Monday, April 1, 2013

Supreme Court to Deliver Key Drug Patent Ruling

Medindia Health News
Medindia largest health website in india. // via fulltextrssfeed.com
Supreme Court to Deliver Key Drug Patent Ruling
Apr 1st 2013, 16:19


The landmark case -- watched closely by global drug firms and patient groups -- involves an updated version of Novartis' blockbuster cancer drug Glivec, for which the company has fought a seven-year legal battle to win patent protection.

India's patent office has so far refused to grant protection, asserting that the amended form of Glivec was not vastly different from the earlier version.

The challenge strikes at the heart of India's patent law, which restricts pharmaceutical companies from seeking fresh patents for making only small modifications to existing drugs -- an industry practice known as "evergreening".

The case is the most high-profile of several patent battles being waged in India and could have far-reaching implications in defining the extent of patent protection for multinational drug firms operating in the lucrative market.

The Swiss firm has threatened to halt supplies of new medicines to India if the court does not rule in its favour, London's Financial Times reported on Sunday.

"If the situation stays as now, all improvements on an original compound are not protectable and such drugs would probably not be rolled out in India," said executive Paul Herrling, who is leading the company's handling of the case.

"Why would we?" he was quoted as saying by the newspaper.

But Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), says a legal victory for Novartis could "set a dangerous precedent, severely weakening India's legal norms against evergreening".

It would "be dire for people in the developing world who depend on generic drugs made in this country. It could seriously curb access".

Generic drug firms in India -- long known as the "pharmacy to the developing world" -- have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford expensive branded versions.

The cost difference between generic and branded drugs is crucial for poor people around the world, MSF says.

It points out that Glivec -- often hailed as a "silver bullet" for its breakthrough in treating a deadly form of leukaemia -- costs $4,000 a month in its branded form while its generic version is available in India for around $73.

But Novartis and other global drugmakers say India's generics industry inhibits pharmaceutical innovation and reduces commercial incentives to produce cutting-edge medicines.

The verdict is keenly awaited by many global drug firms hoping to sell branded medicines in the nation of 1.2 billion people where the pharmaceutical market is set to touch $74 billion in sales by 2020 from $11 billion in 2011.

India's copycat drugs industry, which supplies one-fifth of the world's generics, grew into a powerhouse because the country did not issue drug patents until 2005 when it began complying with World Trade Organisation rules.

India currently allows patents only for new drugs or for an updated version of a drug that displays "enhanced" therapeutic efficiency.

Source-AFP

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Health Scheme Screens Over 17 Million People, Say Officials

Medindia Health News
Medindia largest health website in india. // via fulltextrssfeed.com
Health Scheme Screens Over 17 Million People, Say Officials
Apr 1st 2013, 16:19


Out of the total number of people screened under the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) scheme, 7.18 percent were found to have suspected diabetes and 6.57 percent had hypertension, health ministry officials said Monday.

NPCDCS is being implemented in 100 districts across 21 states.

The districts have been selected keeping in account their backwardness, inaccessibility and poor health indicators, the officials said.

Under the programme, health clinics are functional in 62 districts and 50 community health centres clinics are operational in seven districts.

Cardiac care units are functional in 39 districts.

Source-IANS

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Himalaya: A Booming Herbal Healthcare Company in India

Medindia Health News
Medindia largest health website in india. // via fulltextrssfeed.com
Himalaya: A Booming Herbal Healthcare Company in India
Apr 1st 2013, 16:19


"It's high time people took us very seriously and did not view us as an alternative form of medicine," says Philipe Haydon, the India chief executive of the Himalaya group from his office in tech and healthcare hub Bangalore.

"This is not a feel-good product. This will save a man's life," he says, taking a box from a stack next to his desk.

It is marked Liv 52, a blend of six herbs used to treat liver disorders, and is one of the firms best-selling products.

In two recent clinical tests, results published in the World Journal of Gastroenterology in 2007 and in the Antiviral Research journal in 2009 showed significant results.

"It so happens that the input material is a herb but the rest of it is very very modern," said the 50-year-old, who joined Himalaya in 1979.

The group is an Indian healthcare success story, combining ancient traditional medicine known as Ayurveda with cutting-edge technology.

Its air-tight production facility converts truck-loads of fragrant organic matter into eight million tablets a day and 10,000 bottles of medicine.

In the quality control area, men and women in lab coats sit next to conveyor belts as tablets fly past on their way into plastic pots carrying Himalaya's green and orange labels.

In the research and development wing, 250 scientists are working to find new combinations of herbs whose active ingredients are extracted and concentrated to form products that are then tested by humans.

Sales have quadrupled in the last five years to reach 12 billion rupees ($220 million) in 2012. Its target is a billion dollars in annual revenue in the next four years as it spreads into foreign markets.

Ayurvedic medicine -- which means the "science of life" in Sanskrit -- treats the physical and mental sources of illness through, for example, prescribing herbs in conjunction with yoga or massage.

Much of the knowledge, passed on by word of mouth, predates written records, but two volumes of remedies and prescriptions have survived called the Caraka Samhita and the Sushruta Samhita.

"This is where it all begins, these herbal texts that were handed down 3,000 years ago," said Haydon.

"We look at the kind of combinations (of herbs) that are suggested and from that point onwards we have a group of scientists who bring contemporary medicine and science to those texts."

The group now has 75 remedies, including treatments for hypertension, kidney stones and cholesterol.

An estimated 80 percent of India's 1.2-billion population uses Ayurvedic medicine, partly for cost reasons, with a pack of 100 Liv 52 tablets selling for just 65 rupees ($1.20).

To raise its profile and revenues, Himalaya branched out in 1996 into consumer products such as shampoos and sun cream.

Like the pharmaceuticals, these use herbs such as neem, a tree known as a "village pharmacy" in rural India due to the range of its medicinal properties.

Dotted around India but centred in the temperate foothills of the Himalayas, 4,000 producers of leaves, roots and plants are busy farming for the group on long-term contracts.

The rejection of the "alternative" tag is partly borne of bitter experience in the West, where regulations on pharmaceuticals mean Himalaya's products are classed as food supplements and thus stocked alongside other treatments that Haydon dismisses as "feel-good products".

If Himalaya must be considered "alternative", he says it should be seen only as an alternative to multi-national pharmaceutical firms.

"We are competing with GlaxoSmithKline, Beechams and AstraZeneca. They have products for diabetes, so do we. They have products for hepatitis, so do we," he says.

Overall, the resources are tiny compared with a giant like GlaxoSmithKline which recorded a $7.0-billion profit last year.

And Himalaya holds a mere eight patents having "got out of the patent race" because they offered little protection from competitors who could simply copy a combination, add a new herb and then claim it as a different product.

Jon Tilburt, an expert on modern Western and traditional medicine at the Mayo Clinic healthcare group in the United States, says he understands why Himalaya rejects the "alternative" label.

"There are plenty of herbal companies and all of them in some ways would like to have the esteem of a pharmaceutical company but then none of them wants the regulatory burden," he told AFP.

"They really want their own category of a sort of executive club for herbal players."

Generally the scientific evidence on alternative medicine is mixed, he said, echoing the World Health Organisation which has called for more funding to test traditional treatments from India, Africa or China.

And there are potential dangers that give the herbal industry a bad name.

A study published this month by Graham Lord, a professor of medicine at King's College London, warned about remedies once sold but now banned in the West that contain aristolochic acids linked to kidney failure.

"Herbal remedies around the world are not legislated as medicines," he told AFP. "Because it's herbal, it's not necessarily safe."

But for Himalaya, the future appears bright -- not least because the domestic drugs market is growing at an annual rate of 15 percent, according to the Confederation of Indian Industries.

Source-AFP

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Elderly Dementia Patients can Successfully be Taken Off Harmful Antipsychotic Drugs

Medindia Health News
Medindia largest health website in india. // via fulltextrssfeed.com
Elderly Dementia Patients can Successfully be Taken Off Harmful Antipsychotic Drugs
Apr 1st 2013, 16:19


Now, a new evidence review from The Cochrane Library has found that most older people on antipsychotic medication can be successfully weaned off, although some people experience a reoccurrence of their dementia-related symptoms.

The reviewers searched for evidence about the benefit of stopping these medications versus the risk that discontinuing use would result in a reoccurrence of distressing dementia symptoms.

"We have enough evidence to prevent people with dementia and [the behavioral and psychological symptoms of dementia] from experiencing side effects associated with antipsychotic medication. Consequently, withdrawal of chronic antipsychotic medication should be incorporated in daily practice," said the review's lead author Tom Declercq, M.D., assistant professor in the department of family practice at Ghent University in Belgium.

Dementia is a condition that causes people to gradually lose cognitive function. People with dementia often develop behavioral symptoms such as agitation, anxiety, screaming, wandering and resisting the care of people working with them. Up to 78 percent of people in nursing homes have dementia and 76 percent experience some behavioral and psychological symptoms of dementia. Antipsychotic medication is often used to treat patients when behavioral treatment to control or lessen these troubling symptoms hasn't proven effective.

Researchers compared the results of placebo-controlled trials where antipsychotic medications were withdrawn to trials that continued using antipsychotics in people with dementia. Participants included 606 adults who were 65 or older.

In seven of the nine studies included in the review, people with dementia who had been treated with antipsychotic medications over a long period of time did not experience a deterioration of their behavior when the medications were withdrawn. However, in two studies, patients experienced a relapse after their antipsychotic medications were discontinued.

Declercq noted, "Unfortunately, it is not clear which patients are eligible for discontinuation of antipsychotic medications without relapse."

"Based on FDA black box warnings about increased mortality in this patient population, the Center for Medicare Services (CMS) and regulatory agencies dealing with nursing homes are already pushing to reduce antipsychotic use with dementia patients," added Iqbal "Ike" Ahmed, M.D., clinical professor of psychiatry and geriatric medicine at the University of Hawaii.

Ahmed, who agreed with the review's findings, said, "It should be emphasized that while behavioral problems in dementia patients should be carefully assessed and treated with non-pharmacologic approaches, some patients may need antipsychotics at least in the short term.

Stopping treatment, as two review studies pointed out, may result in some patients worsening with these efforts." Iqbal added, "That's why it is important for patients, guardians and families to be involved in discussing the risk and benefits of the use of these agents."

Source-ANI

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Autistic Children Benefit from Shakespeare

Medindia Health News
Medindia largest health website in india. // via fulltextrssfeed.com
Autistic Children Benefit from Shakespeare
Apr 1st 2013, 16:19


Children with autism often struggle to communicate. Many avoid eye contact, don't understand the context of conversation and may miss visual cues from others around them.

But by allowing children with autism spectrum disorder (ASD) to study with Ohio State University student actors who are engaging students in Shakespeare-based activities, the hope is that they will improve their socializing and communicating skills, Dr. Marc J. Tasse, director of the Nisonger Center and principal investigator on the waitlist control trial studying the unique intervention, said.

"In this intervention with middle school children with autism, we're using Shakespeare's play, The Tempest," Tasse, who is also a clinical psychologist, said.

"It's quite amazing to see how a Shakespeare play can be transformed into a therapeutic intervention that encourages students to express themselves and communicate," he said.

The research project is a collaborative effort with the Nisonger Center, the Ohio State University Department of Theatre, Columbus City Schools and the Ohio State University/Royal Shakespeare Company (RSC) partnership.

The Nisonger Center is the only place in the United States testing this idea, said Tasse.

The idea originated about 20 years ago in Great Britain with Kelly Hunter, an actress in the Royal Shakespeare Company in London, who developed the "Hunter Heartbeat Method." Her signature approach pairs the recitation of Shakespeare's rhythmic language with physical gesture.

Hunter reached out to Ohio State asking researchers here to develop the study protocol.

Now, students in the Department of Theatre are teaming up with researchers at the Nisonger Center to try and figure out exactly what it is about Shakespeare that reaches these children with autism, when many other approaches may not.

"The distinctive methodology I have created uses Shakespeare to release the communicative blocks within children with autism," Hunter, who is visiting Columbus now and working with some of the children in the intervention sessions said.

Source-ANI

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Japanese Football Superhero Returns to Save His Birthplace

Medindia Health News
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Japanese Football Superhero Returns to Save His Birthplace
Apr 1st 2013, 16:19


His bronze statue was unveiled on Saturday in a newly built park in the eastern Tokyo town of Yotsugi, the hometown of Captain Tsubasa creator Yoichi Takahashi, as a tourist attraction to help boost the community's flagging fortunes.

"Yotsugi is where I was born and brought up but it appears to have run down since when I was a child," Takahashi, 52, told the unveiling ceremony attended by about 700 dignitaries, townspeople and fans including children.

"I wish every kind of people will come from across the nation and from around the world to see, touch and photograph this statue."

The statue shows Tsubasa Ozora as an elementary school boy in the early phase of the comic series -- standing 145 centimetres (4 feet 9 inches) tall, smiling broadly and putting on a captain's armband.

The Captain Tsubasa strip, also featuring goalkeeper Genzo Wakabayashi, was launched in a Japanese boys' weekly magazine in 1981 when football was still a minority sport in baseball-hooked Japan.

Over the years, the star player, Captain Tsubasa, has become a professional player in Brazil and moved to Barcelona.

His fortunes rose alongside those of the game in Japan, where the J-League was launched in 1993. The national side reached the last 16 of the 2010 World Cup.

The series has featured around the world in cartoon books, animated films and video games, read and watched avidly also by the likes of Messi of Barcelona and Argentina and Torres of Chelsea and Spain on their way to superstar status.

It is entitled "Holly e Benji" in Italy, "Campeones: Oliver y Benji" in Spain and "Super Campeones" in Spanish-speaking Latin America. North American viewers know him as "Flash Kicker".

"There are many people who fell in love with football after reading this manga among the world's top players and Japan's national team players," Japanese MP Katsuei Hirasawa told the ceremony.

Takahashi said more than 100 countries are believed to have tuned in to the series. And the stories have sold more than 70 million copies in book form at home. Foreign sales are estimated at 10 million-plus copies.

The series has been suspended since last year and the creator, who became hooked on football after watching the 1978 World Cup on television, said he had no immediate plans to produce new material, but had a lot of ideas.

"As a matter of course, Tsubasa's dream is to see Japan win the World Cup. I definitely hope I get to draw this scene one day," he said.

Source-AFP

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Measuring the Quality of Hospitals and Doctors: When Is Good Good Enough?

The Health Care Blog
The Health Care Blog
Measuring the Quality of Hospitals and Doctors: When Is Good Good Enough?
Apr 1st 2013, 12:26

By Bob Wachter, MD

In the past, neither hospitals nor practicing physicians were accustomed to being measured and judged. Aside from periodic inspections by the Joint Commission (for which they had years of notice and on which failures were rare), hospitals did not publicly report their quality data, and payment was based on volume, not performance.

Physicians endured an orgy of judgment during their formative years – in high school, college, medical school, and in residency and fellowship. But then it stopped, or at least it used to. At the tender age of 29 and having passed "the boards," I remember the feeling of relief knowing that my professional work would never again be subject to the judgment of others.

In the past few years, all of that has changed, as society has found our healthcare "product" wanting and determined that the best way to spark improvement is to measure us, to report the measures publicly, and to pay differentially based on these measures. The strategy is sound, even if the measures are often not.

Hospitals and doctors, unaccustomed to being rated and ranked like resort hotels and American Idol contestants, are suffering from performance anxiety and feeling an intense desire to be left alone. But we also bristle at the possibility of misclassification: to be branded a "B" or a "C" when you're really an "A" feels profoundly unjust.

In my role as chair of the ABIM this year, I am awed by the amount of time and expertise that goes into ensuring that the pass/fail decisions of the Board are valid and defensible (legally, if necessary). They are. But as new kinds of measures spring up, most of them lack the rigor of the verdicts of the certifying boards. For example, Medicare is now penalizing hospitals that have excessive numbers of readmissions. As Harvard's Karen Joynt and Ashish Jha observed in 2012, there is considerable doubt that the 30-day readmission rate is a valid measure of quality, and clear evidence that its application leads to misclassifications – particularly for penalized hospitals whose sins are that they care for large numbers of poor patients or that they house teaching programs. Quite understandably, these hospitals cry "foul."

Yet the Medicare fines have contributed to a falling number of readmissions nationally – from 19 percent in 2011 to 17.8 percent in 2012, which represents more than 100,000 patients spared an unpleasant and risky return trip to the hospital. While cause and effect is difficult to prove, it seems likely that hospitals' responses to the Medicare program (better discharge planning, earlier follow-up appointments, enhanced communication with PCPs, post-discharge phone calls to patients) are playing a role. "Readmissions are not a good quality measure," Jha observed in a recent blog, "but they may be a very good way to change the notion of accountability within the healthcare delivery system." Medicare's Jonathan Blum puts it more bluntly. "I'm personally comfortable with some imprecision to our measures," he said, as long as the measures are contributing to the ultimate goal of reducing readmissions.

With Jha and seven other experts, I am an advisor to the Leapfrog Group's effort to grade hospitals on patient safety. Using the best available publicly reported data, our panel recommended a set of measures and a weighting system that Leapfrog has used to assign patient safety letter grades to U.S. hospitals. The hospitals that have received "F's" (25 out of the 2619 hospitals that received ratings) have been up in arms – I've received several calls from their representatives, livid about what they believe to be a vast injustice. Yet there is no question that these hospitals are working on improvement with a passion that, in many cases, was previously lacking.

Of course, before getting down to business, everyone's first two responses to poor grades are to question the validity of the measures and to work on better coding. I know one hospital that received a stellar grade in the Consumer Reports ranking system (one of the several systems now out there), and responded by festooning the hospital lobby and halls with banners. A few months later, when they received a "C" from Leapfrog, their reaction was to inveigh against the methods. This, of course, is natural: we embrace the rankings we like and reject the ones we don't. But it is largely unproductive.

At a recent conference on transparency, I heard Arnie Milstein, a national leader in assessment and a professor at Stanford, speak about the current state of quality measurement. He described the Los Angeles Health Department's program that rates restaurants on cleanliness, and mandates that restaurants post large signs with their letter grades (A, B, or C) in their windows. According to Milstein, the measures "would not have passed the National Quality Forum," the agency that vets healthcare quality measures for scientific rigor. Yet the results were strikingly positive: a 20 percent decrease in patients hospitalized for food poisoning. This raises the central question: "At what point are measures good enough?"

In a 2007 study, Milstein and colleagues asked 1,057 Americans about physician quality measures. Specifically, they wondered what level of potential inaccuracy people would accept before they would not want to see the results. About one in five respondents said that they would want to see a measure even if its rate of misclassification (calling a doctor fair when she is excellent, or vice versa) was as high as 20-50 percent. Another third would not tolerate that degree of uncertainty, but would want access to measures that might be as much as 5-20 percent inaccurate.

Milstein hypothesized that these results might be a manifestation of the public's famous innumeracy: perhaps these folks didn't really understand the hazards of relying on such flawed information. So he asked the same question of a group of PhD statisticians at a national meeting. If anything, they were even more tolerant of misclassification risk. "'P equals less than 0.05' was nowhere to be seen," he quipped.

Why were experts and non-experts alike so accepting of misclassification? Milstein came to the conclusion that the measures that they were being offered were better than what they had, which was nothing. Moreover, they probably sensed that public reporting of such measures would not only help them make better choices as consumers, but would also spur the doctors to improve. "Measures can motivate or discriminate," Yale's Harlan Krumholz reminded us at the same meeting. And in most cases, they do a bit of both.

Does the public's tolerance for misclassification give measurers – the ABIM, Leapfrog, or Medicare – a free ride on the "Ends-Justify-The-Means" Express? Absolutely not. Measurers need to do their honest best to produce measures with as much scientific integrity as possible, and commit themselves to improving the measures over time. Medicare's decision to ditch their four-hour door-to-antibiotic time pneumonia measure in the face of evidence of misclassification and unanticipated consequences (antibiotics at triage for everyone with a cough) is a shining example of responding to feedback and new data. In a recent NEJM article, Joynt and Jha recommend a few simple changes, including taking into account patients' socioeconomic status, that could improve the readmission measure. The trick is to adjust appropriately for such predictors without giving safety net and academic hospitals a pass, since these organizations undoubtedly vary in performance and many have room for improvement.

Now that I have been on both sides of the measurement equation, one thing that has become clear to me is this: Public reporting of quality measures not only improves the work of the measured, it improves the work of the measurer. Ultimately, a healthcare ecosystem in which reasonable measures help guide patient and purchaser choices will lead to improvements in both the quality of care and of the measures themselves. I believe we can look forward to an era of more accurate measures, measures that capture the right things (not just clinical quality but teamwork and communication skills, for example), and measures that are less burdensome to collect and analyze.

If there were a way of getting to this Nirvana without ever unfairly characterizing a physician or hospital as a "C" when she/it is really a "B+", that would be splendid. Personally, I can't see how we can manage that. Seen in that light, the question to ask is not, "Are the measures perfect?" (clearly, they're not) but, "Is the risk of misclassification low enough and the value of public reporting and other policy responses high enough that the measure is good enough to use?" A second, equally important question follows: "Is the measurer committed to listening to the feedback of the public and profession and to responding to the emerging science in an effort to improve the measure over time?"

Measures that do not meet the first criteria should not be used. And organizations that do not meet the second should be ejected from the measurement and judgment business.

Robert Wachter, MD, professor of medicine at UCSF, is widely regarded as a leading figure in the patient safety and quality movements. He edits the federal government's two leading safety websites, and the second edition of his book, "Understanding Patient Safety," was recently published by McGraw-Hill. In addition, he coined the term "hospitalist" in an influential 1996 essay in The New England Journal of Medicine and is chair of the American Board of Internal Medicine.  His posts appear semi-regularly on THCB and on his own blog, Wachter's World.

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