Edmund's Newsletter January 22, 2008 Issue: #4 Volume 8 Join Our List In This Issue Mercury-Vaccine Link to Autism Disproven Value Of Drugs For Pre-osteoporosis Exaggerated, Experts Warn Combined Hormone Therapy Increases Risk of Lobular Breast Cancer Fourfold After Just Three Years of Use Medical Error Reporting by Doctors to Hospitals Seems Underused The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States FDA Approves Update to Label on Birth Control Patch Gay Men May Be At Higher Risk for MRSA 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 Mercury-Vaccine Link to Autism Disproven  A new study provides more proof that childhood vaccines with mercury as a preservative -- no longer on the market -- did not cause autism, researchers reported on Monday. The findings came from a look at children diagnosed with autism in California from 1995 to 2007. It found that the number of autism cases continued to rise through that period even though the preservative thimerosal -- nearly half of which is made of ethylmercury -- was removed from most vaccines in 2001. The data "do not show any recent decrease in autism in California despite the exclusion of more than trace levels of thimerosal from nearly all childhood vaccines (and) do not support the hypothesis that that exposure (to it) during childhood is a primary cause of autism," the study concluded. Some earlier studies had linked mercury to autism, theorizing that as more and more children were being vaccinated against more health threats, it could explain increases in autism. Read more..... Value Of Drugs For Pre-osteoporosis Exaggerated, Experts Warn  A series of recent scientific publications have exaggerated the benefits and underplayed the harms of drugs to treat pre-osteoporosis or "osteopenia" potentially encouraging treatment in millions of low risk women, warn experts in the British Medical Journal. The authors believe that this represents a classic case of disease-mongering: a risk factor being transformed into a medical disease in order to sell tests and drugs to relatively healthy people. Osteopenia or "pre-osteoporosis" is said to affect around half of all older women and, in at least one country, drug companies have already begun to market their drugs to women with osteopenia, based on re-analyses of four osteoporosis drug trials. But the authors of this week's BMJ paper argue that this move raises serious questions about the benefit-risk ratio for low risk individuals, and about the costs of medicalising and potentially treating an enormous group of healthy people. These reanalyses tend to exaggerate the benefits of drug therapy, they say. For example, the authors of one reanalysis cite a 75% relative risk reduction, though this translates into only a 0.9% reduction in absolute risk. In other words, up to 270 women with pre-osteoporosis might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture. Read more..... Combined Hormone Therapy Increases Risk of Lobular Breast Cancer Fourfold After Just Three Years of Use Fred Hutchinson Cancer Research Center leads first study designed to evaluate the association between combined HRT use and the risk of lobular breast cancers Postmenopausal women who take combined estrogen/progestin hormone-replacement therapy for three years or more face a fourfold increased risk of developing various forms of lobular breast cancer, according to new findings by researchers at Fred Hutchinson Cancer Research Center. "Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," said Christopher I. Li, M.D., Ph.D., the lead author of the report, published in the January issue of Cancer Epidemiology, Biomarkers and Prevention. "Our study, the first specifically designed to evaluate the relationship between combined HRT and lobular breast cancers, suggests that a significantly shorter length of exposure to such hormones may confer an increased risk." The study, which confirms previous reports of the association between combined hormone-therapy use and increased risk of lobular breast cancers, is the largest study of combined HRT and lobular cancer risk in the United States. It is also the first such study to take into account the recency and duration of hormone use and the first to include a centralized pathological review of tumor specimens to confirm their histological type: ductal, lobular or mixed ductal-lobular. Read more..... Medical Error Reporting by Doctors to Hospitals Seems Underused Actual medical error reporting by doctors to hospitals seems to occur less than it should when compared to physicians' views on whether they should report such errors, University of Iowa researchers said in the Jan. 14 issue of the Archives of Internal Medicine. A related UI-led study, published in the May 2007 issue of the Journal of General Internal Medicine, found a similar, although smaller, gap between physicians' attitudes and actual actions in the disclosing of medical errors to patients. Information from the two studies, which were based on surveys of doctors in teaching hospitals, shows an apparent disconnect between error disclosure to patients and error reporting to hospitals and points to the need for a more integrated view of medical error communication, said Lauris Kaldjian, M.D., Ph.D., associate professor of internal medicine at the UI Roy J. and Lucille A. Carver College of Medicine. As an example, 41 percent of physicians in the earlier study said they actually had disclosed a minor error to a patient but only 18 percent of physicians in the current study said they had reported a minor error to their hospital. "Taken together, the findings indicate that physicians have more experience talking to patients about medical errors than reporting them to hospitals," said Kaldjian, who also is director of the college's Program in Biomedical Ethics and Medical Humanities. Read more..... The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States In the late 1950s, the late Democratic Senator Estes Kefauver, Chairman of the United States Senate's Anti-Trust and Monopoly Subcommittee, put together the first extensive indictment against the business workings of the pharmaceutical industry. He laid three charges at the door of the industry: (1) Patents sustained predatory prices and excessive margins; (2) Costs and prices were extravagantly increased by large expenditures in marketing; and (3) Most of the industry's new products were no more effective than established drugs on the market. Kefauver's indictment against a marketing-driven industry created a representation of the pharmaceutical industry far different than the one offered by the industry itself. As Froud and colleagues put it, the image of life-saving "researchers in white coats" was now contested by the one of greedy "reps in cars". The outcome of the struggle over the image of the industry is crucial because of its potential to influence the regulatory environment in which the industry operates. Fifty years later, the debate still continues between these two depictions of the industry. The absence of reliable data on the industry's cost structures allows partisans on both sides of the debate to cite figures favorable to their own positions. The amount of money spent by pharmaceutical companies on promotion compared to the amount spent on research and development is at the heart of the debate, especially in the United States. A reliable estimate of the former is needed to bridge the divide between the industry's vision of research-driven, innovative, and life-saving pharmaceutical companies and the critics' portrayal of an industry based on marketing-driven profiteering. IMS, a firm specializing in pharmaceutical market intelligence, is usually considered to be the authority for assessing pharmaceutical promotion expenditures. The US General Accounting Office, for example, refers to IMS numbers in concluding that "pharmaceutical companies spend more on research and development initiatives than on all drug promotional activities". Based on the data provided by IMS [4], the Pharmaceutical Research and Manufacturers of America (PhRMA), an American industrial lobby group for research-based pharmaceutical companies, also contends that pharmaceutical firms spend more on research and development (R&D) than on marketing: US$29.6 billion on R&D in 2004 in the US [5] as compared to US$27.7 billion for all promotional activities. Read more..... FDA Approves Update to Label on Birth Control Patch The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE. "For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products." Read more..... Gay Men May Be At Higher Risk for MRSA A new study from the Annals of Internal Medicine is showing that a highly drug-resistant strain of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus (MRSA) is being spread among gay men in San Francisco and Boston. Local health officials say they have not seen evidence of the multi-drug resistant MRSA in the Nashville area, but cautioned those who travel frequently. "MRSA skin infections have become very common all across the US, but this is the first report that gay men might be at higher risk - at least in San Francisco," said William Schaffner, M.D., professor and chair of the department of Preventive Medicine at Vanderbilt University Medical Center and a leading expert on infectious diseases. Schaffner said that while the study used "admittedly imprecise" calculations showing gay men in San Francisco have a higher rate of MRSA skin infections than the general population, it was concerning that multi-drug resistant MRSA strains were being seen in San Francisco. Read more..... Believe it or not Man who hid knives in pants stabs self A man who hid hunting knives in his pants to try to steal them from a western Michigan store tripped while fleeing and stabbed himself in the abdomen, police say. The suspect was hospitalized after Monday night's attempted theft from a Meijer Inc. superstore in Grand Rapids and is expected to face a misdemeanor shoplifting charge, police say. The wounds did not appear to be life-threatening, The Grand Rapids Press reported. The man had put about $300 worth of hunting knives in his waistband, police told WZZM-TV. Police say he tried to leave the store, but Meijer employees confronted him and a scuffle followed. The man then fell and was stabbed by the knives he had hidden in his clothing, police said. They said it happened about 5:40 p.m. "The man was taken to the hospital," said Meijer spokesman Frank Giuliano. "We are cooperating with the investigation by police." Police said the suspect has a record of retail fraud. "I saw a man laying down on the mat by the carts, a knife by him with blood on the full blade of the knife," shopper Heather Dodd told WOOD-TV. "It was not a dull kitchen knife or a sharp butcher's knife, it was somewhere in between. "Someone was holding him down so I just walked around him, grabbed my cart, made sure everything was OK and got out of the way." 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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