5 ms·

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 blin

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.

newishuser 14y ago
There are certainly ways to simulate fish oil with biologically inert ingredients.
- pmelendez 14y ago
  I think you're missing the point. He was talking about this section of the article: >That way, of course, they can say things in their ads like "[drug name] has a low occurrence of side effects, such as dry mouth, which occurred about as often as they did with placebo." cooldeal point is that you need to mimic the side effects to make the control group believable. Whether it is needed to use inert components or not would depend on the nature of the drug in test.
- kragen 14y ago
  There are? What do you have in mind? If you use mineral oil or Olean, you get diarrhea as a side effect in doses of more than a few grams per day.
pygy_ 14y ago
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.
- Locke1689 14y ago
  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).
  - DigitalJack 14y ago
    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.
    - Locke1689 14y ago
      The "placebo" mostly is the current standard of care in many cases.
  - starpilot 14y ago
    There are no ethical issues. 1. Study participants are told that some of them will receive a "sham" (placebo) treatment. Participation is voluntary. 2. It is not known whether the drug they are testing is effective or comparable to the current standard of care. Determining that is the purpose of the study.
    - refurb 14y ago
      This is not correct and not currently accepted policy by the FDA. Take oncology drugs for example. Let's say you come up with a great new drug to treat Non-Hodgkin's lymphoma (NHL). Currently approved drugs already are very effective, pushing overall survival to close to a decade. If you're a drug company, there is zero chance you'd get approved (by the independent IRB board who monitor ethical considerations) to run an NHL trial using a placebo. Even if patients agreed to take part in the trial, it would be unethical to deny effective treatments for a potentially fatal disease. Hence, the FDA has softer data and efficacy requirements for oncology therapies. There is no requirement for a placebo arm unless there is no currently effective treatment available.
pleiotrope 14y ago
I think you're correct. The example given in the linked article mentions dry mouth, but it's arguably important in double-blind studies to have both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group. I don't think it's entirely due to nefarious motives from the drug company.
- bestes 14y ago
  True. Just a happy side effect for the advertising in that example. Also, I'm not a huge fan of more regulation, but scientific integrity seems to demand the placebo ingredients be disclosed. From the discussion, it seems clear the doctor-scientists have to think about and carefully consider what to use for the control. A single, simple answer cannot work.
- pbhjpbhj 14y ago
  >both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group // If the physician can effect the trial by knowing to whom they're administering the placebo it seems that the trial lacks in its design. Someone else said that the person administering the drug/control could repeat a test because they felt the result was wrong - why is such a person involved in a drug trial? If they lie about that then it seems they can pervert the trial any number of ways. How do the patients know how the other members of the study are being affected? If they don't get a dry mouth, but the drug company thinks they should, how does the patient know? Surely you need the physicians and patients to record exactly what happened, no more and no less. It seems that you're doomed to fail if you don't know that this is what's happening: suppose you use an active control that dries the mouth (for 95% of patients), if you don't have the side-effect with the drug on test then you know you're part of the active group with a high enough confidence level to alter the results in a qualitatively similar way to using a non-active control (placebo). So what you need is a placebo that matches exactly the profile of the side-effects of the drug. I'd warrant that's impossible - you don't know the side-effects of the drug that are expected in a wide scale longitudinal study because that's what you're testing isn't it? What is entirely nefarious is any use of "no significant side-effects beyond that experienced under placebo" when in fact they don't mean placebo but "active-control". Placebo may be synonymous with active control in Pharma circles but it's not in common usage and so this is still a fraud.
jat850 14y ago
Is it not possible that, via whatever mechanism placebo drugs have positive intended effects, that they could also cause side effects?
- tedunangst 14y ago
  Placebo effect is not a 100% effective substitute for the real deal. If the drug makes you pee more, you could convince yourself of that. If the drug makes your pee turn purple, that'd be harder to achieve just by willing it to happen.
  - warmwaffles 14y ago
    This is a straw man example. Headaches or sinus pressure may be a better way to explain your point.

newishuser 14y ago

There are certainly ways to simulate fish oil with biologically inert ingredients.

pmelendez 14y ago
I think you're missing the point. He was talking about this section of the article: >That way, of course, they can say things in their ads like "[drug name] has a low occurrence of side effects, such as dry mouth, which occurred about as often as they did with placebo." cooldeal point is that you need to mimic the side effects to make the control group believable. Whether it is needed to use inert components or not would depend on the nature of the drug in test.
kragen 14y ago
There are? What do you have in mind? If you use mineral oil or Olean, you get diarrhea as a side effect in doses of more than a few grams per day.

pygy_ 14y ago

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.

Locke1689 14y ago
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).
- DigitalJack 14y ago
  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.
  - Locke1689 14y ago
    The "placebo" mostly is the current standard of care in many cases.
- starpilot 14y ago
  There are no ethical issues. 1. Study participants are told that some of them will receive a "sham" (placebo) treatment. Participation is voluntary. 2. It is not known whether the drug they are testing is effective or comparable to the current standard of care. Determining that is the purpose of the study.
  - refurb 14y ago
    This is not correct and not currently accepted policy by the FDA. Take oncology drugs for example. Let's say you come up with a great new drug to treat Non-Hodgkin's lymphoma (NHL). Currently approved drugs already are very effective, pushing overall survival to close to a decade. If you're a drug company, there is zero chance you'd get approved (by the independent IRB board who monitor ethical considerations) to run an NHL trial using a placebo. Even if patients agreed to take part in the trial, it would be unethical to deny effective treatments for a potentially fatal disease. Hence, the FDA has softer data and efficacy requirements for oncology therapies. There is no requirement for a placebo arm unless there is no currently effective treatment available.

pleiotrope 14y ago

I think you're correct. The example given in the linked article mentions dry mouth, but it's arguably important in double-blind studies to have both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group. I don't think it's entirely due to nefarious motives from the drug company.

bestes 14y ago
True. Just a happy side effect for the advertising in that example. Also, I'm not a huge fan of more regulation, but scientific integrity seems to demand the placebo ingredients be disclosed. From the discussion, it seems clear the doctor-scientists have to think about and carefully consider what to use for the control. A single, simple answer cannot work.
pbhjpbhj 14y ago
>both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group // If the physician can effect the trial by knowing to whom they're administering the placebo it seems that the trial lacks in its design. Someone else said that the person administering the drug/control could repeat a test because they felt the result was wrong - why is such a person involved in a drug trial? If they lie about that then it seems they can pervert the trial any number of ways. How do the patients know how the other members of the study are being affected? If they don't get a dry mouth, but the drug company thinks they should, how does the patient know? Surely you need the physicians and patients to record exactly what happened, no more and no less. It seems that you're doomed to fail if you don't know that this is what's happening: suppose you use an active control that dries the mouth (for 95% of patients), if you don't have the side-effect with the drug on test then you know you're part of the active group with a high enough confidence level to alter the results in a qualitatively similar way to using a non-active control (placebo). So what you need is a placebo that matches exactly the profile of the side-effects of the drug. I'd warrant that's impossible - you don't know the side-effects of the drug that are expected in a wide scale longitudinal study because that's what you're testing isn't it? What is entirely nefarious is any use of "no significant side-effects beyond that experienced under placebo" when in fact they don't mean placebo but "active-control". Placebo may be synonymous with active control in Pharma circles but it's not in common usage and so this is still a fraud.

jat850 14y ago

Is it not possible that, via whatever mechanism placebo drugs have positive intended effects, that they could also cause side effects?

tedunangst 14y ago
Placebo effect is not a 100% effective substitute for the real deal. If the drug makes you pee more, you could convince yourself of that. If the drug makes your pee turn purple, that'd be harder to achieve just by willing it to happen.
- warmwaffles 14y ago
  This is a straw man example. Headaches or sinus pressure may be a better way to explain your point.