Friday, December 16, 2005

More Shoddy Work by Commercial Research Firm

Last month, we posted about allegations that private, for-profit clinical research firms, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that one such firm, SFBC International, had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices.

SFBC International is now back in the spotlight.

On one hand, the Miami Herald reported that "outside counsels" hired by SFBC International to review its operations had partially exonerated their clients. Some of the "outside counsels'" arguments were:
  • That the apparent conflict of interest raised because the wife of a Vice President of SFBC worked for one of its IRBs, was less serious because she did not vote on panels that reviewed SFBC studies. Replied Ken Goodman, of the bioethics program at the University of Miami, "this doesn't clear the arm's length test."
  • Responding to allegations that SFBC International is a "recruiting mill" using "poor desparate people," the counsels said "our review revealed that SFBC requires valid Social Security or tax identification numbers, in order to ensure that its participants are legal United States residents."
  • Responding to allegations that SFBC International's CEO threatened research participants who talked to the press with deportation, the counsels noted that it was really Jerry Seifer, SFBC International's Vice President for Legal Affairs, who said "Well, if you don't have your immigration, don't you know you can get deported?" "If you're illegal, immigration is down the street on 79th street." Also, "I have a friend in the INS and I can ask my friend and I can deport you guys." [The Miami Herald just reported that Seifer, who just bought a $15 million dollar house and a Rolls-Royce jointly with SFBC International chair Lisa Krinsky, settled charges by the US Federal Trade Commission that he misrepresented wireless cable TV licenses he was selling to consumers. He also was fined and subject to a cease and desist order by the Commodities Futures Trading Commission.]
Although SFBC International Lead Director Jack Levine said that this reporte exonerated the company, per Bloomberg news, it sounds to me like the counsels were just quibbling about the prior allegations.
Furthermore, Bloomberg News has just reported more evidence of shoddy, sloppy work done by SFBC International.
SFBC International's Canadian subsidiary, SFBC Anapharm Inc, was running a trial of an immunosuppressant drug, ISA 247, for Isotechnika Inc. At their Montreal test center, patients were to be confined to the center 24 hours a day for a total of 31 days, for which they would earn Canadian $6800, most to be paid after the full 31 days.
One patient, identified only as Moshen, was confined in a double room with a man from Haiti, whom Moshen described as "lethargic," and coughing up blood. Despite Moshen's multiple complaints to SFBC Anapharm Inc. staff, the patient remained in the room for eight days. Moshen was assured that he was "okay."
He wasn't okay. He later turned out to have active tuberculosis (TB). Moshen and eight other study participants have now tested positive for latent TB. SFBC Anapharm staff did not initially test Moshen's room-mate for TB. Even though the study protocol involved an immunosuppressant drug that could activate latent TB, the study protocol did not require prospective subjects to be screened for TB by skin PPD testing or chest x-rays.
On learning that he had latent TB presumably acquired from his room-mate during the study, Moshen said "I was shocked." "They never apologized. They don't care. They don't give a damn."
The study was ostensibly supervised by a for-profit IRB, Aurora. Its argument for not requiring TB testing of study participants was since Montreal has a large Haitian population, "many potential participants would likely tested positive and have been excluded from the trial. 'It's clear the test has not utility,' said [Aurora President Jack] Corman." Responded Professor Steven Miles of the University of Minnesota, "That statement doesn't make any sense."
SFBC International's lawyer reacted to Moshen's anger by saying, "Anapharm very much regrets that the subject feels this way. They hope he recalls that Dr. Larouche apologized to him and to his fellow volunteers." SFBC International, however, has also asked study participants to sign a waiver releasing the company from any claims. Trudo Lemmons, a Professor of Law and Bioethics at the University of Toronto, described the requests for a waiver, "outrageous," and "unethical."
Have we fallen so far? Clinical research is the only way to tell what tests and treatments really do for patients. Clinical research was once an honorable undertaking, done mainly at teaching hospitals and academic medical centers. As a physician, I have taught about the importance of clinical research and how best to use its results to make better health care decisions. I have urged patients to enter clinical trials. Putting my money where my mouth was, I was the proud participant in one major trial (and just had my five-year follow-up visits for it.)
But we have noted again and again how commercial research sponsors may manipulate how clinical research is designed, carried out, analyzed, and disseminated. Now I would be very cautious about suggesting anyone should enroll in a clinical trial, especially if it has commercial sponsorship.
And hearing about these outrageous practices perpetrated by commercial research firms with the acquiescence of commercial IRBs, I sadly would not suggest that anyone enroll in a trial run by a for-profit research firm. We have fallen so far.

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