handouts for feature writing

6
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 it’s 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 yea r . Of course, all drugs need to undergo this rigorous testing bef ore they are approved. Currently an estimated !,!!! medical trials are underway around the world.  " oday, #astern #urope is a growing locale for clinical trials, with $uality healthcare systems, lower overheads and highly educated and motivated investigators proving attractive to the pharmaceutical industry . Companies are also e%tending clinical trials to &sia, especially China and 'ndia. (unning trials across many di)erent countries gives drug companies access to a much larger population, means they can test drugs in people of di)erent ethnic backgrounds, and can also be cheaper. *ut no matter where the trial is held, it’s 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 + is when the drug is put into humans for the rst time, to enable researchers to work out whether it’s safe and what is the highest dose they can use before side e)ects kick in. "hese trials are usuall y conduc ted on a sma ll gr oup of healthy vol unt eer s unde r tig htl y contro lle d medica l 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 we’re still working o) our best guess and we are never completely sure what’s going to happen, says /r 0anelle *owden, who coordinates clinical trials for children at the 1ids (esearch 'nstitute in 2ydney. -We usually start with a really tiny dose and gradually work up. 'f any safety events occur, we stop, and that’s why participants are in hospital, to make sure we catch everything. 't’s about the same level of risk as going into a pharmacy and starting a new dose of a new medication for the rst time, says *owden. Once a Phase + trial has proven the drug’s initial safety, it progresses to Phase 3, when it’s trialed in a group of a couple of hundred patients, who actually have the condition the drug is being developed to treat. 'f it’s shown to work at this dose, a Phase 4 trial is launched, testing the drug on a group of several thousand people.  "hese larger trials usually involve partici pants being split into two groups5 one receives the new drug, the second the proven standard therapy. 'f there is no e%isting treatment for this particular disease, this second group might get a placebo 6an inactive medicine7. "his is called a -randomised controlled trial 8 because participants are randomised into two groups, and those who receive the new drug are compared to the control group. "he trial is carefully organised so no9one administering the therapy 8 neither the participants nor the doctors 8 knows who is getting what. 'f the drug is proven to work without damaging side e)ects, the government gives it approval and doctors can start prescribing it to patients. *ut strict regulations mean getting a drug from laboratory to market usually takes seven to + years. Of +!,!!! compounds developed, only about ve make it through to a clinical trial and just one will make it to market. /rug companies invest billions of dollars in clinical trials every year 8 but it’s worth it. :inding the ne%t big blockbuster drug can reward the companies many times over. Once a drug is approved comes the nal stage, Phase ;. "his stage collects ongoing safety informati on from the general population rat her than the tig htly controlled conditions of the previous clinical trials. -<aybe only !!! to +!,!!! people have been tested by this stage, says *owden, so if an event only happens once in every +!,!!! people, it may not show up in the earlier trials. ho volunteers? One of the challenges facing researchers is nding the large numbers of people needed to participate in a clinical trial. " o give statistically valid information, sometimes they need to recruit thousands of people, all of whom have to meet very specic health criteria. -One of the biggest problems is time, says =ucy Williams, director of "rialspotting, a

Upload: loueljie-antigua

Post on 08-Jul-2018

216 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Handouts for Feature Writing

8/19/2019 Handouts for Feature Writing

http://slidepdf.com/reader/full/handouts-for-feature-writing 1/5

Should You Be The Human Guinea Pig?

For every headache tablet, cough syrup or antibiotic you swallow, for every prescribedinjection you receive, someone, somewhere, has volunteered to let that drug loose on theirsystem before it’s been deemed safe for public consumption. Perhaps they have been motivatedby the chance of free medical treatment for whatever is ailing them. Or by the chance to makeeasy 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 eachyear. Of course, all drugs need to undergo this rigorous testing before they are approved.Currently an estimated !,!!! medical trials are underway around the world.

 "oday, #astern #urope is a growing locale for clinical trials, with $uality healthcaresystems, lower overheads and highly educated and motivated investigators proving attractive tothe pharmaceutical industry. Companies are also e%tending clinical trials to &sia, especially Chinaand 'ndia. (unning trials across many di)erent countries gives drug companies access to a muchlarger population, means they can test drugs in people of di)erent ethnic backgrounds, and canalso be cheaper.*ut no matter where the trial is held, it’s important for people who are contemplating taking partto know the processes involved.

The four phases

Clinical trials fall into four categories, which are standard throughout the world. Phase + iswhen the drug is put into humans for the rst time, to enable researchers to work out whetherit’s safe and what is the highest dose they can use before side e)ects kick in. "hese trials areusually conducted on a small group of healthy volunteers under tightly controlled medicalconditions, 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 aperson, but basically we’re still working o) our best guess and we are never completely surewhat’s going to happen, says /r 0anelle *owden, who coordinates clinical trials for children atthe 1ids (esearch 'nstitute in 2ydney.

-We usually start with a really tiny dose and gradually work up. 'f any safety events occur,

we stop, and that’s why participants are in hospital, to make sure we catch everything. 't’s aboutthe same level of risk as going into a pharmacy and starting a new dose of a new medication forthe rst time, says *owden.

Once a Phase + trial has proven the drug’s initial safety, it progresses to Phase 3, when it’strialed in a group of a couple of hundred patients, who actually have the condition the drug isbeing developed to treat. 'f it’s shown to work at this dose, a Phase 4 trial is launched, testingthe drug on a group of several thousand people.

 "hese larger trials usually involve participants being split into two groups5 one receives thenew drug, the second the proven standard therapy. 'f there is no e%isting treatment for thisparticular disease, this second group might get a placebo 6an inactive medicine7. "his is called a-randomised controlled trial 8 because participants are randomised into two groups, and thosewho receive the new drug are compared to the control group. "he trial is carefully organised so

no9one administering the therapy 8 neither the participants nor the doctors 8 knows who isgetting what.

'f the drug is proven to work without damaging side e)ects, the government gives itapproval and doctors can start prescribing it to patients. *ut strict regulations mean getting adrug from laboratory to market usually takes seven to + years. Of +!,!!! compoundsdeveloped, only about ve make it through to a clinical trial and just one will make it to market./rug companies invest billions of dollars in clinical trials every year 8 but it’s worth it. :inding thene%t big blockbuster drug can reward the companies many times over.

Once a drug is approved comes the nal stage, Phase ;. "his stage collects ongoing safetyinformation from the general population rather than the tightly controlled conditions of theprevious clinical trials.

-<aybe only !!! to +!,!!! people have been tested by this stage, says *owden, so if 

an event only happens once in every +!,!!! people, it may not show up in the earlier trials.

ho volunteers?

One of the challenges facing researchers is nding the large numbers of people needed toparticipate in a clinical trial. "o give statistically valid information, sometimes they need to recruitthousands of people, all of whom have to meet very specic health criteria.

-One of the biggest problems is time, says =ucy Williams, director of "rialspotting, acompany that recruits people for clinical trials. >oung travellers are a common group for drug

Page 2: Handouts for Feature Writing

8/19/2019 Handouts for Feature Writing

http://slidepdf.com/reader/full/handouts-for-feature-writing 2/5

companies to target with advertisements for participants. -*ackpackers don’t mind because theyare locked away with nothing to distract them, but for other people it can be hard.

People who take part in Phase + trials, and receive no physical benet themselves, may beo)ered anything from movie tickets to several thousand dollars. :or others, the incentive is thepossibility of receiving free medical treatment and a range of tests to which they would notnormally have access.

:or many sick people, especially those with rare illnesses, taking part in clinical trials is theonly way they can get access to e%perimental treatments or new drugs that have been approvedoverseas but not yet in their own country. :or others with more common conditions like asthmaor dementia, agreeing to a clinical trial means they get free medicine and e%pert care.

*ut for otherwise healthy people, are clinical trials worth the risk? 'n the @1 in 3!!A, si%young, healthy volunteers collapsed with multiple organ failure during a disastrous Phase +clinical study into a new anti9inBammatory drug, "D+;+3. &ll were rushed to intensive careafter the very rst infusion of the drug at a hospital in =ondon, in which they were given a dose!! times smaller than that proved to be safe in animals. &ll survived after months in hospital,but many lost ngers and toes.

Dow, there are concerns that people are dying during clinical trials in the "hird World,where patients receive insuEcient protection. 2tandards in &ustralia, however, are e%tremelyhigh and researchers have to meet stringent ethics criteria. "hey must also provide detailedinformation about the potential side e)ects, benets and risks, so that participants can give theirinformed consent.

Devertheless, it’s important to get as much information as possible about the trial beforeproceeding, says Carol *ennett, C#O of the Consumers Fealth :orum in &ustralia.

Prospective participants should consult their doctor about the risks involved, and also $uiGthe researchers about what monitoring takes place. 2he also points out they can leave a clinicaltrial at any stage if they feel their health is deteriorating. -et all the information on which tomake an informed decision, then if you have any doubt about the safety, impact of treatment onyour condition or side e)ects, don’t participate, she says.

!" did it to slim do#n$

=ynne Foward, a eld interviewer with the &ustralian *ureau of 2tatistics, was ! whenshe saw an ad in the paper looking for people who were interested in losing weight. 2he rang thenumber and went along to nd it was a clinical trial comparing the e)ects of lap band surgerywith slimming shakes on overweight people, and how losing weight a)ected other problems likediabetes.

Faving struggled with her weight for years, =ynne was delighted when she was placed inthe group that was to receive the surgery. 2he underwent a range of medical tests, looking at herbone density and whether she had sleep apneaH she even had a nasogastric tube put down hernose to determine if she had reBu%. 2he also had to ll out many forms before and after thesurgery, assessing whether her $uality of life and self9esteem improved after she lost weight.

 "he keyhole surgery went well and she lost 4! kg. 'n the +3 years since, the lap band has slippedtwice, and both times she has received free corrective surgery. 2he still pays follow up visits to

the clinic.-'t’s been fantastic, says =ynne, who has since taken part in two more clinical trials,

looking at the impact of repetitive movement on the painful condition :ibromyalgia, and also onfollow up care after breast cancer treatment. -' want to be able to help those who are trying tohelp us and pass on their ndings to those who treat or have an interest in this illness, she says.

!" did it for money$

2tefan Wolinski lay on a hospital bed in <elbourne and felt the sharp prick of the needle asthe nurse injected a clear li$uid into his thigh. 2he recorded his vital signs and for the ne%t fourhours he lay there, forbidden from getting out of bed, as the medical team watched him for any

sign of side e)ects to the drug.:or the ne%t eight days and nights 2tefan and the other few participants were conned to

the hospital ward. "hey watched television, played electronic games or just trawled the internet.-"he sta) made our time as pleasant as possible, he says.

#very morning they gave blood and urine, which was analysed to see how the drug wasa)ecting their bodies.:or 2tefan, a 39year9old traveller from =eeds in *ritain, giving up eight days of his life earnedhim I3!! 8 far more than what he’d earned driving machinery on a building site and labouringat landscape gardening.

Page 3: Handouts for Feature Writing

8/19/2019 Handouts for Feature Writing

http://slidepdf.com/reader/full/handouts-for-feature-writing 3/5

-' heard about earning money in clinical trials from a mate, says 2tefan, who e%tensivelyresearched the drug, which was already being used to treat bowel disease and is now beingtrialled as a drug to prevent it. Fe was submitted to a barrage of medical tests to conrm he wasin top health before commencing. -'t was e%hausting staying there for so long, but ' didn’t haveany side e)ects.

!" did it for a better life$

&ngela (iach, +4, was born with cystic brosis, which limited what she could do until sheand her parents agreed to take part in the trial of the new drug 1alydeco at "he Children’sFospital at Westmead, 2ydney. "he researchers knew immediately who was on 1alydeco and whowas on the placebo, so dramatic was the improvement.

 "he medication means &ngela now competes at 2tate =evel Cross Country and is playingthe Bute. :or &ngela and other participants, the trial has been e%tended so they can keep onreceiving the drug. *ut her younger brother Dicholas, who also has cystic brosis, didn’t takepart in the trial so wasn’t able to access the drug.

-"he average life e%pectancy for people with cystic brosis is 4J, but people who havestarted on the drug are planning for their retirement, that’s how good they feel, says hermother, (uth. -We’re so lucky &ngie was able to take part 8 she didn’t realise how unwell shewas before, and now she just feels fantastic.

Building the Bionic %an

&mputees will tell you it’s the simple things you miss most when you lose a limb 8 the ability tohold a 2tyrofoam cup without crushing it, the de%terity to pick up a piece of paper o) a Batsurface.

&drian Ware, a 439year9old electrical worker from Wollongong, lost his right arm below the elbowafter a horric high9voltage electric shock nine years ago. Fe was tted with a prosthetic limb,but for years relied mainly on his left hand. "hen, late last year, &drian became the rst patientin &ustralia to be tted with a bionic hand that enables him to use all ve digits independently,grasp, rotate the limb, and grip with nger and thumb. -'t’s given me so much more condence.Dow ' don’t have to worry about dropping things, he says of the device imported from the @1.

 

't may have cost IA million to develop the bionic man of ’J!s "K show fame, but today thatfantasy is closer to reality than you think. :rom bionic eyes and ears to kidneys and spines, asurge of activity around the world has created huge advances in medical bionics in the last veyears.

Patients of the future may not have 2teve &ustin’s super powers, but the bionics revolutionmeans something just as wonderful 8 doctors will be able to replace broken body parts withprostheses that work in much the same way as the real thing.

*ionics is the interface of biology and electronics. 't works on the basis that we are all naturallycharged5 the millions of cells in our bodies are in e)ect tiny batteries, carrying about a twentiethof the charge of a normal && battery. Cells communicate with each other by electrical signals,

and proteins move in and out of cells under the inBuence of electrical charge.

 "he theory is that if you can introduce electricity into the body in a targeted way, you caninBuence the way the body works at a molecular level. "hat means you can stimulate nerves andmuscles to make them work normally. &nd the possibilities are endless.

 "he rst successful bionic body part, the cochlear implant, was developed in &ustralia byProfessor raeme Clark some 4! years ago. "o date, the device has restored hearing to morethan L!,!!! 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

Page 4: Handouts for Feature Writing

8/19/2019 Handouts for Feature Writing

http://slidepdf.com/reader/full/handouts-for-feature-writing 4/5

environments through thought. 't is hoped that balance could be restored to the elderly, anddevices will be developed to allow the deaf to hear clearly and the blind to see. Prosthetic limbswill work more like the real thing and will communicate with our brains.

 "he reason for all this new activity is the development of a range of new materials that makebionic body parts work more e)ectively. 2mart plastics can conduct electricity in a precise wayHnanotechnology 8 the science of controlling matter at a molecular level 8 is helping to create newcoatings for the surfaces of devicesH and scientists are discovering how to implant drugs to leachslowly into the body, helping with the targeted delivery of antibiotics and medications.

 "he bionic hand tted to &drian Ware was developed by @1 company "ouch *ionics.

#lectrodes on his skin pick up electric signals from &drian’s remaining arm muscles and thecontrol system enables him to move each nger individually, so he can pick up objects gentlyand with precision. -"he hope is there will be some way of connecting these devices directly tothought and have feedback 8 to have a sense of touch and feeling, says "ouch *ionics’ C#O2tuart <ead.

 <eanwhile, researchers at Kanderbilt @niversity in the @2 have developed a prototype bionic armthat combines a mechanical prosthesis with a miniature rocket motor. 't weighs the same and isas strong as a real arm. 't’s also very close in function, with a wrist that twists and bends andngers and thumb that open and close independently.

Fresh loo& on the !'anitor Fish$

*y /r. (afael /. uerrero '''

#%ecutive /irector, PC&<(/

 "he -janitor sh, is considered a nuisance species in =aguna de *ay and the <arikina (iver .

 "his 2outh &merican a$uarium catsh introduced in the country possibly by hobbyists has

escaped into local freshwaters.

 "he Philippine Council for &$uatic and <arine (esearch and /evelopment of the /epartment of 

2cience and "echnology recently issued updates on the -janitor sh.

:irst, there are two species of the -janitor sh that have been correctly identied by senior

shery biologist #dna &gasen of the /epartment of &griculture’s Dational :isheries (esearch and

/evelopment 'nstitute with the assistance of /r. 0onathan &rmbruster, curator of shes at &uburn

@niversity 6@2&7. "he species are Pterygoplichthys pardalis found in the <arikina (iver and =ake

Paitan in Cuyapo, Dueva #cijaH and the Pterygoplichthys disjunctivus found in =aguna de *ay.

 "his new report now corrects the previous identication of the -janitor sh as Plecostomus

hypoglosus in the country.

2tudies indicate that the -janitor sh has also become invasive in other countries. &ccording to/r. &rmbruster, the Pterygoplichthys species have become established in tropical and semi9

tropical regions of Dorth &merica , Puerto (ico , <alaysia , 'ndonesia and possibly other places

where these were introduced.

'n spite its unpleasant reputation, the -janitor sh is edible. 't is eaten by 2outh &mericans who

usually gut and grill them whole or make soup with them, says /r. &rmbruster. "he sh can

survive up to 4! hours or more out of water as long as they are kept moist. "his applies well in

rural areas where refrigeration is not available.

Page 5: Handouts for Feature Writing

8/19/2019 Handouts for Feature Writing

http://slidepdf.com/reader/full/handouts-for-feature-writing 5/5

 "he -janitor sh caught in =aguna de *ay has been declared safe for human consumption by

 0ose CariMo of the =aguna =ake /evelopment &uthority. 't does not contain to%ic levels of heavy

metals.

/r. &rmbruster says, -the sh builds its nests in mud banks and can contribute to water

turbidity. "hey may compete with other shes feeding on algae and detritus 6organic matter7

on the bottom. 'n its natural habitat, it feeds on tadpoles and insects.

 "here appears some practical control measure that can be applied for the -janitor sh. 2incethe -janitor sh breeds and grows $uickly, /r. &rmbruster suggests that the best way to reduce

its population is by catching the adults through grill nets or traps at their nesting sites.

'n the @nited 2tates, the sh does well in reservoirs and canals than in natural freshwater bodies,

he said.

 "he ==/& is implementing a World *ank9funded project to reduce the population of -janitor sh

in =aguna de *ay by paying sherfolk P+! per kilogram of the sh which is converted into

shmeal for pig feed by a cooperative in 2iniloan =aguna.