Monday, March 19, 2012

News and Events - 20 Mar 2012




NHS Choices
16.03.2012 21:00:00

“Human resistance to antibiotics could bring ‘the end of modern medicine as we know it’,” according to The Daily Telegraph. The newspaper says that we are facing an antibiotic crisis that could make routine operations impossible and a scratched knee potentially fatal. Similarly, the Daily Mail’s headline stated that a sore throat could soon become fatal.

The alarming headlines follow a new report by the World Health Organization (WHO , which set out ways to fight the growing problem of antimicrobial resistance (AMR . AMR occurs when infectious organisms, such as bacteria and viruses, adapt to treatments and become resistant to them. The publication specifically addressed the long-known problem of antibiotic resistance, where increasing use of antibiotics can lead to the formation of “superbugs” that resist many of the antibiotic types we currently have. It outlined a variety of measures that are vital for ensuring we can still fight infections in the future and described how other major infectious diseases, such as tuberculosis, HIV, malaria and influenza, could one day become resistant to today’s treatment options.

However, despite the future danger posed by antimicrobial resistance, the situation is not irretrievable. As Dr Margaret Chan, director general of WHO, said: “much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” The report also highlighted successful cases where antimicrobial resistance has been tackled, demonstrating that we can safeguard the effectiveness of important antimicrobial medicines with dedicated, rational efforts.

 

Where has the news come from?

WHO has just published a new report (“The evolving threat of antimicrobial resistance - Options for action” that sets out a global strategy for fighting antibiotic resistance. It explores how over past decades, bacteria that cause common infections have gradually developed resistance to each new antibiotic developed, and how AMR has evolved to become a worldwide health threat. In particular, the report highlights that there is currently a lack of new antibiotics in development and outlines some of the measures needed to prevent a potential global crisis in healthcare.

This is not the first time WHO has set out such a strategy. In the 2001, WHO published its “Global strategy for containment of antimicrobial resistance”, which laid out a comprehensive list of recommendations for combating AMR. The current report looks at the experiences over the past decade of implementing some of these recommendations, the progress made, and what else should be done to tackle AMR.

 

What is antimicrobial resistance?

Antimicrobial resistance (AMR occurs when microorganisms, such as bacteria, viruses, fungi or other microbes, develop resistance to the drug that is being used to treat them. This means that the treatment no longer effectively kills or inactivates the microorganism. The term “antimicrobial” is used to describe all drugs that treat infections caused by microorganisms. Antibiotics are effective against bacteria only, antivirals against viruses, and antifungals against fungi.

The case of penicillin illustrates the AMR phenomenon well. When penicillin was first introduced in the 1940s, it revolutionised medicine and was effective against a wide range of staphylococcal and streptococcal bacteria. It was also able to treat infections that had previously been fatal for many people, including throat infections, pneumonia and wound infections. However, with increasing use of antibiotics over the decades, bacteria began to adapt and develop changes in their DNA that meant they were resistant to the actions of the once powerful antibiotic. These bacteria would survive and proliferate, which meant their protective genes would then be passed on to other strains of bacteria. As a result, new and stronger antibiotics had to be created to combat the resistant bacteria.

AMR is driven by many factors, including overuse of antimicrobials for human and animal health and in food production, which can allow microbes to adapt to antimicrobials they are exposed to. Poor infection-control measures, which fail to prevent the spread of infections, also contribute. In particular, the WHO publication reports what it describes as the five most important areas for the control of AMR, as recognised in its 2001 strategy:

  • surveillance of antimicrobial use
  • rational use in humans
  • rational use in animals
  • infection prevention and control
  • innovations in practice and new antimicrobials

 

How big is the problem?

As the report describes, AMR makes it difficult and more expensive to treat many common infections, causing delays in effective treatment or, in the worst cases, an inability to provide effective treatment at all. Many patients around the world suffer harm because infections from bacteria, viruses, fungi or other organisms can no longer be treated with the common medicines that would once have treated them effectively.

The report presents some startling facts on major infectious diseases worldwide:

  • Malaria: malaria is caused by parasites that are transmitted into the bloodstream by a bite from an infected mosquito. Resistance to antimalarial medicines has been documented for all classes of the drug, which presents a major threat to malaria control. The report describes that a change in national antimalarial treatment policy is recommended when the overall treatment failure rate exceeds 10%. Changes in policy have been necessary in many countries due to the emergence of chloroquine resistance. This means that alternative forms of combination therapy have to be used as first-line treatment.
  • Tuberculosis: in 2010, an estimated 290,000 new multidrug-resistant tuberculosis (TB cases were detected among the TB cases notified worldwide, and about one-third of these patients may die annually. Inaccuracies in diagnosis also impede appropriate treatment.
  • HIV: resistance rates to anti-HIV drug regimens ranging from 10% to 20% have been reported in Europe and the USA. Second-line treatments are generally effective in patients when the first-line therapy has failed, but can only be started promptly if viral monitoring is routinely available.
  • Common bacterial infections: various bacteria can cause infections within the chest, skin and urinary tract bloodstream, for example, and the inability to fight these infections appears to a growing problem in healthcare. Estimates from Europe are that there are 25,000 excess deaths each year due to resistant bacterial hospital infections, and approximately 2.5 million avoidable days in hospital caused by AMR. In addition, the economic burden from additional patient illness and death is estimated to be at least ˆ1.5 billion each year in healthcare costs and productivity losses.

 

What can be done about AMR?

The five key areas that the report highlights could tackle the problem of AMR are as follows:

 

Surveillance of antimicrobial use

Tracking antimicrobial use (in particular antibiotic use and looking at the emergence and spread of resistant strains of bacteria is a key tactic in the fight against AMR. This can provide information, insights and tools needed to guide policy and measure how successful changes in prescribing may be. This can happen both locally and globally.

AMR is a global problem but, at present, there appears to be wide variation in the way regions and countries approach AMR surveillance. This means there is a long way to go before it can be carried out worldwide.

 

Rational use in humans

Antimicrobials can obviously be important or even lifesaving in appropriate situations, but it is just as important to prevent unnecessary use of antimicrobials, which can lead to resistance. Putting this into practice worldwide is said to be difficult, but rationalising antimicrobial use has had a demonstrable impact on AMR in some cases.

 

Rational use in animals

Antibiotics are said to be used in greater quantities in food production than in the treatment of disease in human patients. Also, some of the same antibiotics or classes are used in animals and in human medicine. This carries the risk of the emergence and spread of resistant bacteria, including those capable of causing infections in both animals and people.

The problems associated with the use of antibiotics in animal husbandry, including in livestock, poultry and fish farming, are reportedly growing worldwide without clear evidence of the need for or benefit from it. There are said to be major differences in the amounts of antimicrobials used per kilogram of meat produced in high-income countries, and actions need to be taken by national and international authorities to control this.

 

Infection prevention and control in healthcare facilities

The hospital environment favours the emergence and spread of resistant bacteria. The report highlights the importance of infection-control measures to prevent the spread of microbes in general, regardless of whether they are resistant to antimicrobials. Many facilities and countries are reported to have progressed well since 2001, implementing many recommendations on infection control and prevention, although gaps and challenges still remain.

 

Innovations

Lastly, the report describes how innovative strategies and technologies are needed to address the lack of new antimicrobials being produced. As the report says, while antimicrobials are the mainstay of treatment for infections, diagnostics and vaccines play important complementary roles by promoting rational use of such medicines and preventing infections that would require antimicrobial treatment. So far, new products coming on to the market have not kept pace with the increasing needs for improvements in antimicrobial treatment. However, current challenges to new research developments can be both scientific and financial.

 

Can these strategies really stop AMR?

While AMR poses a significant threat to health in the future, the situation does not appear to be irretrievable. The WHO report and an accompanying press release highlight some examples of success stories over the past years:

  • In Thailand, the "Antibiotic Smart Use" programme is reported to have reduced both the prescribing of antibiotics by prescribers and the demand for them by patients. It demonstrated an 18–46% decrease in antibiotic use, while 97% of targeted patients were reported to have recovered or improved regardless of whether they had taken antibiotics.
  • A pharmacy programme in Vietnam reportedly consisted of inspection of prescription-only drugs, education on pharmacy treatment guidelines and group meetings of pharmacy staff. These measures were reported to give significant reduction in antibiotic dispensing for acute respiratory infections.
  • In Norway, the introduction of effective vaccines in farmed salmon and trout, together with improved fish health management, was reported to have reduced the annual use of antimicrobials in farmed fish by 98% between 1987 and 2004.
  • In 2010, the University of Zambia School of Medicine was reported to have revised its undergraduate medical curriculum. AMR and rational use of medicines were made key new topics to ensure that graduates who enter clinical practice have the right skills and attitudes to be both effective practitioners and take a role in fighting AMR.  

 

How can I help?

There are times when antibiotics are necessary or even vital. However, as patients and consumers, it is important to remember that antibiotics or other antimicrobials are not always needed to treat our illnesses, and we should not expect them in every situation.

For example, the common cold is caused by a virus, which means it does not respond to antibiotics. However, people may expect to be given antibiotics by their doctor when they are affected, even though they offer no direct benefit and could raise the risk of bacteria becoming resistant. Furthermore many common viral and bacterial infections such as coughs, throat and ear infections and stomach upsets, are “self-limiting” in healthy people, which means they will generally get better with no treatment at all.

If, on the other hand, you are prescribed an antimicrobial, it is important to take the full course as directed. Taking only a partial course of an antimicrobial may not kill the organism but may expose it to a low dose of a drug which can then contribute to resistance.

Links To The Headlines

Health chief warns: age of safe medicine is ending. The Independent, March 16 2012

Resistance to antibiotics could bring "the end of modern medicine as we know it", WHO claim. The Daily Telegraph, March 16 2012

Why a sore throat could soon be fatal: Bugs are becoming more resistant to antibiotics, warn health chiefs. Daily Mail, March 16 2012

Links To Science

WHO: The evolving threat of antimicrobial resistance - Options for action. March 16 2012




18.03.2012 3:00:00

A multinational research team led by scientists at
Duke-NUS Graduate Medical School has identified the reason why some patients fail to respond to some of the most successful cancer drugs.

Tyrosine kinase inhibitor drugs (TKI work effectively in most patients to fight certain blood cell cancers, such as chronic myelogenous leukemia (CML , and non-small-cell lung cancers (NSCLC with mutations in the EGFR gene.

These precisely targeted drugs shut down molecular pathways that keep these cancers flourishing and include TKIs for treating CML, and the form of NSCLC with EGFR genetic mutations.

Now the team at Duke-NUS Graduate Medical School in Singapore, working with the
Genome Institute of Singapore (GIS ,
Singapore General Hospital, and the
National Cancer Centre Singapore, has discovered that there is a common variation in the BIM gene in people of East Asian descent that contributes to some patients' failure to benefit from these tyrosine kinase inhibitor drugs.

"Because we could determine in cells how the BIM gene variant caused TKI resistance, we were able to devise a strategy to overcome it," said
S. Tiong Ong, MBBCh, senior author of the study and associate professor in the Cancer and Stem Cell Biology Signature Research Programme at Duke-NUS and Division of Medical Oncology, Department of Medicine, at Duke University Medical Center.

"A novel class of drugs called the BH3-mimetics provided the answer," Ong said. "When the BH3 drugs were added to the TKI therapy in experiments conducted on cancer cells with the BIM gene variant, we were able to overcome the resistance conferred by the gene. Our next step will be to bring this to clinical trials with patients."

Said Yijun Ruan, PhD, a co-senior author of this study and associate director for Genome Technology and Biology at GIS: "We used a genome-wide sequencing approach to specifically look for structural changes in the DNA of patient samples. This helped in the discovery of the East Asian BIM gene variant. What's more gratifying is that this collaboration validates the use of basic genomic technology to make clinically important discoveries."

The study was published online in
Nature Medicine on March 18.

If the drug combination does override TKI resistance in people, this will be good news for those with the BIM gene variant, which occurs in about 15 percent of the typical East Asian population. By contrast, no people of European or African ancestry were found to have this gene variant.

"While it's interesting to learn about this ethnic difference for the mutation, the greater significance of the finding is that the same principle may apply for other populations," said
Patrick Casey, PhD, senior vice dean for research at Duke-NUS and James B. Duke Professor of Pharmacology and Cancer Biology.

"There may well be other, yet to be discovered gene variations that account for drug resistance in different world populations. These findings underscore the importance of learning all we can about cancer pathways, mutations, and treatments that work for different types of individuals. This is how we can personalize cancer treatment and, ultimately, control cancer."

"We estimate that about 14,000 newly diagnosed East Asian CML and EGFR non-small-cell lung cancer patients per year will carry the gene variant," Ong said. "Notably, EGFR NSCLC is much more common in East Asia, and accounts for about 50 percent of all non-small-cell lung cancers in East Asia, compared to only 10 percent in the West."

The researchers found that drug resistance occurred because of impaired production of BH3-containing forms of the BIM protein. They confirmed that restoring BIM gene function with the BH3 drugs worked to overcome TKI resistance in both types of cancer.

"BH3-mimetic drugs are already being studied in clinical trials in combination with chemotherapy, and we are hopeful that BH3 drugs in combination with TKIs can actually overcome this form of TKI resistance in patients with CML and EGFR non-small-cell lung cancer," Ong said. "We are working closely with GIS and the commercialization arm of the Agency for Science, Technology & Research (A*STAR , to develop a clinical test for the BIM gene variant, so that we can take our discovery quickly to the patient."

The major contributors to the study include additional researchers and teams from the Duke-NUS Graduate Medical School, Genome Institute of Singapore (Dr. Yijun Ruan and Dr. Axel Hillmer , Singapore General Hospital (Dr. Charles Chuah , and National Cancer Centre Singapore (Dr. Darren Wan-Teck Lim .

In addition, the investigators also received important contributions from Akita University Graduate School of Medicine, Japan (Dr. Naoto Takahashi , the Cancer Science Institute of Singapore (Dr. Ross Soo , the National University Cancer Institute of Singapore (Drs. Liang Piu Koh and Tan Min Chin , the Yong Loo Lin School of Medicine, National University of Singapore (Dr. Seet Ju Ee , the University of Bonn, Germany (Dr. Markus Nothen , the University of Malaya (Dr. Veera Nadarajan , and the University of Tokyo, Japan (Dr. Hiroyuki Mano .

The study was supported by grants from the National Medical Research Council (NMRC of Singapore; Biomedical Research Council (BMRC of A*STAR, Singapore; Genome Institute of Singapore; Singapore General Hospital; and two NMRC Clinician Scientist Awards to Dr. Ong and Dr Chuah.




19.03.2012 15:00:00

by


counterfeitdrugs.jpg
Last week, the U.S. Sentate unanimously passed a bill sponsored by Patrick Leahy (D-VT ,
S. 1886, the Counterfeit Drug Penalty Enhancement Act of 2011. The Bill increases penalties for trafficking counterfeit drugs.

Currently, it is illegal to introduce counterfeit drugs into interstate commerce, but the penalties are the same as for illegal trafficking other goods, such as electronics or other merchandise. In essence, the penalties for copying a company's logo on a prescription bottle were more severe than for making and selling counterfeit drugs. The Bill targets violators who knowingly manufacture, sell, or traffic counterfeit medicines in the United States.

Senator Leahy was clearly pleased with the result and is urging the House to act quickly on the Senate's lead,
stating:

We cannot allow the counterfeiting of life-saving medicine to be just one more low-risk venture from which international organized criminals can profit . . . While we should not expect that enactment of this or any legislation will completely deter the serious problem of counterfeit medication entering the American supply chain, it is an important step in the fight. I urge the House of Representatives to act quickly on this legislation.


Worldwide counterfeit medicines are a multi-billion dollar industry, and growing at an alarming pace, especially over the internet. These medicines pose a serious threat to the health and safety of unsuspecting Americans . . .The House should act as quickly as possible to ensure that counterfeit drug traffickers are punished accordingly for putting people's lives at risk with this serious crime.

Continue Reading



2012-03-17 04:08:12
Bacteria could soon become so resistant to antibiotics that common injuries or illnesses could eventually become life-threatening, the head of the World Health Organization (
WHO warned during a conference of infectious disease experts on Friday. According to
NewsCore reports, WHO Director-General Margaret Chan told those attending the meeting, which was held in Copenhagen, Denmark, that even ailments as simple as a scratched knee or a sore throat could someday become fatal. Furthermore,
Daily Mail reporter Mario Ledwith writes that Chan believes that the Earth was quickly approaching what she referred to as the "post-antibiotic era." As these disease-causing microbes become more and more resistant to the drugs meant to treat the conditions they cause, those injuries and illnesses will become increasingly harder to treat, thus making some "remedies more expensive, and some conditions… untreatable," Ledwith added. If this so-called post-antibiotic era does, in fact, happen, Chan said that it would result in the "end to modern medicine as we know it." This "post-antibiotic era" would "include many of the breakthrough drugs developed to treat tuberculosis, malaria, bacterial infections and HIV/AIDS, as well as simple treatments for cuts," says Hannah Furness of
The Telegraph. Any medicines that would replace existing treatments would not only become more costly, but would also take longer in order to have similar affects as today's antibiotics. "Some sophisticated interventions, like hip replacements, organ transplants, cancer chemotherapy and care of pre-term infants, would become far more difficult or even too dangerous to undertake," Chan said, according to Ledwith. "Antimicrobial resistance is on the rise in Europe, and elsewhere in the world. Replacement treatments are more costly, more toxic, need much longer durations of treatment and may require treatment in intensive care units." Chan's warning comes following the release of a WHO book on the topic. According to Furness, that book, which is entitled '
The Evolving Threat of Antimicrobial Resistance- Options for Action,' claims that "a crisis has been building up over the decades, so that today many common and life-threatening infections are becoming difficult or even impossible to treat, sometimes turning a common infection into a life-threatening one." The Daily Mail reports that while many countries have already introduced policies attempting to prevent the overuse of antibiotics, that the UN's public health group is seeking worldwide implementation of such measures. The UK paper says that the European Union has acknowledged that they are aware of the problem and have developed a five-year plan to slow down antibiotic use, while medical experts in developing nations are also attempting to find ways to stop the substances from being prescribed too often.



20.03.2012 0:23:30



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16.03.2012 13:28:54
Many patients taking a widely prescribed class of oral cancer drugs are also using a variety of medications that could reduce the effectiveness of the cancer treatment or increase its toxic side effects, according to research by Medco Health Solutions Inc.
Source: Reuters Health
Related MedlinePlus Pages:
Cancer Chemotherapy,
Drug Reactions



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MONDAY, March 19 (HealthDay News -- A new type of medication for type 2 diabetes helps to lower blood sugar levels when used in concert with insulin and other diabetes drugs, new research suggests.



editors
20.03.2012 0:14:00
The National Institute for Health and Clinical Excellence (Nice issued new draft guidance recommending fingolimod (brand name Gilenya on the NHS for some patients with a form of MS. The new drug can help reduce the number of relapses in adults with highly active relapsing-remitting multiple sclerosis (RRMS , which is characterized by periods when symptoms worsen and then improve.
http://www.news-medical.net/news/20120319/Gilenya-pill-for-relapsing-remitting-multiple-sclerosis-recommended-by-NICE.aspx#comment



19.03.2012 10:00:00
New technology being developed at Florida State University could significantly decrease the cost of drug discovery, potentially leading to increased access to high-quality health care and cancer patients receiving personalized chemotherapy treatments...



16.03.2012 18:52:27
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19.03.2012 13:00:00
Unless we solve the problem of antimicrobial resistance to drugs, we will be facing a post-antibiotic era where things as common as strep throat infection or a child's scratched knee could once again kill, said Dr Margaret Chan, Director-General of the World Health Organization (WHO , in a speech she gave at an EU conference last week in Copenhagen, Denmark...



19.03.2012 22:15:02
Health Canada is warning that two popular medications used to treat baldness and enlarged prostates may put men at an increased risk of a serious form of prostate cancer, known as high-grade prostate cancer.

Saturday, March 17, 2012

News and Events - 18 Mar 2012




NHS Choices
16.03.2012 21:00:00

“Human resistance to antibiotics could bring ‘the end of modern medicine as we know it’,” according to The Daily Telegraph. The newspaper says that we are facing an antibiotic crisis that could make routine operations impossible and a scratched knee potentially fatal. Similarly, the Daily Mail’s headline stated that a sore throat could soon become fatal.

The alarming headlines follow a new report by the World Health Organization (WHO , which set out ways to fight the growing problem of antimicrobial resistance (AMR . AMR occurs when infectious organisms, such as bacteria and viruses, adapt to treatments and become resistant to them. The publication specifically addressed the long-known problem of antibiotic resistance, where increasing use of antibiotics can lead to the formation of “superbugs” that resist many of the antibiotic types we currently have. It outlined a variety of measures that are vital for ensuring we can still fight infections in the future and described how other major infectious diseases, such as tuberculosis, HIV, malaria and influenza, could one day become resistant to today’s treatment options.

However, despite the future danger posed by antimicrobial resistance, the situation is not irretrievable. As Dr Margaret Chan, director general of WHO, said: “much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” The report also highlighted successful cases where antimicrobial resistance has been tackled, demonstrating that we can safeguard the effectiveness of important antimicrobial medicines with dedicated, rational efforts.

 

Where has the news come from?

WHO has just published a new report (“The evolving threat of antimicrobial resistance - Options for action” that sets out a global strategy for fighting antibiotic resistance. It explores how over past decades, bacteria that cause common infections have gradually developed resistance to each new antibiotic developed, and how AMR has evolved to become a worldwide health threat. In particular, the report highlights that there is currently a lack of new antibiotics in development and outlines some of the measures needed to prevent a potential global crisis in healthcare.

This is not the first time WHO has set out such a strategy. In the 2001, WHO published its “Global strategy for containment of antimicrobial resistance”, which laid out a comprehensive list of recommendations for combating AMR. The current report looks at the experiences over the past decade of implementing some of these recommendations, the progress made, and what else should be done to tackle AMR.

 

What is antimicrobial resistance?

Antimicrobial resistance (AMR occurs when microorganisms, such as bacteria, viruses, fungi or other microbes, develop resistance to the drug that is being used to treat them. This means that the treatment no longer effectively kills or inactivates the microorganism. The term “antimicrobial” is used to describe all drugs that treat infections caused by microorganisms. Antibiotics are effective against bacteria only, antivirals against viruses only, and antifungals against fungi.

The case of penicillin illustrates the AMR phenomenon well. When penicillin was first introduced in the 1940s, it revolutionised medicine and was effective against a wide range of staphylococcal and streptococcal bacteria. It was also able to treat infections that had previously been fatal for many people, including throat infections, pneumonia and wound infections. However, with increasing use of antibiotics over the decades, bacteria began to adapt and develop changes in their DNA that meant they were resistant to the actions of the once-powerful antibiotic. These bacteria would survive and proliferate, which meant their protective genes would then be passed on to other strains of bacteria. As a result, new and stronger antibiotics had to be created to combat the resistant bacteria.

AMR is driven by many factors, including overuse of antimicrobials for human and animal health and in food production, which can allow microbes to adapt to antimicrobials they are exposed to. Poor infection-control measures, which fail to prevent the spread of infections, also contribute. In particular, the WHO publication reports what it describes as the five most important areas for the control of AMR, as recognised in its 2001 strategy:

  • surveillance of antimicrobial use
  • rational use in humans
  • rational use in animals
  • infection prevention and control
  • innovations in practice and new antimicrobials

 

How big is the problem?

As the report describes, AMR makes it difficult and more expensive to treat many common infections, causing delays in effective treatment or, in the worst cases, an inability to provide effective treatment at all. Many patients around the world suffer harm because infections from bacteria, viruses, fungi or other organisms can no longer be treated with the common medicines that would once have treated them effectively.

The report presents some startling facts on major infectious diseases worldwide:

  • Malaria: malaria is caused by parasites that are transmitted into the blood stream by a bite from an infected mosquito. Resistance to antimalarial medicines has been documented for all classes of the drug, which presents a major threat to malaria control. The report describes that a change in national antimalarial treatment policy is recommended when the overall treatment failure rate exceeds 10%. Changes in policy have been necessary in many countries due to the emergence of chloroquine resistance. This means that alternative forms of combination therapy have to be used as first-line treatment.
  • Tuberculosis: in 2010, an estimated 290,000 new multidrug-resistant tuberculosis (TB cases were detected among the TB cases notified worldwide, and about one-third of these patients may die annually. Inaccuracies in diagnosis also impede appropriate treatment.
  • HIV: resistance rates to anti-HIV drug regimens ranging from 10% to 20% have been reported in Europe and the USA. Second-line treatments are generally effective in patients when the first-line therapy has failed, but can only be started promptly if viral monitoring is routinely available.
  • Common bacterial infections: various bacteria can cause infections within the chest, skin and urinary tract bloodstream, for example, and the inability to fight these infections appears to a growing problem in healthcare. Estimates from Europe are that there are 25,000 excess deaths each year due to resistant bacterial hospital infections, and approximately 2.5 million avoidable days in hospital caused by AMR. In addition, the economic burden from additional patient illness and death is estimated to be at least ˆ1.5 billion each year in healthcare costs and productivity losses.

 

What can be done about AMR?

The five key areas that the report highlights could tackle the problem of AMR are as follows:

 

Surveillance of antimicrobial use

Tracking antimicrobial use (in particular antibiotic use and looking at the emergence and spread of resistant strains of bacteria is a key tactic in the fight against AMR. This can provide information, insights and tools needed to guide policy and measure how successful changes in prescribing may be. This can happen both locally and globally.

AMR is a global problem but, at present, there appears to be wide variation in the way regions and countries approach AMR surveillance. This means there is a long way to go before it can be carried out worldwide.

 

Rational use in humans

Antimicrobials can obviously be important or even lifesaving in appropriate situations, but it is just as important to prevent unnecessary use of antimicrobials, which can lead to resistance. Putting this into practice worldwide is said to be difficult, but rationalising antimicrobial use has had a demonstrable impact on AMR in some cases.

 

Rational use in animals

Antibiotics are said to be used in greater quantities in food production than in the treatment of disease in human patients. Also, some of the same antibiotics or classes are used in animals and in human medicine. This carries the risk of the emergence and spread of resistant bacteria, including those capable of causing infections in both animals and people.

The problems associated with the use of antibiotics in animal husbandry, including in livestock, poultry and fish farming, are reportedly growing worldwide without clear evidence of the need for or benefit from it. There are said to be major differences in the amounts of antimicrobials used per kilogram of meat produced in high-income countries, and actions need to be taken by national and international authorities to control this.

 

Infection prevention and control in healthcare facilities

The hospital environment favours the emergence and spread of resistant bacteria. The report highlights the importance of infection-control measures to prevent the spread of microbes in general, regardless of whether they are resistant to antimicrobials. Many facilities and countries are reported to have progressed well since 2001, implementing many recommendations on infection control and prevention, although gaps and challenges still remain.

 

Innovations

Lastly, the report describes how innovative strategies and technologies are needed to address the lack of new antimicrobials being produced. As the report says, while antimicrobials are the mainstay of treatment for infections, diagnostics and vaccines play important complementary roles by promoting rational use of such medicines and preventing infections that would require antimicrobial treatment. So far, new products coming on to the market have not kept pace with the increasing needs for improvements in antimicrobial treatment. However, current challenges to new research developments can be both scientific and financial.

 

Can these strategies really stop AMR?

While AMR poses a significant threat to health in the future, the situation does not appear to be irretrievable. The WHO report and an accompanying press release highlight some examples of success stories over the past years:

  • In Thailand, the "Antibiotic Smart Use" programme is reported to have reduced both the prescribing of antibiotics by prescribers and the demand for them by patients. It demonstrated an 18–46% decrease in antibiotic use, while 97% of targeted patients were reported to have recovered or improved regardless of whether they had taken antibiotics.
  • A pharmacy programme in Vietnam reportedly consisted of inspection of prescription-only drugs, education on pharmacy treatment guidelines and group meetings of pharmacy staff. These measures were reported to give significant reduction in antibiotic dispensing for acute respiratory infections.
  • In Norway, the introduction of effective vaccines in farmed salmon and trout, together with improved fish health management, was reported to have reduced the annual use of antimicrobials in farmed fish by 98% between 1987 and 2004.
  • In 2010, the University of Zambia School of Medicine was reported to have revised its undergraduate medical curriculum. AMR and rational use of medicines were made key new topics to ensure that graduates who enter clinical practice have the right skills and attitudes to be both effective practitioners and take a role in fighting AMR.  

 

How can I do my part?

There are times when antibiotics are necessary or even vital. However, as patients and consumers, it is important to remember that antibiotics or other antimicrobials are not always needed to treat our illnesses, and we should not expect them in every situation.

For example, the common cold is caused by a virus, which means it does not respond to antibiotics. However, people may expect to be given antibiotics by their doctor when they are affected, even though they offer no direct benefit and could raise the risk of bacteria becoming resistant. Furthermore many common viral and bacterial infections such as coughs,  throat and ear infections and stomach upsets, are “self-limiting” in healthy people, which means they will generally get better with no treatment at all.

If, on the other hand, you are prescribed an antimicrobial, it is important to take the full course as directed. Taking only a partial course of an antimicrobial may not kill the organism but may expose it to a low dose of a drug which can then contribute to resistance.

Links To The Headlines

Health chief warns: age of safe medicine is ending. The Independent, March 16 2012

Human resistance to antibiotics could bring "the end of modern medicine as we know it", WHO claim. The Daily Telegraph, March 16 2012

Why a sore throat could soon be fatal: Bugs are becoming more resistant to antibiotics, warn health chiefs. Daily Mail, March 16 2012

Links To Science

WHO: The evolving threat of antimicrobial resistance - Options for action. March 16 2012




16.03.2012 14:00:00

Lynne Taylor

Drugmakers' fury as China plans to widen price-cutting system

Domestic and multinational drugmakers in China have strongly criticised government plans for a wider roll-out of a piloted competitive tendering system for medicines procurement which has been shown to cut the prices of essential drugs by at least 30%.

The plans were announced at the annual National People's Congress in Beijing, where national leaders said the tendering system would be rolled-out further to support an increase in state health insurance coverage and moves to make health care more affordable.

Although the tendering scheme was piloted in five Chinese provinces, it is generally referred to as the "Anhui model" because in Anhui, the country's fourth-poorest province, it has been shown to reduce prices of essential drugs by an average of 53% below their officially-set maximum retail prices, with some price levels being slashed as much as 90%.

"The tendering system that we have implemented for basic drugs has proved to be effective and able to guarantee the drugs' safety, reasonable price and timely supply. Our next step is to further improve on these plans," Bloomberg reports Sun Zhigang, deputy director of the National Development and Reform Commission and head of the health care reform bureau at the State Council, as saying.

Currently, the tendering system covers 307 essential drugs but Ministers want to increase this to around 800 products, and also to cover the procurement of more expensive drugs used in hospitals in the treatment of diseases such as cancer. Research-based drugmakers say that doing so would force them to compete on price with generics makers, but supporters of the proposal point out that most such drugs are expensive imports.

While some observers feel that drugmakers will benefit as the government continues to add more products to the essential drugs list and extend state health insurance coverage to more and more of China's 1.3 billion population, others believe that manufacturers are being used as scapegoats and sector leaders are unhappy at the implications for their industry of a wider roll-out of the Anhui model. Several domestic firms have warned that their profits are likely to be cut as a result of the widening of the competitive tendering model, with some saying that they have already had to take a loss in order to sell their drugs to the authorities in Anhui.

The healthcare reform "is basically about tendering to compete on prices," but what needs to be prioritised is "guaranteeing quality first, rather than focusing on just prices, or this will be very unfair to China's drugmakers," Bloomberg quotes Guo Guangchang, chairman and co-founder of Fosun International, which controls the major drug maker Shanghai Fosun Pharmaceutical Co, as saying.

Last year, IMS Health forecast that drug spending in China will increase at the fastest rate globally during 2010-1015, with annual growth averaging 19%-22% and reaching as much as $125 billion by the end of the period.

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16.03.2012 17:42:00

International phase 3 trial is largest study ever of rare endocrine disorder

 

A new investigational drug significantly reduced urinary cortisol levels and improved symptoms of Cushing's disease in the largest clinical study of this endocrine disorder ever conducted. Results of the clinical trial conducted at centers on four continents appear in the March 8 
New England Journal of Medicine
 and show that treatment with pasireotide cut cortisol secretion an average of 50 percent and returned some patient’s levels to normal. 

"Cushing's disease is a rare disorder, with three to five cases per million people. It can affect all ages and both genders but is most common in otherwise healthy young women," says 
Beverly M.K. Biller, MD, of the Massachusetts General Hospital 
Neuroendocrine Unit, senior author of the study. "Often misdiagnosed, Cushing's is associated with a broad range of health problems – causing physical changes, metabolic abnormalities and emotional difficulties – and if not controlled, significantly increases patients' risk of dying much younger than expected."

One of several conditions that lead to Cushing's syndrome – chronically elevated secretion of the hormone cortisol – Cushing's disease is caused by a benign pituitary tumor that oversecretes the hormone ACTH, inducing increased cortisol secretion by the adrenal glands. Symptoms of Cushing's syndrome include weight gain, hypertension, mood swings, irregular or absent periods, abnormalities of glucose processing – insulin resistance, glucose intolerance and type 2 diabetes – and cardiovascular disease. Since those symptoms are associated with many health problems, physicians may not consider the rare possibility of Cushing's. The diagnosis can be difficult to make and usually requires the expertise of an endocrinologist. Since cortisol levels normally fluctuate during the day, a single blood test probably would not identify chronic elevation, so the most common diagnostic test measures a patient's 24-hour urinary output. 

First-line treatment for Cushing's disease is surgical removal of the ACTH-secreting tumor, which can lead to remission in 65 to 90 percent of patients who are treated by expert pituitary surgeons. But symptoms return in 10 to 30 percent of those patients, requiring repeat surgery, radiation therapy or treatment with drugs that interfere with part of the cortisol control system. Until last month, there was no specific FDA-approved medical treatment for Cushing's syndrome; and while the newly approved drug mifepristone should benefit some patients, it does not affect the pituitary source of the condition or reduce cortisol levels. 

The current phase 3 trial of pasireotide – the first drug that blocks ACTH secretion by binding to somatostatin receptors on the pituitary tumor – was sponsored by Novartis Pharma and enrolled 162 patients at 62 sites in 18 countries. Almost 85 percent of participants had either persistent disease that had not responded to surgery or had recurrent disease. The other 15 percent were recently diagnosed but not appropriate candidates for surgery. Participants were randomly assigned to two groups, one starting at two daily 600-microgram injections of pasireotide, the other receiving 900-microgram doses. Three months into the 12-month trial, participants whose urinary cortisol levels remained more than twice the normal range had their dosage levels increased. During the rest of the trial, dosage could be further increased, if necessary, or reduced if side effects occurred. 

At the end of the study period, many patients had a significant decrease in their urinary cortisol levels, with 33 achieving levels within normal range at their original dosage by month 6 of the trial. Participants whose baseline levels were less than five times the upper limit of normal were more likely to achieve normal levels than those with higher baseline levels, and the average urinary cortisol decrease across all participants was about 50 percent. Many Cushing's disease symptoms decreased, and it became apparent within the first two months whether or not an individual was going to respond to pasireotide. 

Transient gastrointestinal discomfort, known to be associated with medications in the same family as pasireotide, was an expected side effect. But the investigators observed elevated glucose levels in 73 percent of participants, something not seen to the same extent with other medications in this family. That will require close attention, since many Cushing's patients already have trouble metabolizing glucose. Biller explains, "Those patients who already were diabetic had the greatest increases in blood sugar, and those who were pre-diabetic were more likely to become diabetic than those who began with normal blood sugar. However, elevations were even see in those who started at normal glucose levels, so this is real and needs to be monitored carefully." 

Additional trials of pasireotide are in the works, and a phase 3 study of a long-acting version of the drug was recently announced. Biller notes that the potential addition of pasireotide to available medical treatments for Cushing's disease would have a number of advantages. "It's very important to have medications that work at different parts of the cortisol control system – which is the case for the currently used medications that work at the adrenal gland level, pasireotide which works at the pituitary gland, and mifepristone which blocks the action of cortisol at receptors in the body. Having more options that work in different ways is valuable because not all patients respond to one medicine and some may be unable to tolerate a specific drug's side effects. 

"As we have more drugs available to treat Cushing’s," she adds. "I think in the long run we may start using combinations of drugs, which is the approach we use in some patients with acromegaly, another disorder in which a pituitary tumor causes excess hormone secretion. Ultimately we hope to be able to give lower doses leading to fewer overall side effects, but that remains to be determined by future studies." Biller is a professor of Medicine at Harvard Medical School. 

Annamaria Colao, MD, PhD, University of Naples, Italy, is the lead author of the 
New England Journal
 report. Additional co-authors are Stephan Petersenn, MD, University of Duisberg-Essen, Germany; John Newell-Price, MD, PhD, University of Sheffield, U.K.; James Findling, MD, Medical College of Wisconsin, Milwaukee; Feng Gu, MD, Peking Union Medical College Hospital, Beijing, China; Mario Maldonado, MD, Ulrike Schoenherr, Dipl-Biol, and David Mills, MSc, Novartis Pharma; and Luiz Roberto Salgado, MD, University of São Paulo Medical School, Brazil. 

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $750 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.

From 
http://www.massgeneral.org/about/pressrelease.aspx?id=1444#.T2I2Ue9AMtQ.facebook

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16.03.2012 20:38:00


  1. Ganapati Mudur

Author Affiliations

India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar , used in chemotherapy for hepatic and renal cancers.

Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (?110; ˆ135; $175 a month rather than the 280?000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.

Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.

Bayer, which has the right to appeal, has said it is disappointed by the decision.

However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”

A single vial of patented trastuzumab (Herceptin , which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132?000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.

Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”

A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.

A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (
BMJ
2011;343:d6774, doi:
10.1136/bmj.d6774 .

Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”

India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.

“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the
BMJ
. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.

The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.

India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.

But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.

Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.

“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.

Notes

Cite this as:
BMJ
2012;344:e2132

via
bmj.com

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16.03.2012 8:44:00

Recent shortages of critical drugs in the USA have hampered patient care and attracted much media attention. Sharmila Devi examines the problems with America's drug supply.
Severe shortages of drugs such as sterile injectables that have forced physicians in the USA to practise medicine from crisis to crisis are likely to continue for several more years, say regulators and health-care providers.
Around 280 drugs, almost all manufactured in the USA, remain in short supply because of factors including a dwindling number of makers of some drugs, deteriorating conditions in factories, and low prices for generics leading to a lack of investment to upgrade plants.
The shortages have led to delays in surgery and cancer treatments, left patients in pain, and forced hospitals to prescribe less effective treatment, said a review by the Associated Press late last year. At least 15 deaths in 15 months were blamed on the shortages, according to data compiled by the Institute for Safe Medication Practices, a patient safety group, and the true number might be higher because many deaths and injuries caused by shortages go unreported.
“We don't have any expectation the issue will be resolved soon”, Sandra Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, told The Lancet. “It will be several years before companies building new plants get them up and running.”

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16.03.2012 14:12:15
Few Americans think twice about whether their medicine bottle really contains what it says on the label.



15.03.2012 23:53:19
Few Americans think twice about whether their medicine bottle really contains what it says on the label.



17.03.2012 13:00:27



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rss@dailykos.com (Joan McCarter
15.03.2012 23:34:36

Public confusion about the status of the Affordable Care Act continues, according to this month's
Kaiser Health Tracking Poll [pdf]. Sadly, nearly 40 percent of the population either thinks that the Supreme Court has already overturned the law, or are unsure of its status.

KFF poll
That's the power of the Wurlitzer, and the focus of the traditional media on the controversy of the law rather than the facts of the law. That's borne out by the fact that, two years after passage of the law, "six in ten Americans say they don’t currently have enough information about the health reform law to understand how it will impact them personally." The media has spent far more time focusing on challenges to the law than the law's policies, so the average person is going to have to work to seek out that information.

Among those who are aware that the ACA is the law of the land, a two-thirds majority remains opposed to the individual mandate, "including 54 percent who feel “very unfavorable” (up from 43 percent last November ." That number tracks very closely with how respondents expect the Court to rule.

In line with these views, about half the public (51 percent thinks the Court should rule that the mandate is unconstitutional, while just under three in ten (28 percent think it should be ruled constitutional, and another one in five don’t know enough to say. Similarly, about half expect the Court to strike down the mandate as unconstitutional (53 percent while a third expect them to find it constitutional (33 percent .
One really interesting aspect of the polling illuminates just how much the ACA has become a proxy for government itself.

KFF poll
Among those who are against the law, "a larger proportion say their opposition is based at least in part on their displeasure with the direction of the country in general (and the direction of Washington in particular than say it is based on what they know about the law." The three years of relentless Republican attacks and lies about the law, the complicated nature of it, the fact that information about it isn't readily available to the public, all combine to make it the perfect target for general dissatisfaction with how our federal government is working.

There are a few upsides, here. Slowly, very slowly, seniors are becoming more supportive of the law to the point where as many are supportive (44 percent as opposed (42 percent . They've seen their prescription drug costs lowered, get more free screening and services, are not having to pay more for Medicare, and aren't being subject to death panels, which is perhaps why they're slowly coming around.

In the general population, the edge still goes to those who want to keep or expand the law, 47 to 41, and the majority wants Congress to keep working on making health care more affordable. "Six in ten say that in the wake of a ruling unfavorable to the ACA, lawmakers should focus on developing new proposals to improve Americans’ access to affordable health care, while a third say policymakers should stop talking about health care and focus on other national problems." Even a slim majority of Republicans thinks it's a priority.







2012-03-16 09:44:38
A recent study, published in the journal
Cancer Research, explains that dietary cadmium - a heavy metal long identified as a carcinogen which leaches into crops from fertilizers and when rainfall or sewage sludge deposit it onto farmland - can potentially increase a woman's risk for breast cancer, writes Christine Kearney for
Medical News Today. Associate professor Agneta Akesson, from the
Karolinska Institute in Sweden said in a recent press release: “Because of a high accumulation in agricultural crops, the main sources of dietary cadmium are bread and other cereals, potatoes, root crops and vegetables. In general, these foods are also considered healthy.” The 12-year study found that among 55,987 post-menopausal women, the one-third with the highest cadmium intakes were 21 percent more likely to develop breast cancer than the one-third with the lowest intakes. Among obese women, the study found no increase in breast cancer rates with higher cadmium exposures. The finding comes just three months after the Institute of Medicine (
IOM , a prestigious body of independent biomedical researchers, concluded that a host of other factors — most within a woman’s power to control, such as obesity and hormone-replacement medication — were the most important sources of breast cancer risk. The IOM had called it “biologically plausible” that estrogen-like pollutants promote breast cancers, but noted that evidence that they contribute significantly was inconclusive. By contrast, studies in human populations strongly point to fattening foods, hormone-replacement drugs, alcohol and cigarettes as having roles in boosting a woman’s breast cancer risk. A woman’s lifetime exposure to estrogen powerfully influences her risk. In animals and in laboratory tests, cadmium has been shown to exert estrogen-like effects more powerfully than other environmental pollutants, and so suspicion has fallen on the heavy metal as a possible promoter of breast cancer. “Cadmium is receiving a lot of attention these days because of its estrogenic properties,” Rudolph Rull, a research scientist at the Cancer Prevention Institute of California in Berkeley, told Melissa Healy of the
Los Angeles Times. Both estrogen receptor-positive and negative tumors had the same risk increase at roughly 23 percent. Akesson said that women who consumed higher amounts of whole grain and vegetables had a lower risk of breast cancer compared to women exposed to dietary cadmium through other foods. “It’s possible that this healthy diet to some extent can counteract the negative effect of cadmium, but our findings need to be confirmed with further studies,” said Akesson. “It is, however, important that the exposure to cadmium from all food is low.”



17.03.2012 1:10:00

A claim for restitution filed by Pennsylvania's attorney general caused a last-minute delay in the sentencing of
Merck & Co. (MRK for its violation of a federal drug law in connection with its marketing of former painkiller Vioxx.

At a hearing Friday in federal court in Boston, U.S. District Judge Patti Saris delayed Merck's sentencing until April 19 to allow for more time to consider the Pennsylvania claim. Merck was originally scheduled to be sentenced Friday.

Merck, of Whitehouse Station, N.J., agreed in November to pay $950 million and plead guilty to a misdemeanor charge of marketing a misbranded drug, to resolve government allegations that the company illegally promoted Vioxx and deceived the government about the drug's safety.

The government alleged Merck promoted Vioxx for treatment of rheumatoid arthritis before that use was approved by regulators. A portion of the $950 million settlement also was to resolve parallel civil allegations that Merck made false and misleading statements about Vioxx's safety, causing government health programs to pay for the drug's use. Merck denied the civil allegations.

Merck had withdrawn Vioxx from the market in 2004 after a study showed it increased the risk of heart attacks and other cardiovascular events.

The proposed November settlement was to resolve claims by the U.S.
Justice Department, more than 40 states and the District of Columbia.

But last week, the Commonwealth of Pennsylvania filed a so-called victim impact statement with the court. Pennsylvania's attorney general office argued that Judge Saris shouldn't impose a sentence unless Pennsylvania obtains restitution for
Medicaid payments allegedly resulting from Merck's criminal misconduct, according to a court document filed by the U.S. Justice Department.

Pennsylvania is continuing to pursue Vioxx-related claims against Merck in proceedings coordinated by a federal judge in Louisiana, according to the Justice Department.

The Justice Department argued that Pennsylvania therefore has a forum to pursue its claims, and it shouldn't hold up the sentencing in Boston.

Merck also urged Judge Saris to decline Pennsylvania's application for restitution because it would delay distribution of the settlement money to participating states.

In a written statement Friday, Merck said: "Through a last minute request the Commonwealth of Pennsylvania has attempted to derail an agreement already reached in good faith with the federal government, 44 other states, and the District of Columbia. There is no legal foundation for the Commonwealth's claim in this court and Merck will vigorously oppose it."

The Justice Department said Pennsylvania was allocated $4.5 million for alleged Medicaid losses under the $950 million settlement. States had the choice of either accepting their allocations or initiating or continuing litigation against Merck.

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16.03.2012 22:15:59

Sanuwave plans to run additional clinical trials of its dermaPace foot ulcer treatment after the FDA deems its initial submission insufficient.

Sanuwave logo

Regenerative medicine firm
Sanuwave Health (OTC:
SNWV will run another clinical trial of its dermaPace foot ulcer treatment, after the FDA determined that its initial pre-market approval bid failed to meet its primary endpoint.

New trials may take up to 2 years before the company re-submits its device for FDA review, according to a press release.



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http://www.massdevice.com/news/sanuwave-takes-its-dermapace-foot-ulcer-treatment-back-trials#comments



16.03.2012 19:49:36

Medtronic enrolls the initial patient into its Medtronic Registry for Epilepsy to look at the long-term efficacy and safety of deep brain stimulation therapy for patients with drug-resistant epilepsy.

MassDevice On Call

MASSDEVICE ON CALL — As neuromodulation therapy celebrates its 25th year,
Medtronic (NYSE:
MDT enrolled the 1st patient into its Medtronic Registry for Epilepsy, a database tracking the safety, efficacy and quality of life of patients receiving deep-brain stimulation for treatment of drug-resistant epilepsy.



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http://www.massdevice.com/news/medtronic-enrolls-1st-patient-epileptic-brain-stim-registry-massdevicecom-call#comments



16.03.2012 10:00:00
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Use of Meds That Conflict With Cancer Drugs Common: Study



16.03.2012 15:42:55
Health Canada is speeding up the review process needed to approve replacement medications in a bid to ease the drug shortage affecting the country, federal Health Minister Leona Aglukkaq confirmed Thursday.



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17.03.2012 22:16:51
Bacteria could soon become so resistant to antibiotics that common injuries or illnesses could eventually become life-threatening, the head of the World Health Organization (WHO warned during a conference of infectious disease experts on Friday. According to NewsCore reports, WHO Director-General Margaret Chan told those attending the meeting, which was held in Copenhagen, Denmark, that even ailments as simple as a scratched knee or a sore throat could someday become fatal. Furthermore, Daily Mail reporter Mario Ledwith writes that Chan believes that the Earth was quickly approaching what she referred to as the "post-antibiotic era." As these disease-causing microbes become more and more resistant to the drugs meant to treat the conditions they cause, those injuries and illnesses will become increasingly harder to treat, thus making some "remedies more expensive, and some conditions... untreatable," Ledwith added. If this so-called post-antibiotic era does, in fact, happen, Chan said that it would result in the "end to modern medicine as we know it." This "post-antibiotic era" would "include many of the breakthrough drugs developed to treat tuberculosis, malaria, bacterial infections and HIV/AIDS, as well as simple treatments for cuts," says Hannah Furness of The Telegraph. Any medicines that would replace existing treatments would not only become more costly, but would also take longer in order to have similar affects as today's antibiotics.



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