WASHINGTON --For about a million Americans, Thursday will be a seminal day. That's when some of them come before the
Food and Drug Administration to petition for approval of a potent and controversial drug, a so-called Lazarus drug.
The drug, first synthesized by Hemispherx Biopharma, Inc., of Philadelphia, in the 1970s, is Rintatolimod (tradename Ampligen), which is used to treat chronic fatigue Syndrome, also known as myalgic encephalomyelitis. It is a grim but little-understood disease of the immune system, resulting in collapse, pain, confusion and sensitivity to light and noise.
Patients and their doctors want the drug, but there is concern that the FDA will fault -- as it has in the past -- the scope of the clinical trials and the documentation of collateral effects.
The FDA is expected to rule early next year.
The sickest of the sufferers, mostly bedridden and some so sick they have to lie in dark rooms for 18 hours a day, are pinning their hopes on a drug that will allow them to rise from their sick beds, thus the Lazarus appellation.
Dr.
Andreas Kogelnik, who runs the
Open Medicine Institute in Mountain View, Calif., puts the chances of FDA approval for Ampligen at just 50 percent. Although he is rooting for the drug to be approved, he says the FDA may require more data on collateral effects. This has happened in the past and the FDA has not been satisfied with previous applications....
When patient activists face the government in various hearings, it is painfully asymmetrical, it seems to me. The sick tell sad stories of suffering, loss of love as well as health, while the government people talk abstractly about patient loads, international disease definitions, allocation of resources and appear self-important rather than appalled at the suffering that passes before them.
The patients turn to the government for recognition, but the government turns them into a statistic.
