I am not particularly disturbed by this ruling depending upon just what claims are being made. If it is clear the claim is based on a collection of anecdotes rather than empirical study informing physicians that others have found a drug useful seems fine. I say this as one who regularly takes a drug for off label use. It is a generic drug and has been for a very long time. Thus it costs very little. No one would invest the time and money to conduct a clinical trial for my issue. Yet the drug has dramatically improved my quality of life. Were the FDA to take away my physician's ability to prescribe it for me, I would be quite disappointed.
Joe Joseph J. Horton, Ph. D. Box 3077 Grove City College Grove City, PA 16127 724-458-2004 [email protected] In God we trust. All others must bring data. -----Original Message----- From: Mike Palij [mailto:[email protected]] Sent: Tuesday, January 08, 2013 10:53 AM To: Teaching in the Psychological Sciences (TIPS) Cc: Michael Palij Subject: [tips] Failure of Critical Thinking: When Advertising Trumps "Truth" The journal "Nature Medicine" has a disturbing article on a legal decision concerning whether a Food and Drug Administration (FDA) approved drug can be used or advertised for "off-label" use. The FDA typically requires that a drug company demonstrate evidence that a drug is effective in the treatment of a condition and, if shown to be effective, the drug can then be marketed for treatment of this disease/disorder. However, physicians sometimes (often?) will use a drug shown to be effective for one condition for another condition for which it has not been researched, a practice called "off-label" use. Physicians can take any FDA approved drug and use it in an off-label manner for a condition that they and their patients are willing to treat even though there is no research evidence that such use is effective. It should not come as a big surprise that off-label drug use is a widespread practice among physicians. However, according to the FDA such use is not legal but it usually prosecutes cases where significant marketing is involved.. The FDA will prosecute individuals and companies that promote off-label use of its approved drug, especially in advertising, and this is the heart of our story. Quoting from the article: |In a 2-to-1 decision, the judges stated that banning off-label marketing |violated the representative's freedom of speech. This ruling is a mistake, |as it upholds the freedom of speech of people with a vested interest in |promoting a product without considering the risk this represents for patients. |By opening the door to off-label drug promotion by people with commercial |motivations, the court decision undermines the authority of the FDA and the |process whereby new drugs are approved. Indeed, the dissenting judge, |Judge Debra Ann Livingston, argued that if pharma companies can promote |FDA-approved drugs for nonapproved uses, "they would have little incentive |to seek FDA approval for those uses." In other words, why bother with a |long and expensive clinical trial if one can just market a drug without it? | |The court found that, as long as the information that pharma sales representatives |give to doctors is true, the FDCA cannot curtail their freedom of speech. The |decision therefore changes the burden of proof for prosecution of companies |for misbranding a drug in accordance with the FDCA. It will no longer be |enough to spot off-label marketing to cry foul; instead, it will be necessary to |show that the information presented is false. Here is the critical part: |But, considering that there are essentially no clinical efficacy data for using |Xyrem to treat Caronia's broad list of diseases, the ruling did not seem to |take into account whether his statements were true or not. For the purpose |of the decision, they seem to have been considered as true enough. http://www.nature.com/nm/journal/v19/n1/full/nm.3061.html?WT.ec_id=NM-201301 The original case involved a physician's treatment of several conditions (e.g., fibromyalgia, chronic pain, Parkinson's disease) with the drug Xyrem (a drug FDA approved to treat catalepsy and narcolepsy; it is also known as GHB and has been used as a date-rape drug). The judges essentially said that banning off-label marketing of a drug was a violation of a person's freedom of speech. The issue is whether any claim that the drug is effective for conditions that it was not originally FDA tested for, should be considered a "true" statement because there is no evidence that it is an appropriate treatment for the condition. Yet it appears that the judges did not appreciate this point and/or considered the truthfulness of the statement as not as important as a person or drug company's "right" to claim that the drug can be used for almost any condition. Something to think about. -Mike Palij New York University [email protected] --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13276.cca437dfff11995edc035566eabec9a7&n=T&l=tips&o=22757 or send a blank email to leave-22757-13276.cca437dfff11995edc035566eabec...@fsulist.frostburg.edu --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13090.68da6e6e5325aa33287ff385b70df5d5&n=T&l=tips&o=22760 or send a blank email to leave-22760-13090.68da6e6e5325aa33287ff385b70df...@fsulist.frostburg.edu
