The medical literature is full of promises for the future. Helping patients right now appears to be less attractive.
JAMA, the Journal of the American Medical Association recently published an opinion article by two influential scientists, Alan Leshner of the American Association for the Advancement of Science, and Victor Dzau of the National Academy of Medicine, who make a case for so-called ‘medication-based treatment‘ of opioid use disorder. Medication based treatment involves the use of methadone, buprenorphine, or extended-release naltrexone to “alleviate withdrawal symptoms, reduce opioid cravings, and decrease the response to future drug use” caused by the use of opioid pain killers.
Prescribing drugs to solve problems caused by other drugs
What Lesnher and Dzau suggest is to use prescribed drugs to solve problems caused by other prescribed drugs. I agree that in certain instances this can be helpful or may even be necessary to help patients. But I struggle to understand the omission of a solution which, to me at least, seems better for the patient in the long-term; namely helping them to safely and gradually taper the opioid-based painkiller that they have become dependent on.
This omission obscures a major factor in the opioid crisis, which has been deliberately exploited by pharmaceutical companies. The drugs are easy to obtain, to prescribe and to take but very difficult, sometimes near-impossible, to stop taking.
The US Food and Drug Administration (FDA) has recognized this problem. On April 9, the Agency issued the following safety announcement:
‘FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering‘.
I fully support this statement, but I also see a large practical problem. How are doctors supposed to follow the regulator’s guidance? Using only standard medication this cautious approach is simply not possible. Far too many patients who tried to do this have already suffered needlessly. This must stop. I will not elaborate on their stories, but they can be easily found on Mad in America and on peer-support websites such as Surviving Antidepressants, but rarely in the scientific medical literature.
To follow the FDA advice, doctors must be able to prescribe personalized tapering schedules allowing patients to taper gradually over longer periods of time in very small steps. In the Netherlands, this has been made practically possible by the development of so-called tapering strips. As a comment on Leshner and Dzau, I considered this to be relevant information for the readers of JAMA. Therefore, together with Jim van Os, we submitted the following letter to the Editor.
Letter to the editor of JAMA: Tapering medication enables compliance with new FDA opioid withdrawal guidance
The toll of opioid abuse on the US population, with an estimated 130 people dying each day from opioid overdoses, is saddening.1 To help reduce the impact of the current epidemic Leshner and Dzau argue for the use of medication-based treatment for the treatment of substance use disorder. Although we agree that in some cases a medication-based approach may be called for and helpful, we wonder if, by solving the problem of overprescribing of one drug by prescribing other drugs, we are not merely substituting one substance dependence problem for another.
On April 9 the FDA announced that it will require label changes to guide prescribers on gradual, individualized tapering of opioid pain medicines because (forced) discontinuation of opioids can result in uncontrolled pain, serious withdrawal symptoms, psychological distress and suicide.2
Health care professionals, the FDA warns, should not abruptly discontinue opioids in a patient who is physically dependent. Because no standard opioid tapering schedule exists that is suitable for all patients, they should create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.
The important question is: can we make gradual tapering practically possible in such a way that this good advice, which is equally fitting for other types of drugs where withdrawal is known to occur, can be followed?
We have addressed this issue specifically by developing so-called tapering strips which allow a doctor to prescribe personalized gradual tapering schedules using a shared decision-making approach.3 The results of the first observational study of the use of tapering strips show how successful such an approach can be.4 Of 895 patients who wished to discontinue an antidepressant 636 (71%) succeeded in tapering completely, many of which had previously failed one or multiple times to withdraw using other methods.
Initially, tapering strips were developed only for tapering paroxetine and venlafaxine, but after receiving requests from patients as well as doctors to also make them available for other types of medication, they have also been developed for other antidepressants, antipsychotics, sedatives, anti-epileptics, centrally working analgesics like methadone, oxycodone and tramadol and some other medications. The first experiences with the use of tapering medication 5 suggest that the use of tapering strips for opioids like oxycodone could be a valuable first treatment option for patients wishing to discontinue opioid medication.
‘Unfortunately, because of the many submissions we receive and our space limitations in the Letters section, we are unable to publish your letter in JAMA. . . . . we determined your letter did not receive a high enough priority rating for publication’
JAMA did not want to publish our letter, because it did not earn a high enough priority rating. I was surprised and disappointed and wanted to know which criteria were used to come to this conclusion. So I wrote the following email to the editor.
Email to the editor of JAMA
You write that our letter does not have a high enough priority rating. Why this is so is not explained, so I can only guess. Does this mean that JAMA:
- Does not find it a high priority problem that in the US each day 130 patients die of an opioid drug overdose and a much higher number suffers badly trying to come off these drugs safely (and often in vain)?
- Does not find it a high priority to inform readers about the existence of a novel tool that can help to do something about these problems?
- Does not find it a problem if an unknown number of patients in the near future will have to suffer needlessly because they could have been helped better if their doctors would have been informed by JAMA? JAMA is an important and influential platform which reaches a large audience. Every doctor promises to do no harm. Does this pledge not also apply to JAMA?
In view of these questions, I kindly ask you to reconsider your decision. If, after reconsidering, the editorial board still finds that our letter does not have a high enough priority rating, I would very much appreciate it if you would be so kind to explain to us what the reasons are to come to this conclusion.
Within a few days, I received the following answer:
‘I am sorry that you were not happy with our decision. We have published many articles about the opioid epidemic, so it is not accurate that we don’t find the topic a high priority. However, every journal has different priorities when it comes to selecting letters to the editor to publish. We consider letters to be a form of post–publication peer review. Hence, we look for letters that comment directly on an issue raised in a Viewpoint or research study. For JAMA, the letters column is not a venue to inform readers about new scientific discoveries, which we consider the province of research articles’.
Only letters ‘that comment directly on an issue raised in JAMA‘
JAMA, seemingly, only wants letters which ‘comment directly on an issue raised in a viewpoint or research article’. In my view, this is precisely what we had done. Given the urgency and severity of the problem — every day 130 people dying of an opioid overdose in the US alone! — I fail to understand how our contribution could not be considered directly related to the issue raised in the JAMA article by Leshner and Dzau.
I concluded that JAMA simply did not want to publish our contribution and that it would be a waste of time to write to the editor again. Instead, I decided to write this blog, to raise the following question:
“Why is an influential medical journal not interested in a practical solution which is proven to help patients and is available right now?”
In the future, but not right now
Over the years, after reading thousands of scientific articles about psychiatric disorders and the use of psychiatric medications, it has become very clear to me that medical journals want to publish mostly about drugs or interventions which are expected to work better than the existing ones, to have less adverse effects and which should ultimately lead to better treatments and better guidelines. In the future.
Perhaps I have become a bit cynical, but what I see happening over and over again is this:
Promises made in medical journals are mostly about helping patients in the future and rarely about helping them right now.
The general message, especially in editorials, invited comments and opinion articles, is that ‘this new study shows great promise‘, that ‘we are almost there‘, and, perhaps most importantly, that ‘we need further research‘. My interpretation is: ‘give us the money and we will be happy to carry this out‘. With the implied promise that, once this new research has been done, we will get a better world.
But do we get a better world? In many cases I do not see this happening. What I see is that after a number of years the cycle simply repeats itself, leading to new editorials, invited comments and opinion articles stating that ‘this new study shows great promise‘, that ‘we are almost there‘ and that ‘we need further research‘. And so on, and so forth. Work in progress that will never be finished and that keeps generating a steady income for researchers. Without helping patients and doctors much in daily clinical practice.
How much progress have we really made in improving pharmacotherapy for mental health problems?
What I observe is that we have increasingly and purposefully made it easier to start patients on psychiatric drugs, with little research or clinical effort put into helping patients to come off the drugs or to attempt to understand or reduce withdrawal symptoms.
And we are not talking about new drugs here. We are talking about drugs that were discovered decades ago (more than 70 years in the case of lithium and chlorpromazine). Many of these drugs are still in use today and most have become extremely cheap because they are all out of patent. So cheap that the cheapest solution to ‘help’ patients almost invariably is to prescribe more drugs, rather than to try something else or to help them come off medication.
Pharmaceutical companies who brought these drugs to market know about withdrawal problems, but have done nothing, and are still doing nothing, to develop practical solutions to prevent them. Sadly, they still do not have the obligation to do this when they bring a new drug on the market.
And what has psychiatry done thus far to find a solution for withdrawal problem? What I see is that we had to wait until 2019 before the UK Royal College of Psychiatrists even admitted that withdrawal symptoms could be more severe and longer lasting than the official guidelines stated. Let alone do something about them. That is something that they promise they will do in the future.
This brings me back to my question. Why are influential medical journals such as JAMA only interested in solutions that will lead to better treatments and guidelines in the future? And not in a practical solution like tapering medication which is available and can and does help patients right now?
Is this because helping patients to come off medication safely is bad for business?
- Leshner AI, Dzau VJ. Medication-Based Treatment for Opioid Use Disorder. JAMA. 2019;321(21):2071-2072. https://jamanetwork.com/journals/jama/article-abstract/2732941 ↩
- FDA drug safety announcement: FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes ↩
- Groot PC. Tapering strips for paroxetine and venlafaxine. Tijdschrift voor Psychiatrie. 2013;55(10):789-794 (article in Dutch, English version available at https://www.taperingstrip.nl/wp-content/uploads/Groot_2013_Taperingstrips_paroxetine_venlafaxine.pdf ↩
- Groot PC, van Os J. Antidepressant tapering strips to help people come off medication more safely. Psychosis 2018;10(2):142-145. https://www.tandfonline.com/doi/full/10.1080/17522439.2018.1469163 ↩
- taperingstrip.org (a not-for-profit website of the User Research Center of Maastricht/Utrecht University Medical Center, the Netherlands) ↩