Edmund's Newsletter December 25, 2007 Issue: #52 Volume 7 Join Our List In This Issue Vitamin B-12 Function May Be Diminished By Excessive Folate Drug Study for Brain Cancer Shows Promising Results Three-Drug Combination "Extremely Promising" As First-Line Therapy for Multiple Myeloma Drug Aimed at Two Bioterror Agents Blocks Live Viral Infection Older Antibiotic Gains New Respect as Potent Treatment for Tuberculosis Cardiovascular Disease Death Rates Decline, But Risk Factors Still Exact Heavy Toll 7 Medical Myths That Might Have Your Doctor Duped Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days 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 Vitamin B-12 Function May Be Diminished By Excessive Folate In a study of adults aged 20 and over, researchers at Tufts University showed that homocysteine and methylmalonic acid are at much higher levels in individuals who have a combination of vitamin B12 deficiency and high blood folate levels than in individuals who are also vitamin B12 deficient but have normal folate levels. Homocysteine and methylmalonic acid, compounds used by enzymes that contain vitamin B12, accumulate in the blood in patients who are vitamin B12 deficient. "Finding that the combination of high blood folate levels and low vitamin B12 status is associated with even higher levels of these compounds is a strong indication that the high folate is interfering with the action of these B12-containing enzymes, thus resulting in the exacerbation or worsening of the vitamin B12 deficiency," says corresponding author Jacob Selhub, Ph.D., director of the Vitamin Metabolism Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (USDA HNRCA). In an earlier study, Selhub and co-authors Martha Savaria Morris, Ph.D., and Paul Jacques, D.Sc, also of the USDA HNRCA, have shown that the prevalence of anemia and cognitive impairment among U.S. elderly who are vitamin B12 deficient is much worse if this B12 deficiency is also accompanied by high blood folate rather than normal blood folate. This indicates that the worsening of the vitamin B12 deficiency, as indicated by higher homocysteine and methylmalonic acid due to high blood folate, is also manifested clinically through higher prevalence of anemia and cognitive impairment. Read more..... Drug Study for Brain Cancer Shows Promising Results A clinical study conducted at Henry Ford Hospital on the use of a drug to extend the survival of patients with the most common and aggressive type of brain cancer, has yielded results that were significantly better than expected. The randomized Phase II study focused on patients with glioblastoma multiforme (GBM), whose cancer had recurred after first- or second-line therapy. The study revealed that more than a third who were treated with Avastin (bevacizumab) alone, as well as more than half of those treated with Avastin in combination with the chemotherapy drug irinotecan, lived without further progression of the disease for a period of six months. In addition, no new or unexpected adverse effects from the use of Avastin were observed during the study. "This is very encouraging news," says Tom Mikkelsen, M.D., a neuro-oncologist who is the study's principal investigator at Henry Ford and co-director of the Hermelin Brain Tumor Center. "Historical estimates suggest that only 15 percent of patients with this aggressive type of brain cancer live without their cancer progressing within six months. Although gliomas [fast-growing malignant brain tumors] are nearly always incurable, use of a drug like Avastin may help to buy precious time for patients, as well as to preserve their physical and mental functions longer than was previously possible." Avastin is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that stimulates development of new blood vessels in a process known as angiogenesis, while maintaining existing tumor vessels. By binding to VEGF, Avastin acts as an anti-angiogenesis agent that chokes off the blood supply to tumors, which in turn inhibits their growth and metastasis.  Read more..... Three-Drug Combination "Extremely Promising" As First-Line Therapy for Multiple Myeloma A new combination of bortezomib (Velcade) and two other drugs is showing a very high response rate in patients newly diagnosed with multiple myeloma, a team headed by Dana-Farber Cancer Institute investigators reported at the annual meeting of the American Society of Hematology. The three-pronged regimen of Velcade, lenalidomide (Revlimid) and dexamethasone - referred to as Rev/Vel/Dex - has achieved an overall response rate of 98 percent in 42 patients evaluated thus far in a Phase 1-2 trial, said Paul Richardson, MD, of Dana-Farber and the study's principal investigator. He added that 52 percent of the patients had high quality responses (very good partial response or better), with 30 percent achieving complete response to date. "These may be some of the best response rates we've seen to date with up-front therapies, and although these are preliminary results, they are extremely promising," Richardson said. The patients were previously untreated when they received the Rev/Vel/Dex combination. Velcade is a "smart" drug known as a proteasome inhibitor that blocks the myeloma cells' waste disposal system, creating an accumulation of toxic compounds that poison the cell. Revlimid is a chemical relative of thalidomide that affects several pathways in cancer cells, including immune mechanisms and blood vessel growth to tumors. Dexamethasone is a steroid hormone that counters inflammation and is used to treat hematologic malignancies such as myeloma. Studies leading to the trial of the three drugs in combination were carried out at Dana-Farber. Read more..... Drug Aimed at Two Bioterror Agents Blocks Live Viral Infection Two deadly and highly infectious viruses-both potential bioterror threats-may have met their match in a new drug developed by scientists at Weill Cornell Medical College in New York City. Hendra and Nipah viruses are related, newly recognized zoonotic viruses that can spread from their natural reservoir in fruit bats to larger animals-including pigs, horses and humans. The mode of transmission isn't clear, but is thought to be relatively easy-either by close contact with an infected host or by breathing in the microscopic pathogens. Infection often leads to a fatal encephalitis, and there is currently no effective treatment against these illnesses. However, in breakthrough research conducted last year, researchers at Weill Cornell manipulated a peptide (protein) related to a third pathogen, parainfluenza virus, that appeared to block "pseudo" Hendra and Nipah viruses from entering and infecting human cells. Now, this "entry inhibitor" approach has proven effective in blocking the infection of live virus in animal cells, pointing the way to a drug that could be stockpiled to help stop an outbreak in humans. Those findings appeared recently in the Journal of Virology. Read more..... Older Antibiotic Gains New Respect as Potent Treatment for Tuberculosis It has no current market, not even a prescription price.  Its makers stopped commercial production years ago, because demand was so low.  But an antibiotic long abandoned as a weak, low-dose treatment for tuberculosis (TB) may have found renewed purpose, this time as a potent, high-dose fighter against the most common and actively contagious form of the lung disease. "Rifapentine is back," says Johns Hopkins infectious disease specialist Eric Nuermberger, M.D., whose studies in mice, to be published in the Public Library of Science journal PLoS Medicine online Dec. 17, have found it so promising as an initial treatment for active TB that clinical trials are scheduled to begin next year in at least eight countries. The mouse studies showed that substituting higher and daily doses of rifapentine for another antibiotic, rifampin, cured mice two to three times faster than the much older, standard regimen of drugs that includes rifampin.  Researchers say if tests in people confirm the findings in mice, the average time to clear the potentially fatal bacterial infection could be reduced from six months to three or less. "People infected with TB are desperate for better therapies to combat the infection, therapies that can work more quickly and thus limit its chances to spread," says Nuermberger, who headed the team of researchers from Hopkins and elsewhere.  "And having the ability to more effectively treat the most common form of the disease, so-called drug-susceptible TB, is a key step in holding off multidrug-resistant strains from developing, too." Read more..... Cardiovascular Disease Death Rates Decline, But Risk Factors Still Exact Heavy Toll Cancer Cardiovascular disease (CVD) death rates are declining, but CVD is still the No. 1 cause of death in the United States, and risk factor control remains a challenge for many, according to the most recent data from the American Heart Association's Heart Disease and Stroke Statistics - 2008 Update.   The Update will be available in the Dec. 17 online issue of Circulation: Journal of the American Heart Association at http://www.americanheart.org/statistics. The Update provides statistics about cardiovascular diseases, risk factors, treatments, quality of care and costs.  The American Heart Association does not generate the data, but synthesizes it from many sources and provides it online without charge for government policymakers, physicians, researchers, educators and the public, making the Update a unique national - and even international - resource.   Cardiovascular diseases include heart disease, stroke, high blood pressure, heart failure and several other conditions including arrhythmias, atrial fibrillation, cardiomyopathy and peripheral arterial disease.    CVD has been the leading cause of death in the United States every year since 1900 except during the 1918 flu epidemic.   In 2004, the most recent year for which final statistics were available for this report, the age-adjusted CVD death rate per 100,000 persons was 288.0, compared to 307.7 in 2003.   CVD (the No. 1 overall cause of death) was listed as the underlying cause of death in 869,724 deaths, compared to 911,163 deaths in 2003.   Cancer was the second-leading cause of death, responsible for 553,888 lives lost. Stroke, when considered separately from other cardiovascular diseases, was the nation's third-leading killer (150,074 deaths), followed by accidents (112,012).  Coronary heart disease, even when considered separately from other cardiovascular diseases, was still by far the nation's single leading cause of death (451,326). "These statistics make it clear that cardiovascular disease remains, by far, our greatest public health challenge," said Donald Lloyd-Jones, M.D., Sc.M., chair of the association's Statistics Committee, which, along with the association's Stroke Statistics Subcomittee, is responsible for the Update. Read more..... 7 Medical Myths That Might Have Your Doctor Duped Medical myths abound. For Aaron Carroll, a pediatrician at the Regenstrief Institute in Indianapolis, the last straw was hearing an ominous radio report that warned parents that strangers might try to poison their kids on Halloween. "There hasn't been one documented case of a stranger actually doing that," Carroll says. (He adds that the few Halloween candy poisoning cases that have occurred have involved the child's family, not strangers.) The radio story prompted Carroll and a fellow pediatrician, Rachel Vreeman of the Indiana University School of Medicine, to start looking for other common, unsubstantiated beliefs. They found numerous examples and have just published a report in the British Medical Journal naming seven common medical misconceptions and laying out the evidence for why they're not true. Read more..... Believe it or not Christmas Disease Christmas Disease is a form of haemophilia caused by deficiency of Christmas' factor. It is a disturbance of coagulation that may easily be confused with classical heamophilia, with which it is clinically almost identical. The condition was described in 1952 by Biggs, Douglas, Macfarlane et al. at Oxford. It has not been named for Santa Claus, but for Stephen Christmas, a five year old British boy who was the first patient in whom this was recognized to be different from classical haemophilia. Incidence: 1/40,000 (15-20% of haemophilias). The condition is transmitted as a sex-linked recessive trait through female carriers. Prevalent in males. 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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