Dear Senator,

We wish to inform you of a situation involving dangerous human pathogens at a research facility in Maryland with potential lethal consequences for citizens of the state.  The case we relate below, a nearly fatal laboratory-acquired infection of which one of us (RcH) was a victim over Christmas 2003, illustrates this continuing dangerous situation.  We are both expert microbiologists with over 40-years combined experience in research and teaching on infectious disease microorganisms.  Our CVs are enclosed (Appendix A-B).  In July 2003, RcH, who until then had been on the faculty at the University of Maryland, Baltimore (UMB), took a faculty-level position at the Produce Quality & Safety Laboratory (PQSL), Agricultural Research Services (ARS), USDA in Beltsville, Maryland, to start an independent program of research on food-borne pathogens.  In December 2003, RcH was infected with E. coli O157:H7 through an experiment conducted by a technician from another group.  The design and conduct of this experiment was in full, multiple violations of the CDC guidelines for Biosafety Level 2 pathogens including E. coli O157:H7 (http://www.cdc.gov/od/ohs/biosfty/bmbl4).  Briefly, the experiment involved the use of sub-standard scientific equipment (household salad spinners) and was performed on an open bench, instead of in a biosafety cabinet as required by the CDC guidelines.  Moreover the experiment was performed by a poorly trained, unsupervised technician.  There were multiple opportunities for contamination (e.g. from splashes, aerosols, and inadequate disinfection procedures) with this extremely infectious microorganism that is listed as a potential bioterrorism agent (B list) by federal agencies.  Indeed, the dose required for E. coli O157:H7 infection of one healthy individual is 10-100 bacteria.  RcH had previously repeatedly expressed her concerns about the messiness of this experiment to the scientists performing it and about the unsafe working conditions for PQSL employees including herself to her direct supervisor, but her concerns had been repeatedly ignored.

RcH developed hemorrhagic colitis, and subsequently the complication known as hemolytic uremic syndrome (HUS).  She suffered multiple organ failure, including full bilateral kidney failure, fell in a month-long coma on a respirator, and had several secondary life-threatening infections.  HUS is fatal at sufficiently high frequency (10-20% fatalities in some outbreaks, mostly in children), such that it made for a very difficult Christmas for all of us, including our two children.  She somehow survived and is now mostly recovered owing to outstanding medical care and to the fact that she had been very healthy.  Because of the risk of relapse through re-exposure however, her chosen career, for which she had trained for more than 20 years, is all but obliterated.  She also suffers from debilitating headaches and a general right side weakness. She is now being treated for major post-traumatic depression.

While she was still in a coma, a joint team from the Center for Disease Control and Prevention (CDC) and Maryland Department of Health and Mental Hygiene (MDHMH) came in to investigate for several weeks and a report authored by the CDC became part of the public record in August 2004 (Appendix C).  We have obtained a copy of the report through the CDC Freedom of Information Act Office. To our shock and dismay, the 16-page report is replete with falsehoods, inconsistencies, contradictions and inaccuracies, and includes a breach of patient privacy.  The report identifies two factors as responsible for the contamination: substandard safety conditions at the facility and RcH's laboratory techniques.  Since RcH was a bystander in the experiment, her laboratory techniques were actually irrelevant to the contamination, however the report egregiously states at the very top that RcH was the 'official supervisor' of the technician and goes on to describe the E. coli O157:H7 experiment as part of her research project, hence her responsibility. This flagrant lie is compounded by the fact that the scientist who was the actual supervisor of the technician performing the E. coli O157:H7 experiment and who was responsible for the design and conduct of the experiment was not investigated, and is not mentioned or alluded to in the report.  Based on this ‘mistake’, the investigation focused on RcH’s laboratory technique.  The report indicates that some staff members saw RcH using inoculating loops on the open bench and reusing gloves and assumed she was doing so with infectious microorganisms.  The investigators drew the same conclusion and did not verify this interpretation with RcH later although these allegations originated from individuals who had peripherally observed RcH and were not involved in her research.  In fact, RcH had used loops and reused gloves, but only in the context of molecular biology experiments, i.e. while she was manipulating harmless cloning strains and DNA samples, never while performing experiments with infectious microorganisms.  RcH’s practices are common practices in microbiology laboratories in the USA and abroad and are completely consistent with her PhD training in the department of Microbiology and Immunology at Stanford University.  It should also be noted that the PQSL employees who were interviewed were trained in food technology, horticulture and plant pathology, no one in microbiology, and this includes the Research Leader for the group who studies tomato ripening.  In contrast in December 2003, RcH had already accumulated 20 years of hands-on, accident-free experience working with dangerous pathogens.

The disinformation of CDC investigators appears to be intentional and the administrative record will unequivocally show that RcH was never the official supervisor of the technician performing the E. coli O157:H7 experiment and that this experiment was never her research project.  However, we do not have access to the administrative record or to the details of the investigation, which are the property of USDA and CDC.  Because of the numerous flagrant mistakes in the CDC report, we sent an extensive point-by-point rebuttal on 9/22/04 (rebuttal, rebuttal cover letter and reminder letter in Appendix D-F), with copies to USDA and MDHMH.  More than two months later, we are still waiting for a reply from CDC.  A response from MDHMH dated 11/18/04 (Appendix G) defers to the CDC scientists who authored the report.  In a letter dated 10/13/04 (Appendix H), Dr. Phyllis Johnson, Director of the USDA Beltsville site writes that ‘because the investigation was conducted by the CDC, the report is their report.’  She adds that she is ‘not in a position to judge the validity of the arguments raised in [our] rebuttal.’  There are two fundamental problems with this position.  First, our rebuttal gave strong supportive evidence of misconduct in the form of lying to federal investigators by two PQSL employees, which we identify.  It is mystifying that Dr. Johnson chooses not to consider this evidence when a simple verification of the administrative record in her own office files would suffice to clear up the issue of who was supervising the technician and whose project this was.  Second, the CDC report revealed that another PQSL researcher was infected with E. coli O157:H7 in April 2004, i.e. four months after RcH had left.  This infected investigator was more fortunate than RcH and did not develop HUS.  This second incident however indicates that the threat to PQSL employees and the associated public (E. coli O157:H7 is extremely contagious) that existed at PQSL in December 2003 still existed in April 2004, several months after the arrival of the CDC team and the presumed implementation of ‘corrective’ safety measures.  The inescapable conclusion is that this threat still persists today.  Hence, the decision by Dr. Johnson to ignore our rebuttal is utter negligence that puts the public once more at high risk of a life-threatening infection.  The evidence suggests that USDA has not learned the lesson of the first laboratory-acquired infection involving RcH and is intent on covering up these incidents by all means possible.

Because so much is at stake, we feel a strong sense of responsibility to engage ourselves and to fully expose what led to the contamination of RcH in December 2003.  We have held back until now because we thought, perhaps naively, that the CDC would correct the situation.  This has unfortunately not happened.  It is clear now that the people responsible for the accident misdirected the investigation in order to protect themselves, and in so doing are putting the health and life of others at risk.  This cover up is unacceptable: RcH was a simple bystander who was not involved in the E. coli O157:H7 experiment and scientists at USDA are covering up their responsibilities by placing the blame on her.  RcH is currently preparing an administrative grievance (draft in Appendix I) against the two individuals whom she believes intentionally misinformed the CDC investigators: the Research Leader (RcH’s direct supervisor) and the scientist actually responsible for the experiments.  These two individuals were interviewed by the investigators and had ample opportunity to correct mistakes as they had exclusive access to a draft of the CDC report.  Had they not implicated RcH in their place, these two individuals would have been the focus of the investigation instead.  

Moreover, the larger problem of laboratory-acquired infections in research laboratories transcends the case of RcH's accident alone.  Her accident is the most recent illustration of this problem and probably one of the most revealing.  The backdrop for RcH’s infection is the spectrum of bio-warfare and emergent infectious disease (e.g. SARS) on our TVs and newspapers almost daily.  In its own laboratories, without the media spot lights, the government has a policy of looking the other way.  Indifference of federal agencies to laboratory-acquired infections is little short of a cover up.  A surveillance mechanism with systematic reporting and institutional accountability is long overdue.  The current indifference means that reckless science, the kind of which led to RcH nearly dying and ruined her career, will continue unchecked and undeterred.  This problem is most acute now because research on dangerous pathogens is at an all-time high.

We are constructing a web site (www.laboratory-acquired-infections.info) that will include a forum for debating issues of biosafety and the means for visitors to report the laboratory-acquired infections they know about into a database.  We will reach the scientific community through a letter authored by PB to be published in January 2005 in ASM News, the periodical of the American Society for Microbiology (Appendix J).  PB has submitted a similar letter to the journal Emerging Infectious Diseases, which is published by the CDC (Appendix K).  We are receiving a great deal of support, including from some of the leading microbiologists in the land and in the world.  Many scientists in our field have expressed their outrage at the specific case involving RcH, and at the outcome of the CDC investigation.  Finally, since lying to federal investigators is a criminal offence and since this offence potentially puts the health of researchers at PQSL, their families and the associated public at grave risk of a life-threatening infection, we have also approached the FBI in a letter dated 11/22/04 (Appendix L).

We respectfully ask that your office exercise appropriate pressure on the USDA, the CDC and the FBI in particular to identify the true cause of the continuing threat to public health at the Beltsville facility of ARS-USDA.  The PQSL Research Leader who has no relevant competence in infectious disease microbiology, and the scientists involved in willful misinformation of the CDC investigators should be suspended until resolution of their respective roles in the misinformation is determined.  A new investigation should be initiated in light of the information we have provided in rebuttal to the CDC report and in the pending grievance document.  The latter document includes evidence of discrimination against RcH that has not been investigated to date.  All research activities involving pathogens at the PQSL should be suspended immediately.  Last the CDC report should be retracted in its entirety until the whole, unaltered truth about what happened in December 2003 at PQSL is revealed.  We appreciate that you will recognize the urgency of this request since researchers at PQSL, their families and associated public are still at high risk of contracting a life-threatening infection.

We will be grateful for your consideration.