Cancer patients turn to India, hoping for cureLee Mi-young, 33, sits patiently beside her 12-year-old son, who is lying on a bed in a Seoul hospital, not knowing where his life is heading but also not willing to give up hope.
Her son has been ill for most of his life. For nine years, Tae-in has been in and out of hospital with neuroblastoma, a form of cancer that most commonly occurs in small children.
He has relapsed twice in the last three years and has been going through chemotherapy and radiation therapy, but the cancer cells have developed resistance to the treatments. Morphine shots are the only things that offer relief.
Spending all day by his bedside, Ms. Lee recently had to quit her housekeeping job and sell her house to pay for medical expenses.
“The doctor told me to do everything I can do for him and buy everything I can,” Ms. Lee said.
His doctor is planning to try one last treatment, a tiny green pill produced in India called Veenat, a drug many desperate cancer patients are eagerly ordering even though it’s not approved for use in Korea.
Veenat is a generic version of Glivec, a leukemia drug produced by Novartis AG of Switzerland, also known as Gleevac. The main reason for Veenat’s popularity is the cost. Each pill costs only $1 compared with 23,045 won ($20) for each Glivec tablet.
But Veenat also represents hope for those who have exhausted all other treatments. Among four types of leukemia ― acute lymphoblastic leukemia, acute myeloid leukemia, chronic lymphoblastic leukemia and chronic myeloid leukemia ― the Korea Food and Drug Administration has approved Glivec only for chronic myeloid leukemia (CML), although Glivec has shown some promise with acute lymphoblastic leukemia and other types of cancers.
As a result, national health insurance covers most of the cost of Glivec only for those suffering from CML. Patients with acute lymphoblastic leukemia or other cancers, like Tae-in, aren’t eligible for health insurance coverage of Glivec.
CML patients take four tablets a day on average, and Glivec costs more than 3 million won a month without health insurance coverage.
Even with insurance, patients need to pay 20 percent of the cost, which amounts to 550,000 won. However, Novartis covers half of that amount as part of a deal it made with the Korean government in setting the retail price of the drug.
For those who can’t afford to take Glivec, either because insurance won’t cover it or the cost is still too high, the generic version is the next best thing, even without regulatory approval.
Different types of leukemia
Leukemia is a cancer in which the body produces too many abnormal white blood cells. The symptoms of leukemia are frequent bruises, nosebleeds, headaches and excessive bleeding. CML has an incidence of one to two cases per 100,000 people worldwide a year and accounts for 15 to 20 percent of all adult leukemia cases.
Although Glivec is not a cure for the disease, it can effectively suppress the Philadelphia chromosome, which is known to cause CML.
The Korean government conducted a clinical trial of Glivec on a dying patient in April 2001 as a last attempt to save his life. After taking an experimental drug for nine days, the patient left hospital healthy.
The U.S. Food and Drug Administration approved the drug for CML in May of that year, followed by the Korea Food and Drug Administration’s OK in June. This was the fastest approval for any kind of medicine in history for both Korea and the United States.
Glivec was available in Korea beginning in 2001, but the government and civic groups objected to Novartis’ suggested price for its drug. The two-year dispute between the government, civic groups and Novartis ended when the government gave in by setting the price of Glivec at 23,045 won per tablet on Feb. 1, 2003.
Although Glivec is protected by a patent in Korea and all over the world, an India-based pharmaceutical firm, Natco Pharma Ltd., lobbied to get the patent overturned in its home country.
Under the Indian Patent Act and Rules, exclusive rights can be granted only for patents and applications filed in India after January 1, 1995. The applications for patents for imatinib mesylate, the main ingredient in Glivec, were filed by Novartis prior to 1995, the Indian pharmaceutical company argued, and so Novartis had no claim to exclusive rights.
The Indian government agreed and overturned the patent, allowing Natco to produce Veenat, which is approved for CML patients in India.
Leukemia patients in Korea became aware of the existence of Veenat through people such as Kwon Sung-ki, 34, the head of the Korean Leukemia Patients Community, their doctors or the Internet.
Importing Veenat from Natco began on June 10, 2003, said Mr. Kwon, a leukemia patient himself. He has been helping leukemia patients to individually bring in the medicine from India. Now more than 40 leukemia patients are taking Veenat in Korea, Mr. Kwon said.
“Korea is one of the few countries where there are organized efforts by leukemia patients to bring in Veenat,” Mr. Kwon said, citing the advanced Internet infrastructure in Korea to help in organizing patients scattered around the country and to spread information. The Korean Leukemia Patients Community now has about 4,000 members.
All that patients need to import Veenat are a prescription from their doctor and an import recommendation from a mayor or provincial governor.
Although importing generic medicines such as Veenat for commercial purposes is not allowed, bringing them in for personal use is legal. The drug costs a $1 per tablet and around $140 for shipping fees. Patients receive their drugs a week after placing an order.
Novartis Korea appeared unconcerned by Korean efforts to import a generic version of the company’s patented medicine.
“The patients took standard procedures and did not violate any laws,” said Ahn Byung-hee, a spokesperson for Novartis Korea.
Other clinical trials
What may make Veenat even more attractive is if some clinical studies show that Glivec is effective against more than one kind of cancer.
The Philadelphia chromosome, which Glivec suppresses, has been observed in all CML cases and is said to cause the white blood cell abnormality.
However, the chromosome was seen in relatively fewer cases among acute lymphoblastic leukemia patients, and was not present in patients with the other two leukemias.
Clinical trials are now under way to see whether Glivec can treat acute lymphoblastic leukemia. But researchers are facing difficulties due to the nature of the disease.
“Life spans of acute lymphoblastic leukemia patients were too short to conduct an extended period of study to draw a conclusion,” said Bae Kyung-eun, an official at Novartis Korea.
Though Glivec was able to keep patients alive for several months, many died within a year, she said.
There is still a ray of hope for these patients. Clinical trials for Glivec on 12 of 16 acute lymphoblastic patients by Asan Medical Center researchers have been successful, they said in November.
Glivec is being clinically tested also for patients with neuroblastoma, from which Tae-in is suffering. His doctor said trials so far have shown “some success.”
However, it will take time before the Korea Food and Drug Administration approves Glivec for other purposes, so those waiting for health care coverage for Glivec will have to be patient.
“Approval for a drug needs consolidated results of clinical trials in a number of advanced countries,” said Oh Cheon-yeon, an official at the Korea Food and Drug Administration.
A delicate matter
It’s not illegal for doctors to prescribe Veenat or Glivec for diseases other than CML, but Tae-in’s doctor said he was afraid that if his decision to give the boy Veenat for his neuroblastoma became public, other patients might ask for the same treatment, even though it is not certain the medicine will work.
“Doctors can prescribe a drug that is not yet approved according to their own judgment,” Mr. Oh of the Korea Food and Drug Administration said. “And they will be held accountable for consequences.”
Though prescribing and taking Veenat is not illegal, it’s still a delicate matter for some doctors and patients, making them reluctant to talk about taking Glivec or Veenat for purposes outside Korean Food and Drug Administration approval. Kim Jin-ju, an acute lymphoblastic leukemia patient who is taking Veenat, declined a scheduled interview at the last minute after a brief phone conversation with her doctor.
Still, many doctors aren’t worried about Veenat’s quality, even though it is produced outside the country and doesn’t have Korean regulatory approval. According to Kim Dong-hwan, a professor of medicine at Kyungpook National University, the ingredients and effects of Glivec and Veenat are “nearly identical.”
“Cancer drugs are often very toxic and involve side effects. But if therapeutic effects are sufficient enough to offset negative side effects, doctors can prescribe the drugs.”
Despite the possible risks, cancer patients who have undergone the usual treatments are willing to try Veenat, even if it’s not proved to help their particular disease.
Kang Mi-ja, a 46-year-old woman living in Busan, was diagnosed with acute lymphoblastic leukemia two years ago and has been taking Veenat for the past eight months. She went through a bone marrow transplant after having undergone lengthy anti-cancer therapy.
Lee Min-suk, a 37-year-old Busan resident, has suffered from the same type of leukemia, which was diagnosed in February 2002. Ms. Lee recently underwent a bone marrow transplant as well, and has been taking Veenat for four months.
Preventing a relapse is paramount for both women. National health insurance will not pay for a second bone marrow transplant.
“This is like saying people like us should die if the disease recurs,” said Ms. Lee. “Everything needs to be covered by insurance. We all have a right to live.
“My doctor told me to take Glivec to lower the rate of recurrence of the disease,” she said.
She took Glivec for one month before she knew about Veenat. She spent 3.4 million won for Glivec for one month. She switched to Veenat because of Glivec’s high cost.
“In the beginning, we weren’t sure [about taking Veenat],” said Cha Yong-jun, Ms. Kang’s husband. “But it was absolutely impossible to pay for Glivec.”
“The doctors never told me there was such a drug,” Ms. Lee said. She accidentally came across information about Veenat on the Internet.
Mr. Kwon of the leukemia patients’ group, Ms. Kang and Ms. Lee said Veenat’s side effects were similar to Glivec’s, such as a swollen face, nausea, fatigue and loss of appetite.
“In the beginning when taking Glivec or Veenat, I had a swollen face in the morning, and stomachache and felt nauseated,” Ms. Lee said. “Now vomiting occurs less frequently.”
For the three, the side effects are a small price to pay for a treatment that could possibly halt the diseases that have not only damaged their health but depleted their savings.
“It is only a matter of time before leukemia patients have to spend a few hundreds of million won on treatments,” Mr. Kwon said.
He quit his job as an executive of a high-tech firm four years ago when he could no longer work because of his deteriorating health. Two years later, he divorced his wife over the financial difficulties resulting from the enormous medical bills.
By that time, he was heavily indebted. Now Mr. Kwon depends on welfare and receives 400,000 won per month from the government.
“My family could have been wiped out because of my medical expenses,” Mr. Kwon said.
“Extending the life of a patient for a few months, or even a few days, will sacrifice his family.” The divorce was an inevitable choice, Mr. Kwon said.
“In a capitalist society, economic breakdown means a deterioration of a life. Many leukemia patients who could not afford the drug passed away,” Mr. Kwon said. “People dying because of their inability to pay for medicines is a modern catastrophe.”
Until the health care agency alters insurance coverage, these people see only one solution. “To live, to live, there is no other option but to take Veenat,” Ms. Lee said.
by Limb Jae-un
More in Features
[Shifting the Paradigm] With one epidemic under control, another is threatening Korean society
Kakao TV launches this month, takes on Netflix
[TURNING 20] In a sea of hate, change flourishes
Criticism of sex ed books for kids raises more questions than answers
When it comes to sex ed, this Danish author says just talk about it