I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families. Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.
Our Center has expertise in evaluating the safety and effectiveness of medical products, and specifically treatments for depression. In addition to my graduate degree in public health from Columbia University, I have experience working with substance abusers in harm reduction and drug prevention programs.
I am here today to express our support for the FDA’s position that the available scientific evidence does not support reclassifying Cranial Electrotherapy Stimulators or CES. The Class III designation for CES for the indications of insomnia, depression or anxiety is warranted.
The studies that have been conducted on CES have conflicting results, with the more rigorous studies generally showing no advantage over placebo.
- Overall, the studies are marred by small sample sizes and inconsistencies that make them inappropriate to combine in meta analysis or to compare.
- Only 5 out of the 39 studies used DSM criteria to diagnose depression, anxiety or insomnia, which is a major failure of these studies.
- The studies fail to establish which patients with what kind of mental disorder or what kind of substance abuse are most likely to benefit in what way.
- The studies fail to establish the appropriate dose or even the appropriate placement of electrodes.
- What the available evidence does establish is that in studies where there was a control group, the placebo was often as effective as the treatment. The good news for those in the placebo arm is that they got some relief from their symptoms without the risk of seizure and without experiencing side effects like blurred vision, headaches or skin irritation. Although having substantial benefits from placebo is not unusual in studies of depression, that is not a justification for considering CES effective.
I am particularly disturbed by the lack of rigor in the studies on adult substance abuse patients. As the FDA correctly points out, “there are… differences in situational depression, anxiety, or insomnia related to chemical withdrawal versus these conditions as underlying clinical diagnoses.”
Given the limited success of evidence-based substance abuse treatment and the high rate of relapse, the last thing substance abuse patients need are devices that make promises they can’t deliver on, and which have risks that outweigh the rare and rarely statistically significant benefits. And, that would be a concern for patients with depression as well. If a patient has already failed in attempting treatment with medication, it will contribute to feelings of hopelessness to also fail using CES, especially since most patients would consider electrical stimulation of the brain as a more radical treatment.
All of us share the desire to have more treatment options for patients. But the FDA is not supposed to allow snake oil on the market. We do patients no favors by allowing the sale of medical products whose effectiveness is questionable, especially when more effective treatments are available. And, even more problematic, when the product has risks such as seizures, blurred vision, and adverse effects from electrical stimulation of the brain.
In conclusion, it is not possible to conclude that CES provides a meaningful improvement compared to placebo for insomnia, depression, or anxiety. Perhaps some patients would benefit in some way, but the scientific evidence does not adequately define a clinically accepted target population for whom the benefits of CES outweigh the risks in the treatment of insomnia, depression, or anxiety. Since available valid scientific evidence does not demonstrate that CES is effective in treating those symptoms, any risks are unacceptable. And CES clearly has substantial risks.
Under these circumstances, it would be unethical to clear CES for market based on a 510(k) application with controls such as subjective reports from the physicians who are paid for treatment and to patients who are clearly vulnerable to placebo effects. What is needed is scientific evidence that CES is more effective than placebo, and that the benefits outweigh the risks. A PMA is needed to establish whether or not that is true. Without solid scientific evidence, it is impossible to conclude that there is a reasonable assurance of effectiveness or the absence of unreasonable risk of illness or injury.
Brandel France de Bravo, MPH and Diana Zuckerman, PhD
UPDATE: The Advisory Committee agreed with us and the majority recommended not to reclassify cranical electrotherapy stimulation for insomnia, depression, and anxiety as a “moderate risk” rather than “high risk” device.