'My job involves giving children a sense of control over their environment'

Rob Beadel is employed by Buckinghamshire county council to develop policies and train school staff in dealing with vulnerable children. Photograph: Alamy

Name: Dr Rob Beadel

Age: 53

Job: Senior educational psychologist

Council: Buckinghamshire county council

What is an educational psychologist? Educational psychologists advise local authorities in developing policies around education, carry out psychological assessments on children and train school staff in dealing with vulnerable children. We also have a role supporting families throughout Buckinghamshire..

Describe a typical day in your job: What I do is very interesting because it is so varied. It can involve seeing children, or working with local authority policy and practice at quite a senior level.

What kind of children do you work with? Children with no school place, or those with complex behavioural difficulties or significant mental health conditions. We also work with schools to produce materials for children who move home a lot, such as those whose parents are in the military. Military children who have lost a parent because of war or injury would be a priority group for us.

How do you help them? People have to adapt to new environments and psychology can help us understand what that means and how best to do that. That's why we developed "my passport" – a booklet that children take with them when they move schools. They can fill out information in it about themselves and their family, giving staff a better understanding of their background and history. The idea is to increase the child's sense of control over their environment so they settle in quicker.

What other interesting projects have you worked on? I've been talking to health professionals about the possible impact of returning veterans who have experienced trauma or post traumatic stress disorder and the possible impact that will have on their children.

What are the biggest challenges you face in your job? I work with some extremely vulnerable children and families, which makes demands on you personally. I think the variety of the job is an advantage – it makes it interesting – but it requires a very wide skill set. It's also keeping up to date with psychological literature; we are expected to do that. I have just finished a four year doctorate that I was doing concurrently with my job.

How do cuts and the changes to education the government is bringing in affect you? One of the ways we have reacted is to develop our services to make money. Schools that have been turned into academies have more control over their budgets and they can buy additional services from us now, such as training. So we've actually recruited additional psychologists who work in a different way.

How do you lead your team? We have 35 psychologists, some part-time some full-time, and it's very much a collaborative approach. The psychology of interaction is a crucial part of what I do, and giving advice to people isn't always the right thing to do. It is about working as part of a team as opposed to telling people what you think they ought to do.

What made you decide to be a psychologist? I was a teacher originally. I spent over 10 years working in a school with children with challenging behaviour and I became curious as to why they behaved the way they did and the best ways to help them. I decided to do a degree in psychology, and that led me to where I am now.

What made you decide to work in local government? The core of it for me is around public service ethos. Where I'm more comfortable is working with children and families who have the highest needs and who are the most vulnerable. And working for a local authority allows me to work in policy development as well at various levels.

What advice would you give to aspiring educational psychologists? Do a properly recognised psychology degree and get some experience working with children and young people and their families in whatever context. I think that's quite a good career route.

Who inspires you? Aneurin Bevan with the National Health Service – that ethos of helping other people but having organisations and structures that can do that.

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Making Sense Of The Latest Twists In The Twenty-Year Agenus Saga

Biotech startups going after blockbusters always have the set up to be nail-biters, edge-of-your-seat type investments. So much so, in fact, that the latest installment of "phase 3 on verge of approval with cash running out" drama is almost run-of-the-mill, as we've heard it all before a hundred times. Agenus (AGEN), however has a 20-year history of tragicomedy and last minute saves on another level. The end of 2013 looks set to make the story either a skin-of-our-teeth success for the biotech history books, or else just another gaffe in a sorry Wall Street slapstick.

Oncophage to Prophage, Antigenics to Agenus, the botch ups of the early days

Taking this story from the beginning, Agenus, then Antigenics, had the good (or perhaps bad?) fortune of going public in February 2000, just one month before the Nasdaq peaked. It raised $66M in an IPO priced at $18 a share, cushioned its cash reserves to $109M, and watched its stock explode along with the rest of the Nasdaq until March 9 when it reached a split-adjusted close of $315. At the time it was developing a cancer vaccine called Oncophage for melanoma, its leading pipeline candidate and the source of most of its expenses of $42M (page 2) up to that point.

From there the tragicomedy that was Antigenics began.

(click to enlarge)

Having priced its IPO just one month before the last secular bull market in stocks ended, it had to first weather that catastrophe. Then for the next 6 years it kept on trudging along moving Oncophage down the clinical pipeline and into two phase 3 trials, one for melanoma and the other for kidney cancer. What happened during the melanoma trial in particular was a total farce. After receiving fast track designation together with orphan drug status and initiating the international phase 3 trial in 2002, the study did not even qualify as registrational because Antigenics could not manufacture the autologous vaccine for 30% of patients in the study, a whopping 40% if only the vaccine arm is counted. Of 215 patients assigned to the vaccine arm of the trial, only 133 even received vaccine. Sure enough, the trial failed, not only for these technical reasons, but because the trial was "underpowered to detect medically relevant endpoints" in the words of one of the researchers. After $225M (page 28) being spent on its development, Antigenics closed up shop on Oncophage, trying to figure out what to do next. For starters, the company changed its name to Agenus in an attempt to shed the past and start anew.

But the Oncophage story doesn't end there. As it turns out, when researchers looked deeper into patient subsets of the failed trials, they found that Oncophage actually had pretty good data for patients in earlier stage cancers. Unfortunately, that ship had sailed. Agenus did not have the cash or the credibility to raise it in order to launch a new phase 3 for earlier stage cancers. Investors were mad and tired and would not have taken lightly to shouldering the costs of yet another expensive Oncophage phase 3.

But as the saying goes, God does not close a door without opening a window. Just one month before AGEN's ignominious fall from grace on news of the Oncophage failure on March 23, 2006, the FDA received a filing from one Dr. Andrew Parsa on February 16 to conduct a phase 1/2 trial using Oncophage (technical name HSPPC-96) on patients with recurrent glioblastoma multiforme, the deadliest form of brain cancer.

Not only that, but Dr. Parsa secured funding from the National Cancer Institute in the amount of $21M (0.4% of the NCI's annual budget) to fund the trials, with Agenus retaining all the rights to Oncophage, a true have your cake and eat it too scenario. The only financial and technical responsibility assigned to Agenus regarding the new trials was to successfully manufacture the vaccine for each patient. Agenus took on the challenge, but not wanting to jinx itself with its previous failure to manufacture a whopping 40% of the required batches, the company changed the name of the vaccine to Prophage.

One scientific word about how Prophage functions before the story continues. Since the antigens in any one person's cancer are unique, there is no one-size-fits-all cancer antigen that can be targeted by a drug and attacked. Therefore, Prophage makes use of heat shock proteins [HSPs] that form complexes with a cancer's antigens. These complexes are then isolated in vitro from the patient's resected tumor, combined with vaccine, and reinjected. Think of HSPs like an antigen mold that fits the cancer like a glove.

Dr. Parsa's phase 2 trial is theoretically large enough at 222 patients to be registrational in and of itself, assuming positive results and Agenus successfully manufacturing the vaccine for all patients. Approval at phase 2 is rare but it does occur 15% of the time as recently happened with Onyx's (ONXX) now famous Kyprolis in a 250 patient phase 2 trial. Though I am not on the FDA board, I suspect incidence has a lot to do with whether a drug is approved after a large phase 2 trial or not. Kyprolis treats multiple myeloma with an incidence of 5.9 per 100,000, meaning 250 is a lot of patients to enroll for a disease so rare. The incidence of GBM is even less than that at 3 per 100,000 and GBM is much deadlier. Given that, this Prophage phase 2 trial is enrolling proportionally more patients to incidence than Kyprolis did.

Prophage for recurrent GBM already has interim results on 40 patients out of a planned 222 as of April reported as follows. Median overall survival for the vaccine arm was 47.6 weeks versus 32.8 control. Six month survival was 93% vs 68% control. There were reports of significant levels of tumor-specific killer T cells and natural killer cells in the vaccine group as well. And so far, there have been no adverse grade III or IV side effects. Data collection is ongoing as enrollment progresses since the trial is open label, and more should be published by the end of the year. One more important implication of these data is that - so far so good and keep your fingers crossed - Agenus is manufacturing Prophage successfully for each patient, a detail that should not be overlooked given the past.

What else has Agenus been up to since the Oncophage debacle?

The rescuing of Oncophage/Prophage from the dustbin of oncological history by Dr. Parsa is not the only encouraging news for Agenus of late. Keeping in line with its HSP approach to vaccines, HerpV is a genital herpes vaccine that uses HSP protein antigen complexes taken from the coat of infected cells. As all antigens of genital herpes are identical, this is an off-the-shelf rather than autologous product using synthetically manufactured genital herpes antigens.

Genital herpes is anything but a rare disease like GBM. It affects 60M Americans according to the CDC, and while it is not deadly, it is more than just a minor nuisance to those affected. HerpV is not designed to cure the disease as the herpes virus cannot be eradicated from the body since it encodes itself directly into a person's DNA after infection. What HerpV is designed to do is drastically lower if not eliminate viral shedding, basically symptomatic outbreaks that make the virus contagious. If that can be done, the virus cannot spread at easily upon sexual contact, if at all. Equally importantly, those who have the disease would not have to suffer the painful and embarrassing symptoms.

This phase II trial is fully enrolled at 75 and will test for viral shedding with swabs of the genital area before and after vaccine. Phase 2 data will be available in Q4 of this year. Phase 1 results showed activation of CD4+ and CD8+ T cells against the virus in the vaccine arm but not in the placebo arm. The phase 2 trial was fully enrolled in only 4 months at only 5 enrollment centers, so assuming positive results and initiation of phase 3, enrollment should be completed quickly. There are, after all, 60 million people to choose from.

HerpV is perhaps the most consequential pipeline candidate for Agenus, as the patient base is huge and the potential revenues are blockbuster. But HerpV is important for two other reasons. First, success would have positive implications for its HSP approach in vaccines, with good tidings for Prophage as well as significant investor attention. Secondly, HerpV employs Agenus' QS-21 Stimulon vaccine adjuvant, which itself is being employed in partnership with GlaxoSmithKline (GSK) in 4 trials phase 3 trials, 17 in total.

QS-21 Stimulon, Agenus' dessert Root Beer Float

A lot of attention is being given to QS-21 Stimulon lately, a vaccine adjuvant that is taken from the extract of the Quillaja saponaria tree, a compound also found in sarsaparilla, which provides the flavoring in root beer. This attention is due to Glaxo's MAGE A-3 vaccine for melanoma wrapping up a very large phase 3 trial for that disease at 1,349 patients as well as the largest trial ever conducted for non small cell lung cancer at 2,300 patients. Agenus is paying nothing for these trials and will instead receive a royalty of 4.5% on sales from Glaxo. Both of the vaccines attack the MAGE A-3 antigen that is expressed in 66% of melanomas and 35% of non small cell lung cancers. Learning from Agenus' prior failure with Prophage due to accepting late stage cancer patients, Glaxo only accepted early stage patients for both trials with a high level of MAGE A-3 expression.

Glaxo has indicated topline results will be available by next quarter for melanoma and Q1 2014 for NSCLC. As QS-21 is Agenus' "root beer float," it is important not to overemphasize the importance of these trials for the company. Royalties will be slow in coming, in addition to the fact that Agenus has signed away 20% of the 4.5% royalties to creditors in exchange for debt forgiveness. Success will not bring the company significantly closer to profitability, but it will give it plenty of attention as the first real success in a 20-year history of failure.

Glaxo's two other phase 3's that employ QS-21 are for malaria and herpes zoster, the former of which should have results by next quarter, but revenues will be a pittance at 1.6% after debt restructuring and the estimated cost of the vaccine will be $2 a shot for African babies. Success with malaria would, however, turn Glaxo and Agenus into biotech rockstars, as malaria takes more human life than any other infectious disease on the planet. Success won't be a financial panacea to the company, but it would be great for the human race.

In a sense, the financial impact of QS-21 has already been felt in providing Agenus with some much-needed breathing room by appeasing its creditors.

The cash picture and bottom line

Agenus has had an average cash burn rate of $7M over the last 4 quarters. With balance sheet cash at $13.5M, there is more than enough cash to bring the company through the QS-21 Stimulon results. The main importance, therefore, of QS-21 will be to help it finance at higher prices, which it will have to do soon anyway.

The only trials Agenus is fully funding are for HerpV. Otherwise, its expenses are mainly administrative and vaccine manufacturing for the Prophage trials. If MAGE A-3 fails, AGEN may be cut to half its value, but the money will eventually be raised to continue the manufacturing for Prophage and the HerpV program, where the real money for the company is. If MAGE A-3 succeeds, AGEN could double in value, though the resulting pop would quickly reach overbought levels as again, the Agenus' real potential value is in Prophage and HerpV, not QS-21, notwithstanding the fact that HerpV itself employs QS-21.

Bottom line, Agenus has come a long way since wasting away $225M on Oncophage and botching the manufacturing in its own phase 3 trial. It is now a much more mature company that has learned from its mistakes, and thanks to Dr. Andrew Parsa, the NCI, and Glaxo, it is still alive and kicking, much wiser for the wear, and has written down $29M of its long term debt (81% of its debt load) in one quarter using QS-21 as collateral.

2014 will mark the 20 year anniversary of Agenus' inception as a company. By then we will know the results of Glaxo's MAGE A-3 NSCLC and melanoma QS-21 vaccines, malaria, Prophage phase 2 (possibly registrational) and HerpV phase 2. That's a whole lot of nail biting over the next 3 quarters.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Hope for motion sickness victims: Key neurons identified that sense unexpected movement

Main Category: Neurology / Neuroscience
Also Included In: Public Health
Article Date: 30 Jul 2013 - 1:00 PDT Current ratings for:
Hope for motion sickness victims: Key neurons identified that sense unexpected movement

It happens to all of us at least once each winter in Montreal. You're walking on the sidewalk and before you know it you are slipping on a patch of ice hidden under a dusting of snow. Sometimes you fall. Surprisingly often you manage to recover your balance and walk away unscathed. McGill researchers now understand what's going on in the brain when you manage to recover your balance in these situations. And it is not just a matter of good luck.

Prof. Kathleen Cullen and her PhD student Jess Brooks of the Dept of Physiology have been able to identify a distinct and surprisingly small cluster of cells deep within the brain that react within milliseconds to readjust our movements when something unexpected happens, whether it is slipping on ice or hitting a rock when skiing. What is astounding is that each individual neuron in this tiny region that is smaller than a pin's head displays the ability to predict and selectively respond to unexpected motion.

This finding both overturns current theories about how we learn to maintain our balance as we move through the world, and also has significant implications for understanding the neural basis of motion sickness.

Scientists have theorized for some time that we fine-tune our movements and maintain our balance, thanks to a neural library of expected motions that we gain through "sensory conflicts" and errors. "Sensory conflicts" occur when there is a mismatch between what we think will happen as we move through the world and the sometimes contradictory information that our senses provide to us about our movements.

This kind of "sensory conflict" may occur when our bodies detect motion that our eyes cannot see (such as during plane, ocean or car travel), or when our eyes perceive motion that our bodies cannot detect (such as during an IMAX film, when the camera swoops at high speed over the edge of steep cliffs and deep into gorges and valleys while our bodies remain sitting still). These "sensory conflicts" are also responsible for the feelings of vertigo and nausea that are associated with motion sickness.

But while the areas of the brain involved in estimating spatial orientation have been identified for some time, until now, no one has been able to either show that distinct neurons signaling "sensory conflicts" existed, nor demonstrate exactly how they work. "We've known for some time that the cerebellum is the part of the brain that takes in sensory information and then causes us to move or react in appropriate ways," says Prof. Cullen. "But what's really exciting is that for the first time we show very clearly how the cerebellum selectively encodes unexpected motion, to then send our body messages that help us maintain our balance. That it is such a very exact neural calculation is exciting and unexpected."

By demonstrating that these "sensory conflict" neurons both exist and function by making choices "on the fly" about which sensory information to respond to, Cullen and her team have made a significant advance in our understanding of how the brain works to keep our bodies in balance as we move about.

The research was done by recording brain activity in macaque monkeys who were engaged in performing specific tasks while at the same time being unexpectedly moved around by flight-simulator style equipment.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our neurology / neuroscience section for the latest news on this subject.

To read the full paper in Current Biology click here.

The research was funded by the Fonds de Recherche du Québec Nature et Technologies and Canadian Institutes of Health Research as well as through a National Institutes of Health grant.

McGill University

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People likely to safeguard common goods when they trust in leaders, have a sense of belonging

Main Category: Psychology / Psychiatry
Also Included In: Public Health
Article Date: 28 Jul 2013 - 0:00 PDT Current ratings for:
People likely to safeguard common goods when they trust in leaders, have a sense of belonging

Every day, people donate to charities, volunteer to clean up city parks, or scale back their driving to curb air pollution. But some take these public goods for granted and ride free on the efforts of others. They watch public television but never make a donation to fund it. Or they run their lawn sprinklers during a drought while their neighbors follow government pleas to limit water consumption.

A new report in Psychological Science in the Public Interest, a journal of the Association for Psychological Science, examines more than 25 years' worth of studies on the use and support of public goods ranging from radio broadcasts to drinking water. Psychological researcher Craig Parks (Washington State University, Pullman) and his co-authors emphasize the urgent need to broaden thoughtful use of public goods, noting that charitable contributions are at historic lows, fossil fuel reserves are shrinking, and climate change threatens the planet's future.

In the report, the researchers discuss a variety of scientific findings on conditions that foster cooperative use of common resources, including:

Strong group identity

People are more likely to act cooperatively when they have a strong sense of belonging to a collective. A 2003 European study showed that fishermen who were strongly connected in their communities were more judicious with fishing stocks than were their counterparts in more loosely connected communities.

Smaller community size

Cooperation is likely to be stronger in smaller groups, particularly when one's contribution is easily identified. Psychological research suggests that cooperation decreases in large groups because people feel less influential, less identifiable, and less responsible for the group's welfare.

High trust in leaders

Citizens are more willing to help out in urgent situations when their government leaders act in transparent and trustworthy ways. A study of people's behavior during a 1991 water shortage in California showed that residents exercised more constraint on their water consumption if they felt local authorities were rationing water fairly.

The article also cites factors that lead to incongruous use of resources, including:

Intergroup conflicts

People often try to prevent those in an opposing group from benefiting from a good or resource in order to advance their own groups' interests. Parks and his co-authors cite as an example the 2011 debate in the U.S. Congress over the nation's debt ceiling. The Obama administration wanted to raise the debt ceiling to support such public goods as Social Security and the military. Republicans who fought the increase drew anger from many Americans, but in doing so helped enhance the GOP's reputation as a party of fiscal watchdogs.

Ideology/values

Individuals may withhold support for a public good that they see as useless or objectionable. Examples of this are environmentalists who fight a highway expansion, or political conservatives who reject public radio as too left-leaning.

Cognitive disconnection

Threats to some common resources are so vast or abstract that people struggle to comprehend the consequences. The most salient example is people's struggle to envision the impact that climate change will have on future generations.

Parks and his colleagues propose some policy steps that could promote better care of public resources. Research shows, for example, that people tend to act for the benefit of those who are powerless or helpless. Framing future generations in that light (e.g., talking about the more-hostile climate that we stand to leave for our great-grandchildren) can spark people today to be more diligent about reducing their carbon footprint, they suggest.

The researchers also argue that policymakers, in promoting optimal use of public goods, must concentrate on building the public's trust in order to garner cooperation.

"Sincere and concerted attempts to collect public input and a general 'let's work together' approach will do much to enhance group identity," they write. "Toleration of a certain amount of deviation from policy, at least in the early stages of implementation, will show that policy makers are forgiving. And last, a policy that gives citizens more than they might have expected - a more well-developed public good and broader access to it - will convey an image of generosity."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our psychology / psychiatry section for the latest news on this subject.

Co-authors on the article are Jeff Joireman of Washington State University, Pullman, and Paul A.M. Van Lange of Vrije Universiteit, Amsterdam.

Association for Psychological Science

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'People likely to safeguard common goods when they trust in leaders, have a sense of belonging'

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