Tuesday, May 18, 2010

May 20 Congressional Hearing Will Address Flawed and Deceptive CDC Study of Lead in DC Drinking Water

On Thursday, May 20, 2010, the Subcommittee on Oversight and Investigations of the US House Committee on Science and Technology will hold a hearing titled "Preventing Harm -- Protecting Health: Reforming CDC's Environmental Public Health Practices." The hearing will be from 9-11 am at 2318 Rayburn House Office Building and will also be accessible online via Webcast.

Why should you care?

Have you ever found yourself in those spirited debates with friends or colleagues or online communities about highly sensitive health issues -- like, for example, childhood vaccinations, alternative therapies, pesticides, autism -- and just before rising blood pressures give way to physical violence, someone invokes an authoritative conclusion supported by the Centers for Disease Control and Prevention (CDC)? So, the conversation comes to a screeching halt? Case closed? Truth spoken? As if Moses had descended from Mount Sinai rendering a stone-engraved verdict from the highest possible authority? One side slinks away with their tail between their legs and the other gloats with a victorious smile?

The CDC, the nation's premier public health agency, has the mission to help improve the health of the people of the United States by promoting disease prevention and control, environmental health, and health education. It is the agency to which we have been conditioned to turn for clear and scientifically sound information on matters of health. With an almost 70-year history of addressing public health problems, it inspires the public's trust. In fact, the CDC's authority is so strong that when its representatives speak, most of us -- including those with medical expertise -- unquestioningly suspend our own judgment and allow our understandings about matters of health to be replaced with the understandings of the CDC.

Our relationship with the CDC is symbiotic. We, on the one hand, desperately need to depend on the agency for reliable information that we can embrace unthinkingly and confidently, especially in times of crisis. The CDC, on the other hand, depends on us for its effectiveness. If our trust in the CDC were to erode, the agency's authority would diminish, its ability to shape public understandings and behaviors would be reduced, and the symbiotic whole would revert to its much-weakened parts.

This week's scheduled hearing sends a clear message of Congressional concern about the CDC's ability to fulfill its mission. It is the second hearing on the CDC's environmental public health practices that Congress is holding in 14 months. The first, in March 2009 (see our 3.22.09 WASAwatch entry), was accompanied by a scathing staff report about the agency's systemic and repeated failures to prevent human harm from toxic environmental substances, and was followed by the demotion of Howard Frumkin, MD, MPH, DrPH, former Director of the CDC's Agency for Toxic Substances and Disease Registry (ATSDR) and its National Center for Environmental Health (NCEH).

Witnesses at Thursday's hearing will include the Government Accountability Office (GAO); Stephen Lester, Science Director from the renowned nonprofit organization Center for Health, Environment & Justice that has been at the forefront of the struggle to address problems with the CDC; and Marc Edwards, PhD, Professor of Civil and Environmental Engineering at Virginia Tech, internationally recognized lead corrosion expert, and 2007 MacArthur Fellow, who has devoted the last 6 years of his career on a voluntary investigation of the multi-agency and multi-year public health fiasco of lead in Washington DC's drinking water.

Mention of the DC "lead-in-water crisis" usually evokes memories of the 2001-2004 historic contamination about which the DC Water and Sewer Authority (WASA), DC Department of Health (DOH), and US Environmental Protection Agency Region III (EPA RIII) knew of, but failed to inform the public for years. To our knowledge, the CDC did not play much of a role in causing this incident. As unbelievable as it may sound, however, the 2001-2004 fiasco was followed by two equally damaging chapters of reckless government behavior in which the CDC's Lead Poisoning Prevention Branch starred.

The first chapter centers on the influential and now infamous 2004 CDC report about the public health impact of the crisis. The second chapter concerns two unconscionable periods of "silence" during which the CDC has failed to disclose to the public its knowledge about public harm from lead in Washington DC's drinking water. Both of these periods extend to the present day.

Chapter 1

Here we'll be brief (ok, as brief as we can!), since we have written extensively about the CDC report in previous WASAwatch entries. If you have time for a quick but relatively comprehensive overview of the issue, we recommend you take a look at this:
  • 4.20.09: How the CDC Failed Our Children and Its Own Mission
Other relevant entries are:
  • 3.15.10: The 2009 Study that Found Health Harm from DC's Lead-in-Water Contamination Wins Best Science Paper Award
  • 8.29.09: It is Time for the CDC to Stop the Spin, Retract its 2004 Report, and Apologize to DC
  • 5.3.09: What the CDC Can Learn from the National Research Council and the Public
  • 3.22.09: A New Congressional Inquiry Into Scientific Integrity Highlights Lead in DC Drinking Water
  • 2.25.09: Bad Science, Conflicts of Interest, and Misuse of Professional Authority: A "Crash Course"
  • 2.5.09: Contemplating the "Slight" and the "Subtle"
In summary, the CDC report titled "Blood Lead Levels in Residents of Homes with Elevated Lead in Tap Water -- District of Columbia, 2004" erroneously concluded that the District's historic 2001-2004 lead-in-water contamination "might" have contributed only to "a small increase in blood lead levels (BLLs)." According to the report, no DC children were identified with BLLs equal to or above the federal lead "level of concern" (10 micrograms of lead per deciliter of blood) from exposure to the contaminated water, even in homes with lead-at-the-tap concentrations twenty times the federal lead action level of 15 parts per billion (ppb) or greater.

The report's message -- that two and a half years of water-lead concentrations far above the allowable federal standard, and in some cases as high as "toxic waste" levels, did not result in significant health harm -- contradicted decades of prior scientific research establishing a clear link between lead-contaminated drinking water and blood lead elevations above the CDC's level of concern, especially for infants dependent on reconstituted formula, toddlers, and young children. The CDC report's deceptive conclusion was reiterated clearly in an accompanying CDC "Talking Points" memo that said:
"There is no indication that DC residents have blood lead levels above the CDC levels of concern of 10 micrograms per deciliter for children 6 months - 15 years old and 25 micrograms per deciliter for adults as a result of lead in water."
Three and a half months after the publication of the CDC report -- when DC WASA, the Washington Aqueduct, and EPA were still trying to decide how to best control the contamination, and the Washington Post was printing almost daily revelations about the multi-agency corruption and incompetence that had led to the historic two-and-a-half-year contamination -- Mary Jean Brown, ScD, RN, Chief of the CDC Lead Poisoning Prevention Branch and principal author of the report, wrote to her DOH coauthor Lynette Stokes, PhD, MPH, then-head of DC's blood lead screening program, that the CDC's research had successfully put the lead-in-water issue to rest. Dr. Brown's letter opened with the following statement:
"Now that there is a better understanding of the public health impact of lead in the drinking water in the District, I hope we will be able to focus on the issue of lead-based paint hazards."
Since its publication, officials across the United States and Canada have repeatedly invoked the CDC report to allay public fears about discoveries of elevated lead in local drinking water. In DC, the paper's no-significant-harm conclusion was used by government officials to justify the virtual exclusion of drinking water as a potentially significant source of lead from both the city's childhood lead poisoning prevention efforts and first-ever lead poisoning prevention bill of 2008.

Further reinforcement of the CDC's message came from a WASA-funded paper written in partnership between the water utility's George Washington University consultants and DOH, and published in the prestigious journal Environmental Health Perspectives (EHP). This bizarre "study" supposedly recounted the city's lead-in-water crisis, but it had so many inaccuracies and omissions that no DC resident who actually lived through the events would recognize it. Wildly applauding each and every action of our city's "heroic" WASA and DOH employees (and ignoring every illegal or embarrassing mistake), the paper concluded that, "There appears to have been no identifiable public health impact from the elevation of lead in drinking water in Washington, DC, in 2003 and 2004." In June 2009, an independent review panel requested that the lead author, Tee L. Guidotti, MD, MPH, retract and apologize for his unfounded conclusion (for more information see our 6.16.09 WASAwatch entry). Guidotti et al. continues to be under investigation. You can read the complete list of concerns regarding this paper in a March 2009 letter from Dr. Edwards to EHP:
  • 3.20.09: Possible Undisclosed Conflicts of Interest and Other Concerns Related to a Publication in Environmental Health Perspectives
Following the publication in January 2009 of an award-winning peer-reviewed scientific study by Virginia Tech and the Children's National Medical Center, which found that in fact hundreds, if not thousands, of District children were harmed from the 2001-2004 lead-in-water crisis, Dr. Brown admitted to the Washington Post that the CDC report was "clearly" not scientific. To date, however, the agency has not only refused to retract its pernicious publication, it has even failed to take such basic corrective measures as disclosing the errors, limitations, and conflicts of interest that mar it. For example, facts that all readers of the CDC report deserve to know include that:
  1. The absence of a link between "worst case" lead-in-water levels and elevated blood lead among District children was based on an analysis of only 17 children, none of whom were consuming unfiltered tap water at the time of their blood test.
  2. The no-significant-harm conclusion was derived from an analysis that inexplicably omitted over 4,500 blood lead tests from 2003, of which almost 300 exceeded the CDC's "level of concern."
  3. Eight of the report's coauthors were employees of the DOH, an agency that had early knowledge of the 2001-2004 lead-in-water crisis and that was being sued together with WASA for causing health harm.
Concerned about the CDC's flawed and deceptive no-significant-harm message, as well as the zeal with which this message was being used to downplay the health risks of lead-contaminated drinking water in communities across the US and internationally, in 2007, Dr. Edwards submitted to the CDC two letters detailing concerns about the report's scientific integrity:
  • 1.17.07: Possible Fabrication and Falsification of Data Used in a CDC Publication
  • 9.18.07: Possible Scientific Misconduct by CDC Scientists and Officials
Although it is unclear if the CDC ever conducted an investigation, it summarily dismissed all of Dr. Edwards' allegations.

In the meantime, DC residents and specifically the parents of the approximately 42,000 children who are today between 5 and 10 years old, have still not received an honest appraisal of the harm that may have been done to their fetuses, infants, and toddlers in the past, especially if they were using unfiltered tap water for mixing infant formula, drinking, and cooking. Moreover, to date, largely due to the CDC report, no government official in any agency -- local or federal -- has acknowledged the true public health impact of the District's historic 2001-2004 lead-in-water contamination.

Chapter 2

Silence 1: Undisclosed evidence of harm from the 2001-2004 crisis

Serious questions about the validity of the CDC report's no-significant-harm message first surfaced in the media in September 2006 when news broke that, contrary to all official claims, numerous 2004 environmental risk assessments at the homes of children with elevated BLLs had pointed to contaminated water as the key source of lead exposure. In her response to this revelation, Dr. Brown told WAMU that the CDC was planning a follow-up study, which would include a review of the District's environmental risk assessments, to determine whether the agency's 2004 finding was correct:
"We're going to do the same sort of analysis on the data that we did [for the 2004 CDC report], just to ensure that the picture that we believe we see, or that we think - we think everything's safe - just to ensure that in fact is the case."
Seventeen months later, in February 2008, the CDC had still not released such an analysis. But representatives from the agency's Lead Poisoning Prevention Branch flew all the way from Atlanta to attend two of several community meetings organized by WASA about the utility's accelerated lead service line replacement program. WASA called these meetings to make the case to DC residents that it was time to abandon mid-way the "remediation" program it had began in 2004. WASA's ambitious program had originally aimed at replacing every single WASA-owned lead service line in the District by 2010. It had been the highlight of the water utility's 2004 "Community Water Pledge" to engage in "a series of activities, well beyond regulatory requirements, to mitigate the elevated lead levels found in the drinking water" of many - if not most - DC homes. The program had also been WASA's desperate public relations attempt to calm the public's wrath about the two-and-a-half year cover-up of the contamination and prove the agency's commitment to public health. Indeed, WASA's determination to "make good" with DC residents was so convincing that two weeks after the announcement of its pledge, a class-action lawsuit against the agency was dropped.

Four years later, aware that it needed compelling reasons to back out of its "remediation" program without jeopardizing its new image as guardian of the public's health, WASA told residents that the majority of DC's lead service line replacements had been "partial" (i.e., only the publicly-owned portion of a home's lead service line was replaced, while the privately-owned portion was left intact), and that partial replacements were "not as effective" at reducing lead-in-water levels as the utility had wished. WASA did not reveal, however, what its data actually showed: that the partial lead service line replacements in the 9,000+ DC homes that had received them often resulted in increases in water lead levels of an undetermined duration.

As part of its presentation at the community meetings, WASA featured Dr. Guidotti who, faithful to the CDC message, assured residents that "water is a small source" of lead exposure, and that there was "no evidence of an adverse effect" from the historic two-and-a-half year contamination. The CDC officials sat through the presentation silently. When asked by a member of the public if they still stood by their 2004 report, all they said was that they were "analyzing some more data" -- that indeed they had "a lot more data" in their possession now -- and would be putting out "a revision for clarification" sometime in the future. In response to a second question about whether the CDC's new analysis was leading the agency to "back off" of its no-significant-harm finding, the CDC representatives said that they were not prepared to make a public statement on the health effects of the 2001-2004 crisis. The questioner, struck by the CDC's refusal to shed any light whatsoever on the question of harm, made the following final remark:
"The way silence is understood sometimes about data is that you [the CDC] are affirming what the word is that the public agencies are putting out. WASA has been very clear that there are no health effects. So I just want to put that out from a public perspective."
Astonishingly, three months prior to this meeting, the CDC Lead Poisoning Prevention Branch had presented data at the annual conference of the American Public Health Association (APHA), which showed that many children in Washington DC actually did experience elevated BLLs from the 2001-2004 lead-in-water contamination. Even though Dr. Brown herself was the study's co-investigator, the CDC chose not to publicize the findings or post the PowerPoint presentation on its website (we discovered that the presentation is available on the APHA website for a fee). Nor did CDC inform DC government agencies or the public. Here are some of the presentation's conclusions:
  • DC children with BLLs equal to or greater than 5 or 10 micrograms per deciliter were significantly more likely to have lived in a house with a lead service line, as compared to children with lower BLLs, even after adjusting for confounders.
  • The proportion of children tested with high BLLs (equal to or greater than 5 or 10 micrograms per deciliter) was significantly higher during 2001-2004 -- when DC used the disinfectant chloramine without a corrosion inhibitor.
  • When in 2004 the use of chloramine alone was stopped (and a corrosion inhibitor was added into the drinking water) there was a dramatic reduction in elevated BLLs in DC children under 6.
These findings, which contradicted the 2004 CDC report, agree with a) decades of prior scientific research about the health effects of lead in water on infants and young children, and b) the 2009 Virginia Tech/Children's National Medical Center paper that found serious public health harm (for more about the 2007 CDC presentation see our 5.3.09 entry).

To date, the CDC has published no study revising or updating its 2004 report.

Silence 2: Only partly disclosed evidence of harm from DC's partial lead service line replacements and undisclosed evidence of harm from intact lead service lines

In January 2010, the CDC posted online an "Important Update," alerting managers of CDC-funded childhood lead poisoning prevention programs nationwide that:
"... when lead service lines are partially replaced children are more likely to have blood lead levels greater than or equal to 10 ug/dL, compared to children living in housing with either undisturbed lead service lines or service lines that are not made of lead."
This preliminary finding, we have learned, comes from a study the CDC conducted on water lead levels and blood lead levels in DC homes with lead and non-lead service line material. It is unclear to us whether this is the study the CDC has been alluding to since 2006 that reassesses the agency's 2004 no-significant-harm conclusion. What we do know, however, is that this new study entered the publication process at least ten months ago, and that the CDC has been aware about lead elevation problems with DC's partial lead service line replacements since at least November 2007.

In a November 2009 meeting that several local and national organizations requested with the CDC, Dr. Brown agreed to share with us further details of the agency's findings. Specifically:

A child's risk of developing elevated BLLs increases twofold when the child lives in a home with an intact lead service line, and fourfold when the child lives in a home with a partial lead service line -- as compared to living in a home with no lead service line. This strong correlation between lead service line and blood lead levels was detected after accounting for confounding factors and even when the District's water met the federal lead safety standard.

Simply put, those of us who live in homes with a lead service line or partially replaced lead service line have something to worry about! In fact, we've had something to worry about for years!

Amazingly, it looks like the CDC will broadcast the "details" of its findings only if and when its manuscript hits the press. In the meantime, DC residents -- and residents in other parts of the US -- who live in high-risk homes will remain in the dark about the potential serious and irreversible health hazards in their tap water.

Other government agencies will have to do the same. It is our understanding that the CDC has not shared its complete study either with the DC Department of the Environment (DDOE), which houses the city's childhood lead poisoning prevention program, or with WASA, which knows where many of DC's 30,000+ lead service lines are and is continuing to conduct some 200 partial lead service line replacements a year.

According to WASA General Manager Hawkins' 4/30/10 testimony to DC City Council:
"So far, DC WASA has not been afforded the opportunity to review a preliminary draft of the CDC study, although we have cooperated in all CDC requests for information on this subject."
Exposure to lead-contaminated drinking water is by and large easily preventable. Yet the CDC's reckless and unethical management of this environmental health threat has needlessly placed hundreds of thousands of children at risk of irreversible harm. How much longer are we expected to embrace the CDC's "knowledge" unquestioningly and confidently, when doing so might hurt us?

Changes in the CDC's Lead Poisoning Prevention Branch are needed urgently. As we have said before, they ought to start with the immediate retraction of the agency's deceptive 2004 report.

We urge Congress to intervene immediately and decisively.

Monday, March 15, 2010

The 2009 Study that Found Health Harm from DC's Lead-in-Water Contamination Wins Best Science Paper Award

Last week, the prestigious chemical and environmental research journal Environmental Science & Technology announced its selection of best papers of 2009.

The journal gave its top award to the paper "Elevated Blood Lead in Young Children Due to Lead-Contaminated Drinking Water: Washington, DC, 2001-2004," coauthored by Virginia Tech Professor of Civil and Environmental Engineering and MacArthur Fellow Dr. Marc Edwards, Virginia Tech doctoral candidate Simoni Triantafyllidou, and Children's National Medical Center pediatrician Dr. Dana Best.

The journal considered 1,400 peer-reviewed studies in total. It awarded the Edwards et al. paper for being "of the highest caliber" and for its anticipated "significant and long-lasting impact on the field."

WASAwatch wrote about the Edwards et al. paper in a previous blog and offered a summary of the study's methodology and findings. It is worth restating that the research contradicted years of public assurances by WASA, WASA's paid consultants at the George Washington University School of Public Health, DC government, the Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC) that exposure to almost three years of astronomical levels of lead in drinking water resulted in no measurable public health harm and that cases of elevated BLLs during that time were consistently linked to lead paint and dust. The Edwards et al. paper also prompted two still active investigations -- one by Congress and the other by the DC Office of the Inspector General -- into possible negligent or intentional wrong-doing by city and federal agencies.

Here are the Edwards et al. key conclusions:
  1. In 2002 and 2003, the total estimate of elevated blood lead level (BLL) cases (i.e., equaling or exceeding 10 micrograms of lead per deciliter of blood) from high water lead levels for children 2 1/2 years old and younger is 859 (this number is probably much lower than the actual for reasons highlighted in the paper).
  2. The greatest health impact from the city's 2001-2004 contamination was in the second half of 2001, when lead-in-water levels rose suddenly and dramatically and the incidence of elevated BLLs increased 9.6 times, as compared to the first half of 2001 (when the lead problem was just beginning).
  3. The incidence of elevated BLLs did not return to levels observed in 2000 (before the contamination) until about 2005, when WASA once again met EPA lead-in-water standards.
  4. The screening guidelines of the CDC, which recommend testing children for elevated BLLs at around 1 and 2 years of age, are not designed to detect lead exposure in infants and thus provide only limited insight to the effects of lead at the tap on the under-12-months age group.
  5. The public health impact of the 2001-2004 Washington DC contamination was consistent with decades of research in the US and Europe linking lead-contaminated drinking water to elevated BLLs.
The Environmental Science & Technology award is a dramatic measure of the highest level of respect the environmental science community has for the Edwards et al. research.

When the paper was originally published, numerous officials from the relevant government agencies and their allies made pejorative private and public statements questioning the study's methods and validity (none of these officials, by the way, had similarly questioned the "no significant harm" conclusions of two earlier papers, authored by government representatives and WASA-paid consultants with clear conflicts of interest).

It has been over a year since the paper's publication and, despite assurances by WASA, DC government, and EPA Region III that they were going to evaluate carefully the merits of the study, to date no agency has made public any such evaluation. More importantly, no agency has ever acknowledged the harm done to DC children in 2001-2004, nor have they once apologized for the role they played in the fiasco. Given the active $200 million class action lawsuit against WASA, maybe this silence is understandable from a legal and economic perspective. From a public health and social justice perspective, however, it is unethical and unconscionable.

Some readers might wonder why we are opening old wounds. After all, the 2001-2004 lead-in-water crisis purportedly ended 5 years ago. Moreover, WASA now has a new, charismatic, highly skilled, and trustworthy General Manager. What's the point of revisiting this controversy from the past?

It's a valid and important question.

Even though positive changes have been made since the publication of the Edwards et al. study, there are three main reasons why the question of health harm from the 2001-2004 crisis continues to matter:

1. DC residents, and certainly the parents of the approximately 42,000 children who are today between 5 and 10 years old, deserve an honest appraisal of the harm that may have been done to their fetuses, infants, and toddlers in the past, especially if they were using unfiltered tap water for mixing infant formula, drinking, and cooking. To date, no government official has acknowledged the public health implications of the city's historic lead-in-water contamination.

2. Critical nodes of the intricate, multi-agency web that created the lead-in-water crisis, and that for five subsequent years misled DC residents and communities around the country about its health consequences, are still firmly in place. Specifically:
  • Several employees at WASA, EPA Region III, and the CDC with a documented history of misleading the public continue to control information and make decisions about drinking water safety in DC or childhood lead poisoning prevention nationwide. None of these employees have been held accountable.
  • The flawed 2004 CDC report -- currently under Congressional investigation -- that found no cases of elevated BLLs due to DC's contaminated drinking water still sits on the agency's website. Seven months ago, Congressional investigators revealed that the CDC analysis had omitted thousands of blood lead measurements, including hundreds of elevated BLL data points, which led WASAwatch to call for the report's full retraction. To date, the CDC has shown no inclination to publicly correct their flawed study, even though its principal author, the chief of the CDC's lead branch, now admits that the work was "not scientific."
  • The WASA-funded paper that was published in the peer-reviewed journal Environmental Health Perspectives (EHP) in 2007 and claimed "no measurable harm" from the 2001-2004 contamination still sits on EHP's website. Serious questions about undisclosed financial conflicts of interest, possible data fabrication, and the scientific integrity of this study, authored by former George Washington University professor Dr. Tee L. Guidotti and his colleagues, are laid out in detail in a March 2009 letter from Dr. Edwards to EHP and have been discussed on WASAwatch and the newsletter of the American Association for the Advancement of Science (AAAS). You may be also interested in Dr. Guidotti's response letter to the AAAS editor, which studiously avoids a factual response to key points of the allegations, and the reporter's reply. Although EHP has not disclosed this publicly, the Guidotti et al. paper continues to be under investigation.
3. Although DC's 2001-2004 lead-in-water contamination was unique in its severity, lead-in-water problems around the country may be more serious and widespread than presently believed. We know, for example, that:
  • Lead service lines, lead-containing solder, and leaded brass fixtures -- which are all sources of lead in water -- are widespread around the country.
  • Even though water utilities may still underreport lead-in-water problems, every year at least some utilities exceed the federal lead-in-water standard.
  • Water utilities that meet federal lead regulations can still have lead-in-water problems in up to 9% of the homes they monitor.
  • The number of documented states affected by lead-contaminated drinking water in schools is at least 39 (including DC). There is no scientific or practical reason to believe that the problem does not extend to schools in all 50 states.
  • Children living in homes with partially replaced lead service lines are at a significantly higher risk of experiencing elevated BLLs than children living in homes without lead service lines, and such replacements have been performed in numerous locales in the US and Canada during the past 20 years.
  • 30% or more of current elevated BLLs do not have an immediate lead paint source, and studies suggest that lead exposures result from multiple environmental sources.
  • The detection of lead-in-water contamination requires a proper testing protocol that not all utilities use. Moreover, the detection of lead particles (i.e., small pieces of detaching lead solder or lead rust that can contain excessively high concentrations of lead) is difficult, even with the use of a proper testing protocol.
Despite these facts, and the high incidence of elevated BLLs among children in cities like Providence, Milwaukee, Chicago, and Philadelphia that are known to have high concentrations of lead service lines, the US approach to childhood lead poisoning prevention focuses almost exclusively on lead paint and dust hazards, and tends to downplay risks of lead-contaminated drinking water.

The Edwards et al. paper points to the need for a serious national reexamination of lead poisoning prevention laws, protocols, and programs to prevent fetuses, infants, and children from being needlessly harmed by lead at the tap.