Wednesday, March 31, 2010

An Ethics Odyssey I

My series of posts addressing the APA Ethics Committee’s opinions documents problems with the national committee’s approach to ethics questions and complaints, but local, district branch and state association, ethics committees do much of the work of handling ethics complaints. Not only does this uncompensated work require substantial amounts of time, but it also involves liability exposure with only limited protection. I believe this story will demonstrate some of the basis for my opinion that APA should do more, if not all, of this work.

During the last months of 2006 I began to consider purchasing a license to provide a proprietary treatment for patients addicted to alcohol, cocaine, and methamphetamine. There was little or no proof that the treatment worked, but given the devastation associated with methamphetamine addiction in particular it seemed this novel protocol using flumazenil, hydroxyzine, and gabapentin (all off-label and off-patent) might be worth trying provided the patient understood that the protocol might not work.

Representatives of the company informed me that I could purchase a license to provide the protocol in my office, but before spending thousands of dollars to use this patented treatment regimen I wanted to make sure my professional liability (malpractice) carrier would cover me and that the financial arrangement would not be considered unethical as some sort of fee-splitting arrangement or kickback to the company. The representatives told me I would collect a fee of thousand of dollars from the patient. One representative wrote in an email January 25, 2007 email, “As the patient comes to your practice for the treatment, our site manager notifies our corporate office who will invoice you for the license fee and the aftercare money of $1500. If the patient stays in your Outpatient tx program, you will bill us for the visits up to $1500. If you refer the patient to an IOP, that group will bill [the company] for their services.” I would then pass along to the company “$7450 for stimulant patients and $6400 for alcohol dependent” patients. This sounded enough like fee-splitting or a kickback to me that I wanted my colleagues in my professional association, the American Psychiatric Association, to assure me that it would meet ethical muster.

Professional Liability

By January 24, 2007 I asked my professional liability carrier about coverage, and by March I had an answer, but first an insurance underwriter raised the question of informed consent in an email: “Informed consent is extremely important as this is an unproven treatment using medications for off-label use. It would be appreciated if you could please provide a copy of the informed consent that you plan to use in your practice. ”

At this stage I had no access to the informed consent form, and I knew that, at least until publication of the applications for US Patents on the protocol, details of the protocol, even the drugs administered, were not divulged to the public. I, too, felt that informed consent would be critical, especially that I should be free to tell the patient what drugs I administered to them or that APA would consider ethical any constraints on that freedom.

The malpractice carrier ultimately declined to cover my use of the protocol in my office, citing what they believed to be an unacceptable risk of seizures associated with intravenous administration of flumazenil, a benzodiazepine receptor antagonist, but told me I could purchase coverage for this activity in a hospital setting such as an outpatient surgery department for a 25% surcharge added to my existing premiums.

The hospital of whose medical staff I am a member declined to allow me to provide the treatment in their outpatient surgery department on the grounds that there was too little evidence of effectiveness, but I decided to pursue the ethics questions anyway, knowing that I could ask the hospital again later and hoping that the requisite evidence of effectiveness might be forthcoming.

Informal ethics question

During my 20 years of membership in the Washington State Psychiatric Association I had twice before submitted questions to the ethics committee. In both cases a few telephone discussions led to consideration of my question at a meeting or two, then I received a letter with a clear determination, and an expression of gratitude for posing an interesting question.

But complications in resolving this ethics questions surfaced early. I first posed the question to WSPA ethics committee chair, Richard Adler, MD, in an email dated January 9, 2007. He asked me to submit the question via the WSPA president, but I knew that the licensing company, a publicly owned for-profit corporation, appeared to want to license physicians all over the country. It occurred to me that while my local APA association (WSPA) might find the financial arrangement ethical, another state association or district branch might determine that it was unethical. I reasoned that if the American Psychiatric Association ethics committee should consider the question so every psychiatrist in the country would know whether there might be an ethics problem.


I contacted the APA ethics committee with the question in an email dated January 10, 2007. The APA ethics committee said they would not consider the question until the next yearly meeting in May, 2007, with an opinion to follow as late as mid summer. I provided her with the names of four psychiatrists listed on the company Web site as providing the treatment in my state.

A January 17, 2007 email indicated the question had been forwarded to APA ethics chair Wade Myers, MD, but he asked me for more information and wrote in a January 20, 2007 email to WSPA ethics chair Richard Adler, MD asking him whether he might be able to “assign a couple members of your Committee to review his concerns and provide him with some written feedback, hopefully within a couple of weeks if possible. I think it is ideal to have local WPSA [sic] MDs review this situation as they will best understand the professional landscape in your state and how it interfaces with this issue.” APA Medical Director and CEO James Scully, MD agreed in a letter dated May 2, 2007.

Non-Disclosure Agreement

The secrecy surrounding this company’s proprietary protocol also presented a problem for an ethics determination. The company apparently and understandably wanted to prevent an unlicensed (by the company) provider from copying the protocol, competing with licensed providers for a much lower fee and depriving the company of profits on its investment in the patents. When I asked a representative for a look at the licensing agreement, he forwarded my request to the company. Another representative of the company, in an email dated January 18, 2008, indicated I would have to sign the company’s “Confidentiality and Non-Disclosure Agreement” (NDA) which I understood would restrain me from revealing the contents of the agreement to anyone else. I realized this would also present a problem for the ethics committee since they might need to examine the exact wording of the agreement to make an ethics determination. If I agreed to non-disclosure, I would not be able to reveal the licensing agreement to the ethics committee. It seemed that at least one member of the ethics committee would have to sign the NDA and read the licensing agreement before the committee would be able to pass judgment.

On January 30, 2007 Dr. Adler forwarded a copy of my earlier email to then WSPA President Jason MacLurg, MD. In this message I had described the financial arrangement and raised the question of ethics related to informed consent. Dr. Adler informed Dr. MacLurg “As is the protocol, you do the initial review on ethics complaints.” On February 1 Dr. Adler wrote that the committee would be “discussing the matter this evening at our Ethics Committee meeting.”

Adler to the Company

Dr. Adler initiated contact with the company. He wrote in a February 2 email to the company:
“We received a complaint alleging that the arrangements related to [the protocol]:
“(1) reflect fee-splitting in that the clinician is provided referrals and a fee is paid for each patient treated and,
“(2) the patient is not provided information on the exact nature of the medication(s) used prior to signing a contract, thus precluding true informed consent.
“To address this ethics complaint it would probably be helpful to have relevant documents provided for review--such as the contract with providers, informed consent form, NDA.  Should you require written assurances about the limitations on the use of the material, I would be happy to sign an appropriate agreement.”

Dr. Adler was right to ask to be allowed to see the agreement, but he had taken some liberty with my original question. I had not complained or “alleged” at all. I had raised some questions. This was to prove a harbinger of things to come. He wrote on February 23 that he “signed an agreement with [the company] and they are sending us ALL relevant materials for review.” He added, “I anticipate 7-10 calendar days would be a good time frame,” but did not say for what.

“Seven to ten calendar days” stretched into weeks. I received no response from Dr. Adler to my phone calls and email. The “lead investigator” assigned to the case, a Dr. William Richie, left a message for me, but I was not able to get through to him until a Saturday in March during the annual meeting of the WSPA, which I attended, but he did not. I had little to offer in the way of additional information, but he promised a determination by March 30.

On April 3, 2007 I wrote newly elected WSPA president Robert Williams, DO, to ask for an explanation for the delay. I attended a meeting of the WSPA Executive Committee where I expressed my dismay at the delay and lack of communication. On April 13 Dr. Adler copied me on an email to Dr. Richie indicating his intent to “make this inquiry and keep all parties informed of the status.”
Dr. Richie replied to Dr. Adler the same day: “Based on this data, (and my interpretation of In re: C. Robert Crow, M.D., and later affirmed by the Fifth District Circuit Court in, Crow v. Agency for Health Care Administration) my preliminary assessment is that the ethics committee may have basis to consider a full case investigation, as the arrangement is apparently not “limited solely to fees generated by the physician from his own professional services and those services provided by individuals under his own direct supervision without reliance on fees generated from ancillary services,”.  (Those ancillary services being the referral service of [the company].) ”

Adler responded the following day: “the situation appears to represent a breach of ethics and [the author] stated last evening that he is aware of specific WSPA members who operate under these conditions/agreements.” Not exactly. To this day I have no direct knowledge of the actual financial arrangement of any physician providing the protocol.

In a letter dated April 16, 2007 I listed the names of four psychiatrists whose names I found on the company Web site said to provide the protocol in Washington State. I asked the committee to investigate whether any of them might be involved in an unethical financial arrangement as part of any license agreement with the company. I received acknowledgement in a letter from the WSPA office dated May 16 which also indicated the office forwarded copies of my letter to Drs. Adler and Williams.

Then I waited.

Continued: An Ethics Odyssey II

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