Evidence

It is customary for a drug company to sponsor new uses for a drug. That hasn’t happened in the case of phenytoin. This doesn’t make the evidence less evidential. Physicians around the world, with no interest but the scientific and a desire to help others, have reported PHT useful for a wide range of disorders. Published in more than 350 medical journals, the reports and studies have many forms of control:

  1. Double-blind studies with placebo or other drugs as controls.
  2. Studies in which PHT has been found effective when other drugs have failed.
  3. Trials in which PHT is found effective—withdrawn and symptoms return, reinstituted and symptoms disappear.
  4. Promptness of action.
  5. Clinical studies in which improvements are confirmed by laboratory means.

The most important control is the fact that the evidence comes from thousands of impartial observers.  So many independent reports are like strands in a rope, each adding to its strength.

Basic mechanism studies confirm the clinical observations.  They demonstrate that phenytoin corrects inappropriate electrical activity at the level of the single cell—with little or no effect on normal cell function. This fundamental property makes understandable how PHT can have so many uses.

Use of Approved Drugs for Unlabeled Indications

FDA Drug Bulletin, April l982

“The appropriateness of prescribing approved drugs for uses not included in their official labeling is sometimes a cause of confusion among practitioners.

“The Federal Food, Drug and Cosmetic Act does not limit the manner in which a physician may use an approved drug.  Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.  Such ‘unapproved’ or, more precisely, ‘unlabeled’ uses may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.”  (Excerpted: See Appendix for full text.)

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