Red Tape Prompts FDA to Outlaw Life-Saving Drug

By National Center for Public Pol... | July 7, 2008 | 8:21 PM EDT

(Editor's Note: The following is the 36th of 100 stories regarding government regulation from the book Shattered Dreams, written by the National Center for Public Policy Research. will publish an additional story each day.)

Matthew Edgar could die from allergic reactions related to foods such as soy, yeast, corn, starch, chicken, fruits, fermented foods and certain vegetables. Unfortunately, the government outlaws the one treatment that could possibly cure his potentially deadly allergies.

Edgar first experienced the full effects of his allergies at 13 years of age. One day, Edgar suddenly could not walk because of severe vertigo. Around the same time, he was hit with pneumonia that evolved into bronchitis and severely restricted his breathing. A doctor concluded that allergies related to certain foods and various environmental factors were the cause. His doctor prescribed a severe diet change for Edgar and altered his living conditions to help Edgar avoid future catastrophic allergic reactions.

Within weeks of eliminating these allergens from his diet, Edgar was walking again and had returned to a semi-normal life. But his life would be forever changed. Since his doctor was fearful of reactions to certain foods, Edgar could not eat a wide variety of foods people typically take for granted. Edgar's allergies also forced his family to rip out the carpet in his room and install tile because light mold was growing in the carpet. In short, life for Edgar was better - but still rough - because of his severe allergies. Enzyme Potentiated Desensitization (EPD) could relieve Edgar's allergy problems.

EPD is administered via skin injection and can alleviate problems associated with allergies. It has been available in New Zealand, the United Kingdom, Canada and Mexico for approximately 30 years and was available in the United States for approximately the last decade. EPD was initially allowed in the United States on a trial basis, falling under the category of an Investigational Review Board (IRB). The IRB study involved more than 10,000 patients, none of whom suffered severe reactions or deaths associated with the drug used in the treatment. The success rate of people helped by the treatment was over 75 percent, and it worked for Edgar until the government disallowed its use in the United States.

When EPD's initial five-year IRB permit expired in 1998, the British manufacturer neglected to submit to the Food and Drug Administration (FDA) an application for an Investigational New Drug trial. This oversight prevented the extension of U.S. government permission for the treatment. In April 2000, the FDA ruled that no new patients were allowed into the American EPD program. In April 2001, the FDA announced that no patients could receive the treatment at all. Edgar criticizes the FDA for preventing this potentially life-altering treatment based solely on bureaucratic red tape instead of factors such as safety and succ ess. Edgar said: "The doctor knows what is right for a patient - the FDA does not."

Sources: Matthew Edgar, Nickie Dumke
Copyright 2003, National Center for Public Policy Research