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Cannabis, Research, and Big Pharma
To conduct clinical drug research with Cannabis in the United States, researchers must file an Investigational New Drug (IND) application with the FDA, obtain a Schedule I license from the U.S. Drug Enforcement Administration, and obtain approval from the National Institute on Drug Abuse.22
The legalization of cannabis still struggles today, with a patchwork of 25 state laws superseding its illegal status at the Federal level. Cannabis first became illegal, in part, because the pharmaceutical companies could not figure out how to quantify it or measure it. Today, at best, they can offer synthesized imitations of specific cannabinoids, but many researchers suspect that the effectiveness of natural cannabis may depend on the symbiotic and synergistic interrelationship of several or even many of the more than 100 cannabinoids in the plant.
Cannabinoids are the chemical constituents in the cannabis plant, some of which can produce specific and powerful effects on the human body. The most familiar of these is delta-9-tetrahydrocannabinol (more commonly called THC), known for its psychoactive effects. The second cannabinoid researchers have worked with extensively is cannabidiol (also known as CBD), an immune system modulator. Many more, which to date are considered to be "minor in effect," remain untested.23
To further confuse the issue, different strains of cannabis have different "formularies." We use the term formulary loosely. In modern use, a formulary is "a list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits."24 Traditionally, however, a formulary contained "a collection of formulas for the compounding and testing of medication"25—that is, it was a recipe book. And it is in that sense that we use the word, although the formularies of the different varieties of the cannabis plant are not recipes for laboratory-synthesized chemicals, but descriptions of what is observed or discovered through chemical analysis.
For Big Pharma, the fact that different strains of cannabis have different amounts of each of the over 100 cannabinoids makes synthesis and testing of each to the degree required by the Food and Drug Administration (FDA) a Herculean job of almost incomprehensible complexity. With the potential need for testing pairs of cannabinoids, triplets of cannabinoids, and all the permutations of cannabinoids, the task becomes impossible, especially when we consider that what needs to be tested is not only the combinations of cannabinoids but the combinations at various strengths and ratios.
Doctors who specialize in pain management or any of the conditions for which cannabis provides benefits and the experts who run cannabis dispensaries will often have the wisdom that comes from experience and will be able to recommend the strains of cannabis most effective for the symptoms and conditions being treated. Patients and caretakers of patients using dispensary-provided cannabis are faced with the need to self-titrate their medication—which is not necessarily a bad thing.
Too often, commercial pharmaceutical drugs are available in specific doses. Physicians prescribe the dose they believe best suits the patient and the condition. If the dose is not enough, the physician can only prescribe a different amount in the increments in which the drug is manufactured. If the patient has a "bad day" and feels the need for just a little bit more of the medication, that extra bit is not an option. If the patient feels that s/he is getting too much of the drug or the side effects become overwhelmingly uncomfortable, the choice may be to either keep taking it until such time as s/he is able to get in to see the doctor to get the dose adjusted, or not to take the drug at all. The difference between a commercial (prescription or over-the-counter) pharmaceutical drug in pill form and a self-titrated medication is like the difference between a light operated by a standard on-off switch and one run off a rheostat, where the light level can be dialed up or down depending on the need for illumination.
Liquid prescription or over-the-counter medications afford the opportunity to adjust dose. One of the authors of this paper kept a leftover bottle of prescription codeine cough syrup in her refrigerator. If she came down with a screaming sore throat, she took the maximum recommended dose to alleviate the pain until she could get into a doctor to get a prescription for an antibiotic. As the sore throat abated, she cut back on the dose until her throat had healed and kept the rest of the bottle so she would have it available for the next sore throat. Probably not the best idea, but it worked . . . for five years.
In the same way, a cancer patient using cannabis for cancer pain can adjust the amount used to find the "sweet-spot" where the pain is sufficiently alleviated and the side effects not overwhelming. The epileptic can experiment to find the right amount to keep seizures under control, but not limit functioning. Yes, finding that sweet-spot can be difficult because of the delay between cannabis administration and drug action, but who better to figure out the "right" amount than the subjects who know what they are experiencing.
The same author noted above recently visited Colorado and talked with a woman who worked in a resort shop. The woman said she and her daughter had moved from Minnesota in the past year because doctors failed to stop or even slow the daughter's almost daily epileptic seizures. Within a week on Charlotte's Web, a high-CBD-content Cannabis sativa L. strain with less than 0.3% THC,26 which she supplemented with another cannabis preparation, the daughter's seizures stopped. The 28-year-old was able to get a driver's license and hold down a job for the first time in her life, and the mother was freed to work because she no longer had to serve as a caretaker.
The "Big Pharma"/governmental regulatory alliance, where heads of the regulatory governmental agencies and the heads of the largest pharmaceutical companies play a never-ending game of "musical chairs," puts "the foxes in charge of the henhouse." The argument for placing top-level drug company executives in top-level regulatory agency positions is that these executives are the people who best know the drug industry. The argument against it is that any rational human being has a hard time setting aside personal interests in favor of the general welfare, especially when prioritizing the general welfare could financially impact the company where s/he last worked, where his/her pension is vested, his/her cronies work, and where s/he might be hoping to return to employment in a high-status, cushy job sometime in the future—to the tune of millions of dollars.
Big Pharma would like nothing better than to squelch cannabis legalization or to control cannabis distribution, neither of which is in the best interests of the American people or any other peoples on this planet. With "last season's" Big Pharma CEOs heading the regulatory agencies charged with governing the drug manufacturers, is it little wonder the drug industry and its regulation are rife with problems?
All too often, we have seen dangerous and deadly prescription drugs foisted on the public at obscenely high prices (then later recalled after physical/mental functions and even lives have been lost); prescription drugs prescribed to ameliorate the uncomfortable side effects of other drugs; prescription drugs that blunted cognitive function and mimicked dementia—depriving patients of years of their lives; prescription drugs taken by parents that destroyed the lives of their children (thalidomide); and misdiagnoses resulting from the identification of drug side effects as new diseases rather than as accumulations of toxic chemicals in bodies more stressed by the treatment than they were by the disease.
Why does this happen?
It all has to do with money, the misuse of governmental authority, and nepotistic favors focused on sending an ever heavier stream of chemicals to the market, regardless of how those chemicals fared in the FDA's requisite safety and efficacy testing.
In order for a new prescription drug to be brought to market, the pharmaceutical company has to run trials to demonstrate "the drug's ability to produce the desired result (efficacy) and the type and likelihood of adverse effects (safety)."27 The FDA-required testing is rigorous and expensive. Yet, all too often, the "red flags" are ignored. Warning voices are shushed. Problems are dismissed as aberrations or labelled as study flaws. Incriminating evidence is "shuffled to the bottom of the stack," just so the product can be rushed to the market, advertised to the masses, and sold to people who believe that, in spite of repeated failures, the FDA "has their backs."
The pharmaceutical companies will argue that, even with millions of dollars of testing, mistakes are made. All too often, the telltale evidence was obvious but either overlooked (no one was competent enough to see it), ignored (someone was competent enough to see it, but was too irresponsible to say anything about it), or dismissed (someone was competent enough to see it, someone who was responsible enough to say something about it, but nobody was willing or ethical enough to do anything about it). The price the consumer pays for these "mistakes" (now more accurately defined as lapses in competence, responsibility, and ethics) is high. Consider, for instance, the drug Fosamax, introduced by Merck in 1995, for the treatment of osteoporosis.
Within several years, women started reporting thighbone breaks and jawbone death, although the FDA continually overlooked the problems. It wasn't until 2004 that the FDA found that long-term Fosamax use was conclusively linked to osteonecrosis (bone death) of the jaw, which causes the jawbone to deteriorate. Then, in 2008, the FDA warned that bisphosphonates were also linked to debilitating bone, muscle, and joint pain.
By 2009, a study in the New England Journal of Medicine linked long-term Fosamax use to esophageal cancer. In 2010, the FDA required Fosamax and other drugs in its class to include warning labels about the increased risk of thighbone fractures. In addition, medical researchers were making clear connections between Fosamax and irregular heartbeat and painful eye disorders that cause inflammation and distorted vision.28
Yes, Fosamax helped lay down new bone. But the bone it built was brittle and tragically prone to fracture. In older people, a broken hip is often a death sentence. You fall, your hip breaks, and you end up in the hospital, where you contract pneumonia from laying around, and then you die.
Just as tragic is the high incidence of breast and reproductive cancers in the daughters of pregnant women who took diethylstilbestrol (DES) to prevent pregnancy complications and miscarriages. From the 1940s to the late 1980s, the FDA approved DES as an estrogen replacement therapy. Not only was the drug not effective for what it claimed to do, it left a legacy of fear, tragic disease, and deaths from breast cancer, cervical cancers, and virtually-impossible-to-detect-until-it-is-too-late ovarian cancers in the daughters of the mothers who took the drug.29
Thalidomide was prescribed to pregnant women in the 1950s to alleviate nausea and morning sickness. The result? The children of these women were born with shortened, malformed limbs, stumps, or no limbs at all. Worldwide, over 10,000 children were born with thalidomide-caused limb malformation and other internal abnormalities. Of these affected infants, fifty percent died. The FDA never approved thalidomide in the U.S. However, the drug was tested here, with the result that 17 US children were born with thalidomide-induced malformations.30
It is obvious, if you are big enough and rich enough, you can get away with murder.
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