Vanderbilt Opioid Mortality Data Comes Under Fire

Vanderbilt Opioid Mortality Data Comes Under Fire

By Ed Coghlan

There is blistering criticism of a Vanderbilt University study released this week about opioid use.

The report said patients who use opioids had a 64% higher risk of dying within six months of starting treatment compared to patients taking other prescription pain medicine.

The study centered around 45,000 Medicaid patients in Tennessee over a 13 year period ending in 2012.It’s the study and the patients that they surveyed that has many crying foul.

One is Terri Lewis, PhD, who studies the health care system in the United States. Dr. Lewis is also a resident of Tennessee, is the mother of an intractable chronic pain patient who lives there and understands the state’s system very well.

She believes there are obvious limitations to the Vanderbilt study and she outlined a number of them.

Here’s her rebuttal:

  1. This was a retrospective study that relied on data coded on death certificates to ascertain all causes of mortality (coroners don’t have to be medical professionals in TN) – there is no indication that autopsies were conducted to ascertain the relationship of coded cause of death to preexisting conditions for which treatment was addressed.
  2. The data between two groups (opioids and others) were tracked over a number of days. Right off the top, there is variability introduced by unknown conditions associated with chronic pain, the course of illness is unknown, the limitations of the medical health care provided, the limitations of the information that was collected, and the detail on codes that were billed for.
  3. Prescription of long-acting opioids for chronic non-cancer pain, compared with anticonvulsants or cyclic antidepressants, was associated with a significantly increased risk of all-cause mortality, including deaths from causes other than overdose, with a modest absolute risk difference. ‘Association’ is not correlation or causation. One cannot conclude, based on the limitations, that there is any real relationship at all that is meaningful from which conclusions should be drawn about treatment decisions that apply to either this population or the population at large.
  4. Cardiac death is the leading cause of death in Tennessee. It takes years to develop and occurs due to poverty, poor diet, community acquired stress, smoking, exposures to a a variety of illness.

Dr. Lewis concluded: “Claiming that Opioids contribute to the COD seems a little over the top to me. While one may make the claim that in this particular cohort, opiates are more frequently associated with deaths among those who died with heart disease, one cannot make the claim that opiates contribute in any way to heart disease as a cause of death. The information simply doesn’t exist to support this claim. One could just as easily conclude that opioids were prescribed to treat pain associated with heart disease.”

This is a perfect example of the need to understand the limitations of health data when evaluating the soundness of a publication.

Dr. Lewis also sent links to some data to support her point of view:

Leading causes of death in Tennessee (link)

To see the Tennessee Drug formularies, click here and here.

To see who is eligible for Tennessee Medicaid, click here.

Subscribe to our blog via email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Authored by: Ed Coghlan

  Subscribe  
newest oldest
Notify of
Melissa – I don’t know where you’re located but if it was me I’d go somewhere and get a comprehensive evaluation (like Mayo Clinic or somewhere that specializes in ankylosing spondylitis and has a good oncology dept). It’s true that there’s an increased risk of DEVELOPING a new melanoma (and other skin cancers, lymphomas, etc.) on TNF alpha biologic drugs; however, your melanoma has already happened and you weren’t on any (as I read your story) so it was a random event perhaps associated with sun exposure or just because. I’ve never read any study that says being on a TNF alpha biologic drug makes some pre-existing melanoma any more aggressive and a study like that would be difficult to do, so it appears to me to all be conjecture. If you had a deep melanoma then the risk of recurrence/spread is based on staging and is a risk for you whether or not you’re on a biologic drug. I’m concerned they may be making an unsupported statement that because there is a higher risk of developing melanoma on TNF alpha biologic drugs, the one you already have had might somehow become more aggressive when it might be cured?? It’d be advisable for you to be under skin surveillance because you’ve already had one melanoma anyway and you’re at higher risk of developing another irregardless of being on a TNF alpha inhibitor or not – you’ll have to be followed for the one you’ve already had anyway. Dermatologists recommend a full body skin exam including eye, dental, and pelvic exam (melanomas can occur anywhere) Only ‘melanoma in situ’ or one that hasn’t yet invaded is 100% cured…. deep ones, irregardless of a negative sentinel node (or other) biopsy and time, always have a statistical risk of returning. There’s a lot of data about increased risk of skin cancers (including melanoma) in transplant cases but that’s not you. You’re a more complicated patient and it’s difficult to know whether TNF alpha drugs would even work for you at this point since you’ve had ankylosing spondylitis for a long time (the drugs work better when started early in disease) and may have questionable efficacy with your late stage complications. I have similar problems – though my rheumatologist wants me to continue trying and I am currently on Cosentyx (and isn’t working so far). Were it me I’d want a combined rheumatology/oncology/dermatology consultation at the same institution to evaluate your particulars rather than a phone consult about your pre-existing melanoma alone. I’ve developed a bi-clonal gammopathy most likely because of all the drugs I’ve been on including Rituxan to control my psoriatic arthritis which could eventuate in multiple myeloma and could be partly responsible for my bad neuropathy. The trade off for all the years of relief (and being able to work) were worth it – I wish they still worked like they once did and I’m still trying new ones because of all the grief over pain meds you correctly state. But… Read more »

Melissa, while I too am a chronic pain person…my heart breaks for you and all that you endure. You are magnificent!
Thank you for writing all that you did, it is so perfectly said and if you haven’t yet…yours is an excellent story to send to your Senator. Keep strong, keep smiling Maureen

Thank you for sharing Melissa. Because every single case of chronic pain is different, no one could actually imagine your life and the pain you exist with every day. But believe me, your explanation almost brought me there. What these government bureaucrats can’t or just refuse to understand is that so many of us live in a prison of absolute misery with no possibility of parole. So many of us would welcome a death sentence if our meds are taken away and far too many of us have already been executed in humanely. Even mass murders get medications to calm their nerves and easy their pain when they are executed for their crimes. But I guess murders have more rights than people who have paid their Taxes and health insurance all their lives.

All I can say is don’t ever feel uneasy speaking your mind. Don’t ever be afraid to confront those who violate your rights. And please don’t ever feel imbarrassed to talk about the pain you live with. Right now the only real outside support each and every one of us have is from those we meet here and in other pain groups. Their are pain suffers here who just read the articles. Than there are those here who comment on story’s and never go any further. But there are also people here who are taking action by writing, emailing and calling senators and congressmen every day in an attempt to make some change. It’s really up to you where you want to be and no one will fault if you just like to observe. Thank you again for your story and I hope your pain relief stays addiquit.

I have suffered with an auto immune condition called ankylosing spondylitis for the last 20 years. It causes constant pain and inflammation in the bones, joints (including insertion points where tendon joins bone) and muscles. It is progressive, there is no cure. The most effective drugs currently used to treat AS are TNF blockers, also known as biologics. Most healthy people have most likely only heard of these drugs through TV commercials. Humira, Enbrel and Remicade are the mostly widely advertised. Phil Mickelson, the pro golfer, promotes Enbrel. He started using this drug after he was diagnose with psoriatic arthritis, another auto immune skin/bone disease. Fortunately for him, this drug was very effective in his case, and he was able to resume his professional golf career. He was quoted with saying that he lived in fear of having to retire, due to severe joint pain and fatigue, prior to starting one of the biologic drugs. These medications calm your immune system down, ultimately relieving a great deal of the pain, stiffness and crushing fatigue that these auto immune diseases inflict on their victims. I highlighted Phil Mickelson and his case of psoriatic arthritis because most people are familiar with him and could maybe relate to something they’ve not experienced themselves. I also highlighted his story because these drugs are NOT an option for me. I was diagnosed 8 years ago with malignant melanoma. Gratefully, it had not started spreading to my organs or lymph nodes, but I did need a surgical procedure called a “wide excision”. My surgeon had to go three layers deep and I awoke from surgery with a 9 inch wound and over 130 stitches on my right thigh, right above the knee. When my rheumatologist wanted to put me on a 3 month trial of a biologic drug, like Humira or Enbrel, I reminded her that I had melanoma in my past. She was not sure of the dangers/risks in my particular case, so she sent me to an oncologist. She also was not exactly sure, so she called Mass General hospital in Boston. She got the opinion of 4 other oncologists, and all of them concurred that going on one of these TNF/biologic drugs would be too high of a risk for me. Melanoma is directly linked to the immune system and these drugs block your over active immune system. I have been on every anti inflammatory drug on the market, over the counter and prescription. The only ones that have decreased my pain at all, were ones that had to be used in such high doses, that they became very dangerous to my kidneys and liver. I also am showing signs of my stomach lining breaking down. Most healthy people do not understand that when your stomach lining erodes, it does not grow back. It’s a very slippery slope because then you add another very serious medical issue on top of another. Once your stomach lining is gone, you can no longer absorb nutrients… Read more »

I had an angioplasty in 2001.
Was it because of the 30 mg of morphine it took to control my renal colic in 1989?
Or
Could it relate to my extensive family history of sudden cardiac death, killing my father at age 58, his father at age45?
This witchhunt must be arrested.
I see the health consequences of poverty
Diet
Altitude
Every day in my role as volunteer physician in a country that really needs my contribution.
Living at 12,000 feet in abject subsistence poverty
These folks have pain.
Severe pain

And
No opiates.
Or any other meds.

We have great health care in America.
The consequence of that:
Pain.
Atul Gawande noted the cost of our medical successes has been a slower
But still inevitable decline toward a delayed death.
“Enjoy yourself
It’s later than you think”

Please let’s get government agencies, regulators and agents
Out of the exam room
Let doctors treat patients!

I could not have said it better myself!! Thank you for your compassion for “us” ! It really makes a difference when “ppl” get it. God bless –

REALLY??? Opioid users are 64% more likely to die in the first six months???
Do you hear what your saying??? These studies are definitely done by ppl that have never had chronic pain before!!!
What “it” should say ,is that 64% of ppl wouldn’t survive more than six months if they were taken off their much needed medicine.
I know that it is so hard to understand and comprehend what just 1 day of chronic painfeels like.. but PLEASE, do not insult us by this “junk science”!!

I simply do not understand why this whole opiate crises encompasses everyone who has used this medication illegally, those who have had acute pain (short term) then became addicted to them for the high. From my understanding, there are 10 million chronic pain syndrome patients who require this drug to function, to be able to get out of bed every morning, to be able to function in the work place (if possible) and to have a sense of purpose rather than requiring 24/7 assistance from others as the pain is so horrific that all they can do is lay in bed, being as still as possible to keep the pain from rearing it’s ugly head. Why is it that those with a little power want to control others who are seriously ill (I consider chronic pain syndrome a serious illness, it robs us of life!), to take away the only medication that actually helps us to be independent based on conjecture, poorly done studies based on assumptions only without clear evidence, and out right lies! These people whom many do not have a medical degree or full knowledge, have developed the suggested implements for doctors using opiates as a last resort only (read “never”) should know that they have blood on their hands from the deaths of the chronic pain patients because their medication was taken away and left with this indescribable body wide pain with no recourse but suicide. This, to me, is the worst case of inhumanity I’ve ever seen!

In order for health data to be usable for analytic purposes it must have the following characteristics (adapted from Stair, 1999):
1. Accurate. Accurate information is free from error.
2. Complete. Complete information contains all of the important facts.
3. Economical. Information should be relatively inexpensive to produce.
4. Flexible. Flexible information can be used for a variety of purposes, not just one.
5. Reliable. Reliable information is dependable information.
6. Relevant. Relevant information is important to the decision-maker.
7. Simple. Information should be simple to find and understand.
8. Timely. Timely information is readily available when needed.
9. Verifiable. Verifiable information can be checked to make sure it is accurate.
We simply cannot make any claims about the data in this study because the authors did not have control of its’ collection. And individual health data in the Medicaid program is almost never collected under research conditions. Therefore, when using it for analytic purposes one has to severely delimit conclusions and rule out alternative hypotheses for one’s findings. Hard to do when you didn’t collect the data.

Dr. Lewis,

You make excellent points. What sickens me, and should sicken every other pain patient in the USA is that this faulty, poorly planned study, meant purely for sensationalism was on the front page of papers across the country.

What difference does it make that this study was truly worthless. They got their point across, along with some great “sound bites” from anti-opioid doctors about another reason, that these senseless drugs should be further restricted.

I feel that regardless of what we do, what we say, we the propaganda is so strong against us that most of the country considers us abusers and we deserve what we get. I’m sick!!!

I always appreciate Dr. LEwis’s posts. …always enlightening and she is such an asset to the pain community. Thank you Ed, and thank you dr. Lewis.

Granny, I’m with you (only my name is Grammy). Let’s make our own poll/study/whatever and use all the people from here and on Facebook and get published here then send it everywhere. I have a good heart (I mean healthy) and have been on opioids for 20 years. Sound good?

Well, now the flavor of the day is to publish a report claiming heart risk and opiod use. Two years ago it was opiod overdose more than auto accidents, Yada, Yada, Yada, anyone with good sense knows that there is abuse and misuse. However, it is senseless studies such as this that punish those that are in need of medication for chronic pain. Vanderbilt could have just as easily conduct this same study showing that the use of long acting opioid medication saves lives by helping to reduce stress, lower blood pressure, thus helping those who need chronic pain long acting opiod medications. Shame on you Vanderbilt, when one of you staff has chronic pain and suffer the I’ll effects of chronic pain, I seriously doubt that your colleagues prescribed two aspirin.

Kris, great comment!

Hmmmm! I have been taking opioids for approximately 15 years. My next
birthday I will be 80 years old. Maybe I should do a survey and say that taking
opioids helped me live longer. Oh, yes! I lived longer without heart disease.

It is like statistics. You can make it say anything you want it to say – even if
it is not true.

Since there weren’t enough studies to show the effectiveness of long-term opiate use, by golly we’ll just whip some out using one of the poorest states in the nation, one who has not expanded Medicaid, coal miners, ranks 47th in the country for smokers, 4th highest for lung cancer….
“Tennessee has the 4th highest incidence (new cases) rate nationally, 3rd highest among men and 11th highest among women. The overall 5-year survival rate observed nationally for lung cancer is only about 15%, one of the poorest survival rates for any of the major cancers.”

Yeah buddy, and we get to be published in a real professional journal to boot!

Now go repeat it nation wide, dumb a@@

Thank You Terry Lewis,
Here is another “Study” that will get run all over the Internet, and picked up by a number of Mainstream Media publications. Just like the “Opiod Analgesia” this one is cherry picked from thousands of of these so called “Scientific Studies”. The Headline and the Narrative dovetail nicely with the current narrative that they are feeding the general public and Policy makers. When you apply a little bit of critical thinking it becomes meaningless. But we will hear this one repeated as naseum because it lines up with the current ideology.
This explains where the Logical fallacies lie. It also points out the reliance on Medicaid data to infer a possible explanation.
The Studies that are repeated in the Corporate Media/Medical Industry/ Court of Public Opinion are only the ones that already dovetail with their pre-drawn conclusion. Once we employ just a little bit one scientific thinking they are rendered meaningless. Unfortunately this will be buried under an avalanche of commentary, hysteria and advertising. The real question here is why are they not collecting the Data? Healthcare is a very big part of our National Budget and we used to believe that Science was a way to guide any kind of decision, yet here we are. Science is still Science, but the application of that Science is determined by Industries and Opinion.
The Industry has so much power they are able to persuade what kind of data is even collected anymore.
Just like anything else the facts are inconvenient, only profit is important, and a small percentage of that profit goes into influencing Politicians and Media.

If you take these studies as truth then you’ve bought the government narrative that pain patients are the cause of heroin addiction they’re undeserving if having their pain treated and generally should be demonized and sent to shrinks instead of doctors

I have been on norco 5 for 8 years and I am not dead ;…hmm..maybe we should take our own survey??

After I read the title to this article, and before I went on to read Dr. Lewis’ information, I immediately thought ‘this does not sound right to me’.
My next thought was ‘perhaps this has nothing to do with a responsible patient and all to do with deaths of addicts who died months after they began abusing opioids?’.
Thank you Dr. Lewis’ for your rebuttal and for keeping up on your research, providing info and your comments (which always make sense to me!).

Dr. Lewis, thank you so much for weighing in on what seems to be an increasingly complicated issue! I don’t even live in the US, but Canada appears to be following similar guidelines, based on these recent publicized “medical studies” (I use the term loosely, as it’s being proven that the accuracy might not in fact be all that accurate after all)

As a chronic pain sufferer (I’ll only speak for myself, as I’m sure not everyone feels exactly the same way) I have enough on my plate without having to worry about my my medication being taken away. When you have an illness that does not have a cure, and is inoperable, pharmaceutical therapy (potentially opiods) are one, if not the ONLY, last resort! Do I want to have to take them? NO! But if they cause less harm on the body than my cocktail of extremely high doses anti-convulsants amongst others, then to deny me that option seems counterintuitive to the study at hand.

Moreover, there are patients who use opioid medications to improve their quality of life and functionality. Is it not inhumane to deny them of that right based on a poorly executed study, likely funded by you know who? In my humble opinion it simply seems unconscionable! (And unconstitutional, if we want tolook at it from a political standpoint).

I’ll cut myself off here and justreinforce my gratitude for you taking the time and being compassionate enough to highlight the inconsistencies in the latest study! I doubt this will be the last, unfortunately.

The world needs more people as kind and understanding as you<3

This is a CALL to action for all pain sufferers! It’s time to speak out against the oppression and discrimination that we have all endoured at one time or another. Myself and my fellow members of the Chronic Pain Rights Support Group are calling on our fellow pain suffers to call and email your Senators about all our concerns and issues with the way that several of the Senate Bills regarding opioid medications and addiction treatment and the way they will negatively impact the Chronic Pain Community. Our concerns should be that these Bills spacifically allocate funding for the treatment of addiction with complete and total disregard to the pain community. We should demand that our rights to proper pain relief be guaranteed whether it be from opiod medications, or from natural means such as marijuana. We also need to extremely express our concerns about funding. Research on efficient and safer therapies for treating chronic pain sould be the first concern before prohibiting the use of opiates. The fact that our government is spending more on the treament of those addicted, 28 million people, than they do on finding better treatment, safer and less addictive treatments for chronic pain suffers, over 116 million people is unforgivable. So on Tuesday, June 21st at 3pm eastern standerd time we are asking all those who suffer from pain 24/7, 365 days a year to call and email your US Senators office and demand to be heard. Our goal of course is to make our calls the only ones heard in Washington DC that whole day.
Please be calm, polite and to the point when you call so we do not fuel the addiction fire any further. If we call and leave angry comments, or just totally be irate and unapproachable, we will appear as we simply want our opiates or Marijuana and are not concerned about anything or anyone else. But if we speak polite and professional, people will listen. Thank you all and we truly hope you can join in.