June 10, 2009
Mrs. Sharon Kramer
2031 Arborwood Place
Escondido, CA 92029

Honorable Members, Senate HELP Committee

Senate Hart Building 215
Washington, DC

Public Comment Submitted To Full Senate HELP Committee Members For Hearing of June 11, 2009

Re: Need For Clear Definition Of The Term “Evidence Based” In The American Health Choice Act.

Honorable Members of the Senate HELP Committee,

Thank you for your combined efforts to provide effective and cost efficient healthcare for all US citizens. You hard work is to be commended. Clearly, this is a monumental task that must be undertaken for the future health, both physically and financially, of the American people. With chronic illness on the rise at an alarming rate, factors causing these illnesses need to be mitigated in an organized, systematic manner. As such, treatment protocols and preventative measures need to be based on the best, most effective evidence available.

What is the definition of the term “evidence based” as it is used within the health reform bills? What is the burden of proof required that constitutes best and effective evidence? How does the standard of proof used impact the advancing or deterring of the understanding of illnesses?

In determining what the definition of the term “evidence based” means, Committee Members should be aware that Evidence Based Medicine (EBM) does not hold the same meaning to all people or all organizations. While EBM has offered much benefit to us as a society, it also has a dark side that must be protected against in an effort to assure best medical practices for the benefit of public health. The term needs to be clearly defined in the health reform bills.

In some instances, EBM has been used synonymously with the term “Sound Science”. Sound Science is a term that originated with Big Tobacco and has been used to cast doubt on causation of illness to the detriment of the public. In this context, the term Evidence Based means that if one cannot prove causation of illness beyond a reasonable doubt in a courtroom setting, then there is not sufficient evidence to acknowledge a particular chemical or exposure may possibly be the root cause of the illness.

While this interpretation of EBM may be appropriate for the courtroom when determining liability for causation of illness or lack there of, it is not appropriate for teaching physicians of practices and protocols that assist to stave off exposures thought have contributed to the increase in chronic illnesses. This courtroom standard interpretation of the term “EBM” is not appropriate to be used to train physicians they should not even consider a potential causative agent when determining their treatment protocols and practices.

As an example of the above misapplication of the term “evidence based” when establishing health policy through private sector medical associations, clinics and teaching hospitals; I offer the highly contentious and highly litigated mold issue. For five years I have been researching how medical information and evidence regarding these illnesses moves from clinic to courtroom to public policy and back to the clinics with the aid of government funds through ATSDR, NIOSH and the EPA.

Primarily, the private sector clinics that we fund to advance the understanding of environmental illnesses such as those caused by mold are the Association of Occupational and Environmental Clinics (“AOEC”). AOEC oversees the funding for the Pediatric Environmental Health Specialty Units (“PEHSU”). A network of these clinics are located at various teaching hospitals throughout the country. PEHSU is meant to provide education and consultation to health professionals regarding children’s environmental health. Several crossover governing members of both the AOEC and the American College of Occupational and Environmental Medicine (ACOEM) are involved with this program which influences the direction of environmental health research, teaching, and distribution of government funding.

As stipulated in the reform bills, billions of dollars in public monies are to be allocated to the private sector organizations such as AOEC to advance the understanding of illness. AOEC/PEHSU also receives funding from the private sector and universities. Rigorous government oversight will be required to assure that outsourcing the funds management and responsibilities of advancing the understanding of environmental illnesses are not misdirected or misused by these organizations; or that the term “evidence based” is misconstrued to mean that our tax dollars are to be used as a method of denying the causation of the exact illnesses we seek to better understand in the name of evidence based medicine.

The problem of inherent conflicts of interest in government funding private Occupational and Environmental clinics with the intent of advancing understanding of environmental illnesses begins with the ambitious attempt to somehow meld Occupational Medicine and Environmental Medicine into a single medical specialty.

Historically Occupational Medicine serves industrial interests, as this medical specialty is often called upon to limit the financial risks to employers and insurers that arise from workplace injury and illness.[1] Environmental Medicine is designed to serve the public interest by increasing understanding of the causes and treatments of illness without any particular regard for industrial concerns. But all too often, the same physicians who advance the interests of employers also serve as experts in environmental health matters. [2] The blurring of the divide between the two specialties with AOEC (occupational) controlling the funding for PEHSU(environmental), also leaves Occupational Medicine in a position to leverage its association with Environmental Medicine into a key public health role beneficial to industry.

In 2001, the Association of Occupational and Environmental Clinics (AOEC) obtained federal funding under cooperative agreements with the Environmental Protection Agency (EPA) and the Agency for Toxic Substances and Disease Registry (ATSDR) for a network of Pediatric Environmental Health Specialty Units (PEHSUs). Each PEHSU is based at an AOEC member clinic or at an academic center.[3] AOEC distributes the funds to its affiliated clinical centers without a requirement to undergo public competition for support. The Pediatric Specialty Units are to provide education and consultation for private and public health professionals and others on the topic of children’s environmental health. Millions of taxpayer dollars are now invested in this project.[4] Soon to be billions.[5]

However, the arrangement for achieving these goals is severely compromised because the government funding first passes through organizations that have inherent bias favoring industry’s concerns about financial risk.[6] The conflict of interest is concealed as it operates through a collection of long-running business relationships between industry, professional organizations, individuals, government agencies, and public hospitals and universities.

A brief history of the ACOEM “Evidence Based” Statement on Mold is presented as an example of the need to clearly define the term “evidence based” when private sector organization are government funded to advance the understanding, prevention and treatment of environmental illnesses in children.

Some of the medical associations which now present themselves as both occupational and environmental experts have created very serious problems for a large group of environmental patients in recent years. This was accomplished by promoting misinformation regarding “evidence based science” of environmental illnesses caused by microbial contamination in damp indoor environments. The misinformation campaign was carried out with a bias that favored industry’s financial liability, taking its toll on the affected environmental patient population.[7], [8], [9]

Historically, one of the most effective ways to limit financial risk for industry is to outright deny that a pollutant or chemical is the cause of an environmental illness.[10] That was the pattern employed in the campaign to deny these particular illnesses. [11] The authors of the ACOEM Statement on Mold translated their purportedly unbiased and scientific evidence based findings into common language for further publication by the U.S. Chamber of Commerce stating, “Thus the notion that ‘toxic mold’ is an insidious secret ‘killer’ as so many media reports and trial lawyers would claim is ‘Junk Science’ unsupported by actual scientific study.” [12] The “junk science” slur has been used repeatedly by industry and its paid medical and scientific experts to obfuscate legitimate health concerns.[13] It is a tactic borne in Big Tobacco science.

Specifically, in 2002, ACOEM produced its “evidence based” policy statement regarding mold-induced illnesses. Experts for the defense in mold litigation were brought in with the intent that they were to author that position statement.[14] The ACOEM Statement on Mold claims that it has been scientifically proven that it is “highly unlikely at best, even among the most vulnerable of subpopulations, that humans could inhale enough mycotoxins within an indoor environment to cause symptoms indicative of poisoning.” The ACOEM Statement on Mold, and the method by which it was developed and distributed, was the subject of a front page Wall Street Journal article in January of 2007 entitled, “Court of Opinion, Amid Suits Over Mold, Experts Wear Two Hats.” 5

Many ACOEM and AOEC members, and thus PEHSU members appear in court as expert witnesses to testify that human illnesses indicative of poisoning from indoor microbial contaminants “could not be possible” based on the “evidence based” policy paper provided by the ACOEM.[15],[16] A past president of both AOEC and ACOEM and now former director of the leading AOEC and PEHSU at George Washington University, Dr. Tee Guidotti, staunchly defends ACOEM’s statement on mold as being evidence based. [17] In his February 2007 rebuttal to the WSJ article on behalf of ACOEM written while he was President of the organization, Dr. Guidotti wrote, “ACOEM is not alone in its interpretation of the evidence”. [18]

Contrary to Dr. Guidotti’s rebuttal to the WSJ article, the ACOEM Statement on Mold is at odds with current accepted science as is established by the Federal Government Accountability Office Report, Indoor Mold: Better Coordination of Research on Health Effects and More Consistent Guidance Would Improve Federal Efforts.

GAO-08-980 September 30, 2008[19]

So what safeguards do we have that in the future, these private sector clinics do not use our government funding to interpret their own meaning of the term “evidence based”? Much like the bailout money for AIG going for employee bonuses, what safeguards are in place to assure governments funds will not be misused by the private sector to advance the interests of industry over that of the American public?

What are the implications for the advancement of understanding environmental illnesses when a leader of AOEC and PEHSU has clearly chosen to promote the concept that the term “evidence based” is meant for the promotion of limiting commerce liability as opposed to advancing the understanding of illnesses?

As it stands today, when an employee is injured or made ill at work by mold or other environmental exposures, the employee may be sent to an AOEC clinic by the employer or insurer for evaluation.[20] These evaluations are known as Independent Medical Examinations (IMEs).[21] The term ‘independent’ as applied to contracted examinations suggests that they are unbiased in comparison with the opinions of personal physicians.

However, the IME is connected financially to the employer/insurer and not the patient. Unlike a second opinion intended to confirm another physician’s findings and assist in establishing treatment protocols, an IME is not likely to be performed unless the insurer or employer is already seeking to deny or minimize an existing claim. The IME physician is typically discouraged from treating the patient clinically or from making any treatment recommendations. The patient is usually cautioned that the insurer will not pay for any such recommendations or treatment resulting from an IME.

As a result, the IME arrangement is strongly biased toward minimizing the recognition of occupational and environmental illness and disability rather than diagnosing or treating it. If the worker attempts to challenge the IME medical finding, these same physicians, located at clinics that we government fund, may then generate additional income as expert defense witnesses on behalf of the employer or the insurer should their conflicting opinion lead to legal action on the patient’s part.[22]

With regard to symptoms of poisoning from mold exposure, many injured workers’ claims are denied by the IME physician who cites the ACOEM Evidence Based Statement on Mold which asserts that evidence is established proving mold does not cause these symptoms.[23] When the expert witness IME physician is also associated with a college or university, much of the funding received for the denial of illness through expert witness testimony goes directly to the educational institution.[24] The rest of the witnessing fees, depending on the contractual arrangements, is paid directly to the physician or the physician’s employers. How does this arrangement of universities generating income from the denial of causation of illness impact the usage of government funds meant to advance the understanding of causation of illness?

AOEC physicians serve as IMEs at many medical centers around the country. These payment incentives can place teaching universities in the position of profiting from denial of environmental illnesses for which they have been funded and charged with advancing understanding, as is the case with PEHSU. How far that bias and financial opportunism are carried is both a matter of pervasive commercial influence over occupational medical practice and personal ethics.[25]

The mere fact that both insurer-funded IMEs and taxpayer-funded public health research and treatment can be, and sometimes are, carried out by the very same institutions should present a red flag to those determining the funding methods for the entire PEHSU project and the need for clearly defining the term “evidence based”.[26]

Potential conflicts of this nature, whether individual or organizational in origin, would reasonably be expected to be reported prior to any resulting research publications, and should be reported and examined thoroughly when the public health may hang in the balance or when public funds are being used.[27] Most times they are not and those that dare to challenge the direction of the private sector definition of evidence, often face retribution for speaking out.[28]

In addition, some physicians at AOEC/PEHSU clinics may simultaneously be employees of environmental risk management companies whose specific function is to limit financial liability for industry.[29] When examining the environmentally ill, these physicians can play an even more conflicted role – that of the government-funded and purportedly unbiased clinic physician examiner on one hand; and on the other, risk manager for an industry client and willing to be compensated for providing testimony against the patients they examine.

As an example of this is a physician from the AOEC and PEHSU at the University of California, Irvine (UCI), Dr. Marion Fedoruk. A California court ordered the evaluation of a teacher made ill from mold exposure in a mobile classroom. The teacher was directed to an Independent Medical Examination at the UC Irvine AOEC, where Dr. Fedoruk, an AOEC physician also was a risk management employee of the private consulting firm, Exponent. Dr. Fedoruk’s independent status was questioned by the court. “It is unclear as to whether Dr. Fedoruk was providing an ‘independent’ examination as a representative of the government funded AOEC, or as an employee of the risk management company, Exponent, and on behalf of a client in litigation.” [30]

Physicians from the AOEC and PEHSU at the University of California, Irvine participated in its second annual mold conference in February of 2008.[31] This seminar provided continuing medical education credits for physicians and other health care professionals who attended. The host of this seminar was Dr. Phillip Harber, Director of Occupational Medicine for the University of California, Los Angeles (UCLA) Division of Occupational and Environmental Medicine. Dr. Harber is an ACOEM member who was a peer reviewer of the ACOEM Statement on Mold.[32] This government-funded AOEC and PEHSU educational seminar was reported to be for physicians to learn how to recognize and treat mold-induced environmental illnesses in both workers and children. The physician education conference featured a mock mold trial, complete with plaintiff and defense attorneys. Dr. Marion Fedoruk was a key presenter at the AOEC Mold Conference, speaking on illness brought on by mold toxins. Dr. Fedoruk is also an ACOEM member, and like Dr. Harber, was a peer reviewer for the ACOEM Mold Statement.[33]

The production of a mock civil trial and presentations at an AOEC – PEHSU event by expert witnesses sometimes paid to testify against members of the public removes any speculation that the lines between public health and the medicolegal industry have become blurred in establishing healthcare policies. It removes any doubt that the term “evidence based” has been used to promote the concept that a courtroom standard burden of proof must be established before clinicians are being taught to acknowledge potential root causes of environmental illnesses. This standard of proof of evidence adversely impacts appropriate treatment protocols and the advancement of understanding of environmental illness.

In some instances, the activities of AOEC and PEHSU centers openly defy the stated mission of the very federal agencies which fund the AOEC clinics, “The Centers for Disease Control and Prevention (CDC) serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States.” [34] Any remaining question as to whether or how AOEC and ACOEM play a direct role in disseminating industry-favored positions to physicians regarding illness connected to mold toxins appears to have been answered.

The award of CME credits for attending a mock civil trial is an event which could not possibly take place in the absence of a pronounced conflict of interests between industry and patients, or “the people of the United States” that funding was provided to serve. While a usual teaching practice in law school, mock trials are a bit of a stretch in teaching medical practices meant to advance the understanding of environmental illnesses. It seems unwise and disingenuous that medical universities and clinics receive funds from expert witness fees paid for denying the possibility of the exact same illnesses they are being publicly funded to advance as areas of research and teaching.

With healthcare reform, will our billions of tax dollars that are to be given to the private sector be used to educate physicians in how to recognize, diagnose, and treat environmental illnesses; or will they continue to be used to groom expert witnesses who will deny the possibility of causation of environmental illnesses in our children, based on applying their interpretation of the term “evidence based medicine”?

The inherent conflict of interest of the matter is deeply seeded. AOEC and ACOEM have been sending representatives to sit on committees of the National Institute for Occupational Safety and Health (NIOSH’s) National Occupational Research Agenda (NORA) program since its beginning in 1996. Now over ten years into the relationship with NORA[35], AOEC has gained significant influence over the distribution of millions of taxpayer dollars. This is, at least in part, a result of their past and present leaders sitting as liaisons between the CDC and the private occupational medicine community that advises the CDC on needed research agendas in occupational medicine.

According to the NIOSH website, NORA was developed to “promote dissemination of research on the National Institute for Occupational Safety and Health (NIOSH) National Occupational Research Agenda (NORA) priorities, including: traumatic injury (unintentional and intentional); occupational health services research; exposure assessment; musculoskeletal disease syndromes; organization of work”.

Very little has been done in the way of unbiased further research into environmental illnesses related to mold toxins during those same years, although millions of taxpayer dollars have been poured into the clinics. Ultimately, the situation has functioned to the detriment of the public and to the benefit of industry.[36] And, where industry’s interests might very well involve environmental medicine at some points, they are, after all, industry’s interests and not particularly symbiotic with the interests of the public at large – most particularly children, who do not participate in industry at all.

None of the foregoing is good reason to dispense with the contributions of occupational medicine. Over the years, occupational medicine has assisted in establishing several safety and health protocols that have protected workers from occupational injury. However, there is a long history of industry’s desire to limit financial risk and liability from environmental exposures by influencing the setting of public policy.[37] The mold issue, the ACOEM Evidence Based Mold Statement and the manner in which it has been interpreted and promoted in AOEC/PEHSU clinics as evidence of absence of causation of illness, demonstrates that more rigorous government oversight is required to assure that research and treatment for environmental illnesses are not stymied by those who place concern for the financial risks of industry over that of the individual citizens who are the American public.

In summary, it is only logical that efforts meant to advancement of the understanding of chronic illness in our children should be based on the best evidence available. Government oversight is required so that any interpretation of the definition of “evidence based” medicine may not be misapplied by the private sector to the detriment of advancing the understanding of illness. Therefore, if we are to base the future of health care on evidence based medicine; we must first clearly define what the term “evidence based” means to our government.

I thank the Senate HELP Committee for their consideration of this serious matter.
Sincerely,
Mrs. Sharon Noonan Kramer

References

[1] LaDou J, Teitelbaum DT, Egilman DS, Frank A, Kramer SN, Huff J. American College of Occupational and Environmental Medicine (ACOEM): A Professional Society in Service to Industry. Int J Occup Environ Health. 2007;13:404-426.

[2] LaDou J. Occupational Medicine in the United States: A Proposal to Abolish Workers’ Compensation and Reestablish the Public Health Model. Int J Occup Environ Health. 2006;12:154-168.

[3] Association of Occupational and Environmental Clinics – Pediatric Environmental Health Specialty Units (PEHSUs). http://www.aoec.org/PEHSU.htm

[4] U.S. Census Bureau. Assistance to Association of Occupational & Environment in DC, FY 2000-2006. Federal Assistance Award Data System (FAADS). fedspending.org

[5] American Health Choice Act, Subtitle E—Improving Access to Health Care Services
SEC. 171. SPENDING FOR FEDERALLY QUALIFIED HEALTH CENTERS (FQHCS). Section 330(r) of the Public Health Service Act (42 U.S.C. 254b(r)) is amended by striking paragraph (1) and inserting the following: ‘‘(1) GENERAL AMOUNTS FOR GRANTS.—For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d), there is authorized to be appropriated the following:

‘‘(A) For fiscal year 2010, $2,988,821,592.
‘‘(B) For fiscal year 2011, $3,862,107,440.
‘‘(C) For fiscal year 2012, $4,990,553,440.
‘‘(D) For fiscal year 2013, $6,448,713,307.
‘‘(E) For fiscal year 2014, $7,332,924,155.
‘‘(F) For fiscal year 2015, $8,332,924,155.

‘‘(G) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for
the preceding fiscal year adjusted by the product of—

…..

…except that in the case of a public center (as defined in the second sentence of this
paragraph), the public entity may retain authority to establish financial and personnel

policies for the center; …’’;

[6] Armstrong D. Court of Opinion Amid Suits Over Mold, Experts Wear Two Hats. Authors of Science Paper Often Cited by Defense Also Help in Litigation. Wall Street Journal. January 9, 2007, p. A1.

[7] Armstrong D. Personality Check, Malingerer Test Roils Personal-Injury Law ‘Fake Bad Scale’ Bars Real Victims, Its Critics Contend. Wall Street Journal, March 5, 2008, p A1

[8] Lees-Haley P. Efficacy of MMPI2 Validity Scales and MCMI-II Modifier Scales for Detecting Spurious PTSC Claims: F, F-X, Fake Bad Scale, Ego Strength, Subtle-Obvious Subscales, DIS and DEB, Journal of Clinical Psychology 48, 681-89 (Sept. 1992).

[9] Butcher J. The Construct Validly of the Lees Haley Fake Bad Scale: Does this Scale Measure Somatic Malingering and Feigned Emotional Distress, Archives of Clinical Neuropsychology l8 473-485, 2003.

[10] Doubt is Their Product How Industry’s Assault on Science Threatens Your Health, Michaels D. Oxford University Press, 2008

[11] Craner J. ACOEM Statement on Mold: Conflicts of Interest in an “Evidence Based” Statement. Int J Occup Environ Health. Oct, 2008

[12] U.S. Chamber of Commerce. Center for Legal Policy. A Scientific View of the Health Effects of Mold. Bryan Hardin, PhD (Veritox), Andrew Saxon MD (UC), Correen Robbins, PhD, CIH (Veritox) and Bruce J. Kelman, PhD, DABT (Veritox). http://www.uschamber.com/publications/reports/030717_ilr_mold.htm

[13] SourceWatch. Junk Science. http://www.sourcewatch.org/index.php?title=Junk_science

[14] Hardin BD, Kelman BJ. ACOEM Position Statement. Adverse Human Health Effects Associated with Molds in the Indoor Environment. 2002. http://www.acoem.org/guidelines.aspx?id=850

[15] Haynes vs. Adair Homes, Jury finds “toxic Mold” harmed Oregon family, builder’s arbitration clause not binding, March 9, 2005. http://www.industrialnewsupdate.com/archives/2005/03/jury_finds_toxi_1.php

[16] Deposition Testimony, Bryan Hardin. Case No. 50 180 T 00150 05 Scotia Prince Cruises, Ltd., vs. City of Portland, Maine, December 20, 2006.

[17] Guidotti T. Ambush above the Fold: ACOEM Response to Recent Mold Issue. January 15, 2007. http://www.acoem.org/moldresponse.aspx.

[18] Guidotti TL, McLellan RK, Borak J. RE: Adverse human health effects associated with molds in the indoor environment. Ambush above the fold: ACOEM response to recent mold issue. http://www.acoem.org/moldresponse.aspx

[19] Federal Government Accountability Office Report, Indoor Mold: Better Coordination of Research on Health Effects and More Consistent Guidance Would Improve Federal Efforts GAO-08-980 September 30, 2008

[20] ACOEM Policies and Position Statements. Guidelines | Preventing Needless Work Disability by Helping People Stay Employed. http://www.acoem.org/guidelines.aspx?id=566.

[21] Lax MB, Manetti FA, Klein RA. Medical evaluation of work related illness: A comparison of evaluations by a treating occupational medicine specialist and independent medical examiners.” Int J Occup Environ Health. 2004;10:1-12.

[22] ACOEM. How to become an expert witness. http://www.acoem.org/uploadedFiles/Continuing_Education/Courses/2007%20Impairment%20&%20Disability%20course.pdf

[23] Mason, E. KATU: Dealing with SAIF – sick and feeling like a criminal. December 15, 2004. http://www.injuredworker.org/ime_reform.htm

[24] Deposition AJ Saxon. Hake vs. Coleman, Superior Court of Nevada, Nov 28, 2006.

[25] Egilman DS. Suppression bias at the Journal of Occupational and Environmental Medicine. Int J Occup Environ Health. 2005;11:202-204.

[26] Baker D. Letter on behalf of the Southern California Education and Research Center (SCERC) to program constituents. The SCERC is in the process of submitting our 5-year renewal application to NIOSH. March 14, 2008.

[27] Manning B. Federal Conflict of Interest Law. Columbia Law Review. 1966;66:1201-1202.

[28] Newsletter of the Association of Occupational and Environmental Clinics. 2003;10:3. http://www.aoec.org/AOEC_News_July_2003.pdf

[29] AOEC. UC Irvine, Marion J. Fedoruk http://www.aoec.org/content/directory_CA.htm

[30] Examination by Marion Joseph Fedoruk. Wayne Hetman vs. Santa Ana Unified School District. Superior Court, County of Santa Ana, California, October 6, 2006. http://www.exponent.com/leaders/bios/marion_fedoruk.asp?employeeID=418

[31] UC Irvine/UCLA Mold Conference, February 2008.

[32] Deposition of Bruce Kelman, PhD. Kerruish et al v. Kimball Hill Homes California, et al. Superior Court of The State of California, County Of Sacramento. Case No. 01AS03525. June 28, 2006. pp. 111-112.

[33] Internet message from Jonathan Borak, MD to Bryan Hardin, PhD, April 22, 2003.

[34] Centers for Disease Control and Prevention (CDC). http://www.cdc.gov/maso/pdf/cdcmiss.pdf

[35] NIOSH. NORA 10 Years: The Team Document. DHHS (NIOSH) Publication No. 2006-121. http://www.cdc.gov/niosh/docs/2006-121/pdfs/2006-121.pdf

[36] Kramer S, Perez J. CDC: The Outsourcing of Environmental Medicine. Submitted to the U.S. Government Accountability Office, August, 2007.

[37] Walker B, Sharp R. Real-Life Epilogue To “Erin Brockovich”: Medical Journal Retracts Fraudulent Chromium/Cancer Study. EWG Investigation Exposes Fakery of Firm Headed by Bush Appointee. http://www.commondreams.org/news2006/0602-01.htm