"I work as a guinea-pig"

 Working as a guinea-pig of new medicines is a real job, which needs a lot of courage and the most important, it is significant for public health.

One morning in March 2012, Vu Van Doan, a student of the Hanoi University of Pharmacy, walked into the hall and saw classmates were handing each other a notice. Someone turned to ask the one who sat next to them: "Are you engaged? I find it terrible!"

Doan curiously asked a classmate: "What notice that all of you are so interested in?” The classmate said secretly: "There are three features in the message: if you join them, you will have nearly VND1 million ($50), your blood will be drawn 24 times and this is the job only for the brave people. Briefly, it is the notice on recruitment of guinea-pigs."

It turns out that is the recruitment of volunteers to test bioequivalence for products containing the active ingredient cefaclor 125 mg. This is the active ingredient effective against upper respiratory tract infections: acute otitis, sinusitis, pharyngitis and tonsillitis. 

Although he had read documents about this activity, Doan and other students wondered about the drugs that need to be tested.

That night Doan was sleepless and surfed the Internet to find out more information. He was very careful because a few days ago he had read in a newspaper about a scandal when a number of organizations had used the homeless, poor students in Britain for drug test and caused lifelong complications. 

The next morning he decided to sign up to be a volunteer. Friends ask him why, he replied: "I want to learn all about the process of production and circulation of a type of medicine to improve my knowledge. I’ve learned about safety issues."

Nearly 20 students in Doan’s university registered to participate. Each person came to the job with the utmost privacy reasons. 

Tran Hai Son did this job by a very...practical reason: "It was the time before the semester exams. I had to pay tuition fees but I spent the money that my parents had given me. If I do that job, I will earn enough to compensate the tuition fees."

Unlike Son, Le Thoan, a leader of the students’ association said: "This is a useful work for medicine and human so I joined it. It is just like "blood donation" or "Green Summer" (programs of voluntary students). I engaged it with passion and the desire to do something useful for society."

They were all eager to wait for the "testing" day. This time only 26 people were chosen and all of them are men.

Before the G hour

Volunteers must undergo extremely rigorous tests and physical examinations. Only those who had a BMI (index assessing the thin or fat state of a person) from 19/24 were selected. They were also tested for the indexes of liver enzymes, urea, HIV, blood pressure, etc. They must be free from chronic diseases of the liver, kidneys, heart, diabetes and tuberculosis.

After two phases of examination, Doan saw that it was not too tough as he had thought. He asked a doctor: "Why did you only choose medical students for the test, not students from other schools?" The doctor smiled and said: "You’ve learned about medicines and have certain knowledge of this field. We chose you to avoid the cases that you are so scared to quit the test in the middle."

After this test, Doan knew that medical students are often chosen for drug tests because they have expertise in pharmacy, with a high sense of discipline. In some test before, a number of volunteers from other schools violated the provisions of not drinking and smoking during the testing time.

A week later Doan and seven classmates received phones called informing that they were selected for the test. A total of 26 people were hired on a total of nearly 80 participants. They had to sign a letter of volunteer and a commitment with the drug test organizer.

The volunteers were informed of the information on the drugs that they would use in the test, as well as the side effects (if any) would occur. At the same time, they also heard about the rights and obligations that they would get in the process of participation. If they agree, they will sign the forms. And since then the drug testing process officially begin.

The time for the test was fixed. Now, there would be no way back. Hai Son decided to inform his family. Just hearing her son talking about the "bio-equivalence test," his mother, a teacher, shouted: "Who would allow you to do that!" Son must spend nearly 30 minutes to explain and persuade his mother on the phone.

Meanwhile, upon hearing that his son would participate in a drug test, Doan’s father took a bus from Nam Dinh province to Hanoi to dissuade him. That night Doan used all the materials, the knowledge he had to prove to his father that bioequivalence test is not as dangerous as people think. But most of other students decided to not tell their families about the test.

In the laboratory

Generic drugs help reduce drug costs by 40-60% compared to the invented drugs, so patients have more access to treatment.

Each testing phase was organized in 2 days of 2 consecutive weeks. For example, the Saturday of this week and the Saturday of the next week. Normally volunteers will take the testing drug and the original drug. Within 24 hours before the test day the volunteers were not allow to drink and they had to sleep from 10pm to 6am, etc. Depending on the type of drugs they have to perform other requirements.

At 7am, putting on white clothes, the volunteers were led into the test room. They were given a dose of the medication. Then on a certain period of time doctors took their blood for testing (depending on the drug, the blood test is conducted for every 5 minutes or 1 hour).

Seeing the worry of some volunteers of the blood tests, Le Thoan reassured: "One day if they get blood for up to 24 tests, the total blood volume is only 120ml. It is equivalent to a half of the blood volume for a blood donation!"

Thoan’s reassurance was very timely because some volunteers were afraid of the continuous blood tests and gave up the test.

During the test volunteers were taken care by a group of doctors with full medical, health monitoring tools. If an incident occurs that the team of doctors will intervene promptly. 

For the 4th year students like Doan, Son, Thoan... this is an unforgettable memory of their student life. They have learned a lot from the drug test like this. 

"Previously I did not imagine that the biological testing process is so rigorous and demanding. Now I know the steps to conduct a trial," Le Thoan said. 

Doan said: "Joining drug tests I’ve learned more knowledge about the methods to evaluate the quality of medicines, what is in vivo bioavailability test..."

Many of them said that after drug tests, they feel conscious, more responsible with their chosen careers, have a better understanding of the pharmacy profession, are aware of the need for this work to study science.

According to the Center for Bioequivalence Assessment of the Drug Test Institute, in Vietnam, more than 80% of the circulating drugs are the generic (medicines that have the same radical with the drugs that are out of the exclusively protected time).

These drugs have production costs less than invented drugs, to help reduce the cost of treatment. However, the number of generic drugs that are tested for bio-equivalence is very limited because Vietnam does not have provisions on this issue.

According to the experts of pharmacology, generic drugs help reduce drug costs by 40-60% compared to the invented drugs, so patients have more access to treatment. However, to confirm the quality of generic drugs, the authorities should have specified regulations on bioequivalence testing. This test indicates the level of similarity between the generic drugs and invented drugs in terms of pharmaceutics, efficiency and safety.

The cost of inventing a new drug is worth hundreds of millions of dollars and it takes years to conduct pre-clinical testing phase, clinical studies as well as after circulation. However, after this invented drug’s copyright expires, the manufacturer can spend only about $1 million to buy the version and produce the generic drug that has bioequivalence to the invested drug. 

Specifically, a sore throat antibiotic pill (American drug) is priced at VND26,000 but a bio-equivalent generic pill is priced only VND3,200. Therefore, generic drugs have contributed to the fight against counterfeit goods in many countries provided that the quality of these drugs is strictly controlled on quality, bioequivalence.

Bioequivalence test is very new in Vietnam and it is different from the clinical trials. These are tested on healthy human body to assess the quality of the medicines of the same type of different manufacturers to see if they can replace each other. Thus we can better assess the quality of drugs.

A drug that is tested means thousands or tens of thousands of people have the opportunity to live, have the opportunity to be treated safely, cheaply. The first credit belongs to the volunteers in this article. They were silent, brave to pioneer in a new work that benefits thousands of people...

Nang Luong Moi