What assures us that the medicine we take in a simple cold has no side effects? Will it have an effect? Mike – not his real name – is willing to guarantee that we don’t have to worry. The young Transylvanian, aged 25, became “a lab rat” for a medical research company.
“It is quite difficult for me to explain the system of bioequivalent studies to a common man, but it is easy for me to say that the drugs tested on me are very effective,” he explains.
Mike told us how you can get “human lab rats” and what happens behind the laboratory doors. This is the primary step, before the clinical trials where they select ill people and get them on the new drug or the placebo. This is the test done on regular healthy human beings.
“Bioequivalence is, in fact, a test that shows the difference between two drugs: one that has the original label and one who is just a copy of the original’s recipe.
Both have approximately the same effects, but they are not identical.
A volunteer is needed to determine the difference between these drugs in matter of side effects”, says the young man.
Mike is a medical nurse and he first accepted `the job of a lab mouse` during his schooling in medical care. It was a curiosity – he says.
`I’m healthy, they needed volunteers and… Anyway, everyone who works in hospitals does it`.
The medical tests on people are not risky, say the doctors, and that’s because the pill that the “mouse” swallows has been studied and analyzed for at least 10 years. “From the design of the product to the launch on the market it takes at least 10-15 years. This means a lot of in vitro studies, on animals, and in the third stage, the final phase, human studies are made!”.
“Volunteers are not at risk, they are fully tested. Patients, smokers, drinkers are not accepted. It is very difficult to find a “pure human lab rat”, explains the man. “Since launching the innovative product on the market, no one is allowed to reproduce it for ten years. After this period, different factories will produce a replica. For example, ibuprophen. There are lots of companies that produce it, but, compared to the original product, these copies are called generic drugs. Like a cake recipe. They never come out the same. Another extremely important detail is that a generic product will never be better than the original one”, he explains. “But they are efficient!”, he adds.
The selection criteria for volunteers seem quite challenging , but Mike says it’s worth it! “You do all your medical tests for free and sometimes you get some money”.
“If you get to enter the test, you are admitted – say, at 19.00 – in the hospital and you are clean-collected, the so-called blank tests. You are given diet food, you are allowed only a maximum of half a liter of water to drink, and then you are not allowed to eat anything until the next day. From that moment the blood collection begins. That depends on the drug. It can be a sample collected 15 to 15 minutes, from hour to hour, or from 12 to 12 hours. Then you’re free to go! You’re back in two weeks, when the “wash-out” of the substance has already taken place, meaning the drug is no longer active in the blood and you are being examined again. Two months after leaving the program, you are not allowed to participate in another clinical test ”, says Mike. He could not disclose his identity, because he signed a confidentiality contract in the current test he participates in, and, he says, if he could, he would make a career out of this: “I am very curious and fascinated by medicine and pharmacy.”
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