WHAT IS THE FDA WARNING ABOUT BUPRENORPHINE PRODUCTS (SUBOXONE/SUBUTEX)?
Some quotes from the FDA warning:
The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.
Some cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events.
CAN I SEE THE REPORTS OF ADVERSE EVENTS OTHER PEOPLE HAVE MADE?
Yes! The FDA has a website called FAERS (FDA's Adverse Event Reporting System). Anyone can search reports of adverse events on this website.
WHAT DO I DO IF I HAVE A SUBOXONE RELATED DENTAL INJURY?
Instead of e-mailing Claudia or Bev your information about your dental injury, please take the following steps:
1. Call the law firm's call center - 401-442-6648
3. Report your dental injury on the FDA's MedWatch website.
"MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:
- Prescription and over-the-counter medicines
- Biologics such as blood components, blood/plasma derivatives and gene therapies.
- Medical devices such as hearing aids breast pumps, and pacemakers.
- Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.
- Special nutritional products such as dietary supplements, medical foods and infant formulas.
- Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
- Food such as beverages and ingredients added to foods."
IS THERE A LAWSUIT ABOUT DENTAL INJURY FROM SUBOXONE (BUPRENORPHINE)?
- There is a law firm interested in this issue.
- Read this website about dental injuries and Suboxone created by the lawyer to have your situation evaluated.
WHAT DOES ANDREW KOLODNY AND PROP HAVE TO SAY ABOUT THIS ISSUE?
Kat Marriot, the Executive Director of PROP had this to say about Suboxone and dental injuries:
PETITION FROM ADDICTION ORGS FOR FDA TO RETRACT THE WARNING
Interestingly, about ten addiction organizations (many that take money from Indivior) quickly petitioned the FDA to retract the warning. Their point is that Suboxone saves lives of those with Opioid Use Disorder, and this warning can discourage people from taking the medication. It's ironic because these same organizations are the ones helping to sue Purdue and other pharma companies for hiding possible negative side effects of opioids for pain. I suspect many of these orgs will also be getting some of the billions in settlement funds from the multi district litigation against pharma.
We 100% understand that this medication saves lives of those with OUD. Does that mean they don't have a right to know what can happen to their teeth? Dental care is extremely expensive, and can cost tens of thousands of dollars. Who can afford that? People with addiction have a right to know the possible side effects of this medication. The other issue is Suboxone/Subutex is being pushed on people in pain. It absolutely works for some people, and we support its use as an option. Unfortunately, it's often not given as AN option it's given as THE ONLY option even to patients who are stable on full agonist opioids. Don't CPP's have a right to know what can happen to their teeth especially if they're told their options are Suboxone or nothing?
- Bev's story about being denied opioids due to having been sexually abused
- What is the ORT (Opioid Risk Tool)?
- Dr. Webster's statement about the ORT being weaponized
- Study validating ORT/Updated version eliminating the sexual abuse question
- Dr. Webster says the original ORT should no longer be used
- What can you do to help?
- Letter to give to your doctor with this information
Bev's story about being denied opioids due to having been sexually abused
In November 2017, I (Bev) did something I had done many times before; I went to the emergency room due to kidney stone pain. I had frequent kidney stones due to having Crohn's Disease. Although I had pain medication at home, I was unable to keep it down, and the pain was unbearable. My doctors had always told me if I couldn't take the pain or couldn't stop vomiting, to go to the emergency room. Recent scans showed multiple kidney stones in the ureters. The ER doctor was kind; she treated my pain and decided to admit me for pain control. That's when things took a turn. Upon entering the room, the hospitalist said "I saw in your prescription history that you have gotten Ativan, What was that for?" I told him it had nothing to do with why I was there, that it was for PTSD. The rest of the conversation went like this: Dr.: "What is your PTSD from?" Me: "Childhood trauma." Dr.: "What kind of childhood trauma?" Me: "I don't understand why this matters." Dr. "Was it from sexual abuse?" Me: "Yes." Dr. "Due to that, I can't give you any IV opioids. I can give you what you take at home, and I'll give you a bit of a higher dose, but you're too high risk of addiction because you were sexually abused as a child." I was shocked and mortified. He then said "IV opioids change your brain chemistry and so does sexual abuse. You have a high risk of addiction and I won't take part in causing that." He then hit me on the arm and said:
"You'll thank me someday for this."
I was then treated horribly for the next 24 hours until I went home. It was from that hospital bed that I first contacted Claudia, and why I started researching and advocating. I had never had childhood abuse used against me in health care. Nobody had ever asked me this question before, and never in my wildest dreams (or worse nightmare) did I think this doctor would use this information to deny pain medication. While researching North Carolina's pain guidance from the medical board, I came across the information about the Opioid Risk Tool (ORT). Their information told doctors to give all patients the ORT before giving opioids.
This was in 2017 and it still affects me. It traumatized me. I'm terrified to ever go to the hospital again. I'm afraid of doctors. I can't express strongly enough how much this one incident changed my life. It damaged me. I'm fighting back and hoping to be a voice to others who this has happened to.
Maia Szalavitz discussed my story in the Wired article "The Pain Was Unbearable So Why Did Doctors Turn Her Away."
What is the ORT?
The ORT is a risk mitigation tool, meant to see who may be high risk for addiction so the doctor can keep a close watch on those patients. It was created in 2005 from Dr. Lynn Webster.
The first thing I noticed was that when a woman answers yes to the sexual abuse question, she's given 3 points against her. Yet, a man gets 0 points. This was done because the study used as evidence for this question was one that only researched the connection of women sexual abuse survivors and addiction. Little did I know that I wasn't the only person this happened to. For the past few years, I've gotten quite a few stories from women who had been sexually abused, assaulted, or even physically abused that had a doctor use that information as a reason to deny opioids
Dr. Webster's statement about the ORT being weaponized
In 2019 Claudia interviewed Dr. Lynn Webster and I called in to talk to him. I told him what happened and he said that was a weaponization of the tool, and it shouldn't be used that way. He then wrote about the weaponization of the ORT in an article in Pain News Network "The Opioid Risk Tool Has Been Weaponized Against Pain Patients."
It is a cruel misapplication of the ORT to use a background of sexual abuse as the only criterion to assess whether a patient should receive opioid therapy. The ORT is an important tool in mitigating harm that prescribing opioids could cause. It should not be weaponized to justify denying people in pain appropriate therapy.
Unfortunately, this didn't help the situation. We've continued to hear from women who were denied opioids due to being a survivor of sexual abuse/assault. Has the ORT been worked into risk score algorithms like NarxCare? Nobody knows for sure since their algorithm is proprietary, but I would say probably. We do know it's been embedded in EHR (Electronic Health Record) CDS (Clinical Decision Support Tools). I was left with the question of how do we fix this.
Study validating ORT/Updated version eliminating the sexual abuse question
Carrie Judy, our other researcher, while researching ORT came across a relatively new study from 2019 by Dr. Martin Cheatle. This study's purpose was to validate the ORT. The results showed that the sexual abuse question wasn't relevant, and that the ORT was actually more reliable when removing that question. He created an updated version of the ORT leaving the sexual abuse question off.
Listen to Dr. Cheatle discuss why the sexual abuse question should be removed:
We got a lot of feedback that female patients didn't want to answer that question; it caused too much trauma
Unfortunately, there hasn’t appeared to be any formal effort to make sure the original ORT would be replaced by the updated version. As we stated, we are aware the ORT has been embedded in some Electronic Health Record platforms and also worked into some risk scores. It’s given by doctors and treatment centers, Since some risk scores such as NarxCare are proprietary, there is no way to know if the ORT is used in their algorithm, and if so which version.
Dr. Webster says the original ORT should no longer be used
Periodically over the years we've asked Dr. Webster to release a statement for agencies and doctors to use the updated version instead of the original. On June 29, 2022 he listened and wrote “Another Look at the Opioid Risk Tool.”
It distresses me to know that, while the original ORT served to help assess the risk opioids posed for individuals, it has also caused harm. Since the question about a woman's sexual abuse history does not provide any additional benefit, there is no reason to retain it. The revised ORT should be used instead of the original ORT.
What Can You Do to Help?
We have noticed that most government agencies, individual doctors, and treatment centers still use the original version of the ORT. We plan to create an open letter (and will post it here) to formally request places that use the original to replace it with the updated version.
If you're given the ORT, please check to see which version it is. If the sexual abuse question is included, please show your doctor this information and explain that evidence shows the updated version is superior, and that the creator of the ORT released a statement to not use the original version.
If you've been denied opioids due to being a survivor of abuse, please contact me at firstname.lastname@example.org.
SCOTUS sides with the petitioner and Health Law Professors in Ruan v. United States 9-0! As explained by Jennifer Oliva:
The bottom line is that the DEA can no longer say "we think this exceeds the legitimate bounds of medical practice" and then put on their paid experts. INSTEAD, they must prove beyond a reasonable doubt that the doctor KNEW/INTENDED that the Rx was outside the legitimate bounds. What matters is the prescribers knowledge and intent.
Here is the ruling of the Supreme Court Ruan case. Here are some comments from the lawyers who worked so hard to
Some comments about the case from Ron Chapman:
Many #cpp are wondering what this decision means for them. Simply put, it will be harder to prosecute physicians for medical judgment. We won’t see immediate effects but over time we will get there.
Once a doctor proves that they are authorized to prescribe a controlled substance (e.g., has state & federal registration), the government must PROVE BEYOND A REASONABLE DOUBT that doc KNEW or INTENDED that their prescribing conduct was unauthorized under the CSA This means that the doc must have known or intended to prescribe outside the legit bounds of medical practice. Not enough for DEA to say "we think this is outside the bounds." Must prove that doc knew it was outside the bounds. Huge win.
This is such a tremendous outcome. Honestly, even the conclusion in the concurrence (which would have required a subjective good faith defense) would have been a win in itself. Amazing news for so many patients. Now we need to get word out to the prescriber.
Today #SCOTUS ruled unanimously in Ruan v. United States, that doctors authorized to prescribe controlled substances can only be convicted for violating the Controlled Substances Act when they intend or know that they are prescribing in an unauthorized manner. The opinion tracks exactly what we argued in our amicus curiae brief and could not have been better for people living with pain. The Court specifically rejects the view that doctors are criminally liable if their prescribing is not in accord with current medical standards. The difference is important, and especially so for doctors treating patients in pain, who might otherwise be deterred from meeting the needs of their patients by the fear that disagreement with their medical judgment would subject them to serious criminal liability. Indeed, Justice Breyer, writing for the Court, specifically singles out the chilling effect of overdeterrence and the importance of distinguishing morally blameworthy from socially necessary and beneficial conduct (i.e., prescribing medication for her patients). Justice Breyer writes, “a strong scienter [or mens rea] requirement helps to diminish the risk of “overdeterrence,” i.e. punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.” The opinion also addresses the “vague, highly general language of the regulation defining the bounds of appropriate prescribing,” and the importance that providers not be convicted criminally for what is essentially negligence: As Justice Breyer writes, “the Government’s standard would turn a defendant’s criminal liability on the mental state of a hypothetical “reasonable” doctor, not on the mental state of the defendant himself or herself.” It is also important thing to note is the concurring opinion by Justice Alito, in which Justice Thomas joins and Justice Barrett concurs in part, concurs fully with the Breyer opinion that the appropriate standard is the subjective state of mind of the prescriber. The government had argued for an objective state of mind standard which we considered to be an oxymoron, and which no Justice agrees with.
For an in depth explanation read the following:
March 1, 2022 at 10am EST, Dr. Ruan's case was heard before the Supreme Court.
We explained it all in detail here.
Attorney Ron Chapman created this post after the case was heard:
"ORAL ARGUMENT IN RUAN V. UNITED STATES
The Supreme Court heard oral argument today in the most important healthcare case since 1975, Ruan v. United States . While we were hoping for a glimmer of justice, what we got was a dizzying lesson on grammar, parsing of words, and speed limit analogies. But Justice Gorsuch in his gentle, fatherly cross examination style attempted to bring the argument for petitioners back on track by showing the nonsensical and circular nature of the Government’s argument.
This issue before the Supreme Court is thoroughly addressed here and if you aren’t familiar go back and read that article first.
Before we get into the oral argument its important to understand the changes in the case prior to the parties taking the podium. The issue before the 11th Circuit was the failure to give a “good faith” instruction which essentially permitted the Government to convict Ruan under a strict liability standard. The 11th Circuit believed that if his conduct failed to comport with the objective requirements of the practice of medicine then he should be convicted. Petitioners argued that if he subjectively believed he was following objective standards then he should be acquitted. The Government, straying from the 11th Circuit’s opinion pivoted in their opening brief and said that the physician must make an “honest effort to comply” with the objective standard of practice. This is where the train left the tracks. As Ruan’s counsel pointedly argued - the Government’s argument is a malpractice standard gussied up as an objective standard. The Government pivoted so hard that their argument appeared to turn in the direction of the petitioner, arguing that a subjective “honest effort” is enough. But instead of seizing on that juicy opportunity the justices questions sped past the issues at the heart of the case and turned into a confusing digression into the statutory elements of the offense.
THE INTENT COMPONENT
21 U.S.C. 841(a) is a drug trafficking statute. It basically says that its unlawful to knowingly and intentionally distribute controlled substances. But an exception exists in the statute for licensed practitioners. Doctors, pharmacists, and other prescribers and dispensers are exempt from the statute as long as their conduct is “for a legitimate medical purpose in the course of professional practice”. In order to address whether the “good faith” of a physician is relevant the court needed to answer a threshold question and that is whether the intent requirement of the statute applies to the distribution or the exception. Thus, the question is: Does the government need to prove that the doctor knowingly and intentionally distributed drugs or does the government have to prove that the doctor knowingly and intentionally prescribed “outside the course of professional practice and for other than a legitimate medical purpose”. If the government needs to prove only that a physician intended to prescribe drugs then the only doctor who escapes this element is one who prescribes in a coma - as Ruan’s counsel pointed out.
And so the court debated, for some time, whether the intent of the statute was to incorporate the prescriber’s exception as an element of the offense or an affirmative defense to the crime. If its an element, the the intent component must apply to the exception if its not then the intent component only applies to the distribution. Justice Alito seemed to think that the intent element is only related to the distribution and Gorsuch seemed to think that its related to the prescriber’s exception. The other justices didn’t offer much of a position but it seems that Breyer and Alito favor applying it to the distribution because failure to do so creates a statute with two separate intent requirements - one for prescribers and a separate for the general public. Breyer and Alito likely believe that such a reading frustrates the intent of congress in creating the statute.
ONE GLARING OMISSION
But in all of the heated debate surrounding the statutory text of the Controlled Substances Act, the Court and the parties missed the most important issue in the case, and all physician prosecutions. Both the Government and Petitioners conceded in their briefs that the standard applied in such cases is an objective standard of practice- which is incorrect. Both United States v. Moore and Gonzalez v. Oregon clearly state that the Federal Government lacks authority to regulate the practice of medicine. The Government only has authority to punish physicians who act so flagrantly that their conduct can be seen as “drug pushing”. And so, the Government’s proof that a physician’s conduct departed from some sort of “objective standard of care” amounts to mere malpractice and something for State Boards to consider - an issue hinted at in Justice Thomas’s final question. Petitioners should have taken the position that the standard of care is relevant in physician prosecutions only to show the jury the reasonableness of the physician’s conduct but in order for the government to fully satisfy the elements of 841(a) they must prove that a physician’s conduct departed so far from the practice of medicine that they ceased practicing medicine at all.
For more on that point read my article “7 Dirty Words”.
Instead of arguing this federalist argument, the parties were landlocked by the fact that the court granted Cert on the “good faith” issue which necessarily requires an argument regarding the intent elements instead of elevating above this crucial digression and discussing the authority of the Controlled Substance Act to regulate the practice of medicine generally.
Tying an objective standard of care to the elements of an 841(a) violation is dangerous because (1) there is no consensus on what that standard actually is in the medical community, (2) it requires juries to grapple with complex and ever changing medical topics, (3) it allows the government and DEA to drive the standards of practice through CDC guidelines, “red flags”, DEA administrative decisions, and other unpromulgated guidance documents. This is dangerous because either subjectively or objectively the parties have permitted the government to take the position that violation of an invisible and ad hoc standard is sufficient for conviction in the first place.
PREDICTION OF THE COURT’S DECISION IN RUAN V. UNITED STATES
Predicting the outcome of a pending supreme court case is a bit like predicting the weather 30 days out - it ignores the dynamic interplay of the politics of the court. But I’ll take a stab. The Government abandoned the 11th Circuit’s rationale and the Court has no choice but to reverse the 11th Circuit and permit a good faith instruction or at the very minimum a proper instruction on the intent component of an 841(a) violation. It seems that at least five justices agreed with the fact that the intent requirement relates to the prescribers exception: Barrett, Gorsuch, Kavanaugh, Thomas, and Roberts. I think there are enough votes for reversal. But the tougher question is what relief, if any, can be afforded to doctors in the future given that both sides seemed to agree that an objective standard of practice is the standard in interpreting the phrase “legitimate medical purpose”. Kavanaugh seems to take the position that the statute is vague in the first place and may offer a concurring opinion and discuss vagueness unless he can pull the other four in his direction. But I don’t think he will be successful because of the politics of the Court. Determining that 841(a) is vague as applied to physicians will disrupt the balance of justice and require reversal of a lot, actually a ton, of convictions. And one thing we know about the Supreme Court is that it doesn’t favor such sweeping changes. Now this problem was set up by the Court in the first place in failing to address the statutory text since it was first enacted. Since 1975 we have been left without the voice of the court on this statute allowing the circuits to take differing interpretations and circuit splits as they grapple with the statutory text that was most likely written by a congressional staffer in 1970. But I do expect at least some comment on vagueness.
In sum, I expect Ruan and Khan to get some sort of relief from this decision because the jury instructions in their case mis-applied the intent requirement of the statute and made drug trafficking a strict liability offense (like speeding) as applied to physicians. But I don’t expect a sweeping change here, I expect a tailored attack on the 11th Circuit’s reasoning and I expect that the Circuit Courts will pigeonhole the Supreme Court’s decision to prevent its broad application to all physicians convicted under the statute.
There is some good news, potentially, on the horizon though. The Court has held the case of Naum v. United States pending the outcome in Ruan. This is a case where the federalism argument is very much alive. Its a case I have personally handled and if Cert is granted I will be arguing before the Supreme Court. We don’t know why Naum was held by the court but its likely because the Court didn’t want to address the federalism argument until it first decided the more minor issue of good faith and its application to the statutory text."