Service to mankind or medicine for profit
By Shan Juan (China Daily)
Updated: 2008-04-23 08:06
Are multinational pharmaceutical companies doing mankind a favor by conducting
clinical trials (on humans) or are they using Chinese people as guinea pigs to
make more money? The question came to the fore again with a court hearing on a
medical dispute in Beijing last week.
Ouyang Lidong, 36, of Hunan province, was admitted to Beijing You'an Hospital in
2006. Doctors diagnosed he had complicated liver problems and only a liver
transplant could save his life. Since a donor liver was not immediately
available, the hospital doctors recommended on Dec 5, 2006, that he be put on
extracorporeal liver assist device (ELAD), or an artificial liver. Developed and
manufactured by Vital Therapies Inc., California, the ELAD is designed to help
liver failure patients survive till a donor liver is available or another mode
of treatment is found, says the US Food and Drug Administration (FDA) website.
The device, however, has not been approved for use in the US.
Ouyang was part of a free trial program, and his wife He Binying accepted the
offer in a desperate bid to save his life. But he soon developed complications,
including rising blood sugar levels, breathing problems and hemoptysis (coughing
up of blood from the respiratory tract that indicates a severe infection of the
bronchi or lungs), which proved fatal.
But before that - in fact, as soon as he developed the new complications - his
wife requested the doctors to put him off the ELAD. Her requests went unheeded
till Dec 7. And by the time the therapy was stopped, Ouyang's condition had
deteriorated. He was transferred to the intensive care unit (ICU) later, and
died on Dec 27, 2006.
A few days after his death, He Binying filed a lawsuit against the hospital,
alleging that its doctors' negligence had caused the death of her husband.
"Before we signed the paper giving consent for the use of the ELAD, the hospital
authorities had promised to stop the therapy as soon as any adverse effect or
discomfort was detected. They had insisted it was very safe, too," she says.
"They made the wrong recommendation for the ELAD trial, which is more suitable
for acute liver failure, whereas my husband had been suffering from hepatitis B
for 12 years." Worse, they broke their promise and continued the trial despite
his worsening condition, she says.
The hospital lawyer, on the other hand, argued in court last week that the
couple had signed the consent form before the trial, and knew full well the
efficacy of and potential risks associated with the ELAD. "That should be enough
to exempt the hospital from any legal liability," he said.
Also, Ouyang's condition was serious, and the doctors had diagnosed that he had
been suffering from the life-threatening hepatocirrhosis, and the only known
cure was a liver transplant. "It was natural for the hospital to have
recommended the therapy to prolong his life so he could get a donor liver," the
lawyer said.
A Beijing Youth Daily report on June 19, 2007, quoted hospital Vice-President
Duan Zhongping, who also heads the institution's Artificial Liver Treatment &
Training Center, as having said that before putting Ouyang on the ELAD, the
doctors had tried it on 28 other patients and none had died.
Vital Therapies Inc. announced on Jan 4, 2007, that it had received positive
response for its clinical trials on the first 45 patients at Beijing You'an and
302 Military hospitals. "Our center has treated a large number of patients with
other mechanical and bio-artificial liver therapies, and although the data for
ELAD are preliminary, none has looked more promising than ELAD to impact a
patient's long-term survival from a single treatment," Duan said in the
announcement.
Ouyang's case does not seem to have changed the course of ELAD treatment, for
the center has said it would continue with the trials till 90 consenting
patients undergo the therapy. The center insists, too, that no significant
harmful effects have been attributed to the ELAD, and has not posted any details
of Ouyang's case. "The ELAD trials in our hospital have been approved and
commissioned by China's State Food and Drug Administration (SFDA), which is
authorized to approve and oversee clinical trials in the country," Duan said.
But according to the paper, SFDA's Medical Device Department official Hu Xueyan
denied that Duan had said so.
Other experts too do not agree with Duan. "It's unethical to conduct clinical
trials in China without the SFDA's approval," says Qiu Zongren of Asian Ethics
Committee, which helps oversee such schemes. "Trial patients should be well
informed of potential hazards and effects of the tests."
"Some foreign pharmaceutical companies and domestic medical institutions just
take advantage of regulatory loopholes to conduct clinical trials for their
products on innocent Chinese patients because the cost involved (in China) is
very low," said SFDA Deputy Director Zhang Jingli said at a workshop organized
by the administration in Beijing early this month. To plug such loopholes, he
said the agency will issue a sound set of laws and regulations on medical device
management.
Duan has a supporter in breast cancer specialist Jiang Zefei, of Beijing-based
Military 307 Hospital, though. Jiang says global drug trials have given Chinese
patients a new hope, especially because many of them are poor. It is not rare
for poor patients to forego treatment because of the high costs involved and the
"not-so-perfect" public healthcare system in China.
"Since 1997, hundreds of my critically ill patients have participated in trials
for different drugs to combat breast cancer," Jiang says. "Nearly all of them, I
should say, have benefited from the trials." Given the strict regulations on
clinical trials, sudden field inspections by the drug watchdog and the
self-discipline practiced by the hospital, there has been no medical dispute
over any of "my department's trials", he says.
"Medical ethics is the top concern in a drug trial Most of the therapies would
fail for terminal cancer patients. But clinical trials of the latest potential
remedies, provided free, might be effective for them. At least, they can save
the patients and their families from the heavy economic burden even if they
don't prove efficacious," he says.
An increasing number of foreign drug and medical device companies have begun
outsourcing their research and development (R&D) work in China, and clinical
trials are on top of their tasks. China attracts them with its sound
infrastructure, low research cost and the huge number of patients suffering from
chronic and infectious diseases. Experts say the cost of drug trials in China
can be as little as one-tenth of that in the US or Europe.
In the US, drug companies have a hard time trying to enroll enough people for
clinical trials. But the situation is quite different in China, which has 130
million hepatitis B patients and carriers alone - a number larger than the
combined populations of Britain and France. And many of such patients are poor
farmers or workers.
"The US has no such pool," says Terry E. Winters, British biochemist and
chairman of the Vital Therapies Inc. Besides, foreign companies' drugs and
medical devices have to be tested locally in China before they can enter the
country's huge market, "That boosts trial outsourcing too," he said.
Big drug companies doubled their investment in R&D to $2.2 billion in China and
India, and most of the additional amount came to China. Drug companies' business
is booming, and with it have increased medical disputes, including those over
clinical trials. Some of these cases, like Ouyang's, end up in court, and
verdicts in such cases are slow to come by, given the series of complicated
medical verifications and appraisals.
Clinical trials for more than 800 new medications, including drugs and medical
devices, are conducted in the country every year, according to official figures,
and most of them are conducted by foreign pharmaceutical companies.
Clinical trials can indeed be a problem - not only of medical ethics, but also
of proper healthcare, poverty and helpless patients' desperation. And only
foolproof government regulation and socially conscious drug companies can make
them beneficial to human beings.
http://www.chinadaily.com.cn/china/2008-04/23/content_6636944.htm