Peer Review and the Suppression of Innovation
While many scientists view peer review as a mechanism of quality control, the purpose of review of medical innovation must align with the purpose of medicine itself: to cure sometimes, to relieve often, and to comfort always. The process of peer review must then aim to facilitate the introduction of improved methods of curing, relieving, and comforting patients. This requires a delicate balance of both quality control and encouragement of innovation. A major issue with this balance; however, is the consistent demand of the public for success, a demand that must be taken seriously since the public is interested only in funding improvements to patient care. While safety is certainly a priority, overzealous monitoring and regulation of research impedes innovation. The number of truly important and innovative articles is small, but this minority is what pushes medicine forward. Editors reading these articles have a great responsibility; true innovation is so rare and so valuable to the improvement of patient care that it should be deliberately encouraged. Unfortunately, there are so many instances of suppression of innovation by the peer review process. Here are a few notable examples.
1) Krebs’ article on the citric acid cycle, one of the most important articles in modern biochemistry, was initially rejected by the peer review process.
2) At least two Nobel laureates have admitted to lying on grant proposals because they knew they would never receive funding for their groundbreaking research had they actually disclosed their true plans.
3) There are multiple documented cases of reviewers rejecting articles because they “do not believe the author’s observations.” (The reviewer had a personal conflict with the author.)
Here, it initially does not matter if the author is correct. Scientists with sound research deserve to be heard, and it is the responsibility of peer reviewers to ensure that this happens. How else will an innovative idea become a reality in medical practice?
Contemporary Examples of Disruptive Innovation in Medicine
Since disruptive innovation emerged as a business model, it is surprising that there have been recent positive examples of the application of this theory to medical innovation. The rise in the number of physician assistants and nurse anesthetists illustrates a classic disruptive innovation. These relatively new positions require less schooling (making them “cheaper” time-wise to obtain) and replace duties typically performed by physicians and anesthesiologists. However, these two jobs will never truly replace the careers they compete with due to the differences in the level of training. Physician assistants and nurse anesthetists allow doctors to see more patients by taking over lower-level duties and much of the patient contact. This increases the efficiency of a healthcare system, especially in the surgical suite, where the money is made.
Pharmacy robots are also an emerging technology that has revolutionized the delivery of medication in larger hospitals. It has replaced traditional “gophers,” which saves the hospital money: One machine can do the job of ten people in less time. This technology has been so successful so quickly most likely due to the lack of safety concerns, which are usually the limiting factor in application of medical innovations.
University-industry research collaborations have been integral in the continuing high degree of technological innovation in medicine. Innovation emerges from the interplay of universities, national laboratories, and industrial firms in an environment shaped by government rules and incentives. Industrial proximity to and collaboration with research universities illustrates the value of academic scientists in biotechnology, since research into the basic mechanisms of disease elucidates pathways and targets for clinical innovation and aids in the development of medical devices. Academic health centers (AHCs) are critical in the clinical evaluations needed to bring innovations to market; but in recent years, the role has been assumed by for-profit contract research organizations (CROs). AHCs offer a greater variety of patients, unique surgical expertise, informed feedback, and identification of new indictions of use. These centers also allow for incorporation of quality and cost-effectiveness data to be added to traditional physiological metrics. CROs, on the other hand, are more efficient and offer the integrated infrastructure of individuals with statistical, management, and economic expertise. Medical innovation depends on extensive interactions between universities and industry, with knowledge and technology transfer flowing in both directions. These interactions can have important public health and economic benefits as long as the cultural and ethical principles of one partner do not overwhelm the other (think corruption from financial conflicts of interest). Maximization of collaboration requires internal organizational changes as well as the formation of new models of collaboration, for instance intellectual partnerships or virtual research organizations.
“Fake” Innovation
“Fake” innovation refers to products created that do not necessarily offer any improvements to existing technology or processes. They are merely perceived as new or different and generally lack important data regarding safety and effectiveness. The most prominent example of this today is the rise in popularity of robotic surgery using the daVinvi robot. This has been called a breakthrough technology for procedures like prostate surgery, but the cost is outrageous and the technology has yet to be shown to improve surgical outcomes in a randomized trial. Consumers must continually ask themselves, “Is this innovation and improvement, or is it innovation just for the sake of making something “new” for financial gain?” Dr. Koplin also provided of “fake” innovation in his field of opthalmology. Using lasers in cataract surgery decreases surgical time, but does not necessarily improve outcomes. This is a much more expensive procedure than traditional phacoemulsification. So, if you had the choice, would you choose faster or better? Are you really better off, or are you simply saving time?
“What procedures or practices are we involved in now which will rank with bloodletting as a folly of our time?”
A surprising amount of current medical practice lacks a scientific foundation, and this discovery has led to the new paradigm of evidence-based practice. Baseless practice is seen in all aspects of practice, from diagnostics to surgery. For example, electronic fetal monitoring during labor became common in the U.S. in the 1970s. Randomized control trials several years after dissemination revealed that this conferred no demonstrable benefit to the fetus and actually increased the risk of operative delivery. A more contemporary example may be the surgical fad of laparoscopically assisted vaginal hysterectomy, a widely popular procedure that increases post-operative pain, operating time, and cost of materials, clearly illustrating that “new” is not synonymous with “improved.”
Several barriers to critical assessment of medical technologies persist. “Seduction by authority” is still common: Decisions about a new technology should be based on the weight of the scientific evidence and not on the perceived prestige of its proponent. The “false idol of technology” trap preys upon the public notion that new is always better. A third barrier is the tendency to accept existing dogmas uncritically. Finally, the rigorous efficacy and safety testing applied to pharmaceuticals and sometimes to medical devices do not apply to diagnostic procedures or to surgeries. Above all else, these not uncommon scenarios illustrate the importance of being critical. Do not accept innovation blindly.
Government Regulation of Medical Inovations
In November 2013, the FDA ordered 23andMe, a genomics company, to cease the marketing of its personal genome system, a DNA sequencing product sold directly to consumers that claimed to “help individuals and their doctors identify health areas that they need to keep an eye on.” This tool provides information of many of the 58 gene mutations associated with 24 genetic disorders that doctors are recommended to report if they are discovered incidentally during genetic testing. However, the test also estimates risk of over 200 other health conditions, many of which are only based on preliminary evidence. Innovative products like the personal genome system challenge the FDA’s regulatory framework, since there is no existing substantially equivalent product for comparison. This raises the question of how the government should go about regulating the availability of innovative medical technology. There is obviously a safety concern (what will people do with the information they have obtained?) but this must be balanced with the right to privacy. Typically the FDA is a reactive regulator, only stepping in after harm has been done. However, the theoretical harm stemming from inaccurate results was apparently great enough to warrant interference. The potential effect of incorrect results from this technology was magnified by its direct availability to consumers, which may have made government involvement more likely. Many medical professionals are uncomfortable with the amount of government supervision of their work with clinical trials, saying that regulations suppress innovation. However, because medical innovation directly impacts patients, safety is always a primary concern. The government must find a balance between ensuring patient safety and providing opportunities for innovative technology to be explored.
Continue on to a list of additional resources and suggested articles
Leave a Reply