The logistics of placebos
August 10, 2010 7:36 PM   Subscribe

Are there U.S. laws or professional guidelines regarding physicians prescribing placebos to patients, or is there really nothing stopping a doctor from misleading a patient about the efficacy of a drug? Furthermore, is it technically possible that popular medications many of us know by name could themselves be nothing more than placebo pills?

And at the very least, if placebos are being prescribed, wouldn't pharmacists have to be complicit in filling prescriptions they know to be ineffective? The placebo pills have to come from somewhere, right?
posted by iamisaid to Health & Fitness (15 answers total)
 
According to this (possibly out of date) page, the AMA declared it to be a violation of professional ethics to use placebos in everyday practice without telling their patients. Obviously, placebos are an essential part of the clinical trial protocol.

I doubt that any popular medications are placebos. However, it seems entirely likely that there is a placebo effect to many medications--i.e., when you take that aspirin, you feel better, partly because of its analgesic effect, partly because you know it's supposed to make you feel better and your brain tells you it's working.

Because it is not, apparently, proper practice to prescribe placebos in everyday practice, I think your last question may be moot. I doubt you could call a pharmacist complicit in some sort of conspiracy to prescribe placebos. Your prescription bottle must state its contents. If it says "sugar pill" it doesn't do anything. If it is just a low dose of a medication and you think it is not effective, or that you would be better treated with a different medication, talk to your doctor or get a second opinion. You have a right to proper care.

I am not a physician or a medical ethicist. Talk to your doctor if you have concerns.
posted by Admiral Haddock at 7:54 PM on August 10, 2010


here

"Here's the official policy of the American Medical Association:

Use of a placebo without the patient's knowledge may undermine trust, compromise the patient-physician relationship, and result in medical harm to the patient.
A placebo must not be given merely to mollify a difficult patient, because doing so serves the convenience of the physician more than it promotes the patient's welfare.
Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use"

posted by HuronBob at 7:55 PM on August 10, 2010 [1 favorite]


Response by poster: Fortunately I don't have any such concerns...just something that popped into my head. Thanks for the responses and links.

Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use

Seems to me that it ceases to be a placebo at that point.
posted by iamisaid at 8:04 PM on August 10, 2010


All of that being true, I think the practice of prescribing real medications for the purpose of using them as placebos - e.g., a doc writing a scrip for an antibiotic for a cold they know is almost certain to be viral - does exist, although it's unethical.
posted by strangely stunted trees at 8:07 PM on August 10, 2010


About half of the 679 surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis (Tilburt et al, 2008).
posted by dephlogisticated at 8:15 PM on August 10, 2010


Furthermore, is it technically possible that popular medications many of us know by name could themselves be nothing more than placebo pills?

FDA tests for clinical efficacy are rigorous. Drugs that do not provide significant benefit in placebo-controlled studies (in relation to side effects, as compared to other available drugs) do not get approved. That turns out to be the vast majority of compounds that make it to clinical testing.
posted by dephlogisticated at 8:26 PM on August 10, 2010 [1 favorite]


(NB: Related to clinical trials and not general practice.)

Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use

It's all part of Informed Consent. As long as the physician gets the patient to sign something saying they understand they may be getting the real treatment or they may be getting a placebo, they've satisfied this requirement. And the patient won't know which group she is in. Of course, then patients get anxious and start demanding to know which treatment they are receiving, because they aren't actually ok with receiving a placebo.

Another important note: the FDA frowns on placebo-controlled trials, as long as there is a "standard of care" already established. This means that if there is a treatment that has been shown to be more effective than a placebo, it is no longer ethical to give placebos to treat that condition.
posted by dormouse at 8:42 PM on August 10, 2010


"Seems to me that it ceases to be a placebo at that point."

You would be surprised; many people prefer to take a placebo even if they KNOW that it doesn't do anything ... they still placebo-effect themselves into feeling better.

At many pharmacies you can get sugar pills to help kids practice/learn to swallow pills ... many people claim it's an effective headache cure! Sometimes just feeling like you can DO something is helpful.

I've noticed with my 14-month-old -- it takes about 20 minutes for ibuprofen to take effect with teething pain. When he was younger he'd take the ibuprofen and immediately return to crying from the teething pain ... and about 20 minutes later, he'd stop when the medicine kicked in. Now, however, he stops crying after he takes the ibuprofen. He'll often continue to rub at his cheek and chew on teethers, but he doesn't keep crying ... I swear he's already learned the medicine WILL make him feel better, so he decides it already HAS the minute he's taken it!
posted by Eyebrows McGee at 8:52 PM on August 10, 2010 [1 favorite]


To elaborate on the article dephlogisticated linked to, only 2% of internists and rheumatologists reported using sugar pills. The most common placebos were over-the-counter analgesics (41%) and vitamins (38%).
posted by epj at 9:16 PM on August 10, 2010


My opinion is the placebo effect is alive and well in the medical field, but it's not as insidious and evil as you make it sound. Your post states that placebos are by definition "ineffective", but that implies that there is no placebo effect. Trust me, there is, and it manifests in all sorts of ways. check out the study linked by dephlogisticated and you will see that a placebo is not necessarily a pill that has no chemical mechanism, or a sugar pill. It's more like any pill that you can make work better by the power of suggestion, belief, or hope.

The placebo effect can be as simple as me saying to a patient "I'm going to give you a drug that really seems to work great for headaches/nausea/pain/this kind of symptom." and the fact that I say that makes the medicine work better.

It's not a lie for me to say, because I have certain drugs that I much prefer using and that in my experience, work quite well, but I think the mere fact that I make these statements prior to giving the medication helps them work better. For example, I've noticed many times when nurses give IV medications without telling the patient, they don't notice that they've received a strong narcotic at all. I say "so, how do you feel after all the pain medicine?" and they say "Pain medicine? Oh, I thought she was just flushing out the IV line." I have a strong belief that the patient not being aware they're being treated is an impediment to them feeling better. Mind over matter!

I will admit that I have also heard (rarely) of nurses flushing the IV line with saline and telling patients that they have received pain medication, and this has been effective in relieving pain (this is more like the kind of situation you're referring to), usually after the patient has received multiple doses of IV narcotics but continues to request more and more. This is not something that I ever advocate or suggest, because of the ethical issues, but it does seem to fulfill some people's beliefs that they need IV pain medicine to feel better.

The same principle works both ways - I see people whose minds are making them physically ill on a daily, nay *hourly* basis! (I work in an emergency department). You know that drug commercial about "the pain of depression"? So true.

To answer your other question, it is not possible that prescription medications sold in the United States "are nothing more than placebos" in the sense of being sugar pills. Prescription medications in the USA are regulated by the FDA and must contain the chemicals they say they contain. Herbal medications have no such requirement and may contain all sorts of illicit ingredients that are not on the label. However, it is unfortunately not true that all medications approved by the FDA have been proven in adequate randomized, placebo-controlled trials, though this is the ideal that we strive towards. There are still plenty of treatments in the medical field which are recommended based on "expert consensus" only that may turn out to be simply nonsense when put to a rigorous test in the future.
posted by treehorn+bunny at 9:31 PM on August 10, 2010 [8 favorites]


I will admit that I have also heard (rarely) of nurses flushing the IV line with saline and telling patients that they have received pain medication, and this has been effective in relieving pain (this is more like the kind of situation you're referring to), usually after the patient has received multiple doses of IV narcotics but continues to request more and more. This is not something that I ever advocate or suggest, because of the ethical issues, but it does seem to fulfill some people's beliefs that they need IV pain medicine to feel better.

Perhaps similarly (and more ethically), there is the self-administered narcotic IV - the patient pushes the button, but it only administers a dose every X hours. The patient doesn't know whether that particular push of the button actually does anything. From personal experience, it still made me feel better.
posted by desjardins at 10:05 PM on August 10, 2010


I just read a blog post by an ER doc about this:

http://allbleedingstops.blogspot.com/2008/10/what-exactly-is-placebo-anyway.html
posted by Metasyntactic at 11:21 PM on August 10, 2010 [1 favorite]


As others pointed out, there are professional policies from AMA and such on the matter. There may also be state licensing board requirements. What I am pretty sure does not exist is any kind of federal regulation. Such regulations, if they existed, would come from FRA; however FDA is explcitly not authorized to make laws and rulings prescribing or interrupting the practice of medicine. They can test a drug or medical device and issue a license or prohibit its distribution or sale in US, but if I am a doctor and I have a mind to advise the patient to take that drug, the FDA has no business telling me that I can or cannot do this. Which is why doctors are technically free to prescribe placebos, medical marijuana, snake oil (literal or figurative) and so on.

Some see this as a big states rights vs. federal government issue. Others view it as an idiosyncracy of our patchwork regulatory system. Mostly, people are just unaware that FDA oversight stops at drug/device/biological distribution point and does not enter the doctor's office.
posted by blindcarboncopy at 12:24 AM on August 11, 2010


there are professional policies from AMA and such on the matter. There may also be state licensing board requirements. What I am pretty sure does not exist is any kind of federal regulation.

I really have to think that giving a patient a placebo while stating or implying that it is an efficacious treatment would fall under standard fraud statutes. And open the physician up to enormous civil judgments if anything goes wrong, since "do nothing but lie to the patient about it" is not the standard of care for pretty much any medical condition.
posted by ROU_Xenophobe at 6:16 AM on August 11, 2010


Any time I get a prescription filled, it comes from the pharmacist with a drug information sheet listing all kinds of data about the drug - pharmacology, side-effects, etc. If a doctor was to prescribe a placebo, they'd need to be sure that the patient would never read or comprehend that drug info sheet. That seems like rather a gamble.
posted by tdismukes at 7:00 AM on August 11, 2010


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