Kenny has told us a tragic story about what happened to him when he underwent electroconvulsive shock therapy. I want to thank him so much for sharing his story with us, because it helps us understand why today’s briefing is so important and why what the FDA does regarding ECT matters so much.
I will help explain how FDA handles ECT devices and what you as Congressional staff and caring individuals can do to make sure that what happens to Kenny doesn’t happen to others.
The FDA requires all prescription drugs to be proven safe and effective in clinical trials, but they regulate devices differently. Devices are categorized as low, medium, or high risk.
Here you can see Class I devices, which are low risk. They are not regulated at all, which means the companies can sell them without submitting any information about them to the FDA. Although these devices are simple, such as crutches, they can be harmful if they break while being used. However, the FDA assumes that companies know how to make them and can make them safe.
Here you can see Class II devices, which are medium risk. You can see that there is a wide range of devices, including implants such as hip implants, and also contact lenses as well as contact lens solution.
Almost all of the devices that the FDA regulates are Class II devices. The FDA reviews them through something called the 510(k) pathway, which does not require clinical trials and doesn’t require any proof that the device is safe or effective. These are the devices that were generally on the market in 1976 when the law first required the FDA to regulate medical devices. The Congress basically grandfathered the thousands of devices that were already on the market and then allowed companies to improve them without proving that the new devices were either safe or effective. The companies just needed to convince the FDA that the new devices was “substantially equivalent” to another device already on the market, and that other device wasn’t proven safe or effective either.
And even though the devices aren’t studied in clinical trials before they are sold, the FDA is not allowed to require that they be inspected or require them to be studied after they go on the market. The FDA can only do that if there is evidence that they are unsafe. And, the FDA can’t rescind approval of these 510(k) devices either.
It doesn’t really make sense that devices that are allowed to be sold based on so little evidence aren’t required to be proven safe after they are on the market, but that’s the law.
Class III devices are the 1% of 2% of devices that are the most risky. The law stated that these devices would be implants, life-saving, or life-sustaining, but as you can see from the previous slide, many Class II devices are also implants and also life-saving or life-sustaining.
Experts told FDA for decades that ECT devices were Class III devices – the most risky. And yet the FDA cleared new ECT devices through the 510(k) process as substantially equivalent. This slide shows how “substantial equivalence” is defined by the FDA.
As you heard previously today, the newer ECT devices use a different mechanism of action than the older ECT machines, but FDA said they were substantially equivalent because the risks and benefits were similar. But the truth is, FDA can’t really determine if the risk: benefit ratio is similar when the new ECT machines aren’t tested in clinical trials
Several years ago, Congress told the FDA to obey the law – either require a PMA for ECT devices, or explain why ECT devices should be considered moderate risk – Class II. The FDA did a review of the research that had been done on ECT. While there are many criticisms of that review, and the standards for a “well designed study” were higher than what FDA usually requires, the FDA scientists concluded that compared to “sham ECT”, real ECT was only slightly more effective in the very short term (a few days or weeks) for depression and not at all effective for schizophrenia.
Sham treatment is basically hooking the patient up to the ECT machine but not turning it on. Since the patient has no memory of ECT afterwards, sham treatment is clearly the best comparison to see if ECT really has any benefits and to determine what the side effects are.
FDA scientists also concluded that ECT was no more effective than sham treatment after 30 days, for either depression or schizonphrenia.
The next slide lists the most ECT common side effects — all of these have been clearly established.
Despite the clear evidence that ECT has many risks, some of them very serious, and no clear benefits after a very short period of time, the FDA announced that ECT devices should be considered Class II.
Keep in mind that depression is long-lasting. What is the point of a treatment that has only slight, very short-term benefits and such high risks?
FDA’s excuse for wanting to categorize ECT as Class II is because “we already know a lot about it.” The FDA has used that excuse for other devices as well.
But think of this: even if we knew that all the ECT devices currently being used have benefits that outweigh the risks – and we certainly don’t know that – it still wouldn’t tell us anything about a newly designed ECT machine, made by a new company or even by a company that has made ECT device before. The new ECT devices are just as potentially dangerous as the old ones, and they should be required to be proven safe and effective.
Everyone in this room has the power to do something about this, to convince FDA that ECT devices should remain Class III and should be required to be proven safe and effective before they can be sold.