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
April 1999
Dear Silicone Survivors and Friends:
Thanks to all of you that have called and written about my health. I am doing fine. I still have elevated tumor markers, but am just plugging along on a daily basis.
I will be moving this Summer. I will continue the newsletter from my new location. The Post Office Box will remain the same. However, the articles that I have carried and the books I have carried will no longer be available. I will continue the website.
UPCOMING EVENTS: Meetings are being held all over the US to help women answer questions about the Dow Bankruptcy. Last month's newsletter contained a notice about most of these meetings. Since one was not scheduled for anywhere near Denver, I e-mailed the people who did the scheduling. Consequently, one was added in Denver for April 7th. All Dow or Dow material claimants close to Denver should have received a notice of this new meeting.
LEGAL INFORMATION: My name is Sybil Goldrich and for those who do not know me, I am an implant claimant. I am also a member of the Tort Claimants Committee and have been active in breast implant awareness and this litigation for the past 15 years. I've come to know many of you over the years in our fight against the implant industry. As someone who was injured by both breast implants and the industry which has targeted me for punishment because of my role as a consumer support leader, I share the frustration, anger, and scars, both physical and emotional, that you have and I can never forgive the implant manufacturers for their cavalier attitude towards us over the years. As a member of the TCC since 1995, I was asked to serve along with Tommy Jacks and Ralph Knowles as negotiators for the TCC to try and reach a settlement on behalf of the women and other implant victims. We began our efforts almost three years ago, first attempting to reach a resolution with all of the other creditors (primarily commercial claimants) of Dow Corning to see if we could stand united and fell Goliath in Goliath's own back yard. It took years of negotiating and litigating before we were able to reach a deal with the other creditors. But when we presented our settlement to the bankruptcy judge, we were turned away. We were told by the bankruptcy judge that Dow Corning as the debtor was entitled to write its own plan of reorganization and that we, as creditors, had to wait on the sidelines for Dow Corning to do what it wanted.
What Dow Corning wanted was a plan in which it paid virtually no money to the women, imposed difficult burdens of proof of the injuries from breast implants (example: requiring a dangerous and painful salivary gland biopsy, at plaintiff's expense to prove auto-immune disease). Their plan then trickled the money into a fund over 20 years that they managed and controlled and which we had no rights, no voice, and no ability to change. We, as negotiators (with our bankruptcy attorneys) worked hard to find a solution to give the women a voice in how we would be treated. Our voice was only heard because the district court was persuaded to appoint a mediator to try and bring the parties together. Before the mediator was appointed, Dow Corning wouldn't even talk to us.
We began our meetings with Dow Corning over a year and a half ago. I have attended each and every negotiating meeting from the beginning of Dow Corning's bankruptcy and my work continues even now. The meetings were, and continue to be, bitter and acrimonious and full of hostility, mistrust, and anger. There were many times when we believed the meetings would go nowhere because we were so far apart in our demands. But it was our sincere desire to give the women a voice in the bankruptcy court, and not allow the Dow Corning-only plan to go out for a vote, which sustained us and kept us going when all looked hopeless.
The Plan that resulted is not perfect. No one on the TCC claims that. There are things we wished we could have gotten, but there are many, many more that we are proud to have won in the negotiations. As negotiators, we never gave up any point without getting something important in return. I assure you that the battle for the Plan as it is now written was hard fought. There was not a single settlement item that was not disputed, argued and reargued. Acrimonious meeting followed acrimonious meeting. Even when there was a final term sheet written, a magistrate had to be called in to mediate the outstanding issues that arose during the drafting of the documents. Writing a simple declarative sentence often took days and days.
You now have before you the final joint resolution which is the result of four years of hard battle with Dow Corning. It is a settlement. And the word settlement includes compromise in its definition. A settlement means that nobody can claim to be "the winner." I support the Plan, flaws and all, and urge you to vote YES in support of the Plan for the following reasons:
1. I am convinced that there will never be a better offer than this one. Should this Plan fail, we will enter another five to ten years of legal debate and argument that might yield a Plan with even less than we have been able to obtain in a settlement. Dow Corning, and Dow Corning alone, has the sole right under the bankruptcy rules to write another Plan -- without our input. Bankruptcy always favors the debtor and considers their needs first which means that Dow Corning has had the edge in bankruptcy proceedings. That is exactly one of the reasons that they declared bankruptcy. Unless this bankruptcy is settled no other opt out cases will be brought to conclusion because they await the resolution of the bankruptcy. (While I have no proof and I make this statement as conjecture, I believe that all of the manufacturers conspired to have Dow Corning declare bankruptcy so that it would effectively stay all of the opt-out litigation in the country to allow all manufacturers time to manufacture more bogus manufacturer paid-for science.)
2. Truly needy people will have to wait even longer for explantation and rupture monies. We all know that those funds are considered an emergency for many.
3. Voting "no" will not change any manufacturer's minds about what happened. They will continue to fight because it is what they do to save face. They will never tell you that you are right about their products. We must all learn to be content with knowing it ourselves. And you can choose to believe as I do that they know they were wrong but that their capriciousness demands that they fight us all the way. Believe me, they know what they did. The more self-righteous they behave, the more I am convinced that they know what they did.
4. Voting "no" will only make all of the many
bankruptcy lawyers very rich. The bills that have been paid to lawyers in this case have been only to lawyers who specialize in bankruptcy. Their experts have been paid as well. We need not make this painful process any more lucrative for others than it has already been.
5. Settling now will not make us stop the fight to get good science to prove our point. We will never have to stop the fight for medical consumer rights. We will never have to stop helping each other in the ways we who share the same problems know best.
We all need closure so that we can heal our bodies at the same time as we each continue our work to insure that the manufacturing community, the FDA, the courts and our Congress do not make it easy to put faulty products on the market without serious consequence. Make no mistake about it; manufacturers are not happy to be exposed in the way this issue has made them. Because of your pain and your courage to demand restitution they have been in a spotlight they did not want. This settlement is far more than money. Despite what many think, we have taken a great deal of money from the Dows'- far more than they would have given to the RSP and far more than they ever imagined they would have to give. And we all know that there will never be enough money to compensate us for our injuries. There will never be any apologies. And given those facts, we must move on and remain active so that another generation of people is not harmed. A "yes" vote will give us closure. And your anger (and mine) can then be directed to positive, constructive support of policies that are more protective of human beings and require accountability for manufacturing misdeeds. Sybil Goldrich, Command Trust Network. (I totally agree with Sybil. However, some group leaders do not and some attorneys do not. Some attorneys do agree. It will be debated until it is settled, just as the MDL was (and I fought that all the way, and see where it got us). We can fight and fight, but those of us who have been around since 1990 and before can surely see the handwriting on the wall. This is the best it will get. I therefore, reluctantly, support it and hope many others, and I, can use this to get on with our lives.
3M did not purchase materials from Dow Corning except in isolated incidents. For example, they had a problem with low gel supplies in the late 1970s and purchased a drum or two from Dow Corning. There was no consistent pattern to purchasing anything from Dow Corning as with CUI or Baxter or Mentor for example. For 3M claimants to qualify they would have to be able to establish that their lot history records support Dow Corning as the supplier of their silicone gel. This is a difficult and time consuming process and would only yield a handful of claimants who would be eligible.
Regardless of whether you feel you have no problems with your implants, as a precaution, you should register before the cutoff date with any Class Actions you might be eligible for; below is a list of them and who to contact. This includes those with other silicone implants such as chin, cheek, etc. Read on! The vast majority should register for the Dow Corning Bankruptcy Settlement if you did not do so by 1-15-97 (your implants were probably filled with Dow Corning gel and you could be eligible for $4,000 to $120,000 eventually from them as a result, see below for more info). Just having registered for MDL or the Global/Revised Settlement is not sufficient; you must also register for the Dow Corning Settlement! If you did register or your attorney handled it, you would have received a postcard confirming the date your Dow Corning registration/claim form was received from Daticon Systems, Inc., Dow Corning's docketing agent, in March, 1997 and should periodically be receiving information or filings on it from the bankruptcy court. That is providing you have not moved with the forwarding address expired, with the last being received about two months ago with the return address being P. O. Box 6200, Midland, MI 48641-6200), you have a window of 90 days after the effective date to do so.
Change of address or name: Claims Administration Facility, Dow Corning, Box 7500, Midland, MI 48641-7500. Be sure to include your Social Security number and claim number you will find on the postcard from Daticon Systems confirming you are registered per above, if you can find it. Do not trust your attorney to handle a change of address with Dow Corning or any class action. Do it yourself by certified mail with a return receipt.
The effective date of the Dow Corning Settlement will not be until the Judge rules on the disclosure statement. I think that what was going on at the bankruptcy court this last week. It could be any time, so for all practical purposes, assume you have 90 days to register. Many who have tried to register have not done so correctly I hear by not sending by certified mail to the 5 parties listed at the end of the Notice of Intent a copy of it. Be sure to have a return receipt so you can prove you did so to all five. There are 700,000 of which 176,000 are breast implant claims registered for the bankruptcy. They could misfile your paperwork so be able to prove each and everything you send!
Did you have a chin, cheek or other silicone implant potentially made by Dow Corning? If you registered, did your claim form have the appropriate box checked for it? If not, it might cost you $2,500 or more. Or, it might also, if you do not register during this 90-day window if you have not already done so. The Notice of Intent will be included with the kit you can receive to register for the Dow Corning Settlement by calling 1-800-960-6784. If you ever had a Dow Corning implant or still have been unable to obtain proof of manufacturer for your present set if not explanted or previous ones, you need to register and get busy finding the proof (orally is not sufficient; you must have written acceptable proof). For a post on how to obtain proof of manufacturer, contact me. Do not give up until you read it first! If you have been or are being explanted and do not have acceptable proof of manufacturer, it is imperative that your implants be saved. If you still have not been explanted, contact the pathologist who will be doing the report ahead of time to save them! Not the Plastic Surgeon. That a lot of times does not work. Remember, after your explantation, the pathologist is the one who has your implants; not your Plastic Surgeon. Also, if you are having Dow Corning implants explanted, the rupture bonus is up to $25,000.00.
Most PATHOLOGISTS do not examine the implants carefully for a small or pinhole opening if no gross rupture is apparent (I think they glance at them for the most part. Any opening in the elastomer shell is legally defined as a rupture even if a pinhole.
Class action Dow Corning-For kit to register: 1-800-960-6784.
Class action silicone injections: Contact Karen: kpowers@thetahoe.net or Barbara and Dan: UBCDan@aol.com.
POREX: Kate: Marielee3@aol.com
Class action Mentor Saline Leaf Valve implanted after 1/1/94: Miles Gersh, Attorney, 1-303-863-1115
Class action Baxter (Heyer Schulte to 3-31-84; after that Mentor), Bristol Meyers (Surgitek), 3M to 8-2-84; after that McGhan and Mentor: Legal Assistance: Office (speak to an attorney; not a clerk!): 1-513-665-9770 (M-F, 10:00 AM to 6:00 PM Eastern Time). Or, for a kit to register as a Late Registrant, I suggest as the Claims Office told me in late December, 1998 it looked like they had money left over to pay many Late Registrants who had their claim in during 1998, Claims Office: 1-800-600-0311.
Class action McGhan/Cox Uphoff (CUI): 1-513-665-9770 (see above also) or Beth West:
bethw@wizzards.net
If you do not have a computer or are not on the Internet, go to your public library and ask for assistance to contact the above resources.
Attorneys: Dianna Pendleton: DPEND440@aol.com Jill Whitbeck (Nevada; maybe taking ladies who have or have had Dow Corning implants who are legal residents of Nevada!): JKWhitbeck@aol.com
Skip Burrell (Florida: taking ladies as clients who are legal residents of Florida who have or had Dow Corning implants.
There is a lot of misinformation being communicated that I want to clear up. First, the settlement documents do NOT say that non-Dow Corning women will be entitled to 40% of the amount given to Dow Corning recipients. The document says that certain women, implanted after 1/1/76 and before 1/1/92 who have silicone gel breast implants made by either Baxter, Bristol, Bioplasty, Mentor or Cox-Uphoff, and who meet the other eligibility requirements, MAY be eligible to apply for either; 1) Up to 40% of the disease compensation offered to Dow Corning claimants (it may turn out to be less than 40% depending on the number of claims). Or, 2) an expedited release payment which releases a claimant's right to recover for disease benefits. The number of eligible claimants determines the amount of the expedited release payment.
There is also a requirement that claimants "marshal" their recoveries from the manufacturers of their breast implants. This means that if they have a Baxter implant for example, then they would first have to recover all available compensation from Baxter before recovering from Dow Corning. There is also a dollar-for-dollar reduction applied. This means that if a claimant recovered $10,000 from Baxter, her recovery under the Silicone Material Claimant Fund would be reduced by $10,000. By Dianna Pendleton (Diana is one of the plaintiffs' attorneys who drafted the settlement documents).
Santa Barbara, CA: (Business Wire): 2/2/99 INAMED Corp. announced that federal Judge Sam C. Pointer Jr. has signed and entered a final order and judgment approving a "limited fund" mandatory class action settlement of virtually all of the breast implant litigation against the company. The final order certifies a mandatory settlement class of plaintiffs including all women, both domestic and foreign, who received breast implant products prior to June 1, 1993, which were manufactured by the company's McGhan Medical and CUI Corp. subsidiaries. The order approves the settlement of the thousands of cases and claims by that class of plaintiffs in exchange for the payment of $32 million in cash, which will be allocated and distributed to class members in future proceedings to be supervised by the court. Individual plaintiffs included within the mandatory class cannot opt out of the settlement. The final order also includes a permanent injunction prohibiting class members from commencing or prosecuting federal or state court lawsuits for claims covered by the class action settlement and a bar against lawsuits by certain persons and entities with indemnification and contribution claims.
The final order also approves the company's amended settlement of a significant contractual indemnity claim by 3M Corp. against the company's McGhan Medical subsidiary. That claim arose from the 1984 acquisition of 3M Corp.'s plastic surgery business. In the amended settlement just reached, 3M Corp. has consented to waive the condition for the release of its indemnity claim which was part of an original April 1998 agreement, in exchange for a payment of $3 million, which will be made shortly, and the company's assumption of contingent liability for a prescribed portion of 3M Corp.'s costs associated with claims involving medical prostheses manufactured by the company after the 1984 acquisition. The amended settlement with 3M Corp. will not have a material financial impact on the company.
If the period for filing appeals of the court's final order and judgment passes with no appeals being filed, then by early June 1999, INAMED Corp. will be required to fund the $25.5 million subordinated note for the benefit of the plaintiff class which was deposited into a court-supervised escrow account in October 1998. At the same time the company will be obligated to pay $3 million for the approximately 426,000 shares of common stock also included in that escrow account; however, as announced in April 1998, the company has assigned that obligation to its senior debt holders. If an appeal were filed, all of those funding obligations would be deferred pending completion of the appellate proceedings.
The company is considering the most effective alternative for financing its obligations under the settlement agreement, including through the exercise of various warrants, which were previously issued for this purpose and/or new bridge or permanent debt financing. Appaloosa Management LP, which is the largest holder of the company's senior debt, has recently confirmed its intention to fund the litigation settlement. It is possible that in order to obtain the financing to fund the litigation settlement the company would adjust the exercise price of certain warrants or issue new equity-related securities, which could be dilutive to current shareholders and other holders of warrants. (It should be noted that all Cox-Uphoff (CUI) recipients should register for the Dow Corning Bankruptcy settlement.)
MEDICAL INFORMATION: BMJ 1998;317:1402-1403 (21 November), Editorials: Prophylactic mastectomy: deliverance or delusion? We don't know, so we need to start registering all cases now. To prophesy the future we no longer need to examine the entrails of sacrificial animals. Mutant genes predisposing affected individuals to life threatening conditions such as vascular disease and malignancy have been identified. Although the multi-factorial and environmental wild cards remain, the genetic card deck is gradually being laid face up on the table. But without effective interventions, knowledge of genetic risk may serve only to fuel anxiety and encourage the adoption of denial behavior. Germ line genetic mutations are responsible for only 5-10% of cases of breast cancer, but worried individuals form a disproportionately large part of the clinical workload. Almost half the cases of familial breast cancer and 75% of those with both ovarian and mammary malignancy are due to BRCA1 mutations, located on chromosome 17q21. The 185delAG mutation is present in 1% of Ashkenazi Jewish women and in 21% of those developing breast cancer before the age of 40. The other major breast cancer susceptibility gene is BRCA2, located on chromosome 13q12-q13, encoding a 3418 amino acid protein of, at present, unknown function. The lifetime risk of cancer in women carrying a BRCA1 pathogenic mutation, previously estimated at 90%, has been revised down to 56%.
Breast surgeons will nevertheless be faced with an increasing number of well-informed young women with pathological mutations. These consultations are as difficult for the doctor as for the patient since no proven preventive approaches exist. Though options such as tamoxifen will probably reduce the incidence, none will obliterate the risk. Intensive surveillance is an option but without proof of benefit.
Many women will want to resort to the more desperate measure of bilateral prophylactic mastectomy, believing that this will save their lives. For some this may prove to be a vain hope. Prophylactic mastectomy was performed on a large number of women in the United States for a range of ill-defined indications. The Subcutaneous Mastectomy Data Evaluation Center collected information from 1500 treated women with varying indications for surgery and reported that 6% had unsuspected ductal carcinoma in situ, or invasive disease. Hartmann et al carried out a retrospective cohort analysis of 950 women who underwent prophylactic mastectomy at the Mayo Clinic in 1980-93. The Gail model predicted 76 cancers during the mean 17 years of follow up whereas the actual number was 7. The original "high risk group" was not well characterized so that the risk of breast cancer may have been overestimated. In the absence of any evidence of benefit, it is now assumed that this same operation will be the answer to the genetically endangered maiden's prayer.
In the Sprague-Dawley rat/DMBA model system removal of ostensibly 100% of the mammary tissue had no effect on subsequent development of neoplasms.11 Breast cancers evolved in all animals, possibly because of the difficulty in removing all subcutaneous mammary tissue. While it could be argued that the diffuse nature of rat breasts makes this a poor model, such problems may also occur in humans with sanctuaries from surgery located in the inferior aspect and the axillary tail. Unless action is taken, another 10 years will see us in the same state of ignorance. While a randomized trial could compare subcutaneous and total mastectomy, in reality the current prejudices of both patients and doctors would probably inhibit accrual. Only a legally binding system of registering all women who have undergone any kind of prophylactic mastectomy could help determine the relative efficacy of the procedure in high-risk individuals. At present no mechanism exists since these individuals do not have cancer and therefore are not reported to cancer registries and only some will have undergone counseling and testing in specialist cancer genetics units. Moreover, the present patchy nature of the links between NHS clinical genetics and breast surgery units, with inequalities of service provision and waiting lists, means that many women are driven into the private sector.
Breast and plastic surgeons may not be depended on to report their cases as, even under optimal circumstances, they are likely to misremember. Pathologists, who have shown their ability to report cancer cases to registries accurately, constitute a more reliable source. Were all cases of prophylactic mastectomy to be reported to a central registry linked to cancer registries, individuals subsequently diagnosed with breast cancer could be identified. The price of inactivity will be high. Prophylactic mastectomy will be otherwise a lottery like procedure in which there will be no winners. Ian S Fentiman, Professor of surgical oncology. Guy's Hospital, London SE1 9RT
The New England Journal of Medicine: 1/14/99: Volume 340, Number 2, Sounding Board: Putting the Risk of Breast Cancer in Perspective: Educating the public about the risk of breast cancer promises to contribute to the prevention or early detection of the disease. Data on the risk of breast cancer are widely available to physicians and the public. However, for this information to be interpretable, it should be presented in a form that enables the risk to be understood in context. This is rarely the case, because of the difficulties involved in conveying such inherently complex information to a population and to individual women.
Several studies have shown that women tend to overestimate their risk of breast cancer and that many fail to understand the importance of age as a risk factor. The familiar "one in nine" statistic, much quoted in both the medical literature and the media, refers to the cumulative lifetime risk of breast cancer for a woman who lives past the age of 85. However, there is a common misconception that the yearly risk of breast cancer remains relatively constant with age, leading many younger women to view this statistic as a short-term probability & grossly overestimate their risk of breast cancer in a 10-year period.
Breast cancer is the most common cancer among North American women and the incidence of breast cancer has been rising for some years. This increase can be attributed in part to an aging population, because increasing age is one of the strongest risk factors for breast cancer. Age-adjusted incidence rates have also increased, although some of this increase can be accounted for by earlier diagnosis as a result of the introduction of screening mammography (lead-time bias). This source of bias is evidenced by the recent leveling off in the incidence of breast cancer in the United States, which would be expected once the use of screening in the population begins to stabilize. Of course, screening mammography also detects pre-invasive (in situ) carcinomas, but these are not included in calculations of the incidence of breast cancer. In contrast to the incidence rates, the rates of death from breast cancer have declined slightly since 1990. This change has been ascribed to increases in early detection as a result of screening mammography and to the use of adjuvant systemic therapy for early-stage disease.
A useful starting point for a discussion of the risk of breast cancer is the one-in-nine statistic. Although seemingly easy to comprehend, this figure warrants closer scrutiny. Put in context, it means that on average, for any group of nine women, breast cancer will develop in one of them at some time in her life, but not in the remaining eight. The one woman in whom breast cancer does develop has a 50% chance of receiving the diagnosis after the age of 65 and a 60% chance of surviving that cancer and of dying from another cause. Because it is a cumulative risk estimate, the one-in-nine statistic, although accurate, is the most dramatic way of describing the risk. It was used by the American Cancer Society in campaigns in the early 1990s to improve compliance with mammographic screening programs. In fact, the risk of breast cancer for a woman in any given decade of her life never approaches one in nine. Breast cancer is uncommon at younger ages, so the risk in earlier decades is low. A woman entering her 30s has a 1 in 250 chance of breast cancer in the next 10 years. The risk of breast cancer increases with age, so that a woman entering her 40s has a 1 in 77 chance of the disease in the following decade. Breast cancer is much more common at older ages, but the risk of breast cancer in any given decade of life never exceeds 1 in 34. Included in the population on which these data are based, however, are subgroups of women who are at significantly higher risk for breast cancer, such as those with a strong family history of the disease.
We are all exposed to multiple risks for various adverse events every day, although we are largely unaware of them. To gain perspective, we should consider the risk of death from breast cancer in the context of the competing risks of death from other diseases. The cause of death among women at any age is always more likely to be something other than breast cancer. This point can be shown by plotting the relative proportions of deaths from breast cancer (or from another cause such as lung cancer or cardiovascular disease) among women according to age 1). At any age, the proportion of deaths due to breast cancer never exceeds 20%. It is in middle age that the proportion of deaths from breast cancer is highest, despite the fact that the incidence of the disease increases with age. This paradox may be due in part to the occurrence of less aggressive breast cancer in the elderly, but it is mainly because the incidence of the other competing causes of death (such as cardiovascular disease) rises exponentially with age. Older women are more likely to have breast cancer, but they are also more likely to have coexisting conditions such as cardiovascular disease from which they will die. Of course, the actual number (rather than the proportion) of women who die of breast cancer is highest at older ages rather than middle age, because the total number of deaths among women increases with increasing age.
Life tables can also help to put these risks in context. Data from the Ontario Cancer Registry suggest that among a birth cohort of 1000 women, an average of 17 will die before the age of 40, but none from breast cancer. In their 40s and 50s, a total of 54 women will die, with equal numbers (9 in each group) dying of cardiovascular disease and of breast cancer. In their 60s and 70s, 305 women will die 105 from cardiovascular disease and 18 from breast cancer. By the age of 85 years, 203 women will have died of cardiovascular disease. In comparison, 33 of the 1000 women will have died of breast cancer by the age of 85, although by that age, the disease will have developed in 99 women (i.e., approaching the one-in-nine statistic). Presenting the data in this way also emphasizes that the majority of women in whom breast cancer is diagnosed do not die of the disease, a fact that statistics on the incidence of breast cancer cannot convey.
The impact of a given disease on a population can also be expressed in terms of the potential years of life lost. This estimate can be obtained by multiplying the number of deaths for each age group by the life expectancy of the survivors. According to the life table, the potential years of life lost due to breast cancer for 1000 women is 463, as compared with 1553 potential years of life lost from cardiovascular disease and 460 years from lung cancer. These calculations show that although breast cancer is an important cause of premature death, its incidence is approximately equivalent to that of lung cancer (a predominantly preventable disease) and vastly smaller than that of cardiovascular disease.
These facts are not well understood by the public. In a recent survey by the National Council on Aging of 1000 women who were between the ages of 45 and 64 years, only about 1 in 4 (26%) understood that lung cancer is the leading cause of death from cancer among women. Only 9% indicated that the condition they feared most was heart disease, as compared with 61% who feared cancer (predominantly breast cancer) the most. Similarly, in a survey by the American Heart Association, only 8% of women recognized that cardiovascular disease was the leading cause of death. Inadequate understanding of the relative magnitude of competing health risks could have important consequences; for example, many women who might benefit from estrogen-replacement therapy may choose not to take it because of their fear of breast cancer.
The way in which information about the risk of breast cancer is conveyed to patients and the public could be improved. The first step is to educate physicians and other primary health care providers, with the use of data such as we have described, so that they can place a woman's risk in context. Health care providers must also have the skills to convey information about risk in a way that takes into account each patient's personality, cognitive level and preconceived perceptions of risk. Physicians should also be able to describe risk in a variety of ways. For example, many women might prefer to be given information on their short-term risk. Your risk of breast cancer over the next 10 years is 1 in x, rather than on their cumulative lifetime risk. In addition, whereas some women may prefer to have their risk explained in numerical terms, others will best understand their risk if it is conveyed in well-designed graphs or charts.
Of course, healthy women, who see their physicians infrequently, derive much of their health information from the media. Indeed, the media have had a central role in communicating information about the risk of breast cancer, particularly in disseminating the one-in-nine statistic. The focus on this statistic, especially when it is sometimes linked to images of young women with incurable stages of the disease, can distort the public's perception of the risk. The media need to present the information in a balanced way, with attention to the important facts that the risk of breast cancer is highly dependent on age and that it is not a lethal disease for the majority of women.
Breast cancer is a serious disease and an important cause of premature mortality and morbidity. It is important to encourage women to participate in mammographic screening programs, which reduce the risk of death from this common and serious disease. It is equally important to describe information about risk in context so that women are not disproportionately frightened by their perceived risk of breast cancer and so that other important, preventable causes of morbidity and mortality are not overlooked.
We are indebted to Dr. Ian Tannock for his valuable comments and suggestions. Kelly-Anne Phillips, M.B., B.S. Princess Margaret Hospital. Toronto, ON M5G 2M9, Canada, Gordon Glendon, M.Sc., Ontario Cancer Genetics Network, Julia A. Knight, Ph.D., Cancer Care Ontario, Toronto, ON M5G 2L7, Canada
Carcinogens everywhere: U.S. EPA [Environmental Protection Agency] published a report in 1998 saying that 100% of the outdoor air in the continental U.S. is contaminated with eight cancer-causing industrial chemicals at levels that exceed EPA's "benchmark" safety standards. Alaska and Hawaii were excluded from the analysis for lack of available data. Using 1990 data on toxic industrial emissions, EPA applied well-known mathematical models to estimate year-round average outdoor air concentrations for 148 industrial poisons in each of the nation's 60,803 census tracts. For each of the 148 toxicants, EPA established a "benchmark" level that the agency considers safe. Eight of the 148 industrial poisons exceed EPA's benchmark safety levels all of the time in all 60,803 census tracts. All eight are carcinogens, that is, they are known to cause cancer: bis(2-ethylhexyl) phthalate; benzene; carbon tetrachloride; chloroform; ethylene dibromide; ethylene dichloride; formaldehyde; and methyl chloride.
In its report, EPA said that outdoor air concentrations provide a reasonable estimate of toxic concentrations "that occur both outdoors and indoors, given the high rates of penetration into indoor environments for various HAPs [hazardous air pollutants]." In other words, EPA believes that being inside your home or workplace does not protect you from constant exposure to these eight carcinogens. EPA said its mathematical models probably underestimate the true levels to which the population is exposed. Where actual measurements of toxic contaminants were available, EPA found that the measured levels exceeded the levels estimated by their mathematical models.
In its report, EPA also acknowledged that it may have underestimated the health effects because the eight chemicals, combined, may have additive or multiplier effects since people
experience all of them simultaneously. However, the agency also acknowledged that it has no way to take such combined effects into account. The agency also acknowledged that many of the chemicals may have health effects for which the agency has established no "benchmark" standards. For example, benzene and 1,3-butadiene have both been associated with reproductive and developmental effects, but EPA currently has set no benchmark safety levels for such effects, and so those effects were ignored in this study. And finally, most (if not all) individuals are exposed to far more than just eight industrial poisons. These eight merely provide a toxic background to which other toxicants are added, depending upon a person's (or a community's) individual situation: automobile and truck exhaust, second-hand cigarette smoke, prescription drugs, emissions from power plants, smelters, incinerators, and so on. Several of the eight chemicals exceed EPA "benchmark" safety levels by a wide margin. For example, the average day-in-and-day-out concentration of carbon tetrachloride exceeds EPA's benchmark level by a factor of 13, and bis(2-ethylhexyl) phthalate exceeds EPA's benchmark by a factor of 6.
Lead in children: Old story, new data: In 1998, the federal Centers for Disease Control and Prevention (CDCP) in Atlanta issued a report saying that only 4.4% of American children between the ages of 1 and 5 have the toxic metal lead in their blood at "levels of health concern," which CDCP defines as concentrations of 10 micrograms of lead per deciliter of blood (10 ug/dL) or higher. A microgram is a millionth of a gram and there are 28 grams in an ounce; a deciliter is a tenth of a liter and a liter is about a quart. The reporting period was 1991-1994.
Although 4.4% sounds like a small percentage, it represents 890,000 individual children whose intellectual capacity is being permanently diminished by exposure to excessive amounts of lead. CDCP established 10 ug/dL as the "unsafe" level of lead in blood in 1991. The limit was set at 10 ug/dL not because 10 is a magic number that protects children but because it was the lowest level that could be detected with an inexpensive test, and because, CDCP said, setting the standard lower would burden the country's health-care system. When it set the official safety level at 10, CDCP acknowledged that something besides pure concern for public health went into the decision. "The recommendations [of 10 ug/dL]...are based mainly on the scientific data showing adverse effects of lead in young children at increasingly lower blood lead levels. They are tempered, however, by practical considerations, for example, of the numbers of children who would require followup and the resources required to prevent this disease," wrote Vernon Houck on behalf of CDCP.[3,pg.iii] In other words, when it set 10 as the "safe" standard, CDCP acknowledged that it was reluctant to set the standard lower because too many children would then qualify for medical help, and too much money would have to be spent removing lead from the environment.
Numerous studies have now shown that there is no "safe" dose of lead in children's blood. Five years ago the National Research Council (NRC) said, "There is growing evidence that even very small exposures to lead can produce subtle effects in humans. Therefore, there is the possibility that future [safety] guidelines may drop below 10 ug/dL as the mechanisms of lead toxicity become better understood." The NRC offered evidence that lead at 5 ug/dL (half the official "safe" level) can cause attention deficit in children and in monkeys; reduced birthweight in children; and hearing loss in children.
In 1993 the NRC summarized a series of recent studies, then said, "Those studies support the general conclusion that there is growing evidence that there is no effective threshold for some of the adverse effects of lead." In other words, in 1993 there was good evidence that there is no safe level of lead. According to careful measurements of human bones, pre-Columbian inhabitants of North America had average blood lead levels of 0.016 ug/dL -- 625 times as low as the 10 ug/dL now established as "safe" for children. On the face of it, it seems unlikely that levels of a potent nerve poison 625 times as high as natural background, or even 300 times as high as natural background, can be "safe" for children.
The CDCP's 1998 study reported that the average (geometric mean) concentration of lead in all 20 million American children between the ages of 1 and 5 was 2.7 ug/dL, or 43 times as high as natural background. The main effect of lead in blood is to reduce a child's IQ. Five years ago, the American Academy of Pediatrics reviewed 18 scientific studies showing that lead diminishes a child's mental abilities. "The relationship between lead levels and IQ deficits was found to be remarkably consistent," the Academy said. "A
number of studies have found that for every 10 ug/dL increase in blood lead levels, there was a lowering of mean [average] IQ in children by 4 to 7 points." This may not sound like a major loss, but an average IQ loss of 5 points puts 50% more children into the IQ 80 category, which is borderline for normal intelligence. It also reduces the number of high IQs; for example, one small group that should have contained 5 children with IQs of 125, contained none.
In recent years, many studies have shown that lead not only diminishes intellectual capacity, but it also causes loss of hearing, reduces hand-eye coordination, impairs the ability to pay attention, and creates a propensity toward violence. Children who have been poisoned by lead are less able to handle stress and are more prone to violent outbursts. The source of the lead poisoning children today is chiefly paint containing lead. In the U.S., approximately 83% of privately owned housing units and 86% of public housing units built before 1980 contain some lead-based paints.
Public health authorities have acknowledged openly since 1952 that black children are being preferentially poisoned by lead in paint. The City of Baltimore began a lead-toxicity-screening program in 1931. With 20 years of data in hand, the head of the Baltimore health department wrote in 1952, that the rate of poisoning among children was "7.5 times as high among the Black population as it was among the white population.... The high rates among Black children are a problem of considerable public health significance since 30% of Baltimore's pre-school population is black. The racial difference in incidence is believed to be due to environmental factors probably resulting chiefly from economic disadvantage."
Today, 47 years later, the situation has changed little. According to CDCP's 1998 study, today the highest concentrations of lead are occurring in non-Hispanic black children. Among non-Hispanic black children ages 1 to 5, living in housing built before 1946, 21.9% have blood lead levels at or above 10 ug/dL. Among those living in housing built between 1946 and 1973, 13.7% had blood lead levels at or above 10 ug/dL, CDCP's 1998 study says. A recent study of children visiting a pediatric clinic in Philadelphia's inner city reported that 68% of the children there have lead levels that exceed the "safe" 10 ug/dL. In sum, roughly a million black children who live in the inner cities are being continuously poisoned by exposure to lead. In 1991, the Centers for Disease Control published a study showing that the nation's taxpayers would save $60 billion in health-care and special education costs by spending $32 billion to eradicate lead from inner city homes. Congress has never been willing to adopt this cost-effective prevention strategy, evidently preferring to produce generation after generation of black inner city children with diminished intellectual capacity and a propensity toward violence. (And we think we have toxicity problems.)
Aesthetic Plastic Surgeons Warn of Physicians Who Are Promoting the Procedure
as Safe and Effective: As a result of the Food and Drug Administration placing restrictions on the use of silicone gel-filled breast implants, women are actively seeking other alternatives for breast enlargement. The American Society for Aesthetic Plastic Surgery (ASAPS), representing board-certified plastic surgeons who concentrate their practices in aesthetic (cosmetic) surgery, is concerned about media publicity on a procedure to enlarge the breasts by fat injection. ASAPS warns that this is an experimental procedure producing only temporary benefits and, more important, posing serious long-term risks to patients.
On the surface, the concept of using liposuction to remove unwanted fat from one's own thighs and buttocks, and then injecting it into the breasts to make them larger, has appeal. However, aesthetic surgeons certified in plastic surgery have long maintained that injection of fat, or any substance, into or behind the breast tissue can be potentially dangerous. For reasons that are not understood, fat cells that are removed from one body site and injected into another usually do not survive. Fat injected into the breast may be absorbed by the body, may become liquid and drain from the injection site or may calcify, becoming a scarred mass within the tissues. Massive calcification of injected fat can mask or mimic the presence of breast cancer. Seven to 14 ounces of fat injected into the breast, the amount required for an average enlargement, could make accurate detection of cancer by mammography extremely difficult.
Since the FDA's virtual ban on the use of silicone gel breast implants for cosmetic purposes, a handful of physicians from various specialties have been aggressively promoting breast enlargement by fat injection as a safe and effective alternative to implants. However, clinical experience with the transfer of fat from one part of the body to another is still in its early stages. Fat injection has primarily been used to correct wrinkles or fill in
minor facial depressions, requiring relatively small volumes of fat. The biggest difficulty in these cases is the absorption of fat, resulting in loss of volume and often only temporary improvement in the appearance of the area being treated.
Most aesthetic plastic surgeons that have used fat injections to correct facial wrinkles and defects report improvements lasting a year or less. For this reason, many plastic surgeons do not perform fat injections; those who do are careful to explain to patients the unpredictability of results and the probable need for repeated treatments. The transfer of large volumes of fat to other parts of the body is performed infrequently. While fat transfer to body sites other than the breast is not known to pose a risk to patients, little if any data exists on its long-term effectiveness.
It is reasonable to expect that breast enlargement obtained by autologous fat injection would not be permanent and may make future detection of breast cancer difficult or impossible. The small number of proponents of this technique claim that, using their methods, mammography has not been impaired in the few patients who have undergone the procedure. However, it is well known that calcification often takes years to develop, and there is no way to predict that women undergoing breast enlargement by fat injection will not develop significant amounts of calcification in the future. Since calcification causes mammographic changes that may be virtually indistinguishable from those associated with breast cancer, these women very likely could require repeated biopsies and possibly removal of their breasts to determine if cancer is present.
Any woman considering breast augmentation by fat injection must understand that this is an experimental procedure, and there is no reliable evidence that it is either safe or effective over a long period of time. While patients may certainly consent to undergo the procedure, they should be certain to have all the information necessary to make an informed decision. In addition, they should determine if the experimental trials have been approved by an Institutional Review Board, an independent body of physicians that reviews medical research for quality and validity while assuring that patients are informed and protected.
ALTERNATIVE MEDICAL: Feverfew: Powerful Migraine Suppressor: Fast facts: prevents migraine headaches, relieves arthritis, eases menstrual cramps. Despite its name, feverfew won't get rid of a fever. In fact, if today's scientists could rename this plant, they might want to dub it migraine-few. In the 1980s, several studies done in the United Kingdom showed that people who regularly suffer from migraine headaches often find relief with feverfew. In the studies, migraine sufferers who chewed fresh feverfew leaves or took capsules of dried, ground leaves experienced fewer and less severe headaches. The key to this effect, researchers believe, is parthenolide, a compound in feverfew that helps control the expansion and contraction of blood vessels in the brain. The unpleasant symptoms of migraine , nausea, throbbing head pain and sensitivity to light apparently occur when blood vessels in the brain overreact, contracting and expanding abnormally. This doesn't mean, though, that you can reach for feverfew to relieve a migraine
Feverfew has no beneficial effect on migraine attacks once they're in gear," says Varro E. Tyler, Ph.D., professor of pharmacognosy at Purdue University School of Pharmacy in West Lafayette, Indiana, and author of The Honest Herbal. "It works as a preventive, and that means taking it regularly over a long period." Researchers suspect that feverfew may also help combat menstrual cramps and arthritic inflammation, although these uses are not as well substantiated.
Using Feverfew: Prescription medications are available for migraines, but they don't work for everybody. According to Daniel B. Mowrey, Ph.D., director of the American Phytotherapy Research Laboratory in Salt Lake City, Utah, and author of The Scientific Validation of Herbal Medicine, "The people feverfew works best for are usually those who don't respond to any other form of medication." To duplicate the doses used in the migraine research, says Dr. Mowrey, "most people must eat a leaf or two or take a capsule or two each day." That's assuming you're getting perfectly potent feverfew, and that could prove difficult. "The problem with feverfew in the United States," says Dr. Tyler, "is that you're very unlikely to get a quality product." Several investigators, he points out, have tested commercial feverfew preparations, such as tablets or extracts, and found that they contain little or no active ingredient.
For this reason, Dr. Tyler suggests taking more than the recommended dosage of any store-bought feverfew preparation to increase the odds of getting an adequate dose of the active ingredient, parthenolide. He recommends taking up to six 300- to 400-milligram tablets of the herb daily. Taking this much feverfew in tablet form is perfectly safe, he says. You can also grow your own supply of fresh feverfew, says Dr. Mowrey. In fact, he suspects that whole feverfew leaves may work better than taking the ingredient in concentrated form. "The research suggests strongly that the whole leaf has to be used," he says "In some studies, people who just chewed on the leaf had better results than those who used pills filled with ground, dried plant material or an extract."
There is one potential drawback to eating feverfew leaves: They may cause irritation or ulcers of the lips, tongue and lining of the mouth. Otherwise, feverfew is generally considered safe. (If chewing feverfew leaves irritates your mouth, discontinue use immediately.) It's also a good idea to steer clear of feverfew altogether if you are allergic to chamomile, chrysanthemum and other members of the daisy family. And since feverfew may also affect the clotting components of blood, people with a clotting disorder or those who take anti-clotting drugs probably shouldn't take it. And, just to be on the safe side, pregnant women should also avoid it.
INSURANCE CLAIMS: "Medical Necessity" Claim Denials: Claims are often denied by administrators or managed-care entities, on grounds such as "lack of medical necessity." Amazingly, this can happen even if an inpatient admission was "pre-certified" and the entire course of treatment "case-managed." But the fact that a claim has been denied does not mean that benefits are not owed. The claim may indeed be covered under the precise terms and conditions of the patient's benefit plan. It's just that in this age of Managed Care insurance companies and administrators are reluctant to let go of a dollar without a fight.
Although the need for inpatient care may be clear and not even in dispute, benefit plans are notorious for raising issues, after the fact, concerning the appropriate duration of inpatient care. This is particularly true in the area of psychiatric and substance abuse treatment claims. Frequently, benefit plans will engage in a retroactive review of a claim; and then apply their own "certification criteria," to deny the claim. The application of such "certification criteria" is usually inappropriate, unless those criteria are set forth in the plan itself. Not only are such "certification criteria" seldom found in the plan, but they frequently contradict the express provisions of the plan.
In those instances, any reliance upon such criteria to deny a claim is highly inappropriate and impermissible under ERISA. For example, in the area of substance abuse treatment, such "certification criteria" are frequently recited, which relate only to acute care procedures (such as detoxification), but these are erroneously applied to rehabilitative treatment. (See: Acute Care vs. Rehabilitation). Whenever a plan refuses to pay for the entire duration of treatment rendered, it puts the medical provider, in a difficult position. Basically, the provider has three options: (1) Pursue the patient for payment, by filing a lawsuit or handing the account over to a collection agency, which does not make for good provider-patient relations and may even undermine the patient's treatment; (2) Write off the account as uncollectable, which could jeopardize the provider's financial ability to provide treatment to other patients in the future; or (3) Pursue the patient's claim against his or her insurance company or employee benefit plan.
Depending upon what the Plan documents say, the third option may be the best one. This can often be done with very little effort, expense or inconvenience on the provider's part. If the provider has obtained an "Assignment of Benefits" from the patient, the provider will usually have standing to pursue the claim through all levels of administrative review and in court if necessary. All that is needed is an attorney willing to handle the case on a fee basis that is satisfactory to the provider.
SPECIAL THANKS TO ALL THE INTERNET PEOPLE WHO PROVIDE US WITH HELPFUL INFORMATION!!!
THIS MONTH'S POEM:
The Dash
Author unknown
I read of a man who stood to speak
at the funeral of his friend.
He referred to the dates on her tombstone
from the beginning...to the end.
He noted that first came the date of her birth
and spoke of the second with tears,
but he said that what mattered most of all
was the dash between those years.
For that dash represents all the time
that she spent alive on earth,
and now only those who loved her
know what that little line is worth.
For it matters not, how much we own;
the cars, the house, the cash.
What matters is how we live and love
and how we spend our dash.
So think about this long and hard,
are there things you'd like to change?
For you never know how much time is left.
(You could be at "dash mid-range.")
If we could just slow down enough to consider
what's true and what's real,
and always try to understand
the way other people feel.
And...be less quick to anger,
and show appreciation more
and love the people in our lives
like we've never loved before.
If we treat each other with respect,
and more often wear a smile,
remembering that this special dash
might only last a little while.
So, when your eulogy is being read
with your life's actions to rehash... would
you be pleased with the things they have to say
about how you spent your dash?
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: Autoimmune 1/93; Fibromyalgia 2/93; Medical Testing 3/93; Sjogren's 4/93; Vasculitis 4/93; Arthritis 5/93; Chronic Fatigue 6/93; Lupus 7/93; Irritable Bowel Syndrome & Inflammatory Bowel Disease 8/93; Insurance 8/93, 9/93; Misc. Med. Info. 9/93; Multiple Sclerosis 10/93; Spasmodic Torticollis 10/93; Hypoglycemia 11/93; Antibodies 12/93; Reflex Sympathetic Dystrophy 1/94; Misc. Med. Info. II 2/94; Scleroderma 3/94; Costochondritis 4/94; Peripheral Neuropathy 4/94; Class Action 5/94; Fungal Infections 6/94; Hypercalcemia (low calcium) 7/94; Raynaud's Phenomenon 8/94; Fibromyalgia Update 9/94; Sarcoidosis 10/94; Free Radicals 11/94; Porphyria 12/94; Interstitial Cystitis 1/95; Mixed Connective Tissue Disease 2/95; Flap Procedures 3/95; Misc. Med. 4/95; Thyroid Disease 5/95; Stress 6/95; Natural Healing 7/95; Adrenal Malfunctions 8/95; Multiple Myeloma 9/95; DHEA 10/95; Chelation Therapy 11/95; Sleep Disorders 12/95; Meniere's Disease 1/96; 33 Tips to Improve Your Health 2/96; Amino Acids 3/96; Enzymes 4/96; Minerals 5/96; Aluminum Toxicity, DHEA Update 6/96; Addictions & Food Sensitivities 7/96; Misc. Med. Info. IV 8/96; Misc. Med. Info. V 9/96; Misc. Med. Info. VI 10/96; Misc. Med. Info. VII 11/96; Transcient Ischemic Attacks 12/96; Symptoms of Breast Implant Problems 1/97; Pap Tests 2/97; Parasitic Infections 3/97; B-Complex Deficiency Syndrome 4/97; Myofascial Pain Syndrome 5/97; Inositol 6/97; Misc. Med. Info. VIII 7/97; High Blood Pressure 8/97; Plaquenil 9/97; Misc. Med. Info. IX 10/97; Misc. Med. Info. X 11/97; Gastroesophageal or acid reflux 12/97; Smoking Dangers 1/98; Misc. Med. XI 2/98; Multiple Chemical Sensitivities 3/98; Misc. Med. XII 4/98; Misc. Med. XIII 5/98; Baylor Studies 6/98; Hyperbaric Oxygen 7/98; IOM Summaries 8/98; CFS 9/98; Trace Metal Toxicology 10/98; Restless Leg Syndrome, Tamoxifen 11/98; Letting Go With Love 12/98; Tumor Markers 1/99; Drug Safety 2/99; Finding proof of manufacturer 3/99; Legal info. and info. on Alternative Medicine Info. contained in most issues.
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