Friday, November 18, 2005

Commercial Clinical Research Firm Accused of Intimidating Study Subjects Who Talked to Reporters

Bloomberg News has published another article on the commercial clinical research industry, this time focused entirely on the firm SFBC International. We had posted here about a previous report by Bloomberg that alleged conduct of clinical research by such commercial firm was sloppy and shoddy, with minimal oversight by commercial institutional review boards (IRBs).

The new report begins by quoting SFBC International Chairman Lisa Krinsky MD, who completely contradicted allegations made in the first article, "Approximately 99 percent of the information that was documented regarding SFBC is a total fabrication, and the remaining 1 percent was entirely misquoted."
The report then alleged that SFBC International intimidated study subjects who may have provided material to Bloomberg for its first article.
  • "When the two [study subjects] arrived and identified themselves, they were taken to an office, where they were met by [SFBC International CEO Arnold] Hantman [CPA] and other SFBC officials, the drug test participants says. CEO 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. The test participant says he first told Hantman the truth: 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. In a taped interview, the drug test participant says he agreed to say what Hantman wanted because the CEO told him that was the only way to prevent him from being arrested and deported. "
  • "The drug test participant says that that when he returned to SFBC for part of a clinical trial, a person at SFBC asked him to sign another version of the statement. The second piece of paper said the reporter never identified himself as a journalist and didn't say he was preparing an article. The participant says he signed the second statement because he would have signed anything just so he would be allowed to leave. The second paper was false, he says."
  • "Another test subject says an AFBC executive told him that SFBC wouldn't pay him for a clinical trial he had participated in and would alert immmigration officials if he didn't sign a statement saying the reported hadn't told him he would publish an article or use his photo. He says the executive said SFBC would pay him for the clinical trial if he signed the paper. The test participant says he agreed to endorse the false information because he thought it was the only way he could leave the test center and avoid being turned over to immigration officials."
  • "A third drug test participant says he went to SFBC 10 days ago to try to enroll in a clinical trial because he needed the money. He says that after he identified himself, a man who said he worked for SFBC security told him to wait in an office. Eventually [CEO] Hantman came into the room and screamed at him with curse words, the participant says. A group of SFBC employees joined Hantman in questioning about how he knew the reporter. Hantman said he would never allow him to be paid for a clinical trial again.... Hantman also threatened to investigate the participant's immigration status, he says. The CEO also said he many look into whether the participant was paying his taxes to the Internal Revenue Service, the participant says."
What a way to run clinical research projects.
In an article in the South Florida Business Journal, SFBC said, "The assertions from 'anonymous sources' concerning coercion and threats by SFBC employees, including contacting immigration authorities, are basesless. In fact, Arnold Hantman, chief executive officer of SFBC International, has never met with any of the participants contrary to the reporting in the article, and, to the best of his knowledge, none of the participants have ever met him." Furthermore, "the company said that it told participants they will not be allowed to take part in further SFBC trials, but that was because the participants told Bloomberg they falsified forms and presented false government identification. The participants also violated the confidentiality agreement that is part of the consent form process, SFBC added."
So at the moment, we have two completely different versions of what happened. Bloomberg reported that SFBC International intimidated its study subjects into signing false documents about their discussions with news reporters. SFBC International completely denies these accusations, but in doing so acknowledged that they were using study subjects who had falsified data forms, and that they had required study subjects to sign confidentiality agreements, and practice almost unheard of in clinical research done in academic settings.
The new Bloomberg article also included strong condemnations of the alleged way SFBC International conducts research. For example, from Arthur Caplan, from the Center for Bioethics at the University of Pennsylvania:
It's clearly beyond the pale to bully and coerce people because they reported ethical violations. It's simply heinous to try and cover up misdeeds with these actions.
From Senator Charles Grassley, Chair of the Senate Finance Committee:
The process which some of these companties 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.
From Adil Shamoo, Professor of Biochemistry at the University of Maryland Medical School, and co-founder of Citizens for Responsible Care and Research:
If this happened, it's awful, unethical, and inappropriate. Oversight and monitoring of clinical trials is very poor. This is further evidence that the system for human subject protection is very broken.
Again, even if one accepts the SFBC International version, major questions have been raised about how commercial firms carry out clinical research. This suggests that physicians and patients need to exercise extreme skepticism about the results of such research and how, or whether it should be applied to clinical care.


Anonymous said...

Yes, these two versions of the story are quite different. In Bloomberg's first article the trial participants admitted they had lied to SFBC while they were participating in the trial. SFCC told them they could not participate in more than one trial at a time. They were boasting about how they had pulled one over on both SFBC and another company in the city by participating in more than one drug trial AT THE SAME TIME! These guys could be killing themselves by doing that and neither SFBC or the other company would know about the other trial. It is no wonder that SFBC told them they were not allowed back in the trial once that article was published. One of them admitted that they had been warned that there were possible side effects of the drugs being tested and had signed papers saying so (SFBC says all trial participants must) but then told the reporter that they just ignore that warning.

It would be stupid for SFBC personnel to threaten these guys with deportation or even come close to suggesting it, but they might have said there was to be a government investigation of the whole affair, Senator Grassley is getting involved. The participants could have figured out that Immigration officials might get involved especially if their Social Security numbers were also falsified.

Anonymous said...

There is no good evidence that Sfbc did anything wrong or conducts sloppy research lacking credibility unless one takes at face value the statements of anonymous self-confessed liars and document falsifiers.