Edmund's Newsletter
October 23, 2007
Issue: #43 Volume 7
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In This Issue
Cross-Species Transplant in Rhesus Macaques is Step Toward Diabetes Cure for Humans
Drug Combination Might Offer Hope for Patients with Deadly Brain Tumors
Discovery Of New Antiviral Mechanism Promising For Hepatitis C Treatment
Nicotine Patch Decreases Post-Surgical Pain
Oral Antibiotics Effective to Treat Severe Urinary Tract Infections
FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
FDA Panel Recommends Ban on Cold Medicines for Kids
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News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
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Cross-Species Transplant in Rhesus Macaques is Step Toward Diabetes Cure for Humans
With an eye on curing diabetes, scientists at Washington University School of Medicine in St. Louis have successfully transplanted embryonic pig pancreatic cells destined to produce insulin into diabetic macaque monkeys - all without the need for risky immune suppression drugs that prevent rejection.

The transplanted cells, known as primordia, are in the earliest stages of developing into pancreatic tissues. Within several weeks of the transplants, the cells became engrafted, or established, within the three rhesus macaque monkeys that received them. The cells also released pig insulin in response to rising blood glucose levels, as would be expected in healthy animals and humans.

"The approach reduced the animals' need for insulin injections and has promise for curing diabetes in humans," says senior investigator Marc Hammerman, M.D., the Chromalloy Professor of Renal Diseases in Medicine. "The transplants worked without a need for immune suppression and that is a major obstacle we have overcome."

The researchers' results appear online and will be published in the journal Xenotransplantation in November.

Drug Combination Might Offer Hope for Patients with Deadly Brain Tumors
Brain cancer patients with the poorest prognosis -- those with a type of deadly tumor known as glioblastoma multiforme (GBM) -- may survive longer with a drug that chokes off a tumor's blood supply.

According to a new study by researchers at Duke's Preston Robert Tisch Brain Tumor Center, a combination of bevacizumab -- commonly known as Avastin -- and a standard chemotherapy agent, may increase the amount of time GBM patients can survive without tumor growth, and may significantly increase their overall survival.

"For this study, we looked at patients whose tumors had returned after initial treatment, and we found that this drug combination could significantly improve outcomes for these people, who are typically given about three to six months to live," said James J. Vredenburgh, M.D., a neuro-oncologist at Duke and lead investigator on the study. "These results represent tremendous hope for these patients and their families."

The researchers published their findings in the October 20, 2007 issue of the Journal of Clinical Oncology and an editorial accompanied the publication. The study was funded by the National Institutes of Health, the Preston Robert Tisch Brain Tumor Research Fund and the Bryan Cless Research Fund.

Discovery Of New Antiviral Mechanism Promising For Hepatitis C Treatment
A team of researchers led by biologists at the University of California, San Diego has discovered a completely new mechanism that mammalian cells employ to fight infections of the Hepatitis C virus, which affects approximately 2.7 million Americans and 170 million people worldwide.

The achievement, detailed in a paper published in the October 18 issue of the journal Nature, could improve current antiviral regimens or result in new treatments that are more effective and possess fewer detrimental side effects for those with the Hepatitis C virus infection, which frequently leads to liver cirrhosis and/or liver cancer.

"Approximately two percent of the human population worldwide is infected with Hepatitis C virus," said Michael David, an associate professor of biological sciences at UC San Diego who headed the research team. "And about 50 to 80 percent of those people develop persistent infections and are at great risk of developing liver cancer."

The only approved therapy for Hepatitis C is alpha-interferon, a protein produced by animal cells when invaded by viruses that induces healthy cells to manufacture enzymes that counter the infection. Often alpha-interferon is used in combination with an antiviral drug called ribavirin. However, only 40 to 80 percent of patients respond to this therapy and about half of those who do respond relapse once interferon treatments are stopped. Only about 25 percent of those treated with interferon, which can also induce flu-like symptoms and kidney damage in some patients, rid themselves of the viral infections. Explaining these varying response rates is difficult, since scientists do not fully understand the mechanisms used by alpha-interferon to fight off Hepatitis C virus infection.

Nicotine Patch Decreases Post-Surgical Pain
The use of a nicotine patch - successfully used to help many smokers decrease their dependency on nicotine - was shown to reduce pain in men after prostate removal surgery in a new anesthesiology study.

While morphine and other opioids (narcotics) remain the most commonly prescribed post-operative pain medications, many patients fear the side effects from these drugs, which can include drowsiness, nausea, slowed breathing, vomiting, constipation, itching and dependence.

"Some patients would rather experience the pain than the potential side effects of morphine and other painkillers," said Ashraf S. Habib, M.D., associate professor of anesthesiology and director of quality improvement, Duke University Medical Center, Durham, North Carolina.

Dr. Habib's study included 90 non-smoking men about to undergo a radical retropubic prostatectomy. Each received a 7-milligram nicotine patch or an identical placebo patch before anesthesia and surgery. After surgery, each patient was able to access morphine through a self-controlled device.

Oral Antibiotics Effective to Treat Severe Urinary Tract Infections
Although doctors routinely use IV antibiotics to cure patients with severe urinary tract infections (UTI), a new review from suggests that oral antibiotics work just as well - from treating acute symptoms to preventing long-term complications of UTI.

In light of this evidence, more doctors might consider using oral antibiotics to treat patients with severe UTI, according to German reviewer Dr. Annette Pohl at University Clinic Freiburg.

This could potentially lead to far fewer hospitalizations, which, besides avoiding disruption for patients and families, could also considerably reduce hospital and related medical costs.

"UTIs cause a significant amount of financial burden on the medical system and families," said Hiep Nguyen, M.D., director of robotic surgery and research at the Urological Research Center, Children's Hospital Boston. "It costs us a couple of billion dollars a year to treat children with UTIs and that doesn't account for the money parents lose being out of work when their child is hospitalized."

Pohl cautions that treatment with oral antibiotics requires careful supervision to guarantee compliance and to make sure patients are tolerating oral drugs.

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
Potential risk of sudden hearing loss with ED drugs to be displayed more prominently

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

FDA Panel Recommends Ban on Cold Medicines for Kids
A U.S. Food and Drug Administration advisory panel on Friday recommended a ban on over-the-counter cough and cold medicines for children younger than 6.

Citing a number of studies that showed the remedies were no better than a placebo, the outside experts also recommended the drugs be tested on children to see if they are effective.

The evidence that the drugs work is "modest at best" even for adults, said Dr. Mary E. Tinetti, chairwoman of the FDA panel and a professor at Yale University School of Medicine, according to The New York Times.

In two separate votes at the end of two days of hearings on the safety of the drugs for children, the advisers said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children aged 6 to 11, failed, the Associated Press reported. The vote for additional testing of the drugs in children preceded the votes to ban the products.

The recommendations apply to medicines containing at least one of the following ingredients: decongestants, expectorants, antihistamines and antitussives, the AP reported.

Believe it or not
Forgetful doctor left body for 9 days in Vienna flat

The body of a 76-year-old woman found dead in her Vienna flat was left there for nine days because a doctor who registered the death forgot to notify a removal service, officials said on Tuesday.

The oversight was noticed when neighbours of the deceased woman, who lived alone, complained of a worsening stench, said Andreas Flaschner, spokesman for the Austrian capital's disinfection department.

"It was a mistake. The doctor thought paramedics had removed the body while the paramedics thought the doctor had arranged for it. I've worked here 20 years and never seen anything like it," said Flaschner. The body was taken for burial on October 8.
News From MedWatch
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Recently Approved Drugs/Indications
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