3 ms·

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

by 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.
BHSPitMonkey 14y ago
Perhaps the real problem the article should hone in on is that drug companies are (allegedly?) permitted to compare side effect rates to that of the "placebos", when the public will undoubtedly not be aware that the placebos used were manufactured to provide those same side effects.
cowsandmilk 14y ago
incidence of side effects can frequently be judged by comparing to incidence rates in the general population. This is indeed how Phase I trials are done to gauge the safety of the molecule and decide what side effects need to be emulated by the placebo in later clinical trials.

by pygy_ 14y ago

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.

BHSPitMonkey 14y ago

Perhaps the real problem the article should hone in on is that drug companies are (allegedly?) permitted to compare side effect rates to that of the "placebos", when the public will undoubtedly not be aware that the placebos used were manufactured to provide those same side effects.

cowsandmilk 14y ago

incidence of side effects can frequently be judged by comparing to incidence rates in the general population. This is indeed how Phase I trials are done to gauge the safety of the molecule and decide what side effects need to be emulated by the placebo in later clinical trials.