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‘A half-truth is more dangerous than a lie’ How to avoid bias in pharmaceutical trials?

Hello, I’m Jack Dryden and I’ll be one of the chairs for the Health I Committee. I've been involved in MUN for five years now, having first been dragged along by a friend, I was hooked in minutes. Coming from a debating background, I've always enjoyed the more serious debates with positions in Economic Committees and Security Councils being amongst my favourites. This is my third time chairing at our conference and this year I’ll be taking up the gavel in the G.A. as one of the Secretary Generals. I look forward to a stimulating debate, some interesting analogies and plenty of rhetoric - but keep it clean!

Introduction to the issue The very basis of the scientific method is empiricism. This means that scientific knowledge is acquired through experiments, which are used to gather evidence to either prove or disprove a scientific theory. In the case of medicine, before Doctors may consider a particular drug fit for purpose, experimental trials must prove that the drug is not only safe to use and won’t cause any major side effects, and that is also effective. A minimum requirement is that it must be more effective than a placebo. Clearly, evidence based analysis is vital to this process. But what if that evidence can be biased?

How they manipulate the evidence ? One of the most common methods used by Pharmaceutical companies to distort evidence are trials against Placebo. At first thought, it seems logical that drug trials should document the comparison between a new drug and placebo, hence proving that the drug does have a true medicinal effect. However, in many cases this isn’t really appropriate, for instance, when there is already a good treatment for the same condition. In these cases it’s not much use to simply “know that your drug is better than nothing”. What doctors really need to know, in order to make accurate decisions on what to prescribe, is how the new drug compares to the old. Is it more effective than the previous treatment?

Even when trials do appear to provide a fair comparison between new and existing medication, there is still plenty of opportunities for Pharmaceutical companies to manipulate their data. For example, by increasing the typical dosage of the old drug in the comparison they can greatly increase its side effects relative to the new contender. This, as has been highlighted by Ben Goldacre, has been used by two generations of antipsychotic drug trials to prove that new medications were more effective than their predecessors.1

It has been discovered that industry funded trials are four times more likely to give a flattering result, yet the scientific methods afforded by industry funded trials are much more

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comprehensive. Thus, one must ask the question: how do they manage to invariably achieve the desired result?

The answer is through publication bias, meaning essentially that negative trials often do not make it into print. As highlighted by the All Trials campaign, over half of all clinical trials have never been published. This is a truly shocking figure. Is such a wide degree of trials never make it to doctors desks how can we have any confidence that the medicine we are prescribed is effective, let alone safe? (More information on how the presence of publication bias can be proven is available in Ben Goldacre’s short presentation to a TED conference.1)

For example, Tamiflu, the drug trusted worldwide to treat flu and reduce the likelihood of complications such as pneumonia still have not published all their data in a usable format for doctors to analyse. Despite years of campaigning by charities and medical professionals to allow them to evaluate the effectiveness of the drug, the pharmaceutical giants refuse to publicise their data, supposedly due to concerns of other firms copying their drug.

It’s not all doom and gloom. In recent years, increased media attention brought by the work of Ben Goldacre, publishing the books “Bad Science” and more recently “Bad Pharma”, have pushed for change in the way medical trials are reported. The AllTrials petition has generated over 50,000 signatures including those of many leading medical bodies including departments of the NHS, charities such as Macmillan and even some Pharmaceutical companies such as GSK.

GSK has made a particularly strong stance against the issue as CEO Sir Andrew Witty has brought in a raft of measures, promising to publish all the detailed reports of medical trials past, present and future. It is hoped that the commitment made by GSK will lead to an industry wide movement towards greater transparency.

Research points. • How does your member state regulate drugs and medicines available to the public? • What criteria must drugs meet before they are permitted in general practice? • How much information can doctors access when prescribing medication? • Does your member state invest in Tamiflu or any other of the drugs affected? • Does your member state play host to any major pharmaceutical companies? • If yes, how will the publication of all their results affect their ability to compete? • Would your member state support the AllTrials petition?

What to do now? I realise you must hear this an awful lot but, I must stress how much of a difference it makes if you prepare properly for our conference. Please do write a position paper - fifty words or so explaining your country’s political stance - for each topic (see timescale for sending them to me below) and indeed at least two resolutions to bring with you to the Conference. The more you know about your country’s viewpoint and the more you have

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thought about the policies you would implement the better, and the easier you will find it to speak on the day. We will be reading all the position papers and resolutions to help us judge the awards so don’t be tempted just to turn up on the day and “wing it”. You will have a lot more fun and we will have a much better standard of debate if you do a bit of research beforehand. Quite literally, the more you put in, the more you will get out.

My email address is [email protected] Position papers are due to be e-mailed by you to me by 15th February 2014 at the latest. Please don’t be late. Feel free to contact me at any time regarding any questions you may have about the health committee or the conference in general.

Useful links On this topic

Fascinating talk by Ben Goldacre to TED conference. (15 mins approx.). go to http://www.ted.com/talks/ben_goldacre_battling_bad_science.html

Interview with CEO of GlaxoSmithKline on increasing transparency of clinical trials (6 mins approx.). Go to http://video.foxbusiness.com/v/2735629915001/glaxosmithkline-ceo-on- increasing-transparency-of-clinical-trials/?playlist_id=937116503001 Website for the AllTrials petition. http://www.alltrials.net Ben Goldacre’s blog. http://www.badscience.net

For Country Profiles and lots of other useful information: http://www.nationsonline.org/oneworld/ http://news.bbc.co.uk/1/hi/country_profiles/default.stm

For issues of current international debate: http://www.newint.org/ http://www.idebate.org/ http://www.amnesty.org/

George Watson’s College MUN Conference 2014 MUN BRIEFING PAPER

George Watson’s College MUN Conference 2014