Editorial by Brent Hanson
With much fanfare the FDA has made an announcement that it will hold hearings on April 24-25 to listen to complaints from the public regarding LASIK eye surgery. While many LASIK patients with bad outcomes hold high hopes that the FDA will ban or restrict this defective medical procedure, a clear understanding of the FDA and its role in "protecting" public health reveals that the FDA does not have the legal authority to ban the procedure, grant approvals to sell or use medical devices, or to even hold public hearings on the safety of LASIK.
The Food and Drug Administration (FDA) was created in 1906 when Congress passed the Food and Drugs Act. This act was the first of a series of laws and amendments that gave the FDA jurisdiction over the regulation of foods and patent medicines. In 1938, Congress granted the FDA new powers to include the regulation of therapeutic and medical devices. However, like so many actions of Congress, the powers given to the FDA completely violated the 10th Amendment to the U.S. Constitution, which states:
The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.
The frequent demands by an aggrieved public for the Federal Government to "do something" to solve a problem, are misdirected due to inadequacies in the public schools with regard to civics education. Under the system of government defined by the U.S. Constitution, the people have been provided the means to regulate, control, or ban defective medical procedures such as LASIK. However, the only governmental bodies which have this authority are the 50 state legislatures, and regulatory agencies to whom the state legislatures have granted powers of regulation.
Given the reality that the FDA does exist, should citizens lobby the FDA with the expectations that the FDA will protect the public from this defective medical procedure? Those who are familiar with the phenomena of deep capture understand that over time, regulatory agencies end up being controlled by the very industries they are supposed to regulate. Thus, it should not come as a surprise to learn that the FDA is now controlled by, and works for the benefit of the LASIK surgeons and laser manufacturers. This is easily illustrated by the following announcement which was released by John Ciccone, the spokesman for the American Society of Cataract and Refractive Surgeons on April 7, 2008, a full two weeks before the FDA's scheduled hearings.
The FDA reaffirms that LASIK is both safe and effective. The Joint LASIK Study Task Force now will examine LASIK'S impact on the quality of patients' daily lives. Simply defined, quality of life refers to a patient's ability to perform the activities of daily living, everything from driving, daily routine, family life, career and sports performance, to personal appearance, after LASIK. While the FDA reports that nearly all patients are satisfied with their procedure, the study will seek to qualify LASIK's benefits and provide greater understanding of the very few patients whose expectations are not met with the procedure, with the goal of identifying ways to enhance patient care.
Clearly, the "fix" is in as John Ciccone would not have issued such a press release, had he not known in advance that the FDA was going to dismiss complaints from LASIK patients in sham hearings.
The FDA's budget in FY 2008 was $869 Million for its Medical Product Safety and Development program and is scheduled to increase to $908 million in FY 2009. In comparison, the cost for privately operated web sites such as USAEyes.us, LasikFraud.com, LasikDisaster.com, LifeAfterLasik.com, and Lasik-Flap.com each run about $15 a month. Private individuals have, and will continue to provide much better protection to the public and with zero cost to taxpayers.
Related Articles