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Nov, 2001 news  (Lynda Roth,  Sat Feb 22 10:07:06 2003) COALITION OF SILICONE SURVIVORS          2739 W. 23rd St., Greeley, CO 80634          Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first) e-mail: : coss1@qwest.net Website: siliconesurvivors.net November 1, 2001 Dear Silicone Survivors and Friends: This is our fifth periodic newsletter.  We postponed it after the atrocities of September 11th.  It just did not seem like the time to send one out.  Then, after that, my computer dumped half of it, so I thought maybe I should just give up for a week or so until I got over being so perturbed about it.  So here it finally is. We will probably only do one more issue when there is something to report about Dow Corning and the settlement of the bankruptcy.  So, considering that, please do not send any new subscriptions or renewals.  If you are up to date, you will receive the last issue when it is published. LEGAL INFORMATION: Information from Patrick Hughes, TCC, on updating medical information for Dow Bankruptcy: "Patrick L. Hughes" There is no current deadline for updating the medical records by Dow Corning claimants.  In fact it is probably better that you wait until the claims office sends out a notice to all those who filed a claim in the bankruptcy case before sending in additional medical information. The TCC is currently working on forms that will be included in the mass mailing that will eventually be made to all claimants in the Dow Corning case.  These will be as user friendly as possible and will provide for the claimants choosing settlement to attach the relevant documentation required to qualify for plan benefits.  Hopefully we will soon see an end to the appellate process that will permit the claims to then start being processed. In this regard, please ensure you have considered and acted on the following points while you are waiting: (1) Gather your medical record relating to any implant or explant procedure.  (2). Gather the medical info. for any disease claims. (3) Keep your address current with the current DCC claims office to ensure the plan claims office will have a good address for you when it starts sending out the claims packages.  We have the forms to do this if you need one.  (4) If in doubt confirm you have the postcard sent by Daticon Systems when you filed the claim to ensure and confirm you filed the claim to register in the right place. Response from Patrick Hughes, TCC, to queries about many more women joining and ratcheting of the Dow Bankruptcy: I am not sure what you mean by huge numbers of women who might yet join the plan.  That has not happened and there is no expectation from the projections generated--in all cases subject to intense examination and evaluation by attorneys and judges--that the amounts provided under the plan will be ratcheted.  The plan represents a hard fought compromise that generated the best result that was deemed possible under the circumstances.  Nothing since has suggested otherwise in terms of the science, though I admittedly am not an expert in the area and remain incredulous that the science cannot be established. Not all women agree that the plan is good.  In response to another question: Plainly a plan that forces all to litigate is no plan at all. (That is what would happen if the Nevada appeal succeeds.)  Litigation by all still would require an allocation of assets.  This had to be done in an organized and fair manner, and was approved after a process that permitted all to vote, all to challenge that wanted to, and all to appeal that wanted to.  While I understand a few are unhappy with the result, and might even sympathize as well, the inescapable fact remains that those that have great knowledge and expertise in the area concluded that the plan represented the best and quickest way to try to deliver the greatest value to the widest range of people.  We can agree that these were terrible products.  We can agree they deserve to continue to be banned.  We can agree that the scientific/medical community let down those who relied upon it both at the start and during the time these were marketed.  However, notwithstanding these apparent injustices, the plan provides a means to proceed and has been approved.  While the appeals continue, and hopefully will end soon, it at least presents a means to proceed that might provide closure and compensation to most--but certainly cannot be liked by all.    Patrick L. Hughes Haynes and Boone, L.L.P.1000 Louisiana, Suite 4300 Houston, Texas  77002713-547-2550 (direct)713-236-5401  (direct fax) For the record, I agree with Patrick Hughes.  I think there are many women who deserve millions, but the only ones who will get it have already gotten it.  We need to proceed with an orderly settlement and get on with our lives.  I know that Patrick Hughes and the TCC have been attacked by a few, but I feel they worked in good faith to get the best settlement possible. Update on DC Bankruptcy Appeals, etc.  Oral arguments occurred a couple of weeks ago before the 6th Circuit.  While a decision is expected quickly by Circuit standards (less than 4-6 months) there was no indication from the justices when they would rule.  There was also no indication of any leanings either way by the questions asked.  Once the 6th Circuit rules, a further request by the losing side may be made for reconsideration.  If the plan is affirmed, it is expected that the appellants will seek review by the Supreme Court.  However, acceptance of such cases is rare.  Implementation by late spring remains possible barring the unexpected or unusual delays. Patrick L. Hughes, Haynes and Boone, L.L.P., 1000 Louisiana, Suite 4300 Houston, Texas  77002. 713-547-2550 (direct) 713-236-5401 (direct fax) 713-547-2000 (main number) We publish the following information in every newsletter so that you can keep updated on your own if you choose.  For information on what is happening: http://www.mied.uscourts.gov/dow/DowAppeals.htm This website lists them all, and you can go there and click on each case. Dow Appeals:  Case Number -------Appellant??.Date Filed 99-75924 Class Five NV Claimants 12/11/00; 99-75925 Class Five TX Claimants, et al.  12/13/00; 99-75927 1300 Australian Claimants  12/11/00; 99-75929 Certain Foreign Claimants  12/13/00; 99-75930 Official Committee of Physician Creditors 12/13/00; 99-75958 Helene D. Schroeder  12/13/00; 99-75960 Marti Jacobs   12/08/00; 99-76007 Beatrix Shishido  12/13/00; 99-76008 Karen L. Hustead  12/14/00; 99-76063 PA Coordinated Silicone Breast Implant Litigation  12/13/00; 00-70176 Hartford Accident & Indemnity Company, et al  12/22/00. Change of Name or Address: To update either your name or address in the Dow Corning bankruptcy case, send your information to the following address: Dow Corning Chapter 11 Claims Administration Facility, P.O. Box 7500, Midland, MI 48641-7500 To update either your name or address with the Revised Settlement Program ("RSP") or MDL Claims Office, send your new information to:  MDL 926 Claims Office, Box 56666, Houston, TX 77256.  Your name/address must be updated separately with each of these facilities. Telehelp information numbers or websites are listed for further information. Dow Corning Bankruptcy Telehelp and Other Information Sources List: Dow Corning Bankruptcy Case General Information Line: 800-651-7030 (recorded message);Implant Information Center:  800-442-5442;  Bankruptcy Court Information Line: 800-222-7198; TCC Mailing Address:  Tort Claimants Committee, P.O. Box 61406, Houston, Texas  77208-1406.  TCC website: www.tortcomm.org DC website: www.implantclaims.com  Daticon Systems, Inc. Mailing Address: P.O. Box 6003, Gales Ferry, CT 06335-6003.  Those outside of the United States may access the foregoing numbers by calling collect to (718) 361-4500.  This is where you register a claim in Dow Corning Bankruptcy. For inquiries not involving Dow Corning but the different legal case generally referred to as the MDL Class Action and Revised Settlement Program, you should contact different numbers: MDL Hotline:                    800-887-6828; MDL Claims Center:                  800-600-0311 (outside the U.S. call                                 713-951-9106)  MDL Claims Center Mailing Address:  P.O. Box 56666, Houston, Texas 77256.  From Sybil Goldrich: The Honorable Denise Page Hood entered an order regarding claim forms. You can read the order on the Internet at www.mied.uscourts.gov Basically the ruling allows for a newsletter to go out in October and the Claims Forms to go out in January.  The claims office is up and running in Houston.I like the new claims administrator, Wendy Trachte-Huber. Her staff selections are really good andI think the claims operation will run smoothly and fairly. Appeals still will go forward. Right now the case is in front of the Circuit Court and regardless of what they rule, I'm sure somebody will try for a Supreme Court ruling. But, at least in the meantime, claimants will be able to gather all-important information together for their claims and be ready to submit once the Supreme Court makes its decision. For the first time in a long time, I feel encouraged. Sincerely, Sybil 09/06/01--The Settlement Facility - Dow Corning Trust (the  "SF-DCT") has been created to administer silicone gel and implant claims against Dow Corning. You may contact the SF-DCT toll-free at 1-866-874-6099 or (713) 874-6099. You may also visit the SF-DCT website at:  www.dcsettlement.com.  The SF-DCT and the RSP Claims Office are two separate entities, and the Claims Office will not be able to answer any questions regarding your claim against Dow Corning, the SF-DCT, the Dow Corning bankruptcy case or the settlement plan for Dow Corning claimants. Please call the SF-DCT, instead. Many of our women have had expert witnesses barred by Daubert.  This following would apply to that. 8/ 6/01: 8th Circuit Rules Expert Testimony Properly Admitted In Toxic Exposure Case: St. Louis: A federal court did not abuse its discretion by admitting expert testimony linking exposure to gammabutylactone and its metabolite gamma-hydroxybutric acid to the Parkinson-like injuries of a plaintiff, even in the absence of confirmation of the link in the scientific literature, the Eighth Circuit U.S. Court of Appeals ruled Aug. 3 (Katie Bonner, et vir. v. ISP Technologies, et al., No. 00-3458, 8th Cir.).  (Opinion available. Document #15-010817-101Z.) "We have held that the first of several victims of a new toxic tort should not be barred from having their day in court simply because the medical literature, which will eventually show the connection between the victim's condition and the toxic substance, has not yet been completed," the court said. ISP Technologies Inc. challenged a $2.2 million judgment awarded in the U.S. District Court for the Eastern District of Missouri (Bonner v. ISP Technologies, No. 97-CV-74 CAS) on the grounds that the evidence should have been excluded under Daubert. The Eighth Circuit found, however, that Bonner did not need to produce a table of levels of exposure and levels of harm, only "evidence from which a reasonable person could conclude that her exposure probably caused her injuries," the court said.  The District Court in this case correctly served its role of gatekeeper under Rule 702 criteria of relevance and reliability, the court said. "[T]he experts' methodology rather than their conclusions ä is the primary concern of Rule 702," the court said. Preventing litigation in breast augmentation Clin Plast Surg 2001 Jul;28(3):607-15 (ISSN: 0094-1298)Gorney M The Doctors' Company, Napa, California, USA.: To obtain patient satisfaction and thus avoid exposure to liability claims in breast augmentation, the plastic surgeon must take pains to exert not only his or her surgical competence but also his or her medicolegal awareness. The recent breast implant crisis should have taught everyone a lesson. The surgeon should remember that the American legal system has more to do with showmanship than with justice, fairness, science, or truth. It is unlikely that anyone beginning a 30- to 40-year career in aesthetic surgery will finish it without an encounter with the US legal system. Surgeons should supplement their CME with "DME" (defensive medicine expertise). Only by cultivating the absolutely crucial elements of patient rapport will surgeons be able to stay one step ahead of the plaintiff's attorney. (No comment!) The Wall Street Journal, 5/16/01: Milo Gevelin: Some companies pay lawyers not to sue again: Ethics codes say agreements must be disclosed to clients, but not all lawyers do so. Here's a way for businesses to rein in costly lawsuits: pay plaintiffs' lawyers not to sue. That may seem far-fetched.  But courts and bar disciplinary groups have been cracking down on deals in which companies privately pay lawyers large sums to settle their clients' cases - if the lawyers promise not to sue again. Sound unethical? Usually it is.  Any agreement by lawyers to limit future representation of possible clients effectively constrains the public's access to the courts.  That's why state legal-ethics codes prohibit offering or accepting "practice restriction agreements" as part of any settlement. But these agreements have become increasingly common, say lawyers and ethics experts, particularly in cases in which lawyers amass a large number of claims involving big potential damage awards against a single company.  A frequent condition of settling, says New York plaintiffs lawyer Paul Rheingold, is that the plaintiffs lawyers agree not to bring similar claims on the behalf of other plaintiffs in the future. For defendant companies, the alternative is to face future lawsuits on behalf of new plaintiffs financed by lawyers' fees from prior settlements, says Geoffrey Hazard, a legal-ethics professor at the University of Pennsylvania.  "There is a strong incentive to get that lawyer out of the picture." he says. One way defendants can ethically do that, says Mr. Hazard, is by signing plaintiffs' lawyers up as "consultants," thereby creating a conflict of interest that prohibits them from suing the company again. "It's a contrivance," says Mr. Hazard, "but it's significantly within the rules."  The only qualification is that the plaintiff's lawyer must disclose the consulting arrangement to the current client beforehand.  "There are some lawyers who don't do that," Mr. Hazard adds. In the biggest case to come to light, DuPont Co. paid a now-defunct Miami plaintiffs' firm a $6.4 million side payment five years ago to settle a batch of crop-damage suits brought by 48 commercial growers who used its Benlate fungicide.  Lawyers for both sides reached the side deal during settlement negotiations after a state judge in Miami barred DuPont's defense arguments as punishment for withholding evidence, leaving the company facing a potentially huge damage award. As part of the deal with DuPont, the two lead plaintiffs lawyers returned all confidential company documents, agreed to seal the court file - including the judge's order sanctioning DuPont for misconduct - and, as newly hired DuPont consultants, effectively barred themselves from any involvement in future Benlate cases.  They got the $6.4 million fee, on top of their contingency fee of roughly 30% of the $59 million settlement they negotiated for their clients. For DuPont, the deal eliminated the threat of future litigation brought by a plaintiffs firm specializing in Benlate.  The agreement surfaced in state court in Gainsville last July, after the firm's clients became suspicious and sued both DuPont and the lawyers for fraud.  The growers contend they were kept in the dark about their lawyers' stake in the settlement and forced to either accept the settlement or find other counsel.  The Florida Bar Association is investigating. MEDICAL INFORMATION:  One person's thinking on these diseases: The linking pathogen in neuro-systemic diseases: chronic fatigue, alzheimer's, parkinson's, multiple sclerosis: Scott, Donald W., M.Sc.  The Mycoplasma: crystalline brucellosis: testing brucellosis upon an unsuspecting public. EXCERPTS: BIOWARFARE RESEARCH Between 1942 and the present time, biological warfare research has resulted in a more deadly and infectious form of the mycoplasma. They extracted this mycoplasma from the brucellosis bacteria, weaponized it and actually reduced the disease to a crystalline form. According to Dr. Shyh-Ching Lo, one of America's top, top researchers, this disease agent, the mycoplasma, causes among other things, AIDS, chronic fatigue syndrome, multiple sclerosis, Wegener's disease, Parkinson's disease, Crohn's colitis, Type I diabetes, and collagen-vascular diseases such as rheumatoid arthritis and Alzheimer's. The mycoplasma enters into the individual cells of the body depending upon your genetic predisposition. You may develop neurological diseases if the pathogen destroys certain cells in your brain, or you may develop Crohn's colitis if the pathogen invades and destroys cells in the lower bowel. Once it gets into the cell, it can lie there doing nothing sometimes for 10, 20 or 30 years, but if a trauma occurs like an accident, or a vaccination that doesn't take, the mycoplasma can become triggered. Because it is only the DNA particle of the bacteria, it doesn't have any organelles to process its own nutrients, so it grows by uptaking preformed sterols from its host cell, literally kills the cell, and the cell ruptures and what is left gets dumped into the blood stream. DOCUMENTED EVIDENCE: My conclusions are entirely based upon official documents: 80% are United States or Canadian official government documents, and 20% are articles from peer-reviewed journals, such as the Journal of the American Medical Association, The New England Journal of Medicine, and The Canadian Medical Association Journal. The journal articles and government documents complement each other. We also have a document from Dr. Shyh-Ching Lo which names the mycoplasma as a cause of cancer. Dr. Charles Engel who is with the National Institutes of Health, Bethesda, Maryland, stated at an NIH meeting on February 7, 2000, "I am now of the view that the probable cause of Chronic Fatigue Syndrome and fibromyalgia is the mycoplasma". For info. on this: http://www.consumerhealth.org/articles/display.cfm?ID=20000830164126 Parathyroid Hormone Increases Bone Formation By medinews.com staff writers, posted on 5/28/01:  A new multicenter study shows  that parathyroid hormone (PTH) treatment for osteoporosis can stimulate bone formation, increase bone mass dramatically, and reduce the risk of vertebral  fractures 65-69%, more than any currently available treatment. The study was  published in the May 10, 2001, issue of The New England Journal of Medicine.  Current medicines approved for osteoporosis are classified as  anti-resorptive drugs because they slow bone resorption, the first step in the  remodeling process. Resorption increases with menopause and advancing age and is  associated with bone loss. Unlike anti-resorptive drugs, PTH stimulates bone formation. PTH treatment appears to be most effective when given for one to two years, although it may be necessary to follow the therapy with an anti-resorptive drug to maintain the benefits. "This research is very exciting for the future treatment of osteoporosis," says Dr. C. Conrad Johnston,  Jr., president of the National Osteoporosis Foundation. "If PTH receives approval for osteoporosis from the U.S. Food and Drug Administration (FDA), it would be the first treatment option to build substantial amounts of bone by increasing bone formation. The Foundation is very encouraged by the evidence of fracture reduction.  Osteoporosis is responsible for more than 1.5 million fractures a year in the U.S. alone." Westport, CT (Reuters Health) 6/08/01:  Women with ruptured silicone breast implants who have extracapsular silicone (i.e., silicone gel outside the scar that forms around the implant) are more likely to report a diagnosis of fibromyalgia than women with intact implants, researchers report.  Dr. S. Lori Brown, from the US Food and Drug Administration, Rockville, Maryland, and colleagues asked 344 women with breast implants to undergo MRI to determine the status of the implants. In addition, the women answered questions about health status, satisfaction with implants, symptoms of connective tissue disease and physician-diagnosed disease. According to the team's report in the May issue of the Journal of Rheumatology, women who had a ruptured implant were no more likely to report a physician diagnosis of connective tissue disease than women with intact implants. But women with extracapsular silicone gel were more likely than the other subjects to report a diagnosis of fibromyalgia, dermatomyositis, polymyositis, Hashimoto's thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis or polymyalgia. The adjusted odds ratios were 2.8 for fibromyalgia and 2.6 for other connective tissue disease.  Dr. Brown's group believes that "if future studies confirm our findings, consideration as to whether women with silicone gel breast implants should be screened for implant rupture should be considered." J Rheumatol 2001;28:996-1003. 5/31/01, Scripps Howard News Service, Lance Gay: The milk industry has spent millions of dollars creating the image of a healthy, wholesome beverage for young and old.  But how safe really is that pasteurized glass of milk?  Preliminary results from an 18-month British study have raised troubling questions by showing that at least one hardy pathogen survived the pasteurization processes and was cultured from 2.1 percent of off-the-shelf milk tested.  The British Food Standards Agency said it ran tests during an 18-month period for 258 large dairies in England and was able to culture the pathogen Mycobacterium paratuberculosis  in 10 of 466 samples taken after milk had gone through commercial pasteurization. That involves heating milk to 162 degrees Fahrenheit for 15 seconds. Some scientists believe the pathogen is connected to Crohn's disease, a serious intestinal disorder in humans. Colonies of the pathogens were also grown from milk heated for 25 seconds at that temperature. Raymond Sweeney, a veterinarian with the University of Pennsylvania, said the preliminary results of the British study "raised eyebrows" because scientists believed that commercial pasteurization effectively killed pathogens.  Sweeney said the study doesn't undermine his confidence in having his children drink milk but does raise questions about the effectiveness of commercial pasteurization.  "This is making us all take another look at thermal resistance," he said. An article, published in May, 2001 by a task force of experts for the U.S. Council for Agricultural Science and Technology, said any evidence that the microorganism survives pasteurization would undermine the government's program ensuring food products are safe.  The U.S. Department of Agriculture adamantly insists that commercial pasteurization is "100 percent effective" in killing organisms in milk. But U.S. studies have involved controlled laboratory efforts to culture the mycobacterium in milk and not supermarket milk produced by commercial plants as in the British study. The U.S. studies have been inconclusive on whether the organism can survive pasteurization, with some indicating it could, and others saying it could not. The International Dairy Federation said earlier this year it could not say with certainty that pasteurization is always effective. Judith Stabel, a federal researcher at the USDA's Agricultural Research Center in Ames, Iowa, who studies the mycobacterium, said the British study should not undermine confidence in U.S. pasteurization processes. "I'm pretty confident we have a good supply of milk here," she said. But Stabel embraced a proposal before Congress made by U.S. milk producers this year to spend $1.3 billion during the next seven years to reduce levels of Johne's disease in dairy herds. Johne's disease is an intestinal infection of ruminant animals caused by the Mycobacterium paratuberculosis, and surveys indicate it infects about 22 percent of U.S. dairy herds and 8 percent of U.S. beef herds.  The same bovine strain of the mycobacterium has been found in humans suffering from Crohn's disease, which is incurable. There is a debate whether humans are picking up the mycobacterium from milk or from other environmental sources like contaminated water. Another possible source, scientists say, could be the several varieties of cheeses made from raw milk. Common Bacterium Implicated in the Triggering of Rheumatoid Arthritis: Beer-Sheva, 3/19/01:  Researchers at Ben-Gurion University of the Negev have shown that a well-known bacterium of the mycoplasma family - commonly found in the human throat - may be involved in the triggering or exacerbation of rheumatoid arthritis (RA). The team found that fluids from the inflamed, arthritic joints of many patients contained the specific DNA characteristic of Mycoplasma fermentans, as well as antibodies against this organism. Their studies also indicate that mycoplasmic membrane proteins capable of triggering inflammation may also be present. Collaborating in this investigation are Prof. Shulamith Horowitz and research assistant Bela Evinson at BGU's Department of Microbiology and Immunology, and Prof. Jacob Horowitz and Dr. Abraham Borer of the Department of Medicine at the Joyce and Irving Goldman Medical School. Prof. Jacob Horowitz also serves as head of Department of Medicine A at Soroka University Medical Center. A report on their work appears in a recent issue of the Canadian publication Journal of Rheumatology. Rheumatoid arthritis, notes husband-wife team Jacob and Shulamith Horowitz, is an autoimmune disease, in which the body's immune system is triggered to attack normal body tissues. Determining the ultimate cause of RA therefore requires the identification of an agent in arthritic joints that interacts with the immune system.  Because mycoplasmas definitely cause arthritis in animals, doctors have suspected since the early '50s that a mycoplasma found in humans might be involved in the disease in man. While a number of researchers over the decades have claimed to have isolated live mycoplasma bacteria from the joint fluid of RA patients, others who attempted to repeat their findings failed to do so. However with the development of advanced DNA analysis techniques, identification of traces of bacterial genomes has become easier to ascertain. Thus British and French scientists have recently shown that M. fermentans DNA is present in the joint (synovial) fluid of many RA patients, findings confirmed by the studies at BGU. In their initial test group of three-dozen RA patients, the BGU scientists found that M. fermentans DNA was present in some 20% of the arthritic joints examined. None of 57 patients with other forms of arthritis had this DNA in their joints. Of critical significance was the additional discovery that half of the RA patients studied, even those with no detectable DNA, had abnormally large quantities of antibodies against M. fermentans in their arthritic joints. Because these patients had the same low quantities of anti-M. fermentans antibodies in their blood serum as do healthy individuals, the BGU team believes that the antibodies they found in the synovial fluid were produced there in response to mycoplasma that had entered the joint. In 57 patients with other varieties of arthritis, the anti-M. fermentans antibody level in their joints was negligible, even lower than that in their serum. The BGU scientists also identified the mycoplasmic proteins recognized by the antibodies. These are specific membrane components known to activate the production of immune system factors, such as TNF-alpha, which are inducers of inflammation. This finding indicates a further mechanism that may contribute to the appearance of RA as a result of M. fermentans entering the joint.  "Our studies suggest," says Jacob Horowitz, a rheumatology specialist, "that mycoplasmas in the joint may stimulate the immune system to produce antibodies and protein factors known as cytokines, several of which produce local inflammation and tissue damage. There are clearly different agents leading to RA. Among them, M. fermentans may play an important role. This finding adds to the growing list of organisms that have long been considered benign residents of the human body but that modern research indicates may be involved in disease." This work is partially supported by a grant from the Israel Ministry of Health. Ben-Gurion University of the Negev, P.O. Box 653, Beer-Sheva, Israel For further information, please contact: E. Tepper, Department of Public Affairs Tel.: 972-8-646-1283 Fax: 972-8-647-2937 E-mail: tepperel@bgumail.bgu.ac.il More on mycoplasms: Gulf War Illnesses Research: Gulf War Syndrome or Gulf War Illness has been used to describe a collection of chronic signs and symptoms reported by U.S., British, Canadian, Czech, Danish, Saudi, Egyptian, Australian and other Coalition Armed Forces that were deployed to Operation Desert Storm in 1991. Over 100,000 American veterans of Desert Storm /Desert Shield (approximately 15% of deployed U. S. Armed Forces) returned from the Persian Gulf and slowly (6-24 months or more) and presented with a variety of complex signs and symptoms characterized by disabling fatigue, intermittent fevers, night sweats, arthralgia, myalgia, impairments in short-term memory, headaches, skin rashes, intermittent diarrhea, abdominal bloating, chronic bronchitis, photophobia, confusion, transient visual scotomata, irritability and depression and other signs and symptoms that until recently have defied appropriate diagnoses (see publications). These symptoms are not localized to any one organ, and the signs and symptoms and routine laboratory test results are not consistent with a single, specific disease. Although there is not yet a case definition for Gulf War Illness, the chronic signs and symptoms loosely fit the clinical criteria for Chronic Fatigue Syndrome and/or Fibromyalgia Syndrome. Some patients have additionally what appears to be neurotoxicity and brainstem dysfunction that can result in autonomic, cranial and peripheral nerve demyelination, possibly due to complex chemical exposures. Often these patients have been diagnosed with Multiple Chemical Sensitivity Syndrome (MCS) or Organophosphate-Induced Delayed Neurotoxicity (OPIDN). Chemically exposed patients can be treated by removal of offending chemicals from the patient's environment, depletion of chemicals from the patient's system and treatment of the neurotoxic signs and symptoms caused by chemical exposure(s). A rather large subset (~40%) of GWI patients have transmittable infections, including mycoplasmal and possibly other chronic bacterial infections, that have resulted in the appearance of GWI in immediate family members and civilians in the Gulf region. It is likely that veterans of the Gulf War who are ill with GWI owe their illnesses to a variety of exposures: (a) chemical mixtures, primarily organophosphates, antinerve agents and possibly nerve agents, (b) radiological sources, primarily depleted uranium and possibly fallout from destroyed nuclear reactors, and (c) biological sources, primarily bacteria, viruses and toxins, before, during and after the conflict. Such exposures can result in poorly defined chronic illnesses, but these illnesses can be treated if appropriate diagnoses are forthcoming. Studies on Gulf War Illnesses: Chronic Infections: Identification of Mycoplasmal Infections in Gulf War Illness Patients: Scientists at The Institute for Molecular Medicine have found that slightly under one-half of the very sick Gulf War Illness patients in a pilot study with the signs and symptoms of Chronic Fatigue Syndrome or Fibromyalgia have chronic invasive infections involving certain uncommon mycoplasmas, such as Mycoplasma fermentans (incognitus strain). This has now been confirmed in a large Department of Defense - Department of Veterans' Affairs clinical trial. Staff at The Institute for Molecular Medicine have recommended that these infections can be successfully treated with certain antibiotics, allowing the recovery of patients who have been long-term disabled. Similarly, in ongoing preliminary studies on Chronic Fatigue Syndrome and Fibomyalgia patients, we have found that a subset of patients have mycoplasmal infections that can be successfully treated with antibiotics, allowing patients to recover from their illnesses. Identification of Other Infections in Gulf War Illness Patients: The Institute for Molecular Medicine has been engaged in examining the blood of Gulf War Illness, Chronic Fatigue Syndrome, and Fibromyalgia patients for chronic infections that could explain their clinical conditions. So far, in preliminary research we have found that some patients have microorganism infections, such as those caused by Brucella or other bacteria. This line of investigation is now being actively pursued at the Institute. 7-25-001Study Confirms Brain's Natural Painkiller System: ImmuneSupport.com A unique experiment that studied chemical activity in the brains of human volunteers while they experienced sustained pain is providing new insight into the importance of the body's natural painkiller system and why each of us experiences pain differently. The results were published in the July 13 issue of Science magazine. The study results confirm long-suspected connections between pain-dampening changes in brain chemistry, and the senses and emotions experienced by people in pain. The findings may help researchers better understand prolonged pain and find more effective ways to treat the chronic pain of several conditions, including fibromyalgia and chronic fatigue syndrome. "This result gives us new appreciation for the power of our brain's own anti-pain system, and shows how brain chemistry regulates sensory and emotional experiences," said lead author Jon-Kar Zubieta, M.D., Ph.D., assistant professor of psychiatry and radiology at the U-M Medical School, and assistant research scientist in the Mental Health Research Institute. The double blind, placebo-controlled, brain imaging study, was conducted by researchers from the University of Michigan Health System and School of Dentistry. It is the first to combine sustained induced pain with simultaneous brain scan monitoring of a key neurochemical system, and the self-reported pain ratings of human participants. The research cements the critical role of the mu opioid system, in which naturally produced chemicals called endogenous opioids, or endorphins, match up with receptors on the surface of brain cells and reduce or block the spread of pain messages from the body through the brain. The body-brain pain connection occurs on many levels. As our bodies respond to the sensation of pain, our brains integrate that sensation with our knowledge of the environment in which it occurs. Then the brain produces the endogenous opiods that lessen our perception of painful nerve signals, protecting us from fully feeling them. The way the chemicals produce this effect is similar to the action of some pain medications. The study found that the onset and slow increase of jaw muscle pain over 20 minutes caused a surge in the release of the chemicals, and that the flood of those chemicals coincided with a reduction in the amount of pain and pain-related emotions the volunteers said they felt.  Instead of looking at the general activity of the brain, the researchers set out to watch the response of the chemical systems involved in suppressing the experience of pain - namely, the opioid system - and to relate its function to the volunteers' subjective reports of what they felt. The researchers chose first to study prolonged jaw pain, mimicking the chronic condition called temporo-mandibular joint disorder. To simulate TMJ's symptoms, they injected high-concentration salt water directly into each volunteer's jaw muscle, causing a painful sensation that continued only as long as the water was injected. A placebo solution that does not cause pain was also used for comparison.  The regions most significantly affected were exactly those involved in the affective, or emotional, responses, and those primarily involved in processing sensations.  The activation of the anti-pain response was dramatic in some volunteers when the placebo and pain-inducing conditions were compared, while in others the response was much less pronounced. And those who had the biggest change tended to rate the experience of pain, both in its sensory and emotional aspects, the lowest. "This may help explain why some people are more sensitive, or less sensitive, than others when it comes to painful sensations," Zubieta said. "We show that people vary both in the number of receptors that they have for these anti-pain brain chemicals, and in their ability to release the anti-pain chemicals themselves. Both of these factors appear to determine the emotional and sensory aspects of a painful experience."  "Such variability in the pain-response system may help explain why some people react to pain and pain medications differently. It may also be quite relevant to why some people, but not others, develop chronic pain conditions." Zubieta said.  The researchers now hope their findings will lead to more understanding of chronic pain and ways to treat it. Also important is the information gathered on variation among individuals' pain response, which may help clinicians tailor treatment or learn why certain chronic pain conditions such as fibromyalgia are more common in women. Westport, CT (Reuters Health) 7/09/01: While exposure to silica has been associated with kidney disease previously, findings from a study conducted by the Centers for Disease Control and Prevention (CDC), Atlanta, suggest that a causal relationship may exist.  Dr. Kyle Steenland and colleagues, from the CDC's National Institute for Occupational Safety and Health, in Cincinnati, Ohio, assessed renal disease morbidity and mortality and arthritis mortality in a group of 4626 silica-exposed workers in the industrial sand industry.  Compared with a cohort from the general US population, the workers had an excess mortality rate from acute renal disease (standardized mortality ratio = 2.61), chronic renal disease (SMR = 1.61), and arthritis (SMR = 4.36). The incidence of end-stage renal disease, particularly glomerulonephritis, was also in excess of what would be expected in the general population. Furthermore, the incidence of end-stage renal disease increased as the cumulative exposure to silica increased. "These data represent the largest number of renal cases observed to date in a cohort study of subjects with well-documented exposure to silica," the authors note in the July issue of Epidemiology.  While the excess in glomerular disease cases suggests a possible immune or autoimmune mechanism, it is possible that silica may be directly toxic to the kidney, the researchers point out.  "We found positive exposure-response trends...based on either morbidity or mortality data," the investigators note. "These exposure-response trends tend to confirm a causal relation between silica exposure and subsequent renal disease," they state.  Epidemiology 2001;12:405-412. Government Studies Link Breast Implants to Cancer, Lung Diseases, and Suicide: By Diana Zuckerman, Ph.D. and Rachael Flynn, MPH Two major new studies raise questions about the long-term safety of breast implants. A team of researchers led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI) recently published these studies on the long-term health effects of breast implants. One of the studies found that women with breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients. The other study found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population. These studies are the first to look at all types of cancer and all causes of death among breast implant patients. While the authors were not able to determine whether implants caused these illnesses, the results show a doubling of brain cancer and a tripling of lung cancer, emphysema, and pneumonia for women with implants. Even though these findings were described as "unexpected," they are consistent with previous research that shows brain abnormalities and lung problems related to breast implants. There was also a four-fold increase in suicide for breast implant patients, which seems to contradict the manufacturers¼ assertion that implants improve a woman¼s feeling of self-worth. Why are these results so different from widely reported claims that breast implants do not cause any diseases? One reason may be that the women included in the studies all had implants for at least eight years. Previous research included women who had only had breast implants for a year or two, or even a few months. Therefore, these new studies are the first examine the long-term health effects of breast implants. Unfortunately, even though diseases may take much longer than 8 years to develop and be diagnosed, the findings from these well-designed studies indicate a potentially serious risk for the health of women with breast implants. Another possible reason for this difference is that plastic surgeons and the implant manufacturers helped design and fund much of the previous research on implants; these groups have a tremendous financial stake, billions of dollars, in the outcome. Perhaps that is why so many previous studies focused on just a few, rare diseases, rather than a more comprehensive evaluation of the women¼s health. Study Design: The comprehensive studies started with the same group of nearly 13,500 women from 6 different geographical regions in the U.S. Information was gathered from patient questionnaires and medical records. Both studies compared women with implants to women who underwent other forms of plastic surgery as well as the general population of women the same age. In general women with implants were healthier than women in the general population, but less healthy than other plastic surgery patients. The latter is a more appropriate comparison because all plastic surgery patients tend to be more affluent than the general population, and more affluent women tend to live longer. More Research Needed: More independent research, funded by the federal government, is needed to determine why breast implants are linked to cancer and other fatal diseases in these new studies. In addition, these two studies need to be continued to see whether the results change as the women (and their implants) age. Since approximately 2 million women in the United States already have breast implants and another 300,000 are planning on getting them this year, research on the long-term health effects is long overdue. The new studies are: Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. Mortality. Among Augmentation Mammoplasty Patients, Epidemiology 2001; 12: 321-326.  Brinton, LA, Lubin, JH, Burich, MC, Colton, T, Brown, SL, and Hoover, RN. Cancer Risk at Sites Other Than the Breast Following Augmentation Mammoplasty. Annals of Epidemiology 2001;11: 248-256. Abstract: Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.  by Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS.  ImmuneSupport.com  05-31-2001  Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA.. Summary: This study found a 'statistically significant' association between the development of fibromyalgia and the rupture of silicone breast implants. Objective: To assess whether breast implant rupture or extracapsular silicone are associated with selected symptoms of self-reported physician-diagnosed connective tissue disease (CTD). Methods: Women with silicone gel breast implants responded to a questionnaire that included questions on health status, satisfaction with implants, symptoms of CTD, and physician-diagnosed disease. These women then had magnetic resonance imaging (MRI) of their breasts to determine the status of the implants with respect to rupture and extracapsular silicone. Results: Women with breast implant rupture diagnosed by MRI were no more likely to report a diagnosis of selected CTD than those with intact implants or those with implants of indeterminate status.  Women with extracapsular silicone (silicone gel outside of the fibrous scar that forms around breast implants) were more likely to report having fibromyalgia (FM, p = 0.004) or other CTD, which included dermatomyositis, polymyositis, Hashimoto's thyroiditis, mixed CTD, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia (p = 0.008) than other women in the study. The association with FM remained statistically significant when adjusted for multiple comparisons (7 diagnoses) and implant age, implant location, or implant manufacturer (p < 0.05 in all cases), but became of borderline statistical significance when adjusted for multiple comparisons and self-perceived health status (p = 0.094) or self-perceived rupture status (p = 0.051). The association with other CTD remained statistically significant when adjusted for multiple comparisons and implant location or implant manufacturer, but became borderline or insignificant when adjusted for multiple comparisons and for implant age (p = 0.051), self-perceived health status (p = 0.434), or self-perceived rupture status (p = 0.145). Logistic regression was used to compute odds ratios of self-reported diagnoses comparing women with and without extracapsular silicone. The odds ratios were 2.8 (95% CI 1.2 to 6.3) for FM, and 2.6 (95% CI 0.8 to 8.5) for other CTD after adjustment for implant age, implant location, implant manufacturer, implant type, self-perceived health, self-perceived rupture status, and site of surgery practice. Conclusion: These data suggest an association between extracapsular silicone from ruptured silicone breast implants and FM. If this association persists in other studies, women with silicone gel breast implants should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and the silicone gel escapes the fibrous scar capsule.  J Rheumatol 2001 May;28(5):996-1003 PMID: 11361228 [PubMed - in process] Implant infections: a haven for opportunistic bacteria: J Hosp Infect 2001 Oct;49(2):87-93 (ISSN: 0195-6701) Schierholz JM; Beuth J Caesar-Center of Advanced European Studies and Research, Friedensplatz 16, Bonn, D-53111. The insertion of implants and medical devices has emerged as a common and often life-saving procedure. A current estimate of the rate of total hip replacement in the world is approximately one million a year, and knee replacements more than 250000. More than 30% of hospitalized patients have one or more vascular catheters in place. More than 10% of hospitalized patients have an indwelling urinary catheter. Some patients require multiple joint replacements. In the United States, approximately 2 million nosocomial infections cost nearly $11 billion annually. Exposure to invasive medical devices is one of the most important risk factors. (1) Devices predispose to infection by damaging or invading epithelial or mucosal barriers and by supporting growth of micro-organisms, thus serving as reservoirs. Invasive medical devices impair host defence mechanisms and, when contaminated, can result in resistant chronic infection or tissue necrosis, the major objections to extended use of implant devices. Implant devices today account for approximately 45% of all nosocomial infections. (2) Implant infections are extremely resistant to antibiotics and host defences and frequently persist until the implant is removed, which is the standard therapy. Tissue damage caused by surgery and foreign body implantation further increases the susceptibility to infections, activates host defences and stimulates the generation of inflammatory mediators; these are enhanced by bacterial activity and toxins.(3)The ability of bacteria such as Staphylococcus epidermidis, which are otherwise virtually avirulent, to escape from host defences and antibiotic therapy, has led to the development of alternative methods of control such as infection-resistant materials acting as antimicrobial drug-delivery  systems. By these methods, there is a sustained delivery of antimicrobial drugs into the local micro-environment of implants, which avoids systemic side-effects and exceeds usual systemic concentrations by several orders of magnitude. Bioengineering of hybrid implant materials in order to achieve optimal performance and to prevent inflammatory reactions and interface cellular disorganization is a field undergoing rapid development. Hybrid materials that slowly deliver antimicrobial drugs may reduce implant infections in the future. [Copyright 2001 The Hospital Infection Society.]. FDA Study Shows That Most Silicone Gel-Filled Breast Implants Rupture: Patricia Lieberman, Ph.D. and Diana Zuckerman, Ph.D.  While the Food and Drug Administration (FDA) has warned consumers that "breast implants do not last a lifetime," new FDA studies by Dr. Lori Brown and her colleagues indicate that most women with silicone gel-filled breast implants will have at least one broken implant within 10 years. In the first study, the FDA interviewed 907 women in the Birmingham, Alabama area who had breast implants for at least six years. In the second study, 344 women with silicone gel breast implants who had been interviewed in the first study and had not had additional surgery after getting their implants received a Magnetic Resonance Imaging (MRI) exam, to determine whether their implants were broken. Interview Study: In the Interview Study, women with breast implants were asked if they had any additional breast surgery after getting their implants. If their implants were removed, they were asked why. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured.  One-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. Of the women who had additional surgeries, more than half reported that at least one of their implants was ruptured or leaking. The average time between getting implants and having additional surgery was 11.5 years. The most common reason for additional surgery was due to complications such as pain, capsular contracture, displaced implant, infection, or a suspected rupture. Those complications occurred in 103 of the 303 women who had additional surgery. An additional 92 women had their breast implants removed because they were concerned about the safety of silicone.     Some women had additional surgery because of diseases or because they had symptoms that they or their doctors thought were due to the implant. Other women had additional surgery that was planned or staged, such as replacing tissue expanders, or to get a different size implant. Of the 73 women who suspected their implant had ruptured, 51 suspected the rupture because they had pain in their breast, chest, or upper body. Thirty-five suspected a rupture because of changes in their breast shape. Since self-reported medical history is not always accurate, the FDA attempted to check to determine if the women's reports were accurate. The FDA was able to obtain medical records from about half of the women who had additional surgeries, and found that the women's reports were quite accurate. There were minor discrepancies between what the women reported and what was recorded in their medical records. Those differences could have been because researchers may have reviewed a medical record from a different surgery than the one the woman reported, the doctor might not have recorded whether an implant had ruptured, or the woman could have been mistaken that her implant was ruptured. In order to eliminate those biases, the FDA performed a second study, using MRIs. The MRI Study, described below, showed even higher rates of implant rupture than the Interview Study. MRI Study: The FDA recruited women from the Interview Study to have a Magnetic Resonance Imaging (MRI) exam to determine if their implants were ruptured. The study looked at 344 women who had 687 silicone gel-filled breast implants and who did not suspect that their implants were broken. The average time a woman had implants was about 17 years. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured. Since the study excluded the one-third of the women in the Interview Study who already had their implants removed due to breakage or other complications, the actual rupture rate is even higher than this study reports. More than two-thirds (69%) of the women who had not previously had surgery were found to have at least one ruptured implant in the MRI Study.  Almost half (48%) of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79%, of the women who had implants for 11-15 years had at least one ruptured implant, and similarly, 72% of women who had implants for 16 to 20 years had at least one ruptured implant. The rupture rate was lower, approximately one in three, among the few women who had implants for 21 years or more. This is probably because implants made prior to 1975 were made with thicker envelopes and thicker silicone gel. Of particular concern was whether the silicone migrated outside of the scar tissue that surrounds the implant. Migrating silicone is almost impossible to surgically remove, and efforts to remove it can result in surgery resembling a mastectomy. The findings were bad news for patients with gel implants: the radiologists agreed that more than one in five women (21%) had silicone gel that had migrated, and could therefore potentially migrate to essential organs. There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle.  Unfortunately, most of these findings have not yet been reported, and the study is not yet published. Implications for Patients and Women Considering Gel Implants: The results of this study show that most women with silicone gel implants will have a broken implant within 10 years but they are unlikely to detect it unless they get an MRI.  The study also indicates that estimates of rupture that are based on the women who have surgery to remove broken implants will grossly underestimate the problem. As a result of the many "silent ruptures," implant patients and their surgeons have been unaware that most women will require repeated surgeries even if they do not have physical complaints about their implants.  Even more worrisome, gel was migrating outside the scar capsule for more than one in every five women who were unaware that their implants were broken. This puts these women at risk for losing at least some of their own breast tissue when the implants are removed. In the most extreme cases, some of these women will need a mastectomy to remove the silicone, and the silicone could also migrate to the lungs or other vital organs.  Posted on ASBI 11/2001) 7/9/2001: Breast Implants Linked To Lung, BrainCancers  http://www.nursinghands.com/news/NewsStory.html?7960 A long-term study has found that women with breast implants seem to have higher rates of brain and lung cancer compared to other plastic surgery patients. The researchers, from the U.S. National Cancer Institute (NIH, Bethesda, MD), stress that their findings do not show a direct cause-and-effect relationship but only a link whose significance is unclear. The study was reported in the May issues of two medical journals, Annals of Epidemiology and Epidemiology. More than 13,000 women with breast implants received prior to 1989 were followed by the researchers for around 13 years and were compared with 4,000 women with other types of plastic surgery and with the general population. The results focused on the plastic surgery group, based on questionnaires returned by 7,500 women and on medical records. Most of the women had silicone implants, which were removed from the market in 1992. Only about 10% of the women had saline implants. The results showed that women with implants of either type had a threefold risk of dying of respiratory tract diseases, primarily lung cancer, compared to women in the general plastic surgery control group. They also had a higher rate of dying from pneumonia and emphysema and had a twofold risk of dying of brain cancer. In trying to understand the high incidence of brain cancer, the researchers noted the many neurologic alterations noted by women with implants, including memory loss and cognitive dysfunction, and concluded that implants might have been more directly involved than previously thought. According to the lead author, Dr. Louise A. Brinton, chief of the environmental epidemiology branch of the NCI, smoking could not be ruled out as a factor. Since no plausible explanation could be found for the brain cancer finding, further research is needed, say the investigators. Several years ago, a panel of scientists assembled by the U.S. Institute of Medicine reviewed the medical literature pertaining to silicone implants and reached the conclusion that the implants were not associated with any major disease. Recently, a study published in the May issue of Plastic and Reconstructive Surgery found no evidence to support a link between breast implants and cancer, based only on an analysis of scientific literature.  By medinews.com staff writers: 09/05/2001 Related Links: U.S. National Cancer Institute  To see more of Medinews.com, or to subscribe, go to http://www.medinews.com 5/16/01 (HealthScout) -- Chemicals that mimic male and female hormones may not be safe even at levels the government now labels safe, a government panel suggests.   The chemicals are called endocrine disruptors, and studies show that some of these hormone-like substances may be harming the reproductive systems or the unborn in animals at levels well below the "no effect" ones defined by previous testing. The Environmental Protection Agency (EPA) asked the National Toxicology Program to review chemicals that seem to provoke an endocrine reaction, says Ronald Melnick, who led the review panel and is a senior toxicologist for the National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, N.C.. "These chemicals, present in the environment, might act as a natural hormone, like estrogen or testosterone, or they might block the effect of that hormone." "The issue that came up is: Are there effects at low doses from these chemicals that would not be picked up by the standard testing paradigm?" Melnick poses. "What's come up in the literature in recent years seems to show that at lower doses, below which the scientists have determined was a 'no effect' level, there still might be effects going on."  Controversy surrounds environmental estrogens and testosterones, Melnick adds. They are found naturally in some plants, and they are also created by manufacturers and used in plastics, insecticides and make-up. The synthetic chemicals can have a profound effect on the hormonal systems of animals or their young, previous research shows. Changes in the size and weight of reproductive organs, like the uterus or the prostate, have been linked to the chemicals. These chemicals can last for years in the environment and may collect in the fat tissue of animals and humans. To get a handle on the issue, the National Toxicology Panel asked a group of outside experts to review published and ongoing research on endocrine disrupters, Melnick explains. "What they found was there was evidence of low-dose effects." The report concludes that experts need to figure out at what levels these chemicals can be considered safe. The panel's report doesn't go far enough, says the executive director of the Children's Environmental Health Network in Washington, D.C.   "These are not problems that we want to wait for a smoking gun to appear before we regulate these chemicals," says Daniel Swartz. "If we are talking about very low levels of environmental estrogens causing fertility problems in animals, that strikes me as a problem. And even before all the evidence is in, that should force us to take some precautionary measures now." "I don't think we know how serious this problem is," Swartz adds. "You are seeing these effects at relatively low levels from chemicals that persist for a long time in the environment, and we are talking about plastics and insecticides, which contain these endocrine disruptors. Even if we stopped right now, we might still see harmful effects for decades." The solution, Swartz says, is to get the synthetic chemicals off the market and help industry invest in research and development to make the transition. "If you are not getting any health benefit [from these chemicals], and there is some evidence of health risk, then let's get this stuff off the market," he says.  If you're interested in seeing the report on Endocrine Disruptors, you can find it at the National Institute of Environmental Health Sciences. Public comment on the report will be provided to the EPA, which provides more information on endocrine disruptors. Blood vessels found to signal chain of destruction in bone diseases: Biologists at Washington University in St. Louis have discovered a mechanism in blood vessels that opens the door for bone loss in such diseases as rheumatoid arthritis, periodontal disease, osteoporosis, tumor-associated bone loss, or artificial implant loosening.  Patricia Collin-Osdoby, Ph.D., research associate professor of biology in Arts & Sciences at Washington University, and Philip Osdoby, Ph.D., professor of biology in Arts & Sciences, and Linda Rothe, Washington University research associate, have for the first time shown that blood vessels at inflamed sites where bone loss is occurring create signals that set into motion a cascade of events leading to local bone destruction. When an area of tissue in or near bone becomes inflamed, key molecules called cytokines are locally produced and increase in the bloodstream. Studying human tissue and cell samples, the Osdobys have shown that two key inflammatory cytokines, interleukin-1 (IL-1) and tumor necrosis factor (TNF), signal the endothelial cells of blood vessels and capillaries to make and display on their cell surface a molecule called RANKL. RANKL is the critical signal that tells the body to make and activate bone-degrading cells called osteoclasts. After osteoclasts take bone away, osteoblasts go back in and add new bone. Normally, this bone remodeling, which is associated with a blood vessel or capillary at such sites, is a carefully balanced process. However, in persons with inflammatory bone disease, osteoclasts out-number and out-work the bone-forming osteoblasts, leading to weakened bone matrix, bone loss, and an increased risk of fracture. The Osdobys believe that inflamed blood vessels beckon cells to the region, and then initiate their development into highly active bone-degrading osteoclasts. The researchers also found that in this biochemical chain of events, the blood vessels themselves make an antagonist molecule, osteoprotegerin (OPG), which neutralizes RANKL activity. Although OPG is made in this process, it peaks early and RANKL gets the upper hand. This is aided by the fact that RANKL is tethered on the cell surface while OPG is a soluble molecule that can be carried away by the circulation. Drug chemical companies are interested in RANKL as a target and OPG as a possible therapeutic or preventative molecule to eliminate excessive osteoclast formation and activity. It is the progressive and irreversible loss of bone and cartilage that is the most difficult to control and treat in rheumatoid arthritis, periodontal disease or cancer. Current anti-inflammatory or chemo-therapeutic treatments are inadequate for this purpose. However, OPG injection prevents such bone and cartilage loss, without interfering with normal bone remodeling. More significantly, the discovery that blood vessel cells themselves are initiators of this elaborate process could make drug delivery easier or more efficient. Rather than receiving a local injection, patients may be able to take an oral or systemic dose that goes directly into the blood stream and allows the drug to work immediately in the early stages of RANKL activity. This could prevent new areas of bone degradation from getting started and slow down those that have already begun. "People in the past few years have been looking at the expression of RANKL and OPG in bone marrow stromal cells, osteoblasts and T cells, but nobody had looked in blood vessels," Collin-Osdoby said. "There is a growing appreciation that blood vessels do much more in the body than simply provide a physical barrier and a route to passively deliver nutrients and cells. Our findings show that blood vessels can play a key role in actively regulating bone remodeling and physiology." According to Osdoby, the discovery opens up several options to eliminate or minimize bone loss in inflammatory-related diseases.  "Because we know that blood vessels overgrow and are activated to cause osteoclast formation in inflammatory  disorders, researchers can begin to think of ways to dampen the formation of new blood vessels or capillaries, deactivate the osteoclasts, or neutralize the RANKL expressed," he said. "It's the osteoclasts that are directly responsible for the loss of bone, even though many other cell types, signals, and enzyme activities are produced and play a role. So, the most obvious approach to prevent such bone loss is to directly interfere with the formation of bone-degrading osteoclasts." The research was published in the June, 2001 issue of the Journal of Biological Chemistry. The research was supported by the National Institutes of Health. 05/23/01,  UK: 'Grow your own breasts': A scientist has grown breast tissue in the laboratory. Scientists claim a laboratory breakthrough could make it possible for women to grow their own breast implants. At present, women seeking breast enhancement have had to rely on artificial implants.  However, there is growing evidence that these pose a significant risk to health if they leak. New Scientist magazine reports that tissue engineer Kevin Cronin, of the Bernard O'Brien Institute of Microsurgery in Melbourne, is working on a safer alternative.  Dr Cronin told a meeting of the Royal Australasian College of Surgeons that he has successfully grown breast and fat tissue in rats, mice and rabbits.  If the technique works in people, it could be used for cosmetic surgery or breast reconstruction after mastectomy.  Scientists have previously carried out experiments on animals in which they have grown tissue in the lab and transplanted back into the body. The research was carried out on mice.  However, Dr Cronin actually grows the tissue within the body itself.  A "chamber" containing a scaffold is implanted into the area where new tissue is needed.  Cells from surrounding tissue then migrate into the chamber and form a three-dimensional blob of tissue. Over time, the scaffold disintegrates. Dr Cronin says the key to the technique's success is a "vascular loop" in the chamber that generates new blood vessels to supply the growing tissue.  But he won't reveal details about how it works or what it is made of until a patent has been granted.  Cronin has already grown fat and breast tissues in female mice by implanting the chamber into their groin. This area is on the animals' "milk line", where the cells are pre-programmed to form breast and fat tissue.  Growing human breasts would involve a similar technique. Problems: Mr Dai Davis, a plastic surgeon from Stanford Hospital in London, says supplying blood to the new tissue will be difficult.  This technique could be wonderful news for women. Christine Williamson, Silicon Support UK He told New Scientist: "We can move fat around [during breast enlargements], but we can't always vascularise it - it calcifies or just disappears altogether." Tissue engineer Julia Polak from Imperial College School of Medicine in London warned that the technique could be fraught with danger if used to re-build the breasts of women who have had breast cancer. "In the case of someone who has already had breast cancer, it would be difficult to ensure that the cells used to regenerate the breast tissue did not also contain the cancer-causing genetic machinery." However, she said the technique did have potential. "It is certainly exciting. It is the way tissue engineering should be going - getting the body to regenerate itself rather than trying to grow complex body parts in a test tube." Christine Williamson, head of the pressure group Silicon Support UK, said artificial implants had ruined the health of many women. She said research from the US indicated that silicone implants increased the risk of cancer, suicide and diseases of the connective tissue.  She told BBC News Online: "This technique could be wonderful news for women who have had a mastectomy or problems with only one breast growing.  It could save a lot of them dying or becoming seriously ill.  "The complications associated with artificial implants are now coming to light as proper research is done for the first time.  Ms Williamson said she would be happy to be the first human to test the technique. INSURANCE INFORMATION: There have been several questions regarding insurance denial for explantation.  We have found the following procedure to be effective. 1. Ask for a hearing, which is usually a part of every insurance policy procedure.   2. For the hearing, have letters from doctors stating that explantation is a medical necessary.  Have an attorney or a support group member present to give support to your testimony.  3. If hearing results in denial, contact your State Board of Commission of Insurance.  They should help resolve the matter.  4.  Our members have never had to go beyond the insurance hearing phase. When you demand this, the insurance company realizes that you mean business and will not be put off by their intimidating tactics.  (Submitted by a survivor). FOREIGN ISSUES:  5/31/01: From the TCC: In response to your inquiry regarding the recent announcement of payment of claims to Australian claimants in the Dow Corning Corporation ("Dow Corning") bankruptcy case, we provide the following information. Generally, there are several class actions in Australia which were negotiated, settled and incorporated into the Joint Plan of Reorganization prior to confirmation of the Joint Plan on November 30, 1999.  A single group of claimants, represented largely by the Australian law firm of Slater & Gordon, 562 Little Bourke Street, Post Office Box 4864, Melbourne VIC 3000, Australia, Telephone: 61 3 9629-7177 has negotiated an agreement with Dow Corning's insurer of foreign claims. On May 21, 2001, the Victoria Supreme Court approved the agreement negotiated between Slater & Gordon and AIU, the insurer of these foreign claims, pursuant to which AIU apparently purchased this block of claims in connection with the resolution of certain ongoing litigation pending in Australia. Under the agreement, approximately 3100 Australian claimants who elected to participate in this settlement will receive benefits directly from the insurance company based upon the degree of their medical problems.  Please note that Dow Corning is not funding these payments nor are the payments being made by Dow Corning.  Payment of claims from Dow Corning to all other Australian claimants, Canadian claimants, United States' claimants and claimants in any other country, is conditioned upon implementation of the Joint Plan and establishment of the effective date. Implementation of the Joint Plan has been delayed for an indefinite time pending the resolution of certain issues on appeal which are now before the Sixth Circuit Court of Appeals. We suggest that you contact the lawyer for your applicable class action for more information  Our firm has no knowledge of the particular laws applicable to Australia or Canada.  The Tort Claimants' Committee ("TCC") was not involved in negotiating the settlements.  As a result, we are not in a position to advise you with respect to your respective rights and remedies in connection with these class action settlements.  Should you wish to attempt to pursue your claims in the American bankruptcy case rather than the class actions, you may attempt to file a claim if you have not already done so. You should contact us further for information regarding the procedure for filing a late claim.  However, we cannot comment nor verify whether your efforts to directly participate in the American bankruptcy case would be superceded by the terms of your respective class actions in either Australia or Canada.  To learn more on this subject, you should immediately contact your own lawyer or one of the lawyers for the class plaintiffs. Current information regarding the status of the bankruptcy case is available toll-free by calling (800) 651-7030 from the United States or Canada.  From outside the United States, you may dial direct (202) 332-5510. The statements contained in this letter are only for information purposes to assist you in better understanding the status of the Dow Corning bankruptcy case.  Please do not construe any of the statements in this letter as legal advice.  We strongly suggest that you confer with and/or retain personal legal counsel if you feel it appropriate and/or necessary to assist you with your claim. Very truly yours, Co-bankruptcy Counsel to the Tort Claimants' Committee. TORT CLAIMANTS COMMITTEE, Dow Corning Corporation Chapter 11 Bankruptcy Case, P.O. Box 61406, Houston, Texas 77028-1406, (713) 547-2271, (713) 547-2600 (Fax), Email address: tortcom@haynesboone.com Web address:  www.tortcomm.org Brussels: 11/15/01: Breast  implants: Commission proposes upgrading technical and health monitoring  requirements and recommends that more information be provided to  women.  The European Commission is to propose tightening control on safety of breast implants, and reinforcing mechanisms to verify that rules are observed. It will also ask for an upgrade of European standard EN 13350, which lays down technical specifications for breast implants. These proposals are part of a wider Commission/Member State joint drive to improve implant quality, information provision, and post-surgical follow-up, and follows requests from citizens and petitions to the European Parliament. The proposals' rationale is set out in a Commission Communication [1] published today, which has one annex on the essential safety requirements, and another one listing issues on which information should be made available to patients. As Enterprise Commissioner Erkki Liikanen stated to the European Parliament, "health issues are a major public concern, and it is our task to ensure that they are addressed in the best possible way, so as to provide European citizens with the highest possible level of safety."  Figures are inevitably incomplete, but it is estimated that in Europe, 75-80% of breast implant surgery is done for cosmetic reasons and the remainder for medical ones.  A recent European Parliament study found that many studies and analyses carried out so far show no evidence that breast implants pose a general health risk. However, it is widely recognised that some specific problems do occur, and that several relate to product design or characteristics. As Mr Liikanen added,  "We should be aware that, like with all implants and medical interventions, there may be inconveniences, and that patients may react in different ways. That is why patients should know the advantages and the disadvantages of implants, and be given all the relevant information, that allows them to make a well informed and thoroughly considered decision." Debates between the Commission, European Parliament and national authorities have produced a wide consensus in favour of a Community-wide policy that would retain the present legal framework, but introduce specific measures to increase and improve information for patients, tracking and surveillance, quality control of  implants, and key research. COMMENTARY:  Washington, DC,  7/23/01: New report debunks drug industry claims about the cost of new drug research and development.  Second report documents industry's intense lobby and political contribution campaign to keep prices and profits high. The pharmaceutical industry spends about one-fifth of what it says it spends on the research and development (R&D) of new drugs, destroying the chief argument it uses against making prescription drugs affordable to middle and low-income seniors, a Public Citizen investigation has found.  The findings are contained in a Public Citizen report, Rx R&D Myths: The Case Against the Drug Industry's R&D Scare Card. The report reveals how major U.S. drug companies and their Washington lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), have carried out a misleading campaign to scare policymakers and the public. PhRMAs central claim is that the industry needs extraordinary profits to fund "risky" and innovative research and development to discover new drugs. In fact, taxpayers are footing a significant portion of the R&D bill, which is much lower than the companies claim. "This R&D scare card is built on myths and falsehoods that are maintained by the drug industry to block Medicare drug coverage and measures that would rein in skyrocketing drug costs," said Frank Clemente, director of Public Citizen's Congress Watch.  Public Citizen based the study on an extensive review of government and industry data and a report obtained through the Freedom of Information Act from the National Institutes of Health (NIH). Among the reports key findings: The actual after-tax cash outlay what drug companies really spend on R&D for each new drug (including failures) is approximately $110 million (in year 2000 dollars.) This is in marked contrast with the $500 million figure PhRMA frequently touts.      The NIH document shows how crucial taxpayer- funded research is to the development of top-selling drugs. According to the NIH, U.S. taxpayer-funded scientists conducted at least 55% of the research projects that led to the discovery and development of the five top-selling drugs in 1995. Public Citizen found that, at most, about 22% of the new drugs brought to market in the past two decades were innovative drugs that represented important therapeutic advances. Most new drugs were "me-too" or copycat drugs that have little or no therapeutic gain over existing drugs, undercutting the industry's claim that R&D expenses are used to discover new treatments for serious and life-threatening illnesses. A second report issued today by Public Citizen, The Other Drug War: Big Pharma's 625 Washington Lobbyists, examines how the U.S. drug industry spent an unprecedented $262 million on political influence in the 1999-2000 election cycle. That includes $177 million on lobbying, $65 million on issue ads and $20 million on campaign contributions. The report shows that: The drug industry hired 625 different lobbyists last year or more than one lobbyist for every member of Congress to coax, cajole and coerce lawmakers. The one-year bill for this team of lobbyists was $92.3 million, a $7.2 million increase over what the industry spent for lobbyists in 1999. Drug companies took advantage of the revolving door between Congress, the executive branch and the industry itself. Of the 625 lobbyists employed in 2000, more than half were either former members of Congress (21) or worked in Congress or other federal agencies (295).  The industry's $20 million in campaign contributions and millions more in issue ads attacking candidates opposed by the industry aided its army of lobbyists in gaining access to congressional representatives. "The drug industry is stealing from us twice," Clemente said. "First it claims that it needs huge profits to develop new drugs, even while drug companies get hefty taxpayer subsidies. Second, the companies gouge taxpayers while spending millions from their profits to buy access to lawmakers and defeat pro-consumer prescription drug legislation."   Rep. Pete Stark (D-Calif.), the ranking Democrat on the House Ways and Means Health Subcommittee, added, "Not surprisingly, pharmaceutical companies have been deceiving Congress and the American public for years. I commend Public Citizen for exposing the industry's long-standing attempt to hide the truth about R&D spending."  Sen. Paul Wellstone (D-Minn.), said, "This well-documented Public Citizen report shows just how much the pharmaceutical industry exaggerates its commitment to research and development and focuses instead on the bottom line."  Added Rep. Tom Allen (D-Maine), "Millions of our seniors have paid taxes for decades and contributed to the development of new drugs. Now in their retirement, they pay the highest prices in the world for these drugs. . . The public deserves better." Public Citizen calls on Congress to pass a Medicare-run prescription drug benefit program with strong cost containment that guarantees affordable prices for middle and low-income seniors. May 18, 2001 ã LONDON (Reuters Health), Richard Woodman: Lancet: FDA  far too cozy with drug industry: Patients taking a controversial new drug for irritable bowel syndrome may have died because the US Food and Drug Administration (FDA) has become a "servant of [the drug] industry," the editor of The Lancet medical journal claimed in the May 19th issue. In a devastating editorial, Richard Horton said that although GlaxoSmithKline (GSK) voluntarily withdrew Lotronex (alosetron) from the US market last November after the deaths of five patients, senior FDA officials were now seeking to reintroduce it. "This story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become the servant of industry," he said.  The two-page editorial, entitled "Lotronex and the FDA: a fatal erosion of integrity," accuses the FDA of receiving hundreds of millions of dollars funding from industry. It claims the views of FDA scientists who raised safety questions about the drug were dismissed by FDA officials and that the scientists were excluded from further discussion about the drug's future. And it alleges that negotiations between the FDA and GSK on the drug's future involved a "two-track process, one official and transparent, one unofficial and covert."  Lotronex was licensed by the FDA in February 2000 but was never approved by the European Medicines Evaluation Agency. The company withdrew the product in the US on November 28 after 49 cases of ischaemic colitis and 21 of severe constipation, including instances of obstructed and ruptured bowel. In addition to five deaths, 34 patients had required admission to hospital and 10 needed surgery. The Lancet says that as early as July, it was known that seven patients had developed serious complications. The clinical data confirmed "substantial and potentially life-threatening risks" but instead of withdrawing Lotronex the FDA issued a medication guide. "This decision was to prove fatal." The editorial says FDA scientists knew that the medication guide advising patients to stop taking Lotronex if they felt "increasing abdominal discomfort" was impractical since abdominal pain is also a cardinal symptom of an irritable bowel.  FDA scientists argued that it was unreasonable to expect either patients or their physicians to judge pain as an early warning of possibly fatal ischaemic colitis. This view was dismissed by FDA officials.  The scientists who raised these issues felt intimidated by senior colleagues and were excluded from further discussions about Lotronex's future." The journal says that in a memorandum dated November 16, FDA scientists said, "Early warning of the dire side effects of this drug is clearly not feasible" and added a "risk management plan cannot be successful." However, this conclusion was blurred by the time of the key November 28th meeting between GSK and FDA officials. Rather than reject the company's risk management proposal and withdraw Lotronex, the FDA offered several conciliatory options including voluntarily withdrawal pending further discussion. The editorial claims "many within the FDA's leadership now want to bring Lotronex back. An advisory committee meeting set up to do so is being planned for later this year.  In April, GSK chief executive Jean-Pierre Garnier said he believed the odds were low that Lotronex would be relaunched because of the difficulty of predicting which patients might be at risk of severe side effects. But industry analysts who have met R&D head Tachi Yamada more recently told Reuters the company now appeared to be more optimistic about a Lotronex relaunch. GSK spokesman Martin Sutton told Reuters, "We regard the editorial as misleading. There have been discussions between FDA and GlaxoSmithKline officials. These meetings have all been conducted according to usual regulatory and industry practices. Both the FDA and ourselves are trying to find a resolution that will benefit and protect patients." He added that the timing of any advisory committee meetings was a matter for the FDA.  An FDA spokesperson said the agency is still formulating its response to the editorial. Horton told Reuters Health he became interested in Lotronex because The Lancet published some of the trial data that led to the FDA approving the drug. "As the year went on, we noticed that there were increasing reports of adverse events.  "Then as I got more intrigued about what was happening, it opened up into an issue of how science is dealt with by the FDA and how, because of industry funding, it has fatally compromised its independence.  "The scientists within the FDA who analyze and interpret adverse drug reactions have been largely ignored after the drug was approved and marketed. That is where there has been a terrible failure in evaluating the safety of this drug.  "The FDA is not only compromised because it receives so much funding from industry but because it comes under incredible Congressional pressure to be favorable to industry. That has led to deaths." Horton pointed out that irritable bowel syndrome may be extremely unpleasant but is not life-threatening. To approve a drug that can lead to ruptured bowel and death was at odds with the normal balance between risk and benefit, he said.  "This is a drug whose application was approved for full unrestricted marketing within 7 months. That is insufficient to gather safety data. Pushing through an application so quickly is irresponsible." Horton said that GlaxoSmithKline "has failed to gather sufficient evidence to justify the safety of this product." He added that the company had applied pressure through private communication to senior FDA officials. "Instead of an accountable review process, one has a covert, unofficial process." This is not Horton's first attack on the drug industry. In recent editorials he has criticised the "tightening grip of big pharma" over what researchers can publish in medical journals. His latest editorial demands that: *  Lotronex should be reclassified as an investigational new drug, thus limiting its use to experimental settings only. *  Covert private communications between FDA officials and industry must stop. *  Drug approvals and safety reviews should take place through accountable procedures.  *  Greater weight should be given to the epidemiologic advice provided to advisory committees. *  There should be an independent congressional audit of the FDA's drug approval processes. *  Oversight of the pharmaceutical industry should be removed from CDER's control because safety cannot be overseen by a centre that received industry funding. *  FDA should welcome, not censure, differences of opinion within the organisation.  *  The FDA's new commissioner should be an epidemiologically trained physician experienced in conducting clinical trials and independent of industry.  SOURCE: The Lancet 2001;357:1544-1545. COCONUT GROVE, Fla., April 30 /PRNewswire/ -- Clinical investigators in three  U.S. cities today reported data on thirty more women who have succeeded in  growing their own breasts by approximately one cup size (120cc) in ten weeks  using a new medical system. Led by Dr. Thomas J. Baker, former president of the  American Society for Aesthetic Plastic Surgery, investigating teams in Miami,  San Francisco and Washington, D.C. using identical protocols, reported growth  among all participating patients. The team of investigators also reported  significant increases in patient self-esteem. This data confirms earlier  findings published by Dr. Baker and other colleagues in the June, 2000 edition  of Plastic and Reconstructive Surgery. Dr. Baker said he expects the system will be made available to U.S. patients  on a limited basis this year. The system has met all the U.S. Food and Drug Administration's marketing requirements.  Investigators, now in final stages of market testing, have data on approximately 200 women who have used the Brava(R) Breast Enhancement and Shaping System developed by Dr. Roger K. Khouri, a renowned plastic and reconstructive surgeon. The Brava System uses a proven scientific principle to  stimulate cell reproduction and long-term tissue growth. The system includes two  plastic domes, a sports bra and a SmartBox(TM) (microprocessor controlled  device). It applies a safe, sustained and gentle pull to the breasts. Women must wear the system ten hours a day for ten weeks to achieve long-term growth according  to Drs. Baker and Khouri. Physicians and nurses monitor their patients through a combination of regular office visits and a unique, secure on-line data  collection system. More than 16 million U.S. women want larger breasts; less than one percent per year have surgery.  According to the American Society for Aesthetic and Plastic Surgery, in 2000,  approximately 200,000 women underwent breast implant surgery. Research conducted  by Brava found that more than 16 million American women between the ages of 18  and 49 are dissatisfied with their breasts because they are too small. Of these  dissatisfied women, 80 percent indicated that they would be content with an  increase of one-half to one-full cup size. Drs. Khouri and Baker believe the Brava System will give many of these women and their physicians a new option to consider.  "Brava helps a woman grow more breast tissue," said Dr. Khouri. "When she has  completed the protocol, she'll have more of her own breast tissue. And that  tissue will follow the contours of her own breasts and will be supported by her  own vascular and neurological systems." Dr. Baker, who has been a leading plastic surgeon for more than 35 years, said he expects The Brava System to compliment surgical breast enlargement. "Brava provides modest growth. I can see it appealing to a lot of women, but not to the women who want or must have a surgical option. I expect Brava to bring many more women into their doctor's offices over the next few years." System will be available through limited number of MD's: Long-term growth of natural breast tissue requires women to use the Brava Breast Enhancement and Shaping System under their physician's supervision and  often with the help of a trained nursing staff. The system requires proper  fitting, regular check-ups and patient support systems. Brava will only be  available through physicians who have been trained by Brava, LLC. Most women wear the system in the evening while they sleep to comply with the ten-hour daily protocol. Although it is comfortable to wear, some women, as is common in pregnancy, need a few days to adjust their sleeping position if they do not sleep on their back. After only a few days of use, women will begin to see increased fullness to their breasts. Women who completed the initial trial were measured 18 months after they stopped wearing the system. All experienced gradual and lasting breast tissue growth of about 100cc -- approximately one cup size. Proportionate enlargement of both adipose (fat) and fibroglandular (breast) tissue, with no edema  (swelling), was confirmed by magnetic resonance imaging (MRI). Women Who Tried the Brava System: "The growth with Brava was gradual. It added fullness and in the last month,  I also noticed lift." (Mary, a 38-year-old clinical trial participant.)  "After breastfeeding, I was a double 'A' and didn't completely fill that up.  With Brava, I quickly went to an 'A' cup and started filling up a 'B' cup. It's such a nice, natural alternative." (Kathy, another clinical trial participant.)  For more information about the Brava System visit www.mybrava.com , or call 1-800-407-5304.  Brava, LLC, a subsidiary of Bio-mecanica, Inc., has the exclusive rights on patents, manufacturing, marketing and distribution of the Brava System in the  United States and Canada. Brava, LLC is headquartered in Miami, Fla. http://www.prevention.com/cda/column/1,1210,928,00.html Calcium supplements can help preserve bone density, protecting you from fractures. But did you know that taking calcium just before a bone scan might blur your bone-density test results?  The very best test for measuring bone density in the spine and hip-dual energy x-ray absorptiometry, or DEXA-works by reading how much calcium is present, not only in the bone, but within a cross section of the body. Poorly absorbed calcium can linger in the intestines and mimic dense bone on a spine scan, obscuring telltale signs of thinning bone, says Jeri Nieves, PhD, director of bone-density testing at Helen Hayes Hospital in West Haverstraw, NY. This rarely happens, but it could at least cause inconvenience: If your doctor notices an odd reading, she may suggest a second scan. "Don't quit taking supplements or cancel your DEXA," says Dr. Nieves. Instead, use a calcium supplement labeled "USP"-meaning it's met the US Pharmacopeia's standard for dissolving. And don't take any calcium supplement within an hour of a DEXA, says Dr. Nieves. Created: June 2001, Reviewed: Aug 16 2001 CHICAGO (AP) Lindsey Tanner, AP Medical Writer: Hospitals will be required to tell patients when they've been victims of medical errors under safety standards that took effect recently.  The rule is the first of its kind from the Joint Commission on Accreditation of Healthcare Organizations, a nonprofit group that monitors nearly 5,000 hospitals nationwide.  The commission acted partly in response to a 1999 Institute of Medicine (news - web sites) report estimating that medical errors kill 44,000 to 98,000 hospital patients each year. Under the guidelines, hospitals that don't discuss harmful mistakes with patients and fail to prove to commission investigators that they're doing so will risk losing their accreditation. "We need to create a culture of safety in hospitals and other health care organizations, in which errors are openly discussed and studied so that solutions can be found and put in place,'' said Dr. Dennis O'Leary, the commission's president.  Some hospitals, including the nation's Veterans Affairs facilities, already tell patients when errors occur. Others may keep quiet to avoid potential lawsuits, said Dr. Sidney Wolfe, co-founder of Public Citizen Health Research Group, a consumer-oriented advocacy group.  He said research showed that hospitals that were honest with patients about mistakes faced fewer lawsuits. "People don't like to get jerked around," Wolfe said. "Part of the understandable anger that accompanies a lawsuit is the idea that something bad happened to me and they didn't tell me."  Rick Hendrick, a Chicago contractor who was given the wrong medicine in a hospital emergency room, agrees.  Hendrick, 47, said the hospital should have "come to me and said, 'This is what happened. I'm sorry, we made a terrible mistake' and had warned him of the side effects.  Instead, he says, hospital staff never admitted that they'd given him a big dose of an antibiotic destined for another patient. Hendrick, who had sought treatment for a bad case of hives, said he had severe heart palpitations, nearly passed out and was weak for several days from the drug. Dr. Don Nielsen of the American Hospital Association said the new standards echo AHA policy for its members - about 5,000 hospitals and health care systems nationwide.  AHA policy even goes further, advising hospitals to tell patients about mistakes that don't cause any harm, Nielsen said. In Congress some legislators are calling for nearly $1 billion to help hospitals and technology companies invest in devices to avoid more deaths and injuries. Congressional figures show medication errors  missed dosages, double dosages, and dangerous mixes - are believed to kill or injure 777,000 people each year. Inamed Wants Silicone Back In Breast Implants: It's been eight years since the U.S. Food and Drug Administration banned silicone breast implants, but the desire among women to boost their bust size hasn't gone away. In the midst of a nationwide health scare, the FDA banned silicone implants in 1992. Since then, most implants are made of either saline or, more rarely, soybean oil. But Ilan Reich, co-CEO of Inamed imdc (nasdaq: imdc), is betting that silicone implants will make a comeback. Massive lawsuits from women who believed leaky silicone implants made them ill forced market leader Dow Corning, a joint venture of Dow (nyse: dow) and Corning glm (nyse: glm), into bankruptcy after a jury awarded plaintiffs billions of dollars in compensation.  Despite negative publicity, the breast augmentation business is again thriving. The number of breast augmentations performed in the U.S. dropped to 32,000 by 1992 from a high of at least 120,000 two years before, according to the American Society of Plastic and Reconstructive Surgeons. By 1998, that number had grown to 122,000. Inamed and its competitor, Mentor mntr (nasdaq: mntr), both based in Santa Barbara, Calif., are the only companies whose saline implants have been approved by the FDA. Saline implants accounted for 95% of Inamed's $189 million in 1999 sales, but the company has since diversified into other areas of cosmetic surgery, acquiring a collagen company and developing a surgical alternative to stomach-stapling which has been submitted for FDA approval. Still, the company estimates that implants will account for more than half its sales this year. Inamed has launched a new ten-year study of silicone implants involving 900 patients in hopes of reversing the FDA ban. A new generation of thicker, less leak-prone silicone implants will prove safe, Inamed argues. Saline implants are safe. If a breast implant springs a leak, the body simply excretes the excess fluid in urine. Silicone was banned mainly because the companies making the implants couldn't prove at the time that it was safe.  But there is a problem with saline. It doesn't feel natural to the touch; silicone does.  "If a man touches a silicone breast as opposed to a real breast, he's much more likely to mistake it for the real thing," says Douglas Wood-Smith, a plastic surgeon and professor at Columbia-Presbyterian Medical School who performs breast augmentations in both New York and London. Soybean oil has been hyped as a natural-feeling alternative to saline. But clinical trials have found it to be more harmful than silicone. If a soybean oil implant leaks, the soy oil breaks down into products that may be harmful either to the surrounding tissue or a fetus, according to the British Department of Health.* On June 6, the British government decided that soy-filled implants posed a danger. Inamed had acquired the rights to those implants when it bought a Swiss company called Lipomatrix, and it agreed to pay to remove or replace the soybean implants of the 10,500 women worldwide,** including 165 Americans, who had the augmentation surgery. Now Inamed's Reich wants to start selling silicone-filled implants in the U.S. again. He argues that silicone gel is the perfect goop to go inside a breast implant and says it is safe and effective. He says no studies have ever shown that the silicone gel used to fill breast implants causes health problems. But will numerous studies and FDA approval protect Inamed from the kind of massive litigation that killed Dow Corning? Dow Corning went down because it didn't conduct any studies on silicone implants and could not refute any of the "science" that lawyers like John O'Quinn of Texas threw at it. But would the thought of the kind of dollar signs torn from Dow Corning again make the lawyers swarm like so many angry wasps? Well, John O'Quinn would. "I made Dow Corning go bankrupt," he brags in a thick Texas drawl. "That's why they call me the lawyer from hell." He says that he would be ready to sue if silicone implants again hit the market.  "I think if they market them, they're subjecting women to an unacceptable risk of disease and injury," O'Quinn says. "I think it would be a shameful exercise in greed to put making money ahead of public health. If people have to have breast implants, they ought to market saline." John Calcagnini, a financial analyst with CIBC World Markets in Beverly Hills, Calif., still thinks the implants are a hot prospect. He rates Inamed as a "strong buy" and says the market for breast implants has been growing at 19% a year.  However, Steve Broznak, an analyst at the Vanguard Group, disagrees: "I'm not a big fan of the technology. I would not be an investor. The benefits of the surgical procedures do not outweigh the risks." But it's hard to think of anyone who ever went broke by betting on the persistence of human vanity. WASHINGTON, 11/14/01, PRNewswire: Breast cancer survivors and scientists will testify before a Congressional panel today to express concerns that poor FDA oversight has led to serious health consequences for many women with breast implants in the U.S. and to ask that more independent research be conducted.  The hearings come only six months after three government studies linked breast implants to serious illnesses.   In May 2001 the National Institutes of Health released two studies linking breast implants to increased rates of respiratory and brain cancer and the FDA reported increased rates of fibromyalgia, a painful immunological disorder, in women whose implants had ruptured. Congressman Roy Blunt (R-MO) will be the first to testify on behalf of the breast implant panel.  He became involved in this issue when a constituent sought his assistance in her battle to have her problems with breast implants reported to the FDA.  Since that time, Representative Blunt has co-sponsored the Breast Implant Research and Information Act asking Congress to mandate additional research and better informed consent.  The bill also asks that an FDA investigation into Mentor, one of two major breast implant manufacturers, be brought to a close and the findings disclosed to the public. Dr. Diana Zuckerman, Executive Director of the National Center for Policy Research for Women and Families (http://www.cpr4womenandfamilies.com ) will call for more independent research and better informed consent.  She initiated the original breast implant hearings in 1990 when the first reports of the serious health implications of implants surfaced. Also testifying will be Pamela Noonan-Saraceni, a breast cancer survivor; Kim Hoffman, a woman who has fought for years to alert the FDA that women's problems are going underreported; and Mary McDonough, who played Erin on The Waltons and one of the few actresses who has been vocal about the health problems she experienced after receiving breast implants. The hearing is being sponsored by the House Energy and Commerce Health Subcommittee. The Command Trust Network is an information clearinghouse for women with breast implants. http://tbutton.prnewswire.com/prn/11690X12608855 SOURCE  Command Trust Network, Inc. THE OPINIONS EXPRESSED IN THIS NEWSLETTER ARE THOSE OF THE EDITOR AND ANY CONTRIBUTORS AND ARE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE.  ANY ARTICLES OR INFORMATION SUBMITTED MAY BE EDITED BECAUSE OF SPACE, CONTENT OR GRAMMATICAL ERRORS. LYNDA ROTH, EDITOR PREVIOUS NEWSLETTER INFORMATION: Previous issues of newsletters available: $2 each U.S., $3 Foreign.  1/93 is the first available issue.  Please indicate months' desired and enclose proper sums.  Some covered subjects: Autoimmune 1/93; Fibromyalgia 2/93; Medical Testing 3/93; Sjogren's 4/93; Vasculitis 4/93; Arthritis 5/93; Chronic Fatigue 6/93; Lupus 7/93; Irritable Bowel Syndrome & Inflammatory Bowel Disease 8/93; Insurance 8/93, 9/93; Misc. Med. Info. 9/93; Multiple Sclerosis 10/93; Spasmodic Torticollis 10/93; Hypoglycemia 11/93; Antibodies 12/93; Reflex Sympathetic Dystrophy 1/94; Misc. Med. Info. II 2/94; Scleroderma 3/94; Costochondritis 4/94; Peripheral Neuropathy 4/94; Class Action 5/94; Fungal Infections 6/94;  Hypercalcemia (low calcium) 7/94; Raynaud's Phenomenon 8/94; Fibromyalgia Update 9/94;  Sarcoidosis 10/94; Free Radicals 11/94; Porphyria 12/94; Interstitial Cystitis 1/95; Mixed Connective Tissue Disease 2/95; Flap Procedures 3/95;  Misc. 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