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Are Placebos Really Sugar Pills?

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Re: Are Placebos Really Sugar Pills?

#61

Post by ahoyhere »

tptacek wrote: post #55
ahoyhere wrote: post #51

Earlier quoted context omitted.

> But the blog post says "Hey! Drug companies are trying to pull a fast on all of you!…" Actually what it says is that placebo ingredients should be documented in studies, and regulated by the FDA. Why is that such heresy? If placebos are sugar pills, they don't need regulation. If they are designed to cause side effects, they are drugs . And that will skew the results of the drug tests, too, and as he describes in t…

That's not all the blog post says. Your implicit summary is inaccurate. The blog overtly implies that drug companies use active placebos to minimize advertised side effects, and later suggests that active placebos be outlawed. In fact, active placebos are a requirement for drug trials, because without them, the trial can't be effectively blinded.

He doesn't simply call for active placebos to be outlawed. He lists several problems with the current system and then says:

FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use.

That's like saying "The US Govt either needs to outlaw medicines OR rigorously define acceptable conditions for their use." Which is not a statement most reasonable people would disagree with… hence the FDA. Everybody would obviously choose the second measure. It's a classic persuasion technique: give an extreme choice so the other choice will seem more reasonable. It gets attention. Nobody is going to outlaw active placebos.

As for overtly implying drug companies manipulate their results, he had a small handful of examples and one of them is a counter example where the drug company looks to be undermining its own results by using a too-good placebo (olive oil) that made its drug look useless.

Finally he raises the question: If you kick people out of the study when they improve on placebo, are you still actually testing against placebo?

How can you know, if the trials don't document what's in the placebo, and the FDA doesn't regulate it?

Re: Are Placebos Really Sugar Pills?

#62

Post by jff »

jeremyarussell wrote: post #43
abtinf wrote: post #36

Earlier quoted context omitted.

The effects of unblinded doctors can be catastrophic and might not even be discovered. There was one study where a drug was designed to improve motor response in patients with retarded motor skills. The doctors had found a way to determine which patient was receiving which drug. So when it came time for the doctors to measure efficacy of the drug, they would do the motor skills test. If the patient was on the actual…

"The doctors had found a way to determine which patient was receiving which drug." - This implies that they consciously tried to bypass their blindness, physical design of the pill being different would do this sure, but that's not an issue with too much disclosure, that's an issue with people either A) Not doing their job well enough(the pill designers) OR B)Trying to find out which one so they could fudge the resul…

If I were a doctor participating in a study like this, I'd have a really hard time not trying to figure out who had the drug and who didn't. It's a secret; humans love secrets, and a doctor is extremely well-suited to figure this one out.

Re: Are Placebos Really Sugar Pills?

#63

Post by Locke1689 »

pygy_ wrote: post #23
cooldeal wrote: post #3

Aren't the side effects mimicked so that participants won't see the lack of them and then know that they're taking the placebo which will defeat the double blind study? For example, if you're testing fish oil, you wouldn't use a sugar pill since it's easy to know what you're taking by looking at it. You would use something like olive oil.

Indeed. It is well known that SSRIs studies were biased because of this, because SSRIs have a lot of early side effects, which break the blinding. Knowing that you're in the treatment branch increases the placebo effect. That being said, the opacity of the manufacture process is concerning. Studies with active placebos should have a third branch with inert placebos, to assess the incidence of side effects.

That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).

Re: Are Placebos Really Sugar Pills?

#64

Post by alayne »

The blog title is "Are Placebos Really Sugar Pills?". Was "Or Something Worse?" editorialized on? The thrust of the article isn't that placebos are bad, it's that they are inert and not regulated or reported on consistently.

Re: Are Placebos Really Sugar Pills?

#66

Post by theon144 »

peeters wrote: post #56
ahoyhere wrote: post #44

Earlier quoted context omitted.

so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies Did we read the same blog post? The author didn't claim any such thing. In fact, he referenced a study where (if you ascribe intent) it sounds like the drug company was undermining itself by using a placebo that worked better than the drug (the olive oil). His actual conclusion, f…

>> so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies > The author didn't claim any such thing. Actually, the author did claim any such thing: > Active placebos are designed to mimic the side-effects of drugs under study. So for example, if a new drug is known (or thought by the drug company) to produce dry mouth, the drug company…

>might use

I feel like the author just provided an example how the drug companies could be exploiting the fact that they do not have to disclose the information about the placebo, not necessarily accusing them of it - I know I wouldn't think of this immediately (especially sleepy me right now).

It is, I agree, unnecessarily alarmist, but the conclusion is true regardless of whether the drug companies are doing that.

Re: Are Placebos Really Sugar Pills?

#67

Post by tokenadult »

It appears that a lot of participants on Hacker News are interested in the role of placebos in treatment trials. I have some recommendations for background articles on the use of placebos in clinical trials and the pitfalls sometimes encountered in interpreting results from such trials. The articles are all by expert authors who practice frequently writing on this topic for general readers.

August 2009 "The Rise of Placebo Medicine" by Steven Novella, M.D.

http://www.sciencebasedmedicine.org/index.php/the-rise-of-pl...

December 2010 "Placebo Effects without Deception? Well, Not Exactly" by David Gorski, M.D.

http://www.sciencebasedmedicine.org/index.php/placebo-effect...

January 2013 "Is acupuncture as effective as antidepressants? Part 2. Blinding readers who try to get an answer" by James Coyne, Ph.D.

http://www.sciencebasedmedicine.org/index.php/is-acupuncture...

There are many more good articles about placebos and how they are used in clinical trials on the site where these articles come from. The issue the blogger whose post is kindly submitted here seems so upset about is simply an issue of making a placebo (sham) treatment indistinguishable from the treatment under investigation, so that doctors and patients are properly "blinded" during the trial. Another comment already posted here on HN has pointed out that the FDA does oversee what ingredients are put into placebos, whether or not those detailed ingredients are published in a peer-reviewed research study. The blogger's concerns are legitimate, but not proportionate to the actual problem.

Disclosure: I have been a subject of FDA-regulated medical trials. I was very impressed by thoroughness of data collection in those trials, and by my inability to distinguish whether I was receiving placebo or genuine medicine in one of those trials. My oldest son, now a hacker for a start-up, had work experience while in college at a medical device company, and he was impressed that every line of computer code he wrote during his summer job was reviewed line-by-line by FDA computer scientists as part of the review process for the medical device he worked on.

Re: Are Placebos Really Sugar Pills?

#68

Post by tptacek »

ahoyhere wrote: post #61
tptacek wrote: post #55

Earlier quoted context omitted.

That's not all the blog post says. Your implicit summary is inaccurate. The blog overtly implies that drug companies use active placebos to minimize advertised side effects, and later suggests that active placebos be outlawed. In fact, active placebos are a requirement for drug trials, because without them, the trial can't be effectively blinded.

He doesn't simply call for active placebos to be outlawed. He lists several problems with the current system and then says: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That's like saying "The US Govt either needs to outlaw medicines OR rigorously define acceptable conditions for their use." Which is not a statement most rea…

I'm not sure we read the same article. The one I read said, and this is the whole graf:

FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use.

That seems like a profoundly ignorant argument. The article doesn't account for the need to blind studies. Why does it come across as credible to you?

Re: Are Placebos Really Sugar Pills?

#69

Post by DigitalJack »

Locke1689 wrote: post #63
pygy_ wrote: post #23

Earlier quoted context omitted.

Indeed. It is well known that SSRIs studies were biased because of this, because SSRIs have a lot of early side effects, which break the blinding. Knowing that you're in the treatment branch increases the placebo effect. That being said, the opacity of the manufacture process is concerning. Studies with active placebos should have a third branch with inert placebos, to assess the incidence of side effects.

That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).

These issues are already present. You already know that some population of the participants are getting a placebo. You don't know which ones, which possibly dulls the anguish you might feel over it.

I think at best you could say it would amplify already present ethical issues.

Re: Are Placebos Really Sugar Pills?

#70

Post by tptacek »

jeremyarussell wrote: post #43
abtinf wrote: post #36

Earlier quoted context omitted.

The effects of unblinded doctors can be catastrophic and might not even be discovered. There was one study where a drug was designed to improve motor response in patients with retarded motor skills. The doctors had found a way to determine which patient was receiving which drug. So when it came time for the doctors to measure efficacy of the drug, they would do the motor skills test. If the patient was on the actual…

"The doctors had found a way to determine which patient was receiving which drug." - This implies that they consciously tried to bypass their blindness, physical design of the pill being different would do this sure, but that's not an issue with too much disclosure, that's an issue with people either A) Not doing their job well enough(the pill designers) OR B)Trying to find out which one so they could fudge the resul…

Your argument here basically questions the whole idea of blinded studies ("Who cares if doctors will figure out which medication is the placebo?", it suggests; "After all, that only matters if doctors are crooked.")

But you're replying to a comment that lays out a scenario in which 8-9 figure clinical trials were ruined by the incidental outcome of reasonable honest doctors accidentally unblinding studies.

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