Volume 118, Issue 3 , Pages 766-767, September 2006
Nondisclosure of conflicts of interest is perilous to the advancement of science
Article Outline
To the Editor:
We are requesting that the American Academy of Allergy, Asthma and Immunology retract, as an official position statement representative of 7000 physicians, “The medical effects of mold exposure” by Bush et al.1 We are dismayed by the article's interpretation of “state-of-the-art” understanding of illnesses caused by molds and mycotoxins. The document appears to be based on many statements that do not reflect state-of-the-art science but are anecdotal in origin.1, 2
A significant finding of the position statement relies on a review piece of another medical association, the American College of Occupational and Environmental Medicine (ACOEM).3 The ACOEM mold statement is also widely promoted as a state-of-the-art scientific review by an influential medical association. The authors are 2 PhD principals of a defense litigation support corporation and a physician who is an author of both the ACOEM and the Academy's mold statement. This physician also provides expert testimony for the defense in mold litigation.
The ACOEM position states, “Levels of exposure in the indoor environment, dose response data in animals, and dose-rate considerations suggest that delivery by the inhalation route of a toxic dose of mycotoxins in the indoor environment is highly unlikely at best, even for the hypothetically most vulnerable subpopulations.” Of the 83 references “reviewed” by the ACOEM, only one comes to the conclusion that human illness is “highly unlikely at best.” It was written by an ACOEM author and fellow principals in the litigation defense support corporation.4 The finding of “highly unlikely at best” is based solely on the mathematic extrapolation from a single rat study and calculated by the litigation defense corporation principals. The extrapolations have been questioned by credentialed scientists active in the field of mold and mycotoxin research.5
The new Academy position paper states that “the occurrence of mold-related toxicity (mycotoxicosis) from exposure in nonoccupational settings is not supported by the current data, and its occurrence is improbable.” There are 44 references listed for the Academy position statement. Other than the ACOEM statement of “highly unlikely at best,” the Academy mold position paper cites, as reference 29, another article based on rodent studies and extrapolated math and written by the same expert defense witness authors in support of this statement.6 This article was recently found by the courts not to be based on sound scientific protocol to deduce absence of human illness. Not one of the other 44 references supports the statement that “its occurrence is improbable.”
Are the members of the Academy of the opinion that it is accepted scientific protocol for 2 influential medical associations to deduce that all human illness is “highly unlikely at best” and “its occurrence is improbable” based solely on questioned math from a rodent study? We ask the authors of the Academy position paper to cite any epidemiologic or mechanistic research that supports the statements of “highly unlikely at best” or “its occurrence is improbable.” We are not aware of the existence of any such studies, other than the articles by the defense litigation support corporation mentioned above.
We are concerned by the fact that the Academy's authors are nationally known expert witnesses for the defense in mold litigation. Yet no conflict of interest disclosures were attached to the document for the Academy members' perusal when researching appropriate diagnoses and treatment protocols for their patients. We are concerned the Academy position will cause those with serious non-IgE–mediated illnesses from exposure to molds and mycotoxins to continue to be misdiagnosed and untreated.7 The Academy position does not accurately reflect illnesses being reported by thousands from across the United States. It does not reflect state-of-the-art research.8 It does, however, reflect a medical position that is beneficial to industry, insurers, and the medical experts that support them in mold litigation.9 Because it is the goal of physicians and researchers to advance science to help the sick and because the current understanding of mold-induced illnesses is highly debated, complex, and contentious within the medical community and the courts, the utmost diligence is required to ensure that journals and medical associations are not misused to strengthen a litigation position.
To advance an appropriate review on this issue and potentially others, we are asking the Academy to consider adopting a transparent conflict of interest policy that will guide the publication of all future articles and position statements. We are requesting this article be retracted as an official position of the Academy until such appropriate review of the matter can be provided.
We thank the Editor of the Journal for the opportunity to present a differing perspective to the members of the Academy in regard to a serious issue that affects the health and safety of countless citizens.
References
- . The medical effects of mold exposure. J Allergy Clin Immunol. 2006;117:326–333
- National Institute for Occupational Safety and Health (NIOSH). Occupational respiratory disease surveillance, hypersensitivity pneumonitis. ICD-9 (1979-1999). Rubrics Code 495; ICD-10 (1999-Present) Rubrics Code J67; National Occupational Respiratory Mortality Surveillance, “Non-paid worker or non-worker or own home/at home” and “Elementary and secondary schools” – two of the ten industries/settings with the most frequent deaths reported as a result of Hypersensitivity Pneumonitis (HP). ICD-9 Rubrics Code 495 (1979-1999). Available at: http://webappa.cdc.gov/ords/norms-icd.html. Accessed July 26, 2006.
- Hardin BD, Kelman BJ, Saxon A, ACOEM Council on Scientific Affairs. ACOEM policies and position statements evidence based statements, adverse human health effects associated with molds in the indoor environment. Available at: http://www.acoem.org/guidelines/article.asp?ID-52. Accessed July 26, 2006.
- . Health effects of mycotoxins in indoor air: a critical review. Appl Occup Environ Hyg. 2000;15:773–784
- . Inflammatory and cytotoxic responses in mouse lungs exposed to purified toxins from building isolated Penicillium. Toxicol Sci. 2005;87:213–222
- . Risks from inhaled mycotoxins in indoor office and residential environments. Int J Toxicol. 2004;23:3–10
- . Mycotoxins. Clin Microbiol Rev. 2003;16:497–516
- . Toxic mold disease: a diagnosis of litigation. Ann Allergy Asthma Immunol. 2005;95:239–246
- Pietrykowski M. Proposed causal connection between inhalation of indoor molds and severe health maladies is “weak and unproven” according to Medical Association. Mold…matters! 2003;3:5. Available at: http://www.gordonrees.com/pubs/pdf/mold_mat_janfeb_03.pdf. Accessed July 26, 2006.
Disclosure of potential conflict of interest: K. H. Kilburn has served as an expert witness in mold litigation primarily retained by the plaintiff bar and is president of Neuro-Test, Inc. M. Gray has served as an expert witness in mold litigation primarily retained by the plaintiff bar, is sole proprietor of ImmunoTox, and has a patent pending with Realtime Laboratories. S. Kramer has been a party in mold litigation represented by the plaintiff bar, volunteers to assist those made ill from mold, and is a real estate agent by profession.
PII: S0091-6749(06)01398-4
doi:10.1016/j.jaci.2006.07.009
© 2006 American Academy of Allergy, Asthma and Immunology. Published by Elsevier Inc. All rights reserved.
Volume 118, Issue 3 , Pages 766-767, September 2006
