Dr Michael Gannon - ABC Radio - Drug Shortages
PHILIP CLARK: Imagine being unable to get a drug that you perhaps desperately need because that drug is in short supply. Now we tend to expect that if the doctors prescribed it, then we'd be able to get it. But in reality, drugs fall into short supply fairly frequently. In many cases, it can have a serious impact on people's health. Dr Michael Gannon is the President of the Australian Medical Association and he's joining us on Nightlife to talk about why drug shortages happen and how they impact on the people who are using those drugs. Michael Gannon, good evening and welcome toNightlife.
MICHAEL GANNON: Yes, good evening Philip. Absolute pleasure.
PHILIP CLARK: I guess we take it for granted that drugs will be available when we're prescribed them. How common is it for the supply chain to run into problems?
MICHAEL GANNON: Well fortunately it's not that common, but certainly it happens from time to time. We've seen in recent months the temporary shortage of three different anti-biotic agents. We've seen the recent shortage of the alcohol withdrawal drug Antabuse. We've seen people being told they'll need to wait months at a time for meningococcal vaccines. So these shortages do happen for various reasons from time to time.
PHILIP CLARK: Is there a common thread to the reasons why it happens?
MICHAEL GANNON: Well I suppose one of the reasons it's happened is that there's been a tremendous consolidation within the pharmaceutical industry, and within those businesses you'll often see those companies choose to make the medications maybe in as few as two or three different factories. And things can happen to those factories. There can be labour disputes. There can be industrial accidents. There can be floods or fires. So this happens from time to time, and if you've got a drug that's literally only made in three places in the world, well if one of those factories goes down you can be in big trouble.
PHILIP CLARK: Yeah, I mean Antabuse - the drug you mentioned earlier - that's a drug used by people to combat problems with alcohol abuse. How does that drug work? I think it makes people feel ill if they drink alcohol, doesn't it?
MICHAEL GANNON: Yeah. Well, the importance of the shortage of a drug like that is that you could potentially lose the effect and you could potentially lose a significant investment of maybe weeks or months off the grog. So it's a real concern when we have medications that people require for chronic disease when they don't become available. But it's a reality of the globalised world in which we live, is that there can be things which will interrupt the sea lanes or other transporting of the drugs from where they're made through to the local pharmacy where they're dispensed with a prescription.
PHILIP CLARK: What about the interweaving of patent laws here too? The thing about drugs is, of course, that they're very expensive to develop and get to market usually, and they rely heavily on research and development expenditure. A lot of which, of course, is money wasted, because good drugs don't result from it. But when companies find a good one, of course they want to make their money back, don't they? Just because there's a good drug around doesn't mean it's going to be available if no-one can make money out of it.
MICHAEL GANNON: Well that's right, and this issue is extremely complicated and it has numerous dimensions to it. But you're quite right, a drug might cost in the tens of billions to develop. It needs to be- the factories need to be- have quality assurance programs which we would hope and expect are at the highest possible level in terms of cleanliness and safety. They need to then go through various stages of testing, whether that involves animal testing, and then phase one, phase two, phase three, phase four human trials to make sure that (a) it's effective, and (b) that it's safe. Sometimes the compounds that are involved in making the medication might be expensive to source. So the companies that develop these drugs that- where it literally costs billions and billions of dollars, they do want to get that back and they enjoy a degree of protection through the patent system. In other words, they effectively own the copyright of the drug for five years, seven years. That varies …
PHILIP CLARK: How long is the patent period, generally?
MICHAEL GANNON: It's about seven years for a lot of drugs, but it varies according to different laws around the world. It was of course- one of the controversial elements in the Trans-Pacific Partnership would have been those kind of arrangements. Of course, the pharmaceutical companies would love to see some uniform regulations and laws around the world, but the truth is it varies significantly.
PHILIP CLARK: Yeah. When drugs come off patent, of course, and drug companies therefore can't get- market them exclusively, they're open to generic manufacturers. I mean, is there a- I mean, do some drugs simply slip through the cracks there? Because manufacturers don't want to make them anymore because they can't make any more money out of them and no-one in the generic industry picks them up?
MICHAEL GANNON: Well, I don't think we've ever had a situation where a drug that was highly effective, where they stopped making it. But certainly we've seen individual companies stop making medications. I'm just not aware of a case where all of the different companies have stopped making one. But certainly they are keen to make money where they can; they have a responsibility to their shareholders to deliver a profit. They will- the pharmaceutical companies will deliberately target the medications that they're most likely to make money on. I've already used the example of antibiotics. The problem with antibiotics is that you might develop a drug that an individual might use for five or seven days once every two years, whereas if you develop a drug for a chronic condition like heart disease, epilepsy, hypertension, high blood pressure, patients are taking that medication every day and its easier to recoup your investment.
PHILIP CLARK: Yeah, I mean we mentioned antibiotic shortages. You'd think- they seem to be becoming- are they becoming more common?
MICHAEL GANNON: Well, certainly what we're more and more concerned about is antibiotic resistance. So there's a number of different classes of antibiotics, but due to a whole selection of pressures including antibiotic resistance developing from overuse, developing from inappropriate use in agriculture, developing from inappropriate use in the third world where often they're available without prescription, inappropriate use in our own community in terms of people demanding antibiotics from their doctor even though they've been told it's a viral infection and it won't help, in hospitals failing to use the appropriate narrow spectrum antibiotics. All of those things contribute to antibiotic resistance, but then earlier this year we did see the temporary shortage of three different antibiotics in common usage just due to simple problems in the supply chain and getting it from the factory on the other side of the world to countries like Australia.
PHILIP CLARK: Do we make any of our own drugs in Australia, or are we reliant on Big Pharma overseas for everything that we get?
MICHAEL GANNON: No, no, there are certainly Australian companies. Better not mention too many of them on the ABC. And of course we've got CSL, a major listed company, which is invested heavily in advanced forms of medication…
PHILIP CLARK: [Talks over] I think we've got some generic manufacturers here too, haven't we?
MICHAEL GANNON: Yeah, we have generic manufacturers in Australia, absolutely. And there are plenty of circumstances where it's appropriate to prescribe generic medications. What's so important in this area is that doctors retain the freedom to prescribe the original drug if they believe that that will make a difference to the patient in terms of avoiding medication errors, etcetera. We see thousands of hospital admissions every year because people are confused about their medications. They take too much or not enough. Some people- it's not ideal, but some people will choose their pills on the basis of its colour and size. We want to reduce medication errors wherever possible.
PHILIP CLARK: Michael Gannon- Dr Michael Gannon is my guest; he's the Federal President of the Australian Medical Association. We're talking about medicine shortages and this idea which is a surprise to me. Some…that if a doctor prescribes a medicine for you, you just go down to the chemist and it's going to be available- but not increasingly but often enough, these drugs are not available for various reasons and it has had an impact. Of course we mentioned the Antabuse drug for people battling dependence on alcohol, and that can set them back. I would imagine the antibiotic shortages too would have a deleterious effect on patient health, wouldn't they?
MICHAEL GANNON: Well, certainly they do if you have to prescribe a broader spectrum antibiotic, so therefore you might be more likely to get side effects like diarrhoea or like thrush if you're using a more potent antibiotic. So just as a rule we always like to use the least toxic agent, the most effective agent, for the shortest period of time. And sometimes if that's not available, then you're compromising in one or more ways.
PHILIP CLARK: Where do you sit on this antibiotic resistance issue? I mean, I think ever since the mid '90s when that book The Coming Plaguecame out there's been a fair degree of apprehension about the idea that we only have a very few last frontier or last ditch antibiotics against a number of infections, including golden staph, that there haven't been any super-duper new classes of antibiotics developed, that we are in a precarious position. Is that your view, or do you think you're- are you more optimistic about this?
MICHAEL GANNON: No, I think we've got a major international problem here. We saw recent reports of an American woman who succumbed to septicaemia from osteomyelitis, so bacterial infection that got into the bones after a traumatic accident in India, and literally there wasn't a single course of antibiotics that worked on this, on a commonly known bacterium called Klebsiella. The problem with widespread antibiotic resistance is that it would fundamentally change the practice of medicine. So for example, right now you've got people who you can get into remission from really severe, potentially life threatening auto-immune disease, but they need a level of immune suppression that their body can't fight bacterial infections. So you might have to make a decision that you couldn't use that medication. We could have similar problems with chemotherapy patients. You could have a potentially curable form of acute leukaemia, but the chemotherapy sends your white cell count down close to zero, and if you don't have antibiotics to get you through neutropenic sepsis then you could die. So we might be in a position where we can stop doing that. Common operations that save lives and stop all sorts of misery, like elective hip replacements and knee replacements, if you couldn't perform them because you might get bacteria in the joints. You know, 30 per cent of women deliver by caesarean section. If you didn't have antibiotics to reduce the risk of wound infection, you would have to have those women facing potentially greater risks pursuing labour. So many of the things that we take for granted, the way we provide health care in other areas, would be compromised if we didn't have the antibiotics that we do to prevent infection.
PHILIP CLARK: They say during the 14th century that the Black Death in Europe killed more than a third of the population - more than half in some places. The Spanish Influenza In 1918 killed 50 million people worldwide. There've been some massive, massive outbreaks of disease which have obliterated large amounts of the population. Are we in danger of something similar to that?
MICHAEL GANNON: Well, certainly there's great fear every time we see something like this. The experts, the epidemiologists say that you get a particularly bad flu about once every 20 or 25 years so we always worry about that one. We saw the huge degrees of fear when we saw the Ebola outbreak in West Africa. Of course, we're talking about sometimes viral infections that you can't cure, that anti-virals just don't work. So whether it's SARS or H1N1, influenza, Ebola, the re-emergence of tuberculosis and sadly drug-resistant tuberculosis - these very basic organisms, bacteria and viruses, are always out there. I suppose one thing which is frustrating is that we seem to be fighting near constantly the lies and half-truths of the curious anti-vaccination movement. Vaccinations are a great way of preventing infection that doesn't rely on antibiotics.
PHILIP CLARK: Yes, alright. Well, what about- I mean is there an issue about why we're lacking another armoury of antibiotics? Is it just that no-one's come up with an appropriate invention or is there some other structural reason why companies aren't bringing new drugs to market?
MICHAEL GANNON: Well, I suspect we're dealing with market failure here. It's just- it's proved very difficult for companies to make the investment for sometimes tens of billions of dollars of investment required to develop a new drug. When you have relatively short patent periods, relatively low using- again, to make the point, you might have a course of antibiotics for seven days. It's very different to developing a medication which someone has to take 365 days per year.
PHILIP CLARK: So companies would rather do the latter.
MICHAEL GANNON: Well absolutely, I think that it's in their interest. Well, I think they've proven that over the past 10 or 20 years that they're not investing in developing this class of drugs. So we saw some move at G20 level. We've seen some cooperation between the World Health Organisation and the United Nations to do some work in this area. It might represent an area where international governments need to get together and make this investment.
PHILIP CLARK: Alright. Michael Gannon, good to talk. Thank you.
26 April 2017
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