(Continued from An Ethics Odyssey II)
Meanwhile, Back in Washington State
After returning from a vacation I contacted the WSPA office hoping for a status report. In an August 24 email the WSPA executive office acknowledged receipt of my inquiries and reported passing them on to the president, Dr. Williams, and, in a later email, to Dr. Adler. I wrote to Dr. Williams on September 4 asking if I should attend a meeting since there had been no response to my contacts via email and telephone.
In a September 13 email Dr. Adler reported, “…in their present incarnation, [the company's] business agreements do not appear to be consistent with ethical medical practice. It is our hope that [the company] will elect to revise the agreements.”
The Martini Doctrine
Dr. Adler wrote in an email dated September 18, 2007, “… our committee has adopted a stance that we term ‘The Martini Doctrine.’ In short, it de-emphasizes punitive approaches in favor of education and advocacy. It may be the view of the committee to update the named WSPA members on the status of this issue, the concerns raised and invite them to contact us to discuss the situation.”
On September 24 the WSPA office wrote me via email that Dr. Williams had received the “USPS documentation” I sent in April, apparently referring to my letter of April 16. It appears that the office received my letter, but it remains unclear whether the executive director forwarded it to the ethics chair, the president, neither or both.
The WSPA Committee Analyzes the Agreements
In a letter dated October 5, 2007 Dr. Adler wrote an attorney for the company to express “concerns about two issues.”
According to Dr. Adler “Although there is not tacit [?] ‘fee splitting’ reflected in the business arrangement, close review… gives the appearance that your arrangements are an elaborate method to achieve ‘fee splitting’ within the letter of the law, but not the spirit of appropriate medical practice.”
On the issue of informed consent Dr. Adler wrote, the agreement appears “… to inhibit the process of providing appropriate Informed Consent to the patient” and “Review of your materials suggests that the patient at the time of consulting with the physician would not be permitted to receive information about the dosage of medication(s) they would be receiving, without the possible delay of the process of written consent by [the company] to do so.”
Adler then suggested the company might want to “… revise its Agreements to conform with the tenets of good medical practice so as to help physicians avoid running afoul of possible ethical violations.”
Perhaps under pressure from the company, or perhaps embarrassed about his earlier mention of The Martini Doctrine, Dr. Adler asked me in an October 19 email to “be kind enough to commit to making no secondary use of communications sent to you regarding this case (prior communications and those going forward)?” I declined after he agreed I was under no obligation to do so.
In a November 27 email Dr. Adler reported, “However, it is [the company’s] assertion that NONE of the named WSPA members were contractees with them. Thus, the only issue ‘on the table’ concerns contractual impingements/restrictions to the provision of proper Informed Consent.” This assertion is interesting in that it leaves the impression that the committee has relied on the company rather than the members for information critical to the determination.
On December 10 2007 a physician with the company emailed to assure me, the “license agreement and its practices have always taken these issues into account. However, your raising them has allowed the company to further strengthen its License Agreement and to make even clearer its requirement of licensees’ conformance with the AMA and APA ethical guidelines. It further demonstrated [the company’s] long-standing commitment to adhere to patient disclosure and its compliance with law and ethics to preclude fee splitting.
“It occurs to me, though, that it is a tedious and inefficient way of having your questions and concerns addressed. I'd therefore like to meet with you for a collegial dialogue and educational exchange consistent with our respective obligations under those Principles.”
I was tempted, but only my own professional association could really answer my ethics questions. The company seemed to be trying to do the right thing, and I was glad for the expressed appreciation for my small role in helping to conform the agreement to ethical guidelines. I would have liked to be able to see the agreement without agreeing to non-disclosure, but the company physician did not make such an offer. I saw no purpose in a meeting, so I declined.
Company Representatives Meet with WSPA Ethics Committee
On December 11 Dr. Adler wrote an email to legal counsel an attorney for the company thanking her on behalf of the committee for her “… having flown in from the East Coast, and [the company doctor’s] trip from California.” He went on to ask her to provide “…the updated contract containing the newly added 9.3 element meant to specifically address our Informed Consent concerns.” He added, “We were very relieved to see the addition.” He mentioned her “…commitment to have the updated agreements endorsed by WSPA members who may have signed the prior contract.”
I had copied Dr. Adler on a November 29 email communication to a local radio reporter who had written a story on the protocol in the context of its use at a nearby clinic. I described my attempts to obtain an ethics opinion. Dr. Adler added in a subsequent message to the company attorney, “Despite assurances that our committee was actively pursuing this issue and making concrete steps forward to resolve the concerns raised, [the author] has made inquiries to the Washington State Psychiatric Association (WSPA) and to a news reporter.”
Ordinarily I would have expected the ethics committee to consider my communications as the “complainant” confidential. On the other hand the complainant should not be obligated to keep anything secret. Although this would seem particularly critical in handling a complaint from a patient I believe a member of the Association should be accorded the same privilege. I remain confused as to Dr. Adler’s need to report this fact to the company. My understanding of the ethics process is that the committee’s duty is to the Association, its members, and the public rather than to a corporation.
A New Licensing Agreement
On January 5, 2008 an attorney from the company wrote an email to Dr. Richie (the “lead investigator”) with a copy to me:
“… the confidentiality restrictions in the agreement in no way limit a physician's ability to disclose information about the Licensed Technology to patients. That new section provides in relevant part:
"Notwithstanding any provision to the contrary in this Section 9 or otherwise in this Agreement, nothing in this Agreement is intended to or shall restrict any Group treating physician’s ability to disclose fully to patients the details of treatment with the Licensed Technology or to provide any and all relevant information necessary to obtain any patient’s informed consent to that treatment, and Group agrees to provide patients with informed consent in accordance with the requirements of controlling law and ethical guidelines as set forth in the American Medical Association’s Opinion Of The Council On Ethical And Judicial Affairs CEJA Opinion 2-I-06 E-8.08.” and…
“We are grateful to you and your committee for the opportunity to further clarify this issue and avoid any future confusion about the restrictions imposed by the license agreement.”
Case closed? Not quite
Dr. Richie wrote me via email on January 16, 2008: “This is the first communication to you since our last ethics committee meeting on January 8th. I had hoped to be able to tell you that the… matter was closed. Unfortunately some investigation remains undone and the case will have to remain open. I will update you and Dr. Adler weekly. You may call me at 253.879.7944 or if you prefer, we can continue these updates by e-mail.”
This was the last I heard from Dr. Richie. There were no further updates. Not weekly. Not ever. The elusive Dr. Richie disappeared from the case without a trace. On the same day (January 16) I received a copy of an email from Dr. Williams: “Regarding the ‘Martini Doctrine’, this is an informal term named after a very proactive WSPA Ethics Committee member, Dr S. Martini, who advocates that the committee always attempt to apply the most corrective approach in a specific situation as opposed to a more punitive approach. Any ambiguities in the term “martini” are strictly coincidental; please do not interpret this as a cavalier attitude on the part of the relevant parties.”
I had recently communicated my concerns about Dr. Adler’s use of the expression “Martini Doctrine” to APA along with my concern regarding the propriety of the committee working so closely with a for-profit corporation, almost seeming to be assisting the company in crafting a contract. This is not an appropriate role for a professional association ethics committee.
Dr. Williams went on to say that I “helped us identify weaknesses in our operations which we are working to correct.” Let us see to what extent WSPA worked to correct those weaknesses.
Continued: An Ethics Odyssey IV