Prescription Drug Overdoses: How Reliable is the Research?

Prescription Drug Overdoses: How Reliable is the Research?

Yet another study is out blaming prescription painkillers for an “epidemic” of overdose deaths in the United States and Canada. What sets this study apart from others, however, is that the authors openly acknowledge how weak the evidence is to support much of their research.

“Prescription painkiller overdoses have received a lot of attention in editorials and the popular press, but we wanted to find out what solid evidence is out there,” says lead author Nicholas King, a professor in the Biomedical Ethics Unit in the Faculty of Medicine at McGill University in Montreal, Quebec.

bigstock-Addiction-504665“Our review identified significant limitations in the evidence base for determinants of increased opioid-related mortality.”

King and his colleagues  conducted a quantitative analysis — a study of studies — of 144 articles and reports dealing with opioid-related mortality. Of those, 47 studies were selected for further review and analysis.

“Few studies in our sample had a study design adequate for robust causal inference or tested the sensitivity of their results to methodological choices, and most studies focused on small populations or geographic areas. Researchers and decision-makers should exercise caution in drawing larger generalizations from this work,” King wrote.

Much of the evidence that researchers did find reliable has been reported before. Between 1999 and 2010, sales of prescription painkillers in the U.S. increased four-fold, while opioid consumption doubled in Canada.

During that period, mortality from overdoses of prescription opioids rose sharply in both countries, surpassing deaths from heroin and cocaine combined. In 2010, prescription opioids were blamed for 16,651 deaths in the United States, according to the Centers for Disease Control and Prevention.

But were opioids solely responsible for those deaths or were other factors involved?

“We found evidence for at least 17 different determinants of increasing opioid-related mortality, mainly, dramatically increased prescription and sales of opioids; increased use of strong, long-acting opioids like Oxycontin and methadone; combined use of opioids and other (licit and illicit) drugs and alcohol; and social and demographic factors,” said King.

“We found little evidence that Internet sales of pharmaceuticals and errors by doctors and patients — factors commonly cited in the media — have played a significant role.”

The findings point to a complicated public health problem in which physicians, users, the health care system, researchers, and the media all play a role — and sometimes add bias to the research.

One study reviewed by King and his colleagues claimed there was “evidence” that media coverage of the issue “often amounted to ‘inadvertent endorsements of  prescription drug abuse,’ thus increasing the popularity of opioids.”

Several studies also speculated that media coverage led to “diagnostic suspicion bias,” causing medical examiners and coroners to screen more carefully for opioids as a cause of death, while ignoring or downplaying other causes.

“Determining exact cause of death is often difficult, particularly in cases involving methadone. Prescription data are proprietary, and data on adverse events are held privately,” King wrote.

“Identification of diversion and doctor shopping is particularly difficult because it generally relies on interviews with contacts or on proxies such as having a prescription in the preceding 30 days. Generalizing from specific studies to national trends or cross-national comparisons seems inadvisable given the population and regional variation in determinants of opioid-related mortality we found across studies.”

Although the research is not always reliable, there is no dispute that Americans and Canadians are the #1 and #2 consumers of prescription opioids in the world. Canada and the U.S. consume 99.9% of the world’s supply of hydrocodone, over 87% of oxycodone, 60% of morphine and over half of the methadone. Many of those drugs are unavailable in other countries.

And because of that, says King, the rest of the world should pay attention.

“As efforts are made to increase access to prescription opioids outside of North America, our findings might be useful in preventing other countries from following the same path as the U.S. and Canada,” he wrote.

The results of this research are published in the American Journal of Public Health, http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2014.301966

Authored by: Pat Anson, Editor

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Doc ForthePeople

In the beginning of the epidemic, the DEA wrote to a significant number of Medical Examiners and asked them to change the way drug overdoses were reported. See this link:

http://headaches.about.com/bl-dea-oxy-deaths.htm

Thus there is in fact a significant role of the DEA in creating or at least cultivating the statistics. Furthermore, according to the information available in 2001 any chronic pain victim who was taking a legitimately prescribed medication and died in a way that triggered a medical examiner review would be categorized as a “Definite” overdose death, no matter that the pain patient would be tolerant to the adverse effects, but not the analgesic effects, of the opioid. While there are too many opioid overdose deaths (even one is too many) the data supporting the “epidemic” have not been given the kind of honest scrutiny that is required for science.

I also note that we arenot seeing an epidemic of heroin overdose deaths among those who suffer truly chronic intractable disabling pain. The heroin overdose deaths, now replacing medical opioids, seems to be limited to those people suffering the disease of addiction, a distinct clinical entity from chronic pain syndromes.

BL

Mark S Barletta, most people don’t want to change their lifestyle and they don’t want to feel any pain. We live in an instant society, we want pain relief right now. Many people will take pain meds before they have any pain, not after it affects them. Chronic severe pain should affect someones ability to do activities of daily living, before they are prescribed strong pain meds. Strong pain meds shouldn’t be used so they can continue their life at the same pace they did before the chronic severe pain.

I do agree with you that the constant strengthening of the pain meds is a big part of the problem. It is much easier to just pop a pill that to go to physical therapy or use accupuncture or biofeedback, etc and that is also part of the problem.

Mark S Barletta

We have a huge epidemic with opioid medications here in the U.S. how did this get started. I have a clue as to what went wrong, well known prominent pain-care specialists drove a movement to help people with chronic pain. They campaigned to rehabilitate a group of painkillers that were long shunned by physicians because of their addictiveness. Now these prominent doctors and other pain doctors who promoted these drugs say they erred by overstating the drugs’ benefits and glossing over risks. Many of those experts now say those claims weren’t based on sound scientific evidence.

Could it be for the past 15 years pain management doctors thought they where helping chronic pain sufferers when indeed most pain sufferers didn’t need such high doses or maybe no pain meds at all. I think a mistake was made and everyone jumped on this wagon thinking it was okay to prescribe to all that suffered from chronic pain without trying other options first and thinking things over very carefully.

Now here we are 15 years later with a huge opioid epidemic on our hands. How do I know this, I got caught up in this way of thinking and treating chronic pain starting in 1999. When ones pain increased the doctor just simply upped the dosage, was this right or wrong. Now I’m not only having trouble finding a doctor to help me with my chronic pain I cant find a pharmacy to fill the scripts.

What can we that got up in this way of treating chronic pain back then do now, you decide. I already know what I’m going to do, the only thing I know to do . I will have to keep my next move to myself for now.

As far as the so called opioid overdose deaths, who really knows what truly happen to the better part of these overdose victims, we will never truly know. That’s the bottom line with these tragic deaths.

Mark S Barletta

Dr. Quintner,

This is the “The Oath of Maimonides” for Psychiatry at Maimonides Medical Center in Brooklyn, NY take.

The “Daily Prayer Of A Physician” is attributed to Maimonides, but was probably written by Marcus Herz, a German physician, pupil of Immanual Kant, and physician to Moses Mendelssohn. It first appeared in print in about 1793. and is written nicely.

John Quintner

@ Mark B. I think you are quoting from the prayer attributed to Moses Miamonides. It was probably penned in the 18th century by Markus Herz, a German Jewish physician, pupil of Kant and Moses Mendelssohn. Nevertheless, this prayer is second only to the Hippocratic Oath in its influence on medical ethics.

Reference: Etziony MB. The Physician’s Creed. Springfield: Charles C Thomas, 1973: 28-31.

Mark S Barletta

Dr. Kolodny joins Phoenix House after serving as Chair of Psychiatry at Maimonides Medical Center in Brooklyn, NY. Board-certified in psychiatry and addiction medicine, Dr. Kolodny is a national expert on the opioid addiction epidemic and has been a go-to expert for numerous media outlets, including CNN, The New York Times, The Wall Street Journal, and The Washington Post.
In Dr. Kolodny’s clinical practice, he specializes in the treatment of opioid addiction. He is currently President of Physicians for Responsible Opioid Prescribing (PROP) and was previously the Medical Director for Special Projects in the Office of the Executive Deputy Commissioner for the New York City Department of Health and Mental Hygiene. For New York City, he helped develop and implement multiple programs to improve the health of New Yorkers and save lives.

BUT

It Seems Dr. Kolodny and his followers from PROP are looking for fame yet they have forgotten the why they became doctors and took the “Oath of Maimonides” .

“The Oath of Maimonides ”

The eternal providence has appointed me to watch over the life and health of Thy creatures. May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.

May I never see in the patient anything but a fellow creature in pain.

Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements.

Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today. Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling.

Jim

To clarify my previous comment, I have no political affiliation with any party, but of course, many people do… My point was that Andrew Kolodny and PROP are trying to magnify their chances of “success” by turning this into a partisan issue…

BTW, as evidenced on Twitter, this article has caught the attention of Paul Coelho, member of PROP. Already, he is attempting to discredit the publication as whole. Must have stuck a nerve.

Keep up the good work.

Mark S Barletta

Dr. Quintner,

I think this is is a fair assessment, it does appear that those who hold political power have sway over doctors ,pharmacist and the entire U.S. for that matter.
This power do deny people access to opioid medications is like torture from a higher entity.

But we don’t do that here in the U.S. torture people ,like water boarding. Instead this gets handed down to us that suffer from those lacking the skill or competence to move forward along with untrue news reporting. The media frenzy has blown this way out of proportion. This has caused a state of uncontrolled activity, agitation, emotion and more out of control suffering.

As much as I hate to admit it this lack of judgment found me not long ago and I was denied a important script over and over for several days.The power to deny people access to much needed medications will eventually cause failing health issues over a period of time.
I’m sorry its become this way to all that suffer from chronic pain.

John Quintner, Physician in Pain Medicine

Thanks Mark. It seems that the figure is around 100 million Americans who report the experience of chronic (persistent) pain. This is the back-drop upon which the opioid-prescribing statistics should be viewed.

We are faced with a number of paradoxes that all come down to an assessment of the benefits versus the risks of opioid prescribing in this population.

From the medical viewpoint, this is not a unique situation. But opinion in your society is divided and it appears that those who hold the political power to deny people access to opioid medications currently hold sway.

Do you think this is a fair assessment?

I want to thank all of you for this elevated discussion that is so important to the 116 million of us who’ve been suffering for decades from something that for so long seemed untreatable. The skewed statistics and bias and prejudice, mainly from addiction specialists has done a huge disservice to large number. Discussions like this go a long way to informing a terrified and often abused patient population that already suffers beyond he comprehension of many of us.

The singling out of a large cohort for opprobrium and blame for what may or may not be happening in our society is simply rank ignorance or willful denial of certain facts. This and like discussions help dispel these myths and I believe help with the survivability of people locked in a battle with the chronic severe pain located in their bodies.

It’s especially nice to see a fellow traveler like Mark continuing to share his knowledge and experience. Good work all. Thanks.

Jim

Oxycontin actually came to market in 1996, during the Clinton administration. Ham-fisted quacks like Andrew Kolodny like to push the beginning of the “soaring upward” figure to 1999 in furtherance of projecting the illusion that this is largely a “republican thing” (implying this all happened during the Bush administration). Truth be told, if an “epidemic” exists, it began with the Clinton administration, and peaked during Obama’s.

Mark S Barletta

Dr. Quintner,
I cant answer that question but maybe you can find the answer here.
http://www.painmed.org/patientcenter/facts_on_pain.aspx
or here
http://www.americanpainsociety.org/uploads/pdfs/Opioid_Final_Evidence_Report.pdf

john Quintner, Physician in Pain Medicine

Thanks Mark. I am well aware of the abuse of the timed-release opioids that took place in both our countries soon after their introduction.

But the point I am trying to make is that our epidemiologists tell us that some 20% of the adult population at any one point in time will report that they experience chronic pain but we do not seem to know how many of these people have actually been prescribed an opioid medication.

Mark S Barletta

More people who don’t respect the strength of time released opioids are dying as a result of abusing these excellent medications, a 300% increase since 1999.

Dr. Quintner,
What no one has told you is as of 1999 the introduction of Time Released Opiates where introduced to America . After the introduction of OxyContin, Opana ER and MS Contin and like medications most all people who abuse drugs saw a fast ,in their minds safe high by crushing the tablet and snorting , injecting or whatever it is abusers do to beat the time released mechanism. From then on things fell apart, abusers ruined all excellent time released pain medications. They don’t realize by crushing and snorting or injecting a 80 mg OxyContin pill is equal to 16 Percocet tablets 5/500 APAP less the acetaminophen. No one wants to admit this but its the truth giving OxyContin a street name called Hillbilly Heroin. Now things have gotten so far out of control suffering chronic pain patients cant get their scripts filled.
Its a sick set of circumstances that led to this epidemic.
Now true chronic pain sufferers are paying the price while the abusers move on to heroin.

John Quintner, Physician in Pain Medicine

The point I tried to make below is that the denominator in the important equation is the 116 million or so Americans who report experiencing chronic pain, whereas the numerator is the number of these people who are being prescribed an opioid medication. Unless I am missing something important, these statistics do not seem to appear in official pronouncements.

Kurt W.G. Matthies

Sorry — I wanted to include this link and forgot.

For a summary look at these arguments behind this latest round of the war on chronic pain, see:

http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

Kurt W.G. Matthies

The numbers are real and can be found on the CDC website reports of annual mortality figures by cause. However, like most statistics, they are open to interpretation and herein lies the problem — public health officials and special interests within the substance abuse community have built simple arguments from these statistics that do not reflect the complex nature of this problem and ignore specific important but inconvenient facts. So, their argument goes like this: 1. More people are dying of prescription opioids — a 300% increase since 1999. 2. More prescriptions for opioids are being written every year — more than twice as many that 10 years ago. QED – this increase in mortality is due to the increased number of opiate prescriptions. There are a number of corollaries to this logic — To lower the mortality rate, simple lower the availability of opiates, or, We can lower the availability of opiates by limiting the supply. This solution didn’t work during prohibition and it hasn’t worked since, but our regulators seem to be in denial over this unpleasant fact. At fault here is a flaw in the fundamental argument. The statistics may be true, but they don’t necessarily lead to the conclusion that a rise in mortality is due to a rise in availability. The situation is complex and our solutions to the problem are both ineffective and inequitable to those of us involved with opioids on a daily basis, whether we prescribe, dispense, or consume. To me, other logical answers to our problem abound that have heretofore not been considered by regulators and public health officials. Before the recent renaissance in pain practice, people were under medicated, so it natural that we see an increase in opiate prescriptions after the middle 1990s. The lack of fundamental medical education about pain and the use of opiates has had deadly consequences. Opioids have been inappropriately prescribed by family practitioners. I hope that someday we’ll be able to take an unbiased and honest look at these factors. One fact that never seems to be raised is that chronic pain patients are extremely opiate tolerant and least likely to succumb to opioid poisoning. If we choose to look, I’m confident we’ll find a majority of overdose cases in the opiate naive patient population and not the people who use opiates on a daily basis for years. The unfortunate fact that we apply unintelligent solutions to address this complex problem has led to increased suffering the chronic pain population, while pain practitioners and pharmacists fear increased interference with their practice. The trend towards arbitrary maximum daily equivalent doses of opioid analgesics is bad medicine. The medical, political, and regulatory parties who have built these new measures and perpetrate this war on chronic pain are in denial about the damage current anti-diversion policies are doing to the chronic pain community. We need intelligent remedies that are both effective and equitable but they require an unbiased approach to problem solving that we seem to be… Read more »

BL

I’m not a pharmacist. But the Walgreens Good Faith Dispensing Checklist is at the link below.

Pharmacy checklist questions doctor prescriptions-
http://www.aapainmanage.org/academy-in-the-news/pharmacy-checklist-questioning-doctor-prescriptions/

Mark S Barletta

I know the frustration of not being able to get a script filled for chronic pain. I did the pharmacy crawl about 3 weeks ago and it will be the last time I do that. I will not let pharmacist humiliate me, lie to me and down right make me angry. I have nothing against these pharmacist, I understand the fear of filling a opioid medication when your job is at stake. But what I don’t understand is how pharmacist gauge their customers as to who they fill for or not. Can one of you pharmacist that’s reading this please let me and other chronic pain sufferers know what it is you look for in a customer and what turns you off about a person needing a opioid script filled. For the Mom and Pop pharmacies that accept cash only and no insurance and charge $5 for a methadone pill your nothing more than a drug dealer at the corner of your street. You all should feel ashamed of yourself. For the past 18 years I’ve dealt with chronic pain in my cervical spine that’s spread to my thoracic spine and I know the life of a chronic pain sufferer all to well. I did volunteer work for a compassionate Pain Specialist for 8 years ,he was my doctor for 12 years. I moderated our website called ,”The National Foundation for the Treatment of Pain”, I advocated for those in chronic pain and found suffering pain patients a doctor to treat their chronic pain in all states for 8 years. I had to have proof the person truly suffered before helping them.I heard of every last chronic pain condition a human can have. This was from 2002 thru 2010, then unfortunately my doctor of 12 years passed away from kidney cancer, his name is Dr. Joel Simon Hochman here in Houston. TX. He was the first doctor to work with me to get my chronic pain under control after suffering for 10 years. I felt I owed it to others and help them find pain relief. I felt this better helped me understand the lives of chronic pain sufferers, their stories and way of dealing with chronic pain was not much different than my own life. I will never forget this one guy that called me on the phone, the desperation in his voice saying, “are you going to help me , are you going to help me” the shear terror in his voice and story how his chronic pain came to be, the desperation to find pain relief. I did help this guy after reading his MRI radiology report. Two weeks later he called me back crying on the phone saying he indeed got help from the name of a doctor I gave him .He thanked me over and over. He wanted to send me money but I said no I do this out of the kindest of my heart ,just take it easy now and enjoy life. Some… Read more »

I fully agree with Robert Wilbur’s take on this article. I, too, find that as Kolodny a few years ago pointed to those who he claimed had blood on there hands for hyping opioid medicines I’ve come to the conclusion that his constant banging the drums of addiction and death has led to blood on his hands.

I hope you had a chance to read my column on NPR just below this article as I say much of the same things.

Surely opioids aren’t the only way to treat chronic pain, but it is a life savor for untold numbers of us. Without these medicines I have little doubt that more pain sufferers like me would opt for suicide.

Yes, to those of you out there who don’t believe your family member, partner or friend is really suffering because you can’t see it, I can only say you are dead wrong. Pain kills.

Robert Wilbur

I am a psychopharmacologist and medical writer/editor. I have been following this discussion with considerable interest because I wrote a semi-popular article for Truthout.org on the hysteria over the opiate “epidemic.” One of the distinguished clinicians I interviewed was Michael Baden, MD, formerly Chief Medical Examiner for New York City. Dr. Baden cast a cold eye on this so-called epidemic. He pointed out that we don’t know, and may never be able to determine, how many of these “accidental overdoses” are actually suicides. Among the other telling points he made: today in the United States only 11% of bodies are examined by autopsy, so we don’t know what drugs, besides opiates, the deceased might have consumed. To compound matters even more, coroners in many jurisdictions are not trained pathologists nor even physicians: some of them are undertakers, yet it is they who fill out the death certificate.

I cannot emphasize too strongly the harm that physicians like Andrew Kolodney are doing to people in pain by fueling the fires of hysteria over a putative epidemic of opiate overdoses. A person falls down a flight of stairs and breaks his nech; should we stop building houses? A woman contracts a venereal disease; should we ban sexual intercourse?

A small minority of troubled people will become junkies. Of these, an even smaller percentage will O.D. Should people in pain be expected to suffer because of the irresponsible few?

RW
June 20, 2014

Mr. Wilbur’s article can be found here: http://truth-out.org/news/item/9544-americas-opiate-war-the-medical-luddites-vs-people-in-pain

Kaylee

It bothers me when media outlets take these numbers and run with them without doing any research or follow up. You see headlines that say that more Americans died of prescription drug overdoses than diabetes and heart disease combined or prescription drug overdoses caused more fatalities that car accidents this past year in the state of (fill in the blank).

Not enough research is done to determine if opioids alone caused the death. If the autopsy report states that the deceased had opioids in their system at the time of death they become a part of these skewed statistics weather or not opioids were the determined cause of death.

In the cases where opioids were most likely the cause of death the people who are compiling these statistics often fail to take into account the following:

Was alcohol being used at the same time as the opioid?
Were there other narcotics being used at the same time?
Were illegal drugs being used at the same time?
Was the deceased using anything to potentiate the opioid(s)?
Was there a legitimate prescription for the opioid(s)?
Was the opioid being used in a manner it was not intended for (snorted, smoked, freebased, etc.)?
Was the recommended dose being exceeded?

It is very rare for a person to die while using opioid medications prescribed by a doctor if the medication is being used exactly as directed. Opioid related deaths occur when people start taking too much or mixing it with alcohol or other narcotics that their doctor is unaware of.

The rest of the world uses DiHydroCodeine as their primary opiate for pain management.. a drug that is not even available in the US.. so .. that being said..we use ZERO PER-CENT of the world’s production of DiHydroCodeine

Mark S Barletta

At what point does a chronic pain sufferer say I had enough of this negativity about opioids in this country. I’m sick and tired of hearing all this bad media coverage of a story to ad nauseam. We never hear information of anything good just bad. After all people like reading bad news so they can gossip. We’ve become a nation of loving to read how bad things happen to good people.
The media have differed markedly in their approaches to coverage of a scandal like this one on opioids and it just keeps getting worse. When will this end and things get back to normal, it looks like this will never happen. I hope all anti-opioid mongers are happy. What a sick world we live in loving to hear how good people suffer.

John Quintner

Although I am not a statistician, it seems to me that the authors of this paper have failed to include an available denominator – the estimated 116 Americans who claim to experience chronic pain.

BL

Can anyone answer these questions ?
1) Were these deaths in all 50 states ? If not, which states.
2) When an overdose is suspected, blood levels are drawn. If this test is not done in a biased way, it will tell what drugs were in the patients system, their blood levels and the MLD’s for each drug. Were blood levels drawn to verify before someone was counted as a death due to prescription opioids ? (I doubt they were) What were the health conditions/diagnosis of the patients before their death ? Were other substances, legal & illegal in the patients system at the time of death ? What were their levels ? Stats can be twisted to look the way someone wants them to. This info, without the needed specifics, is what the medical community and politicians are standing on to deny chronic pain patients treatment. Maybe if it affected those with good insurance and resources the way it affects others, things wouldn’t be so bad.

Mark S Barletta

We cant state that Canada and the U.S. consume 99.9% of the world’s supply of hydrocodone when no other Country in the world has it available for consumption.
Yes we do have a opioid epidemic brought on by people who cant control themselves. Most abusers consume alcohol with these opioids causing respiratory depression.
And who pays for this out of control epidemic , true chronic pain sufferers who need the pain relief the most. Making good people suffer for no good reason because of the handful of people who abuse the very medications needed by chronic pain sufferers.
Its a pathetic set of circumstances true pain suffers have to face each and every day of their lives. We must give these people the pain relief they need to live a somewhat normal life.

I am a chronic pain patient who has been paying the price for what these drug addicts are doing. I did not ask for the numerous incurable diseases that I have and there are no successful or even very good treatments for the things that are wrong with me. All I know is I am no longer receiving adequate pain relief as a result of the changes in the laws in the state of Kentucky, even though I never sold, gave away or took inappropriate doses of my medicine, I am forced to pay for the actions of others who have and always will.
There is no way that punishing chronic patients will stop drug addicts from being drug addicts.

See Link for the following page:
“Opposition to Kentucky HB 1-Reform HB 217 aka “Pill Mill Bill”
https://www.facebook.com/pages/Opposition-to-Kentucky-HB-1-Reform-HB-217-aka-Pill-Mill-Bill/595049517218134