Big Pharma’s cutting corners… and it could kill you

Maybe you think I’m a major conspiracy theorist. (Confession: I might be.) Or maybe you still believe that big businesses really do have our best interests at heart. (Spoiler alert: They definitely don’t.)

Either way, let’s take a quick peek into one of my least favorite industries. If you guessed Big Pharma, you win today’s prize. Granted, they do provide an amazing service — when they’re necessary. But that doesn’t change the fact that their routine practices scare the bejesus out of me.

So, let’s see what they’re up to now.

As it turns out, they were caught cutting corners yet again — and it could be costing patients their lives.

You see, the FDA often rushes new drugs onto the market. They’re typically approved based on small, short-term trials, under the requirement that drug companies continue to evaluate dosages and side effects afterward.

I doubt I need to explain the concern here. The faster a drug hits the market, the less it has been studied, and the less we know about its safety and effectiveness. This policy makes guinea pigs of the American people, with a lot of side effects only coming to light after these drugs are already in widespread use.

That is, if they come to light at all. Because according to a recent study featured in The New England Journal of Medicine, drug companies aren’t always following through. (And who amongst us is shocked by that allegation? Certainly not me.)

This review examined federal records to discover that a whopping 20 percent of studies required between 2009 and 2010 — over 600, in total — had never even been started. And nearly 10 percent had been put off.

That’s one in three. But hey, who’s counting?

I’ll tell you who — Big Pharma. Except they’re only counting in dollars and cents. That’s because faster approval means less money spent on “tedious things” like research (who needs that?!)… and more money spent on marketing.

More marketing equates to more people buying their drug — and consequently, a quicker and bigger profit. If some awful new side effect turns up in the meantime, well… OOPS! The drug company can just pull their product from the market and still walk away with a pocket full of cash.

But even this crooked scenario assumes companies are continuing to research new drugs after they hit the market. Which, once again, many times they’re not. And this recent analysis offers more than one example of the industry’s negligence.

Take Suboxone, a drug used for opioid dependence. After it was approved back in 2002, the FDA wanted this drug’s potential heart risks evaluated. So it gave the manufacturer more than a year to submit trial details — and a full five years to finish the study. But guess what?

As of this summer — a full 15 years later — not even the first step has been completed!

Meanwhile, the FDA asked Novartis to re-evaluate the effective dosage for one of their pricey multiple sclerosis drugs — citing that a lower dose may be equally effective and have fewer side effects. But six years post-approval, how much research do you think they’ve done?

Zip. Zilch. Nada. The reason? They claim “recruitment difficulties” — despite the fact that plenty of people must be taking this drug, considering they’ve raked in nearly $3 billion in sales.

And these are just two examples. This new report states that a mere 16 percent of ongoing research is actually on schedule. But it’s a wonder the number is even that high, considering there are no penalties for missing deadlines.

In fact, in some cases, the FDA will simply drop post-approval study requirements altogether, with no explanation.

And they call supplements unproven and dangerous!

If you think things couldn’t get much worse…well, think again. President Trump has already vowed to make the FDA approval process faster. Which means even shorter research periods and even lower standards for drug regulation are all but guaranteed in the future.

Some will claim that this benefits desperate patients. But the true beneficiary is Big Pharma itself — having convinced the American public that they should be grateful to play Russian roulette with their latest products.

I’ve got three words for you: Don’t buy it.

 

 

Source:

http://www.the-rheumatologist.org/article/many-drug-companies-fail-conduct-timely-safety-checks-medicines-fda-approval/

 


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