Last week, drug company CSL wrote to hospitals, advising them to start rationing an intravenous form of penicillin, known as benzylpenicillin, or BenPen. With supply limited until December, there are concerns about “superbugs” sweeping Australia’s hospitals.
But what exactly is a superbug, and how does penicillin combat this microbial menace? To find out, Crikey spoke with Peter Collignon, an infectious diseases physician and microbiologist at the Australian National University.
What is a “superbug”?
“A superbug is bacteria that doesn’t respond to standard antibiotics. It’s a bit analogous to putting on a Superman suit — all of our bullets bounce off it,” explained Collignon. The most well-known examples of bacteria resistant to antibiotics are golden staph (Staphylococcus aureus) and E. coli (Escherichia coli).
Golden staph is one of the most common causes of septicaemia in Australia. “If we ever got to the stage where we didn’t have antibiotics to treat it, that would be a major problem,” said Collignon.
Why is it a health risk?
A 2011 paper from the Australian Commission on Safety and Quality in Healthcare reports patients with antimicrobial-resistant infections are more likely to “experience ineffective treatment, recurrent infection, delayed recovery or even death.” The death rate for people with these sorts of infections could be as much as two-fold higher. “Basically if you get a serious infection with them you die more often and spend more time in hospital,” explained Collignon.
What creates superbugs?
Superbugs can be cultivated by the indiscriminate use of broad spectrum antibiotics. An April 2011 article in leading medical journal The Lancet argued “from the moment antibiotics were discovered, they have been used excessively and with little attention to the inevitable consequence of resistance.” Antibiotics use can help resistant bacteria grow and spread not only in hospitals, but also in the community at large and in long-term care facilities.
Why is penicillin so important?
Narrow spectrum antibiotics are needed to fight off infections without increasing the likelihood of antibiotic resistance. Collignon says penicillin is “one of the narrowest” forms available. Benzylpenicillin, or BenPen, is even more important because “it’s an example of the only penicillin available that you can use intravenously to treat infections.”
Why is the rationing of BenPen such a big deal?
“For a country like Australia to find it can only get limited supply is astounding,” said Collignon. As a developed nation, we have both the experience and expertise to manufacture this drug, which plays a vital role in the fight against infectious diseases.
One possible downside of the rationing of BenPen is the increased use of broad spectrum antibiotics, which could further increase the likelihood of superbugs in hospitals and the community. “I think it’s unbelievable that a basic drug like penicillin is not going to be available or is to be rationed for a few months,” said Collignon.
There is a serious stench about this so-called ‘shortage’ of Ben-Pen.
If reports in other media are true, Australia is the only country experiencing this ‘shortage’. American hospitals contacted by other media earlier today are reporting no such shortages. Perhaps your medical reporter should investigate this more closely, and enquire as to why we cannot import the product from another supplier, as there is no patent on it?
Over to you Crikey.
Having done this dance a few times, it seems to me likely that this has more to do with the structure of the global pharmaceutical industry than it does the actual shortage of drug.
There are lots of manufacturers of penicillin but, in a given market, a dominant brand tends to develop because it offers the best price to hospitals who have to squeeze the bottom line. Often that becomes the only brand marketed, even if others are ‘registered’ with TGA. When that manufacturer falls over, for whatever reason, the other brands can’t usually suddenly jump from 10% market share to 80% market share quickly and a temporary outage develops.
While one can import alternate brands to get over a shortage, the manufacture of medicines tends to be scheduled out of a few plants for some time in advance on a contract basis. So there are no huge amounts of ‘free’ drug sitting around without someone expecting them, and making some new drug takes time. Manufacturers do not want to welch on their contracts, so the fix for a temporary outage tends to take a few months when you can bring manufacturing capacity online.
There is also the issue of labelling etc, because importing a whole lot of drug with Hindi labels can have its problems for clinicians.
Which leaves the issue of where available supplies actually go in a shortage. Companies will move available supplies to 1) their biggest and most influential customers. Australia has less population than California, let alone the US market generally, so at about 1% of total drug sales worldwide we are not that important commerically. More importantly, 2) our prices are lower than can be gotten in some countries and so people will sell in more profitable markets first. We are way down that supply-demand curve where they almost meet.
Which raises the prominence of the point that CSL doesn’t make penicillin it imports it from a large international company, which I think is Sandoz. So it has no say in how this company moves its supplies around in a shortage. We actually make almost nothing of medical significance unless its a disease which can be treated with lanolin – which would be sunburn.
Why the shortage; usually its something the company doesn’t really want to own up to. GMP failure on a production line, quality control issues requiring machines to be checked or replaced, fire. But the constant in this is that companies will not inform anyone of a problem until they absolutely have to because of commercial sensitivity to their reputation with their customers. The customer is CSL, not the person in the bed with Staph. So its entirely consistent with usual corporate behaviour to tell governments that we suddenly have 3 days suppply of an essential medicine, and its now your problem.
This really should be fixed. The solutions are to actually make some things as a matter of national interest – but that was the whole reason for having the Commonwealth in CSL in the first place. Alternately, TGA and or PBAC should act to enfore minimum stock levels are a condition of registration and/or listing to ensure there are actually 6 months supply of certain essential drugs in the country at any one time. That will not happen by market magic given the incentives in this market.