Editor's note: This is a follow-up to a story that ran in The Seattle Times on Nov. 6. SFBC International, which runs the largest private...
SFBC International, which runs the largest private drug-test center in North America, threatened to arrange federal deportation of Latin American immigrants who disclosed health risks in clinical trials, according to people who participated in the company’s Miami-based experiments.
The participants also said SFBC tried to make them sign false statements.
SFBC placed at least three drug-trial participants in separate rooms with SFBC officials, including Chief Executive Arnold Hantman, said the participants, who requested anonymity.
Hantman, using profanity, said he would call the U.S. Department of Homeland Security to have the participants deported if they didn’t sign statements denying a Bloomberg News story published two weeks ago that showed risks of injuries and death from drug testing, the participants said.
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The three men say they are now worried that SFBC will take further steps against them if their names are published. Each says he is prepared to disclose the details of his experience to U.S. Senate investigators.
“It’s clearly beyond the pale to bully and coerce people because they reported ethical violations,” says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. “It’s simply heinous to try and cover up misdeeds with these actions.”
Hantman didn’t return telephone calls.
Company spokeswoman Erica Pettit declined to comment. Hantman was a certified public accountant and an executive at a hospital-management company before co-founding SFBC in 1984.
In the earlier report by Bloomberg, more than 15 scientists, doctors and government officials said the drug-testing industry inadequately protected participants from the risks of injury and death.
The story also disclosed conflicts of interest in the drug-testing industry, including a company paid to monitor the safety of participants in some of SFBC’s clinical trials that was owned by the wife of an SFBC executive.
In a conference call after the story was published, SFBC President Lisa Krinsky, referring to the Bloomberg report, told analysts: “Approximately 99 percent of the information that was documented regarding SFBC is a total fabrication, and the remaining 1 percent was entirely misquoted.”
Krinsky said, “Like all companies in our industry, our operations are routinely audited by the [U.S. Food and Drug Administration] and we have consistently received positive feedback from the FDA that we are absolutely compliant with the statutory requirements and regulations.”
On Nov. 8, after the Bloomberg report, U.S. Senate Finance Committee Chairman Charles Grassley, R-Iowa, asked federal officials to explain what the government was doing to improve federal oversight of clinical trials, saying “this treatment of participating patients and their families is alarming.”
SFBC, which is based in Miami, has performed clinical trials on five continents in at least 25 countries. During the past 15 years, the industry has shifted from one in which human drug testing was conducted mostly by medical faculties at universities to one dominated by for-profit companies.
The change came about as pharmaceutical companies sought to speed development of profitable new drugs, says Peter Lurie, deputy medical director of Public Citizen, a Washington, D.C., group that monitors drug-safety issues.
Seventy-five percent of all clinical trials today are done in private test centers or doctors’ offices, according to CenterWatch, a Boston-based compiler of clinical trial data.
“The process which some of these companies are going through to test drugs on human beings is putting in jeopardy the life, and sometimes even taking the life, of some of these people,” Grassley said after the Bloomberg story was published. “I’m going to make sure that the FDA does their job.”
One drug-test participant said in an interview that he and another participant were threatened when they went to the Miami center after the Bloomberg story was published.
When the two arrived and identified themselves, they were taken to an office where they were met by Hantman and other SFBC officials, the drug-test participant says.
Hantman asked the participant if he was an illegal alien, and then threatened to call immigration officials who could arrest and deport him, the participant says.
Hantman then questioned him about the Bloomberg reporter who had interviewed him, he says.
The test participant says he first told Hantman that the reporter had properly identified himself and had told him he was researching an article about clinical trials.
The drug-trial participant says Hantman asked that he sign a statement saying the reporter hadn’t clearly said he would publish an article or use his photograph.
The drug-test participant says he agreed because the CEO told him that was the only way to prevent him from being arrested and deported. The person says the statement that he signed for Hantman was false.