I think one aspect to acknowledge about this space of research is that the research itself is attempting to help cure or treat a disease or condition that has not been thoroughly examined. There may be treatments for a particular disease that can help manage the symptoms but does not outright cure the condition. The first batch of people that are taking these "experimental" treatments are placed in positions of life where they have no other option due to the severity of their condition and what treatments and therapeutics are available on the market. The first "real" round of patients may be in a somewhat hopeless circumstance where they might pass away if absolutely no treatment is given and whatever is on the market is not sufficient for their particular condition, therefore, they are more inclined to partake in the treatment as it allows them to have at least a chance to fight their disease rather than suffering through it without any action taken to help them. I personally think that as long as the patient is fully briefed on the circumstances of the trial then there is no problem, however, these situations can be tricky as the patient may not be able to stop treatment in the middle of the trial. In every experiment conducted that has human subjects, they must be freely allowed to leave the experiment at any point in time regardless of circumstance. In this type of space if a patient is undergoing a treatment, they may not be able to opt out of it mid treatment as it could be life threatening. But as I mentioned earlier, as long as these parameters have been thoroughly explained then I see no problem. With 'experimental' treatments as this, I believe that it is the researchers responsibility to be meticulous and thorough with the debriefing of the subjects. Perhaps they should be held to a higher standard of informed consent compared to other less dangerous studies.

This is an interesting discussion topic, while I do believe that more studies on withdrawal and negative side effects should be completed, I don't agree with ag2265 when they state that the first real round of patients could be in a hopeless situation or even pass away. I believe that the regulations of this would be for pre clinical studies (on other animals) to have enough data to prove that clinical studies on actual humans would not cause significant injury or harm. I think that if the customers are being fully informed about the product and it's possible harmful side effects, this is following the regulations. I do agree however that additional thorough research should be conducted for devices that can cause long term harmful effects such as withdrawal, this is a regular practice that medical device companies follow because they also want an effective device with minimal legal issues.  

I am slightly confused on the question being posed. My confusion lies in your definition of "first round of 'real' patients" to be using the new drug or device. When saying first round of real patients does that mean the human test subjects during clinical trials or does that mean the first customers once the drug or device hits the market? The answer to this question determines my answer to your question, but I will answer both situations anyway. 

If the "first 'real' patients" refer to the first set of human test subjects during clinical trials then I think a withdrawal study during clinical trials would be extremely beneficial. This would present as much valuable information, which is highly needed for a new drug or device that has little to no available data prior to entering the market. Withdrawal studies would be most beneficial for drug or devices that are not meant to be taken for the rest of a person's life. So to see how a human subject would react when that drug or device is taken away would be the only way to address any withdrawal issue seen in the market.

On the other hand, if the "first 'real' patients" refers to the first set of customers on the markets, then I don't believe a withdrawal study is necessary. Like the prior post states, if a new drug or device is currently in the market and the customers are made aware of all potential risks then the product has sufficiently done its job. Although the more information to the customer the better, if there is little risk of a patient experiencing withdrawal then this should not be a concern of a customer. 

I assume your question references the first round of commercial patients that the drug or device reaches. These people are indeed in a unique position; at this point, if things have been done correctly, the company selling this product has done all their due diligence. If there are any problems not picked up during the clinical trial, it's entirely plausible that the company will not be found guilty if a lawsuit occurs. Depending on the severity of the condition that the drug is treating, patients may choose to take it or not. This is the reason transparency laws are in place for new products like these, and all products. All drug ads we see on TV have a minute of someone speed-reading a laundry list of side effects. As long as the consumer is properly informed, they should be able to take whatever they need to help their ailments.

I think it's important to mention that the efficacy and safety of a drug that has recently completed clinical trials has been supported, not proven by the FDA. That being said, you do get a comprehensive profile of drug efficacy tempered by warning signs that the drug may not be acting in a way beneficial to your biology or not working at all.

As far as the withdrawal phase of a drug is concerned, there is a substantial portion of a clinical trial design dedicated to follow-up criteria and exit criteria for a new drug. The data should be found in the manuscript that summarizes the clinical trial results. Later timepoints may be part of a metanalysis or wrapped up in a separate study. In my opinion, this is the biggest risk to a newer FDA approved drug.