BC Business
The first time I met Dr. Yan Bin Ma was just over two years ago. For many months previous, I had been dealing with a baffling condition (the details of which I’ll keep to myself ) that necessitated scans, invasive probing and various unpleasant encounters with myriad health-care practitioners, none of whom came up with an explanation.
The answer, when it finally arrived, was simple – my hormones were out of whack – and the solution, a well-meaning specialist told me, was equally simple: estrogen. When I broke into sobs in his office, he was baffled. But at 30 years of age, with a still-unrealized desire to procreate, something about gulping down synthetic hormones seemed very, very wrong. Couldn’t I find a way to get my body to produce its own hormones, rather than putting what seemed like a Band-Aid on the symptoms?
Then an acquaintance suggested I visit her traditional Chinese doctor. What the hell, I figured. And so I entered the small, cluttered West Broadway offices of Dr. Ma, a stocky, no-nonsense middle-aged Chinese woman with a blunt manner. Dr. Ma, whom I visit every two weeks, peers at my tongue, measures my pulse and pokes needles into my skin – not gently, I might add. She also gives me a collection of herbal tablets to be taken 10 at a time with warm water twice a day. Each appointment costs me $50, plus $15 for a week’s supply of herbs; it’s not cheap, but cheaper than the $30-a-day estrogen originally prescribed by my doctor. And most importantly, it works.
But my continued access to Dr. Ma’s herbal treatments may not be assured – that is, if critics of the increasing regulation of the natural health industry are to be believed. According to groups such as the Canadian Health Food Association (CHFA) and the Natural Health Products Protection Association, natural remedies are being threatened by an overly stringent licensing board and an overzealous federal health minister. Physician and consumer protection groups, however, are supportive of increased regulatory oversight of the industry, which they say has been left with too little supervision for too long.
On April 8, when federal health minister Tony Clement introduced Bill C-51 – a series of proposed amendments to the Food and Drugs Act – the alternative health industry exploded in revolt. The bill, which at press time was in second reading, redefined the Food and Drugs Act as “an act respecting foods, therapeutic products and cosmetics,” and lumped natural health products (NHPs) – a category that includes vitamins and minerals, herbal remedies and teas, and plants and plant products – in with drugs under the therapeutics category. In addition, it proposed greater enforcement powers to inspectors, allowing them to seize items without a suspected breach of the act or regulations, and without an appeal or review by the courts. The bill also increased penalties (up to $5 million) for those in contravention of the act. While Clement later proposed changes to assuage some of the fears in the natural health industry, many in the alternative health-care sector say the legislation, along with other recent regulations, threatens to stifle an industry that is just coming into its own.
The appetite for alternative health treatments has grown significantly in recent years, as an increasing number of consumers like me venture outside the conventional Western medical system. According to Statistics Canada, 20 per cent of Canadians aged 12 or older – and almost 23 per cent of British Columbians – used some type of alternative or complementary health care in 2003 (the most recent year for which figures are available), including visits to acupuncturists, homeopaths, naturopaths and chiropractors; that compares to an estimated 7.6 per cent nationally in 1999. For those with chronic health conditions, the numbers are even higher: one-quarter of those with at least one chronic condition said they’d consulted an alternative health practitioner. And according to a 2005 survey by Health Canada, 71 per cent of Canadians have used a natural health product, the three most popular being vitamins, echinacea and herbal remedies. In B.C., 79 per cent of residents have used NHPs – tops in the country. Indeed, peer into the medicine cabinets of your friends and you’re more than likely to find some sort of NHP, whether it’s a bottle of what’s being touted as the new cancer-prevention miracle, vitamin D, a vial of the oft-contested flu remedy echinacea, or a package of the Don Cherry-endorsed cold fighter Cold-fX.
[pagebreak]On the surface, the trend looks good for product manufacturers – a 2005 report commissioned by the CHFA found that total retail sales of NHPs that year were $2.5 billion, with sales expected to grow by more than $250 million by 2010 – but not everyone has embraced non-prescription, non-pharmaceutical remedies with open arms. “As a practicing physician, one’s a bit wary,” says Geoff Appleton, the outgoing president of the B.C. Medical Association and a GP practicing in Terrace. “People will tell you they’re taking this, and you’re not really sure what’s in them, and you’re not really sure how they interact. . . . Our policy always has been that we would support anything that evidence would show is effective and safe. That’s our bottom line. A lot of the complementary medicine really hasn’t been investigated in the same way that we would investigate regular medical science, with controlled trials and that kind of stuff.” As far as Appleton is concerned, “natural” doesn’t necessarily mean safe. “My main tenet is that you can’t have it both ways,” he says. “You can’t say this is natural and therefore harmless, but it does something to your bodily functions, and it works. . . . If it’s doing something to your body, it’s got possible downsides.”The Consumers’ Association of Canada (CAC), led by its Vancouver-based president Bruce Cran, is equally cautious about NHPs. “We’re certainly in favour of there being a system in place that tests the ingredient that’s in the pills or capsules being sold – to both make sure what’s supposed to be in there is and to ensure the quantity is neither higher nor lower than what’s advertised on the label,” says Cran, by phone, in a thick Australian drawl. “We’ve had people say they’ve been taking capsules of whatever it might be – St. John’s wort, say – and it’s produced no effect. That may not be because the capsules don’t have it in it, but it could be.”
So when Clement introduced Bill C-51, the BCMA and the CAC were pleased. NHP manufacturers, alternative health-care practitioners and their clients, however, claimed the proposed act would lead to the seizure and confiscation of herbal remedies and even add prescription requirements on NHPs such as vitamins. Shawn Buckley, a Kamloops-based lawyer and president of the Natural Health Products Protection Association, circulated a 20-page draft discussion paper of the bill, established a Stop Bill C-51 website and organized a June 2 presentation at St. Andrew’s-Wesley United Church in downtown Vancouver to rally the troops. Fit and charismatic, Buckley began the two-hour presentation (entitled “Endangered Natural Health Products?”) by asking the assembled crowd of 500-plus, “Are you free?” It’s “sick and perverted,” he said, that NHPs – which he claimed have never caused any deaths – were being driven off store shelves while peanut butter, which triggers hundreds of sometimes fatal allergic reactions every year, gets a pass. The message: Canadians’ freedom to choose how they treat themselves is being eroded.
The Toronto-based CHFA, which represents manufacturers, wholesalers and retailers in the NHP and organic products industry, didn’t go so far as to call for the withdrawal of Bill C-51, but did lobby for amendments to the act – including the establishment of a third category of products, between food and drugs, to encompass NHPs. “We’ve been mounting campaigns, talking to the government and holding member forums,” Penelope Marrett, the association’s president and CEO, told me in a phone conversation in early May.
On June 9, following meetings with the CHFA, Clement surprised everyone when he proposed inserting a definition of NHPs into the act – within the umbrella of therapeutic products – to make it clear that they remain distinct from food and drugs. Supporters of the original bill say that Clement’s apparent about-face was the result of industry lobbying. The push for changes in the bill “came from the industries that were involved in selling the goods and not from consumers,” says the CAC’s Cran.
Industry players, however, say the fight over NHP legislation and regulation has only just begun. “The amendments are really more window dressing,” complains Buckley. “What’s alarming me is we’ve been told we have a third category: ‘You’ve won, industry, you’ve won! Settle down.’ But I don’t see, really, a change in how we’re going to be regulated.” Vows Marrett of the CHFA, “We have lots more work still to do.”
Bill C-51 comes following the creation in 2004 of the Natural Health Products Regulations and the Natural Health Products Directorate. The regulations require every NHP sold in Canada to obtain a product licence from the directorate, after which point it will be assigned a natural product number to be displayed on its label. To apply for a product licence, manufacturers must provide detailed information about the product, including its ingredients, potency and use, to the directorate. There is currently an implementation period in place in which products can continue to be sold until they receive their product numbers. But while most in the industry say they support the regulations in theory because they enhance consumer confidence, many are also critical of how they are being implemented.
“Almost from the day the directorate opened its doors, it’s been backlogged,” says Maggie Neilson, general manager of Sisu, a B.C.-based manufacturer of vitamins and supplements, as we tour the company’s Burnaby headquarters. (Neilson left this position shortly before press time.) The air at Sisu is tinged with a sweet, lightly metallic scent, as though someone created a room spray out of multivitamins and gave the office a good spritzing. With 90 employees and annual revenues of between $15 million and $20 million, Sisu is one of the largest such manufacturers in the province. (Natural Factors, the largest, employs 400; Viva Pharmaceutical Inc., a custom manufacturer for the pharmaceutical and natural health industry, is the second largest with 130 employees.) Of the 160 Sisu products that have been submitted to the Natural Health Products Directorate, 60 per cent have so far been granted product numbers.
[pagebreak]Critics say that the requirements to support product health claims have been onerous. Some manufacturers, according to Neilson, have been told they need evidence of sophisticated clinical trials to support health claims; others are being rejected outright. Those concerns are echoed by the CHFA’s Marrett. “Some sort of a pharmacological creep, if I could use that term, seems to be entering the picture,” she says. “Natural health products are far more low-risk, generally, than pharmacological products. We’re saying, ‘Why is this lens being put on us?’ ” According to Shawn Buckley, 55 per cent of NHPs are now being rejected by the Natural Health Products Directorate, and that number is expected to increase because the directorate, to date, has primarily been evaluating single-ingredient products. Buckley predicts a failure rate of 70 per cent as multi-ingredient products come under scrutiny. If the enforcement powers of seizure and confiscation in Bill C-51 remain, those products that fail will be yanked from shelves.
“If you or I wanted to get garlic oil approved as an NHP, well, it’s a single ingredient,” says Buckley. “We could come up with studies to suggest that it lowers cholesterol and maybe get it approved with a claim like, ‘Good for the circulatory system.’ But if we wanted to add cayenne pepper to it, now we would have to find studies that show garlic oil and cayenne pepper, in the relative amounts that we have, would support the type of claim that we want to make and show that it’s safe. Add a third one, and it’s getting way complicated.” Some manufacturers, says Buckley, have been told outright by Health Canada that they need clinical trials for these multi-ingredient products – “which will never happen because we don’t have intellectual property rights.”
Sisu’s Neilson says that manufacturers rely mostly on traditional evidence or published research out of universities or other third parties to back up their health claims. “We have a lot of small companies in Canada all looking for the best product combinations, and we’re selling them in a channel where there can be lots of competition,” she says. “To put together a clinical trial, it’s very expensive. . . . If the government is going to require us to have clinical trials for every ingredient in our formulations, we’re concerned that that’s going to drive away some traditional products that have been safe in the market for decades. It’s going to limit the amount of innovation that this industry can do.” (According to a statement posted on the government’s Health Canada website, Bill C-51 “will not change the manner in which clinical trials for natural health products are reviewed and authorized by Health Canada.”)
As more and more consumers start exploring alternative routes to health, the industry is supported by a growing number of practitioners who recommend herbs, vitamins or homeopathic remedies. The College of Traditional Chinese Medicine Practitioners and Acupuncturists of B.C., the provincial licensing body for practitioners of traditional Chinese medicine or acupuncture, lists 1,198 providers in the province, up from 1,091 in 2005. The College of Naturopathic Physicians of B.C., which licenses naturopathic doctors, lists 290 practicing, up from 208 in 2005. The B.C. College of Chiropractors lists 1,000, up from 490 in 1990. These three health-care professions are the only so-called “alternative” practice areas included in B.C.’s 24 provincially regulated health professions. The vast majority of the regulated professions are more conventional in scope, including nurses, pharmacists and podiatrists, among others.
There are also plenty of alternative health-care practitioners – such as homeopaths and herbalists – who aren’t governed by a provincial licensing body but who also use natural alternatives to prescription drugs. Finlandia Natural Pharmacy, for instance, has sold natural health-care products for 30 years and has a staff of eight alternative health practitioners including, for what it’s worth, a “modern African bush doctor.” Founder Harlan Lahti, whose healthy physique and energetic manner make him appear younger than his 66 years, says that between 200 and 400 people visit his West Broadway store each day, bringing in $4 million in annual revenues. Lahti runs a side business, Biomed International, that supplies products directly to natural health practitioners, with annual revenues of more than $2 million; he also once owned Sisu, before selling his remaining interest in the business three years ago. Lahti’s clearly a businessman, but, like others I spoke to in the industry, he’s also not above a good conspiracy theory when it comes to government regulation. “They’ve redefined products that we’re using as therapeutic products,” he says. Should increased regulatory oversight result in NHPs being removed from the prescription-free arena, “then what have you got to fall back on but drugs, right?” he asks earnestly.
The notion that Bill C-51 is the result of lobbying by the pharmaceutical industry is one that has captured the imagination of many, including Buckley. In his address at St. Andrew’s-Wesley United Church, the crowd nodded in assent as he railed, “If they take natural health products away, we are forced to use pharmaceutical products, which carry risk profiles that are just outlandish.” It’s a charge that federal health minister Tony Clement vehemently opposes. “That’s just plainly absurd. This bill is actually creating more regulation for pharmaceutical companies,” says Clement, who, for the record, was forced to sell his 25 per cent stake in the pharmaceutical company Prudential Chem Inc. in July 2006 amid charges of conflict of interest.
As for fears of a crackdown on NHPs, the minister insists they are unwarranted. “I think there are a lot of people who are trying to scare other people with these dire consequences. . . . I know that 99 per cent of natural health products are good products. We want them on the shelves; we want consumers to have more choice. But for the one per cent that are the bad apples – that mislabel their products or have some chemicals in them or some compounds in them that could create liver damage or cardiac arrest or increased risk of stroke – we want to get those off the shelf and make sure people know that what they’re consuming is safe.”
If Clement’s assurances are to be believed, we may be seeing better times ahead for the industry. That’s heartening news for patients like me, not to mention for Dr. Ma, who derives part of her income from herbal remedies that have yet to be given Health Canada’s stamp of approval. As far as I’m concerned, the herbs are working, and I’ve suffered no ill effects – apart from the growing hole in my wallet. (My income is too high to qualify for premium Medical Services Plan assistance, and I don’t currently receive any additional medical insurance – so I just suck it up and pay Dr. Ma her money: by my calculations, some $1,600 last year.)
I know what Dr. Ma would say if questioned about her methods, because I exhibited some hesitancy in our first appointment. “What do they think – that in China we had no health care for 5,000 years?” she asked rhetorically, in reference to conventional Western medical doctors. “How do they think we got to have the biggest population on Earth?” It was a strong enough argument for me to give her a shot; whether it’s enough for Health Canada remains to be seen.