Monday, 31 December 2012

BCAAs and Keto diets

(Note: This article is a departure from our tradition of end-to-end citations, and other practices necessary for establishing high confidence in medical assertions. This departure is merely in the interest of publishing more ideas in less time, as our intensely busy lives have led to a huge backlog of unfinished articles for which the verification and explicit justification process has proved to be at least 80% of the work. Because of its importance to us, though, when we return to more fundamental ketogenic science articles, we will return that style.)

Benefits of BCAAs

If you follow the bodybuilding community, you are probably aware of some of the benefits of branched chain amino acids (BCAAs). That's because they are known to have positive effects on muscle growth and recovery. (See for example Nutraceutical Effects of Branched-Chain Amino Acids on Skeletal Muscle, and Branched-Chain Amino Acids Activate Key Enzymes in Protein Synthesis after Physical Exercise.)

Less well known is that BCAAs have favourable effects on the brain, in particular the glial cells (brain cells that aren't neurons, are more numerous than neurons, and turn out to be essential for supporting neurons — it seems probable that most brain afflictions are caused by problems in the glial cells). The beneficial effects of BCAAs come from their important role in the manufacture of neurotransmitters, and vital metabolic cycles such as the leucine-glutamate cycle.

Here are a couple of examples of beneficial effects of BCAA supplementation on the brain: Dietary branched chain amino acids ameliorate injury-induced cognitive impairment, Branched-chain amino acids may improve recovery from a vegetative or minimally conscious state in patients with traumatic brain injury: a pilot study, Recovery of brain dopamine metabolism by branched-chain amino acids in rats with acute hepatic failure..

The problems being helped by BCAA supplementation are similar to some of the benefits that have been shown to be helped by ketogenic diets, and this is no coincidence.

One important effect of keto-adaptation is a dramatic increase in circulating BCAAs.

This fact is one the many proposed mechanisms of the anti-epileptic properties of ketogenic diets. (See also The ketogenic diet and brain metabolism of amino acids: relationship to the anticonvulsant effect.)

There also appears to be a bit of a feedback loop, in that supplementing a ketogenic diet with BCAAs can itself increase ketogenesis relative to the same amount of other proteins.

Nonetheless, the important point to take away from this post is that a ketogenic diet itself achieves what others are striving for by ingesting expensive (and, frankly, revolting-tasting) powders. Therefore it is quite plausible that in addition to the more-studied positive nervous system effects, a ketogenic diet will improve muscle growth and recovery relative to a glycolytic diet, something already anecdotally reported.

Saturday, 22 December 2012

Plastic Surgeon-Patient Sex

I recently received these questions about doctor-patient sex with a plastic surgeon:
My married sister's plastic surgeon called to give his condolences after the passing of our father. The doctor continued to call and fostered a personal friendship with her. He started to confide in her about his marital problems. They arranged to meet for dinner and entered into a 18 month affair. When my brother in-law discovered the affair, the doctor quickly abandoned her and started to make her look like the person who wanted the affair. My brother in-law filed an ethics complaint which is under investigation for over a year. I am the only person my sister will discuss the affair with, but not the only person that can see how the affair has affected her mentally. She is extremely depressed, filled with guilt and shame and has talked to me about ending her life. She refuses therapy, so I do the best I can to help her. Lately because of our conversations, I truly feel he took advantage of a vulnerable patient who was depressed over the loss of her father. She told me she had become dependent on him. Can you explain this dependence? She says she now knows how people follow a cult leader. Her pain is real and the result of a consensual affair with her doctor. He is not a mental health doctor; will he be held to the same standard? (emphasis added)
 In my response I emphasized that how important it was to help the patient accept counseling. Here I want to discuss the question of whether the plastic surgeon would be held to the same ethical standard as a psychiatrist.

To my eye, although the code of ethics for the plastic surgery specialty prohibits "sexual misconduct," it defines the term in a way that leaves patients and the profession vulnerable:
Sexual or romantic relationships with current or former patients are unethical if the physician uses or exploits trust, knowledge, emotions, or influence derived from the current or previous professional relationship.
The relationship between plastic surgeon and patient is intensely personal as well as technically demanding. Especially for surgery with aesthetic aims, patients entrust the surgeon with potential for making them look more the way they dream of appearing. For female patients, interventions may involve face, breasts, genitals, and their overall sense of "desirability." In terms of the question the patient's sister posed to me - the doctor-patient relationship in plastic surgery would seem to have all of the key characteristics that occur in mental health practice: exposure of deeply personal concerns, potential idealization of the clinician as a "saviour," and "transference" of feelings from the past. And, unlike psychiatry, ordinary practice involves disrobing and touching.

It's hard to see how a "sexual or romantic relationship" between plastic surgeon and patient would not draw in "trust, knowledge, emotions, or influence" derived from the professional relationship, whether or not the physician is consciously "using" or "exploiting" those factors. Even if passions are not involved, it would be very difficult to ascertain whether the factors the code of ethics prohibits were present. Sexual attraction and feelings of love are not known for inducing heightened intellectual and analytic lucidity!

I was unable to find any data on the frequency of complaints about sexual/romantic relationships between patients and their plastic surgeons. Unfortunately, a review of five years of complaints made to the ethics committee of the professional association did not report on the specific content of the complaints. But in light of the nature of the patient-doctor relationship in plastic surgery, I believe that the position of the American Psychiatric Association - that sexual relationships with current or former patients are unethical - would apply with equal relevance to plastic surgery.

In answer to the question posed by the patient's sister, I could not respond that the physician would be held to the same standard as a psychiatrist, but did say that I thought that should be the case.

Monday, 17 December 2012

National Leaders in Pancreas Surgery

Pancreas surgery is technically difficult and specialists at Penn Medicine perform among the highest volume of pancreatic operations in the Unites States, including the Whipple procedure, with complication rates and long-term survival statistics that set the standard nationally. As part of Penn’s Abramson Cancer Center, patients also have facilitated access to the full range of treatment options for pancreatic cancer including radiation, chemotherapy and the latest clinical trials—all under one roof.

At high-volume centers with integrated, multidisciplinary care teams, long-term survival for patients who undergo surgery for pancreatic cancer continues to improve. Recently, in one of the largest studies of its kind published to date, short-term recovery and long-term survival rates at Penn were shown to be among the best in the nation, demonstrating that Penn Medicine is at the forefront of providing the best care available for patients with pancreatic cancer.

Nationally and internationally recognized for their depth of experience and innovative research on the latest surgical treatment options, meet Penn’s pancreatic surgeons:

Jeffrey A. Drebin, MD, PhD
Chairman, Department of Surgery

A graduate of Harvard Medical School, Dr. Drebin continued his surgical training at the Johns Hopkins University School of Medicine before joining the faculty at the Washington University School of Medicine in St. Louis. In 2004 he was recruited to Penn Medicine as chief of the division of Gastrointestinal Surgery and vice-chairman for research for the department of Surgery. Following his tenure as chief, Dr. Drebin was appointed chairman of the department of Surgery at Penn Medicine and the 14th John Rhea Barton Professor of Surgery at the Perelman School of Medicine.

In addition to pancreas surgery, Dr. Drebin specializes in acute and chronic pancreatitis, the use of new technologies to manage liver tumors, disorders of the bile ducts and the management of gallbladder disease.

Learn more about Jeffrey A. Drebin, MD, PhD.



Charles M. Vollmer, MD
Director, Pancreas Surgery Program

Dr. Vollmer received his medical degree from Jefferson Medical College and completed his internship and residency in general surgery at Barnes-Jewish Hospital at Washington University Medical Center in St. Louis. Dr. Vollmer’s training includes a clinical fellowship in hepatobiliary and GI transplantation surgery at Toronto General Hospital, as well as research fellowships in surgical oncology at UCLA School of Medicine and hepatobiliary oncology at the Samuel Lunenfeld Research Institute at the University of Toronto. He comes to Penn Medicine from Boston where he practiced at the Beth Israel Deaconess Medical Center, a teaching hospital of Harvard Medical School.

In addition to pancreas surgery, Dr. Vollmer specializes in treating all malignant and benign conditions of the pancreas and biliary system with a strong emphasis in care of pancreatitis. He also focuses on the management of pancreatic cysts and co-directs the Penn Pancreatic Cyst Program, a multidisciplinary team that evaluates and treats all types of pancreatic cysts.

Learn more about Charles M. Vollmer, MD.


Location:
Perelman Center for Advanced Medicine
West Pavilion, 4th Floor
3400 Civic Center Boulevard
Philadelphia, PA 19104


For more information or to schedule an appointment, please call 800.789.PENN (7366) or request an appointment online.

Sunday, 16 December 2012

Sex isn't the only lust that physicians succumb to

Money and power can also lead to ethical collapse.

A sad story today's New York Times tells how Dr. Sidney Gilman, a respected teacher and researcher on drugs for Alzheimer's disease, has been nailed for warning a hedge fund manager he'd been dealing with to dump a pharmaceutical stock before news of a failed drug trial became public. Gilman had access to the information from his role on an FDA panel.

From responses to a number of the posts I've written about doctor-patient sex, it's clear that physicians who violate basic ethical standards can be superb caretakers for their other patients. Dr. Gilman, now 80, apparently had an exemplary career in teaching and research. A neurology lecture series at University of Michigan Medical School is named for him. And a colleague reported that he frequently turned to Dr. Gilman for advice about ethical issues:
He always gave me rock-solid advice and counseled me to maintain transparency so as to avoid even the appearance of a conflict of interest.
Re Dr. Gilman's teaching about transparency, the Times reports that to avoid arousing suspicion about his consultation to the hedge fund about the Alzheimer's drug, Gilman asked his co-conspirator to label the consultations as about other, unrelated topics.

Dr. Gilman could do a service to medicine and medical ethics by sharing the inside story about how a physician who apparently conducted himself in an admirable manner for most of his career descended into obvious unethicality (and criminality) as he did. What steps led from honorable conduct to dishonor? Did he delude himself as to what he was doing, or did he make a Faustian bargain to proceed? Better understanding of the "mechanisms" that facilitate serious ethical lapses can help educators work more effectively towards prevention.

(For an interesting post from a hedge fund insider, see here.)

Tuesday, 11 December 2012

Accountable Care Sprints Ahead

A recent report from the Oliver Wyman consulting firm - "The ACO Surprise" - argues that ACOs are on the verge of triggering a major transformation of the US health system. I hope their prediction comes true!

For all the complexity of federal ACO regulations, I see ACOs as making four core basic commitments:
  1. Take responsibility for helping a population be as healthy as possible
  2. Connect specialties, disciplines, and sites (hospitals, rehabilitation, nursing homes) in a coordinated manner
  3. Engage patients as active partners - ideally leaders - in promoting their own health and guiding their treatment
  4. Accept payment for producing valuable results for the population, not for the individual units of service rendered
Here's the Oliver Wyman view of the near term ACO landscape:
  • 2.4 million current Medicare ACO patients
  • 15 million non-Medicare patients of the Medicare ACOs. The report predicts that the Medicare ACOs will move towards caring for all of their patients in the "ACO manner"
  • 8 - 14 million patients to be cared for in non-Medicare ACOs
If Oliver Wyman is correct, it won't be many years before 10 percent of the US population receives its care in accord with the ACO philosophy. Insofar as ACOs are successful in creating more value for patients per dollar of investment, they'll come to dominate the marketplace.

In my physician hat I see the ACO vision as embodying the fundamental values that motivate most clinicians. The reason I joined the not-for-profit Harvard Community Health Plan practice in 1975 was because it was organized around those values.

In my patient hat, I've chosen to have my own medical care from one of the "Pioneer ACOs". I want my doctors, nurses and hospitalists (if I come under their wing in the future) to collaborate in what they do with, for and to me.

Some years ago a patient of mine was in a severe state of psychiatric crisis. The long term problem was a major psychiatric ailment, but the immediate challenge was getting control of acute alcohol abuse. I made what felt like a zillion telephone calls (this was before all parties used a shared electronic medical record) to alert all those likely to be involved with my patient to the clinical situation and what I was recommending. A week or so later my patient reported - with appreciation - "I spoke with nine different people last week and they all said the same thing..." The crisis subsided.

From the perspective of clinicians and patients, care delivered in accord with the first three ACO commitments listed above feels right. The three commitments meet patient wishes and reflect the underlying ideals of the health professions. The fourth commitment is what matters to us from the economic perspective. I share CMS's belief that doing the right thing in health care will end up saving money. But that will be a happy result of ACOs, not the reason for going down that path.

Monday, 10 December 2012

Tomatina Ratatouille & Review


I recently had the opportunity of reviewing a new product called Tomatina.  If you have ever tried V8 juice this juice is about 100 times better!!  The first thing I noticed when I received this product sample was how dark red it was.  This told me that it was loaded with lycopene at the highest level. My first taste was so flavorful and delicious. Tomatina was created by John Goldfuss. He is at the point with his new company that he needs some help getting his first production of juice going. Up to now, all of the money invested has been his own. Getting some momentum going is key to Tomatina’s launch and survival.  Please check out the links below to where you can help donate money so he can purchase bottles for his first run of product. Any amount will help him reach the goal of $10,000 by January 7.  It truly is a product beyond others I have tasted and deserves to be on the grocery shelves. 
Tomatina owes its name to a tomato festival in Spain.  In this celebration, the entire town of Buñol is filled with truckloads of tomatoes, and a huge tomato fight ensues. Afterward everyone washes up so the feasting, dancing, and partying festivities can begin. ¡Olé!
Tomatina's unique recipe went through 70+ variations to get to its current delicious state. The recipe includes tomatoes, beets, ginger, carrots, celery, cucumber and red bell pepper. 
The tomatoes support a happy heart by softening sticky cholesterol. It's generous antioxidants also reduce harmful oxidative bone stress. They are the most abundant source of lycopene. Studies that look at large groups of people (observational studies) in many countries have shown that the risk for some types of cancer is lower in people who have higher levels of lycopene in their blood. Studies suggest that diets rich in tomatoes may account for this reduction in risk. Evidence is strongest for lycopene's protective effect against cancer of the lung, stomach, and prostate. It may also help to protect against cancer of the cervix, breast, mouth, pancreas, esophagus, and colon and rectum. Beets anti-inflammatory compounds soothe and repair strained organs.  Ginger, with a magical, almost spiritual repute, is a medicinal root known for its stomach-soothing and anti-inflammatory effects. A carrot a day keeps the dermatologist away. Celery  is associated with reduced blood pressure. The anti-oxidants in cucumbers devour menacing free-radicals. Red bell peppers are dutiful stewards of good health with an abundant mix of nutrients and anti-oxidants.
Please help get this fabulous product to market.
The recipe I created using this delicious tomato juice was a YUMMY Ratatouille. Ratatouille originated in the area around present day Nice. It was originally a meal made by poor farmer's (in essence it started out life as a peasant dish), and was prepared in the summer with fresh summer vegetables. The original and simplest form of Ratatouille used only zucchini, tomatoes, green and red peppers (bell peppers), onions, and garlic. Today, eggplant  is usually added to the list of vegetables. You can choose to add eggplant or not, since the recipe is delicious with or without it. I spiced it up with some oregano & thyme. You can serve it over potatoes, rice or noodles.  Enjoy good health and check out Tomatina's website and facebook pages below. 
PRINTABLE RECIPE

















Tomatina Ratatouille
Serves 4
                                                                                   

1 small onion, diced 
1 garlic clove, minced  
1 tsp. olive oil 
1 medium zucchini, diced
1/2 red bell pepper, diced
5 Shitake mushrooms, sliced
1/2 cup diced eggplant (OPTIONAL)  
1/4 teaspoon oregano leaves
1/4 teaspoon thyme leaves
sea salt & pepper to taste
1 cup Tomatina or your favorite tomato juice
(Potato, Rice or Noodles)

1.  Saute onion and garlic in olive oil until soft. 

2.)  Add diced vegetables and seasonings. Continue to saute until vegetables are soft.  Salt & pepper to taste. 

3.)  Add 1 cup of Tomatina. Simmer for 5 minutes.

4.)  Serve over sliced potato, rice or noodles.  

Check out the links below and follow TOMATINA.

TOMATINA  

Shoulder or Elbow Pain? Penn Orthopaedics Can Help You Live Pain-Free


Whether it’s the result of an injury or just from typical wear and tear, you don’t have to live with shoulder pain.



The Penn Shoulder and Elbow Service provides comprehensive care for shoulder and elbow injuries or problems. Penn’s nationally and internationally recognized orthopaedic specialists create and use the latest advances in shoulder and elbow diagnosis, treatment, surgery and rehabilitation to treat complex issues.

Shoulder and elbow problems can affect your ability to enjoy your favorite activities. Some commonly treated issues include:


For more information about the Penn Shoulder and Elbow Service or the shoulder and elbow specialists, visit PennMedicine.org or call 800-789-PENN (7366).

Penn Presbyterian Medical Center named “50 Top Cardiovascular Hospital”


Penn Presbyterian Medical Center (PPMC) has been named as one of the nation’s “50 Top Cardiovascular Hospitals” by Truven Health Analytics, formerly the Healthcare Business of Thomson Reuters.

The 50 Top Cardiovascular Hospitals annual report identifies the nation's top hospitals performing cardiovascular services, selected from more than 1,000 hospitals across the country.

The honor recognizes PPMC’s consistent leadership and quality in cardiology and cardiac surgery.  Penn Presbyterian is recognized for expertise in:
  • Complex arrhythmia management
  • Interventional cardiology
  • Noninvasive cardiology and cardiac imaging
  • Preventive cardiology
  • Vascular medicine and endovascular therapy 
  • Women's heart health

For more than a century, Penn Heart and Vascular at PPMC has provided outstanding health care services.   Penn Presbyterian's cardiac care teams work together to diagnose, treat and prevent a wide range of cardiac conditions.  In addition to heart operations, PPMC’s cardiovascular surgeons also perform coronary artery bypass in high-risk patients, complex aortic surgery, heart valve repair and minimally invasive robotic-assisted cardiac surgery.

According to Harvey Waxman, MD, chief of cardiology at PPMC, the staff adheres to a process of continuous improvement to reduce surgical complications.  Even though the wound infection rate has been below 1 percent for the past several years, the staff wants to do better.  “Our goal is zero,” Waxman says.

For information about Penn Heart and Vascular at Penn Presbyterian Medical Center, or to request an appointment, visit PennMedicine.org or call 800-789-PENN (7366).


Sunday, 9 December 2012

Politics vs Rational Medicare Reform

I'm a staunch New England liberal/yellow dog Democrat. And I support Howard Dean's organization - Democracy for America. But I shuddered when I received this message in a fund-raising email:
Republicans lost big in the election, but John Boehner is trying to force his right-wing agenda on the American people anyway. Republicans in Congress are taking advantage of the fiscal showdown and trying to jam through massive cuts to Medicare that would be devastating to America's seniors. (emphasis in the original)
Republicans, occasionally joined by renegade Democrats, have plenty of bad ideas about Medicare, like raising the age of eligibility (see here) and turning Medicare into a voucher program (see here).

But experts agree that at least 30% of what we spend on health care is waste. I've talked with lots of practicing physicians about this. No one has ever estimated waste at less than 25%, and many have estimated it at 50%.

The threat to Medicare is dumb ideas like vouchers and raising the age of eligibility, not the idea of reducing the trend line of cost increases. Doing that is an economic necessity for a thriving economy and a moral necessity on behalf of future generations and other social needs.

Dumb cuts "would be devastating to America's seniors." Clinically guided waste reduction would be a positive service, not a devastation. I hope that behind closed doors and away from sloganeering, our leaders - Democrats & Republicans - will move beyond demagoguery to consider how the federal government can promote prudent waste reduction in the Medicare program.



Thursday, 29 November 2012

More about the Massachusetts Board of Registration in Medicine and Doctor-Patient Sex

There were two letters to the editor in today's Boston Globe about the Massachusetts Board of Registration in Medicine's decision to take away Dr. Gary Brockington's license. (See here for my original post.)

Nurse Mary Hourihan gives a perspective on Dr. Brockington's overall practice like what we've heard from patients of other physicians who have been disciplined for sexual relationships with patients:
As a nurse who has worked at the Faulkner Hospital for more than 30 years, I was shocked and saddened to read your article concerning the state Board of Registration in Medicine’s revocation of Dr. Gary Brockington’s medical license (“Board revokes Faulkner cardiologist’s license after affair,” Metro, Nov. 24). The doctor has cared for his many patients with the utmost professionalism and expertise. Although I do not work directly with him, nearly every day I hear from our mutual patients the reverence in which he is held.

The board is denying thousands of patients the skilled, sensitive care this extraordinary physician provides. I feel that Brockington and his patients deserve reconsideration of this decision.

Mary Hourihan

West Roxbury  
There's nothing surprising about the fact that a physician who displayed a serious ethical lapse with a patient may have been an excellent physician for most or almost all of his patients. (For example, see here.) In my own experience, a former colleague who I knew to be a superb physician, such that I referred one of my sons to him for allergy care, has been convicted for murdering his wife! In prison, he continues to evince the caretaking characteristics that were so prominent in his care of patients. (See here.)

Donald Ross, a physician colleague of Dr. Brockington, comes to the same conclusion I did - that if Brockington's relationship with the patient was a brief, one-time event that occurred during a period of major stress, the Board's actions were too harsh. But I don't agree with Ross that the Board's decision necessarily reflects "lack of compassion." A Board can impose a severe penalty and still regard to person being penalized with compassion, in accord with the precept that we should hate the sin but love the sinner.
In reading the story about Dr. Gary Brockington’s affair with a woman who was a patient and a co-worker, it strikes me that the reaction of the state Board of Registration in Medicine was over the top and lacked compassion in its response (“State revokes Faulkner cardiologist’s license after affair,” Metro, Nov. 24).

Perhaps there was poor judgment involved, but this does not sound like a case in which a doctor used his position in the doctor-patient relationship in an exploitative way. Brockington was also going through a difficult time in his own personal life at the time, and sometimes we don’t make our best decisions under such circumstances.

Perhaps it would have been more appropriate to require Brockington to enter a counseling program rather than imposing what is essentially a death penalty to his career.

Dr. Donald G. Ross

North Andover
As I said in my original post, if Brockington's relationship with his patient was (1) brief, (2) a single occurrence in his practice and not a pattern, (3) occurred at a time of major stress, and (4) preceded by years of responsible caretaking, than (5) permanent loss of license seems too severe a penalty. This is not a matter of compassion but of realism. Some perpetrators of unethical behavior can be rehabilitated and will be able to serve others in a reliably ethical manner.

Monday, 26 November 2012

Was the Massachusetts Board of Registration Too Harsh on this case of Doctor-Patient Sex?

The Boston Globe recently reported that the Massachusetts Board of Registration in Medicine revoked the license of Dr. Gary Brockington, a 54 year old primary care physician and cardiologist, for having had a sexual relationship with a patient.

I've not been able to get a copy of the report from the Division of Administrative Law Appeals, so I'm entirely dependent on the Boston Globe story, which has extensive quotes from Brockington's lawyer. The story, if accurate and complete, leads me to speculate that revocation of licensure may be too severe a penalty in this specific situation.

According to the Globe, Brockington experienced a Job-like series of events in 2006. He was newly divorced, bankrupt, and depressed. During the same stretch of time his sister (his only sibling) broke her neck and was left by her husband. Brockington became legal guardian for her two young children.

One of his patients, a married woman who was a technician at the hospital where Brockington practiced, and who had worked with him on procedures, invited him to stay in her basement. According to Brockington's lawyer he told her she would have to get another primary care physician. He did, however, renew some prescriptions for her. He stayed in her home for two months. Apparently the brief sexual relationship occurred during the last two weeks of his stay. He moved out in July, 2006. The woman did not herself register a complaint.

If, as Brockington's lawyer claims, the facts show that this was a single episode in an otherwise exemplary career, it's not clear that public safety requires permanent loss of license. In other posts I've strongly supported permanent loss of license when the pattern of facts was different, as in this case. In another case, I concluded that Rhode Island was correct when it reinstated the license of a physician who participated in an extensive rehabilitation program, and agreed to continue in ongoing psychotherapy and long term supervision of practice. (see here)

The spokesman for the Massachusetts Board of Registration is quoted as saying that "the board has zero tolerance for sexual misconduct between physicians and patients." I believe that "zero tolerance" is the correct stance, but don't believe that sexual misconduct always requires permanent loss of license. If the Boston Globe article is the full story, a case can be made that this was a single, out-of-character episode that occurred in extraordinarily stressful circumstances. If that is how the Board saw the situation, I believe it acted too harshly.

Monday, 5 November 2012

Pay for Performance vs Intrinsic Motivation

Among the many stories about health care heroes during Hurricane Sandy, this was my favorite:

Allison Chisholm, 46, who works for the Visiting Nurse Service, lives with a frail mother in Park Slope, Brooklyn. When the lights started flickering during the storm on Monday, she had images of her mother falling in the dark. But she also had patients who needed her, including one receiving hospice care in a 12th floor apartment in Chinatown, and one needing an intravenous round of antibiotics in the West Village.

“It was treacherous driving during the hurricane,” said Ms. Chisholm, fitting an intravenous line into the arm of Jill Gerson, 71, who teaches social work at Lehman College in the Bronx. “But it’s just something you have to do as a nurse. That continuity of care helps the healing. I don’t see this as being heroic. I have a conscience. I need to get to sleep at night.”
Ms. Chisholm was responding to intrinsic motivation - her values as a nurse, embodying the tradition associated with Florence Nightingale and Mother Theresa. She wasn't being "incentivized" (one of my least favorite words) by pay-for-performance, unless we regard the threat from her conscience that - like Lady Macbeth - she would "sleep no more" if she failed to put her values into action as a performance management system, as an "incentivizing" force!

Pay-for-performance has considerable face validity. Extrinsic motivation clearly works in vast swathes of the economy. But as my friend Dr. Steffie Woolhandler's recent post on the Health Affairs blog shows, it's  not at all clear that pay-for-performance is effective in domains that have historically rested on intrinsic motivators such as idealism, altruism, and care. Pay-for-performance can increase the behaviors that are being measured, but evidence that these systems enhance patient outcomes is weak or absent. And there is substantial evidence from the behavioral economics literature that monetary rewards can actually decrease motivation for tasks that are intrinsically rewarding.

My own reaction when I hear of programs to "incentivize physicians to do [XYZ desirable clinical behavior]" is decidedly negative. When I began my own fee-for-service practice in the 1970s I took pleasure in including Medicaid beneficiaries, but after a time the burdensome paperwork and inefficient reimbursement process, combined with microscopic fees, acted as a disincentive for doing what I wanted to do, and I limited the number of Medicaid beneficiaries I took on. I didn't need to be "incentivized" but I would have responded well to a reduction of disincentives.

Rats in a Skinner box are "incentivized" by food pellets. But as the interview with Ms. Chisholm reflects, the kinds of caretaking we want to encourage in medicine flows from values, not P4P pellets. Program managers will do better by recognizing, respecting, and supporting intrinsic motivation. This is best done by removing impediments, not by the condescending view of doctors and nurses as reluctant laborers.

Tuesday, 16 October 2012

No Treatment as the Treatment of Choice

In the October 3 issue of JAMA, Allen Detsky and Amol Verma offered "A New Model for Medical Education: Celebrating Restraint." Restraint in medical practice is decidedly un-American. Not surprisingly, the authors are Canadian!

Detsky and Verma are concerned with both quality and cost. Here's the essence of their argument:
...we suggest complementing health care cost control initiatives by transforming the current approach used in medical education that primarily rewards meticulousness of clinical investigation to one that also celebrates appropriate restraint...Clinical teachers who are role models could embrace a new approach. They could emphasize teaching restraint, both to improve health care quality and to acknowledge the professional duty of resource stewardship.
The worship of obscure diagnoses is a longstanding part of US medical culture. It's exemplified by the "zebra joke," which I first heard as a medical student in the early 1960s:
Two senior physicians are walking alongside a wall. On the other side they hear galloping foot beats. One says to the other - "what's that?" His colleague replies "it must be a zebra."
Sometimes the search for zebras turns up a real striped quadruped. When that happens it makes a heroic story. More typically the search involves "zebra tests" which turn up "incidentalomas," abnormal findings that have no clinical significance, but which elicit further tests. Apart from the wasteful expenditures the search for zebras can produce, the process can create harmful complications - the side effects of unneeded biopsies or even surgeries, excessive radiation exposure, and more.

I'm a skeptic about medical maximalism and the search for zebras. In the early 1970s, supervising psychiatry residents who had been inculcated in concept of the 50 minute hour, I sometimes had dialogues like the following with my supervisees:
Me: What kind of treatment do you want to prescribe for the patient we've been discussing?
Resident: Twice a week intensive psychotherapy.
Me: How long would each session be, and how long would you want the treatment to last?
Resident: This seems kind of silly, but let's say 50 minutes per session for three years.
Me: That would be approximately 270 50 minute sessions. Do you think we could attain the same outcome if each session was 48 minutes and we had 85 sessions per year instead of 90.
Resident: This really does seem silly. But if you insist on the question, I suppose we could attain the same outcome or close to it.
Me: So even before we look at the techniques psychoanalysts like Peter Sifneos have developed for briefer treatment, we've reduced the cost by 10% without meaningful loss of quality. Not bad!
In 1981 I felt I'd encountered kindred spirits, when Allen Frances, who I've posted about before, and John Clarkin wrote "No Treatment as the Prescription of Choice." They weren't nihilists about treatment, but they correctly noted that psychiatric consultants almost always recommended treatment for the folks they evaluated. Frances and Clarkin suggested a typology of patients who would do better without treatment - patients who were not likely to benefit and for whom treatment might inadvertently be harmful.

As a student, some of the old timers I learned from taught me about the curative impact of "tincture of time." Some conditions will get better on their own if the patient is approached in an optimistic spirit and is willing to allow some time to pass. In non-acute situations where it's not clear what is going on, applying "tincture of time" can be a good diagnostic and therapeutic approach.

Sometimes patients push for this kind of low-interventionist approach. Many years ago I saw a young man who had briefly been hospitalized for what looked like an episode of schizophrenia. I suggested that we start an antipsychotic medication. He objected. He was convinced that the episode came from a recreational drug he'd used. We agreed to follow him - initially weekly, but ultimately every month or two. As best we could tell over the course of two years, he was right. We were both happy. With another patient whose history convinced me that she had bipolar illness, she made a similar argument and refused medication. I told her that I wasn't a worrier, but I was worried about her. I hoped I was wrong and she was right. We followed her status and got to know each other. Unfortunately, as I'd feared, she was wrong - a recurrent episode convinced her of that. But it worked better that she was convinced by her own experience, not simply by yielding to medical authority.

Detsky and Verma come across as wise clinicians. I'm on board with their counsel. I hope others join in. The model they propose would promote a salutary change in US medical culture.

Monday, 15 October 2012

More about the Massachusetts "Death with Dignity" Act

Last week I wrote about the Massachusetts "Death with Dignity" ballot initiative. For those who are interested in the initiative and how it is playing out, this morning's Boston Globe has a very informatinve article on the topic.

Sunday, 14 October 2012

Is it OK for GP's to have sex with their patients?

For anyone interested in the ethics of doctor-patient sex and the relationship between ethics and law, the recent 5-1 decision of the Supreme Court of Pennsylvania in Thierfelder v Wolfert makes fascinating reading. (If the details interest you, make sure to read Justice Todd's dissent - in my view she got the issue right!)

In 1996 David and Joanne Thierfelder became patients of Dr. Irwin Wolfert, a family physician. He treated them both for conditions that included low libido. In 2002 Ms. Thierfelder told Dr. Wolfert that he had "cured" her problems and was her "hero." They began a sexual relationship that lasted for a year. She became more anxious and depressed and finally ended the relationship in January 2003. She told her husband about the affair two months later, and together they brought malpractice action against Dr. Wolfert.

Dr. Wolfert argued that as a general practitioner he should not be held to the same standard as psychiatrists, for whom a clear duty not to have sexual involvement with patients had been recognized. The court accepted this view on the basis that psychiatrists are trained to recognize and deal with "transference" (reacting to current relationships, like Ms. Thierfelder's with Dr. Wolfert, in terms of past relationships). GPs, the court concluded, should not be held to the same duty of care, since they are not trained to do treatment based on dealing with transference. If they were held to this standard it would discourage them from providing mental health counseling to their patients, which would be a bad societal outcome.

The majority made clear that the fact that Dr. Wolfert's actions were seen as unethical within the medical profession did not mean that he had violated legally enforceable duty. The Pennsylvania Board of Medicine had in fact sanctioned Dr. Wolfert before the Supreme Court heard the case. (It ordered a three year suspension of his license, but stayed the suspension under terms that included professional development activities, 550 hours of community service, and a fine.)

The majority cited Korper v Weinstein, a case in my home state of Massachusetts. Dr. Weinstein had done a breast biopsy on Ms. Korper at the Harvard University Health Service. (It was benign.) After completing her followup care, the two had lunch together, and a consensual sexual relationship ensued. Dr. Weinstein was not involved in a further treatment relationship. When he ended the relationship two years later she brought action against him. The court opined:
Any trust and confidence she placed in the defendant as a person...even augmented by circumstances that made her emotionally dependent on him, did not create a fiduciary duty in the defendant to prevent the personal relationship that developed consensually between them, especially where he terminated the physician-patient relationship as soon as the personal relationship began.
In her dissent, Dr. Todd concluded that (a) general practitioners frequently provide mental health services and are allowed to do so by their licenses and (b) sexual relations with patients is explicitly prohibited by the medical community, with (c) the result that she had "no hesitation in concluding that general practice physicians who provide mental health disorders to patients have a duty to abstain from sexual relations with their patients...and that these physicians may be potentially liable in professional negligence actions for any harm to their patients - patients they pledged to take no action to harm - as a result of engaging in such conduct" (page 18 in the dissent).

I believe Dr. Todd, though outnumbered 5 to 1, was correct. It's widely known that sexual relationships with patients being treated for mental health conditions have high potential for causing harm. Treating mental health conditions is within the purview of general practitioners. The ethical standards of the profession are well-known to prohibit sexual relationships with current patients. It's hard to see why the allegation of malpractice should not have been judged on the basis of its facts, rather than being prevented from coming to trial. The facts would have shown that Dr. Wolfert breached a duty. But it would have to be further shown that this had directly led to damage to Ms. Thierfelder.

The majority did not argue that it's ethically acceptable for general practitioners to have a sexual relationship with patients they are treating for mental health conditions. But in my view their conclusion that seeing a duty not to do so sets too high a standard is insulting to GPs. Being sued for malpractice is every physician's nightmare, but implying that GPs don't have enough understanding of human psychology and the treatment process to know that sexual relations and mental health treatment don't go together is demeaning to their competence and maturity.

Tuesday, 9 October 2012

Massachusetts Death with Dignity Ballot Initiative

My home state of Massachusetts has an initiative on the November ballot that would establish a "death with dignity" law closely modeled on the existing laws in Oregon and Washington. Surveys suggest that a majority of the public support the law, but influential groups including the Catholic Church and the Massachusetts Medical Society oppose it.

Today I had the privilege of meeting with a group of elderly men at a community center to tell them about the initiative, summarize the essence of the pro and con positions, and then lead them in discussion. In other words, something like a focus group.

The heart of the discussion was a spirited exchange between two of the participants. One who I'll call "Skeptic," opposed the initiative. Human nature being imperfect, he anticipated that some doctors would "specialize" in certifying that patients met the criteria for receiving a lethal prescription without the kind of careful clinical attention the law encourages. Whether the motivation was financial profit or perverse sadism, Skeptic was certain that this kind of medical misbehavior was inevitable.

The other, who I'll call "Advocate," argued that the right to receive a prescription for ending one's life in the context of a terminal illness is a natural and necessary extension of the right to refuse treatment or to discontinue ongoing treatment. Advocate believed that science has created all manner of life prolonging interventions and that patients need tools to control what they receive or are subjected to.

Skeptic focused on the risks arising from misuse of the proposed law. Advocate focused on the risks arising from lack of autonomy for patients with terminal conditions.

The group agreed that both risks were real. Oversight by the Department of Publich Health, to whom use of the law would have to be reported, and the Board of Medicine, which could sanction outliers of the kind Skeptic envisioned, was trusted by some but not by others.

In my summary of the pros and cons I cited religious beliefs about the wrongness of hastening one's own death and told the group about the Roman Catholic Archdiocese website "Suicide is Always a Tragedy." No one in the group, however, brought in theological reasoning. I don't know if this was because theology was not a driving force for them or if they regarded religious belief as private.

Where we ended was with a sense that the exchange between Skeptic and Advocate was best understood as a "good versus good" conflict. Skeptic took a consequentialist view - the law would allow unethical physicians to consign people to death without application of the safeguards the law sought to put into place. Advocate took a rights-based view - patients need and deserve more tools to allow them to advance their own autonomous choices.

I wasn't trying to persuade the group to any position on the law. My aim was to (a) inform them and then (b) get a sense of how a population for whom the law, if passed, could become relevant, thought about the law. We concluded that intelligent, thoughtful, well-motivated persons of good will could, would, and did disagree.

I'll write more about the topic after November 6!

Wednesday, 3 October 2012

Death by bedsores

The September 15 issue of The Lancet has a fascinating article by Arthur Caplan, who is now at the Division of Medical Ethics at New York University Medical Center.

Caplan tells the story of "Harold Brennan" (a pseudonym), an 88 year old man who had lived an independent life until a series of ministrokes left him helpless and bedridden. He was in a community hospital where, despite apparently good care, he developed bedsores. He experienced great pain whenever he was moved and decided he no longer wanted to be turned. When told that this would lead to worsening infections and death his resolve was all the stronger. A psychiatric consultant assessed him as angry but not depressed and competent to make decisions.

The nurses were horrified. How could they stand by and not provide the most basic form of nursing care? The hospital tried to get Mr. Brennan's daughter to come to a conference, but she couldn't bear to see him deteriorating and did not attend.

Mr. Brennan was not turned. As the infections worsened, his roommate was moved to another room. The nurses had to wear masks when they entered the room because of the smell that came from his decaying body. He died after 5 weeks.

Here's Caplan's conclusion:
Must do not turn requests by competent patients be honoured? Patient autonomy is a strong value in the ethical values that guide health care. It is not, however, the only value. It should not be honoured when such requests pose unacceptable risks and dangers to other patients or the ability of staff to function. Where and how these values are to be balanced against patient autonomy is not clear. That they ought to be balanced is. The “simple” case of a request not to turn reveals a key moral truth—that autonomy has its limits.

I discussed the case with a colleague I respect, who felt that Caplan violated the principle of autonomy "egregiously." I would guess that this would currently be the majority view among US physicians.

Caplan makes two basic arguments - one with reference to other patients and one to "the ability of staff to function." The first point is clear. As John Stuart Mill argued so forcefully in On Liberty, If Mr. Brennan's request endangers other patients - even relatively slightly - via the potential for transmitted infection or some other mechanism, his request should be overruled. His liberty does not give allow him to choose a course of action that threatens the well being of other patients.

But what about the nurses? Caplan's reference to "ability of the staff to function" is too vague. If Mr. Brennan's request prevented them from caring for other patients, the harm to others factor would apply. But if his decision causes moral distress ("how can we let him die that way - it's too terrible?") or disgust ("the smell makes me vomit"), we're on shakier grounds. Moral distress and disgust are subjective reactions. If your decision to refuse dialysis or chemotherapy causes moral distress or disgust for me that's my problem, not yours.

Voluntary refusal of food and liquid is a "cleaner" way to end one's life than allowing rampant skin ulcers to fester untreated. But if we are prepared to allow competent persons to refuse intake, which I believe we should, we should be prepared to allow refusal of turning, unless the refusal endangers others.

Tuesday, 25 September 2012

Barn-Burner Chili from VEGAN FOR THE HOLIDAYS & Book Review

The Holiday season is a special time for gathering with family & friends, and don't forget all the yummy comfort foods. The wonderful traditions that we grew up with and now share with our own families make our lives more beautiful and enjoyable. Food is always a great way to bring everyone together. I love creating and trying new recipes, and the Holidays are a good time to do this. Vegan cooking expert Zel Allen demonstrates in her book, Vegan for the Holidays, that plant-based foods are as delicious, innovative and elegant as their hallowed meat-based counterparts.  You all know I am a big supporter of whole, plant-based foods and my biggest goal is to make it taste delicious and familiar as the memories you grew up with.  I have enjoyed making a lot of the recipes in Zel's book.  They are simple, pure,  and healthful!  I love the quote by Zel from page 3:
"As I sit down to plan my own family holiday dinners, I feel grateful for the rich bounty sown and harvested by our American farmers, who have enabled us to celebrate with an abundance of fresh foods.  And it gives me deep pleasure to invite you to join me in the kitchen throughout the season, as together we participate in fun celebrations and conclude each event with a darned good meal.  And now, let's bring on the holiday feasts."
You can find Zel at either of her websites:
Vegetarians in Paradise or Zel's Vegan NutGourmet.

The recipe I decided to share with you all came from Chapter 5:  Happy New Year Soup and Chili Bash
I made the fabulous Barn-Burner Chili.  You will absolutely love this yummy chili. It is so packed with flavor, I didn't need to add anything to it. It is hot, hearty, and full of spices that will warm you up during the cold months ahead.
Check out Little House of Veggie's with another wonderful recipe from Zel's book - Sweet Potato Soup.

Serves 6-8
2 onions, chopped
2 green bell peppers, chopped
1 red bell pepper, chopped
1 large crown broccoli, coarsely chopped
1 large carrot, chopped
5 cloves garlic, coarsely chopped
2 3/4 cups water
1 tablespoon balsamic vinegar
1 tablespoon tamari
3 cups bite-sized chunks scrubbed white or red potatoes
3 1/2 cups cooked dried kidney beans, or 2 (15-ounce) cans kidney beans, undrained
1 1/2 cups cooked dried pinto beans, or 1 (15-ounce) can pinto beans, drained
1 1/2 cups cooked dried black beans, drained, or 1 (15-ounce) can black beans, drained
2 (6-ounce) cans unsalted tomato paste
1 large tomato, chopped
2-4 tablespoons maple syrup
2 tablespoons chili powder
1 tablespoon plus 1 teaspoon ground cumin
1 tablespoon red wine vinegar (I used Apple Cider Vinegar)
2 1/2 teaspoons liquid smoke (I didn't have this, so I left it out)
1 1/2 teaspoons salt
1 to 2 teaspoons freshly squeezed lemon juice
1/4 to 1/2 teaspoon cayenne
1/4 teaspoon ground pepper
2 dashes hot sauce (optional)

Toppings

1 (15-ounce) can corn kernels, drained (I used frozen)
1 sweet onion, chopped
1 (8-ounce) can black olives, drained and choped
2 cups shredded vegan cheddar cheese (I didn't use any cheese)

1.) Combine the onions, bell peppers, broccoli, carrot, garlic, and 1/2 cup of the water in a large, deep skillet.  Cook and stir the vegetables over medium-high heat for 5 to 7 minutes, or until the vegetables are softened and all the water has evaporated. Add 1 or more tablespoons of water as needed to prevent burning.

2.)Add the balsamic vinegar and tamari, stir well, and transfer the vegetables to a slow cooker.

3.)  Put the potatoes and enough water to cover in a 2-quart sauce pan.  Cover and bring to a boil over high heat.  Decrease the heat to medium-high or medium and simmer for 5 to 7 minutes, or until the potatoes are just fork tender.

4.) Using a slotted spoon, transfer the potatoes to the slow cooker and add the remaining  2 1/4 cups water, all of the beans, tomato paste, tomato, maple syrup, chili powder cumin, vinegar, liquid smoke, salt, lemon juice, cayenne, pepper, and optional hot sauce.  Mix well to distribute the ingredients evenly.  Cover and cook on low for 6 to 8 hours.

5.)  Adjust the seasonings, and spoon the chili into serving bowls.  Serve the toppings in separate bowls on the table or near the slow cooker and make the meal a self-serve chili-and-toppings bar.

Monday, 17 September 2012

Malignant: Medical Ethicists Confront Cancer

I've just read Malignant: Medical Ethicists Confront Cancer, edited by Rebecca Dresser. Seven ethicists who have either had cancer themselves (5) or cared for a spouse with cancer (2), or both (1), write about their experience and discuss what that experience might mean for ethics and clinical care. It's a very approachable book. I think most readers of this blog would find it powerful.

Here are some of the main lessons I gleaned from the book:
  1. Not surprisingly, direct experience deepens our understanding of the issues we teach about in the classroom and write about on blogs and in print. The deepening isn't conceptual knowledge. It's more that the experience acts as a filter, indicating what's truly important in what we've thought and where we've been naive or callous. In my ethics seminar section at Harvard Medical School we regularly work with cases. I've taken to "becoming" the patient in the case, and interacting with the class in that role. I've found that taking on the persona of the patient - even when that persona is very different, as when I play a teen age female - the role comes alive for me in feelings and perceptions. I become a better teacher for it. If the students learn half as much as I do from those exchanges, the class is a success.
  2. Norman Fost describes a remarkable experience. Being worked up for what seemed clearly to be a recurrent kidney stone the resident evaluating him ordered a CT scan. Fost explained to the resident why he thought the scan was (a) medically not called for and therefore (b) an wasteful expenditure. But he didn't refuse it. The scan confirmed what he knew - he had yet another kidney stone. But it also showed a mass, which on further exploration turned out to be an early, and apparently curable, kidney cancer. Kidney cancers are often found too late for cure. Fost believes the CT scan may have saved his life. But he holds to the view that it was wrong to order it and that it reflects an overly interventionist, inadequately cost attentive, US medical culture.
  3. Rebecca Dresser and Dan Brock write about decisions they made that in retrospect (a) went against their values and (b) about which they wish their physicians had discussed/argued with them. Dresser's example is especially telling. She refused a feeding tube and was close to death when a nurse talked her into changing her mind. Dresser and Brock speculate that physicians may have learned the lesson of respecting patients' decisions too well! Rather than challenging bad decisions - decisions that to against the patient's values, they too readily acquiesced. In terms of "Four Models of the Physician-Patient Relationship," a valuable paper  by Linda and Zeke Emanuel from twenty years ago, their physicians applied the "informative" model - provided information and then, in effect, followed the patient's "orders," when the reflective give-and-take of the "deliberative" model would have been more useful.
  4. Arthur Frank sees cancer support groups as potentially hugely valuable for patients, but he warns that these groups and what he calls the "survivorship industry" can thrust identities that don't fit onto patients. His comments helped me understand something I observed several times in my clinical practice. Patients who had experienced a loss, and who by all appearances were going through painful, but "healthy" grief, were frightened by the fact that they weren't crying more. They had imbibed the view that "proper" grief involved lots of tears and feared that they were full of unshed tears that would act like a poison. Explaining that there wasn't a single "correct" way to experience grief reassured them.
  5. Finally, and with most personal impact for me, John Robertson and Leon Kass write in painfully raw terms about accompanying their wives on their journeys with ovarian cancer. Robertson's wife Carlota Smith died. Kass's wife has experienced recurrences, but is still in treatment. I hope that if my wife encounters a similar experience I will respond with the commitment, care, and courage that Robertson and Kass displayed.
There's lots more than I've written about to glean from this moving book!

Monday, 3 September 2012

Allowing import of needed drugs from Canada

Last year I wrote about a well-intended FDA policy about colchicine, a drug used since ancient times for gout, and now for other serious conditions, such as Familial Mediterranean Fever. As an ancient treatment widely used prior to formation of the FDA, colchicine did not require FDA approval as a new drug. Then in 2009, the FDA granted approval to URL Pharma for Colcrys, its version of colchicine, based on randomized controlled trials the company conducted. Because colchicine had never been subjected to the FDA approval process, Colcrys was, in a technical sense, a "new" drug approved for a "new" indication - treatment of gout and FMF - despite the centuries of prior use, and by regulation was entitled to market exclusivity. In 2010 the FDA ordered all other manufacturers to cease production and marketing of their versions of colchicine.

Unfortunately, Colcrys is not effective for some patients with Familial Mediterranean Fever. To maintain their health these patients need the generic form, which must be imported from abroad. A friend recently told me about the new roadblock a family member is encountering. Here's the letter that went to the patient's senators:
I am writing with regards to the recently passed Food and Drug Administration Safety and Innovation Act (S. 3187). The bill includes a provision (Section 708) that may prevent me from being able to import my prescription from Canada, which I depend on for my health and quality of life.
This legislation authorizes the seizure and destruction of safe prescription drug imports valued under $2500. I have a prescription for generic colchicine for a rare genetic disease which I have, Familial Mediterranean Fever. When I tried the US brand of colchicine, Colcrys, I experienced extreme side effects and a relapse of symptoms, resulting in a month of illness, including an overnight stay in the hospital with high fevers and dehydration. Through this experience, my doctor and I discovered that it is essential that I be able to access an alternative brand of colchicine. Due to an FDA ruling, all brands of colchicine except Colcrys were taken off the US market several years ago. I now depend on my prescription from Canada for my health and well being.

When I am able to take colchicine imported from Canada, I have no symptoms and live a normal, healthy life. Without access to this medication, I will experience fever episodes lasting from several days to a month, pain, and inability to eat. It will compromise my ability to finish graduate school, where I am currently working on a challenging program. It will put me at risk of future complications from my genetic disorder.

I am extremely concerned that when Section 708 of Act 3187 is implemented, I will lose access to my direly needed medication. Please let me know what you plan to do to change Act 3187 to allow me to continue my life. Thank you for your time and consideration.
I don't fault the FDA's intentions. But in a country of 300 million people, it will be the rare policy that applies to all in a fair manner. Justice requires a robust exception process in situations like the dilemma of FMF patients who require the generic drug.

The patient did her part in putting the issue onto the public table. Now it's up to the FDA to respond.

Thursday, 23 August 2012

Whole Wheat Cranberry Orange Bread

This is an absolutely delicious, healthier version of a holiday bread I created several years ago. It is a great bread for gift giving and for holiday parties. Cranberries are harvested in  September and October and available fresh up until Christmas.  Keep this recipe in mind as the Fall months approach, and stock up on some extra cranberries in your freezer.


2 cups white whole wheat flour
2 tsp. non-aluminum baking powder
1/2 tsp. baking soda
1 tsp. cinnamon
1/8 tsp. sea salt
1 Tbsp. grated orange zest
2 cups fresh whole cranberries
1/2 cup walnuts, chopped
1 cup raw sugar
1/4 cup Earth Balance butter
1 flax egg (1 Tbsp. ground flax seed mixed with 3 Tbsp. water)
3/4 cup orange juice

1.  Preheat oven to 350 degrees.  Oil and flour a 9 x 5 inch loaf pan.
2.  Whisk together flour, baking powder, baking soda, cinnamon and salt.
3.  Stir in orange zest, cranberries, and walnuts.  Set aside.
4.  In a sauce pan , cream together butter, sugar, and flax egg until smooth.  Stir in Orange juice.
Heat on  medium until raw sugar has been absorbed.
5.  Gently fold wet ingredients into dry and pour into prepared pan. 
6.  Bake for 1 hour in preheated oven, or until the bread springs back when lightly touched.
7.  Let stand 10 minutes, then turn out onto a wire rack to cool. 

Sunday, 19 August 2012

If You Eat Excess Protein, Does It Turn Into Excess Glucose?

Gluconeogenesis is Demand-Driven, not Supply-Driven

We have seen the claim that any protein you eat in excess of your immediate needs will be turned into glucose by spontaneous gluconeogenesis ¹. (Gluconeogenesis (GNG) is the process by which glucose is made out of protein in the liver and kidneys.) Some people think that because protein can be turned into glucose, it will, once other needs are taken care of, and that therefore keto dieters should be careful not to eat too much protein.

While we believe there are valid reasons for limiting protein intake, experimental evidence does not support this one. In our opinion, it makes sense physiologically for GNG to be a demand-driven rather than supply-driven process, because of the need to keep blood glucose within tight bounds.

In brief

  • Gluconeogenesis is a slow process and the rate doesn't change much even under a wide range of conditions.
  • The hypothesis that the rate of gluconeogenesis is primarily regulated by the amount of available material, e.g. amino acids, has not been supported by experiment. Having insufficient material available for gluconeogenesis will obviously limit the rate, but in the experiments we reviewed, having excess material did not increase the rate.
  • We haven't found any solid evidence to support the idea that excess protein is turned into glucose.
  • More experiments are needed to confirm that this still holds true in keto dieters.

Gluconeogenesis has a Stable Rate

Gluconeogenesis (GNG) is a carefully regulated process for increasing blood sugar. It is stimulated by different hormones, including glucagon — the primary hormone responsible for preventing low blood sugar. GNG produces glucose slowly and evenly ². It was once thought that the main determination of the rate of GNG was how much glucogenic substrate, that is, raw materials for it, was available, but further experiments have shown that this is not the case ³. Instead, it now appears that GNG is relatively constant over a large variety of conditions .

As an example of this stability, a study by Bisschop et al. in 2000  showed that subjects following a keto diet for 11 days had only a small (14%) increase in glucose production from GNG after overnight fasting, as shown in this graph. This works out to a difference of less than a gram of glucose per hour.

Note that 11 days might be too little time for all of the subjects to keto-adapt, and it is possible that the rate of GNG would change in subsequent weeks.

Negative Results

In another experiment (this time in subjects on a glycolytic, or carb-based, rather than a ketogenic diet), ingesting 50g of protein resulted in the same amount of glucose production as drinking water . In other words, the amount of glucose that was made after ingesting that protein wasn't any more than would have been produced without it. While it's possible that this protein doesn't count as "excess", it was likely to be nearly half of their daily required protein intake, and eaten in one sitting, and so it is enough to cast serious doubt on the idea.

There are other experiments in which increasing the available material for GNG to high levels didn't increase GNG ³. In these experiments GNG substrates were infused directly into the blood rather than eaten.

The problem with applying the results of these experiments to the question of excess protein consumption is that infusion might bypass some mechanism that increases GNG when the protein is actually eaten. For instance, it is known that protein consumption stimulates a great deal of glucagon (along with insulin) , and it might be suggested that this glucagon would thereby increase GNG. A counterargument to that possibility is that although glucagon stimulates GNG in many conditions, its action appears to always be overridden by insulin . This means that the insulin that is produced when eating protein will counteract the glucagon and GNG will not be affected (except in the case of insulin-dependent diabetes, where insulin is neither created nor responded to in the normal fashion).

Both the argument from infused substrates and the counter-arguments outlined here are plausible mechanism arguments — taking physiological processes known to occur in one context and arguing that they will occur in another context. Plausible mechanism arguments should be used with caution.

Summary

In sum, then, there is no evidence that we could find that consuming excess protein will increase glucose production from GNG. On the other hand, there is much suggestive evidence that it does not.

Further experiments need to be carried out to answer the question completely. In particular, we would like to see a comparison of the rate of GNG in keto-adapted dieters consuming no protein, adequate protein, or a large quantity of protein, with and without dietary fat.

Follow-up posts

For clarification and further discussion of this topic, please see:

References

(We owe a debt of gratitude to a special friend from Windy City for helping us access full texts, as our previous access has expired. Thank you!)

¹ Evidence type: observation

Please note

We have cited some people here as making what we believe to be an unsupported assertion. This does not imply any disrespect for the authors! To the contrary, we believe that writers such as these contribute to scientific knowledge even when they make mistakes. By writing specific and falsifiable statements and by posting them publicly where others can cite them, they give others a chance to learn from both their accurate statements and their mistakes.

We, too are fallible, and we expect that errors of our own will come to light sooner or later; such is the nature of science. There is no shame in this, and we intend none. Please see Apologia for our philosophy about this.

Scientific progress is made in large part through discovering errors and correcting them. We sincerely hope that those we have quoted will be glad to either learn from this post, or conversely, to point out to us where we have erred. In either case, an issue that was obscure will have been clarified for everyone.

Nora Gedgaudas

Also, keep in mind that a significant percentage of protein consumed that is in excess of what you actually need for your daily maintenance and repair will convert to sugar and get used exactly the same way.

Mark Sisson

As I’ve said before, I’m trying to minimize my use of glucose, whether exogenous or endogenously produced. If I’m eating so much protein that the excess is being converted to glucose, I’m not really minimizing it, am I?

Eric Westman in an interview with Jimmy Moore

34:37

JM: Well, and I would think that if you're sensitive to carbohydrate then you would be sensitive to eating too much protein as well, because you want to stave off the effects of gluconeogenesis from happening, which would provide too much glucose in your body, tantamount to eating a lot of carbs.

EW: That's a good point, that some of the protein that we eat can be turned into the glucose through gluconeogenesis, and that may be a reason why someone is not able to get to ketosis -- that too much protein is being converted to glucose.

(Update 2012-08-21)

The Rosedale Diet, p82.

When you eat more protein than your body needs to replace and repair body parts, excess protein is largely converted into glucose and burned as fuel.

² Evidence type: experimental

Jerome W. Conn, L. H. Newburgh. The Glycemic Response to Isoglucogenic Quantities of Protein and Carbohydrate. J Clin Invest. 1936; 15(6):665–671 doi:10.1172/JCI100818

(Emphasis ours)

In the process of protein metabolism, the complex protein molecule is split in the intestinal tract to amino-acids. These are absorbed into the blood stream and transported to the liver where oxidative deamination occurs. Here the glycogenic amino-acids are split to form urea and glucose. That this process is a slow one is shown in the charts by the slowly rising blood urea nitrogen. Glucose is, therefore, liberated into the blood stream in this process at a slow and even rate over a prolonged period of time. Under these conditions the diabetic is able to utilize a greater total amount of glucose without glycosuria in the eight hour period. Therefore, the inability of a diabetic to dispose of large quantities of glucose is partially compensated if the glucose is presented for utilization slowly and evenly. There appears, then, to be some advantage to the diabetic of this slow liberation of glucose from protein foods.

³ Evidence type: review of experiments

F. Jahoor, E. J. Peters, and R. R. Wolfe. The relationship between gluconeogenic substrate supply and glucose production in humans. AJP - Endo February 1, 1990 vol. 258 no. 2 E288-E296

(Emphasis ours)

Gluconeogenesis plays an integral role in the maintenance of glucose homeostasis in humans, contributing about one-third of glucose produced in the postabsorptive state and all glucose produced when hepatic glycogen is depleted by starvation (6, 23-25). Because the results of in vivo experiments in humans and animals (12-15, 20) and in vitro perfused rat liver studies (11, 27) have demonstrated a close correlation between the rate of glucose production and the flux of gluconeogenic substrates, it is believed that gluconeogenic precursor supply plays a major role in the regulation of glucose production (12,13,20). Several studies in vivo support this concept. For example, we and others have demonstrated that the hyperglycemic response to severe burn injury and sepsis is a direct result of an increased rate of glucose production, which is associated with a concomitant increase in the fluxes of alanine and lactate, major gluconeogenic substrates (15, 39). The proposed regulatory role of precursor supply received further support in the quest to rationally explain the paradox of a reduced glucose production rate (and hypoglycemia) in starvation, despite a hormonal-substrate milieu that would normally favor stimulation of gluconeogenesis (2, 7, 12, 13, 28), thus glucose production. After prolonged starvation (3-4 wk), human subjects had low levels of gluconeogenic precursors associated with hypoglycemia and a reduced glucose production rate (6, 7, 12, 25). Infusion of unlabeled alanine caused hyperglycemia and an increased incorporation of [ 14C]label from alanine into glucose in this circumstance (12,13). It was therefore proposed by Cahill, Felig, and Marliss and their associates (7, 12, 13, 20) that the reduced glucose production rate in starvation was due to the reduced availability of gluconeogenic substrates; hence, gluconeogenic precursor supply was rate-limiting for glucose production rate.

In contrast, the findings of several kinetic studies performed in human and dog do not support this proposal (1, 30, 34, 38). These studies in postabsorptive subjects employed either the isotope dilution or hepatic vein catheterization techniques and failed to show any significant change in glucose production rate in response to infusions of substantial quantities of alanine, lactate, and glycerol even when there was a fivefold increase in the hepatic uptake of the infused substrate (1, 30, 34, 38)

These conflicting findings suggest that the relationship between gluconeogenic substrate supply and gluconeogenic enzyme activity in prolonged starvation may be different from that of the postabsorptive state. Alternatively, it is possible that the response to an increase in precursor supply is different from the response to a decrease. This latter possibility could occur if the endogenous supply of gluconeogenic precursors is just sufficient to maximally satisfy the capacity of the gluconeogenis enzyme system or of a particular key-limiting enzyme.

[...]

Our data so far indicate that under almost any physiological situation, an increase in gluconeogenic precursor supply alone will not drive glucose production to a higher level, suggesting that factors directly regulating the activity of the rate-limiting enzyme(s) of glucose production normally are the sole determinants of the rate of production; hence, there will be no increase in glucose production if the increase in gluconeogenic precursor supply occurred in the absence of stimulation of the gluconeogenic system. On the other hand, results of the DCA experiments suggest a coupling between precursor supply and gluconeogenic enzyme capacity. In this light, if there is a stimulation in gluconeogenic enzyme capacity (for example because of hyperglucagonemia of severe trauma), then there will have to be an increased rate of uptake of gluconeogenic precursors to meet the requirements of such a stimulated system. Thus the rate of uptake of gluconeogenic substrates and the rate of glucose production will be closely related, but the increased uptake of gluconeogenic precursors will be a consequence of a stimulated gluconeogenic enzyme system rather than the cause of an increased rate of gluconeogenesis.

Evidence type: review of experiments

Frank Q. Nuttall, Angela Ngo, Mary C. Gannon. Regulation of hepatic glucose production and the role of gluconeogenesis in humans: is the rate of gluconeogenesis constant? Diabetes Metab Res Rev 2008; 24: 438–458.

(Emphasis ours)

Current data support the hypothesis that the rate of glucose appearance changes but the rate of gluconeogenesis remains remarkably stable in widely varying metabolic conditions in people without diabetes. In people with diabetes, whether gluconeogenesis remains unchanged is at present uncertain. Available data are very limited. The mechanism by which gluconeogenesis remains relatively constant, even in the setting of excess substrates, is not known. One interesting speculation is that gluconeogenic substrates substitute for each other depending on availability. Thus, the overall rate is either unaffected or only modestly changed. This requires further confirmation.

Evidence type: experimental

P. H. Bisschop, A. M. Pereira Arias, M. T. Ackermans, E. Endert, H. Pijl, F. Kuipers, A. J. Meijer, H. P. Sauerwein and J. A. Romijn. The Effects of Carbohydrate Variation in Isocaloric Diets on Glycogenolysis and Gluconeogenesis in Healthy Men. The Journal of Clinical Endocrinology & Metabolism May 1, 2000 vol. 85 no. 5 1963-1967

(Emphasis ours)

Abstract

To evaluate the effect of dietary carbohydrate content on postabsorptive glucose metabolism, we quantified gluconeogenesis and glycogenolysis after 11 days of high carbohydrate (85% carbohydrate), control (44% carbohydrate), and very low carbohydrate (2% carbohydrate) diets in six healthy men. Diets were eucaloric and provided 15% of energy as protein. Postabsorptive glucose production was measured by infusion of [6,6-2H2]glucose, and fractional gluconeogenesis was measured by ingestion of 2H2O. Postabsorptive glucose production rates were 13.0 ± 0.7, 11.4 ± 0.4, and 9.7 ± 0.4μ mol/kg·min after high carbohydrate, control, and very low carbohydrate diets, respectively (P < 0.001 among the three diets). Gluconeogenesis was about 14% higher after the very low carbohydrate diet (6.3 ± 0.2 μmol/kg·min; P = 0.001) compared to the control diet, but was not different between the high carbohydrate and control diets (5.5± 0.3 vs. 5.5 ± 0.2 μmol/kg·min). The rates of glycogenolysis were 7.5 ± 0.5, 5.9 ± 0.3, and 3.4± 0.3 μmol/kg·min, respectively (P < 0.001 among the three diets).

Evidence type: experimental

M A Khan, M C Gannon and F Q Nuttall. Glucose appearance rate following protein ingestion in normal subjects. J Am Coll Nutr December 1992 vol. 11 no. 6 701-706

Unfortunately, we have been unable to access the full text of this paper. However, the results are described by the authors in the paper above () in text and in the table in the line marked [108]:

[T]here was no change in glucose production after ingestion of 50 g of protein in the form of cottage cheese.
If anyone having access to this paper would like to share it with us, we would be grateful, because it is the most relevant experiment we could find on the topic, and further details may be important.

Evidence type: experimental

Richard D. Carr, Marianne O. Larsen, Maria Sörhede Winzell, Katarina Jelic, Ola Lindgren, Carolyn F. Deacon, and Bo Ahrén. Incretin and islet hormonal responses to fat and protein ingestion in healthy men. AJP - Endo October 2008 vol. 295 no. 4 E779-E784

(Emphasis ours)

Fasting glucose levels were 4.6 ± 0.2 mmol/l, and glucose levels did not change significantly during any of the tests. Fasting insulin levels were 55 ± 3 pmol/l. Insulin levels were unaltered after water ingestion, whereas they increased after fat and protein ingestion. The increased plasma insulin concentrations were seen between 30 and 240 min after fat ingestion (P = 0.031 vs. water) and between 15 and 240 min after protein ingestion (P = 0.018 vs. water). When compared with water ingestion, fat and protein ingestion both significantly increased early and late insulin responses (Table 1). These responses were more pronounced after protein than after fat ingestion (P < 0.001 for all). Fasting glucagon levels were 65 ± 3.7 ng/l. Glucagon levels were unaltered after water ingestion. In contrast, glucagon levels were increased by both fat and protein ingestion, with significant elevations from minute 120 and onward after fat ingestion (P = 0.019 vs. water) and from minute 30 and onward after protein ingestion (P = 0.005 vs. water). The late glucagon response was increased by fat ingestion, whereas, after protein ingestion, both early and late responses were significantly increased. As for insulin, early and late glucagon responses were higher after protein ingestion than after fat ingestion (both P < 0.001; Fig. 1).

Evidence type: review of experiments

Hua V. Lin and Domenico Accili. Hormonal Regulation Of Hepatic Glucose Production In Health And Disease. Cell Metab. 2011 July 6; 14(1): 9–19

(Emphasis ours)

Tracer studies in dogs have defined hormonal regulation of HGP [Hepatic Glucose Production] in detail. As in the isolated rodent liver, HGP is exquisitely sensitive to glucagon and insulin. Glucagon sets the basal tone, but insulin trumps glucagon at any concentration–just as it does in vitro. Both hormones affect primarily glycogenolysis by reciprocal changes of glycogen synthase and glycogen phosphorylase, and by modulating glycolysis through glucokinase, fructose-bisphosphatase and pyruvate kinase (see below) (Cherrington, 1999). Hormonal regulation of gluconeogenesis has proven difficult to demonstrate.