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PART II:  HERBAL REGULATION

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This was written about 15 years ago, when I was asked to participate in a series of debate forums with a physician and a pharmacist.
 

Herbal medicine has been at the heart of medicine in every culture in the world, throughout history. Today, according to the World Health Organization, more than 80 percent of the world’s population rely on traditional medicines, mostly plant-based, as their main source of health care. This figure includes not only the large populations of China and India and all of the less-developed countries of the world, but also many modern nations. Even in the United States, about 25 percent of our prescription medicines are still extracted from plants or are synthetic copies of plant chemicals, and at least 57 percent of our top prescription medicines are derived in some way from plants, including semi-synthetics, in which plant chemicals are used as building blocks for synthetic drugs.

Synthesizing drugs in the laboratory is a newer practice than most people realize. The first synthetic chemical medicine was produced in the mid-nineteenth century: aspirin. Still, widespread use of synthetic drugs did not begin in earnest until about 70 years ago. In the United States, natural remedies were replaced by synthetics or highly purified “wonder drugs.” In fact, most synthetic drugs are duplicates or modifications of the same plant chemicals that are found in herbs. These compounds can be made synthetically in a laboratory, but are no more effective than extracts of the plant itself.

In our enthusiasm for modern technology during the post World War II era, we hastily worked to replace plant-based pharmaceuticals with synthetic tablets, at the same time that we abandoned traditional agricultural practices in favor of use of environmentally destructive pesticides and herbicides. As a sidebar, it’s interesting to note the simultaneous human health movement back to phytomedicines and agricultural movement back to bio-dynamic farming-  both, based upon science- in defiance of the legal, public policy and marketing efforts of some of the wealthiest corporate industries.

The focus of research in the twentieth century shifted away from the study of whole plants toward perceived single “active principles” and synthetic chemicals. Research into the efficacy of phytomedicines in the United States came to a virtual standstill as medical schools and research laboratories- heavily funded by “philanthropical” organizations which were heavily invested in the pharmaceutical industry-  increasingly focused on medicines made in the laboratory. Drug companies focused their research efforts on developing synthetic drugs they could own through patent protection.

Medicinal plant research was conducted in places where they were still considered an important part of health care, such as Europe and Asia. In the United States, researchers concentrated on isolated plant constituents rather than whole herbs or minimally-processed extracts. For example, until very recently, there was little research on the health effects of green tea, but thousands of studies on caffeine. While the “active” isolated compound in green tea was considered to be caffeine, most of us now recognize the fact that many other health-enhancing compounds are present in a simple, aqueous infusion of green tea. I doubt that anyone seeking to benefit from the now-documented, widely-ranging benefits of green tea would hope to reap those rewards with the use of a synthetic caffeine tablet.

Medicinal herb research in Europe accelerated rapidly from the 1960s to the present. The best herb research was performed in Europe primarily because modern medicine in Europe continued the use of complex- ironically referred to as “crude”- plant drugs and minimally-processed extracts during the time when they were eliminated from the practice of medicine in the United States. With favorable treatment from European governments, phytomedicine flourished and European companies developed compounded herb extracts, sponsored research, and built the European phytomedicine field of study that is impacting medicine worldwide. American doctors, scientists, and regulators decried the lack of sound evidence for medicinal herbs –at the very time US regulatory practice made it economically untenable to perform the research. Meanwhile, European scientists – not beholden to the economic stronghold of the pharmaceutical industry on US medical education and legislation- conducted the studies that allowed phytomedicine to prevail as a dominant form of therapy there.

While many believe herbal medicine was displaced  as a consequence of the advent of scientific progress, by safer or more effective medicines, the truth is that synthetics overtook natural medicines in the pharmacy as a result of social manipulation, political influence and regulatory practices- not the science of medicine. Last week, we discussed the impact of the Flexner Report in the early 1900’s. Later in the century, with the creation of the FDA and resulting legislation requiring that foods and drugs to be proven safe before they could be sold, much financial investment was required to bring a drug to the marketplace, since the cost of research was imposed upon the manufacturer.

In fact, the FDA regualtions were authored by the pharmaceutical companies themselves, as a means of insuring that the only profitable means of bringing a medicine to market was via the mechansim of expensive- yet highly lucrative- patent protection.  As more sophisticated and expensive research methods were devised, it became increasingly expensive to establish the safety of drugs. In 1962, Congress passed the additional requirement that drugs be proven effective, further increasing the cost of drug approval. Current pharmaceutical industry statistics set the cost at an average of $357 million to prove that a drug is safe and effective, and it takes an average of 5 to 12 years –sometimes more- to gain approval. As most of us are aware, drug companies are very wealthy, because they can -and do- recover research and approval costs through the sale of the drug, but only because the company has the exclusive right to sell it, in accordance with US patent law.

Herbal medicines are simply not patentable: Patent law prevents people from claiming exclusive rights to sell a product or technology that is already known. Common substances such as ginseng, butcher’s broom, golden seal- or ice- can’t be patented. There is absolutely no incentive for meeting the $357 million pricetag to bring a phytomedicine to the marketplace as an FDA recognized and sanctioned drug. The effect of the US method of regulation on the economics of medicine has utterly defined the practice of medicine in the United States, effectively banishing the use of phytomedicine during the majority of the twentieth century. Since 1962, not a single new complex plant drug has been approved in the United States. Because herbs could not be sold as medicines, they were regulated as foods, or sometimes as food chemicals (additives). Today, herbs, as well as vitamins and minerals, are regulated as dietary supplements in the United States.

The relationship between the FDA and the American herb industry has long been adversarial. Then, in 1994, the U.S. Congress unanimously passed a bill called the Dietary Supplement Health and Education Act (DSHEA), which defined dietary supplements as special nutritionals and forbade the FDA from treating them as food chemicals or as drugs, unless manufacturers made drug claims for their products. DSHEA allows dietary supplements to bear health benefit claims called “statements of nutritional support,” commonly referred to as structure/function claims because they may describe the effect of the supplement on the structure or function of the body. By law, these statements must be truthful and not misleading, and must be supported by scientific evidence. Labels must carry a disclaimer that the product is not intended for treating, curing or preventing disease. With the passage of DSHEA, the United States changed virtually overnight from one of the most hostile regulatory environments in the world for herbs to one that rationally regulates supplements. DSHEA allows labeling of products without prior government approval, yet requires a scientific basis and truth in labeling, which- contrary to widespread belief- the FDA is empowered to enforce. There are undoubtedly abuses of the law: this is the result of greed, by opportunists making exaggerated or inappropriate claims, selling supplements which simply do not contain ingredients as claimed, or worse, contain adulterated ingredients.

The European regulatory model has provided greater research incentives for herbs than the FDA model. In fact, European regulations have made European drug companies the leaders in natural product medicine. Meanwhile, US regulation is heading in the right direction: just last week, Friday, March 7, 2003, the FDA announced a proposal devised to regulate and monitor manufacturing standards, to insure that supplements both contain labeled ingredients in the quantity claimed, and are free of contamination.

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PART I:  HERBAL MEDICINE: FOLKLORE OR SCIENCE?

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This was written about 15 years ago, when I was asked to participate in a series of debate forums with a physician and a pharmacist.

I’ve spent my adult life studying and working with herbs. As with the succession of women before me -since the most ancient origins of humankind- my education in plant medicine is substantially contemplative, experiential; outside of an institutional setting. My laboratory is the night kitchen, when my children are sleeping, and my classroom is the garden -the forests and the fields- where I become intimate with plants. I know herbs, roots, barks and seeds, how they look and taste and feel when fresh and vital. The properties we recognize with our senses are referred to as organaleptics, and this is our indigenous assessment system.  I believe this skill is crucial to being able to recognize the quality of dried plant materals, as well as prepared herbal remedies.

Additionally, I won’t deny a great affection for my library. My shelves are a treasure of old and new titles, spattered from use while working, battered from repeated re-readings of the poetic turns-of-phrase and the vitalist contemplations of herbalists from distant places and even more distant times. There are hefty, contemporary reference texts in the sciences of medicine, and many books by modern herbal teachers and friends. The community of herbalists is growing, but still accessible and welcoming.  

Today’s forum is titled, “Herbal Medicine: Science or Folklore?” The question itself begins with an assumption that’s common in modern Western societies: science or folkore.

I’ll begin with some help from Webster, and define “science” and “folklore.”

Science:

  1. Knowledge; knowledge of principles and causes.

  2. Accumulated and established knowledge, which has been systematized and formulated with reference to the discovery of general truths or the operation of general laws; knowledge classified and made available in work, life, or the search for truth; comprehensive, profound, or philosophical knowledge.

  3. Especially, such knowledge when it relates to the physical world and its phenomena, the nature, constitution, and forces of matter, the qualities and functions of living tissues, etc.; -- called also natural science, and physical science.

  4. Any branch or department of systematized knowledge considered as a distinct field of investigation or object of study; as, the science of astronomy, of chemistry, or of mind.

Folklore:

  1. The traditional beliefs, myths, tales, and practices of a people, often transmitted orally.

  2. The comparative study of folk knowledge and culture

The notion of either-or is an artificial dichotomy. The study and practice of herbal medicine is science and folklore; more accurately, I argue that many traditional systems of medicine- as practiced across the planet and spanning eras- meet the definitional criteria of science. Of course, this isn’t an original idea of mine. The recognition that folklore is the science of another culture has launched exciting new fields of study in the last few decades. We use names like ethnobotany and ethnopharmacy to describe the study and translation of the science of traditional plant-based medicine from other cultures.

Where, and when, does the use of herbs in healing begin? Because we know that many animals- including primates- use nature to heal themselves, we can fairly assume that we have always sought out plants to assist in healing. Wild Health: How Animals Keep Themselves Well and What We Can Learn From Them documents examples and describes current studies of animals self-medicating to manage injury, infection, parasites and biting insects. In fact, excavation of one of the most ancient archeological sites in the Western Hemisphere- in the high desert mountains of South America- has brought evidence of the use of some 20 plants that are known and used as medicinal resources among the indigenous people of that area to this day.    

A useful way to develop an appreciation for the potential of herbal remedies is to review the systems of healing that have emerged in various cultures through history. It is also valuable to note- contrary to popular, modern prejudice- that writers on medicine -from the very earliest eras and distant places- demonstrate a respect for rigorous observation, theory development and critical assessment. In fact, our contemporary understanding of scientific method originated in 1600, with the recognition that Aristotle’s deductive reasoning method applied beautifully to mathematics, but didn’t fare so well with investigation into the natural world. Current “scientific method” (otherwise known as inductive reasoning), is based upon observation, observation, experimentation (otherwise known as experience), observation, theory development and more observation. Without doubt, the practitioners of traditional healing systems used what we now call “scientific method,” much of which is carefully itemized and described in ancient texts.  

Most of what we know about the earliest healing systems is provided by medical texts, which are often among the most archaic books. One disappointing- but expected gap- is in regard to the place of women as healers. Throughout human history- and indeed today, in much of the world- women are the primary providers of health care in small communities, on a very intimate level.

Additionally, less is known about the practices of ancient cultures in which written language did not develop. As a result, the three main systems of medicine we can explore are the traditions of Europe (usually referred to as Western), India and China.

When we think of the origins of Western medicine, the Greeks- and Hippocrates- may first come to mind. In fact, the Hippocratic writings espoused an enlightened view of invoking dietary, lifestyle, environmental, and psychological means of encouraging health that is stunningly consistent with a contemporary ideal of health. In terms of the practice of herbalism in Europe and the Arabian world, the influence of the 2nd century physician Galen is the most influential. He wrote extensively about the “humors”- blood, phlegm, black bile and yellow bile- and classified herbs by their essential qualities: hot or cold, dry or damp. While the Galenic system is comprised of elaborate classifications of conditions, the primary function of herbs on illness can be described as eliminating toxic accumulations. According to Galenic medicine, it is the accumulation of toxins in the system that cause illness and retard the body’s ability to protect itself and to heal.

While the concept of humors sounds bizarre, the notion of toxic accumulation and the idea that a healthy system heals itself is currently making a bold reappearance. Since the Galenic system prevailed in Europe through the 18th century, spanning some 1,600 years- and is still the framework for Islamic medicine- we can thank its practitioners for the materia medica of Western herbal knowledge we enjoy today. These herbs are the foundation of our medicine cabinets, whether herbal or pharmaceutical.

Next, we move to the Indian system of Ayurveda, which is roughly translated as “knowledge of how to live.” In Ayurvedic medicine, illness is viewed as imbalance, with herbs, diet, meditation and exercise used to restore equilibrium. At the base of the practice is the theory of doshas, or dysfunctions. Three fundamental dosha constitutional types are identified, and herbs are classified according to their effect on each dosha. A primary feature of Ayurvedic medicine involves cleansing, with many varied methods used to elicit elimination.

It’s interesting to note the focus on the elimination of toxic accumulation, both in Western and Indian medicine. Is there anyone here who hasn’t noticed the pervasive numbers of “detox” remedies available? I daresay we’re rediscovering the importance of cleansing, although, I believe a more accurate understanding of the mechanism of action of the herbs is their function in support of the organs and systems of elimination.

Now, we’re going to keep the discussion of Chinese medicine as simple as possible. In fact, Chinese medicine developed from prehistoric times and continues to be the primary medical system in China to this day. It is arguably the most comprehensive and complex system of traditional medicine. It is important to understand that the Chinese worldview has been far removed from Western thought since the time of Aristotle. In Chinese thought, everything moves, and the flow of energy is at the base of life. (In the West, we had our first glimpses of Chinese energy concepts with the work of Einstein.) The framework by which diseases are categorized is composed of a system of four opposites, or eight conditions. The healing principles are divided into five elements, or tastes. Once again, illness is regarded as disharmony, so the task of the traditional Chinese healer is to restore harmony and balance, thus enabling the body’s natural healing mechanisms to function effectively.

It is very interesting to note the broad underpinnings of these three distinctive systems. When reduced to simple terms, there is a pervasive ancient belief in the necessity of eliminating toxic build-up and achieving balance, in order to allow the body to heal, and function as it is designed to do.  It really doesn’t sound foreign at all.       

Now, let’s switch gears and talk a little bit about terminology. When I was given a synopsis of today’s panel and subject matter, I was surprised by the language used to describe the topic to be covered later this morning, wherein a physician and pharmacist discuss “traditional” medicine’s growing acceptance of “alternative” medicine. It reminds me that even within this culture there are many sub-cultures. From my perspective, “traditional” medicine constitutes the use of herbs and healing practices by generations and generations of our ancestors. I use words like “contemporary Western medicine”, “modern medicine” and –probably most often- “conventional medicine” to describe the form of medicine these practitioners refer to as “traditional.”  

I regard the various systems of medicine as essentially complementary; The idea that one needs to “adhere” to- or be stuck to- one system or another is simply false. I had surgery in December. I went to Madison and found a professor in the field at the University and he did a beautiful job correcting a structural problem. No plant on earth could have corrected my problem. Still, I used herbs to encourage healing after the surgery, and my doctor was impressed with my unusual rate of healing and rapid reduction of inflammation. He feels that post-operative inflammation is a significant problem hindering healing, with little relief. That’s what we’re talking about when we use the term, “complementary medicine.”

Now, this little anecdote begs the question of how we arrived at this point, where conventional medicine and herbalism are distinct fields of study? Most people are aware that even today, the majority of medicines originated with natural sources- primarily plant, but sometimes animal as well. At the dawn of the era of the pharmaceutical industry, all drugs were derived from plants and animals. Now, some will argue that pharmaceuticals allow for the standardization of dosages, and that’s a valid argument. There are others who argue that standardizing dumbs-down the natural medicine by sacrificing the complex efficacy of the whole plant. That’s a valid argument as well. But that’s a discussion we’re going to explore in-depth next week. Today, I’m going to tell you how- one century ago- the study of herbal medicine was eliminated from medical education in the United States and Canada.  

In 1908, the American Medical Association- or AMA- wrote to the director of the Carnegie Foundation with the request that they participate in the AMA’s efforts to reform medical education. At the time, members of the AMA were frustrated by the lack of public confidence in the profession and were engaged in fierce debates with practitioners of other systems of study, such as eclectics, physiomedicals, oseopaths and homeopaths. Additionally, the demand for AMA doctors was low, due to a high turnout of doctors from medical schools. In fact, physician incomes were approximately on par with that of train mechanics.

The Carnegie Foundation agreed to collaborate, and documents prove that they deliberately concealed this fact from the public, in a stated effort to “appear impartial.” It was determined that the Carnegie Foundation would fund a complete investigation of all medical colleges in the United States and Canada, and would publish an assessment and recommendations. With the collusion between the AMA and Carnegie Foundation hidden, the report would carry the weight of an independent, disinterested body and would be widely distributed to the public.

The Carnegie Foundation worked hand-in-hand with the Rockefeller Institute for Medical Research. Both the Carnegie and Rockefeller families were heavily invested in the new industry of pharmaceutical companies, and much was to be gained through changing the face of medicine in the US and Canada. As a matter of fact, the investigation was charged to an unemployed, former school master, with absolutely no medical training. His name was Abraham Flexner, and he was the brother of the director of the Rockefeller Institute.

The Flexner Report, published in 1910, is widely considered to have initiated the most significant medical reform in the past 100, maybe 200 years. In it, Flexner claimed to have visited all 167 medical colleges in the US and Canada. (Recent investigation into his records indicate that it would have been virtually impossible for him to have visited all the schools according to the calendar he claims in his documents.) He was caustic in his use of language to describe the schools he recommended closing; his assessments were scathing, shocking and theatrical, clearly intended for public consumption. He recommended that 5 of the 7 “Negro” colleges be closed (explained that two should remain open, in order to allow Negroes to treat themselves, lest they spread infection to whites by contaminating a white doctor.) He also recommended that all 3 women’s medical colleges be closed.

True to the interest of the AMA, he disparaged all the dissenting sects, referring to them as “quacks” and “mercenaries.” Remembering that the public would see the report- which was widely quoted by the media- and regard it to be the work of a neutral expert, one can only imagine the depth of damage to individual practitioners of herbal systems of medicine and homeopathy.

True to the interests of the Rockefellers and Carnegies, he utterly destroyed the reputations of the proprietary schools, which were self-supporting and self-directing. The Rockefellers had long made effective use of philanthropy to further business: in the case of medical education, the Rockefellers contributed enormously to colleges which relied in donations for survival, with the caveat that herbal medicine be completely disregarded in favor of pharmaceuticals. Proprietary schools- which trained students in the use of herbs over industrial pharmaceuticals whenever possible- thus threatened the Rockefeller and Carnegie desire for a monopoly on medicine.  

The effect of the Flexner Report ripped though the medical community. Maligned schools were abandoned, with 25 closing virtually immediately, and many more in the following years. In 1900, there were a total of 167 medical colleges in the US and Canada; following publication of the report in 1910, the number fell to nearly half, with only 85 schools remaining. What racial and gender diversity in doctors existed prior to the report was practically wiped out in a manner of a few, short years.  

Further, Flexner recommended that the purpose of medical education be re-designed, with a greater orientation toward research and drug development and a reduced focus on community practice. Prior to the report, most professors were chosen from the local area, based upon recognition as superior practitioners. Following the report, professors were selected according to researching skills, with the “publish or perish” phenomena beginning with medical education, and now pervading all areas of higher education.

Finally, Flexner recommended that government become significantly involved in controlling medical education, and specific legislative action. This action resulted in the necessity of gaining a license to practice medicine based upon membership in the American Medical Association. Essentially, the government seized authority over the practice of medicine, then transferred that authority exclusively to one group of practitioners. Of course, it was then illegal for a doctor who was trained in an herbal tradition to practice; further, all AMA doctors attended medical schools that were beholden to Rockefeller and were strict adherents of the use of pharmaceuticals. This was the end of the widespread use of herbs in contemporary medicine in the US and Canada. It had absolutely nothing to do with science. It was a condition designed by those with money and power, in order to serve their own interests.

So- in the interest of health and science- it is truly exciting that the turn of this century has brought a renewed vitality and sincere interest in the use of herbal therapies on the part of the public, as well as health care practitioners.   

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Debunking the Marijuana CBD versus Hemp CBD Silliness

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It would be difficult to fail to notice the surge in meaningful media attention to the health and wellness benefits of CBD. 

Even the most entrenched opponents of cannabis legalization have relented, under the weight of emerging research.  Of course, history and testimony to the medicinal use of cannabis is far and deep, reaching into antiquity. 

While marijuana - including CBD (cannabidiol) oil products made from marijuana - must comply with seed-to-sale state laws that make these products illegal to transport across state lines, hemp - whether hemp oil, hemp nuts or hemp supplement oils that are highly concentrated with CBD- is perfectly legal for use throughout the United States, as long as the hemp is imported from an international source. (Hemp oil grown in the United States is subject to the same seed-to-sale state laws that apply to marijuana.) 

Now, many people are understandably flummoxed by a very active campaign to convince the public that CBD is different depending on whether it's derived from marijuana or hemp.  Hemp and marijuana are both Cannabis. Hemp is Cannabis sativa, and marijuana is either Cannabis sativa or Cannabis indica. Hemp is simply the common and legal term for cannabis that contains less than .3% THC, and marijuana is the common and legal term for cannabis that contains .3% and more THC.

CBD, or cannabidiol, is the same plant compound, regardless of whether it's found in a low-THC or high-THC cannabis plant. 

Another rather bewildering allegation claims that hemp-derived CBD oil is "dirty" and marijuana-derived CBD is "clean." 

Let's take a good look at the claim, which is based upon the underlying premise that hemp acts as phyto-remediator. Well, yes, it does. All cannabis serves exceptionally well for phyto-remedation purposes. This means that cannabis mops up contamination and can be used to clean up all manner of nastiness. It also means that if it's grown under less-than-pristine conditions, it carries that nastiness with it when it's harvested. And, it carries that nastiness with it into products made with it. So, clean sourcing is an especially big deal with ALL cannabis. 

The presence of aflatoxins and other fungal and bacterial contaminants, heavy metals and pesticide residues is necessarily the result of agricultural/horticultural conditions. 

Recent testing of cannabis products from Los Angeles marijuana dispensaries showed over 90% of tested products to contain HIGHER than normal contaminants and pesticide levels, despite organic claims. (The USDA National Organic Program does not certify organic claims on marijuana, and it's actually not a legally permitted claim on these products.- FYI, I'm an certified IOIA, Independent Organic Inspectors Association organic processing inspector.) There's no intrinsic difference between high-THC cannabis and low-THC cannabis that somehow renders one clean and one heavy with contaminants. As with every other crop, it is a matter of soil conditions, growing conditions and horticultural inputs. 

Garbage in, garbage out. 

In point of fact, while there is NO third party organic certification system available for marijuana at present, hemp qualifies for organic certification. We extract our CBD rich hemp oil from certified organic Cannabis sativa grown in Europe. Our CBD oil is extracted using supercritical CO2, the cleanest possible processing system. In the US, we are NOT permitted to obtain USDA NOP Organic certification for our product itself, due to our use of CBD rich hemp oil. (This is a decision made by the US government's organic program, that operates under the umbrella of the USDA, despite the legality of hemp and cannabinoid rich hemp oil.) 

Although Luminary Medicine Company formulas are made with exclusively certified organic and wildcrafted ingredients, there is no auditing system in place, so neither our product nor any other consumable product using cannabinoid-rich hemp oil may legally use the word "organic" on the front panel of the product. When the word "organic" is used on the front panel of a consumable, CBD rich oil product, it ought cause a consumer to pause and consider the legitimacy of other claims and the overall qualification and reliability of the manufacturer.  

What this means is that there is no third-party organic certification system in place to vet the growing and production standards and safety of either THC or CBD cannabinoid rich  oils and products in the United States.   

How do we insure that our CBD rich hemp oil is free of these harmful contaminants? We test. And we test again. We use a highly esteemed laboratory. We test for potency- meaning that we test to insure that our claims are accurate- and we test for a complete profile of biological, heavy metal and pesticide contaminants. We encourage others to do the same. 

To my fellow plant medicine makers: we're on the same side, in our commitment to vital nutrients and personal authority and regulatory reforms. Let's not fall prey to squabbling amongst ourselves, and diminishing our credibility and degrading our cause. Let's do this well. 

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soirsce@luminarymedicine.com

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