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    India must address worrying stock out of tuberculosis drugs, says MSF

    The Indian government must urgently address the persistent issues and almost routine delays of procuring drugs to treat tuberculosis, says the international medical humanitarian organization Medecins Sans Frontieres (MSF). The issues are behind a worrying stock out of TB drugs which the country is currently experiencing.

    "As a country with such a high burden of tuberculosis, MSF is deeply disturbed that India is experiencing stock outs of critically needed drugs to treat children and those with drug-resistant TB," said Leena Menghaney, India manager of MSF's Access Campaign, adding: "In this instance, it's a stock out that can cost people's lives and the government must act urgently to fix the problems."

    Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here.

    India is currently experiencing stock outs across the country of both pediatric TB drugs and those used to treat drug-resistant TB (DR-TB). Under India's public TB treatment program, the central government is responsible for buying drugs and distributing them to the states which then provide treatment.

    Indian government drug tender process leads to deadly delay in drug supply

    The stock out is related to the never-ending issues with drug procurement that India faces in many of its public health programs - the routine but deadly delay in tendering for these drugs - and the resulting drug stock outs are one of the reasons why India has one of the world's highest burdens of DR-TB.

    "As a TB treatment provider, MSF is witnessing the impact this is having on our own patients," said Homa Mansoor, the TB Medical Referent for MSF India. "In our Mon, Nagaland project, I've seen a 12 year-old girl on treatment arrive with her father after a long journey to get her medicine. The medicines were out of stock, but luckily we had six days' worth of drugs available from a patient who had died. Otherwise, we're having to resort to breaking adult pills to give to children, which is really dangerous as it could over- or under-dose them."

    Other patients have been forced to purchase medicines from private pharmacies, but have received lower-dosage drugs, which – if it causes a patient to under-dose on that drug – could lead to resistance.

    Continuous supply essential

    "A continuous, sustainable supply of quality-assured medicines is vital for TB patients to have even half a chance of being cured," said Dr Mansoor, adding: "As a doctor, I know the disease, I know how to manage it, but I feel powerless because we don't have the medicines to treat."

    "It's just not good enough that India talks of scaling up DR-TB treatment, but finds the medicine cabinet empty at a time when the most vulnerable patients – those diagnosed with DR-TB - are most desperate to get the medicines that can treat them," said Dr Mansoor, stressing that "the Indian government must act now to address this dire situation."

    The stock outs in India are occurring as the World Health Organization earlier this month issued interim guidelines on bedaquiline, the first new drug to treat TB in 50 years, approved by the US Food and Drug Administration at the end of 2012. MSF has welcomed the release of the guidelines, but has said use of the new drug needs to be regulated and controlled, and studies must be undertaken to find combinations with the new drugs in shorter, more effective and less toxic treatment regimens.

    (source: www.thepharmaletter.com)

     

    Scientists warn against complacency on deadly H7N9 bird flu

    LONDON (Reuters) - A new and deadly strain of bird flu that emerged in China in February but seems to have petered out in recent months could reappear later this year when the warm season comes to an end - and could spread internationally, scientists said on Monday.

    A study by researchers in China and Hong Kong found only one human case of the H7N9 bird flu strain has been identified since early May.

    In the preceding months, the virus, which was unknown in humans until February, has infected more than 130 people in China and Taiwan, killing 37 of them, according to the World Health Organization (WHO).

    "The warm season has now begun in China, and only one new laboratory-confirmed case of H7N9 in human beings has been identified since May 8, 2013," the researchers wrote in a study published in The Lancet medical journal.

    But they added: "If H7N9 follows a similar pattern to H5N1, the epidemic could reappear in the autumn."

    H5N1 is another deadly strain of bird flu which emerged in 2003 and has since spread around the world. Latest WHO data on H5N1 show it has killed 375 of the 630 people confirmed as infected in the past 10 years. Many H5N1 cases have been in Egypt, Indonesia and Vietnam.

    The researchers, from the Chinese Center for Disease Control and Prevention (CDC) in Beijing and the University of Hong Kong, said the potential lull in H7N9 could offer health officials the chance to properly discuss and plan ahead for the possibility of the flu's return and wider spread.

    This should include plans to build healthcare capacity in the region "in view of the possibility that H7N9 could spread beyond China's borders," they said.

    Experts from the United Nations agency said last month the bird flu outbreak in China had cost the economy some $6.5 billion.

    In a second study published in the same journal, the researchers also found that while H7N9 flu has a lower risk of death than its much-feared cousin H5N1, it has a higher fatality risk than the 2009 H1N1 flu which swept the world in 2009 and 2010 in a pandemic.

    After analyzing data on hospital admissions, the team found that H5N1 bird flu had a fatality risk of around 60 percent for patients admitted to hospital - almost double that of the new H7N9 strain which has a death rate of about a third of those hospitalized with the infection.

    Pandemic H1N1, often referred to as "swine flu", killed 21 percent of those it infected who were taken into hospital, the researchers said.

    The team urged health officials and doctors not to be lulled into a false sense of security by the sharp drop off in H7N9 cases in recent weeks.

    "Continued vigilance and sustained intensive control efforts against the virus are need to minimize risk of human infection, which is greater than previously recognized," they said.

    (source: health.yahoo.net)

     

    Striking down life-threatening prejudice

    The struggle against discrimination and injustice scored a major win today with a Supreme Court ruling that the U.S. government may not require anyone to share the government's prejudice, no matter how ancient or widespread that prejudice.

    In a 6-2 decision, the high court struck down the Anti-Prostitution Loyalty Oath (APLO), which since 2003 has required U.S. non-governmental organizations to have "a policy explicitly opposing prostitution" as a condition of receiving U.S. funds for work against HIV/AIDS around the world. Chief Justice John G. Roberts Jr. said in his majority opinion that the requirement violated the First Amendment because it forced grant recipients "to pledge allegiance to the government's policy of eradicating prostitution," whether or not they agreed with that policy.

    The decision implies a victory for all the people who have suffered and continue to suffer any kind of state-sponsored stigma: the U.S. government can no longer require that U.S. organizations concur (the policy may still be applied to organizations outside the U.S.).

    The Center for Health and Gender Equity (CHANGE) had opposed the APLO not only as an unconstitutional violation of an organization's free speech rights but also as a violation of the human rights of sex workers to self-protection and health care. Just as critically, it has also been a barrier to effective work against the pandemic.

    What sex workers will turn for help or treatment to an organization that vows to eliminate them? What program to curb the spread of HIV can succeed without enlisting sex workers? They are among the groups most at risk of HIV infection; their cooperation or lack of it can determine a program's reach and a country's future. Isn't it irresponsible, if not dangerous, to exclude them?

    Programs in dozens of countries have engaged sex workers successfully as part of the solution to the AIDS crisis. Brazil turned down $40 million in U.S. funding in 2005 to avoid alienating sex workers there, who have become critical partners in developing and carrying out effective approaches to curbing the pandemic.

    The oath was written into law when some legislators saw a chance to impose their ideology of purity at the start of PEPFAR, the enormously beneficial President's Emergency Plan for AIDS Relief. Based purely on prejudice, it had nothing to do with effective practices, and in fact undermined them by discouraging their application to sex workers. It never applied to funding for international groups such as the World Health Organization, and the fact it had such "practical" exceptions was another argument against it.

    Strange bedfellows such as the progressive ACLU and the conservative Cato Institute submitted amicus briefs to the Supreme Court supporting the free-speech argument. Deans of public health schools and NGOs including CHANGE documented the public health damage. In 2012, research presented at the International AIDS Conference showed that the oath had caused many U.S. groups to limit or eliminate programs targeting sex workers for fear of losing their funding. Clearly the oath was not only damaging the U.S. role as a human rights defender, it was damaging the global fight against HIV/AIDS.

    When the case was argued last spring, Justice Alito surprised many observers when he said it was a "dangerous proposition" to "condition federal funding on the recipient's expression of agreement with ideas [with] which the recipient disagrees." Today he was with the majority; Justice Kagan recused herself, having worked on the case when she was Solicitor General, and Justices Thomas and Scalia dissented. "The First Amendment," Scalia wrote, "does not mandate a viewpoint-neutral government."

    No, but neither does the First Amendment allow the government to mandate anyone else's viewpoint – or their silence – as a condition of receiving government funding.

    Now U.S. organizations fighting HIV will be able to use evidence-based interventions where they count most, free from others' political agendas. This should boost our fight to get ahead of HIV at last. If we are ever to have an AIDS-free generation, there can be no place for discrimination.

    (source: thehill.com)

     

    AMA Declares Obesity a Disease

    The American Medical Association has officially classified obesity as a disease, a move it believes will spur advancements in treatment and prevention.

    The new policy, announced yesterday in Chicago during the group's annual meeting, was adopted after delegates debated, and ultimately rejected, a committee recommendation cautioning against the new designation.

    "Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans," said AMA board member Patrice Harris, M.D. "The AMA is committed to improving health outcomes and is working to reduce the incidence of cardiovascular disease and type-2 diabetes, which are often linked to obesity."

    In adopting the new definition, the AMA concluded that obesity meets the criteria used to define a disease, including the impairment of normal body function. It cites an abundance of clinical evidence identifying obesity as a "multi-metabolic and hormonal disease state" that can affect appetite, energy, fertility and blood pressure, among other physiological functions.

    The resolution also noted that The World Health Organization, the Food and Drug Administration, and the National Institutes of Health recognize obesity as a disease.

    The decision will likely draw new attention to the obesity epidemic, which affects 78 million adults and 12 million children in the United States. And it could lead to increased reimbursement for obesity drugs, surgery and other treatments, according to AMA, the nation's leading physician association.

    But the association's Council on Science and Public Health, which studied the issue, concluded that the benefits of classifying obese individuals as having an illness rather than a condition are unclear. It advised against a disease classification primarily because there is no widely accepted definition of disease, and because the mechanism for diagnosing obesity, body mass index, is inadequate. (BMI uses height and body weight to calculate a number that indicates a person's fat level. A BMI of 30 or greater is considered obese.)

    "Given the existing limitations of BMI to diagnose obesity in clinical practice, it is unclear that recognizing obesity as a disease, as opposed to a 'condition' or 'disorder,' will result in improved health outcomes. The disease label is likely to improve health outcomes for some individuals, but may worsen outcomes for others," the council wrote.

    The council was also concerned that the "medicalization" of obesity could lead people to rely too heavily on drugs and surgery rather than diet and exercise to lose weight.

    Another argument against the disease label was the potential for increased stigma. If someone alters their lifestyle but fails to drop weight, they'd be still be labeled as having a disease and might feel pressured to receive medical interventions such as drugs or surgery.

    The adopted resolution argued that "the suggestion that obesity is not a disease but rather a consequence of a chosen lifestyle exemplified by overeating and/or activity is equivalent to suggesting that lung cancer is not a disease because it was brought about by individual choice to smoke cigarettes."

    (source: www.runnersworld.com)

     

    Indonesia Shares Experience on Vaccine Quality Management with OIC Members

    The Indonesian government has shared experiences with member states of Organization of Islamic Conference (OIC) in strengthening their national regulatory authority (NRA) functions in vaccine manufacturing for global markets.

    "We are willing to share with all member states of OIC our experiences in strengthening national regulatory authority functions in vaccine manufacturing," said Lucky S. Slamet, head of Indonesian Agency for Food and Drug Control (BPOM), in a workshop held in conjuction with the 2nd meeting of OIC vaccine- and medicine-manufacturers in Bandung, West Java province, on Monday.

    Delegates and experts from nine OIC countries that already have their vaccine making facilities out of the total 57 OIC member countries are attending the meeting which runs from 16 to 19 June, 2013.

    In the workshop, Slamet told the workshop that NRAs hold a decisive role in guarranteeing the quality of vaccine supplied to the global markets. The World Health Organization (WHO), therefore, always evaluates the NRAs through capacity building efforts so as to ever strengthen them.

    "The WHO has declared us, the Indonesian National Agency of Food and Drug Control, to have performed an internatonal standard control function, in particular, on vaccine. With this achievement, Indonesia now has a wide opportunity - through Bio Farma - to export its products to international markets," she pointed out.

    Based on this experience, Slamet added, Indonesia is ready and willing to share with OIC member states the experience in strengthening their RNA functions in vaccine manufacturing.

    "Out of the total 57 OIC member states only five countries having their vaccine manufacturers and out of this five only one that can export its products, namely Bio Farma," Slamet emphasized.

    According to World Health Organization (WHO), NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety.

    Countries producing vaccines need to exercise six critical control functions, and exercise them in a competent and independent manner, backed up with enforcement power. The six functions are a published set of requirements for licensing, surveillance of vaccine field performance, system of lot release, use of laboratory when needed, regular inspections for good manufacturing practices (GMP) and clinical performance evaluation.

    Bio Farma Sales and Marketing Director Dr. Mahendra Suhardono also spoke in the workshop on quality management system (Manufacture, Pre Qualification of Vaccine) in a way to meeting the Good Manufacturing Practices (GMP as set out by the for WHO prequalification.

    Bio Farma, he said, has been able to maintain an integrated system of quality control management as well as efforts on keeping it update with latest GMP requirements.

    Bio Farma is Indonesia's only vaccine manufacturer whose products have been recognized by WHO since 1997 that the company can supply its products to over 120 countries.

    Currently the needs for Expanded Program on Immunization (EPI) vaccines in Indonesia have been supplied solely by Bio Farma by producing and distributing over 1.7 billion doses of vaccine per year to meet the needs of EPI vaccine for national immunization program.

    Bio Farma has an outstanding international reputation based on the WHO prequalification for all of its EPI vaccine products and has also implemented green industry and is environment friendly. WHO acknowledges that Bio Farma vaccine products are of high quality, efficacious, and affordable.

    Bio Farma products are through the direct distribution or through various agencies such as UNICEF, PAHO. The company has obtained the Best Export Performance from the Indonesian Trade Ministry consecutively in 2010,2011, 2012 as an evidence of its consistent exceptional performance.

    About OIC

    The Organisation of Islamic Cooperation (OIC) is the second largest inter-governmental organization after the United Nations which has membership of 57 states spread over four continents. The Organization is the collective voice of the Muslim world and ensuring to safeguard and protect the interests of the Muslim world in the spirit of promoting international peace and harmony among various people of the world.

    About PT Bio Farma (Persero)

    Since its establishment in 1890, PT Bio Farma (Persero) has been active in supplying high quality vaccines and serum for people. Currently, Bio Farma is among the largest vaccines manufacturers and suppliers in the world. The need for EPI vaccines in Indonesia has been supplied solely by Bio Farma.

    Bio Farma has existed for a century and proven its strength and experience world wide. The company has also grown and developed to become a vaccine and serum manufacturer of international reputation. This can be seen from its qualifications and ability to acquire WHO prequalification for all of its EPI Vaccine products. For more information, please visit http://www.biofarma.co.id/.

    (source: www.newsmaker.com.au)

     

    Best Healthcare System Examples From Around The World

    The World Health Organization evaluates international health care systems based on five criteria. Factors include the health of the overall population, care inequalities within the population and the responsiveness of the health system. The WHO additionally assesses heath care provided to the various economic levels of a population along with who covers the cost of the health system. The following countries offer some of the best health care on the planet.

    Switzerland

    The health care system of the country represents the Bismarck Model, named for its founder, Prussian Chancellor Otto von Bismarck. Recipients receive care under an insurance system financed by employees and employers. Approximately 95 percent of Switzerland's residents have private insurance policies. Impoverished citizens unable to afford a policy receive government help. The premiums of all policies cost the same amount and the companies cannot profit from basic health care treatment. The companies may however, receive monies for the costs associated with alternative medicine, dental care or for private hospital accommodations. Studies indicate that the government overall only spends a little over 11 percent on the system.

    France

    France also adopted the Bismarck Model with some variations.Residents obtain medical insurancethrough their place of work in addition to having private supplemental coverage. The government pays around 75 percent of the cost of medical care using the mandatory funds received from employees. Supplemental policies cover the remaining costs. Affluent citizens have the option of receiving elective procedures at their expense. All of the French citizens have the right to choose a health care provider and patients typically receive same day treatment.

    Italy

    According to infant mortality rates and life expectancies, Italy remains one of the countries providing the best health care. Employers provide and pay for the health insurance of employees, which features low-cost or no cost coverage regardless of the type of treatment. Unemployed individuals have the option of obtaining state operated medical coverage. Studies suggest that physicians remain dedicated to patients and receive exceptional training. Private hospitals receive glowing reports that rival any other country.

    Taiwan

    The country adopted the National Health Insurance Model in 1995, which combines the Beveridge and Bismarck systems. Private companies offer the policies that residents pay to the government who in turn covers the cost of medical treatment. The cost effective model does not allow profit by the insurance companies, preventing a motive for denying claims. However, the government only pays for a limited number of services or requires that patients wait a specific period of time for treatment. Individuals not able to afford private policies have the option of obtaining government assistance. Taiwan also implemented the "smart card." Each resident receives a card that contains a continuing medical history.

    Australia

    The country adopted the Douglas Model of healthcare that represents a dual system of private and public health insurance. Affluent residents must have private insurance or pay a specialized tax when using the Medicare public system. Employees pay an insurance premium through their paychecks that covers the cost of using the system. Physicians have private practices and receive wages when treating public patients. They also receive compensation when treating citizens with private policies. Two thirds of the country's hospital beds lie in public facilities. The remainder one third lies in private facilities. A drawback of the public system sometimes means patients wait for treatment.

    (source: www.liveinsurancenews.com)

     

     

    Hundreds donate blood in Cambodia to mark World Blood Donor Day

    PHNOM PENH, June 12 (Xinhua) -- Hundreds of Cambodian citizens and dozens of foreigners working in Cambodia lined up to donate their blood on Wednesday during the celebrations of the 10th World Blood Donor Day.

    Speaking at the event, Cambodian Minister of Heath Mam Bunheng expressed gratitude to all blood donors, saying that their donation was very valuable to save lives of the patients.

    "I urge all of you to continue your donation," he said. " Blood transfusion will not harm your health; instead, your blood will save lives of people who are in need of blood."

    Hok Kim Cheng, director of National Blood Transfusion Center, said the celebrations were to appeal to donors to donate blood in order to ensure the stability of supplying blood to hospitals and health centers throughout the nation.

    He said last year, the center had received voluntary donations of 60,084 units of blood, up 28 percent from 46,690 units in a year earlier.

    "More and more Cambodians are aware of the advantage of blood in saving lives," he said. "About 4.2 out of 1,000 people donate their blood last year, up from 4 out of 1,000 people in a year earlier."

    He said all blood would be tested for four types of diseases, HIV, hepatitis B and C, syphilis, and malaria.

    "The blood that contains any of these diseases will be destroyed," he said.

    Dr. Pieter Van Maaren, representative of the World Health Organization to Cambodia, said a unit of blood could save up to three lives in low income countries including Cambodia.

    "The event is very important to encourage people to donate blood and to thank donors for their blood donation," he said.

    One of the blood donors is a Buddhist monk who has donated blood to the center for 31 times.

    "I have donated blood in every three months, there is no any harm to my health," said Svay Sophea, a Buddhist monk at Botum Vatey pagoda in Phnom Penh. "This is the way I can do to save lives of people who are in need in blood."

    (source: news.xinhuanet.com)

     

    Global Commission on Drug Policy: Hepatitis C an epidemic

    SANTO DOMINGO, Dominican Republic – The counter-narcotics fight is fueling an international hepatitis C epidemic, according to a new report, leading prominent world and Latin American figures to call on countries to decriminalize drug use and focus on treatment.

    "The Negative Impact of the War on Drugs on Public Health: the Hidden Hepatitis C Epidemic," produced by Global Commission on Drug Policy, stated that about five of every eight intravenous drug users are living with the disease.

    The World Health Organization (WHO) estimates that about 150 million people are chronically infected with hepatitis C, which kills about 350,000 people a year – most of whom develop cirrhosis or cancer.

    In the Americas, between seven and nine million are infected with the disease, according to the Pan American Health Organization (PAHO). The organization doesn't estimate the number of deaths specifically caused by the disease, but according to PAHO statistics about 16,500 people die of related disease – such as cirrhosis – annually.

    About 10 million people living with the disease are intravenous drug users. But the Global Commission on Drug Policy said the disease is needlessly spread due to outdated laws and policies that target drug users.

    Hepatitis C, one of the five types of viral hepatitis diseases that affect the liver, is contracted through contact with the blood of infected persons, meaning intravenous drug users run a high risk of contracting the disease. It is a leading cause of liver transplants.

    Infection rates are highest in countries in Central Asia and Eastern Europe, where as many as 90% of intravenous drug users are infected.

    The commission carries the weight of several prominent figures. Former United Nations Secretary-General Kofi Annan, seven former presidents and Virgin Group founder Richard Branson are among the commission's members.

    Former Brazilian President Fernando Henrique Cardoso, the commission's chairman, said hepatitis C is "both preventable and curable when public health is at the core of drug response."

    With the report, "we are exposing the links between repressive drug policies and the spread of hepatitis C, another massive and deadly global epidemic," Cardoso said in a video message introducing the study. "This is another concrete example of the failure and negative impacts of repressive drug policies around the world."

    The commission previously had warned of the link between criminalized drug use and the spread of HIV/AIDS. By linking drug use to hepatitis C, the commission hopes to provide another example in the argument that drug use should be decriminalized.

    Cardoso also said it's a human rights issue.

    "Though human rights abuses are widespread in most parts of the world, they come about in different ways," he said. "In Latin America, the main issue is mass incarceration, violence and corruption and the strengthening of organized crime."

    Specifically, the commission is recommending governments:

    1. End criminalization and mass incarceration of drug users;
    2. Redirect money currently dedicated to the counter-narcotics fight toward public health projects aimed at drug users;
    3. Make sterile syringes available and offer treatment programs, such as opioid substitution therapy for heroin users;
    4. Better report hepatitis C cases by improving surveillance systems and other measures;
    5. Reduce the cost of medicines that can treat hepatitis C by negotiating with pharmaceutical companies and making the drugs more widely available.

    The report was released in advance of the International Harm Reduction Conference in Lithuania, which began June 9.

    Meantime, last week's 43rd General Assembly of the OAS ended with foreign ministers' creating a roadmap they hope leads to long-term renewal of their regional drug policy in 2016.

    Officials at the General Assembly, which was held in the Guatemalan city of Antigua, said they will convene a special meeting during the first half of 2014 to outline the counter-narcotics strategy that will be discussed when the OAS holds its 44th General Assembly in June 2014 in Paraguay.

    "We have already reached a consensus and agreed that our final declaration will include changes to the current anti-drug model," Guatemalan Foreign Minister Fernando Carrera told reporters. "We already have some ideas on how to change drug-fighting policies."

    (source: infosurhoy.com)