http://www.i-sis.org.uk/FDAinDrugTrial.php
ISIS Press Release 01/09/06
FDA in Third World Drug Trial Scandals
See also:
FDA Under Fire for Corporate Links that Compromise Science and other
articles in the Science and Ethics section
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Drugs trials boom in developing countries
By 2010 it is estimated that some two million people in India will be
taking part in clinical trials [20]. Most of the world largest
pharmaceutical companies have established a presence in India, where they
are increasingly recruiting patients and outsourcing trials.
The BBC recently screened a documentary (27 April 2006) called Drug
Trials: The Dark Side that showed the woeful lack of informed consent by
Indian patients, many of whom were taken off their existing medication to
take part in drug trials commissioned by US companies. The patients were
under the impression that their usual drug was no longer available and the
new drug was merely a continuation of their treatment.
Typically, the patients interviewed by the BBC reporter Paul Kenyon were in
awe of their d octors, and because of ill health and poverty, were willing
to agree to anything they were asked to do. Most consent forms were
written in English, which many patients could not read, let alone
understand, and some were able to give only a thumbprint as their
acquiescence to the clinical trial. One patient who agreed to take part in
the placebo part of the trial did so because he believed that if his doctor
was administering the pill, then it must somehow do him good.
None of the patients received any money for their involvement, and when the
trials finish, there is no guarantee that their treatment will continue,
nor that the drug will be available to the wider population as a whole.
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Experimental tests are conducted in developing countries on sick and
vulnerable children under the guise of free and ethical treatments
sanctioned by the FDA and complicit medical institutions. Sam Burcher and
Dr. Mae-Wan Ho
A fully referenced version of this report is posted on ISIS members'
website. Details here
Unapproved GM rice serum tested on sick infants
Two children suffered serious allergic reactions after being used as guinea
pigs by the California-based company Ventria Bioscience in Lima, Peru [1].
The children were part of a clinical trial of a genetically modified (GM)
rice serum containing two synthetic human proteins lactoferrin and lysozyme
(normally found in human milk and other bodily fluids), not yet approved
for testing in the US or anywhere else in the world.
Ventria had experienced stiff opposition for growing the GM rice in its
home country. It was driven out of California and southeast Missouri in
2005, but managed to grow the GM rice in North Carolina [2] (Molecular
Pharming - the New Battlefront over GM Crops , SiS27).
The company was hoping to sell the GM rice as a "nutraceutical" presumably
on grounds that it provided extra nutrition. Nevertheless, it was unlikely
to gain approval for a clinical trial in the US; so, like other companies,
it decided to target Third World countries where regulations are lax.
Trials of proteins known to be unsafe
There are reasons why Ventria's trial should never have been allowed,
anywhere in the world, least of all, on vulnerable infants suffering from
diarrhoea. Prof. Joe Cummins [3] had drawn attention to the potential
hazards of these particular GM rice proteins ( Human Proteins in GM Rice
Linked to Diseases , SiS22). Lactoferrin participates in the regulation of
immune functions and controls pathogens by binding iron required for
bacterial growth. But it has been implicated in asthma with fatal
consequences. Lysozyme breaks down the cell wall material of bacteria, but
may contribute to emphysema. By far, the greater danger is that the
transgenic proteins are only approximations of the natural proteins in
amino-acid sequence and glycosylation (carbohydrate chains added to the
proteins during processing), and may therefore provoke immune reactions.
Glycosylation differs between species; hence transgenic proteins are bound
to exhibit differences in glycosylation patterns from the natural protein.
It was indeed the difference in glycosylation patterns that turned a
normally harmless bean protein into a potent immunogen when transferred to
pea, causing debilitating lung inflammation and food sensitivities in mice
[4] (Transgenic Pea that Made Mice Ill , SiS29).
Other serious breaches in protocol suspected
The trials in Lima were carried out at the Institute for Child Health and
at the Nutrition Research Institute. Ventria had experimented on 140
children from the age of 5 months to 3 years suffering from diarrhoea. It
is doubtful whether informed consent was obtained.
One child is now so ill that according to his mother, Diana Canessa Garay,
he is allergic to many foods such as fruit and chocolate. She said [5], "I
do not know what will happen to him later, the Ministry of Heath must
follow up investigation of his health." She was told that her child was
receiving rice serum, which is medically documented as an efficacious
treatment for diarrhoea. No mention was made of its transgenic origins.
The case is under investigation by the public prosecutor.
A US paediatrician Jim Diamond suspects that the reason that the children
in the control group were given a less effective glucose solution was to
make the positive effect of the transgenic rice appear more dramatic: 5.21
days to recovery in controls as opposed to 3.67 days with GM rice serum
[1]. Ventria wasted no time in announcing theresults.
Professor Flora Gonzales, who specialises in genetics, fears that the tests
could have untoward long-term consequences. She believes that children
given the GM rice serum could suffer degenerative diseases like Alzheimer's
because of damage incurred by the altered proteins.
Not only have unethical drugs trials been pushed onto developing countries,
but also so has pharm crop production itself. GM pharm crops such as rice,
maize, tomato and tobacco crops started in California, but were rapidly
moved on to other states such as Hawaii [6] ('Pharmageddon' / Risks of
Edible Transgenic Vaccines , SiS17), and now France [7] (Transgenic Maize
with Monoclonal Antibodies Grown in France, this issue). The government in
Bangladesh has just announced that its National Biotechnology Policy aims
to introduce GM rice production into the country by 2010 [8].
Nuremberg Code breached by financial incentives
The ethical obligations to protect the best interests of children (and
adults) in clinical procedures are defined by The Nuremberg Code [9]. The
Code was developed in the aftermath of atrocious human experiments during
World War II, and provides guidance for protecting human experimental
subjects from injury, disability or death. Its main principle is the
necessity to obtain voluntary informed consent from the patient.
The latter day US Government, however, offers powerful incentives to
pharmaceutical companies to test on children. Companies that voluntarily
test drugs on children are given a "paediatric exclusivity provision" which
adds six months of patent protection or market exclusivity to their
product, and means more profits [10].
The FDA also imposed a "paediatric rule" that require companies to test on
children under certain circumstances. The rule includes the likelihood
that the drug tested could be used on a substantial number of children and
in different paediatric age groups, leading to high volume sales. The
trials in Peru of a remedy for diarrhoea appear to fulfil the criteria of
this rule; as do the trials of an unapproved antibiotic for meningitis in
Nigeria (see below).
Unregistered antibiotic tested on children
The Washington Post revealed recently that d rug giant Pfizer
Pharmaceuticals was accused of conducting unethical clinical trials on
children in Nigeria in 1996 [11]. This accusation was made in a Nigerian
government report instigated by a whistleblower.
It's a real life story echoing the sentiments of the recent hit film The
Constant Gardener (SiS 30)[12] that highlights the exploitation of African
patients enrolled on drugs trials, often without informed consent.
An experimental antibiotic, Trovan, was given to the children in a field
hospital in Kano where they were treated for a meningitis epidemic. The
parents were not told of the drug's unapproved status and they only gave
verbal consent to the nurses for its use on the understanding that it would
help their children.
The report, which lay buried for five years, revealed that five children
died after being given Trovan. Six other children also died while taking
the comparison drug. The pharmaceutical company later concocted and
backdated a letter of approval from a Nigerian Ethics Committee.
Deadly deviations of clinical protocol
One child in particular was subject to serious deviations in clinical
trials protocol. A ten year-old girl, identified in the report as patient
0069, received only three days worth of Trovan. When her condition
deteriorated she was given no further treatment of any kind, and
subsequently died.
Pfizer maintains that its presence in the Kano hospital was ostensibly a
philanthropic one to fight an epidemic that had claimed the lives of up to
15 000 people. However, as soon as the trial was over the company withdrew.
This action, coupled with the fact Pfizer never obtained authorization from
the Nigerian Government to test Trovan on nearly 100 children and infants,
amounts to an opportunistic and illegal trial of an unregistered drug on
vulnerable patients.
According to the Nigerian government report, Pfizer has violated Nigerian
Law, the International Declaration of Helsinki, and the UN Convention of
the Rights of a Child. The discovery of the report has breathed new life
into a court action against the company initiated by 30 Nigerian families
involved in the trials.
Drug tested on African children first
The US Food and Drug Administration (FDA) subsequently never approved
Trovan for use in treating American children implying that the drug was
tested first on African children before being considered for the American
market. It continued a worrying trend of testing drugs on Africans, both in
Africa and America [13-15] (US Foster Children Used in AIDS Drugs Tests ;
NIH-Sponsored AIDS Drugs Tests on Mothers and Babies ; Guinea Pig Kids in
AIDS Drugs Trials ; SiS27)
The FDA non-approval was a blow to Pfizer, which was looking to gain a
billion dollars per year from sales. The drug was cleared for adult use in
the US, but its use became severely restricted after reports of liver
damage and deaths. Trovan is now banned in Europe.
Tom Lantos is a senior Democrat on the International Relations Committee.
He describes the report findings as absolutely appalling. He said [11],
"I think it borders on the criminal that the large pharmaceutical companies
both here and in Europe are using these poor, illiterate and uninformed
people as guinea pigs".
The FDA is under fire from another senior democrat who has denounced its
links with drugs corporations through the House of Representatives [16].
Not only that, some of the FDA's own scientists have reported that they are
under enormous pressure to alter findings in scientific documents [17, 18].
(See FDA Under Fire for Corporate Links that Compromise Science, SIS31)
HIV-tainted drug dumped on developing countries
The FDA is also implicated in a controversial story involving drugs giant
Bayer Corporation, brought to light by the New York Times [19]. It is
alleged that Factor VIII, a drug for treating mostly child haemophiliac
patients was contaminated with the HIV virus during the 1980s. When
American haemophiliacs contracted HIV after using the injected,
blood-clotting drug made from unheated blood concentrates, the FDA
recommended that Bayer dump their surplus on Japan, Malaysia, Singapore,
Indonesia and Argentina. That way the company could still reap profits from
sales, despite it being pulled from the US market.
In Hong Kong and Taiwan alone it is estimated that over one hundred
haemophiliac patients, including a two-year old child, contracted HIV after
using the tainted medicine.
New stocks of the drug were made using heat-treated blood concentrates
(which kills the virus) for the American market while the remainder of the
old stock went off to France and Spain. Two French officials were later
imprisoned for approving the use of the contaminated, unheated Factor VIII.
The FDA was neither subject to investigation no r indictment and wanted
the problem "quietly solved without alerting Congress, the medical
community and the public." Bayer maintains that it behaved responsibly and
ethically.
Need for global regulation in clinical research
There are serious breaches of ethics and protocol in clinical trials,
especially those conducted in Third World countries, though by no means
restricted to those countries, as the recent London drug trial catastrophe
so clearly demonstrates [21] (Clinical trial on trial series, Science in
Society 30). There is a need for global regulation in clinical research, so
that drugs and trials not approved in one country may not be tested or used
in another.
We hope that the WHO Registry of Clinical Trials (SiS30) [22] will ensure
that all clinical trials are at the very least registered with the World
Health Organisation, and that a minimal set of data about the trial is
readily available, should questions of safety and emergency care of trial
subjects arise
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