Edmund's Newsletter July 15, 2008 Issue: #29 Volume 8 Join Our List In This Issue Fluoroquinolone Antimicrobial Drugs Pioneering heart surgeon DeBakey dies at age 99 Roche To Suspend HIV Research, Seeing No Advances Bright Bugs Discover New Drugs Earlier Alzheimer's Diagnosis Possible With Biomarker Identification Scientists Learn How Food Affects The Brain: Omega 3 Especially Important Fish Oil and Red Yeast Rice Studied for Lowering Blood Cholesterol 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 Fluoroquinolone Antimicrobial Drugs FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. Read more.....  Pioneering Heart Surgeon DeBakey Dies At Age 99 Surgeon Michael DeBakey, whose ground-breaking heart transplants and coronary bypass operations made him one of the giants of 20th century medicine, has died at age 99. The Baylor College of Medicine and Methodist Hospital said DeBakey died on Friday of natural causes. Methodist Hospital in Houston was his primary surgical hospital for many years. In a career that spanned more than seven decades, DeBakey developed a number of new surgical procedures that now are standard in treating heart ailments and led many to consider him the father of modern cardiovascular surgery. Just some of his accomplishments: DeBakey invented the roller pump, later to become a major component of the heart-lung machine used in open-heart surgery. During WW-II developmened the mobile army surgical hospital (MASH units) He later helped establish the specialized medical and surgical center system for treating military personnel returning from war, subsequently the Veterans' Administration Medical Center System. The first removal of a carotid artery blockage The first aorto-coronary bypass surgery Helped establish Medicare in the USA The first use of a ventricular assist device to pump blood and support a diseased heart (1966) DeBakey's helped establish the National Library of Medicine Treated my dad. Read more..... Roche To Suspend HIV Research, Seeing No Advances Swiss pharmaceutical company Roche Holding AG will suspend its HIV research because none of its pending medicines represent significant improvement over existing drugs, a company spokeswoman said on Friday. "Research scientists currently working in HIV will be reassigned to other activities," Linda Dyson, a spokeswoman in Roche's U.S. office in New Jersey, said in an e-mail. Dyson confirmed an e-mail sent on Wednesday to some activists informing them of the decision. In that e-mail, the company said it "decided to refocus our resources within virology on diseases in which we can deliver substantial improvements over existing medications." Dyson declined to specify how much Roche has been investing in HIV research. Read more..... Bright Bugs Discover New Drugs Insects with vivid colors to warn off predators could be telling drug companies that their bodies have chemical compounds active against cancer cell lines and tropical parasitic diseases "Scientists are already seeking inspiration for the next generation of drugs from traditional medicines used by witch doctors and by shaman, even treatments used by apes for parasites and other ailments. Now they can add insects to their list of prospectors for new medicines" writes Roger Highfield, science editor from UK's Telegraph in a review of an article to be appeared in Frontiers in Ecology and the Environment in 2009 by STRI researchers J.E. Helson, T.L. Capson, T. Johns, A. Aiello and D. Windsor. Insects with vivid colors to warn off predators could be telling drug companies that their bodies have chemical compounds active against cancer cell lines and tropical parasitic diseases. The plants used for the study were chosen based on previous screening by Panama's ICBG for activity against cancer cell lines and tropical parasites responsible for malaria, leishmaniasis and Chagas' disease. A search for beetles and caterpillars on plants with and without activity revealed that insects with bright warning coloration were significantly more common on plants that contained compounds with activity against these diseases. "Although the idea that brightlycolored insects could facilitate the search for medicinally active plants has been discussed for decades, the concept had never been rigorously tested... It's very gratifying to see that it works in the field" said Todd Capson, who directed the Panama-based project. The team worked with Panama's Institute of Advanced Scientific Research and High Technology Services, Panama's National Authority of the Environment (ANAM) and the University of Panama. Read more..... Earlier Alzheimer's Diagnosis Possible With Biomarker Identification Researchers at Robarts Research Institute at The University of Western Ontario have found clear evidence that increases in the size of the brain ventricles are directly associated with cognitive impairment and Alzheimer's disease.   The research, led by Robarts scientist Robert Bartha, shows the volume of the brain ventricles - fluid-filled cavities in the brain - expands as surrounding tissue dies. The research was published online today in the neurology journal Brain.      Currently, diagnosis for Alzheimer's relies on neuro-cognitive assessments, such as testing of memory, ability to problem solve, count and so on. Definitive diagnosis is not possible until after death when an autopsy can reveal the presence of amyloid plaques and 'tangles' in brain tissue.      Previous research has shown a link between ventricle size and Alzheimer's over longer time intervals. The Robarts research shows that ventricle size increases with mild cognitive impairment before a diagnosis of Alzheimer's, and continues to increase with the onset and progression after only six months.   Read more..... Scientists Learn How Food Affects The Brain: Omega 3 Especially Important In addition to helping protect us from heart disease and cancer, a balanced diet and regular exercise can also protect the brain and ward off mental disorders.   "Food is like a pharmaceutical compound that affects the brain," said Fernando Gómez-Pinilla, a UCLA professor of neurosurgery and physiological science who has spent years studying the effects of food, exercise and sleep on the brain. "Diet, exercise and sleep have the potential to alter our brain health and mental function. This raises the exciting possibility that changes in diet are a viable strategy for enhancing cognitive abilities, protecting the brain from damage and counteracting the effects of aging." Gómez-Pinilla analyzed more than 160 studies about food's affect on the brain; the results of his analysis appear in the journal Nature Reviews. Read more..... Fish Oil and Red Yeast Rice Studied for Lowering Blood Cholesterol A great deal of scientific evidence shows that cholesterol-reducing medications known as statins can help prevent coronary artery disease. Although the safety of these medications has been well documented, as many as 40 percent of patients who receive a prescription for statins take the drug for less than one year. Doctors believe that several factors - including cost, adverse effects, poor understanding of statin benefits and patients' reluctance to take prescription medications long term - may explain why some patients stop taking these medicines. In the July issue of Mayo Clinic Proceedings, a group of researchers from Pennsylvania examine whether an alternative approach to treating high blood cholesterol may provide an effective treatment option for patients who are unable or unwilling to take statins. Read more..... Believe it or not Drug marketing code draws line at gift pens Come next year, doctors may start to see a problem they've yet to experience -- a pen shortage. New guidelines released on Thursday by the Pharmaceutical Research and Manufacturers of America (PhRMA) prohibit drug makers from giving out pens, as well as other "non-educational" items such as mugs, to healthcare providers and their staffs. As part of its revised marketing code, the pharmaceutical trade organization determined that such items, which are typically adorned with a company or product logo, may foster misperceptions that these interactions with healthcare professionals "are not based on informing them about medical and scientific issues." "It has the look of an unprofessional relationship," said Billy Tauzin, president and chief executive officer of PhRMA, during a media briefing on the revised code. "Removing that look is important." The PhRMA directives, effective January 1, also bar company sales representatives from taking doctors and healthcare providers out for dinners, although they allow companies to provide meals in doctors' offices in conjunction with informational presentations. Merck, GlaxoSmithKline, Amgen and AstraZeneca were among the companies issuing press releases in support of the new guidelines, which are voluntary. The last time PhRMA revised its guidelines was in 2002. A 2007 study in the New England Journal of Medicine reported that drug makers spend $30 billion (15 billion pounds) a year on marketing drugs, although the study did not specify how much the companies spend on so-called "reminder" objects, like bottles of lotion, clipboards and flashlights. "Probably too much," said Seamus Fernandez, an analyst with Leerink Swann. Fernandez said the measure won't result in big savings, although over time they might see cost cuts from reducing the need for representatives. "If you're not dropping off the junk, you probably really don't have to pay for that detail," he said. "You may actually save more." Fernandez added that the policy will probably not hurt drug makers' marketing efforts because their approach has shifted to more direct-to-consumer methods and relying on pitches by sales representatives. At the Thursday afternoon media briefing, Tauzin said PhRMA will soon consider improvements on its code overseeing consumer marketing. The drug industry trade association also is supporting U.S. legislation to create a national registry of payments to doctors. The bill, co-sponsored by Wisconsin Democratic Senator Herb Kohl and Iowa Republican Senator Charles Grassley, would require drug and medical device companies to publicly disclose payments to doctors of $500 or more. Increasingly, states in the U.S. have passed or are debating legislation that would require pharmaceutical companies to disclose the payments they make to doctors. For example, Minnesota has prohibited giving gifts to doctors in excess of $50. On Wednesday, Vermont released its annual report of drug makers' marketing efforts, finding that 84 drug makers spent more than $3 million in fiscal 2007 to market their drugs in the state, up 33 percent from the year before. 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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