I continue my investigation of how two Portland acupuncturist instructors I knew while getting my Master’s degree at the Oregon College of Oriental Medicine caused Beverly Hames to have kidney failure and require dialysis, a kidney transplant and multiple surgeries in order to survive. It has taken me a while to get this far, and the implications keep getting more disturbing. I first learned about the involvement of my teacher Mitch Stargrove and well-known author/teacher/manufacturer Subhuti Dharmananda while reading journalist Dan Hurley’s book, _Natural Causes: Death, Lies, and Politics in America’s Vitamin and Herbal Supplement Industry_. I like to read books that challenge my mind and make me think, but I wasn’t expecting to see people I studied with in there!
While chewing on this issue and considering whether to write about it or not, I was dismayed to see a small movement in the Chinese herbal medicine world adamantly promoting the use of banned herbs containing Aristolochic Acid, the chemical now confirmed beyond doubt in causing severe irreversible kidney damage and vastly increased upper urinary tract cancer risk. On the heels of that, a huge study from Taiwan was published showing that an incredibly large number of citizens have still been taking Chinese herbal medicines containing Aristolochic Acid and have a corresponding world-record level of kidney and bladder cancers, connected beyond doubt.
I just made an important discovery about what went down in Portland with Beverly Hames and Subhuti Dharmananda’s herbal supplement which contained Aristolochic Acid. From Natural Causes:
Following the recognition that unlabeled aristolochia in her supplements could cause kidney cancer, Beverly Hames underwent a second surgery in 2000 to have what was left of her original kidneys removed. By then she had settled for an undisclosed sum from a lawsuit against Stargrove, his company, Dharmananda’s company, and others involved in the case. Living with her Maltese, Sally Anne, in a modest middle-class home, she continues to pay a monthly mortgage, lives frugally, and remains at high risk, due to the aristolochia, of developing cancer elsewhere in her body.
“It’s been a nightmare,” she says. ”I’ll never live out my true life. It’s like someone murdering you slowly. Don’t use the word ‘natural’ on me ever again. That’s how they get away with selling this garbage, by calling it ‘natural.’ It just needs to stop. They’re killing people.”
I had been thinking that Subhuti had been the victim of substitution of Guang Fang Ji (Aristolochia fangchi) for Fang Ji (Stephania tetranda), which was what happened in the Belgian weight loss clinics where researchers first identified 70 cases of death and kidney failure. In that case, Subhuti would have been the unfortunate victim of poor species identification in Chinese markets, which is the impression Hurley gives in his book. This doesn’t let Subhuti off the hook for apparently not doing a recall or alerting his acupuncturist customers and their patients to the tainted batches, but does increase compassion for his position. Hurley introduces Subhuti in _Natural Causes_ after Beverly’s doctors discovered that the cause of her extreme fatigue, poor appetite, and headaches is kidney failure:
Unknown to Beverly, her case bore a striking similarity to twelve other cases of kidney disease linked to Chinese herbs that had first been described in a prominent medical journal on February 13, 1993–months before she had been prescribed one of the same herbs, stephania, highlighted in the report. According to the article in the Lancet, two Belgian women had shown up at the nephrology clinic of the University of Brussels in early 1992 with unexplained kidney failure. Though unexplained cases remain a stubborn fact of life (there’s even a fancy medical word for them: idiopathic disease), a sharp-eyed doctor, Jean-Louis Vanherweghem, noted an odd coincidence in the women’s background: both had followed a weight-loss regimen at the same medical clinic. Curious, Dr. Vanherweghem decided to interview all of the seven other women in Brussels under the age of fifty who had gone into kidney failure between 1991 and 1992. Sure enough, all seven of them had gone to the same weight-loss clinic, an association that no other doctor had noticed. Then he decided to survey twenty-five other women, seemingly healthy and randomly selected, who had attended the weight-loss clinic in the same period. Three of them, it turned out, had impaired kidney function. However, the clinic had specialized in weight loss for fifteen years without any problems. What could be causing the recent disease?
In May of 1990, Dr. Vanherweghem discovered, the clinic had added to its standard therapy two Chinese herbs: stephania and magnolia. But no previous cases of kidney failure due to ingestion of either stephania or magnolia had ever been reported. The only similar type of case, known as Balkan nephropathy, had been possibly linked to aristolochia, but Dr. Vanherweghem could find no trace of aristolochia in the samples of weight-loss formula it tested. Even so, he concluded that something about the herbs almost certainly prompted the kidney failure, and stated in his Lanced report that the link “add[ed] support to the arguments against uncontrolled therapy with herbal preparations.”
Following publication of the study, a distributor of Chinese herbs in Portland wrote a paper for the American Botanical Council titled “Stephania and Magnolia Bark: Targets of a Misdirected Investigation.” The distributor, Subhuti Dharmananda, PhD, was director of the Institute for Traditional Medicine. Casting the Lancet study in terms of a turf battle between Eastern- and Western-style practitioners, he asserted that Dr. Vanherweghem was simply seeking to “enter the fray about herb regulation in Europe.” Dharmananda saw only “flimsy circumstantial evidence” to support the claim that herbs had anything to do with the patients’ kidney failure. In fact, he wrote, “No safety problems have been noted in the U.S. where stephania and magnolia bark (sometimes used together) have been utilized since at least 1976 and continue to be used extensively.”
In January of 1994, Dr. Vanherweghem published an addendum to his original paper in Lancet. By then, 70 cases of what he called Chinese herb nephropathy, including “30 of whom had terminal renal failure,” had been linked to use of the same clinic’s weight-loss formula. Using improved methods to analyze herb powders sold in Belgian pharmacies as stephania, he did indeed find traces of aristolochic acid in eleven of twelve samples. He concluded that aristolochia had been substituted in place of stephania at markets in China, where the herbs originated. ”This report underscores, once again, the absolute necessity of the introduction of measures to control the correct identification of herbal preparations,” he wrote.
In response, Dharmananda wrote an addendum to his paper for the American Botanical Council. Calling Dr. Vanherweghem’s conclusion that aristolochia had caused the kidney disease a “strained hypothesis,” he referred to a recently published report on toxicity and side effects of some Chinese herbs: ”Aristolochia species are not listed among the nephrotoxic herbs. If one clinic in Belgium can produce 70 cases of renal failure, including 30 fatal cases, in a period of about two years using minuscule amounts of aristolochia, one would expect that the Chinese literature would be filled with cautions about the toxicity of these herbs (which all contain aristolochic acid), since they are extensively used at much higher doses.”
Chinese nephrology exists. There have been hundreds of cases of kidney-failure due to aristolochic acid-containing Chinese herbs in the West, and probably many times more in China, Taiwan and throughout Asia.
Here are the facts. Aristolochic acid can be toxic to the kidneys in large amounts or prolonged application, and Chinese TCM textbooks have pointed this out since the 1950s. Well-educated TCM herbalists do not commonly use herbs containing AA. The main cases involving toxic levels of AA herbs have occured with improper substitution of AA herbs for non-AA herbs that have a similar name. For example, the initial situation in Belgium involved the substitution of guang fáng ji (Radix Aristolochiae Fangchi) for fáng ji (Radix Stephaniae Tetrandrae). A medical doctor without knowledge or training in TCM made this substitution in his weight-loss clinic, obtaining the herb from unreliable sources. He used large amounts of guang fáng ji for prolonged periods of time, certainly beyond what a traditional prescription would call for.
Dr. Subhuti Dharmananda, in an excellent article from 2001, questions whether aristolochic acid herbs are even that toxic. First, citing a 2000 NEJM article, he says that while AA may have been a contributing factor, kidney failure at the weight-loss program may have been due to a combination of factors, including serotonin injections that have been shown to cause kidney injury. Secondly, Dr. Dharmananda points out that the AA herbs were used for far longer periods of time than is normal in TCM, and that the herbs were in powdered/capsule form, whereas traditional water extraction minimizes the release of aristolochic acid. Finally, the AA herbs may have become more toxic in combination with Western medications. “It is possible that use of the herb medicines derived from Aristolochia plants when used alone rarely, if ever, cause renal failure, but that when combined with certain drugs, the toxicity develops….If this were the case, it would support the contention that it is the non-traditional use of the herbs that led to the problem, rather than the herbs themselves,”he noted.
In 1994, a 44-year-old woman progressed from normal renal function to advanced renal failure and end-stage renal disease within 8 months. Biopsy revealed extensive interstitial fibrosis with focal lymphocytic infiltration. She received a cadaveric renal transplant in January 1996 and had an uneventful posttransplant course. As a result of a minor motor vehicle accident, the patient had received acupuncture and Chinese herbal medicine for pain relief approximately 5 months before the onset of renal symptoms. After the transplant, analysis of the herbal remedies clearly indicated the presence of aristolochic acid in 2 of the 6 Chinese herbs ingested. Ingestion of aristolochic acid has been linked to a newly defined entity, Chinese herb nephropathy (CHN). This article discusses the history of CHN and its implication in the current case and in other recent similar cases and makes recommendations to avoid future problems caused by unregulated use of herbal medicines. This is the first reported case of CHN in the USA.
A45-year-old woman with end-stage renal failure was referred for a renal transplant workup in February 1995. She had had normal renal function in November 1993 at age 43 and developed malaise, severe anemia, and advanced renal failure 8 months later. Except for a total hysterectomy for uterine fibroids in 1975, she had been entirely well until she suffered a minor motor vehicle accident in 1993 and developed persistent low back pain. Prior to the accident, she had no history of chronic pain or sustained or intermittent use of nonsteroidal anti-inflammatory drugs or other analgesic medication. She had no personal or family history of renal disease, cardiovascular disease, systemic hypertension, or diabetes mellitus. In early 1994, she began receiving acupuncture and Chinese herbal medicine for pain relief.
- Snake bile pellets
- Hypericum/St. John’s wort
- Specific Lumbaglin
- Homeopathic arnica
- Homeopathic magnesium phosphate
- PSI (herbs, vitamins, and mineral compound)
- Jin Bu Huan (for pain and lack of sleep, now removed from the market for pharmaceutical adulteration)
- Ligaplex II
- “Liquid amber, a Chinese remedy for back pain”
- Homeopathic lachesis muta or surukuku
- Eucommia bark
- Chin Koo Tieh Shang Wan (Jin Gu Die Shang Wan)
- Box of Chinese herbs for sciatica
- Homeopathic rhus tox
- Homeopathic bryonia alba
- Asarum (Xi Xin, also contains some Aristolochic Acid)
- Stephania (may be confused with Aristolochia)
- The tail of a gecko
- Dried Earthworm
Given the huffy article Dharmananda had written about Dr. Vanherweghem’s Lancet study, it was a sad twist of fate when it turned out to be Dharmananda’s Institute for Traditional Medicine that supplied, under its Seven Forests brand, the tablets labeled “stephania” that Bevery Hames had taken for months.
Aristolachia leaf, xungufeng, Aristolachia mollissima, tops, dispel wind-damp
The formula Aristolochia (misspelled Aristolachia) was taken from, Du Zhong Hu Gu Wan, is “Eucommia and Tiger Bone Pill.”
Going back to _Natural Causes_ Hurley reports on the eventual testing of the herbs Beverly had taken:
It was during one of those early post-transplant visits that she met for the first time with William M. Bennet, MD, head of the division of nephrology at OHSU. She told him what she had been telling everyone else who would listen for the past eighteen months: ”I don’t understand why I got kidney failure, why this happened to me.”
With a trim graying beard, glasses, and thinning hair, Dr. Bennett began asking her the usual questions. ”Were you taking any new medicines or drugs?”
“I never took any drugs in my life,” she answered. Like most patients asked about “drugs,” she didn’t consider herbs to fall in that category.
But, thinking of the Lancet study, Dr. Bennett pressed on. ”Any herbs?”
It was the first time in more than eighteen months of medical care for her kidney failure that anyone had thought to ask Beverly that question. …
In response to Dr. Bennett’s question, Beverly replied, “Well, I did take these herbal preparations for my back, but that was months before I got sick.”
He asked her what kinds of herbs she’d taken. When she mentioned stephania, his ears pricked up. He told her about the report in Lancet. ”If you have any of the herbs left, it would be helpful if you could bring them in.”
Two days later, she brought in a dozen bottles of the various herbs she’d been prescribed by Stargrove and Grimm-Schaefer, most of them distributed by Dharmananda’s Institute for Traditional Medicine. Dr. Bennett sent samples of each herb first to a colleague of Dr. Vanherweghem’s in Belgium, and then to the FDA.
Karen A Wolnik, director of the Inorganic Laboratory Branch of the FDA’s Forensic Chemistry Center in Cincinnati, had each of the samples ground and an extract made. The extracts were analyzed for the presence of aristolochic acid by high-performance liquid chromatography. The Seven Forests gecko was negative for aristolochic acid, as were the Seven Forests eucommia, cyperus, and salvia. But the Seven Forests asarum, stephania, and clerodendron were each positive for aristolochic acid, as were the Jin Bu Huan and Chin Koo Tieh Sheng Wan made by other companies. And the arnica, one of the homeopathic remedies that Stargrove insisted had no toxicity, was also positive for aristolochic acid.
Note that it’s described as “an experimental formula.” My recent comments about “medical experimentation” don’t seem so far out now, do they? The large mix of supplements given to Beverly was truly experimental, and the experiment was a tragic failure. I didn’t expect to see Subhuti’s “Institute for Traditional Medicine” publish so directly that they were designing experimental treatments. It probably sounded exciting in 1990, after all, it was “natural.” Well, except for perhaps the Borneol.
There is no “stephania” listed as an ingredient in the index to 1990 Bag of Pearls, and no Stephania tablets, but it does show up in the Clerodendron 6:
Yes, Clerodendron 6 has two types of snakes and dried earthworm in it. I was taught that since earthworms burrow through the earth, they can also symbolically burrow through our acupuncture meridians to open them and relieve pain. This wasn’t a memory technique as much as the sympathetic magic theory which led to their use in TCM.
Given that there was some Aristolochic Acid in the unbranded Jin Bu Huan and Chin Koo Tieh Shang Wan (and apparently in Mitch’s homeopathic Arnica, which is very odd indeed), the dire picture gets clearer: Beverly Hames was taking at least 3 different species of Aristolochic Acid-containing herbs in the 3 different Seven Forests formulas she was taking (Aristolochia leaf from Liquidambar 15, Asarum from Asarum 14, and Stephania from Clerodendron 6). Aristolochic Acid isn’t very water soluble. Seven Forests tablets are often (still) made from crude powdered herbs. This is another reason why traditional teapills (made from water extractions) or decoctions are preferred to taking crude herb tablets or innovative extracts (made with alcohol, methanol, etc.).
Looking in the year 2000 edition of _A Bag of Pearls_ we see that Asarum 14 and Clerodendron 6 have been discontinued, but Liquidambar 15 is still available with modifications.
Dharmananda notes the “several practitioners complained that it was too warming” when explaining his modifications to the original formulas (one of which contained cat/tiger bone). Should we think that “too warming” is a euphemism for “I got sued”? A significant part of _A Bag of Pearls_ is devoted to recommending combinations of multiple formulas. There are no footnotes, nor a bibliography even to standard Chinese herb texts. There are certainly no references to scientific literature, even though recommendations are given for cancers, including a general recommendation for “metastisized cancers” in the 1990 book.
There still are some loose ends, so the story doesn’t end here. One troubling piece is raised from Hurley’s report that Dharmananda started checking for Aristolochic Acid in Stephania:
Although he did nothing at that time to directly warn the buyers and prescribers of the herbs he sold, and had publicly cast doubt on the Belgium study, privately Dharmananda felt concerned enough that he called his contact at Taising Trading, the Hong Kong company from which he bought his Chinese herbs. He asked his contact, a guy named Frank, to double-check that the stephania he’d been ordering was not being substituted with aristolochia, as had happened in the Belgium cases. Frank assured him that no such substitution was taking place, and that the company had a Chinese medical doctor who confirmed that the stephania they ordered was the stephania they got. Still privately concerned, however, in 1995 Dharmananda contacted a Chinese pharmacologist he knew and asked him to personally go to the marketplaces in China, buy some stephania, make an extract, and test it for aristolochic acid. The pharmacologist, Dr. Kazhi, did so, and found no traces of aristolochia. At that point, Dharmananda, whose company annually grossed some $1.4 million selling herbs, did nothing more to check on the safety of the 500 to 900 bottles of stephania tablets that he sold each year, even though he did not actually know where Taising obtained its stephania. This much he did know, however: neither Taising nor the California company that turned its raw herb into tablets did any testing of the stephania or any of the other herbs they sold; and neither did Dharmananda himself ever test any of the herbs he sold. He also knew that the purity of the stephania and other herbs he bought from Taising were protected by nothing more, during shipment from China and storage in warehouses, than plain cardboard boxes or burlap bags.
So Subhuti paid attention to the potential dangers of Aristolochic Acid, but didn’t recall or check on the Liquidambar 15 which clearly had Aristolochia leaf in it? Xun Gu Feng isn’t a common TCM herb, it’s not listed in my 1993 Bensky Materia Medica. It is in my rare 1986 _Oriental Materia Medica: a concise guide_ by Hong Yen Hsu, where it clearly states it contains Aristolochic Acid, but doesn’t mention toxicity:
But Jake Fratkin just wrote, “Here are the facts. Aristolochic acid can be toxic to the kidneys in large amounts or prolonged application, and Chinese TCM textbooks have pointed this out since the 1950s.” Bensky’s 1993 _Chinese Herbal Medicine: Materia Medica_ does have an entry for Guang Fang Ji, the Aristolochia species substituted for Stephania tetranda. It mentions Aristolochic Acid as a component, and has notes on toxicity, but not for AA:
For Buddha’s sake, this book has entries for Lead Oxide, Asbestos, and Flying Squirrel Feces (in addition to Rhino Horn, Tiger Bone, and Seal Gonads), you’d think that if Aristolochic Acid had been recognized as toxic from the 1950′s, it would show up in Bensky’s Materia Medica. Apparently the Chinese TCM texts that Fratkin says have pointed this out since the 1950′s never made it into the English literature. Not that it would have made much difference, given that many herbs with toxicity notes in Bensky are routinely included in formulas with little concern. Dharmananda’s more comprehensive review of the herbal literature around Aristolochic Acid casts doubt on Fratkin’s claim that AA toxicity has been noted in TCM texts “since the 1950s.” It still troubles me that Dharmananda can write an extensive review regarding Aristolochic Acid and fail to mention that he had to remove it from multiple products. Even after settling out of court with Beverly, there was apparently no recall of the products, no notification to his acupuncturist customers of this life-threatening issue, and no attempt to warn the end-users that they should be on the lookout for signs of kidney failure and bladder cancer for the rest of their lives. (I could be wrong about the lack of a recall, and will update this if I’m presented with facts that show otherwise. [Updated 5/1/12, see Footnote 1 below]) Adding that to the fact that _A Bag of Pearls_ is marketing material which the FDA considers part of the product labeling, making the entire product line misbranded, unapproved new drugs, I am dismayed at not only Subhuti, but the FDA for completely failing to protect consumers, even after a documented case of kidney failure should have revealed Subhuti’s experimental drugs being inappropriately promoted for a wide range of diseases.
The fact that an herb company can get away with marketing “experimental” formulas for serious conditions, cause kidney failure in end-users, continue with the same marketing approach, and avoid any recalls or bad publicity makes the herbal marketplace seem as unregulated and dangerous as its harshest critics proclaim. By maintaining silence and covering this up, the US TCM herb industry has missed the opportunity to really learn a lesson about safety and demonstrate mature responsibility. The mainstream media and medical worlds now have clear reason to distrust Chinese herbs and acupuncturists in general even more than they did before. Fratkin complains:
In the last month or so, at least three patients reported to me that their physicians told them not to take Chinese herbs because they cause kidney failure. A pediatrician told a mother not to give her baby herbs I had recommended, because she said “Chinese herbs cause kidney failure, especially in children.”
This is absurd. What started as an isolated clinical phenomenon has morphed into a modern urban legend, spread by innuendo and misinformation, and not at all based on the facts.
Similar complaints are being echoed around the acupuncturist world, often followed closely with statistics of damage by Western drugs. I’ve long said that if natural medicine practitioners don’t face their issues and critics head on (by providing good quality research supporting their claims), they will end up being defined by the “enemy.” In this Aristolochic Acid public relations disaster, the opportunity to face it head on was in the 1990s. The facts are in: damage was done, damage was denied, only through good research by mainstream scientists was it discovered what caused the damage, and only through FDA action were the guilty herbs reluctantly removed from the market (though a tiny minority of acupuncturists still go great lengths to obtain them). The Belgian research didn’t start out trying to discredit or control Chinese herbs, but it’s where the trail led. Yes, it’s true that more people die from prescriptions and over-the-counter painkillers. But I’m an herbalist and these were teachers I looked up to. No excuses, this situation sucks!
How does a responsible natural medicine practitioner deal with this reality? Personally, I am conservative about prescribing herbs. I rarely prescribe Chinese products for long-term use. I only buy from companies like Mayway which legally and ethically import, test, and market their products. I recommend dietary and lifestyle changes as being more important than taking any pills. I try more and more to recommend Made in the USA products with a history of safety. I generally only recommend one new therapy at a time. And I continuously study, looking to understand and explore modern research and scientific inquiry showing which natural treatments have evidence for safety and efficacy.
And finally, I alert my customers and readers to illegal and unethical products and practices which may damage their health and bank accounts. Beverly’s kidneys deserve some penance.
Today (May 1, 2012), I e-mailed Subhuti Dharmananda about Seven Forests recalls:
Can you please let me know if there ever has been a recall for any Seven Forests formulas? If so, please let me know which formulas, why, and when. I’ve looked online and haven’t found any evidence of any recalls, so am assuming there haven’t been any. If that’s the case, please confirm.
I’m looking at the history of Aristolochic Acid in US TCM products, and have found recalls for several other companies’ products, and am trying to make sure I have accurate information in my writings.
Here is his reply:
We ceased using aristolochic acid containing herbs before the recalls started (which was after the FDA got involved). ITM provided information about AA for practitioners and manufacturers so that they could be alert to the potential problem. Some companies continued using the herbs, however.