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How Does A New Drug Make It To Market?

How Does A New Drug Make It To Market?

(this will be at least a 2 part)

Researchers are constantly looking for the next new treatment

Once researchers have developed a drug that they “think” might work or improve an existing one they will start a “pre-trial protocol” (animal testing)

This can take years or decades.

This is often when you hear about some wonder drug that “one day may do everything include make your morning coffee”

So IF it passes the pre-trial it goes to Phase 1 Trial

Phase 1 is tested on a small group – as few… read more

posted 6 days ago (edited)
A DiabetesTeam Member

And in this case this wasn’t even a “idea from scratch”, Ozempic was simply looking for a better formula than other drugs in the same class such as Byetta which had been on the market since early 2005

This demonstrates that drugs are “not” rushed to market – it took 5 years to get on the market and essentially only improved on one that had been in wide use for 12 years

Of course they are not “identical” so once goes into wide “consumer use” the “patients” become the Guiney Pigs for what is called Phase 4

This is where the regulatory body collects additional data, side effects/issues once a drug is being used by the general public

(During the Ozempic trials no individual took the drug for longer than 102 weeks – so nobody knows what would happen at year 3 or 5 or 10 and the FDA wants to know)

That is the true test of “what happens, is it dangerous after a few years of use, was something missed in the earlier Phase Trials”

And in the case of Ozempic, after wide use a “Box Warning” (formerly Black Box Warning) was ordered to be put on the packaging since a (few) users developed Thyroid Cancer. Rats/Mice had in the pre-trial phase but it was deemed unlikely in humans (so maybe a fluke or maybe something to watch for)

Not enough to be “statistically significant” (or the drug would have been pulled) but since the issue had been seen in rat/mouse trials they had to at least consider that it “could be” a potential complication from longer term use by humans

Ultimately the regulatory body will determine “how long” the Phase 4 will continue

Usually until they are satisfied that we now know every possible side effect and how well the drug works when in actual use – the drug can be pulled at any time if something pops up

This is one of the main reasons that any new drug is “expensive”. They spent millions, if not hundreds of millions getting Ozempic to market paying researchers, doctors, clinical trial subjects etc for 5 years before they sold the first pen load of this stuff – somebody has to pay for all that and it’s always the “consumer”

So if your Doc prescribes you something "New" at least you can be assured that it "has been looked at closely" - does it mean it's "totally safe"?

Of course not - it's a drug that "doesn't belong in your body" - but if it works for YOU, you will be better off then "if you didn't take it" - and that is not the same as "free of side effects or totally safe"...

posted 6 days ago
A DiabetesTeam Member

Something else to keep in mind as well as "the potential bad" is the "hey we never realized this Good Thing" which is found during that (Phase 4) general use

Jardiance, another popular Diabetes drug was approved back in 2012 so has been on the market for a touch over a decade

After the first few years they realized "Hey, people taking this are having less Heart Attacks or developing Congestive Heart Disease then the average Diabetic"

Since this looked like maybe the drug was helping, back into the study lab to see and sure enough, while it was Not even considered when developed, this is an excellent drug for a Diabetic that already has some level of cardiovascular disease since it actually slows down the vascular disease progression

Bonus

But with the same drug they noted that about 20% of patients that use it develop UTI or Yeast Infections and have to stop using it - hence a new warning for Doctors/Users

posted 6 days ago (edited)
A DiabetesTeam Member

@GrahamLamb- Thanks for the info. Quite infoirmative as usual!

posted 6 days ago
A DiabetesTeam Member

Wow! This article makes me stop and really think, Graham. Even after all the testing on drugs, it still seems like it could be a flip of a coin as to whether a person gets some really lousy side affects since we're all different. I've been very fortunate not to have any side effects but many haven't.
Thank you for all your research and postings.

posted 6 days ago
A DiabetesTeam Member

@A DiabetesTeam Member I love that you dig deep for us with your research & backstories. I love researching. It is good to understand all of this. Right now I take a very low dose of Byetta at night before dinner. I know that after I had non Alcoholic cirrhosis of the liver I researched all of the medications I was taking and had serious conversations and changed many things with the help of my doctor. It is important for all of us to take the reigns of our own health and really look into what exactly these medications do so that we can weigh out if it is worth it. Thank you! I appreciate you very much!!!

posted 6 days ago

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