Clinical trials shed ‘guinea pig’ image

A year and a half ago, Lee Se-yeon, now 68, discovered a tiny tumor under his navel. He thought he had some idea what was coming: He had undergone surgery a few years earlier to treat gastric cancer. This time, a doctor told him that laser therapy would be able to get rid of the tumor, but three months later it had swollen to the size of a chestnut. The cancer had metastasized, and surgery would do nothing.
One year ago, the doctor recommended that Mr. Lee take a clinical trial of a pharmaceutical cocktail, which CT scans have shown has greatly reduced the number of cancer cells in his body. “I’m lucky to still be alive,” Mr. Lee said. “I’m thankful for it.”
Mr. Lee is one of many patients who are undergoing Korean or international clinical trials as a last resort, taking new drugs developed by pharmaceutical companies. Mr. Lee’s test involved a new combination of two existing drugs ― Docetaxel by Sanofi-Aventis and Cisplatin by CJ Corp.
In the past, many patients went to the United States to participate in clinical trials, because the new drugs were not available for trial in Korea. Most were unavailable because international pharmaceutical companies and medical institutions thought Korean medical institutions would not be able to carry out the trials properly. The domestic pharmaceutical market was small and government regulations were tight.
Even if tests had been held, few people would probably have volunteered ― clinical trials were seen as using people like guinea pigs.
That perception has changed, however, and reports about successful trials on new drugs around the world have led to an increase in the number of applicants.
Kim Sam-re, 61, a roundish woman with a slow manner of speaking from Daecheon, South Chungcheong province, had surgery in 2001 to treat intestinal cancer, only to find out later that the cancer cells had spread to her liver.
“I have no strength. I’m on and off. My mind isn’t clear,” Ms. Kim said, explaining the side effects of the chemotherapy she has been going through. She began participating in a clinical trial for a new cancer medicine, identified only as CKD73, from Chong Kun Dang, a domestic pharmaceutical company.
Ms. Kim, who is not well off, said she wanted to discontinue the treatment, so her doctor recommended that she instead receive injections of the new medicine. A nurse said Ms. Kim tried almost every drug she could.
According to the Korea Food and Drug Administration, a total of 95 international clinical studies were conducted last year in Korea; one-third were treatment trials, testing new drugs. There has been a near-steady increase in the number of these studies in recent years: five cases in 2000, 18 in 2001, 17 in 2002, 46 in 2003 and 61 in 2004.
Clinical studies on new cancer drugs or new approaches to therapy are being conducted in about 10 large general hospitals in Korea. “The reason for one going through a clinical trial is to try new drugs or to try different approaches when existing treatments no longer work,” said Dr. Chung Hyun-cheol, head of the medical oncology department at the Yonsei Cancer Center. Currently, 150 cancer patients are undergoing 30 types of clinical trials at the center.
“Patients used to be more resistant to clinical trials, saying ‘Am I some experimental mouse?’ But now patients come here even knowing the codename of the drug they want to use,” Dr. Chung said. “It’s important to make sure that these patients don’t feel like they’re lab rats.”
Each trial is conducted by a group of specialists, including doctors, nurses and pharmacists. The drugs offered by international pharmaceutical companies for clinical studies in Korea have almost always gone through the first and the second stages of clinical trials in another country and are about to be put on the market. The first stage tests for the presence of side effects and the toxicity of new drugs, while the second stage assesses whether the drugs actually have any effect. The third stage looks at whether the new drugs are better or more efficient than existing treatments.
“What’s more important is that there are no negative side effects,” Dr. Choi said. “The issue of whether the new drugs are effective comes later.”
The problem of belated medical trials is that not only patients often miss a chance for a cure, but also the new drugs will be incredibly expensive when they are actually sold in the market.

Glivec, the well-known leukemia medicine from Novartis, was developed in 1999; its clinical trials began in the United States, but Korean leukemia patients were able to take the drugs two years later. More than 8,000 patients benefited from Glivec through clinical trials in more than 30 countries including Singapore and China, but similar clinical trials could not begin here until 2001 due to government regulations, and many patients died while waiting for their chance to test it. Yang Hyang-gil, a leukemia patient who was one of the first in Korea to try Glivec, was in critical condition at the time, but he was released from hospital after only nine days of taking the medicine.
The fiercer debate, however, came after the trials. The government and Novartis could not agree on the pricing of the drug, and haggled over it for a year.
Though the offering of new drugs for Korean patients is limited for now, Dr. Cho said these days some foreign pharmaceutical companies have started providing new drugs in the second stage of clinical studies to local hospitals.
Most of all, pharmaceutical companies want to complete clinical trials quickly, with as many patients as possible. The faster the test, the lower the development costs and the sooner the drugs can be marketed.
“This is a win-win situation. The more drugs available for domestic patients, the better it is for us. All the expenses are provided by international pharmaceutical companies. Clinical testing is a part of the medical industry. It is a valuable national asset,” Dr. Chung said.
Participating in clinical trials is almost free because pharmaceutical companies pay for most of the expenses of medical testing and provide the new drugs - both good reasons why openings for candidates for clinical trials are filled quickly.
“There is an overflow of patients who want to participate in the studies,” Dr. Chung said. “It’s a heartbreaking struggle. This is not some soap opera.”
“Where else can I get such a good opportunity?” said Park Hyeon-hi, 58. Mr. Park has been taking Sutent, a drug made by Pfizer, for the last three months. Ten years ago, Mr. Park had surgery to remove a tumor from his kidney, but in December, 2001, he learned that the cancer cells had spread to his lungs, brain and shoulders. Because cancer cells spread to his brain, he could not write. Mr. Park went through eight weeks of chemotherapy, but his condition did not improve. Like other patients, Mr. Park lost most of his hair due to chemotherapy. Mr. Park said he once had hope that Dr. Hwang Woo-suk, who claimed that he had extracted stem cells from cloned human embryo, could save him, but the doctor was later found to have faked his research results.
“I feel better. Maybe it’s too early to tell. My hands used to feel numb, but don’t any more,” Mr. Park said.
Mr. Hwang’s pronouncement that he had cloned stem cells inspired many people. According to a report in the Jan. 17 issue of JoongAng Ilbo, however, it also unfortunately inspired government officials to relax rules on experimental treatments. In 2005 alone, 118 emergency treatment trials were conducted in Korea; a JoongAng Ilbo survey of 73 of the patients found that more than four-fifths developed serious side-effects, and 12 of them died.
Doctor admit that not everyone is qualified for clinical trials. “There are strict criteria for candidates in clinical trials,” Mr. Chung said. “It’s important to look at what kinds of treatments patients have received in the past and whether it is the first treatment for them, as well as their age.”
More than likely, the drugs being tested will have an effect, given that they have already shown their use in international clinical trials, but there are still risks. All patients need to sign a contract that even if there are side effects, they will not hold their hospital responsible.
Despite the uncertainty and risk related to the trials, most patients undergoing trials are positive.
“I shouldn’t be afraid of that. Even for trivial surgery, people need to sign an agreement,” said Mr. Park, with confidence. But, he said, he feels like taking the risk.
After a short discussion with a doctor about their condition, patients head to a room for injections. Lying down on a hospital bed to receive an injection, Ms. Kim was calm and her face was peaceful.
“I’m grateful to the hospital. The doctor said I was going to live for three more years in 2001, and I am still alive,” Ms. Kim said.

by Limb Jae-un