Wednesday, February 25, 2009

Bad Science, Conflicts of Interest, and Misuse of Professional Authority: A "Crash Course"

This week the independent radio program "Living on Earth" is airing a 7-minute interview with Dr. Marc Edwards, Professor of Civil and Environmental Engineering at Virginia Tech, about lead in the District's drinking water. Dr. Edwards, an internationally renowned water corrosion expert and 2007 MacArthur Fellow, is the first author of a new peer-reviewed study revealing that DC's 2001-2004 lead-in-water crisis caused elevated blood lead levels in hundreds, if not thousands, of infants and toddlers.

Dr. Edwards has stated in numerous presentations that his study does not prove the harmful effects of leaded drinking water. These effects were established decades ago. Indeed, in 2004, Dr. Ellen Silbergeld, Professor of Environmental Health Sciences at Johns Hopkins University testified in Congress that the ability of lead in water alone to cause toxicity, especially in infants, was established in the 1960s (several key studies confirming this finding came out afterwards as well).

The Edwards et al. 2009 study merely confirms prior scientific knowledge. It also reveals the serious flaws of the two government-sponsored papers -- published in 2004 and 2007 -- claiming that "no harm" was done from the unprecedented contamination. For the last 5 years, these two studies have been used repeatedly both in DC and internationally to downplay contaminated drinking water as an important source of exposure to lead. The first study was authored by the Centers for Disease Control and Prevention (CDC) and the DC Department of Health (DOH), and the second, by George Washington University (GWU) and DOH.

If you are wondering about the role of DOH in the 2001-2004 debacle, here's some quick background:

DOH learned about the lead-in-water contamination in October 2002, when WASA approached them with an urgent request for assistance. An independent report later revealed that WASA's calls for help "were met with slow response time from DOH or were not met with any response at all." In February 2004, two weeks after the Washington Post broke the story about excessively high levels of lead in our water, DOH sought the help of CDC to "assess" potential health effects from the contamination. Here's what's key about this partnership: Dr. Lynette Stokes, co-author of the ensuing CDC/DOH report that claimed that no harm was done, oversaw the DOH lead screening program at the time, but was also a former employee of the Agency for Toxic Substances and Disease Registry (ATSDR) -- an agency under the aegis of CDC (for more on Dr. Stokes, see our 1/31/09 blog "5 Year Anniversary").

Almost immediately after she called for CDC's assistance, Dr. Stokes announced on WAMU's Kojo Nnamdi Show that:

"We've found that 34 children have elevated blood lead levels amongst those screened, and we wanted to make sure that we tried to identify all sources of lead. [...] When we did the environmental assessments we determined that every child had a [lead] dust or a soil level that exceeded EPA or HUD guidelines."

This claim, that every child with elevated blood lead levels in the first half of 2004 lived in a home with a non-water lead hazard (and the implication that this hazard was the primary cause of the elevated blood lead levels), was repeated consistently -- even in official documents to the US Senate and the DC Office of the Inspector General -- by government officials and their expert consultants for the next four years. GWU and DOH included a version of it in their 2007 study, and WASA featured it in their public education factsheet even as late as 2008 (see point 7 on the factsheet).

Research by Dr. Edwards, however, revealed that in actuality many of these environmental assessments at the homes of children with elevated blood lead levels pointed to drinking water as the sole or contributing source of exposure to lead. Dr. Edwards talks about both the CDC/DOH study and the GWU/DOH study in this week's "Living on Earth." We contacted him with three follow-up questions.

Here are his answers:

PNA: In the interview with "Living on Earth" you said that you "went to the CDC, asked them for details about their study, and they refused to give [you] any." Can you say more about this? What kind of information did you ask for? Was it proprietary? Is it within a federal agency's legal right to not share information about a study with the public? Do you have any thoughts as to why they didn't give you the information you asked for?

Dr. Edwards: We initially asked for very basic information about how/when their paper was published, how the data was collected, whose blood lead was tested -- the simple information that scientists are supposed to freely share to defend the validity of their work. For the first time in my career, the scientists of a paper would not answer a single question that I posed. I later figured out why they would not answer my questions. The Freedom of Information Act requests revealed their "study" was not at all what it was presented to be. I believe that the people involved in the CDC MMWR [Morbidity and Mortality Weekly Report] are guilty of gross misconduct. These authors refused to correct the scientific record, which was being twisted to suggest that drinking water with even 300 parts per billion lead (20 times the federal limit of 15 parts per billion) would not harm anyone. Someone would have to ask them why they refused to answer my questions or to correct the record.

PNA: What has CDC said about your finding that DC residents' blood lead levels were tested long after they knew not to consume the lead-contaminated water? Have they accepted it as a fact, or are they disputing your claim?

Dr. Edwards: They have flatly refused to answer any questions that I have posed about their work. They admitted to freelance reporter Rebecca Renner a few years ago that I was correct about the months to a year gap between the time residents were told of the high lead in water and the time their blood lead was tested. By the way, their refusal to answer questions and to defend their work is also completely contrary to written CDC policy regarding publications in MMWR. But as far as I can tell, following their own written guidelines does not seem to concern those at CDC who are working on this issue. A few hours after my own work was published, lead author Mary Jean Brown admitted to the Washington Post that the CDC MMWR was "clearly" not scientific. I agree with that statement. First and foremost, the CDC MMWR has been a public relations coup for DC WASA. I don't know why CDC is in the business of publishing work that is "clearly" not scientific, or why they would sit by while DC WASA continued to mis-represent what happened.

PNA: You said that "the data that was presented to the public, much of it was just completely fabricated." Can you say more about this? What are some of the key fabricated data we should know about?

Dr. Edwards: Fabrication involves "making up data out of thin air," as well as knowingly presenting data as if it is something that it is not. Failure to disclose the months to a year that DC residents in the "300 parts per billion" study were not drinking water, and telling everyone in DC that those who were tested represented the "worst case," is an example of fabrication. There was another study of "65 children" who supposedly had elevated blood lead, and whose homes were tested by DC DOH, and it was claimed by DC WASA that "in every case" they found lead paint and lead dust over federal standards. This was even cited to the US Senate in written testimony by DC WASA's General Manager Jerry Johnson. The fact of the matter is that this "study" never existed. The data were made up of thin air. There are many more examples, but I do not have time to discuss them all.

Friday, February 20, 2009

Does WASA's Compliance with Federal Regulations Mean that Your Water is Safe to Drink?

Recent revelations about the harm done to hundreds, if not thousands, of DC's infants and toddlers from the 2001-2004 lead-in-water contamination have raised new concerns about the safety of our drinking water today.

Public officials responded with a new wave of assurances. On Jan. 27, WASA told the Washington Post that "the most recent tests of the city's water show lead levels in the safe range." On Jan. 28, in a web alert, WASA's General Manager Jerry Johnson said, "I want to assure the public that District drinking water is safe and meets or exceeds every federal standard." Mr. Johnson delivered the same assurance on video (see below). On Feb. 1, the Chairman of WASA's Board of Directors wrote to the Washington Post that, "What people should know first and foremost is that DC drinking water is safe and meets or exceeds all federal safety standards." On Feb. 14, DC Attorney General Peter Nickles "warned against panic because officials have found the drinking water to be safe."

The question we have to ask is this: does WASA's legal compliance with the federal Lead and Copper Rule (LCR) mean that the drinking water in every resident's home and every child's school does not contain concentrations of lead that can pose a health risk?

The answer is "no," and this is why:

Even though the District no longer faces the extreme lead-in-water problem of 2001-2004, serious questions remain about the methods by which WASA monitors our water for compliance with the LCR. It is because of these questions that the DC Department of the Environment is currently conducting independent testing of the District's water for lead. In other words, we are not yet sure that our drinking water actually meets federal lead safety standards, as WASA claims (we will write more about this issue later).

But even if WASA monitored our water properly and results showed that they were in compliance with the LCR, DC residents would still have no guarantee that the drinking water in their individual homes and schools is not lead-contaminated.

Here's the reason:
  • The LCR allows for 10% of homes in a water utility's monitoring pool to have lead-in-water problems of any magnitude. In 2006 and 2007, for example, 4.5% of the homes monitored by WASA had elevated levels of lead in the 1st draw sample, and 9% had elevated levels of lead in the 2nd draw (or "flush") sample. These high lead-in-water concentrations were obtained despite WASA's use of a protocol that required 10 minutes of flushing the night before sampling, a practice known to hide lead.
  • According to the EPA, the level of lead in drinking water below which there is no known or expected risk to health is zero parts per billion. The Centers for Disease Control and Prevention states that “for homes with children or pregnant women and with water lead levels exceeding EPA’s action level of 15 parts per billion,” only bottled water should be used. WASA’s 2006 and 2007 compliance measurements show numerous 1st draw samples in the hundreds of parts per billion. These measurements represent lead-in-water levels citywide. The small number of homes with excessively high levels of lead in WASA’s targeted sampling could translate into potentially thousands of District residences with elevated levels of lead at the tap.
  • EPA law regulates only 1st draw water samples. 2nd draw samples, which are more representative of the water we use to drink and cook, do not count. If 2nd draw samples counted, WASA’s 2006 and 2007 LCR compliance monitoring data would have rendered the agency out of compliance with EPA regulations. Specifically, WASA’s July-December 2006 compliance data show that 13 of the 106 2nd draw measurements exceed the EPA action level of 15 parts per billion. Similarly, the agency's July-December 2007 compliance data show that 13 of the 101 2nd draw measurements also exceed 15 parts per billion. These data strongly suggest that lead in the water of thousands of District homes will frequently be elevated above the action level following an initial draw.
  • EPA's LCR does not cover drinking water in schools. This means that neither sampling, nor remediation of lead-contaminated school water is required by law. Schools that test the water do so voluntarily. Although lead-in-water levels at DC Public Schools are dramatically lower today than they were in 2007 due to the installation of water filters, some problems remain (see the 2008 PNA/Virginia Tech report).
DC government data in 2007-2008 show that contaminated drinking water continues to be either the sole or a contributing lead source for 9% of DC children with elevated blood lead levels whose water was tested for lead. This percentage is based on a sampling method that does not follow the standard EPA protocol and can miss lead.

If you want to be sure that lead in your drinking water is below 15 parts per billion, we recommend that you have your water tested by an independent EPA-accredited laboratory. Make sure that you take both a 1st and 2nd draw sample. Mail bottles back to the lab, requesting that they use 2% nitric acid in the first step (prior to the mandatory holding time of the acidified bottle), instead of the specified 0.15% nitric acid (pH < 2). Use of a stronger acid is allowed in the EPA protocol, and makes it more likely that lead particles will not be missed.

A premier water testing lab is the Environmental Quality Institute, at the University of North Carolina, Asheville (we have no ties to EQI, but it has been recommended highly by independent scientists, public health advocates, and government officials alike).

Video: WASA's General Manager Jerry Johnson assures DC residents that the water meets or exceeds federal lead safety regulation standards, 1/28/09.

Friday, February 13, 2009

The Real Cost of 25 Words That Sold for $750,000

Today's front page Washington Post article "Agency's Role Probed in DC Water Report" is the fifth in a series that is slowly but surely lifting the wool from DC's eyes about the harm done to our children from lead in the city's drinking water during 2001-2004.

The article focuses on the paper "Elevated Lead in Drinking Water in Washington, DC, 2003-2004: The Public Health Response," written by WASA consultant and former chair of the Department of Environmental and Occupational Health at the George Washington University School of Public Health, Tee L. Guidotti, MD, MPH. This paper concluded with the following 25 words: "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."

Dr. Guidotti and his client repeated this "no harm done" mantra again and again, in one form or another, at City Council hearings, as well as WASA community meetings and educational factsheets. The claim is contradicted not only by prior scientific knowledge, but also by the new Environmental Science & Technology study, which found that DC's 2001-2004 lead-in-water crisis caused elevated blood lead levels in hundreds, if not thousands, of infants and toddlers.

The WASA/George Washington University contract paid Dr. Guidotti and his colleagues over $750,000 in a 3-year period (as far as we know, this contract is still active). That's a lot of ratepayer money for what we got in return: a rogue water utility that seems answerable to no one, and a public that is in the dark about the real health risks from lead at the tap. Just in the last year, for example, WASA managed to walk away unscathed from wasting around $100 million on 9,000+ partial lead service line replacements, which can at times make lead-in-water levels worse for an undetermined duration. At the same time, many WASA customers remain unaware of and unprotected from the health risks from such replacements.

The real cost of Dr. Guidotti's 25 words was the disbelief it reinforced in us about the toxicity of lead in water. DC Council member Jim Graham echoed the thoughts of many in DC when he told the Washington Post that, "The paper's assurance that drinking water was safe 'was used over and over and over again.'" Indeed, WASA had Dr. Guidotti present his "no harm done" thesis at multiple forums, including a series of community meetings between January-May 2008, and a WASA Board of Directors' meeting in June 2008.

Today a colleague and I got a call from someone we had contacted some time ago to report WASA's water sampling irregularities at DC public schools. At the time, this person was in a position to help, but decided against getting involved. Now, this person said, they too felt partly responsible for the mess we're in. "I thought it was just lead paint...," the caller confessed.

This is what we got for our $750,000: inaction about a serious public health risk, and now guilt by people who are caring and conscientious and would have done something had they known the truth. Tragic.

Thursday, February 5, 2009

Contemplating the "Slight" and the "Subtle"

What did you think about Saturday's Washington Post article on the public health implications of the 2001-2004 lead-in-water crisis?

We were perplexed by it.

"Experts View Public Health Impact as Slight," declared the subtitle. The article said:

"The effects [of the harm on children when lead levels in the District's water spiked in 2001-2004] could include the loss of two to three IQ points and a higher risk for behavioral problems, even in children whose bloodstream lead stayed below the threshold of concern set by federal health officials [i.e., 10 micrograms per deciliter]. But at the exposure levels experienced by the District's children, the public health consequences are likely to be very slight, even under the most pessimistic assumptions, according to several experts as well as published studies."

Very slight, even under the most pessimistic assumptions?!

Then the article quoted the Director of the National Center for Environmental Health at the Centers for Disease Control and Prevention (CDC) as saying that at blood lead levels below 10, "the effects are subtle."

"Slight" and "subtle" were the big takeaways.

You do not have to be an expert to suspect that only one part of the story was emphasized here. First of all, "the exposure levels experienced by the District's children" very likely included hundreds, if not thousands of cases, of blood lead levels at or above 10, the CDC's "level of concern." The scientific literature is absolutely clear that blood lead levels far below 10 are associated with loss of IQ and learning difficulties. In the case of DC, the "slight" and "subtle" characterizations reflect precisely the rhetoric of diminishment that has guided official government statements about lead at the tap since 2004.

Let's briefly revisit the Edwards et al. findings:

The study notes that Environmental Protection Agency models of the harm done from DC drinking water in 2003 predicted that hundreds of DC children's blood lead levels would be raised to 10 or above. Moreover, that thousands more would be elevated to lesser levels (5-9, which are now also associated with health harm), because of exposure to lead through drinking water. That estimate was conservative. Indeed, blood lead data collected from Children's National Medical Center showed a much higher incidence of blood lead over 10 in 2001-2003 as compared to previous years, in keeping with the EPA model and prior scientific research on the subject. In 2001, the incidence of elevated blood lead levels for children under 16 months increased by a whopping 9.6 times.

If this many children were affected and, on average, now perform even a little less well in school and have even a little more difficulty focusing on tasks, wouldn't we want readers of the Washington Post to understand the known adverse health effects of childhood lead exposure and the societal costs of such exposure on a citywide scale? From a family's perspective, aren't symptoms like delayed growth, learning impairment, behavioral problems, and difficulty focusing often coupled with extra needs and costs (let alone worry)? Moreover, isn't the public health impact of thousands, if not tens of thousands, of affected children with high (5-9) and elevated (10 or greater) blood lead levels significant?

On Monday, Dana Best, MD, MPH, a nationally recognized expert in pediatric environmental health and co-author of the new study told listeners of WAMU's Kojo Nnamdi show that "we need to stop trying to diminish the effects of lead and what happened. It's happened. We can't undo that. But we can look forward and make sure that we get clean water, clean lead-free housing, and that our schools are the most well run schools that we can give our children. That's the one way that we can actually reduce some of the harm caused by the lead levels..., by providing a very enriching environment. That can help overcome the loss of 3-5 IQ points."

Dr. Best also explained that it is very difficult to ascertain the "most pessimistic" circumstances, mentioned in the Washington Post. "It is very hard to say what is the worst case," she said. "One of the things that is a concern is that these elevated blood leads due to elevated water lead occur in a background of other sources. So if your child is exposed to lead through other sources plus the water lead level then we get something that can be higher than it would have been otherwise. [...] If you have a child who's already at some risk because they had some other problem that caused them to have lower IQ, or some behavioral problems and then on top of that you add lead, you can be ending up with a child who needs special schooling or is unable to develop into a fully functioning independent adult. These are real issues that we are now facing."

The District's now revamped lead poisoning prevention program takes high and elevated blood lead levels very seriously. It sponsors a service that allows any DC family with a child under 6 years of age to request a home visit by trained staff who offer information about lead poisoning prevention and take a few dust samples for lead analysis. If the analysis shows high environmental lead, the program includes a second visit that teaches parents how to properly eliminate the hazard. When a child has blood lead levels of 10 or greater the city sends trained risk assessors to the child's home to identify potential lead exposure sources. The focus of these assessments is on paint, dust, and soil (water is now beginning to be sampled properly as well). When such sources are identified as contaminated, property owners are required to correct them. If they fail to do so, the city has the legal authority to take them to court. And it does.

On average, DC serves about 90 families annually who are identified with blood lead levels 10 or greater for risk assessments and follow-up care. If the number of children harmed from the 2001-2004 lead-in-water crisis is in fact in the thousands, will the city characterize the impact -- in terms of school performance, socially, and economically -- as "slight"? And will all affected families perceive the burden as "subtle"?

Written with input from Ralph Scott, Alliance for Healthy Homes