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  1. #11
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    Adelaide, no but I did have ulcerative colitis when I was in my late 20's.

    FDA: Pharmacy tied to outbreak knew of bacteria
    27 Oct.`12 WASHINGTON (AP) — Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors.

    In a preliminary report on conditions at the pharmacy, the Food and Drug Administration said Friday that even when the contamination at New England Compounding Center exceeded the company's own safety levels, there is no evidence that staffers investigated or corrected the problem. The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year. The report comes from an FDA inspection of the Framingham, Mass.-based company earlier this month after steroid injections made by the company were tied to an outbreak of fungal meningitis. FDA officials confirmed last week that the black fungus found in the company's vials was the same fungus that has sickened 338 people across the U.S., causing 25 deaths.

    The New England Compounding Center's lawyer said Friday the pharmacy "will review this report and will continue our cooperation with the FDA." Compounding pharmacies like NECC traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They have traditionally been overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.

    The FDA report provides new details about NECC's conditions, which were first reported by state officials earlier this week. The drug at the center of the investigation is made without preservative, so it's very important that it be made under highly sterile conditions. Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility. But FDA inspectors noted that workers at the pharmacy turned off the clean room's air conditioning every night. FDA regulators said that could interfere with the conditions needed to prevent bacterial growth.
    Inspectors also say they found a host of potential contaminants in or around the pharmacy's clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.

    Additionally, inspectors found "greenish yellow discoloration" inside an autoclave, a piece of equipment used to sterilize vials and stoppers. In another supposedly sterile room inspectors found a "dark, hair-like discoloration" along the wall. Elsewhere FDA staff said that dust from a nearby recycling facility appeared to be drifting into the pharmacy's rooftop air-conditioning system.

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    Such ignorance from so-called 'educated' people...

    Boy kicked out of school because he has gene for cystic fibrosis
    A California boy has been ordered to transfer to another middle school because he carries the gene for cystic fibrosis, even though he doesn't actually have the incurable, life-threatening and non-infectious disease. His parents have gone to court to fight the move.

    Their son, 11-year-old Colman Chadam, was told last week that he’d have to transfer from Jordan Middle School in Palo Alto, Calif., to a school three miles away because he posed a risk to another student at school who does have the disease, according to TODAY. “I was sad but at the same time I was mad because I understood that I hadn’t done anything wrong,” Colman told TODAY. He added: “It feels like I’m being bullied in a way that is not right.”


    An inherited condition, cystic fibrosis causes the body to create a thick mucus that clogs the lungs and can lead to life-threatening lung infections. About 30,000 American adults and children have the disease and patients have an average life expectancy in the late 30s.
    While it is not contagious, doctors say people with cystic fibrosis can pose a danger to each other through bacterial cross-contamination if they are in close contact. “In general, we would prefer that there not be more than one cystic fibrosis patient in a school,” Dr. Thomas Keens, the head of the cystic fibrosis center at Children’s Hospital Los Angeles, told TODAY.


    The district’s assistant superintendent, Charles Young, told NBC News that officials relied on medical authorities who said “a literal physical distance must be maintained” between patients and that the "zero risk option" was to transfer Colman. But Colman’s parents, who are home-schooling him while they await a court hearing next week, say the school is overreacting. “Why take a child who’s new to the district, who’s just making friends, who’s just building a support network, who’s just getting to know his teachers, who’s been well his whole life ... why stigmatize him?” his father, Jaimy Chadam, said on TODAY.


    Jennifer Chadam said her son has attended two other schools with students who have cystic fibrosis. “It has never been an issue. Ever,” she said. Colman’s parents told the school about his condition on a form at the start of the school year, the San Francisco Chronicle reported. Colman has not suffered from lung problems, never needed treatment and had a negative result on a sweat test, the most accurate test for the disease, his parents told the Chronicle last week. They told the paper their son has never had a clinical diagnosis of cystic fibrosis.

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    New MS drug effective but expensive...

    Multiple sclerosis: New drug 'most effective'
    1 November 2012 - MS attacks nerves in the brain and spinal cord
    A new drug is the "most effective" treatment for relapsing-remitting multiple sclerosis, say UK researchers. During MS the body's immune system turns on its own nerves causing debilitating muscle problems. Researchers at the University of Cambridge say a cancer drug, which wipes out and resets the immune system, has better results than other options.

    However, there is concern that a drugs company is about to increase the cost of the drug as a result. Around 100,000 people in the UK have multiple sclerosis. When the condition is diagnosed most will have a form of the disease know as relapsing-remitting MS, in which the symptoms can almost disappear for a time, before suddenly returning.

    Built from scratch

    The researchers tested a leukaemia drug, alemtuzumab, which had shown benefits for MS in small studies. In leukaemia, a blood cancer, it controls the excess production of white blood cells. In MS patients, the dose eliminates the immune cells entirely, forcing a new immune system to be built from scratch which should not attack the nerves. Two trials, published in the Lancet medical journal, compared the effectiveness of alemtuzumab with a first-choice drug, interferon beta-1a. One compared the effectiveness in patients given the drug after being diagnosed, the other looked at patients given the drug after other treatments had failed. Both showed the drug was around 50% more effective at preventing relapses and patients had less disability at the end of the study than when they started.

    Dr Alasdair Coles, from the University of Cambridge, said: "Although other MS drugs have emerged over the last year, which is certainly good news for patients, none has shown superior effects on disability when compared to interferon except alemtuzumab." He told the BBC: "It is certainly the most effective MS drug, based on these clinical trials, but this is definitely not a cure." However, he warned there were side-effects. These include developing other immune disorders. He said he thought the drug would be most useful for patients for whom standard treatment had failed and in a "minority" of patients as a first-choice drug. Eventually relapsing-remitting MS can become progressive MS as the good spells become shorter and less frequent. The drug will have no effect on this form of the disease.

    Expense fears

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    Pharmas usin' poor people as drug test subjects...

    Have India’s poor become human guinea pigs?
    31 October 2012 - Drug companies are facing mounting pressure to investigate reports that new medicines are being tested on some of the poorest people in India without their knowledge.
    "We were surprised," Nitu Sodey recalls about taking her mother-in-law Chandrakala Bai to Maharaja Yeshwantrao Hospital in Indore in May 2009. "We are low-caste people and normally when we go to the hospital we are given a five-rupee voucher, but the doctor said he would give us a foreign drug costing 125,000 rupees (£1,400)." The pair had gone to the hospital, located in the biggest city in Madhya Pradesh, an impoverished province in central India, because Mrs Bai was experiencing chest pains.


    Their status as Dalits - the bottom of the Hindu caste system, once known as untouchables - meant that they were both accustomed to going to the back of the queue when they arrived and waiting many hours before seeing a doctor. But this time it was different and they were seen immediately. "The doctor took the five-rupee voucher given to BLPs [Below the Poverty Line] like us and said the rest would be paid for by a special government fund for poor people," Mrs Sodey explains. "This was really expensive treatment for the likes of us."


    What Mrs Sodey says she did not know was that her mother-in-law was being enrolled in a drugs trial for the drug Tonapofylline, which was being tested by Biogen Idec. Neither could read and Mrs Sodey says she does not remember signing a consent form.
    Mrs Bai suffered heart abnormalities after being given the trial drug. She was taken off it and discharged after a few days. Less than a month later, she suffered a cardiac arrest and died at the age of 45. The trial, which was registered in the UK by Biogen Idec, was later halted due, say the company, to the number of seizures recorded. The company also says Mrs Bai's death was not reported to them. Her case is not an isolated incident.


    In a different trial with a different company, Narayan Survaiya says neither he nor his late mother Tizuja Bai were asked if she wanted to participate, or even told that she was taking part in one, when she sought treatment for problems with her legs. And, like Mrs Sodey, he claims the family were told that a charity was footing the bill for the care. A few weeks after taking the drug, Mr Survaiya says his mother's health deteriorated and she was left unable to walk. "I told the doctor, but he said don't stop the doses. It is a temporary paralysis and the drug will make it better." His mother died a few weeks later.

    More http://www.bbc.co.uk/news/magazine-20136654

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    Quote Originally Posted by waltky View Post
    Pharmas usin' poor people as drug test subjects...

    Have India’s poor become human guinea pigs?
    31 October 2012 - Drug companies are facing mounting pressure to investigate reports that new medicines are being tested on some of the poorest people in India without their knowledge.
    India is clearly still a second-world country, which is a scary thought considering they're a nuclear power.
    my junk is ugly

  6. #16
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    Exclamation

    Malaria rates still high in Asia...

    Asia needs new response to malaria threat: experts
    Sat, Nov 03, 2012 - DEADLY SCOURGE:Tougher political leadership and regionally coordinated action are needed against the parasite, which is becoming increasingly drug-resistant
    Asia is hit with 30 million cases of malaria a year resulting in 42,000 deaths, a report said yesterday as experts called for an urgent response to the disease that stalks billions in the region. Most international efforts to defeat malaria have so far been concentrated on Africa, where the majority of the 650,000 worldwide deaths occur. However, out of the 3.3 billion people at risk from the mosquito-borne disease, 2.5 billion live outside the African region — mostly in Asia, where growing resistance to the frontline drug treatment is also causing concern. Leading scientists and health experts meeting in Sydney this week at the “Malaria 2012: Saving Lives in the Asia-Pacific” conference flagged the need for tougher political leadership and regional coordination.

    Fatoumata Nafo-Traore, director of the Roll Back Malaria Partnership, the global framework for coordinated action against the disease, called for a renewed focus in Asia, which has the second-highest malaria burden after Africa. “In the face of persistent economic uncertainty and profound changes in the landscape of global development aid, the region needs strong political leadership,” she said. “It also needs to develop financing strategies that include substantive and sustained domestic investment, traditional multilateral and bilateral aid, and truly innovative sources of funding,” Nafo-Traore added.

    She was speaking at the launch of a new report, Defeating Malaria in Asia, the Pacific, Americas, Middle East and Europe, a joint initiative with the WHO. It showed that the parasite threatens more than 2 billion people each year in the Asia-Pacific region, while smaller numbers are at risk in the Americas (160 million) and Middle East (250 million). There were about 34 million cases of malaria outside Africa in 2010, claiming the lives of an estimated 46,000 people.

    The Asia-Pacific, which includes 20 malaria-endemic countries, accounted for 88 percent, or 30 million, of these cases and 91 percent, or 42,000, of the deaths. India, Indonesia, Pakistan, Myanmar and Papua New Guinea were hardest hit. Australian Foreign Minister Bob Carr, who attended the three-day Sydney conference, yesterday pledged US$100 million over the next four years to fight the scourge in the Asia-Pacific. “Malaria does not respect borders,” he said. “Our focus must be on cross-regional action alongside traditional single-country strategies.”

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    Epidural abscesses developing in meningitis patients...

    Meningitis patients struck by 2nd illness
    Nov. 3,`12 (UPI) -- People recovering from a meningitis outbreak caused by a contaminated steroid drug have been struck by a second illness, officials say.
    The new problem, called an epidural abscess, was caused by the same steroid, methylprednisolone acetate, which was injected into patients to treat back or neck pain, The New York Times reported Friday.

    Epidural abscesses are a localized infection affect the membranes covering the brain and spinal cord. They formed in patients who were taking powerful anti-fungal medicines to fight meningitis, putting them back in the hospital for more treatment, often with surgery. "We're hearing about it in Michigan and other locations as well," said Dr. Tom M. Chiller, deputy chief of the mycotic diseases branch of the U.S. Centers for Disease Control and Prevention. "We don't have a good handle on how many people are coming back."

    More than 400 cases have been reported nationwide. Doctors are trying to figure out how to best treat patients with epidural abscesses. "We are just learning about this and trying to assess how best to manage these patients. They're very complicated," Chiller said. The meningitis outbreak, first discovered in late September, was caused by steroids made by the New England Compounding Center in Framingham, Mass. Three contaminated lots of the drug -- more than 17,000 vials -- were shipped around the country, and about 14,000 people were injected with the drug.

    Twenty-nine people have died, often from strokes caused by the infection. An inspection of the compounding facility, which has since been shut down, uncovered extensive black mold contamination. The company, along with another Massachusetts company, Ameridose, which was also shut down, has recalled its products.

    Read more: http://www.upi.com/Health_News/2012/...#ixzz2BFOgNtXk

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