The focus of World Health Day 2011 was on the increasing spread of resistance to antimicrobial drugs. The slogan chosen for the event was, in fact, ‘No action today, no cure tomorrow’.
A number of crucial factors have influenced drug companies to question the profitabilityof antibiotics inthe long run- Amanda Garzia
Antimicrobial drugs include antibiotics, antivirals and antimalarials. The event underlined that antimicrobials are, it appears, not working as well as they used to.
Statistics issued by the World Health Organisation on the state of affairs in the EU show that circa 25,000 people a year die because of antibiotic-resistant infections.
Tim Walsh, a scientist at the University of Cardiff, has long been investigating the issue of antimicrobial resistance.
This is what he has to say with regard to the situation in Great Britain: “We are very close to having pan-resistant bacteria in this country.
“The consequence of this is that we are more or less back to the pre-antibiotic days of the 1920s, so these drugs that we’ve relied on for so long and taken for granted have now become obsolete because we’ve become complacent.”
How have the antibiotics at the medical establishment’s disposal lost their edge over the course of a century? Why does it seem like pharmaceutical companies are not sufficiently engaged in the research and development of new antibiotics?
In order to make sense of the answers to these questions, it is essential to understand how antibiotics work. It is also necessary to realise that a number of crucial factors have influenced drug companies to question the profitability of antibiotics in the long run.
In the late 1950s, scientists working for veteran pharmaceutical company Beecham joined up with the people at Bristol-Myers, eventually making new inroads vis-à-vis the antibiotic penicillin.
These efforts led to the development and marketing of semisynthetic pencillins. In fact, in 1961, Beecham launched ampicillin on the market. Its trade name was Penbritin.
Such was the global demand for the new antibiotic that the company had to invest in larger premises for its operations.
It continued to invest in researching and developing new antibiotics and in 1972 it launched amoxicillin. Amoxicillin became one of the most widely prescribed antibiotics on the market.
It is usually only a matter of time, however, before an antibiotic becomes less profitable for the company that originally launched it. There are two principal reasons for this.
Firstly, if the antibiotic is misused and/or overused, bacteria may circumvent it sooner or later.
Secondly, in spite of the overall expense shouldered by the parent company to research and develop its antibiotic drug, the company must eventually cede its patent rights to the drug in question.
It is unethical to prescribe an antibiotic unnecessarily. However, doctors are normally required to make an on-the-spot judgement to decide whether or not their patient(s)’s condition merits a course of antibiotic therapy.
In the eventuality that a doctor does prescribe an antibiotic, the patient himself or herself may unwittingly increase the drug’s effectiveness.
If, for example, a patient is instructed to take an antibiotic twice daily, it is important that each tablet is taken regularly which – in this case – means every 12 hours (not 13 or 14). It is also important for a patient to complete their prescribed course of antibiotics.
These potential pitfalls, together with the haphazard use of antibiotics in animal husbandry gradually undermine the ability of the medicine to stop bacteria effectively.
When an antibiotic is prescribed, it is normally prescribed for a (minimum of) five to seven days. Sometimes a patient may require a course of 10 days or a fortnight.
Occasionally, an even longer course is called for. This is the length of time deemed sufficient for the antibiotic to deal successfully with a bacterial infection.
This explains, therefore, why pharmaceutical companies acknowledge that they stand to gain a larger return on drugs which have to be prescribed for longer periods of time. Statins, for example, are used to lower harmful cholesterol levels.
They may be prescribed indefinitely to patients who are either disposed to suffer from high cholesterol levels or to patients who are unwilling to cut down on food products sourced from animals.
About 10 years of research and over a billion euros are required to research and develop a new antibiotic. If, in a best case scenario, a new antibiotic is not misused or overused, the company that launched it still has to deal with the issue of property rights and patent expiry.
In their paper ‘How property rights and patents affect antibiotic resistance’, John B. Horowitz and H. Brian Moehring explain the problem in some detail.
If a pharmaceutical company launches a new antibiotic, it is aware that after a 20-year-or-so period of market monopoly (in which it is guaranteed exclusive rights to produce and sell the drug) other companies will have the right to copy and market this antibiotic. Supply increases and prices fall.
These late arrivals can afford to sell the antibiotic at a cheaper price because they did not invest so heavily to develop it in the first place.
Pharmaceutical companies have understandably become wary as regards the research and development of antibiotics. The prospective financial return does not justify the expense.
As the clock ticks backwards, therefore, it remains to be seen whether or not a minor infection will become, once again, a major event.