Platinum again

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Published Saturday, December 23, 2000 http://webserv3.startribune.com/stOnLine/cgi-bin/article?thisSlug=IMP23 & date=23-Dec-2000 & word=platinumGovernment hasn't pursued suggestions to test silicone breast implantsGreg Gordon / Star TribuneWASHINGTON, D.C. -- A government scientist proposed a study four yearsago to explore whether silicone gel breast implants could have leakedtoxic forms of platinum into women's bodies, as some healthprofessionals feared.But the proposal by Biagini, a research toxicologist at theNational Institute for Occupational Safety and Health who is a leadingplatinum expert, went nowhere.Now, the Food and Drug Administration (FDA) says it needs more data todetermine whether platinum may be a culprit in the illnesses of some ofthe half-million women who have sued implant manufacturers.The issue underscores a handicap routinely confronting the FDA: It lacksthe money to perform research that might settle many of the scientificquestions on which its regulatory decisions hinge. In an interview thismonth, FDA Commissioner Jane Henney acknowledged the problem and saidCongress should consider "at least doubling" her agency's $1.3 billionbudget. The annual budget for laboratory research at the FDA's NationalCenter for Toxicological Research in Jefferson, Ark., has been in the$40 million to $50 million range.To the frustration of some scientists and a number of women who thinktheir silicone breast implants made them ill, no government studies areunderway into the possible effects of platinum, small amounts of whichwere used during manufacturing.Potent allergen In certain reactive forms, platinum is one of the most potent allergensknown to humans. Scientists have yet to establish what level of exposurecauses sensitization, but once a person is sensitized, exposure to thetiniest amounts of the substance can cause allergic reactions rangingfrom asthma-like breathing problems to hives, skin rashes and jointpain. Some studies suggest platinum may also cause neurologicalproblems, such as numbness in fingers and toes.Silicone implant manufacturers, including former makers Dow CorningCorp. and Maplewood-based 3M Co., stress that two national sciencepanels have found no basis for health concerns with regard to theimplants. Scientists at Dow Corning, the leading manufacturer ofsilicone implants before most were removed from the market in 1992, saythey used platinum only to make a catalyst at the beginning of theirmanufacturing process and that any platinum left in the implants was ina harmless form.But a Houston researcher, Ernest Lykissa, says he has detected elevatedlevels of reactive platinum in the hair, fingernails and body fluids ofa number of women who had the implants for years and blame them for avariety of ailments.Lykissa's findings have aroused the interest of Langone, an FDAmolecular biology official who is monitoring the platinum issue. ButLangone said the agency needs more extensive studies to determinewhether reactive forms of platinum are in the implant, how much leachesout and what, if any, health effects it may produce....Platinum leaking Several researchers and health professionals have urged the FDA and theNational Institutes of Health to conduct studies into the platinum inimplants since 1993. , a supervisory research chemist at the Centers forDisease Control and Prevention, reported in the mid-1990s that he hadfound platinum leaking from 15 of 20 implants he tested after they wereremoved from women's bodies. said he proposed further study,but got no response.Biagini, the toxicologist, wrote the FDA suggesting a study in which gelfrom silicone implants would be applied to the skin of platinum refineryworkers known to have been sensitized to the substance and to women withimplants. A pattern of skin reactions would be a strong signal of aproblem, he contended. He also got no response.Later, Biagini said, he wrote to a federal judge in Alabama overseeingbreast implant litigation, offering his assistance if a court-appointedscience panel wanted to investigate the platinum issue. He said hereceived no reply._/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/_/Published Monday, December 18, 2000 http://webserv3.startribune.com/stOnLine/cgi-bin/article?thisSlug=IMPL18 & date=18-Dec-2000 & word=platinumBreast-implant debate may shift focus to effects of platinum leakageGreg Gordon / Star TribuneWASHINGTON, D.C. -- A National Academy of Sciences panel last year foundno basis for concerns that silicone-gelbreastimplants cause healthdamage, but debate on their safety persists with a new focus.Several researchers are trying to persuade the U.S. Food and DrugAdministration (FDA) that implant safety reviews have focused too muchon the effects of silicone and too little on whether toxic platinumleaked into women's bodies from some of the devices.During the past 15 years, the FDA has received more than 193,000 reportsof adverse health effects from users of silicone-gelimplants and the nowmore widely sold saline breastimplants -- ailments that run fromconnective tissue disorders to skin rashes and memory loss.Despite scores of scientific studies and mammoth legal battlessurrounding the implants, the causes of the illnesses remain a mystery.FDA officials are trying to determine whether the platinum issuerepresents a smoking gun, or just more smoke.Lorri Ferraro, a psychotherapist from Forest Lake, Minn., is watchingthe developments with keen interest. She is among about 500,000 womenwho filed claims alleging that implants harmed their health and, in manycases, wrecked the quality of their lives. Ferraro and other womenassert that some of their ailments could be consistent with commoneffects of platinum exposure, such as asthmalike breathing problems,itchy or burning skin, joint pain, hives and possible nerve damage....Potent allergen Platinum is a heavy metal probably best known for its use in jewelry, inwhich it is harmless. But in certain ionized or reactive compounds, itmay be "the most potent chemical allergen on the planet," said a leadingplatinum expert Biagini, a research toxicologist at the NationalInstitute for Occupational Safety and Health (NIOSH). He said platinumis so potent that it also appears to cause people to become allergic toan array of other substances.Researchers found in the early 1900s that 50 to 60 percent of platinumrefinery workers developed asthma and other severe allergies afterbreathing platinum dust. Recent studies suggest that reactive platinumis a neurotoxin that might damage brain cells or attack the nerves infingers, toes and limbs -- ailments similar to those described by someimplant recipients. However, neurological effects were not noticed inthe studies of platinum workers.When silicone implants went on the market in the 1960s, no FDA approvalwas needed: The agency lacked authority to regulate medical devicesuntil 1976. Citing unresolved safety questions, the FDA got a voluntarymoratorium on the sale of siliconeimplants in 1992, limiting their useto clinical trials on women undergoing reconstructive surgery.Now, with overseas sales of the implants rising, the FDA is consideringtwo petitions seeking tougher regulatory action based mainly on platinumconcerns.The agency has heard from physicians and researchers who citesmall-scale studies that they say implicate platinum as a likely causeof immunological and neurological effects in implant recipients. Theseresearchers argue that scientific review panels, as well as lawyersscrambling to recover damages from aggrieved women, focused too narrowlyon connective tissue diseases.The most dramatic evidence comes from Texas researcher Ernest Lykissa,who operates a Houston drug-testing laboratory. Lykissa first reportedidentifying reactive platinum compounds leaking from breastimplants thathad been removed from women's bodies.More recently, he tested samples of hair, fingernails, sweat, blood andurine from eight women who had had their implants removed and complainedof physical ailments. He said he found elevated levels of variousreactive platinum compounds in six of them, declaring that he hasestablished "a public health issue that ... warrants the attention ofthe federal government."The FDA's Langone said, however, that Lykissa's yet-to-be-submittedfindings are too limited to prove that the platinum came from theimplants."We need bona fide, valid studies to determine what platinum species arepresent [in implanted women], how much is there, how much leaches out,where it goes and what it does," Langone said.Strict threshold Platinum is considered such a health hazard that the U.S. OccupationalSafety and Health Administration has set one of its strictest workplaceexposure thresholds for the toxin: 2 parts per billion.Makers of silicone-gelbreastimplants have advised the FDA that they usedas much as 1,500 parts per billion of hexachloroplatinate, a highlyreactive platinum "salt," during manufacturing. The issue is how muchplatinum, if any, remained in the implants in a reactive form.Scientists for Dow Corning, once the principal implant maker, say thecompany used "platinum salts" from 1969 until it quit making theimplants in 1992, but only to produce a different compound that servedas a catalyst. The catalyst caused the silicone oil to thicken into agel and, when more platinum was added, to harden some gel into thedevices' outer shells.Tom Lane, a senior Dow research scientist, said that an "exceedinglysmall" amount of platinum was used and that any that remained afterthose chemical reactions was in a harmless "zero oxidation" state. Hesaid this conclusion is supported by a "huge body of literature" datingback 50 years."There's no harm here. There's no risk here," said Schoettinger,chief trial lawyer for Dow Corning, which is under Chapter 11 bankruptcyprotection in the face of 170,000 implant suits.But NIOSH's Biagini said that however the platinum is used, not all ofit is neutralized. "There is going to be a certain amount ... inbreastimplants," he said.The only companies still selling siliconeimplants in the United Statesunder the FDA's current restrictions are Mentor Corp. and Inamed Corp.,which acquired the implant business that 3M exited in 1984.Bobby Purkait, a vice president for Mentor, which is based in SantaBarbara, Calif., said his company uses platinum salts in a processsimilar to Dow Corning's. He said the company tests of its implants havenot found dangerous salt levels.Inamed spokesman Ilan Reich declined to discuss the company's use ofplatinum, calling it "an issue between us and the FDA."Langone said he does not know whether Inamed's implant subsidiary,McGhan Medical Corp., still uses a platinum compound. FDA officials alsosaid that at least one company uses platinum in the process of hardeningsilicone shells for saline-filled breastimplants.3M spokeswoman Auvin said the company no longer employs scientistswho could answer questions about breastimplants -- a business it shedbecause "we had such a small market share, and there were indicationsthat litigation was coming."Pointing to the Institute of Medicine's report, she said, platinum "isnot an issue."Dow Corning spokesman T. said the company would wait tosee Lykissa's new study, but criticized his earlier work as "dubious."While Lykissa's methodology in a previous implant study has drawnskepticism, his conclusion that platinum leaked from the implantslargely mirrored the results of two other studies, including one aboutsix years ago by , a supervisory research chemist at thefederal Centers for Disease Control and Prevention. Studies, some by theFDA, also have found that about 70 percent of the devices eventuallyruptured.Lykissa said he has received about $40,000 in funding from a group ofbreast-implant recipients headed by Keeling, a Houston woman whosubmitted one of the petitions before the FDA....The second petition was submitted by Dr. Harbut, an occupationalhealth specialist in Southfield, Mich., who said that implantedrecipients he has examined have had symptoms consistent with platinumexposure and that several of them have platinum allergies. He wants theFDA to issue a health warning about platinum risks to all recipients ofany implanted device made with a platinum catalyst.Ferraro says she's sure her implants made her sick. She said she beganexperiencing aching joints, burning and itching skin and numbness in herfingers and toes not long after she chose to have Dow Corning implantsfollowing a double mastectomy in 1984. She said she was too fatigued towork from 1992 until the implants were removed five years later."I used to be a really active person," Ferraro said. "Now I have noenergy."Greg Gordon can be contacted at ggordon@...-- N. Greenberg, MD MPH Sysop / Moderator Occ-Env-Med-L MailListgary.greenberg@... Duke Occupat, Environ, Int & Fam MedicineOEM-L Maillist Website: http://occhealthnews.com---