Complementary Medicines with Ken Harvey

Ken HarveyKen Harvey

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Matt Smith:

This is the La Trobe University podcast. I'd be your host, Matt Smith. Good morning, good afternoon, and good evening, it does all depend on where you're standing. Joining me today is Associate Professor Ken Harvey from the School of Public Health. Thank you for joining me, Ken. How are you today?

Ken Harvey:

Good, thanks.

Matt Smith:

So, we're here to talk today about herbal medicines, regulation of medicines.

Ken Harvey:

Yes. The proper phrase is complementary medicines, which encompasses sort of a broader range of -cines than just herbal medicines. It includes things like vitamins and minerals and also Indian medicines, etc., so it's a fairly broad brush, complementary medicines.

Matt Smith:

Would it be a good way to describe complementary medicines as everything that isn't regulated?

Ken Harvey:

Well, to be fair, there is a degree of regulation. And Australia is actually quite unique in this instance because many countries have no regulation at all or, like the United States, they call them food supplements and do very little with them. So Australia, for a number of years, has had a degree of regulation.

Essentially, there is a list of ingredients that are allowed in complementary medicines. These ingredients are ones that have stood the test of time and been regarded as relatively safe. Equally well, they must be manufactured in accordance with good manufacturing practice standards and the ingredients are checked from time to time to look for adulteration and spiking of various things.

As you might imagine, we found some interesting things: Chinese herbal medicines for sexual enhancement being spiked with Viagra or Sildenafil, so not really a herbal medicine at all--

Matt Smith:


Ken Harvey:

--and equally well weight-loss medicines, again regrettably from China, that have been spiked or adulterated with prescription drugs, some of them quite dangerous. So, certainly regulatory authority, the Therapeutic Goods Administration, does keep an eye out and does do some random testing.

But the big difference between complementary medicines and normal medicines is that apart from the checks I've just mentioned, they are not evaluated to see if they work. They're not actually tested to see if they are efficacious. That's the big difference with normal, conventional medicines.

Matt Smith:

Conventional medicines have to go through a process to be accredited and liscenced?

Ken Harvey:

Yeah. Before any medicine can be marketed in Australia, it's got to be listed or registered by the Therapeutic Goods Administration, or by what's called the Australian Register of Therapeutic Goods, and it's an offence to actually try and sell a medicine if it hasn't gone through that process. There's a need to look at animal studies, human trials, safety, the efficacy of the product, as well as the quality is looked at extensively.

In fact I used to be, in my younger days, an evaluator for the Therapeutic Goods Administration and it was not unique to get an entire truckload of boxes to arrive on your front doorstep full of animal studies, clinical trials, etc. And I was just one of a number of external evaluators that would sift through that information and try to come up with a summary judgment as to whether this medicine was reasonably safe, efficacious, and of good quality.

And if several evaluators come to that conclusion and the Therapeutic Goods Administration agrees and it goes to the appropriate committees and gets passed, then a medicine is registered. And that's most prescription drugs. And as I say, we can be very confident that they are of good quality, that they work for the things that they're meant to work for, and as I say, they've got reasonable safety.

Matt Smith:

So what is stopping our alternative medicine from going through this process?

Ken Harvey:

Basically, money. As you can imagine, that's a rigorous process and it costs quite a lot of money to thoroughly evaluate a new medicine. If it's a prescription product, a new molecule, it's quite likely that the drug company concerned, if it's a good drug, can make a large amount of money because new drug, while it's under patent, they've got a sole right to sell it, and so an investment in actually getting the drug properly evaluated will bring them a big return in terms of profits, if it's a good drug. But, many people felt that that rigorous process wasn't appropriate for complementary medicines. A lot of these herbs have been around for hundreds of thousands of years. They can't be patented in the sense that they're freely available.

Although in practice, some sponsors do actually patent this specific extraction process to make a specific formulation. But, generally, it was thought appropriate in the early days to have a much less rigorous process on the grounds that these medicines surely were relatively safe. They've been around for a long time.

And we didn't care an awful lot if they worked or didn't work. If consumers wanted them, then, you know, let the buyer beware. Well, that was probably not unreasonable 10 or 15 years ago to have this two-tiered system because they wanted a lot of complimentary medicines used. And as I say, we were fairly confident that they were relatively safe.

Matt Smith:

But now it's a different story because there's a lot used.

Ken Harvey:

Well, now, that's right. I mean, essentially, it's several problems. I mean, it's having a second tier, a much easier way of getting complementary medicines listed. We call it a listing process rather than a registering process. It doesn't cost much money because not much is done. As I say, they're not properly evaluated, it doesn't cost much money, and so obviously there was a financial incentive for many manufacturers or sponsors to get in there and start adding lots of products.

And certainly, there was also a temptation, because there was no evaluation of efficacy, to be somewhat creative in terms of the claims being made for the particular products and in the promotion. And, again, these were advertised as natural and safe. And many people, because of perhaps some dissatisfaction with conventional medicine and thinking that conventional pharmaceuticals are nasty, poisonous stuff, have chosen increasingly to use complementaries.

The market has boomed a huge number of products, many of which are very dubious on the marketplace, claims being made, as I say, that often lacks substantiation and a regulatory process that really can't catch up with this. There is a complaint system but it's grossly overloaded and it's not working well. And so there's a lot of concern that perhaps now, 10, 15 years later, this two-tiered system needs to be re-looked at.

The latest figures, the National Prescribing Service has just done some research on complimentary medicines and they found that now, at least two-thirds of the Australian population admits to taking complementary medicines within the last 12 months or so.

People are spending something like $1.5 to $2 billion on them a year. That's much money being spent out of pocket on complimentaries instead of out of pocket on prescription drugs, which as you know is subsidised by the government. Complimentaries aren't.

So, this increasing use, there's a lot of money being spent, and even more worrying is this increasing concern that these are not entirely safe, that they are not without their side effects and their interactions with other drugs. For example, there's been a number of liver transplants recently in Australia due to what appears to be people taking a particular herb, Black Cohosh, which is used for menopausal symptoms. Now, liver failure is a very rare complication of taking Black Cohosh, but it's certainly a serious one if it occurs.

And equally well we know with other drugs, with other complementary medicines like Glucosamine that's used widely in arthritis, it can interact with conventional drugs like blood-thinning drugs like Warfarin. And St. John's wort, which is proven not to be useful in mild depression, interacts with an awful lot of conventional drugs including oral contraceptives which can make them less effective.

And the public has got really very limited understanding of these complexities. Unfortunately, the NPS research shows that doctors and pharmacists haven't got a lot of understanding either, that they're often not aware of the interactions and the side effects, but they don't ask their patients whether they're taking a complementary medicine.

Matt Smith:

Wouldn't that be a problem, anyway? Will the patients be honest with their doctor really if they're taking complementary medicines?

Ken Harvey:

Well, again, the research shows that probably half the patients won't tell their doctors.

Matt Smith:


Ken Harvey:

That's partly because doctors don't ask, partly because patients don't think that complementary medicines are normal medicines, although as I say, they do contain pharmacologically active substances.

And it's partly, I think, also because some patients think it's their business, not unreasonably, as to what they take. Again, equally well I accept except that sometimes some of my colleagues medical practitioners have been a bit down on the complementary side. I think we're trying to change that. There is more education about complementary medicines being put into medical schools, pharmacy schools, allied health schools, nursing schools, and that's very appropriate because, as I say there's a lot being used out there and we should be training people in their advantages and disadvantages.

The basic problem we have in quality, as I say, is that we know that many of these, particularly the herbal preparations, are a chemical soup, that we know that there are clinical trials that say that some formulations of St. John's wort work, but just because someone goes to China and gets some new herbal ingredients of St. John's wort and packages them and sells them, we can't be convinced that that preparation works unless it's had some more testing.

Because, as I say, they have even Glucosamine for arthritis. There are sulfates, there are hydrochlorides, there are different formulations. Clinical trials have shown some work and some don't. But none of this is apparent to any of the Australian consumers if you walk into your pharmacy or health food shop and look at a variety of preparations on the shelf. The problem we have with our regulatory system at the moment is that we can't distinguish between preparations of good complementary medicines that have got evidence for them to work and ones that we don't know whether they work or not.

And again, that wouldn't be a big deal to fix that. For example, there are some sponsors of complementary medicines that import in Australia a product from Europe that's been proven to work in clinical trials, proven to work in the United Kingdom. Now, clearly, that product, if it's been proven to be a specific standardized herb for example that's got positive clinical trials, that's the one that I'd like to recommend to my patients and certainly you'd think consumers would like to buy. But there's nothing at the moment that can distinguish that in the marketplace from ones that have got no such evidence.

Equally well, there are other products, and this happens with conventional medicines where the new drug comes in, it's under patent, the patent goes off, and then we get what we call generic manufacturers coming and making copies.

Now, they can make them much more cost-effectively and cheaper and we recommend them in medicine. Generic medicines are good. But we can only recommend them because the Therapeutic Goods Administration make sure from clinical testing that these work exactly the same way as the original. Now, we don't have that testing in complementary medicines. We don't have the testing that can show that if a sponsor brings in a new St. John's wort, that it works as well as one that's been proven to work in clinical trials.

And that's a limitation, we think. But it could be fixed with not a lot of difficulty. One of the suggestions is an opt-in evaluation process to distinguish products that have been shown to be efficacious from those that haven't.

And some other suggestions that have come up is perhaps the complaint system needs to be fixed up. There's a lot of bad promotion out there, claims being made that can't be substantiated by the evidence. There's always a temptation for marketers to go a little bit further to make their point.

Certainly some of us have thought, well, you know, wouldn't it be easier to stop some of these products that really have no evidence of efficacy at the time of listing and registering, rather than wait for people to complain about them down the track?

For example, weight-loss products, where there is virtually no evidence that any complementary weight-loss product, herb or vitamin or whatever or mineral really gets some added benefit for weight loss over diet and exercise alone. There are one or two prescription medicines that have got some proof that they do something a bit extra, although for everyone really it is diet and exercise. Those are the key things.

Over a thousand of them have been put on the market in the last 10 years. No evidence that any of them worked. Incredible claims being made. "Three times greater weight loss than diet and exercise alone!" That was a claim by Blackmores, which many of us used to think was a good, reputable company.

Matt Smith:

They have got a good name, yeah.

Ken Harvey:

But, again, I think to be fair to all companies, there's a bit of a race to the bottom. If some people are making these claims, then other people think they better join the bandwagon or they'll be left behind. And as I say, if you've got a regulatory system that doesn't keep track of them and there's no penalties, then everyone will end up doing it.

So we have suggested, and in fact the Therapeutic Goods Administration has agreed that, yes, it would be sensible to look at the class of products and perhaps issue more guidelines as to where the sponsors could or shouldn't put these on the market, or at least what make it say about them.

But, again, a review of weight-loss products is now...we understand a report's been sitting with the Therapeutic Goods Administration for over 12 months. It's not been released publicly. No action has happened. There's still all these products out there: Fat Blaster, Fat Magnets, Slim Mate. So, the wheels of government and the regulators turn very slowly.

Matt Smith:

Wouldn't that be one step away from regulating, anyway, if you control what goes into the market?

Ken Harvey:

Yes, and certainly most of the industry is very against anything that might limit their freedom to bring products to market.

The other view, which is certainly held by the Australian Medical Association, myself and others, is it's probably no longer appropriate to really have two separate tiers. My own view is perhaps there should at least be a middle tier. And that certainly if you've got a class of products and weight-loss products, that's a classic one, where there seems to be a gross abuse of the marketplace and really no evidence of efficacy, then perhaps some barriers for this class of products would be reasonable.

Matt Smith:

Dr. Ken Harvey, a lot of good ideas there. Thank you for your time.

Ken Harvey:

Good. That's great.

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