Doing The Right Thing - Part Two
Marijuana "Doesn't Do A Body Good"
Doctors promoting good health and healthy lifestyles, and parents wanting to raise healthy children, share concerns about the affects of marijuana use on our bodies. The medical literature sends an important message on the importance of understanding and following good scientific research, as well as knowing the serious risks of using marijuana and of taking unproven cannabis-based remedies before the evidence is in.
Cannabinoid hyperemesis syndrome (CHS). This horrible syndrome arising from chronic use of cannabis was first recognized in 2004. It results in severe, repeated cyclical vomiting that is usually diagnosed after patients end up in the emergency room or in the hospital. Patients typically find that continual hot baths or showers can provide some temporary relief, but the vomiting only stops when they stop using cannabis. While doctors don't yet understand what causes the syndrome, it is increasing being seen with today's higher potency of marijuana products.
Patients coming to Denver Children's Hospital Colorado for the severe vomiting, paranoia, psychosis and other acute cannabis-related symptoms jumped nearly five-fold over ten years between 2005-2015 (161 to 777 emergency visits each year).
A review by Cook County Hospital emergency department in Chicago said the syndrome is often not recognized by doctors before patients undergo a lot of tests and ineffective treatments. Nor do cannabis users know about this risk when they use cannabis – believing the myth that marijuana is benign − and may try to ease the nausea and vomiting by using cannabis and make it even worse.
New Mexico Department of Health, Epidemiology and Response Division reported a very troubling significant increase in emergency room visits related to marijuana after the State adopted its "medical cannabis" compassionate use legislation in 2007. Between 2010-2015, emergency room visits for marijuana increased by 172.8% − and increased 587% for CHS. This is compared to total emergency visits increasing only 24.2% during that same period. CHS patients were most young, 18-29 year olds…already suffering serious side effects from chronic use.
According to State epidemiologist, Dr. Victoria Dirmyer, this increase "may be just the tip of the iceberg" because studies show there is a delay of one to two years before CHS develops in chronic cannabis users. New Mexico's data coincides with Colorado, which reported that ER visits for CHS doubled after marijuana liberalization and "medical cannabis" legislation went into effect.
Texas DSHS makes no mention of the syndrome and no data is available on its website.
Emergency medicine and toxicologists at New York University School of Medicine studied the syndrome trying to get a handle on how common it was. Surveying a total of 2,127 emergency room patients with vomiting, CHS was diagnosed in one-third of frequent marijuana users. CHS is far more prevalent than previously appreciated by society and the medical community, they concluded. Extracting their data to the general population, about 2.75 million Americans may suffer from various degrees of CHS. They anticipated this awful side effect will continue to become more prevalent as marijuana use increases.
Heart health. Cannabinoids cause changes to the cardiovascular system, including tachycardia, increasing heart rate 20 to 50%. Marijuana's link to serious cardiovascular risks is increasingly evident in recent research. Cannabis use increases heart attack risks five-fold in the first hour after use. A comprehensive review of studies published in International Journal of Cardiology provided supportive evidence that marijuana is a trigger for a variety of cardiovascular complications, including hypertension, cardiomyopathy, arrhythmias, stroke and other even congenital heart defects.
Smoking. Smoking marijuana makes it especially harmful. Marijuana smoke, for example, contains over 1,500 toxic chemicals, significantly higher levels of cancer-causing compounds (such as benzanthracenes and benzypyrenes in the tar) than tobacco, and marijuana smokers inhale greater volume and hold the smoke in for longer periods of time. Back in 1969-70, researchers began following over 49,000 young men in Sweden. Forty years later, those who'd been heavy smokers of the low-THC marijuana of yesteryears, still had over a two-fold higher risk of lung cancer, as reported in Cancer Causes & Control.
Cannabis also burns at a higher temperature than tobacco when smoked, increasing the risks of damage to the lungs. Smoking 3-4 cannabis cigarettes a day damages the bronchial mucosa the equivalent of smoking 20 or more tobacco cigarettes a day. Bullous lung disease occurs in marijuana smokers 20 years earlier than tobacco smokers and risk of COPD is 3.5 times higher than nonsmokers. A study published in the journal Oncology in December 2018, found that among lung cancer patients under 40 years old, half were current or past smokers of cannabis.
Immune system. For decades, scientists have been trying to sort out the complex effects of cannabis on the immune system. In the 1970s, scientists were finding marijuana and THC suppressed blood levels of important immunological measures, rose risks for a range of bacterial and viral infections, including higher risks for septic shock and mortality among HIV patients. Immunologists recognized that marijuana appears to suppress the immune system, increasing chances for serious infections, which is especially dangerous for those with compromised immune systems and those undergoing chemotherapy.
Cancer patients who use marijuana could also be increasing their risks for recurrent tumors or interfering with effective cancer therapies. Research reported at the 2017 European Society of Medical Oncology Congress found that cannabis was the only significant factor that cut the effectiveness − by more than half − of an immunotherapy chemo treatment for patients with three forms of advanced cancers. If you or a loved one is fighting cancer, you both need and deserve every chance to win the battle, not jeopardize it.
Fertility and developing babies. Marijuana has been shown to disrupt fertility in both male and female reproductive systems in animals, and some research of cannabis use among men linked usage to a 200% higher risk of their partner miscarrying, regardless of the woman's use. Marijuana use by women of childbearing age, however, is unquestionably considered risky. It crosses the placenta during pregnancy and can adversely affect the developing baby.
Use of cannabis by women during pregnancy may negatively affect growth and development of unborn babies, increase the risk of low birthweight and small for gestational age babies, premature births, and developmental problems for their babies. A meta-analysis of 24 studies, all the evidence available to date, conducted by doctors in Arizona, found babies born to mothers who used cannabis during pregnancy had lower birth weights and were two times more likely to need neonatal intensive care.
THC has been shown in several studies to remain in breast milk for up to six days after using, and is found in two-thirds of nursing mothers who had used marijuana. Pediatricians are concerned marijuana may affect the baby's brain development and result in hyperactivity, poor cognitive function, and other long-term consequences, as these psychomotor deficits have been shown in 12-month olds in research done when marijuana was a one-third the THC concentration as today. A concerning line of preliminary animal research is showing that exposure to THC in utero may also trigger transgenerational immune responses that may increase the baby's risks for certain infectious diseases later in adulthood.
Yet, pregnant women use cannabis more than any other illicit drug, with use by pregnant women doubling between 2002 and 2017. Many dispensaries even inappropriately recommend cannabis for morning sickness.
The recognized risks to mother and baby during pregnancy and breast feeding are so alarming, the American College of Obstetricians and Gynecologists and American Academy of Pediatrics issued advisories against cannabis use by women of childbearing age and pregnant women, as did the U.S. Surgeon General.
Developing brain. Marijuana is the greatest neurological risks to young people because the human brain is still developing from birth through the mid-20s. Not only are they at highest risk for depression, psychosis and mental health disorders, Cannabis causes physical changes to the brain involved in attention, memory, decision-making, and motivation, leaving deficits identified even a month after abstinence.
Cannabis use among young people has been shown to be clearly and consistently associated with adverse outcomes in all measures. Results from three large long-running international studies found a seven-fold increase risk for suicide attempts, an 18-fold increase in cannabis dependence, eight-fold increase in use of other illicit drugs, as well as poor academic performance, truancy, high risk behaviors, lower psychological well-being, and dropping out of school at dramatically higher rates.
Early use, regular use, and using higher potency cannabis have all been associated with poorer cognitive development, putting young people at a competitive disadvantage in school, work and life.
Is marijuana a gateway drug? Since the 1970s, doctors have had widespread concerns that marijuana use, especially among young people, leads to the use of other illicit drugs, such as heroin, cocaine and hallucinogens.
Ongoing research led by Professor Denise Kandel at Columbia University School of Public Health and New York State Psychiatric Institute was among the earliest to sound the alarm. Their research during the 1970s and 1980s showed a pathway of increasing involvement into drugs after marijuana use, beginning the theory of marijuana as a gateway drug. Studying 1,325 young adults, her team found that only seven percent who had not used cannabis reported using another illicit drug – but among those who had used marijuana, 33% reported using another illicit drug – nearly five times higher. In numerous other studies, she and her colleagues confirmed these results, and found that heavier and more frequent users were also more likely to use more types of harder illicit drugs than their peers, and to go on to use hallucinogens, amphetamines and tranquilizers.
Research published in the journal Drug and Alcohol Dependence more than twenty years ago, using Youth Risk Behavior Survey data, found that high school seniors who'd used marijuana before age 14 were over seven times more likely to also use other illicit drugs.
International researchers studied twins at 30 years of age to determine the effects of early marijuana use in adulthood, reporting their findings in JAMA. They carefully controlled for genetics, family situations, abuse, early use of alcohol or tobacco, and social issues. They found that the adults who had used marijuana before age 17 had two to five-times higher risks of using other illicit drugs and drug abuse compared to their matched biological twins who hadn't used marijuana at a young age. Overall, 38.7% of early users had become dependent and were abusing cannabis.
Most recently, researchers at the University of Nevada examined the real life effects that marijuana legalization itself had on hard drug use. They looked at Washington State data from 2009-2015, and controlled for economic and educational factors that might skew the findings. What they found was that legalization of marijuana, itself, appeared to lead to more people using harder drugs. Pot didn't just "displace" hard drug use, as some have suggested, they said. They concluded that "marijuana legalization functioned as a gateway toward increased hard drug use."
Illicit drug use is driven primarily by marijuana use, accounting for over 88% of all illicit drug users in 2017, according to the National Survey on Drug Use and Health. But among teens, frequent users have a 130% greater likelihood of also using illicit opioids.
Growing evidence has made it clear that young people who start using cannabis at an early age are at higher risks for going on to use other illicit drugs and for developing drug dependence and abuse. This evidence continues to provide a major reason for keeping prohibitions against marijuana and not legalizing marijuana in any form. There is a need among doctors for greater awareness of these risks with early use, said the University of Nevada researchers.
The challenge for parents, health professionals and everyone who cares about young people is to reach out to them with credible health information about the risks of cannabis, and in a balanced way that avoids the sensationalized scare tactics of old Reefer Madness films. The truth is scary enough.
Schedule 1 Controlled Substance
The cannabis sativa plant has been classified as a Schedule 1 Controlled Substance since 1970. Under both federal and Texas law, Schedule 1 controlled substances include opiates (such as illicit fentanyls); opium derivatives (such as heroin); hallucinogens (including peyote, mescaline, methamphetamine, LSD, ecstasy, marijuana, THC, and marijuana or cannabinoid extracts); depressants (such as methaqualone); certain amphetamine stimulants; and cannabinoid receptor agents.
A Schedule 1 controlled substance, by definition, means:
"the clear weight of the evidence shows that it has a high potential for abuse,
there is no recognized safe use even under medical supervision, and it has
no accepted medical value for the treatment of any condition."
After many decades of clinical research, this conclusive determination of marijuana as a Schedule 1 substance has not changed.
It is illegal for any licensed medical doctor in the United States to prescribe any Schedule 1 Controlled Substance. Doctors who prescribe marijuana or any Schedule 1 Controlled Substance risk losing their U.S. Drug Enforcement Agency (DEA) licenses and ability to prescribe other controlled substances such as pain relievers, risk having their Medicare and Medicaid contracts cancelled, imprisonment and fines.
Texas Medical Board follows the same professional practices of other States in tightly regulating the prescribing of controlled substances and prohibiting Schedule 1 drugs.
Safe and Effective Medicines – How Do We Know?
How do doctors (and all of us) know what makes something a medicine that works and won't cause more harm? The practice of medicine has come a long way.
FDA Drug Approval
Since the early days of patent remedies and quack cures, and opium dens that led to an estimated 500,000 Americans addicted to opium by the end of the 19th century, the need was recognized for regulations for the protection of the public. The two main entities that were established to approve science-based medicines and oversee advertising claims were the FDA and FTC. For more than a century, since the 1906 Pure Food and Drug Act and the 1914 Federal Trade Commission Act, they've been tasked with protecting consumers from alternative therapies with unproven claims that put people at risk of harm.
In developing medications that are as safe and effective, the medical profession has a long standing tradition and medical code of ethics that supports the FDA drug approval and regulatory process to protect patients. Sound, evidence-based medicine is founded on the scientific method. It relies on randomized, placebo-controlled clinical trials.
All prescription medicines in the U.S. undergo the same evidence-based review for FDA-approval that calls for the completion of randomized, double-blind, placebo-controlled clinical trials, with the body of evidence showing the medicine is effective for the condition being prescribed, the most effective doses have been proven, the side effects and risks have been identified and are balanced against the benefits for the patients.
Developing a safe and effective medicine takes years of careful study. The most efficacious medications are considered to be those that have been proven in phase three trials. It's important for consumers to remember that only about one-third of drugs in phase two trials ever pass muster and even only about 80% of drugs in phase three trials are ever proven successful. They can end up having unanticipated side effects that make them too dangerous.
Remember, all of the media hoopla surrounding a new miracle weight loss drug, Acomplia (rimonabant)? It was a drug that blocked cannabinoid-1 receptors. Media reported marketing but wasn't reporting the serious psychiatric side effects seen in clinical trials, including suicide risks, which were concerning to the medical community. The FDA first slowed its approval to investigate and then voted unanimously against approval. The potential medicine proved too dangerous. The European regulatory agency also suspended its sales after reports of deaths and serious adverse reactions. Yet, the FDA is still finding dietary and weight loss supplements sold over-the-counter and online that are laced with it and supplements that are even tainted with other controlled substances.
When you read about studies of cannabis or cannabinoids claiming to show promising results, look first at what they are studying. If it is an "in vitro" or "preclinical" experimental study done in a laboratory test tube or a study in mice, that's a tiny and early piece of the puzzle in developing a medicine. Mice are not people and our children are not mice.
Remember that clinical trials of some specific cannabinoid working towards the development of prescription medications, are not studies of the cannabis or CBD available through retail outlets. It's early in the process, at the hypothesis generating stage that leads to more in depth research. Be careful not to get swept up in marketing and exaggerated claims of miraculous benefits from a study investigating one of the 80 biologically active cannabinoids or synthetic derivatives. They may find some effect that "suggests" some beneficial effect or shows promise…but no credible medical professional would ever leap frog this investigational finding and translate it to claim that, therefore, cannabis or CBD products are a safe or effective medicine. That's the work of charlatans.
Remember, the endocannabinoid system. Anytime we mess with this extraordinarily complex system seeking some desired effect with one active component, it causes a cascade of effects to every other system in the body that may be very dangerous and even life threatening. That's why the practice of medicine supports the scientific process and relies on a body of good quality evidence from sound clinical trials.
To protect the public, for a drug to be FDA-approved it also must follow specific manufacturing practice standards to ensure it is pure and free of contaminants, with precise and standardized dosages; be distributed by regulated pharmacies; and given in prescribed doses via a controlled safe route, such as pills or injections.
The marijuana plant is not like medicines. It is a crude delivery system with uncontrolled and unmeasured, and unknown, dosages of varying mixtures of biologically active compounds. Marijuana also exposes patients to potential carcinogens and unknown contaminants, such as microbes, other pathogens, heavy metals and pesticides which would never be accepted for other prescription medicines.
No FDA-approved medication for any condition is smoked, either, including marijuana. When smoked, the combustion changes medication properties and can damage the lungs, mouth and throat.
As the FDA explains, all medications or food additives are held to the same established guidelines and requirements to safeguard consumers. Anything claiming to treat cancer, relieve pain or offer any health benefit becomes, by definition, is a drug and must undergo the same rigorous scientific and medical review. To demand cannabis or CBD products be subjected to the same evidence-based review and regulatory oversight is not an ideological agenda against CBD or cannabis, said the FDA. It's about the scientific process and is supported by the overwhelming majority of medical professionals.
Most major medical professional organization in the country continue to support the FDA approval process for medicines. These include: the American Medical Association, American Society of Addiction Medicine, American Glaucoma Society, Glaucoma Research Foundation, American Academy of Pediatrics, American Academy of Child and Adolescent Psychiatry, American College of Pediatricians, and others. "The American Society of Addiction Medicine does not support proposals to legalize cannabis as medicinal anywhere in the United States," stating:
All cannabis-based and cannabinoid medications should be subjected to the rigorous scrutiny of the FDA regulatory process. This process provides important protections for patients, making medications available only when they: 1) are standardized by identity, purity, potency and quality; 2) are accompanied by adequate directions for use in the approved medical indication; and 3) have risk/benefit profiles that have been defined in well-controlled clinical trials.
Research Myths
Claims that the medicinal benefits of cannabis and cannabinoids "simply haven't been discovered yet" is not because research opportunities have been lacking. Instead, remember the scientific process and drug approval process. In reality, most promising roads of research end up to be dead ends – the potential medication doesn't work or the adverse side effects make them too dangerous, for example.
In fact, cannabis research has been going on for nearly half a century. RTI International is one of the world's largest independent nonprofit research institutes working in more than 75 countries, headquartered at Research Triangle Park, North Carolina, with $963 million in revenue in 2019. It alone has been funding cannabis research for more than forty years. When the U.S. government recently announced $3 million for nine research grants for CBD research for potentially relieving pain, RTI was the winner.
More research is conducted on marihuana, marihuana extracts, and marihuana derivatives than any other Schedule I substance in the United States, according to the Department of Justice.
Over the last five years alone, there's been a 155% increase in the active researchers registered with the DEA conducting research with marihuana, marihuana extracts and marihuana derivatives – 605 research centers just in October 2019.
The more media buzz surrounding marijuana, the more calls for research and more money going to research institutions. Yet, few question this funding as the potential conflict of interest when hearing extraordinary claims or promising potential benefits.
Research is privately funded by industries looking for product support and by cannabis venture capitalists looking for higher returns. The cannabis company Parallel, for example, funded a ten-year research program at the University of Pittsburgh with an initial infusion of $3 million last summer. Charles R. Broderisk donated $9 million to MIT and Harvard University for marijuana research, said to be the universities' largest private donation to date.
Most cannabis-related research is funded by a slew of federal agencies. There's even a federal grants app to find them. The National Institutes of Health (NIH) and the National Center for Health Statistics (NCHS) at the Centers for Disease Control & Prevention funds a wide range of medicinal cannabis research projects and released its latest grants on February 24, 2020. A long list of cannabinoid research and cannabidiol research was funded by the NIH and its agencies this last fiscal year alone.
The National Institute on Drug Abuse (NIDA) also supports cannabinoid research, including even the cultivation of cannabis needed for research. In 2019, it funded 4,409 pounds to be grown at the University of Mississippi's Marijuana Research Project, which has grown cannabis for NIDA research since 1968.
In 2019, for example, NIH funded $30.7 billion in cannabidiol research, with $349 million going to Baylor University and University of Texas-Austin. That same year, it also funded $188.9 million for cannabinoid research, with $4.3 million going to Texas academic research centers (Texas Tech, UT Southwestern, UT Health Sciences, UT-Austin, UT-Dallas, Baylor University, and UT Southwestern).
Since 1992, the National Center for Complementary and Alternative Medicine (later renamed the National Center for Complementary and Integrative Health) under the NIH has also been funding complementary and integrative modalities, spending $151.9 million in 2020. It continually offers funding for many cannabinoid-related research opportunities.
Despite decades of research, worldwide, which have provided an extremely large and ever increasing body of evidence, there are still significant gaps in our understanding of the cannabinoid system, concluded international researchers in Frontiers in Immunology. Cannabinoids and cannabidiols remain investigational. While scientists may again develop a proven prescription, FDA-approved, medication developed from a specific bioactive cannabinoid or synthetic derivative for a particular medical condition, marijuana, itself, will never be a medicine.
What has the FDA Concluded About Hemp and CBD products?
Countless hemp and CBD products are being sold using deceptive marketing to vulnerable patients − for products with no proven value and that can cause serious harm to people's health, said FDA Commissioner, Scott Gottlieb, MD.
People are mislead into spending large amounts of money and even forgoing effective treatments they may really need, he said. A single company may sell dozens of different CBD products, using multiple websites and online store fronts and social media sites. There's been a dramatic increase in CBD products and companies, he said, that "make unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder and other serious diseases, without sufficient evidence."
CBD shops are cropping up all over Texas since the passage of the Hemp bill – at least 31 in Lubbock, 35 in Irving, 44 in Houston, 46 in Austin, 56 in Dallas, 62 in San Antonio, etc. Most are selling tinctures and edibles.
The FDA has repeatedly cautioned consumers against using CBD products because all of the available safety data of CBD point to real risks and the potential to harm people − including causing liver damage, interactions with other substances and medications, and mental health issues. There's also a lot that scientists don't yet know about the long term safety of CBD and hemp products.
Additional safety concerns make it especially dangerous, according to the FDA. CBD products being sold directly to the public have not been evaluated to determine an appropriate and safe dose. These unregulated products lack controls for unsafe manufacturing processes, contain unpredictable levels of THC and CBD, are not labeled appropriately nor have safe use precautions. Some have been found to contain unsafe contaminants − pesticides, heavy metals, pathogens and even to be adulterated with other illegal or prescription medications.
The FDA has especially cautioned women who are pregnant or may get pregnant or breastfeeding to avoid cannabis in any form. They confirm that research shows it can affect the baby's brain development and increase risks for low birth weight infants, premature birth and stillbirth.
It's illegal to taint any dietary supplement or food with a drug. CBD is considered a drug, since it is being promoted for medicinal use, the FDA reminded the public. That makes it illegal to add to nutritional supplements or foods, or to sell in interstate commerce, according to federal regulations.
The FDA has been actively supporting scientific research into medicinal uses of cannabis and providing resources for cannabis developers to complete in the FDA approval process. But despite all of the research and efforts towards getting FDA-approval, no credible studies have been able to show it is safe and effective as a medicine. To date, the FDA has not approved cannabis to be marketed for the treatment of any disease or condition.
Only one prescription cannabidiol drug (Epidiolex) and three synthetic cannabis-related prescription drugs for cancer chemotherapy nausea and anorexia in AIDS patients (Marinol, Syndros and Cesamet) have been approved for very specific conditions in specific dose. These are available only with a prescription from a licensed healthcare provider. Other than those few prescriptions:
"The FDA has not approved any other cannabis, cannabis-derived, or cannabidiol (CBD) products currently available on the market."
For years, the FDA has issued warning letters to companies illegally selling CBD products. But, they can't begin to keep up with the rapidly exploding marketplace, making it more important than ever for the public to be informed.
What has the FTC Concluded About CBD?
"CBD is Junk Science," according to the FTC.
It has issued warning letters to CBD marketers making false CBD claims that have no scientific evidence to back them up, and to anyone disseminating CBD health claims. But, they can't keep up with all of these companies which are popping up all over the place and are urging consumers to not be taken in by CBD junk science. Just a few weeks ago, the FTC launched a law enforcement sweep against illegal CBD companies, along with an urgent message to consumers titled, "Don't be CBDeceived by junk science."
Its Operation CBDeceit poster said:
"Despite what they say, no CBD product is medically proven to prevent, treat or cure: Alzheimers, anxiety, arthritis, autism, autoimmune disorders, bipolar disorders, cancer, cardiovascular issues, childhood autism, chronic pain, colitis, Covid-19, crohn's, depression, diabetes, gastrointestinal disorders, glaucoma, heart attacks, high blood pressure, high blood sugar, hypertension, insomnia, irritable bowel syndrome, multiple sclerosis, overactive bladder, Parkinson's disease, psyoriasis, PTSD, scizophrenia, strokes, substance abuse."
What has the Country's Largest Agency for Alternative Therapies Concluded?
Even the National Center for Complementary and Integrative Health (NCCIH), in its overview for consumers on the status of cannabis and cannabinoid research found valid scientific evidence could only support the specific FDA-approved medications for particular forms of epilepsy, cancer/chemotherapy nausea, and HIV/AIDS weight loss. While some evidence suggests modest benefits of cannabis or cannabinoid products for some other symptoms, its review of each of the popularly claimed potential conditions found: the evidence was limited, of poor quality, small studies and biased studies, results weren't statistically significant, large numbers of people dropped out because of side effects, and based on only subjectively reported measures.
It summarized for consumers the evidence surrounding cannabis and cannabinoids for:
· Other forms of epilepsy − there is not enough evidence to conclude about whether these products are helpful
· Glaucoma – they are less effective than treatments already being used, while increasing risks of increasing pressure in the eye
· Sleep problems – inconclusive benefits
· Anxiety – small and limited studies were among people without anxiety disorder diagnoses
· Inflammatory bowel disease − the side effects and potential harms were greater than potential benefits making their value uncertain
· Multiple sclerosis and spasticity –no statistical improvement in spasticity and other symptoms in multiple sclerosis when measured by objective tests, with most studies reporting only subjective symptoms
· PTSD − little research supports their use for PTSD
· Chronic pain – evidence is unclear if potential benefits are greater than the harms
What Does the Weight of the Scientific Evidence in the Medical Literature Show?
The body of clinical trial research published in medical literature strongly shows that the weight of the evidence fails to support cannabis and consumer cannabinoid products for any condition.
One of many systematic reviews and meta-analyses of the evidence for medical use cannabinoids (prescription and retail products) examined the ten conditions believed to be potential uses for cannabinoids. These are the same ones appearing as "qualifying conditions" in most State "medical marijuana" programs. The international researchers searched 28 databases and analyzed 79 trials. They found only four trials of low bias, with most studies showing high bias and low quality evidence, and only about half of the trials were blinded. Over half of the trials had substantial people withdrawing due to side effects. In other words, very poorly done clinical trials that leave claims of benefits dubious, as best.
Their results, published in JAMA, reported that most trials reporting associations with cannabinoids and subjective improvements in symptoms still did not reach statistical significance consistently, and cannabis was associated with increased risks of adverse reactions, some serious. "Common adverse events included dizziness, dry mouth, nausea, fatigue, somnolence, euphoria, vomiting, disorientation, drowsiness, confusion, loss of balance, and hallucination."
Is There Sound Evidence For Benefits of "Medical" Cannabis For Any Condition?
Doctors with the Alberta College of Family Physicians examined this clinical question. Their conclusion in Tools for Practice for doctors reported that for most conditions, the evidence for cannabinoids "is sparse (at best), low quality and non-convincing." Most studies are small, short, not blinded, and poorly designed and conducted. "Patients' preference for cannabinoids exceeds cannabinoids effectiveness." In every case, safer and more effective treatments for the qualifying conditions already exist.
Pain. Relief of pain is the most popular qualifying condition cited by people in CBD or "medical cannabis" programs, but evidence for it is lacking. Examples of the weight of the medical evidence:
Canada's Tools for Practice by ACFP examined the medical evidence for cannabinoids' effectiveness for pain. The bottom line, it concluded, the evidence of marijuana is too sparse and poor to provide good evidence-based guidance. Prescription, synthetic cannabinoid products modestly improve pain for less than 10% of people with a specific neuropathic pain, but not others; while longer and larger studies show no effect. In contrast, "adverse events are plentiful."
A review of 30 international databases, nine systematic evidence reviews, including seven clinical trials, published in Medwave Clinical Research, concluded the evidence was inconclusive whether cannabinoids help lower pain and improve quality of life for patients with cancer-related pain. Not only was the evidence quality very low, cannabinoids "probably increase adverse effects substantially."
Nausea and vomiting. A Cochrane Collaborative review of 23 randomized controlled clinical trials of "medical cannabis" for nausea and vomiting for cancer and chemotherapy patients reported similarly poor evidence. It found the trials were of low to moderate quality, with most at risk of bias, lacking appropriate randomization or blinding, most were small trials, and participants receiving the cannabis were four times more likely to drop out. They found no evidence of any difference between "medical cannabis" and conventional anti-nausea medications. However, the side effects were significantly higher. Given the low quality of evidence, they concluded they had little confidence in their ability to say if "medical cannabis" works.
Autism. Examining recent peer-reviewed medical literature for the state of evidence for cannabis for autism spectrum disorders, Florida researchers reported in BMC Psychiatry that research of cannabis for all conditions, except the approved prescription forms, is mixed and inconclusive, indirect and insufficient, while adverse effects are well documented. There is not enough evidence to support cannabis use in autism, they concluded.
"Families of children with autism are making cannabis-related decisions based on the plethora of anecdotal evidence," they wrote. "Medical providers treating individuals with ASD should assess the ethical implications of a cannabis recommendation given the uncertainties associated with its utilization at this time. As such, practitioners should consider behavioral supports accessible to the family and only those pharmacological options which are supported by evidence...to ensure safety and effectiveness.
PTSD. Our Veterans are being misled by cannabis marketing, endangering many who are most in need of help and deserving of good medical care. A large Veterans Administration study of PTSD found that many suffers were attempting to self-medicate with marijuana. In fact, marijuana addiction is the most diagnoses substance abuse disorder among veterans since 2009. But marijuana use by those suffering from PTSD actually makes the condition worse, with more depression and anxiety over the longer term, and increasing risks for suicidal thoughts and suicide, as well as raising levels of violence.
As addiction Psychiatrist, Elizabeth Stuyt, MD, wrote, approving PTSD as a qualifying condition for "medical marijuana" programs is not based on any research. There is no evidence that marijuana successfully treats PTSD, she said, while there is evidence it can make it worse. Marijuana is not the answer for PTSD just as tranquilizers or alcohol are not the answer.
A review of the scientific evidence surrounding cannabis on mental health and PTSD by the Alcohol and Drug Abuse Institute at the University of Washington found no randomized controlled trials supported the medicinal use of marijuana for PTSD. Even though growing numbers of States allow it for PTSD, benefits have not been empirically demonstrated.
Cancer. While hundreds of scientific papers have researched cannabinoids for cancer, international researchers with Cancer Research UK warn that claims of proof that cannabis or cannabinoids can cure or treat cancer are extremely misleading. Nearly all the research has been done on cells grown in a lab or animals, which may help offer early indications for particular treatments, they said. But that doesn't apply to people. It's a starting clue for researchers.
There’s also considerable evidence that cannabinoids have unwanted effects. So, while a certain cannabinoid may kill cancer cells, for example, it can also damage crucial blood vessel cells and can actually encourage cancer cells to grow, depending on the different cannabinoid, the dose and type of cancer cells.
Nor is there any reliable evidence that cannabis can prevent cancer, said Cancer Research UK. Most importantly, they emphasized, the "street" cannabis available to the public as "medical marijuana" is not a cure or treatment for any cancer.
What's the Evidence of Harm?
ACFP also conducted an investigation into the evidence of harm associated "medical cannabis" and published their review in Tools for Practice for medical professionals. They found many studies carefully selected patients with a history of marijuana use who would be more tolerant of cannabinoids and less likely to report adverse events, and to be more likely to recognize if they were in the placebo group, skewing the validity of study results. Compared to placebo, multiple adverse events still occurred in patients, including hypotension (in 10-30%) and hallucinations or paranoia (in five percent).
Evaluating eleven systematic reviews with meta-analyses of adverse effects, they concluded: bottom line, regardless of the type of "medical" cannabinoid used, adverse events are common and likely to be underestimated. "Given the extensive harms," they wrote, potential benefits must be impressive to even warrant a trial of cannabinoids.
Bottom Line From Nation's Science Experts
The National Academies of Science, Engineering and Medicine massive report, The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research was concisely summarized on JAMA's Consumer Page. The body of medical literature is clear, it stated:
"The scientific evidence suggests that medical cannabis is neither a first- nor second-line treatment for any medical condition."
In Part Three, we'll look at the pot legalization movement and how legislation is being used.
Sandy Szwarc, BSN, RN is a health and science writer who lives in the great state of Texas.
