Problem with Rushing FDA Approval of New Drugs

Health Wellness

Over the past few years, I’ve written a number of posts about new and exciting research that offer promising results for treating cancers, dementia and other health issues. It’s safe to say that there are hundreds, if not thousands of researchers working hard to discover or create new treatments and cures for many of the diseases and conditions that plague many of us feeble humans. At the end of so many of these exciting posts, I feel that I often dash the hopes of some by saying that further research is needed before these drugs or treatments will be available for the general public. After all, not everyone has time to wait for further research and for that I apologize.

I once had someone tell me that they would be willing to be a human guinea pig for an experimental drug, but the FDA wouldn’t allow it. He even thought of traveling to Mexico if he could get the experimental treatment, but the company, based here in the US told him that they still could not legally allow him to try the experimental drug even if he moved to Mexico. A couple months later, he was dead, killed by the ravages of an aggressive form of leukemia. He was the senior supervisor where I worked and everyone loved and respected the man, including myself.

The FDA, at times is put between a rock and hard place, when it comes to approving new drugs or treatments. The longer the process takes, the more lives that are lost but if approved too soon, devastating side effects and other negative factors could surface, making the lives of those who tried them too soon, a living nightmare, or to find out that they don’t work after all.

Check out this report:

Cancer drugs that speed onto the market based on encouraging preliminary studies often don’t show clear benefits when more careful follow-up trials are done, according to research published Tuesday.

These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe.

In 2018, the FDA looked back on 93 cancer drugs granted accelerated approval and touted that only five had been removed from the market over a 25-year span. A research team at Harvard Medical School’s Program on Regulation, Therapeutics and Law dug deeper to see what had happened with the rest.

In the follow-up studies, only 19 of the 93 drugs clearly extended the lives of the patients taking them, according to the study, published in the latest JAMA Internal Medicine.

For example, Genentech’s Avastin, or bevacizumab, won accelerated approval to treat the deadly brain cancer glioblastoma, but the drug did not extend the lives of patients in a follow-up study…

Before you begin blaming the FDA for dragging their feet or taking too long in approving new drugs or treatments, think twice. The drug or treatment you so anxiously want to try may not help at all and it may create a whole host of other health issues, besides the fact that many of the new drugs and treatments are quite expensive.

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