Have Policies Designed to Mitigate Opioid Deaths Resulted in Unethical Treatment of Chronic Pain Patients?

https://www.medium.com/@mross109/have-policies-designed-to-mitigate-opioid-deaths-resulted-in-unethical-treatment-of-chronic-pain-4cdd235c7fc4

North American doctors are presently engaged in a giant medical and social experiment dictated by both the American and Canadian governments to reduce and lower opiates for chronic pain patients. It is hoped that this practice will reduce opioid overdoses and deaths but it has not. Prescriptions are way down but deaths continue to increase. Patients who have been on high doses of opioids, who have had little negative effects from those drugs and are doing well with good quality of life, are being forced by their doctors to reduce doses often with no discussion — against their will. Some are turning to the black market and others are deciding upon suicide.

These policies defy and run counter to all that modern society has deemed to be ethical in medical research.

If this experiment was being conducted by universities, it surely would be disallowed as all research on humans must first be approved by independent research ethics boards. Any research that resulted in an increase in suffering, disability, and/or deaths of human subjects would never be approved.

These research standards arose out of WWII when the full impact of Nazi atrocities came to light. Aside from genocide, some Nazi doctors engaged in human experiments that were cruel forms of torture.

After the Nuremberg Trials, the allied nations developed the Nuremberg Code with 10 important points. The ones most relevant to what is happening today are listed below with key points in bold.

1. The voluntary consent of the human subject is absolutely essential. Chronic pain patients are not asked for consent to taper but are forced.
2. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. Refusing to treat with opiates that have proven beneficial to a patient or to reduce them drastically will and is causing those patients unnecessary pain and suffering.
3. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Patients who have been doing well are put at risk of becoming worse through forced tapering.
4. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. This is not being done as so many pain patients report that they have gone back to their doctor to tell them of the increased pain and suffering they are experiencing only to be ignored. In one case I am familiar with, the doctor decided to increase tapering despite the severe distress his patient was having. After the initial tapering, the patient reported increased pain and reduced functioning and the doctor told him he was going to reduce his dose even lower because the opioids were obviously not effective as he had pain. They were effective before he reduced them and then he used the increased pain caused by his lowering the dose to reduce further.
5. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. This experiment is being conducted by physicians rather than researchers.
6. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he[she] has reached the physical or mental state where continuation of the experiment seems to him[her] to be impossible. Patients are begging their doctors to stop tapering and to increase back to where they were doing well but doctors are refusing to do so.
7. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he[she] has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him[her] that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. This is not happening.

The Nurenberg Code is still considered to be the most important document in the history of the ethics of clinical research and led to the Declaration of Helsinki ratified by the World Medical Association. The notion of informed consent forms the basis of the UN Covenant on Civil and Political Rights. It also serves as the basis for the International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization. Force tapering patients violates informed consent.

Every university has an Institutional Review Board which looks at research proposals and approves or rejects them based on these principles. No one can be recruited into a study unless the details of the study are fully explained to the subjects and they give their written consent. There are also requirements that if a patient gets worse or is harmed in anyway, the research is cancelled.

According to all of the above, it is reasonable to assert that chronic pain patients being forcibly tapered or denied their opiate medications and being severely harmed. This would never be approved in a university research setting but it is happening to patients every day.

The hypothesis that prescribing doctors and pain patients are the cause of the overdose crisis we are seeing is faulty and without validation in research. That is being proven over and over again as prescribing is significantly decreased but overdose deaths continue to soar. This was pointed out to Health Canada by the Chronic Pain Association of Canada. Health Canada has never responded.

The patients being harmed continue to be harmed and are powerless to stop this treatment. Some of these patients had been taking their medications with benefit and without incident for decades. There is simply no medical reason to interfere with their care and punish them with increased pain, disability and sometimes death.

The unethical treatment of patients has occurred in other instance such as the notorious “Tuskegee Experiment.” This was “an infamous and unethical clinical study conducted between 1932 and 1972 by the U.S. Public Health Service. The hidden purpose of this study was to observe the natural history of untreated syphilis; the African-American [only] men in the study were told that they were receiving free health care from the United States government.”

The “researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin was found as an effective cure for the disease that they were studying.” In other words, these men did not receive treatment for their syphilis which was left to progress for years as they suffered terribly and unnecessarily. We saw then a gross violation of the important points within the Declaration of Nuremberg.

Are we now watching history repeating itself?

Filed under: General Problems