Healthy Skepticism Library item: 14836

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Publication type: news

Hundley K.
India's poor often test drugs bound for U.S. markets
St Petersburg Times 2008 Dec 11
http://www.tampabay.com/news/business/article934677.ece

Full text:

Reporting a story on drug studies in India recently, I had plenty of interviews with people at the top. Doctors, government officials, entrepreneurs who make their living running clinical trials leaned over polished conference tables in modern, air-conditioned offices in some of India’s biggest cities. They assured me that India is capable of running world-class studies on new medicines destined for the U.S. market. No problem.

But finding the people at the bottom rung, those testing the drugs or the experimental procedures, was more difficult. They are all around you, yet they are invisible. They are often poor and illiterate. If something goes wrong in a trial, they don’t hire a lawyer, they just go home. They disappear into a haze of patient confidentiality.

Under international guidelines for clinical trials of new drugs and treatments, there are rules to protect these patients. Consent forms, oversight committees, ethics reviews. The people at the top in India reassured me those protections were rock-solid. But the people at the bottom, when I finally found them, said otherwise.

Here are a few of their stories:

Asif Iqbal

CLUELESS ABOUT CRITICAL TREATMENT

When Asif Iqbal’s father was diagnosed with brain cancer in July, the two men immediately left their village outside Kolkata (Calcutta) and headed to Mumbai. They found free lodging at an ashram, a community run by orange-robed monks. They found hope at the government’s Tata Memorial Hospital.

Iqbal, the eldest son, was told his 61-year-old father had limited options, so the family quickly agreed to what the doctor described as an experimental treatment.

Earnest, intense, worn with worry, the 30-year-old son said the new treatment involved brain surgery followed by chemotherapy and radiation. Though his father now lay weak in a hospital bed, the doctor promised his life would be prolonged.

“They said without it, he would have maximum three months to survive,’‘ the son said.

But the consent forms Iqbal signed on his father’s behalf were in English, a language he neither speaks nor reads. “If they had been in Bengali, I could have followed them,” he said through an interpreter, almost apologetically.

Sitting in the garden at the monk’s ashram at sunset, Iqbal pulled the consent forms from a tattered shopping bag. They indicate that the trial had nothing to do with chemo or radiation. It simply tracked the infection rate in patients whose heads were not shaved before brain surgery.

Told this, the son looked puzzled, then resigned.

“The doctor told me shaving heads was the old process, that not shaving is the latest,’‘ he said as the sunlight faded. “I just told the doctor, ‘Do what is good. You are god to me.’ “

Ramsakhi Devi HER CANCER ULTIMATUM: ENROLL OR GO HOME

At the monk’s ashram in Mumbai, Ramsakhi Devi sat on the bottom bunk of a metal frame bed, cocooned in a sea-green sari. Her thin arms were wrapped around her legs, a feeding tube taped to her nose. Occasionally her fingers swept the dark swell of her left cheek, feeling again where the cancerous tumor once was. She watched warily, lips tightening with pain, as her son, Bablu Gupta, explained how they ended up here, a 48-hour train ride from their home in West Bengal.

The doctors at the government cancer hospital had removed his mother’s tumor then given her an option: sign up for a clinical trial or go home. Devi, a 55-year-old widow who can neither read nor write, put her thumbprint on the consent form, which was in English and Hindi. Her youngest son, suddenly in charge at age 21, signed on her behalf. Anxious to see his mother cured, he said he understood the terms of the trial. But he did not.

The form says there were three treatment options. Gupta was aware of just one.

The form says patients have the right to drop out of the trial at any time. Gupta said his mother was told she had to complete the grueling month-long cycle of chemo and radiation if she wanted to be “fully cured.”

But the treatment left his mother weak, nauseated and more dependent on Gupta than ever. The young man, who has tended his mother during eight months in Mumbai, tried to be hopeful.

“She’s better than before,” Gupta said as his mother pulled her sari over her face and turned away. Dropping his voice, he added, “If you say something about the treatment, the doctors become unhappy.”

Kamlesh Solanki

HE’S TESTED ALL KINDS OF PILLS FOR A PRICE

The crowded slums of Ahmedabad in northwest India are prime recruiting ground for the area’s generic drug makers, who need healthy subjects for Phase I, or first-in-human testing of new drugs. Among those who have responded to the call is Kamlesh Solanki.

A member of India’s Dalit, or untouchables, caste, Solanki has volunteered for about nine Phase I trials of new generic drugs since 2001. Now 24, he’s consumed pills for everything from heart problems to acid reflux in studies that involved X-rays, frequent blood tests and overnight stays. The most complicated trial paid 7,500 rupees ($150), a godsend in an area where farmers earn about 50 rupees ($1) a day.

He said he never suffered side effects but knew others who did. “They assure you that after the test you will be very much okay.’‘

Solanki, who lives with his father and two brothers in a room the size of a single-car garage, said he was treated well at the testing centers. “There is total AC, TV, videos, and a thick cushion on the bed,’‘ said Solanki, who sleeps under a fan on a thin mat at home. “The food is excellent.”

He was once so gung-ho about the studies that he became a recruiter, getting 100 to 200 rupees ($2-$4) for each enrollee. But Solanki turned sour on the business two years ago. As masses of desperate people compete for trial slots, pay has dropped dramatically, he said, to as little as 3,000 to 4,000 rupees ($60-$80). Now working as a lathe operator in a factory, making about 4,000 rupees a month, Solanki has a growing unease about his past as a lab rat.

In late 2002, an unemployed laborer from south of Ahmedabad died after being involved in the Phase I testing of a generic antidepressant. The drugmaker, Sun Pharmaceutical Industries Ltd., denied the death was related to the testing. But the incident made young men like Solanki think twice about the deflated price tag being put on their lives.

“I know they pay more for such trials in the U.S.,” said Solanki, who never told his family about the trials. “Do they think we are worth less?”

Maheshbhai Macwana

“We give our bodies to them’‘

In Dholka, a village in northwest India, three men sat in a lawyer’s office recounting their experiences with Phase I trials. Maheshbhai Macwana, 42, was the veteran, having enrolled in a half-dozen studies.

Macwana, who now has a temporary government job, said financial desperation drives the trial business. “We live here on a dribble a day,” he said as a donkey brayed in the village square and power looms clattered in the nearby homes of Muslim weavers. “The companies are taking advantage of our economic condition. We give our bodies to them.”

He needs, but cannot afford, medications for liver and stomach problems. All he can do is sell his body to test drugs he does not need.

As he ages, he’s started worrying about the long-range effect of participating in multiple tests. But when his 17-year-old son recently got hit by a car and broke his leg, Macwana had little choice: go into debt or enroll in a trial. Embarrassed by his poverty, he wonders if anyone in the wider world cares.

“Are there any international regulations for conducting trials? How do we find out about such things?”

Patient protections
Under international guidelines:
• Trial subjects must be given a consent form in a language they understand, fully explaining the experimental nature of the trial and all possible side effects.
• Patients can drop out of a trial at any time.
• Volunteers in Phase I or first-in-human trials are usually paid enough to compensate them for their time, but not enough to be an incentive. Subjects in later trial phases sometimes receive a token amount of money for time and travel and generally get the trial drug for free.
• The consent form should clarify who is responsible for paying for any injuries sustained as a result of the trials.
Source: FDA, CenterWatch