○ Hundreds of thousands of people are signing up to become medical test subjects every year, lured by cash incentives
○ Many drug testers are college students who face an urgent deadline for short-term loans
○ By participating in drug trials too frequently, they are putting themselves at risk, and could warp the results of the tests
If you input the keyword “clinical trials volunteers” on the social media platform QQ, dozens of chat groups recruiting part-time drug testers appear. Newcomers in the groups can hardly hide their curiosity and fear.
“Is it indeed reliable? Anyone tried this before?” writes one.
“Yes, once when I was driven and desperate,” someone answered.
“Can I really get a lot of money from the trial? I have a loan due, and I can’t think of any other way to pay it back.”
That particular QQ group chat, called The Beijing Trial Information Release Group, has 500 members, who receive regular messages about medical trials, with a clear promise of financial awards.
China is in full swing to develop new drugs to bring to the market every year. These drugs must all be tested for safety, so there is an ever-growing demand for human volunteers to take part in clinical trials.
The first phase of clinical trials involves testing the drugs on healthy volunteers to make sure the drugs are safe, before their efficacy is tested on sick volunteers in the next phases.
The healthy volunteers are normally reimbursed for contributing their time and taking risks in the process of the trial.
With the recent growth and rapid development of generic drugs in China, a group of people working as “professional drug testers” has come into sight. They see drug trials as a risky but rewarding financial transaction, involving their bodies as a commodity and shuttling between different trial hubs. Their desire to maximize income by doing as many trials as possible challenges the basic principles of drug testing.
Zhang Qiang (pseudonym) is a “lab rat,” or “medical guinea pig.” This 38-year-old father has worked as a part-time medical tester for two years, testing various Chinese generic oral medicines in his spare time.
His current live-in medical trial to treat allergic rhinitis will last 20 days, divided into four courses of treatment. He takes only one tablet for each course of five days, but must have a simple blood test 20 times over each course, which makes him feel weak sometimes. Urine samples are also collected at regular intervals.
Although he must follow a strict schedule during the trial, the “air-conditioned accommodation, nutritional meals and meticulous care” make the stay fully relaxing and pleasant. Zhang said that he prefers the carefree life of playing mahjong with his 40 fellow volunteers to a regular job.
“We have precise servings of meals and water, and even our underwear is provided uniformly, due to fear that someone who did not always take a bath may get bacteria that affects the test results,” said another tester who refused to give his name.
According to industry practice, healthy people can only take the trials once every three months, in order to protect their vital organs. Some hospitals are even equipped with facial recognition systems to prevent people from breaking the prescribed waiting period between trials. Such screening applies only to programs requiring human subjects’ real-name registration on the internet.
Not all programs are covered by online registration. In order to speed up the launch of a medicine, many pharmaceutical companies prefer to choose offline trial procedures, leaving space for volunteers to take trials too frequently or even simultaneously.
“The normal person will metabolize the medicine within a certain time after taking it. But it’s impossible to get the drug out of the body completely and there’s always a small amount of residue. If a subject has tried a lot of drugs, the combination can be harmful,” said Zhang Bin (pseudonym), a doctor from a first-class hospital in Beijing. She suggests people should not frequently test drugs.
One 20-year-old male who ignored this advice and repeatedly tested anti-inflammatory drugs developed resistance to this class of drugs, so they no longer worked after he became ill, according to the Beijing News.
He was among many people who do not take the risk of drug testing seriously. For many people who take the test drugs for a living, high risk means high reimbursement.
According to regulations, the risk must be clearly explained to the volunteers, who need to give informed consent and are free to quit at any time. However, signing the consent form is more like “just going through a process” for many of volunteers. Some did not really pay attention to the content and details, and a few are even not literate enough to understand it.
Zhang Qiang was among those who did not fully read the consent form. “If you take oral generic medicine only, nothing will be dangerous,” he said.
“Chinese generic drugs have been on the market for so many years that the risks are normally controlled. To say the least, China’s generic drugs are not strong enough to cause fatal injury,” Zhang said, explaining why he believes there is little risk.
Desperate for money
Despite his nonchalance, Zhang Qiang does not want to give his real name – because he worries his family will find out that his so-called “business trips” were actually for being a medical test subject.
Recalling the first time he entered into a clinical trial, he said he had just quit his job and was broke. He was lured in as a medical human guinea pig on the recommendation of a friend. After finding it is a quick way to make money, he became deeply involved in working as a part-time drug tester.
He has received more than 40,000 yuan ($5,874) from participating in four clinical trials over the last two years. “Testing medicine won’t get me addicted, but making money can,” he said.
Like many other volunteers, altruism did not trigger Zhang’s behavior. Instead, it was “financial reasons.” Zhang has made more money from the trials than most working people could save in a year.
An anonymous user who has four years of clinical trial experience wrote on Zhihu, China’s equivalent of Quora, “In foreign countries, clinical drug testing is done as a public good; but in China it is more like a lure for fast cash. The greatest danger is not coming from the drugs, but from your greed.”
Pharmaceutical companies recruit agents to send out alerts or ads with promises of money to potential candidates based on their own networks or using social media such as QQ to target people who are desperate for money.
Zhang Bin told the Global Times that agents can save a lot of time and effort for the hospitals and pharmaceutical companies. The use of agents can greatly shorten the procedures needed for the introduction of new drugs.
Although recruiters use the term “compensation” rather than “remuneration” in their ads, the posts clearly offer cash “rewards” to lure young people. Zhang Qiang said most people in his testing group were born in the 1990s, and many of them were college students who owed “campus loans” with an urgent deadline.
Because trial programs registered on the internet often require a rigorous physical examination – with a usual 10 percent to 20 percent passing rate, according to Zhang Bin – some agents have come up with many tricks to help their candidates successfully get through it, such as secretly substituting other’s urine samples for a female candidate during her period, or wiping thick liquid foundation on candidates’ arms to cover the dense needle holes from the previous trials.
Some candidates who smoke but wish to participate in a trial requiring non-smokers are encouraged to put a few drops of white vinegar in their urine samples to cover up the physical signs of smoking, said an anonymous tester. After the trial starts, there are even volunteers who swallow the medicine in front of the doctor and then vomit it up once out of sight.
The problem of paid volunteers whose frequent participation in trials may damage the integrity of drug testing is just one major problem facing the drug industry.
Another problem, revealed when a reporter for the Democracy and Law Times went undercover at a drug trial recruitment agency, is that the people conducting the drug trials often falsify the results, preparing two reports.
“The one provided to the pharmaceutical company is the most authentic, while the other one reported to the relevant government departments is mostly glorified,” an experienced trial supervisor told the undercover reporter.
In addition, the people responsible for the integrity of the trials often have close ties or are even the same as the people who profit from conducting the trials smoothly, according to the Democracy and Law Times report.
In order to fill the loopholes, the Center for Food and Drug Inspection of the China Food and Drug Administration had conducted drug clinical trial data verification on 1,467 institutions involved in 508 drug registration applications as of June this year.
The relevant person in charge emphasized to the media that drug clinical trials are the key basis for drug review and approval, and their authenticity determines the safety and effectiveness of drugs, which is directly related to the safety of public medicine.
– Global Times
Sep 22, 2018 0
Sep 22, 2018 0
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