Tag: European Commission

Euro Cancer Leagues calls for action on EDCs now!

Let’s tell the EU to stop exposure to hormone disrupting chemicals

Written by Christel Schaldemose

Association-of-European-cancer leagues (ECL) image
MEPs Against Cancer (MAC) Briefing: EU Consultation on Endocrine Disruptors – Let’s tell the EU to stop exposure to hormone disrupting chemicals, not tomorrow, but today.

A representative of one of Europe’s most influential cancer organisations, the association of European cancer leagues (ECL) recently told a meeting of MEPs against cancer that curbing exposure to endocrine disrupting chemicals should become a central part of cancer prevention strategy in Europe.

ECL, which focuses on the prevention and control of cancer, brings together national and regional cancer leagues with a staff of more than 6000 throughout Europe. Its director Wendy Tse Yared said that rapid rises in rates of breast and prostate cancer in recent decades could not be explained by improved diagnostics.

She noted that this upward trend coincided with an increase in chemicals and that sufficient evidence now exists that endocrine disrupting chemicals heighten cancer risk.

Effective regulation could contribute to reductions in hormonal cancers, including of the breast, which is the most commonly diagnosed cancer in women and of the prostate, the most commonly diagnosed cancer in men.

It may also help to bring down rates of testicular cancer, which is increasing among young men in Europe. A recent study by Nordic countries on male reproductive health problems associated with these chemicals suggested that endocrine disrupting chemicals might be responsible for up to 40 per cent of all cases of testicular cancer.

Dutch toxicologist Dr Majorie B.M. van Duursen told the meeting that numerous studies on breast cancer showed that exposure to endocrine disrupting chemicals, such as BPA, PBDE and pesticides, can adversely affect the normal development of the mammary gland, potentially making it more susceptible to cancers.

She stressed that one or two new studies were appearing each day on endocrine disrupting chemicals and chronic conditions, including hormonal cancers, infertility, obesity and diabetes.

A review by the world health organisation in 2012 recorded the considerable advances in the scientific evidence that had been made since 2002. No-one can say that we don’t know enough to justify reducing people’s exposure to these chemicals, said Dr Duursen.

The not-for-profit Health and Environment Alliance (HEAL), which brings together over 70 member organisations to address how environmental protection can improve health in the European Union has been advocating stronger action to reduce exposure to harmful chemicals for many years.

Genon K. Jensen, HEAL’s director told the meeting that her members, which include cancer groups, are convinced that exposure to EDCs is a likely explanation of why cancers that are hormone dependent have been rising.

She said that HEAL was part of a coalition of non-governmental organisations called ‘EDC-Free Europe‘ that was helping ordinary individuals to respond to the EU consultation on EDCs. An online platform launched five weeks ago has allowed more than 10,000 individuals to respond.

But despite the rapidly growing scientific evidence and the growing public concern, the delays in effective action continue. What is needed now is a proper identification of EDCs – one that ensures these harmful chemicals are found and ultimately eliminated.

My hope is that this MEPs against cancer meeting will help convince the commission that action now needs to happen. Not tomorrow, but today.

Sources and more information

Say NO to hormone disrupting chemicals!

TELL THE EUROPEAN COMMISSION THAT YOU WANT TO REMOVE HORMONE DISRUPTING CHEMICALS FROM OUR LIVES TO PROTECT OUR HEALTH!

Say NO to hormone disrupting chemicals banner
Tell the @EU_Commission to find & remove all #HormoneDisruptingChemicals from our lives to protect our #health!

Due to intensive industry lobbying, the European Commission has delayed action on hormone disrupting chemicals, which is needed to protect health. But now a public consultation has been launched to gather feedback on public concerns. We need you to help us!

As the European Commission has made this public consultation very technical, the EDC-Free Europe coalition has launched an easy to use online platform to enable individuals to submit prepared answers to the European Commission.

This is the only chance you will have to directly give your opinion and call for the urgent removal of hormone-disrupting chemicals from our lives to protect our health!

It will take you less than five minutes to take action. Just fill in your details and with the help of four simple steps your submission will be sent directly to the European Commission. Take action at the No2HormoneDisruptingChemicals.org website.

Need a reminder why we need action?

Watch the video Endocrination – The Magnitude of the Endocrine Disruptors Issue. An amusing film by French journalist Stephane Horel exposes the battle created by industry lobbying on hormone disrupting chemicals.

Why do we need to act urgently now?

Our everyday exposure to hormone disrupting chemicals – in our food, cosmetics, electronic products, schools, hospitals and workplaces, to name a few, must stop in order to protect the health of current and future generations. Humans and wildlife are vulnerable to exposure to these chemicals every day, which are very likely to be contributing to the dramatic increases in many serious, life threatening diseases and health disorders.

By responding to the public consultation, you are sending a strong signal to the European Commission that there are serious concerns and public support for action to protect us, the environment and our children in Europe and beyond. Take action now and say NO2HormoneDisruptingChemicals.

Endocrination: The Magnitude of the Endocrine Disruptors Issue

The potential regulation – for endocrine disruptors – is also a threat for a vast array of economic interests. Watch the result of Stephane Horel’s 18-month investigation…

A countdown has begun in Brussels. Europe is considering a ban on endocrine disruptors, ubiquitous chemicals that hijack children’s hormonal systems and impair their health. But the potential regulation is a threat for a vast array of economic interests. The future generations mandate an astute baby to lead a behind the scenes investigation of European democracy where industry, scientists and NGOs fight for influence.

The result of Stephane Horel‘s 18-month investigation, Endocrination exposes the indulgence and sensitivity of the European institutions towards corporate influence. Attack of independent researchers, instrumentalisation of science, conflicts of interest: the film also lifts the veil on the various strategies used by the chemical and pesticides lobbies, borrowed from the tobacco industry’s tool-box, to short-circuit the forthcoming regulation.

Sources

Conflict of Interest and EDCs – Science, EU Policy and the Transparency of Values

A heated dispute about science communication regarding endocrine-disrupting chemicals…

A Dispute about Science Communication

Abstract

ehp_twitter_graphic
Science, Policy, and the Transparency of Values – Conflict of Interest and EDCs via @EHPonline

Background:
Opposing groups of scientists have recently engaged in a heated dispute over a preliminary European Commission (EC) report on its regulatory policy for endocrine-disrupting chemicals. In addition to the scientific issues at stake, a central question has been how scientists can maintain their objectivity when informing policy makers.

Objectives:
Drawing from current ethical, conceptual, and empirical studies of objectivity and conflicts of interest in scientific research, we propose guiding principles for communicating scientific findings in a manner that promotes objectivity, public trust, and policy relevance.

Discussion:
Both conceptual and empirical studies of scientific reasoning have shown that it is unrealistic to prevent policy-relevant scientific research from being influenced by value judgments. Conceptually, the current dispute over the EC report illustrates how scientists are forced to make value judgments about appropriate standards of evidence when informing public policy. Empirical studies provide further evidence that scientists are unavoidably influenced by a variety of potentially subconscious financial, social, political, and personal interests and values.

Conclusions:
When scientific evidence is inconclusive and major regulatory decisions are at stake, it is unrealistic to think that values can be excluded from scientific reasoning. Thus, efforts to suppress or hide interests or values may actually damage scientific objectivity and public trust, whereas a willingness to bring implicit interests and values into the open may be the best path to promoting good science and policy.

Sources

  • Read the full article: Science, Policy, and the Transparency of Values, Environ Health Perspect; DOI:10.1289/ehp.1408107,
    1 July 2014 – PDF.

Has Big Pharma hijacked the European Health Research Budget?

Pharmaceutical research is a legitimate use of public money. This is not the first time researchers across Europe have taken issue with the priorities of the European Union’s health research programme

a paper by Michael J Galsworthy, Leonardo Palumbo, Martin McKee

mike galsworthy
Mike Galsworthy: Science by day, poetry by night. Tweets mainly on EU & UK science policy, politics, open data – and occasionally poetry/arts stuff.

” The European Commission has just launched its new €80 billion 7-year science fund Horizon 2020. Separately, the Commission has been negotiating five joint-technology initiatives cofinanced by a range of industries. However, the source of matching funds within Horizon 2020 has been unclear.

Now it emerges that one joint technology initiative, the Innovative Medicines Initiative 2 (IMI2), cofunded by the European Federation of Pharmaceutical Industries and Associations, is promised €1·7 billion, not from the Excellent Science (basic research) nor the Industrial Leadership pillars of Horizon 2020, but exclusively from the third pillar, Societal Challenges – specifically the €7·4 billion Health, Demographic Change and Wellbeing stream designed for public health and health services research. An additional €683 million ring-fenced for clinical trials means that 25–32% of health and demographic change research funds are dedicated to drug development.

Pharmaceutical research is a legitimate use of public money. As its name suggests, the IMI2 is the successor to IMI1, which received €1 billion in public funds and was proclaimed as “the world’s largest public-private partnership in health”. However, the source and size of IMI2 funds are alarming. In 2012, the US National Institutes of Health came in for criticism when they decided to divert just 2% of their US$31 billion annual budget on a scheme to speed up drug development. This is not the first time researchers across Europe have taken issue with the priorities of the European Union’s health research programme.

In late 2013, the Commission published its first work programme for health in Horizon 2020. This publication caused immediate consternation, with four of Europe’s leading health organisations expressing, in a letter to the Commissionner, how they were “deeply concerned about the balance of priorities” as the programme focused primarily on biotechnology and personalised medicine, and reiterating the importance of prevention and promotion programmes, tackling social inequalities, providing faster and joined-up services, and improving health-care delivery.

So how did the joint-technology initiatives win these funds without observers of European science policy knowing? First, despite their size, they were never mentioned in the detailed Horizon 2020 breakdowns circulated widely. Second, their finalisation took place separately from the Horizon 2020 negotiations in the European Council, with no meaningful consultation with wider stakeholders. In the same way that hefty donations with strings attached distort spending by WHO,6 the European pharmaceutical industry can use a fraction of its €27 billion annual spend on research and development to leverage public subsidy, seemingly without the wider research community present to offer counterarguments.

Arguments by organisations seeking greater transparency of IMI2 through the European Parliament’s Industry, Research and Energy Committee have been rebuffed because of increases in “administrative burden …undermining competitiveness”. The scale of IMI2 and use of societal challenges funds to pay for it can expect to attract considerable controversy. ”

Sources
  • TheLancet, PDF Downloads, March 19 2014
  • Mike @mikegalsworthy ‘s tweet, 19 Mar 2014

Agreement reached at the European Commission on EU Rules on Clinical Trials of Medicines

Clinical trials: clearer rules, better protection for patients

Clinical trials: clearer rules, better protection for patients
Glenis Willmott led the MPs who proposed the text of the Clinical Trials Regulation. Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under a provisional agreement reached between Parliament and Council of ministers on EU rules on clinical trials of medicines.

Exciting news from Brussels this morning – law that would mean researchers running a clinical trial in Europe have to register the trial before it begins and to publish summary results within a year of its end is a step closer. The committee of representatives from every EU member state government has agreed with the text of the Clinical Trials Regulation proposed by MEPs led by Glenis Willmott. This agreement now has to be formally ratified by the European Parliament and the Council of Ministers (probably in early 2014) but today’s provisional agreement is a fantastic result at a very important stage of negotiation and is down to the hard work of the MEPs and thanks to your input. The legislation will need final approval from the European Parliament.

The proposals agreed today include:

  • A publicly accessible EU database, set up and run by European Medicines Agency, containing:
    • A register of all trials carried out in the EU
    • A summary of results for all trials, uploaded 1 year after the end of the trial at the latest
    • As well as a summary understandable for a layperson
  • Clinical Study Reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
  • A statement that Clinical Study Reports should, in general, not be considered commercially confidential
  • Fines to be imposed by Member States for non-compliance with the transparency requirements
  • A requirement for all trials to be registered or published in order to be used to back up a new clinical trial authorisation (will encourage the retrospective registering/publishing of old trials)
  • The Clinical Trial Master File retained for at least 25 years.

Glenis Willmott MEP said: “For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge they are ineffective, or even dangerous.

We are determined to finalise this before the European elections in May. This legislation will set the global gold standard for transparency in clinical trials, and I call on all EU governments to support the agreement”.

Síle Lane, Director of Campaigns, Sense About Science said: “We are very pleased to hear that EU governments have agreed the draft Clinical Trials Regulation which contains proposals that would mean all clinical trials done in Europe will have to be registered and results reported. Well done to Glenis Willmott MEP who has worked very hard to get this agreement. We know Glenis was helped enormously by the hundreds of individuals and organisations who got involved and told MEPs and Ministers their reasons why transparency is vital. Now is the time for companies and academics to listen to all these voices and commit to registering and reporting results from trials done in the past too. There’s no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients.”

Ben Goldacre, co-founder of AllTrials said: ”This is great news, and patients around the world should be grateful for the fantastic work that has been done on this by politicians in Europe. However we must remember that it only covers new trials, starting from 2014. The vast majority of medicines prescribed today came on the market 5, 10, or 20 years ago. This new law will do nothing to improve the evidence base for those treatments. We still cannot get all the results of all the trials on even the simplest everyday treatments, the antidepressants, the statins, the blood pressure treatments, and more. Those are the drugs that doctors are using right now, and will continue to use for at least a generation. Notably, the law would also do nothing to ensure that researchers and doctors can access all the results of trials on controversial drugs such as Tamiflu.

The campaign for access to trial results began over 20 years ago. Throughout the 1990s and 2000s, industry promised that everything had changed, and that everything had become more transparent. We now know that this wasn’t true. It is unacceptable that results from the 1990s and 2000s should continue to be withheld from doctors, researchers and patients. It is unacceptable to say that these trial results were allowed to somehow continue “disappearing”, even while some of the industry was publicly promising greater transparency. With their reckless belief that they could stonewall forever, too much of the industry have stored up a big problem for themselves, and for patients. We need the results of all trials, of all uses, of all the treatments we prescribe today. Without that, we cannot practice medicine safely and effectively.”

Mark Wilson, CEO, Cochrane Collaboration said: “Cochrane is delighted with today’s agreement on clinical trials transparency; a victory for patients, practitioners and policy-makers across Europe, and a clear and compelling message to decision-makers worldwide. The ratification of the agreement in 2014 will be a key milestone on the AllTrials journey to ‘all results reported’ becoming a reality.”

Sources:

European Parliament Press Release: Clinical trials: clearer rules, better protection for patients, 20-12-2013 – 12:09.

Related: Agreement reached in Europe on Clinical Trials Regulation, All Trials Registered | All Results Reported, 20 Dec 2013.

Our posts tagged AllTrials – Ben Goldacre – Clinical Trials – European Commission – European Union.

A Petition to for Full EU Lobby Transparency

Why is this important?

Full EU lobby transparency now
A petition on the Avaaz community

The Petition text:
Dear Mr Wieland Under the current voluntary EU lobby register, too many lobbyists conduct their lobbying secretively and unethically. This does citizens like me, and the public interest, a great disservice. I want to know who is trying to gain influence on EU politics, with what budget, on which issues and on whose behalf. This situation can only be delivered by the transition to a register in which all lobbyists conducting their work in Brussels have to register. It also needs a clear and enforceable ethics code and strong measures to support full transparency while the new register is introduced. As the European Parliament’s Vice-President for Transparency, it is vital that you stand up for lobbying transparency and implement the view of the majority of MEPs who supported the transition to a mandatory lobby register in their vote in May 2011.

Why this is important:
” …Lobbying works in Brussels, partly because it is able to operate in the shadows, and away from the glare of publicity. Thousands of lobbyists boycott the voluntary EU lobby register including virtually all law firms that lobby on behalf of industry clients. Many of the companies and organisations that do sign up, fail to provide comprehensive, accurate and up-to-date information on their activities. And unfortunately, the EU institutions seem happy to let this situation continue.

You can help to change this situation. Right now, the lobby register is being reviewed in a series of meetings (mostly held in secret) between the Commission and MEPs. In November, they will finalise their views and it is vital that we do not lose this unique opportunity to demand change… ”

Sources: Full EU lobby transparency now
created by Vicky C, ALTER-EU, on the Avaaz community.

Related posts:

The European Food Safety Authority’s Independence Problem

More than half of experts at the EU food safety authority have conflicts of interest

The European Food Safety Authority's independence problem
European Food Safety Authority says it’s “Committed to ensuring that Europe’s food is safe”

Almost 60% of experts sitting on the European Food Safety Authority’s (EFSA) panels have direct or indirect links with industries regulated by the agency, according to an independent screening performed by Corporate Europe Observatory (CEO) – an advocacy group that criticizes corporate influence on public policy – and Stéphane Horel – freelance journalist and documentarian.

The CEO October 2013 report identifies major loopholes in EFSA’s independence policy and finds that EFSA’s new rules for assessing its experts, implemented in 2012 after several conflicts of interest scandals, have failed to improve the situation.

The authors warn that this situation casts a severe doubt on the credibility of the scientific output of the key body responsible for food safety at the EU, with the agency issuing recommendations and risk assessments on crucial public health issues such as food additives, packaging, GMOs, contaminants and pesticides.

The main loophole identified in EFSA’s new rules for assessing its experts’ interests is that the agency’s assessment is too narrow, mainly looking at the panel’s specific remit to determine whether there are conflicts of interest. Instead it should consider experts’ wider conflicts of interest, in line with the agency’s broader mandate to guarantee its decisions remain independent from the industry it regulates. The current approach enables dozens of experts with multiple commercial interests (consultancy contracts, research funding, etc) to still be granted full membership of EFSA panels, including a majority of panel chairs and vice-chairs.

The CEO report also shows that EFSA failed to properly implement its own new rules in several instances, and that there is no visible difference between panels assembled under the new policy and those composed using the old policy.

Scientist with extensive Industry Ties quits the EU advisory Panel

Wolfgang Dekant and 16 others had collaborations with companies and industry trade groups

Scientist with extensive industry ties quits EU advisory panel
Prof. Dekant served as an expert for the European Commission for 13 years

Wolfgang Dekant, a German scientist critical of the European Union’s plan to regulate chemicals, with extensive financial ties to regulated industries has resigned from a key scientific committee of the European Commission.

Prof. Dekant, professor of toxicology at the University of Würzburg, was one of 18 scientists who authored a controversial editorial condemning a proposed regulatory policy for endocrine disruptors chemicals.
A September article by Stéphane Horel and Brian Bienkowski  – awarded by a Laurel – revealed that Wolfgang Dekant and 16 others had collaborations with companies and industry trade groups…

Read Scientist with extensive industry ties quits EU advisory panel, Stéphane Horel, Environmental Health News, 15 Oct 2013

Related post: When Scientists attack: a Laurel to Stephane Horel

When Scientists attack: a Laurel to Stephane Horel

Scientists critical of EU chemical policy found to have industry ties

Scientists critical of EU chemical policy have industry ties
Officials from the European Commission stressed that the best available science will guide their endocrine disruptor regulations

Alexis Sobel Fitts, Editor for CJR.org confirms Stéphane Horel and Brian Bienkowski deserve a laurel for their article investigating a group of scientists who authored a controversial editorial condemning a proposed regulatory policy for endocrine disruptors.
Indeed the two EHN reporters chronicled the scientists’ financial and political affiliations – weaving a comprehensive story of the influences behind science policy.

What is this about?
Seventeen scientists who have criticized plans in Europe to regulate endocrine-disrupting chemicals have past or current ties to regulated industries. An investigation by Environmental Health News reveals that of 18 toxicology journal editors who signed a controversial editorial, 17 have collaborated with the chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries. Some have received research funds from industry associations, while some have served as industry consultants or advisors. The stakes are high in the controversy because it involves the European Union’s strategy to regulate hormone-altering chemicals – the first attempt in the world to do so. The new rules would have sweeping, global ramifications because all companies that sell a variety of products in Europe would have to comply.