The future of healthcare? Kill the bugs save the world! Part 1

Trevor Lewis

Medical Device Consultancy

This is a story about possible good news and bad news, it is a scary ride but offers some hope for us all…failure is not acceptable and success is required for survival!

Is the future of healthcare under serious threat or are we about to enter a brave new world where anything is possible? The media always like healthcare stories where some new device or drug has resulted in a ‘miracle’ cure or a ‘major breakthrough’ that suggests all cancers or diseases will soon be consigned to the history books. Sometimes the good news stories are real and accurately reported but are then often followed by news of setbacks in development or unforeseen problems that undermine the potential that seemed so bright a prospect just a few years ago.

Other scenarios of the future have been portrayed in films like ‘Outbreak’, ‘28 Days Later’, ‘The Stand’, ‘Cabin Fever’, and the ‘Andromeda Strain’ where various pathogens could lead to the demise of the human race. However we probably do not need bio-weapons or alien bugs to really scare us, reality holds some of the scariest possibilities and could be with us any time soon. Indeed some of the potential pathogens are already amongst us, or more literally within many of us…

The World Health Organisation (WHO) has revealed an emerging script that should truly worry all of us and make us all ask: what is the future of healthcare? On the 17th March 2012 Dr. Margaret Chan, Director General of WHO made one of the most dramatic statements yet.

Dr. Chan warned that once all antibiotics become treatment resistant, that even simple throat infections, or a grazed knee, could lead to potentially fatal conditions. She is quoted as stating:

The world is approaching a post-antibiotic era, which could bring about “the end of modern medicine as we know it”…

She said routine operations might become too dangerous, with every antibiotic ever developed “at risk of becoming useless”.

The threat was “global, extremely serious, and growing”, Dr Chan said.

“A post-antibiotic era means, in effect, an end to modern medicine as we know it,” she told a conference of infectious disease experts in Copenhagen. 1

Imagine the horror of a world where no surgery was possible due the huge risk of fatal infections…

The multiple drug resistance (MDR) and extreme drug resistance (XDR) of many pathogens to antibiotics is a major concern to the WHO and all those who fight to combat the effects of infectious diseases. Drug resistance is potentially a major threat to human health on a global scale.

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“For all our sakes we need to preserve what antibiotics we have and to find new ones – urgently.”

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Of great concern to the WHO is the increasing resistance to the treatment of tuberculosis. The WHO believe that one in three people in the world is now infected with dormant TB bacteria, and during 2004, there were almost 500,000 cases of MDR-TB with up to 19% of these being XDR – extremely resistant. In recent years, in response to the ever growing threat of TB and other respiratory infections, lots of projects are being funded in the Europe Union (EU) and the United States (US) but in this fight to the death is it enough to ensure most of us survive?

The future is going to get personal…

One of the great hopes for the future of healthcare is the use of molecular diagnostics to determine the genetic profile of pathogens to enable appropriate specific therapies to be directed against specific diseases. This approach will hopefully replace the age old empiric method of guessing (albeit educated guessing) based on previous patients and limited testing of a sample of a population during a disease outbreak.

The funding by governments of projects is needed because the scale, complexity of the problem and economic drivers are all tough. Most surprisingly antibiotics are not big money spinners for drug companies, indeed they are more typically loss makers! It is well known in the industry and to the public that the pharmaceutical pipeline is running dry for many types of drugs and especially so for antibiotics. For all our sakes we need to preserve what antibiotics we have and to find new ones – urgently.

Molecular diagnostics can help with drug discovery, clinical trials and therapy by ensuring the responsible pathogen is detected, in a timely manner, so the appropriate therapy can be given immediately and cost effectively. Molecular diagnostics can also be used to ensure some drugs, notably some current cancer drugs, are not given to patients for whom they will yield no benefit but possibly make them more ill due to adverse side effects. Here the benefits of the human genome, biomarkers and advanced molecular diagnostics all come together and perform what 50 years ago would seem like magic – accurately targeted therapies based on sound science and evidence. One odd problem with this approach is that some pharmaceutical companies see such technology as comparable to voting for a pay cut – an unwelcome reaction from an ethical point of view. Such pharmaceutical companies should worry more about keeping their products on the market, something this advanced technology can help with and filling their new drug entity (NDE) pipeline, again something this technology can assist with – it has much to offer big pharma.

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“There needs to be a greater sense of urgency into the war on bugs and more resources are required to win.”

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Many pharmaceuticals have a huge placebo effect, a small but critical therapeutic effect and often many side effects. Patients who do not complete their course of antibiotic treatment are effectively helping treatment resistant super bugs emerge more quickly. Prudent and appropriate use of all pharmaceuticals, especially antibiotics, is in everyone’s long-term interests. Sometimes this means not prescribing antibiotics despite huge patient pressure to do so.

There needs to be a greater sense of urgency into the war on bugs and more resources are required to win. The fight against antimicrobial resistance is one where price and cost effectiveness have to be put second to positive clinical outcomes. Diagnostics, pharmaceuticals and systems are needed to combat the threat of large scale antimicrobial resistance continually and to serve as a contingency when a particularly deadly pathogen hits the world. This could happen at short notice, at any time soon.

It has to be noted that treatment resistant or novel viruses are also a major threat to the survival of many of us. Novel strains of hard-to-treat influenza come to mind and the often quoted statistic is that during the Influenza Pandemic of 1918 somewhere between 20 million and 40 million people died from Influenza, more than all the casualties during the First World War, and more than from the Black Death Bubonic Plague from 1347 to 1351. This so called ‘Spanish Flu’ had its greatest mortality in the 15 to 34-year-old range. If Spanish Flu or something similar hit again now its economic effects would be truly devastating, especially with ageing populations that would lead to a much skewed population. This would consequently result in an economically disastrous situation that would probably take more than a generation to recover from.

Enough of the bad news, what about the good news…?

View part 2 of this article here

References:

1 http://uk.news.yahoo.com/global-health-alert-over-antibiotics-misuse-161312158.html

 Talent Forward 2012

About the author:

This article was written by Trevor Lewis, Principal Consultant of Medical Device Consultancy, and was commissioned by PiR Limited.

Trevor has been an independent consultant for around 17 years, after working in industry for than 10 years. Trevor provides specialist business development assistance for universities, medical device, in vitro diagnostic (IVD), biotechnology and pharmaceutical companies. He supports and mentors senior management with their strategic planning, marketing, product management, quality systems and regulatory compliance in the US and Europe. He has become a well known and respected regulatory expert, ultimately leading him to assist in the training of national regulatory authorities and senior officials in the European medical device directives, especially in Egypt and Turkey. He is a partner in the major European Commission-funded diagnostic project TheraEDGE and an advisor to another large scale diagnostic project funded by the Innovative Medicines Initiative known as RAPP-ID.

PiR is a brand synonymous with providing innovative senior resourcing solutions to life science organisations. As a result of our exclusive focus on the sector, we have an understanding of many of the issues faced by pharmaceutical, biotechnology, diagnostic and medical device companies in the 21st century.

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What do you think the future of healthcare is like?