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![]() COALITION OF SILICONE SURVIVORS P. O. Box 129 Broomfield, CO 80038-0129 Lynda Roth - (303) 469-8242
September 1998
Dear Silicone Survivors and Friends:
We lost another dear friend this week. Sue Brown of Lewisville, TX died Sept. 2nd. She was about 43 yrs. old. She will be missed. LEGAL: 9/1/98: Update for INAMED/McGhan/CUI proposed class settlement. The court has approved the request until October 2, 1998, for an extension of INAMED's deadline to satisfy the "3M condition" included in the proposed settlement. This extension will not affect the deadline for INAMED's depositing in escrow the initial settlement consideration but will probably extend for approximately 30 days the projected times for notices and a hearing if this condition is satisfied. NY, 9/2/98 (PRNewswire) After an eight-day trial in a breast implant case, a jury in Federal District Court here ruled in favor of Baxter Healthcare Corporation, finding no liability for claims of defective design, negligence or failure to warn. The jury deliberated for 90 minutes before rendering its verdict. The plaintiff in the case, Leslie DeHoust, had received silicone breast implants in 1983. Baxter has never manufactured nor marketed breast implants. Its contractual liability is a result of a merger in 1985 with American Hospital Supply Corporation, which at one time had owned breast implant manufacturer Heyer-Schulte. American Hospital divested Heyer-Schulte in 1984 and the company no longer exists. DeHoust asserted in her lawsuit that she suffered local injuries, including pain, numbness and a chest rash, due to the implants. Pursuant to the court's order, DeHoust's systemic injury claims were not permitted to be tried, and her claims were limited to local injury. Baxter has won 28 verdicts in breast implant lawsuits. Two cases ended in mistrials, and three cases originally lost are either on appeal or will be re-tried. Baxter's trial team consisted of Debra Pole and David Schrader, both partners in the Los Angeles office of Brobeck, Phleger & Harrison, and Diane Lifton, an associate with that firm's New York office. The plaintiff was represented by Tom deFina and Dawn DeWeil of the Schneider, Kleinick, Weitz, Damashek & Shoot firm in NYC. Leslie is a friend and a former group leader in the NYC-NJ area. Our hearts go out to her and to others who have lost their cases. Baxter is a hard nut to crack, and they win most of these cases. This is not because the women are not ill and their implants caused it, it is because the manufacturers have learned how to play the juries and win. VANCOUVER: A settlement has been reached in a second class action lawsuit by Canadian women against Dow Corning Corp. over silicone breast implants, attorneys for the women said Wednesday. Under the agreement, Dow Corning and Dow Corning Canada will pay C$39 million to the approximately 4,100 women who reside everywhere in Canada expect the provinces of Ontario and Quebec, the attorneys said in a statement. The settlement will be part of Dow Corning's bankruptcy reorganization plan and is subject to approval by courts in Michigan and British Columbia, the statement said. Michigan-based Dow Corning in June signed a C$50 million settlement in a separate case brought on behalf of the Ontario and Quebec women. Women to be compensated under the settlement that was announced Wednesday will receive a range of financial benefits depending on the severity of their injuries from silicone gel or saline breast implants made by Dow Corning. 8/29/98: Mediator says Dow Corning talks are not productive (Associated Press) BAY CITY Talks between Dow Corning Corp. and attorneys for women with silicone-gel breast implants have been less productive than previously reported to the court, a federal mediator says. "We're not moving as quickly or as well as I'd liked," mediator Francis McGovern told U.S. Bankruptcy Judge Arthur J. Spector in a telephone conference call played in court in Bay City. Negotiations on a proposed $3.2 billion settlement will continue through next Tesday, when McGovern is to tell Spector whether the parties reached a consensus. If not, the mediator will reveal publicly what the disagreements are and make suggestions to the court on how the disputes should be handled. Spector said a public discussion of settlement disputes would be significant because, for the first time, "people will know what the hang-ups are." Last week, McGovern told the court that the parties' disagreements were "manageable." At the time, he said he was optimistic the parties would reach a consensus by Labor Day.
On Thursday, Spector asked if there were more or less issues in dispute than reported the week before. "We are regressing," McGovern replied. He said there about 10 "major" issues left to be resolved and some smaller details to fine-tune. The parties have been trying to turn a general term sheet that was part of a mediated settlement reached in July into a detail-packed disclosure statement to send to creditors. The task involves turning about five pages of basic settlement terms into an approximately 400-page document detailing how creditors will be paid. Dow Corning Corp. filed for Chapter 11 bankruptcy protection in May 1995 in response to a flood of lawsuits from women who claimed breast implants caused illnesses. McGovern said the parties have been meeting regularly and will negotiate again on Monday, when they are expected to decide whether a consensus can be reached. From the National Breast Implant Task Force: Dow Corning Settlement Would Give Less to Unsecured Creditors: Bay City, Michigan, August 21 (Bloomberg) A $3.2 billion settlement between Dow Corning Corp. and attorneys for women who received the company's silicone breast implants would give less to unsecured creditors, including holders of medium-term notes, than previously disclosed, court records show. Details of the tentative agreement announced last month still haven't been worked out, and the outline of plan hasn't been made public. Ogden Lewis, an attorneys for unsecured creditors, said in an August 6 hearing that the proposal described to them includes :a financial haircut that's not yet known to the market,'' according to a transcript of the hearing. More than $1 billion in unsecured debt is claimed against the Midland, Michigan-based joint venture of Corning Inc. and Dow Chemical Co. Among the large note-holders is Franklin Resources Inc.'s Mutual Series Fund, the transcript says. BankAmerica Corp.'s Bank of America had $377 million in revolving credit and short-term loans, according to filings in the case. U.S. Bankruptcy Judge Arthur Spector yesterday gave a court- appointed mediator until Sept. 15 to submit the proposal, which then must be approved by a two-thirds vote of each class of creditors, including those with claims not backed by collateral. Spector had earlier anticipated the plan would be filed this week. Commercial Creditors: Under previous proposals to allow Dow Corning to emerge from Chapter 11 bankruptcy, the company said all its commercial creditors would be paid in full. Citing Spector's confidentiality orders, the company and attorneys have declined to detail the changes in the new plan, which increases by $200 million the amount available to women who want implants removed or who have illnesses they attribute to the devices. According to the hearing transcript, much of that money would come from the commercial creditors, who might have to forgo some interest on their claims. "That's where they anticipate getting the extra money,'' Lewis said, calling the gap "material'' to the unsecured creditors. "The quibble will probably be what's the proper methodology for the interest,'' Spector agreed during the hearing in Bay City, Michigan. Lewis said the so-called settlement "is really a negotiating stage,'' since the commercial creditors weren't at the table. The delay means more uncertainty for Dow Chemical, which hopes to be freed from liability for providing silicone to Dow Corning. Under the plan, modeled on a class-action settlement in Birmingham, Alabama, individual implant claimants could choose to accept the money or sue. Dow Chemical and Corning would be released from liability under the settlement and would benefit from increasing earnings at the subsidiary. Two-thirds of the 170,000 women who have filed claims must approve the settlement. Women with specified auto-immune diseases, including lupus and scleroderma, would receive as much as $250,000, while women with no health problems would get $5,000 to have the implants removed. After an undisclosed date, women who choose not to have the implants taken out would be barred from later claims. If you received an Omnibus Claim Rejection letter from Dow Corning (again), ignore it for now! That is the advice given by attorneys I have spoken with. The founder of B.I.R.S., Fran Bates (with whom you may be familiar), has just lost a long running legal battle with six surgeons who she took to court over their incompetence and mutilation of her with breast implants. In 1976, Fran had a bi-lateral mastectomy due to breast cancer and was given her first set of silicone implants which ruptured after a short time. She had two more sets after this, and had so much silicone removed from her chest that she is now an absolute mess. The six surgeons she sued had each assured her that they would fix the damage, and each made it worse. She now has loose silicone oozing out of her body and is very ill. She set up the Breast Implant Resource Service (initially W.I.I.N., Women's Implant Information Network) in 1990 in an attempt to better inform women and not allow them to go down the same road as she had without being aware of what they were getting themselves into. She and her husband, Lionel used $50,000 of their own money to set up and run this service until they both became too ill (Lionel died earlier this year) and passed it onto Yasmin Plichta and Lorraine Williams. Fran lost this battle because the judge believed the surgeons story that, because it happened between 1976 and 1988, they couldn't remember her and so couldn't recall what was done to her. One of the surgeons is the head of the Australian Society of Plastic Surgeons, Cholm Williams. We here in Australia are just astounded, shocked and dismayed at the outrageousness of this judge's decision and want the inadequacies and injustices of the Australian legal system announced to the world. Fran is just too ill to take the case any further, she has also run out of money to pay for more legal bills. To say she is devastated is an understatement. Australia's legal system is like "the good old boys network", the "high-rollers" i.e. judges, lawyers, doctors, etc. all stick together to help each other out! It really stinks. (From Australian friends!!) MEDICAL INFORMATION: 8/19/98, Fredrick M. Wigley, M.D.: BALTIMORE (Johns Hopkins Health Insider) Raynaud's phenomenon is characterized by a loss in blood circulation to fingers, toes and ears at the slightest change in temperature. The body basically exaggerates its normal response to cold. Instead of just decreasing blood flow to the skin, there is a complete closure of the arteries that provide nutrients to the surface tissues of fingers and toes. As the pooled blood loses oxygen, the skin turns white. Poorly oxygenated blood then pools in the capillaries. But new research indicates that Raynaud's, which affects about 4% of Americans, could be more than just a bothersome & sometimes painful annoyance: It could be a symptom or early warning sign of heart disease or another disease. Those with Raynaud's phenomenon have twice the risk of the general population of getting heart disease or having a stroke, according to a cross-sectional study of women in an inner-city African-American community. We're not sure why our study participants with Raynaud's had a higher prevalence of heart disease compared to the general population. Perhaps many had some underlying blockage or were taking medications such as beta-blockers, which can increase risk. But we do know that Raynaud's phenomenon can irritate blood vessels and manifest diseased blood vessels. In the next phase of our study, we'll try to determine what specific types of heart disease those with Raynaud's might face or if the frequency of Raynaud episodes has any correlation with the risk of heart disease. What to Do: Exposure to stress and cold increase the chances of a Raynaud's episode, which typically lasts less than 15 minutes, and may worsen this vascular irritation. To reduce the effect of exposure to cold, it's important to stay as warm as possible. If you've already been diagnosed with Raynaud's phenomenon, here are other ways you can help reduce the frequency and severity of these attacks: Keep moving. When you feel an impending attack, swing your arms in wide windmill-like circles to help improve blood flow to fingers. This type of exercise is also mildly aerobic, and can help raise body temperature. But only do this type of exercise after your doctor has examined you and ruled out underlying problems. If you have damaged blood vessels caused by scleroderma, for example, this type of activity can aggravate the problem. Limit caffeine and avoid smoking. Both constrict blood vessels, thus reducing circulation to your extremities. While we haven't done any studies to see if smokers have a higher incidence of Raynaud's, we do know that quitting helps reduce the symptoms by improving blood flow. Avoid vasoconstrictors. These medications, which include cold preparations, beta-blockers and some narcotics, slow the flow of blood to fingers and toes. Meanwhile, some people with Raynaud's find relief by taking calcium channel blockers, but these medications are not recommended for pregnant women. Fredrick M. Wigley, M.D., is a Professor of Medicine and Director of Molecular and Clinical Rheumatology in the School of Medicine. He was one of the principal investigators in the study that found an increased risk of cardiovascular disease among people with Raynaud's. WASHINGTON: David Pace (AP) After complaining for more than a decade that federal health officials don't take chronic fatigue syndrome seriously, activists for more research into the mysterious illness finally have what they consider the "smoking gun." In a whistle-blower complaint filed earlier this summer, the Center for Disease Control and Prevention's top CFS researcher has accused the agency of lying to Congress by spending money earmarked for the disease on unrelated activities. "I believe the CDC has intentionally misrepresented monies allocated to CFS research and I cannot ethically support this," said Dr. William C. Reeves, a branch chief in the CDC's National Center for Infectious Diseases. From fiscal 1995 through fiscal 1997, some $5.8 million that the CDC told Congress had been spent on CFS research actually went to other activities, Reeves said in a statement. Reeves specifically accused Dr. Claire Broome, acting director of the Atlanta-based CDC, of providing false information to Congress when she testified that part of the money reported by the CDC in 1996 for CFS research went to establish a new laboratory in the branch headed by Reeves. "This evidence confirms the suspicions we've acted on for years, that CDC was using CFS research money to float other programs," said Kimberly Kinney, executive director of an association that advocates for CFS patients. CDC spokesman Tom Skinner said the agency is aware of Reeves' allegations and is taking them "very seriously." He said the CDC has asked the inspector general of the Department of Health and Human Services to investigate, but he declined to address Reeves' specific charges. For the past several years, Congress has included language in the report on spending legislation for the CDC and other health agencies directing that more money be spent on CFS research. Prior to fiscal 1996, the House report called for the CDC to spend specific amounts on CFS research. While report language does not carry the force of law, federal agencies generally follow the recommendations because they do not want to offend the lawmakers who control their budgets. Rep. John Porter, R-Ill., chairman of the House appropriations subcommittee that handles the CDC budget, is taking Reeves' allegations "quite seriously" and may order an investigation by the General Accounting Office, said Porter's press secretary, David Kohn. "There would be repercussions if Mr. Porter felt that he and the subcommittee were misled and the information provided was not accurate," Kohn said. CFS is a debilitating condition in which people become so tired that they cannot function. It is hard to diagnose because it mimics diseases such as multiple sclerosis or Lyme disease, and doctors do not know what causes it. First identified in Nevada in 1985, the disease now afflicts as many as 500,000 Americans, according to the latest CDC estimates. John Friedlich of Cambridge, Mass., a CFS sufferer who has been an advocate of increased federal research into the disease, said the allegations are remarkable because of their source. "Reeves has not been considered a friend of the (CFS) patients' community," Friedlich said. "For him to come forward has caught a lot of people by surprise." Friedlich said the predominant attitude among CDC scientists for years has been that CFS "is not important, is not a real illness and they're not going to commit to try to learn more about it." Reeves filed his statement under the federal Whistle Blower Act, which guarantees job protection for federal employees who report fraud, waste or abuse. He is still working at the CDC, but is not granting interview requests. For Sjogren's sufferers: Dr Haveman at University of Texas at San Antonio Health Science Center Advanced Dentistry School prescribed Saligen. He also prescribed PreveDent 5000 toothpaste made by Colgate, to arrest any further tooth decay. PreveDent 5000 is a high fluoride toothpaste and also requires a prescription. From a silicone survivor. For Reflex Sympathetic Dystrophy Sufferers: An injury as minor as a stubbed toe could mean constant and excruciating pain. For many people, long-term relief is hard to find. A new drug being studied could end the pain. Reflex sympathetic dystrophy, or RSD is a condition that affects the nervous system and causes chronic pain. It is excruciating, burning, acute pain. It doesn't go away. Psychologist David Hanks works with patients who suffer from chronic pain. "The more chronic the condition becomes, the more depressed the person becomes," says Dr. Hanks. Common treatments include physical therapy, psychological counseling and medications to block the pain. Yet, these treatments for RSD provide only short-term relief. Now, a drug called SNX-111, derived from the toxin of snails, might help. Edgar Ross, M.D., is a pain specialist at Meridia Hospital in Cleveland, Ohio. "This drug blocks a particular pathway for a type of pain which is very, very unresponsive to any other kind of medication," says Dr. Ross. A pump implanted in the abdomen delivers the drug directly to the spinal cord. Clinical trials with SNX-111 have just finished. Doctors are analyzing the data. In an earlier study of the drug, six out of seven patients with chronic pain found success. SNX-111 is also being studied for its effect on pain associated with cancer and AIDS. The drug is currently being considered for approval by the FDA. If you would like more information, please contact: Neurex Corporation, 3760 Haven Ave., Menlo Park, CA 94025, (650) 853-1500 Or: Reflex Sympathetic Dystrophy Syndrome Association of America, 116 Haddon Ave., Suite D, Haddonfield, NJ 08033 (609) 795-8845. SURAL NERVE BIOPSY: Dr. V. Bril - Canada Purpose: To look at the structure of nerve in cases of suspected nerve disease when other tests do not provide a diagnosis. Method: A surgeon performs the procedure in a day surgery unit. The procedures take about one hour. You will be able to return home the same day. You should have someone else drive you home. You will be asked to lie down on a stretcher. The skin over the area for the biopsy at the side of the ankle is cleansed. A local anaesthetic is injected into the skin. When the area become insensitive, a 2 - 3 incision is made in the skin and a small sample of the sural nerve is removed. The skin is then sewn together and a dressing applied. You will be asked to keep off our feet, with the biopsy foot elevated for about 48 hours to promote good healing. The area must be kept dry for 1 week to allow the skin to heal. The surgeon will tell you if there are stitches that must be removed. If so, your family physicians can do this after 7-10 days. Results: The reports on the biopsy often take 4-6 weeks to complete. In more complicated cases, the reports can take longer. The results will be given to you in a follow-up interview as soon as possible after they are available. Complications: The biopsy leaves a small surgical scar. Local bleeding and infection occur rarely. Post-operative pan may be experienced at the biopsy site and can be controlled readily with mild pain-killers. A small number of patients who have the nerve biopsy note long-lasting mild discomfort at the surgical site. About 40% of patients who have the biopsy also have long-lasting numbness at the side of the foot, but this is not troublesome. (Note: We have heard from women who have quite severe problems with this surgical site even years later. Blood tests can determine nerve damage without this type of invasive surgery. This should be reserved only for extreme cases. Surgery is always the LAST choice!!!!! Lynda) Monday, August 24, 1998 (CBS) Question: What's red, can crawl across your fingernail, and has exclusive FDA approval? CBS 'THIS MORNING' investigative correspondent Roberta Baskin has the answer: It's cochineal, source of the much sought-after carmine. Cochineal extract and carmine? Still don't know what we're talking about? Few people do. It's a bug that they crush. Specifically, the cochineal is a bug harvested in Peru and in the Canary Islands. As tiny as it is, it's big business. Hundreds of thousands of pounds of these tiny bugs are exported every year, and for what? To turn many of the foods we eat and the drinks we drink red! It's what gives Campari, the popular Italian aperitif, it's bright red hue. And it's the red stripe in a fruit striped gum. For 1,700 years, the cochineal bug has been raised, and then squished for its unique red pigment added to textiles, cosmetics, and foods. Dr. Doug Miller, a bug expert who is an entomologist at the United States Dept. of Agriculture, says, "These little white patches here are the actual insects themselves. [When crushed)...the whole body is red in color." In Peru and the Canary Islands, the cochineal is dried, squeezed, and scraped. Now multiply that by billions. The cochineal bug is the only bug approved for consumption by the Food and Drug Administration. It's considered a 'natural ingredient', so safe it's not even required to be listed on food labels. But is it safe? Dr. Baldwin says: "What's new about it is that it is starting to be recognized as a cause of allergic shock and allergic conditions.... Carmine is a natural color, so companies don't have to list it on the label - making it that much harder to avoid. Dr. Baldwin says he has a problem with that. "I think a known allergen that can cause life-threatening anaphylactic shock in patients allergic to it should be listed on labels." Plast Reconstr Surg 1998 Aug;102(2):528-33 (ISSN: 0032-1052) Women's College Hospital and the Department of Surgery, University of Toronto, Ontario, Canada. Breast milk contamination and silicone implants: preliminary results using silicon as a proxy measurement for silicone. In response to concerns about contamination of human breast milk from silicone gel-filled breast implants, and because silicon levels are assumed to be a proxy measurement for silicone, we compared silicon levels in milk from lactating women with and without implants. Two other sources of infant nutrition, cow's milk and infant formulas, were also analyzed for silicon. The survey took place at the Breast-feeding Clinic at Women's College Hospital in Toronto. A convenience sample of lactating women, 15 with bilateral silicone gel-filled implants and 34 with no implants, was selected. Women with foam-covered or saline implants or with medically related silicone exposures were ineligible. Collection of samples was scrupulously controlled to avoid contamination. Samples were prepared in a class 100 "ultraclean" laboratory & analyzed using graphite furnace atomic absorption spectrophotometry. Silicon levels were analyzed in breast milk, whole blood, cow's milk, and 26 brands of infant formulas. Comparing implanted women to controls, mean silicon levels were not significantly different in breast milk (55.45 +/- 35 and 51.05 +/- 31 ng/ml, respectively) or in blood (79.29 +/- 87 and 103.76 +/- 112 ng/ml, respectively). Mean silicon level measured in store-bought cow's milk was 708.94 ng/ml, and that for 26 brands of commercially available infant formula was 4402.5 ng/ml (ng/ml = parts per billion). We concluded that lactating women with silicone implants are similar to control women with respect to levels of silicon in their breast milk and blood. Silicon levels are 10 times higher in cow's milk and even higher in infant formulas. (Now, when they do a study that checks all the other toxic chemical in breast implants, I will truly be interested!! Also, did they study women with gross ruptures? I doubt it!!! Comment by Lynda!) Brought to you without comment: WASHINGTON (AP) - The Food and Drug Administration says 69 Americans taking the impotence pill Viagra died between late March and July, with 46 of these cases linked to cardiovascular incidents. In a summary issued this week, the FDA said it has actually received reports of 123 patients who died after getting a prescription for the drug. But of these reported incidents, 12 concerned foreign patients, 30 came from unverifiable sources and 12 involved cases where it was unknown if the drug had been used. The FDA said more than 3.6 million prescriptions for Viagra were dispensed between late March and July of this year. Of the 69 confirmed deaths, the cause of death was unknown for 21 patients, two had strokes and 46 had cardiovascular events, including 17 cardiac arrests. The median age among those who died, based on ages provided for 55 of the patients, was 64. The FDA stressed that by posting the reported deaths, the agency was not signaling a change in its perspective on the drug's safety but would continue to evaluate the need for regulatory action. The agency cautioned that it is impossible to calculate a true incidence rate since reports are submitted voluntarily, and in some instances, clinical information may be missing or incomplete. Pfizer Inc., the New York maker of Viagra, has said its product "is safe and effective when used'' properly. Brought to you by the Mayo Clinic: April 18, 1998: It's being called a remarkable advance, a finding that will change the course of breast cancer prevention. In a new study yet to be published, the drug tamoxifen reduced the risk of breast cancer by 45 percent in women considered to be at high risk for the disease. The $68 million study, sponsored by the National Cancer Institute (NCI), was halted 14 months early due to the positive results. Known as the NSABP (National Surgical Adjuvant Breast and Bowel Project) Breast Cancer Prevention Trial, it involved more than 13,000 healthy women ã half of whom received 20 milligrams (mg) of the hormonal drug tamoxifen and half a placebo daily for 5 years. Over that period, there were 85 cases of invasive breast cancer in the tamoxifen group compared with 154 in the placebo group. Women who received tamoxifen also had fewer noninvasive breast cancers. But tamoxifen was not without risk. More women in the tamoxifen group developed endometrial cancer and blood clots than did women in the placebo group. So, who should take tamoxifen? Oasis interviewed Lynn C. Hartmann, M.D., a Mayo Clinic oncologist and expert on breast cancer, to learn more about the study and the drug. Oasis: Does tamoxifen prevent breast cancer? Dr. Hartmann: Tamoxifen didn't eliminate the women's risk of developing breast cancer. It reduced their risk, by 45 percent which is significant. But it will be important to determine how long the risk-reduction lasts after the tamoxifen is stopped. To some people, the term prevention (and this was a 'prevention' trial versus a treatment trial) means a permanent effect, which has not been shown. (Note: Studies in Europe find no difference in women treated with Tamoxifen versus those not treated!) Oasis: Should all women take tamoxifen to reduce their risk of breast cancer? Dr. Hartmann: No one is recommending tamoxifen for women in the general population. And I don't think we're ready to say that every woman over the age of 60 (who by her very age is at an increased risk) should be given tamoxifen. (This prevention trial enrolled women over age 60 regardless of other risk factors and women younger than 60 whose risk was elevated because of family history of breast cancer or other factors.) The greatest interest centers around women at high risk for inherited forms of the disease. In general, that includes women who have two or more close relatives with breast cancer, especially if the breast cancer occurred at a young age or if there is also a history of ovarian cancer in the family. Oasis: Why not have every woman take tamoxifen to reduce her risk of breast cancer? Dr. Hartmann: Because tamoxifen is not without risk. It's associated with some serious side effects. It comes down to a risk-benefit ratio. If you know you're at high risk of developing breast cancer, then you may be more willing to accept some risk from an intervention. But if you're already at low risk, which most women are, then the chance you're really going to benefit is also low. And side effects and other risks are likely going to matter a great deal more. Oasis: What were the side effects associated with tamoxifen? Dr. Hartmann: For most, side effects were minor and included hot flashes and vaginal discharge. But women in the tamoxifen group were found to be at increased risk for three potentially fatal conditions. There were 33 cases of endometrial cancer (cancer of the uterine lining) in the tamoxifen group, compared to only 14 in the placebo group. There were 30 cases of deep vein thrombosis (blood clots in major veins) in the tamoxifen group, compared to 19 in the placebo group. And there were 17 cases of pulmonary embolism (blood clot that has traveled to the lung) in the tamoxifen group, compared with six in the placebo group. Blood clots, Deep vein thrombosis, Pulmonary embolism. Oasis: Did any women in the study die? Dr. Hartmann: The preliminary data released reported three deaths from breast cancer in the tamoxifen group, compared with five in the placebo group. Two women on tamoxifen who developed pulmonary emboli also died. The investigators have not yet reported other causes of death, such as from endometrial cancer. Thus, we don't know now if tamoxifen reduced overall mortality. In other words: 'Were there fewer deaths in the tamoxifen group than in the placebo group?' Oasis: Were the women in this large study representative of women in the general population? Dr. Hartmann: No. The women were generally at greater risk of developing breast cancer than those in the same age group in the general population. Of the 13,388 women in the trial, about 40 % were age 35 to 49; about 30 % were age 50 to 59; and about 30 % were age 60 or older. About 3 % of participants were non-Caucasian. Oasis: How do you know if you're at high risk for breast cancer? What if you have just one close relative with breast cancer or you've had one benign breast biopsy? Dr. Hartmann: Any woman who has such questions needs to sit down with her health care provider and carefully assess her risk. If she's found to be at high risk, then she and her physician should weigh all her options. One option is close surveillance, such as annual mammograms, regular exams by her physician and breast self-exams. Another is prophylactic surgery (removal of the breasts). And now it seems we have a third preventive option:tamoxifen. (Women who choose to take tamoxifen must still follow careful screening guidelines.) Assessing your risk of breast cancer Breast cancer screening, What's available to you, Mammograms, What's the consensus? Genetic testing for breast cancer? Should you be tested? Advances in treating breast cancer. What they could mean to you. Oasis: What is tamoxifen? Is it chemotherapy? Dr. Hartmann: Tamoxifen is not chemotherapy; it's a synthetic type of hormone (but it's not anything like hormone replacement therapy or HRT). It blocks estrogen's effects on breast tissue. But to certain cells in the body, tamoxifen looks enough like estrogen to fool cells into thinking it is estrogen. For example, it acts like estrogen on bone cells. For this reason, women in the tamoxifen group had fewer fractures of the hip, wrist and spine than women in the placebo group. It should be noted that this effect on bone may vary with a woman's age. Thus, it's important to have the final data from this study to determine the benefits and risks for younger and older women. Oasis: Is tamoxifen a pill? Dr. Hartmann: Yes, it's a tablet usually taken twice a day. A month's supply costs about $100. Oasis: How long should a woman take tamoxifen to reduce her risk of breast cancer? Dr. Hartmann: In the prevention trial, women took tamoxifen for 5 years. But we don't know yet what happens once a woman stops taking tamoxifen. Does her risk go back up? We'll need follow-up data on the women in this study. Some British researchers have commented that more valuable data might have been gained if this study had not been halted early. Oasis: Why haven't we known about this breast cancer-reducing effect of tamoxifen before? Dr. Hartmann: Tamoxifen has been used as a breast cancer treatment for more than 20 years. And there has been an orderly progression to its study. First it was studied in metastatic breast cancer, and it was found to work as a treatment. Then it was studied in women who had breast cancer and were at increased risk for recurrence, and it was noted that the drug reduced their risk of a new, second breast cancer by 40% to 50%. That's why it was eventually tried as a preventive agent in at-risk women with no personal history of breast cancer.
Oasis: Does tamoxifen offer any other long-term benefits? Dr. Hartmann: As I mentioned earlier it seems to protect against osteoporosis, but there was no difference in the number of heart attacks between the two groups, something else the researchers were studying. Oasis: What happens next? Is tamoxifen now available as a preventative (prophylactic) medication for breast cancer? Dr. Hartmann: The data from this study will be further analyzed and eventually published in a medical journal. Researchers will analyze, for example, which subsets of women benefited the most from this therapy. I advise that we wait for more definitive information from this prevention trial before starting to prescribe tamoxifen prophylactically. Oasis: Are more studies planned? Dr. Hartmann: Raloxifene (an osteoporosis drug) appears to also have breast cancer-reducing benefits but perhaps with fewer side effects than tamoxifen. A trial to compare raloxifene to tamoxifen is being considered. Now, for another view!!! SOURCE: Cancer Prevention Coalition: FDA Advisory Committee Urged To Reject Zeneca's Application of Tamoxifen For Preventing Breast Cancer in Healthy Women as the Drug is Ineffective and Dangerous: CHICAGO, Sept. 1 (PRNewswire): The following was released today by Samuel S. Epstein, M.D., Professor Environmental Medicine, University of Illinois School of Public Health and Chairman of Cancer Prevention Coalition; Barbara Seaman, co-founder National Women's Health Network, Washington, D.C.; and Ann Fonfa, the Annie Appleseed Project, New York: On September 2, FDA's Advisory Committee on Oncologic Drugs will review Zeneca Pharmaceutical's New Drug Application (NDA) for approval of tamoxifen "for the prevention of breast cancer in (healthy) women at high risk." Claims that tamoxifen can prevent breast cancer are based on an April 6, 1998 National Cancer Institute (NCI) preliminary report, unsupported by a scientific publication, of a short term trial on some 13,000 healthy women at "high risk'' of breast cancer, including women over the age of 60, who were randomly given tamoxifen or a placebo; further details of the report are still not available to the scientific community and the public. The trial was terminated prematurely in view of the reduction in the incidence of breast cancer in all tamoxifen treated age groups. However, serious and sometimes fatal complications, including uterine cancer and pulmonary embolism, were seen in postmenopausal women among whom the incidence of breast cancer was reduced by 1.7%, while the incidence of serious complications was increased by 2.2% in non-hysterectomized women. The brevity of the trial prevented recognition of other delayed serious health risks. Of particular concern is the fact that tamoxifen is a highly potent carcinogen, inducing liver cancer in rats at low doses equivalent, based on blood levels, to those used in the trial. Disturbingly, women in the trial were not informed of the clear evidence of these risks. The absence of reported liver cancer in women treated with tamoxifen for breast cancer is hardly reassuring as relatively few women have been treated for over 5 years and followed up for a further 20 years before which the development of liver cancer would be most unlikely. Additionally, there are serious questions as to whether tamoxifen actually reduced the incidence of breast cancer or merely delayed its onset by treating small undetected tumors. In fact, two articles published on July 11, 1998 in the highly prestigious journal, The Lancet, reported no evidence of breast cancer prevention by tamoxifen in two major European trials. In an August 17 written statement, which will be read into the record at the September 2 Advisory Committee Hearing, Dr. Epstein concluded: "NCI's preliminary April 6 report on the prevention of breast cancer by tamoxifen has still not yet been finalized and published in a scientific journal. The Advisory Committee should also consider the propriety of Zeneca's NDA as it is based, in part, on data which have to been made fully available to the public although the underlying (NCI) research was funded by the public. Furthermore, the claimed evidence or chemoprevention has been discredited by two subsequent scientific publications. Of as great concern is the well documented evidence of short term life-threatening complications, and also risks of delayed fatal complications, evidence for which has been trivialized and suppressed by NCI. Based on these scientific and ethical considerations, the Advisory Committee is urged to deny approval of Zeneca's NDA." Finally, the NDA poses further serious questions in view of Zeneca's control and funding of the heavily promoted annual October National Breast Cancer Awareness Month. This campaign urges women to have mammography, in spite of its highly questionable effectiveness and risks in premenopausal women, while avoiding any reference to a wide range of scientifically documented safe and effective methods for reducing risks of breast cancer. These include avoidance of prolonged and early onset use of oral contraceptives; obesity and inactivity; and high fat and dairy food products contaminated with carcinogenic and estrogenic industrial chemicals. Such critical omissions are favorable to Zeneca's efforts to influence public policy in favor of approval of large scale tamoxifen chemoprevention, targeted for up to 30 million U.S. women at "high risk'' of breast cancer. EDGARTOWN, Mass., Aug 29 (Reuters)- President Clinton announced a new regulation Saturday that gives 120 million Americans enrolled in private employer-based health care programmes the right to a quick appeal of grievances. Speaking in his weekly radio address, Clinton said the order would affect people covered under ERISA, the Employee Retirement Income Security Act, which regulates pension operations and other job benefit plans. "There ought to be an appeal of a medical decision made by an accountant all the way up the chain in a company until it gets to a doctor. People who are hurt ought to have redress,'' Clinton said. "We have worked very hard to make these protections available to everyone we could. Today, we'll take executive action once again,'' he added in his speech from a school on Martha's Vineyard off the Massachusetts coast, where is is vacationing with his family. "More than 120 million Americans are in workplace health plans that are protected under federal law,'' he said. "The secretary of labour has now been instructed to ensure that all these people can quickly appeal through an internal review process any coverage decision that denies the care their doctor said was needed and appropriate."' Clinton said he had heard a litany of stories about people denied medical treatment in an attempt to save money. He said his order-- which has to go through the standard federal regulation process but which is not subject to congressional approval, would help prevent some of the worst abuses. Health maintenance organizations (HMOs), which are financial frameworks set up to oversee health coverage, have been castigated as the worst offenders. "(It) means that 120 million people will no longer have to take an HMO accountant's no for an answer," Clinton said. "Many of these stories we hear about, the HMO actually ultimately approves the treatment the doctor recommended," he said. "But only after it goes through layer after layer after layer and sometimes there is no appeal at all." Clinton said he was trying to speed up the process. Republicans and Democrats in Congress are offering competing versions of a patients bill of rights. But Clinton is trying to nudge them along. He says the Republican plan does not offer the guarantees he is most worried about, the right to emergency room care, the right to see a specialist and the right not to have to switch primary care practitioners suddenly if an employer changes plans White House spokesman Barry Toiv said Clinton's action does not cover all the changes the president wants. "It's why we feel we need legislation," he said. "The House has passed a version, we want the Senate to take it up as the first order of business next week." In February Clinton issued an executive order directing all federal health plans to come into compliance with his patients bill of rights approach & Labor Department & Defense Department extended the coverage. Clinton said his bill of rights now affects 85 million Americans covered under Medicare, Medicaid, the Veteran's Administration & the Federal Employees Health Benefits Programm. >From another survivor: Extreme chest pain when laying down with difficulty breathing is one of the classic symptoms of pericarditis (inflammation of the lining of the heart). I know because I spent three days sleeping upright in my husband's chair. If left undiagnosed and untreated it has the potential to interfere with the electrical impulses of the heart. In other words, it can be fatal. Your doctor won't hear the abnormality. A stress test won't show it. It will usually show on an echocardiogram. The pain is caused by the accumulation of fluid in the sac that surrounds the heart. Since I am young, the doctor's were shocked. They can give you medication for the pain. Depending on the severity, they may take a wait and see stance. Other options include draining the lining (sac). And if you are on death's door, they will remove the lining. I got lucky. Eight months later it was gone. Fibromyalgia intensfies the pain. Get thee to a Cardiologist to have this ruled out! (Especially if you have any of these symptoms!!) Reasons Why Women Who Have a Mastectomy Decide to Have or Not to Have Breast Reconstruction: Linda L. Reaby, Ph.D. Canberra, Australia: Breast reconstruction after mastectomy is chosen by approximately 10% of Australian women. Younger women are more likely to have this surgical procedure. This suggests that there may be many factors determining this choice. Sixty-four women who wore an external postmastectomy breast prosthesis and 31 women who had postmastectomy breast reconstruction participated in the present study. The purpose was to gain a greater understanding through semi-structured interviews of why women who had breast reconstruction chose this alternative and why women who wore the external postmastectomy breast prosthesis elected not to have reconstruction. The study also ascertained how difficult it was for the women in both groups to decide their particular breast restoration alternative. The most frequently endorsed reasons for not having breast reconstruction in the prosthesis group included: (1) not essential for physical well being, (2) not essential for emotional well being, (3) not having enough information about the procedure, and (4) not wanting anything unnatural in the body. When each member of the group was asked to identify a major reason for not having reconstruction, two predominant issues emerged: (1) fearing complications and (2) perceiving themselves as being too old for the procedure. Twelve percent of the prosthesis group experienced difficulty in making the decision not to have reconstruction. Three factors accounted for this difficulty: (1) the lack of family support, (2) the inability to have a specific type of reconstruction, and (3) the perception that friends and acquaintances saw the surgery as cosmetic. The most frequently reported reasons given by the reconstruction group for having reconstruction included: (1) to get rid of the external breast prosthesis, (2) to be able to wear many different types of clothing, (3) to regain femininity, and (4) to feel whole again. The least influential factors were to improve marital and sexual relations. The major reason cited most often by this group was to feel whole again. None of the women in the reconstruction group experienced any difficulty when deciding their method of breast restoration. What factors are taken into consideration by women when they decide either to have or not to have reconstruction need to be understood by physicians. This knowledge will assist them in conveying appropriate information regarding alternatives and will help them deal with the women's concerns and/or misconceptions. (Plast. Reconstr. Surg. 101: 1810, 1998.) DALLAS: 8/19/98: A defective lipid structure appears to be the culprit behind many chronically dry eyes, a condition that affects millions of Americans, according to clinical research by ophthalmologists at UT Southwestern Medical Center at Dallas. Scientists have long known that dry eye (keratoconjunctivitis sicca) could be caused by insufficient tear production. New research suggests the condition also may be the result of tears evaporating too quickly, resulting in inadequate moisture in the eye. This unusually rapid evaporation appears to be the result of a flawed lipid structure, the layer of fatty oils responsible for coating the eye and preventing evaporation of watery tears, said Dr. Ward Shine, assistant professor of ophthalmology at UT Southwestern. In the study, the composition of tear liquid in normal patients was compared to that of patients with chronic blepharitis (inflammation of the eyelids) alone, and chronic blepharitis with associated dry eyes. Dr. James McCulley, chairman of ophthalmology, hopes these latest findings will lead to improved ways of treating dry eye. "Artificial tears and surgical procedures have been commonly used to treat the condition with variable success. Now that we seem to have pinpointed a major defect, we think we'll soon be able to develop better methods for treating dry eye resulting from over-evaporation, (a problem that potentially affects 50% of all patients with keratoconjunctivitis sicca)," said McCulley, holder of the David Bruton Jr. Chair in Ophthalmology. The researchers' findings were published in the July issue of the Archives of Ophthalmology. The research was supported in part by grants from the National Institutes of Health and Research to Prevent Blindness.
>From the SCiENCE newsroom: 5/20/98: Nerve Trigger for Multiple Sclerosis: Scientists have identified a snippet of protein that appears to trigger the immune systems of multiple sclerosis (MS) patients to attack their own nerve linings. The finding, reported in the current Journal of Neuroimmunology, could provide a target for developing new treatments for MS, which afflicts up to 350,000 Americans. MS is a degenerative disease in which the body essentially becomes allergic to its own nerve linings, called myelin. Immune cells attack this insulation, producing a range of neurological symptoms. While investigating a component of myelin, called myelin proteolipid protein (PLP), neurologist John Trotter of Washington University's School of Medicine in St. Louis was startled to find that animals injected with PLP developed an allergic reaction that looks a lot like MS. To see if human immune cells also react to PLP, Trotter drew blood from 12 MS patients and 12 healthy people, then cultured a type of immune cell called T cells from each blood sample. He exposed these T-cells to different portions of the PLP molecule, looking for one that T-cells from the MS patients' blood would attack. The healthy patients' T-cells reacted much less strongly to the protein segment. Now researchers may be able to develop a slightly modified peptide to suppress the myelin-attacking T-cells, says Trotter. Alternatively, if researchers can identify the molecule on immune cells that recognizes the PLP segment, he says, they may be able to create a vaccine that will cause T-cells to destroy their renegade comrades. But such developments are a long way off. First, says Halina Offner, a neurologist at Oregon Health Sciences University in Portland, "we have to wait for another group to repeat the finding." ALTERNATIVE MEDICINE): NY, 8/24/98 (Reuters): Extracts of green tea may make strains of drug-resistant bacteria more sensitive to penicillin, British researchers report. It has long been known both black and green teas have antibacterial properties, according to a report in the August issue of the Journal of Antimicrobial Chemotherapy. "The antimicrobial activity of tea (an aqueous extract of Camellia sinensis) was recognized 90 years ago," reported Dr. J.M.T. Hamilton-Miller and colleagues, of the Royal Free Hospital, London, UK. (Green tea is an anti-oxidant. Capsules are available that contain as much as 10 cups of green tea's components. Lynda) PERSONAL COMMUNICATION: Here's one I had to put in my newsletter!! BUSTED! Teen Lifts Mom's Credit Card To Buy His Girlfriend Bigger Breasts. Now he's facing jail, and she's going to Hollywood. Teenager Michael Copp thought he'd do something really big for his girlfriend, so he treated her to breast implants, on his unknowing mom's credit card! But the 18-year-old Romeo was busted by his own mother, who turned him in to cops. Michael's girlfriend Michelle Pauley, however, is overjoyed with her "gift!". "It's the ultimate love story of the '90s," she giggled to The ENQUIRER after going from a B-cup to a D-cup. "Michael did a very sweet thing for me." Michael's father, Charles Copp, admitted his son has a big heart, but told The ENQUIRER: "While he was creative in doing what he did, we're a little bent out of shape over the way he went about doing it." Michael took his mother's deactivated AT&T MasterCard from a drawer and called the company to reactivate it, his father said. The teen had previously been an authorized user of his mother's card, because she has a physical disability and wanted Michael to use it when she couldn't leave the house. But Michael racked up more than $2,000 in charges in May, and his mother, Gaelene Pokrandt, canceled the card. So when she received an unexpected bill from the credit card company that included a $2,496 charge for Michelle's new chest, his mother called the Sheffield Lake, Ohio, police. "I don't want this to happen to anyone else," Pokrandt said, after her son was charged with felony misuse of a credit card. Michael pleaded innocent to the charge. But Charles Copp said: "He's done this sort of thing before, and his mother had to take out a second mortgage to pay for those bills. So maybe a little time in jail will help him to think straight." Michelle, a stunning 18-year-old blonde with dreams of a modeling or acting career, said: "I didn't know that he had used the credit card his mom had deactivated, I thought it was one of his." They still need to pay off the bill. Her implants cost $4,000 total. Michael had worked out a payment plan with the plastic surgery clinic for $1,500 of the bill and charged the rest to his mom's credit card. IMPORTANT: In a recent issue of Consumer Reports (June 98) there's a must read article about a class of chemicals called endocrine disrupters (hormone mimics). I am sure many of you have heard of the frogs with extra legs & eyeballs on their legs and the male fish with female sex organs. Other infamous endocrine disrupters such as dioxins, PCBs & various relatives of DDT are still being released.They're by products of combustion and other processes. In our air, water & soil and entering our food chain and accumulating in fatty tissue. From baby foods, plastic's, cosmetics, dental sealant, pesticides, etc. We are slowly becoming very toxic. Now the pressure is on. The Environmental Protection Agency is preparing a massive project to screen 15,000 chemicals by the end of 1999 (wonder if they will touch silicone?) This also comes from an article by Science writer Scott Allen of the Boston Globe. He also quotes biologist Theo Cloborn author of "Our Stolen Future" (1996). Chemicals have not only disrupted development in animals but are causing health problems in humans. Keep in mind that drugs are chemicals. If we have a toxin (silicone) in our bodies why add more? From a silicone survivor!! BOOKS: Health & Healing: Understanding Conventional & Alternative Medicine, Dr. Andrew Weil. Boston: Houghton Mifflin, 1983. Natural Health, Natural Medicine: A Comprehensive Manual for Wellness and Self Care, Dr. Andrew Weil. Boston: Houghton Mifflin, 1990. Prescription for Nutritional Healing: A Practical A-Z Reference to Drug-Free Remedies Using Vitamins, Minerals, Herbs and Food Supplements, James F. & Phyllis A. Balch. Garden City, NJ: Avery Pub. Group, c1990. THIS MONTH'S POEM: Do you believe? By Lynda Roth I remember growing up I heard my mother say The doctor said so. That's why We do things this way! But questioning was my nature So ask away I did! And always the same answer Do what the doctor said! But when I had my children The questions I still asked I needed to know the answers Not have the truth be masked! For one who always questioned (And a skeptic I could be) How did I ever end up With a breast implant in me? Unaware and unprepared When cancer came to call So overwhelmed I didn't ask And he didn't tell! What gall!! When I needed to trust the most When I needed to believe When my life was being threatened How could he deceive? First do no harm! That's what the credo says Do you believe it's true? Some still do, I guess! Choose your doctor well Not all have integrity! When it comes to the bottom line I prefer to believe in me! 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 proper sums. Some covered subjects: Auto-immune 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. Med. 4/95; Thyroid Disease 5/95; Stress 6/95; Natural Healing 7/95; Adrenal Malfunctions 8/95; Multiple Myeloma 9/95; DHEA 10/95; Chelation Therapy 11/95; Sleep Disorders 12/95; Meniere's Disease 1/96; 33 Tips to Improve Your Health 2/96; Amino Acids 3/96; Enzymes 4/96; Minerals 5/96; Aluminum Toxicity, DHEA Update 6/96; Addictions & Food Sensitivities 7/96; Misc. Med. Info. IV 8/96; Misc. Med. Info. V 9/96; Misc. Med. Info. VI 10/96; Misc. Med. Info. VII 11/96; Transcient Ischemic Attacks 12/96; Symptoms of Breast Implant Problems 1/97; Pap Tests 2/97; Parasitic Infections 3/97; B-Complex Deficiency Syndrome 4/97; Myofascial Pain Syndrome 5/97; Inositol 6/97; Misc. Med. Info. VIII 7/97; High Blood Pressure 8/97; Plaquenil 9/97; Misc. Med. Info. IX 10/97; Misc. Med. Info. X 11/97; Gastroesophageal or acid reflux 12/97; Smoking Dangers 1/98; Misc. Med XI 2/98; Multiple Chemical Sensitivities 3/98; Misc. Med. XII 4/98; Misc. Med. XIII 5/98; Baylor Studies 6/98; Hyperbaric Oxygen 7/98; IOM Summaries 8/98; Legal info. and info. on Alternative Medicine Info. contained in most issues. NEWSLETTER SUBSCRIPTION INFORMATION Check your mailing label for expiration date. The date is right after your name. We are unable to notify you individually of expiration dates. If your expiration date says June'98, that is the last newsletter you will receive without a renewal. Please return bottom portion with check or Money Order for renewal or include the pertinent information with check or M.O. for $25. COSS NEEDS YOUR HELP!! WITH ALL THE LEGAL PROBLEMS, DONATIONS ARE DOWN, EXPENSES ARE STILL THE SAME!! PLEASE HELP IF YOU CAN!! WE DON'T WANT TO QUIT HELPING OTHERS!!!!!!!!!!!!!! NEWSLETTER SUBSCRIPTION INFORMATION Check your mailing label for expiration date. The date is right after your name. We are unable to notify you individually of expiration dates. If your expiration date says June 98, that is the last newsletter you will receive without a renewal. We no longer take MC/Visa!!!!
YOUR HELP IS NEEDED NOW TO KEEP US AFLOAT. IF WE HAVE EVER HELPED YOU, PLEASE HELP US WITH A GENEROUS DONATION !!!
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C.O.S.S. 09/01/98
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