Electromedical Products International Inc. Reclassifies CES Devices

Posted in Regulatory and Compliance by Jamie Hartford on July 14, 2014

Electromedical Products International, Inc., the manufacturer of Alpha-Stim AID and Alpha-Stim M welcomed the announcement in the Federal Register of June 12, 2014 by the Food and Drug Administration (FDA) of the Agency’s intention to reclassify cranial electrotherapy stimulation (CES) devices from a class III to a class II designation in their Dockets No. FDA-2011-N-0504 and FDA 2013-N-0195.

"We welcome the action taken by the FDA, which reflects the overwhelming evidence of absolute safety and effectiveness of CES treatment for anxiety, depression and insomnia," stated Daniel L. Kirsch, Ph.D., F.A.I.S, Chairman of the Board for Electromedical Products International. "This is a battle we have fought with the FDA for the past 22 years, and are pleased that we can now move forward with the proper classification."

It has been the position of Electromedical Products International that such devices never should have been designated as class III, which is reserved for life-sustaining or life-support devices, such as surgical implants. 

In their statement, the FDA announced it was withdrawing the proposed rule and proposed order to call for premarket approval applications (PMA) for CES devices and would be establishing special controls in addition to general controls, but did not specify what those controls would be. According to the FDA statement, the Committee received more than 300 comments to the docket in response to the proposed rule and proposed order, which were "usually in favor of a class II designation." In addition, the FDA received four separate submissions to request a change in the classification of CES from a class III to class II.  This, combined with information submitted at previous hearings was considered, and the agency decided in favor of reclassification.

Dr. Kirsch noted that the reclassification of CES devices to class II will greatly improve health care providers' ability to treat such conditions as anxiety and depression with an effective alternative to drug therapy and open the door to broader insurance compensation.  

Alpha-Stim's CES therapy has been in use since 2005 by the U.S. Army and the Veterans Affairs Medical Centers (VAMC) as treatment for depressive disorders, anxiety disorders, sleep disorders, and both chronic and post traumatic pain. 

"This reclassification is exceptional news for the many military and veteran patients whose war trauma and postwar symptomatology respond exceedingly well to Alpha-Stim therapy," said clinical psychologist and retired Army Reserve COL Kathy Platoni, Psy.D. "CES frequently permits the reduction and/or elimination of mood-altering medications, many of which have the potential to result in dangerous side effects and to impair Service Members in the performance of their duties in the combat theater. My experience, without exception, is that the effectiveness of CES treatment far exceeds the benefits of long-term drug therapy, whether in the wartime theater of operations, during the reintegration process, or in any case, as this applies to mental health treatment in general.”

see source article on surgicalproductsmag.com....

Half of US clinical trials go unpublished

Results are reported more thoroughly in government database than in journals.
by Nicola Jones
03 December 2013

The results of clinical trials are going unpublished as much as half the time, and those that are published omit some key details, a study has found. 

US law requires the results of medical research for drugs approved by the US Food and Drug Administration to be submitted to a database called ClinicalTrials.gov. Results, including adverse effects, have been made public there since 2008. Researchers who do not post results within a year of trial completion risk losing grants and can be fined as much as US$10,000 per day. But the database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.

In an analysis of 600 trials picked at random from the database, Agnes Dechartres, an epidemiologist at Paris Descartes University, and her colleagues have now found that only 50% had made their way into print. “Non-publication is a crucial problem for all stakeholders, from patients to health policy-makers,” says Dechartres. For one thing, she says, failure to publish results in journals breeches the implied contract with patients who participated in the trials. “If results are not [fully] available, we can consider that research wasted,” she says.

Click here to for full article on www.nature.com