“Right to Try Act”

Interesting. As a stage 4 patient who seems to blowing through therapies left and right and may very soon be applying for the PD-1 EAP, part of me thinks this type of law is long overdue. However, there's some really good points about potential safety. There's a reason we have the FDA approval process in the first place, frustrating as it may be. I agree that it's your body and if you want to try an unproven drug, it's your choice, but perhaps phase I is a bit early? Maybe it would be better to have them pass phase II? That way at least more is known about side effects, dosing, and efficacy. 

Other good points- having to potentially pay out of pocket. Even with good insurance, I can't imagine many of them are going to be on board for people trying to get access to drugs outside of clinical trials without the compassionate use or EAP programs. That just sounds iike a legal and financial nightmare for insurance companies- paying for unproven drugs that may kill the patient, I can only imagine the class action suits.  Along those lines- nothing about these laws means the drug companies have to say yes. It all sounds good, but my guess is that the companies are not going to want to open themselves up for all the potential lawsuits and litigation when a drug that early in testing doesn't work or the side effects kill the patient. Red tape and paperwork are not likely to be any better than they are now, and may be even worse. Similarly, they may simply develop a policy of non-access outside of clinical trials until FDA approval, which doesn't help anyone. The law only gives patients the right to ask, not to recieve.

It will be interesting to see how these laws play out, whether or not they are helpful or a hinderance to accessing new therapies. 

Interesting. As a stage 4 patient who seems to blowing through therapies left and right and may very soon be applying for the PD-1 EAP, part of me thinks this type of law is long overdue. However, there's some really good points about potential safety. There's a reason we have the FDA approval process in the first place, frustrating as it may be. I agree that it's your body and if you want to try an unproven drug, it's your choice, but perhaps phase I is a bit early? Maybe it would be better to have them pass phase II? That way at least more is known about side effects, dosing, and efficacy. 

Other good points- having to potentially pay out of pocket. Even with good insurance, I can't imagine many of them are going to be on board for people trying to get access to drugs outside of clinical trials without the compassionate use or EAP programs. That just sounds iike a legal and financial nightmare for insurance companies- paying for unproven drugs that may kill the patient, I can only imagine the class action suits.  Along those lines- nothing about these laws means the drug companies have to say yes. It all sounds good, but my guess is that the companies are not going to want to open themselves up for all the potential lawsuits and litigation when a drug that early in testing doesn't work or the side effects kill the patient. Red tape and paperwork are not likely to be any better than they are now, and may be even worse. Similarly, they may simply develop a policy of non-access outside of clinical trials until FDA approval, which doesn't help anyone. The law only gives patients the right to ask, not to recieve.

It will be interesting to see how these laws play out, whether or not they are helpful or a hinderance to accessing new therapies. 

Interesting. As a stage 4 patient who seems to blowing through therapies left and right and may very soon be applying for the PD-1 EAP, part of me thinks this type of law is long overdue. However, there's some really good points about potential safety. There's a reason we have the FDA approval process in the first place, frustrating as it may be. I agree that it's your body and if you want to try an unproven drug, it's your choice, but perhaps phase I is a bit early? Maybe it would be better to have them pass phase II? That way at least more is known about side effects, dosing, and efficacy. 

Other good points- having to potentially pay out of pocket. Even with good insurance, I can't imagine many of them are going to be on board for people trying to get access to drugs outside of clinical trials without the compassionate use or EAP programs. That just sounds iike a legal and financial nightmare for insurance companies- paying for unproven drugs that may kill the patient, I can only imagine the class action suits.  Along those lines- nothing about these laws means the drug companies have to say yes. It all sounds good, but my guess is that the companies are not going to want to open themselves up for all the potential lawsuits and litigation when a drug that early in testing doesn't work or the side effects kill the patient. Red tape and paperwork are not likely to be any better than they are now, and may be even worse. Similarly, they may simply develop a policy of non-access outside of clinical trials until FDA approval, which doesn't help anyone. The law only gives patients the right to ask, not to recieve.

It will be interesting to see how these laws play out, whether or not they are helpful or a hinderance to accessing new therapies. 

Just a quick addendum: Accessing non-FDA approved drugs is, in part what clinical trials are for. As a patient who has been denied access to every clniical trial I have ever tried to join (at least 3), i am well acquainted with the frustrations associated with them, but that doesn't mean the process is all wrong. Clinical trials are meant to develop better, safer durgs and it is for that reason both inclusion and exclusion criteria exist for them. As I said before, all the law appears to offer is the chance to ask, not a guarantee of success in gaining access, but I do wonder if this will hinder the actual clinical trial process in some ways, with people simply wanting the drug without participation in a trial. This could lead to even longer approval times as it will take longer to fill trial slots, longer to collect the necessary data, etc.  It also puts the onus on the patient, not on researchers and physicians, leaving our country in a state mcuh more like China, where it's up to the consumer to determine whether or not a product will be harmful. Average patients do not have medical degrees to help them understand how a drug works, drug interactions, etc.  

We'll see what happens, but I think there are aspects to this type of law that have not been adequately considered.

Just a quick addendum: Accessing non-FDA approved drugs is, in part what clinical trials are for. As a patient who has been denied access to every clniical trial I have ever tried to join (at least 3), i am well acquainted with the frustrations associated with them, but that doesn't mean the process is all wrong. Clinical trials are meant to develop better, safer durgs and it is for that reason both inclusion and exclusion criteria exist for them. As I said before, all the law appears to offer is the chance to ask, not a guarantee of success in gaining access, but I do wonder if this will hinder the actual clinical trial process in some ways, with people simply wanting the drug without participation in a trial. This could lead to even longer approval times as it will take longer to fill trial slots, longer to collect the necessary data, etc.  It also puts the onus on the patient, not on researchers and physicians, leaving our country in a state mcuh more like China, where it's up to the consumer to determine whether or not a product will be harmful. Average patients do not have medical degrees to help them understand how a drug works, drug interactions, etc.  

We'll see what happens, but I think there are aspects to this type of law that have not been adequately considered.

Just a quick addendum: Accessing non-FDA approved drugs is, in part what clinical trials are for. As a patient who has been denied access to every clniical trial I have ever tried to join (at least 3), i am well acquainted with the frustrations associated with them, but that doesn't mean the process is all wrong. Clinical trials are meant to develop better, safer durgs and it is for that reason both inclusion and exclusion criteria exist for them. As I said before, all the law appears to offer is the chance to ask, not a guarantee of success in gaining access, but I do wonder if this will hinder the actual clinical trial process in some ways, with people simply wanting the drug without participation in a trial. This could lead to even longer approval times as it will take longer to fill trial slots, longer to collect the necessary data, etc.  It also puts the onus on the patient, not on researchers and physicians, leaving our country in a state mcuh more like China, where it's up to the consumer to determine whether or not a product will be harmful. Average patients do not have medical degrees to help them understand how a drug works, drug interactions, etc.  

We'll see what happens, but I think there are aspects to this type of law that have not been adequately considered.