A decades old loophole in New Zealand’s patient protection legislation is letting quacks get away with what could amount to health fraud, right under the regulator’s nose.
In New Zealand, patients are protected from “health fraud scams” by the Medicines Act. This legislation, which is enforced by Medsafe, only allows products making strong health claims to be sold if they have been approved by the Minister of Health.
In order to get approved, a medicine needs to pass a rigorous submission process that includes providing robust evidence to substantiate all of the health claims that will be made about it. In this way, patients should be protected against health fraud scams.
When I say “health fraud scam”, I am referring to something specific. The US Food & Drug Administration has a nice clear definition of what a health fraud scam is:
Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.
Health Fraud Scams – US Food & Drug Administration
Under this definition, whether or not there is any intent to deceive is not relevant to whether or not something is a health fraud scam. I think that’s sensible – it doesn’t make any difference to a patient who’s misled whether the person who misled them was out to fool them or had been fooled themselves. So when I say it’s my opinion that a product is a health fraud scam, I mean that it appears that there is no evidence that the product is safe and effective for the therapeutic uses it’s claimed to have.
The issue is that there are some products that have this approval here in New Zealand but are clearly and demonstrably not backed up by evidence.
When the Medicines Act came into effect 35 years ago, in 1981, all products that would be covered by the legislation which were already on the market were given automatic approval. This included a bunch of homeopathic products manufactured by the company Weleda.
Weleda, unfortunately, is still in operation today and still sells many of the same products. They operate out of Havelock North, which strikes me as somewhat ironic given their business is based on selling water as medicine. They’re far from tiny, too. In the 2014 financial year alone they made $4.85m in revenue from retail sales.
Weasel words aplenty
Usually, when you see a homeopathic product for sale in New Zealand, its marketing materials will be full of weasel words like “supports”. These ads typically manage to imply a whole lot without really saying anything at all.
Support for a healthy heart.
Maintains joint health.
Supports your body’s natural response to winter ills and chills.
Wink wink, nudge nudge.
There are also many cases where this promotion oversteps the generous line set by the Advertising Standards Authority. Myself and others at the Society for Science Based Healthcare work to bring these to the ASA’s attention when we find them, as part of our efforts to reduce the amount of medical misinformation people are subjected to.
Usually this is a pretty straightforward process, especially for homeopathic products. After all, the evidence on homeopathy is abundantly clear:
there are no health conditions for which there is reliable evidence that homeopathy is effective.
Statement on Homeopathy – Australian Government National Health and Medical Research Council
And so are the ASA’s requirements:
Statements and claims shall be valid and shall be able to be substantiated. Substantiation should exist prior to a claim being made.
Therapeutic and Health Advertising Code – Advertising Standards Authority
However, a recent complaint that we’d expected to be as straightforward as previous ones turned out to be anything but. My colleague at the Society for Science Based Healthcare, Mark Honeychurch, submitted a complaint earlier this year about an advertisement for one of Weleda’s products: Weleda Cold and Flu Drops.
The ad for this product on Weleda’s website gave clear directions for its use, which included strong and unambiguous claims about what the product is meant to do:
Take at the onset of cold or flu to relieve symptoms — fever, muscle ache, headache, sore throat, sneezing and runny nose. Take with Weleda Echinacea/Thuja Comp. Active Strength Immune Support for additional effectiveness. Does not cause drowsiness.
Weleda New Zealand
The problem with this ad is, of course, that there’s no evidence that this homeopathic product can relieve any of those symptoms. Nor is it at all plausible given the lack of evidence suggesting efficacy of homeopathy.
That formed the basis of Honeychurch’s complaint. So it was quite a surprise when the ASA ruled to not uphold it, and passed on this response from Weleda:
Weleda Cold & Flu Drops is a registered medicine with Medsafe (TT50-8039) and is permitted to carry therapeutic claims. In relation to the complaint, the recommendations for the product on the website are consistent with the registered packaging indications which are as follows:
- Take at the onset of cold or flu to relieve symptoms – fever, muscle ache, headache, sore throat, sneezing and runny nose.
Given that the statement on the website is consistent with the registered indications, we consider that the claims do not contravene the Therapeutic Products Advertising Code. We trust that our response resolves this issue.
Weleda New Zealand
No clear answers
Communication with Medsafe quickly uncovered the fact that this approval was granted in 1981, when the Medicines Act came into effect. The issue we identified was that Weleda was using this approval as a substitute for the substantiation required by the ASA’s codes. Under usual circumstances this would make some sense, as Medsafe’s approval typically requires that sort of substantiation. But these are not usual circumstances, and we thought this was a misuse of the approval Weleda had been granted.
Honeychurch sent a list of written questions to Medsafe, to get to the bottom of this and to aid with his appeal to the ASA. Two of his questions were particularly important, in my opinion. The first sought to clarify whether or not Weleda had ever given Medsafe evidence that their product can do what it says on the label:
What substantiation, if any, was used to accept these indications [for Weleda’s Cold & Flu Drops], either when the product was “grandfathered” into Medsafe’s Current registration system, or at any other time?
The product was grandfathered into the current regulatory Scheme following the enactment of the Medicines Act 1981. Products that were eligible for grandfathering were those that were already marketed in New Zealand and had a demonstrated history of safe use. For grandfathered products, the date of approval was deemed to be the earliest date of market availability provided by the product owner.
The product was originally indicated as a homoeopathic medicine for all types of influenza and Colds. These indications were accepted at the time.
Subsequent to the original approval under the Medicines Act the indications have been modified in 2007 and 2014. The modified indications have been accepted as they are all encompassed by the original appoval.
The lack of a clear answer from Medsafe here is frustrating. As far as I can tell, their answer means Weleda demonstrated that their product had a history of safe use, and provided the earliest date of its market availability. But it also seems Weleda never gave Medsafe any evidence to support the claims made about the product’s efficacy.
The other important question Honeychurch asked regarded the scope of the problem. Although this was the only homeopathic product we’d found to have been approved by Medsafe, it seemed unlikely to be the only one that exists.
What other Weleda products, and homeopathic products from other manufacturers, are registered with Medsafe as medicines, and what indications are there for each of them?
You can search for Weleda’s approved medicines that have been transferred into the therapeutics database using the search function above [http://www.medsafe.govt.nz/regulatory/DbSearch.asp] and entering Weleda into the sponsor box. Please note that products in the database are those which have undergone regulatory activity since being grandfathered.
Weleda also notified over 1000 homoeopathic medicines to be grandfathered. The approved product details are only held in hard copy files. Many of the products are intended to be supplied to practitioners of homoeopathy or direct to patients through speciality retail stores.
Providing the requested information would require extensive research and collation and Cannot be Completed within the timeframe you have indicated as necessary for your to lodge an appeal to the Advertising Standards Authority.
As a lower estimate of the number of what the FDA may class as health fraud scams approved by Medsafe, “over 1000” is a pretty scary number.
So what is there to be done about it?
Where’s the evidence of efficacy?
Honeychurch started by submitting an appeal to the ASA, hoping the answers he’d received from Medsafe would be enough to overturn the decision. After all, the decision should hinge on the assumption that Medsafe’s approval of Weleda’s products implies the substantiation required by the ASA’s codes, and that assumption appears to be false.
But the ASA instead ruled to maintain their original decision. This ruling was released today, and makes for interesting reading. For example, this part of Weleda’s response clarifies that they truly have never had to submit evidence of efficacy for their products, simply because they have been sold for a very long time (emphasis in the original):
Weleda accepts that Weleda Cold & Flu Drops was ‘grandfathered’ into the current medicines registration system following the enactment of the Medicines Act 1981 (which replaced the Food and Drug Act 1969 which in turn replaced the Food and Drugs Act 1947. Cold and Flu Drops received ‘default’ approval as a medicine on 31 December 1969, three months before the Food and Drug Act 1969 came into force on 1 April 1970. This ‘grandfathering’ process however was applied to all relevant products at the time, including what may be called ‘conventional’ medicines. There was no favouritism toward one type of medicine or another and there was no requirement to (re-)submit evidence of efficacy to be registered.
Weleda New Zealand
The rest of their response makes it seem pretty clear to me that they’re using this historical approval as a shield to stop the ASA from requiring they provide robust evidence of efficacy that simply does not exist:
In the absence of a statutory or regulatory requirement under either the Food and Drug 1969 [sic] or the Medicines Act 1981 for Weleda to freshly prove the efficacy of our Cold & Flu Drops, we do not accept that it is open to M. Honeychurch to demand we do so by way of this proceeding — particularly when they have provided no evidence to support the view that Cold and Flu Drops has no efficacy.
Weleda New Zealand
And if that all wasn’t clear enough, Medsafe also weighed in on the issue of whether or not substantiation had been supplied by Weleda (this time the emphasis is mine):
The ‘approval date’ published on the Medsafe website in relation to this product (and most Weleda products) indicates approval at 31 December 1969. This means that these products were determined to have been legally on the market prior to the commencement of the Food and Drug Act 1969 and could continue to be marketed under the current legislation, with the same indications. Proof of efficacy is not held by Medsafe.
In my opinion, the decision the ASA should have been making should have been “does this advertisement breach our codes?”. Indeed, this is the question they usually ask when dealing with a complaint, and the fact that advertisements that breach their codes might not be downright illegal isn’t usually enough to stop them from upholding a complaint. But for some reason they’ve decided this case is different:
In relation to the complaint before it, the Appeal Board considered the key issue was a matter outside its jurisdiction, namely the process agreed to with the regulator during a change to legislation some decades ago.
The appeal Board noted the position of the Complainant with regard to the ‘grandfathering’ of certain products but agreed this was a matter that should be raised directly with Medsafe.
Advertising Standards Authority
What’s the harm?
The “grandfathering” process that allowed these hundreds of ineffective health products to get a free pass seems to have been intended to keep low risk products on the market, regardless of whether or not they are effective. With the unfortunately named Natural Health Products Bill lined up to wrap some much needed patient protection legislation around the area of low risk health products of dubious efficacy, it might seem like a great time for these “grandfathered” products to be transferred into that framework.
Unfortunately, the proposed regulations associated with the Natural Health Products Bill explicitly exclude homeopathic products from their rules. In our dealings with Medsafe, time and time again I have come away with the clear impression that they only care about safety issues. So long as a treatment that the US FDA may regard as a “health fraud scam” is safe, Medsafe appears content to do nothing about it.
Magic water? Sure, it’s just water. What’s the harm?
I can certainly see the justification for that. Safety issues are typically more pressing than low risk products that are only doing more indirect harm like causing people to delay effective treatment, putting strain on finances, and damaging public health literacy. Often it’s entirely appropriate for Medsafe to rely on our first line of defence – the Advertising Standards Authority – to deal with misleading health claims. But when that fails, something needs to be done.
There is an ocean of health fraud scams in New Zealand. It’s high time the regulator responsible for enforcing our patient protection legislation started giving a damn about it.
We’ve got in touch with Medsafe to request a meeting in the new year, to discuss what path there might be for addressing the issues I’ve touched on here. While I’m hoping for the best, I’m not holding my breath.