What Is Polypharmacy?

How should polypharmacy be defined? In a list-serve in which I participate psychiatrists commented thus in relation to a case under consideration:

Dr. P: "My definition of "Polypharmacy" would apply to any inappropriate use of any medication."

Dr. R says the term is pejorative.

Dr. M says, "I don't mean to use the term "polypharmacy" in a pejorative way, simply that there are several meds
And it makes it difficult for me to know what is or is not helping..."

Here's my definition, written years ago.

Other thoughts? I think there is also a question of what should be the threshold. I can't see that as some arbitrary number of drugs, though.

An Ethics Odyssey V

Current Status (continued from An Ethics Odyssey IV)

As of April 27, 2010 the initial question regarding possible fee-splitting remains unanswered and the WSPA investigation of the informed consent issue appears to be in limbo, possibly awaiting review by APA. The Illinois committee issued a final determination in a letter dated July 7, 2009 indicating application of the educational sanction but with no mention of an option for the complainant to appeal. The Queens County committee may have been the only one to suggest that the conduct was clearly not unethical, indicating in a letter dated October 20, 2008 that the complaint was dismissed. Aside from WSPA (and possibly IPS) no other committee appears to have taken up the informed consent question.

Ethics Committee Report Card

DB	Date initiated	Date determined	Determination	Communi-cation	Perfor- mance
WA	1.9.2007	NA	None/pending	F	F
FL	4.17.2007	NA	Raised bogus question of illegal activity	C	F
TX	4.17.2007	11.14.2007	Presumed ethical because of informed consent	D	D
GA	4.17.2007	9.17.2007	Different financial arrangement	A	A
NJ	4.17.2007	6.18.2007	Psychiatrist no longer licensed… did not accept any fees	A	NA
Queens Cnty, NY	4.17.2007	10.20.2008	No ethics violation.	B	A
Illinois	1.21.2008	NA	Determination only implied.	A	A-
S CA	1.21.2008	3.10.2008	Raised bogus question of illegal activity; did not respond to questions.	F	F
HI	4.17.2007	2.3.2008	Wrong psychiatrist with similar name	A	NA

Conclusions

This admittedly difficult group of cases has indeed revealed weaknesses in APA’s procedures for handling ethics questions. APA and the local committees have failed to answer a straightforward ethics question posed by a member in good faith after more than two years time. If members cannot expect timely responses to such questions, they may choose to take their chances with conduct that an ethics committee may determine to be unethical after the fact. This places patients and physicians at unacceptable risk and should be remedied immediately.

Unnecessary delay in addressing such a question may adversely affect the member financially by forcing the member to delay making a decision that could have resulted in increased income. This also may create the appearance of anti-competitive activity. If committee members fear that allowing another member to provide a new treatment will take business away from them, they erect temporary road blocks. This could also hurt our patients by delaying availability of needed and effective treatment.

Delay in addressing these questions resulted to a large degree from the WSPA ethics committee’s requirement that the matter be handled as an investigation. The committee should have answered the questions I posed as soon as it gained access to the necessary documents, or the APA ethics committee should have answered the question, as did the Queens County comittee. Delay and avoidance of answering the questions served no legitimate purpose. WSPA subsequently issued a statement to the effect that the ethics committee, as a matter of policy, will no longer take up questions regarding ethics, but will only investigate actual complaints. While I am disappointed, I support this decision. These questions should be addressed by the APA ethics committee.

The quality of response to referrals of potential ethics problems differs markedly from committee to committee. While the Illinois committee’s response appears exemplary Florida and Southern California appear to have used the baseless ploy that their might have been some kind of illegal activity to avoid investigating the cases at all. Texas would appear to believe that informed consent obviates any concern about ethical conduct even without clear evidence that informed consent was obtained, and APA upheld their decision. APA needs a mechanism for assuring consistent quality of investigation across all local committees and should remedy this problem immediately.

It appears likely that determinations will differ among local committees. Texas appears to have determined there has been no violation, but it is not clear that the practice in question actually was used by their members. WSPA pretended to address the question but did not. Only Queens County and Illinois may have come to a real determination. What is considered unethical in Illinois should not be considered ethical in Texas. Nor should this require appeal to APA. APA needs a mechanism for assuring consistency in ethical determinations throughout the association and should establish procedures needed to achieve this goal immediately.

Dr. Adler’s meeting and conversations with representatives of the company gave the appearance that his committee may have assisted this for-profit corporation in crafting their contract. This is not an appropriate role for a professional association ethics committee because of the possibility of conflict of interest or role conflict. Furthermore, he should not have informed company representatives about my “inquiries to the Washington State Psychiatric Association (WSPA) and to a news reporter.” Although the “complainant” has no duty of confidentiality, the committee should consider communications to an ethics committee by the complainant privileged, particularly with regard to a third party like the company. His request that I as the complainant agree to non disclosure after I raised questions about his contacts with the company and reference to the “Martini Doctrine” was not justified. Perhaps the APA ethics committee should address this kind of conduct in formal guidelines.

The company appears to have performed admirably. Their secrecy requirement probably served a legitimate need to protect their investment. When questions were raised, they responded appropriately, apparently bending over backward to assure that their doctors can provide the protocol ethically. However, their charges of harassment and threats of litigation to avoid further referrals of ethical questions by their legal counsel was gratuitous and may have constituted attempted interference with the ethics determination process by intimidation. There remains as well the question of whether the treatment protocol works.

The use of agreements requiring secrecy poses a challenge for APA ethics policy. Members should not be able to avoid scrutiny of their professional activities for compliance with ethics guidelines simply by agreeing with a third party to keep those activities secret. The APA ethics committee should advise members not to enter into such an arrangement unless it specifically allows them to reveal the agreement to an ethics committee. The committee should also advise members not to enter into agreements that do not allow them to provide full informed consent to their patients.

The risks, costs, time and other factors associated with ethics investigations may exceed what is reasonable to expect from members of a district branch or state association. APA should consider increasing the level of indemnification of members investigating ethics complaints and providing more support including access to legal counsel.

The problems with the APA’s system for addressing ethics in the profession described above provide evidence that the system needs to be fixed. Delay in action to correct these problems will hurt our profession.

(Financial interest disclosure: The author owns stock in the company discussed above. One share, valued 4.6.2010 at $0.21.)

DSM-V: A Brief Conversation With Allen Frances

Having come across his email address I could not resist posing a question, and he honored me with a reply, alas another question. I thought the conversation might deserve public exposure.

My question:

"It has seemed to me that in general DSM criteria from 3 on have been necessary but not sufficient to make a dx. The clinician must make a judgement that the pt is ill, THEN use the DSM to classify that illness.

Would it help to emphasize that fact?"

Before I record Frances' response let me elaborate. Many years ago, during a deposition, an attorney pulled out the DSM and walked me through the criteria for some disorder one by one. I had to admit most if not all seemed to be met, at least at first glance, but I still opined that the patient did not suffer from the disorder. This raised a question I might have thought would have an obvious answer: According to the DSM, if the patient meets all the criteria, does that imply they have the illness? I have looked in vein for an answer. This led me to the conclusion that, especially given the Cautionary Statement at the beginning of the book, the proper way to apply the criteria might involve a trained clinician (not an attorney) first making the judgment that the patient suffers from a mental illness, and referring to the diagnostic criteria only to classify the illness, ie to determine which diagnosis fits best.

It seems to me that inclusion of a clear statement on this issue could improve DSM-V.

I figured if anyone knows the answer it must be Dr. Frances. His response:

"Do you mean by ill that the patient has clinically significant distress or impairment?" 

Gee thanks, doc. I think he may be trying to use this as a teachable moment. I believe this question is beside the point, but of course it is very critical.

"Clinically significant distress or impairment," in my opinion, does not qualify as the definition of a mental disorder. Rather it is a threshold. I find it hard to imagine making a diagnosis of mental disorder in the absence of clinically significant distress or impairment, but I hold out the possibility it might be appropriate in some cases. I'm still wondering why he asks. Maybe he just wants to know whether the process I describe above consists of first determining that there is clinically significant distress or impairment, then applying the criteria. Fair enough.

But that is not what I do. I believe there is more to identification of a diagnositc entity than distress or impairment. A disorder must somehow hold together and have a life of its own. It can't just mean feeling really bad or not functioning 100% when things are going rough for example (or did I just define adjustment disorder?).

The term "clinically significant" bothers me too. Does that just mean the problem was so bad the patient sought professional help, or that someone else thought they should seek professional help?

A lot of this debate struggles with determining just how clear the dividing line between normal and sick should be. We lose if we say everyone is sick all the time, or that everyone has an excuse for doing bad things or failing a responsibility. We also lose if we keep those who need it from accessing treatment.

If Dr. Frances responds again, I will post here.

DEA Suboxone Audit Update VIII

Continued from: Worst Experience of My Career: a Follow Up

After numerous phone calls and broken promises, as well as assistance from my congressman, I received a letter from Mark Caverly, Chief the the Liaison and Policy Section, Office of Diversion Control, DEA, responding to my request for a description of the buprenorphine record and stock inspection process when conducted under Administrative Inspection Warrant.

Although Mr. Caverly provided no such description, he did shed some light on what a physician might expect. I am left with the overall impression that the process differs little from an inspection conducted after a physician has signed Form 82, the chief difference being that the inspection is conducted without the physician's permission.

The most egregious aspect of the inspections from the physician's (an patients' present at the office) seems unchanged from the "permitted" inspection: agents will appear unannounced, thus unnecessarily disrupting medical care under the illusion that this will prevent physicians from preparing in advance, so the agents can catch offenders red handed. Because of this I see little advantage in declining to sign Form 82 when agents appear at your office.

Mr. Caverly failed to answer most of the rest of my questions:

"Will agents force entry if the physician is not present?"

He seems to have missed the fact that this is a yes or no question. He simply cited a statute with no reference to forced entry. The statute does refer to a "right" (Shouldn't that be authority?) to "enter such premises... in a reasonable manner," whatever that means.

"Will agents serve the warrant during regular business hours?"

The cited statute also specifies that inspections should be conducted at "reasonable times," whatever that means. Again, he does not seem to recognize a yes or no question.

"If the physician is present when the agents serve the warrant, and is prepared to provide access to the required records, will the audit be conducted as it would have been with Form 82 (Notice of Inspection) consent?"

Once more he evades a yes or no question. He simply tells us that the same records must be made available rather than addressing how the inspection will be conducted.

"Will agents be more or less likely to confiscate records than they would be with Form 82 consent?"

He evades this question as well but does tell us that the physician will be provided with a receipt for any records seized pursuant to the authority of the Administrative Inspection Warrant, and that the records will be returned when the process is completed.

"To what extent does national policy govern the process, and how much latitude and discretion does DEA afford local field offices?"

Once more his answer is uninformative and completely fails to address the question. It would be wonderful to see one of these people cross examined in court where they can't get away with such evasiveness. And these are public servants?

An Ethics Odyssey IV

 (Continued from An Ethics Odyssey III)

More District branches, State Associations

Since no district branch or state association had yet answered my original question, and months had passed since my original round of letters, I wondered whether there might be some new players where inquiries might bare fruit. Another search of the company and APA Web sites revealed members apparently associated with the protocol in two more areas. On January 21, 2008 I wrote letters to the Illinois Psychiatric Society and the Southern California Psychiatric Society.

Southern California

William Arroyo, chair of the ethics committee of the Southern California Psychiatric Society responded with a letter dated March 10, 2008. He referred to my “allegations of illegal fee-splitting” which would require the committee to “reach a legal conclusion of whether the law has been violated before there can be a determination of whether unethical activity has been alleged by you.”

I read on, hoping in vein for clarification:

“The SCPS lacks the authority and the resources to determine such a legal issue.”

This seems obvious.

“Hence it can not determine that there has been an allegation of unethical behavior.”

There clearly has not been an “allegation of unethical behavior.”

“Until such time that a court of law has determined that the ‘fee splitting’ you allege is illegal, the SCPS cannot issue an opinion on the ethical nature of this allegation.”

Dr. Arroyo seems to believe “the courts” can make ethics determination.

“Accordingly, the SCPS is not in a position to proceed with your letter of complaint and must decline to take further action. The SCPS will gladly review any new information related to this matter in the future.”

He went on to inform me that I could appeal to APA, but the letter confused me to such a degree that I was not sure what I might appeal. I wondered whether he had understood my original letter at all.

I got the sense SCPS did not want to pursue this, but I replied anyway, explaining that I had not alleged anything and certainly had not considered that any illegal activity had taken place. After a few weeks without a response from SCPS I did in fact write a letter of appeal to APA whose ethics committee upheld this “non-determination.”

Illinois

I received a letter dated February 7, 2008 from David H. Baron, MD chair of the Illinois Psychiatric Society ethics committee acknowledging receipt of my letter. He explained the process in detail and asked me to provide further information. He enclosed a copy of the APA publication “Information for Complainants on the Ethics Process.” He provided the email address of a contact person in the IPS office.

Correspondence back and forth followed. I was asked whether I might be able to travel to Chicago for a meeting, but I pointed out that this was probably not necessary given that I had little actual knowledge of the critical facts surrounding the question. On June 23 I participated in a conference call with a committee. IPS left me with the greatest confidence that the investigation would be handled professionally and responsibly.

In a telephone conversation on September 10, 2008 Meryl Sosa of IPS told much of the investigation was completed with consideration of the evidence to occur soon. In a subsequent conversation she told me IPS had submitted the committee’s determination to the APA ethics committee for final approval.

Back to the Fee Splitting Question

Dr. Adler wrote on January 31, 2008: “Since the physicians have signed an NDA [non disclosure agreement] they may be in a bind regarding responding to our initial inquiry. We might need to contact the company asking them if the circumstances as conveyed to us are true. Unless they can definitively show otherwise, we would have to assume there is fee-splitting.” He appeared to put the burden of proof on the doctors.

Having heard no more from Dr. Richie I wrote the third psychiatrist to hold the position of WSPA President during this protracted process, Ray Hsiao, MD, on April 20, 2008 via email asking whether I might get a status report. Dr. Hsiao forwarded to Dr. Adler who forwarded to Dr. Richie. Still no response from WSPA, but it appears that I got the attention of the company again.

In a letter dated May 8, 2008 an attorney claiming to represent the company, apparently prompted by my inquiry to the Illinois Psychiatric Society, accurately pointed out that I “did not contact [the company] prior to filing [my] complaint.” She also accurately pointed out that I could have raised concerns with the company, which in fact I had. Then she got off track. She voiced the mistaken impression that company representatives could have somehow provided “information” to allay my concerns about the financial arrangement. “… you now have actual knowledge that your complaints are without merit and baseless.” Although she went on to cite determinations from the Georgia and Texas cases, she seems to have overlooked the questions raised in Washington. And she overlooked the fact that neither of those cases directly addressed the question. “Your actions evidence a malicious effort on your part to harass and intimidate these psychiatrists, and to tortiuosly [ie, We will sue you if you don’t stop.] interfere with [the company’s] professional business relationship with them.”

Her assertions grew wilder: “Moreover, your actions show a complete lack of respect for the several psychiatrists against whom you have filed complaints, in patent violation of the APA guidelines.” There are no such guidelines. In fact one could argue that members of APA have a duty to report possible ethical misconduct. I will readily admit to having a complete lack of respect for more than a few psychiatrists, but probably none of those associated with the protocol can accurately claim membership in that group. And of course no one from APA to this day has accused me of this “patent violation.”

I wrote the attorney promptly, describing my still futile efforts to get my professional association to assure me that any agreement into which I might enter with her client would meet ethical muster and assuring her that I felt no animosity for her client company. Alas she could only respond with another threatening letter (July 10). But then, to paraphrase Tigger, “That’s what attorneys do best.”

The important question raised by the role played by this attorney is whether the psychiatrist might be held responsible for using the threat of litigation to discourage an ethics investigation. I raised this issue with the Illinois committee.

Embarrassed Government Officials

In the fall of 2007 reports of controversy over a program using the protocol at a local clinic emerged. The clinic reportedly abandoned use of the protocol in the spring of 2008 amid questions of conflict of interest in government officials and questions about cost and evidence of effectiveness. In a telephone conversation a psychiatrist who had provided the treatment there told me another psychiatrist called him with questions about the protocol. He told me he was unsure of the psychiatrists name, but added that the caller did not identify himself as pursuing an ethics inquiry. Could this have been the mysterious Dr. Richie?

WSPA, Continued

Finally, action! Dr. Adler wrote a letter dated May 16, 2008 in which he attributed the “delay in reviewing this matter” to “negotiations to obtain contracts from” the company. He addressed the matter of the financial arrangement first:

“… if the member in question were not direct licensees, but only clinicians operating the… protocol for an employer, then our review of the contracts indicate that the member psychiatrists are not participating in fee-splitting or its equivalent.”

On first read I thought the committee had determined the financial arrangement to be ethical. Then I read more carefully. It reminded me of a line from an old Harry Belafonte Calypso song, “It was clear as mud but it covered the ground.” It appears that Dr. Adler carefully worded the statement to avoid revealing information about the members’ relationships with the company. This I respect. But because he implied that none of the psychiatrists named was a party to the arrangement in question he never addressed the original question. Nor did he promise to address it later.

Dr. Adler did proceed to express concern on the part of the committee regarding informed consent. He went on to indicate initiation of investigation of the members to determine whether consent to treatment was informed consistent with ethics guidelines and promised “the entire process” might take “a year or more to complete”

What disturbed me most, however, was the wording of the letters WSPA sent to each of the listed physicians. Each letter stated that [the author] “filed a complaint… alleging that you have acted unethically.” This of course was far from the truth. I wrote to each of the psychiatrists myself correcting the mistake, and I wrote to WSPA to ask that the association likewise write letters correcting and apologizing for the error. Dr. Hsiao wrote back agreeing only to “inform the respondents of your ‘formal complaint’ as outlined in your letter.”

Continued: An Ethics Odyssey V

WSPA Spring Meeting in Seattle

Stephen Michael Thielke, MD, incoming president of the Washington State Psychiatric Association programmed this years meeting around a theme of technology.

WSAP President Elect Robert Hilt, MD led off with a presentation describing experience of delivering child psychiatry services to remote underserved areas of the state, emphasizing the program's telepsychiatry services in a model providing for remote offices staffed and equipped through the program. I disagree with Dr. Hilt's definition of telepsychiatry excluding the telephone which makes teleconferencing look inadequate relative to face to face contacts. In fact we should emphasize that teleconferencing with video is superior to telephone contact which has been an essential part of standard of care for providing medical services for almost as many years as the technology has existed.

Jacob Sperber, MD spoke next on "The Impact of Interactive Digital Social Media on Psychiatry." However, most of the several authors he quoted have published in other fields, like media and sociology, and it soon became clear that he talked not about psychiatry in general but rather about psychoanalytic psychotherapy. He argued that psychiatry, as though it were some kind of monolithic organization, espouses intimacy as a value, and that psychiatrists should oppose activities, such as social networking, that threaten to impair our capacity for intimacy. I strongly disagree with this position. Social networking clearly has potential for good as well as harm, but psychiatrists should stick to treating mental illness rather than promoting values which, at least in this case, are probably based on psychoanalytic views of what should be considered normal. With his views Dr. Sperber would likely have risen to a high position in the old Soviet Union.

Sperber also argued that digital social networking promotes "multiplicity," in that users portray themselves in different ways in different settings on the Web. That may be true, but we would be pretty boring if each of us always acted the same regardless of the situation. And you don't need the Internet to act differently just for fun, or for some other purpose. I guess if Dr. Sperber's mother told him she cried for the cop to get out of a traffic ticket he would want her to sign up for a several years on the couch.

After lunch VA psychiatrist Kenric Hammond, MD described the electronic medical record system that has evolved over many years at the VA. He focused on the problem of copying and pasting of text and encouraged increased use of narrative vs. check boxes. He also suggested hypertext technology might provide a superior alternative, allowing the provider to refer elsewhere in the record rather than copying the same text. Having reviewed many pages of records from VA clinics and hospitals myself I agree the system begs for improvement. I might suggest a system in which each provider could select modules to customize data entry. It appears to me that the tail too often wags the medical dog. EMR's should bend to the style of the physician rather than dictate how the physician works. On the other hand the EMR, properly designed, might also lead to improved care. The proposed use of hypertext, however, will create change in how forensic record reviews proceed. If the reviewer wants an accurate picture the linked document must be readily accessed from the link. This could apply pressure for abandoning paper copies in favor of electronic. This could be good.

Finally librarian Valerie Lawrence told us how to access journals and other resources available to all WA licensed physicians, and attorney Jacqueline Melonas described risk management considerations in communicating with patients via digital media.

iPad. Ho Hum.

I have been using a tablet PC for over 7 years.

I can write on it.

It even recognizes my handwriting.

It's really a computer.

I can read books with it, watch movies on it, surf the Web with it.

iPad? Not.

An Ethics Odyssey III

(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.”

Don’t Tell.

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.”

Sure.

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

Smokin' Joe Califano

If I recall correctly, Joseph Anthony Califano, Jr., who served as Secretary of Health, Education, and Welfare during the Carter Administration, felt obligated to quit smoking in order to set an example in his new post, given the emerging evidence of adverse health effects of tobacco. I was on the medical staff of Gracie Square Hospital, a private psychiatric hospital in New York City, at the time, and an anti-tobacco activist myself, so I was not about to miss the opportunity to hear him speak at the hospital where there was still a cigarette vending machine in the patients' day room upstairs, and patients smoked freely during their hospital stays.

Mr. Califano told a story of driving through suburban Maryland with his teenage son soon after his appointment. He said his son knew of his dad's frustration in attempting to get Americans to give up smoking. Attempting to console him as they passed a high school, his son drew attention to a group of youngsters sitting on the steps at the school entrance. He said something like this, "Don't feel so bad, Dad. A few years ago every one of those kids would have been smoking a cigarette. Now they just have one, and they're passing it around."

An Ethics Odyssey II

(Continued from An Ethics Odyssey I)

Other State Associations, District Branches

By the middle of April I reasoned that the only way to solve the problem of potential disagreements among the various state associations and district branches might be to refer the same question to each of those where I found more apparent APA members listed on the company Web site as providing the protocol. On April 17, 2007 I sent letters to state associations and district branches in Texas, Hawaii, Georgia, Florida, New Jersey, and Queens County in New York. In each letter I provided the name or names listed on the company Web and described the financial arrangement.

WSPA

By May 1, 2007 there was still no determination. I asked Dr. Williams about the letter I had written him to formalize my request, including the names of four psychiatrists listed on the company Web site as providing the protocol in the state of Washington. He responded two days later that the WSPA office had forwarded the letter directly to Dr. Adler and, “The Ethics Committee is meeting tonight and this is the main item on the agenda.”

Months passed with no response from WSPA, but other district branches and state associations began to respond.

Queens County, NY

Stanley Brodsky, MD, Chairperson of the Queens County Psychiatric Society, was the first to respond. In a letter dated May 12, 2007 he asked if I could provide more information. I wrote him a letter and put him in touch with Dr. Adler. He also provided his direct phone number. In our last conversation he told me the Society’s attorney had attempted to review the matter with the APA ethics committee but with no response. In a telephone conversation with Dr. Brodsky on September 10, 2008 he told me, “They dropped it.” When I asked about a written response, he told me the district branch would get back to me.

New Jersey

The New Jersey Psychiatric Association completed the investigation first with a letter dated June 18 indicating that the named member was indeed licensed  with the company “through affiliation with the [a clinic in] NJ” but that he “is no longer affiliated with them and in fact did not accept any fees for any treatments using the… protocol.” The physician later called me to inquire about my letter and explained that he had severed his relationship with the company.

Georgia

Peter Ash, MD, chair of the Georgia Psychiatric Physicians Association Ethics Committee responded with a letter dated September 17, 2007 indicating the committee determined the member there “administered the … protocol [as a] full-time salaried employee of a clinic” and had “no contract” or “other financial arrangement” with the company.

Texas

In a letter dated November 14, 2007 Milton Altschuler, MD, Chairman of the ethics committee of the Texas Society of Psychiatric Physicians wrote that the committee had found no ethical violation. When I telephoned Dr. Altschuler he explained that the committee believed “informed consent” to the financial arrangement obviated any ethics concerns. It was not clear whether anyone on the committee had actually looked at the agreement or whether the committee even determined that either of the psychiatrists named had been involved in the arrangement described above.
I questioned whether otherwise unethical conduct could be made ethical simply by informed consent, so I appealed the decision to the APA ethics committee. The Texas decision was upheld with little further explanation. This determination raised more questions than it answered. First, the committee offered no evidence that they had determined the nature of the financial arrangement between the company and the named members. Second, the committee offered no evidence to support the assertion that informed consent was obtained. Finally, the notion that an action that would otherwise be considered unethical might be rendered ethical simply by obtaining informed consent seems unprecedented. This might mean, for example, that pursuing a sexual relationship with a patient might be ethical provided there is informed consent.

Florida

Karen Teston, MD, Chair of the Florida Psychiatric Society Ethics Committee, wrote in a letter dated December 3, 2007 that she had identified two of the three psychiatrists I had listed as members. She then described a Florida statute (Section 456.054 of Chapter 456) prohibiting “kickbacks.” She suggested I refer the matter to the Florida Attorney General and indicated that only if a member were convicted of violation of such a law the committee would proceed with an investigation.

Kickback?

It had never occurred to me that this arrangement might constitute a kickback, but the label sounded as fitting as fee-splitting. I contacted both the Attorney General and the Florida medical licensing board. Each agency declined to pursue the matter but referred me to the other. I hoped that since there appeared to be little likelihood of a criminal or licensure investigation the ethics committee might look into the matter from a purely ethics perspective, but there was no further response.

Hawaii

If not the most prompt, Hawaii was perhaps the most courteous and diligent. Soon after receiving my letter the Hawaii Psychiatric Medical Association informed me theirs is a small association and that their President who also acted as chair of their ethics committee had died. When they finally regrouped and considered the matter they quickly found that the member I had named had no relationship whatsoever with the company. It was a simple case of mistaken identity, a doctor with a similar, but not identical, name.

Continued: An Ethics Odyssey III

Medical Practice at a Distance May Be Illegal II

Follow up to: Medical Practice at a Distance May Be Illegal 

State medical boards will likely continue to change policies regarding the legality of "practice" from outside the state, but I wanted to share with you the responses I have collected from a few states in the past few days. We will start with several assumptions that may not apply to other physicians, but will likely always apply to myself:

• Practice takes place where the patient is located and is governed by the laws of that jurisdiction.
• Patients reside in my state.
• Patients temporarily travel to states in which I am not licensed.
• Patients may need to contact me by telephone to ask for prescription orders or to discuss clinical matters such as symptoms, side effects, and dosing strategies.
• Patients may benefit from conducting a single contact via teleconference (eg, Skype) if traveling during a time when a visit would ordinarily occur in state. (As of now routine teleconference contacts will occur only alternating with in office contacts.

CA

In this case the patient might actually be located on a vessel either docked in CA or in CA waters. In response to my inquiry of the CA board regarding these questions I received only a letter indicating that I would have to seek the advice of legal counsel.

HI

The HI board responded the same day by email:

"We are in receipt of your message.
 
"Your patient may want to check with the pharmacy, but I believe the Pharmacy Board's laws allow pharmacists to fill one out of state prescription.
 
"With regard to your other two questions, the Hawaii board generally looks at the practice of medicine as occurring where the patient is.  As the patient will be in Hawaii, the practice occurs here and so the physician should be licensed.
 
"However, this is an informal opinion and is not legally binding.
 
"Thank you for your inquiry.
 
"sincerely,
Constance I. Cabral
Executive Officer
Board of Medical Examiners"

NY

I spoke with a lady at the NY board by telephone. She indicated that the board would likely consider a teleconference with a patient located in the state to be practicing without a license. When I asked her about ordinary telephone contact she asked me how anyone would know. But when I pressed her for a statement of policy she indicated that even telephone contact might be considered practice without a license.

Conclusions

I find it interesting that in CA and HI responses were couched as opinions. If provided in writing perhaps NY would have as well. Why can this not be stated as a matter of current policy? Perhaps the boards want to avoid any possibility of appearing to give a green light to, to what? Could it be that they just feel they must act tough but would never prosecute? 

Telephone "practice" across state lines occurs routinely near state lines. Some states may have reciprocity agreements. But no physician should have to break the law to avoid malpractice, and patients in this country should be able to travel freely without concern that their physicians might not be available to them by phone, and better yet by teleconference, regardless of whether the physician bills them for the service.

The reality is that physicians break the law every day because they are unwilling to stand up to irrational regulations. It's just easier to go with the flow. These laws serve no purpose and should be changed. Perhaps the next time we practice without a license in a state where a patient is traveling we should turn ourselves in and see whether prosecution follows. 

It may or may not be good that laws prohibit a physician located in state A from initiating and maintaining care of a patient never examined in person from state B. But every state, if not every country, should immediately enact laws to allow physician-patient contact by phone or teleconference when the patient travels to another state.

The Real Reasons Psychiatrists Want to Provide Psychotherapy

It takes fewer patients to fill your practice, which means:

• Less paperwork
• Less room taken up by file cabinets
• Fewer problems with pharmacies
• You don't have to keep up with so many different drugs
• Fewer phone calls
• You're more likely to get the patient's name right since there aren't that many other patients to mix them up with

Patients visit more frequently, which means:

• Fewer phone calls (because you might see them tomorrow anyway and talk about it in person)
• You're more likely to get the patient's name right since you haven't had as long to forget what they look like.

There is plenty of time, under the guise of "therapy" of course:

• to talk about problems with keeping appointments or being late
• to talk about paying bills
• for the psychiatrist to fill out forms (while still getting paid for the time)

If your patient doesn't like you, you can pretend like that's a symptom of their illness which will require even more treatment.
If your patient does like you, you can pretend like that's a symptom of their illness which will require even more treatment.
Your patients were probably never really sick to begin with.
Patients won't notice you forgot everything you learned in med school.
It takes longer for patients to get better, which means:

• They'll probably get better regardless of the treatment, because time heals all wounds, or
• They'll pretend to get better and leave treatment eventually just because they're so tired of talking to you.

More time to get work done if the patient doesn't show up.
You have more of an excuse for not answering the phone.
You have more of an excuse for not answering the door.
You don't have to split the money with a psychotherapist.
Your appointment book can have bigger spaces.
You get paid to chat with people who are more interesting than you are.
You get paid to tell the patient goodbye.
You don't have to worry about getting all the history in the first session.
Patients know better than to ask if you can "squeeze" them in.
Regular visits make for fewer missed appointments.

I may add to this over time.

If you're a psychiatrist who does psychotherapy or psychoanalysis (a sporkiatrist?), and you're offended by this, you probably just need to get more psychotherapy or psychoanalysis yourself, or at least more supervision.