The FDA Approved A Sentence On The OxyContin Label Which Said That OxyContin Lacked Abuse Liability, Despite The Fact There Was No Evidence To Support That Claim, And This Played A Big Role In Starting The Opioid Crisis Which Has Killed Over 400,000 Americans
The FDA says that Kratom is dangerous, addictive, and deadly, but the FDA is wrong when it comes to Kratom, since Kratom is in-fact safe, lacks addiction potential, and has never caused a death in history.
Notably, this is not the first time that the FDA has been completely wrong. As the Senior Fellow on Public Policy at the American Kratom Association, Mac Haddow, points out, the FDA approved a sentence on the Oxycontin label which ignited the modern day Opioid Crisis and caused hundreds of thousands of deaths.
One sentence the FDA allowed Purdue to use: “Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”— Mac Haddow (@HaddowMac) October 27, 2020
No study to prove that, but created a marketing bonanza for Purdue to mislead doctors and opened the floodgates opioid abuse.
Specifically, when Oxycontin first came out in 1996, the FDA allowed this sentence to be displayed on the Oxycontin label “Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”
This is perhaps one of the deadliest sentences in history, since Purdue Pharma, the company behind Oxycontin, leveraged this sentence as proof that Oxycontin lacked abuse potential, and that is the primary way that Purdue Pharma spread Oxycontin nationwide.
Essentially, even back in 1996 it was well-known that synthetic opioids and opiates were highly addictive, and doctors were cautious to prescribe opioids. Indeed, there is proof that back when Oxycontin launched that various doctors expressed their skepticism regarding Oxycontin’s addiction potential, but the sales representatives for Purdue Pharma would simply say that Oxycontin was a special form of opioid that lacked abuse potential, based on that one sentence which the FDA allowed on the label.
This strategy worked, and doctors nationwide began prescribing Oxycontin. Even worse, doctors commonly told their patients that Oxycontin lacked abuse potential, all because of this one sentence.
Further, whereas other synthetic opioids and opiates were only prescribed for terrible diseases and conditions like Cancer, doctors nationwide began prescribing Oxycontin for any condition which caused pain, since it was believed that Oxycontin lacked abuse potential based on this one sentence.
Shockingly, there were no scientific studies which backed up the claim that Oxycontin lacked abuse potential, so this claim was based on thin air.
The idea was Oxycontin’s slow release mechanism would lower the chance of abuse, and lower the ‘high’ that Oxycontin causes, but ultimately addicts across the country took the time release mechanism off the pill, converting it to instant release. Also, even with Oxycontin’s slow release mechanism, it is still incredibly physically addictive.
Eventually the truth came out, since Oxycontin proved itself to be one of the most addictive drugs in history, which was the opposite of what the label said.
Investigators tried to determine where this statement came from, since there was no science to back it, and Purdue Pharma said the FDA suggested this sentence, and the FDA said Purdue Pharma suggested this sentence. Basically, both Purdue Pharma and the FDA dodged accountability and responsibility.
Zooming out, the FDA has complete control over what is said on a drug label, so it is completely the FDA’s fault regardless.
The sentence was removed after 5 years, and replaced with a black box warning. It is insane that the FDA allowed this sentence to remain on the Oxycontin label for 5 years, since the damage and destruction that Oxycontin was causing was evident well before then.
Unfortunately, by the time the sentence was removed the damage had been done, and Oxycontin had already ignited an Opioid Crisis which continues to this day and has killed hundreds of thousands of Americans.
Thus, despite the fact that the FDA should be the nation’s authority on drug safety, the FDA has proven that it can be completely wrong. Not only that, but the FDA can indirectly cause hundreds of thousands of deaths, such as in this case, and in the end the FDA has no accountability.
Therefore, there is strong precedent for the FDA being wrong and causing deaths, and the same thing is happening today with the FDA trying to ban Kratom, which is a decision that would lead to an untold amount of death and destruction if the FDA ever succeeded.