The Right to Try – The Good, the Bad, and the Just Plain Ugly

The Right to Try law was signed into law by President Trump on 30 May 2018. It is appropriate that anyone that is terminally ill have the opportunity to take the steps determined by them to be appropriate to extend their lives, or improve their quality of life. However, I have a lot of issues with this law, not least of which is the terminology that is being used.

The term “Right” implies that someone has a right that should not be denied them. For instance, everyone has the right to be treated with dignity and respect. Everyone should have the right to free speech and to live their lives as a free human being. Unfortunately, the use of this type of terminology here creates more problems than it solves.

Does everyone really have the right to try an experimental approach that is not yet approved by the Food and Drug Administration? What does this mean in practice? Can this law ever be implemented? Can companies be forced to grant access to their unapproved drugs? Do lawmakers have a realistic or a naïve view of how the regulatory process and systems work?

In practice, no pharmaceutical or biotechnology company is obligated to provide an experimental drug to anyone, regardless of how sick they are. Most will do so on a compassionate basis, depending on the stage of development. However, they will first take into account the risks to the patient, to the drug, and to the company, before granting access. For example, the medical officer overseeing a Phase 3 program for a drug close to securing approval to go onto the market, may determine that it is not in the best interest of the drug or the patients that could receive the marketed drug, to grant access to a dying patient because of the questions that could be raised. On the other hand, the same medical officer could consider the risks to the drug to be low and grant access. In the first case, can the law force the hand of the company to gain access? I very much doubt it.

The death of any patient during a clinical trial, leads to the necessary use of resources to determine why the patient died, and whether or not it could be related to the experimental approach. The death of a patient while taking the drug, prima facie could be considered possibly related to the drug. Any death during a clinical trial puts the program at risk, and could result in the treatment being placed on clinical hold.

Johnson & Johnson have set up an ethics process for the consideration of requests for medicines under compassionate use. The committee that considers the requests for access are a step removed from the executives in the company. They will consider the individual cases and then make recommendations which are provided to the company. If the company endorses the decisions, the patient may or may not receive the drug. However, the consideration of the case by a representative group should provide confidence in the decision even if it is that the drug should not be provided.

Can the Right to Try law require that a company grant access to their experimental drug? We will have to see the extent of this law, if cases are brought to court.

 

Lorna Speid, Ph.D. is the author of the Book Clinical Trials: What Patients and Healthy Volunteers Need to Know, published by Oxford University Press in 2010.  She is also President of Putting Rare Diseases Patients First!(R).

 

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