Guest guest Posted November 26, 2006 Report Share Posted November 26, 2006 Kathynye@... wrote: From: Kathynye@...Date: Sun, 26 Nov 2006 21:27:50 ESTSubject: POST: 3 interesting emails- Dr.Z & Carolyn/Toxic Discovery & IlenaKathynye@...Subj: Re: FDA lift on implants Date: 11/26/2006 12:22:05 PM Eastern Standard Time From: dz@... She also wrote to us, and we will respond. Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.orgWe're Combined Federal Campaign # 1988 Toxic Alert from Toxic Discovery - Junk Science Junk Science Puts Thacker Against Milloy, American Chemical Society, White House When scientific studies are released and reported through media channels, the media's audience most likely takes for granted that a journalist quotes a legitimate subject matter expert. Not so said journalist Thacker. Corporate special interests lie at the core of media control in science reporting Thacker concluded.Thacker was a science reporter for the Environmental Science and Technology journal, the media arm for the American Chemical Society, and it was after he was fired that he exposed evidence of an entire industry built upon spinning science propaganda through the media and Internet in order to benefit corporate interests. Before American Chemical Society fired Thacker, he considered himself to be simply a general news reporter for the organization's small trade publication. The events leading up to Thacker's firing can be traced back to his investigation of website junkscience.com (Junk Science 'All the junk that's fit to debunk.') The website is dedicated to science-related discussion and republishing FOX News and a few other 'rumored to be' media outlets which have bought into the Christian Right movement, but most of all junkscience.com is meant to debunk myths involved in scientific issues of the day. Junkscience.com has been alive for quite sometime and the website's content questions scientific methods and results in determining the research on climate change (or global warming.) The website asks for reader donations via PayPal. The website was registered in February 1996 and is currently operated by Steve Milloy of Washington DC, a young man who also goes by the name Milloy and J. Milloy. Barry Hearn is listed as the website's editor.Milloy also publishes on CSR Watch and SRI Watch, websites dedicated to monitoring the anti-business movement. FOX News lists Milloy as an advocate of free enterprise and an adjunct scholar at the Competitive Enterprise Institute. FOX links to junkscience.com.Thacker alleged that Milloy has financial ties with oil companies and was on the payroll of Philip . Thacker charges that Milloy "was on the Philip payroll as a science consultant at the same he was discrediting studies on the dangers of second-hand smoke in his role as a columnist for FOX News." (Read Think & Ask's story on how anti-smoking advocates spin science to push their agenda.) After publishing his research on Milloy, Thacker moved on to investigate cases in which organizations promoted industry arguments on environmental issues. In an 8 March 2006 article called “Hidden Ties,†he wrote about a group called Project Protect, which appeared to be made up simply of concerned Oregon citizens. Project Protect advocated legislation promoting the cutting of trees to prevent forest fires.As Thacker discovered through IRS documents, however, Project Protect was a $2.9 million media campaign. “This ‘grassroots’ organization,†he wrote, “has clear ties to timber corporations – an industry likely to benefit financially from legislative reforms.â€In reading Thacker's story, and for the record, Think & Ask points out that the story did not address responsible forestry practices. Thacker did not discuss the history behind forestry techniques in the United States, which is now blamed on more destructive forest fires since active fire suppression began in 1910. While research shows deforestation by man --rather than natural forest fire-- is detrimental to the environment, so too has been governmental fire suppression. The forestry service is now faced with a monumental task of returning national forests to their natural state pre-1910. White House reforms under President W Bush have indeed favored timber companies under the guise of "healthy" forest legislation as Thacker concludes, but what should have come of Thacker's article is how --and despite special interest lobby groups-- nothing has actually changed in forestry management despite legislation. Next, Thacker said his reporting on the Weinberger Group upset his employer, the American Chemical Society, in particular one of the Society's board members. The board of American Chemical Society is made up of academics, but also has members from Occidental Chemical Corporation, Procter & Gamble, GlaxoKline, 3M Corporation, Genitope Corporation, the National Research Council, and Sandia Labs. The Weinberger Group is a lobbyist and consulting firm specializing in helping Fortune 500 corporations win litigation across the emerging life sciences industry. Recently, Weinberger Group acquired BCG Europe to expand its reach across the United Kingdom and Western Europe where governments hold much stricter regulations on corporations than is the case in the United States.Without naming the Society's board member, Thacker said the member objected to the Weinberg Group story. Thacker said he examined a proposal made by the Weinberg Group to chemical giant DuPont in the company's defense strategy regarding chemical PFOA, a chemical DuPont uses in the production of Teflon. The story was completed around the time DuPont was facing pressure from the Environmental Protection Agency and a civil-action lawsuit by West Virginia residents who claimed to suffer serious health effects from exposure to PFOA. According to Thacker, the American Chemical Society board member said the journalist was muckraking rather than reporting news. Several months later, Thacker unearthed evidence that the White House, under President W Bush, tried to prevent scientists from speaking out about the link between climate change and the increasing strength of hurricanes. (Think & Ask reported on this topic before Thacker's story however. )Environmental Science and Technology editors refused to use Thacker's story on the White House, so Thacker submitted it to Salon.com --an elitist website based in San Francisco, CA-- which is widely known for a liberal editorial slant on news. Once the article appeared on salon.com 19 September 2006, the Environmental Science and Technology trade journal fired Thacker. On his personal website however he does not mention having worked for Environmental Science and Technology. From 1998 through present day he reports being a freelance journalist and lists more than two dozen news organizations for which he wrote stories.New York City's WNET (PBS Thirteen) will televise the full story of Thacker's investigations on 10 November 2006 at 10 p.m. Eastern Standard Time under the special Air: America's Investigative Reports.The broadcast will be narrated by Sylvia Chase and is in part funded by Bernard and Irene Schwartz, Park Foundation, The Popplestone Foundation, The Burns Foundation, The Betsy and Fink Foundation, and Semler, and Scripps Foundation.***Too bad we didn't know about this program before it aired, so we could have watched it.. If anybody hears of it's being repeated, please let us know!!Carolyn======================================================Subj: L.A. Times: Silicone: Now a solid 'maybe' (????) Date: 11/26/2006 8:58:51 PM Eastern Standard Time From: ilena.rose@... Sent from the Internet (Details) Silicone: Now a solid 'maybe' The breast implants' approval by the FDA was not fine-print free. Women must weigh the impact, and costs, of follow-up care.By Healy, Times Staff WriterNovember 27, 2006 The days before Thanksgiving are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 prompted a flurry of excited calls and inquiries last week from prospective patients. The giddy welcome may not last. Even as the two U.S. manufacturers of silicone implants gleefully projected a surge in demand for their products, physicians began poring over the fine print of the Food and Drug Administration's recommendation and finding reasons for caution. Like a holiday hangover that sets in before the dishes are washed, the sobering details of the government's decision are making some doctors less than exuberant about the newly approved implants. As they begin to share their wariness with patients, some expect many women will stick with saline implants or wait for the FDA to give its blessing to a new generation of silicone implants sometime in the next two years. The agency's decision "does create a whole host of questions" for women considering silicone breast augmentation and for the doctors who perform those procedures, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons' public education committee. "Many women were waiting in the wings to see when [the] FDA would approve silicone," said Brent Moelleken, a plastic surgeon with practices in Beverly Hills and Santa Barbara. Patients intent on getting silicone implants "really look on the bright side of the controversy," he said. Although many prospective patients will inquire, "my recommendation to them may not be to have surgery" at this time, he added. Key among the questions that doctors are pondering is the cost of using the newly approved gel implants in the manner outlined as safe by the FDA in its Nov. 17 announcement. The agency recommends that each woman using the implants have her breasts checked by magnetic resonance imaging, or MRI, three years after her surgery and every two years thereafter "over a woman's lifetime" to check for any ruptures of the implant. If any break is detected in the seal of the device, "the implant should be removed and replaced, if needed," the FDA added. Medical insurance doesn't cover cosmetic breast enhancement. Similarly, the cost of postoperative tracking and repeat surgery, the FDA notes, "may not be covered" by a woman's medical insurance and "may exceed the cost of her initial surgery." Even if women can afford the original breast implant surgery, a subsequent surgery — not to mention periodic MRIs — may be out of their price range.Cleared but questionedThe FDA's approval — after 14 years of study — had been expected to end the controversy around silicone gel implants.The devices were pulled from the general marketplace in 1992 amid concerns that they could rupture and endanger women, possibly contributing to autoimmune diseases. Although a link to health problems was never proved, long-term safety has remained an issue. In the meantime, the implants have remained available to cancer survivors and a wide range of women who agreed to enroll in studies of the implants' safety. But the new recommendations present patients and their plastic and aesthetic surgeons with additional uncertainties: Who will pay for the recommended MRI scans? What danger does the FDA foresee if patients, as expected, fail to get them? Does the FDA consider that a ruptured implant device — even one that presents no discomfort or proven danger to the patient — must necessarily be surgically removed and replaced? If so, whose financial responsibility would that be? "Do you think [insurance companies] are going to say, 'No problem, we want what's best for the patient?' " asks plastic surgeon Marcel s of Long Beach. "No. A lot of third-party payers have ruled out payment for any treatment — including complications — related to breast implants." What to do if those MRI scans detect cracks or breaks in an implant "is another conundrum that's created by this [FDA] recommendation," said Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures and potential replacement surgery in such cases, the FDA is suggesting to patients and physicians that leakage may present safety concerns. "But we still don't have science that [a silent rupture] creates a harmful situation for the patients. And the FDA hasn't addressed that either," Erhardt said. Plastic and aesthetic surgeons currently are divided on the question of whether "silent ruptures" — breaks in a silicone implant that are not noticed by the patient — need to be replaced for safety. Laurie Casas, a Chicago plastic surgeon, says she believes a broken implant could eventually cause inflammation and so "should be replaced, as you would any broken device." Beverly Hills plastic surgeon Ellenbogen, whose view is widely shared among plastic surgeons, counters, "If it ain't broke, why fix it? Why submit a woman to that trauma?"Among young women, who are considered a key market for this so-called "third generation" of silicone devices, plastic surgeons predict the FDA's follow-up recommendations and the improving alternatives will temper enthusiasm. But they acknowledge that many women will get them anyway and simply ignore the FDA recommendations that come with them. "Most women want to put them in, go on with their lives and forget they got the surgery," said Beverly Hills plastic surgeon Motykie. "That'll be a big question, whether they're going to want to be burdened with that follow-up." The specialized MRI images required to detect the integrity of a breast implant typically cost between $1,500 and $1,800, said Zuckerman, director of the National Research Center for Women & Families, a nonprofit research and education organization in Washington, D.C. Costs at some centers can reach up to $4,000, and many women would have to travel long distances to get the recommended images, added Zuckerman, whose organization testified against the latest silicone implant approval. "These young girls are often going into debt that they can't really afford to get out of, and they're paying for something on installment that they can barely afford," Zuckerman said. "I certainly think any woman who is not affluent would be crazy to choose silicone because of the additional cost." Saline improvementsMeanwhile, the look and feel of saline implants have been improved by a generation of surgeons who have had only that type of device to offer their patients. To overcome the wrinkles and folds that often mar the appearance of a saline implant in the breast, surgeons have begun to implant them under muscle and other breast tissue. At the same time, a newer and reportedly better generation of "highly cohesive" silicone devices is making its way through the FDA approval process. Although the silicone in the implants just approved is considered resistant to leakage and running if broken, the next generation — often described as having a consistency similar to that of gummy candy — is designed to be even more resistant. "Patients that really are interested in gel implants have done their homework" and know what advances lie ahead, said Erhardt, adding, "it will be interesting to see how many people will want to accept the old technology" approved after such exhaustive study by the FDA, when a new generation may be just a year or two down the road. ~~~~~~~~~~~~~www.BreastImplantAwareness.org Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.