J&J Janssen Pharmaceuticals loses first Risperdal jury trial

Gynecomastia, enlargement of breast tissue in males, was an adverse effect of using the antipsychotic drug Risperdal

risperdal drug image
Gynecomastia, enlargement of breast tissue in males, was an adverse effect of using the antipsychotic drug Risperdal.

After a trial that lasted almost a month, the 12-member Philadelphia jury in the Austin Pledger – the plaintiff in the case – v. Johnson & Johnson Janssen Pharmaceuticals, ordered J&J to pay $2.5 million to the 20-year-old autistic man from Alabama who developed 46DD breasts while taking the Risperdal antipsychotic drug.

Austin Pledger took Risperdal to assist with behavioral symptoms related to autism and claimed to have developed gynecomastia from taking the drug. The young man argued that J&J knew for years that the drug could cause gynecomastia, but kept the data to itself rather than telling the FDA. The agency added a warning about the condition to Risperdal’s official label in 2006, four years after this trial plaintiff started taking the drug in 2002.

Austin Pledger’s lawsuit is the first of more than 1,000 similar cases pending over Risperdal’s breast-growth side effects.

Sources and more information
  • Man, 20, awarded $2.5M in damages after drug gave him breasts, philly, February 25, 2015.
  • Johnson & Johnson loses first Risperdal jury trial, philly, February 25, 2015.

Fear and loathing in modern medicine

Vaccination Nation Infographic

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Infographic: Vaccination Nation. Image via: Good.
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Why the EU Lobby Register still fails to deliver

EU lobby register: still failing to deliver real transparency

EU-Lobby-Register-still-fail image
New ALTER-EU report shows why the current EU lobby register is still failing to deliver real transparency. Some of the main groups actively lobbying the EU institutions did not register and too many of the register’s entries are not reliable.

This new research published January 27, 2015 by the Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), shows how the voluntary approach to EU lobby transparency regulation fails to provide citizens with an accurate picture of the lobby scene in Brussels. Some of the main groups that are actively lobbying the EU institutions have still not registered in the EU’s Transparency Register. These include:

  • Financial lobbyists such as Standard & Poors, City of London Corporation and Credit Suisse;
  • Lobby consultancies, such as EUTOP Brussels;
  • Law firms such as Covington & Burling and Freshfields Bruckhaus Deringer;
  • Major corporations such as Electrabel, Anglo American and General Motors.

Meanwhile, too many of the register’s entries are unreliable: lobby firms and law firms fail to disclose clients – which is a clear breach of the rules for the register – or they mask their identities behind meaningless acronyms. In addition lobby spending and lobbyist numbers are often under-reported, and there are far too many implausible entries. For example:

  • Google and Novartis list more European Parliament entry passes than the total number of lobbyists they say they employ, which cannot be correct according to the register rules.
  • Goldman Sachs and Honeywell under-report their lobby expenditures as the amounts they declare are less than the amounts they have paid to lobby consultancies.
  • Meanwhile, some entries are simply absurd: BearingPoint, a professional consultancy, states that its lobby turnover is a staggering €552,795,000! [Addendum 28-01-2015: Since this report was published, BearingPoint has contacted us to clarify that the figure declared in its register entry was not, in fact, its lobbying expenses, but rather its annual turnover. Whilst this is an easy mistake to make, this example shows that there is a lack of proactive checking by the Transparency Register Secretariat that the entries are accurate and credible.]

The European Parliament, alongside transparency campaigners including ALTER-EU, have long demanded a tougher approach to EU lobby regulation. It is now time for the European Commission to take up this challenge. The revamped register currently being launched, will not significantly improve the accuracy of the lobby data (as outlined in this report) and will not enable any interested person to really know who is lobbying whom, and how much is being spent on lobbying in Brussels  – surely the key tests of any proper transparency register. Despite numerous commitments to improve the poor quality of information in the register, too little has happened and even the most obvious absurd entries have not been corrected.

The Juncker Commission is now proposing to introduce a so-called mandatory lobby register via an inter-institutional agreement. This is very misleading, as such an inter-institutional agreement would not be binding on lobbyists and thus not properly mandatory.

What is needed is a proposal for EU legislation to introduce a legally-binding EU lobby register, which would ensure that lobbyists are obliged to be fully open and honest about all their lobbying activities. This would allow the register secretariat to investigate incorrect and misleading entries, and ensure that effective sanctions can be applied in cases of breaches of the register rules. That is the only way to ensure that we know who is influencing the decisions coming out of Brussels, which affect EU citizens’ daily lives.

Sources and more information

ALTER-EU Europe’s campaign for lobbying transparencyALTER-EU Europe’s campaign for lobbying transparency
  • EU lobby register: still failing to deliver real transparency, press-releases and PDF January 27, 2015.
  • New and Improved? Why the EU Lobby Register still fails to deliver, press-releases and PDF January 27, 2015.

Cellular and molecular effects of developmental exposure to DES: implications for other environmental estrogens

Exogenous estrogen exposure during critical stages of development can result in permanent cellular and molecular alterations in the exposed organism

This 1995 study found that low doses of DES demonstrate alterations in both male and female exposed offspring

1995 Study Abstract

Concerns have been raised regarding the role of environmental and dietary estrogens as possible contributors to an increased incidence of various abnormalities in estrogen-target tissues of both sexes. These abnormalities include breast cancer, endometriosis, fibroids, and uterine adenocarcinoma in females, as well as alterations in sex differentiation, decreased sperm concentrations, benign prostatic hyperplasia, prostatic cancer, testicular cancer, and reproductive problems in males. Whether these concerns are valid remains to be determined; however, studies with the potent synthetic estrogen diethylstilbestrol (DES) suggest that exogenous estrogen exposure during critical stages of development can result in permanent cellular and molecular alterations in the exposed organism. These alterations manifest themselves in the female and male as structural, functional, or long-term pathological changes including neoplasia. Although DES has potent estrogenic activity, it may be used as a model compound to study the effects of weaker environmental estrogens, many of which may fit into the category of endocrine disruptors.

Conclusions

There are many possible cellular and molecular mechanisms that may be involved in the toxic response to DES and other environmental estrogens if an organism is exposed during critical stages of development. Several mechanisms have been discussed in this report. Studies with the developmentally DES-exposed murine model have duplicated and predicted many of the lesions seen in similarly DES-exposed humans and in the wildlife population. Currently, there is increased interest in the effects of other environmental estrogens and antiandrogens on reproductive tract differentiation and development. Whether these compounds have effects similar to DES is uncertain, but since low doses of DES demonstrate alterations in both male and female exposed offspring, the possibility of adverse effects from other compounds with estrogenic and/or antiandrogenic activity must be considered.

Sources and Full Study
  • Cellular and molecular effects of developmental exposure to diethylstilbestrol: implications for other environmental estrogens, Newbold R, Environ Health Perspect. 1995 Oct;103 Suppl 7:83-7. PMID: 8593881.
  • Full study, Environ Health Perspect. 1995 Oct; 103(Suppl 7): 83–87, PMC1518878, 1995 Oct.
More DES DiEthylStilbestrol Resources

Three-People IVF: Mother’s Day Card

In the UK, MPs are clearing the way for three-parent babies…

Three-Person-IVF-cartoon
MPs clear the way for three-parent babies: Commons in historic vote despite opposition from church leaders.
Watch @DES_Journal diaporama and health cartoons album on Flickr. Image via: DailyMail.
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Baby formula can pose high arsenic risk to newborns, much more than breast milk

Arsenic in Well Water Can Raise Level in Baby Formula

In the first U.S. study of urinary arsenic in babies, Dartmouth College researchers found that formula-fed infants had higher arsenic levels than breast-fed infants, and that breast milk itself contained very low arsenic concentrations.

baby image
In the first US study of urinary arsenic in babies, Dartmouth College researchers found that formula-fed infants had higher arsenic levels than breast-fed infants, and that breast milk itself contained very low arsenic concentrations.

2015 Study Abstract

Background:
Previous studies indicate that breast milk arsenic concentrations are relatively low even in areas with high drinking water arsenic. However, it is uncertain whether breastfeeding leads to reduced infant exposure to arsenic in regions with lower arsenic concentrations.
Objective: We estimated the relative contributions of breast milk and formula to arsenic exposure during early infancy in a U.S. population.

Methods:
We measured arsenic in home tap water (n=874), urine from six-week-old infants (n=72), and breast milk from mothers (n=9) enrolled in the New Hampshire Birth Cohort Study (NHBCS) using inductively coupled plasma mass spectrometry. Using data from a three-day food diary, we compared urinary arsenic across infant feeding types and developed predictive exposure models to estimate daily arsenic intake from breast milk and formula.

Results:
Urinary arsenic concentrations were generally low (median 0.17 µg/L, maximum 3.0 µg/L) but 7.5 times higher for infants fed exclusively with formula than for infants fed exclusively with breast milk (β = 2.02; 95% CI: 1.21, 2.83; P<0.0001, adjusted for specific gravity). Similarly, the median estimated daily arsenic intake by NHBCS infants was 5.5 times higher for formula-fed infants (0.04 µg/kg/d) compared to breastfed infants (0.22 µg/kg/d). Given median arsenic concentrations measured in NHBCS tap water and previously published for formula powder, formula powder was estimated to account for ~70% of median exposure among formula-fed NHBCS infants.

Conclusions:
Our findings suggest that breastfed infants have lower arsenic exposure than formula-fed infants, and that both formula powder and drinking water can be sources of exposure for U.S. infants.

Sources and more information
  • Estimated Exposure to Arsenic in Breastfed and Formula-Fed Infants in a United States Cohort, Environ Health Perspect; DOI:10.1289/ehp.1408789, and full PDF.
  • Baby formula poses higher arsenic risk to newborns than breast milk, Dartmouth study shows, DARTMOUTH COLLEG, 23-FEB-2015.
  • Arsenic in Well Water Can Raise Level in Baby Formula: Study, health, February 23, 2015.

Feb 28 is Rare Disease Day! RDD2015 official video

Raise awareness about DES during Rare Disease Day!

#RDD2015 official video by @rarediseaseday for #RareDisease awareness

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Raise awareness about DES during Rare Disease Day ! Use tags #RDD2015 #RareDisease #RareDiseaseDay .

The main objective of Rare Disease Day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives.

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Is DES a rare disease? How much do you know about DES?

Health NGO: Endocrine disruptors are one of the biggest public health threats of this century

Génon K. Jensen, Director of HEAL, answers questions posed by Henriette Jacobsen, EurActiv

Content on this post is produced by EurActiv.com
Génon K. Jensen, director of the not-for-profit organisation Health and Environment Alliance (HEAL), answered questions by EurActiv‘s Henriette Jacobsen.

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Although hormone-disrupting chemicals are recognised as a global public health threat by the World Health Organization (WHO), the European Commission’s public consultation on the matter, is only meant to delay action and regulation, argues Génon K. Jensen.

What does HEAL think of the concept of the Commission’s endocrine disruptors consultation?

The consultation is only one part of a larger impact assessment process, which has been introduced to delay action on endocrine-disrupting chemicals to protect public health.

HEAL believes it to be strange to hold a public consultation, and even an impact assessment, on the scientific criteria for the identification of endocrine disruptors when the Commission has spent years obtaining scientific work and advice on this subject: for example, the Kortenkamp report contracted by the Commission; the two-year long Expert Advisory Group on endocrine disrupting chemicals, which included member state experts, NGO experts and industry experts, and which resulted in a report by the EU’s own Joint Research Centre; and even the European Food Safety Authority’s (EFSA) opinion.

The fact that we are having an impact assessment at all is already testament to the influence the pesticides and chemicals industry have on the Commission.

It was already democratically agreed by 28 member states in 2009 and 2011 through the Parliament and the Council to remove these endocrine-disrupting pesticides and biocides, because of the risks of diseases and environmental problems generated by these products, which are widely dispersed and end up in our food, air, water and bodies. The laws agreed foresee exemptions to these bans when, for example, there is a serious danger to plant health.

So a broad agreement has been reached, but it seems the pesticides and chemical industries deliberately ignore it and keep fighting the same old battle.

What are your views on endocrine disruptors? Have you made your views heard during the consultation?

Endocrine disruptors are one of the biggest public health threats of this and possibly the next centuries, maybe on par with global climate destabilisation. The World Health Organization (WHO) and UNEP say they are a global threat to health and the environment that needs to be resolved as soon as possible.

We believe that systematically reducing exposures to endocrine-disrupting chemicals provides a massive opportunity to prevent many chronic diseases, such as hormonal cancers (of breast, prostate, and testicles), diabetes and obesity, learning disabilities and attention deficit disorder, and fertility problems. So it’s imperative that all endocrine-disrupting chemicals are properly identified. To this end, we believe the WHO definition, in combination with three categories that rank the endocrine disrupting chemicals according to the strength of the scientific evidence, is the single best way to proceed. It’s the same way that we identify chemicals that cause cancer, gene mutations or that are toxic to reproduction.

With respect to the different regulatory approaches in the consultation, HEAL does not think that making post-jure changes to the democratically agreed existing pesticides and biocides laws, which already allow for exceptions in case of need, is acceptable. Firstly, because the changes being considered would not be subject to a fully democratic legislative process, the way the pesticides and biocides laws were decided, and secondly because either of the two options (B or C) would essentially build a different escape hatch for hormone disrupting pesticides and biocides, which we had already, as a society, agreed must be phased out – unless they qualify for the already agreed exemptions built into the laws!

We have made our views known on the criteria, and insofar as the slanted format of the consultation allowed it, on the importance of the societal, environmental and health benefits that would come from properly identifying endocrine disrupting chemicals and proceeding with their phase out as agreed in the 2009 and 2011 laws.

HEAL and many other NGOs in the endocrine-disrupting chemicals-free Europe coalition, known as “EDC-Free Europe”, have facilitated the voices of a large number of citizens across Europe on this. So far over 18,000 people have also asked for use the three categories with the WHO definition, and for no change in the existing laws and exemptions.

What do you expect will come out of the Commission’s consultation?

We hope that the Commission will not be able to deny the political significance of (so far) over 18,000 people who have used our online platform to say it’s time to stop hormone disrupting chemicals from contaminating our environment and harming our health.

In the past, industry has greatly exaggerated the costs to their business, using models that are too static and limited. The agricultural industry has miscalculated the impact on farming yields by using bogus baselines, ignored or underestimated the benefits of adaptation, and so on. This has been detailed in the new report Predicted costs by industry in the face of new environmental regulations.

The Commission should conclude that we must systematically reduce our exposures to endocrine disrupting chemicals and phase out their uses – something which will help prevent cancer, diabetes, obesity and infertility and can be an enormous catalyst for innovation and improvement because it will stimulate safer, healthier products and environments.

How many endocrine disrupting substances are a priority to you?

All those that are contaminating our bodies, our babies before birth, our breast milk and our environment.

HEAL supported and participated in the WWF human biomonitoring of three generations in Europe in 2005, and they found an average of at least 73 synthetic chemicals in the bodies of those tested. In the US, biomonitoring has found an average of 200 chemicals and contaminants already in newborns. Not all may be endocrine-disrupting chemicals, even though they are still hazardous and may interact with endocrine-disrupting chemicals to exert cocktail effects.

Commission First Vice-President Frans Timmermans is also in charge of ‘better regulation’ and cutting red tape. Do you fear that regulation on endocrine disruptors could be one of the areas that he would consider scrapping?

Junker and Timmermans have stressed many times that they want the Commission to make a fresh start and bring the EU closer to citizens again.

Protection against exposure to endocrine disruptors is a key issue for people all over Europe. Consider for example the thousands of people in Germany using an app to detect endocrine disrupting chemicals in consumer products, the pregnant women in Denmark who consult a guide on endocrine-disrupting chemicals and how to avoid them, and the huge numbers of others throughout Europe who feel it necessary to empty food from plastic packaging before heating or microwaving.

The Parliament has made it abundantly clear they’re expecting the EU to act to reduce harm from endocrine disrupting chemicals. in December, nine EU member states – including Denmark, Germany, France and others – launched an initiative to urge the Commission to act. Several member states are frontrunners in adopting laws to phase out endocrine-disrupting chemicals in products.

Surely Timmermans doesn’t want to ignore all these concerns?

In addition, a recent assessment on cutting red tape in Europe by the High Level Group on Administrative Burdens found that environmental regulation accounts for less than 1% of the total administrative burden, with regulations in the areas of taxation/customs and annual accounts having a much higher toll.

We therefore hope that Timmermans will share our view that regulation on endocrine-disrupting chemicals is not only crucial to protect public health but also can actually be a driver for innovation towards less harmful chemicals. After all, he is also in charge of sustainable development in the EU. ”  – 16/01/2015.

Cancer Research UK: at the forefront of developing new drugs

“We are unique. No other charity does anything like this”

Content on this post is produced by Cancer Research UK

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Dr Nigel Blackburn explains how CRUK takes risks that industry won’t, making it an exciting place for those who want to beat cancer with science : ‘We are unique. No other charity does anything like this.’ Photograph: @CR_UK

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives, and the second biggest funder of cancer research worldwide. In the last 40 years, we’ve helped double the cancer survival rate so that now, two in four people survive their disease. But this is only the beginning. We have now set ourselves a target that within 20 years, three in four people will beat cancer.

If we are to achieve this goal, then new, more effective treatments are required. This is why we are working to accelerate the development of novel therapies, bringing them to patients as quickly as possible.

Dr Nigel Blackburn leads Cancer Research UK’s Centre for Drug Development (CDD), a centre of excellence in early phase cancer drug development, focusing on novel technologies that wouldn’t progress without the charity’s support.

We are unique,” says Blackburn. “No other charity does anything like this; we are the only charitably funded drug development group in the world – and that’s an exciting place to be.”

Industry is naturally driven by the market, and is therefore risk adverse. Because we are free of this profit burden we get to be more innovative, we can try new things and take more risks, and so the rewards are potentially greater. The ideal project for CDD will be one that is first in class, first in man, novel – in short we want exciting science. If you love drug development and are interested in oncology, this is a great place to be.”

With a portfolio of 28 projects, CDD’s cancer portfolio ranks alongside those of the top five pharmaceutical companies in terms of cancer drugs in development. These drugs range from small molecules, immunologicals and cell therapies through to imaging agents and vaccines.

Blackburn adds: “At the moment we are working on the world’s first therapeutic IgE antibody, called MOV18. Originally no companies were interested in this as it was deemed too new, too risky. But now we are showing that it is viable, several companies are interested in licensing it. As another example, we are also developing a chimeric antigen receptor (CAR) immunotherapy which will be the third ever CAR trial in the UK (and CDD will have run two of them). Being a charity we can be brave and take risks that no one else will. And if it one day results in new treatments that might give more people more time with their families, then that is a fantastic result.”

As part of Cancer Research UK’s new strategy, CDD is expanding, aiming to increase its portfolio to around 35 projects. These are sourced from both industry and academia, picking up on good projects that are not being taken forward, either because of a lack of funding, being outside a company’s strategic priorities, or deemed too novel for pharma giants to adopt.

We recently took on a cancer vaccine called IMA950 from a small German biotech,” says Blackburn. “They lacked the resources to carry out phase one trials on a glioblastoma treatment, so we ran it for them. After successfully meeting all our end points, the biotech company were in a place to buy the data back from us and continue its trials. Should the drug progress, not only will we receive milestones payments and royalties, but most importantly we will have helped a potential life-saving therapy to reach the people who need it. Without our work this vaccine may have remained on the shelf indefinitely.”

As well as carrying out early stage trials, CDD also runs Combinations Alliance, a matchmaking service for investigators seeking novel drug combinations. “Here, we don’t fund trials,” explains Blackburn. “Industry partners open up their portfolios of phase 2 and 3 drugs, and we act like a dating agency, providing the framework, resources and knowledge to help partners find potentially exciting new matches. We also offer preclinical funding to help investigators acquire the data they need to carry out a new combination trial. This service could really help advance cancer therapy, and is only possible because we are a charity.

He adds: “We are now recruiting for new researchers for our team. As we typically focus on smaller, phase one projects, our researchers get to work on five, six, even seven projects, all with different modalities. There is an incredible breadth of research here. If you are interested in becoming an expert in oncology, in working on novel and exciting science, and in helping to beat cancer, then there is nowhere better to work.”

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