04.28.17

Is The “Right To Try” Medical Product Law Harmful Or Helpful?

Posted in Consumer Law at 3:03 pm by kevin

The road from an experimental drug becoming available for the market is long and arduous. A frustration for those who need life-saving drugs, often the trials can take decades for the FDA’s approval, and sometimes even longer. In the meantime, people who could benefit from medications wait on the sidelines hoping for the drugs to clear so that they might be available to save either their own life or the life of someone they love.

There aren’t many who, if they had a terminal disease, wouldn’t at least try a hopeful experimental drug and pray for the best. The problem is that even if you want to try a drug to save your life, you can’t. A new push is being made to pass laws to give patients the right to try medications before they are given FDA approval.

Over the last three years, 33 states in the US have passed legislation that is aimed at helping those with terminal illnesses by giving them the right to try experimental treatments and drugs in the earlier stages of a drug’s development. A trial lawyer can confirm that these “right to try” laws are expediting the use of medical procedures and pharmaceuticals to make them available to people who will certainly die without them and who might survive if given a chance to take them.

California has a “right to try” law that went into effect just this past January. Hospitals and doctors in the state are now allowed to prescribe any medication that has made it through the trial-one phase of drug development. That is the first stage where a drug is tested on human beings on the way to gaining FDA approval. In phase one, typically a drug focuses not on whether a drug helps someone, but rather that it doesn’t have any risks for use. It also answers questions of dosage but has no relation yet to effectiveness about a particular disease.

It is in the second and third phases of drug development that researchers find out if there are toxic side effects to an experimental medicine or procedure by using the drug on the very people it aims to cure or help. Only about 20% of those medications that make it to the second phase and are found to have serious side effects will move onto the third phase. In the third phase, the medicine is tested for its side effects and effectiveness.  Only after passing all three phases is a drug even eligible to be examined by the FDA or slated for the market.

The problem is that the process of going through the three phases is anything but quick and easy. That is why Ian Calderon, a Democrat from Southern California, proposed the bill to give people who will die without the use of some intervention, the right to try experimental medications. If there is a chance that one life can be saved by not waiting for FDA approval, then it is worth it. When talking about people who are terminally ill and will certainly die, what harm could it possibly do to allow them to at least give a potential cure, a try?

In 2016, assisted suicide was made legal giving someone the chance to decide when they want to die; why should someone who is dying not be given the opportunity to decide how far they will experiment to live? The proponents of the bill maintain that often doctors are fearful of allowing patients the right to try medications, even for off-label use, just in case they have serious or deadly side effects. If a drug doesn’t have FDA approval, then the onus falls on the prescribing physician. Not many clinicians are willing to take that chance or to have blood on their hands by offering false hope.

The new law allows doctors and patients the ability to investigate medicines in the phase-one testing phase, and it also limits the obstacles that stand in the way of allowing terminally ill patients the ability to give them a try.

Those who stand in opposition to the “right to try” laws believe that it is morally wrong to allow patients the right to take something that they hope will cure them, especially if it gives them false hope or hastens their death. There is a fear that drug manufacturers will prey on those who are looking for a cure and will try anything out of desperation. Moral ethics upholders are worried that terminally ill patients might be taken advantage of and considered “free lab rats.”

For now, those who want to try a medication to save their life have been given a new lease to try what they can research and find. If it saves one life in the process, it is a miracle. If it helps to prove that a cure for a disease is available more quickly, it’s even better.

 

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