Dose of reality: the ethics and politics of drug development

Sunday 19 October, 10.00 until 11.30, Pit Theatre, Barbican Biomedical Battles

Whenever medication is prescribed to you by a doctor, given to you in a hospital or sold to you over-the-counter, almost every substance you ingest, inhale or inject will have a long and tangled history behind it. This will be a history of research, development, trials, patents, regulation, policy and commerce, involving a complex set of interests that are often in conflict with one another. Recent pharmaceutical controversies attest to difficult tensions that exist between private interests, the public interest and scientific disinterest, making it difficult to develop drugs that reward investment and are affordable while also being proven to do more good than harm.

One major controversy involves statins, the most widely prescribed drugs in medical history, which lower blood cholesterol and are given even to healthy people who have no history of heart problems. In 2014, a leading journal published, and then issued corrections to, papers suggesting that the side effects of statins pose a significant risk. This prompted accusations and counter-accusations of bias, vested interest, undisclosed research data and inadequate peer review, which are ongoing. Another perennial controversy is antibiotic resistance, with the UK prime minister, David Cameron, recently blaming ‘market failure’ for a lack of new industry-developed antibiotics to tackle the threat of superbugs. And then there is also the question of access to drugs. 

When politicians aren’t worrying about Big Pharma’s capacity to innovate, they’re concerned about its capacity to sustain the economy. Pharma giant Pfizer’s 2011 closure of its 60-year-old UK research plant dealt a major blow to British industry, while the same company’s attempted takeover of Anglo-Swedish firm AstraZeneca in 2014 prompted concern and calls for intervention at the highest levels of government. The decision in August by the National Institute for Health and Care Excellence’s (NICE) not to offer a life-extending drug to prostate cancer sufferers until after they have received chemotherapy, was described as a ‘kick in the teeth’ for patients by one charity. NICE defended its decision by explaining the drug was ‘not cost effective at its current price’, a reasonable point for a cash-strapped NHS. But as any new drug roughly takes 10 years to reach the market, at a cost of approximate £1 billion, how can we square the ethical circle? Indeed, protagonists in all of these controversies have issued dire warnings that failure to follow a certain course of action will cost lives.

If it’s true that the stakes are this high, then how - and by whom - can drugs best be developed and prescribed, for the longer term and the greater good?

Watch the debate:

Listen to the debate:

Danny Altmann
professor of immunology, Imperial College; editor-in-chief, Immunology; associate editor, Vaccine

Professor Mark Baker
director, Centre for Clinical Practice, NICE

Dr Eliot Forster
CEO, Immunocore; chairman, MedCity

Dr Clare Gerada
GP; past chair, Royal College of General Practitioners

Sandy Starr
communications officer, Progress Educational Trust; webmaster, BioNews

Produced by
Claire Fox director, Academy of Ideas; panellist, BBC Radio 4's Moral Maze; author, I Find That Offensive
Sandy Starr communications officer, Progress Educational Trust; webmaster, BioNews
Recommended readings
What kind of research can we trust?

Research involving pharmaceutical company input is notoriously compromised. While not all industry ties lead to biased research, and not all biases are a consequence of industry ties, many studies show industry influence can make drugs look safer and more effective than they really are. So where can doctors and indeed the public turn to for reliable information?

Adam Dunn, Florence Bourgeois, The Conversation, 7 October 2014

BMJ 'right' in statins claims row

An investigation has backed the British Medical Journal's handling of two controversial and inaccurate articles it published on the harms of cholesterol-reducing statins

James Gallagher, BBC, 2 August 2014

NHS medicines watchdog lowers bar for statins prescriptions

An estimated 4.5 million more people will be eligible for statins under new guidance, in addition to 13 million already eligible

Sarah Boseley, Open Democracy, 18 July 2014

The microbe is mightier than the market

Appointing an economist to save us from superbugs might seem odd but, as with many problems, money is at the root of it

Paul Vallely, Independent, 6 July 2014

Evidence based medicine: a movement in crisis?

Trisha Greenhalgh and colleagues argue that, although evidence based medicine has had many benefits, it has also had some negative unintended consequences.

Trisha Greenhalgh, BMJ, 13 June 2014

Surveillance for Antimicrobial Drug Resistance in Under-Resourced Countries

Antimicrobial drug resistance is usually not monitored in under-resourced countries because they lack surveillance networks, laboratory capacity, and appropriate diagnostics. This accelerating problem accounts for substantial number of excess deaths, especially among infants.

Guy Vernet, Catherine Mary, Dany M. Altmann, Ogobara Doumbo, Susan Morpeth, Zulfiqar A. Bhutta, Keith Klugman, CDC, March 2014

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