Document a11ZjdxNBg8NY1ky14BaG8L3e
STEIN SPERLING
BENNETT . DE J O N G DRISCOLL pc
ATTORNEYS AT LAW
D ecem ber 1, 2016
Via electron ic m ail (ehollan (KccaUfela.com ) an df ir s t class m ail Eric D. Holland Holland Law Firm c/o Ashcraft & Gerel LLP 1825 K Street, NW Ste. 700 Washington, DC 20006
DEANNA L. PETERS
ATTORNEY AT LAW SENIOR COUNSEL
25 W est Middle Lane Rockville, Maryland 20850
301-838-3231 direct 301-340-2020 main 301-354-8131 direct fax
admitted in MD, VA, NC dpeters@ steinsperling.com
www.steinsperling.com
File Number: 83145-78
Re: Ingham, et al. v. Johnson & Johnson, et al.
Dear Mr. Holland:
This law firm represents The Weinberg Group Inc. Pursuant to your third-party Subpoena to The Weinberg Group in the above-referenced case, please find enclosed responsive documents. Y ou've noticed a corporate designee deposition on Decem ber 8, 2016. M atthew W einberg, who will be the corporate designee, is unavailable for deposition on that date as he is out o f the country. Mr. Weinberg has little if any recollection o f the matters listed in your corporate designee notice, and no others at The Weinberg Group were involved in these matters. Accordingly, we would like to discuss with you whether any deposition will be necessary. Please contact me at your earliest convenience in that regard.
Very truly yours,
DLP w/enclosures
Deanna L. Peters
4916796_1
Total Weinberg Hours: 405.75 (including meetings, etc.) Total Expert Hours: 168.30 hours
Total Weinberg Billing (not inclu. reimbursable expenses): $64,942.11 Total Expert Billing: $84,150
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November 13,2000
Gerald McEwen, Ph.D. CTFA 1101 17th Street, NW, Suite 300 Washington, DC 20036-4702 Dear Gerry:
Enclosed please find our invoice for reimbursable expenses and technical support to CTFA during October 2000. Please be advised that reimbursable expenses often lag by a month.
We appreciate the opportunity to be of service, Very truly yours.
RosanneB. McTyre, PhJD, Practice Director, Epidemiology & Btostatistics THE WEINBERG GROUP INC. RBM/aif Enclosure
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G.N. MeEwen, Jr., Ph.D,, J.D. Director o f Science
Cosmetic, Toiletry, and Fragrance Association 1101 17th, Street NW
Suite 300 Washington, DC 20036
INVOICE
For professional services rendered and expenses incurred in comprehensive literature search, critical review of epidemiology papers and retention of experts for NTPs Board o f Scientific Counselors meeting
F o r th e period ending: 10/31/00
For professional services
513,552.59 512,179,25
NAME/TASK ROSANNE B. fvicTYRE, Ph.D.
Cotuacts/Meetings Wriung/Anaiysis
KERRY E. ROCHE Analysis
BRIAN NICHOLS Contacts/Meetings Research Writing/Analysis
JULIE JAKUM
RATE 5235.00
5175,00 $120.00
$100.00
HOURS
10.50 8.25
3.00
2.00 8.00 17.00
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The Weinberg Group 0002
Research Writing^Analysis
GEORGE GLEKAS Information Management
For reimbursable-expenses In-house Reproduction information'Acquisition General & Administrative
PAGE 2 INVOICE
S82.00 '
8.00 16.50
19.00
Total hours (minus information management): 73.25 hours
$12.60 $295.06
$1,065.65
TOTAL INVOICE -
51,373.34 513,552.59
INVOICES ARE HUE WITHIN 30 DAYS O F RECEIPT. OUTSTANDING INVOICES WILE SE ASSESSED A FINANCE CHARGE OF 1.0% PER MONTH.
PLEASE REFER TO INVOICE 4220 AND RETURN A COPY OP THIS INVOICE WHEN MAKING PAYMENT.
WE APPRECIATE THIS OPPORTUNITY TO BE OF SERVICE.
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December 6,2000
Gerald McEwen, PhJD. The Cosmetic, Toiletry, and Fragrance Association 1101 I7,h Street. NW, Suite 300 Washington, DC 20036*4702 Dear Gerry:
Enclosed please find our invoice for reimbursable expenses and technical support to CTFA during November 2000. As we discussed on the telephone, with the added tasks we were asked to perform, the amount of this invoice is higher than that budgeted for the project as outlined in my letter dated October 20.2000. The initial assignment from you specified three tasks:
1) Retrieve literature on non-asbesiiform talc aiid ovarian cancer, . 2) Summarize each of the available studies in a format usable by experts; and 3) Retain two experts to review the literature provided by us, prepare testimony, and
present this testimony at the Board of Scientific Counselors' meeting in December.
Our initial task was to retain two well-qualified, renowned epidemiologists who would work independently and present at the meeting. However,, no expert we contacted could fulfill the assignment as initially conceived because of the quick turnaround required. With your verbal agreement, we retained a group of pre-eminent, epidemiologists (Drs. Rothman, Pastides, and Samct) to work in a manner chat would minimize each individual's time on the project, In addition, we were able to retain Drs, Shapiro and Muscat to provide individual statements. Thus, what seemed initially to be a straightforward task turned out to be a much more complex endeavor requiring additional hours of expert time and additional efforts by THE WEINBERG GROUP INC. to recruit and coordinate rhe team of experts.
The Weinberg Group
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Gerald McEwen, FhJD. December 6 2000 Page 2
Tasks authorized verbally by you after the issuance of October 20 2000 letter, given the new working scenario presented above, include;
Retention of three additional epidemiologists. The retention of a total, of five epidemiologists (two who worked independently and three who worked as a team) for this project required considerable time and effort on my part beyond what was budgeted. Numerous hours were spent not only in identifying and contacting experts, but also in researching expert qualifications, and in numerous discussions with CTFA Most importantly, the rate estimated for the experts ($350) was an underestimate of the amount actually charged; the going rate for such highly reputed epidemiologists for work with such a short turnaround time is $500 per hour,
* Organization of, preparation for, and coordination of a meeting of the- three experts who worked as a team in Boston on November 14, 2000. The costs incurred in this meeting were not budgeted originaliy. but i believe the meeting was essentia! to the success of this project. Meeting early in the review process allowed the group to develop a cohesive working style; they discussed the literature, drafted bouomdine conclusions, and developed an effective group strategy. The experts worked productively together, but my coordination and .guidance were essential to the successful completion of the Final draft of this effort. Costs were minimized by taking
'advantage of attendance of 2 of these experts at the APHA meeting,
The five experts required far more support in conducting their analyses and preparing draft statements than was originally anticipated. Additional work was required by THE WEINBERG GROUP to retrieve literature and perform critical reviews of papers! Other WEINBERG GROUP staff were brought on the project to provide expeditious resolution to the experts' questions and meet their needs In a timely manner.
A s this project has played out, THE WEINBERG GROUP was instrumental in retaining and managing experts of considerable stature and importance whose opinions supported the Association's position. Wc were also instrumental in negotiating the participation of the speaker of your choice to represent your interests in the presentation to the Board. This has been a difficult process, but we believe that you will be going into the Board of Scientific Counselors' meeting with the most qualified person to speak on your behalf.
Please be advised that this invoice does not include professional time and effort that is being expended in December to assist Dr. Paslides in preparing his oral presentation. THE WEINBERG GROUP is supporting Dr. Pastides both in the development of the substance of his presentations and in the preparation of Power Point slides. In addition. Dr. Pastides' time to attend the preparatory meeting at CTFA on December 13Ihand the Board's meeting on the
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Gerafd McEwen, Ph.D. December 6,2000 Page 3
14* plus associated expenses, will appear in the December invoice. Please be advised that in addition, reimbursable expenses often lag by a month.
Please let me know jf you have any questions on the invoice or if we can be of further help. Thank you for the opportunity to help you on this project.
Very truly yours, Q
(f, Rosanne B. McTyre, Ph.D; Practice Director, Epidemiology & Biostatisucs THE WEINBERG GROUP INC.
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The Weinberg Group 0006 I
G.N, McEwen, Jr., Ph.D,, J.D. Director of Science
Cosmetic, Toiletry, and Fragrance Association 1101 l?th Street, NW
Suite 300 Washington, DC 20036
INVOICE
For professional services rendered and expenses incurred in comprehensive literature search, critical review of epidemiology' papers and retention of experts for NTPs Board o f Scientific Counselors meeting
F o r the period ending: 11/30/00
For professional services
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NAME/TASK MYRON S. WEINBERG. Ph.D.
Contacls/Meetings
ROSANNE B. McTYRE. Ph.D. Comacts/Meetings Maitagement Wdng/Analsis
CARRIE RABE. Ph.D. Analysis
KERRY E. ROCHE Analysis
RATE $365.00 $235.00
$180.00 $175.00
HOURS 4.50
27.50 3L50 6.00
12.00
25.50
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The Weinberg Group 0007
PAGE 2 INVOICE
GARY O'DONNELL Analysis
BRIAN NICHOLS Analysis Research WritingAnalysis
JULIE JAKOM Analysis Research
GEOKGb ULEKAS Research
ANGELA FUERTES Support
For subcontractors HARRIS PAST1DES, Ph.D. JONATHAN M. SAMET. M iX M.S JOSHUA E. MUSCAT KENNETH J. ROTHMAN -SAMUEL SHAPIRO For reimbursable expenses
Delivery In-house Reproduction Information Acquisition T ravel General & Administrative
S05.00
$120.00
$100.00
$2.00
$70.00
$20,000.00 $3,000.00 $7,275.00 $23,000.00 $12,500.00
$189.18 $494.64 $219.42 $725.00 $9,459.78
TOTAL INVOICE
17.25
29.50 8.00
29.50
7.00 20.00
Total Weinberg 19.00 hours: 273.25
26.00 $65,775.00
Expert hours: 131.55 Expert Bills: 65,775
511,088.02 $119,199.77
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PAGE 3 INVOICE
INVOICES ARE DUE WITHIN 30 DAYS O F RECEIPT. OUTSTANDING INVOICES W ILL BE ASSESSED A FINANCE CHARGE O F 1.0% PER MONTH, PLEASE REFER TO INVOICE 4 294
AND RETURN A COPY OF THIS INVOICE WHEN MAKING PAYM ENT. WE APPRECIATE THIS OPPORTUNITY TO BE O F SERVICE.
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January 15,2001
t22>Nineteenth S t W, Sotte 3C0
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Gerald McEwcn, Ph.D. CTFA 1101 17th Street, NW, Suite 300 Washington, DC 20036-4702
ATTORNEY W ORK PRODUCT - PRIVILEGED AND CONFIDENTIAL PREPARED AT THE REQUEST OF COUNSEL
Dear Gerry:
Enclosed please find our invoice for reimbursable expenses and technical support, to CTFA during December 2000. Please be advised that reimbursable expenses often lag by a month.
We appreciate the opportunity to be of service.
Very truly yours,
Rosanne B. McTyre, Ph.D. Practice Director, Epidemiology & BEostatistics THE WEINBERG GROUP INC.
RBM/ebb
Enclosure
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G.N. M cEwen, Jr., Ph*D., J.D. Director o f Science
Cosm etic, Toiletry, and Fragrance Association .110117fb Street, NW
Suite 300 W ashington, DC 20036
IN V O IC E
For professional services rendered and expenses incarred in
papers and retention o f experts for NTP$ Board o f Scientific Counselors m eeting
For the period ending: 12/31/DO
For professional services
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BRIAN NICHOLS Research
GEORGE GLEKAS Research
ANGELA FUERTES Support
rate
$235.00
$120.00 $82.00 $70.00
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HOURS
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For subcontractors HARRIS PASTIDES- Ph,D. For reimbursable expenses
Delivery In-house Reproduction Information Acquisition Travel General & Administrative
PACE 2 INVOICE
--------------------S18J75.O0
S67.42 $51.48 SI.891.92 51,600.20 S2.502.41
TOTAL INVOICE
$18,375-00 Expert Hours: 36.75
$6,113.43 $34,712-48
INVOICES ARE DUE WITHIN 3ft DAYS O F RECEIPT. OUTSTANDING INVOICES WITT BE ASSESSED A FINANCE CHARGE OF 1.0% PER MONTH. PLEASE REFER TO INVOICE 4 4 4 7
AND RETURN A COPY OF THIS INVOICE WHEN MAKING PAYMENT.
WE APPRECIATE THIS OPPORTUNITY TO BE OF SERVIC.
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February 15,2001
Gerald McEwen. PhX>. CTFA 1101 17th Street, NW, Suite 300 Washington. DC 20036-4702 Dear Gerry: Enclosed please find our invoice for reimbursable expenses and technical support to CTFA during January 200!. The attached arc reimbursable expenses which, as you know, often lag by month. Wc appreciate lire opportunity to be of service. Very truly yours.
R.osannc B. McTyre, Ph.D. Practice Director, Epidemiology & Biostatistics THE WEINBERG GROUPING RBM/cbb Enclosure
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THE WEINBERG GROUP (iVC.
G.N. M cEwcn, Ji% Ph.D,, J.D. Director o f Science
Cosm etic, T oiletry, and Fragrance Association 1101 17tli Street, KW
Suite 300 W ashington, DC 20036
INVOICE
For professional services rendered and expenses incurred in eoutprehensive literature search, critical review o f epidem iology papers and retention o f experts for NTPs Board o f Scientific Counselors meeting For the period ending: 01731/01
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$202,06 TOTAL INVOICE
$202.06 $2& M
INVOICES ARE DUE WITHIN 30 DAYS OF RECEIPT. OUTSTANDING INVOICES WILL BE ASSESSED A FINANCE CHARGE OF 1.0% PER MONTH.
PLEASE REFER TO INVOICE 4643 AND RETURN A COPY OF THIS INVOICE WHEN MAKING PAYMENT.
WE APPRECIATE TIBS OPPORTUNITY TO BE OF SERVICE.
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"The Weinberg Group 0020
Project Nape:
M anagem ent Piati
Emi Date: ' ' d H
Tcd Dunkelberger Rosarme McTyre Mark Kohorsl Kerry Roch David Sandler
Terri Cassidy Annette- DehI
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The Weinberg Group 0021
THE WEINBERG GROUP INC.
WASHINGTON. DC BRUSSELS
Marsh 6,199?
G. N. McEwen, Jr., Fh.D., J.D. V ice President, Science Cosmetic, Toiletry, and Fragrance Association 1101 17th Street, NW, Suite 300 Washington, DC 20036
.
Dear Jerry:
Thank von lor asking THE WEINBERG GROUP INC, to assist you in finding an expert to comment on the recent Cook ct al paper, "Perineal Powder Exposure and the Risk o f Ovarian Cancer."
We agreed that professional fees will be in the S2,0OO range, not including any fees charged by lhe expert for his or her lime. The renowned expert is to provide a quotable letter lo THE WEINBERG GROUP by Monday, March 10, 1997.
I look forward to working with you again.
Very truly yours,
THE WEINBERG GROUP INC. Marcia F, Silcox
M-FS/af
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NEW PROJECT REQUEST
New Project Name:
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Invoice Recipient:
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Expenses (d rd e one): If adjusted, (please list):
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The Weinberg Group 0023
THE COSMETIC, TOUETir. ANO FRaO ANC ASSOCIATION
May 30,1995
I. EDWARD CAVAMUCH M ES I 0 ENT
Ms. Marsha Siicox W einberg Consulting Group, Inc, 1220 19th Street, N.W. Suite 300 Washington, D.C. 20036*2400
Dear Marsha:
This letter will serve a s authorization to conduct the research proposed in your letter of May 30, 1995, subject to the terms and conditions of that tetter and of CTFA's Basic Consulting Agreement (5/30/95), attached.
I look forward to seeing your report.
Best Regards,
Vice President *Science
GNM/pd Attachment
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Keywords. PleaseCircle aStiatapp)y.
Epidemiology Risk Respiratory Wound Surveillance
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Nate: Keywords are essential to the effectiveness o fthe New Projectprocess please take the time to circle or highlight those keywords that best representyourproposal* If you would like to adda keyword to die list, please contact Nick Nelms in the Washington
DC office (exL 4146)
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i The Weinberg Group 0026 j
PROJECT PLAN- CITATALO
Goal: To have two prominent epidemiology experts argue (in front of the NTP Board of Scientific Counselors (December 13-14,2000) against the allegation that perineal use of noaasbestiform talc is associated with an increased risk of ovarian cancer. NTP has listed this exposure to be considered for classification as a known human carcinogen. All tasks have to be completed by Monday November 20 (4 weeks)
Major Tasks:
1. Perform comprehensive search of the literature (sec "Identify relevant literature" in proposal letter 10/20. page 2. This includes troc-scarching of articiews and culling of literature to arrive at the list of epidemiologic papers (analytic) that speak to this issue, (Siarig imineditately; finished by November 3)
2. Prepare critical reviews (table format or critical abstract) of all relevant papers. (Start immediately; due on November ?; should overlap task I)
3. Identify 2 prominent epidemiologists or 1epidemiologist and 1 clinician who are familiar enough with this literature to have a position. To arrive at tilts number first make a short list of about 4 or 5 potential candidates. (Start immediatjely; secure experts by November I )
Specfk: Assignments:
Task . Perform comprehensive search of the literature (kero, juja, gegf)
- Kero to manage effort and select papers for inclusion ( 12 hours) - Juja and Gegl to conduct search, order and retrieve papers (20 hours each) - Rome general oversight and direction (5 hours)
Task 2. Prepare critical reviews (kero, bm i, juja)
- Kero to manage effort and set format (10 hours) - Bmi to perform critical reviews according to standard format (60 hours- depending on
number of papers) - Juja to Q/A and standardize reviews (30 hours depending on number of papers) - Rome general oversight and direction (6 hours)
Task 3. Identify and Retain experts (romc, gegl, bm i)
- Gegl to research the composition of the NTP Board of Scientific Counselors and other information readily available about the meeting in December (right away).
- Bmi to review readily available materials (internet, existing papers, review papers, etc.) to inform Romc where we stand regarding the data (by October 26)
- Romc to work with Tcdu and Mywe to identify and call relevant experts
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- Gcgl to prepare dossiers on experts (working with Dan Mallon) (as soon as list of 4-5 is secured) - Rome to call experts and gauge their position; prepare list for CTFA; retain experts - Gegl to work with experts to get them their materials, etc.
Hours allotted for task 5:
Gegl- 40 hours B m i-10 hours Rome- 15 hours
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Gerald McEwen, Ph.D. The Cosmetic. Toiletry, and Fragrance Association 1101 !7th Street. NW. Suite 300 Washington. DC 20036-4702
Dear Mr. McEwcn:
'
We arc pleased to have this opportunity to provide you with a revised proposal in response to your request for experts and analyses of the literature on talc and ovarian cancer- This letter summarizes our undemanding of the scope of work, our proposed technical approach, the qualifications and experience of our proposed project team, and our schedule and costs for completing the work.
OUR UNDERSTANDING OF THE SCOPE OF WORK
THE WEINBERG GROUP INC, is aware that the National Toxicology Program (NTP) has proposed non-asbestiform talc for possible listing in its 10* Report on Carcinogens, NTP is taking this action based on some evidence that non-asbestit'orm talc causes certain cancers in rats, as well as epidemiologic studies that have linked perineal talc exposures with lung and ovarian cancer in women. The CTFA is concerned about such a listing and is interested in an independent review of the literature on non-asbestiform talc and risk of ovarian cancer. In addition, CTFA would like THE WEINBERG GROUT INC. to identify two experts who can address this topic at NTP's Board of Scientific Counselors' Meeting.
TECHNICAL APPROACH
We propose to identify the relevant literature on uon-asbestiforrn talc and ovarian cancer, and to develop experts on this topic through the following tasks:
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TASK I ; Retrieve Literature
Identify rettvant literature
The goal of this task is to identify all relevant epidemiologic literature icase-eontfol and cohort studies) on oon*a$hestifonn talc and risk of ovarian cancer. We will begin by retrieving all references (there appear to be 17 on uon-asbesJifonm talc and ovarian cancer) cited in the NTP's "Draft Report on Carcinogens, Background Document for Talc, Asbestrform and Non-Asbesuform." However, our previous experience in examining NTP review suggests that the NTPoften fails to consider relevant literature. Therefore, wc propose to >nduct a comprehensive search of the readilyavailable English-language literature using proven on-line searching techniques (Dialog, etc.) for additional epidemiologic studies on non-asbestiform talc and ovarian cancer.
We will search only for those papers published after 1986 (when Cramer first reported an association) to ensure that the exposures examined were non-asbestiform talc. We estimate that this search may yield approximately 46 relevant epidemiologic studies (case-control and cohort), in addition, wc will search (to the extent possible) for papers that have relevant
information, but were not specifically designed to examine the issue of talc and ovarian cancer.
. An electronic database of relevant citations will result from THE WEINBERG GRGC/Fs citation ordering and tracking system. We routinely maintain electronic copies of all relevant publications collected in support of a project The resulting literature maintenance system allows articles to be searched, reproduced* and sorted.
Trte'Xearch each relevant paper
As each relevant paper is identified, its bibliography will be "tree-searched'' to identify other relevant studies that may have been missed m the on-line search, Tree-searchirtg involves reading an mtkfe's bibliography, and then identifying relevant publications cited therein, based on the title or author. Experience has taught us that this step is often essential to identify alt relevant papers.
TASK 2: Summarize Important Elements o f Each Paper
Once the relevant epidemiologic studies on non-asbestiform talc and ovarian cancer have been identified, we will summarize them in a manner that wilt facilitate their review by the experts. We propose a tabular format that we have used successfully in the past that presents details on the citatton/authors, study design and population, exposure information, odds rados/relative risks, and critical comments. Such a format will facilitate review of each paper by the experts, and will enable direct comparisons of similarities and differences among the
studies.
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October 20,2000 Page 3
TASK 3: identify and Prepare Experts for M eeting of the NTP Board fScientific Counselors
Identify experts
We will use our proven search techniques to identify two noted epidemiologists who can effectively address the issue of iKm-asbcstiform talc and ovarian cancer for one day at the meeting of the NTT's Board of Scientific Counselors, scheduled for December 13-14,2000. THE WEINBERG GROUP INC. has substantial experience in identifying, expens with impressive credentials who are qualified to address specific issues. We will begin by researching several renowned epidemiologists who are qualified and able to Speak tut mcthodologic issues surrounding this area of literature. We will speak with them to assess their views on and proposed approach to this topic.
With your approval and input, we will proceed to contact and secure the services of two individuals, THE WEINBERG GROUP INC. will provide the experts with the appropriate literature (identified in Task 1 above), as well as the summaries of each paper (prepared as part of Task 2 above). Each expert will be asked to read and critique the literature and prepare concise reports that summarize their conclusions. These reports will be submitted to you by THE WEINBERG GROUP ENC and may serve as the basis for their testimony before the Board.
QUALIFICATIONS AND EXPERIENCE OF OUR PROJECT TEAM
The following individuals will participate in this project:
Rosarme B. McTyre, PluD, Dr. McTyre is an epidemiologist with advanced training from Johns Hopkins and Yale Universities. She has more than 20 years of experience in consulting . both for government and private clients, and presently leads the Epidemiology and Biostatisfics Practice at THE WEINBERG GROUP INC. She has worked closely with clients who are concerned about products In crisis and has provided scientifically based assessments of numerous exposures to lifestyle products and disease outcomes. She has participated in projects involving hair dyes, vaginal douches, mouthwashes, lead, MTBE, and other chemical contaminants. Dr. McTyre is experienced in the conduct of comprehensive literature reviews, and has considerable experience working: part of public relations teams and media groups to convey scientific date to lay audiences. As a Board Member of the American College of Epidemiology, she is connected to a wide network of colleagues and has been instrumental ir retaining epidemiologists and blostoristicians on behalf of industry, and working with experts In preparation for trial or other public meetings.
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Kerry Roche, M-5. Ms. Roche is a biologist with 20 years of experience as a consultant for industry as welt as the government She is experienced in evaluating scientific literature on a wide variety o f health outcomes. She wifi design the search strategy and direct the literature search, and will evaluate the relevant epidemiologic literature.
Ja lie JaJkuov MJU3 M s. M u m is a research assistant at THE WEINBERG GROUP INC., where she is experienced in the identification, retrieval and analysis o f scientific literature. On this assignment, Ms, M u m will be responsible forperforming the literature search and retrieving relevant articles. Ms. M u m worked previously as an intern at the Environmental Protection Agency's office in Atlanta, Georgia, and as an environmental safety intern ut a major brewery.
George GJekas Mt-Glekas is a reseateh assistant in the Epidemiology and Biostatistics Practice at THE WEINBERG GROUP INC. Mr, Glekas' academic background is in the biological sciences with a concentration in physiology and bio-ethics. He is knowledgeable about techniques for identifying potential experts and obtaining all publications of these experts.
PROJECT SCHEDULE/DELIVERABLES
We anticipate the following schedule for completion of each task identified in this proposal:
TASK 1: TASK 2: TASK 3:
Identify literature Prepare literature summaries <40papers) Retain experts and expert activity
2 weeks 2 weeks 4 weeks
\
(
We expect that several of these tasks overlap, and therefore, we anticipate that the entire scope of work can be completed w ith^ e weeks. If this proposal is accepted no later than October 25. we should have no problem completing this assignment in sufficient time forth Board meeting.
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COST
We estimate the following hours for each of the three tasks:
TASK Xi IDENTIFYLITERATURE
stair
Rosanna McTvre, PhJD. KerryRoche, M.S.
JulieMum, M.P.H. George GJekas
Hourly Rate $235 175
89 82
Number ofHours 5 12 20 20
Total Cost 51175 2.100
1,730 1,640
Total Professional Tftne
G&Aonprof. Time (8.75%) Reimbursable expenses (60 papers @50)
54 ... * m ..
586 3.000
TOTALTASK 1
10,281
TASK 2t PREPARELITERATURESUMMARIES
1 starr Rosaunc McTyre, Pti,D.
Kerry Roche, M,S.
Julie Mum. M.P.H,
Hourly Rate $235 175 89
Numberof Hours 6 80 40
Total Cost 51,410 14,000 3,560
Total Professional Time
124 m $70
G&A on prof.Time (8.75%) Reimbursable expenses (5%)
TOTAL TASK2
1.660 1 925
i 21,555
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FROM* U IHBER
FOX H O .t 392 625 7057
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Mr. Gerald McEwen
October 20.2000 Page 6
TASK 3: RETAIN EXPERTS AND EXPERT ACTIVITY
stair Rosanne MeTyrc. Ph D. Julie Jafcum, MP.H. Expert l Expert 11
Hourly Rate $235 89
350 350
Number of Hours 20 40 4? 48
Total Cost $4.700 3.560 K>,800 16.800
Total Professional Time
156 41,860
G&A on prof. time ($.75%) :Reimbursable expenses (5%)
3,663 2.093
TOTAL TASK 3
47,61
Please note that we have made rhe following assumptions in developing these cost estimates:
* In Task 1. we expect to collect and review 60 articles: approximately 40 articles will form the basis o f the subsequent review.
* In Task 2, we plan to abstract no more than 40 papers.
" Experts'rate is averaged at SJSOrtir.
The tola] cost o f this effort is expected to be about $79,432. Our estimates are usually reliable to within 10 % however, they are subject to change if the scope o f work changes. Of course, no additionui work would be authorised without your expressed approval. THE WEINBERG GROUP invoices clients on the basis of professional time expended plus reimbursable expenses (for this assignment, approximately 10% o f professional Fees). Reimbursable
expenses include cost for purchasing papers, Xeroxing, etc. These costs have been estimated as line items above. Cost of expert travel and expenses are not included in these estimates as they could vary widely.
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Mr. Gerald MeEwen October 20 2000 Page 7
Please lot me Know if I have accurately captured your expectations. We look forward to working with you on this important issue.
Practice Director, Epidemiology and Biostatistics THE WEINBERG GROW INC.
RBM/bb
Enclosures ec: LindaLoretx. PhJD.
il }
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The Weinberg Group 0035 j
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ctober 20, 2000
Gerald McEwen, PhD. The Cosmetic, Toiletry, ami Fragrance Association 110117th Street, NW, Suite 300 Washington. DC 20036-4702
Dear Mr. McEwen:
-
.
We are pleased to have this opportunity to provide you with a revised proposal in response to
your request for experts and analyses of the literature on talc and ovarian cancer. This letter
summarizes our understanding o f the scope o f work, our proposed technical approach, the
qualifications and experience o f our proposed project leant, and oar schedule and costs for
completing the work.
.
OUR UNDERSTANDING OFTHE SCOPE OF WORK
' THE WEINBERG GROUP INC. is aware that the National Toxicology Program (NTP) has proposed non-asbestiform talc for possible listing in its 10* Report on Carcinogens. NTP is taking this action based on some evidence that non-asbestiform talc causes certain cancers in rats, as well as epidemiologic studies that have linked perineal talc exposures with lung and ovarian cancer in women. The CTFA is concerned about such a listing and is interested in an independent review- o f the literature on non-asbestiform talc and risk of ovarian cancer. In addition, CTFA would like THE WEINBERG GROUP INC. to identify two experts who can address this topic at NTP's Board o f Scienti fic Counselors' Meeting.
TECHNICAL APPROACH
We propose to identify the relevant literature bn non-asbestiform talc and ovarian cancer, and to develop experts on this topic through the following tasks:
1 i
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Mr. Gerald McEwen October 2 0.2000 Page 2
TASK. 1: Retrieve Literature
Identify relevant literature
The goal of this task is to identify all relevant epidemiologic literature (case-control and cohort studies) on non-asbesufonn talc and risk of ovarian cancer. Wc will begin by retrieving all references (there appear to be 17 on non-asbestiform talc and ovarian cancer) cited in the NTP's "Draft Report on Carcinogens. Background Document for Talc, Asbestiform and Non-Asbestiform." However, our previous experience in examining NTP reviews suggests that the NTP often fails to consider relevant literature. Therefore, we propose to conduct a comprehensive search of the readily available English-language literature using proven on-line searching techniques (Dialog, etc.) for additional epidemiologic studies on non-asbestifonn talc and ovarian cancer.
Wc will search only for those papers publislied after 1980 (when Cramer first reported an association) to ensure that the exposures examined were non-asbcslifonn talc. We estimate that this search may yield approximately 40 relevant epidemiologic studies (case-control and cohort). In addition, we will search (to the extent possible) for papers that have relevant information, but were not specifically designed to examine the issue of talc and ovarian cancer.
An electronic database of relevant citations will result from THE WEINBERG GROUPS citation ordering and tracking system. We routinely maintain electronic copies of all relevant publications collected in support of a project. The resulting literature maintenance system allows articles to be searched, reproduced, and Sorted.
Tree-search each relevant paper
As each relevant paper is identified, its bibliography will be "tree-searched" to identify other relevant studies that may have been missed in the on-line search. Tree-searching involves reading an article's bibliography, and then identifying relevant publications cited therein, based on the title or author. Experience has taught us that this step is often essentia! to identify all relevant papers.
TASK 2; Summarize Important Elements of Each Paper
Once the relevant epidemiologic studies on non-asbestiform talc and ovarian cancer have been identified, we will summarize them in a manner that will facilitate their review by the experts. We propose a tabular format that wc have used successfully in the past that presents details on the citation/authors, study design and population, exposure information, odds ratios/reiative risks, and critical comments. Such a format will facilitate review of each paper by the experts, and will enable direct comparisons of similarities and differences among the studies.
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Mr. Gerald MeEwen October 20, 2000 Page 3
TASK 3: Identify and Prepare Experts for Meeting of the NTP Board of Scientific Counselors
Identify experts
We will use our proven search techniques to identify two noted epidemiologists who can effectively address the issue of non-asbestiform tale and ovarian cancer for one day at the meeting of theNTP's Board of Scientific Counselors , scheduled for December 13-14,2000. THE WEINBERG GROUP INC, has substantial experience in identifying experts with impressive credentials who ace qualified to address specific issues. We will begin by researching several renowned epidemiologists who are qualified and able to speak on metbodologic issues surrounding this area of literature. We will speak with them to assess their views on and proposed approach to this topic.
With your approval and input, we will proceed to contact and secure the services of two individuals. THE WEINBERG GROUP INC. will provide the experts with the appropriate literature (identified in Task l above), as well as the summaries of each paper {prepared as part of Task 2 above). Each expert will be asked to read and critique the literature and prepare concise reports that summarize their conclusions. These reports will be submitted to you by THE WEINBERG GROUP INC. and may serve as the basis for their testimony before the Board.
QUALIFI CATIONS AND EXPERIENCE OF OUR PROJECT TEAM
The following individuals will participate in this project:
Rosanne B. McTyre, PH.D. Dr. MteTyre is an epidemiologist with advanced training from Johns Hopkins and Yale Universities. She has more than 20 years of experience in consulting both for government and private clients, and presently leads the Epidemiology and Biostatistics Practice at THE WEINBERG GROUP INC. She Jus worked closely with clients who are concerned about products in crisis and has provided scientifically based assessments of numerous exposures to lifestyle products and disease outcomes. She has participated in projects involving hair dyesr vaginal douches, mouthwashes, lead, MTBE. and other chemical contaminants. Dr. McTyre is experienced in the conduct of comprehensive literature reviews, and has considerable experience working as part of public relations teams and media groups to convey scientific data to iay audiences. As a Board Member of the American College of Epidemiology, she is connected to a wide network of colleagues and has been instrumental in retaining epidemiologists and blostmisticians on behalf of industry, and working with experts in preparation for trial or other public meetings.
.
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Kerry Roche, M S. Ms. Roche is a biologist with 20 years of experience as a consultant for industry as well as th government. She is experienced in eval uating scientific literature on a
wide variety Of health outcomes. She will design the search strategy and direct the literature
search, and will evaluate the relevant epidemiologic literature.
Jolie Jakum , M.PJHL Ms. Jakum is a research assistant at THE WEINBERG GROUP INC,, where she is experienced in the identification, retrieval and analysis of scientific literature. On this assignment. Ms. Jakum will be responsible for performing the literature search and retrieving relevant articles. Ms. Jakum worked previously as an intern at the Environmental Protection Agency's office in Atlanta, Georgia, and as an environmental safety intern at a major brewery.
George Glekas Mr. Glekas is a research assistant in the Epidemiology and Biostatistics Practice at THE WEINBERG GROUP INC. Mr. Glekas' academic background is in the biological sciences with a concentration in physiology and bio-cthics. He is knowledgeable about techniques for identifying potential experts and obtaining all publications of these experts.
PROJECT SCHEDULEfDELIVERABLES
We anticipate the following schedule for completion of each task identified in this proposal:
TASK l; Identify literature
2 weeks
TASK 2: Prepare literature summaries {40 papers)
2 weeks
TASK 3: Retain experts and expert activity
4 weeks
We expect that several of these tasks wilt overlap, and therefore, wc anticipate that the entire scope of work can be completed within 6 weeks. If this proposal is accepted no later than October 25, wc should have no problem completing this assignment in sufficient time for the Board meeting.
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Mr. Geraid McEwen October 20, 2000 Page 5
COST
We estimate the following hours for each of the three tasks:
TASK Is IDENTIFY LITERATURE
Staft Rosaline MeTyre, PhJD. Kerry Roche, M,S. Julie Jakum. M.P.H. George Glekas
'
Hourly Rate $235 175 89 82
Number of Hours 5 12
20 20
Total Professional Time
54
G&A on prof. Time (8,75%) Reimbursable expenses (60 papers 50)
TOTAL TASK 1
Total Cost 51175 2.100 1,780 1,640
6,695
586 3,000
10,281
TASK 2: PREPARE LITERATURE SUMMARIES
Staff Rosanne MeTyre, Ph,D. Kerry Roche, M.S. Julie Jakum, M.PJ4,
Hourly Rate $235 175 89
Number of Hours 6
: 80 40
Total Professional Time
124
G&A on prof. Time (8.75%) Reimbursable expenses (5%)
TOTAL TASK 2
Total Cost $1,410 14,000 3360
i s sm
1,660 925
2135$
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TASK 3: RETAIN EXPERTS AND EXPERT ACTIVITY
Staff
Rosanne McTvre, Ph,D.
Julie Jakum, M.P.H.
Expert I
Expert II
...........
Hourly Rate . $235
89 350
350
Number of Hours 20 40 48 48
Total Cost $ 4 ,7 0 0 3.560 16.800 16,800
Total Professional T te e
156 41,860
G&A on prof, time (8.75%) Reimbursable expens (5%)
3,663 2*093
TOTAL TASK 3
47,616
Picas note that we have made the following assumptions in developing these cost estimates:
* In Task I , we expect to collect and review 60 articles; approximately 40 articles will form the basis of the subsequent review.
In Task 2, wc plan to abstract no more than 40 papers.
* Experts' rate is averaged at $35G/hr.
The total cost of this effort is expected to be about $79.452. Our estimates are usually reliable to within 10%; however, they are subject to change if the scope of work changes. Of course,
no additional work would be authorized without your expressed approval. THE WEINBERG GROUP invoices clients on the basis of professional time expended plus reimbursable expenses (for this assignment, approximately 10% of professional fees). Reimbursable expenses include cost for purchasing papers. Xeroxing, etc. These costs have been estimated as line items above. Cost of expert travel and expenses are not included in these estimates as they could vary widely.
\ I iIl
iI!
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Mr. Gerald McEwen October 20,2000 Page 7
Please let me know if I have accurately captured yourexpectations. We look forward to working with you on this important issue.
Practice Director, Epidemiology and Biostalistics THE WEINBERG GROUP INC.
RBM/bb
Enclosures
cc: Unda Loretz.. Ph.D.
Signature
Date
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The Weinberg Group
1220 Nineteenth Street, NW, Suite 300 Washington, DC 20036-2400 Phone (202) 833-8077 Fax (202)833-7057
e-mail: science@weinbecggroup.corn
THE WEINBERG GROUP INC
WASHINGTON
BRUSSELS
PARIS
NEW YORK
FAX TRANSMITTAL FORM
SAN FRANCISCO
TO: Gerald McEwen, Ph.D.______________ FROM: Rosanne McTyre, Fb.D.______ '_______ DATE: October 20,2000______________ TIME: 4:51 PM_________________________ PAGES: 8____ FAX NUMBER; 202-33 M 969
(INCLUDING COVER PAGE) MEMO:
Hard copy to follow via regular mail.
COSFtOENTtAUTV NOT1CG-' Tbe lactunccts- acccagnayisg tiij teltsopy tr-xtmiisicw cantis rontknti! iatatnation bolosjing to fi>t nder *t* b fegoly priviliged. The nferaujli Is nlcndtt) Otdy fot the tat of fbe isdivslajt (r emtiy nanea a b o v t . l yon * oat t>e atended templeai. yoni t e h e ttb y stifcd dud aoy is d o o m . opylnt, dlstribulos. or he takingof ony amina mroBanueuc thc ooienEof <h* wlrcepied iafomion is tricity peotuWied. ir y e ti hve ftedvcd tbii idecopy is o w , pitase ImtKcdfaKy ootry THE WEKDERG GROE? INC. by telephone tarfante fbfjeium o tke oripral etocoroenti.
PLEASE DELIVER IMMEDIATELY
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