Chest
Special Reports: ReviewsClinical Experimentation: Lessons From Lung Volume Reduction Surgery
Section snippets
HISTORY OF LUNG VOLUME REDUCTION SURGERY
The idea that patients with emphysema might derive benefit from reducing the volume of lung parenchyma was first tested by Brantigan and Mueller2 in 1957. Despite the apparent improvement seen in several of their patients, the high perioperative mortality and substantial postoperative complication rate (particularly persistent air leaks) resulted in poor acceptance of the procedure. The development of a method that markedly decreases the incidence of air leaks after resection of emphysematous
ETHICS AND EXPERIMENTS
Much of the commentary regarding the ethical issues surrounding LVRS centers on whether the surgery is experimental. Some have argued that the operation simply represents an extension of an accepted practice of excising nonfunctional bullae from the lungs of patients with emphysema and that, as such, it is not experimental.7 We have disagreed, arguing that the uncertain risk/benefit ratio of the procedure together with the paucity of long-term follow-up requires that lung reduction, at that
INFORMED CONSENT
The difficulty in distinguishing between experimental and established treatment has led to calls to abandon such labels and for physicians to focus on providing meaningful justification for whatever they recommend for their patients.23 While such a goal is laudable, we submit that there remains a fundamental difference between experimental and standard medical therapies that is manifested by the nature of the informed consent required for each and that cannot simply be dismissed. Although
ANALOGY WITH MEDICAL THERAPY
The recent decision by Medicare to stop reimbursing for LVRS and a request in the Federal Register (November 15, 1995) by the Agency for Health Care Policy and Research for information pertinent to an assessment of the safety and efficacy of the procedure indicate that, at least for these groups at that time, LVRS remained unproved, requiring further study to ascertain the likelihood, duration, and degree of benefit, as well as the risks, both short and long term. Challenges to this proposition
THE DOUBLE STANDARD
There is no FDA for the surgeon.26 Recognizing this fact raises the obvious question of whether surgery is to be held to a different standard than the rest of the medicine. Despite disagreements about proper time frames and voluminous paperwork, the medical community fundamentally supports the work of the FDA and the requirements for evidence documenting the safety and efficacy of new medications prior to approval. The FDA requires extensive data, coming from carefully designed studies, which
SUGGESTIONS
The Belmont Report, the influential statement of the National Commission for the Protection of Human Subjects, recommends that “medical practice committees” be responsible for ensuring that major innovations undergo proper scientific evaluation.35 We know of no such committees with the mandate or power to do so, but agree that both medical science and individual patients would be best served by requiring thorough evaluations of new procedures and interventions. Institutional review boards, the
CONCLUSION
Examining the history and current status of LVRS provides an opportunity to reassess the way new surgical therapies become standard therapy. This analysis also applies to some medical interventions that fall outside the purvey of federal regulatory agencies. The medical community must learn to recognize when treatments are experimental without relying on the determinations of courts and third-party payers. Although there may be no universal test to determine when a particular therapy has
REFERENCES (35)
- et al.
Bilateral pneumonectomy (volume reduction) for chronic obstructive pulmonary disease
J Thorac Cardiovasc Surg
(1995) - et al.
Comparison of early functional results after volume reduction or lung transplantation for chronic obstructive pulmonary disease
J Thorac Cardiovasc Surg
(1996) - et al.
Unilateral thoracoscopic surgical approach for diffuse emphysema
J Thorac Cardiovasc Surg
(1996) - et al.
A randomized, prospective trial of stapled lung reduction versus laser bullectomy for diffuse emphysema
J Thorac Cardiovasc Surg
(1996) - et al.
Lung reduction surgery: great expectations and a cautionary note [editorial]
Chest
(1995) Human experimentation in historical and ethical perspectives
Soc Sci Med
(1982)Lung reduction surgery: a true advance?
J Thorac Cardiovasc Surg
(1996)Lung reduction surgery: where are we heading [editorial]?
Chest
(1996)Evidence-based medicine: A new approach to teaching the practice of medicine
JAMA
(1992)- et al.
Surgical treatment of pulmonary emphysema
Am Rev Respir Dis
(1959)
Technique to reduce air leaks after resection of emphysematous lung
Ann Thorac Surg
Reduction pneumoplasty for COPD [abstract]
Chest
Room to breathe
Saturday Evening Post
Breakthrough for emphysema patients
Saturday Evening Post
Is volume reduction surgery appropriate in the treatment of emphysema? yes
Am J Respir Crit Care Med
Cited by (26)
To treat or not to treat: On what should surgical therapy be based?
2015, Journal of Vascular SurgeryEthics of surgical innovation to treat rare diseases
2004, Journal of Vascular SurgeryEthics of rapid surgical technological advancement
2000, Annals of Thoracic SurgerySurgery for lung volume reduction
1999, Annales Francaises d'Anesthesie et de ReanimationLung volume reduction surgery for emphysema: Out on a limb without a NETT
1998, Mayo Clinic Proceedings
revision accepted May 2.