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![]() THIS IS OUR NEW SYSTEM FOR THE NEWSLETTER: There are two ways to go: You can download the .doc (word for windows file) or the .zip (standard text file, compressed you will need winzip, stuffit expander, or pkunzip to decompress the .zip file), or you can print out this web page from your browser. DOWNLOAD NEWSLETTER: coss7-98.doc coss7-98.zip COALITION OF SILICONE SURVIVORS P. O. Box 129 Broomfield, CO 80038-0129 Lynda Roth - (303) 469-8242 Fax (303) 466-4084 e-mail: coss@siliconesurvivors.net Website: http://www.siliconesurvivors.net
July 1998
Dear Silicone Survivors and Friends:
UPCOMING EVENTS: The Washington, DC meetings (Committee on the Safety of Silicone Breast Implants: July 22-24, 1998), Cecil and Ida Green Building, 2001 Wisconsin Ave. NW, Washington, DC. (PLEASE NOTE THAT THE LOCATION FOR JULY 24th PUBLIC MEETING HAS BEEN CHANGED TO THE AUDITORIUM, NAS MAIN BUILDING, 2101 CONSTITUTION AVENUE, NW.) are coming up soon. Check last month's newsletter for more details. I plan to be there. Many are staying at Capitol Suites Hotel for 104/flate rate + taxes. Reservations should be made under WIMDO 1-899-424-9165. I hope many of you have also registered.
LEGAL: The Louisiana Spitzfaden Class Has Been Decertified. If you have questions or do not have your own attorney, you may contact an attorney at the Louisiana Plaintiffs' Steering Committee Office. You may write to the Louisiana Plaintiffs' Steering Committee at 600 Carondelet Street, Suite 607, New Orleans, LA 70130, or call them at 504-524-0071 or 1-800-378-5710.
Michigan: Cheryl Wade, Daily News: The mediator in the Dow Corning Corp. bankruptcy case said he'll be finished with his work by month's end, whether or not the parties have worked out their differences. Dow Corning filed for protection from its creditors under Chapter 11 in 1995 after thousands of women sued the company, claiming its silicone gel breast implants made them sick. Dow Corning has ceased making implants and contends implants do not cause disease. The company has filed its third plan to remain solvent and pay women who filed claims. That plan has been the focus of intense discussion among the parties for months. Duke University Professor Francis McGovern was named mediator last fall and has had his appointment extended piecemeal, most recently until June 30. In a telephone conference in open court Thursday, McGovern said he won't continue past that date. "Any mediator has to be optimistic by definition, particularly in this particular case," he said. "I am quite optimistic at this point. We have reached substantial conceptual agreement in a number of areas."
McGovern said the parties haven't yet approved a plan document. "But we are, I think, quite close to being in the position where we can determine, one way or the other, whether or not such a document is feasible." U.S. Bankruptcy Judge Arthur J. Spector and U.S. District Judge Denise Hood have held off making some key rulings in the case. Spector has said that, when mediation is over, he will rule on whether the plan will go to women for a vote, and whether Dow Corning has the exclusive right to file a plan. Attorneys representing women with implants have filed an outline of a plan of their own. Based on his talks with the parties, McGovern said "the playing field is pretty stable right now from a legal perspective." He said rulings from the judges now would be counterproductive to talks. He said he gave the same progress report to Hood. Spector agreed to delay his decisions until McGovern "gives up hope and tells me there's no way around it." Spector set July 1 as a tentative date for McGovern to give the results of the talks. Spector is scheduled to hold court in Flint that day so attorneys in the case are likely to meet there. McGovern said he wants to work "very hard on the day-to-day basis," and will report to the court daily. He said he needs to verify "empirical data" and will make phone calls to experts. Attorney Kenneth Eckstein, representing women with implants, said it makes sense for the parties to work hard and try to settle disagreements. Attorney Barbara Houser, representing Dow Corning, said the company has given "an intense amount of effort" to the talks, and she expected that to continue.
Update: July 1, 1998. FLINT, Michigan: A federal mediator in the multi-billion dollar Dow Corning Corp. bankruptcy case has given the company and women with breast implant claims six days to accept his undisclosed proposed settlement. Intense negotiations between the former breast implant maker and attorneys for thousands of women claiming the implants injured them failed to produce a deal, mediator Francis McGovern said Wednesday. "I have reached a settlement. The question is whether the parties agree. I have submitted a take-it-or-leave-it proposal,'' McGovern said in a conference call hearing with U.S. Bankruptcy Judge Arthur Spector. Spector agreed to hold off on issuing his already prepared bankruptcy plan until after the deadline set by McGovern, next Tuesday at noon.
The woman want $3.8 billion, paid out over three years. At a 15-minute hearing in Flint on Wednesday, negotiators for Dow Corning and its creditors accepted the six-day deadline and agreed to keep details of McGovern's plan confidential. McGovern's appointment as mediator in the case expired Tuesday and he did not ask for an extension. Once a worldwide settlement plan is approved, ballots could go out to women with silicone breast implants. It would need approval by women representing two-thirds of the total settlement amount to take effect. The U.S. Supreme Court last November upheld a federal appeals court ruling that consolidated all implant-related litigation in Michigan. The company sought the consolidation, saying it would ensure that complaints would be handled in an orderly way. Once the largest manufacturer of breast implants, Dow Corning no longer makes them. But it maintains that the implants are safe and that studies have failed to prove a link between the devices and the alleged health ailments.
THE SUNDAY TIMES [London] 6/28/98, BRITAIN: Thousands of British women have been offered payments of up to 33,000 in a one-off global settlement of claims for health damage suffered by leaking silicone breast implants, writes Lois Rogers. Even those who have not proved they have suffered any illness or injury will receive minimum payouts of 2,200. The climbdown by three of the leading manufacturers of the implants,3M, Baxter International and Bristol-Myers, will influence the outcome of the government's review of the safety of silicone breast implants due to be published soon.
Health ministers agreed to re-examine the evidence of the dangers of leaking silicone for a third time following a ban on the use of the implants in America and growing protests from representatives of up to 60,000 women here who have had them inserted. Silicone gel leaking from the implant capsules is believed to cause severe allergies and paralysis as well as chronic fatigue, loss of balance and memory problems. Despite there being alternatives such as saline-filled capsules, more than 5,000 patients a year are still receiving the silicone implants in Britain. A third are breast cancer patients undergoing reconstruction after surgery, but the rest are women seeking cosmetic enhancement. Margo Cameron, who runs Silicone Support UK, a pressure (support) group for victims, said: "A survey of women who came to us for help found that nine out of ten had experienced some kind of leakage."
6/27/98, Portland, The Oregonian (Ashbel S. Green): A mediator has settled most of the approximately 100 breast implant lawsuits remaining in Oregon, and many of the rest appear close to settlement. Still, women with implants and implant manufacturers remain far apart on at least a few cases so more appeals or trials are expected. The biggest Oregon verdict was $1.5 million; a judge later overturned it. In addition to paying out millions in jury verdicts and confidential out-of-court settlements, the four main breast implant-makers probably will pay more than $6 billion in mass settlements.
In Oregon, an estimated 1,200 women with implants filed lawsuits or made financial claims against implant-makers. During the last ? years, cases have been quietly settling out of court. In the past week, a three-day mediation session whittled down the number of cases from 100 to less than two dozen, and Potter said that most of the rest have offers on the table that are likely to be accepted (many for much less than they should settle for, we hear). The exact number of cases remaining was unavailable Friday because several participants could not be reached. Velure plans to hold additional mediation sessions but so far has scheduled none. At least a few cases, however, will go to trial or be the subject of appeal. The most significant involves a federal lawsuit that U.S. District Judge Robert E. Jones used to make a landmark ruling in 1996. (Remember him, his wife has implants.) Jones, in a serious blow to plaintiffs, refused to allow scientific testimony that silicone implants cause various diseases because he said the evidence did not support such a claim. Bogus evidence kept out by Jones' ruling, which has been followed by similar decisions by at least three federal judges in other states (including Colorado, just recently), was one of the first attempts to implement a 1993 U.S. Supreme Court ruling ordering federal judges to keep bogus scientific evidence out of the courtroom.
06/22/98: San Francisco (Reuters): Crooked lawyers in the nation's most populous state may soon find it easier to lie, cheat and steal if the California Supreme Court ignores a last-ditch request it was sent Monday. The State Bar of California, which regulates and disciplinesall lawyers in the state, will go out of business this Friday because of a dispute with Calif. Gov. Pete Wilson over its main funding source, the annual license fees it collects from the state's 128,000 practicing attorneys. With four days to go before it was due to lay off some 500 workers, the bar Monday asked the California Supreme Court to grant an interim order that would set attorney licensing fees immediately and keep the bar's discipline system operational. "We regret that without court intervention, the state bar's ability to effectively protect the public will be irreparably harmed,'' State Bar President Marc Adelman wrote in a letter to the Supreme Court. Frustrated by some of the bar's liberal stances, the Republican governor vetoed a bill in October that would have authorized the bar to collect the bulk of the fees. Since then, the bar, lawmakers and Wilson have been locked in a legal stalemate that threatens to put the bulk of workers at the bar out of work at the end of this week.
Before Wilson's veto, the bar collected $458 a year from each attorney to pay for most of its $61 million budget. Now, however, the bar collects only $77 from each member. By contrast, the Medical Board of California charges doctors $300 a year, according to the Los Angeles Times newspaper. The bar has already stopped investigating new complaints and has shut down its consumer hotline, which typically responds to some 140,000 calls each year. Bar spokeswoman Anne Charles said only a bare-bones staff would remain if the layoffs occur as scheduled. She said the number of people available to discipline errant attorneys would be reduced by 90 %.
OTTAWA (CP): By Laura Eggertson, Toronto Star Ottawa Bureau, The Royal Canadian Mounted Police refused to investigate an alleged Health Canada cover-up involving breast implants eight years ago, the case the Mounties are now probing, The Star has learned. Officials from the RCMP's commercial crimes division are seeking documentation and questioning former Health Canada officials and others. Health Canada is overlooking the health risks associated with saline breast implants, despite recent legal action taken by the U.S. Food and Drug Administration (FDA) against a leading manufacturer, a former government scientist warned Wednesday. Dr. Pierre Blais, now an Ottawa-based consultant on high-risk medical devices, warned the department about silicone breast implants years before they were banned and said he was later dismissed for making his concerns public. Now Blais said the federal government risks facing the same public relations mess it had on its hands when it finally banned Meme implants in 1993 if it doesn't start to take a hard look at the safety of saline implants. The RCMP confirmed earlier this week that it had launched an investigation into how the government regulated the silicone products. "The department once again is going down exactly the same track, they're not making any decision and they're going to wait until we have a major public health problem on our hands. It's hepatitis C all over again," Blais said. A Health Canada release Wednesday acknowledged the probe, saying the agency would "co-operate fully with any investigation," and adding the issue had already been subject to "significant independent scrutiny." An internal review and an external audit were conducted in 1991 into the way the department regulated the products, the release noted. Both investigations concluded Health Canada had fulfilled its obligations.
The FDA announced last month that it took legal action against Texas-based Mentor Corp. for failing to comply with the agency's quality standards in the production of saline implants. A group of women in Denver are also mounting a class-action suit against the company for a line of saline products which have since been discontinued. The FDA will wrap up a four-year study on the safety of saline implants later this year. Health Canada said it approved two types of Mentor implants in 1997. An epidemiological study on all types of implants is currently underway, a spokeswoman said. Saline-filled implants are silicone envelopes filled with salt water. They were on the market before either the FDA or Health Canada began to have regulatory authority over the products. Risks associated with the implants include rupture and infection. Dr. Walter Peters, a University of Toronto surgeon who regularly analyses implants, said saline products are perfectly fine and there have only been a few documented cases of microrganisms growing inside the sacs. "We've never seen a fungus culture in over 400 implants we've looked at .. The saline ones, if they rupture, just release saline. I don't see that as the next doomsday with breast implants." But Blais said he's also studied hundreds of saline implants, some of which look like a "dirty aquarium" after just a few years in a patient's body because of fundamental design flaws that allow materials to pass through the silicone envelope. "Everyone forgot what happens when you keep water in a closed but not quite well closed enough container ... Give it a year or two inside someone, and you then look at the saline and it contains decaying tissue, dead blood cells and in some cases bacteria."
Breast Implants on Trial: A 55-year-old Oklahoma City doctor who performs breast augmentation is serving six months in federal prison for smuggling into the United States unapproved silicone gel-filled breast implants from a foreign manufacturer. J. Dan Metcalf, M.D., a family practitioner, is believed to be the first person prosecuted for violating U.S. restrictions on use of unapproved silicone gel-filled breast implants. He illegally imported the implants from Brazil and the Bahama Islands, used them to enlarge the breasts of 200 women and sold some to other U.S. doctors. The federal investigation continues, according to Special Agent Kent Wood of FDA's Office of Criminal Investigations. Since April 1992, FDA has allowed silicone gel-filled breast implants only in women enrolled in clinical studies and then mainly for reconstruction after breast cancer surgery and certain other medical conditions. At this time, women who want implants for augmentation must get saline-filled breast implants.
FDA issued a three-month moratorium in April 1992, following years of debate on the safety of silicone gel-filled breast implants and whether or not the medical devices should remain on the market. FDA turned down manufacturers' applications for approval of the implants submitted after the three-month moratorium because FDA found that the information was not sufficient to prove the safety and effectiveness of the devices. The studies under way are intended to provide more definite information about implant safety. (See "A Status Report on Breast Implant Safety" in the November 1995 FDA Consumer.) Metcalf was indicted in the U.S. District Court for the Western District of Oklahoma in July 1995. He was sentenced last March. In addition to the prison sentence, he was fined $5,000, ordered to forfeit assets of about $312,000 and sentenced to one year's probation. FDA, along with U.S. Customs and the Internal Revenue services, began investigating Metcalf in early 1994 after Metcalf's former office manager, who also doubled as Metcalf's surgical assistant, and her mother reported the doctor's activities to investigator Lloyd Paine at FDA's Oklahoma City resident post. The former office manager who provided most of the information said she had quit her job because Metcalf's wife, her sister, had been taking over her role in the business. She provided photocopied documentation of Metcalf's activities including lists of patients' names and records of phone calls and financial transactions between the doctor and his implant sources.
Armed with this information and a search warrant, FDA, Customs and IRS special agents searched Metcalf's office, residence, and bank safe deposit box on May 24, 1994. At Metcalf's office and residence, they seized 470 pairs of silicone gel-filled breast implants, worth about $200,000, medical records of all patients who had received silicone breast implants since April 1992, and various business records. With this information, the agencies determined that Metcalf had been importing silicone breast implants made by the Brazilian silicone implant company Silimed, of Rio de Janeiro, since shortly after FDA turned down the implant manufacturers' applications in 1992. According to FDA's Wood, Metcalf tried to buy direct from the Brazilian company, but the head of the company told him he would not do business in the United States. So, Metcalf arranged to buy the implants through doctors in Brazil and Nassau, in the Bahamas. Metcalf had the implants delivered through such mail carriers as Skynet and Federal Express to his employees' residences in Oklahoma City. He then implanted the devices in 200 women, who, according to Wood, learned about his augmentation business by word of mouth. He kept some implants on hand and sold the rest to other U.S. doctors who also performed breast augmentation.
On July 19, 1995, a federal grand jury returned a 15-count indictment against Metcalf that included, among other things, charges of illegally importing silicone gel-filled breast implants and laundering more than $300,000 in proceeds. Metcalf pleaded guilty Nov. 14, 1995, to one count of violating the Federal Food, Drug, and Cosmetic Act. The remaining charges were dropped. According to Wood, the state of Oklahoma is investigating Metcalf for possible improper medical practice. He also faces a number of class-action suits brought by his breast implant patients, who, according to Wood, were unaware that Metcalf was illegally importing the breast implants until news of his indictment and arrest on July 26, 1995, became public. The seized implants remain in FDA's possession and will be destroyed. (by Paula Kurtzweil)
WASHINGTON (AP) By Laurie Asseo: A Texas woman who says she had to have plastic surgery after receiving collagen injections to reduce facial wrinkles lost a Supreme Court appeal today that sought to revive her lawsuit against the collagen maker. The court, without comment, turned away the woman's argument she should be allowed to sue the Collagen Corp. under state law even though its product was approved as safe by the Food and Drug Administration. Tempie Fortson Worthy of Dallas received injections in 1991 of Zyderm, a collagen product used to treat facial defects including wrinkles. In 1992, she sued the Palo Alto, Calif.-based Collagen Corp., saying the treatment caused a severe reaction that required reconstructive surgery, among other treatments. Zyderm was approved for sale in 1981 by the FDA under procedures set up by the 1976 federal Medical Device Amendments, intended to ensure that medical devices are safe and effective. Texas state judges dismissed Worthy's lawsuit, saying the federal approval procedure pre-empted any damage claims filed under state law. While the case was pending, the Supreme Court ruled in a 1996 case involving a heart pacemaker that manufacturers of medical devices at least sometimes can be sued in state courts over alleged defects in their products. But the Texas Supreme Court ruled last February that even under that decision Worthy could not sue under state law. "Collagen cannot both market Zyderm in compliance with FDA requirements and not market Zyderm because it is unsafe," the state court said. In the appeal acted on today, Worthy's lawyers said the Texas court misinterpreted the 1996 ruling. The approval received by Zyderm does not automatically pre-empt lawsuits under state law, her lawyers argued. Attorneys for Collagen said, "Congress did not intend the FDA's findings of safety and effectiveness to be overridden by state court juries." Zyderm went through a more rigorous approval process than the device in the pacemaker case, they added. The case is Worthy vs. Collagen Corp., 97-1831.
MEDICAL INFORMATION: Chicago, 6/17/98 (Reuters): An inhaled form of insulin appears to be successful in treating patients with both type 1 (juvenile onset) and type 2 (adult onset) diabetes. Data from clinical trials involving the new delivery system were presented Tuesday at the 58th Annual Scientific Sessions of the American Diabetes Association.
(God help us all, look at what they are doing now!!) PERMANENT LIP AUGMENTATION USING AUTOLOGOUS BREAST IMPLANT CAPSULE, Author: Isenberg JS: University of Oklahoma Health Science Center, Oklahoma City, USA. Source: Ann Plast Surg, 1996 Aug, 37:2, 121-4; Abstract: Permanent augmentation of lip volume can be achieved either with autologous or nonautologous implants. The constant risk of infectious complications remains the disadvantage of nonautologous implants. Likewise, autologous implants of dermis, fat, or fascia are prone to reabsorption and require an additional donor incision. In several patients undergoing revisional aesthetic breast augmentation, grafts of scar capsule were utilized for lip augmentation. At 10 months, persistent volume enhancement results.
ROCKVILLE, Md., June 18 (Reuters) A shortage of a vital immunity-boosting blood product called immune globulin is easing slightly, a U.S. Food and Drug Administration (FDA) official said. "Since November 1997, there has been a 40 % increase per month in the supply released,'' said Basil Golding of the FDA's division of hematology. However, physicians said supplies remain short. Last November, the FDA became aware, through 30 to 40 calls per day from concerned physicians and hospitals, of a severe shortage, Golding said. The product is given intravenously to people with weakened immune systems or rare immune defects. At least 25,000 Americans receive immune globulin regularly. The FDA does not monitor blood products to ensure proper supplies, but has worked with manufacturers to improve quality and reduce the time it takes a finished lot of immune globulin to reach the market. It now takes two to three days instead of two to three weeks, Golding said. Much of last year's shortage was due to recalls as a result of contaminated products or other manufacturing defects. One unnamed company was responsible for the majority of recalls, he said. The main manufacturers are Baxter International, Bayer, Centeon, and Alpha Therapeutic. There was also higher-than-expected demand as unapproved uses soared. Also, many recalls occurred when donors, whose blood was used to make immune globulin, were discovered to be at risk for, or to have, the fatal Creutzfeldt-Jakob disease. Manufacturers were accused of stockpiling the substance to extract higher prices and of diverting product overseas, which they heatedly denied. 87% of several hundred doctors polled in April by the Immune Deficiency Foundation said they had trouble getting immune globulin in the last six months. They coped by postponing and delaying infusions, switching brands and decreasing dosages. As a result, almost half said their patients had experienced a negative health effect.
Wyeth-Ayerst Laboratories of St. Davids, Pa. has announced that it is voluntarily withdrawing Duract (bromfenac) from the market. The action follows postmarketing reports of rare severe liver failure in patients in whom the drug was used for extended periods of time which was not in accordance with labeling instructions. The following may be used to respond to questions. Duract, a NSAID (non-steroidal anti-inflammatory drug), was submitted to the Agency in l994 and was approved in July l997 for short term management of acute pain (use for 10 days or less). It was never approved as a treatment for longer term use for chronic conditions such as osteoarthritis or rheumatoid arthritis.
In February l998, in response to the reports of severe liver failure (and transplants), FDA and the company strengthened the warnings in Duract's labeling with a special black box warning and Wyeth-Ayerst issued a Dear Doctor letter. The revised label re-emphasized that patients should not take the drug for more than 10 days and alerted physicians and other health care professionals to the cases of severe hepatitis and liver failure (and cases in which patients required a transplant) in patients who had taken Duract. Despite these efforts, the agency and the company continued to receive reports of severe injuries and death with long term use of Duract. Given the availability of other therapies, FDA and Wyeth-Ayerst concluded that it would not be practical to implement the restrictions necessary to assure the safe use (less than 10 days) of Duract. The company and FDA agreed that it would be prudent to withdraw the drug from the market. Wyeth-Ayerst is advising doctors to discontinue prescribing and dispensing Duract immediately. FDA is also advising patients to contact their doctors with any questions about use of the drug. Wyeth-Ayerst is providing the new information in a Dear Doctor letter to physicians, pharmacists, and health care professionals. Questions from patients or health care professionals about the withdrawal of Duract can be addressed to Wyeth-Ayerst's hotline at 1-800-281-9260.
June 22, 1998 Published UK: Immune system blamed for Chronic Fatigue: Melatonin could be the secret behind chronic fatigue syndrome. Health Scientists are confident they have found a physical cause for the conntroversial condition Chronic Fatigue Syndrome. They believe it may be caused by the body's reaction to stress which effectively leads to the immune system becoming overloaded. Researchers found that people with CFS produced unusually high levels of the hormone melatonin, which stimulates the immune system and plays an important role in promoting sleep.
Melatonin is vital for maintaining the body's correct diurnal rhythms, helping a person sleep at night and stay awake during the day. for this reason it is used to treat insomnia and jet-lag. The researchers at Guy's and St Thomas's Hospitals, London, are convinced that the hormone is the key to CFS. They believe their findings may lead to the much-misunderstood condition being re-classified as an immune system disorder. Some doctors still believe CFS to be "all in the mind", although most now agree that to some degree it has a physical cause. The symptoms of CFS include debilitating fatigue, neurological problems, general pain, gastro-intestinal problems and a variety of flu-like symptoms. Severity can differ widely among patients and will also vary over time for the same patient. Suicides rise. Severity can vary between getting unusually fatigued following stressful events to being totally bedridden and completely disabled. The symptoms will tend to wax and wane over time. Dr Theodore Soutzos and Dr Ram Seth discovered the melatonin link after measuring daily production of the hormone in 44 CFS patients and 17 healthy volunteers.
They found that melatonin levels were higher in the CFS group as a whole. When patients with "active" symptoms, as opposed to those who were "improving", were looked at in isolation, the pattern became "massively significant". The findings were presented at the Royal College of Psychiatrists' annual meeting in Belfast.
Pathological problem: Dr Soutzos said: "What is interesting is that melatonin is an immuno-enhancer; it drives the immune system. If you deprive mice of melatonin, for instance, they start dying of cancer. "One theory could be that some people drive their immune systems so hard that it becomes pathological. In certain individuals with an inherent vulnerability it could set off chronic fatigue syndrome." This in turn could be stress-related, which would explain how psychological and physical factors could work together in CFS, said Dr Soutzos. "People who drive themselves excessively and are under stress artificially put their immune systems under pressure," he said. "There is a negative feedback system which returns things to normal, but all you need is a slight imbalance and you get a vicious cycle." A possible answer would be to treat the problem aggressively at the outset, before the vicious circle becomes established. This might involve either adjusting peak melatonin levels or reducing production of the hormone. (Wonder if this explains why melatonin kept me awake when I had CFIDS?).
LOS ANGELES 05/17/98 (Reuters): Trials show Herceptin slows spread of breast cancer: Human trials of Genentech Inc.'s drug Herceptin showed it can prevent the spread of metastatic breast cancer by up to three months, cancer researchers said Sunday. Phase III trials of the drug in human patients, typically one of the final hurdles before approval by the U.S. Food and Drug Administration, showed Herceptin helped stop the spread of cancer and slowed tumor growth in women with metastatic breast cancer when added to chemotherapy. If Herceptin gains FDA approval, as expected later this year, it will become the first monoclonal antibody for the treatment of metastatic breast cancer. A cancer is metastatic when it has spread from the original tumor to other parts of the body. Herceptin works by targeting the HER2/neu protein. About 25 to 30 % of women with breast cancer "overexpress'', or produce too much of the protein due to a genetic defect. The trial was conducted on 469 women who produced too much of the HER2/neu protein. Dr. Dennis Slamon, director of the Revlon/UCLA Women's Cancer Research program who was a lead scientist on the trial, said Herceptin slowed or stopped the spread of the cancer by up to three months in women with metastatic breast cancer who produced too much HER2/neu protein. Women with metastatic breast cancer who over-produce the protein typically live for 10-18 months once the cancer has become metastatic, he said. Doctors at the American Society of Clinical Oncology's annual meeting here called the drug a medical breakthrough because it is the first breast cancer treatment targeted to attack a specific genetic defect. "This proves the paradigm that if we understand what is broken in the malignant cell we can possibly fix it," said Slamon. "Herceptin is the first successful cancer treatment that targets a specific genetic alteration as opposed to using a shotgun approach that kills both diseased and healthy cells," he added. Herceptin avoids traditional chemotherapy side effects such as hair loss and significant drops in blood counts, he said. When taken with the drugs Adriamycin and Cytoxin, Herceptin showed 50 % greater breast cancer reduction in 52 % of patients compared to a 43 % response in patients who took Adriamycin and Cytoxin alone. When taken with the drug Taxol 42 % of women had a significant response compared to just 16 % in patients taking Taxol alone. Overall, Herceptin taken with traditional chemotherapy drugs had a 50 % better response rate than women who only used usual chemotherapy. Dr. Craig Henderson, who was on a panel to discuss the drug, said that the trial, paid for jointly through public and private funds, was a true pay-off for taxpayers. "The tax payers are getting their money back," he said. This is science at its best and most elegant.'' Another doctor on the panel said he expected "a tidal wave" of future drugs would use a similar approach. Breast cancer is the most prevalent form of cancer in women, with about 180,000 cases diagnosed each year in the United States and 43,500 deaths from breast cancer expected this year. Slamon said Herceptin had the potential to treat other forms of cancer where the HER2/neu protein was overexpressed such as ovarian and gastric cancer. Monoclonal antibodies can recognize antigens on the surface of cancer cells and bind to tumor cells thereby interrupting their biological processes and killing them. Herceptin was made using genetic material from a mouse and then "humanizing'' it so the body's immune system would not attack it. Almost 20,000 doctors attended the ASCO conference to discuss new advances in cancer treatment. Cancer is second only to heart attacks as a cause of death in the United States. About half of those diagnosed do not survive, 1.2 million cases of cancer are diagnosed annually and about 565,000 American are expected to die of the various types of cancer in 1998.
ALTERNATIVE MEDICINE: Press Release, Contact: Maria Perry, IBIS medical software: With nearly half of Americans now using some form of alternative therapies, Integrative Medical Arts Group Inc. (IMAGUS) of Portland, OR., has released a new version of its IBIS medical software, the standard reference tool on natural medicine for healthcare professionals (for over six years). IBIS, The Interactive BodyMind Information System, provides therapeutic options to treat 282 common medical conditions, drawing from the full spectrum of alternative therapies and integrative medicine. IBIS also contains clinical information on herbs, nutritional supplements and a wide range of natural substances as well as a patient educational materials such as home care instructions, visualizations, recipes and exercises. The newest version of IBIS features state-of-the-art multiplatform programming, an elegant and intuitive interface and hundreds of new articles providing up-to-date information on topics of concern to patients and physicians alike. Yet this new version of IBIS is generating a new level of attention not just because of what's in it but because of who's using it. Even the most conservative elements of the medical community recognize the need for an authoritative reference on these often confusing topics. While previous versions of IBIS have been widely praised in the natural medicine community, this new release has generated excitement in some unexpected quarters, conventional medical schools, clinics, pharmacies and hospitals. Likewise, patients everywhere will be happy to know that their medical doctors and the local hospital now have access to reliable information on herbs, homeopathy, nutritional supplements and the other forms of alternative medicine that they want to include among their healthcare options.
The Interactive BodyMind Information System (IBIS) is a comprehensive clinical database that enables healthcare providers and allied professionals to become more familiar with nutrition, acupuncture, homeopathy, Western and Chinese herbs and psychospiritual approaches and integrate these remedies into their own practices. Designed by practicing healthcare professionals, IBIS was originally compiled over four years of research by a team of Naturopathic Physicians (NDs), herbalists, acupuncturists, chiropractors, homeopaths and medical students. It features more than 10,000 pages of hyperlinked clinical data together with modules that enable users to add their own notes, record patient-visit records and analyze clinical outcomes. Since it was first published in 1992, IBIS has become the standard reference tool for healthcare professionals needing quick, balanced and reliable information on alternative medical therapies. While usage during its first three years was tilted toward naturopaths, acupuncturists and chiropractors, the last three years have seen a large increase in demand from medical doctors, pharmacists, clinics, medical schools, libraries and hospitals. Doctors hear the boom in natural medicine. Natural medicine and alternative therapies are booming, a trend that appears to be no passing fad but a fundamental shift in American healthcare. In response to consumer demand, a new ''integrative medicine'' is emerging, combining the best of conventional medicine and alternative therapies.
Many doctors were taken by surprise in January 1993 when Dr. David Eisenberg of Harvard Medical School released a landmark study in the New England Journal of Medicine showing that one-third of Americans were using unconventional medicine. More recent studies have found that 40 to 50 percent of Americans are using alternative therapies (Elder, Archives Fam Med., March 19, 1997; Astin, JAMA, May 20, 1998). Other research shows that even more are taking herbs and supplements on their own. Patient interest has far outpaced the resources of doctors, hospitals and insurance companies as they discover that their standard texts and reference books do not cover herbs, supplements and homeopathic remedies. Patients often feel that they know more than their doctors do and that physicians aren't listening to them or respecting their choices. Responsible physicians, for their part, desire reliable information about the choices that their patients are making so that they can give better advice and treatment.
It is crucial that physicians, pharmacists and other healthcare providers have up-to-date, balanced and scientifically-founded reference tools to effectively and responsibly approach non-conventional medicine, to become aware of its strengths and informed about clinical indications, proper dosages, toxicities and interactions. Just because something is natural doesn't mean it is effective or safe; if a medicine or supplement is powerful, then a trained healthcare professional needs to supervise its use. In response, we see practitioners from all fields of medicine communicating more and starting to work together to create a new integrative medicine: A 1994 survey of physicians from a wide range of medical specialties and diverse locales revealed that more than 60 % recommended alternative therapies to their patients at least once in the preceding year, while 38 % had done so in the previous month. 47 % used alternative therapies themselves, while 23 % incorporated them into their practices. (Borkan, et al, J Fam Pract, 1994;39:545-550; Perkin, et al. J R Soc Med, 1994;87:523-525; MacLennan, et al. Lancet. 1996;347:569-573) Last fall's NIH Consensus Conference on Acupuncture gave enhanced credibility to the ancient art of acupuncture based on solid scientific findings and a meta-analysis of placebo-controlled clinical trials of homeopathy published in The Lancet (Sept. 20, 1997) confirmed that positive clinical results were significantly greater than could be attributable to placebo effects. A majority of conventional medical schools in the United States now have at least minimal coursework available as an introduction to nonconventional therapies and medical traditions such as acupuncture, herbalism, Ayurveda and homeopathy. Many of these are considered conventional or traditional in many parts of the world but are new to most doctors. Likewise, professional and post-graduate doctoral programs in naturopathic medicine, chiropractic and acupuncture are flourishing as new colleges are being accredited and graduates move into the professional healthcare delivery system.
IBIS helps bring alternatives into the mainstream. IBIS provides an easy-to-use reference tool for evaluating alternative and complementary medical disciplines as they become part of the medical mainstream. Such tools will certainly be necessary as traditional insurance companies further expand their coverage to include alternative therapies and HMOs begin to enroll the licensed practitioners of such therapies in their plans. This has already occurred in Washington state and is part of nearly every coverage-provider's future direction. Medicine has always been based on discovery, innovation and dialogue. To be successful in achieving meaningful evolution, healthcare practitioners emphasize the need for shared assumptions, increased familiarity and common language.
''Just as a naturopathic doctor or an acupuncturist needs to study and be able to look up information on pharmaceuticals and surgical procedures, every medical doctor, nurse and pharmacist should be at least conversant with the basics of alternative therapies and be able to access clinical data on herbs, supplements, homeopathics and other medicines,'' said Mitchell B. Stargrove, N.D., L.Ac., the developer of IBIS and a Professor of the History of Medicine. ''More and more we will be seeing teams of practitioners from various approaches working together to care for patients with more chronic and severe conditions.''
Dr. Stargrove and his associates have hosted HealthWWWeb, a popular educational and resource-oriented website, and Paracelsus, an Internet discussion group for dialogue among healthcare professionals of different disciplines for the past four years. Patients will be reassured to see their healthcare providers talking with each other, gaining respect for each other's strengths, and cooperating together for greater clinical effectiveness. Tools such as IBIS and forums such as Paracelsus contribute toward this goal.
IBIS runs on Windows95/98/NT, with minimum system requirements of 35 megabytes of hard drive space available and 16 megabytes of RAM. A new version for Macintosh OS and UNIX will soon be available and World Wide Web access is planned for later this year. The cost of IBIS is $695 for clinics, hospitals, pharmacies, healthfood stores and other institutions; individual healthcare providers are eligible for a $100 discount and students at accredited schools are eligible for a 20% student discount. Quarterly content updates are available by subscription. The current Professional Version of IBIS is only available to healthcare practitioners, educators and allied professionals, but a version for the general public is anticipated in response to high demand. You can learn more about IBIS on the World Wide Web at <www.Integrative-Medicine.com.>
HealthWWWeb, and its calendar of events, Resource Guide, links to related World Wide Web sites, and directory of educational institutions, professional associations, and other valuable resources, can be accessed via the URL: <www.HealthWWWeb.com.>
If you are a healthcare professional and want to share insights with over 600-900 other practitioners, send an e-mail message to <ParacelsusSupport@HealthWWWeb.com> and ask for information on how to subscribe.
About the company: Integrative Medical Arts Group, Inc. (IMAGUS) develops and distributes software tools and other resources for healthcare professionals and the general public. We can be reached at 503/526-1972 or via e-mail as imagus@Integrative-Medicine.com. Our fax number is 503/641-4541. Interactive BodyMind Information System®, Imagus * and HealthWWWeb* are trademarks of Integrative Medical Arts., Inc. WHAT IS HYPERBARIC OXYGEN? Hyperbaric Oxygen, also called HBOT. Is medical treatment in which the patient breathes pure oxygen under a pressure greater than normal atmospheric pressure. It is used, usually as part of an overall medical care plan, for a wide variety of treatments. HBOT is simple in concept and is both safe and effective. The patient's bloodstream has its oxygen level raised many times above the normal which helps control infections and promote healing many types of illness or injury (as well as plastic surgery). In the plastic surgery patient, it can rapidly speed the healing process which would mean much less down time for the patient who has had elective surgery.
How is HBOT administered? The patient is placed inside a chamber which is then pressurized with medical quality air. When pressurization is completed, the patient breathes healing oxygen from a mask. Plastic surgery patients have a mask made just for this reason. In France there are many units only for plastic surgery because of the dramatic effects in many cases (up to 70% reduction in recovery time). Usually treatment time will be between 30-90 minutes. The number of treatments will vary with the patient and the illness. Is it safe and are there side effects? Trained support technicians monitor and control the chamber. Most patients read or watch videos during treatment. Some sleep or listen to music. There are few counter-indications for HBOT. It is not for patients suffering with heavy colds or sinusitus. Extra precautions can be taken with pressure changes. What can be treated with HBOT? HBOT can be used to treat all conditions which benefit from the increased tissue oxygen availability.
HBOT has angiogenic (growing new blood vessels) properties. It will boost the immune system. HBOT can also be used for its antibiotic properties, either as a primary therapy or as an adjunct to other procedures or medications. A unique and valuable attribute of HBOT lies in its ability to bring back into full body bio-electric activity brain cells or neurons which have been compromised by hypoxic or neurotoxic accidents and have been 'idling' (That is, they are alive but not functional). Some indications for HBOT: Carbon monoxide or smoke inhalation, crush injury, acute ischemia, burns, plastic and reconstructive surgery, near death drowning, hanging or electrocution, gangrene, soft tissue necrosis, spider bite, wound healing, radiation sickness, bone infections (osteomyelitis), acute peripheral arterial insufficiency, skin grafts, all edema, (spinal, cerebral, under cast plastic surgery), congestive heart failure, stroke, lupus, scleroderma, rheumatoid arthritis, lyme's disease, closed head injury, anoxic brain injury, spinal cord contusion, cranial nerve syndrome, encephalitis, peripheral neuropathy, frostbite, non-union fractures. Current advances: Migraine headaches, Alzheimer's/senility, acceleration of tumor necrosis in cancer, AIDS, cardiac dysfunction, detox, stroke, M.S., Parkinson's disease, prarsites, toxic brain. In Germany, HBOT is given to all stroke victims under the German Health Scheme. It has been shown to reduce aftercare cost by more than 70%. It has also shown great improvement in M.S. patients. HBOT is the healthy way to improve health.
HBOT FOR SILICONE POISONING: About 2 million US women have had silicone breast implants. Polydimethylsiloxane has been used either in implants or by injection for a variety of purposes including mammoplasty, filling of the tissue voids in reconstruction surgery and prostheses for cosmetic and other purposes and of course silicone was used for some years for brain "Shunts". Injected silicone material was found to pose severe health problems including cancer, arthritis and chronic fatigue syndrome as well as other immunobased and allergic reactions. Some patients with breast implants who exhibited such symptoms have been shown by Enzyme-linked Sero Assay (Elisa) test to posses elevated IgG, IgA, IgM, and IgE silicone antibodies. In addition to the silicone reactions from silicone implants, the polyurethane implants shells themselves are now known to break down under metabolic activity and produce 2,4, toluenediamine and 2,6 toluenediamine, both of which are carcinogenic and able to react with the neurominic acids to produce phthalocyanine dichloride which in turn reacts with silicone to produce a precursor to silicone "stacked rings" phthalocyanines.
This form of cyanide toxin induced metabolic impairment in the brain inhibits production of adenosine triphosphate, adequate supplies of which are required to avert lipofuscin accumulations, to promote phagocytosis and for natural detoxification. An abnormal sodium and potassium ion interchanges. In the course of this abnormal chemistry in the brain, polyunsaturated fatty acids become destabilized as the double bonds within membranes allow the easy extraction of hydrogen atoms. This starts a reaction in which peroxy radical combine with hydrogen to lipid hyperaldehydes. This series of reactions conjugated as diones can initiate chain reactions leading to numerous toxic and allergic responses in the patient as membranes cross link damaging their integrity and their essential proteins. The glutamatergic neuronal process can lose energy dramatically due to hypoxia or hyperglycemia and from further neurotoxins. SYMPTOMS: Dopamines can be released, and the patients may suffer symptoms of confusion or intermittent panic. In the immunsuppressed patient, many strains of fungi will be able to flourish and allergic reactions to these and other invasory micro-organisms are common as are developing allergies to many chemicals (especially hydrocarbons). The symptoms of silicone allergy are therefore associated with cyanide blockage of part of the hemoglobin oxygen transportation mechanism with neurotoxin responses and with lipofuscin accumulation.
Hyperbaric Oxygen Therapy (HBOT) has been shown to disperse lipofuscins, burn out cyanide poisoning (a category one use for HBOT) and in many cases destroy a wide range of neuro-toxins. HBOT also has a well earned reputation as an immune system enhancer and is also able in many cases to reactivate idling neurons. Experience with anoxic encephalopathy has shown that neurons are able to be "idling" for up to 15 years and still be recovered to normal activity as soon as good oxidation is present. Over 90% of all the oxygen used by humans is consumed in the mitochondria and this makes hypoxic conditions in that area singularly threatening, as the mitochondria are not very efficient in any case at controlling the electrical components of the mechanism of breathing. It is notable that restoration of good oxidation of the mitochondria usually results in the breathing difficulties of silicone reaction patients (usually described as "choking sensations") resolving very quickly. Single Photon Emission Computer Tomography (BRAIN SPECT SCAN): Patients with sequelae to silicone implant leakage almost always exhibit the same abnormalities on Spect Brain Scan and seem to recover from their symptoms when SPECT scans become normal. Abnormalities usually include bilateral cortical lack of perfusion; this together with a history of silicone implants or past silicone injections and the symptoms described would seem to be a good rationale for HBOT treatment. Some patients have in the past been mis- diagnosed as cases of Multiple Sclerosis (MS), and while they exhibited all of the symptoms of silicone reactions, they did not show the usual "plaqueletts" distributed in the brain scans by Magnetic Resonance imaging (MRI). Patients have also been diagnosed as having ALS, Lupus, and sclerodrema and have later been found to have silicone reactions instead. However, the disease process does indeed mimic the above stated. It must also be stated that Hyperbaric oxygen therapy has been used in Europe for treatment of MS, ALS, as well as lupus and has been very successful in the typical disease. Written by Susan Rodriguez. To contact Susan for info.: (909) 989-3378, 7734 Perlite Ave., Rancho Cucamonga, CA Rapid Recovery Hyperbarics.
PERSONAL COMMUNICATION: From our readers: After you shampoo, does your hair have a glossy look and feel? If it does, you might not guess your shampoo's secret ingredient. It's probably silicone. And, oh yes, silicone helps prevents split ends. Also, clothes that stay crisp even when the weather goes damp have likely been treated with silicone fluid. The versatility of silicone can waterproof your jacket or even give an absorbent luster to your towels. (Doesn't this just thrill you??!! Do you read labels??)
IMPORTANT: Warning about tampons: Tampons contain two things that are potentially harmful: Rayon (for absorbency) and dioxin (a chemical used in bleaching the products). The tampon industry is convinced that we, as women, need bleached white products; they seem to think that we view the product as pure and clean. The problem here is that the dioxin produced in this bleaching process can lead to very harmful problems for a woman. Dioxin is potentially carcinogenic (cancer associated) and is toxic to the immune and reproductive system. It has been linked to endometriosis as well as lower sperm counts for men-for both, it breaks down the immune system. Last September the Environmental Protection Agency (EPA) reported that there really is no set "acceptable" level of exposure to dioxin, given that it is cumulative and slow to disintegrate, the real danger comes from repeated contact (Karen Houppert "Pulling the Plug on the Tampon Industry"). I'd say using about 5 tampons a day, five days a month for 38 menstruating years is "repeated contact," wouldn't you? Rayon contributes to the danger of tampons and dioxin because it is a highly absorbent substance and therefore when fibers from the tampons are left behind in the vagina (as usually occurs), it creates a breeding ground for the dioxin and stays in a lot longer than it would with just cotton tampons. This is also the reason why TSS (toxic shock syndrome) occurs. WHAT ARE THE ALTERNATIVES? Using feminine hygiene products that aren't bleached (which causes the dioxin) and that are all cotton (the rayon will leave fibers and "breeding grounds" in the vagina). Other feminine hygiene products (pads/napkins) contain dioxin as well, but they are not nearly as dangerous since they are not in direct contact with the vagina. The pads/napkins need to stop being bleached, but obviously tampons are the most dangerous. So, what can you do if you can't give up using tampons? Use tampons that are made from 100% cotton and that are unbleached. Unfortunately, there are very very few companies that make these safe tampons. They are usually only found in health food stores. Countries all over the world (Sweden, Germany, British Columbia, etc.) have demanded a switch to this safer tampon, while the U.S. has decided to keep us in the dark about it. In 1989, activists in England mounted a campaign against chlorine bleaching. Six weeks and 50,000 letters later, the makers of sanitary products switched to oxygen bleaching (one of the green methods available) (Ms. magazine, May/June 1995).
Dow Told to Clean Up Contaminated Water The San Francisco Chronicle: Dow Chemical Co. is expected to spend millions of dollars cleaning up contaminated water believed to be seeping toward a nearby water supply, after a recent order by the Regional Water Quality Control Board. The company, located along the banks of the San Joaquin River between Pittsburg and Antioch in Contra Costa County, has until March 2000 to comply with the clean-up order issued Wednesday, plant spokesman Scott Anderson said. The company must capture and treat contaminated water stemming from chemical discharges in the 1950s when environmental restrictions were less stringent. State officials said the contaminated water is flowing into the New York Slough, downriver of an Antioch water pumping location and several miles from a Contra Costa Water District water source.
Meanwhile, the environmental group, San Francisco Bay Keeper, is suing the company for allegedly violating terms of Proposition 65, which regulates the release of carcinogens into the environment. Anderson said the company now discharges treated water according to federal Environmental Protection Agency and Regional Water Quality Control guidelines. "There is groundwater contamination all along the river," Anderson said, noting that the plant has been monitoring wells and treating groundwater since the early 1990s. "It's moving slowly northeast. We have to either have a system to prevent it from moving off the plant site, or we have to capture all the water and treat it."
The Cost of Being a Woman: Although sex differences in health care expenditures have been observed, (1) it is unclear whether they are related to differences in patterns of illness or preferences for care or to sex bias among health care providers. As health care resources become more constrained, it is important to examine whether women and men receive equitable care. In this issue of the Journal, Mustard et al. (2) report an elegant study of sex differences in expenditures for physicians' services and acute hospital care among all citizens of the province of Manitoba, Canada, during 1994-1995. Expenditures were divided into three categories: those related to conditions specific to sex, those related to the process of dying (i.e., for care during the last year of life), and those related to all other conditions. The data presented by Mustard et al. suggest that health care expenditures are similar for women and men after adjustment for differences in the use of services related to reproductive biology and for differences in mortality. Overall, women were found to use approximately 30 percent more health care resources than men, but the majority of this excess was associated with conditions related to reproduction. The authors carefully examined sex differences in expenditures over the course of life. Women used more services during the childbearing years, and men used more services at the extremes of age. Although expenditures for sex-specific conditions explain most of the differences in expenditures during the childbearing years, the higher expenditures for elderly men persisted after the authors controlled for the costs of dying.
Although this study suggests that biology explains a substantial portion of the difference in health care expenditures between women and men, a more vexing question remains unanswered. Is the apparently equal distribution of health care dollars equitable? Several facts suggest that equal spending is nonetheless inequitable. Women in Canada (and in the United States) live longer than men, but longevity is associated with a greater lifetime risk of functional disability and chronic illness, including cancer, cardiovascular disease, and dementia and a greater need for long-term care. (3) Preventive measures and interventions to reduce risk factors for chronic disease and functional decline are needed to improve the health status of women. In addition to the greater lifetime risk of a chronic disease and disability for women, several observations suggest that inequalities between the sexes in health status are present throughout life. To some extent, discrepancies between women's and men's health status reflect the social inequality of women and men. In Canada, the rate of poverty is higher for women than for men in all age groups, and this social adversity may result in poorer health. (4) After adjustment for age, women in the United States are more likely than men to report that they are in poor or fair health. (5) Although women continue to live longer than men, by an average of 6.4 years, the age-adjusted mortality rate is declining for men, largely because of decreasing mortality from cardiovascular disease and cancer, but is essentially unchanged for women. (5,6).
A growing body of literature suggests that women receive fewer therapies of demonstrated effectiveness for a variety of conditions. Women with end-stage renal disease are less likely to receive a kidney transplant than men. (7) Women with coronary artery disease are less likely than men to undergo cardiac catheterization and revascularization, (8,9) despite their greater disability, and they are more likely to have their symptoms attributed to psychiatric causes. (9) In contrast, men may be more likely to be referred for unnecessary cardiac surgery than women. (10) Despite the repeated documentation of sex differences in the provision of health care, there is little information to pinpoint a cause. In one large study, after control for clinical condition, health status, and daily responsibilities, women were almost four times as likely as men to be prescribed bed rest; this finding suggests that sex differences in illness-related behavior or clinicians' attitudes account for the difference between the sexes. (11) That women and men who undergo noninvasive exercise testing do not differ in their willingness to seek a second opinion or to take medications to avoid cardiac surgery suggests that the observed variation in the use of cardiac procedures may not be related to differences in patients' preferences with respect to care. (12) Women and men have unique medical problems and health care needs. At a time when there have been improvements in the health status of men, the health status of women does not appear to be improving, (5,6) perhaps because of the long-held assumption that disease patterns for women are the same as those for men. A greater emphasis on prevention and treatment for women, particularly for conditions that are not specific to their sex, is necessary, not only to prolong life, but also to postpone and diminish disability. The use of health care services and expenditures for those services cannot by themselves be used to evaluate access to care or the appropriateness of care. The health care needs of women and men should not be defined and examined solely in relation to reproductive function but, rather, should be viewed in terms of health status, preferences for care, and documented evidence of the effectiveness of therapy. Written by: Jennifer Haas, M.D. University of California San Francisco, San Francisco, CA 94143
Scientists, Celebrities Join Senator Boxer to Call for More Study into Silicone Breast Implants and Disease: Boxer Legislation Urges NIH Research. Calling for an end to the "junk science" wars, on Wednesday, June 10th Senator Barbara Boxer introduced legislation urging the NIH to dramatically expand research and to consider beginning the largest clinical effort to date on the link between silicone breast implants and disease. "Many implanted women have legitimate health complaints and it's time to get down to the bottom of this problem for once and all," says Boxer. "Women need adequate information to make informed choices and to get unbiased medical treatment, especially cancer survivors who chose implants after surgery only to suffer all over again."
Cancer survivor and activist Sybil Niden Goldrich, talk show host Jenny Jones and Waltons' actress Mary McDonough joined Senator Boxer (D-CA). The legislation will provide suggested guidelines to streamline government activities on implants and improve FDA oversight of the current limited clinical trials. Boxer was also joined by researchers. Dr. Robert Garry is a Tulane University immunologist and microbiologist who discovered the non-HIV AIDS virus HIAP. Diana Zuckerman, Ph.D., trained in epidemiology at Yale Medical School and is Director of Research and Policy Analysis at the Institute for Women's Policy Research. Dr. Zuckerman initiated the first congressional hearings on the safety of silicone breast implants. Dr. Susan Kolb is a plastic surgeon who has removed the implants of scores of sick women and had problems with her own breast implants which subsided when they were removed. The Institute of Medicine says implants may break and or leak at rates as high as 70%. In 1997 the Mayo Clinic found that one in four women require additional surgery because of their implants within five years of receiving them. Last Spring an NIH panel of independent researchers expressed concerns about implant safety and called for more research. Last Fall both the National Cancer Institute and the U.S. FDA called for additional research in separate peer-reviewed papers. Fenton Communications, 202-822-5200
British plastic surgeons cannot keep up with the demand for an adjustable tear-shaped silicone breast implant. The implant includes a small internal sac that is filled with a saline solution during the operation, by means of a tube hidden behind the silicone sac. The implant is in great demand by women who have had mastectomies because it can be adjusted to match the remaining breast. Dr. Adam Searl of Charing Cross Hospital in London states that the implants are so strong that they would burst only if put under the kind of pressure that would kill the patient. (Where have we heard this before??) Only about 30 plastic surgeons in Britain are able to perform the operation and many women in some parts of the country have had to wait as long as a year for these implants. (Medical-Legal Aspects of Breast Implants June, 1998.)
BOOKS: See attached list of books available from COSS.
PRODUCTS AVAILABLE: If you are still trying to get well using drugs and prescriptions, call me for some alternatives. I avoided drugs and have improved greatly. Many natural products can help you heal without side effects!! Every drug is toxic and adds to your body' toxic load. Since we are already toxic, this is a significant problem with prescription drugs. You can brush this off for years, but it will catch up with you eventually.
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 Malfunction s 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; Legal info. and info. on Alternative Medicine Info. contained in most issues.
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C.O.S.S. 06/01/98
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