Environmental Working Group Concerns of NTP's affiliation with the tobacco indus

[Guest guest]

_http://ntp.niehs.nih.gov/files/MoldConceptforwwwFNL1.pdf_

(http://ntp.niehs.nih.gov/files/MoldConceptforwwwFNL1.pdf) .

NTP on mold, see above

February 28, 2007

A. Schwartz, M.D.

Director

National Toxicology Program

National Institute of Environmental Health Sciences

P.O. Box 12233

Research Triangle Park, NC 27709

Fax: 919.541.2260

Dear Dr. Schwartz,

We are writing to express significant concerns with the National Toxicology

Program's (NTP) Center for the Evaluation of Risks to Human Reproduction

(CERHR) management and review process for evaluating the reproductive and

developmental effects of chemicals. It has recently come to our attention that

CERHR

is managed by a private consulting firm, Sciences International (SI), a

company with historic ties to the tobacco industry and a client base that

appears

to include manufacturers of substances that might be subject to CERHR review,

including the chemical up for review on March 5, 2007, bisphenol A (BPA). We

think that the public would be very surprised to learn that industry

consultants are managing critical public health agencies.

The ties between SI and industry raise important ethical issues that we

describe in detail below. The fundamental question raised by the BPA case is

whether or not government health assessments should be managed by private

consulting firms with ties to the industry that manufactures the chemicals under

review. We are very concerned that this relationship may influence the outcome

of the BPA assessment.

These concerns are heightened by the Conflict of Interest policy document we

received from Shelby, the director of CERHR. In contrast to the CERHR

policy for panel members who must disclose all potential conflicts of

interest, the CERHR policy for consultants, sent to us by Mr. Shelby, states

plainly that, " No specific restrictions are placed on the contractor. " [1] This

seems to mean that contractors with serious conflicts of interest would not

have

to disclose them and, in fact, could oversee analyses that could

dramatically affect the future health and wellbeing of the American public. We

would

very much appreciate your clarification of this policy. Further, we request

that

prior to the March 5, 2007 meeting, SI and its employees disclose all

potential conflicts of interest relative to BPA. Absent such disclosure, the

integrity of the entire BPA review process will be in question.

In 1998, NTP established the Center for the Evaluation of Risks to Human

Reproduction (CERHR) to " serve as an environmental health resource to the public

and to regulatory and health agencies, " and to provide " scientifically-based,

uniform assessments of the potential for adverse effects on reproduction and

development caused by agents to which humans may be exposed " via " rigorous

evaluations of the scientific literature by independent panels of scientists. "

[2]

CERHR's mission is vital because five to ten percent of couples experience

fertility problems, up to five percent of babies have birth defects, and a

growing body of scientific evidence shows that exposures to industrial chemicals

can impact reproduction and development. [3]

Environmental Working Group (EWG) was shocked to learn, therefore, that CERHR

— a government agency under the auspices of the National Institutes of

Health — is actually being run by a private consulting firm known as Sciences

International (SI). To quote the SI website:

" The most significant project at our firm is the management of the National

Toxicology Program's Center for the Evaluation of Risks to Human

Reproduction, one of the premiere institutions for evaluation of reproductive

and

developmental health issues. " [4]

This relationship is even more troubling because there are serious conflicts

of interest and ethical concerns surrounding this contractor that involve

apparent financial ties with the chemical industry and non-disclosure of these

relationships.

On March 5, 2007 a CERHR expert panel is scheduled to evaluate the

reproductive hazards presented by bisphenol A (BPA). This expert panel will be

basing

their decision on a 300-page document describing the hazards of BPA that was

prepared by Sciences International. BPA is a heavily used industrial chemical

that is integral to production of hard plastics and is found in the liners

of metal food cans and in hard plastic containers. More than 200 animal

studies show that BPA is toxic at very low doses. [5] The Centers for Disease

Control has found BPA in 95 percent of people tested at levels that raise health

concerns sufficient to warrant this major review by CERHR. [6] And the peer—

reviewed science suggests that BPA may be contributing to increases in many

adverse health conditions in the human population including breast cancer,

prostate cancer and insulin resistance. [7-12]

Several ethical concerns surround SI's role in this process, including the

company's financial ties to the chemical industry and their failure to disclose

key information in the BPA review that may affect the expert panel's

assessment of the chemical. These concerns are discussed further below.

SI conflicts of interest.

SI appears to have a close working relationship with, and financial ties to,

companies that manufacture the chemicals SI is charged with reviewing for

CERHR. To our knowledge, SI has not disclosed these ties. As one example, in

2004, Scialli, the SI employee named as the lead SI manager of CERHR,

co-authored a scientific paper with an employee of Dow Chemical Company on the

critical issue of how animal test results can be applied to human health

risk. [13]. Dow is a major producer of BPA. [14] The study was funded by the

European Chemical Industry Council. There appears to be no way for the public

to

determine whether or not any SI clients are manufacturers or major users of

BPA or any other chemical that may be reviewed by CERHR. SI notes on its

website that its clientele comprise " approximately 50% public sector and 50%

private sector clients. " [15] Yet while SI lists the names of many of its public

sector clients, SI's private sector clients are identified only as " various

companies, trade organizations, and law firms. " [16]

Scientists must sign conflict of interest forms before they may serve on a

CERHR panel. [17] But CERHR's Director Shelby indicates that " no

specific restrictions are placed on the contractor. " [1] This policy is in stark

contrast to the disclosure procedures applied to CERHR panel members, and is

completely unacceptable. To earn the public trust, SI must disclose all

financial and research ties that it has with any company or other entity that

might

have even a potential conflict of interest with the work carries out in its

managing duty at the CERHR.

SI failure to investigate study funding sources. In its review document on

BPA, SI fails to disclose industry funding sources and author affiliations for

major studies cited in the document. For example, on page 177 in the

document, SI states " [financial] support not indicated " for several important

studies finding no adverse effects from BPA at low levels of exposure. [18]

But, in

fact, both studies are authored by scientists who routinely perform work for

the chemical industry trade organizations: CEFIC-the European Chemical

Industry Council and SPI-the Society of the Plastics Industry, both of which

have

member companies who manufacture or use BPA. [19] A simple request to these

scientists would likely have revealed the source of funding.

SI's failure to identify the source of funding for these studies is more than

just an oversight. A distinct pattern in BPA test results, relative to

funding source, has been documented in the peer-reviewed literature, most

notably

in a 2005 review published in the National Institutes of Health journal

Environmental Health Perspectives. This analysis examined more than 100

peer-reviewed studies on BPA and found a stunning relationship between funding

source

and study outcome: 100% of industry-sponsored studies found no adverse effects

of BPA at low doses, compared to just 4% of independent studies. [20] Given

the severe bias for industry-funded studies to find BPA " safe, " funding

sources for studies are a key piece of information the CERHR expert panel

should

review in making determinations on study utility. Without this information,

CERHR assessments are incomplete.

The CERHR expert panel must have thorough information on study funding

sources for the panel in order to make informed decisions on study utility. SI

has

failed to provide this.

SI failure to disclose key study limitations. In its review of BPA studies,

SI scientists fail to document known, glaring design deficiencies that make

it nearly impossible for certain studies to detect BPA toxicity. Without this

information, in some cases the expert panel has issued glowing endorsements

of seriously flawed studies, including a study [21] deemed by the expert panel

to be " exceptional " and " very useful, " when in fact the researchers in this

study used resistant animals and animal feed that is known to mask the

toxicity of chemicals like BPA. To quote the SI document: " This exceptional

study is

very useful for the evaluation process, and will carry significant weight in

the evaluation of structural, histogenic, and fertility endpoints. " [22]

In another example, the expert panel found a study " very useful in the

evaluation " when, in fact, the National Toxicology Program (NTP) had noted

issues

with the study design that cast the findings into doubt, including the

quality of the feed, concerns with animal weight, and data strongly suggesting

that

the particular experimental animals used would be insensitive to BPA's

effects. [20, 23, 24] SI did not note these concerns in its review.

The CERHR expert panel is asked to review the usefulness and quality of

literally hundreds of studies summarized in the SI review. The panel members

cannot feasibly review each study individually, and therefore must rely heavily

on SI interpretations. Therefore, it is critical for SI to thoroughly and

accurate document study findings and deficiencies. Their failure to do so in the

case of these key studies can inject critical bias into the review process and

severely inhibit the expert panel's ability to make sound decisions.

SI's history as industry consultant. SI's history of compromised ethics

leads to deep concerns about its role in managing CERHR chemical assessments.

In

September, 2006 the journal Environmental Science & Technology (ES & T)

detailed SI's dealings with the tobacco giant RJ Reynolds and its efforts to

prevent

the Environmental Protection Agency (EPA) from tightening its regulation of

a toxic pesticide. [25] ES & T wrote that:

In December 1998, the U.S. EPA proposed several risk-mitigation measures to

protect workers handling phosphine — a chemical for fumigating grain and

other commodities. The proposals included creating a buffer zone around

fumigation sites and notifying residents living within 750 feet. EPA also

proposed

lowering the exposure threshold of phosphine from 0.3 parts per million (ppm)

to

0.03 ppm. Court documents show that, to fend off regulations, RJ Reynolds

Tobacco Co. (RJRT) funded the Phosphine Coalition, which successfully fought

against the proposed changes. A centerpiece of its strategy was hiring the

consulting firm Sciences International to lobby EPA and to write a study on

phosphine's toxicity.

The study was finally published in Risk Analysis in 2004. Five people appear

as authors on the paper: Betty and two of her employees at Sciences

International, and Seckar and R. Harp, who are listed as members

of the Phosphine Coalition of Washington, D.C. The Phospine Coalition does not

have a street address, and the paper does not note that Harp and Seckar are

employed by RJRT.

In April 1999, officials with Sciences International met with EPA staff to

try to persuade the agency to halt the proposed changes to phosphine

regulations. A month later, , Sciences International's executive

director,

sent a memo to Seckar stating, " I believe that the approach with the greatest

likelihood of affecting EPA's position is to prepare and publish in a

peer-reviewed journal a scientific paper or article that describes the current

science

on the toxicity of phosphine. " She continues, " Since I am currently

Editor-in-Chief of the international journal Risk Analysis, perhaps the

peer-review

process could be expedited, if we decide that it is the journal of choice. "

At the end of 1999, RJ Reynolds released a report highlighting the company's

accomplishments. " R & D led the Phosphine Coalition in addressing the

scientific issues involved when the Environmental Protection Agency (EPA)

proposed a

new phosphine exposure standard, " reads a passage. Further along, the

document states, " The efforts of the Coalition saved RJRT many millions of

dollars. "

Clearly, serious questions are raised when a company with this history is

charged with running a government program vital to the protecting public

health.

SI involved in all aspects of running CERHR

It is clear that SI is deeply involved in all aspects of CERHR, from

selecting expert panel members, setting the agenda for panel meetings, preparing

the

literature reviews, and helping to draft the panel's reports. The intimate

and unusual relationship between the firm and CERHR is extensively documented.

For example:

* CERHR's website describes the agency's structure as follows: " 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. " [26]

* The website of Sciences International states that: " The most

significant project at our firm is the management of the National Toxicology

Program's Center for the Evaluation of Risks to Human Reproduction, one of the

premiere institutions for evaluation of reproductive and developmental health

issues. " [27]

* Although Dr. Scialli is the Vice President of SI, on CERHR's on-line

" contact " page his affiliation is listed simply as " NTP Center for the

Evaluation of Risks to Human Reproduction. " [28]

* The Federal Register notice describing the creation of CERHR explains

that: " Scientists representing NTP agencies and Sciences International,

Inc., the contractor who will support the Center, will constitute a core

committee which will provide the initial review for [panel member] nominations,

select the expert panel membership and establish the meeting agenda. " [29]

* Expert panel and chemical nominations are sent directly to the SI

offices. Some CERHR workshop sessions take place there as well. [30, 31]

For its work — and influence — SI gets paid heftily. The firm's current

contract, which runs from June 2003 through June 2008, is worth $5,241,109.

[32]

It is not uncommon for federal agencies to contract out certain pieces of

work to consulting firms or other contractors. However, we are unaware of any

other instance in which nearly all of the functions of a pubic health agency

have been outsourced to a private entity. Please provide us with details on

when this has been done previously and what the bidding parameters were.

It is also unclear whether the SI contract was put out to bid. If it was put

out for competitive bid, please provide us with the bid notice and

parameters. If it was a no bid contract, please explain the rationale for this

decision.

The arrangement between CERHR and SI raises serious ethical questions that

demand immediate disclosure of financial and research ties to chemical

manufacturers and other industries that make or use substances under review by

the

CERHR. These disclosures must apply both to individual SI staff as well as the

greater institution. Questions about the objectivity and adequacy of this

review process and the reviewers must be resolved before a final decision on BPA

is reached.

It is also critical that CERHR incorporate into its final decision on BPA

critical input from an NIEHS-sponsored expert workshop convened in November

2006. Forty-two leading scientists on the effects of BPA at low doses reviewed

existing literature on the issue (see attached list). The experts are producing

a series of papers addressing the very issues being reviewed by CERHR, but

expect to have only two of them completed by the March 5th meeting. It is our

understanding that these experts are seeing a pattern of adverse effects at

low levels of exposure similar to those measured in humans by the Centers for

Disease Control and Prevention [33]. We are concerned that CERHR is poised to

make a decision on BPA prior to the review of this important information.

Regulators, policy makers, and the general public desperately need the

" readily accessible, scientifically authoritative " evaluations of potential

reproductive and developmental toxins that CERHR is supposed to be providing.

[34]

But these evaluations will only serve to help protect human and environmental

health if they are truly objective and trustworthy. Given that bisphenol A

is found in consumer products as diverse as baby bottles, food-can linings and

dental sealants, this is a question that the public has a right — and a need

— to know.

Sincerely,

Wiles

Executive Director

Environmental Working Group

Cc: Mike Leavitt, Secretary, U.S. Department of Health and Human Services

, M.D., M.P.H., J.D., LL.M., Director, National Institutes of

Occupational Safety and Health, Centers for Disease Control, U.S. Department of

Health and Human Services

C. von Eschenbach, M.D., Commissioner, U.S. Food and Drug

Administration

Slikker, Jr., Ph.D., Director, National Center for Toxicological

Research, U.S. Food and Drug Administration

Shelby, Ph.D., Center for the Evaluation of Risks to Human

Reproduction, National Toxicology Program

Representative Henry Waxman, Chair, Committee on Oversight and Government

Reform

Representative Tom , Ranking, Committee on Oversight and Government

Reform

Representative Dingell, Chair, Committee on Energy and Commerce

Representative Joe Barton, Ranking, Committee on Energy and Commerce

Senator Barbara Boxer, Chair, Committee on Environment and Public Works

Senator Inhofe, Ranking, Committee on Environment and Public Works

E. Chapin, Ph.D., Chair, CERHR Expert Panel on BPA, Pfizer, Inc.

Jane , Ph.D., CERHR Expert Panel on BPA, University of Massachusetts

Kim Boekelheide, M.D., Ph.D., CERHR Expert Panel on BPA, Brown University

A. Gallo, Ph.D., CERHR Expert Panel on BPA, UMDNJ — Wood

Medical School

L. Earl Gray, Jr., Ph.D., CERHR Expert Panel on BPA, U.S. Environmental

Protection Agency

Simon W. Hayward, Ph.D., CERHR Expert Panel on BPA, Vanderbilt University

Medical Center

S.J. Lees, Ph.D., CERHR Expert Panel on BPA, s Hopkins University

Barry S. McIntyre, Ph.D., CERHR Expert Panel on BPA, Schering Plough

Research Institute

J. McPhaul, Ph.D., CERHR Expert Panel on BPA, University of Texas

Southwestern Medical Center

M. Portier, Ph.D., CERHR Expert Panel on BPA, American Cancer Society

M. Schnorr, Ph.D., CERHR Expert Panel on BPA, National Institute for

Occupational Safety and Health

Sherry G. Selevan, Ph.D., CERHR Expert Panel on BPA, U.S. Public Health

Service (Ret.)

G. Vandenbergh, Ph.D., CERHR Expert Panel on BPA, North Carolina State

University

Kendall B. Wallace, Ph.D., CERHR Expert Panel on BPA, University of Minnesota

R. Woskie, Ph.D., CERHR Expert Panel on BPA, University of

Massachusetts

References

[1] Personal communication with Shelby. Received summary of CERHR's

conflict of interest policy on February 23, 2007 prepared by Shelby in

response to EWG's request for official copies of this policy on February 16,

2007.

[2] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

" About CERHR. " _http://cerhr.niehs.nih.gov/aboutCERHR/index.html_

(http://cerhr.niehs.nih.gov/aboutCERHR/index.html) . Accessed on February 13,

2007.

[3] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

" About CERHR. " _http://cerhr.niehs.nih.gov/aboutCERHR/index.html_

(http://cerhr.niehs.nih.gov/aboutCERHR/index.html) . Accessed on February 13,

2007.

[4] Sciences International. 2007. " Reproductive and Environmental Health

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(http://www.sciences.com/practice-areas/reproductive.html) . Accessed on

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[5] The Endocrine Disruptor Exchange. Accessed on February 23, 2007.

_http://www.endocrinedisruption.org/products/bisphenol_a_

(http://www.endocrinedisruption.org/products/bisphenol_a)

[6] Calafat AM, Kuklenyik Z, Reidy JA, Caudill SP, Ekong J, Needham L. 2005.

Urinary concentrations of Bisphenol A and 4-Nonylphenol in a human reference

population. Environmental Health Perspectives 113:391-395.

[7] Munoz-de-Toro M, Markey CM, Wadia PR, Luque EH, Rubin BS, Sonnenschein C,

Soto AM. 2005. Perinatal exposure to bisphenol-A alters peripubertal mammary

gland development in mice. Endocrinology 146(9):4138-47.

[8] Markey CM, Luque EH, Munoz-de-Toro M, Sonnenschein C, Soto AM. 2001. In

utero exposure to Bisphenol A alters the development and tissue organization

of the mouse mammary gland. Biology of Reproduction 65(4):1215-23.

[9] Timms BG, Howdeshell KL, Barton L, Bradley S, Richter CA, vom Saal FS.

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[10] Ho SM, Tang WY, Belmonte de Frausto J, Prins GS. 2006. Developmental

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[11] Alonso-Magdalena P, Morimoto S, Ripoll C, Fuentes E, Nadal A. 2006. The

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and induces insulin resistance. Environmental Health Perspectives

114(1):106-112.

[12] Vandenberg LN, Maffini MV, Wadia PR, Sonnenschein C, Rubin BS, Soto AM.

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148(1):116-27.

[13] Carney EW, Scialli AR, RE, DeSesso JM. 2004. Mechanisms

regulating toxicant disposition to the embryo during early pregnancy: An

interspecies

comparison. Birth Defects Res C Embryo Today. 72(4):345-60. Abstract

available at:

_http://www3.interscience.wiley.com/cgi-bin/abstract/109867213/ABSTRACT_

(http://www3.interscience.wiley.com/cgi-bin/abstract/109867213/ABSTRACT)

[14] US Environmental Protection Agency (USEPA). 2002. Inventory Update

Reporting. _http://www.epa.gov/oppt/iur/_ (http://www.epa.gov/oppt/iur/)

[15] Sciences International. 2007. " Clients. "

_http://www.sciences.com/clients/index.html_

(http://www.sciences.com/clients/index.html) . Accessed on

February 13, 2007.

[16] Sciences International. 2007. " Clients. "

_http://www.sciences.com/clients/index.html_

(http://www.sciences.com/clients/index.html) . Accessed on

February 13, 2007.

[17] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

CERHR Expert Panel Guidelines.

_http://cerhr.niehs.nih.gov/aboutCERHR/guidelines.pdf_

(http://cerhr.niehs.nih.gov/aboutCERHR/guidelines.pdf) .

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bisphenol A. December 2006.

_http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html_

(http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html)

[19] Frederick S. vom Saal. 2007. Comments on the report of the expert panel

on bisphenol A. _http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm/

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[20] vom Saal FS, C. 2005. An extensive new literature concerning

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[21] Tyl RW, Myers CB, Marr MC, BF, Keimowitz AR, Brine DR, Veselica

MM, Fail PA, Chang TY, Seely JC, Joiner RL, Butala JH, Dimond SS, Cagen SZ,

Shiotsuka RN, Stropp GD, and Waechter JM. 2002. Three-Generation Reproductive

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68: 121-146.

[22] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2006.

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bisphenol A. December 2006.

_http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html_

(http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html)

[23] National Toxicology Program (NTP). 2001. National Toxicology Program's

Report of the Endocrine Disruptors Low Dose Peer Review. Research Triangle

Park, NC:National Toxicology Program.

_http://ntp.niehs.nih.gov/ntp/htdocs/liason/LowDosePeerFinalRpt.pdf_

(http://ntp.niehs.nih.gov/ntp/htdocs/liason/LowDosePeerFinalRpt.pdf)

[24] Ashby J, Tinwell H, Haseman J. 1999. Lack of effects for low dose levels

of bisphenol A (BPA) and diethylstilbestrol (DES) on the prostate gland of

CF1 mice exposed in utero. Regul Toxicol Pharmacol 30:156—166.

[25] Environmental Science & Technology Policy News. 2006. Journals feel

pressure to adopt disclosure rules. After an inquiry by ES & T, three leading

science societies say they will now examine conflict-of-interest policies.

September 20, 2006.

_http://pubs.acs.org/subscribe/journals/esthag-w/2006/sep/policy/pt_disclosure.h\

tml_

(http://pubs.acs.org/subscribe/journals/esthag-w/2006/sep/policy/pt_disclosure.h\

tml)

[26] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

" About CERHR. " _http://cerhr.niehs.nih.gov/aboutCERHR/index.html_

(http://cerhr.niehs.nih.gov/aboutCERHR/index.html) . Accessed on February 13,

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[27] Sciences International. 2007. " Reproductive and Environmental Health

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(http://www.sciences.com/practice-areas/reproductive.html) . Accessed on

February

13, 2007.

[28] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

" Contact CERHR. " _http://cerhr.niehs.nih.gov/contactus/index.html_

(http://cerhr.niehs.nih.gov/contactus/index.html) . Accessed on February 13,

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[29] Federal Register. December 14, 1998. Volume 63 (239): 68782.

DOCID:fr14de98-73

[30] Federal Register. August 5, 1999. Volume 64 (150): 42707-42708.

DOCID:fr05au99-108

[31] National Institute of Environmental Health Sciences. 1999. Center set up

to evaluate evidence of chemical threats to human reproduction. Press Jan.

6, 1999. _http://cerhr.niehs.nih.gov/news/press/pr1_6_99.html_

(http://cerhr.niehs.nih.gov/news/press/pr1_6_99.html)

[32] Office of Acquisitions, National Institute of Environmental Health

Sciences. Active Research and Development Contracts as of Oct 12, 2006.

_http://www.niehs.nih.gov/omamb/rcb/randdext.htm_

(http://www.niehs.nih.gov/omamb/rcb/randdext.htm)

[33] Calafat AM, Kuklenyik Z, Reidy JA, Caudill SP, Ekong J, Needham L. 2005.

Urinary concentrations of Bisphenol A and 4-Nonylphenol in a human reference

population. Environmental Health Perspectives 113:391-395.

[34] Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007.

" About CERHR. " _http://cerhr.niehs.nih.gov/aboutCERHR/index.html_

(http://cerhr.niehs.nih.gov/aboutCERHR/index.html) . Accessed on February 13,

2007.

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