The scary truth about human drug testing

Indrek Kelder received a drug test because he was promised to travel abroad for free, stay in a high-class hotel and only drink a few vitamins. But he was pushed to a place where he was sucked, had to drink strange drugs, and was not allowed to leave.

The drug administration of developed countries said that new drugs that want to enter the market take 11-12 years, through many complicated steps of review. Therefore, consumers are convinced that this 'heavy pain' makes everything perfect. But the truth is not always like that.

Many parts of the review process are kept confidential by the US Food and Drug Administration (FDA) for reasons of protecting business secrets for firms.Thanks to the law of freedom of information, in recent years, some of these secrets, including drug testing abroad, have been revealed.

If you want to test drugs on humans, you must try them first on animals.Based on this regulation, the FDA did not give Maxim Pharmaceuticals Inc a try to treat liver disease in the United States.This delay means the slow introduction of drugs, causing millions of dollars in damage.Therefore, in 1999, the company went into law, went to Russia to test on 149 people in just 3 weeks.

According to Bristol's Myers Squibb, a complicated test, if done on a Western European person, would cost $ 10,000, but on a Eastern European person only costs $ 3,000, in developing countries even lower.Overseas drug testing is allowed by the FDA so US pharmaceutical companies often do this.

The drug tester is not sure to volunteer

The drug test is not perfect as expected.(Artwork: Cancer.about.com)

Wanting to complete a new drug test, about 4,000 people are needed.It is not easy to find a large number of volunteers, so firms must go through brokers, use tricks, even cheat.

Lanszlo Lajtavari - a doctor in Budapest (Hungary) with a salary of 178 USD / month - was paid 1,000-2,000 USD by Johnson & Johnson and other European American pharmaceutical companies for a drug tester he 'lured' OK.Pharmacia & Upjohn also paid Latin American physicians $ 1,300 when trying to lure a man.

Poor hospitals in some developing countries need to purchase high-tech equipment and money to maintain operations.Pharmaceutical companies 'generous' help.In return, the hospital happily accepted the words 'support the test work'.

The test participants or representatives (who are brokers) must sign a contract before attempting.These are documents that contain many confusing scientific terms, many confusing terms.However, when signing a contract, they all had money so they easily put pen and sack into the trap, there was no way to get out even after realizing that they were cheated.

A survey of anti-AIDS testing among South African women showed that, among respondents, 88% said they were forced, 33% said the hospital would treat them worse if they did not accept it. 99% said the hospital and pharmaceutical company would not let them withdraw when they joined.

For psychiatric drug testing, when it began to be tested, it was considered ' imprisoned '.Adam Novavak, 25, who participated in testing Bristol's aripiparazol - Myers Squibb and Otsuka Pharmaceuticals, said that during the test, he was not allowed to go home and contact anyone.Ms. Erzsbet Terjek, 45, who participated in Johnson & Johnson's risperidone psychiatric drug test confessed: Because she believes the US drug is good, she accepted to participate even though the contract has many things wrong.

Mr. Indrek Kelder, an Estonian accountant, is eager to take a free trip abroad and take a trial.Instead of staring at the hotel and drinking some promised vitamins, he was taken to the commune health center in the mountainous town of Bazel, forced to drink an unknown drug.He insisted but could not, he had to sign the contract in German, but I did not know the content.

In the United States itself, how to entice participants to experiment with such tricks has been banned.But many developing countries do not have this rule.Firms take advantage of the gaps of the state, taking advantage of the poverty of the people to manipulate.

Difficult to track and check

In Hungary, there is only one inspector specializing in drug trials.Every year, he only has enough strength to reach 30 of the 200 test sites in his country.These trips are only observable but not detectable, handle errors, because the law does not allow penalties or prohibition of researchers' activities.In developing countries, organization of monitoring is even worse.

Even in the US, FDA has only 11 inspectors specializing in monitoring overseas trials.Meanwhile, their mission is to cover the tests spread in many countries and continents.The inspector is not knowledgeable in the local language, every transaction with the establishment and the testers must go through the interpreter paid by the pharmacy itself.

According to David Lepay, FDA's investigative director, more than 90% of overseas tests are not reported as FDA regulations, meaning the FDA is not aware of the plan or testing process.In fact, when it comes to testing at the testing site, everything is completed, the inspector can only look and check the available records.

The test results are not useful

Lontronex intestinal disease medication was approved by the FDA in February 2000.Glaxo Welcom brings this medicine to try over 7,500 people around the world.The trial only stopped when the FDA issued a ban on circulation in the US because it did not guarantee safety, because three deaths were recorded as caused by the drug itself.

In July 1997, Triangle Pharmaceuticals purchased a license to manufacture AIDS drugs Mozenavir dimosylate.Because testing in dogs shows that the drug causes an arrhythmia, FDA immediately issued a ban on human trials in the United States.However, the company eventually ran a limited research license in the US and secretly experimented in Eastern Europe, then in Mexico.

Drug treatment of diabetic troglitazone (rezulin) was tested on 2,510 people.As a result, nearly 7% of them had an increase in the enzyme alanin aminotranferase that exceeded the limit of 10 to 20 times.By convention in Europe, a substance that increases the enzyme index of alanin aminotranferase by 2 times the limit has been considered to cause liver damage.However, the drug was marketed, until 2 years later it was withdrawn when used for 2 million people, with 94 cases of liver failure.

The brand name Vioxx (rofecoxib) - a strong anti-inflammatory analgesic, does not cause gastrointestinal ulceration - was circulated in 1999, with 84 million users, in 2003 alone, turnover of $ 2.5 billion.A year later, the UK Drug Administration recommended that this drug cause heart attacks.In August 2004, FDA warned: 'Patients taking rofecoxib are 3 times more likely to develop heart attacks and sudden death than non-users.'And two months later, Merck just acknowledged this dangerous side effect and pulled it out of the market.

According to the New England Journal of Medicine , Merck found three cases of cardiovascular events in the clinical trial but hid it.