The U.S. healthcare system, believed by many to be the most scientifically advanced in the world, is a system in which patients have access to the latest drugs, medical devices, and state-of-the-art techniques. Recent advances in neurosurgery have been closely tied to industry-driven procedures. Image-guided surgery, endovascular surgery and deep brain stimulation are some examples of the latest technological advances that reduce morbidity and improve clinical outcomes.
The United States routinely lags behind other Western countries, however, in the availability of new medical technology. Innovations are routinely available in Europe, Canada, Australia and Japan years before their availability in the United States. This lag period is due primarily to the lengthy approval process of the U.S. Food and Drug Administration. The Kefauver-Harris drug amendments of 1962 expanded the FDA’s role from merely assuring the safety of drugs to assessment of their clinical efficacy. It now takes 15 years for a newly synthesized drug to go from the laboratory to use in U.S. patients. In 1976, this authority was expanded by Congress to include medical devices as well. Furthermore, physicians cannot be informed by equipment manufacturers of new uses for existing, approved medical devices (so-called “off-label” indications).
The process of bringing innovation to patients evolves through a delicate dance between industry, clinicians and federal regulatory authorities. Vocal critics of all parties abounds. Have we found the right balance?
Case in point: spinal cord stimulation for angina pectoris.
Angina pectoris has become the number one indication for epidural spinal cord stimulation, or SCS, in Europe. In the United States, despite routine use of SCS for a variety of chronic somatic pain syndromes, the treatment of angina with SCS remains off-label. Medtronic, a manufacturer of SCS implants, had planned initial trials, but never got past numerous FDA hurdles. A manufacturer-sponsored multicenter trial is currently underway, but patient accrual remains low.
In contrast, over 2,000 patients with angina have received SCS systems throughout the rest of the world since this procedure was first performed in Australia in 1987. Numerous controlled studies have demonstrated that SCS decreases the number of anginal attacks and the number of ischemic episodes, while increasing exercise duration and time to anginal attack. European trials have also demonstrated that these patients have a reduced number of hospital admissions with no increased risk of arrhythmias, while not masking the signs and symptoms of myocardial infarction. Indeed, a Swedish study which randomized refractory angina patients to either SCS or coronary artery bypass graft showed comparable symptom relief with both techniques, with lower mortality and morbidity in the SCS group.
The slow FDA approval process impacts patients and clinicians in several ways. Currently, government insurance and most private insurers will not reimburse for off-label procedures. For the time being, U.S. patients wishing to undergo this procedure must either pay out-of-pocket for the entire costs or travel outside the United States. for treatment. Similarly, for a period of 10 years, patients with Parkinson’s disease had to travel abroad or pay out-of-pocket to obtain bilateral subthalamic nucleus or globus pallidus deep brain stimulation implants until the FDA approved the procedure in January 2003.
In the case of angina treatment, the opportunity for collaboration between neurosurgeons and cardiologists may be lost. Other competing technologies such as enhanced external counterpulsation and transmyocardial revascularization target a similar patient population and can be performed by a cardiologist or cardiac surgeons. Comparing benefits such as cost and efficiency of these other procedures with SCS may never be possible if SCS trials fail to gain sufficient recruitment.
There is no evidence to support the claim that the current, slow process of FDA approval has resulted in “safer” medicine for our population compared with the rest of the world. One may argue that the highly litigious atmosphere in the United States necessitates more rigorous approval standards than those that may be required in other countries. Ultimately, however, withholding the benefits of medical advances from U.S. citizens as a consequence of cumbersome regulatory procedures may prove to be more harmful than beneficial for our society.
Alon Y. Mogilner, MD, PhD,is assistant professor, and Deborah L. Benzil, MD, is associate professor of the Department of Neurosurgery, New York Medical College in Valhalla, N.Y.
For Further Information
Bagger, J.P., et al. “Long-term Outcome of Spinal Cord Electrical Stimulation in Patients With Refractory Chest Pain.” Clinical Cardiology. 1998 Apr;21(4):286-8. PubMed ID 9562939
Conko, G. A National Survey of Neurologists and Neurosurgeons Regarding the Food and Drug Administration. 1998. Competitive Enterprise Institute, www.cei.org/gencon/025,01586.cfm
Mannheimer C., et al. “Electrical Stimulation Versus Coronary Artery Bypass Surgery in Severe Angina Pectoris: The ESBY Study.” Circulation. 1998 Mar 31;97(12):1157-63. PubMed ID 953734