April 15, 2002

Unravelling the herbal myth

By Farah Ali
fali@uwo.ca

The two divergent views highlight the struggle faced by Canada's herbal medicine industry. Drug sales are flourishing but the $2.9 billion industry is plagued with controversy about whether or not the drugs can cure or prevent illnesses or are injurious to one's health.

Photo by Farah Ali

Sameralli will not use herbal drugs.

"When I first knew I had arthritis some of my friends and family told me to use herbal medicines but I was always skeptical about them. Now I distrust them totally because so many drugs are being recalled from the market after receiving such good reviews from the industry. I am disappointed because I heard so much over the years from the media about these drugs but I never hear enough research on the products to convince me that they are good. Sometimes I wonder how this herbal craze got created," says Sameralli.

The health craze that started in the 1990's created such a boom for herbal products that an estimated 50 per cent of Canadians now consume natural health products. This boom led to general confusion among Canadians, however, and consumer confidence is now waning.

The major problem concerns regulation. The future of herbal drugs is shadowed by the pervading lack of regulatory control. Although research is being done, it is very limited and buyers are often left on their own to decide what is safe and effective for them. Doctors along with other professionals are now working on untangling this herbal maze.

According to Alison McCutcheon, a botanist who sits on a Health Canada scientific advisory committee on herbs, there is a serious misconception that herbs are safe because they are natural products and have been available for centuries. She thinks there are dangerous herbs, some of which cause serious liver disease, certain types of cancer and can lead to death.

Health Canada had to advise consumers in January 2002 not to use any products containing Ephedra/Ephedrine after a risk assessment concluded that these products pose a serious risk to health. A recent National Institute of Health study also showed beta-carotene may increase cancer risk.

Health Canada has stepped in to try to rectify the situation. Kyra Paterson from the natural health products directorate of Health Canada says her organization was recently formed to ensure that all Canadians have ready access to safe, effective and high quality products. Before authorizing the sale of an herbal medicine, Health Canada has to verify that the product does what it is advertised for.

Other Health Canada activities include customs surveillance to prevent the importation of illegal drugs that may be unsafe. Manufacturers' premises are inspected to ensure that products are manufactured to acceptable standards of quality.

Health Canada helps safeguard Canadians' health by carrying out pre-market reviews of all drugs before they are authorized for sale and those that do not meet the requirements are removed from sale. There is also regular analysis of products on the market to ensure that products do not contain unsafe ingredients and that the product actually contains the ingredients indicated on the label.

Photo by Farah Ali

Herbal products are sold in many stores.

There are certain indications for customers to know if an herbal medicine has been approved by Health Canada. There must be an eight digit drug identification number (DIN), with dosage instruction in both French and English.

However, this does not solve the problem, as getting drug approval for many herbal products is relatively simple. Not all the scientific research that is required for pharmaceuticals has to be done for traditional herbal medicines.

Doctors who were not initially trained to deal with herbal medicines are concerned with the growth of the herbal industry. Dr. William McCauley, assistant professor in the faculty of medicine and dentistry at the University of Western Ontario, treated a patient who had acute renal failure. The patient required dialysis after using herbal remedies.

Although he feels most products sold over the counter are safe if used properly, Dr. Mark Levine, assistant professor in the faculty of medicine at McMaster University, thinks there is a problem with drug interaction and quality control. "Herbal users are not telling their family doctors that they are using herbal remedies and physicians should ask all their patients this," he says. In his opinion, not many herbal products are better than traditional medicines and Levine does not advise patients to use herbal medicines.

According to the Canadian Medical Association, standards should be developed for each natural health product. These include manufacturing processes that ensure the purity, safety and quality of the product and labeling. The association feels more clinical studies are needed, and the same regulatory standards that apply to pharmaceutical products should apply to herbal products.

Most associations recognize that the herbal industry needs to follow strict guidelines. Margaret McHugh, executive director of the Ontario Association of Naturopathic Doctors, says regulations are needed since herbal products are now classified as medicines, which only MDs can prescribe. Naturopathic doctors have to go beyond their role of just telling patients what products to take and start prescribing products, especially for botanical medicines now classified as drugs, says McHugh.

There is still the confusion as to whom people should consult with. "'Herbalist' is not a meaningful description of a profession. There is no province in Canada where herbalists are regulated or where the title is protected, so anyone can call himself or herself an herbalist," says McHugh. Patients should consult with naturopathic doctors who are regulated in many provinces and have a minimum of seven years of post-secondary education. There is also a regulatory body that consumers can complain to, adds McHugh.

The herbal industry needs to follow regulations in order to succeed, agrees Scott Sawler, manager, scientific and regulatory affairs for the Nonprescription Drug Manufacturers Association of Canada. He says manufacturers tend to resist these laws because they will increase cost, which will have to be passed on to consumers, and thus the appeal of herbs might then be lost. New Health Canada regulations request that all products must undergo pre-market authorization but this will delay bringing products to market.

Herbs are still marketed without sufficient research and Sawler says evidence must always be shown to consumers to support claims of products. An herb claiming to cure cancer needs to have more evidence to prove this than a tea-tree oil deodorant claiming to be fresh scented. Although most herbal products are safe enough for self-care sale, he says in the case of conditions such as kidney functions these might be inappropriate.

Even though herbal users rely on family and friends to decide whether or not to use an herbal remedy, the primary source of information is the product label. However, laboratory testing commissioned by the Toronto Star in January 2002 found that herbal remedy labels often cannot be trusted to reveal what is in the bottle.

Amidst all the speculations, McCauley, an expert in education research, patient-centred medicine and emergency medicine, says he lets consumers decide if they want to use herbal medicines. However, he promotes the use of both traditional and non-traditional medicines.

Pharmacists are also faced with the situation of advising the public on whether or not to use herbs. Scott Coulter, a pharmacist and owner of Coulter's Guardian Pharmacy in London, says he received complaints of side effects from herbal products that were more severe than from some traditional medicines.

McHugh says Medline, a bibliographic database of citations and abstracts from over 4,600 biomedical journals published in the United States and worldwide, contains articles that "demonstrate the effectiveness of a variety of herbs, such as Kava." However, in January 2002, Health Canada advised consumers not to use products containing the herbal ingredient Kava. There were recent reports of liver toxicity related to the use of these products in Europe. This further illustrates the need for additional research to be done before herbal products are marketed.

There was also a study quoted by the Herb Research Foundation, the source of science-based information on the health benefits and safety of herbs. On an open clinical trial of 16 men with advanced metastatic prostate cancer, the herbal combination PC-SPES improved quality of life and caused significant reductions in pain with no major side effects. But, Health Canada recently had to warn Canadians not to use PC-SPES after further tests carried out by the California Department of Health Services proved them unsafe.

Marketing plays a big part in the use of herbal products and the media help significantly to provide information about natural health products to consumers. There is caution that one of the biggest problems with many mass media stories today is scientific inconsistency. There are many articles about the possible uses for herbal products yet few include the scientific evidence to support many of the claims made.

Critics tend to focus on two areas -- safety and the lack of evidence of effectiveness. Unlike conventional drugs, herbal products are not regulated for purity and potency and this could cause adverse effects and drug interactions. Studies of herbal medicines are fewer than for drugs mainly because herbs cannot be patented so there is little money to be made by funding studies. In terms of safety, McHugh says it is true that many herbal medicines react with prescription medications so it is a good reason to see an expert in herb/drug interactions, such as a naturopathic doctor.

"Better collaboration between conventional MDs and naturopathic doctors would work very well for patients," says McHugh. Some medical doctors and pharmacists are well informed, but she thinks the core curricula in medicine and pharmacy still do not include information on botanical medicines and nutrition.

Doctors like Levine agree it is essential to train doctors to appreciate that there are drug interactions and MDs and naturopathic doctors should work together. Health Canada is in the middle of making changes but Levine feels progress can only be made if greater emphasis is placed on quality control.

With proper enforcement of regulations, more products that are legitimate will come to market and the consumers will see justifiable claims on labels, argues Sawler. He thinks appropriate regulation will rejuvenate a mature market.

The controversy surrounding the herbal industry continues and although regulations are being put in place the situation is still "buyer beware." Currently no minds are being changed. Khan still thinks herbal medicines have value because they have a long history and she will continue using them. Sameralli, 87, adamantly refused to use herbal medicines and underwent surgery for her arthritis.