Deadly rise of 'superbugs'? It's business as usual for Big Pharma!

There can be no better illustration of Big Pharma's obsession with short-term profits than its refusal to invest in the development of new antibiotics to combat diseases caused by the new deadly strains of multi-drug-resistant bacteria.  Shila Kaur elucidates.

EVEN as the soaring rates of potentially lethal infections threaten to turn into a public health catastrophe, Big Pharma stubbornly refuses to invest in antimicrobial innovation.  

The World Health Organisation has warned that without antimicrobial innovation which is needed to combat multi-drug-resistant bacteria that are spreading quickly around the world, there will be a health emergency of global proportions.  The recent move by Britain urging the G8 leading industrial countries to take action against antimicrobial resistance through coordinated international action attests to the seriousness of the problem  (see 'UK raises alarm on deadly rise of superbugs', The Guardian, 11 June 2013).

Drug resistance is an inevitable consequence of antibiotics.  The drugs wipe out susceptible infections but leave resistant organisms behind.  The survivors multiply and, in time, can become immune to even the strongest antibiotics. 'Superbugs' and resistant strains in hospitals are currently on the rise. 

In efforts to curb the spread of multi-drug-resistant bacteria, healthcare facilities and providers are being told to go back to basics: the focus is on appropriate hand-washing techniques and hand hygiene as well as sanitation as first-line prevention measures.  The health community is waking up to the fact that while there is an urgent need for antimicrobial innovation, excellent prevention and control measures must regain the status of standard operating procedure.

According to a status report published in April 2013 by the Infectious Diseases Society of America (IDSA), only two new antibiotics have been approved in the US since its 2009 pipeline report.  Since 1998, only four antibiotics were approved by the US Food and Drug Administration for use by doctors.  The last approval came in 2010.  Only seven antibiotics are currently in any kind of advanced state of development and are years away from approval and use.

There was a time when 11 Big Pharma companies were involved in antibiotic research and development.  Today the figure is down to four:  GlaxoSmithKline, Pfizer, AstraZeneca and Merck.

So what's keeping Big Pharma away from antimicrobial innovation?  According to Helen Boucher, lead author of the 2013 IDSA report, amongst the major encumbrances to antibiotic innovation is the low return on investment. Drug development takes a lot of time and money; drug companies prefer investing in drugs that treat chronic or lifelong diseases which guarantee big returns in terms of profits.  Why invest in antibiotics which are typically prescribed for just a few days and are cheap?  The returns are comparatively small and Big Pharma is just not interested. 

For example, in Australia, according to the pharmaceutical industry peak body Medicines Australia, it takes about A$1.4 billion, 10,000 molecules and 12 to 15 years of research and development before a new medicine is approved for use.  In 2010 there were more than 2,950 medicines under development, of which more than 800 were cancer drugs, 250 cardiovascular drugs and only 83 were antibiotics.

Big Pharma also complains of another obstacle: the 'lack of regulatory clarity' from the US Food and Drug Administration, which has made it increasingly difficult for antibiotic development to surmount all the necessary regulatory hurdles. Critics of this view, however, point out that fast-tracking regulatory approval processes could compromise drug safety. It could of course make antibiotic development more profitable for Big Pharma - at the expense of small pharma which actually focus exclusively on superbugs and other resistant bacteria and are able to reap profits due to smaller overhead costs. 

'There are only a handful of companies like us out there,' said Steve Gilman, chief scientific officer and executive vice president of Cubist, a bio-pharmaceutical company based in the US.  'Our guidance for R&D for 2013 is between $400 and $420 million, with the bulk of that focused on antibiotics,' Gilman was quoted as saying in a news report ('Big Pharma exit: Who's fighting the superbugs?', 23 April 2013).  'Our overhead is much less than a larger firm,' he added.  Cubist reported a net revenue in 2012 of $926.4 million, up 23% from 2011.

'We've been able to find a steady stream of revenues that keeps growing.  We're happy to pursue a $500 million market, where the bigger firms won't,' he added.  'I don't think the bigger pharmaceutical firms are going to change their mind about getting back into antibiotic research anytime soon.  It's up to us [smaller firms] to get involved.'

While antibiotic resistance is threatening public health, for Big Pharma, 'superbugs' requiring treatment are less appealing targets for drug development than chronic conditions such as statin (cholesterol-lowering drugs) and anti-depressants, beta-blockers or anti-rheumatics.  Pfizer's cholesterol pill Lipitor remains the best-selling drug worldwide.  Its annual sales in 2010 were $12.9 billion, and its closest competitors were Plavix, a blood thinner from Bristol-Myers Squibb and Sanofi-aventis; Nexium, the heartburn pill from AstraZeneca; and Advair, the asthma inhaler from GlaxoSmithKline.

But not all is doom and gloom.  Experts from the medical, veterinary, agriculture, infection control and public health sectors advocate a multi-faceted strategy combining antibiotic stewardship with a comprehensive national  resistance monitoring, surveillance and audit system, coordinating education and stewardship programmes and implementing infection prevention and control guidelines.

Peter Taylor, assistant director of Microbiology at the Prince of Wales and St George hospitals and a lecturer in Pathology at the University of New South Wales in Australia, said it well: 'It is important that those with the information use it wisely and do not spread unnecessary fears.  The answer lies in excellent diagnosis, excellent care and excellent pharmacy support, as well as continuing education of the medical profession and the community at large.'

The underlying message appears to be: Prevention is still better than cure.                                         

 Shila Kaur is a health consultant with the Third World Network.

*Third World Resurgence No. 273, May 2013, pp 26-27