FDA Ignores Studies of Safe, Non-Pharma Products

The story of Cranial Electrical Stimulation (CES) in North America is a tale of government intrigue. CES technology applies gentle and pleasant-feeling frequencies, using electrodes that are usually attached to the earlobes, to balance neurotransmitters in the brain. Decades ago, one pioneering company for this technology decided to get FDA approval, in order to make claims beyond pain relief. This century old technology, originally known as Electro-sleep, has hundreds of research studies behind it and has been in common use over many decades. Studies show that CES helps with depression, learning disorders, insomnia and even addictions. It has been well proven to be a safe and effective technology, which can readily be used at home. And yet, thirty years after it first entered the market in the US, CES companies continue to have an uphill battle with the FDA. 

Categorized by Risk

 As background, health or medical devices are categorized according to risk. The “risk” is based on what claims are made for the device, how it will be used, and the danger of the device itself. An example of a Class I device, the safest category, would be a tongue depressor. An example of a Class II device would be an electronic instrument such as a TENS microcurrent device. Examples of Class III devices are implanted devices and lasers for surgery on corneas.

510k Application or Pre Market Approval (PMA)

To get approval to market a device in the US, either a 510k application or a Pre-Market Approval (PMA) application is required. The 510k process is the simpler of the two application processes. All a company has to demonstrate is that the device is safe and effective and it is substantially equivalent to other devices already on the market. The PMA process is far more complicated and requires a long and expensive process of scientific and regulatory review to evaluate the safety and effectiveness of a device. For a PMA application, the FDA has determined that requirements of a 510K application, including general (good manufacturing practices) and special controls (requiring a doctor’s prescription) are not enough. The process is arduous, and the rules are stringent. A PMA must provide a greater burden of proof of the scientific merit of the device. If a device can’t meet the expectations of the FDA, then it is considered adulterated and cannot be marketed. This doesn’t indicate there is a real safety or efficacy risk - it can simply mean the FDA doesn’t like it.

The FDA and CES Devices

 Politics, not science, dictated from the beginning that CES devices be classed as a Class III device with special controls - meaning the device can only be sold with a doctor’s prescription. Since CES devices were substantially equivalent to other devices already on the market, only a 510k application was needed at that time instead of the more rigorous PMA. Despite assurances of safety from the FDA’s own review panels, the agency has maintained a bias towards the technology. For thirty years, CES companies have been continually bullied by the FDA. Harassment has ranged from delaying shipments, to mixing up paperwork, physical harassment by officials and generally causing both a costly and emotional experience for the companies involved.

Despite the harassment, the companies have persisted to try and get CES reclassified to a Class II device, which would allow it to be sold directly to the consumer, without a doctor’s prescription. All of the safety and scientific data supports a Class II designation. China and European governments have given Class II status to CES devices. This means these governments, after reviewing the same documentation as the FDA, consider the technology so safe it can be sold directly to the consumer. Over the years, however, the FDA has continually rejected reclassification – that is until recently.

From 2009 to 2013, the FDA required all manufacturers of CES devices to resubmit all known research and safety data. The FDA indicated it would review the resulting 275 pages of research and clinical data to finally determine if CES should be reclassified to Class II, or even to Class I. In 2011, the FDA published a new (and shocking) rule that all CES devices, including those already on the market, had to go through the PMA application process. Despite the 30 years of evidence of safety and efficacy, the more strict and expensive PMA process would be necessary. The manufacturer of one CES device has pointed out how unusual this is, as the purpose of the PMA process was to determine safety and efficacy of only new devices. “It is strange, to say the least,” he said, “to put a device through that process when it has already been legally marketed for 30 years.”

In essence, the FDA reset the clock and rewrote history. Manufacturers have to start all over again at a cost of many more millions. A safe and effective non-pharmaceutical therapy is now classified in the same group as implantable devices such as pacemakers, spinal cord stimulators and replacement heart valves.

The FDA justified the need for a PMA application based on some of the following reasons: The FDA cites the theoretical possibility that someone might have a seizure, even though in a hundred years this has never been reported in any study. The FDA has also said there was potential for blurred vision because of placement of electrodes over eyes. This is irrelevant, as no manufacturer in North America has ever had a protocol to place the electrodes over the eyes. It was a practice in Russia that was stopped several decades ago. The FDA further pointed out the theoretical possibility of adverse events from electrically stimulating the brain. Again, in all the studies, over all the years, this has never been an issue.

Basically, the FDA has created potential side effects to make CES appear unsafe while at the same time  ignoring all CES research including those studies that meet their own definition of "scientifically valid." In contrast, the FDA applies a different rule to drugs that are given a “black label warning” despite the fact that very real dangerous side effects occur and which have maimed and killed people. In the end, the FDA panel concluded that the excellent and proven benefits of CES did not outweigh the non-existent risks.

What does this mean for consumers? It means most consumers won’t discover this safe and effective technology as an alternative to drugs because it has to be prescribed by a doctor. Doctors are not trained in non-pharmaceutical technologies, so most physicians don’t even know it exists. It also means much higher prices to consumers as companies must recoup the costs of continually going through expensive, unnecessary, and burdensome bureaucracy. It means some good companies are forced underground. It means new, innovative products are either bullied from the marketplace or don’t even get to the market because of the costs and harassment involved.

To read one company's interactions with the FDA, please read:
http://www.alpha-stim.com/wp-content/uploads/FDA-History-Alpha-Stim-CES-FINAL.pdf

In Summary

Once again the FDA’s actions speak to their bias against low cost, non-pharmaceutical and natural treatments, and the lengths they are able to manipulate the process to treat one group of therapies different than their pharmaceutical counterparts.