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SEC Investigations and Clinical Trials

August 22, 2005

Dear Colleagues,

The Seattle Times and The New York Times recently published investigative reports and articles on physicians serving as consultants to investors and investment companies. The New York Times also published an editorial. Senator Charles Grassley has asked the Department of Justice and the Securities and Exchange Commission (SEC) to review the findings of the investigative report.

As described in these articles (see URLs below), some physicians who have consulted for investment companies - either directly or via

"matchmaker" firms - have disclosed confidential information regard ing clinical trials. Disclosing of material, non-public information in violation of an obligation of confidentiality to individuals or entities who engage in trading on the basis of the information may be considered a violation of insider trading laws. A description of the SEC’s insider trading regulations is at: http://www.sec.gov/answers/insider.htm

Faculty physicians serving as investigators on clinical trials or as members of data safety monitoring boards generally are bound by strict confidentiality terms. I urge you to be scrupulous in adhering to the letter and spirit of those obligations.

Let me remind you that all private consulting agreements and ongoing relationships with outside companies must be reported to the Office of Policy Coordination (OPC). OPC provides guidance regarding management of these private relationships. Information regarding submission of consulting agreements is on our Web site.

Thank you for your attention to this important matter.

Sincerely,

Edward Miller, MD
Dean of the Medical Faculty
CEO/Johns Hopkins Medicine

Chi Dang, M.D., Ph.D.
Vice Dean for Research

Recent articles on physicians consulting for investment firms:

"Drug Researchers Leak Secrets to Wall Street"
Seattle Times
August 7, 2005
By Luke Timmerman and David Heath

Selling Drug Secrets Series - related articles "Senator wants SEC to probe leaks of drug-research secrets"
Tuesday, August 9
Seattle Times
By Alicia Mundy

"Doctors' Links With Investors Raise Concerns"
August 16, 2005
New York Times
By Stephanie Saul and Jenny Anderson

Editorial: "When Doctors Advise Investors"
August 17, 2005
New York Times

 

 
 
 
 
 

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