Should our attitude towards 'never events' change?

There are twenty-five errors in the NHS that are classed as 'never events', including wrong site surgery and retained foreign objects. Photograph: Sean Smith/The Guardian

Twenty-five errors in the health service are considered so intolerable and inexcusable that they have been designated 'never events'. They include wrong-site surgery, retained foreign objects and administering chemotherapy by the wrong route.

When a never event occurs, the organisation concerned must follow national procedures for reporting and investigating what happened and may pay a significant financial penalty. The object of the policy introduced in 2009 is to encourage greater organisational focus on specific serious safety issues. The problem with categorising certain incidents as never events is that it may divert attention from the most important goal of improving patient safety across the board. The term is also misleading because these events do occur, usually because of a combination of chance and human error, factors that can never be totally eliminated. In his positively received report into NHS patient safety Professor Don Berwick states: "'Zero Harm' is a bold and worthy aspiration, [but] the scientifically correct goal is 'continual reduction'. All in the NHS should understand that safety is a continually emerging property, and that the battle for safety is never 'won'; rather, it is always in progress."

In May 2013 a BBC investigation identified 762 never events in four years, including 322 retained items and 73 misplaced nasogastric feeding tubes. I do not believe the categorisation never events is helpful. This is not to dismiss the distress these errors cause to patients and their families, but the term and the financial penalties create a stigma for individuals and organisations, which may not be conducive to a culture that should promote reporting and learning from mistakes. When our members, who are 50% of UK GPs and hospital doctors, approach us for advice about what to do if there has been a mistake in a patient's care or treatment, we advise them to ensure the patient receives a sincere apology, together with an explanation of what went wrong and how it will be put right. Irrespective of whether the incident was a never event, it is vital that there is a full investigation and that steps are taken to avoid the incident happening again.

For patients who are harmed, the last thing on their minds is probably whether it was a never event. There are incidents in which patients are harmed that fall outside the classification. One example is where patients have been given a drug, such as penicillin, to which they have a known allergy. The consequences of this could be anaphylactic shock and even death and in many cases the error could have been prevented by taking and recording of a medical history, checking records before administering medication and checking if the patient is wearing a red wristband. These preventable errors must be treated as seriously as a never event but there is a risk they may not get the same attention.

Medicine, even when properly and carefully practised, is not a zero-harm or a zero-risk profession.

Preventable things can and do go wrong, sometimes with severe consequences for patients and to the distress of the healthcare professionals involved.

Berwick argues there is a need for a transparent culture within the NHS where mistakes are reported and learning is shared to improve patient safety. Patients who have suffered harm because of any medical error should rightly expect that what happened to them has been the subject of a thorough investigation to determine what happened, why and what lessons have to be learned. Wouldn't it be better to concentrate on this than on determining whether an incident classifies as a never event?

Dr Christine Tomkins is chief executive of the MDU

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'We should not miss the opportunity for change within the NHS'

'We should not fail to take previously missed opportunties to learn from some excellent reports', says Tony Yeaman. Photograph: Christopher Thomond

Prof Don Berwick's report Improving the Safety of Patients in England follows a long line of investigations into failures in care within the NHS and a plethora of responses to them; and yet we are no closer to the solution of the wide-ranging problems. 

While a number of commentators say the Berwick report contains nothing new, this should not devalue its positive recommendations and the chance it provides to advance patient safety throughout the NHS. Nor should we fail to take previously missed opportunities to learn from some excellent reports, not least Robert Francis's two reports into Mid Staffordshire.

Berwick's advisory group identified a number of problems that related more to systems, procedures and priorities than staff, and argued that there was a lack of focus on the patient. The group advised that continuous improvement and investment in life-long learning is needed, with the patient at the heart of this. It also suggested a move away from a blame culture to greater transparency. They recommended that the service must accept the need for systemic change, move away from blame as a tool and work more closely with service users and providers.  A more careful approach on quantitative targets is needed, as is clarity on which body is actually charged with delivering safety.

There is a real opportunity – and importantly public and political appetite – for change, with a radically reformed NHS putting clinicians at the heart of commissioning through CCGs, a public shift in attitude, and a willingness to learn and share experience exemplified by the NHS Litigation Authority's new approach of using its unique data sets from claims to develop learning initiatives to reduce harm, thereby improving patient and staff safety. 

The biggest challenge for all those in healthcare – the commissioners, providers and regulators who wholeheartedly accept this drive for improved patient safety – is to have sufficient time and resources to implement the changes needed against a moving target that is created by publication of report after report, making slightly different but overlapping recommendations, guidance and regulation. This job is made all the more difficult by the reality of working under the spotlight of external review and public suspicion, and doing so in a constrained financial environment.

Going forward it will not just be the providers who will have to ensure patient care is at the top of their agenda, but also those who commission care and regulate the service. Commissioners will have to ensure they commission with safety at the heart of their intentions, assuring themselves of a provider's track record and ongoing safe performance, using appropriate data metrics to do so. There will be an extra impetus on them not to miss any warning signs – whether they be complaints, claims or mortality indicators.

The whole healthcare economy will have to work much more closely and find a way not only to hear the voice of regulators but importantly patients, their representatives and those delivering the care in a more open blame-free environment. But as Berwick points out, in order to keep this promise it's not just about the staff – even Berwick's recommendation of a criminal sanction against those found to have wilfully neglected patients comes with this warning.

It is more instead about systems, procedures and culture and all these require a unified approach and proper resourcing. Boards are being asked to take a long hard look at their organisations and ensure they are adopting current and best practice, and their staff as a whole are being developed. Let's hope they are given time to do so.

Tony Yeaman is head of healthcare at law firm Weightmans LLP

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

View the original article here

TEVA Should Embrace Copaxone Patent Expiration

As a long suffering investor in Teva Pharmaceutical Industries (TEVA), I have wondered many times why the valuation that the market gives Teva is so much lower than most other large pharmaceutical companies. Among the many reasons I have come up with are:

Lumpy revenue and profits depending on exclusive generic launches, as well as the associated legal expenses.Lack of transparency on executive compensation.History of acquisitions, which only seem to add to the top line and not the bottom line.Company is based in Israel, although this really shouldn't impact much other than the foreign exchange rate between the shekel and the dollar for dividend payments.Potential patent expiration of Copaxone, as well as competition from new oral MS drugs.

The fifth reason is probably the biggest driver for Teva's valuation. Copaxone brought in $1.1 billion of revenue in the 2Q 2013, which represented about 22.4% of total revenue in the quarter. With new oral MS drugs getting approved by the FDA, in particular Biogen Idec's (BIIB) Tecfidera, Copaxone is unlikely to keep growing at a fast pace. But while you can argue about how much market share Tecfidera will take from Copaxone, the bigger issue is probably the looming patent expiration. Both Momenta Pharmaceuticals (MNTA) and Mylan (MYL) have reportedly developed a generic version of Copaxone and have been sued for infringement of patents by Teva. On June 24, 2012, a U.S. court upheld Teva's patents until the last one expires on September 1, 2015, but this verdict was promptly appealed.

On July 26, 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the last patent was invalid and would allow a generic version of Copaxone to be launched May 24, 2014, assuming FDA approval of course. Whether or not a generic would be approved, given that Copaxone is considered a "pseudobiologic", is a topic for another article in itself, but I am assuming that a generic will be launched in May 2014. As crazy as it sounds, this may actually be a good thing for Teva by getting rid of one big "overhang" that the company is facing.

Here is a look at what happened to the revenue in the quarter before and the quarter after 5 different pharmaceutical companies lost patent protection on their blockbuster drugs, as well as how the stock price reacted in the year leading up to drug exclusivity loss:

Pfizer (PFE)

Pfizer lost Lipitor exclusivity in November 2011, which was the best selling drug of all time.

3Q 2011 Worldwide Lipitor Sales: $2.602 billion (15.1% of total revenue), total revenue: $17.193 billion

1Q 2012 Worldwide Lipitor Sales: $383 million (2.49% of total revenues & 85% decrease from 3Q 2011), total revenue: $15.4 billion

Pfizer stock price first week of December 2010, 1 year before loss of Lipitor: $16.50, which marked low point from then until now.

Pfizer stock price first week of December 2011, after loss of Lipitor: $19.50 (18% gain, excluding dividends)

Forest Laboratories (FRX)

Forest Laboratories lost Lexapro exclusivity in March 2012, which was the most prescribed branded anti-depressant.

4Q 2011 Lexapro sales: $593 million (49.4% of total revenue), total revenue: $1.2 billion

2Q 2012 Lexapro sales: $110 million (13.4% total revenue & 81% decrease from 4Q 2011), total revenue: $821 million

Forest stock price mid March 2011, 1 year before loss of Lexapro: $31, with the lowest price in November 2011 at $28.50.

Forest stock price mid March 2012, after loss of Lexapro: $34 (10% gain). Forest Laboratories currently trades about $43 per share.

Eli Lilly (LLY)

Lilly lost Zyprexa exclusivity in October 2011.

3Q 2011 Zyprexa sales: $1.18 billion (19.2% of total revenue), total revenue: $6.15 billion

1Q 2012 Zyprexa sales: $0.56 billion (10% of total revenue & 52.5% decrease from 3Q 2011), total revenue: $5.60 billion

Lilly stock price at the end of October 2010, 1 year before loss of Zyprexa: $35, with the lowest price in November 2010 at $34.

Lilly stock price at the end of October 2011, after loss of Zyprexa: $38 (9% gain, excluding dividends). Lilly currently trades about $52 per share.

Bristol Myers Squibb (BMY)

Bristol Myers Squibb lost Plavix exclusivity in May 2012.

1Q 2012 Plavix net sales: $1.69 billion (32.2% of total revenue), total revenue: $5.25 billion

3Q 2012 Plavix net sales: $0.064 billion (1.71% of total revenue & 96.2% decrease from 1Q 2012), total revenue: $ 3.74 billion

Bristol Myers Squibb stock price May 2011, 1 year before Plavix exclusivity loss: $28, with the lowest price in mid-June 2011 at $27.

Bristol Myers Squibb stock price mid-May 2012, after loss of Plavix: $33 (18% gain, excluding dividends). BMY currently trades about $42 per share.

Endo Health Solutions (ENDP)

Endo has an agreement with Actavis (ACT) subsidiary Watson for the exclusive generic version of Lidoderm to launch on September 15, 2013, with FDA approval. The actual patent expiration date is October 27, 2015. Since the Lidoderm generic has yet to launch, going over the revenue numbers and generic impact is not applicable. It is interesting to note, however, that the stock price is following a similar pattern to the other companies I have detailed.

Endo stock price in the first week of September 2012, 1 year before Lidoderm exclusivity loss: $32, with the lowest price in the first week of January 2013 at $25.

Current Endo stock price is about $41, or 28% gain in the past year.

RECAP

All 5 stocks saw gains in the year leading up to exclusivity loss of a blockbuster drug, with gains ranging anywhere from 9% - 28%. In 4 of the 5 stocks, with Pfizer being the exception, the lowest stock price happened less than 1 year before loss of exclusivity, with the low point averaging 8.5 months prior to exclusivity loss. I don't know if I can explain exactly why this happens, but would be interested in hearing any reader's theories. My thought is that the various management teams had to start keeping a keen eye on expenses, and the ability to control expenses is very important for investor confidence. I also wonder if just simply removing the "patent overhang" allows management to focus on growth again.

SO WHAT DOES THIS MEAN FOR TEVA?

Since the July 26, 2013 announcement that TEVA would lose Copaxone exclusivity in May 2014, the stock has fallen from $40 per share to the current price of $38.25. If the average lowest stock price of 8.5 months prior to the loss of exclusivity holds true, then this current price will mark the low point for the stock going forward. This would certainly be welcome news to every patient TEVA investor.

Disclosure: I am long TEVA. 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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2 Biopharma Stocks You Should Be Buying This Month

To sustain growth under stiff competition, biotech companies are always under pressure to improve their drug pipeline through continuous drug development initiatives. These initiatives help the companies offset potential revenue loss that occurs with patent expiration. Apart from launching new drugs, biotech companies also look for Merger and acquisition route for top line growth, as this strategy helps them expand their domestic and foreign operations.

Continuing our research on Healthcare Picks, (Read: 2 Pharma Stocks With More Than 25% YTD Returns To Consider AND Don't Miss These 3 Healthcare Sweet Spots) we at Fusion Research scouted out three biotech companies that are taking such initiatives to provide solid returns to their shareholders. Let's discuss these initiatives in detail.

Good revenue growth opportunity from the Multiple Myeloma drug market

Pomalyst is the new drug in Celgene's (CELG) Multiple Myeloma portfolio. This drug is a third line treatment medication for Multiple Myeloma, a type of blood cancer disease. Third line treatment signifies that doctors can only give it to patients after two dosages of other drugs. The FDA approved this drug in February this year, and according to a survey by R.W. Baird, it has attained 27% market share in third line blood cancer drugs in March this year. On August 9, 2013, the drug has received approval for distribution in the European Union.

Pomalyst is currently priced at $10,500 for a 28 day cycle. If we assume Pomalyst will achieve the same 27% market share in Europe's drug market too, then annual revenue of Pomalyst is expected to cross $122 million with 43,000 new Multiple Myeloma patients who are diagnosed each year in the U.S. and Europe combined. This calculation is just a small reflection of potential revenue growth that Pomalyst can generate due to growing multiple myeloma patients and expected market share growth.

The company has a strong presence in the Multiple Myeloma drug market. Its blockbuster drug Revlimid commanded 41% share in second line treatment. Second line drug treatment signifies that this drug can be given only after the first dosage of a different drug hasn't produced the desired improvement. With this strong share in the second line drug market, the company is striving to register this drug as a first line treatment drug, so doctors can give it to newly diagnosed patients. For registration, the company is conducting a MM-020 study, and recently it announced that it has achieved its first target of progression free survival, or PFS, in Phase III MM-020 study. PFS is the length of time during and after the treatment that the patient lives with the disease without it getting worse.

Based on this result, the company has initiated Revlimid's registration process as a first line treatment in the U.S. and Europe. Looking at the growth potential from newly diagnosed patients and an expected 5.2% annual growth in the Multiple Myeloma drug market until 2021, this approval could bring strong revenue growth from Revlimid.

Pomalyst is expected to capitalize on the company's strong presence in Multiple Myeloma, with Revlimid achieving 41% market share. Celgene can expect revenue growth potential from this market and with current MM-020 trials, the company will increase its presence in first line treatment of this disease.

Is $10.4 billion acquisition justifiable?

Amgen (AMGN) is expected to increase its share in the cancer drug market with the recent acquisition of ONYX Pharmaceuticals (ONXX) for $10.4 billion, or $125 per share. Onyx sells liver and kidney cancer treatment drugs under the Nexavar brand name, and it sells a third line Multiple Myeloma treatment drug under the brand name Kyprolis, which it launched last year. Kyprolis is the most preferred third line treatment drug with 52% share in the third line treatment drug market. Therefore, due to its market leadership and growth in multiple myeloma patients, analysts have pegged the drug's annual revenue to reach an expected $1 billion by 2016. This acquisition provides Amgen the opportunity to sustain top line growth in the future. The company is facing increased pressure from the market to increase its drug development program since patents on four of its five best selling drugs are expiring in 2015.

Kyprolis is approved in the U.S. market only, so Onyx is conducting Phase III FOCUS trials in order to register it in the European market for patients suffering from Multiple Myeloma. The company is expected to apply for registration approval after the interim results of these trials, which are due during the fourth quarter of this year. Looking at the company's previous trials results, Onyx should post good results in the current trial, and it expects no hurdle in approval. Europe is among the biggest markets for Multiple Myeloma drugs with registration of 21,240 new cases each year.

Meanwhile, Amgen is developing a heart failure drug called AMG 423. Heart failure accounts for 30% of global deaths in those suffering from heart diseases, and the demand for new effective drugs has been growing accordingly. AMG 423 is currently in phase two testing, and its result is expected to come in the first quarter of next year. It expects to conduct a phase three test after that.

To have a look at the potential of this drug, we can look at figures of Johnson & Johnson's (JNJ) Natrecor, which was approved in 2001 for acute heart failure. The frequency of this drug was around once a week. Its cost was around $500 per dose. If we consider three months of use at the same cost as Natrecor, AMG 423's annual cost comes to around $6,000 per patent.

If we assume that this drug achieves a peak penetration level of 20% of the 1 million patients that are hospitalized with heart failure in U.S., as per healthcare research and quality agency, then this drug's annual revenue is expected to reach $1.2 billion.

Acquisition of Onyx and the AMG 423 drug trial provide Amgen an opportunity to sustain its market leadership in the drug market. As patent expiration dates come near, the company has increased its research and development to enhance its drug pipeline, which can minimize the potential loss expected to come from patent expirations.

Conclusion:

Both companies are expecting good revenue growth from the Multiple Myeloma market.

Celgene's drugs are expected to leverage the Multiple Myeloma drug market growth, thus providing bright future prospects for the company and with MM-020 results on the chart, investors can expect good growth in company's top line, resulting in earnings growth.

Amgen's acquisition of Onyx provides good opportunity for it to benefit from the leadership of Kyprolis in the Multiple Myeloma drug market. Also, with new drug AMG 423 in the pipeline, it is expected that company will sustain growth in the future despite patent expirations in 2015. Investors can expect good top line growth reflecting in the company's EPS, which is expected to increase from $6.51 in 2012 to $8.28 in 2014. Investors have to remain patient for sustained growth from Amgen, as the world's biggest biotech company faces tough conditions ahead with patent expirations.

Both Amgen and Celgene currently trade at a 12 months trailing PE of 18.35 and 39.87 respectively, against the industry average PE of 53. Therefore, their current initiatives in the growing Multiple Myeloma market and low PE ratio, signify that both these stocks have upside potential.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (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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'We should not miss the opportunity for change within the NHS'

'We should not fail to take previously missed opportunties to learn from some excellent reports', says Tony Yeaman. Photograph: Christopher Thomond

Prof Don Berwick's report Improving the Safety of Patients in England follows a long line of investigations into failures in care within the NHS and a plethora of responses to them; and yet we are no closer to the solution of the wide-ranging problems. 

While a number of commentators say the Berwick report contains nothing new, this should not devalue its positive recommendations and the chance it provides to advance patient safety throughout the NHS. Nor should we fail to take previously missed opportunities to learn from some excellent reports, not least Robert Francis's two reports into Mid Staffordshire.

Berwick's advisory group identified a number of problems that related more to systems, procedures and priorities than staff, and argued that there was a lack of focus on the patient. The group advised that continuous improvement and investment in life-long learning is needed, with the patient at the heart of this. It also suggested a move away from a blame culture to greater transparency. They recommended that the service must accept the need for systemic change, move away from blame as a tool and work more closely with service users and providers.  A more careful approach on quantitative targets is needed, as is clarity on which body is actually charged with delivering safety.

There is a real opportunity – and importantly public and political appetite – for change, with a radically reformed NHS putting clinicians at the heart of commissioning through CCGs, a public shift in attitude, and a willingness to learn and share experience exemplified by the NHS Litigation Authority's new approach of using its unique data sets from claims to develop learning initiatives to reduce harm, thereby improving patient and staff safety. 

The biggest challenge for all those in healthcare – the commissioners, providers and regulators who wholeheartedly accept this drive for improved patient safety – is to have sufficient time and resources to implement the changes needed against a moving target that is created by publication of report after report, making slightly different but overlapping recommendations, guidance and regulation. This job is made all the more difficult by the reality of working under the spotlight of external review and public suspicion, and doing so in a constrained financial environment.

Going forward it will not just be the providers who will have to ensure patient care is at the top of their agenda, but also those who commission care and regulate the service. Commissioners will have to ensure they commission with safety at the heart of their intentions, assuring themselves of a provider's track record and ongoing safe performance, using appropriate data metrics to do so. There will be an extra impetus on them not to miss any warning signs – whether they be complaints, claims or mortality indicators.

The whole healthcare economy will have to work much more closely and find a way not only to hear the voice of regulators but importantly patients, their representatives and those delivering the care in a more open blame-free environment. But as Berwick points out, in order to keep this promise it's not just about the staff – even Berwick's recommendation of a criminal sanction against those found to have wilfully neglected patients comes with this warning.

It is more instead about systems, procedures and culture and all these require a unified approach and proper resourcing. Boards are being asked to take a long hard look at their organisations and ensure they are adopting current and best practice, and their staff as a whole are being developed. Let's hope they are given time to do so.

Tony Yeaman is head of healthcare at law firm Weightmans LLP

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

View the original article here

'We should not miss the opportunity for change within the NHS'

'We should not fail to take previously missed opportunties to learn from some excellent reports', says Tony Yeaman. Photograph: Christopher Thomond

Prof Don Berwick's report Improving the Safety of Patients in England follows a long line of investigations into failures in care within the NHS and a plethora of responses to them; and yet we are no closer to the solution of the wide-ranging problems. 

While a number of commentators say the Berwick report contains nothing new, this should not devalue its positive recommendations and the chance it provides to advance patient safety throughout the NHS. Nor should we fail to take previously missed opportunities to learn from some excellent reports, not least Robert Francis's two reports into Mid Staffordshire.

Berwick's advisory group identified a number of problems that related more to systems, procedures and priorities than staff, and argued that there was a lack of focus on the patient. The group advised that continuous improvement and investment in life-long learning is needed, with the patient at the heart of this. It also suggested a move away from a blame culture to greater transparency. They recommended that the service must accept the need for systemic change, move away from blame as a tool and work more closely with service users and providers.  A more careful approach on quantitative targets is needed, as is clarity on which body is actually charged with delivering safety.

There is a real opportunity – and importantly public and political appetite – for change, with a radically reformed NHS putting clinicians at the heart of commissioning through CCGs, a public shift in attitude, and a willingness to learn and share experience exemplified by the NHS Litigation Authority's new approach of using its unique data sets from claims to develop learning initiatives to reduce harm, thereby improving patient and staff safety. 

The biggest challenge for all those in healthcare – the commissioners, providers and regulators who wholeheartedly accept this drive for improved patient safety – is to have sufficient time and resources to implement the changes needed against a moving target that is created by publication of report after report, making slightly different but overlapping recommendations, guidance and regulation. This job is made all the more difficult by the reality of working under the spotlight of external review and public suspicion, and doing so in a constrained financial environment.

Going forward it will not just be the providers who will have to ensure patient care is at the top of their agenda, but also those who commission care and regulate the service. Commissioners will have to ensure they commission with safety at the heart of their intentions, assuring themselves of a provider's track record and ongoing safe performance, using appropriate data metrics to do so. There will be an extra impetus on them not to miss any warning signs – whether they be complaints, claims or mortality indicators.

The whole healthcare economy will have to work much more closely and find a way not only to hear the voice of regulators but importantly patients, their representatives and those delivering the care in a more open blame-free environment. But as Berwick points out, in order to keep this promise it's not just about the staff – even Berwick's recommendation of a criminal sanction against those found to have wilfully neglected patients comes with this warning.

It is more instead about systems, procedures and culture and all these require a unified approach and proper resourcing. Boards are being asked to take a long hard look at their organisations and ensure they are adopting current and best practice, and their staff as a whole are being developed. Let's hope they are given time to do so.

Tony Yeaman is head of healthcare at law firm Weightmans LLP

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

View the original article here

Preventive Isoniazid therapy should be considered for millions of HIV-infected people globally

Main Category: HIV / AIDS
Also Included In: Tuberculosis;  Preventive Medicine
Article Date: 19 Aug 2013 - 0:00 PDT Current ratings for:
Preventive Isoniazid therapy should be considered for millions of HIV-infected people globally

As part of the largest international research effort ever made to combat tuberculosis, a team of Johns Hopkins and Brazilian experts has found that preventive antibiotic therapy for people with HIV lowers this group's chances of developing TB or dying. Specifically, they found in men and women already infected with HIV that taking isoniazid reduced deaths and new cases of active TB disease by 31 percent, while new cases of TB alone decline by 13 percent.

The research team's findings, published in the journal Lancet Infectious Diseases online, stem from what is believed to be the largest expansion of a clinic-based, community health program designed to curb the spread of TB, and the first evidence that such a community-wide effort can be highly effective at preventing people who are co-infected from developing active TB disease.

According to senior study investigator and Johns Hopkins infectious disease specialists Richard Chaisson, M.D., his team's latest study results firmly support broad use of preventive isoniazid therapy for millions of people infected with HIV in Latin American, Asian, and Eastern European countries heavily burdened by TB.

Chaisson says TB disease remains the leading cause of death worldwide among those with HIV/AIDS and is epidemic in developing countries with the highest HIV-infection rates. Isoniazid treatment, which costs less than $1 for a full course of therapy, is already recommended by the World Health Organization to prevent TB in people with HIV disease. The policy, however, has not been widely adopted and its broad impact on the HIV-infected community never shown until the Johns Hopkins and Brazilian team's latest study.

All of the 12,816 study participants were eligible for screening for TB infection or active TB disease. Some 1,186 tested positive for TB infection, but did not have symptoms of TB sickness and could start taking 300 milligrams of isoniazid daily for six months. All received routine follow-up care for as little as a few weeks to as long as four years after initially seeking treatment at any of 29 HIV clinics across Brazil, a country hit hard by both infectious diseases. Some 838 deaths occurred during the study, which took four years to complete, and 475 developed TB. Symptoms of active TB disease, indicating the disease has progressed from latent infection, include persistent cough, chest pain, chills, fever, muscle weakness and fatigue.

"Our study results show that routine testing for TB and preventive isoniazid therapy works well at the community level in people with HIV disease in curbing the spread of TB and lowering the number who die," says Chaisson, a professor at the Johns Hopkins University School of Medicine and founding director of its Center for Tuberculosis Research.

"People with HIV disease living in all countries with rampant TB should be asking their physicians if they are good candidates for preventive isoniazid therapy," says Chaisson, who leads the overall global research effort, in support of this study and others, called the Consortium to Respond Effectively to the AIDS/TB Epidemic. CREATE, as it is known, is funded by the Bill and Melinda Gates Foundation.

When researchers restricted their analysis to 12,196 study participants who kept at least one annual check-up appointment, the overall death rate and number of new TB cases was even lower, at 55 percent. The number of active TB cases decreased by 58 percent. Among study participants who received isoniazid, commonly marketed under the brand names Niazid, Laniazid and Nydrazid, 85 percent took a full course of drugs for six months, as prescribed.

Another important finding, researchers say, was that initial TB screening of those seeking HIV care led to diagnosis of over a third (34 percent, or 250) of the total 725 new clinic patients found to have active TB. All were offered treatment for their disease but were excluded from the study analysis.

Lead study investigator and Johns Hopkins epidemiologist Jonathan Golub, Ph.D., M.P.H., says the study was, on its own, an effective screening tool, and affirms how unknown TB cases can be found when public health officials focus on community health programs in local clinics that service people more likely to become infected. In Brazil, an estimated 10 percent of people diagnosed with TB sickness are co-infected with HIV.

Golub says further research is needed to determine how long lasting are isoniazid's protective effects are and whether the single course of treatment used in the latest study is sufficient, or if repeat or lifelong antibiotic therapy is needed to suppress TB.

"Our efforts highlight the importance of continuous training in diagnosing TB, and our immediate priority is to train community doctors and nurses in HIV clinics to make TB testing part of routine HIV care," says Golub, an associate professor at Johns Hopkins. Golub points out that in Brazil, TB screening policies have been in place since 1995, but simply not followed. Golub says that once clinics involved in the study began more rigorous screening, the number of initial TB skin tests performed jumped threefold, and the number of patients taking isoniazid went up fourfold.

For the study, clinic staff were rigorously trained in correct procedures for screening all patients with HIV for possible TB infection and signs of active TB disease. Patients who tested positive for active TB disease were offered treatment, but were not included in study monitoring. Those who met study criteria were offered preventive isoniazid therapy. To detect TB, a simple skin test is initially performed, which if positive for signs of an immune response, can lead to further, confirmatory lab and X-ray testing.

Intensive training at all 29 clinics was randomly staggered every two months, allowing staff at all clinics to eventually benefit from the enhanced study effort. The staggered timeline also gave researchers a long period to assess isoniazid's effects pre- and post-training. Study participants were 61 percent male, and on average 37 years old. Sixty percent were receiving antiretroviral therapy for HIV.

Chaisson says the team next plans to evaluate faster diagnostic tests for TB, other than the initial skin test, which takes only minutes to administer, but requires a 48-hour waiting period to show any reaction. He says the ideal test would be a blood test that could be performed at the same time as routine anti-HIV tests for blood levels of CD4 immune cells.

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

Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial, doi:10.1016/S1473-3099(13)70187-7

In addition to the Bill and Melinda Gates Foundation, funding support for this study came from the National Institutes of Health Fogarty International Center and the National Institutes of Health. Corresponding grant numbers are U2RTW006885, AI066994 and AI001637.

Besides Chaisson and Golub, other Johns Hopkins researchers involved in this study were Lawrence Moulton, Ph.D.; Bonnie King, M.P.H.; Silvia Cohn, M.S.; and Anne Efron, M.S.N. Additional research assistance was provided by Betina Durovni, M.D.; Valeria Saraceni, M.D.; and Solange Cavalcante, M.D., at Municipal Health Secretariat in Rio de Janeiro, Brazil, and the Federal University of Rio de Janeiro; and Antonio Pacheco, Ph.D., at the Scientific Computing Program, Oswaldo Cruz Foundation, also in Rio de Janeiro.

Johns Hopkins Medicine

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Hospital screening tool for suicide risk among self-harmers should be ditched, UK

Main Category: Mental Health
Also Included In: Psychology / Psychiatry;  Medical Devices / Diagnostics
Article Date: 30 Jul 2013 - 0:00 PDT Current ratings for:
Hospital screening tool for suicide risk among self-harmers should be ditched, UK

A screening tool used in general hospitals to detect suicide risk among patients who have self harmed should be ditched, concludes a study published online in Emergency Medicine Journal.

The technique (SADPERSONS Scale) fails to pick up most of those who require admission to a psychiatric unit, community psychiatric aftercare, or to determine those at risk of self harming again, say the researchers.

The SADPERSONS Scale was developed in the USA in 1983 as a means of assessing suicide risk among patients who had self harmed. It is based on 10 major risk factors, but has changed little since it was first devised, say the researchers.

National guidance in England stipulates that all patients who go to hospital after an episode of self harm should be given a full psychosocial assessment. But current pressures in hospitals to meet waiting time targets, combined with a reduction in the availability of mental health services, mean that emergency care staff are increasingly minded to use rating scales to find out which patients can be discharged without a full psychosocial assessment, say the researchers.

They therefore assessed SADPERSONS scores that had been recorded for 126 patients consecutively admitted to one emergency medicine department in a major general hospital in Oxford during the summer of 2011, to see how accurate it was at predicting how these patients were subsequently managed and treated.

This included admission to a psychiatric unit, a proxy for psychosocial assessment; the provision of community psychiatric aftercare; and bouts of repeated self harm in the following six months.

Self harm was defined as any act of poisoning or injury, irrespective of its purpose. Most of the patients (102; 81%) had taken an overdose; around one in 10 (11%) had cut themselves; and the remaining 10 patients (8%) had inflicted other forms of injury on themselves.

Admission to a psychiatric unit was required in five cases (4%) and community psychiatric aftercare in just over half (55%; 70). One in four patients (24.6%) self harmed again at least once.

The SADPERSONS Scale only picked up 2% of those requiring admission to a psychiatric unit, around 6% of those needing community psychiatric aftercare, and just over 6.5% of those likely to self harm again.

The authors point out that for the purposes of suicide prevention, any technique designed to spot potential suicide risk must have a low rate of false negative results - in other words, it must be accurate and not miss most of those at risk of killing themselves.

While the small numbers of patients in this study don't allow any conclusions to be drawn about the Scale's usefulness in predicting suicide risk, the scores did not pick up very accurately those most at risk of further self harm, which is particularly associated with suicide risk, say the study authors.

Twenty three out of 31 of the episodes of self harm occurred within the first three months of the first visit to emergency care. But only two of these patients had high scores on the SADPERSONS Scale; the rest had low to moderate scores, suggesting they were not at high risk.

"The results clearly show that the SADPERSONS Scale has a very limited role, if any, to play in the assessment of patients presenting to the emergency department following an episode of self harm," write the authors.

"Indeed, arguably, our results show that reliance on the scale for determining who should receive a psychosocial assessment or otherwise using it for prediction is not only misleading, it could be dangerous," they add.

The use of rating scales has become increasingly widespread in response to the need to standardise practice for ever increasing numbers of patients. But these tools often overlook individual dynamics, they say.

"A greater focus on clinical judgement is needed, accompanied by the necessary education, training and supervision, if we are to more accurately fully identify and intervene with those who are at greatest risk following self harm," they conclude.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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What questions should we be asking about end-of-life preferences?

Ensuring people die at home is being used as a quick and easy proxy for a good death. Photograph: Layton Thompson

With the current focus on the Liverpool care pathway (LCP), there is a lot of talk about how people's end-of-life wishes are taken into account.

This is a very specific example of where a tool designed to improve co-ordination between professionals has sometimes been poorly implemented to the detriment of patients and their families.

But focusing on the LCP alone means we fail to see the wood for the trees.

The LCP is one element of a vast end-of-life care system, which has, since 2008, been geared up to help people achieve their preferred place of death. This has led to an underdeveloped system.

The fact is, ensuring people can die at home is currently being used – both by health and care professionals and by dying people themselves – as a quick and easy proxy for a good death.

In a way, this is understandable. Decisions about end-of-life care are often made under difficult circumstances and it can be hard for professionals to discuss the intricacies of medication and families' wishes. Under these circumstances, it is tempting to simplify the decision-making process, by making this into a choice about place.

But it is clear this has undermined the development of the end-of-life care system: it has led to a lack of proper scrutiny of the experience of dying at home and leaves other settings neglected when it comes to developing them as good places for people to die.

The result is a system where no single place is able to meet all of people's preferences.

Inevitable compromises ensue – which is most evident for people expressing a wish to die in their own home.

Successive surveys have found that around two thirds of people say that home would be the place they would want to die – but research recently carried out by Demos for the charity Sue Ryder reveals that although 78% of people surveyed said that dying without pain was important to them, only 27% felt that home was a place where they would be free from pain during their final days.

This suggests the public is switched on to the fact that pain relief and out-of-hours care in one's own home is an acknowledged weakness in the system.

Despite knowing this, people are still opting to die at home because it satisfies more of their preferences overall – such as being surrounded by loved ones, in familiar surroundings and having privacy and dignity.

Such a trade off – sacrificing pain relief to be with your family – is not acceptable in today's care system, and yet it goes unscrutinised due to a prevailing assumption that once someone dies at home, all their wishes have been taken into account.

In order to align the end-of-life care system with the rest of health and social care, we must shift the emphasis from where to how and think about what outcomes people value, regardless of where they end up.

This places a lot more responsibility on health and care staff to communicate honestly and sensitively with patients and their families about the kind of death they would like to achieve, and inform them of their options across all available locations.

This is not an easy conversation to have, and doctors, nurses and other health and care staff should be supported to ask the right kinds of questions – not where, but how.

This will require rethinking and adapting existing tools, such as advance care plans, to ensure that place is not viewed as the most important – or the only – choice that a person needs to make about their death.

We should be aiming for a system where a person can say "I want to die without pain" and know what their options are for achieving this – whether at home, in hospital or in hospice.

Perhaps Baroness Neuberger's more constructive recommendations will finally create such a system.

Jo Salter is a researcher at the thinktank Demos

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

On 17 July 2013, this article was amended to correct a link to the research conducted by Demos for Sue Ryder

View the original article here

Should You Try Botox? What We Wish We'd Known Before We Did

From wrinkles to migraines to happy faces, women share why they jumped on the Botox bandwagon

By Jeannette Moninger - June 26, 2013

It’s not just Real Housewives and Hollywood stars who want to stay youthful. In 2012, a record-setting 6.1 million Americans (94 percent of them women) received Botox injections. While some turn to the procedure to fight migraines or excessive sweating, the majority simply want to look younger. Here, women reveal the good, the bad and the ugly truth they learned from getting Botox.

Beware the Dog Face
“I loved how Botox softened my crow’s feet, so I tried it for frown lines between my brows. The effects were great — until I cried (and I cry often out of joy, sadness, hormonal reasons, you name it!). My inner eyebrows stayed the same, but the lower sections moved down giving me a basset hound appearance. I am an emotionally expressive person, so I will not be repeating that procedure.” —Stacey, age 45

It Can Cure Your 'Anger' Problem
“The deep crease between my eyebrows always made me look angry even when I was in great spirits. Without that line, I look so much more relaxed and youthful—happy even!” —Tina, age 48

Your Face Might Spasm
“When my Botox started to wear off, it felt like my forehead was having muscle spasms and contracting my eyebrows up toward my scalp. Thankfully, these spasms weren’t noticeable to others, but the sensation (which lasted for days) was very strange and really annoying.” —Sarah, age 44

You’ll Start Seeing Wrinkles Everywhere
“Since starting Botox, I’m very aware of how wrinkly other people’s foreheads are. But I would never tell my friends that.” —Ashlie, age 21

This Is Not the Time to Bargain Hunt
“I once experienced significant swelling after going to an inexperienced clinician. Ask your friends who they recommend and make sure the technician is well trained.” —Marisa, age 51

You Need to Be Realistic
“Botox isn’t a facelift-in-a-bottle. As a registered nurse who has both given and received injections, I find that most women’s expectations are too high. Botox is great at diminishing mild to moderate facial lines and wrinkles, but it won’t help saggy skin or deeply-etched lines. A good clinician should outline the changes you can realistically expect.” —Beth, age 52

It Really Can Prevent Migraines
“Getting Botox for migraines is like being stung repeatedly in the head. Still the pain is nothing compared to an actual migraine. My migraines have gone from about 15 a month to half that. It’s a win-win: Less pain and fewer wrinkles!” —Kari, age 44

It'll Stop Drippy Armpits
“My underarms used to drip before I started getting Botox for excessive sweating. The twice-yearly injections — about 20 per armpit — are not fun, but the payoff is sweet smelling.” —Robin, age 51

You Could Get Hooked
“At first I didn’t think I needed Botox. Now I’m scared to stop because I love what it has done for me. I feel younger, prettier and more confident” —Melissa, age 35

It's Not Just for Women With Wrinkles
“When deep creases started lining my forehead at age 27, I knew they’d only become deeper and more noticeable with age. I use Botox not necessarily to look younger, but to ensure that I won’t look older.” —Michelle, age 30

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View the original article here

Should You Try Botox? What We Wish We'd Known Before We Did

From wrinkles to migraines to happy faces, women share why they jumped on the Botox bandwagon

By Jeannette Moninger - June 26, 2013

It’s not just Real Housewives and Hollywood stars who want to stay youthful. In 2012, a record-setting 6.1 million Americans (94 percent of them women) received Botox injections. While some turn to the procedure to fight migraines or excessive sweating, the majority simply want to look younger. Here, women reveal the good, the bad and the ugly truth they learned from getting Botox.

Beware the Dog Face
“I loved how Botox softened my crow’s feet, so I tried it for frown lines between my brows. The effects were great — until I cried (and I cry often out of joy, sadness, hormonal reasons, you name it!). My inner eyebrows stayed the same, but the lower sections moved down giving me a basset hound appearance. I am an emotionally expressive person, so I will not be repeating that procedure.” —Stacey, age 45

It Can Cure Your 'Anger' Problem
“The deep crease between my eyebrows always made me look angry even when I was in great spirits. Without that line, I look so much more relaxed and youthful—happy even!” —Tina, age 48

Your Face Might Spasm
“When my Botox started to wear off, it felt like my forehead was having muscle spasms and contracting my eyebrows up toward my scalp. Thankfully, these spasms weren’t noticeable to others, but the sensation (which lasted for days) was very strange and really annoying.” —Sarah, age 44

You’ll Start Seeing Wrinkles Everywhere
“Since starting Botox, I’m very aware of how wrinkly other people’s foreheads are. But I would never tell my friends that.” —Ashlie, age 21

This Is Not the Time to Bargain Hunt
“I once experienced significant swelling after going to an inexperienced clinician. Ask your friends who they recommend and make sure the technician is well trained.” —Marisa, age 51

You Need to Be Realistic
“Botox isn’t a facelift-in-a-bottle. As a registered nurse who has both given and received injections, I find that most women’s expectations are too high. Botox is great at diminishing mild to moderate facial lines and wrinkles, but it won’t help saggy skin or deeply-etched lines. A good clinician should outline the changes you can realistically expect.” —Beth, age 52

It Really Can Prevent Migraines
“Getting Botox for migraines is like being stung repeatedly in the head. Still the pain is nothing compared to an actual migraine. My migraines have gone from about 15 a month to half that. It’s a win-win: Less pain and fewer wrinkles!” —Kari, age 44

It'll Stop Drippy Armpits
“My underarms used to drip before I started getting Botox for excessive sweating. The twice-yearly injections — about 20 per armpit — are not fun, but the payoff is sweet smelling.” —Robin, age 51

You Could Get Hooked
“At first I didn’t think I needed Botox. Now I’m scared to stop because I love what it has done for me. I feel younger, prettier and more confident” —Melissa, age 35

It's Not Just for Women With Wrinkles
“When deep creases started lining my forehead at age 27, I knew they’d only become deeper and more noticeable with age. I use Botox not necessarily to look younger, but to ensure that I won’t look older.” —Michelle, age 30

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here

Should You Try Botox? What We Wish We'd Known Before We Did

From wrinkles to migraines to happy faces, women share why they jumped on the Botox bandwagon

By Jeannette Moninger - June 26, 2013

It’s not just Real Housewives and Hollywood stars who want to stay youthful. In 2012, a record-setting 6.1 million Americans (94 percent of them women) received Botox injections. While some turn to the procedure to fight migraines or excessive sweating, the majority simply want to look younger. Here, women reveal the good, the bad and the ugly truth they learned from getting Botox.

Beware the Dog Face
“I loved how Botox softened my crow’s feet, so I tried it for frown lines between my brows. The effects were great — until I cried (and I cry often out of joy, sadness, hormonal reasons, you name it!). My inner eyebrows stayed the same, but the lower sections moved down giving me a basset hound appearance. I am an emotionally expressive person, so I will not be repeating that procedure.” —Stacey, age 45

It Can Cure Your 'Anger' Problem
“The deep crease between my eyebrows always made me look angry even when I was in great spirits. Without that line, I look so much more relaxed and youthful—happy even!” —Tina, age 48

Your Face Might Spasm
“When my Botox started to wear off, it felt like my forehead was having muscle spasms and contracting my eyebrows up toward my scalp. Thankfully, these spasms weren’t noticeable to others, but the sensation (which lasted for days) was very strange and really annoying.” —Sarah, age 44

You’ll Start Seeing Wrinkles Everywhere
“Since starting Botox, I’m very aware of how wrinkly other people’s foreheads are. But I would never tell my friends that.” —Ashlie, age 21

This Is Not the Time to Bargain Hunt
“I once experienced significant swelling after going to an inexperienced clinician. Ask your friends who they recommend and make sure the technician is well trained.” —Marisa, age 51

You Need to Be Realistic
“Botox isn’t a facelift-in-a-bottle. As a registered nurse who has both given and received injections, I find that most women’s expectations are too high. Botox is great at diminishing mild to moderate facial lines and wrinkles, but it won’t help saggy skin or deeply-etched lines. A good clinician should outline the changes you can realistically expect.” —Beth, age 52

It Really Can Prevent Migraines
“Getting Botox for migraines is like being stung repeatedly in the head. Still the pain is nothing compared to an actual migraine. My migraines have gone from about 15 a month to half that. It’s a win-win: Less pain and fewer wrinkles!” —Kari, age 44

It'll Stop Drippy Armpits
“My underarms used to drip before I started getting Botox for excessive sweating. The twice-yearly injections — about 20 per armpit — are not fun, but the payoff is sweet smelling.” —Robin, age 51

You Could Get Hooked
“At first I didn’t think I needed Botox. Now I’m scared to stop because I love what it has done for me. I feel younger, prettier and more confident” —Melissa, age 35

It's Not Just for Women With Wrinkles
“When deep creases started lining my forehead at age 27, I knew they’d only become deeper and more noticeable with age. I use Botox not necessarily to look younger, but to ensure that I won’t look older.” —Michelle, age 30

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here