The Right to Try Act, was signed into law May 30, 2018. This law gave patients another way to access treatments that have not been approved yet the patients that are eligible have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a to access certain unapproved treatments. This is a last resort chance for people who have run out of options and I think it was the right thing to do for the government to give this patients an option to try something that could possibly give them a chance to live.
As with many things in medicine and healthcare it looks good on paper. In action is where the ethical dilemmas present themselves. On one side there is a huge opportunity to advance medicine in real time. On the other end there is the potentially for bias to present itself. There could be increased suggestions for right to try in at risk communities. Inequities could exist in a number of other ways. It will be important for there to be close oversight of such activities that provides specific data that represents equitable distribution of the practice.
This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current "compassionate use" framework, but no actual law. This law allows for drugs as early as Phase I to be used. Patients may be charged the direct cost of treatment, but the company cannot make a profit.
Personally I cannot think of any negative issues with this. This law is meant for those who have a life-threatening disease/condition. At this point they would exhaust all possible options, but if there are no current solutions, they should be able to choose to try a potentially life saving drug. It may seem like there may be ethical issues with this, but I believe the current set-up for the law alleviates those worries. Hope is something that these patients deserve, and though these drugs may not save them, at least they can give them some hope.What is your opinion on this? Feel free to add more of your own research.
I think these only benefits patients who don't have long to live. Testing is very important and should not be used if it has not fully been approved and had enough time to reach its full potential. But as you stated if this is their last resort, I would say go for it, if you REALLY REALLY HAVE TO. It is a risky thing all around because you want them to get better if you allow it, but what if it makes their condition worse. While I see the benefits am a little reserved about it.
This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current "compassionate use" framework, but no actual law. This law allows for drugs as early as Phase I to be used. Patients may be charged the direct cost of treatment, but the company cannot make a profit.
Personally I cannot think of any negative issues with this. This law is meant for those who have a life-threatening disease/condition. At this point they would exhaust all possible options, but if there are no current solutions, they should be able to choose to try a potentially life saving drug. It may seem like there may be ethical issues with this, but I believe the current set-up for the law alleviates those worries. Hope is something that these patients deserve, and though these drugs may not save them, at least they can give them some hope.What is your opinion on this? Feel free to add more of your own research.
My opinion on the Right to Try Act is a great opportunity for those who have life threatening diseases and they want to have a fighting chance at life. Many have already been turned away from different treatments because of the diseases and how far processed they are. I do believe it is a patients choice if they would like to try the option as they are giving their informed consent. It is also a positive that the company cannot profit from someone trying to save their lives. As with anything there are ethical issues that can arise from it but I do believe for most part this is a plus for those who deserve hope.
The Right to Try Act gives hope to individuals who have terminally ill diseases. Trying these medications that are in early phases of development is very risky. If some of these medications are successful, I think this is a great opportunity for those suffering to capitalize on. However, since these medications are in their early phases of development, there could be other side effects not known yet and could extend their quantity of life but drastically decrease their quality of life by increasing pain and suffering. One would need to diligently research the medication and similar predicates, if there are any, to determine if participating would be the right decision.
This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current "compassionate use" framework, but no actual law. This law allows for drugs as early as Phase I to be used. Patients may be charged the direct cost of treatment, but the company cannot make a profit.
Personally I cannot think of any negative issues with this. This law is meant for those who have a life-threatening disease/condition. At this point they would exhaust all possible options, but if there are no current solutions, they should be able to choose to try a potentially life saving drug. It may seem like there may be ethical issues with this, but I believe the current set-up for the law alleviates those worries. Hope is something that these patients deserve, and though these drugs may not save them, at least they can give them some hope.What is your opinion on this? Feel free to add more of your own research.
I believe this is great that this law got passed. If the company is not in it for profit the price shouldn't be unnecessarily high and it gives individuals affect by diseases that current treatments aren't work for a chance.
I am very much with the Right to Try act. I personally think that no one should use any medical device or drug without completing the clinical trials fully to understand the effects and side effects of the product on the human body. There is an exception to this statement though: terminally ill patients. These patients have tried every possible method or treatment and have no chance of surviving anymore according to the doctor. This law gives these patients hope and more importantly one more chance of surviving. Moreover, it is also beneficial to the company making the product as they get to see how the drug performs on a live human being without any ethical issues. However, a lot of companies have questioned the extent to which right-to-try laws will actually benefit patients and were against it. There is a possibility of hastening their death or increasing their suffering. Moreover, the pharmaceutical manufacturers would have no obligation to provide the therapies being sought. In the end, I believe it should be the terminally ill patient’s decision on whether to try the product or not.
I believe that their are great positives that come with this Act, but also some negatives. Two factors which should largely be considered at play in this case is the risk severity associated with the treatment, and how severe the patients condition is. In theory this sounds like a promising way to get patients seek living saving treatment which would otherwise not be available. However, this also opens up the possibility of an individual potentially dying from the same method. I think at the very least this should be limited for patients which have no other options and must therefore take the treatment mentioned.
I am in favor of this law because it provides hope and a sense of ownership to those with life threatening issues. If a person is allowed to make the choice of stopping treatment or to move forward with a do-not-resuscitate order, then they should have full control of their treatment options after all possible options have been exhausted. I feel that as long as the patient is in a proper mental state, they should have this option.
I did not know this was a law. I would hope doctors would provide this as an option to their terminally ill patients. This may give their patient a little bit more hope and put them in the proper mental state to heal. While many diseases and conditions are physical, having the right mindset will put them on a path to recovery.
This isn’t something we can rule out and give a definite answer to. Most laws face a problem because they open ways for other possibilities that could hinder other basic morals and laws. Considering the Right to Try Act, this proposed law is for people who are diagnosed with terminally ill or life-threatening conditions. People who volunteer to take the drug are doing it because for them, the pain is worse than the possible outcome of the drug. But please keep in mind that a drug that hasn’t even passed Phases 1 of the FDA has a very low chance of being a lifesaver. It’s not rational to make the claim that these people are dying so we should approve the use of drugs that haven’t passed basic tests.
I understand the approach that this is their choice but making this a law is something more serious than the claim that “they have no other choice” or “ it’s the freedom to choose”. Keep in mind that laws regarding health also run through the ethics committee or some form of ethic regulations. It’s extremely unethical to open a way for patients to use the unapproved medication just because they are dying. The repercussions would outstand the pro’s. This would also set a precedent that leniency on health is accepted in terms of death. Bribery and other criminal activities would also increase because although companies won’t be allowed to profit from the drugs, people would bribe ill people to use the drug and provide feedback.
Thanks!
I have mixed emotions on the implementation of the Right to Try act. On one hand, it sounds like a great idea to present those with life threatening illnesses an opportunity to utilize medications in their early clinical trial phases in hopes of overcoming or mitigating their illness; however, it can also be very dangerous due to the lack of knowledge about side effects, dosages, and other things of that nature. I also read through and agreed with someone else’s post that discussed the potential for bias in at risk communities. It is something that I did not originally think about but made me pull back in my support of the act. Without FDA or state involvement, there is no way to monitor these types of instances, which further raises concerns on the safety of the act. At the end of the day, I think people should be able to make their own decisions about their health but believe they should be given as much information as possible to make an informed decision.
After doing some research, I haven't found any discrepancies in the Right to Try act. I think one of the advantages is that the law allows patients to request the use of investigational drugs (without FDA interference. This law allows for drugs as early as Phase I to be used and is ultimately up to the patient. As far as I am concerned, this is a good idea. Those with life-threatening diseases/conditions are covered by this law. If all current options have been exhausted, then it would be time to choose a potentially lifesaving drug if there are no available solutions. Despite the fact that the law currently stands, there are no ethical concerns in my view. Despite the fact that these medications may not save these patients, at least they can give them some hope.
I feel that this law is very beneficial to those that are terminal and/or looking for the last hope to find a way to stop the progression of their disease. Making this a law is allowing people more hope. While I can see where some say this would be an ethical issue, I believe that is true if you're giving this to someone that is not in an aggressive or terminal state. Allowing patients the options to have more control in a situation they cannot really control is life-changing for some and could potentially help the research that is being done on the new drug/treatment.
The objective of the Right to Try Act seems beyond reproach, the law purports to provide a new avenue to treatment for patients with terminal illnesses after they have exhausted all other options and for whom no suitable clinical trial exists. However, its striking similarity to the FDA’s Expanded Access Program has led some clinicians to view Right to Try as a politically motivated attempt to undermine and jettison the FDA. Further, without the FDA program’s protections and oversight, Right to Try could be more harmful than helpful for patients, especially those of the vulnerable cancer population. The Right to Try Bill or Act became law on May 30, 2018. It provides a way for people with life-threatening conditions to access investigational treatments. This includes drugs and biologics in clinical trials before they have received FDA (Food and Drug Administration) approval. The law gives terminally ill people the chance to try treatments that could save their lives. Because many terminally ill patients are living with cancer, oncologists are likely to face many Right-to-Try requests. As clinicians begin to encounter these requests, they may consider using this teachable moment to educate patients about reasonable expectations for any experimental therapy and seek to identify and discuss equally promising options. It all stems from the groundwork that’s been laid between the oncologist and the patient from the start in terms of the goals of treatment and the expectations for their outcomes, it is always best to be direct with patients, but not direct to the point of removing all hope. In order to use the Right to Try law, you have to be eligible. There are three basic requirements for eligibility. First, you have to have a life-threatening disease or condition. Federal law defines this a disease or condition with a high likelihood of death if the course of the disease is not interrupted. You also have to have exhausted all approved treatments and be unable to participate in a clinical trial. Your doctor must certify this requirement. Lastly, you must give written informed consent to your doctor. This verifies that you understand the risks of using an investigational treatment. The Right to Try law does not require a manufacturer or sponsor to allow use of a drug or biologic. And the FDA can’t require them to do so. Manufacturers may offer an investigational drug under Right to Try if it meets three general criteria. First, it must already have completed a Phase 1 trial, the first human phase of drug trials with a main focus of safety. The drug must also be in an active phase 2 or later clinical trial or have an application filed for FDA approval. Lastly, it must be in ongoing active development or production. In other words, it can’t have been discontinued by the manufacturer or have a clinical hold from the FDA. There is no need for Right to Try to cover drugs that already have FDA approval. Doctors can prescribe any drug for an “off-label” use. Off-label means using a drug for a condition or at a dose or in a population other than what its labeling lists. For example, doctors can use a drug with only adult approval in a child. Doctors do not need permission to prescribe off-label because the FDA does not regulate medical practice. Instead, the FDA ensures the drugs doctors prescribe are safe to use.
