FootForum: Roadblocks to Medical Advances

The ongoing saga related to the growth factor rhBMP-2 has highlighted some of the ugliest by-products associated with the technological advancements of modern medicine. The FootForum has previously discussed the disturbing editorial in The Spine Journal dealing with the question of allegedly unreported adverse events that occurred during the original FDA-sanctioned clinical trial. Had the FDA been aware of these serious adverse events, the drug might not have been approved for sale in the United States. As the facts associated with development of rhBMP-2 have come to light, the orthopaedic foot and ankle community has been concerned that slow approval processes of the FDA have impeded our ability to offer the mobile-bearing total ankle replacement and the recombinant growth factor rhPDGF to our patients. We look at the prospective clinical trials presented to the FDA and marvel at their scientific validity. At the podium, we confidently state that the total ankle replacement improves the quality of life for our patients. We have learned from a prospective randomized clinical trial that rhPDGF is as safe as autologous bone graft in supporting fusion in foot and ankle surgery, without the pain and untoward events associated with autologous bone graft. We wonder why the process is so long when our data is so good. If we step back and take a deep breath, we can now envision the FDA commissioners wondering what information we withheld in these clinical investigations. We view their actions as impeding medical progress, while they envision the same action as a safeguard from the harm afforded certain patients during the rhBMP-2 trial. They now wonder if they prematurely approved use of rhBMP-2. In fact, this process might have uncovered an even greater dilemma. Spine surgery is big money. Spine surgery programs make huge profits for the hospital and the device manufacturers, and spine surgeons are among the highest paid physicians in the United States. One can see why device manufacturers are anxious to support the development of more specialty-trained spine surgeons who can use more of their products. As hospitals face growing financial barriers, the profits associated with a successful spine program can be used to offset losses in other necessary areas. Was information withheld from the FDA? If so, who is responsible? New drugs and new devices can only be developed utilizing the resources of venture capitalists and “for-profit” businesses. In the purest form, we strive for advancement of science. The unfortunate reality is that clinical scientific advancement must come on the back of commercial success. If companies do not make money, there will be no impetus to assist us in scientific progress. This places an incredible ethical burden on both the device makes and the clinical scientists. When is regulation burdensome versus protective? As the profit margin for all stakeholders is diminished, there is more potential for abuse. In our small sector of the medical universe, we have demonstrated that ankle replacement appears to be at least as good as successful ankle fusion at 2 years. Our next ethical responsibility is to perform quality comparative therapeutic research to support the notion that ankle fusion or ankle replacement provide long-term positive benefits as compared with medical therapies. We must create compelling supportive data that these benefits are sustained over time and are worth the resource commitment necessary from the allocaters of healthcare. We need to objectively analyze the role of the so-called “orthobiologics” to determine their efficacy and benefit in altering the natural history of disease and improving quality of life. We need to avoid the spectra associated with our spine collegues. Good comparative effectiveness research, objective longitudinal outcome data and ethical relationships with industry will be essential to insure our continued growth and prosperity. What are your thoughts? The FootForum wants to know. Please let us know at mpinzur@faijournal.com. Note: Michael Pinzur is both an investigator and a paid consultant to Biomimetics, Inc. (the maker of rhPDGF)