St. Clair Pulmonary & Critical Care Port Huron, MI
Correspondence to: Sridhar P. Reddy, MD, MPH, FCCP, St. Clair Pulmonary & Critical Care, 1210 Tenth Ave, Port Huron, MI 48060
Dr. Reddy has participated in an advisory board for CSL Behring and dinners (in Philadelphia, PA, at the CHEST conference), and in a Champions for Alpha-1 Testing (CAT) study sponsored by CSL Behring. Ms. Zaremba has participated in a round table discussion for the University of Michigan and dinners (one in Detroit, MI, with Dr. D. Kyle Hogarth, of the University of Chicago; and one in Philadelphia, PA, at the CHEST conference), and in a CAT study sponsored by CSL Behring.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
We read with interest and great anticipation the clinical commentary in a recent issue of CHEST (October 2008)1 regarding α1-augmentation therapy for PI MZ heterozygotes, but disagree with the conclusions reached by the Medical and Scientific Advisory Committee of the Alpha-1 Foundation in the strongest terms.
The authors acknowledged, although their evidence is somewhat anecdotal, the existence of patients with MZ phenotype who have severe obstructive disease despite being nonsmokers. They also acknowledged the difficulties involved in enlisting a subset of rapidly declining MZ phenotype patients in a trial to be “daunting.” There are also no data available that have looked at the quantity of Z or M α1-antitrypsin (AAT) within a given patient and the protectiveness of the level of each subtype in preventing disease.
The authors reiterated the fact that physicians legally enjoy the privilege of prescribing medications that have not been approved by the US Food and Drug Administration. They failed to realize that the physician is the greatest advocate for their patients, and that the doctor-patient relationship is an ethical one that is above any legal obligations and goes beyond any approval by a third party. We have for centuries advocated for our patients and have not placed an economic value on each individual's life, though it is common knowledge that third-party payers have done so.
Given this background and the bleak prospects for any new knowledge being imminently available in a randomized prospective trial, we believe that the interim recommendation to clinicians by Sandhaus et al1 to avoid prescribing augmentation therapy for MZ heterozygotes is a disservice to patients and physicians alike. Patients who in today's economy can hardly afford to reach the office (due to gasoline prices and increasing rates of copays) will never be able to reach specialists with experience in treating AAT deficiency (whatever the definition of an AAT deficiency specialist might be), and it is fair to say that deserving patients will be denied treatment based on this article.1
To ask the insurance industry to closely evaluate reimbursements for such a scenario is at the least an irresponsible recommendation after a doctor-patient relationship has been set up and a decision to treat has been made based on the best available knowledge. To our knowledge, this is the first time in a prestigious journal such as CHEST that a third party has been asked to police medical professionals and interfere in the doctor-patient relationship. This sets a dangerous precedent in which a document does not just give us the science about a somewhat controversial scenario but is asking the insurance industry and the US Food and Drug Administration to trump physician judgment in an area that is not black and white.
In conclusion, we believe that this clinical commentary only creates more problems for the practicing clinician who is in the trenches and has only muddied up the trench for those of us who are in the field.
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