Are “breakthrough drugs” really worth it?

by Paula A. Wyatt | October 1, 2018 | Blog, Defective Products | 0 comments

Are “breakthrough drugs” really worth it?

When you are sick, you want relief fast. You have likely called friends for advice, searched the internet or tried trusted home remedies to ease the symptoms. Moreover, when a loved one is suffering, you may take any risk to find relief for him or her.

In fact, that is what you may be doing if your loved one is suffering from Parkinson's disease, cancer or another life-threatening condition. That is because the Food and Drug Administration - the government agency that approves the safety of new drugs and medical devices - often fast-tracks new medications through the approval process, especially if they are designed to treat serious conditions where few options exist.

Is your loved one an experiment?

If your loved one's doctor has recommended Nuplazid to treat some of the more disturbing symptoms of Parkinson's disease, you may be taking a chance with your loved one's life. Nuplazid is one of hundreds of drugs that go through the FDA's "Breakthrough Therapy" program. These drugs speed through the approval process, skipping important studies and tests so their manufacturers can get them to patients faster.  

Nuplazid, for example, supposedly reduces the psychosis many patients with Parkinson's experience, such as hallucinations, delusions and dementia. Currently, no other therapy exists to combat these symptoms, and the manufacturer of the drug stands to benefit from being first. Unfortunately, over 700 people have died after taking Nuplazid, others found little relief of their symptoms, and for many, the symptoms worsened. Was your loved one among these?

How can this happen?

If a pharmaceutical company creates a drug that potentially fills a desperate need, the FDA may approve it for the Breakthrough Therapy program. Preliminary tests of the drug must show that it provides significant benefits. Making these drugs available to your suffering loved one is certainly an advantage if they work. However, breakthrough drugs often skip over critical testing stages, so the FDA may not learn of dangerous or deadly side effects until hundreds of patients, like your loved one, display them.

The suffering your loved one experiences throughout the day can be painful to watch, and a drug with the label of "breakthrough" may fill you with hope. If that drug added to your loved one's misery or contributed to his or her untimely death, you have a right to seek answers. An attorney with experience assisting Texas families with such issues can provide guidance.


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