Friday, September 30, 2011

Should this be a tweet?


Dispute as McGorry complaint dismissed | The Australian

A COMPLAINT against former Australian of the Year Patrick McGorry for planning a trial of drugs on children has been dismissed.

But the 13 international health experts who lodged the complaint with the ethics committee at Melbourne Health calling for the trial to be abandoned say they are dissatisfied with the finding and have lodged a complaint against the ethics committee.

Geoff Stuart from La Trobe University's school of psychological sciences, who signed the complaint, said there were concerns about the circumstances in which the proposed trial was aborted that deserved to be examined.

He said the "derisory and dismissive" one-sentence response of the ethics committee fell well short of explaining the "huge error" that was made in approving the trial.

Professor McGorry, executive director of the Orygen Research Centre and one of the Prime Minister's key mental health advisers, planned to trial the effectiveness of the drug Quetiapine on patients "who are deemed at risk of developing a psychotic disorder", listing it on the Australian New Zealand Clinical Trials Registry last March.

The trial, funded by the drug's manufacturer, was to investigate whether it would decrease or delay the risk of people between 15 and 40 with early signs of mental illness developing a psychotic disorder such as schizophrenia.

On July 31, 13 psychiatrists, psychologists and researchers from Australia, New Zealand, Canada, Britain and the US objected to the trial for reasons including "the ethics of causing unnecessary harm to individuals not requiring treatment, to possibly prevent harm to a smaller number who do require treatment".

Professor McGorry said last night the study was approved by the ethics committee after a "very rigorous process" before being "reluctantly" abandoned in June, when it was decided to proceed with a more promising trial involving fish oil.

"As far as I'm concerned, the trial isn't going ahead - it was ethically approved to do so, the committee has considered the complaint very carefully and has made a decision," he said.

He said the complaint against the trial was "able to be defended on every level".

But Associate Professor Stuart said there was a lack of transparency in how such a controversial trial was ethically approved.

He said Professor McGorry's plan to use anti-psychotic drugs on children as young as 15 had "raised alarm bells around the world".

Melbourne Health said last night its mental health research ethics committee was "satisfied the process and the decision to give ethics committee approval of the study were appropriate".

The health organisation said the study had been abandoned by the research team for "logistical reasons".

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Thursday, September 29, 2011

Use of cancer drugs questioned - Health News - NHS Choices

The Daily Mail has reported that doctors do not support giving life-extending drugs to patients with terminal cancer. The newspaper says that a new report has said the treatments “give false hope and are too costly for the public purse”.

The news story is based on an extensive international report that examined the cost and value of cancer care in developed countries. In the report doctors, health economists and patient advocates voice their opinions and suggest potential policy changes that could make cancer care more affordable for both patients and society. However, the report does not actually suggest that life-extending drugs should be withheld from terminal cancer patients, rather that there is a greater need to understand whether treatments at this stage will actually extend life, and whether resources would be better directed at improving patients’ quality of life through options such as palliative care. The report also suggests several policy areas that could be targeted to improve quality of care while reducing its cost.

This report is likely to stimulate discussions on policy relating to cancer care, but it is not policy itself. The report is of great interest but a broad agreement within the health service would be needed if it were to change the manner in which care is provided in the UK.

 

Where did the story come from?

The report was created by researchers from a variety of institutions from the UK, US, Australia, Canada and across Europe. These institutions include King’s College London, CancerPartnersUK, North of England Cancer Network, Northumbria Healthcare, the Institute of Nuclear Medicine, the Association of the British Pharmaceutical Industry, the University of London and Oxford University.

The commission was funded by the Conquer Cancer Foundation and the Greenwall Foundation for Bioethics, the University of California Los Angeles, Belgium’s Herculesstichting and Fonds voor Wetenschappelijk Onderzoek-Vlaanderen, and the UK’s National Institute for Health Research (NIHR) Biomedical Research Centre and Department of Health.

The study was published in the journal The Lancet Oncology. However, it was published as an opinion piece and was not subject to the peer-review process.

The media focused on futile care, which is a particular issue highlighted in the report. This is addressed under the issue of ‘overutilisation’ in general, and is not the primary focus of the report. That said, the report does recommend that special attention should be paid to end of life cancer care. They say that improving the ability to predict the effectiveness of treatment could spare patients side effects and false hope from ineffective care, and also spare the healthcare system the cost of ineffective care. However, some life-extending drugs are valuable for people with terminal illness and the authors do not say that all of these give false hope or are too expensive.

 

What kind of research was this?

This is a discursive policy report written by a panel of international cancer experts. The report is intended to guide public debate on cancer care in developed countries, including the UK. The report attempts to identify the drivers of high-cost cancer care, as well as to propose solutions for these issues.

The extensive report looks at many of the different factors that drive the cost of cancer care. It gathers opinions from a variety of experts, including clinicians, patient advocates, policy makers and cancer survivors. The authors examined the cost and effectiveness of cancer care, and identified issues that drive up the cost of care but that may not provide great improvements in health outcomes. Among the issues examined are the economics of cancer care, the individual and societal impact of cancer treatments, areas where new technology could be improved or developed, predicted rates of cancer in the years to come and whether current methods for evaluating evidence are appropriate.

 

What did the research involve?

The authors collected opinions from a wide variety of experts on the status of cancer care costs and the effectiveness of cancer treatment in developed countries. They examined the role that cost drivers, evolving patterns of disease and trends in the provision of care play in determining the amount of money spent on cancer care. They then examined the value of cancer care from various perspectives, including the role played by:

  • health research and research into cost-effectiveness
  • available treatment options, such as surgery, radiation and imaging technologies
  • the possibilities offered by new testing technologies, including genetic testing
  • anti-cancer drugs, the pharmaceutical industry and the processes for developing new drugs
  • patients’ involvement in treatment and their ability to express their wishes

They also examined current approaches to addressing the affordability of cancer care in different countries.

The authors say that there are several areas that could be addressed to reduce cost and improve the quality of cancer care. These are as follows.

 

Cost of care

The authors first examined the cost of cancer care, and specifically ‘cost drivers’. These are those interventions that account for most of the costs. They examined the cost of cancer from the perspective not only of the price paid for treatments, but also in terms of the economic impact of patients not being able to function normally due to illness or early death.

 

Burden of disease

The authors also looked at the patterns of disease, the complexity of illness and how research accounted for these patterns. They then examined how this burden of disease translates into the cost of treating individual patients and the cost of treating cancer in society as a whole.

 

Technological development

The authors next highlight the process by which technologies are developed and the cost of this process, and suggest ways in which these costs could be reduced without forfeiting benefits in terms of health outcomes.

 

Overutilisation

The report looks at how ‘overutilisation’ of cancer technologies and services can drive costs without adding any additional benefit in terms of health outcomes, for example the use of expensive diagnostic tests that provide no greater benefit than cheaper alternatives. The authors identified areas of care that could be reduced without reducing health outcomes.

 

What were the basic results?

The study is extensive so the following section only provides a very brief overview of its findings. The authors identified multiple sources of high cancer costs, and outlined recommendations for improving care and reducing costs in each of the identified areas.

 

Cost of care

The authors found that the absolute amount spent on cancer care is increasing in all developed countries, and that the rate of this increase is going up year by year. They say that this is not simply due to the increasing number of cancer cases seen, but that the rise is also driven by factors such as the use of increasingly individualised treatments that are expensive to develop and the use of inappropriate cancer products (although they say this is more of an issue in the US than in the UK). They found that in 2009-2010, the NHS spent £5.86 billion on cancer care, which is 5.6% of the UK’s total health spend.

They recommend that countries attempt to drive the development of new low-cost technologies by increasing the use of off-patent products and rethinking the pathway of care that patients follow when they have cancer.

 

Burden of disease

The report says that one of the main drivers of cancer care costs is the ageing population (more people are being diagnosed with cancer) and the increasing complexity of disease, including patients with multiple illnesses. They say that the increase in cancer care costs is due both to the amount spent per patient and the number of patients diagnosed.

The authors found that current clinical research often fails accurately to reflect the burden of disease seen in the real world. Patients with multiple illnesses are often excluded from clinical trials, so that the evidence base for new technologies does not accurately reflect the way in which cancer occurs and will be treated in the real world. The researchers recommend that clinical research into new treatments be reflective of this real-world burden of disease for society, and take into account patient frailty and multiple illnesses.

 

Technology development

The authors found that many technologies that provide little additional benefit are taken all the way through the technology development phase, which becomes increasingly expensive the further along it goes. They recommend that the technology development process be changed, and that the design of early clinical trials be improved. They say that technologies that show little additional benefit should be halted earlier in the development process so that they do not reach the most expensive phases. The researchers say that this should result not only in reduced research costs, but also in more rigorous standards of evidence.

 

Overutilisation

The report found that overutilisation of cancer services is an issue in all areas of care. The authors say that the need to treat cancer promptly plays a role in overutilisation as it may be quicker and easier for medical staff to discuss a plan for treatment than to discuss why other treatments may not be suitable for use. They say that clinicians are also increasingly relying on technology and scans to assess new symptoms rather than physical examinations, but that the costs of using imaging techniques are also increasing per patient. The sheer amount of information on new technologies may also prevent clinicians from thoroughly understanding the evidence base needed to decide on the most appropriate treatment plan for a patient.

The report recommends six indicators of when interventions may be suitable for reduction, where cutting the use would have minimal effect on health outcomes. These include interventions that:

  • provide no benefit
  • result in little increased benefit
  • have no clearly defined benefit
  • are not desired by patients
  • are duplicates of other tests or services
  • are more expensive than an equally effective alternative treatment

 

How did the researchers interpret the results?

The authors say that “in general, there are two primary mechanisms to control costs. We can lower the cost of cancer-care services or interventions, or we can reduce [their use]”. They say that examining current policy can result in decreased utilisation of ineffective services, and increased utilisation of effective services. This, they say, is the way to improve efficiency and value of cancer care. They further say that rethinking how research, policy and clinical practice interact can result in reduced costs and improved quality of cancer care.

 

Conclusion

This is an extensive expert opinion piece looking at the high cost of cancer care. The authors examined cost drivers from a variety of policy and clinical perspectives – from epidemiology to research to technology development and health economics. The report identifies key areas that they feel could be addressed to reduce the cost and improve the quality of cancer care. Although the paper discusses specific treatments and national healthcare systems (including the NHS) it is not a specific analysis of where changes in individual systems would be beneficial. Instead, the document raises many issues pertaining to whether cancer care strategies need to be examined and reformed in terms of both cost-effectiveness and clinical benefit.

However, the media generally focused on one specific recommendation outlined in the report - the suggestion that attempts to use cancer-fighting therapies to lengthen the lives of terminal-stage cancer patients may not always be appropriate. Newspaper coverage may not fully reflect the tone and context of the report, which arguably raises questions on the issue rather than attempting to provide a definitive verdict on the current situation.

For example, rather than suggesting that medical care should be withdrawn from cancer patients within their last few weeks of life, the report says that continuing care strategies such as chemotherapy may be problematic for patients, and that focusing on palliative care may improve their quality of life and possibly prolong their survival. In short, the researchers question whether spending could be directed at cheaper, potentially better methods for helping people with late-stage cancer, and (contrary to some news coverage) do not suggest that they should not be helped at all.

The researchers also suggest that there is a need for clinical measures that can accurately determine which late-stage patients would and would not benefit from further disease-fighting therapy, highlighting that they are not advocating the withdrawal of appropriate care options for terminal patients.

The authors say that each health system now needs to consider how much is spent on cancer care and prevention compared with other healthcare priorities. This should include funding the most effective interventions, and insistence on a strong evidence base before adopting newly available medical technology.

The authors say that focusing on areas of care that provide little or no benefit, increasing the use of low-cost technologies and refocusing care pathways on high-quality, cost-effective and value-based care can reduce the cost of cancer care without sacrificing benefits. They also say that countries could further address cancer care costs by developing new ways of financing cancer care, including evaluating the pricing of drugs.

Overall, this is a valuable and intriguing exploration of the nature of current cancer treatment and, contrary to the impression given by media reports, these authors do not suggest that all end of life care should be stopped. Instead the report focuses on value, saying that the benefits of cancer care should be weighed from both an individual and societal perspective, and that the cost of care, in terms of price as well as side effects, should be balanced against the benefits, including quality as well as extension of life.

Links to the headlines

Dying cancer patients should not be given 'futile' drugs. The Daily Telegraph, September 27 2011

Don't give out cancer drugs if it's just to extend life: Treatment costs can't be justified, say experts. Daily Mail, September 27 2011

Cancer cost 'crisis' warning from oncologists. BBC News, September 27 2011

Links to the science

Sullivan R, Peppercorn J, Sikora K et al. Delivering affordable cancer care in high-income countries. The Lancet Oncology, Volume 12, Issue 10, Pages 933 - 980, September 2011

via nhs.uk

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NICE blames pharma R&D model for spiralling cancer drug costs | InPharm

Published on 29/09/11 at 09:49am

NICE has blamed the pharma industry’s ‘inefficient’ and increasingly costly R&D model for the rising price of cancer drugs.

NICE chairman Sir Micheal Rawlins and director of NICE International UK Dr Kalipso Chalkidou used an editorial in The Lancet Oncology to criticise the growing costs of clinical trials.

They say that over the past 40 years the median monthly cost at launch (and adjusted to 2007 prices), has risen from less than $100 in 1965-69 to more than $5,000 in 2005-9.

The authors believe this is down to the “escalating costs and inefficiencies of clinical trials”, coupled with additional burdens imposed by drug regulators such as the FDA.

“The sums spent on research and development have increased three times over the past two decades but, as judged by the number of drugs licensed per dollar of research and development, the innovative performance of the drug industry has declined,” Rawlins and Chalkidou say.

As a solution to the problem, the authors point to a recent study that suggests clinical trial costs could be decreased by 40-60% without adversely affecting their quality.

They say this figure can be achieved with simple measures to reduce costs, including electronic data capture, reduction in the length of case-management forms, and modified site-management practices.

The latter should include greater use of statistical techniques to detect fraud, rather than over-reliance on site visits by regulators and sponsors, they add.

Pharma pricing needs more scrutiny

NICE was responding to a new report in The Lancet Oncology that estimates the annual cost of new cancer drugs rose to £185 billion ($286 billion) in 2009 in high-income countries.

The report, authored by 37 leading researchers, criticised both this growing cost and bodies such as NICE for delaying new cancer treatments from reaching the market.

In response NICE said: “Rather than criticise organisations such as NICE for declining reimbursement on grounds of cost-effectiveness, clinicians and patient advocates should start challenging pharmaceutical companies about the high prices they seek for products with modest benefits.”

In their final note, Rawlins and Chalkidou said that the focus should not be on high-income countries: “We should all be more concerned about the difficulties facing low and middle income countries in accessing affordable cancer care, rather than constantly focusing on the problems facing developed countries.”

Ben Adams

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J&J Buys Merck’s Share of OTC Drug Partnership for $175 Million - Businessweek

Sept. 28 (Bloomberg) -- Johnson & Johnson bought Merck & Co.’s half of the companies’ joint venture for over-the-counter medicines for heartburn and digestive diseases for $175 million, ending a 22-year partnership in the U.S. and Canada.

The deal announced today includes a manufacturing plant in Lancaster, Pennsylvania, that is part of a consent decree with U.S. regulators because of production violations. J&J, the world’s second-biggest seller of health products after Pfizer Inc., has recalled dozens of drugs and devices in the past two years, including nonprescription medicines such as Tylenol.

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Pfizer faces off-patent smoking drug threat - FT.com

Pfizer is facing a threat to its top-selling smoking cessation drug Champix from the Bulgarian company that has long marketed the low-cost off-patent medicine from which it was derived.
via ft.com

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Medicis, its auditor will pay $18 mil to settle suit

Medicis said in a filing in June that its share of the proposed settlement would be paid entirely by its insurers. The company admits no wrongdoing as part of the settlement.

The shareholders' lawsuit stems from Medicis' announcement in September 2008 that it would restate earnings from 2003 through the first half of 2008.

Shareholders alleged that Medicis offered its wholesale customers generous return policies for prescription drugs as part of an effort to inflate the company's revenue. Medicis would accept returned products that were expired or about to expire at either no cost or substantial discounts to the wholesale customers, according to the lawsuit.

When Medicis disclosed that it would need to restate nearly six years worth of earnings statements, the company's share price dropped $2.34, or 13 percent, in one day of trading, erasing about $125 million in shareholder equity.

In addition to Medicis and Ernst & Young, the lawsuit names Medicis CEO Jonah Shacknai, Chief Financial Officer Richard Peterson and President Mark Prygocki as defendants.

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Wednesday, September 28, 2011

Meltdown - The men who crashed the world


The first of a four-part investigation into a world of greed and recklessness that brought down the financial world.

BBC News - Cervical cancer vaccine: NHS choice questioned

The UK government may have chosen the least cost-effective vaccine to immunise teenage girls against viruses that cause cervical cancer, a data study suggests.

In 2008, the Department of Health picked the cheaper of two options - a vaccine called Cervarix.

But the Health Protection Agency (HPA) concludes that a different vaccine, Gardasil, could provide better value.

Cervarix would need to be £19 to £35 cheaper to match Gardasil's payback.

Although it is not known what deal the government was able to strike with GSK, the pharmaceutical company that manufactures Cervarix, the NHS list price for the drug is £80.50 per dose.

In comparison, Gardasil, made by Merck & Co, is £88.50 per dose.

The current tender for the vaccination is due to run out before the end of 2011.

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The Elizabeth Warren Quote Every American Needs To See

BBC News - 'Anyone can make money from a crash,' says market trader Alessio Rastani

Drugs: The doctor's dilemma -- The Independent

When treating terminally ill patients, should medics prescribe expensive drugs that offer a few more weeks – or help them enjoy what time they have left, free from invasive treatments?

By Dr Margaret McCarthy

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Matt Herper on Orwell, Pens and Pharma

Former employee says 1982 Tylenol murders were inside job | PoconoRecord.com

CHICAGO -- A former employee of Johnson & Johnson has written a book about the still-unsolved 1982 Tylenol poisonings in which he suggests the pills were tampered with in the drug company's distribution channels, rather than in retail stores.

The so-called "Tylenol murders" killed seven people in the Chicago area who took pain-relief capsules laced with potassium cyanide. The deaths sparked a nationwide scare and led product tampering to be declared a federal crime.

Scott Bartz's book "The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson," also accuses the drug company of conducting a cover-up to avoid liability.

Johnson & Johnson said that Bartz's theory has no merit.

The FBI says its Tylenol investigation is still active, but so far, no one has come forward with enough evidence to press charges.

Bartz told the Daily Herald that he currently has two unrelated lawsuits pending against Johnson & Johnson.

One accuses the company of Medicaid fraud by inflating the price of a prescription drug. The other was filed under the New Jersey Conscientious Employee Protection Act, which prohibits retaliation against whistle-blowers.

The lawsuits were filed in 2005, before Bartz was terminated by the company.

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Perry’s Wife Influenced Stance on HPV Vaccine

PhRMA shroud waving 101 - Curtailing patents will cripple R&D on pharmaceuticals, industry warns - Washington Times

J.M. Eddins Jr./The Washington Times  BITTER PILL: John Castellani, president and CEO of PhRMA, cautions against cutting from 12 years to seven the length of a patent on a company's new drug.J.M. Eddins Jr./The Washington Times BITTER PILL: John Castellani, president and CEO of PhRMA, cautions against cutting from 12 years to seven the length of a patent on a company’s new drug.

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Tuesday, September 27, 2011

Occupy Wall Street: Michael Moore Arrives in Liberty Plaza | Suite101.com

Occupy Wall Street protesters had just returned to Zuccotti Park (renamed Liberty Plaza) from the latest of their daily marches through the streets of New York. It had been a peaceful progress with none of the controversial arrests, which had marred a similar progress two days before. Several people Tweeted that they had made it to the famous Wall Street bull, before turning around and heading to the small urban park that many have been calling home for the past ten days.

They were in good spirits. This was September 26th 2011, when Noam Chomsky had announced his solidarity with the Occupy Wall Street movement. The protesters had seen their inspiration create several parallel demonstrations around the USA. OccupyChicago has already been set up. As the first of the New York marchers entered Liberty Plaza, a huge cheer went up. Another legendary American activist was standing in their midst. Michael Moore had arrived in person.

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After The Turmoil: Former Merck CEO Says Execs Need New Beliefs - By Ed Silverman in Forbes

In an attempt to wax philosophical, former Merck ceo Ray Gilmartin has begun contributing to a blog for the Harvard Business Review and his new post is about what he sees as a “flawed set of beliefs” that have been increasingly embraced by chieftains of major corporations over the past 25 years. This, of course, coincides with his tenure not only at Merck, but also Becton-Dickinson. 

In his view, they have placed “way too much emphasis on maximizing shareholder value and not enough on generating value for society.” He notes, not surprisingly, that execs and boards are motivated by such things as the short-term outlook on Wall Street and stock-based incentive compensation. But he frets that these have led managers and their boards to take actions that have had “unintended, destructive consequences.”

In particular, he writes that “it seems as though CEOs are recognized and rewarded handsomely for downsizing and outsourcing, acquiring or merging, and making the quarter – all justified by the responsibility to maximize shareholder value…Any of these actions can be necessary in certain circumstances; most of us have taken one or another. My concern is that these actions have become the standard by which CEOs are expected to manage.”

And so Gilmartin then lists an alternative set of guiding beliefs that he hopes can right the world. These include the notion that “the market favorably receives projects with long-term payoffs, particularly those in research and development.” Specifically, he cites cuts in research that would undermine efforts to create new drugs. However, he fails to note that his successor, the recently retired Richard Clark, took this same step last year. Hmm… Could this have been oversight?

To wit, Merck announced plans in July 2010 to save up to $3.5 billion by closing eight research sites and eight manufacturing plants by next year (read here). This left Merck with just seven therapeutic categories: cardiovascular, diabetes and obesity; infectious disease; oncology; neuroscience and ophthalmology; respiratory and immunology; and endocrine and women’s health.

The move, you may recall, came as part of a huge cost-cutting effort that followed the $41 billion acquisition of Schering-Plough. So perhaps one could argue that the decision to reduce research was a necessary step toward finding ’synergies’ in the wake of a big acquisition. In fact, Merck execs have been struggling to cut costs and eliminate jobs ever since (see here). Was this an example, though, in which such a move was necessary? Gilmartin is coy and avoids mentioning the episode. Nonetheless, it could be interpreted as a rebuke of his former employer and colleagues.

Curiously, he is silent altogether on the propensity among some pharma execs and boards to pursue mergers as strategic salves, which is what led to the ongoing bloodletting at Merck. There have, of course, been competing theories about the extent to which this is a useful notion. Some, such as Pfizer, have repeatedly embraced the concept and others, such as GlaxoSmithKline, downplay its utility. Unfortunately, Ray chose not to mention this in the context of research cuts (here is his blog).

As for the ceo who is “recognized and rewarded” for downsizing and outsourcing, Gilmartin glosses over his own attempts to calibrate shareholder value. Let’s go back to late 2003, for instance, when he was mistakenly clinging to the belief that Merck labs could generate a sufficient supply of big-selling drugs. Wall Street, however, was beginning to clamor for his head as sales, profits and share price were all declining. His response ? Eliminate 4,400 jobs. The move didn’t help bolster confidence in his reign and his total 2004 compensation fell slightly, according to Forbes. Perhaps he has grown wiser during the intervening years?

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9 Stages of an Acid Trip (Pic) | Daily Dawdle

Feds Probe Marketing Of 3 Merck Drugs

Drugmaker Merck says it has received a subpoena from federal prosecutors investigating the company's marketing of three drugs acquired through its 2009 acquisition of Schering Plough.

Merck & Co. Inc. disclosed the request for information from the Department of Justice in a regulatory filing Monday morning. The government is investigating marketing and selling of the brain cancer drug Temodar and hepatitis C drugs PegIntron and Intron A. The probe involves company activities between 2004 and today. Merck, based in Whitehouse Station, New Jersey, said it is cooperating with the government.

Merck and Schering Plough completed their merger in November 2009.

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Delivering affordable cancer care in high-income countries - TheLancet.com

Delivering affordable cancer care in high-income countries

Published September 26, 2011


Executive summary
The burden of cancer is growing rapidly, and the disease is becoming a major challenge for all developed countries. This is not simply due to an increase in absolute numbers or need for optimised treatments, rather it relates to the unsustainable rate of increase in expenditure on cancer within health-care systems. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high-quality and equitable care? In this Commission and the linked Comments, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer-care in high-income countries.
Comments
Striking a balance between idealism and fatalism
David Collingridge
Full Text | PDF
…And the only side-effects are good ones
Dean Ornish
Full Text | PDF
Challenges related to palliative care
Stein Kaasa, Sheila Payne , Per Sjøgren
Full Text | PDF
Paediatric oncology: are there ways to bend the costs?
Gabriele Calaminus
Full Text | PDF
Caring for patients with haematological malignancies
Robin Foà, Ulrich Jaeger
Full Text | PDF
Regulators, payers, and prescribers: can we fill the gaps?
Francesco Pignatti, Xavier Luria, Eric Abadie, Hans-Georg Eichler
Full Text | PDF
The opportunity cost of cancer care: a statement from NICE
Michael D Rawlins, Kalipso Chalkidou
Full Text | PDF
The Lancet Oncology Commission
Delivering affordable cancer care in high-income countries
Richard Sullivan, Jeffrey Peppercorn, Karol Sikora, John Zalcberg, Neal J Meropol, Eitan Amir, David Khayat, Peter Boyle, Philippe Autier, Ian F Tannock, Tito Fojo, Jim Siderov, Steve Williamson, Silvia Camporesi, J Gordon McVie, Arnie D Purushotham, Peter Naredi, Alexander Eggermont, Murray F Brennan, Michael L Steinberg, Mark De Ridder, Susan A McCloskey, Dirk Verellen, Terence Roberts, Guy Storme, Rodney J Hicks, Peter J Ell, Bradford R Hirsch, David P Carbone, Kevin A Schulman, Paul Catchpole, David Taylor, Jan Geissler, Nancy G Brinker, David Meltzer, David Kerr, Matti Aapro
Summary | Full Text | PDF

Return to Clinical Series | Return to Global Health Series

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Don't give terminal cancer patients drugs just to prolong their lives, say experts | Mail Online

Patients with terminal cancer should not be given life-extending drugs, doctors said yesterday. The treatments give false hope and are too costly for the public purse, they warned. The group of 37 cancer experts, including British specialist Karol Sikora, claimed a 'culture of excess' had led doctors to 'overtreat, overdiagnose and overpromise'. Read more: http://www.dailymail.co.uk/health/article-2042172/Dont-terminal-cancer-patien...

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Cancer Cost Swells, Risks Becoming ‘Unsustainable,’ Lancet Says - Bloomberg

Cancer treatment costs are rising at such a rapid rate that they threaten to become “unsustainable” even for rich countries, according to an expert panel assembled by The Lancet Oncology medical journal.

About 12 million people worldwide get cancer every year, and the costs associated with new cases was at least $286 billion in 2009, according to a report compiled by 37 experts from countries including the U.K., the U.S. and Germany. By 2030, about 22 million people will be diagnosed with the disease annually, the panel told a cancer conference in Stockholm today.

Cancer diagnosis and treatment is becoming more complex, with a mix of imaging, surgery, radiation and drug therapy involved in fighting tumors. Experts in those fields need to come together and discuss with patients, insurers and industry players the best ways to lower costs without compromising care, the panel said.

“With an aging global population and an endless conveyor belt of expensive new drugs and technologies and increasing financial pressures, the cost of cancer care in high-income countries is becoming unsustainable,” The Lancet Oncology said in a statement.

More than half of the $286 billion in costs was related to treatment, while a quarter was linked to lost productivity, the report found.

The panel included economists, patient advocates and physicians, the journal’s editor, David Collingridge, wrote in an accompanying comment. Input from drugmakers, payers and educators will be key to future discussions, Collingridge said.

“We are at a crossroads for affordable cancer care, where our choices, or refusal to make choices, will affect the lives of millions of people,” said Richard Sullivan, a professor at King’s College Integrated Cancer Centre in London who presented the report to the European Multidisciplinary Cancer Congress in Stockholm.

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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Illinois doctors get payments, perks from drug companies

US FDA remains wary of drospirenone clot risk | Reuters

(Reuters) - The U.S. Food and Drug Administration said it remained concerned about birth control pills containing the compound drospirenone that might pose higher risk of developing blood clots in women.

The drug regulator said it has completed its review of the two studies evaluating the risk of blood clots in women, but has not reached a conclusion yet.

Germany's Bayer AG's (BAYGn.DE) best-selling birth control drugs, including Yaz and Yasmin, contain the compound.

The agency said it is continuing the review of the compound in a separate FDA-funded study.

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FDA insider trader to plead guilty - court papers | Reuters

(Reuters) - A U.S. Food and Drug Administration chemist plans to plead guilty to charges he used secret information about pending drug approvals to make millions of dollars, according to court documents filed on Monday.

Cheng Yi Liang, 57, was accused of buying and selling stock in more than 25 companies with confidential FDA information to rack up more than $3.77 million in profits and avoided losses, according to court papers filed in federal court in Maryland.

Prosecutors filed a criminal information, typically used in guilty pleas, charging him with two counts of insider trading and making false statements. He bought and sold the stocks using the secret information between July 2006 and March 2011.

In March, prosecutors accused Liang and his son, Andrew, of insider trading. Prosecutors moved to dismiss the charges against the son, though last week he pleaded guilty to a separate charge of possession of child pornography.

Cheng Yi Liang examined documents about the progress of experimental drugs using an FDA database that includes confidential and non-public documents about trials, studies and correspondence, according to the criminal information.

Information about prescription drug approvals or denials can prompt big stock swings and has been the subject of other insider trading cases, though it is rare for such a case to involve a government employee.

The cases are: USA v Cheng Yi Liang, No. 11-cr-530; USA v Andrew Liang, No. 11-cr-501, and SEC v Liang, No. 11-cv-00819 in U.S. District Court for the District of Maryland. (Reporting by Jeremy Pelofsky; Editing by Richard Chang)

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Monday, September 26, 2011

Steven Pinker: Why Violence Is Vanishing

An Important Video to Watch: Pepper-Spray by a Cruel and Cowardly NYC Cop - James Fallows - National - The Atlantic

soulful sepulcher: Dr.Steve Balt: Dollars for Docs, Pfizer and a $306 dollar questionable "meal"

Novartis ready to shed jobs to keep costs low | City A.M.

SWISS drugmaker Novartis will make sweeping job cuts at sites across the world in a bid to keep a cap on costs, according to sources in its home country.

Like many pharmaceutical companies, Novartis is starting to face generic competition, with its breast cancer drug Femara and its blood pressure medicine Diovan losing patent protection.

A spokesman for Novartis said the firm could not confirm that number. Novartis’ local rival Roche has announced it would cut several thousand jobs in a similar cost-saving drive.

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Novartis ready to shed jobs to keep costs low | City A.M.

SWISS drugmaker Novartis will make sweeping job cuts at sites across the world in a bid to keep a cap on costs, according to sources in its home country.

Like many pharmaceutical companies, Novartis is starting to face generic competition, with its breast cancer drug Femara and its blood pressure medicine Diovan losing patent protection.

A spokesman for Novartis said the firm could not confirm that number. Novartis’ local rival Roche has announced it would cut several thousand jobs in a similar cost-saving drive.

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Drugged Kids - Marilyn Wedge interviews Prof. Joel Bakan about Joe Biederman

MW: How do pharmaceutical companies influence the creation of childhood psychiatric diagnoses?

JB: "The Diagnostic and Statistical Manuel of Mental Disorders (DSM)" is the bible of psychiatric disorders. Indeed, the lead authors of the last two editions have joined forces to publicly warn that the broadening of diagnostic categories ill-serves patients and is a bonanza for the pharmaceutical industry. For pharmaceutical companies, more and wider diagnoses of mental disorders mean larger markets for their products. That cannot be denied. Nor can it be denied that the companies influence not only the "DSM" process, but other less formal channels through which diagnoses are formed, such as medical research, the medical literature, and continuing education for doctors.

Child psychiatrist Dr. Joseph Biederman, for example, was highly influential among child psychiatrists and pediatricians -- "if he breathed a drug at a conference, thousands of kids would be on it," according to physician Dr. Lawrence Diller. The same was true for diagnoses, in particular the diagnosis of pediatric bipolar disorder the he almost single-handedly created. The fact that his work was supported by several drug companies, and that he was paid handsomely for giving speeches and consultations on their behalf, does not necessarily deny the validity of his work. But it does raise serious questions.

MW: How is medical research corrupted by Big Pharma?

JB: There are really two points where pharmaceutical companies exert influence over medical research -- the research itself, and then the publication of that research. At both points that influence can create a tilt towards over prescribing drugs. In terms of the conduct of research, for a variety of reasons, including changes to the laws regulating research, medical research is more under the direct control and sponsorship of pharmaceutical companies than ever before. With that power, they are able to define research questions, choose methodologies, and do analyses, all of which gives them the ability to increase the likelihood of certain results.

As Marcia Angell, Harvard professor and former editor-in-chief of "The New England Journal of Medicine," described it in a clinical trial "you can control what data you look at, control the analysis, and then shade your interpretation of the results. You can design studies to come out the way you want them to." This can help yield "science" that emphasizes the efficacy of drugs and downplays the drugs' negative side-effects. But if a study does come out negative, a company can simply refrain from publishing it and it never reaches the public.


MW: In your chapter "Prescriptions for Profit," you discuss how profitable diagnoses are invented by psychiatrists. What was the role of Harvard Medical School professor Joseph Biederman in creating the diagnosis of childhood bipolar disorder?

JB: As I understand it, Dr. Biederman began to notice in the 1990s that some kids who had been diagnosed with ADHD were not responding to treatment with stimulants, the usual approach to treating that disorder. He attributed this to the fact they actually had bipolar disorder. This was a radical idea at the time. Bipolar disorder was believed to be a disorder that only afflicted adults, and perhaps teens in rare cases. While some kids were afflicted with depression, the telltale symptom of mania did not show up in kids. What Biederman declared, however, was that in kids agitation and distraction were substitutes for mania in adults, and therefore it made sense to diagnose kids with bipolar disorder. That is a fairly stripped down explanation, but I believe it is essentially accurate.

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Payments to health professionals - The ProPublica State List

A breakdown of disclosed payments made in 2009, 2010 and early 2011 by 10 pharmaceutical companies to health professionals in each state, plus Puerto Rico and the District of Columbia, according to data compiled by ProPublica.

1. California $89,422,406

2. New York $60,145,751

3. Texas $59,499,510

4. Florida $56,001,451

5. Pennsylvania $40,064,872

6. Ohio $33,834,904

7. North Carolina $29,592,466

8. Illinois $24,988,591

9. Massachusetts $22,135,703

10. New Jersey $21,773,190

11. Michigan $21,542,619

12. Tennessee $20,863,412

13. Georgia $20,014,467

14. Missouri $18,902,337

15. Maryland $18,635,466

16. Indiana $13,878,303

17. Colorado $13,383,820

18. Virginia $13,170,777

19. Arizona $12,171,338

20. Washington $11,909,748

21. Alabama $11,088,674

22. Kentucky $10,909,633

23. Connecticut $10,835,250

24. Minnesota $10,706,336

25. South Carolina $10,073,500

26. Wisconsin $9,229,426

27. Kansas $9,223,710

28. Louisiana $8,502,889

29. Utah $7,588,632

30. Oklahoma $6,303,237

31. Oregon $5,937,530

32. Rhode Island $5,664,244

33. Nevada $5,273,745

34. Iowa $5,215,997

35. Nebraska $5,059,794

36. Arkansas $4,953,714

37. Puerto Rico $4,789,479

38. Mississippi $4,447,250

39. D.C. $3,619,223

40. West Virginia $3,343,424

41. New Hampshire $2,742,608

42. Idaho $2,555,576

43. New Mexico $2,166,325

44. Delaware $1,921,487

45. Hawaii $1,415,005

46. North Dakota $1,322,998

47. Maine $1,244,415

48. South Dakota $803,491

49. Vermont $768,856

50. Montana $692,983

51. Wyoming $319,996

52. Alaska $263,333

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Teva Falls to Lowest Since 2006 in Tel Aviv, Closing Gap With U.S. Shares - Bloomberg

Teva Pharmaceutical Industries Ltd. (TEVA) slumped to the lowest level since December 2006, narrowing the gap with the U.S.-traded shares, after European regulators said they need more time to review its bid for Cephalon Inc.

The stock of the world’s largest maker of generic drugs declined 3.1 percent to 130.30 shekels, the equivalent of $35.19, at the 4:30 p.m. close in Tel Aviv. The New York-traded shares lost 8.6 percent last week to $35.26.

The European Commission on Sept. 23 extended its antitrust review of Teva’s bid for Cephalon, setting a new deadline of Oct. 13. Teva’s $6.8 billion acquisition of the U.S. biotechnology company was supposed to be concluded by the end of the third quarter, according to Natali Gotlieb, a Tel Aviv-based analyst at IBI-Israel Brokerage & Investments Ltd.

“As long as the deal isn’t closed, it will take longer for Teva to include Cephalon’s earnings,” Gotlieb said by telephone.

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Slumdog clinical trials contd. - Clinical trials claimed 1,600 lives in 3 years, 22 compensated, - Bangalore Mirror

Nearly 1,600 people died during clinical trials of drugs conducted by various multinational pharmaceutical companies between 2008 and 2010, according to the Directorate General of Health Services.

However, it is learnt that compensation was paid only in 22 cases.

Replying to an RTI query, the DGHS said 288 people lost their lives during clinical trials in 2008, while 637 and 668 deaths were reported in the year 2009 and 2010 respectively.

A total of Rs 53.33 lakh was paid as compensation in 22 cases only out of 668 deaths in 2010, it said.

This information was obtained by Hisar-based RTI activist Ramesh Verma. In his RTI application, Verma had sought details of the clinical trials conducted in India in last 10 years, the number of people died during these trials, and the compensation paid to their families.

The DGHS reply said that some of the deaths occurred due to side-effects of the medicines developed to cure serious illness such as cancer.

DGHS rules prescribe for a compensation in cases of deaths during clinical trials, but they do not say anything on the amount of money to be paid as compensation.

According to the RTI reply, the number of registered clinical trials in the country from 2007 to 2010 stood at 1,502.  

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Roche grumble: Drug deliveries to Greek hospitals halted | New Europe

Basel-based pharmaceutical company Roche has stopped deliveries of medications to Greek hospitals because of non-payment of bills, Swiss Info reported on 19 September.  Roche managing director Severin Schwan said some Greek hospitals had not paid their bills for three or four years.  “We have arrived at a point where we can no longer conduct business normally,” Schwan said.  

Since Roche stopped deliveries in the summer, certain hospitals had begun to pay their bills because they realised their reputations were on the line, Schwan said. He added that the company had increased its drug deliveries to Greek pharmacies because they paid their bills more regularly.

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Sly Stone - then and now

Former NEJM Editor Criticizes Publication and Peer Review of ARISTOTLE Trial - Forbes

Sunday, September 25, 2011

Elizabeth Warren on Debt Crisis, Fair Taxation


Novartis cut 2,500 jobs globally-paper | Reuters


(Reuters) - Swiss drugmaker Novartis is in the process of cutting 2,500 jobs at sites across the world in a bid to control costs, daily Tages Anzeiger reported on Saturday.
Like many pharmaceutical companies, Novartis is starting to face generic competition, with its breast cancer drug Femara and its blood pressure medicine Diovan losing patent protection.
A spokesman for Novartis said the firm could not confirm that number.
Novartis' rival Roche has announced it would cut several thousand jobs in a cost-saving drive.
(Reporting by Catherine Bosley; Editing by John Stonestreet)

Saturday, September 24, 2011

left flank: The McGorry-Hickie reform controversy: Why has mental health become so political?

Johnson & Johnson recalls anemia drug Eprex in 17 countries for inconsistent potency - OrlandoSentinel.com

NEW YORK (AP) — Johnson & Johnson is recalling about 200,000 syringes of the anemia drug Eprex because of inconsistent potency in dosages.

There were no reports of any adverse events, according to Stefan Gijssels, spokesman for the company's Janssen Pharmaceuticals division.

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Roche expects $10 billion sales for HDL drug

"This is the order of magnitude we are looking at," Jean-Jacques Garaud said in an interview on Friday, when asked if dalcetrapib could produce annual sales in the $10 billion range.

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Dangerous Minds | Amazing Rolling Stones jam session, 1972

Friday, September 23, 2011

Nurofen tampering: police make arrest | The Guardian

Watch David Healy and Robert Whitaker speak


Hat tip: http://1boringoldman.com/

Well worth the time and trouble.

Tales From the PMPCA contd. - The Case of the Disparaged Rat Poison

A GP complained that a number of articles about Boehringer Ingelheim’s product Pradaxa (dabigatran) which appeared in the Daily Mail, The Telegraph and the Express on 5 April 2011, referred to the use of the medicine to prevent stroke, an unlicensed indication.  

Pradaxa was indicated for the primary prevention of venous thromboembolic events in adults who had undergone elective total hip or knee replacement surgery.  Boehringer Ingelheim had made an application to the European Medicines Agency (EMA) to extend the licence to prevention of stroke and systemic embolism in atrial fibrillation.

The complainant was concerned that the articles contained exaggerated claims about Pradaxa which had arisen from misleading press releases issued by Boehringer Ingelheim. The coverage contained quotations from UK experts and patient group representatives and it was likely that Boehringer Ingelheim had facilitated access to these individuals and approved this unlicensed promotion of Pradaxa within the UK.

The claims for stroke prevention were based on a retrospective subanalysis of the Randomized Evaluation of Long-Term Anti-coagulant Therapy (RE-LY) study (Connolly et al 2009), which compared the effect of Pradaxa with warfarin in preventing strokes in people with atrial fibrillation.   The complainant noted that this promotion took place after an application was made to the EMA to extend the licence of Pradaxa for the prevention of thromboembolism and stroke in people with atrial fibrillation and the recent approval by the Food and Drug Administration (FDA) for the same.

The complainant also alleged that the press articles disparaged warfarin, a current option, referring to it as a rat poison.   The complainant noted that packs of Pradaxa were also pictured.

The complainant alleged that the promotion to the public of an unlicensed indication was irresponsible and would encourage the public to seek the prescription of Pradaxa for this purpose.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that the Code prohibited the advertising of prescription only medicines to the public.  However, the Code permitted information about prescription only medicines to be supplied directly or indirectly to the public but such information had to be factual and presented in a balanced way.  It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.  Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.  Complaints about articles in the press were judged on the information provided by the pharmaceutical company or its agent to the journalist and not on the content of the article itself.

The Panel noted that Boehringer Ingelheim had engaged as spokespeople two health professionals and two patient organisation representatives.  At least one of the health professionals was briefed by Boehringer Ingelheim’s media agency, and the company had facilitated the availability of the spokespersons for interviews.  The Panel considered that Boehringer Ingelheim was responsible under the Code for comments made by these spokespersons.  Companies could not use independent experts as a means of avoiding the restrictions in the Code.  The Panel noted that the contract between Boehringer Ingelheim and one health professional spokesperson referred to some of the requirements of the Code, but did not refer either to the prohibition on the promotion of prescription only medicines to the public or the Code requirements on the content of information directed at the public.  The Panel considered that this was a significant omission particularly as the press release was aimed at the consumer press.

The Panel noted that the health professional spokesperson briefed by Boehringer Ingelheim’s media agency was quoted in the press release issued by Boehringer Ingelheim to the consumer press and that some of the press articles included further quotes from him and other spokespersons.  The Panel was concerned that this health professional spokesperson was quoted in The Telegraph article describing Pradaxa as preventing ‘clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs’.  

The Panel noted that the press release discussed the comparative data in relation to stroke prevention from Flaker et al (2011) a sub-group analysis of the RE-LY study, Connelly et al (2009) the RE-LY study and Connelly et al (2010a) newly identified events in the RE-LY study.  The press release included quotations from the same health professional which described Pradaxa as an ‘invaluable option’ for patients.  The press release did not include the pack shot.
 
The press release stated that, compared to well-controlled warfarin, 150mg dabigatran twice daily showed a 39% reduction in the risk of stroke in patients with paroxysmal atrial fibrillation, 36% reduction in the risk of stroke in patients with persistent atrial fibrillation and a 30% reduction in the risk of stroke in patients with permanent atrial fibrillation. There was no mention of major haemorrhage or any other adverse event in the press release. The Panel noted that Pradaxa was not authorized for use in atrial fibrillation.  The Panel questioned whether in the absence of information in the consumer press release about side effects the press release was balanced.

The Panel noted that the press release mentioned warfarin solely in relation to its use as a comparator in Flaker et al and the RE-LY studies.  It did not refer to warfarin as rat poison and otherwise made no disparaging remarks about the medicine.  The Panel had no evidence about how warfarin had been described by Boehringer Ingelheim’s spokespersons or at any press conference.  No breach of the Code was ruled in that regard.

The Panel was concerned about the very positive statements in the ‘Notes to Editors’ section of the press release which described Pradaxa as ‘leading the way in new oral anticoagulants/direct thrombin inhibitors …targeting a high unmet medical need’ and queried whether this was a fair reflection of the evidence.  The press release did not refer to Pradaxa as a ‘super pill’ or as a ‘revolutionary drug’.  These phrases only appeared in the press articles.

Overall the Panel was very concerned about the content of the press release and the briefing material for spokespersons.  The Panel considered that these would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine.  The Panel was concerned about the lack of information in a consumer press release relating to side effects.  A breach of the Code was ruled.  The press release advertised a prescription only medicine to the public for an unlicensed indication.  The Panel ruled a breach of the Code in that regard.  The Panel considered that promotion of Pradaxa for an unlicensed indication was inconsistent with the terms of its marketing authorization.  A further breach of the Code was ruled.

The Panel considered that high standards had not been maintained and ruled a breach of the Code.  The material promoted a prescription only medicine to the public in an indication that was not yet licensed.  The Panel noted that promotion prior to the grant of a marketing authorization was listed as an example of an activity that was likely to be in breach of Clause 2.  Overall the Panel considered that the press release and the material for spokespersons brought discredit upon, and reduced confidence in, the industry.  A breach of Clause 2 was ruled.

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