the Times said, citing a law enforcement official who was not authorized to discuss the matter publicly and requested anonymity.

Busuttil performed liver transplants at UCLA on three other men now barred from entering the U.S. because of their criminal records or suspected affiliation with Japanese organized crime groups, the Times said, citing a law enforcement official who spoke on condition of anonymity.

The Times said it was not naming those three transplant recipients because neither they nor their lawyers could be reached.

Goto underwent a successful transplant in July 2001. He received the liver of a young man who died in a traffic accident, said Goto's Tokyo-based lawyer, Yoshiyuki Maki.

"Goto is over 60 now, but his liver is young," Maki said.

Goto continued to receive medical care from Busuttil in Japan. Busuttil traveled there and examined Goto more than once, Maki said. Busuttil also evaluated Goto while he was in custody in 2006, Maki said.

In May 2006, Goto was arrested in Japan on suspicion of real estate fraud. He was acquitted of the charges in March of this year.

It is unclear when Goto joined UCLA's waiting list, but he had been in the U.S. two months when he received a new liver, the Times reported. Overall, 34 percent of the patients added to UCLA's liver waiting list between January 1999 and December 2001 received a new liver within three years of being listed, the Times reported, citing national transplant statistics.

"The more critically ill you are, the higher on the list you move," UCLA spokeswoman Roxanne Moster said Friday.

In a statement, the UCLA Health System said privacy laws prevented it from commenting on specific cases.

Busuttil, a former president of the American Society of Transplant Surgeons who has testified before Congress on who should receive priority for transplants, released a statement this week.

"As a surgeon, it is not my role to pass moral judgment on the patients who seek my care," read the statement, which didn't directly address the Japanese patients. "If one of my patients, domestic or international, were in a situation that could be life-threatening, of course I would do everything in my power to assure that they would receive proper care."

It could not be determined how much UCLA and Busuttil were paid for the Japanese transplants, the Times reported.

© 2008 The Associated Press.

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Baby born after rare ovarian pregnancy

May 31st, 2008 by Luis
SYDNEY, Australia (AP) -- A woman in a northern Australian city gave birth to a healthy baby girl after a rare full-term ectopic pregnancy, a hospital official said Friday.

Meera Thangarajah, 34, had no symptoms or complications during her pregnancy, so doctors performing a routine Caesarean section Thursday were shocked to find that the baby had developed in the ovary rather than the uterus.

An ectopic pregnancy, which occurs when a fertilized egg develops outside of the uterus, usually miscarries or is terminated by doctors because of the threat it can cause to the mother.

Baby Durga weighed 6 pounds, 3 ounces, and both she and her mother are healthy, said Robyn Cahill, general manager of the Darwin Private Hospital.

"We're calling it a miracle," Cahill told The Associated Press.

The baby's father, Ravi Thangarajah, told Nine Network television that doctors had told him, "You're one of the luckiest men in the world at the moment."

But Cahill said the mother had no complications or symptoms of an ectopic pregnancy, and it did not show up on a scan halfway through the pregnancy. She said only 1 in 40,000 fertilizations implant in the ovary, and it is unheard of that one of those fetuses grow to full term, generally 37 weeks.

Durga was born at 38 weeks.

"It is extremely rare," said Mark Erian, a specialist in high-risk obstetrics at the University of Queensland. "I have never seen a case that progresses until fetal viability. She was absolutely lucky to have the pregnancy progress."

© 2008 The Associated Press.

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