Also in this edition: New study: Anaplastic Large-Cell Lymphoma in Women With Breast Implants
Also in this edition: Tara Reid Scared To Have More Plastic Surgery (USA) NE patients left scarred after plastic surgery for eye bags (UK) Former MP’s wife, in coma after plastic surgery, dies (Malaysia) Plastic Surgeon arrested returning from Europe (USA) Botox breast jabs could damage health, doctors warn (UK) Alive Mind Media and Our Bodies, Ourselves Present the DVD Release of "Absolutely Safe"(USA) Industry backed BPA study, report says (Canada) Canada declares bisphenol A toxic (USA) Motion Filed to Consolidate Mentor ObTape Sling Lawsuits (USA) Patient Sues Heart Surgeon for Unauthorized Implantation of Experimental Device (USA)
Tara Reid Scared To Have More Plastic Surgery Starpulse.com Branford, CT, USA October 30th, 2008 5:00pm EDT Tara Reid is too scared to go under the knife to fix the scars left by her last botched cosmetic surgery procedure. The Van Wilder star and former surgery junkie had breast implants and underwent abdominal operations that left her stomach grossly disfigured. The episode has left her self-conscious about her appearance, but she isn't prepared to have it fixed and run the risk of further complications. She tells People magazine, "I'm scared about getting surgery ever again. It's like surviving a plane crash and getting on a plane again. My stomach scars are my battle wounds."
NE patients left scarred after plastic surgery for eye bags Northern Echo Darlington, England, UK 3:19pm Tuesday 28th October 2008 THE medical director of two North-East cosmetic surgery clinics has been issued with a formal warning by the General Medical Council after two patients were left scarred. Dr Ash Dutta, a former GP who runs the Aesthetic Beauty Centre clinics in Sunderland and Newcastle, has been warned that he must keep up to date with the latest in cosmetic surgery techniques. The warning will stay on his GMC record for five years. It follows a hearing by the GMC’s Fitness to Practice panel in Manchester which found his approach to surgery in the case of two patients was "irresponsible, inappropriate and not in the best interests of your patients." At the end of the hearing the GMC panel stated: "Your conduct risks bringing the profession into disrepute and must not be repeated." The panel heard from two of Dr Dutta’s former patients who had facial surgery to remove bags from under their eyes in 2005 and 2006. Both patients complained after being left with scarring. The panel heard expert evidence from consultant plastic surgeon Roger Green that the best result was obtained by making incisions below and parallel to the eyelash margin. Dr Dutta admitted that the incisions he made on patients A and B were lower than the accepted standard and in the case of patient B were uneven. The GMC panel determined that this constituted misconduct but because of remedial measures taken by Dr Dutta, this fell just below the threshold for a finding of impaired fitness to practice. The panel heard that Dr Dutta had taken steps to improve his surgical technique in relation to removal of eye bags, a procedure known as bletharoplasty. This involved attending a one day advanced course approved by the Royal College of Surgeons in September 2006 and taking part in a supervised fellowship programme. The GMC panel considered that any repetition of the problem with eye bags is now "highly unlikely". The panel also took account of evidence that Dr Dutta had carried out 153 successful blepharoplasties and the only two complaints he was aware of were from patients A and B. *In a separate case the GMC’s Fitness to Practice panel is due to resume its hearing into allegations of deficient professional performance against a leading North-East orthopaedic surgeon next week. (Nov 3 onwards) Shankar Kashyap, who heads the highly-rated joint replacement unit at the Queen Elizabeth Hospital in Gateshead, has been accused of lacking basic surgical skills.
Former MP’s wife, in coma after plastic surgery, dies Malaysia Star Malaysia Updated: Tuesday October 28, 2008 MYT 4:36:23 PM By LOH FOON FONG KUALA LUMPUR: The wife of former Labuan MP Datuk Suhaili Abdul Rahman, Datin Fatimah Wan Chik, died Tuesday. She had been in a coma since January after complications arising from cosmetic surgery.
Fatimah died at 7.40am Tuesday morning at a private hospital here.
She had reportedly had a tummy tuck, liposuction and surgery on her eye bags. The surgeries were done at a clinic in Klang on Jan 9. She then suffered complications and went into a coma. Her body arrived at the Federal Territory Mosque at 12.30pm and prayers were carried out at 2pm. Asked what Fatimah had died of, Suhaili who appeared calm said she had been in a coma for a long time. “Her body will be flown back to Labuan in the evening where she will be buried,” he said. Suhaili, who had flown in from Kuching and arrived at KLIA at 1pm, said he had wanted to visit his wife in the hospital on Tuesday. Among the Ministers and MPs who came to offer condolences to Suhaili at the mosque were Federal Territories Minister Datuk Seri Zulhasnan Rafique, Youth and Sports Minister Datuk Ismail Sabri Yaakob, Special Adviser to the Prime Minister for Women and Social Development Affairs Datuk Seri Shahrizat Jalil and Titiwangsa Umno branch chief Datuk Seri Suleiman Mohamed. Besides her husband, Fatimah leaves behind three sons and a daughter, aged between 18 and 25. She was 44.
Plastic Surgeon arrested returning from Europe KPNX-12 Phoenix, AZ, USA Oct. 24, 2008 01:20 PM 12 News A Scottsdale plastic surgeon charged with murder was arrested in Ohio. Dr. Peter Normann was arrested after he returned to the United States on a flight from Germany. Customs and Border Patrol matched Normann's name to the national data base of wanted people. "This apprehension by our CBP officers helps demonstrate our diligence, vigilance and dedicated commitment to apprehending and preventing wanted persons from entering this country and our communities and doing harm to others," said David Murphy, CBP director of field operations in Chicago. Normann was charged with 2nd degree murder and manslaughter in connection with the death of three of his patients. The Arizona Medical Board says the deaths resulted from botched plastic surgery procedures.
Botox breast jabs could damage health, doctors warn Telegraph.co.uk United Kingdom Doctors have warned that a new technique using botox to raise women's breasts may cause long term damage to patients' health. By Alex Starritt Last Updated: 11:09AM BST 21 Oct 2008 The procedure, pioneered by American doctors, involves injecting the botulinum toxin into the pectoral muscles, causing the chest to rise up.
Trends in American cosmetic surgery tend to be transferred quickly to the UK, but British surgeons have expressed concern about the possibility of the "Botox boob job" being carried out by beauticians or nurses, due to less strict regulation than in the US on non-surgical treatments. "These are the major muscles that you use to ski, turn over in bed, do everything. For me, the risks outweigh the benefits," Dr Nick Milojevic, a Botox specialist at the Harley Medical Group cosmetic surgeons, told the Independent. "You'd need a lot of Botox for this treatment to work, so it would cost around £1,000 per treatment, and it is something you'd need to repeat three times a year." There are a range of similar treatments already available in the UK, the most popular being the "boob jab," in which a temporary filler is pumped into the breast. Milojevic described the most popular filler, Macrolane, as "one of the most exciting things to happen in aesthetic medicine in years." Despite the high cost of Macrolane, at around £2,800 for the initial treatment and a £1,400 annual top-up, interest in the procedure has grown exponentially. Nationwide cosmetic surgery chain SurgiCare, which has recently introduced Macrolane, yesterday announced a 135% increase on last September in enquiries about breast augmentation. However, Nigel Mercer, president of the British Association of Aesthetic Plastic Surgeons (Baaps), warned that: "If put in the wrong place, filler can leak out through the ducts in breasts. You can also get granular formation – lumps". He added: "The thought of a nurse performing this is alarming. The Government are shy of regulating this industry, although professionals and consumers are pushing for it."
"Absolutely Safe" reveals that the conversation on implant safety is far more complex than mere health issues. Rather, the real question is how women can make informed decisions in a culture that equates female value with conformity to a synthetic ideal, and sexuality with large breasts. "Absolutely Safe" presents the personal stories of women who chose implants.
“['Absolutely Safe'] is the perfect antidote to ads and TV shows that now routinely mislead women into thinking that these devices have been proven to be safe.”–Judy Norsigian, co-author and Executive Director, Our Bodies Ourselves Alive Mind is the exclusive home video distributor of "Absolutely Safe," a personal journey by Mrs. Ciancutti-Leyva to bring awareness to women’s health and rights; because every woman has the right to make an informed decision about her body. This release will be available in November 2008. About Our Bodies, Ourselves Our Bodies Ourselves (OBOS) is a nonprofit, public interest women's health education, advocacy, and consulting organization. Beginning in 1970 with the publication of the first edition of Our Bodies, Ourselves, OBOS has inspired the women's health movement by: Producing books that make accurate health and medical information accessible to a broad audience by weaving women's stories into a framework of practical, clearly written text; Identifying and collaborating with exemplary individuals and organizations that provide services, generate research and policy analysis, and organize for social change; Inspiring and empowering women to become engaged in the political aspects of sustaining good health for themselves and their communities. For more information visit Our Bodies Ourselves at www.ourbodiesourselves.org/ About Alive Mind Alive Mind releases on DVD and digitally specialty documentary programming in the areas of new consciousness, rational spirituality, and cultural transformation. Launched by industry pioneer Richard Lorber, Alive Mind seeks out intellectually provocative work from leading filmmakers – media content that delivers the "aha" response of a transformative experience. To advance discussion of issues related to our films, Alive Mind hosts Alive Mind Woman, where you will find open discussion about issues ranging from the decision not to have children to how to earn more money without selling your soul. AliveMindWoman.com hosts blogs for some of today’s most stimulating thinkers, filmmakers and activists including Ariel Gore, Carol Ciancutti-Leyva, and Jennifer Fox. Visit them online at www.alivemind.net Video Information: "Absolutely Safe" Price: $24.98 Genre: Documentary Availability: Worldwide Running Time: 83 minutes Technical Aspects: 4:3, NTSC Region 0 Language: English
More Plastic Surgery News: Spiral Flap Surgery vs. Breast Implants
Bisphenol A
Industry backed BPA study, report says Ottawa Citizen Ontario, Canada Canwest News Service Published: Thursday, October 23, 2008 A U.S. government report claiming bisphenol A was safe was written largely by the plastic s industry and others with a financial stake in the controversial chemical, the Milwaukee Journal Sentinel reported last night. Although the Food and Drug Administration will not reveal who prepared its draft, the agency's documents show the work was done primarily by those with the most to gain by downplaying concerns about the safety of the chemical.
Canada declares bisphenol A toxic Dallas Morning News Dallas, TX, USA 12:00 AM CDT on Sunday, October 19, 2008 The Associated Press TORONTO – Canada on Saturday became the first country to declare a chemical widely used in food packaging a toxic substance. It will now move to ban plastic baby bottles containing bisphenol A. The announcement came six months after Canada's health ministry labeled BPA dangerous, particularly to newborns and infants. Baby bottles frequently contain the chemical, which hardens plastic and makes it shatterproof. Several U.S. states are considering restricting BPA use, some manufacturers have begun promoting BPA-free baby bottles, and some stores are phasing out baby products containing the chemical. The European Union, the U.S. Food and Drug Administration and the chemicals industry say BPA is safe. The biggest concern is BPA's possible effects on reproductive development and hormone-related problems. Traces of the chemical can be found in more than 90 percent of Americans. The Associated Press
Medical Device News
Patient Sues Heart Surgeon for Unauthorized Implantation of Experimental Device Newsinferno.com New York, NY, USA Date Published: Thursday, October 16th, 2008 The Associated Press (AP) is reporting on a prominent Chicago surgeon earning royalties on a new heart device he implanted in a 41-year-old woman without her consent; this, according to a lawsuit filed by patient Toni Vlahoulis. Dr. Patrick McCarthy claims he donates the royalties to charity. Vlahoulis underwent a second surgery to remove the device because of inflammation and may require a heart transplant, Vlahoulis claims and her cardiologist confirmed. “There’s no way I would have consented to putting an experimental device in my body,” Vlahoulis said.
McCarthy denies the device was experimental. Vlahoulis claims McCarthy neglected to inform her he invented the device before the surgery to repair a leaky heart valve in April 2006. Vlahous’ negligence lawsuit, filed in April 2008, seeks over $50,000 in damages from McCarthy; Chicago’s Northwestern Memorial Hospital; and Irvine, California-based device manufacturer Edwards Lifesciences. The AP reports that McCarthy, the hospital, and officials from the manufacturer all argue that the device was not experimental because “it was commercially available more than a month before Vlahoulis’ surgery” and that it was a “slightly modified version of one previously available.” The hospital maintains it obtained “appropriate consents for the procedure.”
McCarthy also claims that he and his partners have implanted “close to 200″ of the devices, which are called Myxo ETlogix rings, with no problems and does not feel Vlahoulis’ reactions were a result of the ring, which he says was made of similar materials as a previous model and was just “a little bigger” and “a different shape.” The AP also noted that McCarthy is a consultant for the device maker and that the royalties he receives for three heart devices he developed are donated to the Greater Chicago Food Depository. This case is a clear example of the “close business ties between some heart surgeons and device manufacturers,” said the AP. TheHeart.Org, a Website for cardiologists that is owned by WebMD, first reported the case and its related ethical issues. “It’s not hard to tell a patient, ‘You may be receiving a device for which the physician receives royalties,’” said Maisel, former chair of the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Panel. “Then the patient may say, ‘I’m not comfortable with that. Pick one of the other devices.’” Maisel called it unethical to keep such information from patients and that he’s not persuaded it becomes ethical in McCarthy’s case because he donated his royalties, said the AP. “It’s not just about the money,” said Maisel, who pointed out that making product innovations and publishing research on results increases a doctor’s “prominence in the profession.” According to medical ethics experts, surgeons should inform their patients if they will receive royalties on a device they may use in surgery. Similarly, patients who are involved in medical research must be told and must agree to take part in such research by signing an “informed consent” form. Meanwhile, the FDA—which has received 10 reports of adverse events related to McCarthy’s design—is investigating whether it received proper notice about the device, said agency spokeswoman Peper Long.
Also in this edition: It's the subdermal crisis: the Botox is wearing off and the money is running out(AUSTRALIA) Time to disinfect research dollars (USA) Donation raises questions for head of FDA’s bisphenol A panel (USA) The F.D.A. and Engineered Food (USA)
HADCORP NEWS: October 14, 2008
Reward To Find Cat Serial Killer By Sky News SkyNews A £1,000 reward has been offered to bring a serial cat killer to justice.
In the last two weeks, nine pet cats in Weston-super-Mare, six of them in the same street on the Bournville housing estate, have died after being poisoned with anti-freeze. The recent spate of feline deaths follows an identical poisoning outbreak between April and August in nearby Bridgwater, which took the lives of 19 moggies. All suffered vomiting, diarrhoea and fits and eventual kidney failure, caused by ingesting ethylene glycol - the agent commonly found in anti-freeze. Animal rights organisation Peta (People for the Ethical Treatment of Animals) believes the poisonings were deliberate and has stumped up a cash reward to track down the killer. It is offering £1000 in exchange for information leading to the prosecution of the culprit or culprits. Peta's Suzanne Barnard claimed that because animals were often the perfect "practice" victims for violent people. "Weston-super-Mare residents have good reason to be concerned," she said. "Research in psychology and criminology shows that people who commit acts of cruelty to animals often go on to commit violent acts against their fellow humans. "As long as the perpetrators of this crime are at large, other animals in the area - and human residents - might also be in danger. "Animal abusers are cowards. They take their issues out on the most defenceless beings available to them." Peta is urging residents to keep a watchful eye on their animals and to keep all cats indoors. A police investigation was launched last month by Avon and Somerset Police and the RSPCA. The RSPCA said its investigation was split between searching for a malicious psychopath and an innocent source of the chemical, like a breaker's yard. Police are awaiting the outcome of post-mortem examinations to determine the exact cause of deaths. In September, Inspector John Norman said: "Geography and distance would suggest the fact that cats being poisoned in both places is just a coincidence. "However, as we don't know if this is an accident or deliberate poisoning, it is possible that the person responsible read about what was happening in Bridgwater and decided to be a copy-cat cat killer."
Anyone with information about the killings is asked to contact the RSPCA on 0300 1234 999.
BIG PHARMA
Time to disinfect research dollars Atlanta Journal Constitution - GA, USA Sunday, October 12, 2008 OUR OPINION It now seems pretty clear that researchers at major universities — including the head of psychiatry at Emory University — failed to properly disclose their financial ties to drug companies. And evidence of that failure suggests academic medical centers are not capable of policing their faculty’s potential conflicts of interest. Documents released recently by congressional investigators show that Emory’s Dr. Charles B. Nemeroff received $2.8 million in consulting fees from drug companies from 2000 to 2007; he was paid for, among other things, serving on advisory boards and giving lectures about new drugs to psychiatric colleagues. But on conflict-of-interest forms filed with Emory, Nemeroff reported his income from drug companies was much less than that, $1.6 million. Investigators paint a disconcerting picture of Nemeroff and his financial connections to drug companies. The documents also seem to show that Emory was wholly dependent on Nemeroff to make good on his promises to fully detail his income from drug makers. Failure to disclose financial conflicts is a violation of rules governing federally funded research and could jeopardize Emory’s $251 million in National Institutes of Health funding. In 2004, Nemeroff agreed to Emory’s demand that he limit his income from any single drug manufacturer to less than $10,000 a year. But congressional investigators found that Glaxo-SmithKline alone paid Nemeroff $170,000 that very same year. In both 2005 and 2006, Nemeroff also greatly exceeded the $10,000 limit, according to documents provided by GlaxoSmithKline, while Nemeroff filed disclosure forms with Emory attesting he was within the yearly limits. From 2000 through 2006, Nemeroff earned $960,000 from GlaxoSmithKline alone, but he declared less than $35,000 on his disclosure forms. During some of that time, Nemeroff was the principal investigator of a five-year, $3.9 million grant from the National Institute of Mental Health for testing GlaxoSmithKline-provided drugs. Had Emory known about his higher income, it would have been required to inform the institute of his potential conflict or remove him as principal investigator. (Nemeroff voluntarily resigned his department chairmanship after news of the congressional investigation was reported in The New York Times. Emory emphasized his resignation is temporary, pending the outcome of the university’s investigation of his actions.) The Emory physician is the latest in a string of high-profile academic researchers whose ties to drug companies have shaken up the relationship between medical scientists and Big Pharma. Last spring, Sen. Charles Grassley (R-Iowa) — who has been pushing the investigation in the Senate — reported that a University of Cincinnati researcher told her medical school that she had earned $100,000 from 2005 to 2007 from eight drug firms. But documents from one firm, AstraZeneca, revealed she was paid $235,000 from that company alone for her work during those years. In June, Grassley’s investigators reported that two well-known Harvard child psychiatry researchers apparently underreported their payments from drug companies to the university for a seven-year period by hundreds of thousands of dollars each. The congressional probe provides further evidence of just how tangled medical research has become with medical marketing. It begins with company sales representatives sponsoring lunches for medical students and extends to doctors’ offices being festooned with drug advertisements encouraging patients to “ask your physician” about their latest product. It also extends to lucrative contracts among scientists, universities and manufacturers that sometimes include sharing large profits from patents for new drugs or products. Much, if not most, of the research done for these products — many of them with the potential to save and improve lives — is scientifically grounded and conducted ethically. Still, it’s difficult for consumers to determine the credibility of work if the drug companies are underwriting not just the researchers, but also the universities that employ them. Grassley’s investigators released a letter from Nemeroff to Emory officials labeled “confidential” in 2000; the doctor warned the university that it shares some of the potential conflict connected to his work. In the letter, Nemeroff pointed out that his service on the advisory boards of several large drug companies resulted in endowed chairs and other monetary awards to Emory. The same could be said for other well-known researchers, the academic medical centers that employ them and among the medical speciality societies where word of new products is most effectively spread. Grassley’s investigation has focused heavily on drug company connections to psychiatry researchers, including Dr. Alan F. Schatzberg, a well-known Stanford University researcher and the president-elect of the American Psychiatric Association. Schatzberg holds $4.8 million in stock in a drug development company, and Big Pharma accounts for about 30 percent of the psychiatry association’s $62.5 million annual budget. A subsequent investigation by Stanford found that Schatzberg complied with the university’s disclosure and conflict-of-interest rules. Nevertheless, the university decided to clamp new restrictions on industry financing of doctors’ continuing education courses at its medical school. Drug company contributions will now have to go into a pool of money to the university that can be used for any class, even ones that never mention a company’s products. (In the past, drug companies routinely funded specific courses, usually those associated with new clinical practices in areas where their products could be used.) Five other major medical schools have developed similar rules for how to use continuing education grants from drug makers. These recent disclosures are more evidence that the requirements for reporting payments from the drug industry — in essence an honor system that relies on the researchers to tell their universities what they are earning — are simply inadequate. At a minimum, Congress should approve Grassley’s proposal requiring annual disclosures by companies of payments of $500 or more to researchers, a suggestion several pharmaceutical manufacturers have voluntarily adopted. But much more needs to be done. The culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing. Disinfecting it may result in a temporary reduction in the amount of money going into research and continuing physician education. But in the long run, the nation’s medical schools will want to enhance the reputation of faculty members who are doing quality, independent research unencumbered by questions about whether they are protecting the lives of patients or protecting their own wealth. Mike King, for the editorial board
Donation raises questions for head of FDA’s bisphenol A panel Milwaukee Journal Sentinel Milwaukee,WI,USA By SUSANNE RUST and MEG KISSINGER Posted: Oct. 11, 2008 A retired medical supply manufacturer who considers bisphenol A to be "perfectly safe" gave $5 million to the research center of Martin Philbert, chairman of the Food and Drug Administration panel about to make a pivotal ruling on the chemical's safety. Philbert did not disclose the donation, which is nearly 25 times larger than the $210,000 annual budget of the University of Michigan Risk Science Center, where he is founder and co-director. FDA officials learned of the link from the Journal Sentinel. Donor Charles Gelman, once labeled the second worst polluter in Michigan by the state's Department of Natural Resources, said in an interview that he considered the chemical, which is used to make baby bottles and aluminum can liners, to be safe. Worries about health problems that may be caused by the chemical are exaggerated by "mothers' groups and others who don't know the science," Gelman said. He said that he had made his views clear to Philbert in "several conversations." Philbert denied that. "At no time have the Gelman family or any other interested/disinterested person, persons, corporations or other entity contacted me or attempted to influence my scientific judgment on the matter," Philbert said in an e-mail response to questions from reporters. Norm Fost, director of the bioethics program at the University of Wisconsin, said Philbert should have disclosed the donation. "The public has a right to know about those connections whether they have any effect on the outcome or not," Fost said. "It sounds like a conflict of interest." Philbert was chosen to chair the FDA's subcommittee on bisphenol A by Barbara McNeil, head of the FDA's Science Board. She selected him from a list of 12 scientists on her board. Philbert then filled out a conflict of interest statement but did not list Gelman's donation. McNeil said she could not recall exactly when she picked Philbert to head the committee, but she thought it was sometime in July. Gelman's donation to the Michigan center was made in July. Philbert's committee is expected to release its opinion this month. It will advise the FDA on whether to accept, reject or amend a draft released by the agency in September. That draft found that products made with bisphenol A are safe for food storage. The decision of Philbert's committee is being watched carefully by chemical-makers and is expected to have huge implications on the regulation and sale of the chemical in items such as baby bottles, reusable food containers and plastic wraps. Developed originally as a synthetic form of the hormone estrogen, bisphenol A is used to make hard clear plastic in water bottles, baby bottles and other household products. It is also used as a liner in aluminum cans and in many dental sealants. The chemical has been detected in the urine of 93% of Americans tested. In the late 1990s the FDA and other government agencies discovered that bisphenol A was leaching from baby bottles. It was also migrating into liquid infant formula from cans. Since then, a host of studies have found that the chemical causes cancer, heart disease, obesity, reproductive failures and hyperactivity in laboratory animals. In April, Canada proposed classifying bisphenol A as a toxin and banning its use in baby bottles and other products for children. A number of manufacturers, such as Wal-Mart, Nalgene and Toys "R" Us, have said they will begin phasing out its use. The National Toxicology Program, formed to advise the FDA, released its report in September citing some cause for concern about the chemical's impact on the development of children, infants and fetuses. The discrepancy between the FDA and its advisory program has been confusing to consumers. Last year, the Journal Sentinel reviewed 258 research papers and found that a large majority of those studies showed bisphenol A was harmful to lab animals. Those that didn't find harm overwhelmingly were paid for by the chemical industry. Gelman, a retired manufacturer of syringes and medical filtration devices, has fought against government regulation of pollutants for years. He is an anti-regulation activist and an outspoken supporter of organizations including JunkScience.com, the Cato Institute and the Competitive Enterprise Institute that attack the credibility of government and academic scientists on such topics as global warming and hazardous chemicals. Gelman said he and Philbert talk often. He said Philbert eventually told him that he did not want to have any more discussions on the subject of bisphenol A because he was concerned about the appearance of impropriety. But, Gelman said, "He knows where I stand." Norris Alderson, the FDA's associate commissioner of science, learned of the link from the Journal Sentinel. He looked into the matter and said he was satisfied there was no conflict of interest because Philbert's salary is not paid by the donation. Still, the connection troubles scientists familiar with the chemical controversy. "This definitely raises some red flags," said Sarah Vogel, a post-doctoral fellow at the Chemical Heritage Foundation in Philadelphia who did her dissertation on the politics of bisphenol A. "Is there an expectation that Dr. Philbert would vote one way or another?" Philbert serves as co-director of the University of Michigan's Risk Science Center, which he helped develop in 2003 to assess health risks from environmental agents. Gelman said he hopes his grant money to Philbert's center will get people to consider risks of chemicals outside a highly charged political atmosphere. "Too often politicians are responding to what they think a small part of the public wants," Gelman said. Philbert said Gelman's gift was made with the understanding that it conformed to the rules and policies of the Standard Practice Guide of the University of Michigan. "No influence may be exerted on the Center, its management, direction or on the statements made by members of the Center," Philbert said. He steadfastly denied any conflict of interest. "Until today, no question has been raised with respect to my impartiality in this matter," he said in an e-mail to the Journal Sentinel. "I am not open to any undue influence and have taken on this (unwelcome) task with all due diligence and seriousness." The announcement of the Gelmans' gift was hailed in university publications as a way to position the University to become the nation's premier center to determine health risks from environmental agents. Philbert was pictured with Gelman and his wife, Rita, in publicity press about the donation. The FDA draft has been criticized by environmental groups for relying on two industry-funded studies and for selecting Philbert, who has no expertise or background in bisphenol A. There are seven members of Philbert's subcommittee. Two are from the Science Board and five were picked by Philbert and McNeil. One of those five is a faculty member at Philbert's Risk Science Center.
Genetically Engineered Animals
The F.D.A. and Engineered Food New York Times United States Published: October 12, 2008 LETTERS To the Editor: Re “Coming to a Plate Near You” (editorial, Oct. 4): We agree with you that the Food and Drug Administration’s proposed regulation of genetically engineered animals is more rigorous than its regulation of genetically engineered crops or cloned animals. Unfortunately, however, the F.D.A. will not be as rigorous as it needs to be. The agency may assess environmental impact, but it is not required to prohibit an animal that causes environmental damage. Although the F.D.A. says it will protect the animal’s health, we note that it approved the sale of milk and meat from cloned animals even though the data show that more than 50 percent of cow clones are born with an abnormality known as large offspring syndrome, which adversely affects their health. Perhaps more important, the F.D.A. proposal has one glaring defect: there is no requirement to label food that comes from genetically engineered animals. Surveys clearly show that the vast majority of Americans want genetically engineered animals to be labeled as such. By not requiring labeling, the F.D.A. will take away a consumer’s right to know and right to choose what she eats. Michael Hansen Senior Scientist, Consumers Union Yonkers, Oct. 6, 2008
Reminder: Public comment is open on "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" until Nov. 18. The 25 page document is available at www.fda.gov/cvm/GEAnimals.htm Watch the videos and visit the links on Hadcorp's GM Foods section at http://implants.webs.com/gmfoods.htm to learn more about Genetically Modified Foods. Pamela Jones Thank you for supporting Hadcorp.
