Editor’s note: The following article was written in response to “The Bleeding Edge,” Netflix’s documentary about risks posed to patients by medical devices, including Bayer’s Essure implantable birth-control device. The opinions expressed here are solely those of the author. Questions and comments can be made below or directed to firstname.lastname@example.org.
By Binseng Wang, SCD, CCE
The recent documentary “The Bleeding Edge” released by Netflix[i] has created a lot of intense interest and debate about the safety of medical devices, not only implants but also equipment. Since it is an exposé geared towards the general public, it is predictably sensational. While it has some truths and facts, it propagates some myths and misconceptions. As healthcare technology professionals, I think we have the obligation to examine not only the allegations but also to get to the underlying root causes. Furthermore, we should contribute to find and fight for the right solutions.
First, let’s address the myths and misconceptions. The documentary said the adverse reporting is voluntary. While this is true for doctors working within their own clinics, healthcare institutions—as we all know—are required by the Safe Medical Device Act to report such events. Therefore, surgical extractions of the Essure implants that caused problems should have been reported and both Bayer and FDA should have realized that despite the small percentage of patients affected, the side effects are quite serious. Underreporting of adverse events is a well-known deficiency in our litigious society and needs to be addressed eventually.
More serious is the misconception that the “substantially equivalent” clearance process is inherently unsafe. The European Union does not offer such a “loophole” but typically approves the same devices cleared by FDA through the 510(k) process (e.g., the metal-on-metal hip implants), so both sides of the Atlantic have roughly the same amount of device problems. Thus clearly this “loophole” is not the sole or even primary root cause of the problems revealed by the exposé. Incidentally, the 510(k) process was not invented internally by FDA but was imposed by the Congress under intense lobbying by the manufacturers. It is interesting to see that Dr. David Kessler is now harshly criticizing it but did nothing while he was the FDA commissioner for almost 7 years[ii].
The documentary correctly identified two main culprits. First and foremost is unchecked greed. Not only the manufacturers are pressured by their stockholders to create more products and generate more revenue, the healthcare providers are also competing against each other in an arms race that has contributed to make the American health (non-)system become by far the most onerous one in the world without evidence of better outcomes[iii],[iv]. Some doctors apparently also have received monetary incentives to recommend certain devices[v]. The second and related culprit is political interference. Not only the manufacturers but also the lobbying arms of the medical profession and hospitals have managed to persuade the legislature to tilt the laws and regulations in their favor and, sometimes, even interfering with FDA decisions.
On the other hand, the documentary failed to look more deeply into more insidious underlying root causes and propose concrete solutions. If one stops to reflect for a minute, one will quickly realize that technology is nothing but a tool. It must be used by the right (properly trained and credentialed) professional at the right time and place, for the right reason and purpose. These “rights” are not inherent to technology and, thus, must be debated and properly controlled by the clinical professionals, healthcare establishments, government and, ultimately, the society. For example, one of the devices mentioned in the documentary is the CT scanner. If properly used, it can—and has—diagnose critical health problems and save lives. If abused, it can overdose the patient with radiation and cause long-lasting damages.
However, in order to have a meaningful debate, all the parties involved should have access to and understand the scientific facts and clinical evidence. This is easier said than accomplished because we are now faced with the “markets with asymmetric information” reality that earned George Akerlof, Michael Spence and Joseph Stiglitz their Nobel economy prize[vi]. Very few patients are able to fully understand the risks of side effects explained to them by their physicians, much less to challenge the proposed therapy. Not only the public lacks the necessary educational background, many healthcare professionals themselves are not able to keep themselves up-to-date with the most recent literature due to their heavy workload.
Worse yet is the fact that, despite tremendous benefits provided by the advance of science and medicine in the last several centuries[vii], the knowledge of the human physiology and pathology is still imperfect and incomplete. Even less understood are the causes of the different reactions among individuals. Some drugs and implants perform well for many patients but can cause serious side effects for some others without any clear reason. Some of those deleterious effects only become apparent after a long time, especially in the case of implants.
Unfortunately, instead of acknowledging this ignorance, most of the clinical professionals, healthcare providers, government agencies and device manufacturers prefer to pretend that they know enough to ensure the public that almost any illness can be treated and discomfort attenuated. This creates an unrealistic expectation from the public, who come to expect that they can get a prescription or surgery for every one of their health problems and almost never have to experience pain or discomfort. Such a collective mental block seems to be rooted in the loss of critical thinking ability among the vast majority of citizens who prefer to believe in everything they are told by “experts” instead of always taking everything “with a grain of salt” and doublechecking all the facts for themselves.
The current opioid crisis is a good example of this collective mental block. Too often patients are reluctant to put up with any pain and their doctors are only too eager to please them by prescribing excessively potent drugs for too long time. The drug manufacturers are happy to comply because the growing demand helps to increase their revenue. After the patients become addicted, everyone is pointing fingers at others claiming innocence.
In this context, FDA is in the unenviable position of being incapable to satisfy almost anyone. If it decides to be very strict and demanding in premarket review, it will face public outcry of bureaucratic incompetence and delays in releasing innovations, like what happened with some AIDS treatment drugs. On the other hand, if it approves something that later turns out to have significant safety risks, it will be harshly criticized by the Congress and the public, like what was presented in this documentary. It is totally unrealistic to expect that there is a device that can be 100% safe and effective, without any side effects.
Now let’s see what we can do to help. It is utopic to eliminate greed as it is inherent to our genes. Only a very small fraction of human beings managed to contain this instinct. Furthermore, greed is a powerful motivator for new discoveries and innovations that can benefit not only the originators but also the public. What is needed is a check-and-balance system that encourages greed but prevents excess. Political interference also cannot be eliminated completely because it is also motivated by human instincts: greed and power. However, it can and must be limited. If the public truly desires and demands safer medical devices, FDA should be better financed and staffed and, above all, be more independent to make sound decisions based on evidence. The recent FDA report on the need for regulating device servicing[viii] is a good proof that it is capable of making a sound decision based on evidence.
In addition, if we all are willing to admit our collective ignorance, we should encourage all the stakeholders to continually collect and review postmarket data and make revisions and improvements as soon and often as needed. Incident reporting should be protected from litigations and viewed as a civic and ethical duty of all healthcare professionals. The same duty applies to willful violations by any stakeholder[ix]. Updates and recalls should not be considered a shameful admission of incompetence but a clear, positive commitment to learning and improvement. If Nature learned a long time ago that nothing is perfect and evolution is the only way for any species to survive and thrive, why human beings think they are capable of creating products that is perfect the first time? Have we all forgotten the maxim errare humanun est?
[ii] FDA. David A. Kessler, M.D. Available at https://www.fda.gov/AboutFDA/History/FOrgsHistory/Leaders/ucm093724.htm. Accessed July 29, 2018.
[iii] Davis K, Stremikis K, Squires D & Schoen C. Mirror, Mirror on the Wall – How the Performance of the U.S. Health Care System Compares Internationally. The Commonwealth Fund, 2014. Available at https://www.commonwealthfund.org/sites/default/files/documents/___media_files_publications_fund_report_2014_jun_1755_davis_mirror_mirror_2014.pdf. Accessed July 29, 2018.
[iv] Papanicolas I, Woskle LR & Jha AK. Health Care Spending in the United States and Other High-Income Countries. J. Am Med. Assoc., 319(10):1024-1039, 2018.
[v] Cohen E & Kessler A. CNN Exclusive: Bayer paid doctors millions for
questionable birth control device. Available at https://www.cnn.com/2018/07/27/health/essure-bayer-doctor-payments-eprise/index.html. Accessed July 29, 2018.
[vi] Nobel Prize. Markets with asymmetric information. The Sveriges Riksbank Prize in Economic Sciences in Memory of Alfred Nobel 2001. Available at https://www.nobelprize.org/nobel_prizes/economic-sciences/laureates/2001/press.html. Accessed July 29, 2018.
[vii] Pinker S. Enlightenment Now: The Case for Reason, Science, Humanism, and Progress. Viking, 2018
[viii] FDA. FDARA Section 710 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. Available at https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/UCM607469.pdf. Accessed July 29, 2018.
[ix] Wang B, If You See Something, Say Something, 24×7 magazine, 21:12-14, Dec 2016. Available at http://www.24x7mag.com/2016/10/see-something-say-something/. Accessed July 29, 2018.