Sunday, June 16, 2002

Bill Quick and Megan McArdle seem to have an interesting debate about resident work hours going on on their blogs. I personally believe that resident work hours are often onerous beyond any need for patient care, but I don’t think that’s necessarily a disaster in and of itself. I believe that the long work hours are, in fact, not a problem, but a symptom of the real problem, which is the total control residency programs have over medical licensure and board certification. This control can be misused in many ways, like making residents work long hours for cheap; to me, however, the greater misuse of that control is the ability of residency program directors to demand unethical and arguably criminal behavior from their residents.

Yeah, I bet that got your attention. What am I talking about? Well, here’s my story.

While in medical school, I was the second author of a national presentation on the law and ethics of informed consent in emergency situations (Prehospital use of Tissue Plasminogen Activator, Pamela Grim et al, presented at the 1988 meeting of the University Association for Emergency Medicine). In order to help create that presentation, I studied the law of informed consent from many perspectives. As such, I feel that I was, and to a lesser extent still am, well versed in the legal and ethical requirements of obtaining informed consent for medical procedures.

One of the main tenets of obtaining informed consent is the requirement that the patient, or the patient’s guardian be informed about all significant risks to a procedure. There are some exceptions for emergencies, and a few other situations, under the “doctrine of implied consent,” but, in general, patients rely on their doctors to inform them, and doctors have an obligation to do so. Contrary to some opinions, it is not the job of a physician to talk the patients into whatever cockamamie procedure happens to generate the highest reimbursements.

For anesthesiologists, for example, what constitutes a “significant risk” is often a matter of disagreement but it’s very hard to make the argument that THE most common cause of lawsuits against anesthesiologists should not be considered a “significant risk.” On the other end of the spectrum, it’s very hard to argue that death, which, though rare, is a particularly horrible consequence of general and spinal anesthesia, is not a significant risk.

After graduating from medical school, I took a residency spot at the UCLA department of Anesthesia. I made an effort to meet my responsibilities regarding informed consent, and it was there that I eventually realized that there was a problem. After obtaining consent for various procedures, I was often told that I could not tell patients the risks I had just told them. There seemed to be no set of risks that I was allowed to tell patients. In particular, Dr. Michael Sopher, the residency program head, specifically told me that I could not tell patients about the risks of dental damage (the number one source of lawsuits against anesthesiologists) because dental damage “wasn’t a significant risk.” He told me that I could not inform patients about the risk of death because “it was too rare.”

A quick aside: although I believe that death is a significant risk even if the chance of death is rare, the sad fact is that death from anesthetic misadventure was all too common at UCLA. I am aware of two children who died prematurely while under anesthesia at UCLA during the less-than-a-year that I was there. One child was not my patient, but I understand it was a healthy child who suffered an arrest while under, and simply died for “no reason.”

The other child was one of my patients, assigned to me when I had been a resident for about two months. This two year old child had a congenital heart defect, and essential tachycardia, with baseline hypoxia. Because of that tachycardia, my attending elected not to give the child pre-induction atropine. When the child was induced, he had an apparently vagal response to intubation, had a short period of bradycardia, and got even more hypoxic. This was followed by asystole. He was coded, and his heart came back, but the child never woke up. An EEG two days later was flat. If the child had been atropinized, I believe he might have survived the procedure (a hernia repair, for anyone who is interested).

It was bad enough that these children died. What was completely mind-boggling was that there was no M&M (morbidity and mortality conference) related to those deaths. In the case of "my" patient who died: once it became obvious that the resident (me) could not be blamed for the death, it was as if the death never happened. (It was the attending's plan that had gone wrong, and the attending never had a chance to leave the OR after induction since the plan went wrong so quickly.) In neither case was there a serious investigation into the cause of death, nor any attempt to generate lessons learned. Yes, I learned something – always atropinize children before induction of general anesthesia – but my attending and I should have presented that mismanaged case to the rest of the department, in an effort to prevent future mishaps. I probably should have learned something from the death of the healthy child who died for "no reason," but that death was also never presented at M&M. Draw your own conclusions. That sort of pretending that bad things didn't really happen had echoes in other cases, such as the "intentional, despicable and unprofessional" actions surrounding damage to Ms. Denise DeSoto. (last link added 03/26/2011)

Back to the main story. Dr. Sopher told me that I would bear no legal responsibility for failure to inform of the risks of anesthesia because “I guarantee you, no one has ever been sued for that.” Another attending, Dr. Blockmaans, told me “you can’t tell old people the risks of anesthesia …. old people just can’t handle it.” Finally, I was asked by the residency program director that if a patient refused a surgery based on what I had told him, “don’t you realize that you would be responsible?” The implication was clear to me then, and I trust it is clear to you now.

Of course, every one of the quoted statements above is mistaken, and was mistaken at the time. It is relevant to note that, since I left UCLA, UCLA, UCI, UCSD, and UCSF have all had suspension or cancellation of programs after medical research or practice was done without proper informed consent. In UCLA’s case, the Westwood VA (partially administered by UCLA, with physicians who work at both UCLA and at the Westwood VA) had it’s human research approval suspended because they had conducted research on people not only without their consent, but allegedly over the express refusal of at least one patient (I can't find a reference for that last part, but I believe that's what led the VA to suspend human research).

Due to my expressed difference of opinion about what constituted proper informed consent, I made multiple appointments with my residency program director to watch him obtain informed consent. He missed every appointment, and I never saw him obtain any consents.

It is also relevant to note, that, before I left UCLA, I encountered a patient who had apparently been advised by her surgeon, Dr. Susan Love, to bring a tape recorder with her to her preoperative meeting with the anesthesia department. I never spoke to Dr. Love about this, so I don’t know her motivation behind that recommendation, but it is my guess that Dr. Love also understood that the consent obtained by the department of anesthesia was not truly informed.

I also encountered what I eventually realized was “Hollywood-style” medicine. In one case, I personally witnessed the director of the pain management program, Dr. Anthony Nyurges, berate one of my postoperative patients to the point of tears when she requested Demerol (as opposed to other narcotics) for her pain (this patient was a former drug abuser, and knew her narcotics). I don’t believe in Demerol, but this same physician, on the same service, in the same hospital, in the same month, authorized very large doses of Demerol, on an ongoing basis (i.e. not immediately post-op) for a “powerful” Los Angeles figure when that patient had no objective signs of pain. Demerol is generally considered to have one of the greatest euphorogenic to analgesic ratio of any common narcotic (i.e. it makes people feel “happy” out of proportion to it’s pain-killing properties), and is therefore a drug generally favored by people who want to get high, and disfavored by people who are in actual pain.

I admit, and am glad, that I did not fit into the UCLA anesthesia residency program. I resigned from that program.

Unbeknownst to me at the time, federal agencies were also finding fault with University of California informed consent procedures while I was struggling to convince my superiors at UCLA of the importance of informed consent. Here is a list of publicized scandals revolving around informed consent in the University of California System:

UCLA: From the LA times:
• 1993: UCLA informed consent procedures had already been criticized by federal regulators, and had been changed in response to federal requirements. Even so, a 1993 law review article by Dr. Jay Katz of Yale, “tore into the new [informed consent] form that UCLA created in response to the government's [earlier] requirements, still finding it misleading, vague and inadequate.”

• March 1994: Dr. Michael Gitlin and Dr. Keith Nuechterlein of UCLA were officially reprimanded by the NIH in March of 1994 for issues with the procedure used to obtain informed consent. Procedures used to obtain informed consent, presumably approved by the UCLA IRB, were described as “immoral from the perspective of informed consent, because (they) were deceiving subjects” in an article about this in the LA times. The research for which Drs Gitlin and Neuchterlien apparently did not obtain informed consent may have been responsible for the suicide of Tony Lamadrid, one of the research subjects.

(addendum: Mr. LaMadrid, apparently unknown to him, was a research subject in an experimental protocol designed to assay the pharmacokinetics of drugs for schitzophrenia. According to the father of one of the surviving members of the Nuechterliein-Gitlin study, Mr. Lamadrid, a previously well-compensated adult, and apparently unaware that he was in the study, drifted into decompensated schitzophrenia as his meds were replaced with placebos. Mr. Lamadrid then told his "counsellor," who apparently was, in reality, a research monitor, that he was planning to kill himself. Nothing was done, Mr. Lamadrid's meds were not restarted, and Mr. Lamadrid went home and killed himself.

Further, according to this same source, the existence of a federally-required advocate whose presence might have prevented such an outcome had been fraudulently certified by someone in the office of the Chancellor of UCLA. In other words, a ghost UCLA employee had been created and certified to exist, but was later found out never to have been real.

You may wish to keep those items in mind as you read the next sentence)

• September 1994: According to the LA times, “from all appearances, the controversy over the Nuechterlein-Gitlin study hasn't caused any deep soul-searching at UCLA.”

• March 1999: The West Los Angeles Veterans Affairs Medical Center (which shares physicians, staff, research, etc with UCLA) had it’s authorization to conduct human research suspended after continuing allegations of failure to obtain informed consent for studies. I can’t find documentation for the following assertion, but I believe that, in this case, at least one person was alleged to have been the subject of medical experimentation even after expressly refusing to be part of a research protocol.

UCI (From the Orange County Register):
• May 1995: Three doctors at UCI Center for Reproductive Health accused of stealing eggs from an Orange County patient without her consent and transferring them to another woman, who delivered a baby boy. Eventually, doctors resign from university, two flee country and clinic closes. More than 100 women are victims.

Years later, (the rest of this paragraph is not from the OC register) I worked with a former trustee of the University of California who told me why he had resigned his trusteeship. According to him, up until the time the reproductive endocrinology staff fled the country, the trustees had been planning to back them to the hilt, not because of contractual obligations, a sense that they had been unfairly accused, or a commitment to their employees, but because of the money brought in by the reproductive endocrinology clinic. When the department fled the country to avoid federal prosecution, the point was moot, but this trustee resigned anyway.

• 1996: Researcher Dr. John Hiserodt treated cancer patients with unapproved doses of experimental vaccine, grew human tissues without required federal and university approval, and injected experimental compound not approved for human use into brain of Miami girl dying from cancer.
• June 1997: UCI Medical Center tissue and organ bank closed after finding employee has personal relationship with president of company that does business with the bank. Hundreds of human-tissue specimens had to be destroyed because of poor record-keeping and storage.
• December 1998: UCI officials say 27 dying cancer patients in clinical trials may have been improperly charged thousands of dollars. At least nine others were encouraged to make donations to get loved ones into trials. UCI offers refunds of $1,450 to $4,000.
• September 1998: Associate clinical professor Dr. Darryl See resigns after university inquiry concludes he used patients' blood samples in two unapproved research projects on AIDS and chronic fatigue syndrome. He later publishes a study, purportedly based on his UCI research, that is used to sell nutritional supplements.
• August 1999: UCI suspends the director of the medical school's Willed Body Program, Christopher S. Brown, after finding evidence that he sold donated bodies. UCI fires him in September.

UC San Diego:
• 1995: Dr. Ricardo Asch, as well as Drs. Jose Balmaceda and Sergio Stone, and their employee, Dr. Jane Frederick, of UCSD, are sued by three different parties alleging unapproved use of human eggs for zoology research, and transfer to other childless couples without the consent or knowledge of the egg “donor.” I don’t have the results of those lawsuits.

Again, the above cases are simply the ones that made the papers. I know of more.

My point? Residency programs have far too much power over their residents, and can generally act with impunity towards them. This causes problems. Just this month, I became aware of a woman who came to UCLA with chest pain in late May 2002, was sedated for the pain, and WHILE SEDATED AND ALONE was then induced to give consent for entry into a cardiology research protocol.
This wasn't a resuscitation situation, or apparently even much of an urgent situation. This woman's caretaker had simply gone out to the car to get a few things, and, in the interim, the sedated woman "gave consent" to be entered into a research protocol. This same woman eventually sustained so much heart damage that she wound up getting a heart transplant. It’s my bet that the resident or fellow who got the "consent" for research felt that he was under pressure to enroll people in the study, and that it wasn’t such a great idea to wait for family members or for the patient to no longer be sedated. Long work hours aren’t the worst effect of the control training programs have over their trainees. Not by a long shot.

Oh yeah ... since I'm naming names, I might as well put up my own name. For those who don't want to deal with the challenge of figuring out who I am ... my name is Peter T. Banos, MD, MBA. I got the MBA a few years after leaving UCLA; graduated from the University of Chicago in 1999, with concentrations in entrepreneurship and finance. And yes, I have met Megan McArdle.