Pharmacies, the FDA, and homeopathy

It seems like mostly what I cover in this blog is bad news.

People believing crazy stuff, bizarre actions people take (or refuse to take) because of their superstitious beliefs, mind-bending cases of illogic.  But today, I want to deliver some good news to anyone who thinks that rationalism and evidence should carry the day:

The FDA is finally moving toward taking a stand on homeopathy.

[image courtesy of the Wikimedia Commons]

Next Monday and Tuesday, April 20 and 21, 2015, from 9 AM to 4 PM Eastern Daylight Time, the FDA has actively solicited input from stakeholders regarding the preparation and sales of the preparations that homeopaths refer to as "remedies" but the rest of us call "water" and "sugar pills."  These stakeholders include, but are not limited to, "consumers, patients, caregivers, health care professionals, patient groups, and industry."  The hearing is to be held at the FDA White Oak Campus in Silver Spring, Maryland, and required preregistration (which unfortunately closed two days ago; I didn't find out about this until yesterday).  However, you can watch a live webcast of the proceedings if you're so inclined (information about how to do this can be found here).

Even if the opportunity to present publicly has passed, you can still voice your opinions to the FDA review board in writing until June 22.  Here are the questions they are trying to resolve:

• What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
• What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
• Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
• Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
• Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
• A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
• Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
• Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

If you are a medical researcher or health care provider, it's crucial to get information to the FDA that would give them leverage to remove these worthless "remedies" from pharmacy shelves.  It's critical, however, that any submissions not be simple rants.  Make them evidence-based, and specific to the questions for which the FDA is seeking information.  Sharon Hill, over at Doubtful News, directs you to frame your responses thusly:

If you are in the medical profession, I HIGHLY RECOMMEND YOU SPEND SOME TIME TO SUBMIT COMMENTS.  If you have pertinent info as an educator, parent, or consumer, your voice is needed also...  You can submit either electronic or written comments to http://www.regulations.gov or Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Organize your comments to identify the specific questions or topic to which they refer and be sure to reference the docket number.

Let me reiterate what I've said before: there is no scientific evidence that homeopathy works, and no logical mechanism by which it could work, given that the dilutions involved result in there being not a single molecule of the original active ingredient left by the time the preparation is sold.  There is no reason these quack cures should be sold in pharmacies, even with any number of disclaimers on the label, given the potential for uninformed or misled consumers to take them rather than seeking out legitimate medical help.

And high time for the FDA to take a stand on this.  Let's make sure that they get the information necessary for it to be the right stand.

Brain on fire

When a new discovery in medical science is made, there's always the danger that gullible and/or hopeful people will misinterpret the results.  The danger is especially high when the discovery has to do with something simple and accessible, such as the find that trans-cranial electrical brain stimulation leads to higher cognitive function.

[image courtesy of the Wikimedia Commons]

A year ago, some researchers at Oxford University found that a painless, non-invasive application of "electrical noise," delivered through electrodes attached to the scalp, improved attention, accuracy, and memory, and that the effect lasted for weeks or months.  The procedure is called TRNS (transcranial random noise stimulation), and shows great promise in helping individuals with cognitive impairment -- and perhaps even us ordinary folks who just want a boost in our thinking ability.

"Performance on both the calculation and rote learning tasks improved over the five days, and the former improvements were maintained until six months after training," study leader Dr. Roy Cohen Kadosh told reporters.  "Research has shown that by delivering electricity to the right part of the brain, we can change the threshold of neurons that transmit information in our brain, and by doing that we can improve cognitive abilities in different types of psychological functions...  Our neuro-imaging results suggested that TRNS increases the efficiency with which stimulated brain areas use their supplies of oxygen and nutrients...  Participants receiving TRNS showed superior long-term performance, compared to sham controls, six months later."

So far, pretty cool.  But of course, when a researcher discovers something like this, it opens the door for the greedy to take advantage of the gullible by creating their own electrical stimulation devices, and claiming that "research shows" that they'll help you to think better.

"A headset for gamers, take charge... Overclock your brain," claims one company that sells home electrical stimulation devices.  Another one states: "Can you learn 20-40% quicker, reduce pain, feel better, increase energy or reduce stress with tDCS?  Research studies say, YES!"

There's even a forum on Reddit devoted to the subject -- complete with claims that TRNS can treat everything from autism to schizophrenia.  Less publicized, though, are the accounts of people who have burned their scalps because of leaving the electrodes on too long, or using a unit that delivers a higher-than-recommended voltage.

Through all of this, there have been some voices calling for reason.  Dr. Hannah Maslin, also of Oxford, published a paper calling for regulation of these devices.  "It is becoming increasingly easy for individuals to buy brain-modulating devices online that promise to make the user’s brain work faster, or more effectively, or more creatively," Maslin writes.  "Such devices can involve passing electrical currents through one’s brain or using electromagnetic fields to penetrate the scalp and skull to make neurons fire.  Yet, when purchased outside clinical settings, these devices are unregulated, with no system in place to ensure their safety.  With the market for enhancement technologies expanding, and with devices already crossing international borders, controlling which products are approved for sale is a global issue, potentially requiring international regulatory harmonization."

Steven Novella, neurologist at Yale University, put it even more bluntly.  "Any device with medical claims that it's meant to affect our biological function should be appropriately regulated.  Regulation is the only thing that creates the motivation to spend the money and take the time to do the proper research."

Of course, I'm expecting that this will bring howls of anger from the alternative-medicine crowd, who get their jollies claiming that the medical establishment is actively trying to keep us all sick so that they can make more money.  The truth, of course, is that regulation is about protecting people from their own ignorance.  TRNS does show great promise in improving memory and cognition -- but putting those devices in the hands of people who don't know how to use them correctly is asking for trouble.

So if you're tempted by the hype, my advice is to put away your credit card and read some of the actual research.  It may be that eventually TRNS units will be available for use for ordinary folks, but right now they're (rightfully) in the hands of the medical researchers.  Heaven knows I'd like to think more clearly; but I'm not going to cave in to that desire and end up burning a hole in my scalp.

Call me a Nervous Nellie, but I'm just going to err on the side of caution in this instance.