December 17

Drugs Getting “Fast Track” Approval May Then Be Taking It Slow On Proving Effectiveness And Safety

When patients take medications to help with a health condition, the last thing they want are for them to cause additional unwanted problems due to side effects or safety issues. But if you’re taking a drug that has been given FDA “fast track” approval, you may be putting yourself at greater risk of this happening!

According to a recent report published in the Journal of the American Medical Association in August, nearly half of these fast-tracked drugs may not be getting the required rigorous scientific scrutiny needed to ensure their safety and effectiveness, or confirm their benefits. “Accelerated approval” allows the FDA to fast-track approval of drugs that fill an unmet medical need, particularly if the medication is for a life-threatening illness and there are no other treatment options. Even though this sounds like a “last chance effort” on the front end, it’s the back end of the bargain that is not being upheld consistently, and this may be putting health and lives at risk!

Using this approach, the FDA can approve a drug based on weaker-than-usual evidence showing that the medication is reasonably likely to be beneficial to patients, without actually proving real benefit. (You may want to read that sentence again for full impact…) The drug manufacturers are then required to produce follow-up studies within three years that confirm that the drugs actually do provide the benefits that were promised.

The researchers reviewed 22 drugs that were given this approval between 2009 – 2013, 19 of which were intended for cancer treatment. The FDA ordered that 38 follow-up studies be performed after these drugs were available on the market as a condition of accelerated approval. However, after three years:

  • Only half of the required 38 confirmatory studies had been completed
  • And of those 19 studies, about 42% were not performed to a higher standard, but used the same “less than optimal” type of evidence previously produced to get the initial accelerated approval

So basically, the companies got the conditional fast approval to get their drugs pushed through to be sold, but then didn’t have the same sense of urgency to make sure long-term use of them was safe, or that the drugs really added some type of lasting or significant benefit. Which makes it seem like the people taking these drugs end up being the “guinea pigs” because they’ll likely be the ones using it for a prolonged period of time. And only time will tell then if the possible positive results were worth any potential risks or side effects. Do you like gambling with your health?

Now this may be on one end of the spectrum where patients don’t have any other viable options other than something unproven. But it should reinforce the importance of doing all that you can from as natural means as possible to help maintain proper body function in the first place. That is why an approach utilizing functional medicine or functional wellness can be such a great benefit. First, it is a more proactive approach in the sense that if we begin to see early signs of possible problems, it gives us the opportunity to address them at earlier, and more easily correctable, stages, and with less harsh means than the sometimes side effect-heavy drugs. There’s also less of an uphill climb when chronic diseases haven’t been allowed to progress. It’s much easier to help someone in the pre-diabetic range than when they have become full-blown insulin dependent.

Secondly, it allows us to address the lifestyle factors people typically follow that lead to many of these common conditions. Diet is the most important, but others like water intake, exercise habits, sleep patterns and social habits all play into how well, or how little, you are supporting your body. Clearing the junk out of the body and supplying it with what it needs to heal and repair is usually first on the list, followed by helping the patient understand how to best support the body moving forward. In addition to changes in symptoms, follow-up blood work will help us assess progress being made and how to best keep improvements coming going forward.

If a safer, more natural approach to maximizing your health makes sense to you and you’re looking to make some improvements, we encourage you to schedule a discovery day to see if this may be just what you’ve been looking for all along. There is no cost for the consultation, so you have nothing to lose and everything to gain from taking a first step in a healthier direction.

And there are no “rush jobs” here when your health is concerned.


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