Deconstructing Maxamine

The Oncologic Drugs Advisory Committee's (ODAC) recommendation that FDA turn down Maxim Pharmaceuticals Inc.'s application to market Maxamine histamine immune stimulant demonstrates the risks posed by failing to follow FDA's advice on trial design.

According to FDA documents, the company declined to accept a number of the agency's recommendations and did not heed warnings from senior FDA officials that its clinical trial plan might not provide data to support approval. As a result of these disagreements, the company and FDA ended up producing analyses of the trial results so disparate that it is impossible even to guess whether the product has any efficacy. ...