Read the full letter published in Biological Psychiatry (available to subscribers of Biological Psychiatry)
Read our response to a response to our letter (available to subscribers of Biological Psychiatry)
The letter responds to an article describing the clinical trial that served as the basis for approval of the device in October 2008. That article concluded that TMS, which is made by Neuronetics, is “safe and effective in the treatment of major depression.”
“This conclusion,” wrote Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, and Eunice Yu, a researcher at Public Citizen, “has the potential to mislead readers.”
The letter identifies a series of problems in the original article. These include that the study did not statistically show a reduction in the main measure of depression; statistical significance was achieved only after the exclusion of six patients. Moreover, the authors reported only about half of the 26 so-called secondary measures. Measures written about in the article were 3.3 times as likely to be favorable to the device as those omitted from the article.
“The availability of this product creates the real possibility that patients may be diverted from effective drugs to this ineffective product at significant cost to their health,” Lurie said.
On June 18, Lurie testified before the House of Representatives’ Subcommittee on Health of the Committee on Energy and Commerce on his concerns about this ineffective device and his opposition to its approval. He also spoke more generally about problems with the Food and Drug Administration’s (FDA) medical device approval process.