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The hidden side of clinical trials

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'The Ugly Truth'

by Tracey Brown, director of Sense About Science

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Blog


 

May 2013

Quick update from vote in EU

It hasn’t been easy to follow the votes on the clinical trial regulation in the Environment, Public Health and Food Safety Committee in Brussels today but I think we can say that the result isn’t bad, and that we all made a difference.

MEPs accepted compromise amendment 11 which says that all clinical trials must be registered and summary results published within a year of its end, with financial penalties for those who don’t comply.

MEPs rejected consolidated amendment 40 which would have put into law that clinical trial data should not be considered commercially confidential once a marketing authorisation has been granted. MEPs did accept consolidated amendment 41 which says the same thing but puts it into the recitals (to help with interpretation of the law) not actually into law. Therefore this is not as strong as we would like it to be, but still important.

Amendment 61 which says that when considering what is commercially confidential, policy makers should adhere to the European Medicines Agency’s guidelines on this and cannot override public health research interests was accepted.

We have heard from a number of MEPs’ offices that your letters made a difference to the votes. The pharmaceutical industry has 350 lobbyists at the European Parliament so in the run up to the vote MEPs were hearing that commercial concerns should trump transparency every day. MEPs told us that your letters, which they received from 100s of members of the public and medical and science organisations, gave them the arguments to make in favour of transparency.

If the clinical trial regulation became law today it would be a big step forward. We have to say well done to Glenis Willmott MEP and her colleagues for all the hard work that has gone into it.

But the regulation still contains loopholes, inconsistencies and ambiguities that all need to be tidied up, and in front of us are four or five months of negotiations between the Parliament and the EU Member States’ governments where gains could be lost. We’ll let you know about next steps soon.

www.alltrials.net


Dr Phil Howell talks about taking part in our recent Q&A

Dr Phil Howell

 

 

 

Dr Phil Howell is Programme Leader of the Cereals Pre-Breeding group at The National Institute of Agricultural Botany and has over 20 years of experience in crop improvement.

The National Institute of Agricultural Botany’s work on breeding with ‘Synthetic Hexaploid’ Wheat was featured on BBC Countryfile a couple of weeks ago and since then the whole world wants to know about ‘superwheat’ (the BBC’s term, not ours). This includes Sense About Science who invited us to take part in an online Q&A. I knew about them from last year’s petition supporting the Rothamsted GM wheat trial, but hadn’t really appreciated the range of issues that they addressed.

The Q&A seemed like a great opportunity to answer questions about wheat in a fun and stimulating way. I’d have a captive audience and could extol the many virtues of the plant breeder, and I wanted to show people the difficult juggling act breeders must perform. After all, a successful new variety has to clear four different hurdles. Firstly, it has to emerge as the best material amongst the millions of plants produced within a breeder’s own programme. Then it must negotiate the registration trials system in competition with its peers from other programmes, which usually takes at least three years. Once launched onto farm it must gain acceptance as something farmers want to grow, and then when harvested show it has value for end-users, whether as a component of animal feed, bioethanol, spirits like whisky and gin, biscuits and cakes, breads and pastries, breakfast cereals, or suitable for the export market. See, once I get started I can go on and on...

A week or so before the Q&A I had a chat with Sense About Science about how the session would work, and was reassured to hear that my live answers would be checked for spelling and clarity before being posted online for the world to see! A couple of days before the event, we had a practice to see that our answers were pitched at the right level. So, Wednesday lunchtime passed and it was time to sit at my desk and wait for the questions. I was a bit apprehensive about being able to respond fast enough but it’s amazing what you can do when the adrenaline kicks in.

The questions were very wide-ranging. Some were particularly imaginative, with visions of wheat rafts stretching across the oceans, of crops that trapped insect pests and of wheat which had no risk of catching fire even in the fiercest summer heat. Others were rooted more in science than science fiction, asking about nitrogen fixation and C4 metabolism. There were questions which wore muddy boots, asking about specific disease resistances, rooting ability, speed to maturity and competition against weeds. One notable theme was nutrition – wheat suitable for those suffering from coeliac disease or irritable bowel syndrome, wheat bio-fortified with vitamins, wheat with a lower glycaemic index, and wheat with straw that would make a suitable animal feed.

The hour flew past, especially the second half when questions were coming in two or three at a time and whole batches were beginning to stack, but between us all I hope we tackled everything. Direct questioning like this is great; it makes you look at things from a different viewpoint which can only be a good thing. It’s clear that we’re still a long, long way from having all the answers. So, plant scientists, lay down your sequences, step away from the Arabidopsis and step out into the fresh air, it’s a really exciting time to be working in crop science!

Read the "What would your ideal wheat look like?" Q&A in full here.


International Clinical Trials Day

It’s International Clinical Trials Day and just over four months since the AllTrials campaign started. A lot has happened – 300 organisations and 52,000 people have joined; AllTrials was launched in America; patients who took part in clinical trials wrote to the European medicines regulator; and regulators, publishers and researchers have started discussions on practical issues on trial transparency.

Carl Heneghan from the Centre for Evidence-based Medicine told us that “We have seen GSK become the first pharmaceutical company to commit to publish the results of all its drug trials and provide clinical study reports. And Roche has publicly confirmed it will make clinical study reports for all 74 Tamiflu trials available. Three years this has taken and it couldn’t have happened without the support of the AllTrials campaign. It’s hard to envisage the impact publication in full will have on health, but it will be immense.”

However, those who don’t want transparency are making their arguments heard too. The head of pharmaceutical company Lilly UK said last week that patients don’t want companies like his to spend their money sharing “old data.” These “old data” are of course the results on which all treatments in current use are based! Perhaps he is hoping that AllTrials can be headed off into a siding, like all previous attempts to establish transparency.

There are 350 lobbyists from the pharmaceutical industry at the European Parliament so MEPs are hearing arguments against transparency every day. We have until 29th May – when MEPs vote on new proposals that could increase clinical trial transparency – to make sure they hear our arguments too. Many of you have written to your MEP already – thank you especially to those of you who have kindly allowed us to share your letters in case they are useful for others. If you haven’t already please write to your MEP, let us know if you do and if you get a response.

There are lots of discussions about transparency going on this International Clinical Trials Day …

… the Cochrane Collaboration has put up some short podcasts on international efforts

… there’s an interview with Ben Goldacre about AllTrials and our future plans at BioMed Central

…here’s a blog on why the open science community should sign up and support AllTrials

… but this has to be the last International Clinical Trials Day of the era when trial results are withheld. Please ask 5 people you know to add their name at www.alltrials.net today. Ask your organisation to join if they haven’t already and please write to your organisation’s European and International umbrella groups. Help us get enough resources to continue the campaign by donating at https://www.justgiving.com/alltrials

And write to your MEP today if you haven’t already.


Dr Juliet Stevens responds to misleading article on National Cervical Screening programme

This letter written by Dr Juliet Stevens was sent to the Observer on 2nd April

Dear Editor

Barbara Ellen's article, Denying young women smear tests is a disgrace (28th April) was poorly informed and dangerously misleading.

She confuses the tragic death of Becky Ryder from cervical cancer aged 26, with an argument concerning the age at which the National Cervical Screening programme should commence.

The Screening Programme is only for asymptomatic patients, and is offered in England to women from 25 years of age because studies show that starting screening earlier causes anxiety and unnecessary investigation and treatment, which outweigh the health benefits. The age cut off is not, as the article states, related to a judgement as to the sexual promiscuity of young versus older women.

Crucially, Ms Ryder would have qualified for NHS investigation for cervical cancer when she presented to her GP aged 24 with vaginal bleeding on the basis of her symptoms alone, irrelevant of her age.

The article continues, implying that the HPV vaccine, now offered to all teenage girls, offers substandard protection from cervical cancer as it does not protect against all HPV strains. What she does not mention however, is that the majority of HPV strains are not associated with cervical cancer.

The vaccine (Gardasil) offers extremely reliable protection against both HPV strains which lead to the development of cervical cancer, and two others which cause benign genital warts.

Articles such as these only contribute to misinformation and decreased vaccine uptake, putting more women at risk,

Yours faithfully

Dr Juliet Stevens 


Keel libel laws out of science

This is an article for the Index on Censorship magazine and you can read the full piece here.

Tracey Brown looks at one of the UK’s most challenging and important free expression campaigns

As 2013 began, advocates for libel reform looked forward to the final stages of the Defamation Bill passing through UK parliament and greater protection for free speech and the public interest. But on 6 February, members of the House of Lords introduced an amendment to the bill, adding a ‘Leveson clause’ on press regulation. This brought with it the perverse possibility that the bill would introduce serious curtailment of free speech alongside its improvements, and that the government might drop the bill altogether to avoid the amendment becoming law. What will come out of the Leveson Inquiry and its ensuing report is still being contested. The bill, by contrast, has been through three public consultations and seven debates in Parliament. We know that current libel laws in Britain stifle debate and damage the public interest.

We cannot allow political tactics to destroy the work of so many people over so many years. There’s too much at stake