July 30, 2013

Ranking Member Johnson Responds to Chairman Smith’s Threat to Subpoena EPA Documents

(Washington, DC) – Today, Ranking Member Eddie Bernice Johnson (D-TX) sent a letter to Chairman Smith in response to his recent letter to Environmental Protection Agency (EPA) Administrator Gina McCarthy threatening to subpoena documents related to the Clean Air Act.  Chairman Smith has now scheduled a business meeting for Thursday morning to authorize the issuance of subpoenas.

You can find the text of Ms. Johnson’s letter below and the letter with attachments at the link. 

Ranking Member Johnson’s letter with attachments

July 30, 2013

The Honorable Lamar Smith

Chairman

Committee on Science, Space, and Technology

2321 Rayburn House Office Building

Washington, DC  20515

 

Dear Chairman Smith,

It was with great interest that I read your July 22, 2013, letter to Environmental Protection Agency (EPA) Administrator Gina McCarthy.  In that letter, you outline the several requests Majority Members of the Committee on Science, Space, and Technology have made to the EPA for disclosure to the Committee of research data used in certain studies which the EPA relied upon in various Clean Air Act related regulatory decisions.  Your letter states that you haven’t received an adequate response from the EPA regarding these requests.  Perhaps you are unaware that the EPA has responded on at least two occasions with detailed information pertaining to the studies you requested (attached).  Since these detailed responses have not satisfied you, I feel compelled to highlight my own concerns about these ill-advised requests for vast quantities of American citizens’ personal health data.

Your July 22 letter contains material inaccuracies and conveys a general sense of misunderstanding of the underlying issues.  Although the letter is mysteriously silent in specifying exactly which research data you are seeking, it is apparent from context that the information you are requesting stem from to two seminal studies on the health effects of long-term exposure to air pollution:  “An Association between Air Pollution and Mortality in Six U.S. Cities” published in the New England Journal of Medicine and “Particulate Air Pollution as a Predictor of Mortality in a Prospective Study of U.S. Adults” which was published in the American Journal of Respiratory and Critical Care Medicine.[1]  Both of these groundbreaking studies showed a causal relationship between long-term exposure to air pollution and an increased likelihood of death.  In addition, both studies were the subject of peer reviewed follow-up studies.[2]

Despite the widely acknowledged seminal nature of these studies, in your July 22 letter you state:

“The National Academy of Sciences has stated that these analyses have “little use for decisionmaking.”

This is a gross mischaracterization of what the National Academy of Sciences (NAS) report says.  What is most remarkable about this mischaracterization is that you actually provided the original NAS document in one of your previous letters which you attached to the July 22 letter.  The relevant sentence you purport to paraphrase reads in full:

“Although these cohorts have provided critical evidence for long-term effects, evidence from further follow-up of these two U.S. cohorts alone will have little use for decisionmaking.” (emphasis added)

I assume that the mischaracterization in your July 22 letter is due to a misunderstanding of the difference between a research finding and a cohort.  However, if this is a case of misunderstanding, then it gives me great pause in considering the prospect of you and your staff receiving the underlying data being sought.

The cohorts to which the NAS document you mischaracterized refer to are actually groups of American people.  The Harvard Six Cities Study involved a cohort of random samples of adults collected from six different U.S. cities.  The Pope study utilized the American Cancer Society’s Cancer Prevention Study II (CPS 2) cohort, which consisted of 1.2 million human subjects from across America.  In both studies, the researchers tracked the cohorts over long periods of time to ultimately reach their conclusions.  In other words, the cohorts are the groups of people being tracked (the research subjects), not the conclusions being reached by the researchers.

What the NAS was referring to in the above quote is that by 2004, the cohorts used in the Harvard Six Cities Study and the CPS 2 study were aging, dying, and otherwise losing touch with the researchers.  For instance, of the CPS 2 cohort of 1.2 million people the American Cancer Society began tracking in 1982, almost 500,000 were deceased by 2006.  The NAS document was saying that because of these inevitable issues with the existing aging cohorts, new cohorts were needed in order to conduct these types of long-term epidemiological studies in the future.  This was in no way a criticism of the cohort data that had been collected up to that point, or any of the research results based upon that data.  In fact, the American Cancer Society began enrollment for a new cohort (CPS3) in 2006 to address this very issue.  I would also note that the CPS 2 cohort data has been widely used in much groundbreaking health and cancer research, with scores of peer-reviewed papers based upon this data set.  In addition to the groundbreaking air pollution research findings, scientists have also used CPS 2 data to show that cigarettes with reduced yield of tar and nicotine do not reduce the risk of lung cancer and that obesity is associated with increased mortality from at least ten cancer sites.  These are just a few highlights of the significant contributions to public health associated with research using the CPS 2 cohort data.

Moreover, the same paragraph that you mischaracterize in support of your arguments criticizing these research papers actually refutes your own unsupported assertions.  Not two sentences before your misquote, the NAS paper reads:

“The findings of the two studies were confirmed with an extensive reanalysis (Krewski et al. 2000) and on further follow-up of the CPS 2 cohort (Pope et al. 2002).”

Again, I do not understand how anyone could read that page of the NAS report (attached), and then describe it as it was described in your July 22 letter.

In further criticism of these two studies you go on to state that “these analyses are inconsistent with studies based on more recent information.”  However, you fail to support that loose assertion with any relevant research citations.  You also conveniently ignore the other confirmatory research which was cited in the NAS report your letter mischaracterized.  That paragraph, which can be found in an attachment to your own letter, lists no fewer than five other studies which support the general findings of the Harvard Six Cities Study and the CPS 2 study.

This cavalier mischaracterization of the results of research that has a profound impact on the health of American citizens concerns me greatly.  It concerns me because nowhere in your letter do you indicate what you propose to do with this cohort data once it is in your possession.  I have reviewed your staff list, and there does not appear to be a single epidemiologist in your employment.  I can’t identify a single person on your staff who would be qualified to use this data in any meaningful way.  And to be clear, we are talking about a massive amount of information.  As I mentioned before, the CPS 2 cohort consisted of 1.2 million subjects.  It is absurd to consider that our small Committee staff, talented as they are at their jobs, could make any legitimate use of this massive amount of health and environmental data.

So, I am at a loss to understand why you are requesting this data.  Some would see this request as simply an attempt to harass the EPA.  I would obviously strongly object to the needless harassment of the EPA, which is already operating in difficult budgetary times.  Others may suggest that these are efforts to supply outside parties with data they could otherwise not obtain.  I would also strongly object to obtaining this data for outside parties, who would not otherwise be given access to this sensitive data.  That is not our job.  Much, if not all of this data is already available for legitimate research purposes.  For instance, a simple search through the American Cancer Society’s website will lead you to the policies and procedures they have for application to access the CPS data sets.  Many of the policies on CPS data access relate to human subject confidentiality and research protocols.  Since the data in question are from human research subjects, there are, understandably, ethical training requirements for researchers requesting this data.  People requesting this data must also have a legitimate research aim, as the subject data was released by the participants for this purpose only.

I am forced to question the scientific legitimacy of groups which cannot already obtain this data.  They must not be legitimate scientists or must be untrustworthy with human research subject data, or they could simply apply to the American Cancer Society directly.  I certainly don’t think Congress should be obtaining confidential human research data to supply to outside groups who can’t pass ethical muster, and I sincerely hope that is not the goal of this endeavor.

In conclusion, I am increasingly skeptical of the legitimacy of this data request.  The data you are requesting is data that American citizens allowed to be collected with the understanding that it would be for scientific research purposes only.  You have requested the personal medical histories of literally hundreds of thousands of American citizens.  And for what purpose?  There is no conceivable way that you or your staff could meaningfully use this data to refute the seminal health studies you seem preoccupied with attacking.  Not unless you hired a team of expert epidemiologists.  With the Republican budget cuts to our Committee’s funding, your ability to do such hiring seems highly unlikely.  The truth is that there is no legitimate reason to warrant violating the trust of hundreds of thousands of American citizens who volunteered their personal information to make everybody’s lives better.  For all of the reasons I have noted in this letter, I strongly urge you to stop what you are doing.

If you persist in this effort, I want to let you know in the clearest terms possible that I will require the following information before I can even consider supporting authorizing a subpoena for this information:

1.      For what purpose do you seek this human subject data?

2.      If Committee staff are to review this data, who are they, what are their scientific qualifications, and have they completed ethical training for handling human subject data?  What steps will the Committee take to ensure compliance with the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report)?

3.      If it is your intent to transmit this data to outside entities, who are those entities and for what purpose are they being supplied with this data?

Thank you for your attention to this matter.

Sincerely,

EDDIE BERNICE JOHNSON

Ranking Member

Committee on Science, Space, and Technology

 

Cc: The Honorable Gina McCarthy

Administrator, U.S. Environmental Protection Agency

Members, Committee on Science, Space, and Technology

 

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