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 [email protected].
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].
Binseng Wang
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?
[i] Netflix Original. The Bleeding Edge. Available at https://www.netflix.com/title/80170862. Accessed July 29, 2018.
[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 https://24x7mag.com/2016/10/see-something-say-something/. Accessed July 29, 2018.
I agree with your analysis and, especially, with your recommendations for improving the safety, effectiveness, and economy of medical technology. We need an independent FDA with more resources and we, as clinical engineers and HTM professionals, need to be vigilant. In my forensic engineering work, I see the consequences of weak medical device regulation.
Thanks Binseng for the excellent review. As a 30+ year professional in the medical device regulatory field I am curious to know what is meant by an “Independent FDA”? Does it make and enforce its own laws? Is it accountable to no one? How is it rewarded – by the number of devices it clears or by the number of devices it rejects? Does it see 100% safe and effective as the only objective for device/pharmaceutical clearance? If this independent FDA clears a device that later is found to harm patients, what is the redress of the affected patient, or family of the patient? We need to be, as Binseng so astutely pointed out, critical thinkers, especially when it comes to granting any Government institution “independence” from accountability. Be careful what you ask for; you may get it.
Perhaps I did not express myself clear enough. By “more independent,” I meant “free from political interference.” A good example is the issue of device servicing. After asking the Congress to force FDA to issue a report, MITA said it is unhappy with it and wants Congress to take further actions. Being a rule-of-law country, no one—including the President—is above the law, so FDA must be accountable for its actions too. However, as I said, no one should expect it to be perfect either. FDA must also learn from its own mistakes and take corrective and preventive actions in the continual improvement process we all should adopt. One initiative that FDA is taking is the Case for Quality. Let’s give it a chance to prove whether it will be better than the traditional inspection process. Wayne: since you are clearly more experienced and wiser than me, what is your proposed solution?
Hi Binseng, as usual you provide additional insightful comments. As you know all US Government agencies are inherently political by definition. By way of example, the Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services with more than 14,000 employees and an annual budget of more than $5B. The commissioner is appointed by the president of the United States with the advice and consent of the Senate.I had the opportunity to meet the current Commissioner, Dr. Gottlieb recently at a MITA Board of Directors meeting and I can assure you he is political. So, given that the FDA is inherently political, as are all Government Agencies, your hope/wish that the FDA be free from “political interference” is not possible. I wish I had a good answer for you regarding a proposed solution, all I can say is that we must all collectively become part of the process that is, not what we might like it to be (almost certainly whatever you or I would propose would be objected to by someone else anyway!). Therefore in the absence of the magic bullet that would make the Agency free from politics we must continue to nudge the process, through the political process, toward a more equitable and accountable direction. One way to do this might be eliminating the funding component of the Agency that comes from the OEMs – MDUFA. Thanks for bringing up this topic!
Wayne: What you said about the current FDA Commissioner is exactly what I am worried about. Indeed, most leaders of federal agencies are appointed by the President and, thus, are called “political appointees.” Call me naïve if you wish but I don’t think once appointed these agency leaders need to or should allow the President and other elected officials interfere with the internal processes of their respective agencies. Being “public servants,” their primary duty is to serve the public and fulfill the agency’s mission and not to be subservient to the President or his/her political party. An example of such “independent” agency is the Federal Reserve. Its decisions do not have to be ratified by the President or anyone in the Executive Branch even though its chair is nominated by the President. The Fed is not free from accountability because it is subject to oversight by Congress, with the duty to submit semi-annual reports.
I have been associated with the design and manufacture of CT systems, and other X-Ray both medical and non-medical, for close to 30 years. I can speak from experience that there are considerable safety requirements associated, not only with CT, but with all X-Ray equipment, both medical and non-medical. You may not be aware, but in addition to the 510k submission, X-Ray system manufacturers are required to submit Initial Product Safety Reports and Annual Safety reports under 21CFR Subchapter J, https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081561.pdf which has not been updated since the 1980’s. Technology has far surpassed these regulations prescribed in the 1980’s. In some cases, the requested information seems ludicrous, due to the fact that most all of today’s x-ray technology is digitally controlled and is unconditionally designed to fail safe. Multiple redundancies have to be inherent in the system in order to meet the appropriate consensus standards, results of which have to be included with the 510k. not because of the FDA reporting requirements. Misuse both intended and unintended are thoroughly reviewed during the risk assessment process. As with most active medical devices, the fact is that deliberate overrides by an operator, although identified as “Misuse” can not always be prevented.
Thanks Binseng for your insightful comments. Would love to see your “counter documentary,” one less inclined to spread false impressions of what FDA does or doesn’t achieve–and in fact is even capable of accomplishing!
But I’m concerned at the thought of any agency free from political interference. The 510k program was a badly needed creation imposed by Congress due to industry insistence that reigned in an arrogant FDA, which cares not what it costs or how long it takes to bring new products to market, nor the harm that results from artificially high barriers to entry.
The Federal Reserve and Consumer Financial Protection Bureau are poster children for the case against “independence.” We can thank the Fed for single handedly creating the investment environment that wrecked our economy and led to an unprecedented bailout of bankers gone astray (Wall Street gamblers should have lost all, to teach them a lasting lesson–the Main Street banking system would have survived the resulting carnage just fine). And the CFPB is yet another government agency captured by its biggest customers, the too-big-to-fail banks who shouldn’t be allowed to exist in the first place. It’s taking political pressure in a Republican administration to for some badly needed push back.
Federal agencies are an arm of the executive branch. They are not, nor should they be, a fourth branch of government. Being stocked by progressives (as opposed to liberals or conservatives), they expand, by their very nature, into every reach of the citizenry, and thereby smother individualism and the natural emergence of a healthy economy that Hayek first observed.
Yes, government has an important role to play. Human greed is want to play outside the boundaries. My point is simply that an unfettered FDA is likely to cause more harm than good.
Again, greatly enjoyed your comments. Well done!
Do hospitals really report failed implants that are removed therein? I don’t recall ever seeing such a report.
And the non(or not yet)-removal pain and suffering is dealt with at the doctor’s office, not the hospital.
Here is my take on the film:
https://www.mddionline.com/device-safety-and-regulations-questioned-bleeding-edge
On the subject of “innovation” we must remember that new and different is not the same as good or better. We need to stop automatically celebrating innovations that have not actually been shown to be clinically safe. If there hasn’t been a clinical trial, then we are just guessing. Look for “might” in promotional articles.
Thanks, Professor Hyman, for 3 comments in 3 days! Perhaps I missed something but I did not see any constructive criticism or concrete proposals from you on how to improve the current situation in your comments or in your MDDI article. As a former resident of “Ivory Towers,” I thought teachers should not simply criticize the doers when they fail but also guide them on how to learn from mistakes they made, as well as those made by others.
Thanks to the excellent manual