Archive for the ‘Medical Ethics’ Category

Week in Review: (June 13 – June 17, 2001) Eye Opener Health, Law and Medicine Blog

Saturday, June 18th, 2011

Eye  Opener’s Week in Review

 

Jason Penn

From the Editor:  Today marks the end of week two as “guest” editor for the Eye Opener. I can tell you that the title “editor” is a misnomer. When it comes to the Eye Opener and its panel of bloggers, very little (if any) editing takes place. Consistently, our blawgers provide you with timely and topical posts. This week was no different. Let’s take a retrospective look at what the “Eye Opener” offered this week (and, of course, a sneak peek at the week ahead.)

– Jason Penn, Guest Editor

 

(Many thanks to Jason and all those back at the firm, who helped get the word out on some great topics this past week while I’ve been wrapping-up week #2 of the trial from hell…….Brian Nash)

July 1 – New Residents, New Rules……Again!

By: Theresa Neumann

While the loss of sleep is rarely a topic on Gray’s Anatomy (or any made-for-television medical drama), it is a genuine quandary for non-actor, medical residents. This past Monday, Theresa Neumann explored the ACGME’s limitations on the hours worked by medical residents in the United States. As Theresa explained, the overall maximum hours per week will not change; it remains at 80 hours.  One big change is the limit on the maximum continuous duty period for first year residents; this will be decreased from 24 to 16 hours.  It will remain 24 hours for residents after their first year, but recommendations include “strategic napping.” Curious about the other changes?  Read more

Newest Word on Crib Safety: Ban the Bumpers?

By: Sarah Keogh

Sleep isn’t only important for medical residents; it is also important for the smallest members of our families. As Sara Keogh explained on Tuesday, Maryland is considering regulations to ban the sale of crib bumpers. For many years, more and more emphasis has been placed on infants sleeping in safe cribs without any additional “stuff” in them. This has included the elimination of lots of former nursery staples. Baby blankets, stuffed animals, pillows and other loose items have been banned from the crib by safety experts for years. As requirements for cribs have required slats that are closer together, the utility of using a bumper to help a child from getting stuck between crib slats has been eliminated. More recently, the Consumer Product Safety Commission has developed even newer crib safety standards, including eliminating the use of drop-sides, and warned against the use of sleep positioners. Yet, despite the advice to put babies to sleep only on their backs in cribs empty of everything except a well fitting mattress and fitted sheet, many parents and caregivers persist in using other items in cribs. Now, with an increasing number of deaths associated with crib bumpers, Maryland is considering a stronger stance. Read more

Legal Boot Camp Class Four. Sean and Kristy’s Story: How a Jury Award is Conformed to the Cap

By: John Stefanuca

On Wednesday blogger Jon Stefanuca broke out his calculator:  bootcamp style.  In the state of Maryland, there is a cap on the damages that can be awarded.  But what happens when a jury returns a verdict in excess of the statutory amount?  Mathematics and law intersect.

To see the results, and a detailed explanation of how it all works, you can read more ….

 

Confusion with Advanced Directives: Palliative Care, End-of-Life and Hospice Care

By: Theresa Neumann

With the death of the always controversial Jack Kevorkian, we revisited a post by Theresa Neumann.  Breathing a little life into the post (pun intended), Theresa provides an excellent primer for readers that are facing end of life situations.  The differences are nuanced and can be difficult to understand at a most difficult time. Are you sure you know the difference between palliative, end-of-life and hospice care?  Read more

Acquired Brain Injuries: Subdural Hematomas

By: Theresa Neumann

When Humpty Dumpty fell, they were able to put him back together again.  Because our lives are nothing like a children’s nursery rhyme, when we fall, we get hurt.  A head injury is particularly serious. Have you ever bumped your head and developed a “goose-egg?” It’s truly amazing how fast that big bruise under the skin grows. That bruise, or hematoma, is from a broken blood vessel, usually a vein. The pressure from the swelling helps with clotting, along with the blood’s own clotting factors. This types of hematoma typically takes a week or more to go away. If it’s on the forehead, it’s often followed by one or two “black eyes.”  That’s because the blood tends to spread along  tissue planes, and gravity notoriously pulls everything downward causing it to pool in the eye sockets, where the blood cells degrade and their components are reabsorbed by the body. Unlike a fairy tale, however, this goose-egg can be serious.  Read more

Sneak Peak of the Week Ahead:

As I told you at the beginning, the Eye Opener’s writers continue in their efforts to provide you with timely and topical blogs for your reading pleasure. As evidenced by the above, this past week was no exception. The Eye Opener and its writers are excited about the week ahead too!  Here’s a sneak peak of what’s in store for you:

  • Service dogs for children:  more than just a pet
  • Changes in Sunscreen:  will regulation prevent cancer?
  • HIV Patients:  Increased risk for developing cancer
  • Legal Boot Camp is back in session and Part III of our Cerebral Palsy tutorial.

Wishing You and Yours a Great Week Ahead!

Images courtesy of:

www.theepochtiems.com

www.sleepzine.com

www.nailsmag.com

www.aginglongevity

 

 


Confusion with Advanced Directives: Palliative Care, End-of-Life and Hospice Care

Thursday, June 16th, 2011

From the Editor:  Today, with the recent death of controversial figure Jack Kevorkian we revisit blogger Theresa Neumann’s thoughts on Palliative Care, End of Life and Hospice Care.  The ethical questions raised by end of life situations are difficult for families to deal with and this blog provides an excellent primer.

In a previous blog, I raised the issue of “Advanced Directives” and how, according to a Medscape physician survey, physicians do not always honor these legal documents.  One of the “excuses” cited the definition of futility in treating a terminal medical condition, arguing for palliative care as opposed to withdrawal of care.  Obviously, confusion exists amongst these providers as to what constitutes comfort care versus unnecessary prolongation of life and/or exposure to unnecessary procedures in a patient with a terminal condition.

Palliative, End-of-Life and Hospice Care

Palliative care is essentially comfort care.  To “palliate” means to “ease” or “make less severe” – therefore, medical care that is designed to palliate symptoms of a particular disease is care designed to ease or lessen the severity of symptoms associated with that disease.  It can be in an acute condition, a chronic condition or even a terminal condition depending on the stage of the illness.  Some of the symptoms often palliated are nausea and vomiting (chemotherapy, cirrhosis), anorexia (cancers, AIDS), pain (rheumatoid arthritis, cancers), shortness of breath (COPD/emphysema, interstitial lung disease), dizziness (Meniere’s disease, multiple sclerosis), incontinence (spinal cord injuries, stroke), constipation (inflammatory bowel disease, chronic pain syndromes), and many others.  There are various treatments available for the treatment and/or management of these symptoms, but they are not necessarily curative of the underlying condition.  Some chronic conditions, like Rheumatoid Arthritis, are manageable but not necessarily curable, so the treatment rendered is to palliate/lessen the symptoms and hopefully put the auto-immune disorder into remission for a period of time.  Rheumatoid Arthritis, however, is NOTterminal condition; patients usually die of complications or other co-morbidities.  Palliative care can also incorporate a variety of specialties with overall coordination of care that involves communication with the family, spirituality and emotional support.  Palliative care is a critical component of end-of-life and Hospice care.

End-of-Life care is a well-coordinated approach to end-of-life issues when a condition is deemed terminal, such as incurable metastatic cancer, end-stage multiple sclerosis or even liver cirrhosis when organ transplant is not an option.  Life expectancy can vary widely, with physician guestimates being greater than 6 months (as much as one year or more).  End-of-life care typically incorporates palliative care to ease the symptoms of the disease process as well as counseling services, emotional support and even spiritual support.

Hospice care is end-of-life care, incorporating palliative care, reserved for the last 6 months of life or less.  Care is shifted from curative therapies to pain management and ease of other symptoms of illness.  There are many Hospice programs that offer services in a variety of locations, all of which is dependent on the patient’s and the patients’ family’s wishes. They can be rendered at home, in a nursing home, in the hospital or in a dedicated Hospice facility.  Services provided by these organizations can even include basic housekeeping, personal hygiene care, grocery shopping, and even companionship in addition to the palliative medical therapies.

Where do advanced directives come into play?

Advanced directives can affect every one of these aspects of care.  They reflect the patient’s or the patient’s medical power of attorney’s wishes regarding palliative care modalities, end-of-life care and Hospice care.

About.com’s website on palliative care offers a great example of palliative care that transitions to end-of-life and at-home Hospice care for “Aunt Tilly”.

A patriarch of the family has essentially been healthy his entire life, shoveling  snow and cutting grass into his 85th year of life.  Things shift during the 86th year, and he develops congestive heart failure which has triggered multiple falls and syncopal episodes, presumably from hypoxemia.  There are several hospitalizations to evaluate his condition with institution of multiple medical therapies/drugs to stabilize his condition.  Unfortunately, his heart is weak, and ultimately his kidneys begin to fail.  No advanced directives had ever been discussed, as with many people of his generation; fortunately, he remained of sound mind.  At first, everything was a whirlwind……medication infusions to prevent irregular heart rhythms, blood transfusions to address his anemia since the kidneys were no longer working properly to stimulate the bone marrow to make more red blood cells, and finally, dialysis???  Well, if the kidneys are not working very well, not filtering the blood to produce urine and not stimulating the bone marrow to produce RBCs, we have to fix this, right?  What was not mentioned was that blood transfusions have to be given with intravenous fluids, which then worsen the fluid overload and congestive heart failure making it even more difficult for the poor man to breathe.  Higher and higher amounts of oxygen are needed to keep him comfortable, while his body is swelling up with fluids.  So, STOP THE MADNESS!  This family patriarch, after being informed of the complicated nature of his essentially end-stage condition, opted to forego hemodialysis; he did not want to be hooked-up to a machine for 3 hours a day, 3 days a week, just to filter his blood in an attempt to garner perhaps 6 more months of life; that kind of life had no quality to it in his mind.  In addition, since the blood transfusions would only worsen his breathing, he refused any more blood.  He wanted to be kept comfortable with pain medications and oxygen which was done in the hospital; he did not want to be shocked (defibrillated) or resuscitated in any way.  Comfort measures were provided in the hospital where he was given a large, private room, and he passed away peacefully within 3 days; there were no restrictions on family visitation, and he was surrounded by those dearest to him.  A chaplain was available within minutes of his death to comfort the family and offer prayer to ease everyone else’s suffering and loss; this patriarch was already at peace and without pain.

In this particular example, it was beneficial that my family member was of sound mind to make his own decisions at the end of life with regard to blood transfusions and hemodialysis.  It would have otherwise been very difficult for the family to come to some kind of consensus.  It was also better, in this case, that he remain in the hospital since his wife was still living and would have to return to their home alone following his death; having her live in the house in which her husband of 67 years had died would have been too much for her to bear.  This emphasizes the importance decision-making while one is of sound mind.  Cancers can spread to the brain; toxic metabolites that accumulate when vital organs fail can render a patient confused or even comatose; acute strokes can also affect one’s cognitive capabilities, not to mention other organ systems (breathing, toileting, swallowing, etc.).

Advanced directives can be as precise or as vague as one desires.  It seems to me that the more detailed the directive, the less chance one encounters of a physician or care provider ignoring the directive or “interpreting” the directive in a way that confuses loved ones, exposing the patient to unnecessary procedures and/or life-extending treatments.

Have you ever had to deal with any of these issues – advanced directives, palliative care, end-of-life care or hospice care? What has your experience been? Do you have any suggestions that might be helpful to others, who may be faced with similar issues?

More on this topic soon: What constitutes a terminal condition?

Related Posts:

Advanced Directives: The Right to Die With Dignity. Does the Medical Profession Honor Them?

Making Your Wishes Known at the End of Life (NY Times article by Dr. Pauline W. Chen )

Image from mylocalhealthguide.com


 

Week in Review (April 16 – 20, 2011) The Eye Opener Health, Law and Medicine Blog

Saturday, May 21st, 2011

From the Editor (Brian Nash)

Another week of great posts (IMHO) by our blawgers. Apparently, I’m not the only one who thinks so since we have now surpassed 21,000 page views in the last 30 days. The number keeps rising. Our sincere gratitude to all our readers!

Our topics were once again quite varied. They spanned the law, health, science and medicine. We even had a piece on a local event – Marathon Kids. This piece is part of our new program to promote charities and civic organizations in our own backyard – Baltimore and Washington.

We try week in and week out to find topics of interest for you, our readers. If you ever have any suggestions for topics of interest to you, please leave a comment or send us an email or fill-out the contact form with your thoughts and suggestions. We’d love to hear from you.

Let’s get to it then. What did we cover this past week that you might be interested in reading? Take a look -

Why early settlement is a win-win for all

By: Michael Sanders

There is an old adage in the law that cases settle on the courthouse steps. There is a reason for that. When the parties are actually walking into court to try their case, they seem to suddenly recognize that there are significant risks to going to trial, and that there is serious money at stake. When you go to trial, only one side can win. The other side goes home a loser. Faced with such a stark outcome, both sides tend to become more reasonable in their assessment of their case and more willing to talk settlement. After all, despite all the years of experience that trial attorneys amass, no one can ever predict what a jury is going to do in any specific case. As one mediator I know likes to tell the litigants, going to court is like going to Vegas:  you roll the dice and you take your chances. Read more….

Milk from Mom: Effective in preventing common infant complication (NEC)

By: Jason Penn

The debate among parents regarding the use of human milk vs. formula wages on, but according to a recent study, you can chalk one up for the human body.  That study, headed by the Johns Hopkins University in Baltimore, concluded that premature babies fed human donor milk were less likely to develop the intestinal condition necrotizing enterocolitis (NEC).  Both sides has its advocates, willing to do battle at any time. When it comes to NEC, Mom’s milk has the decided advantage. Read more….

H.I.V. treatment advances, but what are the implications of terminating research early?

By: Sarah Keogh

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge. Read more….

A Windy, Rainy but Fabulous Day in Baltimore: Marathon Kids Final Mile Celebration

By: Rachel Leyko

Despite the wind and rain, this past Saturday I volunteered at the Marathon Kids Final Mile Celebration Event at Western Polytechnic High School in Northwest Baltimore.  I learned of the event through the Junior League of Baltimore and to be honest, prior to Saturday, I did not know much about the organization, its purpose or effect on the children it sought to serve.  However, after Saturday’s event, not only was I impressed with the purpose of Marathon Kids, but I saw firsthand the positive effect this program has had on the children who have participated. Read more….

Acquired Brain Injuries: Causes and Impact

By: Theresa Neumann

On the heels of Jason Penn’s blogregarding calling “911″ for signs of a possible stroke, I decided to introduce a variety of acquired brain injuries for further discussion in future blogs since damage to the brain results in some of the most catastrophic injuries possibly sustained by the human body with significant “collateral damage” for all of the friends and family involved in the individual’s life. Read more….


Sneak Peak of the Week Ahead

Some topics we’ll be covering next week…and then some…

  • You or someone you know has been diagnosed with cancer, now you have to deal with the horror. Jon Stefanuca will be writing a piece based on our experiences with a number of clients “living with cancer.”
  • Mike Sanders and I have both recently resolved cases involving families who have lost a child. Mike’s involved the death of a fetus very near term. He’ll share that story and the experience of the case with you.
  • Maybe those of you who have children with special needs are familiar with the local (Maryland and Washington, D.C.) resources to help you and your child. For those who may not be or just want to learn more, Jason Penn will be providing information on this next week.
  • You may have heard the recent news about labeling of certain medications for children. Sarah Keogh will report on this and also delve into some practical problems and issues that parents face every day in terms of medicating their children.
  • We’re going to begin a new series on exactly what is recoverable in our jurisdictions (Washington, D.C and Maryland) under what is known as the Survival Act and the Wrongful Death Act. We’ll be paying particular attention to issues involving what’s known as pecuniary benefits, loss wages and diminished earning capacity. Should be educational. We hope you enjoy it.

Have a great weekend, Everyone!

H.I.V. treatment advances, but what are the implications of terminating research early?

Wednesday, May 18th, 2011

Scientific Method; image from: scifiles.larc.nasa.gov

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge.

The study details are fascinating, particularly in regards to the results. For example:

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

What I found most interesting, however, was that the study was not completed. The reported findings were the preliminary results from the clinical trials. In fact, the article explained that “[t]he data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.”

The way these results were discovered and released during the course of the study was what intrigued me. Here’s how the study data was described:

“[U]nblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

This means that the clinical trial was stopped before reaching completion so that all of the participating couples could receive treatment.

The implications of ending this trial short are complicated. For the participants, the decision can be nothing but positive since it may provide the study participants with the opportunity to receive treatment that could hopefully lead to a dramatically decreased likelihood of infection with a potentially deadly disease. For many others around the world who have a partner with H.I.V., the implications are likewise a boon for public health. The release of these early results may impact treatment of H.I.V. infected individuals around the world who may now be able to protect their partners from infection. However, the end of this study is not as clear-cut in terms of research and ethical implications as it might seem.

I originally became aware of the idea that clinical studies are sometimes cut short in the mid 1990s. My father, an occupational health doctor who died in 1999, was involved in the CARET studies during the 1990s. This large-scale double blind study was looking at whether beta-carotene and retinyl palmitate would be able to prevent lung cancer in heavy smokers and workers who had been exposed to asbestos.  However, the study was ended prematurely based on interim results that suggested an adverse affect on the study participants. Since I was only a high school student at the time that the trial was ended, I did not know many of the details at the time. I understood the basic idea that if a medical research study was causing harm to the participants, that it must be ended. When I read the recent news about the H.I.V. treatment study, it prompted me to try to learn more about how and when clinical studies are interrupted.

There was an article published called “Stopping the active intervention: CARET” that I found enlightening about how and why the CARET studies were ended.  The article provides an overview that I found helpful in thinking about the current H.I.V. study:

The optimal design of a randomized clinical intervention trial, where the outcome is a disease endpoint, includes a set of criteria for stopping the active intervention before planned. These criteria, called “stopping rules,” guide the review of findings by key study scientists and an independent set of reviewers. If the pattern of outcome, effect or harm, is large enough to be attributed to the intervention, the trial is halted, regardless of the planned completion date or the readiness of staff to end the trial.

While in the H.I.V. study, the impact was positive, rather than negative as in the CARET study, the procedure seems to be similar. A procedure in the study allowed for data to be unblinded and examined by an independent panel which then recommended that the trial be stopped early.

However, this does present two potential problems. One is that the study, scientifically speaking, did not reach its full conclusions. It may not provide as much evidence of implications as it might have if it had continued or if the study population had been larger. For example, the New York Times article mentioned the following:

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

Another implication is that the results may not be as scientifically accurate if the trials are stopped early.  A study published in JAMA entitled “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis” explains:

Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect. Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit. Statistical modeling suggests that RCTs stopped early for benefit (truncated RCTs) will systematically overestimate treatment effects, and empirical data demonstrate that truncated RCTs often show implausibly large treatment effects.

(internal footnotes omitted)

So, perhaps, if the trial were continued, the results would not have been as overwhelmingly positive. Perhaps the percentage of partners infected in the two groups would not have been as widely divergent. But perhaps they would – and would you want to gamble with someone’s life?

Have you ever been involved in a clinical research study that has been ended early? Was it for positive or negative results? What should be done to maximize public health and safety while still providing the benefits of full blind research studies?

 

Medical Second Opinions: An Under-utilized Option for Patients

Monday, May 2nd, 2011

Today’s medical world is vast with various technologies, treatments and options.  So, if a patient is diagnosed with a medical condition, and doctor A recommends treatment A, what keeps the patient from seeking a second opinion? This is an interesting phenomenon.  After performing intake summaries and client interviews for quite a while now, it still amazes me how many people have bad outcomes from surgery simply because they never requested a second opinion. Second opinions are not simply reserved for surgery, though; cancer treatment options, medical therapies for chronic conditions like rheumatoid arthritis or inflammatory bowel disease, chiropractic care of chronic back or neck pain are some other conditions that, in my mind, scream for a second opinion!

Having practiced medicine for 13 years, working with physicians from all specialties, I can honestly say that doctors are not gods. They are human beings, no different than you or me, and human beings are prone to prejudice and errors. Granted, physicians go through a lot of education and training to perform their daily duties, but location of training, timing of training and educational mentors play a huge role in shaping the decision-making process of these humans.

Inherent limitations that can affect physician recommendations

For example, the latest technology for prostatectomy has been the DaVinci procedure, using minimally invasive robotic technology to surgically remove the prostate.  Operation of the robotics involves manipulation of “joysticks”, much like video-gaming. No offense, but if your particular urologist is 60 years of age or older, what are the chances that this particular surgeon is as adept with these skills or technology as a 30-year-old urologist?  Special training is required for use of these robotics, and not all hospitals even have the technology available. Therefore, one’s choices are automatically limited, and a minimally-invasive robotics-assisted procedure may not even be an option! A second opinion by another urologist at a different facility might be able to provide that option. A similar situation would be the use of gamma knife surgery for removal of brain tumors; it is not always an option available based on the facility or the neurosurgeon providing the consultation.

Can recommendations be limited by specialty?

Another example has to do with medical specialty affiliation. If one is trained as a surgeon, he/she focuses on the technical removal or repair of abnormal body parts. If one is trained in radiation-oncology, the focus would be the various radiation technologies available for treatment of disease. If one is a medical oncologist, chemotherapy protocols for the particular neoplastic condition would be the focus.  So who ties all of this together?  First of all, is the tumor even operable? Is the patient a good candidate for surgery? Should one try radiation first to shrink the tumor, then follow it with an operation? Is chemotherapy the way to go, but which regimen of drugs is really appropriate? These are very technical and complex questions. Should one leave the ultimate recommendation up to one specialty physician?

Suggested approach to the problem

For me, it would be a little more comforting to get the same overall recommendation from two independent physicians. What if the opinions differ?  A third opinion? – or, simply focus on the discrepancies with direct questioning of the two physicians and find out the rationale for the recommendation being made. You do not know how many times I have heard, “I trusted my doctor.” I ask you, if your car was making a rattling noise but seemed to be running okay and a mechanic told you a new transmission was necessary at the cost of $1800, would you get a second opinion?

Don’t let fear or reprisal get in your way

One of the main reasons for fear in seeking second opinions is anticipated disapproval and potential retaliation by the first physician or fear of a change in the patient-physician relationship.  I pose to you the following:  if a physician has done his/her research regarding the condition and is confident is his/her recommendation, then he/she should not fear the opinion of a peer. If that opinion differs, it should be reviewed for accuracy and appropriateness because it might just be a viable option not previously considered. If the physician is “offed” by the patient’s search for a second opinion, that physician thinks way too highly of himself/herself; keep in mind that this is about the patient who has a condition that requires treatment, not the physician’s integrity or ego. It is my firm opinion that physicians should be proud of those patients who advocate so strongly for themselves and seek to be educated about their condition.  Education leads to a better understanding of the disease process, better expectation of the “road ahead,” and better patient compliance with medical therapies. Retaliation is prohibited by the medical code of ethics; if there is a retaliatory action, the state’s Medical Board should be notified and prompted to investigate.

Beware of the on-line second opinion approach!!!

Recently, multiple facilities have offered a “second opinion service” via the internet. A patient submits his/her medical condition along with various lab studies and other diagnostic imaging (CT scans, x-rays, MRI scans, etc.) for review over the internet; an opinion is provided based on these facts!  What this really doesn’t take into consideration is the patient!  Patients are people – human beings with emotions, physical limitations, families (or not), previous histories and other underlying health conditions. One of the things I was taught in PA school was to treat the patient and not the numbers!  Not all patients are surgical candidates.  Not all patients can emotionally or physically tolerate some of the chemotherapy protocols. Someone might look good on paper with great blood parameters, vital signs, etc., but in person, one’s assessment changes dramatically.  These virtual second opinions may have their place in certain situations, but I generally have to question the validity of such an assessment.

A “real-life” story

I leave you with a quick summary of a case:  Mr. B was a 40-something, physically fit male professional, who loved to work out and exercise. He developed some mechanical back pain for which he sought treatment. An MRI scan revealed an incidental finding of small spinal cord glioma in the low back. Clinically, there was no evidence to support that this incidental finding was in any way related to Mr. B’s pain. He sought the advice of a neurosurgeon, who immediately wanted to operate. Well, if research had been done, these particular tumors are 99% benign, very slow-growing and can often be monitored for 10 to 20 years before surgery might even be necessary.

Mr. B followed the advice of the surgeon and underwent a resection of this small tumor. The surgery required resection of the S1 nerve root, which affects sensation in the genital region and anus; Mr B was now impotent and had problems with bowel movements in addition to a chronic burning sensation in his genital region. A second opinion might well have saved Mr. B a lot of pain, permanent erectile dysfunction and money required to undergo alternative methods for conception. He’ll never know now.

Have you or someone you know gotten second opinions before making a decision about an important medical procedure? What’s your approach? Have you ever received different opinions about how to treat a condition? How did you resolve this situation? Any tips for others?

Image: Wellsphere.com

Update: After posting Theresa Neumann’s piece this morning, I came across a somewhat related post on KevinMD.com entitled Marcus Welby and the relentless growth of specialization. The author, Jan Henderson, PhD, raises some very interesting thoughts about what I would call the “over-specialization” of medicine. She provides the following quote of Dr. Welby from very first episode of this TV show of years gone by, which – to me – supports one of the concerns raised by Theresa in her blawg:

… I hope some of you will go into general practice. For if you don’t, where will a patient turn who doesn’t know that he has an orthopedic problem? Or a neurological problem? Or a psychiatric problem? Or a nutritional problem? But who only knows that, in lay terms, he feels lousy.

Just some food for thought you might enjoy.

Brian Nash (editor of “Eye Opener”)

Makena: Drug to fight prematurity leads to major firestorm.

Thursday, April 7th, 2011

Last week, I started following a still emerging story about a drug that I had never heard of before called Makena. The medication is a synthetic form of progesterone that is used for women who have a high risk of prematurely delivering a baby based on having had a premature delivery in the past. The drug must be injected by these women weekly for 18-20 weeks of their pregnancy.

According to the Baltimore Sun, the controversy surrounding this drug began when the “…K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.” This was possible because originally the medication was created by a compounding pharmacy mixing it together for patient use. Then in February, the FDA granted K-V Pharmaceutical Co. the exclusive rights to manufacture the medication for seven years.

If raising the cost of the medication 75 times its original cost (from $10-20/dose to $1,500/dose) were not enough, the Baltimore Sun reports that the company then went on to “sen[d] letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug.”  However, the FDA, amid a loud outcry of complaints, has “…declared it would do no such thing.  In its statement, the FDA noted that the drug was important and K-V ‘received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.’”

What has been so interesting are the implications of this story and the reactions to it. Clearly, the original decision by the pharmaceutical company to raise the cost of the drug 75 times the old cost is an attempt to make money from their exclusive rights. I can hardly imagine that there is any reason other than profit creation for this move given that they did not have costs associated with research and development or any other clearly identifiable costs. So, aside from my initial reaction of disgust that this might make it harder for women who need this medication to protect their children, I also thought about the bigger implications.

First of all, the cost issue is not so simple as it first appears.  As another article from the Baltimore Sun mentioned, “[t]he burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.” The increased costs of drugs impact many Americans directly – those without insurance or those for whom even co-pays are a major budgetary struggle. However, the costs here also reach all of us. If the costs associated with the company’s increased profit are borne by the insurance companies and Medicaid, it also means that the costs are going to be felt by all of us who pay for health insurance or whose companies pay for health insurance and yes, by all of us, who pay taxes.

Secondly, for those women who do not realize that they could still go to a compounding pharmacy for this prescription and for whom it is not covered by insurance, the increased cost may mean that some woman will go without these injections. The Baltimore Sun article reports that:

About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.

The implications here deal with both the health and safety of the unborn child who is now at risk of premature birth. But, unfortunately, they also have an associated monetary cost. The cost of a baby being born prematurely is also going to weigh on the insurance companies and is, therefore, going to be shared by all in the form of potentially increased premiums.

Given the intense criticism in the news, K-V Pharmaceutical Company moderately changed course in the last few days, according to Medical News Today and said they would bring the cost of Makena down to $690 per dose from the originally announced price of $1,500 per dose. While this is lower, this is hardly a significant adjustment given that the compounded version costs between $10-20 per dose. The March of Dimes, which originally backed FDA approval of the drug and was allowing the pharmaceutical company’s use of its name and logo, is apparently embarrassed by KV Pharmaceutical’s decisions. According to an article on the nonprofitquarterly.org, “…the March of Dimes is backing out of a sponsorship deal with the [pharmaceutical] company that sells [Makena]. Last Friday, the nation’s leading nonprofit focused on the health of pregnant women and babies said it would no longer allow St. Louis-based, KV Pharmaceutical Co. to use its name or logo in any of the drug company’s promotions.”

The response from the March of Dimes is not KV Pharmaceutical Co.’s only trouble as the Wall Street Journal is reporting that after the FDA announcement that it will not take action against pharmacies that compound the drug, and the company subsequently announced that it would cut the cost, the company’s shares fell 5.2%.  Reuter’s is reporting that this represents a drop of more than 20 percent.  Congress is also in an uproar about this issue.  The Reuter’s article says that elected officials are creating pressure for more to do be done on this issue.

What do you think should be done about KV Pharmaceutical Co.? Are they really any different from any of the other pharmaceutical companies? Is it relevant to consider that this is a so-called orphan drug and that the company has exclusive rights because of this? Do you think that allowing compounding pharmacies to create the drug for woman separate from the FDA approved drug is a sufficient solution? What about the bigger question of companies creating inflated prices for their products and having insurance (and all of us) foot the bill?

 

Baltimore Abortion Ordinance Declared Unconstitutional – How Did We Get Here and Why?

Saturday, February 5th, 2011

Pro-Life and Pro-Choice Advocates

Last April, we posted a blog regarding a Baltimore City ordinance, which required local crisis pregnancy centers to post signs in their clinics disclosing that they did not offer abortion or birth control services if, they in fact, did not offer such services. Because of this requirement, many clinics chose to post separate notices informing the public about clinics that offered abortion services. Consequently, the Archdiocese of Baltimore, filed a lawsuit in the Federal District Court, seeking to have the ordinance declared unconstitutional.  One of its arguments was that the City should be prohibited from compelling speech by requiring the clinics to post signs.

On January 28th, 2011, District Court Judge, Marvin Garbis, ruled that the ordinance violates the First Amendment of the U.S. Constitution and, as such, is unenforceable. In his opinion, Judge Garbis wrote: “Whether a provider of pregnancy-related services is ‘pro-life’ or ‘prochoice,’ it is for the provider — not the Government — to decide when and how to discuss abortion and birth-control methods.” According to the opinion, “[t]he Government cannot, consistent with the First Amendment, require a ‘pro-life’ pregnancy-related service center to post a sign as would be required by the Ordinance.”

The dynamic of this litigation is fascinating, revealing nonsensical and unpredictable aspects of the abortion debate.  One could argue that the original passing of the ordinance was fueled by an underlying “pro-life” attitude.  After all, why would the City require clinics that don’t offer abortion services to publically state that they don’t offer abortion services? My personal opinion is two-fold: 1) to discourage individuals in need of abortion services from seeking abortion services, and 2) to reveal to the public the number of clinics that don’t offer abortion services in order to paint a picture that the public is generally pro-life (this is particularly true because the ordinance did not require clinics offering abortion services to post notices that they offered such services).

Interestingly, the ordinance backfired. Some of the clinics required to disclose that they did not offer abortion services chose to inform the public about other clinics where abortion services are available. There is nothing wrong with that, right? Well, apparently the Archdiocese did not think so, and, in my personal opinion, here is the real reason why: As soon as it became apparent that many of the clinics could simply choose to post notices about other clinics, which offered abortion services, it also became apparent that the ordinance was de facto prompting free advertising for abortion services all over the city.

I can’t imagine that the Archdiocese was too thrilled about that. Hence, the litigation ensued and the opponents of the ordinance prevailed on an argument, which is commonly and usually made by the “pro-choice” side of the abortion debate. At the heart of Judge Garbis’ opinion is the notion that the government should not legislate morality or religion. On January 28th, the Archdiocese and other “pro-life” groups prevailed on an argument, which has undermined and discredited the “pro-life” position for decades. How ironic!

Have you have been following this litigation in Baltimore City? What are your thoughts? Was Baltimore’s ordinance misguided or spot-on? Will Judge Garbis’ decision be reversed or upheld on appeal?

Photo from foxnews.com

Confusion with Advanced Directives: Palliative Care, End-of-Life & Hospice Care

Tuesday, December 21st, 2010

In a previous blog, I raised the issue of “Advanced Directives” and how, according to a Medscape physician survey, physicians do not always honor these legal documents.  One of the “excuses” cited the definition of futility in treating a terminal medical condition, arguing for palliative care as opposed to withdrawal of care.  Obviously, confusion exists amongst these providers as to what constitutes comfort care versus unnecessary prolongation of life and/or exposure to unnecessary procedures in a patient with a terminal condition.

Palliative, End-of-Life and Hospice Care

Palliative care is essentially comfort care.  To “palliate” means to “ease” or “make less severe” – therefore, medical care that is designed to palliate symptoms of a particular disease is care designed to ease or lessen the severity of symptoms associated with that disease.  It can be in an acute condition, a chronic condition or even a terminal condition depending on the stage of the illness.  Some of the symptoms often palliated are nausea and vomiting (chemotherapy, cirrhosis), anorexia (cancers, AIDS), pain (rheumatoid arthritis, cancers), shortness of breath (COPD/emphysema, interstitial lung disease), dizziness (Meniere’s disease, multiple sclerosis), incontinence (spinal cord injuries, stroke), constipation (inflammatory bowel disease, chronic pain syndromes), and many others.  There are various treatments available for the treatment and/or management of these symptoms, but they are not necessarily curative of the underlying condition.  Some chronic conditions, like Rheumatoid Arthritis, are manageable but not necessarily curable, so the treatment rendered is to palliate/lessen the symptoms and hopefully put the auto-immune disorder into remission for a period of time.  Rheumatoid Arthritis, however, is NOT a terminal condition; patients usually die of complications or other co-morbidities.  Palliative care can also incorporate a variety of specialties with overall coordination of care that involves communication with the family, spirituality and emotional support.  Palliative care is a critical component of end-of-life and Hospice care.

End-of-Life care is a well-coordinated approach to end-of-life issues when a condition is deemed terminal, such as incurable metastatic cancer, end-stage multiple sclerosis or even liver cirrhosis when organ transplant is not an option.  Life expectancy can vary widely, with physician guestimates being greater than 6 months (as much as one year or more).  End-of-life care typically incorporates palliative care to ease the symptoms of the disease process as well as counseling services, emotional support and even spiritual support.

Hospice care is end-of-life care, incorporating palliative care, reserved for the last 6 months of life or less.  Care is shifted from curative therapies to pain management and ease of other symptoms of illness.  There are many Hospice programs that offer services in a variety of locations, all of which is dependent on the patient’s and the patients’ family’s wishes. They can be rendered at home, in a nursing home, in the hospital or in a dedicated Hospice facility.  Services provided by these organizations can even include basic housekeeping, personal hygiene care, grocery shopping, and even companionship in addition to the palliative medical therapies.

Where do advanced directives come into play?

Advanced directives can affect every one of these aspects of care.  They reflect the patient’s or the patient’s medical power of attorney’s wishes regarding palliative care modalities, end-of-life care and Hospice care.

About.com’s website on palliative care offers a great example of palliative care that transitions to end-of-life and at-home Hospice care for “Aunt Tilly”.

A patriarch of the family has essentially been healthy his entire life, shoveling  snow and cutting grass into his 85th year of life.  Things shift during the 86th year, and he develops congestive heart failure which has triggered multiple falls and syncopal episodes, presumably from hypoxemia.  There are several hospitalizations to evaluate his condition with institution of multiple medical therapies/drugs to stabilize his condition.  Unfortunately, his heart is weak, and ultimately his kidneys begin to fail.  No advanced directives had ever been discussed, as with many people of his generation; fortunately, he remained of sound mind.  At first, everything was a whirlwind……medication infusions to prevent irregular heart rhythms, blood transfusions to address his anemia since the kidneys were no longer working properly to stimulate the bone marrow to make more red blood cells, and finally, dialysis???  Well, if the kidneys are not working very well, not filtering the blood to produce urine and not stimulating the bone marrow to produce RBCs, we have to fix this, right?  What was not mentioned was that blood transfusions have to be given with intravenous fluids, which then worsen the fluid overload and congestive heart failure making it even more difficult for the poor man to breathe.  Higher and higher amounts of oxygen are needed to keep him comfortable, while his body is swelling up with fluids.  So, STOP THE MADNESS!  This family patriarch, after being informed of the complicated nature of his essentially end-stage condition, opted to forego hemodialysis; he did not want to be hooked-up to a machine for 3 hours a day, 3 days a week, just to filter his blood in an attempt to garner perhaps 6 more months of life; that kind of life had no quality to it in his mind.  In addition, since the blood transfusions would only worsen his breathing, he refused any more blood.  He wanted to be kept comfortable with pain medications and oxygen which was done in the hospital; he did not want to be shocked (defibrillated) or resuscitated in any way.  Comfort measures were provided in the hospital where he was given a large, private room, and he passed away peacefully within 3 days; there were no restrictions on family visitation, and he was surrounded by those dearest to him.  A chaplain was available within minutes of his death to comfort the family and offer prayer to ease everyone else’s suffering and loss; this patriarch was already at peace and without pain.

In this particular example, it was beneficial that my family member was of sound mind to make his own decisions at the end of life with regard to blood transfusions and hemodialysis.  It would have otherwise been very difficult for the family to come to some kind of consensus.  It was also better, in this case, that he remain in the hospital since his wife was still living and would have to return to their home alone following his death; having her live in the house in which her husband of 67 years had died would have been too much for her to bear.  This emphasizes the importance decision-making while one is of sound mind.  Cancers can spread to the brain; toxic metabolites that accumulate when vital organs fail can render a patient confused or even comatose; acute strokes can also affect one’s cognitive capabilities, not to mention other organ systems (breathing, toileting, swallowing, etc.).

Advanced directives can be as precise or as vague as one desires.  It seems to me that the more detailed the directive, the less chance one encounters of a physician or care provider ignoring the directive or “interpreting” the directive in a way that confuses loved ones, exposing the patient to unnecessary procedures and/or life-extending treatments.

Have you ever had to deal with any of these issues – advanced directives, palliative care, end-of-life care or hospice care? What has your experience been? Do you have any suggestions that might be helpful to others, who may be faced with similar issues?

More on this topic soon: What constitutes a terminal condition?

Related Posts:

Advanced Directives: The Right to Die With Dignity. Does the Medical Profession Honor Them?

Making Your Wishes Known at the End of Life (NY Times article by Dr. Pauline W. Chen )

Image from mylocalhealthguide.com


Advanced Directives: The Right to Die with Dignity. Does the Medical Profession Honor Them?

Friday, December 3rd, 2010

Anyone who has presented to a hospital with some type of ailment in the last 10 years or so has been asked about advanced directives, a living will and/ or medical power of attorney. What are these things?  What do they do?  Better yet, you may ask: what are they intended to do?

Advanced directives are legal documents prepared while an individual is of sound mind that indicates his or her wishes with regard to medical decisions to be made in the event that the same individual becomes incoherent, comatose, or unable to make decisions for themselves.

These directives are intended to instruct the care-providers with regard to various medical interventions should their condition warrant intervention. These can be as “simple” as resuscitation orders (being “coded,” “shocked,” being intubated and/or placed on a mechanical ventilator), or they can be more complex such as gastric feeding tubes if one cannot eat by mouth, dialysis should one’s kidneys fail (even temporarily), intravenous fluids or intravenous nutrition, blood transfusions, surgical procedures if the condition is deemed terminal, pacemaker/defibrillator placement, and many other form of possible medical intervention.  A living will is a form of advanced directive that is less precise, but it is a legal document indicating a patient’s wishes with regard to end-of-life or terminal-condition medical care without assigning a medical power of attorney. A medical power of attorney legally identifies an individual, who is intimately trusted by the patient to make appropriate decisions with regard to medical care in accordance with the patient’s wishes should the patient become incapable of making those decisions. The American Academy of Family Physicians offers good information with regard to these topics.

How well does the medical community deal with these issues?

This is all well and good from the patient’s perspective, but where do the physicians and other medical care providers fall in line with such legal documents and end-of-life ethical decision-making?  According to an electronic survey of 10,000 physicians in 2009 by Medscape on medical ethics, a physician’s personal bias and personal beliefs played a role in their approach to end-of-life care. A second article from Medscape dealt specifically with end-of-life issues.

When queried as to physicians recommending or administering life-sustaining therapy, when one judged it as futile (otherwise terminal condition), 23.6% of the respondants (~5,300) said “yes”; 37% said “no”; 39.4% stated that their decision was situational. The second end-of-life ethical dilemma involved whether the physician would withdraw life-sustaining care in accordance with family wishes even if the physician thought it was premature; the results showed that 54.5% would NOT withdraw care while 16.3% would withdraw care, leaving 29.2% deciding upon the actual situation. Let’s not overlook that astounding number – only 16.3% said they would follow the patient/family’s wish to withdraw care!

Various rationales were cited as to why these physician-respondents held such opinions. Some questioned the motives of the patient’s family members, while others noted fear of litigation for providing medical interventions.  The very definition of “futile” took on both curative and palliative connotations. The legitimacy of advanced directives were also questioned since these can become viewed as stagnant, especially if created 5 or 10 years earlier while the patient was in a different mindset. Keep in mind, people do change their mind, as do their perspectives with age, experience and wisdom. Likewise, advanced directives need to be changed, modified or simply updated periodically to reflect such changes.

The Terri Schiavo lesson (if there was one)

The Terri Schiavo story brought the whole end-of-life ethical decision-making into the limelight in 2005. This very sad story was in the headlines every day as legal maneuvering played out on national television. People were divided on “who was right,” and they will always be divided. These decisions are personal. They are difficult to share and discuss with family members, let alone physicians, who are admitting patients for the first time. In Maryland, physician assistants have been required to acquire continuing education hours in end-of-life care on a yearly basis for the last 10 years! This is a critical step in understanding the terminal stages of disease as well as the psychologic impact it can have on patients and their families.  Being comfortable with the discussion of death and dying, and doing so with dignity, is a key component in the management of end-of-life decision-making.

A Personal Experience

On a personal note, as a practicing physician’s assistant, I have been involved in end-of-life decisions with several family members as well as patients presenting to the ER in my 13-year Emergency Medicine career. The family members I have encountered have run the gamut from cancer-related deaths to brain hemorrhages to congestive heart failure leading to kidney failure.

One memorable, personal, family incident that sticks involved a relative, who had been living with a stroke, chronic lymphocytic leukemia followed by the development of large cell lymphoma. The two different courses of chemotherapy for the lymphoma resulted in damage to his heart, causing episodes of ventricular tachycardia (a life-threatening heart rhythm); however, the lymphoma had returned, and he couldn’t eat due to illness.  His options with regard to the cancer were extremely limited with an extremely poor prognosis, but the cardiologist wanted to insert a defibrillator in case the ventricular tachycardia re-occurred; the defibrillator would deliver an internal shock to the heart to return it to a normal rhythm and prevent death. Well, what is worse in this case – dying from a painless, silent heart dysrhythmia or suffering from malnutrition and systemic pain from the cancer that was everywhere in his body?  This situation required forcing both the oncologist and cardiologist to meet with my relative and with the our family to discuss each option and the prognosis. My relative decided he wanted to go home as soon as possible without the defibrillator; he died within a few days, silently and by all observations – peacefully. That was his choice, and it was honored after convincing his caregivers to abide by his decision.

It’s not Marcus Welby who will be taking care of you

Our current medical system is so over-burdened with patients at every level of care that the days of the old-fashioned family doctor who still admits his or her own patients and “rounds” on them every day (in addition to fulfilling their office obligations) are long-gone. Some patients are admitted to “hospitalists” (whom they have never met before) while others get admitted to whomever might be on-call in any variety of specialties (whom they also have never met before). Specialty medicine is just that……they focus on their particular specialty (as in the case of my relative). So, having a heart-to-heart discussion with your trusted family physician regarding your beliefs about end-of-life issues many (if not most) times never translates to the acute medical condition that lands you in the hospital. Even nursing home patients with DNR (do not resuscitate) forms can be ignored if they are not properly completed or the patient is not wearing the matching bracelet!

It seems that not only do patients need to be educated about the benefits of an advanced directives, living will and power of attorney, but physicians also need to be educated regarding compassionate, end-of-life and terminal care involving the whole being, such that they can communicate with family members, accept advanced directives and offer solutions to the dilemmas often faced by confused and emotionally drained family members faced with such situations.

Just as there should be dignity with life, there should be dignity with death.  It is the responsibility of both patients and providers to ensure this aspect of the human condition at whatever stage of a patient’s illness.

Have YOU ever been faced with such a situation?

Have you ever been faced with a situation where you were asked to make care decisions without an advanced directive? Have you ever found yourself in a situation where there was an advanced directive but the physician would not abide by it? Do you believe that it is a patient’s right to determine how they want to die and what medical interventions should be withheld under certain circumstances? How did YOU deal with such a situation?

Photo from enrichmentjournal.ag.org