HEALTH AND SAFETY

» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing

 

More Information on Repetitive Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation Not Proven Effective

October 1, 2009

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.

Read Lurie’s full congressional testimony on the ways the FDA needs to improve its medical device approval processes.

Copyright © 2014 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.