What if I told you a company found the cure to the common cold, but it only works 50% of the time? What if a clinical trial (all stages) was performed and the drug outperformed the placebo? Now, what if it was determined that the pill itself WAS a placebo? There were no adverse effects to this "drug" and half of all patients tested saw a noticeably quick recovery time from the common cold. Would it be acceptable to put it out into the market?
Clinical Trials (in all of the different stages) require a lot of data to display two aspects of the drug: safety and efficacy. If the "drug" has no adverse effects and the data displays positive symptom relief, then it would be acceptable to put it out on the market EVEN if this drug is a placebo. Based on the prompt above, to put the drug out into the market the drug would have to gain approval from the FDA. If the drug DOES gain approval, then the clinical trials must have adequately shown the safety and efficacy of the drug through pharmacokinetics and pharmacodynamics. To simplify my statement, any drug that the FDA approves is allowed to be put into the market. However, it is much much harder to gain approval than the prompt makes it seem, especially when dealing with a placebo product.
The scenario you describe raises several important ethical and regulatory considerations.
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Efficacy: If a drug is found to cure the common cold only 50% of the time but performs better than a placebo in clinical trials, it may still be considered effective to some extent. However, the level of efficacy and the clinical significance of this improvement are critical factors to consider.
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Placebo: If the "drug" is essentially a placebo with no active ingredients and yet shows improved recovery times compared to a control group, this could be due to a placebo effect, where patients experience improvements because they believe they are receiving treatment.
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Ethical Considerations: The use of placebos in clinical trials is subject to strict ethical standards, and their use is generally limited when effective treatments exist. If there are known treatments for the common cold that are more effective, it might not be ethical to introduce a placebo drug to the market, as patients may be better served by existing treatments.
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Regulatory Approval: Regulatory agencies like the FDA (in the United States) typically require drugs to demonstrate safety and efficacy before they can be approved for the market. The fact that the "drug" is a placebo may raise regulatory concerns, as it does not have an active ingredient to provide the intended therapeutic effect.
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Informed Consent: Patients have a right to know what they are receiving in a clinical trial. If they are being given a placebo, this should be clearly communicated, and informed consent is necessary.
In summary, whether it would be acceptable to put such a placebo on the market would depend on various factors, including the level of efficacy, ethical considerations, regulatory requirements, and the presence of other effective treatments for the common cold. Introducing a placebo as a treatment in cases where more effective treatments are available could be ethically problematic and may not meet regulatory standards.
Placebo pills work because the person taking its expects that pill to work and it works(sometimes) because of the power of the mind. For instance, stress has been shown to increase blood pressure which can lead to a risk factor such as heart disease so the state of the mind can be controlled so that the patient feels more calm which in turn contributes to the cure effects it has. If a company were to ever advertise and sell this product, it will definitly receive a lot backlash from the market. People would agree its just another scheme from the medical industry that is made to deceive people even though it may help with someone's symptoms. Or it may have some unwanted side effects known as the nocebo effect where negative effects can be triggered if the patient is also informed about the negative effects of the drug. Advertising something like this does not seem possible to me especially with the negative views that people have about medicine.
@atk27njit-edu I would disagree that the placebo effect is “all in the mind.” While the placebo effect does rely on expectation, it’s not simply a mental trick played by the mind. This is rather a real phenomenon that is exploited to impact and improve health outcomes like reduced pain. Also, there is ethical advertising that would not spark backlash from consumers regarding placebo treatments. If a company advertises a placebo treatment with full transparency, it could avoid the backlash you mentioned. There is evidence that placebos still take in effect even when people know they are taking a placebo, as long as its presented positively. Also, along with this, placebos are already used in clinical trials! Many people also use over the counter treatments with questionable active ingredients simply because they feel better using them. With the right intentions, placebos can be used as a very valuable tool in treating people.
This is an interesting prompt. I seriously question if this product will be able to be brought to market. One of the requirements of a product is that it must solve a problem and is effective. In this case, it technically is effective and does solve the problem. However, it cannot be marketed as a cure for the common cold, because that is not true. At that token, can orange flavored powered with Vitamin C that is mixed with water to make a fizzy beverage be brought to market because it "helps" people with the common cold? Now, in the case of the the fizzy drink, it cannot be marketed as such (see Airborne effervescent tablets and other related products lawsuit). I think the question of acceptability is not the most important for this hypothetical product. Rather, it is whether it will be marketed accurately, not face legal struggles, and if it will be used by the public.
This is a very interesting prompt to start with. However, I do not think the drug, if it is truely a placebo, will be approved by the FDA. It will involve ethic issues since most of the clinical trials, if effective treatments exist and are available, the use of placebo drug is generally very limited and controlled strictly. But at the end of the day, I do not see any reason why they would allow any kind of drug, aka chemicals, into the body just for "placebo effect". Also, it is hard for any drug to come to clinical phase without showing real effect on molecular level prior to the clinical trial, so I think it is pretty impossible.
From my understanding, if a study is properly designed with an actual placebo control group and a treatment group, and the treatment provided to the treatment group was also a placebo drug it should be pretty much impossible for that group to outperform the actual placebo control group. With a small number of subjects, it is possible to randomly have one placebo group out perform another. But with sufficiently large samples in each group and the same spread of demographics across groups, if both groups are receiving a placebo treatment the only effect should be the placebo effect. Because of this neither group should out perform the other.
