Letter to King County Councilmembers

The following is a letter addressed to the King County Council by
Dr. Alonzo Plough, Director and Health Officer of Public Health - Seattle & King County

To:	King County Council members
From:	Dr. Alonzo Plough, Director and Health Officer
Re:	King County Medical Examiner's Office and the Stanley Medical Research Institute

I am deeply troubled by a recent false and misleading news report on KIRO TV regarding a research grant involving the King County Medical Examiner's Office. This letter is intended to provide you with facts about the King County Medical Examiner's Office research relationship with the Stanley Laboratory in the Department of Psychiatry at the Uniformed Services University for the Health Sciences in Bethesda, Maryland. This is the elite medical school and medical sciences university serving the U.S. Armed Forces. The research and the consent procedures used were consistent with state law and medical research ethics. Great care was taken to obtain consent, including extensive telephone discussions with next of kin of people who died and whose next of kin consented to have brain tissue submitted as part of this research.

In response to a news media report March 31, 2005, (www.kirotv.com/news/4335506/detail.html), our King County Medical Examiner is issuing the following statement today:

The King County Medical Examiner's Office and Public Health - Seattle & King County are extremely concerned about the misrepresentation of a research grant that was part of a study to better understand the cause and needed treatment of mental illness.

The King County Medical Examiner's Office had a grant from the Stanley Medical Research Institute, a non-profit foundation, to send specimens to the Uniformed Services University for the Health Sciences, for 10 years. The grant paid for salaries of a pathologist and technical support from 1995 to 2004.

As part of the grant, the Medical Examiner's Office sent brain tissue for research purposes to the University after having received consent from the next of kin. We took great effort and care to ensure that families understood the nature of the research and that their participation in this activity was completely voluntary.

We have complete documentation in 185 out of 186 cases. In one case we have incomplete records but the file indicates consent was given. Consent included the initial conversation with the next of kin plus a written description of the research mailed to the next of kin and a follow up phone call.

There was no financial incentive to acquire tissue samples, in other words there was no quota and no profit. All funds paid for the salary of a full-time pathologist and other costs to provide the capacity within the medical examiner's office to take the samples when needed.

We would never have entered into an agreement that provided an incentive tied to the number of brain tissue provided.

As Chief Medical Examiner I am very upset that this erroneous media report would cause additional pain to the families of the deceased who contributed to the understanding and treatment of serious mental illness.

-- Dr. Richard Harruff, King County Medical Examiner

Background

For ten years and ending in 2004, the King County Medical Examiner's Office (KCMEO) had a research contract with the Stanley Medical Research Institute to support research on the causes of serious mental illness. The contract called for the KCMEO to provide post mortem brain tissue and pertinent medical information about the deceased person to the Stanley Laboratory at the Uniformed Services University for the Health Sciences in Bethesda, Maryland, the elite federal medical school and health sciences university for the Armed Services. The contract also specified that the KCMEO would be reimbursed an annual fee for the salary of a pathologist and technical support to ensure that King County had staffing to do the work.

The Stanley Medical Research Institute and the research conducted

The Stanley Foundation, a private, non-profit organization that funds medical research, supports all the research at the Stanley Laboratory in the Department of Psychiatry at the Uniformed Services University for the Heath Sciences (USUHS) in Bethesda, Maryland. The Foundation funds research related to mental illness. The specific research related to this case was designed to identify potential causes of serious mental illness, such as schizophrenia or bipolar mood disorders. Brain tissue and pertinent medical history from two categories of deceased persons are needed for this research: (1) donors who had a history of serious mental illness, and (2) donors who did not have this history. At the Stanley Laboratory, USUHS, expert researchers study the brain tissue for the presence of viruses or chemicals suspected to cause serious mental illness.

Work done by the KCMEO to support this research

The KCMEO was one of several medical examiner offices around the United States which held contracts with the Stanley Medical Research Institute to support this research.

Per the contract and consistent with the standard practice of the King County Medical Examiner's Office, brain tissue was collected with permission of the donor's next-of-kin, or other legally authorized person(s). Consistent with RCW 68.50.550 this consent was obtained by "telegraphic, recorded telephonic, or other recorded message, or other form of communication from the person that is contemporaneously reduced to writing and signed by the recipient of the communication."

In other words, consent was obtained as follows:

1.	A pathologist at the KCMEO contacted a deceased person's next-of-kin by telephone, explained the purpose of the research, and if consent was given, recorded that consent in a record at the KCMEO.
2.	The KCMEO then mailed to the consenting person (next-of-kin) a written description of the research investigation that was being conducted.
3.	4 to 6 weeks after initial contact, a pathologist from the KCMEO re-contacted the next-of-kin by telephone to seek permission to review the deceased's medical records in order to confirm information pertinent to the deceased's medical history.

From 1998 through 2004 the KCMEO collected and shipped to the Stanley Laboratory brain tissue from 186 cases. Unlike some other jurisdictions around the country, the KCMEO received a flat annual fee, and the annual fee did not depend on the number of brain samples provided.

If you have any questions please call immediately. I am working with the Chief Medical Examiner, Dr. Harruff, to aggressively provide the facts to counter this erroneous media report.