Skeptophilia (skep-to-fil-i-a) (n.) - the love of logical thought, skepticism, and thinking critically. Being an exploration of the applications of skeptical thinking to the world at large, with periodic excursions into linguistics, music, politics, cryptozoology, and why people keep seeing the face of Jesus on grilled cheese sandwiches.

Wednesday, April 15, 2015

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 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.

1 comment:

  1. I can't understand how so-called intelligent people could think that homeopathy would work. As you said, they're so diluted that there would be none of the active ingredient. I think those that report success are experiencing a placebo effect.