Subject: Research Subjects and the Bloomberg News Report: Disturbing Allegations.
Date: 2005-12-02
Bloomberg News recently reported disturbing allegations in an update to their report exposing inadequate protections for people in research:
SFBC placed at least three drug trial participants in separate rooms with SFBC officials, including Chief Executive Officer 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 refuting a Bloomberg News story published Nov. 2. [1]
Subsequently Dow Jones reported that SFBC International Inc. Chief Executive Arnold Hantman denied the gist of the allegations, adding that subjects interviewed by Bloomberg had been banned from further studies at SFBC. At the same time Hantman disclosed that Senator Grassley, Chairman of the Senate Finance Committee, had asked the company to meet with the committee to discuss allegations raised by Bloomberg. [2]
We are concerned that action was taken against research subjects because they allegedly violated a Confidentiality Agreement
, something that SFBC claims is part of the consent form process.
Bloomberg relied on study consent forms to be sure, but consent forms aren't confidential because one purpose of providing them to research subjects is to allow them to discuss the information with others. [3]
We were surprised to read that an institutional review board approved a consent form that included the clinic's Volunteers Rules and Regulations.
The consent form is a written record of the consent interview, not a contract to obey rules to protect private property. [4] We were troubled to see that payment to subjects was referred to as Indemnity Compensation
in study advertisements on the SFBC International Inc. web site. We are concerned that people might be confused by the term Indemnity Compensation
and incorrectly conclude that this payment was all that was available if they sustained injury during the study. Compensation paid to study subjects is a recruitment inducement, not an indemnity
, and it's unrelated to payments for injuries in research. [5]
CIRCARE is particularly concerned about research that enrolls vulnerable populations, such as economically or educationally disadvantaged persons, and we commend Senator Grassley for his concerns about inadequate safety and oversight in research with humans. At the same time we respectfully suggest the Division of Scientific Investigations at FDA carefully assess the issues raised by Bloomberg News.
Readers can find further information about drug studies subject to FDA IND regulations conducted by SFBC International Inc. on the CIRCARE web site at: http://www.circare.org/info/sfbctables.htm. The latest information is available on our media page at: http://www.circare.org/mediaTOC3.htm.
Michael A. Susko MS, CIRCARE President
(410) 499-4895
Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327
Elizabeth Woeckner MA, CIRCARE Board of Directors
Notes
1. Evans D. and Smith M. SFBC Threatens Human Drug Testers for Exposing Risks (Update 4). Bloomberg News web site. Available at: http://www.bloomberg.com/apps/news?pid=specialreport&sid=aF3ZWezawt5k&refer=news. November 16, 2005. Accessibility verified on November 17, 2005. Evans D, Smith M, and Willen L. Big Pharma's shameful secret. Bloomberg Markets Magazine. Bloomberg News web site. Available at: http://www.bloomberg.com/media/markets/pharma.pdf. November 3, 2005. Accessibility verified on November 17, 2005.
2. Stepankowsky PL. SFBC CEO Defends Against Allegations In News Report. Dow Jones Newswire. November 18, 2005.
3. SFBC International Inc. SFBC International Inc. Press Releases, SFBC International Responds to Stock Activity. Business Wire web site. Available at: http://home.businesswire.com/portal/site/sfbc/. November 16, 2005. Accessibility verified on November 17, 2005. United States Food and Drug Administration. United States Food and Drug Administration, IRB Information Sheets — Frequently Asked Questions, Section V Informed Consent Process, Q and A 36. United States Food and Drug Administration web site. Available at: http://www.fda.gov/oc/ohrt/irbs/faqs.html#Informed%20Consent%20Process. September, 1998. Accessibility verified on November 17, 2005.
4. Evans D, Smith M, and Willen L. Big Pharma's shameful secret. P. 6. Bloomberg Markets Magazine. Bloomberg News web site. Available at: http://www.bloomberg.com/media/markets/pharma.pdf. November 3, 2005. Accessibility verified on November 17, 2005.
5. SFBC International Inc. SFBC International, study advertisement for study no. 50641001. SFBC International Inc. web site. Available at: http://www.sfbci.com/sfbc/SFBC/client/en/Study/Liste.asp?id=23&ActiveStudy=644. Undated. Accessibility verified on November 17, 2005. United States Food and Drug Administration. United States Food and Drug Administration, IRB Information Sheets, Payment to Research Subjects. United States Food and Drug Administration web site. Available at: http://www.fda.gov/oc/ohrt/irbs/toc4.html#payment. September, 1998. Accessibility verified on November 17, 2005.
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Last Updated: 2005-12-11
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