The original Treatment of Lead-Exposed Children (TLC) trial was documented on the NIEHS
Epidemiology Branch website, which is now offline. Below are the relevant pages, recovered
from the Internet Archive Wayback Machine and grouped by section. The site moved over time —
first dir.niehs.nih.gov/direb/tlc1/ (1998–2005), then
direb/studies/tlc/ (2005–2007) — and many pages were edited along the way,
so each entry lists every distinct version the Archive holds (identical re-captures
are collapsed). Where a page's wording changed in a way that matters to the re-examination,
a short note flags it. 55 pages, 176
distinct archived versions.
Original TLC trial website (1998–2005)
The original NIEHS site at dir.niehs.nih.gov/direb/tlc1/. These pages describe the trial's design, sites, enrollment, publications, and Protocol v10.
Protocol v.10 /direb/tlc1/admin/prot_v10.html Protocol version 10 (dated Nov 4, 1997) — the version NIEHS posted publicly. Single Wayback capture (2004-10-30). Enrollment & retreatment data /direb/tlc1/enroll.htm Enrollment figures stable across all versions (780 total; 213/208/165/194 by center). Only the final-assessment date slipped (Jan→Apr 2000). No retreatment counts appear here. TLC homepage /direb/tlc1/home.htm Flipped from describing an ongoing trial to reporting the primary null result in 2001 (“no difference … on any of the psychological tests at three years”). Post-2005 “page has moved” stubs are omitted. Investigators (early) /direb/tlc1/invest.htm Harvard data-center lead PI changed Dockery→Ware (1998→1999). J. Julian Chisolm Jr. listed unchanged — all captures predate his 2001 death. Sites & Investigators (final) /direb/tlc1/investfinal.htm Study in a nutshell / Study Operations (DSMC) /direb/tlc1/nut.htm DSMC description reworded Feb 2001 (added “active”, the “(DSMC)” acronym, “annual” review; member attendance softened). Screening figure revised 1999→2000 from “about 2,000” to “evaluated 1,854” children (randomized 780 held constant). Publications /direb/tlc1/pub.htm Grew 2→9 entries 1998–2004. A treatment-phase results manuscript appeared (1999) then was deleted; the Serwint iron paper's title flipped from a question to a null finding; the “heavy hippos” vitamin paper was retitled; the NEJM 2001 paper was posted late (Chisolm's authorship posthumously). Clinical sites /direb/tlc1/sites.htm Supplemental table X2 /direb/tlc1/treat/tableX2.htm Supplemental table X3 /direb/tlc1/treat/tableX3.htm Supplemental table X4 /direb/tlc1/treat/tableX4.htm Supplemental data tables (index) /direb/tlc1/treat/tables.htm Vitamin/mineral supplement contents /direb/tlc1/vitamins/vitscontents.htm Relocated TLC site (2005–2007)
After 2005 the site moved to direb/studies/tlc/. The Questionnaires page indexes the full case-report-form set (the form PDFs themselves were not archived by the Wayback Machine).
Summary (home) /direb/studies/tlc/home.htm Investigators /direb/studies/tlc/pi.htm Post-2005 investigator roster; J. Julian Chisolm Jr. is marked “(deceased)” in both the clinical-center and Steering-Committee lists. Publications /direb/studies/tlc/pubs.htm Questionnaires / FORMS INDEX (lists all ~37 CRFs + versions) /direb/studies/tlc/question.htm Index of all ~37 TLC case-report forms with their version-years (e.g. retreat05, tx1–3_05, visit1a_04). The form PDFs themselves were not captured by the Wayback Machine. Investigators & the NIEHS Epidemiology Branch
Bios and CVs of the TLC principal investigator (Walter Rogan) and trial statistician (N. Beth Ragan), plus the Epidemiology Branch pages that situate the trial.
CV — Matthew P. Longnecker /direb/cv_mpl.htm Bio sketch — Stephanie J. London /direb/cv_sjl.htm CV — Walter J. Rogan /direb/cv_wjr.htm Rogan's CV lists him as NIEHS IRB founding chair (1980–1983) and chair (1992–1993). Epidemiology Branch — home/mission /direb/home.htm Ragan bio (legacy) /direb/ragan.htm N. Beth Ragan described as “alternate project officer” on the Coordinators' and Environmental Subcommittees; she also designed/maintained the NIEHS IRB website. Rogan bio (legacy) /direb/rogan.htm Rogan's self-described role escalated from “project officer” (1998–2000) to “project officer and one [of] the principal investigators” only after the 2001 NEJM null result. Epidemiology Branch — Staff roster (1999) /direb/staff.html Epidemiology Branch — Staff roster (modern) /direb/staff/home.htm Ragan CV (PDF) /direb/staff/ragan/cv.pdf Ragan staff — Research Statement /direb/staff/ragan/home.htm States verbatim that “Ms. Ragan was a project officer for the Treatment of Lead-exposed Children (TLC) Trial.” Ragan staff — Studies (TLC) /direb/staff/ragan/study.htm Rogan CV (17pp PDF; ACCLPP/NTP roles) /direb/staff/rogan/cv.pdf 17-page CV documenting Rogan's ACCLPP liaison and NTP lead-carcinogenicity roles, and an April-2001 NIEHS seminar titled “Treatment of Lead-exposed Children.” Rogan staff — Education & Employment /direb/staff/rogan/employ.htm Rogan staff — Research Statement /direb/staff/rogan/home.htm Rogan staff — Studies (describes TLC) /direb/staff/rogan/study.htm Epidemiology Branch — Studies index /direb/studies/ TLC study — directory listing /direb/studies/tlc/ TLC publications — full text hosted by NIEHS
Full-text papers the NIEHS Epidemiology Branch posted for the trial, including the main NEJM 2001 results paper and its editorial.
Serwint 1999 — iron status (J Pediatr) /direb/fulltext/jpeds1999wjr1.html Dietrich 2000 — symptomatic lead poisoning (J Pediatr) /direb/fulltext/jpeds2000knd1.pdf Gladen/Ragan/Rogan 2000 — PCB-DDE pubertal growth (J Pediatr) /direb/fulltext/jpeds2000wjr1.pdf Rogan 2001 — MAIN TLC RESULTS (NEJM) /direb/fulltext/nejm2001wjr1.pdf NEJM 2001 editorial /direb/fulltext/nejm2001wjr1ed.html TLC Group 2000 — succimer safety/efficacy (Pediatr Res) /direb/fulltext/pr2000wjr1.pdf NIEHS IRB & conflict-of-interest records
The NIEHS Institutional Review Board section. Of note: Epidemiology Branch (TLC's branch) protocols received scientific review within the branch, merely 'accepted by' the Deputy Scientific Director, and the branch held ≥2 seats on the IRB.
COI Guide — financial & non-financial (Oct 2006, 10pp) /dirosd/ocr/irb/COI GUIDE FINAL OCTOBER 11 2006PDF.PDF NIH guide to financial & non-financial conflicts of interest, incl. IRB-member recusal rules (Oct 2006). Single fragile Wayback snapshot. Protocol Conflict of Interest Statement form /dirosd/ocr/irb/PROTOCOL CONFLICT OF INTEREST STATEMENT.DOC IRB accreditation page ('last updated June 11 1999') /dirosd/ocr/irb/irb_acc.html IRB Bulletin #1 — submitting applications (EB carve-out) /dirosd/ocr/irb/irb_bulletin1.htm IRB Bulletin #2 /dirosd/ocr/irb/irb_bulletin2.htm IRB Bulletin #3 /dirosd/ocr/irb/irb_bulletin3.htm IRB Bulletin #4 — studies involving genes (Apr 2000; signed by chair) /dirosd/ocr/irb/irb_bulletin4.htm IRB Bulletin #5 — EB self-review accepted by Dep. Sci. Director /dirosd/ocr/irb/irb_bulletin5.htm States Epidemiology Branch projects' pre-IRB scientific review is “typically done by the Branch, and this review is accepted by the Deputy Scientific Director” — branch self-review of its own (TLC) protocols. IRB basic info sheet (path under EB tree) /dirosd/ocr/irb/irb_info.html IRB meeting schedule (EB statistician carve-out) /dirosd/ocr/irb/irb_meet.html IRB Membership Roster /dirosd/ocr/irb/irb_members.html The Epidemiology Branch (TLC's branch) held ≥2 IRB seats continuously: Baird + London (2004 roster) → Baird + Longnecker (2006). IRB Staff / officers /dirosd/ocr/irb/irb_staff.html IRB Standard Format for Protocols (Nov 1999; TLC-era template) /dirosd/ocr/irb/irb_stan_format_99_w6.htm The “November 1999” IRB Standard Format — the protocol template that would have governed TLC-era submissions. Media & file index
A NIEHS video-interview series with TLC co-PI Joseph Graziano (indexed but the video files are streaming/unarchived) and a Graziano/Hamilton Q&A PDF.
Graziano (TLC co-PI) video index (listallvideos.cfm) /admin/listallvideos.cfm Graziano & Hamilton — follow-up questions (Q&A PDF) /news/assets/docs_f_o/followup_questions_from_joseph_graziano_and_joshua_w_hamilton.pdf