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Should You Be The Human Guinea Pig?

For every headache tablet, cough syrup or antibiotic you swallow, for every prescribed
injection you receive, someone, somewhere, has volunteered to let that drug loose on their
system before its been deemed safe for public consumption. Perhaps they have been motivated
by the chance of free medical treatment for whatever is ailing them. Or by the chance to make
easy money lying around. Or maybe they just want to help medical science.
Whatever the reason, hundreds of thousands of people take part in clinical trials each
year. Of course, all drugs need to undergo this rigorous testing before they are approved.
Currently an estimated 50,000 medical trials are underway around the world.
Today, Eastern Europe is a growing locale for clinical trials, with quality healthcare
systems, lower overheads and highly educated and motivated investigators proving attractive to
the pharmaceutical industry. Companies are also extending clinical trials to Asia, especially China
and India. Running trials across many different countries gives drug companies access to a much
larger population, means they can test drugs in people of different ethnic backgrounds, and can
also be cheaper.
But no matter where the trial is held, its important for people who are contemplating taking part
to know the processes involved.
The four phases
Clinical trials fall into four categories, which are standard throughout the world. Phase 1 is
when the drug is put into humans for the first time, to enable researchers to work out whether
its safe and what is the highest dose they can use before side effects kick in. These trials are
usually conducted on a small group of healthy volunteers under tightly controlled medical
conditions, with continual testing before and during the trial.
We have to collect lots of data in test tubes and animals before we can put a drug into a
person, but basically were still working off our best guess and we are never completely sure
whats going to happen, says Dr Janelle Bowden, who coordinates clinical trials for children at
the Kids Research Institute in Sydney.
We usually start with a really tiny dose and gradually work up. If any safety events occur,
we stop, and thats why participants are in hospital, to make sure we catch everything. Its about
the same level of risk as going into a pharmacy and starting a new dose of a new medication for
the first time, says Bowden.
Once a Phase 1 trial has proven the drugs initial safety, it progresses to Phase 2, when its
trialed in a group of a couple of hundred patients, who actually have the condition the drug is
being developed to treat. If its shown to work at this dose, a Phase 3 trial is launched, testing
the drug on a group of several thousand people.
These larger trials usually involve participants being split into two groups: one receives the
new drug, the second the proven standard therapy. If there is no existing treatment for this
particular disease, this second group might get a placebo (an inactive medicine). This is called a
randomised controlled trial because participants are randomised into two groups, and those
who receive the new drug are compared to the control group. The trial is carefully organised so
no-one administering the therapy neither the participants nor the doctors knows who is
getting what.
If the drug is proven to work without damaging side effects, the government gives it
approval and doctors can start prescribing it to patients. But strict regulations mean getting a
drug from laboratory to market usually takes seven to 15 years. Of 10,000 compounds
developed, only about five make it through to a clinical trial and just one will make it to market.
Drug companies invest billions of dollars in clinical trials every year but its worth it. Finding the
next big blockbuster drug can reward the companies many times over.
Once a drug is approved comes the final stage, Phase 4. This stage collects ongoing safety
information from the general population rather than the tightly controlled conditions of the
previous clinical trials.
Maybe only 5000 to 10,000 people have been tested by this stage, says Bowden, so if
an event only happens once in every 10,000 people, it may not show up in the earlier trials.
Who volunteers?
One of the challenges facing researchers is finding the large numbers of people needed to
participate in a clinical trial. To give statistically valid information, sometimes they need to recruit
thousands of people, all of whom have to meet very specific health criteria.
One of the biggest problems is time, says Lucy Williams, director of Trialspotting, a
company that recruits people for clinical trials. Young travellers are a common group for drug

companies to target with advertisements for participants. Backpackers dont mind because they
are locked away with nothing to distract them, but for other people it can be hard.
People who take part in Phase 1 trials, and receive no physical benefit themselves, may be
offered anything from movie tickets to several thousand dollars. For others, the incentive is the
possibility of receiving free medical treatment and a range of tests to which they would not
normally have access.
For many sick people, especially those with rare illnesses, taking part in clinical trials is the
only way they can get access to experimental treatments or new drugs that have been approved
overseas but not yet in their own country. For others with more common conditions like asthma
or dementia, agreeing to a clinical trial means they get free medicine and expert care.
But for otherwise healthy people, are clinical trials worth the risk? In the UK in 2006, six
young, healthy volunteers collapsed with multiple organ failure during a disastrous Phase 1
clinical study into a new anti-inflammatory drug, TGN1412. All were rushed to intensive care
after the very first infusion of the drug at a hospital in London, in which they were given a dose
500 times smaller than that proved to be safe in animals. All survived after months in hospital,
but many lost fingers and toes.
Now, there are concerns that people are dying during clinical trials in the Third World,
where patients receive insufficient protection. Standards in Australia, however, are extremely
high and researchers have to meet stringent ethics criteria. They must also provide detailed
information about the potential side effects, benefits and risks, so that participants can give their
informed consent.
Nevertheless, its important to get as much information as possible about the trial before
proceeding, says Carol Bennett, CEO of the Consumers Health Forum in Australia.
Prospective participants should consult their doctor about the risks involved, and also quiz
the researchers about what monitoring takes place. She also points out they can leave a clinical
trial at any stage if they feel their health is deteriorating. Get all the information on which to
make an informed decision, then if you have any doubt about the safety, impact of treatment on
your condition or side effects, dont participate, she says.
I did it to slim down
Lynne Howard, a field interviewer with the Australian Bureau of Statistics, was 50 when
she saw an ad in the paper looking for people who were interested in losing weight. She rang the
number and went along to find it was a clinical trial comparing the effects of lap band surgery
with slimming shakes on overweight people, and how losing weight affected other problems like
diabetes.
Having struggled with her weight for years, Lynne was delighted when she was placed in
the group that was to receive the surgery. She underwent a range of medical tests, looking at her
bone density and whether she had sleep apnea; she even had a nasogastric tube put down her
nose to determine if she had reflux. She also had to fill out many forms before and after the
surgery, assessing whether her quality of life and self-esteem improved after she lost weight.
The keyhole surgery went well and she lost 30 kg. In the 12 years since, the lap band has slipped
twice, and both times she has received free corrective surgery. She still pays follow up visits to
the clinic.
Its been fantastic, says Lynne, who has since taken part in two more clinical trials,
looking at the impact of repetitive movement on the painful condition Fibromyalgia, and also on
follow up care after breast cancer treatment. I want to be able to help those who are trying to
help us and pass on their findings to those who treat or have an interest in this illness, she says.
I did it for money
Stefan Wolinski lay on a hospital bed in Melbourne and felt the sharp prick of the needle as
the nurse injected a clear liquid into his thigh. She recorded his vital signs and for the next four
hours he lay there, forbidden from getting out of bed, as the medical team watched him for any
sign of side effects to the drug.
For the next eight days and nights Stefan and the other few participants were confined to
the hospital ward. They watched television, played electronic games or just trawled the internet.
The staff made our time as pleasant as possible, he says.
Every morning they gave blood and urine, which was analysed to see how the drug was
affecting their bodies.
For Stefan, a 25-year-old traveller from Leeds in Britain, giving up eight days of his life earned
him $2500 far more than what hed earned driving machinery on a building site and labouring
at landscape gardening.

I heard about earning money in clinical trials from a mate, says Stefan, who extensively
researched the drug, which was already being used to treat bowel disease and is now being
trialled as a drug to prevent it. He was submitted to a barrage of medical tests to confirm he was
in top health before commencing. It was exhausting staying there for so long, but I didnt have
any side effects.
I did it for a better life
Angela Riach, 13, was born with cystic fibrosis, which limited what she could do until she
and her parents agreed to take part in the trial of the new drug Kalydeco at The Childrens
Hospital at Westmead, Sydney. The researchers knew immediately who was on Kalydeco and who
was on the placebo, so dramatic was the improvement.
The medication means Angela now competes at State Level Cross Country and is playing
the flute. For Angela and other participants, the trial has been extended so they can keep on
receiving the drug. But her younger brother Nicholas, who also has cystic fibrosis, didnt take
part in the trial so wasnt able to access the drug.
The average life expectancy for people with cystic fibrosis is 37, but people who have
started on the drug are planning for their retirement, thats how good they feel, says her
mother, Ruth. Were so lucky Angie was able to take part she didnt realise how unwell she
was before, and now she just feels fantastic.

Building the Bionic Man


Amputees will tell you its the simple things you miss most when you lose a limb the ability to
hold a Styrofoam cup without crushing it, the dexterity to pick up a piece of paper off a flat
surface.
Adrian Ware, a 32-year-old electrical worker from Wollongong, lost his right arm below the elbow
after a horrific high-voltage electric shock nine years ago. He was fitted with a prosthetic limb,
but for years relied mainly on his left hand. Then, late last year, Adrian became the first patient
in Australia to be fitted with a bionic hand that enables him to use all five digits independently,
grasp, rotate the limb, and grip with finger and thumb. Its given me so much more confidence.
Now I dont have to worry about dropping things, he says of the device imported from the UK.
It may have cost $6 million to develop the bionic man of 70s TV show fame, but today that
fantasy is closer to reality than you think. From bionic eyes and ears to kidneys and spines, a
surge of activity around the world has created huge advances in medical bionics in the last five
years.
Patients of the future may not have Steve Austins super powers, but the bionics revolution
means something just as wonderful doctors will be able to replace broken body parts with
prostheses that work in much the same way as the real thing.
Bionics is the interface of biology and electronics. It works on the basis that we are all naturally
charged: the millions of cells in our bodies are in effect tiny batteries, carrying about a twentieth
of the charge of a normal AA battery. Cells communicate with each other by electrical signals,
and proteins move in and out of cells under the influence of electrical charge.
The theory is that if you can introduce electricity into the body in a targeted way, you can
influence the way the body works at a molecular level. That means you can stimulate nerves and
muscles to make them work normally. And the possibilities are endless.
The first successful bionic body part, the cochlear implant, was developed in Australia by
Professor Graeme Clark some 30 years ago. To date, the device has restored hearing to more
than 80,000 profoundly deaf people by replicating the actions of the inner ear.
Work is already underway around the world to enable paraplegics to feel, walk and control their

environments through thought. It is hoped that balance could be restored to the elderly, and
devices will be developed to allow the deaf to hear clearly and the blind to see. Prosthetic limbs
will work more like the real thing and will communicate with our brains.
The reason for all this new activity is the development of a range of new materials that make
bionic body parts work more effectively. Smart plastics can conduct electricity in a precise way;
nanotechnology the science of controlling matter at a molecular level is helping to create new
coatings for the surfaces of devices; and scientists are discovering how to implant drugs to leach
slowly into the body, helping with the targeted delivery of antibiotics and medications.
The bionic hand fitted to Adrian Ware was developed by UK company Touch Bionics.
Electrodes on his skin pick up electric signals from Adrians remaining arm muscles and the
control system enables him to move each finger individually, so he can pick up objects gently
and with precision. The hope is there will be some way of connecting these devices directly to
thought and have feedback to have a sense of touch and feeling, says Touch Bionics CEO
Stuart Mead.
Meanwhile, researchers at Vanderbilt University in the US have developed a prototype bionic arm
that combines a mechanical prosthesis with a miniature rocket motor. It weighs the same and is
as strong as a real arm. Its also very close in function, with a wrist that twists and bends and
fingers and thumb that open and close independently.

Fresh look on the Janitor Fish


By Dr. Rafael D. Guerrero III
Executive Director, PCAMRD
The janitor fish, is considered a nuisance species in Laguna de Bay and the Marikina River .
This South American aquarium catfish introduced in the country possibly by hobbyists has
escaped into local freshwaters.
The Philippine Council for Aquatic and Marine Research and Development of the Department of
Science and Technology recently issued updates on the janitor fish.
First, there are two species of the janitor fish that have been correctly identified by senior
fishery biologist Edna Agasen of the Department of Agricultures National Fisheries Research and
Development Institute with the assistance of Dr. Jonathan Armbruster, curator of fishes at Auburn
University (USA). The species are Pterygoplichthys pardalis found in the Marikina River and Lake
Paitan in Cuyapo, Nueva Ecija; and the Pterygoplichthys disjunctivus found in Laguna de Bay.
This new report now corrects the previous identification of the janitor fish as Plecostomus
hypoglosus in the country.
Studies indicate that the janitor fish has also become invasive in other countries. According to
Dr. Armbruster, the Pterygoplichthys species have become established in tropical and semitropical regions of North America , Puerto Rico , Malaysia , Indonesia and possibly other places
where these were introduced.
In spite its unpleasant reputation, the janitor fish is edible. It is eaten by South Americans who
usually gut and grill them whole or make soup with them, says Dr. Armbruster. The fish can
survive up to 30 hours or more out of water as long as they are kept moist. This applies well in
rural areas where refrigeration is not available.

The janitor fish caught in Laguna de Bay has been declared safe for human consumption by
Jose Cario of the Laguna Lake Development Authority. It does not contain toxic levels of heavy
metals.
Dr. Armbruster says, the fish builds its nests in mud banks and can contribute to water
turbidity. They may compete with other fishes feeding on algae and detritus (organic matter)
on the bottom. In its natural habitat, it feeds on tadpoles and insects.
There appears some practical control measure that can be applied for the janitor fish. Since
the janitor fish breeds and grows quickly, Dr. Armbruster suggests that the best way to reduce
its population is by catching the adults through grill nets or traps at their nesting sites.
In the United States, the fish does well in reservoirs and canals than in natural freshwater bodies,
he said.
The LLDA is implementing a World Bank-funded project to reduce the population of janitor fish
in Laguna de Bay by paying fisherfolk P10 per kilogram of the fish which is converted into
fishmeal for pig feed by a cooperative in Siniloan Laguna.