Affiliations: City of Hope National Medical Center, Duarte, CA,
H. Lee Moffitt Cancer Center, Tampa, FL,
Chair, Health and Science Policy Committee, American College of Chest Physicians
Correspondence to: Frederic W. Grannis, Jr, MD, FCCP, General Oncology Surgery, City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010-3012; e-mail: email@example.com
As a member of the American College of Chest Physicians (ACCP) Health and Science Policy Committee, involved in review of ACCP Lung Cancer Guideline 2 (LCG2), I feel an obligation to inform CHEST readers of what I consider major problems with LCG2.1First, there are flaws in methodology. Lung cancer is a unique preventable disease caused by an industry. The ACCP has chosen Duke University, recipient of hundreds of millions of dollars from the cause and vector of lung cancer, the tobacco industry, to conduct the systematic literature review that anchors the guideline process.2Since Duke investigators might be expected to show bias in selection of evidence in areas where guidelines might adversely effect the interests of their tobacco industry benefactors (eg, tobacco control, smoking cessation, and screening), it should not surprise readers that the evidence base in these areas ranges from weak to absent.5
Thus, although tobacco control public policy combined with smoking cessation interventions can reduce lung cancer incidence and mortality, there is literally no tobacco control content in the entire guideline, and minimal evidence or guideline recommendation in the critical field of smoking cessation. There is, in fact, nothing in the guideline that would evoke even minor distress for a tobacco executive.
The lung cancer screening chapter reflects unfavorably on the ACCP guideline process.6 The choice of authors reflects no effort to empanel a balanced group of experts: the inclusion of Peter Bach, William Black, and Gerard Silvestri virtually “stacks the deck” and guarantees a chapter with negative screening recommendations. Black, an author in the first guideline, is absent, presumably because he provided paid testimony for Philip Morris in a medical monitoring lawsuit. Although ACCP guideline authors theoretically are subject to a rigorous conflict of interest policy that mandates provision of conflict of interest statements prior to all meetings, this process failed to invalidate lead author Bach, who had a major conflict of interest, working not at Memorial Sloan-Kettering, but as a consultant to the director of the Centers for Medicare and Medicaid Services. ACCP leadership has not provided a clear answer to repeated queries whether Bach informed ACCP of his Centers for Medicare and Medicaid Services involvement in a timely fashion.
Publications demonstrate that protocol-based CT screening is effective in the detection of lung cancer at small size and early stage: actuarial survival at 10 years in screen-detected lung cancer is > 80%.7Instead of presenting an evidence-based guideline based on systematic literature review, lung cancer screening chapter authors omit almost all pertinent articles published in the past 3 years, including a reference to a 2005 CHEST article8 in which chapter author James Jett recommends screening of high-risk individuals outside of research trials. The result is a peculiar muddle of conjecture and biased opinion supported only by questionable mathematical models incorporating grossly inaccurate assumptions.
These deficiencies result in a chapter that is a disservice to physicians and patients. Nothing in LCG2 will result in an increase in lung cancer long-term survival. LCG2 should be supplemented by new chapters on tobacco control public policy and smoking cessation and a fair and balanced, evidence-based chapter on lung cancer screening. Damage repair cannot wait more than 3 years until the release of the third lung cancer guidelines. Lives that might have been salvaged will be lost.
The author has potential conflicts of interest with regard to lung cancer screening in that he is a principal investigator in the International Early Lung Cancer Action Program, with a $35,000 grant for data management. He is also an expert witness in a medical monitoring trial against Philip Morris Corporation in New York State.
The author has no conflict of interest to disclose.
Thank you for the opportunity to respond to the issues raised by Dr. Grannis. He seems to harbor four concerns: Duke as the evidence-based practice center (EPC), the space allocated to tobacco policy, the selection and approval of chapter editors, and the recommendation on lung cancer screening.
First, his assertion that the Duke EPC “might be expected to show bias” is extremely troubling. Besides the fact that the American College of Chest Physicians (ACCP) Lung Cancer Guideline Panel (not the EPC) graded the evidence collected from the systematic review and crafted the recommendations, the individual investigators at the Agency for Healthcare Research and Quality-approved EPC at Duke are expert objective reviewers of the literature and held to strict conflict of interest policies.1 To assert otherwise, without substantiation, is inappropriate.
All agree that tobacco control is vital. In fact, in my introduction, I stated that “tobacco control is the single most effective method available to address the dismal statistics associated with lung cancer.”2 The editorial decision to limit the amount of space allocated to this area was made solely by page restraints (the supplement is 422 pages long already), along with the knowledge that information and guidance is readily available from other ACCP courses, publications, and enduring products.
All selected chapter authors and writing panels underwent significant scrutiny and were subject to a vigorous conflict of interest policy.1 Drs. Bach, Silvestri, and Jett, as authors of the second edition Lung Cancer Screening chapter,3 are internationally known experts in the field and physicians whose integrity is above reproach. They were subjected to the same procedure of approval. The Health and Science Policy Committee had full knowledge of Dr. Bach’s government service when he was approved to serve as a member of the panel and chapter editor.
All hope that lung cancer screening by low-dose CT will be shown to provide a mortality benefit. Studies are underway that are designed to address this hypothesis. Until such information is available and because of the very real risks inherent in screening (false-positive results, unnecessary procedures, radiation exposure, and psychological stress), the ACCP cannot recommend screening outside the protections afforded by a clinical trial. The ACCP is not alone in this conclusion because there are currently no guidelines that recommend screening for lung cancer. We cannot abandon the scientific method even when we fervently hope the hypothesis is proven correct. The literature is replete with examples of promising hypotheses generated by observational studies that were so obviously true until they were proven to be incorrect or nonbeneficial when subjected to the rigors of a randomized controlled trial.
It should be noted that Dr. Grannis was provided an opportunity to present these very same concerns to the entire ACCP Board of Regents at the spring board meeting. His accusations were judged to be baseless, and his suggestions were believed to be unnecessary.
Thank you for the opportunity to respond to the issues raised in the letter from Dr. Grannis. As current chair of the American College of Chest Physicians (ACCP) Health and Science Policy Committee, I feel it is necessary to respond to several issues brought up by Dr. Grannis about the ACCP process for guideline development.
Guideline development over the last several years has advanced steadily and undergone rigorous change. The ACCP has been a leader in this area and prides itself on a transparent and rigorous guideline development process. The Health and Science Policy Committee provides oversight for the development of all ACCP evidence-based guidelines. This process has recently been outlined and published1by the prior Health and Science Policy Committee leadership, and commented on favorably by directors of the Agency for Healthcare Research and Quality.2
The “Conflict of Interest Policy for the ACCP Guideline Development”1 outlines a process ensuring that disclosed conflicts of interest are properly evaluated and resolved at several key points during the development of guidelines. This process was adhered to throughout the Lung Cancer Second Edition guideline3 development. All selected chapter authors, including Dr. Bach, and writing panels underwent significant scrutiny by the Policy and Procedures Subcommittee and then by the complete Health and Science Policy Committee.
Dr. Grannis, as a current member of the Health and Science Policy Committee, was part of all committee discussions regarding the Lung Cancer Second Edition guideline. The committee heard, discussed, and voted on the issues for which he had significant concerns. He was also granted, at his request, a chance to present his thoughts to the ACCP Board of Regents at the spring meeting. Final voting was not in his favor.
Certainly, the field of guideline development and issues of conflict of interest will continue to evolve in the future. The ACCP will be active in these areas as we move into the future, priding itself in a thoughtful, transparent, and rigorous process.2
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