What the Actual FDA!!!

Day 1622.

I make no secret of my wrath at the The Food and Drug Administration’s (FDA) Teflon coating. No matter what shit goes down - nothing sticks to them or their officials. They are never blamed, punished or reformed.

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs - it says so on their website.

The revelations in courts of the ‘pay to play’ schemes approving OxyContin for long term and chronic use (pivotal in this crisis), without any science to support that it was either safe or effective, over lavish dinners, were indeed embarrassing, but nobody went to jail, no heads rolled. Nothing changed.

I used to think of the FDA as an agency of checks and balances, full of brilliant and impartial minds, panels of experts pouring over the supporting studies, enforcing standards and compliance and removing approvals if studies are later found to be falsified; and so making sure that me and mine are safe.

Guess what?…

The agency leadership has authority to override the decisions of it’s own advisory committee of experts.
Study rules can be shifted after the fact to allow approval.
Persons suffering adverse effects in a drug trial may be removed from the data. (Enriched enrollment)
Evidence that safety or efficacy was falsified or misunderstood, does not change the approval.

There went all my notions of checks and balances!

All this actually happens,
and yet, the words “It’s FDA approved! “….ring out from people’s mouths, like it actually fucking means something.

The FDA’s constant dereliction to protect public health in favor of supporting the pharmaceutical industry, astounds me.
I can’t decide if they are inherently corrupt, or whether the full force of the profit driven pharma-machine out guns them at every turn, rendering them impudent.

Whether they don’t protect us or
Whether they can’t protect us - it either needs fixing or disbanding.

Here’s how they ‘protected’ us from the opioid manufacturers:
See what you think:

1995 FDA approves OxyContin
and allow Purdue’s claim ‘believed to reduce abuse’ on a theory, rather than scientific evidence.

1995 FDA approves Tramadol
without the appropriate opioid prescribing restrictions, so doctors don’t even realize it’s an opioid.
This unstable and unpredictable opioid didn’t get classified as a controlled substance until 2014 -19 YEARS!!
and even then, is in the lowest category with Ambien.

1998. FDA approve Actiq
a fentanyl lollypop (50- 100 more powerful than heroin), specifically for breakthrough pain for cancer patients.
But when the makers later ignore that and sell it with improper tactics for all pain - and get caught in 2008 ….all they get is a fine which is a fraction of one year’s sales and it stays on the market. So fiscally it’s worth it and the playbook is written.

2001 FDA approves OxyContin for chronic pain.
With NO supporting science.
Despite the discovery in court transcripts that this was approved without supporting science, in closed door meetings, in fancy restaurants and the fact that current evidence proves otherwise - it still stands. Today victim groups still implore the FDA to rescind their endorsement for OxyContin for chronic pain and longterm use, to no avail.

2002 OxyContin is clearly a huge problem.
The FDA respond by forming an advisory panel to examine their opioid approval policy.
8 of the 10 panel members are already in the pocket of opioid makers as consultants and/or ‘speakers’. 5 with Purdue (the makers of OxyContin) specifically. Guess what? ….No changes were made.

2003 FDA refuse to license Opana
Oxymorphone, was previously banned by the FDA in 1979 as too dangerous. Now they rule that it is still too dangerous. BUT 3 years later….
2006 BINGO! FDA grants that license.
What changed? …..the rules of the clinical trial, not the drug.
Pharmaceutical companies paid $35,000 per person to be present when those new trial rules were drawn up, according to The Guardian. Oxymorphone, is just as dangerous as it ever was… but now it is back and with the FDA’s blessing.

2006 A Department of Justice Memorandum
describes the 1995 FDA approval process for OxyContin as having been ‘tainted’ by Purdue’s efforts to position the drug as less addictive and prone to abuse than other opioids. The dodgy approval process has been outed … surely the terms of the license will be revisited?… but no!

2006 Prescription opioid related deaths more than double,
so we know the crisis is mounting. We know there is a terrible problem. Maybe changes should be made?

2007 3 Purdue executives plead guilty
to misleading regulators, doctors and patients about the addiction risks of OxyContin. No one goes to jail. A chance to change the trajectory of the opioid crisis is missed.
So we know Purdue had lied to the FDA, surely the license changes?? No.

2010 Purdue (yep, they are back) wins approval for ‘tamper resistant’ OxyContin
despite the agency’s own findings that it had no effect on abuse potential.
So its approved despite the fact that the FDA knows it’s claims are false and always were.

2012 FDA approves Subys.
More Fentanyl for severe pain in cancer patients. The same sales exec that flouted the rules of Actiq takes the rule-breaking next level and it takes 7 years before he’s jailed. “If Cephalon executives had gone to jail for the way they promoted Actiq, for actions they took that promoted a loss of life, then maybe we wouldn’t have had a Subsys,” says Andrew Kolodny.

2013 FDA approves Zohydro ER
despite the advisory committee voting 11-2 against.
They find it to be unsafe and as easily abusable as OxyContin had first been. Why don’t they listen to their committee?

2014 FDA approves Hysingla ER.
Remember the FDA does not have to establish that something is safe or effective, just that it is as safe or as effective as existing products. That, as we see, is a low bar.

2015 FDA approves OxyContin for children as young as 11.
We know it’s highly addictive. We know its fucking up our adult population… so let’s give it to our kids!

2017 FDA asks Opana to be removed from the market,
because the 2012 abuse resistant reformulation clearly isn’t working - that took 5 years!
Why did the trials not tease that out? Maybe those trial rules shouldn’t have been adjusted? But don’t worry ……Generics are still on the market today.

2017 A Presidential Commission Combating Drug Addiction & The Opioid Crisis
finds that the FDA’s ‘inadequate oversight’ had a part in the opioid crisis. Busted!!!! ……But that doesn’t stop them.

And now for the drum roll…

2018 Dsuvia is approved.
It’s sufentanil, it’s more powerful than fentanyl, 1000 x more potent than morphine, developed in conjunction with the US Defense department for the battlefield.
It’s approved despite:
- A refusal in months prior over safety concerns
- 4 US senators urging the FDA to not approve it
- The FDA Advisory Chair Dr Raeford Brown himself predicting approval will lead to more abuse and death.
Brown calls Dsuvia a “terrible drug”, that was approved in a process he alleged was manipulated and in his absence.
Nearly 47,000 people died of opioid related overdoses this year.… the last thing we need is a super potent drug like this. The FDA thinks otherwise.

I could go on … there’s so much more. The agency approved 27 new opioids for sale between 2009 and 2015 alone.

So, what is going on at the FDA?

Dr Raeford Brown told The Guardian of ‘a war’ at the FDA between officials who “failed to learn lessons”’ in the opioid crisis and those who had. Brown said that the FDA had learned nothing ..
“the lack of insight that continues to be exhibited by the FDA is in many ways, a willful blindness that borders on the criminal” ….that’s from a man on the inside!

He also says that Congress is owned by pharma. That’s not me talking - that’s the Chair of the FDA Committee on Analgesics and Anesthetics.
Is this really all about profit?
Did Luke die so some Congress member can go to Hawaii?

So with our new administration, will it change? Seems unlikely.

During this entire period Janet Woodcock was head of the FDA’s watchdog, the Center for Drug Education & Research (CDER). According to the FDA website that department is ‘the gold standard for drug approval and safety. Including the concept of risk management as a new approach to drug safety’
So, you’d think she’d have been fired, or jailed or banished to obscurity…
BUT NO!
She’s getting promoted!

In January, Woodcock was named, by our new administration, Acting FDA Commissioner and is reported to be up for consideration for that post to be permanent. WTF! It is unimaginable… but it is true.

Pharmaceutical manufacturers are reported to be delighted.
Activists are livid.

28 action groups, all of which I support, have sent a letter to Biden’s administration imploring it to consider Woodcock’s track record in the mass prescribing of pain killers. “Woodcock has presided over the worst regulatory agency failure in US history” says Dr Andrew Kolodny of Physicians for Responsible Opioid Prescribing (PROP) in that letter ….and I am right there with him.
We have yet to see whether the President and his administration will either read or heed that letter.

If I could talk to him personally .... “You too know what it is to lose a child, now think… over 500,000 children. Don’t pick her”

We have so much evidence of the unholy alliance between the FDA and pharmaceutical companies under Woodcock.
The list is endless.
The effects are dire …. and nothing is going to change?

“The FDA should stop considering any new opioid evaluation,” says Dr Raeford Brown.
“For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets.”|
Like my boy, Luke.

What the actual fuck has to happen before the lessons of this crisis are learned?
And someone who considers these lessons is put in charge of the FDA?
Someone who acts as a watchdog for the people, rather than for the pharmaceutical industry?

We’ve marched
We’ve litigated
We’ve exposed
We’ve screamed from the roof tops til we are hoarse
……For decades!

People say “it takes time”.
A person dies of an overdose in the USA every 8 minutes….