Monday, December 20, 2010

Deadly Medicine: FDA Fails to Regulate Rapidly Growing Industry of Overseas Drug Testing

Pharmaceutical companies are increasingly conducting clinical trials for new drugs outside the U.S., usually in countries where regulations are less stringent and trials are much cheaper, often leading to deadly results. Twenty years ago, only 271 trials of drugs intended for use by Americans were conducted overseas. By 2008, the number had risen to nearly 6,500—many taking places in areas with poor and illiterate test subjects. Journalist Jim Steele joins to talk about his special investigation just published in Vanity Fair.
http://www.democracynow.org/2010/12/17/deadly_medicine_fda_fails_to_regulate

Sunday, December 19, 2010

Call for ban on shock therapy

Jill Stark
December 19, 2010

    ELECTRIC shock therapy may cause permanent brain damage and long-term memory loss and should no longer be used as a treatment for mental illness, researchers say.

    Psychologists who analysed more than 100 studies of the controversial treatment say the risks of shock therapy outweigh the benefits and it should be consigned to the ''historical rubbish bin'' alongside lobotomies.

    Electroconvulsive therapy, or ECT, induces seizures by delivering an electric current to the brain. It has divided the medical profession, with some arguing the practice is archaic and others maintaining it is highly effective and can be life-saving for severely depressed patients.

    Earlier this year, The Sunday Age revealed there had been a 10 per cent increase from 2008 to 2009 in the number of Victorians receiving ECT. A third underwent the procedure against their will.

    The review's lead author, John Read, of the University of Auckland, looked at placebo-controlled studies and concluded shock therapy had minimal effects for people with depression and schizophrenia.

    ''The dwindling numbers of psychiatrists who still use this procedure, which sends 150 volts through brain cells equipped to deal with tiny fractions of one volt, are no doubt well-intentioned, but the research just does not support them,'' Associate Professor Read said.

    The review, published this week in the journal Epidemiologia e Psichiatra Sociale, found almost all ECT patients suffered some amnesia. ''For a proportion of those people some of that memory loss is recouped over time,'' Associate Professor Read said. ''However, we are now seeing that for a significant proportion of people that brain dysfunction is permanent. ECT can, for a minority of people, produce some very short-term benefits; it can lift people's mood quite quickly.

    ''The problem is that there's no evidence at all that that benefit lasts beyond the end of the period that you're giving the electric shock treatment for.''

    However, eminent psychiatrist Ian Hickie, executive director of the Brain and Mind Research Institute, said the findings were ''ridiculous'' and that while previously it was presumed that ECT caused memory loss, advances in brain imaging had shown the patient's depression was often to blame.

    ''The relative safety of ECT has actually improved over time and there have been major changes in the way it is delivered to minimise the risks,'' Professor Hickie said.

    ''This review is completely out of step with the last decade of systematic neuroscience and related clinical studies.''

    While shock therapy is not commonly given to young people, statistics from Victoria's Chief Psychiatrist show seven children under 17 were given a total of 46 ECT treatments last year. Associate Professor Read said this was particularly concerning because the brain was still developing.

    The Royal Australian and New Zealand College of Psychiatrists says ECT is one of the least risky medical procedures carried out under general anaesthetic and is beneficial in treating some serious mental illnesses.

    http://www.theage.com.au/victoria/call-for-ban-on-shock-therapy-20101218-191e2.html

    Flu vaccine to be thrown out

    AUSTRALIA'S remaining stock of swine flu vaccine will expire soon and will have to be thrown out, at a cost of $100 million.

    At the height of last year's pandemic, the federal government spent almost $200 million buying 21 million doses of Panvax H1N1.

    Just under half was distributed to doctors, with fewer actually used on patients. That leaves 3.8 million doses to be donated to the World Health Organisation and 7.8 million doses to be destroyed.

    A Health Department spokeswoman said the first batch of vaccine began to expire in October and the entire stock would expire by December 31. Expired vaccine will be disposed of as medical waste.

    Opposition Health spokesman Peter Dutton said the destroyed stocks represented huge waste.

    ''This is yet another rounding issue for this government,'' he said. ''The Gillard government just can't get the detail right. They have overreacted to a number of key issues and their response to this issue is going to cost taxpayers tens of millions.

    ''The government saw political advantage and they put their own spin ahead of patients' own interests.''

    Health Minister Nicola Roxon said at the start of the month Australia's pandemic phase had moved from ''protect'' to ''alert'', signalling the end of the swine flu pandemic here.

    http://www.smh.com.au/lifestyle/lifematters/flu-vaccine-to-be-thrown-out-20101218-191c2.html