Breast Implant Public Health Project
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The Breast Implant Public Health Project (BIPHP) was set up and run for Dow Corning by George L Carlo through his Health and Environmental Sciences Group when a scare arose about the possible dangers of silicone breast implants.
It was run at HESG by Martha A Embrey who was effectively the supervisor of Carlo's bevy of young female researchers who provided the necessary staff for his Washington DC operations.[Also Center for Risk Sciences and Public Health, The George Washington University School of Public Health.]
See a related article Confidence Game: Burson-Marsteller's PR Plan for Silicone Breast Implants
Documents & Timeline
1960-63 Breast implants first came onto the market in the early 1960s, but not then subject to any agency oversight.
1976 The FDA takes control of breast implants under the Medical Devices Amendment to the Food, Drug, and Cosmetics Act. At the discretion of the FDA a manufacturer of silicone-gel breast implants could be required to provide data on safety and effectiveness established by animal studies. But since they were already on the market, this requirement was "grandfathered" (assumed to be OK) <h> 1988 With a rise in concerns following anecdotal suggestions of systemic diseases following breast augmentation by direct injections of silicone (mainly into Japanese prostitutes), the FDA announced that the manufacturers should submit evidence of safety of their products within 30 months.
1990 The breast implant controversy erupts in the public media.
- The CBS program "Face to Face with Connie Chung" interviewed women who believed that their breast implants have caused an autoimmune disease. Chung blamed the FDA for inadequate action.
- Congressman Ted Weiss (D-NY) held public hearings on the claims.
- the Nader 'Public Citizens' Health Research Group (headed by Dr Sidney Wolfe) publicised the issue.
Following this publicity Dow Corning claimed to have had 20,000 lawsuits filed in two years.
1991 Dec David Kessler, FDA Commissioner, gave the manufacturers 90 days to provide evidence of implant safety
1992 early A San Francisco jury awards a woman $7.34 million. She claimed her breast implants cause mixed connective-tissue disease. Claims made at the trial (never really established) were that Dow Corning had been aware of the dangers but suppressed the evidence.
1992 Mar The FDA believes the manufacturer's 'proof of safety' is inadequate. An FDA Advisory Panel is convened to advise on future regulatory activities.
1992 April 16 After holding public hearings the FDA Advisory Panel advises Kessler to ban silicone implants entirely until they were proven safe. Saline-filled implants were to remain for reconstruction after radical cancer surgery.
However, while Kessler was careful to spell out that "lack of evidence of safety, is not proof of harm" the public reaction was the opposite. A million or more women had had implants, and his "reassurance fell on deaf ears." [2]
- Many doctors and biomedical scientists now gained media exposure with concocted theories as to how silicone affected the immune system. None of these was established by research.
1994 Apr-May: A class action suit over breast implant ruptures. This was progressively filed against the major manufacturers (Dow Corning, Baxter, Bristol-Myers Squibb and 3M) who eventually agreed to settle the action by providing $1.2 billion for existing claimants and $1 billion for their lawyers. They also established a future-fund of $2.25 billion for women who may later prove to have been injured by the implants.
The agreement specified that women no longer needed to prove their illnesses were 'caused' by the implants - they only needed to provide medical records and a doctor's diagnosis (which proved to be an open invitation to shysters). Consequently some medico's set up practices which specialised in providing diagnoses for a variety of health conditions where silicone was identified as the cause. The lawyers queued up to send these doctors potential claimants, and soon nearly half the number of women with breast implants registered for this settlement.
Dow Corning (which was half-owned by Dow Chemicals) was the largest manufacturer, and it reacted during the following 12 months by filing for Chapter 11, which gave them bankruptcy protection. The lawyers then turned their sights on Dow Chemicals since Dow Corning was no longer functional.
1994 June:A retrospective study done by the Mayo Clinic was published in the New England Journal of Medicine (NEJM). It had compared a cohort of women with implants to a matching cohort of women with with any of 12 connective-tissue diseases (and a variety of signs and symptoms). It was a small study which found no statistical evidence of a link.
1994The British Department of Health's Medical Devices Agency issued a review of the published studies and found that the quality of most of the research was "disappointingly poor ... [and concluded that] ... there remains no scientific evidence from the literature of any increased risk of connective tissue disease associated with silicone gel breast implants."
1995 June The NEJM publishes another retrospective cohort study, the Nurses' Health Study. It also found no evidence of a connection.
1995 Jun 13 Peggy Carter at RJ Reynolds is writing to the top misinformation team in the company, Tom Griscom, Chuck Blixt and Dan Donahue about her observations at a recent Manhattan Institute seminar on "Junk Science and the Law".
- Walter Olson and Peter Huber at the Manhattan Institute were both in the pay of Philip Morris and promoting their junk-science propaganda. She comments on some in attendance:
- Public Citizen Research Group: Dr. Sidney Wolfe's name also came up repeatedly for his $750 kit on how to sue breast implant manufacturers. His links to the plaintiffs' bar were also noted several times. Interestingly, no one addressed advocacy groups' roles in the junk-science
problem.
- Plaintiffs' Bar/Tort Reform: With the exception of being outspoken about the need for tort reform, Dow Corning hums the same tune as we do on class actions: that they aren't saying consumers can't or shouldn't sue, but that class action litigation ought to be used appropriately
to settle a common claim by multiple plaintiffs for a common set of circumstances. Hazleton, you'll see, dubs plaintiffs' bar as "Litigation, Inc."
Several interesting tactics by the plaintiffs' bar we may want to note:
- (1) they created implant support groups which were nothing more than a foil to identify potential class members, and
- (2) absent any epidemiological studies showing a relationship between the auto immune system and breast implants, they've developed claims of atypical symptoms that aren't going to show up in epi studies
- The tobacco industry was beginning to see the breast implant problem as potentially valuable to them in their fight against restrictions on smoking. The breast implant silicone problem was still highly disputable - so bother the implants and ETS could be grouped together as victims of junk-science.
1995 Oct: Charlotte Mahlum won a $14.2 million jury verdict in Nevada against Dow Chemicals over ruptured breast implants made by their subsidiary Dow Corning. [The award was later struck down to $4.2 million.] The action against the parent company became possible because Dow Chemicals had performed the toxicology tests on the silicone compounds. However the trial's presented research evidence did not support the case that silicone produced connective tissue disease.
This was the first major win against Dow Chemicals (which didn't make or sell breast implants) since its subsidiary Dow Corning had filed for Chapter 11 bankruptcy protection following a 1994 class action with 10,000 participants.
- [The high punitive decision was seen as more in the nature of 'pay-back' to Dow for it's Chapter 11 filing.]
The unexpected success of this action against Dow Chemicals made the industry sit up and take notice, since they had assumed that the bankruptcy filing would have ended any possibility of class actions. About a year after this, Carlo was hired by Dow Chemicals to run the Breast Implant Public Health Project.
1995 Nov /E Late in this year, the Federal Focus group (headed by Thorne Auchter, James J Tozzi and perhaps George Carlo) established a subsidiary called the Center for the Study of Environmental Endocrine Effects (CSEEE)
- [Probably for Dow Chemicals, or for a group of companies from the Chemical Manufacturer's Association]
The CSEEE was supposedly a 'non-profit' dealing with hormone-mimics in water, and health effects of the kind caused by the DDT-breakdown products, furans and dioxins and atrazine.
The silicone breast implant rupture problem had triggered a fresh interest in the possibility of hormone-mimics/endocrine disrupters causing breast cancer, among other problems. That fed back into fears of auto-immune problems resulting from the silicone in breast implants. Both the real science and the lay science all became very confused. This was not helped by the knowledge that the implants were made by the company which gave the world Agent Orange, and denied the obvious for 40 years.
The guff at the web-site said that the CSEEE's...
"... basic mission is to provide the public with objective and unbiased information on the state of scientific knowledge regarding issues of 'endocrine disruption', and to conduct, or sponsor the conduct of scientific research in that area."
The original website at endocrine.org/ appears to have ceased functioning in 2003 but it later existed as a reference page on Federal Focus website. This said:.
The core of CSEEE was an academic science panel made up of two scientists who are prominent in toxicology and pharmacology relating to the human endocrine system (Drs. William J Waddell and John A Thomas), and two in wildlife toxicology (Drs. William H Benson and Keith Solomon). This information was also sent to Philip Morris
- [Note how the same names keep turning up!
- Keith R Solomon was an old Canadian (Uni of Guelph) associate of Carlo and Munro on dioxins,
- William J Waddell also served on the GEP - London Principles review panel for Federal Focus.
- William G Keely was a staff lawyer who had once worked with the US Department of Interior. He ran both the London conference and the CSEEE projects.
- Daniel M Byrd, a toxicologist had been on the EPA's Scientific Advisory Board, now staff.
- Joel Rosenblatt had worked for Jim Tozzi when he ran the OIRA division of the Office of Management and Budget in the Reagan White House.
1996 /E As Director of the Breast Implant Public Health Project, Carlo co-authored a study on the risks of breast implant rupture sponsored by Dow Corning. Dow Corning which made silicon implants was a joint venture between Dow Chemical and Corning Inc. It was sued in the mid 2000s for personal damages caused by ruptured implants, but the actions were dismissed. [6]
1996 Nov The CSEEE sponsored and arranged a symposium on the science of environmental endocrine effects (both human and ecological) at the annual meeting of the American College of Toxicology held in November 1996 at Valley Forge, Pennsylvania.
Five papers reflecting the presentations made at the symposium were later published in the January-February 1997 issue of the International Journal of Toxicology by John Thomas, Keith Solomon, William Benson, William Waddell, and Daniel Byrd.
Note that George Carlo was occupied during most of this year running the Wireless Technology Research (WTR) project for the Cellular Telecommunications Industry Association (CTIA) -- See Part 5, but he still had time for Dow Chemical projects ]
1996 Jan The Elizabeth Whelan/Fred Stare scientific astroturf, the American Council on Science and Health (ACSH) also got into the Dow Corning silicon breast implant defence business by publishing a paper "Silicon Breast Implants: Why Has the Science Been Ignored?" It was written by the well-known penny-a-word hack journalist Michael Fumento.
At the time Dow Corning was fighting the FDA's 1992 semi-ban on cosmetic use of silicone (as distinct from saline) implants. [9]
1996 Jan 16 The Chicago Tribute article "How the Media and Lawyers Stir Up False Illness"by Michael Fumento, journalist, tobacco lobbyist and TASSC associate of Steve Milloy and George Carlo. He also promotes the Nocebo effect and the safety of breast implants.
A Nocebo is a negative placebo. That is, while a placebo pill makes you feel better though unbeknownst to you it's only made of sugar, a nocebo makes you feel bad though physiologically speaking it shouldn't be able to. Nocebos don't get talked about much, which is why the [Wynder's] American Health Foundation (AHF) recently called together a number of experts for a conference on the subject. For nocebos aren't just minor curiosities, but are wreaking havoc in America today.
Fumento identifies some Nocebo health scares:
- Gulf War Syndrome
- Love Canal dioxin and chemical contamination
- Silicone Breast Implants
"For 30 years women were satisfied with implants," Emory University gynecology and obstetrics professor Dr Elizabeth Connell (of TASSC) told me.
Connell headed the FDA panel that investigated the implants. "Lot of studies at the [FDA] hearings and since then showed a very high level of pleasure and acceptance and gratitude." But then the media and the lawyers got in the act. Newspapers and magazines ran stories with titles like "Ticking Time Bombs," "Toxic Breasts," and "After Implants, Horror Began."
Suddenly women with implants were suffering all sorts of strange illnesses and "realizing" that illnesses they already had must be related to their implants. "When you have women being told they have ticking timebombs in their breasts, what are they to think?" said Connell.
- [If you've got a a suspicious mind you might guess that this article was funded by Dow Chemicals. If you know anything about Fumento -- you'd be certain of it. The article was also promoted at the Overlawyered.com website by Walter Olson who is Peter Huber's ("junk-science") associate at the Manhattan Institute. Fumento and Steven J Milloy are both associated with this think-tank also.][10]
1996 Nov By mid 1997 Carlo was listed as the director of the "Breast Implant Public Health Project" (BIPHP), and the organization was being run out of the HES offices in Washington DC. This was a project of HES -- not a separate company. Dow Corning Corp funded it to the tune of $1.3 million.
The BIPHP is dealing with problems like scar tissue and causes of implant rupture, and the project document states that "at this time" it will not address the controversy over the risk of systemic disease.
The Press Release also says that they are supervising Dow's grants.
- [Note that some references claim the BIPHP's activities were overseen by the FDA. But they weren't.]
| DC Wright |
|---|
| Note that DC Wright which manufactures medical devices (eg hip prostheseses) and surgical instruments, also marketed silicone breast implants. This firm is actually Dow Corning Wright, a joint venture between Dow Chemical and Corning Inc. |
1996 Nov 6 The Breast Implant Public Health Project, LLC is now registered by Carlo as a private startup company incorporated in Wilmington, Delaware on the 6th November 1996 by "The Corporation Trust Company" [11]
It is still being funded by Dow Corning to do a number of literature and psychological profiling studies of breast implant problems.
The pilot study's goal was to test the feasibility of a data collection form which will be used in a scale-up study analyzing multiple surgeons' records. The goal of this expanded study will be to develop identifying factors for women who are at greater risk for having ruptured implants and, if necessary, target them for screening, surveillance, or intervention.
This was published as
- A review of the literature on the etiology of capsular contracture and a pilot study to determine the outcome of capsular contracture interventions.
- Factors associated with breast implant rupture: pilot of a retrospective analysis in May 1999. (Also:)
1996 Nov In a later disclaimer email George Carlo attacks his critics. His email reads:.
Breast Implant Public Health Project:
"This project was very important work done in cooperation of the Food & Drug Administration and at the request of the Food & Drug Administration head at the time, Dr David Kessler.We identified which types of problems from silicone breast implants warranted different types of corrective intervention -- ranging from localized corrective surgery to implant replacement.
Dow Corning funded the work, but it was overseen by the FDA. The same model was later used in the WTR where industry money was used to support public health work regarding EMR but with government oversight.
The Breast Implant Public Health Project was ended in agreement with the FDA in 1995, when the project was completed to everyone's satisfaction."
- [Carlo's date is wrong and his claims are misleading to the point of being false. The BIPHP was originally a 'project' of the HES and only registered as a company in November 1996 -- and it was still operating in 1998 and getting articles published in medical journals in 2002.]
1997 Oct 27 See this Jeff Silva article (Silva was a journalist who understood how Carlo operated, fairly early) "Harvard Peer Board Frustrated with WTR: Carlo to study implant risks" Silva comments on the problems of the Wireless Technology Research (WTR) project Carlo is also doing for the cellphone industry, and how Carlo is looking for other potential sources of income while his Wireless Technology Research program was stalled (His staff were on strike - insisting the CTIA pay a hefty insurance premium for research staff).
Dr George Carlo is quietly ramping up a new industry-backed health program on possible silicone breast implant health risks that is based on the troubled WTR model.
The "Breast Implant Public Health Project LLC" is one of several endeavors Carlo and his 30-person crew oversee at Health & Environmental Sciences Group Ltd. here.
Just as Carlo teamed with the Cellular Telecommunications Industry Association (CTIA) in early 1993 when fear of pocket phone-related brain cancer was at fever pitch -- and again in the early 1980s, with the Chlorine Institute on the dioxin debate, the embattled WTR chief now has joined forces with Dow Corning Corp, the leading breast implant maker, to delve into one of the hottest women's health issues today. Dow Corning has given Carlo $1.3 million to date.
Whether science ultimately declares cell phones, silicone implants and dioxin to be major health problems is another question. But where there is health controversy, Carlo seems to be near.
How can one man, Carlo, and his 30-person crew at Health & Environmental Services juggle so many complex and seemingly scientific time-consuming public health issues at one time and deliver solid science on them all?
Time is running out on Carlo at WTR and it appears he has lost the confidence of federal regulators, the scientific community, the wireless industry, and now-in perhaps the most devastating blow of all-the revered Harvard Center for Risk Analysis and Peer Review Board (PRB) on Cellular Telephones that has served as WTR's advisor and guardian angel.
In a July 15 letter to Carlo from Harvard Center Director John Graham and Project Director Susan Putnam, which incorporated views of the cellular Peer Review Board, WTR was all but disowned by the Harvard group.
Graham, declining to comment on WTR, made the letter available to RCR. While noting early accomplishments and acknowledging disruptions caused by legal and funding problems, the Harvard Center for Risk Analysis slammed Carlo for appearing to cave to political and industry pressure; for creating ...
- "expectations in the scientific, business and regulatory communities that have not been matched by meaningful funding of original research; for taking important steps without consulting the peer review board and for not making public disclosure of WTR's work and its financial records.
- "Given the likely expectation that health-related questions related to the use of wireless technology will persist when the current WTR research program ends in two years, the PRB is concerned that industry has not come forward with a plan to support a continued program of health research," stated the Harvard peer review board in the 6-page letter.
- [Note that the Peer Review Board was essentially controlled by John Graham at the Harvard Center for Risk Analysis which lobbies for industry and had direct links to the CTIA. So it is pretty safe to assume that this is a backdoor CTIA attack on Carlo -- and Carlo would have known it.]
"The PRB is not comfortable with pursuit of new research endeavors until these questions about continuity of funding and management are addressed," the board added. While the board wants Carlo to drop animal exposure studies and emphasize epidemiology more, the Food and Drug Administration has made animal exposure work the top priority for WTR.
Industry, meanwhile, wants a clean bill of health from research.
Carlo, following a meeting last month with federal health and safety regulators, revealed he will not conduct either short-term, sub-chronic or lifetime rat RF exposure studies but will pursue acute (two hour) rat RF exposure experiments, as well as cell culture and epidemiology studies.
WTR plans to replicate Dr Henry Lai's research at the University of Washington that found single- and double-strand DNA breaks after radiating rats with low-level RF for two hours at 2 GHz.
But at this late date, some four years after Lai submitted his proposal to WTR, there is no contract. Lai and WTR principals are supposed to meet in January to complete the research itinerary. [12]
- [They met on Nov 24, but for various reasons the Lai-Singh study was never fully replicated despite the enormous significance of their findings.
Lai and Singh believe deliberate attempts were being made to block further research along their pioneering lines after another researcher (Ray Tice) part-replicated their DNA-break findings.] - [Jeff Silva is a highly reliable journalist, however it is hard to know how a staff of 30 could have been supported at HES on just the WTR work and the preliminary work for Dow Corning. Obviously, many of their other projects are unknown.]
1997 Nov Microwave News, another critic of Carlo, was a journal run by Louis Slessin who kept his eye on Carlo's various get-rich-quick schemes. He pointed out that the Breast Implant Public Health Project (BIPHP] received $1.3 million from Dow Corning, but the focus was only implant rupture and scar tissue formation, and it largely avoided investigating systematic immune system reactions.
Despite Carlo's "reports," Dow Corning filed for bankruptcy and the FDA subsequently banned silicon breast implants for 15 years.
1997 Dec Martha Embrey spoke at the Society of Risk Analysis Annual Meeting:
Abstract: Local Complications from Silicone Breast Implants.
The Breast Implant Public Health Project's goal is to develop and carry out a public health approach to help women identify and remedy localized problems derived from their silicone breast implants. This public health program has been initiated to provide a remedy for known problems and in anticipation that the public, government agencies, scientists, and industry will use the results and findings.
The work done under the program is not intended to identify risk, but to find ways to best characterize and mitigate risk that has already been established. The existing scientific evidence supports the hypothesis that women with silicone breast implants are at risk of local complications including rupture and capsular contracture; therefore the research plan simultaneously addresses the questions related to risk characterization and intervention, so that appropriate risk management recommendations are available. The research agenda will be the basis for developing requests for proposals that address specific research issues important to managing any public health or clinical risk from local complications.
- [Most observers believe that the BIPHP project in its later stages was reasonably legitimate. Martha Embrey went on to work on the pharmacuetical management of AIDS via the Center for Pharmaceutical Management, Management Sciences for Health, Arlington, VA]
1998 May 1: Martha Embrey, George Carlo and three surgeons (who only provided access to their files) presented a joint paper at a plastic surgeon's meeting "Factors Associated with Breast Implant Rupture: Pilot of a Retrospective Analysis". This claims to have been funded by the "Breast Implant Public Health Project" [With no mention of Dow Corning.]
After all these years they had only got to the stage of "testing the feasibility of a data collection form which will be used in a scale-up study analyzing multiple surgeon's records"
A total of 92 records had been collected and analyzed to "identify factors for women who are at greater risk for having ruptured implants." [14] The same crew had also produced: "A Review of the Literature on the Etiology of Capsular Contracture and a Pilot Study to Determine the Outcome of Capsular Contracture Interventions"[15]
1998 Nov /E Carlo is now concentrating on the Breast Implant Public Health Project for Dow Corning. The Wireless Technology Research (WTR) operation has used up all its $25 million funding and is being wound down. It is to be replaced by a public relations organisation called WIN.
2002 An article on "Mental Models of Women With Breast Implants: Local Complications" deals with profiling the psychology of women with implants by the BIPHP team led by Martha Embrey.
The article gives details which suggest that this is a project being run by George Washington University -- and it leaves out any mention of Carlo's Deleware LLC.
The Breast Implant Public Health Project provided financial support for this study through a grant from the Dow Corning Corporation. We wish to express our thanks to Liz Adams, Barbara Blasick, Julie Downs, and Susan Houston for their help with the conduct of this research, as well as to anonymous reviewers. The views expressed are those of the authors.
NOTE: For further information, please address communications to Martha A Embrey, MPH, Department of Environmental and Occupational Health, The George Washington University School of Public Health and Health Services.
- Martha Embrey ran BIPHP for George Carlo, and was a long-term employee of HES. She is also listed here as being a "research associate" at the University (Center for Risk Sciences and Public Health). Carlo was also associated with the university.
