In the 10 May 2002 issue of the New Zealand Medical Journal, Florkowski et al presented two cases of patients with adrenal suppression.1 Both patients had been using Shen Loon, a natural Chinese herbal product. Simultaneously, and with no knowledge of Florkowski’s work, I had been investigating the circumstances that led to five people, including myself, notifying Medsafe about another Chinese herb called Cheng Kum over the preceding 18 months. Cheng Kum was marketed as a natural product made of “...pure Chinese herbs”. The accompanying literature stated that Cheng Kum was “...beneficial for people suffering from arthritis, rheumatism, skin diseases like acne, dermatitis and scabies, menstrual pain, asthma, rhinitis, leukorrhea, sinuses and migraine”. Cheng Kum was imported and distributed by Lee Bye NZ Ltd (Lee Bye), a company based in Wellington. The following is a timeline detailing the extraordinary events surrounding Cheng Kum and Shen Loon.

In early 1999, Lee Bye became the New Zealand importer and distributor for Cheng Kum. Medsafe, the division of the Ministry of Health responsible for medicines compliance and monitoring, first had contact with Cheng Kum in early 1999 over issues of product labelling. An ESR (Institute of Environmental Science and Research Ltd) analysis of Cheng Kum, arranged by Lee Bye and dated 21 April 1999, showed homeopathic concentrations of arsenic, lead, cadmium and mercury (certificate of analysis number BU2780 RE2/5). This analysis was later presented to enquiring consumers.

A general practitioner (GP) in Auckland was the first to notify Medsafe, when a patient he was treating for osteoarthritis miraculously improved her arthritis shortly after commencing Cheng Kum. The doctor records the patient as having “general Cushingoid features”, a clinical sign of excessive steroids. A serum cortisol of 39 nmol/L (normal 200–700) was also consistent with the use of a glucocorticosteroid (steroid). After receiving the notification, Medsafe purchased and submitted a sample of Cheng Kum to ESR for analysis. The GP further progressed his concerns by directly notifying Lee Bye, and the local health shop from which the product was sourced.

A week later, a second notification was made, by a Wellington rheumatologist who noted unexplainable improvement in a patient with rheumatoid arthritis who was taking Cheng Kum. This patient did not have clinical features consistent with excessive steroid use.

The ESR certificate of analysis number PHA01/167 dated 12 December 2000 states “The capsules did not contain corticosteroids. The capsules were found to contain chlorpheniramine.” Chlorpheniramine is a reasonably common over-the-counter type antihistamine recommended for coughs and colds. Because chlorpheniramine is a pharmacy only medicine, Lee Bye now required formal registration and approval for Cheng Kum, to allow ongoing distribution and retailing under regulations applicable to pharmacy only medicines. This would likely be a lengthy and expensive process.

Medsafe immediately requested Lee Bye make a product recall, and a public notification in the form of a Director General’s statement was issued. Because Cheng Kum was now technically a medicine, Medsafe granted Lee Bye a special pharmacy wholesale licence to store the recalled product. As well as the required product recall letter, customers received an accompanying request from Lee Bye to make a complaint to the Ministry of Health to reinstate the product as follows: “In relation to this if you really think that you do need this product I would like to suggest you to write a letter to the Ministry of Health, complaining about why they stop this product. I wish that you can tell your customer to work together to bring this product back into the market and I think this is the only way that I could see now.”

It is interesting to note that, despite the recall notice and being granted a special wholesale pharmacy licence, Medsafe records no instance of any Cheng Kum at all being returned.

By liasing with customs, Medsafe were able to determine that significant quantities of Cheng Kum were now being imported by individuals, from the Malaysian manufacturer under existing “medicines for personal use” regulations. To further monitor this, Medsafe required a signature from all those importing, to remind them that the medicines were for personal use only.

Medsafe now believed that Lee Bye was offering advice to customers as to how to import Cheng Kum in quantities that would not attract customs attention, under the label of personal medicines. This by itself probably breached no regulations, however, by investigating Lee Bye’s financial accounts, Medsafe were able to determine that orders were being placed by Lee Bye to Malaysia, and customers were continuing to pay Lee Bye in Wellington. Medsafe notified Lee Bye that this was still considered to be importing and distributing and that this activity must stop. Medsafe believe Lee Bye subsequently made arrangements for New Zealand customers to directly contact the Malaysian manufacturer, and established a Malaysian bank account for further payments.

It is significant that the Malaysian manufacturer was also the uncle of Chee Chai Lee, the director of Lee Bye.

Soon after Cheng Kum was prohibited from retail distribution in December 2000, significant quantities of another herbal product, Shen Loon, began to be imported from Malaysia by members of the public, again under the “medicines for personal use” regulations. Medsafe, now suspicious of Lee Bye, accosted Lee Bye who confessed his association with Shen Loon, and that Shen Loon was the same product as Cheng Kum.

At this point, there was still no clear breach of regulations, and personal importation of Cheng Kum and Shen Loon continued from Malaysia to customers in New Zealand.

The next formal notification to Medsafe concerned Shen Loon. A GP in Palmerston North became suspicious when a ten year old he was looking after showed significant improvement in her previously resistant chronic excema and asthma. She had been taking Cheng Kum for six months prior to its ban, and Shen Loon for the previous five months. Although the excema and asthma had improved, the child showed all the clinical signs of taking steroids. This was confirmed with laboratory tests and she was referred to a paediatrician. As part of the assessment, samples of Shen Loon were sent from Palmerston North to Canterbury Health Laboratories where Florkowski et al undertook the analysis reported in the New Zealand Medical Journal.1

The next notifier was a Hamilton haematologist who had been referred a patient for investigation of bruising. This lady had been taking Cheng Kum for psoriasis with dramatic improvement. The haematologist records her as being “mildly Cushingoid”. Laboratory investigations were again consistent with taking steroids. The doctor notified Medsafe of his concerns regarding Cheng Kum, and also forwarded samples to Medsafe for analysis.

It is at this point that I became involved. On 8 November 2001, I notified Medsafe with concerns about a patient who had been taking Cheng Kum for dermatological purposes for many months. Her skin had improved dramatically where other potent preparations had been ineffective. She had, however, also become markedly Cushingoid with laboratory investigations consistent with taking steroids. This patient provided a remarkable insight into how friends and family had sourced Cheng Kum. After being made aware 11 months previously that Cheng Kum was to be withdrawn, friends and family had immediately gone from shop to shop throughout the country, and purchased the product. A number of contacts were also now importing the product directly.

By this time, the haematologist in Hamilton had discussed the case with colleagues who were also of a view that Cheng Kum capsules most likely contained steroids. He subsequently contacted Medsafe again, and Medsafe decided to undertake further testing in a specialist laboratory in Australia.

On 19 December 2001, Medsafe contacted all of the notifiers detailing the finding of the steroid betamethasone in Cheng Kum capsules. The accompanying information stated: “Please note, that this product has also been distributed under the name Shen Loon capsules, which have also been found to contain betamethasone”. Shortly after this, Medsafe made a general public warning regarding the dangers of Cheng Kum and Shen Loon. Medsafe advised Lee Bye that Customs would seize all further imports of Cheng Kum and Shen Loon, and that he should notify his customers not to attempt to import these products. Medsafe communications with Customs confirmed that imports had stopped.

This story raises several important issues around the regulation of alternative therapies, private medicine importation regulations, and patient rights and responsibilities.

First, is the issue of the regulation of “natural herbal” products. Other authors have presented evidence for the potential toxicity of herbal products and the misrepresentations relating to them.2,3 It is also not the first case in New Zealand of a steroid being found in a herbal product used for, amongst other things, dermatological purposes.4 This case adds yet further to the discussion on the regulation of alternative therapies.5 Current legislation separates complementary healthcare products such as Cheng Kum and Shen Loon into two categories – dietary supplements or medicines. Medicines are legislatively administered under the Medicines Act 1981, and the Misuse of Drugs Act 1975, and are subject to a rigid pre-market approval process. Dietary supplements are managed under the 1985 Dietary Supplements Regulations as a part of the Food Act 1981. Dietary supplements include vitamins, minerals, herbal products, nutritional supplements and homeopathic remedies. There are comparatively few restrictions on dietary supplements other than labelling, maximum allowable daily doses, and inability to make therapeutic claims. Outside these parameters, there are no other requirements for pre-market approval, with the responsibility resting completely with the distributor to ensure the products are safe and comply with legal requirements. It is this author’s view that current regulations fail the consumer by relying solely on the integrity of the distributor, and not requiring at a minimum, a pre-market, independently verifiable, scientific analysis of the product. There is also no requirement for a manufacturer of dietary supplements to adhere to any code of practice or accepted manufacturing standards.

Second, is the issue of regulation based on clinical findings even in the absence of formal identification. Formal identification of the exact substances producing the marked clinical signs and symptoms was problematic. While the exact chemical composition was and may still be under debate, patients were clearly manifesting clinical signs and symptoms that were potentially irreversible and life threatening. Regulations need to be developed that protect consumers from potentially harmful products, simply on the basis of a “high index of suspicion”.

Third, is the issue of personal importation regulations. Current regulations under the Medicines Act 1981, allow any individual to import unregistered medicines under the umbrella of personal use. This story raises some interesting issues regarding the regulations associated with the personal importation of unregistered medicines. Some of these are:

a) Signing a declaration did not stop people from distributing the product to others;

b) Significant quantities of medicines were imported successfully by each individual on a regular basis;

c) Who carries the responsibility for any complications that may arise from an imported medicine? Should public funds be used for doctors’, hospital, and any ACC costs that arise from a consumer’s personal decision to import an unregistered medicine from overseas?

It seems incongruous that products such as Cheng Kum and Shen Loon can be banned for safety reasons from retail distribution, yet immediately be available through private importation.

In summary, through a combination of factors, there has been a disservice to a large number of people. To the physicians involved, there is the disservice of dealing with patients’ mistrust of conservative treatments, when a “natural” product has had miraculous effect. To the patients themselves, there is the disservice of being lied to, and being unknowingly subjected to a potentially toxic substance. There is also the guilt associated with passing on what was genuinely believed to be good advice from one friend to another. To the Ministry, there is the disservice of being responsible for protecting the public from hazardous medicines, yet in my view, not having a full armament of legislative tools to undertake the task. Finally, there is also a disservice to the proponents of natural remedies. Rogue traders hiding under the “natural” guise create considerable damage to the integrity of those legitimate products that do seem to safely, and naturally, confer benefit. In conclusion, we can probably all be very grateful that this product was not more harmful.

Acknowledgements: To the staff of Medsafe, and the many colleagues and patients who were willing to share their story.

Correspondence: Dr Shane Reti, 15 Rust Ave, Whangarei. Fax: (09) 438 2011; email: herb@selectpost.com