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Kyle Potter, Published October 18 2013

Dilworth-bound clinical trial company brings troubled past

DILWORTH – The India-based clinical trial company aiming to open a new facility here had its research license revoked for several months in 2011 after the company allegedly enrolled poor and illiterate Indian women in a breast cancer drug trial without properly obtaining their consent.

India’s oversight body, the Drug Controller General of India, suspended Axis Clinicals’ license in June 2011 after an investigation at its facility found “irregularities” with how it obtained informed consent from enrollees and the decision-making process of its Ethics Committee – both staples of conducting ethical clinical trials. After revising its procedures to address those issues, Axis Clinicals’ license was eventually reinstated, according to documents submitted to India’s Parliament.

The documents do not elaborate on those irregularities.

Company spokesman Sidharth Mishra downplayed the allegations and ensuing investigation as being politically motivated, and called it a reflection of India’s lack of clear regulations for clinical trials, rather than their own ethical lapses.

Mishra acknowledged that Axis likely enrolled illiterate women in that trial, as did other contract research organizations throughout the country – they frequently volunteer for clinical trials, he said.

The problem, Mishra said, is that there was little guidance from the government about what steps they needed to take to ensure each subject was properly informed. In the past, they required a literate family member to be present.

Since the investigation, Mishra said Axis has moved away from enrolling illiterate women in its clinical trials. The company also instituted a recording system to capture and verify every test subject’s consent to the trial.

“We are not scared about the investigation on this. I think Axis did good,” Mishra said.

Mayor undaunted

Axis Clinicals announced earlier this week it plans to take over the vacant Dilworth Wal-Mart with the help of property tax credits from the city – a package worth about a quarter-million dollars, according to city officials.

Dilworth Mayor Chad Olson said he was unaware but undaunted by the 2011 investigation at Axis Clinicals’ facility in Hyderabad, the capital of the Indian state of Andhra Pradesh.

“I’m very confident that Axis will meet the standards established by the United States,” Olson said.

Olson guessed the company’s Dilworth facility may open within the first several months of 2014. It will be the company’s first facility in the United States. Axis Clinicals also operates in Mexico and Thailand.

Regulation

Clinical trials, in which a drug is tested for efficacy and safety using human subjects, are a critical step in a new drug or medical treatment’s path to market. With that come a handful of stringent ethical stipulations such as informed consent of each subject and independent ethical review committees.

A 2008 report from the World Health Organization on India’s booming clinical trial industry highlighted a lack of proper regulation, poor informed consent practices and shoddy ethical reviews. Mishra said there has been political pressure in India to curtail or even ban clinical trials in the country.

“That’s the reason we’ve decided to expand in the U.S.” Mishra said.

In the U.S., clinical trials are regulated by a handful of governmental bodies, including the Office for Human Research Protections and the Food and Drug Administration.

And though the regulatory structure for clinical trials is undoubtedly different in India than it is in the United States, Dr. Steven Miles, a professor at the University of Minnesota’s Center for Bioethics, said that shouldn’t matter.

“The company doesn’t get a free pass if it moves a portion of its operations to another country,” Miles said. “We’ve got Indian companies all over the U.S.”

In their presentation in Dilworth on Monday, Axis officials emphasized their clean regulatory records in several countries, including the U.S. Because the company has tested drugs that eventually went to market in the United States, the FDA has audited Axis Clinicals’ facility in India 13 times since 2008, according to the company.

Of those, the FDA raised concerns about possible issues four times. Mishra said all of those issues were quickly corrected or resolved. The FDA could not immediately provide copies of the audits to The Forum.

Miles said although the allegation of enrolling illiterate women in India was “obviously unacceptable, I can’t tell what it means in the world scale of things.”

“Violations are just part of the corporate environment,” he added. “Some mean a lot, others don’t.”

Readers can reach Forum reporter

Kyle Potter at (701) 241-5502