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Thu, Aug 14, 2008
The Straits Times
Paid to be lab rats

BY: Liaw Wy-Cin & Shobana Kesava

FOR 10 days, Mr Gilbert Tan was holed up in an air-conditioned hospital room, working on his university project.

The 27-year-old had free Internet access and could also watch videos, play games, read, chat with friends - or just sleep.

His end of the bargain involved eating at appointed times and popping a pill at 9am every day. For his time and trouble in the three 10-day periods over two months, he was paid $5,000.

He was among 14 healthy volunteers testing drug company's Pfizer's new anti-HIV drug for the first time.

These human tests, known as clinical trials, must be run before any drug or vaccine gets the go-ahead to be put on the market.

Typically conducted in three phases, the trials involve healthy individuals, followed by patients of the disease the drug is designed to treat.

The trials test how safe and effective a drug is and the doses in which it should be manufactured. Mr Tan, for instance, was in Phase I, aimed at determining the safety of the drug in healthy individuals.

The number of clinical trials in Singapore has been on a steady rise in the last 10 years. About 500 trials are ongoing, said the Health Sciences Authority, the body that approves the running of clinical trials and the marketing of drugs here.

The number of new trials started in the Republic each year has been on the rise - from 99 in 1998 to 253 last year. In the first six months of this year alone, curtains went up on 133.

At least nine global drug firms are testing a few hundred drugs and vaccines in Singapore, for illnesses ranging from heart disease and gastro-intestinal disorders to diabetes and cancer. Cancer drugs made up the largest proportion of new trials conducted last year - about one in four.

And by the looks of what is happening in scientific research here, all these numbers can only head north. With the decade-old push for biomedical sciences starting to bear fruit in laboratories, drugs have reached the testing stage.

Official figures are not available, but the number of people involved in clinical trials here is estimated to run into the tens of thousands.

Their reasons for signing up for drug trials vary: Among the healthy, it could mean an additional source of income or a getaway to study for an examination.

Some participants do it for altruistic reasons. They may have lost loved ones to an illness and so want to be able to help future patients, said Dr Goh Boon Cher, who sits on a review board with the National Healthcare Group, a major cluster of public medical institutions here.

For drug trial participants who are already ill, the trial may be a last-ditch attempt to prolong their lives. Madam Nora Smah Md Eunos, 43, who was dying of colorectal cancer in 2004, is certain that an experimental drug she tried bought her 12 cancer-free months.

Patients on trials are covered for their time as well as medical and transport expenses, a sum that ranges from $20 to $160 a day or visit.

Drug trials are usually run in partnership between hospital doctors and drug companies or research organisations.

Recruitment is done through newspaper advertisements about once or twice a month, by word of mouth or by inviting former participants to take part again.

Doctors interviewed said response rates vary with the nature of the trial and the relationship between the doctor running the trial and the patient. The more promising the drug is, the more people want to take part in its trial; and the greater the trust a patient has in his doctor, the more likely he is to sign up for a trial.

Still, there are risks involved. People in drug trials have died or developed serious side effects or complications in the United States and Europe.

So far, though, the trials here have not seen any serious fallout. The more common side effects include rashes, fever and diarrhoea, said doctors interviewed.

Strict guidelines are in place to protect patients and these, together with Singapore's efficiency, are factors making the Republic attractive as a trial venue. Large drug firms are also looking this way as it is important to get patient data on Asian diseases and drugs for Asian patients.

Professor John Wong, one of the founders of the Cancer Therapeutics Research Group, said that in 1997, when the group was set up, pharmaceutical companies were not terribly interested in Asia.

Now, however, with China and India advancing and doing well, treatments for cancer will be in demand.

The centre, which is doing clinical trials for cancer drugs, found a few years ago that the two-drug cocktail of docetaxel and carboplatin was more toxic for Chinese than for Caucasians. It was one of the first studies to show that ethnicity mattered in lung cancer treatment.

Singapore's ethnic mix is thus a pull for drug companies wanting to gather data on how their drugs work across ethnic groups, said doctors.

Professor Soo Khee Chee, assistant chief executive of research and education at SingHealth, another public health group here, said: 'Singapore's population reflects half the population of the world.'

He did it for the money

HE NEEDED money. His tuition fees were due and he had to pay legal fees for a minor brush with the law.

The prospect of downing pills and losing some blood to a syringe seemed like an easy way to make a few thousand
bucks, so he became a paid drug-trial guinea pig.

"David", 22 and a finance student at SIM University, said: "I'm not unique in having done it for the money, but I'm different because I'm a model volunteer. I'm young and fit."

After his first trial, he signed on for three more in eight months. Drug-trial participants are supposed to put one to
three months between trials to give their bodies time to "clean up". David said he observed this, but not everyone does.

From the $7,000 he made from those four trials, he could pay his tuition fees and other expenses without having to ask his taxi-driver father for money.

He has stopped being a drug-trial participant because a clinical-trials unit has barred him following his premature pullout from one.

But he can still get on the trials run by other units. Newspaper advertisements appear often calling for willing bodies.

A "club" seems to have sprung up among drug-trial junkies - mostly middle aged - who pore over newspaper ads, go in groups for the "qualifying tests" and then run a "circuit" of Pfizer, Eli-Lilly and Changi General Hospital.

Why would healthy volunteers put themselves through possible side effects of fever, nausea, headaches, rheumatism, lethargy or worse? David said: "It's simple: the money."

Trials pay each healthy volunteer about $2,000 for transport and time away from work. Even those who are rejecte are paid at least $50 to undergo a basic medical check-up.

David said the unscrupulous may say at the end of the check-up that they cannot commit to the timeframe, when the real reason is that the trial overlaps with one that they are already on.

Recalling the drug trial from which he withdrew prematurely, he said it was because he was sick from side effects.
He did not know then his withdrawal would get him barred.

His memory is hazy about what the drug was meant for, but he said: "I felt a gripping pain in my chest and my body
was like lead. I could hardly lift an arm and was so drowsy that I slept all day," he said.

After the two-night hospital stay, he was discharged but was required to return exactly 12 hours later for a blood test.

Laid up in bed at home for the next two weeks, he missed the appointment. He showed up at the hospital when he felt better, and was paid $600 for the part of the trial he underwent.

Two months later, ready for another trial, he found that he had been blackballed. Today, he puts more energy into planning events and spinning music tracks at nightclubs.

She did it to save her life

BACK in 2004, Madam Nora Smah Md Eunos was diagnosed with Stage 4 colorectal cancer which had spread to her liver.

The then 39-year-old mother of three, an administrative officer with SIA Engineering, was staring death in the face
when she underwent an operation to remove her colon.

Her doctors at the National Cancer Centre could do nothing about the tumour in her liver until she had first healed
from that operation.

Then along came cetuximab, a newly developed drug to be taken alongside chemotherapy, which was being put through a trial here to ascertain its effectiveness among Asians. She was among the 1,217 cancer patients from three hospitals invited to take part in it.

Aside from the possibility that the drug could shrink her cancer cells, she stood to save money. This drug, then not
available yet here, would have cost her at least $66,000 for nine months and she was to get it free. The scans and blood tests she would need as part of the trial were also free. On top of this, she was put under the care of the most senior doctors and was reimbursed for transport as well.

She felt she had little to lose by getting on the Crystal trial, as it came to be called. All she needed to do was pay $24 a week for an anti-vomiting drug.

It was no walk in the park, however. While other patients not on the trial could choose to have their chemotherapy
sessions once a fortnight, Madam Nora had to go through it every week, as required by the trial, with each session running into six hours at the hospital.

Aside from nausea, which the anti-vomiting pills took care of, and hair loss from the chemotherapy, her upper body, fingers and toes broke out in itchy blisters.

But she stuck it out. She had known what she was in for, from the research she did online about the drug and what her doctor warned her about. "It was really tough. I know of other patients who couldn't take it and quit half way, but I kept telling myself to think positive," she said.

The drug worked, and she was able to have her liver operation after nine months. She was cancer-free the followin year, but suffered a relapse in May last year, when two tumours measuring 7cm across were found in her liver.

"Of course I wanted the drug again. It saved me before, but now it's on the market, I can't afford it," she said of the drug, which costs $6,000 a month. Her employer is subsidising the cost of a less expensive drug, Avastin.

The tumours have since shrunk to 4.5cm each, and she is hopeful. She is nevertheless convinced about the usefulness of drug trials, and advises patients to "make the most of it and think positive" if they are given a place in one.

Dr Robert Lim, an oncologist who headed one of the Crystal trials here, said that, besides helping herself, Madam Nora and other trial participants also helped doctors understand when and for whom cetuximab might be effective.

This article was first published in The Straits Times on August 12, 2008.

 

 
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