Edmund's Newsletter June 24, 2008 Issue: #26 Volume 8 Join Our List In This Issue FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Hormone May Help Dieters Keep Weight Off Novel Compound May Treat Acute Diarrhea Should Doctors Be 'Selling' Drugs For The Pharmaceutical Industry? FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs Study Links Vitamin D to Colon Cancer Survival Same Drug, Different Results Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days Drug Shortages Quick Links Edmund's Blog Edmund's Newsletter Edmund's Web Page Past Issues SPECIAL THANKS TO Michael R. Cohen President The Institute for Safe Medication Practices and Dr. Stephen Barrett Quackwatch Some links in Edmund's Newsletter will point to a page that requires registration.  In all cases the most you will have to do is fill out a simple form to enroll as a member.  In no case will I point you to a site that requires payment to view the page. PRAY FOR PEACE © 2001,2002, 2003, 2004, 2005, 2006, 2007 Join Our List FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm. "Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs. "These warning letters are an important step to ensure that consumers do not become the victim of false 'cures' that may cause greater harm to their health." Read more..... Hormone May Help Dieters Keep Weight Off: U.S. Falling levels of a hormone called leptin that helps the brain resist tempting foods may explain why people who lose weight often have a hard time keeping it off, U.S. researchers said on Friday. Restoring leptin to pre-diet levels may reverse this problem, they said, offering a way for weary dieters to finally win the weight battle. "When you lose weight you've created about the perfect storm for regaining weight," said Michael Rosenbaum of Columbia University Medical Center in New York, whose research appears in the Journal of Clinical Investigation. After weight loss Rosenbaum said the metabolism not only becomes more efficient, so the body needs fewer calories, but the brain becomes more vulnerable to tasty-looking treats. Read more..... Novel Compound May Treat Acute Diarrhea In a development that may lessen the epidemic of diarrhea-related deaths among children in developing countries, scientists in the laboratory of Nobel Laureate Ferid Murad, M.D., Ph.D., at The University of Texas Health Science Center at Houston have discovered a novel compound that might lead to an inexpensive, easy-to-take treatment. The results of pre-clinical tests appear in the June 16 online edition of the journal Proceedings of the National Academy of Sciences of the United States of America. The compound - a pyridopyrimidine derivative - targets acute secretory diarrhea caused by E. coli and other enterotoxigenic strains of bacteria, which produce toxins that stimulate the linings of the intestines, causing them to secrete excessive fluid, thereby producing diarrhea. Diarrhea kills an estimated 1.6 to 2.5 million children every year, according to researchers quoted in the Bulletin of the World Health Organization. Enterotoxigenic strains of bacteria may account for a significant amount of these deaths, according to an article in Clinical Microbiology Reviews. Enterotoxigenic E. coli or ETEC is a leading cause of bacterial diarrhea. During pre-clinical tests, the compound was associated with a significant reduction in intestinal fluid secretion in an animal model of bacterial diarrhea. It was also linked to reduced fluid build up during laboratory tests on human colon cells. It caused significant decrease in fluid secretion without apparent toxicity. Read more..... Should Doctors Be 'Selling' Drugs For The Pharmaceutical Industry? Are senior doctors who help drug companies sell their drugs independent experts or just drug representatives in disguise, asks Ray Moynihan from the University of Newcastle in Australia, in the British Medical Journal. Moynihan exposes the reality behind the practice with some candid revelations from industry insiders. Pharmaceutical companies regularly sponsor leading specialists with "generous fees to peddle influence" and promote drugs to the profession and the public, writes Moynihan. Drug companies will pay influential doctors up to $400 an hour to act as key opinion leaders, and some doctors earn more than $25,000 a year in advisory fees. Kimberly Elliot, a former award-winning drug company sales representative interviewed by Moynihan, reveals that drug companies desperately need key opinion leaders in order for doctors to believe what they are saying and prescribe their products, because drug representatives are often not believed. Essentially, she says, key opinion leaders are just salespeople. Read more..... FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis. "It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia." Read more..... Study Links Vitamin D to Colon Cancer Survival Patients diagnosed with colon cancer who had abundant vitamin D in their blood were less likely to die during a follow-up period than those who were deficient in the vitamin, according to a new study by scientists at Dana-Farber Cancer Institute. The findings of the study - the first to examine the effect of vitamin D among colorectal cancer patients - merit further research, but it is too early to recommend supplements as a part of treatment, say the investigators from Dana-Farber and the Harvard School of Public Health. In a report in the June 20 issue of the Journal of Clinical Oncology, the authors note that previous research has shown that higher levels of vitamin D reduce the risk of developing colon and rectal cancer by about 50 percent, but the effect on outcomes wasn't known. To examine this question, the investigators, led by Kimmie Ng, MD, MPH, and Charles Fuchs, MD, MPH, of Dana-Farber, analyzed data from two long-running epidemiologic studies whose participants gave blood samples and whose health has been monitored for many years. They identified 304 participants in the Nurses' Health Study and the Health Professionals Followup Study who were diagnosed with colorectal cancer between 1991 and 2002. All had had vitamin D levels measured in blood samples given at least two year prior to their diagnosis. Each patient's vitamin D measurement was ranked by "quartiles" - the top 25 percent, the next lowest 25 percent, and so on. Those whose levels were in the lowest quartile were considered deficient in vitamin D.  Read more..... Same Drug, Different Results" Minor genetic differences between individuals change the effect of a common medication, study shows Medicine has moved a little bit closer to the era of tailor-made treatments, based on the unique genetic profiles of individual patients, according to recent research conducted by Dr Rima Rozen of the Research Institute of the McGill University Health Centre (RI MUHC) at the Montreal Children's Hospital and McGill University. Her study, published June 18 in the journal Pharmacogenetics and Genomics, shows how minor genetic differences between individuals alter the way a common drug affects the body. Rozen has measured the impact of Methotrexate -- a drug that inhibits the metabolism of folate -- on mice with an altered MTHFR gene, which is a gene crucial for folate metabolism. The results were striking: after treatment with Methotrexate, mice with the altered gene had approximately 20 per cent less hemoglobin and red blood cells than their counterparts with non-altered genes. The altered mice also showed increased susceptibility to liver and kidney damage following treatment. "We know that these results are applicable to humans because a parallel mutation in the human MTHFR gene affects human folate metabolism similarly. The results demonstrate that medication affects subjects differently according to individual genetic traits," Dr. Rozen explained. "And tests exist to detect this mutation." Genetic testing would allow physicians the modify treatment based on each patient's personal genetic makeup, limiting potential side effects. Read more..... Believe it or not NC 'Big twins' tip scales at a combined 23 pounds They aren't America's heaviest newborn twins on record, but they certainly tip the scales: Sean William Maynard and Abigail Rose Maynard weighed in at a combined 23 pounds and 1 ounce at birth this week, a North Carolina hospital announced Friday.   Freda Springs, spokeswoman for Forsyth Medical Center, said the twins were delivered two minutes apart by Caesarean section on Tuesday at the center's Sara Lee Center for Women's Health in Winston-Salem. The boy weighed 10 pounds, 14 ounces; the girl, 12 pounds, 3 ounces. Springs said both babies are in excellent condition after their birth to parents Joey and Erin Maynard of Winston-Salem. The combined weight of the twins is about four pounds shy of the combined weight of twins born in Arkansas in 1927, the hospital said. Those twins weighed a total of 27 pounds, 12 ounces, hospital researchers said, adding they could find no public record of any heavier twins than the Arkansas pair born since 1900. They said the Maynard twins topped a 1997 delivery in North Carolina of big twins weighing a total of 18 pounds, 10 ounces. Sean, tucked in a blue blanket, was held by his mother and his sister, swaddled in pink, was cradled by her father at a hospital news conference Friday. The infants slept quietly through their first public appearance. 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  CLICKING HERE   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 by CLICKING HERE   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   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   Recommend Edmund's Newsletter Edmund's Newsletter is published for only one reason and that is expand our knowledge base, join people together with like minds and to disseminate valuable information. If you feel this newsletter is of worth, please pass it along to your friends and colleagues. 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