The FDA condemns you to death.

• Author: Emord, Jonathan W.
• Position: Medicine & Health - Food and Drug Administration - Viewpoint essay

ONE OUT OF EVERY two Americans likely will be stricken with some form of cancer. Food and Drug Administration-approved cancer treatments ordinarily are not curative. Those treatments, consisting principally of radiation and chemotherapy, offer little hope and much misery for the vast majority of cancer patients. The FDA-approved treatments rarely result in longevity greater than if the patient received no treatment at all, yet access to unapproved, experimental treatments depends on FDA allowance. While the FDA allows access to experimental drugs sponsored by favored regulatees (large drug companies with a long history of agency drag approvals), it often denies access to experimental drugs sponsored by innovative companies that lack a cozy relationship with the agency. The FDA's control of access is rife with conflict of interest, bias, arbitrariness, and subjective discrimination. Assuming near Godlike power, the FDA ultimately determines who may have access to unapproved cancer treatments that hold out hope for a cure and who may not.

A brilliant documentary by Nehst Out, "Cut Poison Burn," reveals the desperate and horrible circumstances befalling those who not only must struggle to fight cancer afflicting their loved ones, but a Food and Drug Administration that denies them access to their treatment of choice. The documentary focuses on the Navarro family's battle to save a beautiful young boy, Thomas, from the ravages of glioblastoma (an aggressive brain tumor). As if the torture endured through rounds of chemotherapy and radiation were not enough, the Navarros must contend with an FDA that, in their most urgent hour, denies them access to a promising experimental cancer treatment and consigns Thomas to a horrible death.

Despite its abysmal track record since Pres. Richard Nixon declared war on cancer in 1971, conventional cancer treatment has become very big business. In 2010, cancer care cost the American public an estimated $125,000,000,000, yet, even with expenditures of that enormous size, almost all have died either from the treatments administered or from cancer progression, or both. The ugly truth is that the Federal government has lost the war on cancer, yet compels Americans to purchase the same failed treatments for the disease by locking out promising experimental alternatives.

Federal law allows FDA regulators to possess the power to determine the fate of the terminally ill, yet those regulators have an inherent conflict of interest that influences their decisions. If they leave government service, they will do well financially if they secure positions of employment with major drag companies, but they will limit prospects for such employment if they offend those regulatees by allowing competing innovators to expand treatment uses of experimental cancer drugs. A just government would do everything in its power to ensure that those diagnosed with cancer would be informed of--and encouraged to explore--alternatives, provided they were informed of the potential risks and known benefits of each option as compared to the FDA approved treatment.

Economists schooled in public choice theory regard the FDA as a quintessential example of industry capture (whereby the regulators become servants of the agency's principal regulatees). FDA argues that it paternalistically must police who has access to experimental...