PART 2
From the Food and Drug Administration’s website, fda.gov (fonts emboldened by FDA; ellipses are this writer’s and indicate that some FDA text was omitted):
Depakote and Depakene can cause serious side effects, including:
1. Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.
Call your healthcare provider right away if you get any of the following symptoms:
- Nausea or vomiting that does not go away
- loss of appetite
- pain on the right side of your stomach (abdomen)
- dark urine
- swelling of your face
- yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
2. Depakote or Depakene may harm your unborn baby.
- If you take Depakote or Depakene during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. . . . Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. . . .
- If you take Depakote or Depakene during pregnancy for any medical condition, your child is at risk for having a lower IQ. . . .
3. Inflammation of your pancreas that can cause death.
Call your healthcare provider right away if you have any of these symptoms:
- severe stomach pain that you may also feel in your back
- nausea or vomiting that does not go away
4. Like other antiepileptic drugs, Depakote or Depakene may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety . . .
- acting aggressive, being angry or violent
- acting on dangerous impulses . . .
(After listing a number of other possible adverse side effects under the “suicidal thoughts” category, the FDA website goes on to warn that someone who is taking Depakote or Depakene should not stop without first talking to their doctor, as stopping these drugs suddenly if a person suffers from seizures can lead to status epilepticus — seizures that last longer than 5 minutes or that follow each other closely without the person regaining consciousness between them.)
What are the possible side effects of Depakote or Depakene?
Depakote or Depakene may cause other serious side effects, including:
- Bleeding problems: red or purple spots on your skin, bruising, pain and swelling [in] your joints due to bleeding, or bleeding from your mouth or nose.
- High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
- Low body temperature (hypothermia): drop in your body temperature to less than 95 deg. F, feeling tired, confusion, coma.
- Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, skin blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing. . . .
From RxList.com and fda.gov:
Hepatic [liver] failure resulting in fatalities has occurred in patients receiving valproate. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema [swelling], anorexia and vomiting. . . . Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity . . .
From WebMD:
More rare and dangerous effects include hearing loss, liver damage, decreased platelets [clotting blood cells], and pancreas problems.
Many of the above potential side effects are not exclusive to Depakote and Depakene, of course; while these drugs are two of the most dangerous, there are many other anti-seizure drugs that carry serious risks when administered to children (or adults). The active-ingredient chemicals are toxic to a person’s system, whether the recipient is healthy or ill, and they have the potential to do great and even deadly harm, as seen above.
And we haven’t yet discussed the drugs’ “inactive” ingredients, which add volume or flavor to the dosages, act as carriers, binders or dispersants, or give pills and liquids like Depakote and Depakene their pretty, bright, inviting (and totally fake) colors. These additives are not much safer than the active ingredients, as we’ll see next.
The following presumably inactive ingredients (“excipients”) are found in Depakene Capsules:
- Parabens (methylparaben, propylparaben): Commonly used as preservatives in cosmetics to discourage microorganism growth, parabens can mimic estrogen, the primary female sex hormone, so they are considered endocrine disruptors. One study found parabens in human breast cancer tissues, raising the possibility that they may be cancerous beyond certain levels. In studies, the CDC found four different parabens in human urine samples, indicating exposure despite the small amounts found in consumer products. In the European Union, parabens are not allowed in foods, or in products used on infants younger than six months (such as diaper creams). The EU also limits their concentration in cosmetics.
- Titanium dioxide: being that titanium does not exist in our bodies naturally, it is difficult to reason away swallowing small piles of it in medicines, being that it’s a metal — even though it’s a natural substance and is abundant in Earth’s crust. The white powdered metal oxide is used to make the bright artificial color used to coat Depakene capsules more solid (opaque) and lighter. An article published in late 2011 in PubMed Central, a division of the National Institutes of Health (“Titanium dioxide in our everyday life: is it safe?”), cites studies which found that microscopic titanium dioxide particles harm cells by inducing oxidative stress, which causes cell damage, mutations in the cells’ genetic material (DNA and RNA), inflammation and activation of the immune response (a sign that the cells perceive themselves to be under attack), and other adverse effects. The authors go on to say that although titanium dioxide is allowed as an additive in foods and pharmaceutical drugs, available data are insufficient to determine its absorption, distribution, excretion and toxicity when taken orally. A 2012 study found that titanium dioxide particles mixed in water given daily to rats produced inflammation in the small intestine. (“Titanium dioxide induced inflammation in the small intestine,” PubMed Central.) In the environment, researchers in the first study stated that titanium dioxide causes low “acute” (sudden and / or short-lived) toxicity to aquatic life; but long-term exposure results in a range of “sub-lethal effects.”
- Iron oxide: this is purified, powdered, rusted iron; that is, iron that has been exposed to oxygen and is now “oxidized.” As its name would indicate, it has a reddish-brown color, and it’s used in some Depakene (and Depakote) pills as a coating-coloring agent. Mixed with an artificial color, iron oxide makes the pills’ coating an attractive, bright orange color. (Surely, the pretty color would make even adults, let alone children, that much more inclined to swallow the enormous pills that look like candies, without suspecting that they could do great harm.) Produce picked from the ground is likely to contain a few iron oxide particles, as soil has a tiny percentage of this natural compound. Iron oxide is not the type of iron that our guts digest, so, there is no danger of iron poisoning. However, why would a person want to regularly swallow small piles of rusted iron — something that their bodies cannot use and that offers no biological benefit? The few particles of iron oxide in produce will be easily pushed through the digestive tract with the heavy water and fiber content in the fruit or vegetable. That’s not the same as swallowing an uncommonly large pill that contains the substance, combined with the pill’s toxic chemicals, and no fiber to help push all that out (unless the person has just eaten a fiber-rich meal, which is not always the norm in the United States, even under normal circumstances; in the case of epileptic children, it is sometimes difficult for them to eat much, or at all; so, whatever undigestible excipients they ingest might stay in their gut longer and potentially increase the possibility that they’ll do harm).
- Artificial color: artificial colors are linked in studies to attention deficit / hyperactivity disorder (The Lancet, 2007) and are believed by some to trigger allergic reactions.
The following “inactive” ingredients are found in Depakene Oral Solution:
- Methylparaben (see above)
- Propylparaben (see above)
- Artificial color (see above)
- Artificial flavors: there are thousands of artificial flavors from which food and drug manufacturers can choose, to come up with a certain flavor. One flavor can include dozens or even hundreds of different synthetic chemicals (which won’t be named on a label, because they are considered a “trade secret.”) That increases the possibility of someone experiencing an allergic reaction from ingesting one or more of those chemicals. Allergy dangers aside, why would anyone want to overwhelm their system with that many synthetic and unknown substances?
The following “inactive” ingredients are found in Depakote Extended Release Tablets (“Depakote ER”):
- Polyethylene glycols: PEGs are petroleum-based viscous compounds that can trigger asthma attacks and other allergies, may be linked to cancer, may damage the endocrine / reproductive systems, may harm unborn babies, are known to damage cell DNA, and persist in the environment. (Source: Environmental Working Group.)
- Propylene glycol: a colorless, odorless thick liquid used as a softener to make polyesters, as a solvent, and in brake fluids and antifreeze; also used in pharmaceuticals, artificial flavorings and artificial scents. It is found in many processed foods. Propylene glycol is related to PEGs; both serve as penetration enhancers and allow organ tissues to absorb ingredients better — including harmful ones. Propylene glycol can produce allergic reactions and cause headache, dizziness and loss of consciousness. When applied to the skin (in skin creams) often, it can cause skin rash, dryness and redness. Repeated high exposure may produce kidney damage. (Source: New Jersey Dept. of Health, Hazardous Substance Fact Sheet.)
- Potassium sorbate: a common antibacterial and antifungal preservative that is synthetically mass-produced, it is used in many consumer products such as soft drinks, processed foods including baked, canned and frozen foods, salad dressings, ice cream, personal care products (baby shampoo, body creams, etc.) and pharmaceutical drugs. Unless someone is a label reader and goes out of their way to use chemical-free products, they may be getting too much of this substance, as it is, being that its use is so prevalent. While potassium sorbate in small quantities might not harm your child (there are worse, stronger preservatives out there), it’s certainly not something you want to ingest frequently, if it can be avoided. Studies have shown that potassium sorbate can damage in vitro human white blood cells’ genetic material, as well as produce mutations and damage DNA in cultured animal cells. (Sources: “Does potassium sorbate induce genotoxic or mutagenic effects in lymphocytes?”, Toxicology in Vitro, April 2010; “Effects of sorbic acid and its salts on chromosome aberrations, sister chromatid exchanges and gene mutations in cultured Chinese hamster cells,” July 1984, PubMed.gov.) In addition, it is a possible allergen; some people may have reactions or not tolerate it well. Symptoms of a potassium sorbate allergy can include: itching of the mouth, throat, eyes or skin, nasal congestion, runny nose, abdominal pain and headache.
- Silicon dioxide: also called silica, this material is the main component of sand. It is a trace mineral in humans and specks of it are found in fruits and vegetables. Powdered silica is added to pills to keep chemicals from clumping; it is non-toxic. But just like with iron oxide, why would someone want to deliberately swallow crushed sand (mixed with the pill’s toxic chemicals), purified though it may be, every time they take a pill? Some people posting comments online complain that taking silica orally constipated them or irritated their stomach.
- Iron oxide: used in the 500 mg dose of Depakote ER as a coating-coloring agent (see above, Depakene Capsules).
- Polydextrose: the 500 mg dose of Depakote ER contains this ingredient, a chain molecule synthetically made from dextrose (glucose), sorbitol (a sugar alcohol usually made from corn syrup) and citric acid. This compound is used as a bulking and low-calorie sweetening agent. In high doses and in sensitive individuals, polydextrose may cause cramping, bloating and excessive gas.
- Triacetin: an artificial chemical with wide-ranging applications; in medicines, it is mixed with flavoring compounds or active ingredients, to aid distribution or absorption. Triacetin is considered safe by the FDA (“Generally Regarded as Safe,” or GRAS) for human consumption in very small amounts. A study with rats found that the substance was safe at up to 5 g per kg of weight; but when it was given at 10 g (.35 oz — one third of an ounce) per kg (2.2 lb), the testicles in male rats were atrophied, and the uteruses of female rats became discolored — i.e., lost blood flow. (Source: Select Committee on GRAS Substances, fda.gov.) The question should be asked: if something has the potential to do such great harm to the reproductive systems of rodents, sturdy creatures that they are, why would humans want to take it regularly, even in lesser amounts?
- Titanium dioxide (see above, Depakene Capsules)
- Artificial colors (see above, Depakene Capsules)
The following “inactive” ingredients are found in Depakote Tablets:
- Diacetylated monoglycerides: these artificial chemicals are used in pills to keep ingredients together, helping to mix components that would normally separate. They are made by reacting fats with glycerol (a sugar alcohol also called glycerin, which can be made synthetically or from plants) and triacetin (the reproductive-system-harming chemical mentioned above). Monoglycerides can be synthesized using dangerous chemicals that may still be present in the final product. In addition, they are likely to contain trans fats, linked to heart disease, stroke and diabetes. Because monoglycerides are considered emulsifiers and not trans fats, labels on products that have monoglycerides are not required to list them as trans fats.
- Povidone: also called crospovidone, polyvinylpyrrolidone or PVP, this is a synthetic compound used in many pharmaceutical formulations, both solid and liquid. In pills, it is used to bind them, then disperse them once swallowed. Concerns have been brought up by researchers that when exposed to oxygen, some pharmaceutical-grade povidone forms toxic compounds, including formaldehyde (present in many non-edible consumer products and classified by the Environmental Protection Agency in 1987 as a “probable human carcinogen”). There are also questions about how those newly formed contaminants may interact with some active pharmaceutical ingredients (APIs) that are themselves changed when exposed to oxygen. (Source: “Does PVP Purity Affect API Stability?”, American Association of Pharmaceutical Scientists, 2009.) A few pharmaceutical drug consumers can also be sensitive or allergic to povidone. A povidone allergy can manifest itself as anaphylaxis (difficulty breathing that is life-threatening and requires immediate medical attention). One mother posting on a Drugs.com forum wrote about her daughter’s allergy to povidone; on two occasions when the girl was taking pills containing povidone, she developed mild rashes on her hands that quickly became intense and red, and spread to her forearms. The rashes caused itching and pain. Both times, the suspect medicines were stopped, and the rashes cleared up.
- Talc: also called talcum powder or magnesium silicate, its chemical composition. It is used in pills as a bulking and anti-caking agent. Talc came to light as a dangerous substance several decades ago, when it was discovered that inhaling significant amounts of it (as can happen when a person applies talc to their body daily) can cause temporary or long-term lung irritation. Studies have also found that years-long, frequent application of talc to women’s genital areas increases risk for ovarian cancer. In one study, researchers discovered that most ovarian tumors had talcum particles in them. They speculated that talc may become trapped in the ovaries, having traveled from the outer genitals. Once trapped, it might cause inflammation (i.e., irritation or infection) and contribute to the development of cancer cells. (Sources: “Perineal exposure to talc and ovarian cancer risk,” Obstetrics & Gynecology, July 1992; “Genital powder use and risk of ovarian cancer: a pooled analysis of 8,525 cases and 9,859 controls,” Brigham and Women’s Hospital, published in May, 2013 in Cancer Prevention Research.) So, even when talc in a pill is not inhaled into the lungs — if it doesn’t mix well with a woman’s reproductive soft tissues, why would it be good for the gastrointestinal mucous membranes? In addition, one must think of the workers who are exposed to inhalation of talc when mining it from rock, crushing it and milling it into a fine powder. All around, talc is not a good thing for our bodies. (To control body moisture or odor, doctors say that instead of using talc, corn starch is a safer substitute, though it should still not be inhaled heavily; even plant-based powders that are inhaled in unusually high amounts can irritate the airways.)
- Iron oxide: the 250 mg and 500 mg tablets contain rusted iron as a coating-colorant (see above, Depakene Capsules).
- Titanium dioxide (see above, Depakene Capsules)
- Silica gel (see above, Depakote ER)
- Artificial colors (see above, Depakene Capsules)
- Vanillin, an artificial flavorant (see above, Depakene Oral Solution).
The following “inactive” ingredients are found in Depakote Sprinkle Capsules:
- Magnesium stearate: this is a salt of magnesium and stearic acid — a natural element and a fatty acid, respectively, which are found in animal products and plant foods we eat. But magnesium stearate is made synthetically, it is not a naturally occurring compound. For pharmaceutical pills, it is usually made from vegetable oils. It’s a “flow agent” — a lubricating, anti-caking compound — in the manufacturing process, preventing different ingredients in tablets or capsules from clumping together or sticking to the machines compressing the pills. Magnesium stearate is mixed with all the ingredients that go inside a pill, which helps keep their amounts consistent in the mixing process. But the advantages vs. disadvantages of magnesium stearate in pills are being hotly debated online by natural-supplement makers. Some believe that at worst, magnesium stearate slows down the absorption of active ingredients or nutrients, thus delaying therapeutic effects, as studies have shown. (Source: “Effect of magnesium stearate concentration on dissolution properties of ranitidine hydrochloride coated tablets,” Bosnian Journal of Basic Medical Sciences, August 2007.) Other naturopaths have conducted experiments with beakers, posted on YouTube, demonstrating under acidic conditions resembling those in the stomach, that even when a pill’s contents are mixed for one full hour, magnesium stearate coats and surrounds the ingredients, and allows only part of them to become “bioavailable,” while the rest would be presumably excreted. Some natural-supplement manufacturers are also concerned that a person’s ability to absorb nutrients or active ingredients from pills would decrease over time as an oily “film” could form on the gastrointestinal mucosa, due to repeated exposure to the synthetically made magnesium stearate.
- Titanium dioxide (see above, Depakene Capsules)
- Iron oxide (see above, Depakene Capsules)
- Silica gel (see above, Depakote ER)
- Artificial colors (see above, Depakene Capsules)
Clearly, as seen above, the perils of both active and presumably inactive ingredients are practically endless. Active ingredients may have dangerous effects on the child. And so-called inactive additives, too, may do a whole lot that users did not bargain for.
It is easy to understand why parents whose children get seizures are desperately looking for safer, non-toxic, and in many cases more effective medicines.
In reports by different newspapers, Time magazine, CNN and local television stations from several states in the U.S., parents describe how their children basically stopped functioning while they were on anticonvulsants. One father recalled how his little daughter would lie in what he called “a vegetative state” for hours at a time on the living room couch every day, not wanting or able to interact with the family. Another father told how he and his wife had to hide all the kitchen knives out of reach from their 7-year-old daughter, because she had become prone to fits of violence and anger while on epilepsy drugs.
On top of the terrible side effects, the drugs often work only for a period of time, and then, parents are back to square one, unable to control their children’s seizures. They try drug after drug prescribed by their neurologists, and find that the drugs either don’t work, or they, too, only work for a while, then stop working.
Tens of thousands of American families in that same situation were immediately interested when they heard about a documentary that aired on CNN in 2013, which detailed the story of a 5-year-old girl who was suffering hundreds of epileptic seizures every week, and whose seizures were reduced to almost none after she started taking the cannabis extract cannabidiol, or CBD, every day.
How Recent Interest Grew in Cannabis for Childhood Epilepsy
Sanjay Gupta, MD, CNN’s chief medical correspondent, narrated the documentary, titled simply, “Weed.” Before the program aired, Dr. Gupta published a written apology for his previous opposition to using cannabis as a medicine.
The girl featured in the program, Charlotte Figi, suffered from intractable epilepsy caused by Dravet syndrome, a condition that most often also produces developmental delays. She had her first seizure when she was only 3 months old. By the time she was 5, she was having 300 grand mal seizures per week. These are severe, debilitating seizures that produce jerking motions and make the person lose consciousness.
Pharmaceutical drugs were not helping Charlotte. Epilepsy drugs usually don’t help children who have Dravet syndrome. Then, Charlotte started taking a daily mixture of vegetable oil infused with CBD extract. The extract was derived from a strain of cannabis that is high in CBD, one of dozens of “cannabinoid” compounds that are naturally present in the cannabis plant, and does not have “psychoactive” properties (does not get a person “high”). The strain was low in THC, or tetrahydrocannabinol, the cannabinoid that produces the feeling of mild euphoria that cannabis is commonly known for.
The Colorado Springs, Colorado growers of the plant that was given to Charlotte tried different varieties before finding one that worked and stopped her seizures. The growers now call that strain Charlotte’s Web, in honor of the little girl.
A few other medical marijuana producers in some states where cannabidiol has been approved by state lawmakers for treating childhood epilepsy, have since begun growing cannabis plants similarly high in CBD and low in THC, selling oils, body lotions and other products infused with the medicinal extract. The growers all strive to sell the natural epilepsy medicines at reasonable costs, to help parents be able to afford them.
Demand for the infused oils is great, with producers reporting many thousands of families on waiting lists. These are families of children with epilepsy, and in some cases, children with autism spectrum disorders, who also sometimes suffer from seizures. (Between 20 and 40 percent of autistic children also have epilepsy, with the highest rates seen in those most severely impaired by autism. Source: AutismSpeaks.org.)
Charlotte, considered a trailblazing figure in the movement to legalize cannabis for childhood epilepsy, is now 9, and her seizures have been reduced to 2 or 3 a month during the four years she’s been taking the cannabis oil. More than 99 percent seizure control has been obtained through the daily oral administration of the infused oil, according to the girl’s mother, Paige Figi. Charlotte was being fed through a feeding tube 100 percent of the time before she started her cannabis therapy; now, the tube has been removed. She is much better able to interact socially, and she sleeps a lot better. She no longer uses a wheelchair like she did before, being able to walk on her own now. The little girl who couldn’t talk before, is now able to do so. (Source: “Charlotte Figi: The Girl Who Is Changing Medical Marijuana Laws Across America,” International Business Times, June 20, 2014.)
Charlotte’s parents have testified before different states’ legislatures, pleading with lawmakers to legalize cannabidiol for children in states where using the medicine is still considered a crime. The Figis have pointed out at hearings that American children are literally dying, by not having the cannabis medicines available to them to control seizures.
Currently, many countries in the world, including the United States, have laws prohibiting the use of cannabis recreationally or as a medicine. But that’s actually a relatively new development, historically speaking. There is substantial record of ancient cultures using the cannabis plant for many purposes, including as a medicine. Cannabis was in fact an important, multi-use crop for most of human history.
The fiber of “hemp,” a type of cannabis plant with very low THC, was used by the Chinese to make textiles, rope and other similar goods, starting thousands of years ago. (Source: “Cannabis in the Ancient World,” Ernest Abel, 1980). The oldest Chinese agricultural treatise, the Xia Xiao Zheng, notes that hemp was a primary crop in ancient China.
The Chinese also ate hemp seeds as one of their staple grains for thousands of years, before other grains became more common. (“The cultivation and use of hemp [Cannabis sativa L.] in ancient China,” Lu Xiaozhai & Robert Clarke, Journal of the International Hemp Association, DrugLibrary.org.)
Cannabis tea was used in China to treat gout and rheumatism (the latter is a chronic pain in muscles, joints, connective tissues or bones). Later, in the second century AD, famed Chinese surgeon Hua T’o made an anesthetic from cannabis seeds seeped in wine (the alcohol drew out the cannabinoids), to perform complex abdominal surgery. (Xiaozhai & Clarke.) The ancient Greeks used hemp seeds to expel tapeworms and seeped them in a tea to treat earache. (“The Medical Use of Cannabis Among the Greeks and Romans,” James Butrica, 2002.)
Dried cannabis leaves were used in medicines in those cultures, and in Egypt, India, the medieval Islamic world and east Africa. Some Hindu sects in India used cannabis for stress relief. Ancient doctors also prescribed it for pain, including pain from childbirth. Arabic doctors prescribed cannabis for nausea and vomiting, pain and inflammation. (Sources: AmericanScientist.org; Time.com; NPR.org.)
While cannabis was also considered an aphrodisiac, doctors warned against overuse, advising that too much was unhealthy, and could cause impotence and other undesirable conditions.
Medical cannabis was used extensively in the medieval Islamic world from the 8th to 18th centuries — where it was also known for its anticonvulsive properties and was used for epilepsy. (Source: Indalecio Lozano: “The Therapeutic Use of Cannabis sativa in Arabic Medicine,” Journal of Cannabis Therapeutics, 2001.) But the first record of cannabis as a seizure treatment is from ancient Indian literature, where cannabis was recognized as a medicine since 1000 B.C. (Time.com; NPR.org.)
In the West, medical interest in cannabis began in the mid-1800’s and rapidly spread. An Irish physician, William Brooke O’Shaughnessy, is credited with being the first to introduce cannabis to Western medicine, in a 40-page paper that he read before colleagues and medical students in 1839 in India, where he had been commissioned by the English crown to teach and practice medicine during the expansion of the British Empire in that nation.
O’Shaughnessy had first observed the use of the cannabis herb in India. He then did his own safety experiments. A surgeon and chemistry professor at the Medical College of Calcutta, O’Shaughnessy conducted tests with cannabis formulations on different animals, then on his patients, to treat a number of conditions, including muscle spasms (such as the uterine contractions that produce menstrual cramps), pain and epilepsy. He also used the drug himself, to acquire a firsthand understanding of its effects. (Sources: “On the Preparations of the Indian Hemp or Gunjah,” Transactions of the Medical and Physical Society of Bengal, 1839; “Hemp for Health,” Chris Conrad, 1997.)
Of epilepsy, Dr. O’Shaughnessy said the following:
“In Cannabis, the medical profession has gained an anti-convulsive remedy of the greatest value.” (Source: “New Remedies: Pharmaceutically and Therapeutically Considered,” Robley Dunglison, MD, 1843.)
Not long after, French psychiatrist Jacques-Joseph Moreau started using hashish (a paste from cannabis sap, more concentrated than the dried leaves) to treat anxiety, depression, pain and epilepsy. (Conrad, 1997.) Dr. Moreau had become familiar with hashish in his travels abroad and, like O’Shaughnessy, used the drug himself, to learn about its effects firsthand.
By the second half of the 1800’s, cannabis had become one of the most commonly prescribed medicines for many ailments, and a number of prominent physicians noted that it helped prevent epileptic seizures.
Sir John Russell Reynolds, former president of the British Medical Association and the Royal College of Physicians in London, and Queen Victoria’s personal doctor, was an acclaimed 19th century neurologist who was consulted in difficult cases of nervous diseases. He said this about using cannabis extracts in tinctures to stop certain types of convulsions (seizures):
“There are many cases of so-called epilepsy in adults . . . in which Indica hemp is the most useful agent with which I am acquainted.” (Source: “Therapeutic Uses and Toxic Effects of Cannabis Indica,” J. Russell Reynolds, MD, The Lancet, March 22, 1890, p. 638.)
Dr. Reynolds also found cannabis tinctures worked for treating migraine, menstrual cramps, neuralgia (especially facial nerve pain), gout and insomnia. He said the following about cannabis extracts as medicines:
“[Cannabis], when pure and administered carefully, is one of the most valuable medicines we possess.” (Ibid, p. 637.)
Dr. Reynolds was partial to liquid cannabis extracts in tinctures because he believed it was easier to control dosage, and increase it gradually as needed (per doctor’s recommendation), by shaking container, then placing the prescribed number of drops on something like a piece of bread, as opposed to taking cannabis medicines in pills. The latter would make gradual dose increase more difficult and slow down absorption in the gut. (Ibid, p. 638.)
In the United States, cannabis had made it into the U.S. Pharmacopoeia by 1850. Before 1937, there were at least 2,000 medicines in the U.S. that contained cannabis, made by hundreds of manufacturers. (Source: “The Antique Cannabis Book,” AntiqueCannabisBook.com, March 2012.) Among these companies were some of today’s top U.S. drug makers, including Eli Lilly, Parke-Davis (now owned by Pfizer) and Squibb (of Bristol-Myers Squibb). (Source: “Pfizer, Eli Lilly Were the Original Medical Marijuana Sellers,” by Debra Borchardt, Forbes.com, April 8, 2015.)
Almost six percent of all pharmaceutical drugs sold at the beginning of the 1900’s had cannabis in some form. Squibb sold the herb as a powder, tablet, liquid extract and tincture. But Squibb only offered 15 cannabis products; there were other pharmaceutical companies that sold even more. Upjohn (which has now been acquired by several companies) listed 30 different cannabis medicines in its medical catalog, Parke-Davis sold 27, and Eli Lilly offered 23. (AntiqueCannabisBook.com, 2012; Borchardt, 2015.)
Cannabis was prescribed by doctors in the U.S. for an array of conditions, including epilepsy, migraine headaches, depression, anxiety, opiate addiction, alcoholism, rheumatism and stomach worms. Parke-Davis, once the biggest drug maker in the U.S., even worked with Eli Lilly to develop a potent proprietary domestic Indica strain that they called “Cannabis Americana.” Parke-Davis also sold cannabis products for use in veterinary medicine as pain relievers and sedatives. (Borchardt, 2015.)
Cannabis-based medicines were very common in American pharmacies. Between 1839 and 1900, scientific journals in the U.S. published more than a hundred articles about the medicinal benefits of cannabis. (Sources: AntiqueCannabisBook.com; DrugLibrary.org: Lester Grinspoon, MD, Assoc. Prof. Emeritus of Psychiatry, Harvard Medical School.)
Cannabis Prohibition Came Suddenly
So, how did the United States go from being a country where cannabis was promoted and advertised by drug companies as a medicine, and was prescribed by doctors for many ailments, to becoming a Schedule 1 drug, the most stringent level under federal law, determined by federal authorities to have no legitimate medical use — and placed on the same category as heroin and LSD?
Attorneys Richard Glen Boire and Kevin Feeney describe in their book, “Medical Marijuana Law,” how that change occurred rather suddenly. They explain that a few factors were involved.
When taken in tinctures, as it was commonly used, cannabis potency could change from bottle to bottle, due to differences in the plants and in processing. Further, with advancing medical technologies, such as the invention of the syringe in the 1850’s and synthetic drugs newly on the market, herbal medicines became less popular — even though synthetics were often more harmful than the herbal remedies that they replaced. (“Medical Marijuana Law,” Richard Glen Boire & Kevin Feeney, 2006, p. 16.)
Because opium derivatives are water-soluble, and cannabis compounds are not, opium-based drugs could be injected, while cannabis medicines had to be taken orally. In cases where pain was being medicated, the instant relief from injected opiates was a desirable characteristic; oral cannabis medicines took longer to relieve pain. As a result, injected opiates rose in popularity for treating pain.
According to Boire and Feeney, the reclassification of cannabis, from lawful medicine to strictly controlled substance, also involved a new exorbitant tax that priced it out of the market — as well as some bold-faced lies and slick moves from high-ranking politicians.
The “Marihuana Tax Act,” passed in 1937, required all growers, doctors and others who dispensed cannabis products to consumers to register with the federal government and pay an annual tax of $1, about $17 in current dollar valuation. Others, such as importers and drug makers, also had to register, and pay a little more in a yearly tax.
But the brunt of the new tax fell on consumers, who also had to register, pay the yearly $1 tax — and pay an additional $1 tax each time that they purchased a cannabis product. If a consumer had not registered and hadn’t paid the annual $1 tax, they were ordered to pay a penalty tax of $100 per purchase (of one ounce or less of cannabis) — more than $1,700, in today’s dollars. If the unregistered consumer did not pay that $100 penalty tax, the person giving or selling the cannabis medicine to that consumer was held liable for the $100 tax. (Source: “Full Text of the Marihuana Tax Act as Passed in 1937,” Schaffer Library of Drug Policy, DrugLibrary.org.)
In addition, people wanting to buy a cannabis medicine had to fill out an order, through their doctors, for each purchase. The form was to be submitted to the authorities by the doctors — making prescribing cannabis not only an added expense, but more cumbersome for the physicians, and making using cannabis not only expensive, but more cumbersome for the consumers.
While the measure was called a tax act, its effect was the prohibition of any use of cannabis, including medicinal. (Boire & Feeney, 2006, pp. 18-19.)
Just before the Act’s passage, Dr. William C. Woodward, who was a practicing physician and a practicing attorney, and was representing the American Medical Association as its legislative counsel, testified against the bill before the House Ways and Means Committee. Below are just a few of the objections Dr. Woodward raised in his oral testimony and exchange with several committee congressmen:
“The obvious purpose and effect of this bill is to impose so many restrictions on the medicinal use as to prevent such use altogether . . . it may serve to deprive the public of the benefits of a drug that on further research may prove to be of substantial value.” (Conrad, 1997, p. 25.)
Dr. Woodward also objected to the fact that the Federal Bureau of Narcotics (FBN, which later became the Drug Enforcement Administration), an agency of the Dept. of the Treasury at the time, had formulated the tax act without giving the AMA any notice or, therefore, the opportunity to submit more extensive testimony and evidence than what he was able to present on short notice, at the last minute:
“We cannot understand yet, Mr. Chairman, why this bill should have been prepared in secret for two years without any intimation, even to the profession, that it was being prepared.” (“Statement of Dr. William C. Woodward,” May 4, 1937, DrugLibrary.org.)
Woodward stated his belief that the Treasury Department and members of Congress had acted underhandedly by using a word — marihuana — that was actually not part of the English language, but newer slang with which many people were not familiar. The many doctors who prescribed cannabis medicines, and the many business owners who used parts of the hemp plant in their industries, simply had no idea that the crop that was about to be heavily restricted, “marihuana,” was the same one they used in medicine and in industry:
“I use the word ‘Cannabis’ in preference to the word ‘marihuana’, because Cannabis is the correct term for describing the plant and its products.
The term ‘marihuana’ is a mongrel word . . . and has no general meaning. It is not recognized in medicine, and I might say that it is hardly recognized even in the Treasury Department.” (DrugLibrary.org.)
The AMA was not alone in raising that objection: legislative representatives from industries that used hemp seeds for everything from bird feed to making house paints and lubricating oils, expressed similar alarm that they had only recently realized which crop the Tax Act was aiming to restrict. Hemp growers themselves expressed indignation also, as this brief excerpt from the bill’s 1937 Senate hearings shows (quoted in Jack Herer’s 1985 book, “The Emperor Wears No Clothes”):
Mr. Rens [Matt Rens, of the Rens Hemp Company]: Such a tax would put all small producers out of the business of growing hemp, and the proportion of small producers is considerable . . . . The real purpose of this bill is not to raise money, is it?
Senator Brown [Prentiss Brown, D-MI]: Well, we’re sticking to the proposition that it is.
Mr. Rens: It will cost a million.
Senator Brown: Thank you. (Witness dismissed.)
The AMA’s Dr. Woodward also strongly protested the fact that Congress was seemingly largely basing its decision to restrict cannabis on the many sensationalistic newspaper articles that had appeared in the years leading up to the 1937 Tax Act — news reports that are now known to have been false or greatly exaggerated, which claimed, among other things, that cannabis smoking was quickly on the rise, that it was killing many American youths, and that most violent crimes were being committed by people after smoking cannabis. (“Outlawing Marihuana,” DrugLibrary.org.)
Woodward’s remark:
“It has surprised me . . . that the facts on which these statements have been based have not been brought before this committee by competent primary evidence. We are referred to newspaper publications concerning the prevalence of marihuana addiction. We are told that the use of marihuana causes crime. . . . An informed inquiry shows that the Bureau of Prisons has no evidence on that point.” (DrugLibrary.org.)
Some present-day scholars and authors believe that the newspaper articles linking cannabis use with violent crimes, which started appearing more often in U.S. dailies in 1930, were part of the “yellow journalism” schemes by two publishers in fierce competition with each other — William Randolph Hearst and Joseph Pulitzer. Newspaper reporting that was big on hype and short on truth was common in the first decades of Hearst’s and Pulitzer’s publishing empires, using attention-grabbing gore and exaggeration to boost readership and unduly influence readers.
The steady stream of fabricated “reports” that linked cannabis use with murders and rapes was later presented as “evidence” before Congress, of the need to strictly regulate cannabis. The person who presented the yellow-journalism articles as scientific proof was none other than Harry Anslinger, head of the Federal Bureau of Narcotics, who played a key role in pushing the bill through Congress, in conjunction with the Treasury Department’s general counsel, Herman Oliphant, who had written the lengthy tax act. It was also Anslinger’s FBN which had fed the misinformation for those articles to the newspapers, in the first place, from Anslinger’s so-called “gore files.” (Herer, Rev. 2010, JackHerer.com, Ch. 4; “Outlawing Marihuana,” DrugLibrary.org.)
But despite the strong opposition to the Tax Act from the AMA, hemp industries and farmers, the bill made it to the full Congress for a vote. It is also interesting to note that while the measure could and should have gone to other more suitable House committees, such as agriculture, health or commerce, the Treasury Department’s Oliphant instead submitted it directly to Ways and Means — the one committee where the bill was not subject to debate by other committees before going to the House floor for a vote. (Herer, Rev. 2010.)
Attorneys Boire and Feeney describe what happened when Congress voted on it:
“The debate on the floor of Congress lasted mere minutes, with the only question coming from a Republican congressman who inquired as to the AMA’s position on the bill. Democratic congressman Fred M. Vinson responded by lying.
“In reference to Dr. Woodward and his testimony, Vinson claimed that ‘Dr. Wharton came down here. They support this bill one hundred percent.’ ” (Boire & Feeney, 2006, p. 19; “The Marijuana Conviction: A History of Marijuana Prohibition in the United States,” U of VA Law Prof. Richard Bonnie & USC Law Prof. Charles Whitebread, Rev. 1999, p. 174.)
Boire and Feeney continue:
“Not only did the Congressman perjure himself, but he got Dr. Woodward’s name wrong. No one inquired further, and the bill was passed without fanfare or public attention.” (Boire & Feeney, 2006.)
Democratic President Franklin Roosevelt passed the Marihuana Tax Act on August 2, 1937; the law went into effect on October 1, 1937. Cannabis — or “marihuana” — was removed from the U.S. Pharmacopoeia in 1941, at the request of the FBN’s Anslinger. (Boire & Feeney, 2006.)
Some modern authors and historians believe that Anslinger was anxious to produce a new segment of people that his FBN could arrest and prosecute, after Pres. Roosevelt ended alcohol prohibition. Additionally, as the federal government began cutting funding to agencies during the Great Depression, Anslinger felt that going after cannabis tax-evading patients, growers, doctors and pharmacists would insure that the FBN would continue to serve a seemingly valuable function in the eyes of the federal government, and its future would be secure.
That would explain why in 1932, Anslinger had issued an agency memorandum stating that news reports of “marihuana” use, and alleged related problems in American society, had been overblown. His memo read in part:
“A great deal of public interest has been aroused by newspaper articles appearing from time to time on the evils of the abuse of marihuana, or Indian hemp, and more attention has been focused upon specific cases reported . . . than would otherwise have been the case. This publicity tends to magnify the extent of the evil and lends color to an influence that there is an alarming spread of the improper use of the drug, whereas the actual increase in such use may not have been inordinately large.” (“Outlawing Marijuana,” DrugLibrary.org.)
But later that same year, when the FBN started losing funding and agents from its payroll, Anslinger vastly transformed his position on cannabis — not because his opinion had changed, but because he wanted to avoid further budget cuts to his agency. (DrugLibrary.org.)
Regarding Pres. Roosevelt, an interesting historical note is that his maternal grandfather, Warren Delano, Jr., had acquired much of his wealth by importing goods from China — including opium. (“Franklin Delano Roosevelt: Champion of Freedom,” Conrad Black, 2005, pp. 1126-27.) Opium started being heavily imported into the U.S. in the mid-1800s, as opium-based, doctor-prescribed medicines became common for treating pain.
One can’t help but wonder if Pres. Roosevelt might have had a personal interest, or at the very least, a philosophical bias, in heavily restricting cannabis medicines, which can be taken orally and soothe a number of ailments, and can be extracted from low-THC plants that don’t get a person “high” — while opiates, which are often injected and are much more physically addicting, and equally or more potentially harmful when used excessively, remained more easily accessible medicines, and their consumption only increased once cannabis medications were prohibitively taxed.
Another interesting point is that Pres. Roosevelt was a cigarette chain-smoker. Nicotine is a drug that most medical authorities believe is more addictive and more potentially dangerous than any of the compounds in cannabis, including THC. No doubt his heavy smoking, and all the added cigarette chemicals, contributed to his early death from a stroke just three months after he’d assumed his fourth presidential term.
As for Vinson, the U. S. representative who lied to Congress, he was a loyal supporter of Roosevelt and of Roosevelt’s successor, Democratic President Harry Truman. Roosevelt appointed Vinson judge to the U. S. Court of Appeals, starting in December, 1937 — just four months after passage of the Marihuana Tax Act. Truman appointed Vinson as treasury secretary a few months after Truman took office. One year later, Truman appointed him chief justice of the U.S. Supreme Court, where Vinson remained until his death. While biographical information on Justice Vinson is not abundant, some historians and political scientists who have written about him characterize his legal voting record as having zealously protected the interests of government at the expense of individual civil liberties.
By Cynthia Sanchez. A graduate of the University of Washington, Cynthia has extensive experience writing about health and wellness topics for different media.