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The curvy and lengthy nature of expanded access program of the Food and Drug Administration (FDA) for experimental drug therapy as well as the inability to enroll all the sick patients in the clinical trials led to the formation of a channel through which terminally ill patients could have access to these investigational drugs which are yet to be scientifically proven safe and efficacious by FDA. To accomplish this, Right to Try act was passed federally by President Trump on May 30th, 2018. The Federal legislation though built on a similar model as earlier accepted in several States, it is different substantially. This law allows only those patients who are diagnosed with life-threatening diseases and have exhausted all the approved treatment options, to access the experimental drugs. These drugs are made available only if the patient is ineligible in a clinical trial and their doctor believes that the investigational treatment can potentially help the patient’s condition. The law necessitates that the drug should have passed the phase 1 of the clinical trial and is under clinical review. It allows the terminally ill patients right to get investigational drugs from the drug companies, but the law does not put the pharmaceutical companies under any obligation to provide the medication. These patients will have to give informed consent in writing and the pharma companies will have to provide yearly report of the drugs details including the adverse effects.
At the State of the Union, President Trump said “People who are terminally ill should not have to go from country to country to seek a cure- I want to give them a chance right here at home. It’s time for the Congress to give these wonderful, incredible Americans the Right to Try. ”
The Right to Try will help many patients in United States to have access to being saved from life threatening diseases.
There are certain strong arguments in the support of the Right to Try legislation. Most importantly, the patient wants an opportunity to survive and have access to the investigational drugs. All the patients are well informed and educated about harmful effects of the investigational drugs and the unpredictive results of the drug usage. The law opens a window for those who cannot be enrolled in clinical trials. To be enrolled in the clinical trials the patient must be sick with the disease but does not have to be terminally ill. This is done to make sure that the safety and efficacy of the drug in question can be tested. If clinical trials enroll a terminally ill patient and that patient dies soon anyhow, it cannot be predicted with surety that the patient died of the ill effects of the drug or otherwise. Also, a very small percentage of patients get admitted to the clinical trials, leaving the rest of the population wanting. Moreover, children less than age 18 cannot participate in any clinical trial thus limiting the options of finding life changing drugs which can be used to save the life of the children. These diseases could range from life-threatening cancer or life-crippling Duchenne Muscular Dystrophy.
Secondly, even if the drug in the trial gets approved in the clinical trials, it takes several months to years to come in the market. This is a drawback for the critically ill patients enrolled in the trials who will be stopped from the medication once the clinical trial is over as there is no provision of getting the drug elsewhere. Right to try can ensure the availability of the curing drug during the interim phase of completion of clinical trials and approval of the drug by the FDA.
Thirdly, FDA’s compassionate use process does not help enough people. The compassionate program does offer access to the investigational drugs through an application process and it’s true that 99 percent of the times FDA approves the application. However, the application process is very intricate, laborious and highly priced. This makes it very hard for the patients to reach out for the treatment drug. Several lifesaving drugs which are already curing millions of lives in other developed countries like Canada, Europe are still in the long processing of FDA’s approval. Right to try act can make the cure to certain terminal illnesses available to the people who may not be at a financial advantage of travelling to these countries offering treatment.
Also, people argue that it’s the patient’s fundamental right to be able to save his life if it is possible. The individual should be at a liberty to choose treatment drug if available and that the State should not control over what drugs people are taking and that patient’s autonomy should be practiced as a moral obligation. The opponents, however argue that this law can sabotage the FDA’s overseeing the clinical trials process in the testing of the experimental drug. As the perception is built that FDA is to be blamed for the unavailability of the drug, it is the pharmaceutical companies that hold these experimental therapies and there are no bylaws which compel these companies to provide specimens of these untested drugs. The pharmaceutical companies are more inclined towards opposition of the Right to Try Act because they want FDA’s involvement in the decision to make the investigational drugs available in the market. They, however do not raise their voices out openly in the fear of displeasing certain patient groups. The drug companies also restrict the availability of the experimental drugs because of the cost, limited supplies of the drugs and concerns about the effect on the ongoing clinical trials of that investigational drug. They also worry because the insurance does not cover the experimental treatments and the access of these drugs will only be limited to the wealthy class. Though Right to Try act protects the companies against any possible side effects the drug may cause, the pharmaceuticals remain concerned and cautious. Also, there are several examples where FDA saved the public from many fatal drugs which could have costed millions of lives as well as millions of dollars spent on getting treated with these unsafe drugs. Also, this law can do more harm than good by uplifting hopes regarding the treatment therapies whose safety and effectiveness are yet in question.
The doctors and researchers also oppose the legislation as the dose of the drug or the mode of delivery of the drug are unknown and in the dark. If the drug is cleared by the FDA for safety and effectiveness, the above-mentioned details are available for the doctor for adequate care. Blindly using the experimental drugs may shrink the lifespan of the patient and might end up increasing their sufferings. Undoubtedly, the patients have a fundamental right to treatment and should be provided access to care including investigational drugs with minimal hurdles. Right to Try Act is an attempt to provide this basic right which is of utmost importance. However, the law does little to correct the information asymmetry for the FDA to determine the safety of the experimental drugs. Since the marketed drugs are approved by FDA to be safe, any harm caused by the approved drug leads to bad publicity (also known as Type one errors where the drug is approved by FDA, but it is a harmful drug). Thus, FDA invests more in thorough testing which leads to more fiscal investments and delayed approvals and heightened recognition in case of failure of the drug to perform in the market. However, if FDA delays or rejects the marketing of the helpful drug which could cure terminally ill patients, but the patients suffer because patients never got access to the potentially lifesaving drug. This leads to Type 2 Error induced by the FDA officials which often goes unnoticed as the drugs were never tested in real grounds. Hence, violating the patients right to treatment. The need of the hour is to strike a perfect balance between allowing access to the investigational treatment for the patients yet making it harmless for them while working on methods to eliminate the harmful drugs. The main aim should be reducing both Type I and Type II errors.
In my opinion, FDA is in its position for a reason and its role should not be undermined. The drugs should go through the testing procedure put in place by the FDA to ensure safety of the patients. The insurance carriers cannot be expected to pay for these experimental drugs as the side effects of the drug can put the patient to a worse medical condition costing insurance companies a fortune. Also, the idea of free/reduced price of the medication will lead to exploitation of these drugs which may end up doing more harm than good.
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