Therapeutic Products Bill: Oral Submissions

It's only been a couple of weeks since the closing of the Health Committee accepting submissions on their Therapeutic Products Bill consultation, but the committee have already been running follow-up oral submissions. We know that there were 16,549 submissions to the bill, as with the help of a work colleague I've been able to scrape all of the submissions. This is a pretty high number for a bill, but still dwarfed by the number of submissions for the Conversion Therapy Bill a couple of years ago - over 107,000 of them! I'm currently in the middle of trying to run an analysis of all the Therapeutic Products Bill submissions, and if there's anything interesting in there I may write an article soon about what I find.

In the last couple of weeks both the NZ Skeptics and our sister organisation, the Society for Science Based Healthcare, have made oral submissions - these are a much easier read than our longer written submissions, so I figured it would be good to publish them here. As the email we received about our oral submissions kindly reminds people, “the committee has your submission so there is no need to re-read it at the hearing”. This means that an oral submission is a great place to summarise some of the key points of your written submission, and also to allow MPs to ask you questions.

There was also a follow-up question that SBH was asked about the safety of Natural Health Products (NHPs), and Daniel Ryan did a great job of putting together an email response to that question so I've published it below as well.

NZ Skeptics

On Tuesday last week Bronwyn and I visited Parliament to give our oral presentation to MPs from the Health Committee in person. We decided to present in person, even though most hearings at the moment are on Zoom, because we figured it's more impactful to be able to speak in front of a group of MPs, face to face, than via a screen. Sadly, though, on the day Wellington experienced high winds and the flights for out of town MPs were cancelled. So we sat in front of committee chairperson Dr Tracey McLellan and Lemauga Lydia Sosene. Here is the text that Bronwyn and I used, that was the basis of our oral presentation:

Hi, I'm Bronwyn. I'm a midwife, and a committee member of the New Zealand Skeptics. We'd like to thank you all for taking the time to hear from us today on what we think is an important matter, one that is very relevant to the work the Skeptics have been doing since 1986.

One of the first lessons I had during my midwifery training is that just because a product is natural or purported to be natural, we should never take it for granted that it is safe.

That measure of safety covers a wide breadth of dimensions. Failures in the supply chain can occur with overseas suppliers, and in NZ packaging and manufacturing companies. Being “natural” does not exempt NHPs from causing serious drug interactions, as studies about St. John's Wort, Ginkgo Biloba, and Black Cohosh have indicated. NHPs are often sold in retail settings, rather than under the guidance of health care practitioners who can provide the appropriate advice about dosing and side-effects in the context of an individual's medical history.

To protect public safety from being harmed or misled in these ways, the Skeptics made two recommendations: first, the inclusion of an expedited process for handling reports of concern about the misrepresentation of NHPs; and second, a thorough vetting process for any NHP that may be approved due to their inclusion in a pharmacopoeia. We would be very interested in learning which Pharmacopoeia the government are planning to include, as we couldn't find this information in the Bill or its Explanatory Note.

The key message that we would like you to take away today is that no class of healthcare product should be exempt from this legislation - if a product is safe, no matter what its source, consumers should have the right to purchase and use it. Conversely, if a product is not safe, the public should be protected from it - including homeopathy (aka low-concentration NHPs) and personalised NHPs.

Hi, I'm Mark and I'm the Secretary of the Skeptics.

I want to start by talking about what many people consider a dirty word - “science”. Science isn't a mystical process, it's not something owned by academics or corporations, it's just a tool. With this tool we can carefully measure and evaluate whether something is effective or not. We've learned over and over that we need this kind of rigorous testing, because personal anecdotal evidence is inherently untrustworthy. It turns out that science is the best tool we have for figuring out what works and what doesn't.

When it comes to people's health, it's imperative that we do all we can to ensure that people are receiving the best level of healthcare possible. And so for this piece of legislation (section 67) we really think that health claims should only be permitted if they have been validated using scientific evidence. We know that evidence of traditional use is not evidence of efficacy - only science, through proper testing, can do that. So it makes no sense to allow health claims based on traditional use.

If a product hasn't been tested to see if it works or not, nobody should be allowed to make a health claim about it. And if someone claims that their product “can't” be tested to find out if it works (and this is something that natural health product sellers often attempt), that's okay - they shouldn't get special treatment, they should just not be allowed to make any health claims about their product. And like for the safety issue, we think that all health products should be covered when it comes to proving efficacy before being able to make claims of efficacy - no exclusions for homeopathy or one-off medicines (or their ingredients).

Healthcare in New Zealand has been rightly centred around informed choice. Allowing consumers to buy NHPs, if they've been proven to be safe, covers the “choice” part of this important concept. But the government also needs to ensure that nobody can make unsupported health claims about an NHP, so that the “informed” part is also covered. If we allow NHP practitioners to make claims about their products that aren't evidence based, New Zealanders will be dangerously misinformed.

If “traditional use” and “pharmacopoeia” are removed from this bill, NHP practitioners would still be able to sell their products - if they're safe. They just won't be able to make misleading claims about them to their customers. And that seems like a good outcome.

SBH

Luke Oldfield and Daniel Ryan from the Society for Science Based healthcare presented their oral submission the week before last, via Zoom. Here's the submission that was read by Luke:

Kia ora koutou,

Just by way of introduction. I am Dr. Luke Oldfield, and am here today representing the Society for Science Based Healthcare. I am also joined by Daniel Ryan, who is the Chair. Just to account for any potential ambiguity, I am not the Dr. you would go to in an aeroplane emergency. I am a political scientist, and so unless the pilots are arguing over whether we should maintain or abolish the 5% threshold, then I might not be able to help!

Nonetheless, we are a society dedicated to combating bogus health care claims. The sorts of claims that could impact the ability of New Zealanders to make informed decisions about their health. We are particularly concerned with claims about products which cannot be substantiated through rigorous academic peer review. With that in mind, I wanted to just briefly summarise some key points from our written submission, after which I will pass the time over to Daniel, should you have any questions.

First, we broadly support this bill and hope that it passes through the house expeditiously.

Second, we wish for the final iteration of the bill to be definitive about what is allowed and what is not allowed, in terms of the claims that health care products are allowed to make.

Thirdly, we think that some aspects of the bill could be improved, in particular, by removing references to ‘traditional use'. We know that many useful products have emerged outside the realm of western episotology. What we think is that the way forward is to contribute resources to further testing the efficacy of products based on ‘traditional use'.

Ultimately, we believe that the law should protect an individual's right to pursue health products that they feel are in their own best interests, and that this can be enhanced by strengthening the law to ensure that the consumers of therapeutic products are not being misled.

We want to see New Zealanders properly informed about the evidence for the health products they consume and not dangerously misinformed.

Recently our group has tackled dangerous products that were sold in New Zealand, such as bleach being marketed as a cure for cancer and herbal remedies that were claimed to be able to treat COVID-19. There are numerous other examples, and over the last few years these have included the promotion of Black salve, which eats your skin away; bitter orange, which can cause heart attacks and strokes; laetrile (also known as “vitamin” B17), which contains cyanide; and even, more bizarrely, coffee enemas, which are obviously a bad idea!

In addition to this, some effective treatments are also commonly used in ways that are not useful, and are obviously dangerous when used outside of their proper therapeutic context. The use of Ivermectin as a treatment for COVID-19 is one obvious example.

Most alternative treatments are benign in isolation. But belief in their effectiveness can be dangerous or even deadly. We note that some practitioners of the most popular alternative treatments also have a tendency to tell their customers that their treatment is a panacea, able to treat all medical conditions.

These safe but ineffective treatments are harmful to consumers in both direct and indirect ways, affecting their health literacy and their pockets. We also note that sometimes people being “treated” with an alternative medicine also opt out of conventional treatments that actually do work. The more that people end up believing in magical claims of things like homoeopathy fantastical cures, the less likely they are to use real medicine when they get really sick. And if the people selling these natural health products are allowed to make health claims that aren't backed by evidence, the consumer will almost certainly be worse off for it.

The New Zealand public pays over two billion dollars a year on supplements and associated potions, many of which are sold using unproven health claims.The general scientific consensus is that these supplements do very little for one's health. This includes homoeopathic products, for which there is not only no evidence that they work, but also no kind of plausible working mechanism for how they work.

One concern for our group is that, as it stands, otherwise reputable pharmacies are filled with natural health products making unproven claims. Outside of pharmacies, things only get worse.

Our Society is all about consumer protection. We want to see consumers shielded from unproven therapies, but still allow for people's freedom of choice. If a natural health product is proven to be effective, then practitioners should have the right to sell it in New Zealand, and make claims about its efficacy. But if there's no evidence of efficacy for a health product, it seems obvious that no health claims should be allowed to be made.

Indeed, our healthcare shouldn't have separate rules for medicines and natural health products; if something is being sold as a treatment for a medical condition, it needs to be proven that the treatment works, whether it's a pharmaceutical drug or a herbal pill. And that proof should be scientific, given that science, practised ethically and with care, is the best tool we have for figuring out what works and what doesn't.

Many thanks for considering our submission, our written submission goes into further detail for those who are interested.

After Luke's presentation, Daniel Ryan was asked a question by MP Sarah Pallett about the harms of Natural Health Products, and whether he had any evidence of this. At the time I assumed that Sarah doubted the claims made by the Society that NHPs can cause harm, but Bronwyn pointed out that she knew Sarah from her training as a midwife, and that Sarah had talked in the past about how natural doesn't mean safe.

Dan took a few days to write an email, and it was great to see Sarah's response when she received the email. Here are the email and response:

Daniel's Email

_Dear Ms Pallett,

Thank you for taking the time to both read our written submission to the Therapeutic Products Bill consultation and listen to our oral submission last week. During our oral presentation we talked about some of the direct harms of Natural Health Products, and you asked me if we had any more information about this issue that you could see.

There have been a few reports in the media of specific cases. For example, there's a pair of cases where a naturopath in New Zealand “treated” two women for breast cancer, and in the end both women died because they delayed medical treatment. Thermography was used for diagnose, and zambuk ointment, homoeopathic melatonin and vitamin C were used to treat - all pseudoscientific treatments. One of the women even called out for effective regulation of naturopaths. A Feilding alternative practitioner (iridologist) treated her patient's carcinoma with colloidal silver. Because of the delay in the actual treatment of her cancer, it had eaten through her scalp, exposing her brain and, in the end, causing her death.

There is further evidence online of how individuals have made fatal decisions based on unevidenced healthcare claims. By looking at Givealittle, you can see how health claims made by NHP practitioners often fool people. Steve, who passed in 2021, said he would stop chemotherapy ASAP and move on to intravenous Vitamin C. He believed he would “champion a new era in the use of Alternative Medicine”. Maria, who passed in 2020, avoided chemotherapy and opted to have Vitamin C infusions. Patwinder, who passed in 2019, said she would treat her cancer with ozone therapy, marine plasma, Rife and supplements. She wanted to “shine a light on the benefits of alternative treatments”. Paul, who died in 2019, avoided chemotherapy because of the low success rate (30%) and instead used tonics and supplements. Because he held the belief that alternative natural treatments had cured stage 4 cancer. Hope, who passed in 2017, declined to receive chemotherapy, radiation, and a bone marrow transplant for her returned cancer. Instead she went to the Global Health Clinic to receive ozone therapy. Her reason was her research, and in person testimonies showed many successful cancer outcomes. Sharon, who died in 2019, refused chemotherapy and radiology for her breast cancer. She took 18 supplements per day and had a blood test called RGCC at an alternative clinic in Nelson which analysed “appropriate” supplements for her treatment.

We wonder how many of these people would have avoided alternative treatments if they had been properly informed about the reality of the benefits and risks.

The website What's The Harm (now archived) attempted to monitor news reports of harm from natural health products and services. The site is sober reading, and shows that many people have died unnecessarily worldwide because of natural health products. The book “Do you believe in magic: Sense and Nonsense of Alternative Medicine'?” by Dr Paul Offit is also a good read on the subject.

Below is a small list of recent scientific papers we've collected that you might be interested in, detailing both direct and indirect harm from alternative medicine. As an example, the paper “Adverse effects of herbal medicines: an overview of systematic reviews” is an excellent introduction to the harm that can be done.

Once again, thank you and the other MPs for taking the time to consider our concerns. We are hopeful that, with some adjustments, this new legislation will protect consumers from potentially dangerous claims being made about the healthcare products they have a right to use.

You are welcome to pass this email on to your colleagues.

Regards,

Daniel Ryan.

Chair, the Society for Science Based Healthcare_

Direct harms of NHPs

_Adverse effects of herbal medicines: an overview of systematic reviews (2013)

“The most severe adverse effects were liver or kidney damage, colon perforation, carcinoma, coma and death.”

Adverse effects of nutraceuticals and dietary supplements (2017)

"An overview of the major supplement and nutraceutical classes is presented here together with known toxic effects and potential for drug interactions."

Supplemental Vitamins and Minerals for CVD Prevention and Treatment (2018)

"Vitamin B3 (or niacin) might increase all-cause mortality, which was possibly related to its adverse effects on glycemic response. Antioxidant mixtures… might increase all-cause mortality"

Effects of Nutritional Supplements and Dietary Interventions on Cardiovascular Outcomes (2019)

"Combined calcium plus vitamin D might increase risk for stroke."

Emergency Department Visits for Adverse Events Related to Dietary Supplements (2015)

"An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Such visits commonly involve cardiovascular manifestations from weight-loss or energy products…."_

Contaminated and unapproved ingredients in NHPs

_Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings (2018)

"The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement…"

Prohibited Contaminants in Dietary Supplements (2017)

"Poor manufacturing processes and intentional contamination with many banned substances continue to occur in dietary supplements sold in the United States. Certain sectors … pose a greater threat because they are more likely to be contaminated."_

Indirect harms of NHPs

_Adverse effects of homeopathy: a systematic review of published case reports and case series (2012)

"Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly."

Is There an Epidemic of Research Fraud in Natural Medicine? (2022)

“...an uncomfortably large and growing number of published papers related to my area of expertise have left me wondering whether the research was fabricated… it has the potential to harm practitioners and patients who rely on its findings.”_

Sarah's Response

_Kia ora Daniel

Thank you for taking the time to follow up and send this information through – I will forward it to the Clerk of the Committee.

I have been concerned about the conflation of ‘natural' with ‘harmless' for some time.

Thank you again for this further information

Sarah_