HICNet Medical News Digest Wed, 15 Jun 1994 Volume 07 : Issue 27 Today's Topics: [FDA] Breast Implant Update [FDA] Striking Back at Stroke [FDA] Advisory Committee Reevaluates Tamoxifen Prevention Trial [FDA] Combination Tuberculosis Drug Approved +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Medical Newsletter ! +------------------------------------------------+ Editor: David Dodell, D.M.D. 10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA Telephone +1 (602) 860-1121 FAX +1 (602) 451-1165 Internet: mednews@stat.com Bitnet: ATW1H@ASUACAD Compilation Copyright 1994 by David Dodell, D.M.D. All rights Reserved. License is hereby granted to republish on electronic media for which no fees are charged, so long as the text of this copyright notice and license are attached intact to any and all republished portion or portions. The Health Info-Com Network Newsletter is distributed biweekly. Articles on a medical nature are welcomed. If you have an article, please contact the editor for information on how to submit it. If you are interested in joining the automated distribution system, please contact the editor. Associate Editors: E. Loren Buhle, Jr. Ph.D. Dept. of Radiation Oncology, Univ of Pennsylvania Tom Whalen, M.D., Robert Wood Johnson Medical School at Camden Douglas B. Hanson, Ph.D., Forsyth Dental Center, Boston, MA Lawrence Lee Miller, B.S. Biological Sciences, UCI Dr K C Lun, National University Hospital, Singapore W. Scott Erdley, MS, RN, SUNY@UB School of Nursing Jack E. Cross, B.S Health Care Admin, 882 Medical Trng Grp, USAF Albert Shar, Ph.D. CIO, Associate Prof, Univ of Penn School of Medicine Martin I. Herman, M.D., LeBonheur Children's Medical Center, Memphis TN Stephen Cristol, M.D., Dept of Ophthalmology, Emory Univ, Atlanta, GA Subscription Requests = mednews@stat.com anonymous ftp = vm1.nodak.edu; directory HICNEWS FAX Delivery = Contact Editor for information ---------------------------------------------------------------------- Date: Wed, 15 Jun 94 06:52:26 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Breast Implant Update Message-ID: <4DsyNc9w165w@stat.com> BREAST IMPLANT UPDATE FDA has been receiving inquiries in advance of its June 2 public hearing on a proposal to require manufacturers of saline- filled breast implants to submit data showing safety and effectiveness before the products can continue to be marketed. The hearing will focus on the status of the manufacturers' studies, reports of independent research, consumer and professional concerns, and the timing of the requirement for submission of the data. FDA has also received inquiries on the status of silicone gel-filled breast implants. The following is a summary of the main issues and may be useful in responding to inquiries. Saline-filled and silicone gel-filled breast implants were already on the market when FDA began regulating medical devices in l976. Like other devices that were grandfathered under the Medical Device Amendments of l976, breast implants were allowed to remain in use with the understanding that FDA would later require manufacturers to submit evidence of product safety and effectiveness. Saline-filled breast implants are silicone envelopes filled with salt water. Currently, only saline-filled breast implants are commercially available for both breast augmentation and reconstruction. The short and long-term safety of saline implants has not been established. It is known that the implants can leak or rupture, requiring further surgery for replacement. Other known risks include infection, capsular contracture, interference with mammography, and altered breast sensation. In addition, because the envelope is made of a silicone elastomer, there is concern about any systemic problems that may be related to exposure to silicone. In a January l993 proposed rule, FDA notified manufacturers of saline-filled implants that the agency intended to require submission of data demonstrating product safety and effectiveness, and that each company's products would have to receive agency approval to allow continued marketing. At its June 2 public hearing, FDA will solicit public comment on the timing of this requirement, which could affect availability of the products. The agency will consider this testimony in determining when to promulgate the final rule. FDA also has asked the manufacturers to present testimony on the status of their clinical studies on saline implants, including patient enrollment. In regard to silicone gel-filled implants, none are available commercially. This type of implant is available only as part of a clinical study, and currently only for breast reconstruction. Mentor Corp. of Santa Barbara, Calif., is at this time the only manufacturer allowed to conduct clinical studies of silicone gel- filled implants. Manufacturers currently are gathering data on women who already have breast implants in order to provide important information about long-term effects of the implants. The agency advises potential implant recipients to discuss risks with their doctors before undergoing implant surgery, and to read carefully the patient information that accompanies the products. The record of hearing will remain open until July 5, l994. Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, Room. 1-23, 12420 Parklawn Drive, Rockville, MD 20857. ------------------------------ Date: Wed, 15 Jun 94 06:53:14 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Striking Back at Stroke Message-ID: Striking Back at Stroke by Evelyn Zamula At the time, the president's personal physicians believed it was necessary to keep from the public the truth about the president's health. With the second World War not yet won, they would neither confirm nor deny that he was ill and told no one, not even his family, that he had serious heart problems and blood pressure as high as 260/150. But Americans could see for themselves that the president was failing rapidly. The signs of it were in his face, and in the reduced vigor of his voice. Still, it came as a shock when Franklin D. Roosevelt died of a massive cerebral hemorrhage nearly 50 years ago. President Roosevelt was one of 129,144 Americans who died of stroke in 1945. Today, with a population almost twice as large, about 150,000 people die of the half million who are stricken each year. Another 200,000 are left with some disability. Although the statistics are looking better, stroke remains the third leading cause of death, preceded only by heart disease and cancer. A stroke is damage to brain cells resulting from an interruption of the blood flow to the brain. The brain must have a continual supply of blood rich in oxygen and nutrients for energy. Although the brain constitutes only 2 percent of the body's weight, it uses about 25 percent of the oxygen and almost 75 percent of the glucose (sugar) circulating in the blood. Unlike other organs, the brain cannot store energy. If deprived of blood for more than a few minutes, brain cells die from energy loss and from certain chemical interactions that are set in motion. The functions these cells control--speech, muscle movement, comprehension--die with them. Dead brain cells can't be revived, but in recent years the Food and Drug Administration has approved new drugs that may prevent stroke in susceptible people and in those who have already had a stroke. The majority of strokes are caused by blockages in the arteries that supply blood to the brain. (These are called ischemic strokes or infarctions, just as a heart attack--in which the heart muscle is deprived of blood--is called myocardial infarction.) The blockages may be caused by a clot, or thrombus, that forms on the inner lining of a brain or neck artery already partly clogged by atherosclerotic plaque--deposits of fat- containing materials and calcium. Although atherosclerosis, or hardening of the arteries, is primarily a disease of the elderly, the process may begin as early as childhood. Autopsies of soldiers who died in the Korean and Vietnam wars showed that atherosclerosis was already evident in the arteries of many of the young men. A blood clot formed in another part of the body may also cause stroke. Usually, a wandering clot like this--called an embolus--breaks off from plaque in an artery wall, or originates in the heart. Emboli may form in rheumatic heart disease, after a heart attack, or during atrial fibrillation, an abnormal heart rhythm. Instead of beating forcefully to fill the ventricles (the larger heart chambers that pump blood to the lungs and throughout the body), the atria (smaller heart chambers) beat irregularly and don't empty fully, causing blood to stagnate in the heart and form clots. If one lodges in a brain artery, a stroke results. The most serious kinds of stroke occur not from blockage, but from hemorrhage, when a spot in a brain artery weakened by disease--usually atherosclerosis or high blood pressure--ruptures or begins to leak blood. If an artery inside the brain ruptures, it is called a cerebral hemorrhage. When a blood vessel on the brain's surface ruptures, filling the space between the brain and the skull with blood, it is known as a subarachnoid hemorrhage. This type of stroke may also be caused by an aneurysm, a section of the artery wall so thin that it may balloon out and burst, especially when high blood pressure is present. (In many cases, people are born with these fragile spots in a brain artery wall, or may develop weak spots in arteries due to malformed blood vessels or hemorrhagic disease.) Not only does the part of the brain served by the blood vessel die in hemorrhagic strokes, but blood may spurt out so forcefully that surrounding brain cells are damaged. A large clot may form and press on adjacent brain tissue, increasing pressure inside the skull and causing swelling. Hemorrhagic strokes account for less than 20 percent of all types of strokes, but are far more lethal, with a death rate of over 50 percent. Strokes caused by emboli or hemorrhage usually strike suddenly, with little or no warning, and do all their damage in a matter of seconds or minutes. In thrombotic strokes, symptoms often progress by steps. A slight clumsiness on arising in the morning may be followed by loss of half the field of vision in both eyes by breakfast time (which the victim may not be aware of) and an inability to speak. Paralysis in one arm may be followed in the course of several hours or a day or so by complete paralysis on that side of the body. Distinguishing a Stroke from a TIA Any evidence of disruption of blood supply to the brain (such as inability to grasp with one hand or difficulty speaking) that lasts longer than 24 hours may be used to diagnose stroke. Effects of a stroke can range in severity from a slight one-sided facial sagging that disappears within two weeks to inability to walk or loss of control of bodily functions that lead to long- term problems such as incontinence. The kind of disability a stroke victim is left with depends on the location and extent of brain damage. An incident involving physical symptoms that last less than 24 hours (usually not longer than a few minutes or hours at most) and leave no permanent disability is called a transient ischemic attack (TIA) or "ministroke." A TIA is a signal that the brain's blood supply has been temporarily interrupted, either from small clots that lodge in a tiny brain artery and then dissolve spontaneously, or from briefly reduced blood flow in narrowed arteries. The most commonly reported symptoms of a TIA include temporary difficulty in speaking or understanding the speech of others; minor numbness or weakness of the face, arm or leg on one side of the body; unsteadiness, dizziness or falls; and blurred vision or sudden blindness in one eye that may last a few minutes. A TIA may occur shortly before a stroke occurs, or may be a predictor of future stroke. Some individuals have repeated attacks of TIAs without any serious consequences, but these symptoms should not be ignored and need immediate medical attention. Resourceful Brain The brain is resourceful. After brain swelling goes down following a stroke, small blood vessels around the blocked area enlarge to allow more blood flow to the damaged section. Some incapacitated cells may recover partially or completely. In many cases, other brain cells can assume the functions of the damaged ones. This is especially true of infants and young children, whose nervous systems are still developing. "Less than 1 in every 50,000 newborns suffers a stroke caused by clots that travel from the fetal or placental circulation around the time of birth," says Rebecca Ichord, M.D, a pediatric neurologist at Johns Hopkins University Hospital, Baltimore, Md. "Newborn infants do remarkably well and have less long-term disability than an adult with a comparable injury. Even though part of the brain is damaged, infants have other healthy brain cells that aren't dedicated to any particular function as yet, and these take over for the damaged cells." Each of the two hemispheres of the brain controls the opposite side of the body. Paralysis on the right side of the body means that the left side of the brain (the dominant hemisphere in a right-handed person) is injured. As speech and language are associated with areas in the left brain, individuals with left-brain damage may have trouble with speaking and understanding, a condition called aphasia. A right-brain stroke may leave persons with a paralyzed left side and spatial-perceptual deficits--difficulty in judging distance, size, position, and speed. They may not know whether they're standing or sitting upright or leaning. Because they may cholesterol diet benefits not only the coronary arteries, but arteries throughout the body, including those supplying blood to the brain. ~ Cigarette smoking. Many studies have shown a relationship between smoking and strokes. If you smoke, try to stop. ~ Heavy alcohol consumption. Chronic alcoholism and very heavy drinking are risk factors for both thromboembolic and hemorrhagic stroke, as well as increased mortality from stroke. Some studies show that moderate alcohol consumption may protect against cerebrovascular disease by raising HDL levels and helping prevent excessive blood clotting. But alcohol consumption should be limited to no more that one or two drinks a day, a drink being defined as 12 ounces of beer, 4 ounces of wine, or 1.5 ounces of 80-proof spirits. ~ Diabetes. People with diabetes--especially women--have almost double the risk of stroke. Diabetes causes atherosclerosis earlier in life and of greater severity. Besides damaging blood vessels, diabetes appears to interfere with the normal breakdown of fibrin, a plasma protein that holds blood clots together. ~ TIAs. If you have any evidence of a TIA--a sudden buckling of one leg leading to a fall, temporary blindness in one eye, slurred speech--tell your doctor immediately. ~ Family history. If a parent or sibling has had a stroke or TIA, you may also be at increased risk. It's not known whether this increased risk is inherited or from unhealthy family lifestyles. ~ Men have a higher stroke risk than women, and blacks have a higher stroke risk than people of other races. Since age, gender, heredity, and race can't be changed, it's wise to work on the stroke risk factors that can be altered, such as high blood pressure, high cholesterol levels, cigarette smoking, and heavy alcohol consumption. ------------------------------ Date: Wed, 15 Jun 94 06:55:28 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Advisory Committee Reevaluates Tamoxifen Prevention Trial Message-ID: <5isyNc11w165w@stat.com> Advisory Committee Reevaluates Tamoxifen Prevention Trial FDA's Oncologic Drugs Advisory committee, a group of outside experts, today recommended that the tamoxifen breast cancer prevention trial be continued with additional endometrial monitoring to assure safety of women in the study. The following may be used to answer inquiries. In l990 an FDA advisory committee supported the concept of a large long-term randomized study to determine the effect of tamoxifen in healthy women and in l991 recommended that FDA allow such a trial to proceed. The NCI-funded prevention study was designed to determine whether tamoxifen can reduce the incidence of breast cancer in healthy women who are at increased risk for this disease, and to evaluate the risks and benefits of tamoxifen treatment in this study population. The trial is based on evidence that the drug reduces the risk of a new cancer in the other breast in women taking the drug after surgery for breast cancer. The trial has enrolled over 10,000 subjects since it began in 1992. In April l994, based on the latest data in a Swedish trial and the B-14 trial conducted by the National Surgical Breast and Bowel Project (NSABP), the drug's package insert was revised to relect an updated warning on the increased risk of cancer of the uterus. The informed consent for the tamoxifen breast cancer prevention study was also updated in early l994. The committee was asked to evaluate several questions. They discussed whether patients should be required to undergo endometrial procedures and whether such procdures could be expected to reduce uterine cancer morbidity and mortality. The committee concluded that no procedure was studied well enough to be recommended but that the usefulness of various screening procedures should be vigorously evaluated. They also discussed whether revisions of the study design were necessary, such as limiting duration of treatment, changes in the eligibilty criteria, inclusion of a significant number of minorities and consideration of increasing the sample size. They concluded that no changes were needed. FDA emphasizes that tamoxifen should not be used as a preventive in women who have not had breast cancer outside of a clinical trial. ------------------------------ Date: Wed, 15 Jun 94 06:56:15 MST From: mednews (HICNet Medical News) To: hicnews Subject: [FDA] Combination Tuberculosis Drug Approved Message-ID: Combination Tuberculosis Drug Approved We have been receiving inquiries about the approval of Rifater, a product that combines three existing tuberculosis drugs into a single tablet. The drug is designed to decrease the number of patients who do not comply with the standard long-term, multi- drug regimen for treating tuberculosis. The following may be useful in answering questions. Rifater combines in one dose three first-line tuberculosis drugs -- isoniazid, rifampin and pyrazinamide. The fixed-dose product was developed to simplify dosing, make it easier for patients to take their medication and thus increase patient compliance with the dosing regimen. Noncompliance with the dosing regimen has been a public health concern in the control of the disease. Use of the combination drug should also slow emergence of multi-drug-resistant tuberculosis, a problem in part attributable to not following the dosing regimen. In addition, the use of Rifater will prevent inadvertent under or overdosing of any of the three component drugs, and will safeguard against patients deciding to stop taking one or two of the three drugs. In a survey conducted by the Centers for Disease Control and Prevention (CDC) in 1985-1986, more than 17 percent of tuberculosis patients did not take their medications continuously. In fact, one out of every four patients were still testing positive after six months of being prescribed drugs for treatment. In a recent survey of tuberculosis in New York City, 33 percent of patients had tuberculosis organisms resistant to at least one drug, and 19 percent had organisms resistant to both isoniazid and rifampin. Rifater has been used in Europe, Africa and Hong Kong since the mid-1980s. Nearly two years ago, FDA encouraged Marion Merrell Dow, the drug's manufacturer, to seek U.S. marketing approval. Since that time, FDA and the company have worked together to make the drug available. The use of combination products such as Rifater in treating tuberculosis has been recommended by CDC, the World Health Organization and the Committee on Treatment of the International Union Against Tuberculosis and Lung Disease. ------------------------------ End of HICNet Medical News Digest V07 Issue #27 *********************************************** --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet : ATW1H@ASUACAD