To the honorable Senator Dick Durbin:
As we commemorate the 50th anniversary of the War on Drugs it is appropriate that we communicate an issue of extreme national concern. Our group represents over 400,000 healthcare professionals and 8 million patients who have been harmed by the current and past opioid policies in the United States. Recent guidelines set forth by the CDC (Center for Disease Control) have been promulgated by a vocal minority group of anti-opioid zealots including the group known as PROP (Physicians for Responsible Opioid Prescribing) which has directly caused the abandonment of medical treatment for at least 8 million patients. An avoidable tragedy congruent with the opinions of the leadership of the AMA (American Medical Association).
We are asking for a review of the activities of our federal drug policing activities with respect to the delivery of compassionate medical care with respect to the recent unbridled “crackdown” enforcement of the CSA (Controlled Substance Act federal statute 21 USC § 841). These indiscriminate “ham fisted” actions has caused extensive harm to patients with long term chronic and painful diseases who require and are deserving of daily narcotic pain medications to improve quality of life and activities of daily living.
Our primary goal is a request for new laws requiring the separation of the regulatory functions from the enforcement functions of the Drug Enforcement Agency especially as no medical professionals have executive supervisory control of Drug Enforcement Agency Controlled Substance Licensing.
These haphazard policies have had a chilling effect on the compassionate delivery of medical treatment by reducing the ability of pharmacies to maintain the needed supply of well-established pain medications for the people who need them the most. Most importantly they have forced millions of people to taper off of one or more of their necessary medications that allow them to engage in life and enjoy their families. These unsupervised law enforcement actions has left patients with uncontrolled and excruciating pain as no scientific or medical literature justifies opioid tapering once a patient’s painful condition is stabilized successfully. Uncontrolled pain leads thousands of Americans and US veterans to commit suicide every year because life with pain becomes intolerable with death by suicide as the only escape. Pharmacists, family physicians, pain specialists, 10 million patients (3%) with chronic and rare diseases, stand strong, willing testify that 3000 people per day are being forced off their long-term pain regimens non consensually, without medical justification.
CDC and PROP viewpoints have been codified into state legislation without appreciating the consensus viewpoint of the entire medical establishment. These guidelines which have been inconsistently revised many times are enforced as gospel by the DEA with numerous physician arrests, pharmacist arrests and independent pharmacy closures without due process by the DEA or US Department of Justice.
The prime motivation of the DEA appears to be the false assumption that any prescribed opioid pain medication can worsen the “opioid crisis” that we now know is caused predominantly by illegal flooding of illicit Chinese fentanyl and heroin overdose deaths. A review of statistical trends shows that this “crisis” has been present since 1970 and that the trajectory of overdose deaths was well established in numerous studies and was not effected by the entry of novel medications like OxyContin. Lawmakers must understand that the DEA regulates the entire legal opioid market and that if prescription opioids were fueling the crisis then the government themselves would be liable and responsible for the increase in overdose deaths. Although prescribing of opiates has decreased in the past few years there has been a vast acceleration of overdoses proving that prescription opiates does not have a causal effect on overdoses.
Lawmakers also ignore the costs of all alternative therapies. The high costs of physical therapy, topical medications, hypnosis, massage therapy and behavioral modification, prohibits patients from engaging in these therapies. Nothing is free and there is always a cost and thus many of the 8 million US citizens who currently benefit from opiate therapy cannot work or engage in meaningful life.
Finally the Federal government is interfering with medical law that is governed by the States. Each State of our Union is sovereign and infringement by the Federal government concerning medical treatment is a clear violation of our constitutional 10th amendment.
Respectfully, the involvement of federal agencies in many of our opiate policies has clearly been shown to be an unmitigated failure especially with respect to recently released data on overdose deaths. Over 3000 hard working physicians, pharmacists, mid-level practitioners and clinic owners have been sanctioned, arrested and in some cases imprisoned for taking care of the 3-4% of our population that has been abandoned by the vast majority of practitioners. It is estimated that a maximum of only 6000 physicians are involved in the treatment of pain with half of these experiencing formal reprimands. Frankly these policies will destroy the delivery of compassionate care from the rest of practicing physicians. Health care providers and other members of the learned medical professions have error of diagnosis risks, treatment risks, infectious risks, risks of contagion, criminal risks and malpractice risks. The war against physicians who prescribe opiates by the DEA and DOJ are a violation of our constitution rights. We are humbly requesting your help in ending the tyrannical actions of these 2 agencies before compassionate care is entirely driven out of our entire medical profession.
Dr. Jay K Joshi
1216 Richfield Court
Woodridge, IL 60517
Claudia A. Merandi
5 Chedell Avenue
East Providence, RI 02914
Don't Punish Pain Rally
The Doctor Patient Forum
All on behalf of 400,000 healthcare professionals and 8,000,000+ US Citizens
Letter Addendum and Additional Facts Of Note
- At all levels the DEA continues its medical mission to extirpate our best and safest pain reliever, the opiate group of medication and those who are willing to prescribe and dispense them. Adverse effects can occur in about 1-2 per 1000 patients with a familial genetically controlled opiate addiction. These are obvious facts. Failing to separate the more permanent opiate addiction from the transient but serious addictions to cocaine and methamphetamine have left many policy makers confused, but helps explain the universal failure of the one trillion dollars spent “fighting” the opioid crisis with “strike teams”, “surges”, “task forces"," crackdowns”, “opioid take downs", "fraud strike forces”, “national drug threat assessment”, and ‘tactical diversion squads”. Of the $1 trillion dollars spent on drug wars, $600 billion has been spent on substance control (CRS) which has yet to show any improvement in the benchmarks of overdose deaths or addiction. Perhaps it is time to realize nothing has worked due to pursuing the wrong premise.
- At the headwaters of the problem is the failure to treat more than 20% of the nation's patients with substance use disorder (SUD) with Medicated assisted treatment (MAT) which is the best evidence-based treatment we have. Countries that have successfully combatted their substance use disorder and crime issues have taken a harm reduction approach centered on MAT and legalization of opioids and other non-harmful drugs. The United States has an unregulated drug rehabilitation industry where MAT is not universally offered. The DEA is also targeting MAT prescriptions by wrongfully arresting physicians who prescribe them as well as pharmacists who fill them. This has successfully removed all regulation of MAT from the medical community, and instead placed it into the hands of those trained in law enforcement with no knowledge of the medicine nor of SUD treatment. The U.S. is the only country with a dedicated federal drug police and separate prescribing licenses for narcotics an housed under the same authority. The DEA is also the only agency with both regulatory and enforcement functions which is a violation of Due Process. Much of patient harm would disappear if the regulatory function of the DEA were separated from the law enforcement function. The regulatory function could be reassigned to either the FDA or HHS as they are both medical regulatory bodies. All federal contractors are required to respond to regulatory request for information from the parent agency. This is usually done with the letter or a certified letter requesting specific information. The DEA does not take this approach with physicians or pharmacists. Instead, these professionals are treated the same as dangerous criminals. Their places of business are raided by SWAT teams with guns loaded as are their homes and frequently with a cavalcade of state and federal agencies - just to request the medical records. The accused are to be presumed innocent but medical professionals are tried in the media and lives are ruined.
- While a federal judge needs to sign for professional license suspensions (life, liberty, property rights are at stake under the Constitution) and perhaps for the illegal use of entrapment through undercover agents only with probable cause of trafficking, selling of drugs for personal gain outside the medical practice function, the DEA has the authority to close physician offices and pharmacies on very short notice and frequently use potentially lethal force to do so which they complete without due process. The DEA uses suspension of DEA licenses without due process to leverage large fines, “restitution” and seizure of all other assets and appear to have a strong incentive to do so in the way of illegally acquired “income.” We would also like to point out that it is illicit drugs causing the vast majority of overdose deaths since 2013-2015 and the DEA has intercepted only 1% of illicit drugs in spite of having over 90 offices in 70 different countries which is an epic failure to address the root cause of overdose deaths in our nation.
- 21 USC § 841 the trafficking law of selling drugs for personal gain, is the law that has been wrongfully applied to doctors who are practicing medicine and caring for some of the 8 million US citizens whose pain is treated with opioids. The DEA uses this law to falsely portray physicians as practicing medicine contrary to non-existent federal practice standards. The practice of medicine is regulated by the states. Each state has a State Medical Board entrusted with this task. The Department of Justice misconstrues the CSA and U.S. v. Moore 423 U.S. 122 (1975.) In that case, Dr. Moore was seen by the Court as trafficking and no longer practicing medicine. The DEA has taken that narrow decision and simply used the terminology to spin it on every case. They have taken advantage of a Circuit split on the meaning of “outside the medical practice standard” to call their own medical experts who provide harmful, subjective interpretations of the law, exposing to the government to liability commensurate with the declining expert’s credibility. Jury instructions sound more like medical malpractice trials which are not the standard set out in Moore nor were the intent of Congress in the CSA.
- The DEA is using entrapment by having agents pose as patients who are well trained in using false but convincing stories of past injuries, having a past record of prior prescriptions, are trained in feigning the injury in a convincing manner and use this “visit” to accuse the physician of selling a prescription that the physician believes was necessary, thus constituting medical care. Physicians are paid to see, listen to, evaluate, assess and form a treatment plan and an essential part of medical care is that it is based on TRUST. Studies even of law enforcement show that they are only able to detect lies about half the time. Physicians are not trained in law enforcement. Physicians are compassionate and trained to trust what patients tell them. The DOJ uses this deficiency to convict Doctors and pharmacists by charging them with “should have known” that some people are crooks. Physicians are smart at medicine, but are often naïve about the ways of the world. Should we hold law enforcement responsible for not preventing car theft?
- Pain patients are also being abandoned by insurance companies. Insurance companies are removing physicians from their plans who write prescriptions for some of the 8 million US citizens whose pain is stabilized on opioids. Some insurance companies (BCBS-MI) are taking their opioid phobia a step further and are now giving an illegal kickback to surgeons (35% higher payment) if they do not write for opiate pain medicine after major surgery. This culture of opioid-phobia is how the DEA has a 95-98% conviction rate, a tyrannical rate, in their prosecution of HCP. This fear of addiction seems to also determine sentencing. Dr. Steven Henson missed detecting criminals in his practice as most physicians will because no physician is ever trained as a criminal investigator, and he had a single drug overdose death of a person he had never met but had taken (stolen or bought) medication written by Dr. Henson for a legitimate patient. Clearly the overdose was outside of Dr. Henson’s ability to influence to either deter or to cause. At sentencing, the Federal Judge pointed a finger at him and said “you are evil” and sentenced this innocent man to life in prison.
- Documentation is usually one of the key issues for prosecution Most physicians have less than perfect documentation and lack of documentation might be a reason for a reprimand from a State Board of Medicine but should never be allowed to be a cause for imprisonment.
- Yet another egregious attack by the DEA on HCP is that of “dangerous combinations of medications” mentioned frequently in DEA public notices. The combination of medications prescribed is strictly a medical issue. No medication combination including an opiate has been proven to be a harmful combination beyond hearsay. It is not the business of the federal government to determine what medication combinations fit the definition of drug trafficking (21:841 which is the only statute used to prosecute physicians) but yet “dangerous combinations of medications” appears on most all charges against physicians. A separation of regulatory functions from enforcement functions of the DEA would likely resolve most of these abuses.
- The truth is overprescribing has no definition, is not a medical term and it has not been proven that substance exposure alters any aspect of the “opioid crisis”. In fact, patients on long term opiate therapy for pain stabilization are the least likely to overdose on their medications. Yet independent pharmacies are being targeted for this exact concept of “overprescribing” and are being forced to close due to continuing to dispense the opiate medications 8 million US citizens need to function. The major chains have already restricted opiate medications and are targeting patients who were previously treated by any physician who has been sanctioned or arrested or previously had filled their prescriptions at a pharmacy that was shut down by the DEA. Pharmacies have recently been only allowed to dispense a certain percentage of opiates compared to their total pharmacy revenue. This leads to rationing. Pharmacies cannot get medicines from the distributors. It is thought the DEA is behind this but we cannot prove that. Distributors are required to support suspicious orders but there is no standard except what the DEA dictates. This is further increasing the difficulty that over 8 million US citizens have in maintaining their pain stabilizing medications and is increasing the risk of severe rebound pain from rapid removal of that medication. The increase in pain may become intolerable and many of them then believe suicide is the only option for relief.
- We recognize and acknowledge the inherent risks of pain medicine but the reality of addiction is that the rate of true addiction has not ever changed worldwide and affects about 1% of the population. The peak of opiate prescribing occurred in 2012 with more than 255,000,000 prescriptions written or 81.3/100 persons and as of 2019, that number has fallen to 153,000,000 prescriptions or 46.7/100 persons while the rate of overdose deaths for those same years has continued to rise. In 2012, our nation had slightly over 38,000 drug related overdose deaths and we now have a 75% increase with 70,630 deaths in 2019, the same time period that saw a 40% decrease in prescriptions written. The current guidelines are making it difficult for people with intractable pain to get the relief they need, making suicide the only option.
- During the peak of opioid prescribing, Andrew Kolodny believed he saw the problem our nation was facing as the pendulum swung in favor of controlling pain. He formed the politically active organization, Physicians for Responsible Opioid Prescribing in 2011, just as the peak of opioid prescribing was being reached. PROP waged a war on the 8 million US citizens living with chronic painful conditions by focusing only on patients with substance use disorder which very few patients with chronic painful conditions suffer from and failed to recognize the rightful place of opiate prescribing. More than 50% of patients needing long term pain medications, have limited resources and it is estimated that over 5 million can no longer get the medications that have stabilized their pain for years yet cannot afford non-opioid alternatives. Abrupt withdrawal due to this lack of access causes their pain to be at intolerable levels putting them at risk for suicide.
- The fact that the DEA supports this extremist agenda proposed by PROP, whose goal is to eliminate opiate pain medicine treatment completely is particularly concerning for the 8 million US citizens who rely on opiate medication to stabilize their pain and allow them to engage in life. Dr Andrew Kolodny founder of PROP helped create the CDC Guidelines, and said of our 4000-year usage of opiates: these are not medicines (opioids) these are lethal weapons that should be removed from the market. 2019
- The NARX score algorithm for the prescription monitoring program allows the DEA to target patients and their providers. This scoring system has not been adequately defined, disclosed, tested nor proven to have any predictive value at all, yet it has been adopted by the DEA and it was formulated by PROP. Physicians are being targeted simply based on number of prescriptions which is a useless predictor of contributing to addiction or overdose death rates. The DEA statistics are also questionable since every medication list will have a number one prescriber even if only prescribing once or twice per year.
- How far a patient drives to see their doctor is also included in the NARX algorithm. This not a valid marker since fewer physicians are writing opiates and fewer pharmacies are dispensing them. According to a Medical economics magazine survey 80% of US doctors will not take a patient who takes opiate medication even though most of these patients have rare chronic and rare painful diseases and very few others take opioid pain medications on a long-term basis. The NARX score is penalizing patients who are victims of domestic abuse, our veterans, the 8 million US citizens with chronic painful conditions and anyone now traveling to get their healthcare due to the government-imposed shortage of physicians writing opiate prescriptions and of pharmacies filling them. These factors are not predictors of overdose death yet the DEA relies on the NARX score which is forcing patients whose pain was stabilized on their medication to resort to the dangerous illicit drugs.
- By the government’s own data, number of prescriptions for opiates does not correlate with number of opioid involved overdose deaths (drugabuse.gov) again confirming that illicit and synthetic opioids are the reason drug overdoses are rising in our nation as more lethal variants of fentanyl are being purposefully injected into the drugs crossing our borders illegally.
- There have been five US government drug wars on opiates beginning with Eisenhower none of them have ever impacted overdose deaths or addiction rates. This current war on opiates started several years ago and has for the first time, has serious unintended consequences. This is a war on 8 million US citizens whose pain is stabilized by the very medications that PROP would like to see eliminated without providing any viable and affordable alternative treatments.
- The belief that destroying the profession and removing physicians from practice will reduce overdose deaths and addictions has been proven to be a false premise based on the relentless and aggressive actions the DEA over the past 2 decades. The harm being caused must end as a plea for humanity. It is estimated that between four and 8 million people are suffering every single day, applying for Social Security disability, losing their jobs, applying for Medicaid and not being able to engage with their family or in life.
- Moving forward, we also would like to address the risks and limited benefit of some of the alternative treatments being promoted by PROP, the most important of which are spinal cord stimulators. Dr. Neel Mehta states “one of the most significant drawbacks of spinal cord stimulation is that the therapy does not produce the desired results for everyone. Spinal cord stimulation is considered successful if pain is reduced by at least half but not everyone reaches that goal. With traditional low frequency therapy, about 50-60% of those using spinal cord stimulation reach that goal.“ Dr. Mehta further states that 38% of patients had device related problems, 12% had pain at the implant site and 4.5% had infections, a very high rate by surgical standards of 2%. The other confounding factor is that a high percentage of patients on long term opioid therapy do not have health insurance or at least not health insurance that will cover this expensive procedure.
- Eight million US citizens are in this position because of failed policies.