Pharmacy News For 3 May 2008

Top : 2008 : 2008_05_03

Intestinal virus kills at least 21 children in China

Sat, 03 May 2008 01:05:29 GMT

BEIJING - An outbreak of intestinal virus in eastern China has claimed the lives of at least 21 children and the number of reported cases has risen to nearly 2,500, the official Xinhua News Agency said Friday.
Xinhua said all those suffering from Enterovirus 71 were under age 6 and most were under age 2. The outbreak was first reported in March in Fuyang, a city in the eastern province of Anhui.

The report gave no details on the latest death from the virus, which causes fever, mouth sores and a rash with blisters.

Xinhua quoted Gao Kaiyan, director of the Anhui provincial health department, as saying the total number of infected children stood at 2,477.

It said about 700 children are hospitalized, 36 of them in serious condition, and just over 1,000 are being treated as outpatients. Some 740 youngsters have recovered, Xinhua said.

Some of the children have been diagnosed with brain, heart and lung damage, the report said.

The number of cases has steadily increased, the Anhui Health Bureau's Web site said earlier this week. An official investigation into the cause of the outbreak is under way, along with a prevention and control effort to contain infected areas, the bureau said.

The World Health Organization said Thursday that experts predict the virus will continue to spread in coming months, with a peak in June or July.

The WHO said there is no specific anti-viral therapy, adding that "in certain situations, it may be advisable to close child-care facilities and schools to reduce the intensity of transmission."

Enterovirus 71 is one of several viruses that cause hand, foot and mouth disease, which is characterized by fever, mouth sores and a rash with blisters. It is spread by direct contact with nose and throat discharges, saliva, fluid from blisters, or the stool of infected persons.

The illness mainly strikes children young than 10 and is not related to foot and mouth disease, which infects cattle, sheep and swine.


FDA says wider use of Cephalon drug carries risks of misuse

Fri, 02 May 2008 20:28:06 GMT
By MATTHEW PERRONE, AP Business Writer

WASHINGTON - Government regulators on Friday said encouraging wider use of a powerful painkiller made by Cephalon Inc. raises the risk of potentially fatal misuse of the drug.
Shares of the Frazer, Pa. drugmaker fell $2.7, or 4.2 percent, to $60.72 in morning trading.

Cephalon's drug Fentora is already approved to treat severe pain flare-ups in cancer patients. On Tuesday FDA will ask a panel of outside experts whether it should be approved to treat pain in non-cancer patients, a larger market that includes those suffering from back and nerve pain.

But FDA took a cautious tone in draft questions posted to its Web site Friday, stating that "Fentora has attributes that make it particularly attractive to abusers" and questioning whether broader approval would "lead to widespread abuse."

FDA is not required to follow the advice of its panelists, though it usually does.

The drug is currently used by about 20,000 patients, according to Cephalon. Fentora along with Actiq, an older version of the drug, accounted for 29 percent of Cephalon sales last year.

In its review of the new indication, FDA said granting wider approval could encourage "abuse and misuse, and increase the incidence of accidental exposures which ... could potentially have devastating effects."

FDA first approved the drug in 2006 with a strict indication for adults suffering from cancer pain who are already taking opioid drugs, a class of narcotics that includes morphine and codeine as well as Fentora.

But FDA said the drug has frequently been used outside those recommendations, resulting in negative side effects and death. Cephalon has reported five patient deaths due to improper use.

Prescription narcotics can quickly become addictive and are often abused for their euphoric effects.

Cephalon said in a statement Friday that there is "no evidence that Fentora poses risks of abuse and diversion greater than other opioids."

The company cited a study that showed medications like Fentora are no more appealing to heroin addicts than other types of narcotics.

Cephalon spokeswoman Stacey Beckhardt acknowledged Friday that many doctors already prescribe the drug off-label, or for uses not approved by FDA. She said the company felt a responsibility to expand the drug's FDA-approved indication to ensure it is used safely.

"Without that broader indication it is difficult for us to share important prescribing information with doctors, pharmacists and patients," Beckhardt said.

Despite the negative FDA review, Oppenheimer & Co. analyst Brett Holley maintained an "outperform" rating on the stock. Even without a larger Fentora franchise, Holley writes "the company has multiple revenue growth drivers beyond Fentora."


The Androgynous Pharaoh Akhenaten had feminine physique

Fri, 02 May 2008 20:12:56 GMT
By ALEX DOMINGUEZ, Associated Press Writer

BALTIMORE - Akhenaten wasn't the most manly pharaoh, even though he fathered at least a half-dozen children. In fact, his form was quite feminine, which has puzzled experts for years. And he was a bit of an egghead.
Dr. Irwin Braverman, a Yale University physician who analyzed images of Akhenaten, has a new theory on why. He'll be presenting his findings at an annual conference Friday at the University of Maryland School of Medicine on the ailments and deaths of historic figures.

The female form was due to a genetic mutation that caused the pharaoh's body to convert more male hormones to female hormones than needed, Braverman believes. And Akhenaten's head was misshapen because of a condition in which skull bones fuse at an early age.

The pharaoh had "an androgynous appearance. He had a female physique with wide hips and breasts, but he was male and he was fertile and he had six daughters," Braverman said. "But nevertheless, he looked like he had a female physique."

Braverman, who sizes up the health of individuals based on portraits, teaches a class at Yale's medical school that uses paintings from the university's Center for British Art to teach observation skills to first-year students. For his study of Akhenaten, he used statues and carvings.

Akhenaten , best known for introducing a revolutionary form of monotheism to ancient Egypt, reigned in the mid-1300s B.C. He was married to Nefertiti, and Tutankhamun, also known as King Tut, may have been his son or half brother.

Egyptologist and archaeologist Donald B. Redford was interested in Braverman's findings and looked forward to the conference but said he currently supports an older theory. He believes that Akhenaten had Marfan syndrome, a genetic disorder marked by lengthened features, including fingers and the face.

Visiting clinics that treat those with the condition has strengthened that conviction, "but this is very subjective, I must admit," said Redford, a professor of classic and ancient Mediterranean studies at Penn State University.

Others have theorized Akhenaten and his lineage had Froehlich's syndrome, which causes feminine fat distribution but also sterility. That doesn't fit Akhenaten, who had at least six daughters, Braverman said.

Klinefelter syndrome, a genetic condition that can also cause gynecomastia, or male breast enlargement, has also been suggested, but Braverman said he suspects familial gynecomastia, a hereditary condition that leads to the overproduction of estrogen.

The Yale doctor said determining whether he is right can easily be done if Egyptologists can confirm which mummy is Akhenaten's and if Egyptian government officials agree to DNA analysis.

Braverman hopes his theory will lead them to do just that.

"I'm hoping that after we have this conference and I bring this up, maybe the Egyptologists who work on these things all the time, maybe they will be stimulated to look," he said.

Previous conferences have examined the deaths of Edgar Allan Poe, Alexander the Great, Wolfgang Amadeus Mozart, Florence Nightingale and others.




Medical marijuana user who was denied liver transplant dies

Fri, 02 May 2008 20:27:41 GMT

SEATTLE - A man who was denied a liver transplant largely because he used marijuana with medical approval to ease the symptoms of hepatitis C has died.
Timothy Garon, 56, died Thursday at Bailey-Boushay House, an intensive care nursing center, said his lawyer, Douglas Hiatt, and Alisha Mark, a spokeswoman for Virginia Mason Medical Center, which operates Bailey-Boushay.

His death came a week after a doctor told him a University of Washington Medical Center committee had again denied him a spot on the liver transplant list. The team had previously told him it would not consider placing him on the list until he completed a 60-day drug-treatment class.

The case highlights an ethical consideration for those allocating organs for transplant: whether using dope with a doctor's blessing should be held against a dying patient in need of a transplant.

The Virginia-based United Network for Organ Sharing, which oversees the nation's transplant system, leaves it to individual hospitals to develop criteria for transplant candidates.

At some, people who use "illicit substances" — including medical marijuana, even in the dozen states that allow it — are automatically rejected. At others, patients are given a chance to reapply if they stay clean for six months. Marijuana is illegal under federal law.

Dr. Brad Roter, who authorized Garon to smoke pot to alleviate nausea and abdominal pain and to stimulate his appetite, said he did not know it would be such a hurdle if Garon were to need a transplant.

Garon told The Associated Press last week he believed he contracted hepatitis C by sharing needles with "speed freaks" as a teenager. In recent years, he said, pot was been the only drug he used.




Special Diet Can Ease Epileptic Seizures in Kids

Sat, 03 May 2008 03:47:38 GMT

FRIDAY, May 2 -- The "ketogenic" diet, which features high levels of fat, low levels of carbohydrates and controlled protein intake, helps control and prevent seizures in children with drug-resistant epilepsy, a new study finds.

The trial is the first randomized controlled study to confirm that the ketogenic diet -- widely used since the 1920s -- is effective against epilepsy, the British researchers said.


Experts believe that the regimen's high fat and restricted carbohydrate content mimics the biochemical response to starvation, when compounds called ketone bodies provide the main source of energy for the brain.


Ketone bodies are byproducts produced when fatty acids are broken down for energy in the liver and kidneys. They are used as energy sources in the heart and brain. In the brain, ketone bodies are a crucial source of energy when a person fasts.


This University College London study included 145 children, aged 2 to 16, who suffered seizures at least once a day or more than seven seizures per week. These patients hadn't responded to treatment with at least two epileptic drugs, and hadn't previously been placed on the ketogenic diet.


Baseline information about the children's seizures was first recorded. Seventy-three of the children started the ketogenic diet immediately, while the other 72 started it after a three-month delay. The delay group acted as a control group during the study. Complete data was obtained from 54 children in the diet group and 49 children in the control group.


The overall number of seizures in the diet group declined by more than 38 percent, while seizures in the control group increased by 36.9 percent, the researchers report. The study found that 28 of the 54 children who completed three months in the diet group had a greater than 50 percent reduction in seizures, compared to four of 49 children in the control group. Five children in the diet group had more than 90 percent fewer seizures. None of the children in the control group experienced that kind of improvement.


The study appears in the current online edition of The Lancet Neurology and will appear in the June print issue.


"We have shown that the diet has efficacy and should be included in the management of children who have drug-resistant epilepsy. However, the diet is not without possible side effects, which should be considered alongside the risk-benefit of other treatments when planning the management of such children," the study authors wrote.


More information is needed about the long-term effects of the ketogenic diet, such as changes in blood fat concentrations and ketosis, Dr. Max Wiznitzer, of Rainbow Babies and Children's Hospital in Cleveland, wrote in an accompanying comment article.


"Better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed," he wrote.


More information


The Epilepsy Foundation has more about the ketogenic diet.



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