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

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.

Advertisement: Story continues below

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

WikiLeaks cables: Pfizer 'used dirty tricks to avoid clinical trial payout'

Cables say drug giant hired investigators to find evidence of corruption on Nigerian attorney general to persuade him to drop legal action

The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government.

The cable reports a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It states: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media."

http://www.guardian.co.uk/business/2010/dec/09/wikileaks-cables-pfizer-nigeria?CMP=twt_gu

only 1% of the articles in medical journals are scientifically sound

According to the editor of the British Medical Journal, Richard Smith, only about 15% of medical interventions are supported by solid scientific evidence.

According to Professor David Eddy, of Duke University, only 1% of the articles in medical journals are scientifically sound and many treatments have never been assessed at all.

The British Medical Journal (BMJ) website Clinical Evidence reports that, of the 2404 treatments they have surveyed, only 15% are rated as beneficial, while 47% are of unknown effectiveness.

Where is the wisdom…? The Poverty of Medical Evidence

By RICHARD SMITH, Editor of BMJ

British Medical Journal 1991 (Oct 5); 303: 798–799

Safety and Ethics in Healthcare

"...professionals may adopt unreasonable practices. Practices may develop in professions, particularly as to disclosure, not because they serve the interests of the clients, but because they protect the interests or convenience of members of the profession. The court has an obligation to scrutinize professional practices to ensure that they accord with the standard of reasonableness imposed by the law."

Incresingly, the question is not whether the defendant's conduct conforms with the practices of the profession, but whether it conforms with standards of reasonableness. (p. 150)

"The right of patients self-determination is well entrenched both in law and in ethical codes. Respect for patient autonomy now occupies centre stage in medical ethics. In considering patient autonomy one needs to think about truth telling, confidentiality, privacy, disclosure of information and consent. Each is important and all have important implications for healthcare professionals." (p. 167)

Safety and Ethics in Healthcare: A Guide to Getting it Right, By Bill Runciman, Alan Merry

Published by Ashgate Publishing, Ltd., 2007

Fluvax side effects worse than the flu

Public health experts want an independent body to monitor drug safety following an analysis of the flu vaccine that showed young children were more likely to end up in hospital from its side effects than they were from the disease itself, according to the Sydney Morning Herald. The analysis also raises concerns about the Therapeutic Goods Administration’s assessment of the vaccine which caused more than 1000 adverse responses in children under five.
MJA Insight

• Issue 12, 20 September 2010

Elective treatment for sweaty palms is classified as psychosurgery

ETS can alter many bodily functions, including sweating , heart rate , heart stroke volume , blood
pressure , thyroid , baroreflex , lung volume , pupil dilation, skin temperature, goose bumps and
other aspects of the autonomic nervous system . It can diminish the body's physical reaction to
exercise and/or strong emotion, and thus is considered psychiatric surgery. In rare cases sexual
function or digestion may be modified as well.
LVHyperhidrosis.com
Aury Nagy MD

Wikileaks.org releases documents that show the influence of "Big Pharma" on the policy making decisions of the WHO

Documents can be accessed here:
http://wikileaks.org/

after a unilateral sympathectomy customary sensation of shivering while listening to a stirring passage of music occurred in only one side

The surprising fact is that the unpleasant sensation of fear was felt in one side of the body, contralateral to the brain stimulation, Sweet (221) has reported the case of a very intelligent patient, the dean of a graduate school, who after a unilateral sympathectomy to treat his upper limb hyperhydrosis, found that his previous and customary sensation of shivering while listening to a stirring passage of music occurred in only one side and he could not be thrilled in the sympathectomized half of his body. These cases were interesting because emotions are usually experienced in a rather diffuse and bilateral fashion unless innervation has been specifically interrupted.

Physical Control of the Mind, Jose DELGADO

Mindcontrol not just science fiction

"We need a program of psychosurgery and political control of our society. The purpose is physical control of the mind. Everyone who deviates from the given norm can be surgically mutilated.

"The individual may think that the most important reality is his own existence, but this is only his personal point of view. This lacks historical perspective.

"Man does not have the right to develop his own mind. This kind of liberal orientation has great appeal. We must electrically control the brain. Some day armies and generals will be controlled by electrical stimulation of the brain."

Dr. Jose Delgado (MKULTRA experimenter who demonstrated a radio- controlled bull on CNN in 1985)
Director of Neuropsychiatry, Yale University Medical School
Congressional Record No. 26, Vol. 118, February 24, 1974

Biochemical theories - of mental disorders - are an entirely "unproven hypothesis"

In his 1988 book, Blaming the Brain: The Truth about Drugs and Mental Health, Valenstein
argues that while psychotropic drugs sometimes do work, they do not even begin to address the
real cause of mental disorders, since in his view biochemical theories are an entirely "unproven
hypothesis" used to excuse what he sees as often unconscionable marketing practices of the
drug industry. Valenstein acknowledges a combination of medications and psychotherapy often
offers the best chance of success at treating common disorders, but stresses no one knows
exactly why.

Economic factors distorting the practice of medicine

"The influence of the pharmaceutical companies is so great these days because of the resources
they have at their disposal. There are tremendous economic factors distorting the practice of
medicine, just as there were in the lobotomy period. It is hard to find any clinicians or
researchers who don’t have vested interests in the development of procedures or drugs. I mean
that. Of course, they will deny that funding from drug companies has an influence, but it is so
subtle that they’re unaware of it themselves."
Elliott Valenstein (Stay Free! interview, Fall 2003).

Even a surgeon who was convinced that he was not obtaining good results seldom gave up lobotomy

There are many parallels between Lobotomy and Sympathectomy. One of them is that they are performed by surgeons who know very little about the part of anatomy they choose to burn, cut, clamp, disable. The other parallel is that the surgeons refuse to acknowledge the validity of the complaints of many people who have been often disabled by the procedure - and are declared 'screamers' or simply 'mentally unstable'. Those who complain are 'militant'.
The next similarity can be witnessed in the literature, as surgeons struggle to come up with milder, cuter names for their procedure, in order to differentiate themselves, competing with a horde of doctors willing to try their hand, and trying to undermine those who - they believe - are less qualified to perform it. Thus neurosurgeons are attacking thoracic surgeons, who attack vascular surgeons, and they all have a really good go at the cosmetic surgeons... Besides all these pressures, the doctors have to come up with results that match those that were already published in the literature.

"Even a surgeon who was convinced that he was not obtaining good results seldom gave up lobotomy. It was difficult to admit that the effort had been completely wasted, especially when other surgeons were reporting success. Rather than abandoning psychosurgery, neurosurgeons
much more commonly introduced some change in the operation in the hope of increasing the success rate."
Elliott Valenstein, in Great and Desperate Cures (1986).