COALITION OF SILICONE SURVIVORS

P. O. Box 129 Broomfield, CO 80038-0129

Lynda Roth - (303) 469-8242 Fax (303) 466-4084 Website: http://www.siliconesurvivors.net

E-mail: coss@siliconesurvivors.net

April 1998

Dear Silicone Survivors and Friends:

UPCOMING EVENTS: There are no known upcoming conferences. PALS will have a reunion and welcome for new members in Cincinnati, Mercy Hospital, 7:00 P.M. April 15th. Those interested should contact Alice Cooke ( 513) 481-7171, Loretta Metzler (937) 256-0278 or Pat Frank (513) 851-9662. They will follow this with a meeting on May 15th at the same location, same time.

LEGAL: Baton Rouge, LA., 4/2/98 (PRNewswire) The Louisiana Supreme Court denied a plaintiffs' emergency request to "recertify" the Spitzfaden class-action. The decision upholds a unanimous ruling by the Louisiana Fourth Circuit Court of Appeal and a decision by the Civil District Court for the Parish of Orleans which also denied similar requests to recertify the silicone gel breast implant class-action, involving an estimated 10,000 women, against Dow Chemical and other defendants. Simultaneously, the court also denied plaintiffs' emergency request to reverse lower court decisions allowing Dow Chemical to appeal the 8/18/97 verdict in the first phase of the trial.

Commenting on today's ruling, John Scriven, Dow Chemical vice president and general counsel, said, "This is a major victory for Dow Chemical. With the rulings from Judge Magee, the Fourth Circuit and the Supreme Court, there can be no question that the Spitzfaden class-action was improper and our

efforts over the past 18 months to decertify this class have been vindicated. Dow Corning's bankruptcy reorganization process remains the most appropriate forum for resolving any woman's claim involving Dow Corning silicone gel breast implants. The decision today will facilitate resolution. Dow Corning's Plan of Reorganization provides compensation for women with valid breast implant related claims," added Scriven. Hearings to determine the suitability of this plan for claimants will be commenced in the Bay City, Michigan bankruptcy court on April 6. Previously, on 12/1/97, Louisiana District Court Judge Yada T. Magee ruled to decertify the Spitzfaden class based on a recent Louisiana Supreme Court opinion (Ford v. Murphy Oil USA, Inc.) that had provided guidance on the criteria for class-actions in the state. Consistent with the Ford opinion, Judge Magee said in her ruling, "There are simply too many individual issues due to the fact that members of the class were implanted with various types of breast implants, at different times in varying degrees and the implants have caused different diseases. Additionally, there are individual questions regarding each class members lifestyle and medical condition which are paramount to causation." On 1/5/98, Judge Magee denied plaintiffs' attorneys' request to reconsider her decertification order and on 1/2/98 the Louisiana Fourth Circuit Court of Appeal followed suit. Also, the Supreme Court's ruling denying plaintiffs' request to overturn the lower courts' decisions allowing Dow Chemical's appeal of the findings in the first Phase of the trial confirms that there will be no immediate trial of any plaintiffs against Dow Chemical in Judge Magee's courtroom. All proceedings in that courtroom remain suspended pending resolution of Dow Chemical's appeal of the first phase findings and an appeal as to whether venue is proper in New Orleans for any of the eight formerly designated class representatives, now plaintiffs.

The Dow Chemical Company did not develop, test or manufacture silicone breast implants, and it has been dismissed from some 4,000 implant cases on the grounds that there is no basis in the law or the facts related to this issue sufficient to hold Dow Chemical liable. The overwhelming weight of medical evidence demonstrates there is no association between silicone breast implants and systemic disease. Source: Dow Chemical Company. (This information is from Dow Chemical, and is not necessarily the way many others see the facts!)

In the Dow Corning bankruptcy, The Tort Claimaint Committee (TCC) still hopes to file its own reorganization plan (Dow Corning Bankruptcy), At this point, the court has still not made a ruling on this proposal.

The AMA will now police it own members to check up on how they testify. Those who serve as expert witnesses will not be allowed to testify on 'junk science'. This is obviously an attempt to stop doctors from testifying in cases such as the breast implant lawsuits. A testifying doctor could be subject to loss of license or other sanctions. Expert-witness peer review programs will have to be set up to evaluate testimony by doctors. This could put doctors who dare to speak out in great jeopardy. The courts are using a number of defenses (Restatement of the Law of Torts, Product Liability) to keep the suppliers of non-defective raw materials from being liable for what these products are later used for. The courts continually recognize that suppliers often do not know what use will be made of their raw materials, therefore they cannot be held liable. This should not apply to Dow Chemical or Dow Corning, as they obviously knew exactly what was happening to the raw materials (which I think were defective from the start). In fact, they did most of the research on breast implants, so claiming they are innocent would take a great leap in logic.

In order to claim this defense, the manufacturer must establish that: 1) The raw material supplied is not itself inherently dangerous or defective; 2) The purchaser of the raw materials is knowledgeable, sophisticated & subject to independent duties to test & warn; 3) The raw materials undergo 'substantial changes' in the manufacturing process before the product is resold to consumers; and 4) The raw material supplier has not 'substantially participated' in the design of the end product. Judge Pointer (Order # 38 at 5-6).

GE was held not liable for its silicone raw materials under this ruling. The court found that silicone products have many safe uses and are not themselves inherently defective or unreasonably dangerous. GE has sold silicones for a variety of purposes that were not implant related. Customers of GE that used silicone for breast implants were 'sophisticated buyers' of silicone and had evaluated the risks and had a duty to warn consumers. GE's silicone underwent substantial changes before it reached the consumers. GE only provided technical services to customers who used their products for implants and therefore did not substantially participate in the design of the integrated products. This exempts them from liability for the finished product.

Toronto, 4/2/98 (Reuters): Thousands of Canadian women involved in two class action suits against Dow Corning Corp. (DOW-news; GLW-news) will receive compensation under a $50 million deal with the now-bankrupt manufacturer of silicone breast implants, a law firm said. Individual compensation will vary according to the age when a woman's symptoms began, the disability level and the severity of her illness,'' Eizenga said. This is a similar formula to those used in the Bristol-Myers and Baxter deals. According to estimates, some 150,000 Canadian women have had breast implants with about 1/3 suffering problems. The deal is subject to court approval & confirmation of Dow Corning's reorganization plan by the bankruptcy court in the United States.

MEDICAL INFORMATION: Over-exposure to the sun is a concern at any time of the year, but the tendency to spend too much time in the sun increases as the days lengthen and the temperature rises. Here are some important things for you to know about the causes and prevention of skin cancer: What Causes Skin Cancer? Sunburn and ultraviolet (UV) light. Heredity: if there is a history of skin cancer in your family, you are probably at a higher risk. Environment: factors include elevation, latitude (how close you live to the equator) and cloud cover. The strength of UV light increases with elevation. Risk of skin cancer increases with the total amount of sun received over the years and overexposure resulting in sunburn. Most people receive 80% of their lifetime exposure to the sun by 18 years of age. Skin cancer develops slowly; the sunburn you receive this summer may become skin cancer years later.

What Is Skin Cancer? Skin cancer is a disease in which cancer cells arise in the outer layers of the skin. The most common cancers are basal cell cancer and squamous cell cancer. Skin cancer is more common in persons with light-colored skin. It appears most commonly on the face, neck, hands and arms, but can occur anywhere on the body. Changes in skin aren't always, but might be signs of skin cancer. If you notice changes in your skin (change in the size, height and/or sensation of an existing mole or growth of a new mole) see your doctor. Early detection is the surest way to a cure.

Reducing Risks: The American Academy of Dermatology and the Skin Cancer Foundation recommend these actions to reduce chances of sunburn and skin cancer: Minimize sun exposure at midday (10:00 am to 3:00 p.m.). Apply a sunscreen with a minimum SPF-15 or higher to all exposed areas of the body. Reapply sunscreen every two hours, even on cloudy days. Reapply after swimming or perspiring. Wear clothing that covers the body & shades the face. Avoid unnecessary exposure to radiation through sunlamps or tanning parlors. Protect children by keeping them from excessive sun during the hours of strongest sunlight. Apply sunscreen liberally and frequently to children older than 6 months of age. Do NOT use sunscreen on children under 6 months. Instead, their sun exposure should be severely limited.

Looking for the Warning Signs: Periodic self-examination is an important preventive tool against skin cancer. Lesions caught in the early stages are almost totally curable and periodic self-examinations are especially helpful. Examine your body (front and back) in a mirror, then right and left sides, with arms raised. Bend elbows, look carefully at forearms, back of upper arms and palms. Next, look at backs of legs and feet, spaces between toes, and soles of the feet. Examine back of neck and scalp with a hand mirror. Part hair to lift. Finally, check back and buttocks with a hand mirror.

Patients should consult a physician whenever they have a question or concern about moles or other markings on their skin or about skin cancer. Resources for Info.: Am. Academy of Dermatology, (847) 330-0230, Cancer Info. Service, National Cancer Institute, (800) 4-CANCER, Am. Cancer Society, (800) ACS-2345, Skin Cancer Foundation, (212) 725-5176. Sources: Am. Acad. of Dermatology, Am. Assoc. of Ophthalmology, Am. Cancer Society, National Cancer Institute, & the Skin Cancer Foundation. Massachusetts Medical Society. For more information, contact: Maria Iacobo, (781) 893-4610, ext. 1318.

Spontaneous autoinflation of saline mammary implants. Source: Annals Plast. Surg 1997 Aug;39(2):114-8; discussion 118-21. Author(s): Robinson, OG, Jr; Benos, DJ. Abstract: This study was prompted by 5 patients (seen by OGR) presenting with unilateral enlargement of the breasts 4 to 9 years following augmentation mammaplasty with saline-filled implants. At exploration one breast implant was seen to be markedly enlarged when compared to the other, with a brownish yellow material that had the consistency of serum. Studies were undertaken to determine the permeability of the silicone container to various body fluids and a study of the contained fluid itself. Protein, viscosity, and osmotic water permeability measurements were performed. The results were consistent with the hypothesis that these silicone implants were indeed permeable to both water, glucose, and protein. We hypothesize that the mechanism underlying this in vivo expansion is colloid osmotic swelling. Why one breast should be more involved than the other is unknown. We believe that this phenomenon is occurring more frequently than is being reported. Author's Address: Department of Plastic Surgery, Brookwood Medical Center, Birmingham, AL 35209, USA.

3/26/98: US plastic surgeons saw a steep rise in the demand for their services during 1997, performing almost 40% more breast augmentation and liposuction surgeries compared with 1996, according to statistics released by the American Society of Plastic and Reconstructive Surgeons (ASPRS). Annual statistics from the ASPRS put the number of liposuctions performed in the US during 1997 at 149,042, up from 109,353 in 1996, and nearly triple the 47,212 performed in 1992. The report also shows that the number of breast augmentation surgeries rose at similar rates, with over 122,000 procedures being performed in 1997 alone.

Dr. Phillip Haeck, a Seattle plastic surgeon and spokesperson for the ASPRS, says the surge in numbers reflect the country's robust economy. "The American economy is going gangbusters," Haeck explained, "and when people have disposable income, they can afford to pamper themselves." Haeck notes that liposuction and breast augmentation are popular in the 27 to 40 year age group, "and I think that's where the increase in income levels are being noticed most." He says rates for plastic surgeries have been on the upswing since at least the early 1990s, but really took off last year. The ASPRS's numbers are based on surveys completed by 800 of their 4,000 members nationwide. Statistics don't include procedures performed by non-plastic surgeons (including dermatologists), so Haeck believes the "numbers could actually be higher."

The report also shows a rise in other cosmetic procedures, but at a somewhat slower pace. The number of eyelid surgeries has risen from nearly 60,000 cases in 1992, to nearly 111,000 procedures in 1997. Facelifts rose from 40,007 cases to 61,692 cases over the same period. Approximately 10% to 15% of all plastic surgeries are currently performed on men. That gender ratio has remained relatively stable since the early 1990s. The ASPRS survey found the incidence of laser skin resurfacing procedures declining from 46,253 cases in 1996 to 36,860 a year later. "Those procedures have only been out for about 3 years," Haeck said. He believes numbers in past years were artificially high because "of the numbers of people who came rushing in initially to get that procedure done." Source: Journal of Health and Social Behavior (1998;39:18-37).

Lipid infiltration as a possible biologic cause of silicone gel breast implant aging. Source: Plast Reconstr Surg 1998 Jan;101(1):64-8; discussion 69-71 Author(s): Adams, WP Jr; Robinson, JB Jr; Rohrich, RJ. Abstract: The cause of silicone gel implant aging and rupture is not known. Recent reports indicate the failure rate is higher than previously published, and implant aging and rupture may be due to progressive mechanical deterioration of the outer vulcanized silicone shell. It is known that lipids are absorbed by the hydrophobic silicone elastomer and lipid infiltration causes mechanical attenuation and possible failure of the elastomer. The purposes of this article are to analyze the silicone envelope/gel of explanted prostheses and the silicone elastomer of other medical grade silicone devices for lipid content and to suggest its possible role in implant aging and rupture. We assayed 33 ruptured silicone breast implant shells (mean age 13.1 years; range 8 to 26 years) and 8 medical grade silicone elastomer devices (mean age 3.7 years; range 3 months to 12 years) for evidence of lipid infiltration using thin layer chromatography. These were compared with control group assays from two nonimplanted silicone gel implants and one unused Silastic catheter. 98% of implants and other previously implanted silicone devices were found to have evidence of lipid infiltration compared with none in nonimplanted controls (p 0.005). We conclude that lipids infiltrate the outer silicone shell and may be a factor related to breast implant aging and rupture due to progressive mechanical weakening of the outer silicone shell. Author's Address: Div. of Plastic and Reconstructive Surgery, Univ. of Texas SW Med. Center at Dallas, TX, 75235, USA.

LONDON (Reuters) Patricia Reaney. A vitamin injection given to new-born babies in many Western countries may be increasing their risk of developing childhood leukemia, British doctors said Friday. Infants in Britain, the United States and most European countries are given vitamin K shortly after birth to prevent a deficiency of the vitamin, a rare condition that can cause hemorrhaging, brain damage and death. But conflicting results of four new studies probing the link between the vitamin and childhood cancers have cast doubt on its safety. `We think there may be a risk. Intramuscular vitamin K looks like it may be dangerous,'' Gerald Draper, the director of the Childhood Cancer Research Group, told Reuters.

Two studies published in the British Medical Journal found no evidence of a link. The results of a third were inconclusive but a fourth said the vitamin injection could be associated with an acute form of leukemia. `We all thought there really wasn't a risk but we can't be absolutely certain. We can't exclude it on the basis of the data. The papers give very disparate results but they don't absolutely exclude it,'' Draper added. Research carried out by Dr. Louise Parker of the Sir James Spence Institute of Child Health in Newcastle upon Tyne produced the most startling results. She and her colleagues studied 685 children in northern England who developed cancer before their 15th birthday and a control group of 3,442 healthy children. They found no link with vitamin K and all childhood cancers but they uncovered a raised risk for acute lymphoblastic leukemia, the most common childhood cancer. `It is not possible, on the basis of currently published evidence, to refute the suggestion that neonatal intramuscular vitamin K administration increases the risk of early childhood leukemia,'' she said.

Professor Jean Golding, of the University of Bristol in southwest England, first raised the alarm about the possible dangers of vitamin K in a 1992 study, but most subsequent research failed to support her evidence. Some doctors now suspect that if there is a link between the injection and leukemia it could be due to the high levels of the vitamin inserted into the blood. Others think it may be caused by another constituent in the injection, rather than the vitamin K itself. "Vitamin K injection was a relatively easy way of preventing a deficiency without any side effects. Now people are worried that there may be a cost attached in terms of cancer,'' said Draper.

Although there is no conclusive evidence, recent studies have raised enough doubt for doctors to recommend oral supplements of vitamin K except in the most serious cases of a deficiency. `Regular low dose oral supplementation can be effective, making it unnecessary to give a form of treatment over which doubt still lingers,'' said Parker. Acute lymphoblastic leukemia, characterized by an increased number of white corpuscles in the blood, accounts for about 85 percent of childhood leukemia. There is no cure but medical advances have pushed survival rates as high as 60 percent and remission rates have reached up to 90%.

1/28/98 BOSTON (AP), A new study challenges the long-held belief that multiple sclerosis damages nerves in the brain solely by stripping off their insulation. The research found that the disease actually severs nerve fibers in the brain causing irreversible damage that probably begins even before symptoms are noticed. The research raises the possibility that patients should begin treatment very early in the disease. "This paper changes our perception of the underlying nature of multiple sclerosis," said Dr. Richard Rudick of the Cleveland Clinic Foundation, a co-author of the study.

Experts long believed that MS did its damage almost exclusively by attacking myelin, the protecting covering on nerve fibers in the brain and spine. This was thought to interfere with the fibers' ability to transmit signals and led to the many different symptoms of MS. The new study shows that besides stripping off myelin, the disease frequently slices through the nerve fibers themselves, destroying their ability to carry messages. Rudick said the study is the first to actually visualize these severed cells through a microscope, although indirect hints of this have been building up for several years. For instance, magnetic resonance imaging (MRI) has shown that MS victims' brains actually shrink, suggesting loss of nerve cells.

Dr. Stephen Reingold of the National Multiple Sclerosis Society said the earlier clues had already led many experts to conclude that the disease damages and perhaps cuts nerve cells. While the latest finding is likely to be news to practicing physicians, Reingold said, "this will not be a surprise to scientists in the field." The study, directed by Dr. Bruce D. Trapp, was published in NEJM.

About 350,000 Americans have MS, and it most often begins when victims are in their 20's. Symptoms often include numbness, tingling, poor coordination, slurred speech and weakness. While the precise cause is unknown, experts know that inflammation, perhaps caused by a misguided attack on the body's imunse system, damages the nerves. Rudick said the research suggests that doctors may need to be more aggressive in treating MS with medicines such as interferon that may protect nerves from permanent destruction. However, Reingold cautioned that there is no proof that this early treatment actually slows the disease.

Are you ready to be glued together? Pay close attention to this story, as this is the wave of the future? More toxins, anyone??? (AP) 1/31/98, Gaithersburg, MD. Doctors may soon abandon stitches and staples in favor of painlessly gluing together many patients' wounds. Scientific advisers recommended that the FDA approve the nation's first surgical glue, Closure Medical Corp.'s DermaBond. A variation of the same chemical used in Super Glue, DermaBond takes far less time to apply than sutures, does not require a repeat visit to remove stitches, and, particularly important for children, does not hurt, doctors told the FDA meeting. "The addition of tissue adhesives should prove a rapid, painless alternative to sutures for one-third of patients treated in emergency rooms", said Dr. Judd Hollander of the University of Pennsylvania, who tested the glue.

"Cosmetically, it is better,'' added Dr. Dean Toriumi of the University of Illinois, Chicago, a plastic surgeon who showed photographs of nearly invisible scars on some of his test patients. The FDA panel unanimously recommended that the government approve DermaBond but advisers cautioned there is no proof DermaBond is better than sutures, just an alternative. The FDA is not bound by its advisers'. Raleigh, N.C.-based Closure tested 814 patients over age 1. Between 75 percent and 84 percent of the glued patients had healed within 10 days, while 89 percent to 96 percent of patients who were stitched, stapled or treated with surgical adhesive tape had healed that quickly. That is not a statistically significant difference, nor was overall final healing and scarring different at three months, leading the FDA advisers to conclude the glue was probably as good as standard care. There were slightly more infections in DermaBond patients, although not statistically significant. But the panel said doctors should be warned to thoroughly cleanse wounds, even those that do not appear contaminated, before sealing them with DermaBond. Surgical glues are sold in other countries and U.S. doctors often bring them back from trips abroad or mix some in private labs to use on their own patients. But the FDA has never approved a surgical glue for sale in this country and analysts predict DermaBond could quickly become a multimillion-dollar product.

DermaBond is modified so that it does not harm delicate tissue. Doctors squeeze the liquid vial until the glue saturates an applicator tip and then roll the glue over the wound, much like rolling a tube of lip gloss. Within 2 minutes, the glue sets, forming a see-through film that lasts five to 10 days. On a videotape, doctors were shown squeezing and pulling skin to demonstrate the glue film is flexible and the cut will not break open. The glue gradually wears off as new skin cells form beneath it. DermaBond is only for skin-deep cuts, not very deep wounds, the FDA panel warned. Doctors could try it on accidental cuts or for minimally invasive surgery. For larger wounds, doctors would still use small sutures beneath the skin surface and DermaBond then would hold the top layers of skin together for less scarring.

Toriumi, the plastic surgeon, uses that glue-suture combination in facial surgery. In his own study of 111 patients, those who got DermaBond had less swelling and inflammation and none of the suture scars that standard facial suturing can cause, he said. Total treatment time, including examining and cleansing a wound, took half as long with DermaBond, Hollander said. Add that to no more need for a stitch-removal visit and DermaBond should reduce medical costs, he said, although the company has not announced the glue's price. "It was very desirable to patients,'' Toriumi said.

CLEVELAND (AP): An Army review board ruled that it would be unethical to give soldiers heading to the Persian Gulf War an experimental vaccine without warning them the effects were unknown, The Plain Dealer reported. However, that ruling was overridden after the Department of Defense cited national security concerns, the newspaper said. The botulinum toxoid vaccine was given to 8,000 troops as protection against chemical and biological warfare. The soldiers were not told the vaccine, now being studied as a possible source for the variety of health problems known as "Gulf War syndrome," was unlicensed.

The mysterious ailment afflicts 80,000 veterans and civilians who were involved in the conflict. Some think the syndrome stems from a chemical or biological attack. Others link the illness to diseases in the Middle East or smoke from oil fires. A transcript of the ethics committee's meeting at the Army's biological defense research station in Maryland on Oct. 4, 1990, showed that Army physicians weren't confident the unlicensed vaccine would protect troops from an illness. The transcript obtained by the newspaper showed the committee learned that while limited testing in laboratory animals showed promise against the deadly botulism toxin, believed to be in Iraqi president Hussein's arsenal, researchers were uncertain whether it would work. The FDA requires that Americans be fully informed about an experimental drug before consenting to take it. But in 1994, the FDA agreed to let the Department of Defense use experimental drugs to protect against battlefield exposure without following all FDA rules, including informed consent. The Army review board decided the vaccine could be administered, but only if the troops were told in "an abbreviated oral informed consent statement." But the Defense Department opted not to tell the troops the vaccine was unlicensed.

The ethics committee's chairman, Col. Arthur Anderson, said there was no way to determine if the vaccine could protect soldiers. "It would seem morally wrong to gather prospective or retrospective data on the efficacy of unproven drugs in military volunteers facing exposure to biological or chemical weapons," Anderson said. Quoted from the Fayetteville (N.C.) Observer-Times.

Medical Journal Panned for Review: BOSTON: The New England Journal of Medicine allowed a chemical company official to write an unfavorable review of a book that claims chemicals in the environment are responsible for an epidemic of cancers. The journal, which has been drawing criticism since the review was published last month, apologized for not informing readers that the author was the medical director of W.R. Grace, a company that has been accused of polluting the environment. "We should have recognized that W.R. Grace has a conflict of interest, but unfortunately the person who handled it didn't recognize that," the journal's editor-in-chief, Dr. Jerome P. Kassirer, said in Saturday editions of The Boston Globe.

Kassirer said the journal, which has had similar problems in the past, would print a complete explanation of its gaffe within four weeks. "Our conflict-of-interest policy is pretty tight, the tightest in the business," he said. "It was a simple oversight." In 1989, an article in the journal downplayed the dangers of exposure to asbestos but did not inform its readers that the author had ties to the asbestos industry. After that, the journal changed its policy to refuse reviews or editorials whose authors were connected to firms with a financial interest in the topic. But last year, the journal ran an editorial claiming the benefits of diet drugs outweigh the risks. It failed to note that the authors were paid consultants for companies that made or marketed one of those drugs, Redux, recently pulled off the shelves due to safety woes.

"I think there's an infection at the New England Journal of Medicine that is badly in need of treatment," said Paul Brodeur, a journalist who has written about chemical pollution. (Could that infection be Dr. Angell???)

The author the book review, Dr. Jerry H. Berke, said he had signed a conflict-of-interest statement spelling out his affiliation with W.R. Grace. Berke said his first drafts of the review mentioned his connection to Grace, but that he decided "at the very last minute" to identify himself as independent. "The folks at Grace wanted to make certain that I was writing my own opinion," he said. "I wasn't trying to be cute or duplicitous or anything." In the book and upcoming movie "A Civil Action", Grace is blamed for polluting the drinking water in a Boston suburb, sickening several children. "It's laughable that Berke would think that he could write an objective review of the book given that he was an employee of W.R. Grace," Kassirer said. Quoted from The Associated Press. (??Can you believe someone like this? I have a few doubts!!)

Scientists Identify Tantalizing New Brian Messengers: Stanford: Researchers have discovered two chemical messengers in the brain that may lead to new insights into weight control. The messengers, or neurotransmitters, are described by scientists from Stanford University and four other institutions in the Jan. 6 Proceedings of the National Academy of Sciences. "The discovery of a new neurotransmitter is always significant but the location of these neurotransmitters in the brain makes this work particularly exciting," said senior research scientist Thomas Kilduff, a co-author on the research paper and director of molecular neurobiology at Stanford's Center for Sleep and Circadian Neurobiology. The two newly identified neurotransmitters, dubbed hypocretins, are made only in a brain region called the hypothalamus. This pea-sized structure, located deep in the brain, controls such basic functions as temperature regulation, fluid balance, hunger and feeding behavior.

The hypocretins are made by only a few groups of cells in the hypothalamus. In other studies, researchers have linked cells in this area to the control of food consumption. "If you show the pictures of where the hypocretins are to anyone in the field, they will think of energy balance and food intake," said Kilduff, who holds dual appointments in the departments of biological sciences and psychiatry at Stanford. The discovery of the hypocretins began with work by J. Gregor Sutcliffe, Luis de Lecea and their colleagues at the Scripps Research Institute in La Jolla, CA. Sutcliffe's group isolated a large number of genes whose products are made only in the hypothalamus. Intrigued that the product of the hypocretin gene is made in only a tiny portion of the hypothalamus, the Scripps researchers teamed up with Kilduff and others to study that gene further.

Nerve cells chemically chop the gene's protein product into two short segments, called peptides. The researchers focused one of these peptides, known as hypocretin 2. Hypocretin 1 and 2 are similar to each other, Kilduff said. They are also somewhat similar to the hormone secretin which controls the secretion of gastric acids in the stomach. Other peptides have been found to have roles in both the stomach and the brain, he noted. Kilduff and his colleagues found that hypocretin 2 meets three criteria necessary to be considered a neurotransmitter: It is made in nerve cells (neurons), it ends up in special compartments called vesicles that the neuron uses to store neurotransmitters, and, when added to neurons in culture, triggers them to send an electrical message. Hypocretins join a growing list of neurotransmitters, including a handful of small molecules and more than 50 peptides. Neurons release neurotransmitters in response to various signals. The neurotransmitters then latch on to a nearby neuron causing it to fire an electrical signal from one end of the cell to the other. Once the electrical signal reaches its destination, it can cause another round of neurotransmitter release and signal generation.

The hypocretins may have functions other than weight control, noted Kilduff, so their proposed role in obesity must be confirmed by further experiments. The scientists now plan to test the effects of supplying excess hypocretins or preventing hypocretin production in experiments with mice or rats. If it turns out that the hypocretins are involved in weight control, researchers will also want to know how the peptides fit in with the other proteins, such as leptin, that have demonstrated roles in weight control. With all the corporate and public interest in obesity-related pharmaceuticals, Kilduff believes there will be plenty of others vying to do this follow-up work. He and his colleagues first presented the newly published work in the form of adjacent posters at the Society for Neuroscience meeting in New Orleans in Oct.

Kilduff's work was supported by grants from the National Institute on Aging and the Army Research Office. Additional funding for the study came from the Air Force Office of Scientific Research, the Norwegian Research

Council, the Fyssen Foundation, and Digital Gene Technologies of La Jolla, CA.

SAN FRANCISCO 1/13/98 PR Newswire, Influence, Inc. announced it received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for its Triangle gelatin-sealed sling material designed for a least-invasive transvaginal procedure to treat female stress incontinence. Unlike conventional sling materials, the Triangle material is sealed with an absorbable bovine gelatin that is cross-linked to control the rate of its resorption in the body. Managing the rate of resorption may help to reduce inflammation in the patient during the healing process. The sling procedure is a method used to treat stress incontinence, which is the most common type of urinary incontinence in women. This disorder results in the involuntary loss of urine commonly caused when the bladder neck and urethra descend during exertion. The sling procedure, traditionally performed through an abdominal incision, supports the prolapsed muscles by securing a piece of material, such as the Triangle, beneath the bladder neck to return it back to its original position.

"The sling procedure is gaining acceptance as a primary method to treat stress incontinence; however, the abdominal surgical approach is very invasive and results in higher morbidity," said Peter Bick, M.D., president and chief executive officer of Influence, Inc. "Influence's transvaginal sling system, now complete with the Triangle sling material, allows the incontinence surgeon to perform an incisionless procedure, thereby reducing the risks associated with invasive surgery." Influence's Triangle gelatin-sealed sling is used in conjunction with the company's In-Tac(TM) bone anchor system and In-Fast(TM) bone screw system. Both systems incorporate the company's proprietary bone anchor insertion device to attach the Triangle sling material transvaginally and on an outpatient basis. The Triangle is inserted without abdominal incisions, thereby reducing the recovery period and need for lengthy hospitalization.

Influence Inc., of San Francisco, CA., designs and develops disease management systems of least-invasive medical devices that improve clinical outcomes and enhance patient quality of life. The company is initially

focused on providing an integrated family of implantable medical devices and incisionless diagnostic, therapeutic & surgical instruments for restoring urinary continence in men and women. SOURCE: Influence, Inc.

Huntingdon Valley, PA., (PR Newswire) Immunicon Corporation has developed a rapid and ultra-sensitive blood test for detection and monitoring of breast cancer. The blood test functions at the break-through detection level of 1 tumor cell in 20 million white blood cells. Oncologists collaborating with Immunicon Scientists believe it is the most significant discovery in cancer in the past 25 years. In studies on more than sixty breast cancer patients done with two major medical centers, the test was able to detect small numbers of tumor cells in the blood of women with very early stage breast tumors and greater numbers in those with advancing disease. In a 12 month study of selected patients, it was discovered that when disease worsened or when patients did not respond to treatment, the numbers of tumor cells in blood increased. When treatment was effective, tumor cell levels dropped. In several instances, tumor cells were found in women thought to be in complete remission. Subsequent, more in-depth clinical reexamination showed that these patients were, indeed, relapsing. Although the test will have to be validated on large numbers of patients and in well controlled studies, no test developed to date has the promise of the Immunicon test.

The cancer test works by isolating tumor cells directly from blood in a way that they can accurately be counted and analyzed by standard pathology procedures. This means that the test can be used in conjunction with biopsies or in some cases in place of them. The blood test will be positive when there are as few as 1,000 tumor cells in the entire circulation. In the event that breast tumor cells shed from very small tumors, the test may replace or augment mammography for screening. Unlike mammography, the blood test does not expose the patient to potentially dangerous radiation. The lack of radiation exposure and the extraordinary sensitivity of the Immunicon test could make it a primary means for breast cancer screening, particularly for women who are at high risk for cancer. Based on the test's sensitivity and the fact that it is a blood test which may detect many other cancers, Immunicon's cancer test is being referred to as a "whole body biopsy" by clinicians involved in the testing.

The cancer blood test was developed by a team led by Immunicon's Director of R&D and Chief Scientific Officer, Dr. Leon Terstappen. Dr. Terstappen is regarded as an international authority on cell analysis and flow cytometry technology. The test uses magnetic liquids and devices invented by the Company's founder and CEO, Dr. Paul Liberti. Immunicon, whose focus is cell diagnostics, will make its cancer blood test available to Clinical Researchers by June. The test is currently being evaluated on prostate cancer patients. Early results are very promising. The Company will continue to refine its Cancer Blood Test and determine its applicability to lung, colon, ovarian and pancreatic cancers and melanoma. In a parallel program, Immunicon is developing a fully automated instrument which can perform all of the relevant analytical tests for its cancer cell blood test. Immunicon is a privately held biotechnology firm that was founded out of Thomas Jefferson Univ. Med. School. Source: Immunicon Corporation.

2/26/98, Washington (AP): The FDA says doctors who prescribe the powerful acne drug Accutane should watch their patients carefully for signs of depression. Manufacturer Hoffman-La Roche argued that there is no proof cases of depression and a few suicides among Accutane patients reported to the FDA can be blamed on the drug. It said people with severe acne are at risk for depression anyway. But the FDA counted about a dozen patients who became depressed while taking Accutane, then found that their depression disappeared after they stopped the medication and recurred once they took it again. That was enough of a link to prompt the precautionary warning, FDA said. Roche wrote thousands of doctors Wednesday that it is relabeling Accutane to warn: "Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide." Patients should tell a doctor if they're feeling depressed, said FDA dermatologic drugs chief Dr. John Wilkin. And at every visit, doctors should "ask questions to the patient about changes in mood," he said. Roche officials refused to say how many depressed patients or suicides they know of but stressed that more than 4 million Americans have taken Accutane since it was approved in 1982 and the possible side effect is very rare. Roche also argued that teen-agers, prime acne sufferers, often suffer depression and hormones involved with acne also may contribute to depression.

FDA officials also would not say how many depression and suicide reports among Accutane patients it has received but called them "isolated." Wilkin emphasized that the estimated dozen patients whose depression occurred and then disappeared as they started and stopped Accutane were enough to suggest a link. Accutane, considered a significant help to people with severe nodular acne, already carried a stern warning that it is never to be used by women who are pregnant or may become pregnant because it can cause birth defects.

2/11/98, WASHINGTON (AP): Duract, a potent new painkiller on the market since August, could lead to potentially fatal liver damage for patients taking the drug longer than 10 days, according to the FDA. Duract began selling as a nonnarcotic alternative for the short-term pain relief needed after surgery and for other acute pain. But the FDA, in a stern warning Tuesday to doctors who prescribe the drug, said at least seven patients since then have suffered jaundice, severe hepatitis or even liver failure that required transplants. The FDA had approved the potent analgesic to be used for just 10 days but each injured patient had taken Duract for more than a month, manufacturer Wyeth-Ayerst Laboratories said in letters to 200,000 doctors Tuesday.

Duract is not intended for arthritis or other chronic pain that requires long-term medication. The agency warned doctors last summer that anyone prescribing Duract for longer than the FDA-approved time must watch for signs of liver toxicity. The health-care information company IMS America counts 1.3 million Duract prescriptions written since August. Wyeth-Ayerst contends the vast majority are for appropriate, short-term use. "When used as directed, Duract remains highly effective," said spokesman Doug Petkus.

2/2/98, LONDON (Reuters), Patricia Reaney British researchers said on Monday they had developed a new scanning technique that could lead to less surgery for women with breast cancer. Using special antibodies that attach themselves to cancerous cells and a tiny amount of radioactivity, it can determine whether malignant cells have reached the lymph nodes under the armpit and are more likely to spread to other parts of the body. Up until now the only sure way of knowing if nodes are malignant was to remove them in a painful operation and examine them in a laboratory. The new technique, developed by doctors from the Imperial Cancer Research Fund(ICRF) and St. Bartholomew's Hospital in London, will give doctors an indication if surgery to remove the nodes is necessary and will eliminate the need for an operation in women with no sign of cancer spread.

"If a node is positive it can be removed and looked at by pathology to double check if cancer is present. That way we can tell women in advance exactly how extensive their breast cancer operation is going to be,'' Keith Britton, head of the ICRF Nuclear Medicine Unit, told a news conference. Results of a pilot study of 29 breast cancer patients, published in the British Journal of Cancer, showed it was 90% correct in predicting cancer spread. The results need to be confirmed with other studies and the technique will be used in other clinical trials. But Britton said it would not be available to all breast cancer patients until it is licensed to a commercial company. "It is a phenomenon of the modern age that it has to go through a

commercial process in a capitalist society," he told the news conference. "The commercial market is very small because it is less viable on a commercial basis than a blood pressure tablet," he added.

The scanning method uses monoclonal antibodies (MAbs) designed by ICRF scientists that locate and stick to cancer cells. The MAbs are armed with a tiny amount of radioactivity and injected into the patient. "Pictures are taken twice over 24 hours using a gamma camera and a computer then compares the two images showing the probability of a tumour being there,'' Britton explained. He said other antibodies are already being used in the United States and Canada but the ICRF's is the latest generation. In addition to determining the need for surgery, Rob Carpenter, a surgeon at St. Bartholomew's, said the technique could also be an important prognostic tool. "Anything that removes an area of uncertainty is beneficial,'' he said. An estimated one in 12 (in the U.S., it is now one in 8) women will develop breast cancer sometime during their life. It is the most common form of cancer among women and mainly strikes those over the age of 60. Although the number of cases are still increasing, thanks to new screening methods, earlier detection, chemotherapy and hormone treatments following surgery, the number of people who die from the disease is decreasing.

BALTIMORE, January 7, 1998, Natural estrogens may offer some protection to premenopausal women threatened with severe brain damage during stroke, according to a study led by researchers at Johns Hopkins and the National Institutes of Health. Results of the study are published in the January issue of the journal Stroke. They show that in female rats, endogenous estrogens, those naturally produced by menstruating females, support blood flow to the brain during stroke and limit brain tissue damage.

"What we have is a possible explanation for the well-documented but poorly understood clinical observation that premenopausal women are at lower risk for stroke damage than men of the same age," says Patricia D. Hurn, Ph.D., senior author of the study and an associate professor of anesthesiology and critical care medicine at Hopkins. "It may also explain the steep rise in stroke incidence in women after menopause." The researchers created strokes in anesthetized male and female rats by blocking blood flow for two hours through the middle cerebral artery, a brain blood vessel commonly linked to cerebrovascular disease and stroke in humans. Female rats had higher percentages of cerebral blood flow during stroke than males and smaller amounts of damaged brain tissue afterward. When strokes were created in female rats whose ovaries had been surgically removed and who therefore had lower levels of natural estrogen, stroke damage was essentially the same as in males. This indicates that female sex steroids, most likely estrogen, protect the brain, according to Hurn.

"A growing body of evidence indicates that estrogen has multiple vascular effects, all of which could contribute to the salvage of brain tissue during episodes of inadequate blood flow," she says. Ongoing studies suggest that estrogen supplements would have similar effects, she says. The study's other authors were Nabil J. Alkayed, M.D., Ph.D.; Izumi Harukuni, M.D.; and Richard J. Traystman, Ph.D., of Hopkins; and Alane S. Kimes, Ph.D., and Edythe D. London, Ph.D., of the National Institute on Drug Abuse. The study was supported by three grants from the National Institutes of Health. (Johns Hopkins)

Psychological stress that often accompanies the diagnosis and treatment of breast cancer can have a negative impact on the immune system, according to a study in the Journal of the National Cancer Institute. According to the report, psychologic stress diminishes natural killer cell and T-cell activity which may place patients at increased risk of infection both during and after treatment. The study, led by Dr. Barbara L. Andersen of Ohio State University in Columbus, included 116 women who had recently undergone surgery for breast cancer. The women completed a "...validated questionnaire assessing the stress of being cancer patients," the investigators explain in their report. The investigators also measured natural killer cell and T-lymphocyte responses in blood samples taken from each patient and "...developed multiple regression models to test the contribution of psychologic stress predicting immune function."

A significant correlation between the level of psychologic stress and natural killer cell activity the greater the level of stress, the lower the natural killer cell activity. A high stress level was also associated with a diminished response of natural killer cells to cytokine proteins (recombinant interferon gamma), which aid immune system responses, the team reports. Andersen's team theorizes that reducing psychological stress through "psychologic/behavioral intervention" may boost the immune system and lead to improved outcomes. It's possible, Dr. Sheldon Cohen of Carnegie Mellon University in Pittsburgh, PA, & a colleague say in an accompanying editorial, but it remains to be seen. It's also unclear, they note, whether the diminished immune system responses associated with high stress levels will have a negative impact on progression or spread of the disease. The Ohio study "...provides an important piece of this fascinating puzzle, but the solution is still a ways off," Cohen says. SOURCE: Journal of the National Cancer Institute (1998;90:3-4, 30-36). (Reuters, NY).

Biomaterials 6/16/95 (9):681-4: Arciola CR; Cenni E; Caramazza R; Pizzoferrato A, Abstract: In an in vitro study, we have quantitatively evaluated the capability of seven different types of silicone to retain a Staphylococcus aureus strain, isolated from a surgical wound. All the silicone specimens were taken from prostheses already used in plastic or ophthalmological surgery. Two polymers were used as controls: polystyrene, because of its known capability to favour in vitro bacterial recovery, and nylon, for its bacterial repellence. The results show that all silicones are suitable substrata for Staphylococcus aureus. However, there are some differences among silicone types. The amounts of bacteria retained from silicone oils are greater than or equal to those obtained from the positive control material. Author's Address: Lab. for Biocompatibility Research on Implant Materials, Istituti Ortopedici Rizzoli, Bologna, Italy. Unique NLM Identifier: 96075731

January 12, 1998, WILMINGTON: Jack Nelson said his company's magnetic resonance imaging (MRI) system is a powerful weapon in detecting the early signs of breast cancer that can't be spotted by conventional mammography & ultrasound. It's not a far-fetched boast from the chief executive officer of Caprius Inc., the $3.5 million company launched six months ago by the merger of two companies specializing in breast cancer detection. Besides its ability to distinguish cancerous tissue, the system, called Aurora, has a head start on the competition: It's the only U.S. FDA approved breast scanning system to use MRI technology. Even more critical, doctors say, Aurora could have far-reaching potential in saving lives. One in eight women will develop breast cancer in her lifetime, according to the American Cancer Institute.

"It has picked up things we weren't aware of originally," said Dr. Norman Sadowsky, director of the Boston-based Faulkner Sagoff Breast Imaging and Diagnostic Centre, one of five medical centers across the country testing the new machine. "We hope it will detect cancer earlier and better and contribute to saving lives by finding earlier cancer. We'll continually improve this with our

feedback." Also in its favor is the system's relatively low cost, $600,000 versus $2 million for other MRI systems, and its small size, which enables it to be located within a breast imaging center. "If we're going to learn to use this equipment, it has to be done in conjunction with other imaging modalities, such as ultrasound and mammography and correlate it with biopsies," said Sadowsky.

At Faulkner, the only Massachusetts site to use Aurora, about 200 women at high risk will be screened starting in February. Once completed, Sadowsky said the center can embark on a national study of the MRI system. Aurora has the ability to detect tumors and abnormalities through dense breast tissue. It can also identify rupture or leakage of breast implants and the extent of tumors or lesions in breasts prior to surgery. That way surgeons can map out the routes to see if lumpectomy or mastectomy is necessary, said Sadowsky.

With 26 million mammography screenings a year, Nelson sees unlimited potential to reduce both health care costs and instances of breast cancer. Women typically undergo X-ray mammography, ultrasound and biopsy when unusual lumps are found in their breasts, a process that can cost thousands of dollars. The Aurora system used in conjunction with conventional mammography, could eliminate the need for costly, unnecessary biopsy procedures, said Nelson.

About 15 percent of mammograms are ambiguous because the images are blocked by dense tissue. An X-ray can't differentiate between a fibroid or other kinds of scar tissue. Aurora can. "Those are clarion calls for increased screening," said Nelson. "These are problems that conventional mammography can't address and there is a toxicity effect of mammography. We eliminate that toxicity."

Betty Dickson, who was diagnosed in May 1996 with breast cancer and underwent a lumpectomy, called the innovative MRI "another tool to use in addition to the mammogram." "You have to take advantage of any technology you can to show if you're in the beginning stages of cancer, not advanced," she said. According to Dickson, the Aurora system, which places a patient face-down on a stretcher and enters the machine feet first, does not have "the claustrophobic feeling you get from conventionall MRI. You can watch what they're doing." The patient is surrounded by special radio-frequency coils that examine the breast area without compression, as in the case of mammograms. There are no X-rays or radiation but a magnet that highlights hydrogen molecules in the body.

The six-month-old Caprius Inc., based in Wilmington, arose from the merger of the Boston-based Advanced NMR Systems Inc. and Advanced Mammography Systems Inc. It employs 65. Sales this past year totaled $3.5 million, much of it from related rehabilitation services in Springfield and Holyoke. General Electric Medical Systems invested $5.1 million in the system last August. Plans call for opening three more Aurora MRI centers over the next 90 days with 10 more to follow in 1998. The sites include Englewood Hospital in Englewood, N.J., Magee Hospital in Pittsburgh and the University of Arkansas for Medical Sciences at Little Rock, Ark. Nelson said the centers would either be company-owned or comprehensive breast imaging centers, including biopsy, ultrasound, X-ray as well as the Aurora MRI. "The market for opening up centers is there," said Nelson. "There are 50 to 100 cities that could provide sufficient flow for revenue stream and benefit flow. Right now it's an open field. The opportunities are rich." © 1998, Boston Business Journal

1/10/98, WASHINGTON (Reuters): Janssen Pharmaceutica and the U.S. FDA say they issued a warning to doctors about possible drug interactions with the antihistamine Hismanal. Taken at higher-than-recommended doses or with some drugs, Hismanal can cause irregular heart rhythms or severe allergic reaction, the FDA said in a statement. Janssen said it was changing the label on the drug. "Hismanal is associated with risks of death due to irregular heart rhythms when taken with certain other drugs and when used at higher than the recommended labeled dose," the FDA statement said.

Dr. Alan Solomon, University of Tennessee Medical Center professor of medicine and head of the Human Immunology and Cancer Program, has received a $1.5 million grant from the National Institutes of Health. Solomon will use the grant to fund the project "Proteins in Multiple Myeloma and Related Blood Diseases," the focus of which is learning more about human antibody structure and diversity through studies of antibody proteins associated with certain cancers of the blood and lymph glands, so that diagnosis and treatment of patients with multiple myeloma, lymphoma and other diseases can be improved.

Special attention is also being directed toward investigation of a disease process termed amyloidosis, a protein deposition disorder that affects organs throughout the body including the brain in patients with Alzheimer's disease. "I hope the information gained through basic and clinical research will

ultimately benefit patients by reducing their suffering and improving the outcomes of these dreaded diseases," Solomon said. Solomon is a medical oncologist and hematologist and is one of six American Cancer Society Clinical Research Professors of Clinical Medicine. The grant marks the 31st year NIH has supported Solomon's research. (Knoxville News-Sentinel Co.)

1/22/98 NY: Columbia-Presbyterian Medical Center: Ruth Flaherty 212/305-5587 Radiation treatment for breast cancer slightly raises a woman's long-term risk for esophageal cancer, according to a study conducted by epidemiologists at Columbia-Presbyterian Medical Center. The findings, published in the January 15 issue of the Annals of Internal Medicine, do not imply that patients should avoid lumpectomy and radiation, the standard therapy for early-stage breast cancer. Rather, physicians should be especially alert to symptoms suggestive of esophageal cancer in patients who have received radiation treatment, says the principal investigator, Habibul Ahsan, MD, Assistant Professor of Clinical Public Health at the Columbia School of Public Health at Columbia-Presbyterian. This is particularly important for patients who smoke cigarettes or drink alcohol, the two major risk factors for esophageal cancer.

The study was conducted by examining the records of more than 220,000 breast cancer patients diagnosed between 1973 and 1993. The group included both patients who received radiation therapy and those who did not. Ten or more years after diagnosis, irradiated patients were roughly four to five times more likely to develop esophageal cancer than nonirradiated patients or women in the general population, according to Dr. Ahsan and his co-investigator, Alfred Neugut, MD, PhD, Associate Professor of Clinical Medicine and Public Health at Columbia-Presbyterian. This is the first study to link radiation therapy for breast cancer with an increased risk for esophageal cancer.

In an earlier study, the researchers demonstrated that breast-cancer irradiation raises one's risk for lung cancer. The risk was substantially higher among patients who smoked. The same pattern may hold true with esophageal cancer, says Dr. Neugut. "In the lung cancer study, the effect of smoking turned out to be multiplicative. That is, you ended up with 40 times the risk if you were both a smoker and had radiation therapy. With esophageal cancer, the combined effect of irradiation and smoking may turn out to be even more dramatic. We don't know that yet. We're just starting a study that will give us some answers in a couple of years." The researchers also plan to analyze the effect of radiation dosage, alcohol consumption, and body mass index on the incidence of esophageal cancer. "Because survival among women with breast cancer is gradually increasing, we believe that clinicians should be aware of the possibility of a second cancer in the esophagus should suspicious symptoms arise among long-term survivors, particularly those who received radiation therapy in the past and who smoke cigarettes or drink alcohol," conclude Drs. Ahsan and Neugut in their paper. The primary symptoms of esophageal cancer are difficulty swallowing and pain with swallowing. "The actual absolute risk for esophageal cancer, even among irradiated women, is still trivial," adds Dr. Neugut, putting the study in perspective. "Esophageal cancer occurs in about one out of every 2,000 women with breast cancer so we certainly don't want to imply that women shouldn't get radiation therapy. Radiation therapy improves survival after breast cancer and that should be the first consideration."

Loretta Lynn is refuting a Globe story that says she had cosmetic breast surgery. The country music singer went into the hospital in January for medical reasons, not for a "boob job" as the tabloid says. Lynn said Tuesday that doctors removed a ruptured breast implant she received 25 years ago after the removal of multiple breast tumors. It had leaked silicone into her chest cavity. She didn't need a "sexy" new shape. "I've always had a pretty darn perky figure," retorted Lynn, 62. Editor Tony Frost said the Globe stands by its story. (No comment!!)

ALTERNATIVE MEDICINE: A safer alternative to Premarin is Triest. You can get Triest at College Pharmacy in Colorado Springs, Colorado and possibly at your local pharmacy. It is totally organic and safe (i.e., nonchemical). (800) 888-9358.

Green Tea, which contains a major polyphenol, Induces Apoptosis (Cell Cycle Arrest): Scientists at Case Western Reserve University have found biologic support for the anticancer effects of green tea. "The polyphenolic compounds present in green tea show cancer chemopreventive effects in many animal tumor models," Dr. Hasan Mukhtar and colleagues in Cleveland, Ohio, report. They investigated the effects of the major polyphenolic constituent of green tea, epigallocatechin-3-gallate, "on the induction of apoptosis...and regulation of cell cycle in human and mouse carcinoma cells."

Treatment with the compound induced apoptosis in human epidermoid carcinoma cells, human carcinoma keratinocytes, human prostate carcinoma cells and mouse lymphoma cells, whereas the compound had no effect on normal human epidermal keratinocytes. In at least one of these cell lines, treatment with the catechin resulted in arrest of the cell cycle at the G0-G1 stage. Other green tea polyphenols were able to induce apoptosis in human epidermoid carcinoma cells, but not in the other cell lines examined. Dr. Mukhtar and colleagues explain that epigallocatechin-3-gallate is considered to have stronger effects than other green tea polyphenols because it possesses two triphenolic groups. Though the precise mechanisms underlying the effects of epigallocatechin-3-gallate are unclear at this time, the authors "...speculate that cyclin kinase inhibitor(s), cyclin dependent kinase(s) and their regulatory cyclin(s) proteins operating in G1 phase of the cell cycle may be involved." But even in the absence of a clear understanding of how epigallocatechin-3-gallate works, the Ohio team suggests that the current scientific and epidemiologic evidence support the examination of the compound in clinical trials "...in a population with high cancer risk." J. Natl Cancer Inst 1997;89:1881-1886.

Avoid Pessimism, Be Happy: NY (Reuters): While the ``power of positive thinking'' is encouraged as a way to improve health and well being, new research shows that it may be more important to avoid negative thinking. Researchers at Ohio State University in Columbus studied 224 middle-aged and older adults, half of whom were caregivers for a relative with Alzheimer's disease. At one-year intervals for three years, participants reported their degree of optimism and pessimism, negative life events, depression, stress, anxiety and other issues.

The researchers found that optimism and pessimism, previously thought to be linked, are actually independent factors that individually influence stressed & nonstressed people. And one factor is more foretelling than the other. "Of greatest interest, we found that pessimism, not optimism, was a prospective predictor of psychological and physical health outcomes a year later," write Susan Robinson-Whelen and colleagues in Journal of Personality & Social Psychology. Specifically, pessimism predicted anxiety, perceived stress and self- rated health for the next year while optimism did not predict anything. The researchers explain that negative life events may not impact caregivers as much as noncaregivers because caregivers' outlook for the future is already influenced by the stress of caring for an ill family member. Previous research has shown that optimism may affect people's success in alcohol treatment programs, with recovery from coronary artery bypass surgery and breast cancer surgery and in other health-related concerns. This new study, the authors conclude, emphasizes the need to also consider how pessimism affects such outcomes. Source: J of Personality & Social Psy. (1997;73:1345-1353).

PERSONAL COMMUNICATION: HOW TO DETOX YOUR BODY WITHOUT DOCTORS AND HUGE EXPENSES. The first thing to do in a detox is not take drugs. The second thing to do is to drink at least two quarts of good, purified water a day. The third is to avoid all pesticides, chemicals, food additives, etc. Fourth, all caffeine, alcohol, tobacco, sugars, white starches, etc. also have to go. Fifth, eat organic, healthy food, whole grains, free range meat (chicken, turkey, beef) and eggs. Eat deep ocean fish 2-3 times a week. Sixth, take good organic holistic nutrients. Seventh, if you need to, find a good Naturopathic Doctor and ask about a good detox program. Eighth, stick to this, even if you get a little worse at first because when the toxins come out, you may feel worse for a while. Ninth, you may need to gear a specific program to your own needs, but this is the basic one. I can give some recommendations for good nutrients to you if you would like. See our web page for some information on nutrition and how I helped heal by detoxing & good nutrition. Health web site is located: http://www2.privatei.com/~coss/dar2care/home.htm

This newsletter is a little late because I was hit with stomach flu (like a ton of bricks). I am better (after one week), but now have a sore throat and swollen glands (one side only) and still am running a fever. I promise to be better before the next newsletter is due.

IMPORTANT: MENTOR: In early November, 1992, Tobias Meeker, Director of Ethics Program of St. John's Hospital in Springfield, Missouri, sent an 8 page FAX to the ASPRS. The documents included an internal St. John's memo and a letter to David Kessler of the FDA concerning some serious reservations concerning the protocols of the Phase II Mentor study of silicone gel implants allowed by the FDA.

"The protocol did not appear to be a 'research study' in any familiar sense of that term. ... inclusion criteria are very subjective and general. The consent form omitted a good deal of information that we believed should be revealed. In one section we found an outright error (when compared to information given in the protocol itself)."

Tobias Meeker contacted a doctor at the FDA for clarification, and was told " ... breast implants were grandfathered in. That means they were 'unapproved but legally marketed. ... 'It is an administrative device to continue to make these devices widely available to those who have such need that the lack of established safety can be overlooked if there is a good informed consent process and the oversight of an IRC.'" An IRC is an Institutional Review Committee. St. John's quotes Joyce Denny, adjunct study coordinator at Mentor who said "that the consent form had been 'negotiated' between Mentor and the FDA and could not be changed." St. John's ethics review indicated that "This makes these devices widely available on the one hand and, on the other hand, calls into question the validity of data that will be collected. Many will share the subcommittee's concern that the very subjective determination of 'medical need' opens the door for conflict of interest by researchers and that it is irresponsible to widely disseminate these untested devices. St. John's will appear irresponsible if the IRC reviews and approves this protocol. Our IRC met 9/25. One of the surgeons who hopes to do these procedures met with us. The discussion was lively. The surgeon gave his understanding that this protocol was designed 'to give the illusion of a study' so that these devices could remain on the market. We unanimously agreed that this protocol does not meet criteria that we normally expect of a clinical study." In the letter to David Kessler from Meeker it was stated, "We realize that many plastic surgeons have firm convictions that the silicone poses no health risk. We respect their convictions, but point out that wrong convictions do not constitute scientific evidence." (Do you think the FDA is catching on to the fact that this study is a fraud??)

Note that the Mentor Study to be released soon will have Garry Brody as one of its key contributors, as he is now a consultant for Mentor, the only remaining breast implant manufacturer. In a letter dated November 12, 1992, to the Journal of the American Medical Association, Brody says of women with breast implants, "The real cause of delayed detection of breast cancer in the augmented patient appears to be the same four horsemen of the apocalypse that are responsible for delay in all women, i.e., denial, neglect, complacency and ignorance."

The following documents were used in preparing this article: ASP034217-34227, ASP034214-34216 and a copy of the Wash. Edition of the Los Angeles Times 06/26/97. Ronald C. Cole, 6931 Foxvalley Lane, Humble, Texas 77338-1313.

THIS MONTH'S POEM:

A Reluctant Recluse

by Saundra Sharp

I've been a reluctant recluse

But allow me to make it clear

No hermit by choice, but condition

'House bound' by illness for years.

There's no escaping my dwelling

That keeps me confined within

A prison, perhaps, or a shelter

Truth is, that both it's been.

No knack have I for pretending

Or reason to make believe

That seclusion is any way normal

Or the life I'm forced to lead.

This existence so foreign my nature

Puts patience and courage to test

This battle at length I've wagered

Has proven a draw at best.

Disappointment and setbacks encountered

Have pushed me close to the edge

With every emotional letdown

I'm weaker when forging ahead.

Shut off from other people

Is bizarre as one would think

With limited human contact

Your psyche's thrown out of sync.

Isolation with little diversion

To distract the eye or mind

Leaves time for inner reflection

For thought of the spiritual kind.

I sit in austere surroundings

Jotting verse on how I live

However peculiar my lifestyle

I believe it has lessons to give.

The world outside that awaits me

I view with a closer stare

Beyond its frills and outer veneer

To the really important there.

I pray that whatever my losses

I never lose sight of myself

One day, when well, this former recluse

Will offer to others her help.

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

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