American Thoracic Society Publishes Biased, Flawed Review of Non-Malignant Asbestos Disease

Medical Journal Violates Its Own Ethical Standard in Publication

Lawrence Martin, M.D., FACP, FCCP
(Member, ATS)


For Adobe format of this and related sites, see:
The 2004 ATS Statement on Asbestos Disease Diagnosis: Scientific and Ethical Problems

Related sites (HTML format):
ATS Official Statement 2004 -- Omitted References
ATS Bias: Origins of Anti-Science in the 2004 Official Statement on Asbestos Diagnosis
'Open Letter' to ATS/AJRCCM

Summary

In September 2004 the American Thoracic Society published a long awaited update on diagnosis of nonmalignant asbestos diseases. Authored by 11 physicians, it appeared in the ATS publication, Journal of Respiratory and Critical Care Medicine (AJRCCM). The update covers developments over the past 2 decades and offers guidelines for diagnosis. By making statements regarding x-ray diagnosis that are unsupported (indeed contradicted) by the peer-review literature, and omitting numerous key references, the authors evidence bias in favor of mass screenings by plaintiff-attorney-hired physicians (PAHP). The vast majority of diagnoses by PAHP have been discredited as non-objective, but this is not mentioned by the ATS statement. Instead, the authors assume PAHP diagnoses are valid in making their recommendations. Apart from inherent bias in the article's content and presentation, AJRCCM also violated its own ironclad policy by not publishing the authors' conflict of interest statements.

CONTENTS
Why This Web Site?
Why does AJRCCM Require Conflict of Interest Statements?
Specific Problems with the 2004 ATS Asbestos Article


WHY THIS WEB SITE?

A) There has been an ongoing 'epidemic' of asbestos disease over-diagnosis in the United States, fueled by plaintiff-attorney-manufactured mass asbestos claims. The vast majority of these diagnoses, when objectively analyzed, have been proven inaccurate. The process by which plaintiff attorneys have manufactured these asbestos claims has been labeled a 'scam' and 'swindle.' (See Runaway Asbestos Litigation - Why it's a Medical Problem)

B) After a delay of 18 years, in 2004 the American Thoracic Society -- one of two major medical lung organizations in the U.S. -- published an update on the diagnosis of non-malignant asbestos claims. Non-malignant asbestos disease covers the two principal diagnoses in mass asbestos claims: asbestosis and asbestos pleural disease. This ATS update, authored by 11 physicians, appeared September 15, 2004 in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). AJRCCM is the American Thoracic Society's major scientific publication, aimed at both practicing physicians and researchers in the field of lung diseases. The article's full title (with web link) is

Official Statement of the American Thoracic Society. Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos (Amer Jour Res Crit Care Med 2004;170:691-715)

Click here for .pdf version of article

C) The ATS "Official Statement" shows evidence of author bias, as it contains several unreferenced and unfounded assertions that seem to support plaintiff-attorney-manufactured asbestos claims. The most telling evidence for author bias is that AJRCCM violated its own ethical standard by failing to publish any Conflict of Interest statements for the authors. Lack of any Conflict of Interest statements is an ethical lapse that cannot go unanswered indefinitely, at least not by an organization dedicated to science.

D) Attempt to publish a brief letter-to-the-editor, pointing out this lapse and biases in the article, was rebuffed by the AJRCCM editor, Dr. Edward Abraham (University of Colorado Health Science Center). An e-mail promise from Dr. Abraham to forward my letter to the authors, so that they could individually respond, elicited zero responses. A follow up e-mail to Dr. Abraham asking if there would be any financial disclosure by the authors elicited a response that “The issue of financial disclosures is an important one and the appropriate approach is being actively discussed within the ATS."

E) I put together this and related web sites so that anyone with an interest can clearly see the concerns, and take appropriate action. They have already elicted an e-mail promise to eventually publish some disclosures, although the full extent of the biases I have uncovered will likely never see print in AJRCCM.


WHY DOES AJRCCM REQUIRE CONFLICT OF INTEREST STATEMENTS FOR ITS AUTHORS?

The answer is simple: So readers can judge for themselves if the authors' financial interests affect the article's findings. Asbestos litigation is a multi-billion dollar business. Physicians who take part in plaintiff-attorney-manufactured asbestos claims stand to make a lot of money if they can opine about asbestos disease when none exists. And if authors of the "Official Statement" can change the criteria for mass asbestos diagnosis to fit in with plaintiff-attorney theories (as opposed to results from objective scientific studies), they also stand to benefit handsomely. And 'benefit' doesn't have to be purely monetary. There may be political or personal biases served by this work, such as a desire to punish big business for past sins, or as a way to thank attorneys the authors may have worked for in the past. Bias can be subtle and non-monetary, but it is bias nonetheless. I am sure the 11 authors of this paper don't see themselves as influenced by plaintiff attorneys, but that's not for them to decide; that's why medical journals have mandatory financial disclosure, to discover hidden biases so readers can judge for themselves. Hence, if ever there was an article that cried out for full financial disclosure of the authors, the ATS "Official Statement" is it. Lack of such disclosure for this article represents a major lapse in medical journal ethics.

AJRCCM recognizes the importance of financial disclosure, at least in theory. Below is the journal's position on conflict of interest for its authors. It is quoted verbatim from the AJRCCM web site on author requirements ("Disclosure of Financial Interest").

AJRCCM Disclosure of Financial Interest

Every author on the manuscript is required to complete this form

A conflict-of-interest is defined as a set of conditions in which professional judgment concerning a primary interest, such as the validity of research, may be influenced by a secondary interest, such as financial gain. As such, a conflict-of-interest is a condition, not a behavior -- being determined by circumstances, not outcome. A conflict exists not only when judgment has been clearly influenced. It also exists when judgment might be influenced or might be perceived to be influenced. That is, a conflict exists before any actual breach of trust, and irrespective of whether a breach of trust actually occurs.

When submitting a manuscript to the Journal, authors are required to disclose any financial relationship with a biotechnology manufacturer, a pharmaceutical manufacturer, or other commercial entity that has an interest in the subject matter or materials discussed in the manuscript. The Journal's policy on personal financial interests also embraces money received in the names of the children, spouse, and partner (i.e., life companion) of an author.

For inexplicable reasons, "Every author" did not include the 11 authors of the ATS "Official Statement" on asbestos diagnosis. They published NOT A SINGLE "Disclosure of Financial Interest" statement. Why are they exempt? To show how strict AJRCCM is on its conflict of interest disclosure requirement, here are some articles in the same issue of the AJRCCM for which financial disclosure WAS published:

  • Dexamethasone blocks hypoxia-induced endothelial dysfunction in organ-cultured pulmonary arteries. Pages 647-655. Authors from Tokyo. Conflict of Interest Statement published at end of article, page 654.
  • Fluorescein-enhanced autofluorescence thoracoscopy in primary spontaneous pneumothorax. Authors from Belgium. Pages 680-682. Authors from Belgium. Conflict of Interest Statement published at end of article, page 682.
  • Future Research Directions in Asthma. Pages 683-690. Authors from National Heart, Lung and Blood Institute, Bethesda, Maryland. Conflict of Interest Statement published at end of article, page 688.
  • Pharyngeal Anatomy and Severity of obstructive apnea. Letter to the Editor, page 716. Conflict of Interest Statement published at end of letter.

None of the above articles (nor others published in that issue of AJRCCM), comes close to the ATS "Official Statement" in terms of potential financial importance to the authors or the authors' associates. Regarding the AJRCCM requirement, "other commercial entity" would include the dozens of law firms that rake in billions of dollars a year from filing mass asbestos claims. Virtually every asbestos claim is predicated on a physician-authored diagnosis, but these diagnoses (arising from plaintiff-attorney-sponsored mass claims) are seldom based on objective evaluation of the claimant, and never on blinded interpretation of chest x-rays. The physicians involved in these attorney-sponsored mass claims know what diagnoses they are expected to deliver, and they deliver them.

Intentionally or not, the authors of the Official ATS Statement on asbestos disease diagnosis seem to be playing into the hands of those plaintiff attorneys who set up, pay for, and profit handsomely from, mass asbestos claims. Because of all the biases in this article, it stands as a classic example of (to use AJRCCM's own language): "A conflict exists not only when judgment has been clearly influenced. It also exists when judgment might be influenced or might be perceived to be influenced."

For the authors not to state their own financial involvement in asbestos litigation (or to be required to do so by AJRCCM) is unethical in the extreme, and a genuine 'black eye' for both ATS and AJRCCM. By violating its own standard, AJRCCM makes much of the Official Statement suspect. Certainly unreferenced statements and conclusions in the article cannot be considered authoritative, and should not be used in any legal situation. The only solution is for AJRCCM to disclose the detailed financial interests of all the authors, and also to publish a reasoned rebuttle.

* * *

WHAT ARE THE SPECIFIC BIASES AND FLAWS IN THE AJRCCM ARTICLE?

Listed below are the 2004 Asbestos Statement's major flaws and biases. In each example a passage is quoted from the article, followed by my Comment.

Page 696

  • "A critical distinction is made between films that are suggestive but not presumptively diagnostic (0/1) and those that are presumptively diagnostic but not unequivocal (1/0). This dividing point is generally taken to separate films that are considered to be "positive" for asbestosis from those that are considered to be "negative"."


COMMENT: There is no reference for this statement, because none exists; it appears to be simply made up, and thus to reflect inherent bias of the authors. In fact, this dividing point (0/1 to 1/0) exists only in the play book of plaintiffs' attorneys and their hired experts. It is well known that a B-reading of 1/0 is non-specific and non-diagnostic, as it is commonly found in middle-aged smokers and in ex-factory workers never exposed to asbestos (see References omitted from ATS Official Statement). Furthermore, the prevalence of asbestosis among asbestos-exposed workers is far less than what is promulgated by mass asbestos screenings (Ross RM. The clinical diagnosis of asbestosis in this century requires more than a chest radiograph. Chest 2003;124:1120-28), making it clear that a "1/0" reading alone does not make a diagnosis of anything.


Page 692, Table 1

This table supposedly compares the 1986 guidelines with 2004 guidelines. However, in this table there is no explanation for why a profusion of 1/0 is the threshold for asbestosis in 2004 (as stated on page 696, quoted above), whereas the stricter 1/1 was the profusion threshold for this diagnosis in 1986. Here is what the table includes for the category dealing with x-ray diagnosis (quoted verbatim).

TABLE 1. CRITERIA FOR DIAGNOSIS OF NONMALIGNANT LUNG DISEASE RELATED TO ASBESTOS

1986 Guidelines:
"Chest film (irregular opacities)"

2004 Guidelines:
"Imaging methods"

Comparison and notes:
"Chest film, HRCT, and possibly future methods based on imaging. The 1986 guidelines specified ILO classification"

COMMENT: Unlike other categories in Table 1, the statements here do not convey any information about why there was a change between 1986 and 2004 for this category (i.e., why the profusion criterion was changed). It is as if the authors purposely do not want to answer this all important question, and is remindful of the way plaintiff-attorney-hired physicians diagnose most cases of asbestosis: 'It is because we say it is'.


Page 697

  • PULMONARY FUNCTION TESTS, 2nd Paragraph. "As with other interstitial lung diseases, the classic finding in asbestosis is a restrictive impairment. Mixed restrictive and obstructive impairment is frequently seen; isolated obstructive impairment is unusual."

COMMENT: The authors are misleading here. First, mixed impairment is "frequently seen" only in cigarette smokers." This mixed pattern is NOT frequently seen in non-smokers. Leaving out smoking as the cause of air flow obstruction in asbestos claimants allows the sentence to be quoted as an isolated "ATS statement" in a legal proceeding. The authors can deny this was their intent, but anyone with litigation experience knows that a medically-incomplete statement like this one is ripe for legal abuse.

Second, "isolated obstructive impairment" is not unusual, it is non-existent. Like other made-up statements in this article, it is unreferenced. Most likely the architect of this statement is Dr. Tee Guidotti, ATS Statement committee chairman, who wrote an article on the subject published in 2002: Apportionment in Asbestos-Related Disease for Purposes of Compensation. In that article he attempts to show how reduction in FEV-1 can be apportioned to asbestos, but his argument is full of unwarranted assumptions and does not prove that airway obstruction, as most physicians understand it (reduced FEV-1/FVC), occurs from asbestos inhalation. Nonetheless, the clear intent of the phrase on page 697 is that you can sometimes find reduced FEV-1/FVC from just asbestos inhalation, even though that has not been documented, and was not shown in Dr. Guidotti's 2002 review. (If such article existed, it would have been referenced.) Like the first example from page 697, this phrase opens the door for plaintiff attorneys to argue for causation when there is air flow obstruction but no smoking history. There are of course other causes for air flow obstruction in non-smokers (e.g., chronic asthma, industrial bronchitis), but they are not mentioned.

(Note: The 3rd paragraph under pulmonary function testing discusses diffusing capacity, and states: "Although a low diffusing capacity for carbon monoxide is often reported as the most sensitive indicator of early asbestosis, it is also a relatively nonspecific finding." This is true, and the statement helps counter the oft-assumed idea that EVERY low diffusing capacity means asbestosis. The PFT section should have also clarified/qualified statements in the 2nd paragraph.)


Page 700

  • "The abnormal PA chest film and its interpretation remain the most important factors in establishing the presence of pulmonary fibrosis. Compensation systems may require that the chest radiographs be classified by the ILO system once it is established that the patient has been exposed to asbestos. A profusion of irregular opacities at the level of 1/0 is used as the boundary between normal and abnormal in the evaluation of the film, although the measure of profusion is continuous and there is no clear demarcation between 0/1 and 1./0....The specificity of the diagnosis of asbestosis increases with the number of consistent findings on chest film, the number of clinical features present (e.g., symptoms, sings, and pulmonary function changes), and the significance and strength of the history of exposure."

COMMENT: The authors make no attempt to reconcile the above statement and the following unreferenced statement that appears on page 710. "The sensitivity of the plain chest film for identifying asbestosis at a profusion level of 1/0 has been estimated at or slightly below 90%. The corresponding specificity has been estimated at 93%."


Page 700

  • “Some studies suggest that smokers without dust exposure may show occasional irregular opacities on chest film, but if so the profusion is rarely as high as 1/0; smoking along there fore does not result in a chest film with the characteristics of asbestosis (Zitting, et al 1996).”

COMMENT: This statement is a major distortion of the extant literature on the subject. It quotes only one article, a study from Finland, and omits several disproving articles, including:

  • Weiss W. Cigarette smoke, asbestos and small irregular opacities. Am Rev Resp Dis 1984;130:193-301.
  • Weiss W. Cigarette smoking and small irregular opacities. Br J Indust Med 1991; 48:841-844.
  • Dick JA, Morgan WKC, Muir DFC, et al. The significance of irregular opacities on the chest roentgenogram. Chest 1992;102:251-260.
  • Meyer JD, Islam S, Ducatman AM, et al. Prevalence of small lung opacities in populations unexposed to dusts. A literature analysis. Chest 1997;111: 404-10.

This omitted literature shows that 1/0 profusion in smokers and ex-smokers is not rare, and may be confused with asbestosis. As Weiss wrote in his 1991 paper: “The prevalence [of small opacities] increased with increasing age to 31.6% among smokers aged 50-64. Prevalence was 10% among ex-smokers of cigarettes. Among current cigarette smokers, prevalence was 5.3% in those who smoked less than one pack per day, 31.3% in heavier cigarette smokers, and 52.9% in 17 heavy cigarette smokers aged 50-64...The data in this study indicate that such abnormalities are directly related to age and smoking habits among workers not exposed to hazardous dust.”


Page 710

  • "Workers referred for evaluation of asbestos-related disease today differ from those referred in past years. Exposure to asbestos among these workers is likely to be more remote in time and to have been less intense. Exposed workers may live longer and progress later to more advanced stages of disease. They are more likely to survive to develop additional outcomes associated with asbestos, such as malignancy, and to present more complicated management challenges (Ohar J, Sterling DA, Bleecker E, Donohue J. Changing patterns in asbestos-induced lung disease. Chest 2004;125:744-753.)."

COMMENT: This paragraph leads to a single reference, an article published by Ohar, et al in Chest. That Ohar, et al article has been discredited, by three letters: 2 published in print format in Chest, and a third letter, published in e-format, by myself. Though ostensibly 'peer reviewed', Ohar, et al is an example of "junk science" because the diagnoses of asbestos disease in their cohort were made exclusively by plaintiff-attorney-hired physicians (PAHP). Thus the article was based on diagnoses not made objectively, but by physicians paid to make asbestos diagnoses and ONLY asbestos diagnoses. Unfortunately, the article is now being quoted as if its conclusions were valid, when they have no medical validity whatsoever. The total lack of response by Ohar, et al to any of the published criticisms supports this contention.


Page 710

  • "The sensitivity of the plain chest film for identifying asbestosis at a profusion level of 1/0 has been estimated at or slightly below 90%. The corresponding specificity has been estimated at 93%. Applied to populations with varying prevalence of disease, the positive predictive value of the minimally abnormal chest film alone in making the diagnosis of asbestosis may fall below 30% when exposure to asbestos has been infrequent and exceed 50% when it has been prevalent. This suggests that screening programs based on the chest film alone may vary considerably in their yield of true cases depending on the characteristics of the population being screened. In the general population and for occupational groups with low levels of exposure they may be unreliable in identifying asbestosis. The application of multiple criteria, as outlined in this statement, is a preferable approach (Ross RM. The clinical diagnosis of asbestosis in this century requires more than a chest radiograph. Chest 2003;124:1120-28.)"

COMMENT: Note that only the last sentence of this paragraph is referenced, and the title of that reference speaks clearly to much of what is wrong with the ATS Official Statement. Being committee-authored, the Official Statement twists and turns in its deliberations, never sure if it wants diagnostic criteria to be simple and subjective (favored by plaintiff attorneys) or comprehensive and objective (the real world, apart from litigation). Thus there are unreferenced statements about the plain chest x-ray that can be used by plaintiff attorneys to make or support a claim, and then there are more reasoned statements that the authors can use to say 'this is what we really mean'. I doubt that all the authors are naive in the ways of litigation, and surely they must at some level appreciate the quagmire they have written.


Page 711

  • "In the spring of 2001, the Association of Occupational and Environmental Clinics adopted a resolution recommending necessary standards for screening programs. This action was taken in response to the proliferation of screening programs undertaking to identify cases for possible legal actions in which counseling and education may be lacking, but the recommendations also apply to those conducted for patient care and protection."

COMMENT: This is the only mention of problems with attorney-manufactured asbestos claims, and it is an oblique one at that. Yet in this paragraph the authors assume that the main problem arising from the screening programs is inadequate "counseling and education" for people diagnosed with asbestos disease. Nowhere do the authors acknowledge the fact that most ILO readings by plaintiff-attorney-hired B-readers (PAHP) are inaccurate (the films are generally over-interpreted), or that PAHP are paid more for a positive diagnosis than a negative one. This is crucial information, as it should invalidate all medical conclusions based on "diagnoses" generated by PAHP (such as those published by Ohar, et al). Nowhere do the authors acknowledge that the real abuse is a process by which attorneys solicit hundreds of thousands of factory workers and ex-workers, then pay a handful of physicians to make diagnoses the vast majority of which are not supported by objective medical evidence. "Counseling and education" are lacking because the real world of treating doctors does not find the diagnoses made by PAHP.


Page 711

  • These criteria and the guidelines that support them are compatible with the Helsinki criteria, developed by an expert group in 1997, which represents substantial consensus worldwide (Anonymous. Asbestos, asbestosis, and cancer: the Helsinki criteria for diagnosis and attribution. Scand J Environ Health 1997;23:311-316.).

COMMENT: The Helsinki criteria was a completely unreferenced editorial, and thus offered not a single reference for any statements in the article. That article also did not acknowledge any of the mass-asbestos claim abuse evident at the time, nor did it list any financial disclosure of the authors.


Page 711

  • "CONCLUSIONS: The diagnosis of nonmalignant asbestos-related disease rests, as it did in 1986, on the essential criteria described: a compatible structural lesion, evidence of exposure, and exclusion of other plausible conditions, with an additional requirement for impairment assessment if the other three criteria suggest asbestos-related disease. Each criterion may be satisfied by one of a number of findings or tests. The 2004 criteria are open to future testing modalities if and when they are validated. For example, HRCT has greatly increased the sensitivity of detection and has become a standard method of imaging. Evidence for exposure still rests on the occupational history, the demonstration of asbestos fibers or bodies, or pleural plaques. Impairment evaluation is largely unchanged from 1986 and remains an essential part of the clinical assessment. Potentially confounding conditions, such as idiopathic pulmonary fibrosis, are better understood and many, such as tuberculosis, are less common than in the past so that the clinical picture is less often confusing."

COMMENT: This conclusion, while seemingly rational, is at singular variance with many of the unreferenced statements in the article. This is another example of how the Official Statement twists and turns, at one point allowing for simplistic and subjective diagnosis, then reversing course and requiring comprehensive and objective assessment. This would all be academic were it not for the fact (again, never acknowledged) that the vast majority of asbestos diagnoses in this country are attorney-driven (e.g., all the cases in the Ohar, et al cohort), and do not "exclude other possible conditons," do not satisfy the "additional requirement for impairment assessment." (Never once, in evaluating hundreds of claims on behalf of defendants, have I come across PAHP-authored reports that considered a non-asbestos diagnosis for an abnormal profusion reading. In the real world or pulmonary medicine, such an obviously biased evaluative process would be instantly discredited.)


The next three quotes are related, and will be commented on as a group

  • Page 691 "On the other hand, the risk of cancer may be elevated in a person exposed to asbestos without obvious signs of nonmalignant asbestos related disease. However, a diagnosis of nonmalignant asbestos-related disease does imply a lifelong elevated risk for asbestos-related cancer."
  • Page 705 "The presence of [pleural] plaques is associated with a greater risk of mesothelioma and of lung cancer compared with subjects with comparable histories of asbestos exposure who do not have plaques (Hillerdal 1994; Hillerdal 1997)."
  • Page 711 "Persons with a history of exposure to asbestos are also at risk for asbestos-related malignancies."

COMMENT: The authors have ignored a mountain of data that either contradicts these statements or at least puts them in perspective. Of the three statements, only one (p. 705) is referenced, citing just one article and one abstract, both by Dr. Hillerdal, a Statement Committee author. Conspicuously omitted are several countervailing studies, including:

  • Browne, K. Is asbestos or asbestosis the cause of the increased risk of lung cancer in asbestos workers? Br J Ind Med 1996: 43,145-149.
  • Jones, RN, Hughes, JM, Weill, H (1996) Asbestos exposure, asbestosis, and asbestos-attributable lung cancer. Thorax 51(suppl 2),S9
  • Weiss W. Asbestosis: A Marker for the Increased Risk of Lung Cancer Among Workers Exposed to Asbestos. Chest 1999;115:536-549.

The phrase "history of exposure" is so vague and broad that it could encompass every patient with lung cancer (170,000 new diagnoses each year in U.S.) who ever worked in a factory, warehouse, gas station or garage. Considering the fact that very few of the hundreds of thousands of attorney-solicited asbestos claimants have a documented history of working with friable asbestos, this wording is, in the context of asbestos litigation, irresponsible. (See also ATS Bias: Origins of Anti-Science in the 2004 Official Statement [Dr. Wagner].)


FINAL COMMENT

In summary, there are 3 basic problems with the ATS Official Statement as published in AJRCCM:

1) There is no Conflict of Interest Statement for any of the 11 authors. This omission casts doubt on the article's honesty and integrity.

2) Numerous references - legal and medical - that should have been included in a comprehensive review (26-pages, 160 references) are omitted, references that disprove some of the authors unfounded conclusions.

3) There is no acknowledgment that 'non-malignant asbestos-disease' diagnosis has been almost entirely co-opted by plaintiff-attorney-hired-physicians, who have provably over-diagnosed it in the extreme. There is no acknowledgment that this PAHP-driven 'epidemic' of asbestos disease (over 500,000 claims to date) is a legal fabrication, not at all evident to either the body of pulmonary physicians in the U.S., or the specific physicians who actually care for these claimants.

Sadly, inexplicably, ATS/AJRCCM has published a tarnished "Official Statement" on diagnosis of nonmalignant asbestos disease. The root cause of this is easy to see - bias among key ATS Officials and Statement Committee members. I have also authored an 'open letter' to ATS/AJRCCM about theses issues, and recommended an independent panel of non-asbestos experts to examine the ATS article and write a report.


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Originally posted November 15, 2004; updated through February 14, 2005.

Lawrence Martin, M.D., FACP, FCCP