I am Nancy Burleson, MD. I am a Board Certified Fellow of the American College of Obstetrics and Gynecology currently practicing in Texas. This website is dedicated to justice for my son, Max Cronin, who committed suicide because of refractive surgery. The site is also dedicated to others who have committed suicide, and to other victims of the refractive surgery industry and the FDA, which continues to "approve" refractive surgery as "safe and effective," despite ample evidence otherwise, and despite corruption in the clinical trials process.
The public knows refractive surgery mostly through its marketing. But what if I told you that the clinical trials, supposedly the scientific basis on which claims of safety and efficacy are made, never investigated safety? What if told you that common consequences of refractive surgery, like dry eyes and visual aberrations, were simply classified as side-effects, in order to reduce the adverse event rate to a level the FDA would approve? What if I told that the FDA continues to maintain that refractive surgery is safe, although the clinical trials data shows no evidence to support this?
After Max's death, I needed to understand how this could possibly happen. I began to look into the history of refractive surgery and the refractive surgery industry more deeply. I discovered an online community called "Lasik Complications Facebook Group" where depressed and suicidal individuals meet online to try to help each other and to discuss the refractive surgery industry. I discovered that these individuals have deep knowledge of the FDA clinical trials on Lasik and other refractive surgeries. I believe that the Food and Drug Administration is captured by industry, and that a federal investigation of the FDA will be required to expose this corruption. I believe that the Ophthalmic Devices Panel that recommended Lasik to the FDA as safe and effective operated unethically, in direct contradiction to the Hippocratic Oath, and that it chose to ignore the importance of "First, do no Harm."
I believe that the Food and Drug Administration's role in approving Lasik as safe should be criminally investigated.
Finally, I believe the members of the Ophthalmic Devices Panel that recommended the approval of Lasik, the FDA, and the refractive industry murdered my son. Refractive surgeries such as Lasik were approved with the explicit purpose of being performed on the majority of nearsighted people in the United States and worldwide. As such, the clinical trials for these surgeries carry an enormous evidentiary and ethical burden. Some medical devices will be used with thousands of people, some with tens of thousands, and some with millions. Lasik was intended for tens of millions. As such, an exceptionally high threshold of safety was required. Having read the clinical trials literature for Lasik, there appears to be no consciousness of the importance of establishing safety. Instead, the Ophthalmic Devices Panel, the FDA, and the refractive surgery industry set into motion a series of causal processes that led to my son's suicide. There have been other suicides, as well. There will be more in the future. These suicides are the direct and logical result of clinical trials research that not only failed to establish safety, but in fact never investigated safety, and covered up evidence supporting lack of safety. The FDA continues to suppress this evidence to this day.
To understand why I make these claims, some background in the purpose and language of clinical trials is required. A clinical trial is a research study intended to establish "safety" and "efficacy." These two are often confused. Efficacy is concerned with the extent to which a medical device performs its purpose. Safety is concerned with unintended results, that is, with "side-effects" and "adverse events." The term "side-effect" is not well defined, and can include effects that are either irrelevant or undesired. The definition of an adverse event, however, is obvious: An adverse event is any event which is adverse, that is, which impacts quality of life. The purpose of a clinical trial, then, is to determine whether unintended events occur that impact quality of life. The frequency and nature of adverse events inform assessments of safety. Understanding the nature of adverse events is particularly important, because it prevents industry from hiding patient suffering by reporting only statistics concerned with the frequencies of events. Behind every adverse event is a human life.
"How do you want the checks made out?"
Before the FDA approves a drug or medical device for use on the public, it is evaluated by a panel of researchers and physicians, who then make a recommendation to the FDA. For refractive surgery, this is the Ophthalmic Devices Panel. The physicians on this panel subscribe to ethical codes that have existed for over 2500 years, long before the Food and Drug Administration came into existence. Foremost among these is the Hippocratic Oath, which states famously that physicians must "First, do no harm." Physicians are required to swear by the Oath that they will uphold its standards. Taking the Oath is a right of passage into the practice of medicine. Medicine is widely considered society's most respected profession, not only because of the Oath, but also because of the dedication of physicians to the general values its supports, which include honesty, courage, dedication, and selfless devotion to healing. The Oath specifically requires not only that adverse events be avoided, it requires that the potential for harm be systematically and empirically investigated: To first do no harm, one must determine what harm is. Failure to first establish scientifically what constitutes harm is intrinsically unethical. There are no exceptions to this rule.
The clinical trials that launched Lasik were conducted in the mid- to late-1990s. When you review this literature, you see no earnest attempts to quantify the risks of Lasik. Quite the reverse, in fact. Instead, you see industry and regulators playing with definitions in order to make refractive surgery APPEAR safe, apparently so that industry could begin making money. Patients that I've met online who are distressed, depressed, or suicidal seem to exhibit three symptoms, either alone or in combination, namely dry eyes, visual aberrations, and less frequently, chronic eye pain. Dry eyes and visual aberrations do not occur at the rate of a few percent in the clinical trials literature. Instead, they occur at rates of between 10 and 20 percent. Patients with whom I have spoken maintain that their surgeons told them that these problems would disappear after six months. The regenerative powers of the human body are truly miraculous, so for some patients, I have no doubt this is true.
But the issue here is not rates. The issue here is what is a lie and what is not. Dry eyes and visual aberrations were not considered adverse events in the clinical trials for Lasik. They were considered side-effects. Contrary to the Hippocratic Oath, their potential as adverse events was never investigated. They were simply declared to be side-effects. Their potential as adverse events was defined out of existence. Many patients I have spoken with experience BOTH, yet their suffering continues to be dismissed, because it is inconvenient for an FDA that has chosen to be dishonest with the public.
The issue here is what is a lie and what is not. The potential of dry eyes and visual aberrations as adverse events was simply defined out of existence in the clinical trials
Yet, it is the explicit purpose of a clinical trial to gather scientific evidence concerning safety. Like a good detective, an honest scientist is required to avoid bias, and to follow any reasonable lead that might affect his or her ultimate conclusions. If researchers are dishonest, and do not follow reasonable leads, the physicians who advise the FDA are required by the Hippocratic Oath to recommend against approval and expose unsafe medical practices. The deliberately conservative standard established by the Oath is intended to elevate its values to a self-conscious standard that becomes part of the conscience of every physician. Had the physicians on the Ophthalmic Devices Panel honored their Oath, my son Max Cronin would be alive right now. Other Lasik patients who committed suicide would be alive. Again, to "First, do no Harm," one must seek to determine what harm is. Only then can adverse events and side-effects be distinguished. As such, the approval of any medical device that fails to investigate the potential of symptoms as adverse events is by definition unethical. This is true whether the symptoms ultimately prove problematic, or not. What is unethical is the failure to investigate. When the Ophthalmic Devices Panel recommended to the FDA that it approve Lasik as "safe" for public consumption, there was no scientific or ethical basis for doing so. This was simply a falsehood, a bold and blatant lie, one that has produced tens of thousands of victims and a number of actual deaths.
Dr. Oz Exposes Lasik
Whenever the potential for adverse events is left uninvestigated, there is the potential for human beings to suffer the consequences. As my son, Max, and other Lasik suicides found out, defining adverse events as side-effects does not make it so. The human body functions according to its own logic. By ignoring the Hippocratic Oath, the members of the Ophthalmic Devices Panel and the FDA regulators involved in approving Lasik and lying about its safety share personal responsibility for the death of my son. They share personal responsibility for other Lasik suicides, be they past, present, or future, as well. I am not alone in this assessment. Thousands of patients who recognize the role of the Ophthalmic Devices Panel and the FDA in creating lifelong miseries of dry eye, visual aberrations, and chronic pain feel exactly the same way. Patients damaged by refractive surgery are not simply unfortunate random events or idiopathic reactions to treatment. Instead, they are the systematic product of bad clinical trials research, unethical physicians who failed to honor their Oath, and a Food and Drug Administration that apparently succumbed to industry pressure by shortcutting its own processes. This led to a massively unethical decision: A surgery was stamped as safe and effective when, in fact, its potential to do harm had never been investigated. My son, Max, was but one victim of this decision. There are tens to hundreds of thousands of others who are living with damaged eyes, damaged vision, and damaged lives. They are the logical product of corruption in medicine and in the FDA.
For whatever reason, the FDA has chosen to continue its lie. Informed consent is fundamental to the practice of medicine. But no patient would ever have Lasik if they were truly informed. And by "truly informed," I am not talking about the rates of dry eyes or visual aberration or even chronic pain. Drawing a bright line around these consequences of Lasik, whatever they might be, is simply a way of diverting attention from the truth. The truth is about corruption in the clinical trials process and its logical and inevitable connection with suicidal ideation and with actual suicides. To be truly informed, patients must be told that the clinical trials for Lasik were a sham.
To be truly informed, patients must be told that the clinical trials for Lasik were a sham.To be truly informed, patients must be told that FDA approval rested upon no solid empirical foundation. What patients need to know, and what medical ethics requires they be told, is that the FDA was complicit in a lie: There was no attempt to establish which symptoms might, in fact, constitute adverse events and which symptoms were side-effects. Tens to hundreds of thousands of damaged patients had Lasik believing the clinical trials methodology through which Lasik was approved to be rigorous and well validated. These patients are the logical outcome of the FDA's reckless disregard for the truth. The FDA's failure to disclose to prospective candidates for Lasik that the clinical trials were fundamentally unsound constitute an ongoing deception of patients by undermining their informed consent. For patients to be informed, the FDA must tell the truth about its clinical trials. The FDA must come clean about its own scientific and ethical misconduct. The families of those patients who have committed suicide deserve nothing less. So do the many thousands of damaged patients who have survived Lasik. They are victims of the FDA, and the logical product of its deception. To be truly informed, patients must be told that "safe and effective" is a sham.
Lasik and Extreme Eye Pain
A criminal investigation of the FDA is morally and responsibly needed. The billion dollar Lasik industry is driven by money and has to date quieted and dismissed the devastation of lives from the "side effects" its refractive surgeries. Efforts to change this harmful elective procedure have, and are, being met with resistance. The potential for big money leads to the promotion of Lasik as safe, while the FDA remains silent. I am making my son's death public in an attempt to make a difference for all the future victims of this industry. I represent all those victims currently struggling with the side effects of Lasik. I believe this elective procedure has been driven by billion dollar profits at the expense of a naive public. I believe the FDA, the Opthalmolgic Devices Panel, and the individual ophthalmologists that promote this procedure for economic gain do not have people's medical well being as their priority. As such, they have harmed and are responsible for murdering my son for monetary gain by their intentional omissions. In a world where physicians, FDA, the Opthalmic Device Panel, and ophthalmologists have the responsibility to ensure elective procedures are safe, they have intentionally put profits over safety. They should be investigated criminally for failure to uphold their trusted positions to keep the public safe.