IN THIS ISSUE:

• Hormone Inhibitor Promising For Hard-to-treat Prostate Cancer
   
• Pills Becoming The New Marijuana On Campus
   
• FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet
   
• Rash From Newer Cancer Drugs Linked To Longer Survival
   
• Medical Tourism Takes Flight
   
• Chemotherapy May Enhance the Effectiveness of Brain Tumor Vaccines
   
• Study Shows Surgery Is More Effective Than Other Treatments for Common Back Problem

• Believe It Or Not

• News From MedWatch

• Research Update

• Recently Approved Drugs/Indications

• FDA Recalls and Safety Alerts in the Past 60 Days

• Drug Shortages

• Recommend Edmund's Newsletter

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Hormone Inhibitor Promising For Hard-to-treat Prostate Cancer

For prostate cancer patients whose tumors have continued to grow despite medical or surgical castration, a new drug candidate that inhibits production of male hormones anywhere in the body is showing promise in early trials.
Two poster presentations at the recent ESMO Conference Lugano show that the drug, called abiraterone, reduced levels of "prostate specific antigen", a marker of cancer activity, and shrank tumors in patients in whom hormone therapy had stopped working and also in patients who had previously been treated with chemotherapy.
Male hormones such as testosterone are produced mainly in the testes, but are also produced by the adrenal gland and elsewhere in the body. These hormones can stimulate prostate cancer cells to grow, so the first treatment option for all men with prostate cancer that has spread, is to use chemical suppressants or surgery to inhibit testicular synthesis of male hormones. However, this treatment does not block the production of male hormones elsewhere in the body. Abiraterone, a drug that is taken orally, inhibits an enzyme called CYP450c17, which is critical to the production of the male hormones -- not only in the testes, but also at other sources.
Dr. Alison Reid from The Institute of Cancer Research and Dr. Gerhardt Attard from The Institute and The Royal Marsden NHS Foundation Trust in London described two ongoing Phase II trials of the drug in men with advanced prostate cancer.


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Pills Becoming The New Marijuana On Campus

The prescription drugs allegedly found in Al Gore III's possession this week are favorites among young people, according to drug abuse experts, who say prescription drugs may soon overtake street drugs in popularity.
Some young people perceive that prescription drugs are safer than street drugs, experts say.
"I wouldn't be surprised if right now at this point in time, there are more kids abusing prescription drugs than abusing marijuana," said Joseph A. Califano Jr., chairman and president of CASA, the National Center on Alcohol and Substance Abuse at Columbia University.
Gore was arrested on charges of possessing -- in addition to marijuana -- Vicodin, Xanax, Valium and Adderall.
According to a CASA report, between 1993 and 2005 the proportion of college students abusing Vicodin and other opiods went up 343 percent, about 240,000 individuals. The numbers increased 450 percent, or by 170,000 students, for tranquilizers such as Xanax and Valium, and 93 percent, or 225,000 students, for stimulants, including Adderall.
Prescription drug abuse is particularly common among upper middle class students, according to Lisa Jack, a clinical psychologist at Augsburg College in Minneapolis, Minnesota.

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FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet

The U.S. Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet.
New data collected by the FDA show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States. This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription.

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Rash From Newer Cancer Drugs Linked To Longer Survival

The appearance of a rash in cancer patients treated with erlotinib (Tarceva) is strongly associated with longer survival, according to researchers from the drug’s developer, OSI Pharmaceuticals, Inc.
This is not the first time that rash has been associated with a survival advantage with EGFR inhibitors – a class of drugs which includes erlotinib, cetuximab (Erbitux), panitumumab (Vectibix) and others designed to block overproduction of the epidermal growth factor receptor – but it is the most detailed analysis to date.
The rash, which often looks like acne, can be unpleasant enough for some people to consider discontinuing treatment, but “it is important for physicians and patients to understand that this is a positive event because it means there is likely to be a better clinical outcome,” said the lead author, Bret Wacker director of biostatistics at OSI Pharmaceuticals, Inc. “Further studies are needed to both identify patients most likely to develop rash and to determine if dose escalation to induce rash can improve efficacy.”
The study, published in the July 1 issue of Clinical Cancer Research, a journal of the American Association for Cancer Research, reports that for patients taking Tarceva who developed a moderate to severe rash, survival without progression of disease was 245 percent longer than in patients who had a mild rash or none at all. In fact, in the majority of cases, the more severe the rash, the longer a patient’s cancer was held in check, researchers found.

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Medical Tourism Takes Flight

Soaring U.S. medical costs are causing many Americans to take to the skies on "medical tourism" junkets, looking for high-quality yet low-priced health care at foreign clinics.
In many cases, patients get exactly what they are looking for, but experts also warn that the booming industry does have some risks.
"My own advice would be to look carefully at the accreditation of the hospital and consider the nature of the procedure. Are you sure it is the procedure you need? And is it done well at the place you are going?" said Dr. Ann Marie Kimball, a professor of epidemiology and health services at the University of Washington School of Public Health, in Seattle.
The surge in medical tourism over the past decade is being driven by rising U.S. health-care costs and growing numbers of uninsured or under-insured Americans, said Josef Woodman, the author of a guidebook on the topic called Patients Beyond Borders.
Almost 45 million Americans, or slightly more than 15 percent of the population, are currently uninsured, according to U.S. Census Bureau statistics from 2005, the latest available.
Woodman estimated that more than 150,000 Americans traveled abroad for health care in 2006. The number is projected to double in 2007, he said.

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Chemotherapy May Enhance the Effectiveness of Brain Tumor Vaccines

Chemotherapy temporarily hinders the body's immune response, creating a concern that it may interfere with the promising new cancer vaccines being used against brain tumors. But a new study led by researchers at the Preston Robert Tisch Brain Tumor Center at Duke University and The University of Texas M. D. Anderson Cancer Center has found that the opposite is true: chemotherapy may actually enhance the effectiveness of the vaccines.
"In its quest to kill cancer cells, chemotherapy also wipes out immune cells," said John Sampson, M.D., Ph.D., a neurosurgeon at Duke and lead investigator on the study. "But we found that the process by which they regenerate makes them strong and hungry -- in a sense, they come back with a vengeance."
Cancer vaccines are drugs that enlist the help of the body's immune system to fight cancer cells. "Since the introduction of a vaccine serves to boost immune function, these hungry immune cells become even more effective in targeting and fighting off foreign invaders, such as tumor cells," Sampson said.
The researchers will present their findings in a poster presentation on Sunday, June 3, at the American Society of Clinical Oncology annual meeting, in Chicago. The study was funded by the National Institutes of Health, Celldex Therapeutics, the Rose Foundation and donations from cancer patients and their families.

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Study Shows Surgery Is More Effective Than Other Treatments for Common Back Problem

When it comes to low back pain, physicians generally advise exhausting nonsurgical options before resorting to surgery. But a new study shows that for degenerative spondylolisthesis with spinal stenosis, surgery provides significantly better results than nonsurgical alternatives. The study, published in the May 31 issue of the New England Journal of Medicine, is the second in a series reporting findings of the Spine Patients Outcomes Research Trial (SPORT), a five-year, multicenter study supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health.
Degenerative spondylolisthesis is a condition in which breakdown of the cartilage between the vertebrae of the spine causes one vertebra to slip over the one below. This can result in narrowing of the spinal column (spinal stenosis), which can put pressure on the nerves, resulting in pain in the buttocks or legs with walking or standing. The condition generally occurs after age 50 and it affects six times as many women as men.
The management of degenerative spondylolisthesis with spinal stenosis is controversial, says James N. Weinstein, D.O., M.Sc., lead author and chairman of the Departments of Orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School. Surgery is widely used, but its effectiveness in comparison with nonsurgical treatment had not been demonstrated in controlled clinical trials. The purpose of this arm of the SPORT trial was to make that comparison.

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Believe It Or Not

German man's smelly feet trigger police raid

German police broke into a darkened flat fearing they would find a dead body after neighbours complained of a nasty smell seeping out onto the staircase.
The shutters of the apartment had been closed for more than a week and the post-box was filled with uncollected mail.
But instead of a corpse police found a tenant with badly smelling feet asleep in bed next to a pile of foul-smelling laundry, police in the south-western town of Kaiserslautern said on Sunday.

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News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICK HERE

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Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs CLICK HERE

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FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

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Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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