Congressional Investigation of Bisphenol A .......and silicone

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http://acronymrequired.com/pharmaceutical-interests-public-interests/

Congressional Investigation of Bisphenol A

By a.r.e. on March 28, 2008 8:02 PM

BPA -- Here to Stay (In the Environment) Bisphenol A (BPA) is a chemical used in plastic products we all use, everything from dental resins to household products, canned foods, plastic food containers, and baby bottles. Since the chemical gives plastic products useful properties, its ubiquity means that most of us have traces of it in our bodies -- 93% of populations tested have BPA in their blood. Chemists originally developed BPA as a possible synthetic estrogen so it binds to estrogen receptors, is potent at low doses, and as such it can cause deleterious health effects such as decreased sperm count, enlarged prostate, cancers, diabetes, early puberty, and immunological and developmental effects.

Legislators for the city of San Francisco recently proposed bans on bisphenol A and phthalates, however in the final bill, after the legislators had probably duly considered circumstances such as a lawsuit against the city by bisphenol A manufacturers and toy retailers, as well as sustained lobbying from chemical company lobbies, they removed bisphenol A from the bill. The states of California, land and Minnesota all produced bisphenol A bills that died in process. The America Plastics Council rigorously lobbied against all these bills and is relentless in its efforts to convince the public that there's no scientific evidence to support the dangers of health effects of bisphenol A. In fact, there are hundreds of government sponsored research studies showing health effects of BPA.

Chem Link Love: BPA-->EPA--> FDA--> APC--> RTI--> PPG

Now Congress has taken interest in Bisphenol A. The U.S. House of Representatives and Committee on Energy and Commerce chaired by D. Dingell (D-MI), and its Subcommittee on Oversight and Investigations, launched an investigation of Bisphenol-A in January. The subcommittee is focusing on BPA found in products made for infants and children like infant formula, where BPA is used in the epoxy liners of cans.

The subcommittee has sent out a series of letters requesting more information about the safety of BPA from the makers of infant formula, the EPA, the FDA, and others, including the consulting firm the Weinberg Group. The manufacturers of infant formulas responded variably that BPA was not found in formula, was found at levels considered safe, and/or BPA epoxy was the only option for lining cans*.

In a letter to the FDA the subcommittee questioned what evidence the FDA used to deem BPA safe, to which the FDA wrote back citing two studies both "sponsored by the American Plastics Council". Both of these studies were done by Research Technologies Inc. (RTI) and scientists have cited problems with at least one of the studies' methodology's. (The president and CEO of RTI Haynes coincidentally cut her teeth at Monsanto, rising to the post of director of their plastics division. In addition to her RTI post she was an adviser to the Homeland Security Advisory Committee and is a director at several companies, including PPG Industries, a company whose products include epoxy resins for cans as well as *'non-epoxy liners for the European market.')

Government and Industry Consulting, a Lucrative Formula Perhaps?

Last year Acronym Required wrote about Sciences International Inc. (SII), a small consulting firm that was fired for conflicts of interest from its contract running the NIH Center for the Evaluation of Risks to Human Reproduction's (CERHR) assessment of Bisphenol-A's safety for neonates and infants. We wrote that SI's mission included public education, such as publishing their own research on chemical safety in their own scientific journal headed by their own company executives. They cited this as "peer reviewed" research on their website and in white papers perhaps to increase their scientific credibility and assure people of chemicals' low safety risks.

The Sciences International website touted the company's abilities to leverage government contacts for corporate benefit, and their history of producing favorable regulatory outcomes and public opinion. For example SII described their risk analysis work used to influence lower regulatory standards for clean air for the EPA. On one version of their site, SII wrote: "Sciences' methods development work is often sponsored by public agencies, such as the U.S. EPA, while applications work is most often for the private sector where agents of particular concern need to be addressed."

In that post in 2007, Acronym Required wondered about the nature of regulation in Washington when the company NIH chose to assess the safety of BPA for neonates and infants that seemed to be more focused on industry objectives: "[sciences International scientists]...have applied a biologically-based model approach to coke oven emissions for the industry and derived an alternative cancer potency factor which has been accepted by the EPA. We believe that our ability to utilize accurate dosimetry and pharmacodynamic models in tandem in risk assessments provides unique opportunities to the chemical industry",

Acronym Required is heartened to know Congress is paying attention. Similar to the SII example, the subcommittee explored the marketing website (since removed) of the chemical industry consulting company the Weinberg Group. As per the subcommittee's quotes in their request for more information, the Weinberg site was a virtual rodomontade of feats pulled off by Weinberg on behalf of chemical companies versus government regulatory agencies, all of which seemed to skew scientific integrity in favor of client "results".

The subcommittee sent a letter to the Weinberg Group asking about a series of case studies that included verbiage about various projects, such as swaying an FDA decision on a drug with "life-threatening adverse events", and being "at the forefront" of public relations addressing endocrine disrupting chemicals "leaching from food containers", and contained in "children's toys". (the latter sounding a lot like bisphenol A.)

The subcommittee requested information on details of another letter from the Weinberg Group to DuPont de Nemours referring to their work on the chemical perfluorooctanoic acid (PFOA), a carcinogenic chemical used to manufacture Teflon. Weinberg says they produced scientific papers on "PFOA, junk science and the limits of medical monitoring", handled scientific testimony and expert witnesses for court cases, and "[reshaped] 'the debate by....analyzing existing data, and/or constructing a study to establish not only that PFOA is safe over a range of serum concentration levels, but that it offers real health benefits.'" PFOA Dupont has been fined by the EPA and sued for its PFOA activities including suppression of safety information for 20 years.

The committee has now widened its scope beyond BPA. Their letter to the EPA's requested information about the dismissal of Dr. Deborah Rice as the chair of an external review panel that was investigating a type of polybrominated dephenyl ether (PBDE), decabromobiphenyl ether (deca) used as a flame retardant. Rice's sacking followed a letter the EPA received from the American Chemistry Council (ACC) complaining that she had testified for the State of Maine on the dangers of deca. The ACC called her expertise a "conflict of interest". The subcommittee's letter challenged the EPA's firing and included 9 incidences of people from industry who testified on various EPA chemical safety panels despite real conflicts with obvious pecuniary connections in the chemical industry.

It will be interesting to see where this goes beyond the obvious -- subcommittee members burnish their environmental credentials while giving companies serving both government and chemical industries another lesson on the pitfalls of producing zealous marketing material for the company websites. We remain optimistic that the inquiry will produce results and anyway, the public outing of information is always useful. Happy belated Sunshine Week.

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Acronym Required wrote about bisphenol A in the following posts:"Phthalates and Bisphenol A: Media and Politics" (November, 2007) Plastic Bottles- Protecting Your Baby, by the ACC (July, 2005) "Bisphenol-A and Phthalates Bill in California" (January, 2006) "San Francisco Bans Bisphenol A, Phthalates" (July, 2006) "San Francisco Phthalates & Bisphenol A Ban" (November, 2006)"Sports Retailers Stop Selling Polycarbonate Bottles" (December, 2007) We wrote about PFOC in these posts: "PFOC: Likely Carcinogen" (January, 2006)"Dupont, The Teflon Company" (December, 2005) "Slick Company Stands behind Teflon"(July, 2005)

Corporate Interests, Public Health & Bisphenol A (Part I)

By a.r.e. on May 13, 2007 8:01 AM

Sciences International: Health and the Environment

It reads like the classic story of the fox guarding the hen house. Sciences International, (SI), a small company with clients like the American Chemistry Council, Dupont, WR Grace, and Exxon Mobil, also ran the Center for the Evaluation of Risks to Human Reproduction (CERHR), a project in the NIH's toxicology program (NTP) charged with deciding which environmental toxins pose health risks to reproduction and the development of unborn children.

Science International wrote a report last year on bisphenol A's (BPA) safety, which came to the attention of the public and congress when the Environmental Working Group (EWG) alleged that the conclusions were biased towards industry research studies in a Feb. 28th letter to the NIH hiring director.

Reproductive health and development, like children's health, is always a lightening rod for public attention, and increasingly, so is bisphenol A. Science International's review of the literature on bisphenol A caused enough concern among scientists, members of congress, and public health official that in the ensuing brouhaha, the NIH's National Institute of Environmental Health Sciences (NIEHS) terminated Science International's $5.24 million contract running CERHR. After the termination, Herman Gibb, the president of the approximately ten person company insisted to the Washington Post, "I don't ever believe in my heart of hearts there was a conflict of interest".

When the story made headlines last month it seemed to confirm our worst fears. NIEHS accepted a contract apparently written by Science's International to run CERHR without listing company's conflicts of interest, an arrangement that seems ripe for abuse. Acronym Required looked into the details of the story, which do little to allay those concerns. Had SI, working for the FDA, the NIH, and now CERHR, as well as significant numbers of chemical companies perhaps systematically watered down environmental safeguard regulations over the past decade to suit it's corporate clients? The Science International incident reveals the potential pitfalls of blending government and industry work, both for companies like SI and for public health and welfare.

Science International's Bisphenol A Study

Bisphenol A binds to estrogen receptors and can cause deleterious health effects such as decreased sperm count, enlarged prostate, cancers, diabetes, early puberty, and immunological and developmental effects. It's potent at very small doses and ubiquitous, found in everything from dental resins to household products like canned food, plastic food containers, and baby bottles. Today 95% of the population carries detectable levels of the chemical in their blood and hundreds of scientific research reports indicate BPA's toxicity to humans.

According to critics, Science International's first draft report on the health effects of BPA was biased. The report concluded the opposite of what hundreds of government funded BPA studies conclude. A survey of the research on bisphenol A effects shows that 92% over 100 (109/119) government studies on BPA found adverse health effects, whereas all 11 industry funded studies found that BPA caused no adverse health effects. Scientists critical of the Science's International report said that the review panel favored industry results while ignoring unreliable industry results base on unscientific methodologies like lab protocols that used no controls.The EWG also questioned whether SI's principal scientist could neutrally evaluate the dangers of bisphenol A (BPA) since he had worked with Dow Chemical and the European Chemical Industry Council -- entities with business interests in BPA.

Sciences International wrote the meta-study of the research studies, then chose the panel who reviewed their work. While SI said that the final conclusions as to the hazards of bisphenol A during reproduction and development were the panel's, when Acronym Required looked at the panel's edits of Science International's first draft they were stylistic, not scientific.

A New GovBiz Model?

Can a company consult to the chemistry industry and also evaluate the safety of that industry's products -- without bias? Can we trust government, industry partnerships to evaluate science when their contractual agreements cede the very principles we use to ensure integrity in research and in business, like peer review, conflict of interest statements, and competitive bidding processes? An older CERHR website described the partnership between SI and the CERHR:

"Under the direction of Shelby, Ph.D., Director, CERHR at NIEHS, scientific and support staff at NIEHS and Sciences International, Inc. operate the Center for the Evaluation of Risks to Human Reproduction (CERHR). The Principal Investigator, Scialli, M.D., leads the scientific and support staff at Sciences International, Inc."

In addition to the BPA report, SI also produced reports profiling the safety of many other chemicals during their contract with CERHR. Sciences International consulted for 10 years with the FDA and the EPA, and worked with corporate clients like GE, Union Carbide, Hoechst Celanese, Otsuka Chemical, Cytek Industries, a plethora of law firms, and industry groups such as the American Chemical Council, Synthetic Organic Chemical, the Acrylonitrile Group, and the American Petroleum Institute. The EWG wrote in one letter to the director of the National Toxicology Program (NTP), about the "ethical concerns surrounding this contractor that involve apparent financial ties with the chemical industry..." Indeed, when we perused SI's older websites, they wrote clearly about the work they performed:

"Nowhere is Sciences' exposure assessment experience more evident than in EPA's new Clean Air Act residual risk program...[]...EPA generally applied, for the first time, this guidance in a recent residual risk case study of the secondary lead smelting industry. That guidance, or some variation of it, will be used to address residual risks for all remaining industrial categories with MACT standards. Working for a coalition of seven major trade associations (Chemical Manufacturers Association, American Petroleum Institute, American Coke and Coal Chemicals Institute, American Iron and Steel Institute, National Mining Association, American Forest and Paper Association, and Association of International Automobile Manufacturers), Sciences prepared detailed comments on the case study approach and results, and presented a report on March 1, 2000, to EPA's Science Advisory Board (SAB). The ensuing SAB draft meeting report clearly showed that Sciences' comments played a major role in their analysis, which included a recommendation to revise the case study and return it to the SAB for a second review. Sciences also developed a vastly improved exposure and risk assessment method for evaluating coke oven residual risks and recently gathered residual risk data on the gasoline distribution industry for the American Petroleum Institute. Sciences' staff includes an ex-EPA manager who led for six years the hazardous air pollutant regulatory efforts for the Office of Air Quality Planning and Standards (OAQPS). In that position, he managed the initial development of the Human Exposure Model and was a member of the group that wrote the Agency's initial exposure and risk assessment guidelines. Earlier, he conceived of and managed the original 4-year study of the organic chemical manufacturing industry that ultimately formed the basis of the Hazardous Organic NESHAP (HON), he also..."

Naive marketing hype, or conflict of interest? If boasting to chemical companies about your company's power to have its way with government is inherently wrong, then for years Sciences International promiscuously flouted the rule in marketing material on their public website. Clearly, SI had strong ties to the chemical industry. But was it some especially insidious arrangement, a punishable offense? Or is this just how the U.S. government works?

Many companies who contract with the government also work for business clients who gain honest efficiencies and insights from consultants' familiarity with government rules and ruminations. In general, we wouldn't be shocked to find private contractors running public agencies, because privatization is a goal of recent governments -- both Democrat and Republican. The increasingly fuzzy demarcations between private and public entities constitute contracts in Iraq, New Orleans, U.S. National Parks and atmospheric weather monitoring operations. Overall, companies who mix business relationships with government work fare well these days. The Homeland Security Index, for instance, which includes SI's parent company Tetra Tech, rose 5.3% last quarter, whereas the S & P 500 posted -.86%, the DJIA; -1.70%, and Nasdaq; -1.57%. Are these corporate/public relationships the new normal, or something else, given that SI was summarily fired?

The Etiquette of Serving Two Masters

In one of two good pieces Nature wrote on the subject a couple of weeks ago, ("Regulators pull contract for chemical review" 446;958-959, Apr. 26), the author noted, "there's a legal grey area" that contractors navigate in dealing with clients. Nature makes a point. If you find SI's client mix disturbing, then the client list of most law firms or consulting companies might also disturb you. How are consulting companies supposed to separate the clients? Nature quoted one toxicologist who pointed out that the rules are unclear, even for companies like Sciences International, he said, who (as Nature summarized) "try to segregate industrial and government work to limit conflicts".

Contrary to what the consultant assumed, however, and perhaps leading to to its undoing, Science's International did not convincingly "segregate" it's constituencies. Here are some excerpts from their 2005 site.

"...EPA estimated very high cancer risks in one assessment of a regulated industry. Sciences developed a much more accurate exposure model and also reassessed the cancer unit risk estimate using much more recent worker epidemiology data and biologically-based modeling approaches, originally developed by Sciences' experts. Sciences' revised study showed that actual risk estimates were two to three orders of magnitude lower than EPA's earlier conservative estimates...." "Sciences has unique experience in assessing health risks due to inhaled air toxicants. Sciences' experts were selected by the EPA, as sole source contractors, to work on the underlying methodology by which the EPA develops its safe levels of exposure to chemicals by the inhalation route..." "...Through a contract with the EPA, Sciences carried out the quality assurance and validation of BMDS, making several critical recommendations that influenced its development. ...[]...Sciences is also currently involved in a similar effort for EPA's recently developed Categorical Regression (CatReg) software...[]...A 5-person Sciences International team is writing the EPA Benchmark Dose Guidelines. With all these considerations in mind, we are in an excellent position to apply the BMDS and CatReg methods to particular substances that would benefit from these approaches." "[sciences International scientists]...have applied a biologically-based model approach to coke oven emissions for the industry and derived an alternative cancer potency factor which has been accepted by the EPA. We believe that our ability to utilize accurate dosimetry and pharmacodynamic models in tandem in risk assessments provides unique opportunities to the chemical industry."

SI's statements seem clearly intended to sway a corporate audience. SI clearly tries to establish itself as an ally to the chemical industry, "working on underlying methodogies", a company who changed EPA estimates "two to three orders of magnitude lower", who made "critical recommendations" that "influenced" standards, and created "unique opportunities [for] the chemical industry". Under their "sole contractor" status, SI and its government clients had perhaps short-circuited the bidding process. EWG highlighted portions of a 1999 a letter from SI to RJ Reynolds, where the company wrote:

"Our experience in supporting these government agencies in the advancement of science gives Science a unique credibility to negotiate with regulators of behalf of our private sector clients, to speak authoritatively in the scientific community, and to be accepted in legal proceedings and by the public."

According to Sciences International's own self-promotion, it had broad influence in many agencies, which benefited chemical companies. But without knowledge about the specific science behind SI's marketing, it's difficult to discern what changes they made. It would require a research team to analyze whether those changes were indeed detrimental to health -- whether they are a sleight on behalf of industry, or whether SI simply refined the EPA's less accurate or outdated measurement techniques. Maybe the government standards for indoor and outdoor air, water, etc., did benefit from adjustments based on SI's expertise.

Toxic Puffery

Many big companies in Science International's position keep a more sanctified public front, a website splashed with value concoctions of their love for children, concern for animals and stewardship of the great outdoors. Naively or greedily, Sciences International tossed discretion to the wind and instead promoted their business, aggressively emphasizing the their influential role in government and their willingness to leverage that value proposition for corporate clients.

SI redesigned their website a couple of years ago, and seemingly came to its corporate senses, including a more publicly agreeable photo collage of children and trees, and a client list scrubbed of corporate entities. The new site brags less about the company's experience drafting "more accurate" measurements of exposure assessment and dose-response for the EPA. But sometimes information on the internet doesn't die as cleanly as people might wish. Occasionally ghosts of past lurk about to startle the unsuspecting with a bump in the night, a startling reminder of pasts long since banquished. SI's old website revealed SI's habit of not separating clients. The entire business model, in fact, leveraged conflicts of interest.

"...Sciences' methods development work is often sponsored by public agencies, such as the U.S. EPA, while applications work is most often for the private sector where agents of particular concern need to be addressed. Sciences' knowledge of the acceptable regulatory methods and practices can facilitate ultimate acceptance of these analyses for the private sector."

Dr. Gibb insisted that in cases where SI's government work with one chemical coincided with corporate work, consultants on one contract had no knowledge of what their cohorts were doing on another. How shall we interpret that? On one hand, consulting can be like that. On the other, this was a ten person company. The president doesn't know what people are working on? He complained to the journal Nature that the NIEHS action was unfair "with a capital U". Perhaps so, but then it would probably be fair to say that for whatever their intents and purposes, SI's record just happened to look fishy with a capital F.

Despite the challenge of sorting out what the company was really up to, SI's work is fraught with appearances of conflict of interest. As EWG pointed out, the NIH was remiss not to look at Sciences International's website years earlier. Even a half-hearted glance would have hinted at a slew of conflicts.

According to the Los Angeles Times, in response to NIH inquiries about their duel roles, Sciences International acknowledged that they had prepared Federal health reviews for styrene, ethylene glycol, and soy formula, while working for a styrene trade group, the American Chemistry Council, and the United Soybean Board. However, the president, Herman Gibb, told the Washington Post that he had only learned "last month", because of the NIH's information request request, that the company had worked for the chemical trade companies while simultaneously working to ascertain safe levels for those chemicals.

(Read the continuation of this story, starting with "Vanity Press and Educating the Layperson", in the next post)

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Acronym Required previously wrote about bisphenol A in the following articles:

Plastic Bottles- Protecting Your Baby, by the ACC (July, 2005) Bisphenol-A and Phthalates Bill in California (January, 2006) San Francisco Bans Bisphenol A, Phthalates (July, 2006) San Francisco phthalates & Bisphenol A Ban (November, 2006)

Platinum Bonds and Silicone Implants

By a.r.e. on August 16, 2006 3:46 PM

The Food and Drug Administration had convened on the subject of silicone breast implant safety:

"But as the panel members spoke up one by one, it became clear that they were far from certain about the risks and benefits of the devices. The first scientist to speak quoted the prophet Isaiah and writers Ralph Waldo Emerson and before calling for more testing. The second said it was impossible for women to make an informed decision about whether to use implants because there was not enough information. The third complained that the issue should have been resolved years ago.

Unable to agree on how to interpret the jumble of opinion, fragmentary data and scientific speculation, the panel members finally threw up their hands in frustration."

So reported Malcom Gladwell for the Washington Post in March, 1992, perhaps before he reached a tipping point, blinked, and got off that beat. ( "Breast Implants; After a Decade of Controversy, Key Questions are Unanswered and the Future of the Device is Unresolved"). In the intervening fifteen years, scientists have continued to debate the safety of the implants. But doctors and patients say they prefer silicone over the currently available saline implants because "silicone implants feel more natural and look better". Is the time once again ripe for silicone implants?

Scary memories of silicone implants from Dow Corning, which the Economist said "earn[ed] a lifetime achievement award for the courting of controversy", in "America's Most-hated Companies: The Very Bottom Line" (Dec 20th 2005), have faded. The company once besieged and routed by the legal repercussions of leaking breast implants in the 1990's, has reorganized, emerged from bankruptcy, paid out at least 3.2 billion dollars to plaintiffs, and is once again courted as a Wall Street "darling". Although the scientific research on silicone implant safety is no less controversial then it was 15 years ago, the FDA is once again edging towards approving silicone implants.

Unfortunately, if silicone implants are approved, women will still be challenged in their quest to make informed decisions about implants. Who should they trust? Their surgeons? Scientific research in prominent journals? The FDA? If women turn to the internet for safety data, they will quickly find reassuring answers from sites like LookingYourBest.com, or CosmeticSurgeryTimes.com. The latter site features interviews with well-tanned, well-fed doctors who report that a women's safety is their primary concern. A more time consuming search might turn up more alarming news, such as the controversial paper in the journal Analytical Chemistry, widely covered in the national press.

The journal published a paper on silicone breast implants last May which provided evidence of platinum leakage from the implants. The authors proposed that the blood, urine and hair of 18 of 23 women who had implants contained higher levels of platinum then the controls. (Lykissa, ED and Maharaj, 2006. Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS. Anal. Chem. 78:2925-2933). Lykissa and Maharaj asserted that the platinum was found in oxidized reactive states, states that are associated with toxic physiological affects.

After that widely reported publication, Analytical Chemistry then published two articles that criticized the study. When the journal's editors quasi-retracted the paper, did that soothe readers, potential patients? It actually should have alarmed them. One was written by a chemist at Dow chemical, Lane. Lane has long been a supporter of silicone implants. He had testified about implants to the FDA, the National Institute of Cancer, and "other similar venues", but he had not been an expert witness, said the journal's disclaimer. Also, "Dow Corning Corporation has not manufactured silicone breast implants since 1992." Lane might be an unbiased scientist, yet he has long claimed that silicone implants are "harmless". Dow Corning might not currently manufacture implants, but that is irrelevant since as a corporation it is compelled to mount an active defense that 'the implants are and always were safe'. , the other expert in the 'field' who wrote in to provide criticism of the paper was a 'neutral commenter' - according to Analytical Chemistry. However his background is not 'neutral'.

" ...he provided information on the chemical nature of the platinum in silicone breast implants at the FDA panel hearing on breast implants April 2005 on behalf of Inamed Corporation. He was also a member of Health Canada regulatory advisory panels considering applications by Mentor Corporation and Inamed Corporation for new breast implant models in March and September 2005."(Analytical Chemistry 78 (15), 5609 -5611, 2006.)

and Lane leveled specific criticism at the chromatography methods the authors used, as well as the authors' interpretation of their statistics. The original report's conclusion that "Pt levels [in the experimental group] exceed that of the control group" was spurious, and Lane said. According to them, the statistics in the paper proved there was no difference in platinum levels between the control and the implanted groups.

Clearly and Lane represent the interests of silicone implant manufacturers. But what are Lykissa's interests? Once a doctor at Baylor University, he now owns a toxicology lab and has been trying to show the presence of platinum for years. In 2000, the Minnesota Star Tribune reported that Lykissa had identified reactive platinum in implants that had been removed from women. (The FDA discarded that research for the same reasons.) His latest research was sponsored by a non-profit group dedicated to fighting the use of silicone implants. We can only speculate how he might benefit from the research.

A couple of weeks ago, when editors for Analytical Chemistry published a warning that Lykissa's and Maharaj's evidence flunked "this journal's standards", we wondered about the truth. The editors of Analytical Chemistry chose to throw a lot of doubt on the publication but do we really know why? The journal didn't accommodate a rebuttal from the original authors when they published Lane's and Brook's critiques. Should we trust that the science was lousy? Or should we wonder whether the journal was swayed by the critics' affiliations with Dow Corning Corporation, Mentor Corporation and Inamed Corporation?

The FDA is still wobbly on the implant safety issue, but we can see which way their leaning. A couple of years ago, in "FDA Breast Implant Consumer Handbook - 2004 (Specific Issues To Consider), the agency provided ample warnings about the implants. Among them, the FDA said that implants could interfere with cancer detection via mammograms, and that mammograms might cause implants to rupture. Women "may not be able to breastfeed" their babies, and there were safety risks to unborn children and nursing infants. There was a "...slight increase in deaths due to suicide", the FDA said, and there was a risk of "Gel bleed". The 2004 report also stated that although "platinum leaches (leaks) from these implants and is present in the surrounding tissue" causing "concern" there was no evidence that "leached platinum causes illness in women with breast implants." Today, two years later, the FDA is hardly more confident about the platinum risks and they continue to call for more research:

"Some studies have shown that small quantities of platinum may bleed through an intact implant shell and be present in trace amounts (parts per billion) in surrounding tissue. However, these results need to be confirmed using a larger number of subjects...Even if the analytical results of large, well controlled studies were to show relatively high levels of platinum in biological samples, the toxicological significance would still need to be determined."

For now, the FDA cites , the consultant for the silicone implant manufacturer, who votes: "The experimental evidence supports the conclusion that there are no clinical consequences of the platinum in silicone breast implants". The FDA concludes:"[The]FDA concurs with Brook's conclusions.".

So while it seems that neither the FDA nor the journal can really judge the veracity of competing conclusions in the available research, both the journal and the FDA nevertheless appear to favor the opinions of scientists with vested interest in promoting implants. The FDA has repeatedly discounted Lykissa's work. Yet he is not the only scientist with these concerns. Where are the "neutral" scientists? After a quarter of a century, women are still confronted with a sea of confusing, biased data in the leaky boat that is science research on silicone implants.

On a final, slightly different note, breast implant advocates might have more evidence for for their arsenal of reasons for why women should trust the implants. MSNBC reports in "The Breast Job That Saved a Life", that a women hit with shrapnel from an exploding rocket was spared piercing of her heart by her silicone breast implants.

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Acronym Required previously reported on silicone breast implants in Silicone Implants -- A Health Risk to Choose?, and Silicone Implants and the FDA (more).

Silicone Implants -- A Health Risk to Choose?

By a.r.e. on May 24, 2005 3:02 PM

In 1992 the Food and Drug Administration (FDA) took silicone implants off the market because of concerns about the health affects of leaking silicone when the implants burst, which they often did. The manufacturers were not deterred though. From the late 1990's on, they persistently lobbied the FDA to get silicone implants allowed back on the market.

The FDA periodically reviewed available clinical safety data, however analysis of the data wasn't straightforward and the results from all sources; studies, patient's and doctor's testimonies, and silicone manufacturers' testimonies were often contradictory. For instance in 1999 the Institute of Medicine published a literature review of clinical data that although health problems with implants were often recounted by patients and documented in numerous clinical and research studies, they concluded there was no link between health problems and implants. Many were suspicious of this conclusion since there were so many immunological, connective tissue, neurological diseases and systemic complaints, as well as conditions in breast feeding children that seemed be contracted from moms with silicon implants. Some people criticized IOM for considering too much data produced by the manufacturers.

There are passionate advocates for and against silicone implants and each side argues that public opinion, the media, junk science or corporations bias the views' of the other. The truth may hard to sort out but recent evidence reported in Sunday May 22, 2005, The New York Times indicates that the manufacturers who are providing the silicone breast implant safety data to the FDA may not be the most reliable source of the information for evaluating the health affects of implants or potential market suitability.

The FDA is currently reviewing two manufacturers safety data, Mentor's and Inamed's. On April 13, 2005 the an FDA advisory committee voted (7-2) to approve Mentor's breast implants for re-entry in the market, with some conditions. But despite similar results, the same panel voted against Inamed's implants. The FDA committee is being criticized for relying on Mentor's own reports disputed self-reporting of low rupture rates.

The Mentor data is controversial because of other documents recently released to the New York Times. These documents show discrepancies between accounts from Mentor's employees and the records produced by the company at the hearing. The NYT reported that, "In its recent filing with the FDA, Mentor said that it received a total of 8,060 rupture complaints from 1985 to September 2003". However according to the NYT, one of the employees in their deposition, "said that Mentor received about 6,000 complaints of ruptured implants in each of her three years there."

A plaintiff testified a case against Mentor before the Senate in 2002 (HTML version at senate.gov) that as a participant in a post-operative clinical study her health complaints to her surgeon, the manufacturer of the implants and the FDA were ignored. A longer version of the complaints is here.

The plaintiff, whose case was dismissed by the court, just turned over depositions from two former Mentor employees to the NYT. The ex-employees reported, that they had falsified records, that often the silicone was contaminated and sometimes "contaminated with fleas", and that workers sometimes "[hid] defective implant parts above ceiling tiles so managers and inspectors would not realize how often the plant failed to make the parts properly". Why didn't the employees speak out sooner? Reportedly:

[T]op executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products "are in the customers".

As if the leaking, defective, and flea-infested implants weren't enough to dissuade the FDA from allowing them to re-enter the market, a study released in April shows that silicone from implants does enter the lymph nodes. The study, published in the American Journal of Surgical Pathology, reports the pathology of 96 women who had breast plants removed. The results of this study were reported to the FDA on April 12, 2005 according to Public Citizen:

"Although there was evidence of implant rupture in only 47 (49%) of these women, lymph nodes from 86 women (90%) contained droplets consistent with consistent with silicone. A control group consisted of 12 women with breast surgery mainly associated with breast cancer but without silicone gel implants. None of the lymph nodes from these 12 women contained silicone droplets. Similarly, microscopic examination of the lymph nodes revealed abnormal cells, "foamy macrophages," occurring much more frequently in women with silicone gel breast implants than in the control group."

The National Organization of Women is among many groups who weighed in on the matter. NOW sent a a letter (PDF) (PDF!) to Congress questioning the bias of the FDA committee, the Mentor's lack of response to specific toxicity data requests, and the company's skewed clinical trial patient selection protocols.

Despite the allegations of document manipulation, the unsavory clinical evidence, and the FDA's questionable review process, the demand for implants continues to rise. The Institute of Medicine estimated that 1.5 million women had breast implants as of 1997 and 70% of those were cosmetic procedures. The San Francisco Chronicle reported in "Limiting Options for Breast Implants" (May 12, 2005) that many women testified to the FDA in favor of allowing implants in 1992 and in 2003, and last month at the latest hearing. The SF Chronicle reported that the women often reiterated the theme of an American Society of Plastic Surgeons marketing slogan, that breast implants were "A Women's Right to Choose". Co-opting the pro-choice women's rights slogan and recruiting women to chant it on behalf of manufacturing companies who produce silicon implants associated with multiple health risks, seems particularly perverted.

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