Alpha-Stim is a cranial electrotherapy stimulation (CES) device that has been clinically proven to be effective for treating pain, anxiety, insomnia, and depression, with very few or no side effects. It utilizes a microcurrent wave form that stimulates the brain's natural alpha rhythm.
Alpha-Stim can also be applied to various body sites to relieve joint and musculoskeletal pain. It is so safe and effective, that it is available over the counter in Europe, Asia, Australia, Canada and elsewhere. The United States is the only country that requires a prescription.
The justification for Alpha-Stim requiring a prescription is not clear, especially since the device has a very good record of safety and efficacy in the U.S. for over three decades. The Food and Drug Administration (FDA) has investigated it on numerous occasions during this period and have not uncovered anything to dispute this. It has been suggested that pressure from powerful drug manufacturers and others whose profits would be threatened may be responsible for denying greater availability to the public. Official documents and live recordings of FDA proceedings support this opinion.
To provide some background, when the FDA first began to regulate medical devices in 1976, it literally dumped many devices into the highest risk category (Class III), simply because it didn’t have sufficient information to process each application appropriately. The law required the FDA to review and appropriately reclassify those devices temporarily placed in Class III within 36 months. That was 40 years ago and this has still not been done!
Class III designation is for high risk devices like heart valve replacements. Electromedical Products Inc. (the makers of Alpha-Stim) strongly felt that they had more than enough data in over 125 clinical and 2 dozen animal studies to show that a lower risk categorization (Class II) was more appropriate and would make the treatment more readily available.
This led to a long running battle with the FDA, during which there were numerous events that hindered rather then helped to resolve this conflict. For example, Alpha-Stim is used widely within the U.S. military, but in a 2012 FDA meeting, one of the panel members tried to suggest that hardly anyone in the Army was using it. This was based on a conversation he had with a colonel at Walter Reed and allegedly "spent hours" in seeking to find information on the use of Alpha-Stim. In reality, the conversation could only have been for a few minutes, since it was during the break. He was unable to contact Dr. James Kelly, who heads the National Intrepid Center of Excellence (NICoE), who "has not used it." The fact is that at a 2011 NICoE meeting with Dr. Kelly and his senior staff, all were aware of Alpha-Stim, many had prescribed or used it on patients, family members and in a few instances, personally, with satisfactory results. One of these individuals was present at this FDA meeting but was prevented from testifying. In addition, none of the panel members had any personal experience with Alpha-Stim despite the fact that including such an individual was required for the proceedings.
In the first video clip, you can see these spurious comments and then the misinformation being corrected by a qualified Army Colonel with extensive military and personal practice experience with Alpha-Stim therapy.
Video 1 FDA Panel Member Tries to Misinform.
As can be seen, this appears not to have been an objective fact finding meeting, but rather a kangaroo court devoted to rubber stamping approval of a decision that had already been made. In the second video clip Dr. Jeffrey Marksberry discusses some of the Alpha-Stim double blind clinical trials studies currently in progress at Walter Reed (in contrast to the comments made by the FDA panel member) and other leading medical centers. A list of studies is available here.
Video 2 Dr. Jeff Marksberry
This is important, since other CES devices may not adhere to such rigid standards or obtain the same results. In addition, there are numerous copycat electrical stimulation devices that are applied to the skull and elsewhere that are much less expensive and do not require a prescription since they are generally regarded as safe. Although they make similar claims, they have no supportive studies and are not effective. Some describe themselves as CES devices, which is confusing to the public and possibly the FDA. Because they provide no benefit other than a transient placebo response, CES gets a bad reputation and the baby is thrown out with the bathwater.
The FDA's Center for Devices and Radiological Health (CDRH) had been severely criticized by Congressional Committes following a 2008 letter written on behalf of a large group of CDRH scientists and physicians who stated that CDRH managers had “corrupted and interfered with the scientific review of medical devices.” Six employees later sued the FDA, alleging that it had conducted surveillance of their communications without regard to their privacy rights under the law. A 2014 lengthy follow-up Congressional report repeatedly excoriated the FDA for intercepting communications between CDRH employees and members of Congress. In a letter to the FDA, Senator Charles Grassley Chairman of the Committee on the Judiciary, wrote, "It is absolutely unacceptable for the FDA to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies." Senator Grassley and House Oversight Committee Chairman Darrell Issa subsequently accused the FDA of "stonewalling" their investigation into the matter.
There may be some light at the end of the tunnel, since there have been some changes in CDRH leadership and the FDA Commissioner has promised a thorough internal investigation. Others believe that reclassification is more likely to remain in limbo because the Agency is not willing to admit its mistakes and continues to be influenced by powerful drug companies and others whose income is threatened. The Alpha-Stim experience is important since it helps to explain why this and other innovative electrical energy therapies are not more widely available, particularly in the U.S.