What stopped the FDA from taking tougher action sooner in the opioid crisis, and why it will happen again

It's not because they're bad people

Vol. 1 issue 9

"The individual has two choices when faced with this kind of ‘group think’: either call out what’s wrong and be the target of those who will have to now be made responsible; or, give up one’s voice and just go with the flow, even if it’s not what you would do as an individual outside of the Blob.”

Greetings,

I’m making this free to all subscribers today.

It’s later in the week than I like to send this out, but I was looking for something, a photo. I took it in October 2016 when I was covering a National Academies of Science hearing requested by the FDA to study what more could be done to prevent “diversion” of prescription pain medications. Essentially, agency officials wanted to know what experts thought the agency could do to stop opioids from being used recreationally — and then killing people.

If I could find the darned snapshot, what you’d see is two FDA officials looking bored: one of them is picking at his cuticles, something he did when he wasn’t shifting papers or staring into space as witness after witness — many of whom had flown in from elsewhere at the FDA officials’ request — gave their testimony.

The point of this is not to bash the FDA. I have covered other FDA meetings where I was truly moved by the passion of the government scientists in their quest to protect the population.

And yet, despite plenty of good public servants within the agency, the FDA, like any big organization, is not without its inherent evils. That was why I was looking for the photo: to make a larger point about the idea of “too big is bad, except when it isn’t”, and to underscore how the “except for when it isn’t” comes down to us as individuals.

The photo demonstrated to me that the FDA higher-ups present at that hearing understood at some level that there is protection in inertia. Calling for the hearing was perhaps nothing more than a sophisticated ruse, designed to make the agency look interested in reversing the rampant opioid addiction crisis even though they were not about to do it on their own mettle. While I doubt any of them thought, “Opioid addiction is a great idea!”, my conjecture (because I don’t know for certain if this is true) is that doing so would have required some serious mea culpas that would be beyond their scope to elicit or act upon. And, who wants to self-accuse?

Besides, it’s Congress’s job to oversee the FDA, making it complicated to unpick a problem that spans several election cycles.

So, asking the Academies to weigh in was a good route to go by.

And yet, as was apparent to me, and to six of the witnesses and others in attendance whom I interviewed, all the testimony of that day made it abjectly easy to conclude that the FDA already knew it had the answers necessary to address the problem. What was, to me, even more difficult for the FDA to admit, was that it had allowed flimsy science to serve as the predicate for approving OxyContin, the drug that started the whole horrible epidemic, and that it hadn’t reeled in the manufacturer, Purdue Pharma, sooner with better risk evaluation and mitigation strategies.

Here’s a story from the LA Times, one of many by several outlets, on how Purdue manipulated crap data to keep its juggernaut of a marketing campaign going, even as people were dying at a staggering rate.

Why would the FDA, as a collective agency, filled with many good intentions, have allowed this to happen? If there were any illicit “backroom deals”, I personally haven’t gone digging around for them and I haven’t seen any reported. While that doesn’t eliminate the possibility that they exist, I think it is more likely that because there was pressure to approve the drug from two nascent stakeholders. The first was the pharmaceutical industry, which in the early 1990s when OxyContin first came to market, was in a bit of turmoil and needed a win. The second was what one witness that day derisively called, “the pain crowd”, who had been advocating that pain should be seen as the fifth vital sign and that to ignore it was cruel. Even if the pressure was tacit, I imagine it created a sense of urgency at the FDA that seemed to require a response.

How pain as the “fifth vital sign” actually perverted the medical profession is an interesting side line, but not the point of this, so here is an excellent article from the American Journal of Medicine that goes into great depth about it. It explains how advocates for treating non-cancer related chronic pain helped play into pharma’s plans to market opioids to people who really didn’t need them. The article also asserts that the FDA slept its way though the crisis.

To me, the FDA’s failure to act is an example of what can happen in any big blob of an organization, government or private: At a certain point, there arises a kind of willful inertia where the balance of action seems to be in favor of doing just enough to seem like one is carrying out a big organization’s stated mission, but not enough to actually dismantle mechanisms of bad things, deadly things.

It’s Schopenhauer’s “will to live” principal applied broadly: an entity given life will do anything to sustain it.

One such life sustaining fuel for a Blob is fear. It keeps would-be whistle blowers silent. The FDA was under pressure to approve new medications, analgesic or otherwise. It also found itself in a position of appeasing “the pain crowd”.

Who wants to stand in the way of something that will drive economic indicators in the right direction or make people feel better when they are nearly demented with pain? These sound like worthy causes, right?

The individual has two choices when faced with this kinds of “group think”: either call out what’s wrong and be the target of those who will have to now be made responsible, and probably the target of the rest of the group that doesn’t want to lose the status quo; or, give up one’s voice and just go with the flow, even if it’s not what you would do as an individual outside of the Blob.

Meanwhile, the reason I am thinking about this at all is to do with amalgam fillings. I will tie all this together, I promise. But first, let me tell you a bit about why amalgam fillings are on my mind.

In an earlier issue, I made an oblique reference to my having recently received an autoimmune disease diagnosis. It’s a real drag. Takes a lot of time to deal with. Makes me tired and grumpy.

My diagnosis is Hashimoto’s disease. It means I have a hypoactive thyroid that is under attack from two particular antibodies that think it’s the enemy. Why did this start? The line I was getting is that it was my diet. I knew that was just hogwash. I have excellent eating and exercise habits and I instinctively knew that was wrong. But I did what I was told and followed the protocol…and did not get better. I got worse. Thus, I got a second opinion, this time from a famous endocrinologist who’s written a New York Times bestseller. This physician also would not hedge a bet on what is the cause of my diagnosis.

Could be genetics, could be diet, could be an infection, who knows?

Well, I want to know. What I have discovered is what brings me back to that day at the National Academies building when I snapped the photo of the bored FDA official.

Here’s my theory based on what I have learned so far:

I believe there is a strong possibility the cause of my Hashimoto’s is a series of dental procedures beginning early in 2017, that I had to replace several amalgam fillings. This meant I was exposed to mercury vapors over the course of several days and at high levels. I won’t bore you to tears with the science of how mercury overload and thyroid disorders are thought to be related, but a growing body of literature suggests they are, although there is not consensus. If you want more about that, here is a website that goes into great depth about it, written by a pharmacist, and one who has created a business out of helping people heal from various thyroid disorders, so keep that in mind. Meanwhile, I have yet another appointment with another specialist, this time in mercury toxicity.

In my head, the whole time I have been doing this research, I have heard the chorus of status quo’ers:

“Oh, please! That’s ridiculous. You’re making a hobby out of this. Get back to doing more productive things…besides, so many people have amalgam fillings. If they were dangerous, no one would have them. The FDA would never allow it.”

In fact, much is known about the potential toxic effects of mercury in amalgam fillings, but not enough to force federal action, and not enough to alarm the largest professional organization of dentists in this country, at least not yet.

And the FDA is not unified in its messaging to the public about mercury. In July of 2016, the agency released a strongly worded statement warning against its use in cosmetics, and advised the public to avoid products that include mercury, specifically stating that:

“Exposure to mercury can have serious health consequences. The danger isn’t just to people who use mercury-containing products but also to their families, says Arthur Simone, M.D., a senior medical advisor at FDA.

Your family might breathe mercury vapors released from these products. Your children might touch washcloths or towels that are contaminated with mercury. It could be as simple as touching someone’s cheek or face,” Simone says.

But when it comes to amalgam fillings, the agency is still unwilling to warn against the use of amalgams outright. That’s even though in 2009, they moved mercury-containing amalgam up to a higher risk class, and issued guidance for how to properly remove it from a person’s mouth.

In 2017, the FDA issued a white paper on mercury in amalgam fillings, with an appendix to an earlier statement, declaring:

“Dental amalgam has been demonstrated to be an effective restorative material that has benefits in terms of strength, marginal integrity, suitability for large occlusal surfaces, and durability. Dental amalgam also releases low levels of mercury vapor, a chemical that at high exposure levels is well-documented to cause neurological and renal adverse health effects. Mercury vapor concentrations are highest immediately after placement and removal of dental amalgam but decline thereafter.”

And yet the agency reaffirmed its stance, giving a little bit of wiggle room by stating that the ultimately decision is up to you, which I take to mean that if you do think mercury in your body isn’t a great thing, you are in fact NOT crazy:

“The FDA does not recommend that you have your amalgam fillings removed or replaced. Removing sound amalgam fillings results in unnecessary loss of healthy tooth structure, and exposes you to additional mercury vapor released during the removal process.

“However, if you believe you have an allergy or sensitivity to mercury or any of the other metals in dental amalgam (such as silver, tin, or copper), you should discuss treatment options with your dentist.”

The FDA has done just enough here to claim it has acted in good faith. Really, who can fault them for the statements they have put out? And yet, there is legitimate doubt about the safety of mercury fillings. This leads me to wonder what pressures might be keeping the FDA in what I consider a state of inertia on this.

One factor is that it would be just too damned expensive.  In my informal poll, to a person, they all had excellent insurance or the money to pay out of pocket for such procedures. That’s important to note because amalgams are still considered a standard, even though according to a paper in the well-respected journal BioMetals:

“The largest mercury-free professional dental association…[states]… there is no situation in which amalgam is either required or preferred…The predominant alternative—resin-based composite—requires more skill to install, but when properly placed it is as durable as amalgam according to a recent meta-analysis.”

More skill, more money. More money, more fighting with insurance companies for reimbursement. Upshot: it’s not an easy sell to the government, which funds Medicare and Medicaid, which set the tone for other third party payers, that resin should be the standard.

To that end, I have been talking about my research to a whole range of folks, and to my surprise, a lot of them – “normal” people, not people who rage against the Man and the Medical Establishment – have had their amalgams removed, and not in accordance with the FDA guidance, but in fact by going to amalgam removal specialists.

That’s just an informal, observational study on my part, but it tells me that already there is a market demand for not having amalgams.

The reason amalgams went so long without raising suspicion is just simply because they had been around so long, that their being part of the “status quo” made them so easy to overlook.

Here’s what the article in BioMetals said:

“In use since the 1800s, dental amalgam has never undergone the regulatory proof-of-safety testing that is required for other medical implants under US law. Under the 1976 Amendments to the Federal Food, Drug, and Cosmetics Act, Congress directed the FDA to assess the safety of medical and dental devices and to require premarket approval of safety for any device that “is intended to be implanted in the human body” (USC §§ 360a, et seq.), yet the FDA has interpreted the statute to exempt dental amalgam.”

What’s more curious to me about it is that the FDA came out with their statement in 2017, even though the BioMetals paper was published in 2014, and suggested that there is enough evidence for us to stop using it in this country, and listed countries where it is already banned or prohibited in certain populations, such as pregnant or nursing women.

This is where the “big is bad except when it isn’t” meets civic duty, i.e., us as individuals.

It’s clear from our nation’s opioid crisis that even when the FDA is not working at its most effective, we have to have some kind of powerful body looking over the shoulder of drug makers. If we don’t want even more raging opioid crises or the like, we need the FDA.

But we also need good oversight of the FDA, because no matter the number of people with good intentions, as a big agency, it can fail at its job. Congress is the FDA’s overseer, and the Academies helps Congress in that job.

Thus, the “ruse” I mentioned: the FDA leaned on the Academies to say what I think people within the FDA probably knew needed to be said, but weren’t sure how to say or what might happen if they did say it. It was a lengthy process, but it got done and no one had to become a target in the agency.

And by the way, the Academies did release a paper based on the hearings, and there have been actions taken subsequently, including the current administration declaring the opioids crisis a public health emergency and the Opioid Crisis Response Act.

Let’s not forget why the FDA called in the Academies, though. It was because citizens demanded that something be done to reverse the death rate from opioid abuse.

I am not a crusader of causes, but I am keenly interested in pointing out why we should not take anything our policymakers and their enforcement arms say and do at face value. There’s oversight, and then there is “oversight”, meaning that we as citizens can’t assume any public policy is founded on perfect science or that it was explicitly created to protect us, since it’s possible that it just ended up that way as an “oversight” of the “we never thought to question it” kind.

With opioids, It took nearly three decades, but change is finally happening.

That means nothing to the over half a million dead Americans opioids killed. That’s also meaningless to their families. But, okay, so we have change. Less people will die in the future.

And I suspect in another 30 years, it’s highly possible no one in this country will have amalgam fillings.

~Whitney