Acadia Stock Report: Business Overview And Revenue Projection

Investment Summary

Acadia Pharmaceuticals (ACAD) is a mid-cap biopharmaceutical company focusing on the development of drugs for neurological and central nervous system disorders. Its stock is currently trading at $23.5 (as of 9/18/13), placing its market cap at $2B.

Acadia's leading drug candidate, pimavanserin, is in Phase III development as a potential first-in-class drug for Pakinson's disease psychosis (PDP). Pimavanserin is a small molecular inhibitor of the serotonin receptor 5-HT2A and has potential applications for psychosis in patients with other neurological diseases, including Alzheimer's and schizophrenia. Acadia plans to file for a new drug application (NDA) for FDA approval toward the end of 2014 for Pimavanserin for Parkinson's disease. If approved, the drug could be in the market by 2015.

The company has had a long-term partnership with Allergan (AGN) to co-develop treatments for chronic pain and glaucoma. The drug candidates are based on alpha-adrenergic receptor agonists and muscarinic agonists discovered at Acadia. The alpha-adrenergic receptor agonist program is in Phase II. Allergan is looking for a partner to conduct Phase III trials. Acadia's R&D pipeline also includes a preclinical program developing inhibitors for ER-Beta and Nurr-1.

In this report, we will address the following questions. First, what is the probability of pimavanaserin approval by the FDA based on its clinical trial results? How big is the market for psychosis and the neurological space? Who are the competitors for Acadia's product?

Second, Acadia has a partnership with Allergan to develop pain-related products. Does the partnership sufficiently pay for the development costs? Or will Acadia need to raise more money through public or private capital markets? More equity offerings will certainly dilute existing shareholders' holdings.

Finally, we will review ACAD's financial status, forecast its revenues and earnings for the next 5 years and derive an intrinsic value for the stock.

This report contains three parts. Part 1 is an overview of ACAD's business model, its key products, and risk factors associated with the company. In Part 2, we will review its partnership agreements with Allergan and point out relevant royalty payments and liabilities that ACAD will incur. A 5-year revenue projection for ACAD will be presented. In Part 3, we will analyze its financials and derive an intrinsic value for ACAD. Our analysis suggests that the intrinsic value for ACAD is ~$31.

Part1: Business Overview

Acadia Pharmaceuticals is a mid-cap biopharmaceutical company that develops serotonin receptor inhibitors with applications for psychosis in patients with neurological diseases, including Parkinson's disease, Alzheimer's disease and schizophrenia. The company currently has a market cap of ~$2.1B with a stock price of $23.5 per share and about 83 million weighted average shares outstanding.

Its leading drug candidate is pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson's disease psychosis (ACAD 10K 2012). Acadia plans to file an NDA toward the end of 2014 for Pimavanserin for Parkinson's disease. Pimavanserin also has potential application for the treatment of psychosis associated with Alzheimer's and schizophrenia.

The company has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. These programs are based on alpha-adrenergic receptor and muscarinic agonists discovered at Acadia.

Key issues

When evaluating a company like ACAD, we need to consider several key issues (or potential risk factors) uniquely associated with the company.

First and foremost, what are the future growth rates for its product revenues and product royalty revenues paid by its corporate partners? When will the company turn profitable? What is the competitive landscape for its drugs? Obviously, the company's profitability is closely tied to its drug sales. ACAD has collaborated with Allergan to develop drugs for chronic pain and glaucoma. How much in milestone payments and royalty from sales will Acadia expect to receive over the next 5 years?

A second issue is related to the expansion of its clinical trials on various fronts. While the company intends to expand its drug franchises to as many indications as possible, there are significant costs associated with each clinical trial. Does the company make wise investments on this front? What is a likelihood of success for these trials? We will review its late-stage clinical programs.

A third issue is related to the company's financial strength or weakness. Due to mostly non-profitable quarters in the past, ACAD's accumulated deficit is $382M as of June 30, 2013 (ACAD 10Q2013). With over $564M additional paid-in capital, Shareholder equity is $181M as of June 2013. In the financial projection section, we will discuss when the company will turn profitable.

As of June 2013, ACAD had $205M cash and cash-equivalent securities. It has no long-term debt nor convertible notes. However, the company has continuously funded its development through stock offerings in both private and public capital markets. These activities have led to significant expansion of stock shares and dilution of shareholders' equity for years. Going forward, the company will need to raise additional funds for Phase III trials in schizophrenia and Phase II trials in Alzheimer's associated psychosis (ADP). It is inevitable that further stock offerings are anticipated. We will discuss the impact of its equity offerings during stock valuation.

Part 2: Product Sales and Revenues from Partnership Agreements

Pimavanserin

Pimavanserin is an inhibitor of the serotonin receptor (5-HT2A), and is currently in Phase III clinical development for Parkinson's disease psychosis. At present, there is no drug approved for PDP. Therefore, pimavanserin could be the first drug approved for this indication. It is estimated that 60% of patients with Parkinson's disease have psychosis that require medical assistance. The potential market for PDP is estimated to be $1B.

Acadia announced pimavanserin Phase III data in March 2013 (Pimavaserine phase III data March2013). The data indicated that the drug is safe and well-tolerated. In addition, it reached statistical significance when meeting primary and secondary endpoints, which include improved motor control and sleep, and reduced delusions and hallucinations. Based on the data, Acadia received a green light from the FDA to file for a new drug application (NDA) for the treatment of PDP scheduled at the end of 2014 (Pimavaserin expediated NDA filing April2013). The expedited progress means that Acadia does not need to conduct an expanded phase III trial, thus speeding up commercialization of the drug to market by 2015.

Psychosis is also frequently associated with other neurological disorders, including schizophrenia and Alzheimer's disease patients. The combined market for antipsychotic medicines was estimated at $28B in 2011, so there is a large unmet need in this space (ACAD 10K 2012).

Therefore, Acadia's strategy is to further expand the potential use of pimavaserin to these indications. The company is currently conducting pimavaserin Phase II clinical trials for schizophrenia (Pimavanserin with risperidone schizophrenia Phase II data 2012). The published Phase II indicated that pimavaserin co-treatment with current anti-psychotic medicine (risperidone) enhanced efficacy and reduced side effects associated with existing medicine. Acadia is considering further studies (Phase III) to pursue this indication, but has not specified whether the company will go alone or seek a corporate partner.

About 20%-50% of patients with Alzheimer's disease suffer from psychosis. Acadia plans to initiate Phase II trials for ADP by 2H 2013. There are around 5 million people with Alzheimer's disease in the United States alone. So, the potential market for ADP is ~$3B.

The competition in the anti-psychotic (PDP and ADP) markets includes Seroquel marketed by AstraZeneca (AZN) and the generic drug clozapine. These drugs are used off-label as they are not officially approved in the US for PDP and ADP.

For schizophrenia, competition includes Zyprexa made by Eli Lilly (LLY), Risperdal by Johnson & Johnson (JNJ) and Ability by Bristol-Myers-Squibb (BMY). The first two drugs are already generic.

We estimate that pimavaserin sales will be about $100M (2015), $200M (2016), and $360M (2017). With an 80% probability of approval, the revenues for Acadia are estimated to be $80M (2015), $160M (2016) and $288M (2017). The slow ramp-up of sales reflects that Acadia is a small company without an existing sales force. In addition, the sales numbers account for the PDP indication only, because an expansion of pimavaserin to ADP and schizophrenia will require completion of Phase III trials and approval of the drug for these indications, which is unlikely to happen before 2017.

Alpha Adrenergic Agonist

Acadia is collaborating with Allergan to develop drugs (alpha adrenergic agonist) for the treatment of chronic pain. Allergan reported preliminary proof-of-concept data in Phase II for visceral pain, fibromyalgia and irritable bowel syndrome. Further studies in Phase III will be needed before regulatory approval and commercialization. Acadia did not disclose the royalty rate that Allergan will pay to Acadia under the partnership agreement. We estimate that it is around 10%-25% of net sales, based on comparable transactions in the industry.

Chronic pain treatment has a big market but also many players. For chronic pain treatment, competition includes Lyrica and Neurontin marketed by Pfizer (PFE) and Cymbalta by LLY. Lyrica and Cymbalta have sales of $4.2B and $5B in 2012, respectively.

Assuming Allergan completes Phase III in 2014, receives the FDA approval in 2015, and launches the drug in 2016, we estimate that revenues will be about $80M (2016) and $144M (2017). With a 70% probability of approval, it will be $56M and $100M, respectively. However, Acadia will only receive a fraction of the royalty from the net sales. If we assume the royalty rate is 15%, the royalty revenues for Acadia will be $8M (2016) and $15M (2017). So, the bottom line is that the royalty revenues from its corporate partnership have a very modest contribution to Acadia's earnings.

Muscarinic Agonist

Acadia is also collaborating with Allergan to develop a drug for glaucoma, based on the muscarinic agonist discovered by Acadia. The program is still in Phase I development, and will thus have little impact on revenues over the next 5 years.

Partnership with Allergan

Acadia has collaborated with Allergan to develop drugs for chronic pain, glaucoma and other indications. The drugs are based on alpha-adrenergic receptor agonists and muscarinic agonists discovered at Acadia. There are separate collaborative agreements between these two companies signed in 1997, 1999 and 2003. The upfront payments and partial development milestones have already been paid out. So, here we only look at future potential payments.

The remaining development milestone payments that Acadia is potentially entitled to receive are $10M, $15M and $13.5M for the three agreements, respectively. Thus, the combined potential milestone payments are $38.5M. We assume that it will be paid out over the next 4 years. This translates to an average of $9.6M in milestone payments each year from 2013 to 2016. The numbers are included in our financial forecasts.

Projected revenues for Acadia

Adding together the product revenues from pimavaserin and the royalty revenues from the Allergan collaboration, we estimate that total revenues for ACAD will be $9.6M (2013), $9.6M (2014), $89M (2015), $178M (2016) and $300M (2017). These revenue numbers will be used for stock valuation.

References:

ACAD 10K 2012

ACAD 10Q2013

Pimavaserine phase III data March2013

Pimavaserin met Phase III endpoints Nov2012

Pimavanserin with risperidone schizophrenia Phase II data 2012

Pimavaserin expediated NDA filing April2013

Disclosure: I am long ACAD, JNJ. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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KPMG report urges radical new look at long-term care

'We need to support [the public's] informed choice so that the A&E department is not be seen as the inevitable solution', writes Hilary Thomas. Photograph: Christopher Thomond

For much of the 20th century, the biomedical model of care constructed around hospitals served us well. It was ideal for a time when a paternalistic approach to disease was deemed as the right way to go. But in a world of Web 2.0, with an ageing demographic and where multiple conditions are becoming the norm, it is no longer appropriate to suggest that "doctor knows best".

In the report, A promise to learn – a commitment to act, Don Berwick, the legendary patient safety guru, set out four guiding principles. One of these is to engage, empower and hear patients and carers throughout the entire system and at all times.

The point made was that engaging and hearing patients will lead us to understand how current experience suggests poor co-ordination between healthcare and community support. It also hints that poor engagement results in individuals not admitting when and with what they need help – and this cannot be good for patients or the professionals trying to help them.

Yet, the solution must lie in the system and not within the walls of an institution. Integration is a term much bandied about in healthcare and could become a weasel word in the healthcare lexicon if the many pilots we have at present are not effectively implemented; if they don't begin to provide more care at home and in the community, and if they don't ensure a more seamless experience.

It's against this background that KPMG recently conducted a survey of 1000 patients, asking them about the future of the NHS. It revealed – surprisingly – that only 36% were comfortable with the idea of using technology, with 54% also arguing that taxes should rise to pay for healthcare.

So the public are ready to have a much more mature and sophisticated dialogue – but we need to support their informed choice so that the hospital and the A&E department are not seen as the inevitable solution.

While news of an additional £500m to A&E departments may defer some of the pain of demand over the winter, the sticking plaster approach is not going to yield the sustainable change required. The best integrated systems in the world have sustained leadership, an effective clinical leadership and engagement and have usually invested considerable sums in their IT infrastructure.

Two examples speak volumes. To begin with, take Virginia Mason in Seattle – where Gary Kaplan, the medically qualified CEO, has been in post for 15 years and where Toyota and Six Sigma approaches to clinical practice are a way of life. He says that "you don't have to be a champion, but you can't be a burier". There's also Kaiser Permanente, where almost 50% of the 9 million population can access their healthcare records online.

Yet despite these great examples of care being made fit for the 21st century, KPMG's latest report, called An Uncertain Age: re-imagining long-term care in the 21st century, suggests that few, if any societies, are facing up to the long-term care problem. Commissioned by the Lien Foundation – a Singapore philanthropic foundation – it makes the point that an ageing population coupled with changing demographics, where people move away from their home base, means the threat of less family support is becoming a reality. Add to this the growing cost of healthcare and the dwindling available funding and we need to redraw the way we provide care and the way we engage the population in that change.

As our report suggests, person-centred care is a must, institutional boundaries must be redrawn or erased and technology must play a part. Perhaps this is Berwick's most important guiding principle as, without that engagement, empowerment and listening we will not be able to make the seismic shift required to a holistic view of the system. In other words, we will not be able to move beyond the walls of the hospital, where patients and the public expect increased autonomy in return for greater responsibility for their health.

And without that, governments will continue to deploy expensive sticking plasters and the benefits will become increasingly short-lived.

Professor Hilary Thomas is a partner in KPMG's public sector healthcare advisory service

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

Why healthcare managers welcome the Berwick report

People enter the NHS wanting to prioritise the quality of patient care but become bogged down by operational and financial management. Photograph: Getty

Few healthcare managers care that the Berwick report says many things we know already. The policy wonks and commentators who have had little moans about "nothing new in Berwick" are part of a longstanding problem that bedevils the NHS: the unhealthy desire for novelty. Managers (and other staff) don't want new structures, rules or strategies; managers want Terry Leahy-style consistency.

What really matters is that someone of huge stature has delivered another considered, mature report – following Bruce Keogh's clear message last month. Who delivers the message is as important as what they say. Few shine brighter in the healthcare firmament than Don Berwick.

When Berwick endorses the NHS – in ringing tones – as a unified system of healthcare which we must cherish, we should be encouraged. When he says we must abandon the use of blame as a tool, and instead "trust the goodwill and good intentions of the staff", and build a culture of learning, we should sit up and act, especially politicians and senior policymakers. When he says criminal sanctions should only be used in cases of "wilful, reckless behaviour or neglect", we should agree and avoid getting sidetracked by new legal sanctions.

Yet again the message that culture and engagement of staff and patients is crucial comes through loud and clear. As the report states: "In the end, culture will trump rules, standards and control strategies every single time …"

But Berwick is clear about the challenges we face in the NHS and suggests four guiding principles to inform every step we take. These are good not just for the so-called front line of care and here is how managers should respond:

1. "Place the quality and safety of patient care above all other aims for the NHS …" No manager enters the NHS not wanting to do this, but, until relatively recently, operational and financial management has often been prioritised by politicians and policymakers. The new quality agenda will inevitably slow movement on finances and operational targets (eg expect the NHS Trust Development Authority to live on beyond 2016) but this will take nerve from Whitehall to boards.

2. "Engage, empower, and hear patients and carers throughout the entire system, and at all times." I regularly speak to chief executives who place staff engagement at the heart of their professional practice or who spend up to a fifth of their working week considering and responding to complaints from patients and their families. But these skills are not easily acquired or developed in a system that has tended to place highest value on what is done, rather than how it is done.

3. "Foster wholeheartedly the growth and development of all staff, especially with regard to their ability and opportunity to improve the processes within which they work." Managers, together with other elements of the healthcare workforce, especially clinical support staff, need greater investment in their skills and development career-long. Much more is needed if they are to learn, master and apply modern methods for quality control, quality improvement and quality planning.

4. "Insist upon, and model in your own work, thorough and unequivocal transparency, in the service of accountability, trust, and the growth of knowledge." Too many people are in charge, which often means no one is in charge. Managers deserve clearer definition of their responsibility for safety and improvement and they want accountability and openness that is fair and robust not a cynical exercise to find a scapegoat.

Finally, Berwick instructs us to "Make sure pride and joy in work, not fear, infuse the NHS." This may be nothing new, but every member of Managers in Partnership will embrace it.

Jon Restell is chief executive of Managers in Partnership

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

KPMG report urges radical new look at long-term care

'We need to support [the public's] informed choice so that the A&E department is not be seen as the inevitable solution', writes Hilary Thomas. Photograph: Christopher Thomond

For much of the 20th century, the biomedical model of care constructed around hospitals served us well. It was ideal for a time when a paternalistic approach to disease was deemed as the right way to go. But in a world of Web 2.0, with an ageing demographic and where multiple conditions are becoming the norm, it is no longer appropriate to suggest that "doctor knows best".

In the report, A promise to learn – a commitment to act, Don Berwick, the legendary patient safety guru, set out four guiding principles. One of these is to engage, empower and hear patients and carers throughout the entire system and at all times.

The point made was that engaging and hearing patients will lead us to understand how current experience suggests poor co-ordination between healthcare and community support. It also hints that poor engagement results in individuals not admitting when and with what they need help – and this cannot be good for patients or the professionals trying to help them.

Yet, the solution must lie in the system and not within the walls of an institution. Integration is a term much bandied about in healthcare and could become a weasel word in the healthcare lexicon if the many pilots we have at present are not effectively implemented; if they don't begin to provide more care at home and in the community, and if they don't ensure a more seamless experience.

It's against this background that KPMG recently conducted a survey of 1000 patients, asking them about the future of the NHS. It revealed – surprisingly – that only 36% were comfortable with the idea of using technology, with 54% also arguing that taxes should rise to pay for healthcare.

So the public are ready to have a much more mature and sophisticated dialogue – but we need to support their informed choice so that the hospital and the A&E department are not seen as the inevitable solution.

While news of an additional £500m to A&E departments may defer some of the pain of demand over the winter, the sticking plaster approach is not going to yield the sustainable change required. The best integrated systems in the world have sustained leadership, an effective clinical leadership and engagement and have usually invested considerable sums in their IT infrastructure.

Two examples speak volumes. To begin with, take Virginia Mason in Seattle – where Gary Kaplan, the medically qualified CEO, has been in post for 15 years and where Toyota and Six Sigma approaches to clinical practice are a way of life. He says that "you don't have to be a champion, but you can't be a burier". There's also Kaiser Permanente, where almost 50% of the 9 million population can access their healthcare records online.

Yet despite these great examples of care being made fit for the 21st century, KPMG's latest report, called An Uncertain Age: re-imagining long-term care in the 21st century, suggests that few, if any societies, are facing up to the long-term care problem. Commissioned by the Lien Foundation – a Singapore philanthropic foundation – it makes the point that an ageing population coupled with changing demographics, where people move away from their home base, means the threat of less family support is becoming a reality. Add to this the growing cost of healthcare and the dwindling available funding and we need to redraw the way we provide care and the way we engage the population in that change.

As our report suggests, person-centred care is a must, institutional boundaries must be redrawn or erased and technology must play a part. Perhaps this is Berwick's most important guiding principle as, without that engagement, empowerment and listening we will not be able to make the seismic shift required to a holistic view of the system. In other words, we will not be able to move beyond the walls of the hospital, where patients and the public expect increased autonomy in return for greater responsibility for their health.

And without that, governments will continue to deploy expensive sticking plasters and the benefits will become increasingly short-lived.

Professor Hilary Thomas is a partner in KPMG's public sector healthcare advisory service

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

Why healthcare managers welcome the Berwick report

People enter the NHS wanting to prioritise the quality of patient care but become bogged down by operational and financial management. Photograph: Getty

Few healthcare managers care that the Berwick report says many things we know already. The policy wonks and commentators who have had little moans about "nothing new in Berwick" are part of a longstanding problem that bedevils the NHS: the unhealthy desire for novelty. Managers (and other staff) don't want new structures, rules or strategies; managers want Terry Leahy-style consistency.

What really matters is that someone of huge stature has delivered another considered, mature report – following Bruce Keogh's clear message last month. Who delivers the message is as important as what they say. Few shine brighter in the healthcare firmament than Don Berwick.

When Berwick endorses the NHS – in ringing tones – as a unified system of healthcare which we must cherish, we should be encouraged. When he says we must abandon the use of blame as a tool, and instead "trust the goodwill and good intentions of the staff", and build a culture of learning, we should sit up and act, especially politicians and senior policymakers. When he says criminal sanctions should only be used in cases of "wilful, reckless behaviour or neglect", we should agree and avoid getting sidetracked by new legal sanctions.

Yet again the message that culture and engagement of staff and patients is crucial comes through loud and clear. As the report states: "In the end, culture will trump rules, standards and control strategies every single time …"

But Berwick is clear about the challenges we face in the NHS and suggests four guiding principles to inform every step we take. These are good not just for the so-called front line of care and here is how managers should respond:

1. "Place the quality and safety of patient care above all other aims for the NHS …" No manager enters the NHS not wanting to do this, but, until relatively recently, operational and financial management has often been prioritised by politicians and policymakers. The new quality agenda will inevitably slow movement on finances and operational targets (eg expect the NHS Trust Development Authority to live on beyond 2016) but this will take nerve from Whitehall to boards.

2. "Engage, empower, and hear patients and carers throughout the entire system, and at all times." I regularly speak to chief executives who place staff engagement at the heart of their professional practice or who spend up to a fifth of their working week considering and responding to complaints from patients and their families. But these skills are not easily acquired or developed in a system that has tended to place highest value on what is done, rather than how it is done.

3. "Foster wholeheartedly the growth and development of all staff, especially with regard to their ability and opportunity to improve the processes within which they work." Managers, together with other elements of the healthcare workforce, especially clinical support staff, need greater investment in their skills and development career-long. Much more is needed if they are to learn, master and apply modern methods for quality control, quality improvement and quality planning.

4. "Insist upon, and model in your own work, thorough and unequivocal transparency, in the service of accountability, trust, and the growth of knowledge." Too many people are in charge, which often means no one is in charge. Managers deserve clearer definition of their responsibility for safety and improvement and they want accountability and openness that is fair and robust not a cynical exercise to find a scapegoat.

Finally, Berwick instructs us to "Make sure pride and joy in work, not fear, infuse the NHS." This may be nothing new, but every member of Managers in Partnership will embrace it.

Jon Restell is chief executive of Managers in Partnership

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

Why healthcare managers welcome the Berwick report

People enter the NHS wanting to prioritise the quality of patient care but become bogged down by operational and financial management. Photograph: Getty

Few healthcare managers care that the Berwick report says many things we know already. The policy wonks and commentators who have had little moans about "nothing new in Berwick" are part of a longstanding problem that bedevils the NHS: the unhealthy desire for novelty. Managers (and other staff) don't want new structures, rules or strategies; managers want Terry Leahy-style consistency.

What really matters is that someone of huge stature has delivered another considered, mature report – following Bruce Keogh's clear message last month. Who delivers the message is as important as what they say. Few shine brighter in the healthcare firmament than Don Berwick.

When Berwick endorses the NHS – in ringing tones – as a unified system of healthcare which we must cherish, we should be encouraged. When he says we must abandon the use of blame as a tool, and instead "trust the goodwill and good intentions of the staff", and build a culture of learning, we should sit up and act, especially politicians and senior policymakers. When he says criminal sanctions should only be used in cases of "wilful, reckless behaviour or neglect", we should agree and avoid getting sidetracked by new legal sanctions.

Yet again the message that culture and engagement of staff and patients is crucial comes through loud and clear. As the report states: "In the end, culture will trump rules, standards and control strategies every single time …"

But Berwick is clear about the challenges we face in the NHS and suggests four guiding principles to inform every step we take. These are good not just for the so-called front line of care and here is how managers should respond:

1. "Place the quality and safety of patient care above all other aims for the NHS …" No manager enters the NHS not wanting to do this, but, until relatively recently, operational and financial management has often been prioritised by politicians and policymakers. The new quality agenda will inevitably slow movement on finances and operational targets (eg expect the NHS Trust Development Authority to live on beyond 2016) but this will take nerve from Whitehall to boards.

2. "Engage, empower, and hear patients and carers throughout the entire system, and at all times." I regularly speak to chief executives who place staff engagement at the heart of their professional practice or who spend up to a fifth of their working week considering and responding to complaints from patients and their families. But these skills are not easily acquired or developed in a system that has tended to place highest value on what is done, rather than how it is done.

3. "Foster wholeheartedly the growth and development of all staff, especially with regard to their ability and opportunity to improve the processes within which they work." Managers, together with other elements of the healthcare workforce, especially clinical support staff, need greater investment in their skills and development career-long. Much more is needed if they are to learn, master and apply modern methods for quality control, quality improvement and quality planning.

4. "Insist upon, and model in your own work, thorough and unequivocal transparency, in the service of accountability, trust, and the growth of knowledge." Too many people are in charge, which often means no one is in charge. Managers deserve clearer definition of their responsibility for safety and improvement and they want accountability and openness that is fair and robust not a cynical exercise to find a scapegoat.

Finally, Berwick instructs us to "Make sure pride and joy in work, not fear, infuse the NHS." This may be nothing new, but every member of Managers in Partnership will embrace it.

Jon Restell is chief executive of Managers in Partnership

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

Report describes malignant melanoma that developed on a pigmented skin lesion within a tattoo underlying laser removal

Main Category: Melanoma / Skin Cancer
Also Included In: Dermatology
Article Date: 31 Jul 2013 - 13:00 PDT Current ratings for:
Report describes malignant melanoma that developed on a pigmented skin lesion within a tattoo underlying laser removal

A case report from Germany describes a young man who developed malignant melanoma on a pre-existing nevus (skin lesion known as a mole or birthmark) within a tattoo during and between the phases of laser tattoo removal, according to a report by Laura Pohl, M.D., of Laserklinik Karlsruhe, Germany, and colleagues.

"Pigmented lesions in decorative tattoos cause diagnostic difficulties at a clinical and dermoscopic level. In cases of laser removal of tattoos, hidden suspicious nevi may be revealed gradually," the researchers stated.

In the case study, the researchers describe a malignant melanoma that developed on a preexisting nevus within a tattoo during and between the phases of laser removal. According to the authors, 16 other cases have been reported in the English literature of malignant melanoma developing in tattoos. Dermoscopic assessments on a regular basis during the period of tattoo removal are recommended.

"If any question about malignancy arises, we suggest an excision before treatment. In general, tattoos should never be placed on pigmented lesions; if they are, the tattoos should never be treated by laser," the authors conclude.

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

JAMA Dermatol. Published July 31, 2013. doi:10.1001/jamadermatol.2013.4901.

Please see article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

JAMA Dermatology

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Fullest clinical report of Saudi MERS cases to date points to important differences with SARS

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Flu / Cold / SARS
Article Date: 26 Jul 2013 - 2:00 PDT Current ratings for:
Fullest clinical report of Saudi MERS cases to date points to important differences with SARS

Saudi and UK scientists provide the most detailed picture yet of the clinical and laboratory characteristics of Middle East Respiratory Syndrome (MERS) coronavirus, revealing a wide range of clinical symptoms and an extremely high death rate among patients with co-existing medical conditions.

The new research, published in The Lancet Infectious Diseases, also reveals some important differences with severe acute respiratory syndrome (SARS).

MERS emerged a year ago in Saudi Arabia and almost all those infected have been reported there, or have been linked to people who contracted the virus there.

The new analysis, the largest case series to date, includes 47 cases (46 adults, 1 child) of confirmed MERS infections from Saudi Arabia between Sept 1, 2012, and June 15, 2013.

By combining clinical records, laboratory results, and imaging findings with demographic data, the authors noted a trend of older patients, more men, and patients with underlying medical conditions who succumb to the disease.

As with SARS, MERS infections presented with a wide spectrum of symptoms. Most patients admitted to hospital exhibited fever (98%), chills/rigors (87%), cough (83%), shortness of breath (72%), and muscle pain (32%). A quarter of patients also experienced gastrointestinal symptoms, including diarrhoea and vomiting.

However, in contrast to SARS, the majority of cases (96%) occurred in people with underlying chronic medical conditions including diabetes (68%), high blood pressure (34%), chronic heart disease (28%), and chronic renal disease (49%).

"Despite sharing some clinical similarities with SARS (eg, fever, cough, incubation period), there are also some important differences such as the rapid progression to respiratory failure, up to 5 days earlier than SARS"*, explains Professor Ziad Memish, the Deputy Minister for Public Health from the Kingdom of Saudi Arabia, who led the research.

"In contrast to SARS, which was much more infectious especially in healthcare settings and affected the healthier and the younger age group, MERS appears to be more deadly with 60% of patients with co-existing chronic illnesses dying, compared with the 1-2% toll of SARS. Although this high mortality rate with MERS is probably spurious due to the fact that we are only picking up severe cases and missing a significant number of milder or asymptomatic cases, so far there is little to indicate that MERS will follow a similar path to SARS."*

According to co-author Professor Ali Zumla from University College London, "The recent identification of milder or asymptomatic cases of MERS in health care workers, children, and family members of contacts of MERS cases indicates that we are only reporting the tip of the iceberg of severe cases and there is a spectrum of milder clinical disease which requires urgent definition. Ultimately the key will be to identify the source of MERS infection, predisposing factors for susceptibility to infection, and the predictive factors for poor outcome. Meanwhile infection control measures within hospitals seem to work."*

Writing in a linked Comment, Professor Christian Drosten from the University of Bonn Medical Centre in Germany points to the urgent need for accurate diagnostic tests to help focus control efforts and minimise the risk of spread to others, "To ascertain relevant data for MERS epidemiology, we need to develop serological assays using samples from well defined groups of patients, such as described here. Population-based antibody testing could establish the extent of MERS-CoV infection, instead of only seeing the tip of the iceberg represented by cases admitted, such as those summarised in this important paper."

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

*Quotes direct from authors and cannot be found in text of Article.

The Lancet

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More people beating skin cancer - UK report

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Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology
Article Date: 25 Jul 2013 - 3:00 PDT Current ratings for:
More people beating skin cancer - UK report

Cancer Research UK says more and more people are surviving malignant melanoma, the most dangerous form of skin cancer. Their latest statistics, published online this week, reveal that more than 8 in 10 people diagnosed with malignant melanoma will now survive the disease. Forty years ago, the survival rate was only around 5 in 10.

The charity says the improvement is most likely due to better treatments and earlier diagnosis, and also because people are more aware of the symptoms.

The report shows that 80% of men and 90% of women live more than ten years after being diagnosed with malignant melanoma compared with only 38% of men and 58% of women in the early 70s.

In the UK every day, around 35 people discover they have malignant melanoma, totalling nearly 13,000 new cases a year.

Professor Richard Marais, director of the Cancer Research UK Paterson Institute for Cancer Research at the University of Manchester, says in a statement that much of the huge progress in the fight against skin cancer is down to the generosity of supporters who have funded research that increases understanding of the disease and finds new ways to beat it. He says:

"More and more people are beating skin cancer but we can't stop there and we need to develop better treatments for the 2 out of 10 where things don't look so good."

There are now some very effective new drugs, such as vemurafenib, which was developed with the help of research funded by the charity.

"Although these drugs do not cure skin cancers, they can give patients with advanced melanoma valuable extra months and show the progress we are making," Marais adds.

Skin cancer is one of the fastest rising cancers in the UK, which the charity says is likely due to more Britons sunbathing than before, and the rise of cheap package holidays in earlier decades.

Treatment for skin cancer is more likely to succeed the earlier the disease is detected.

The key to early diagnosis, says Dr. Harpal Kumar, Cancer Research UK's chief executive, is to get to know your skin, notice anything unusual, such as a change to a mole or a blemish that hasn't healed after a few weeks, and see your doctor.

One area that has seen enormous progress in research on melanoma is genetics.

Melanoma is really an umbrella term for the most virulent types of skin cancer. It is a highly complex disease from a genetic point of view: melanoma tumors have more mutations per cell than any other type of cancer.

An example of how scientists are investigating the genetics of melanoma is following up on the knowledge that ultraviolet light from the sun damages DNA, which increases the chance of normal skin cells becoming cancerous.

Scientists can use the information gained from studying how UV light damages DNA to develop new treatments.

One study by Cancer Research UK, which is looking at genetic changes that cause skin cancer, is collecting samples of tissue and blood from people diagnosed with melanoma and non-melanoma skin cancer of the head and neck.

The researchers are examining the samples to find genetic changes that may be responsible for the cancer and to discover how the immune system reacts to the cancer.

In another piece of research, scientists have discovered that people who have inherited a faulty gene called p16 or CDKN2A have a higher risk for developing melanoma than people who do not have the faulty gene.

They are now running a long-term study to find out how genes and environment affect risk of developing melanoma.

Fortunately thanks to new tools like DNA sequencing, scientists are able to sort through huge volumes of data to decode each melanoma tumor's genetic "fingerprint."

For example, Prof. Marais was the lead author on another Cancer Research UK study that recently revealed how DNA sequencing helped the team find possible new treatment targets for a rare form of cancer known as mucosal melanoma.

The list of known gene flaws that cause melanoma is growing. This opens doors to new drugs that can target the effect of these faulty genes by blocking the signalling pathways that cause cells to malfunction and make tumors grow and spread.

There are currently about 100 new drugs being developed to treat melanoma, and new combinations of drugs show promise as treatments that block these tumor-causing signalling pathways.

In a recent journal report, Brian Nickoloff, director of a dermatology and cutaneous sciences division at Michigan State University's College of Human Medicine in the US, and colleagues outline recent advances that have put melanoma at the forefront of cancer research.

Nickoloff says he has been working in this field for 30 years, and "now is by any measure the most exciting time for melanoma research."

"In the past melanoma outsmarted us, but now we're starting to outsmart melanoma," he adds.

For more information on the latest melanoma research see the Cancer Research UK web page.

Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our melanoma / skin cancer section for the latest news on this subject. "Cancer Statistics Report: Skin Cancer"; Cancer Research UK, July 2013; Link to Report (pdf). Additional source: Cancer Research UK Press Release. Please use one of the following formats to cite this article in your essay, paper or report:

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New SANE Australia report calls for action to reduce stigma against mental illness

Main Category: Mental Health
Article Date: 25 Jul 2013 - 2:00 PDT Current ratings for:
New SANE Australia report calls for action to reduce stigma against mental illness

A new study from mental health charity, SANE Australia, reports that stigma and discrimination against people with mental illness is widespread, harmful to recovery, and is a major barrier to participation in society for those affected.

The new report - A Life without Stigma - concludes that a national strategy to tackle stigma and discrimination associated with mental illness is vital, and should be a non-negotiable component of mental health policies and plans.

'Stigma is a major issue for people affected by mental illness, influencing how they are viewed and how they view themselves' says Jack Heath, CEO of SANE Australia. 'It is destructive, hurtful, and excluding. If we are to help people with mental illness lead a contributing life, it is essential that we take action against stigma.'

A Life without Stigma points out that while significant progress has been made to reduce the stigma associated with depression, Australia urgently needs a national, long-term strategy to reduce the stigma associated with schizophrenia and other psychotic illnesses.

The report's recommendations stress that the strategy must be:

comprehensive, targeted, long-term, and robustly fundedinclusive of people living with mental illness and family carersbased on evidence of good practice, and evaluatedcomplementary to existing stigma reduction strategies for depression and anxiety, as well as the Mindframe strategy to reduce stigma in the mediaconsistent with the mental health plans of national and state governments, as well as the National Mental Health Commission.

SANE Australia is calling on the major political parties to commit to a national, long-term strategy and campaign to reduce the stigma and discrimination associated with mental illness, with a particular focus on psychotic illness. SANE has written to the Minister for Mental Health, Jacinta Collins as well as the mental health spokespeople for the Coalition and the Greens party, asking them to make stigma reduction a priority for the next government.

'Mental illness is common. With one in five of us affected every year, reducing stigma across all diagnoses is an important issue for everyone' says Jack Heath. 'SANE Australia calls on each party to review the report and make stigma reduction for mental illness a commitment in the upcoming Federal election.'

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

Report: A life without Stigma, funded by the Department of Health and Ageing

SANE Australia

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