Archive for the ‘informed consent’ Category

Skin Cancer Prevention: The Dangers of Tanning Beds

Friday, July 1st, 2011

 

Image from hometanningbed.com

In my last two posts, I have examined the various types of skin cancer, their prevalence and survivability rates, and some prevention methods. Today, I will focus on another major risk factor for skin cancer. The use of tanning beds or “indoor tanning” greatly increases a person’s risk of developing skin cancer. It is a completely voluntary exposure to UV radiation, and yet many people choose to expose themselves despite all of the risks.

Known Dangers of Tanning Beds

Here are just a few statistics about indoor tanning from the Skin Cancer Foundation:

  • “Ultraviolet radiation (UVR) is a proven human carcinogen. Currently tanning beds are regulated by the FDA as Class I medical devices, the same designation given elastic bandages and tongue depressors.
  • The International Agency for Research on Cancer, an affiliate of the World Health Organization, includes ultraviolet (UV) tanning devices in its Group 1, a list of the most dangerous cancer-causing substances. Group 1 also includes agents such as plutonium, cigarettes, and solar UV radiation.
  • Frequent tanners using new high-pressure sunlamps may receive as much as 12 times the annual UVA dose compared to the dose they receive from sun exposure.
  • Ten minutes in a sunbed matches the cancer-causing effects of 10 minutes in the Mediterranean summer sun.
  • Nearly 30 million people tan indoors in the U.S. every year; 2.3 million of them are teens.
  • On an average day, more than one million Americans use tanning salons.
  • Seventy-one percent of tanning salon patrons are girls and women aged 16-29.
  • Indoor ultraviolet (UV) tanners are 74 percent more likely to develop melanoma than those who have never tanned indoors.
  • People who use tanning beds are 2.5 times more likely to develop squamous cell carcinoma and 1.5 times more likely to develop basal cell carcinoma.
  • The indoor tanning industry has an annual estimated revenue of $5 billion.”

Internal references omitted

 

Horrifically, it is mainly young people choosing to use these devices despite the greatly increased risk of melanoma and other skin cancers. Given the enormous financial incentive to service young people – the industry cannot be expected to regulate itself. If they can make $5 billion dollars a year in revenue with a largely young female population, why would they stop? (Aside from morality of course…)

How to Protect the Skin – Even if You Don’t Want To

From a social perspective, there need to be some changes to the value our society places on certain skin color and beauty. This is outside of the realm of this post – but what a shame that in this century, men and woman would still rather expose themselves to harmful radiation than live life with their natural coloring (or lack thereof).

From an education perspective, I think that public awareness and an increased focus on education must continue to be one prong to battle this problem. However, clearly warnings alone are not enough. This is exemplified by a recent news story about a now 23-year-old woman who visited tanning salons three to five times a week starting when she was 16 years old.  This young woman, who despite knowing the risks of tanning continued to use tanning beds until 2009, had to endure surgeries, drug therapies and over a year of painful treatment at the age of twenty-one for the advanced melanoma that had spread to her lymph nodes. Luckily, she is now cancer-free, but living with a greatly increased risk of developing another cancer. This is a cautionary tale, but it is also an example of the invincibility thinking of many young people that makes the risks seem lower than they really are to using tanning beds.

Legal Options – Regulation

So what remains? The tanning salon industry has a financial disincentive towards preventing skin cancers, the young patrons of these establishments may not understand the risks and consequences, yet the individuals and society are going to pay the price of devastating illness, high cost medical treatments and people’s lives if the current use of tanning beds continues. That is where the legal side of this post enters. There are a number of states that have started to regulate the use of these tanning beds – at least for minors. Most states do not regulate these very heavily. The National Conference of State Legislatures has compiled regulations from many states on their website. There are a combination of approaches which generally include either banning the use of tanning beds by very young children and teens (typically under 14 or 16 – but few states have an outright ban) and/or requiring parental consent for the use by children below a certain age (typically 18, occasionally 16). Some of these consent statutes require the parent to be present (in person) to provide consent. Others allow written consent or require the parent to be present only one time in the year. Do you think that these statutes are sufficient? Should the requirements involve vivid pictural warnings like the new requirements for cigarrettes?

In Maryland, Howard County is a leader in regulating this industry. In Howard County, minors under 18 years of age are not permitted to use tanning devices without a doctor’s note stating a medical reason and allowed frequency.  These rules are not subject to a parent’s consent. Many states legislators have proposed tougher legislation in the past few years to increase the regulations on this industry across the country, but few have been successful.

Your Thoughts?

What do you think should happen with the tanning industry? Do you think that there should be an outright ban for any minors using these devises? What about adults? There are still lots of tanning customers who are young adults who are over 18. What can be done to protect them from the increased risks of skin cancer? Is public education sufficient? Could it be done better?

Related Posts:

Skin Cancer: Types, Causes and How to Protect Yourself

Skin Cancer Prevention: Will New FDA Rules Help?

Skin Cancer Videos

 

Week in Review: If you missed this past week’s blogs – catch up!

Sunday, April 10th, 2011

This past week was a busy one for our bloggers. It was also a very busy week in our law practice. Over the last two months, we have also had two new lawyers join us – Sarah Keogh and Jason Penn. Sarah has contributed a number of posts already. Jason , who just started this past Monday, will soon be sharing his contributions, thoughts and comments with you as well. We’re very happy to have both of them. I’m sure you join us in wishing them a very warm welcome.

Last week our writers covered a number of topics related to health, medicine, child safety, medical technology and patient safety. We started the week off with a piece by Brian Nash on some key facts women need to be aware of when having an epidural for labor, delivery and post-partum pain relief.

Epidurals

There can be no doubt that thousands of epidurals are administered to women every day throughout this country. This form of analgesia (pain relief) has become probably the most popular form of anesthetic management and apparently is generally believed to be essentially risk free. As this week’s piece, Having an epidural when you have your baby? 3 questions to ask the doctor, reports, some literature gives the figure of complications from epidurals as high as 23% - ranging in severity from minor inconveniences, to life-long major disabilities and even death.

This particular piece was written as a result of several cases in which we have been involved when women, who had undergone an epidural, became essentially paralyzed from the waist down. We raise some questions for women to ask the doctor and suggest they just might want to ask those questions before they find themselves in the process of labor or when they are going through the recovery phase of having given birth to their baby. We believe it’s an important piece for women – and frankly for all – to read so that they have a much better idea of what they should expect with an epidural and what the risks and benefits are of this wonderful yet potentially life-altering anesthetic technique.

Shaken-Baby-Syndrome

On Wednesday, Jon Stefanuca again brought to the public’s attention a problem that is probably as old as childbirth. Everyone who has had the experience of taking care of a child – particularly a baby – knows that along with the joy of parenting comes the physical and emotional toll on parents and care-givers. The human condition makes us all susceptible to being less than completely tolerant, forgiving and gentle with little ones when we are under stress, frustrated or just plain exhausted. The response to the persistent crying can simply not be “a good shake.”

Medicine and science (and unfortunately the courtroom) have given a name to a syndrome of injury babies can suffer when that “just a good shake” approach is used. While a parent or care-giver may think it unimaginable to strike a child, they may not realize just now much harm they can do with “just a good shake.” Jon brings this information and some expert tips and tricks on how to deal with these difficult times parents and care-givers face in their everyday lives in his piece Shaken Baby Syndrome – What we all should know to prevent child abuse.

Makena: New Anti-Prematurity Drug

Thursday, Sarah Keogh reported on a relatively new drug called Makena, which has been found to help pregnant women, who have previously had a premature infant. I say “relatively” since according to Sarah’s piece, a compounding pharmacy could and was making this medication prior to the FDA giving K-V Pharmaceutical Company the exclusive rights to manufacture this drug for a period of 7 years.

Read Sarah’s piece, Makena: Drug to fight prematurity leads to major firestorm, and see what the controversy is all about. How could people possible be upset with a drug that can fight premature birth? Prematurity is one of the major causes of significant childbirth injuries such as cerebral palsy. Sarah’s blog makes it all too clear why people are upset and why the March of Dimes withdrew its sponsorship for Makena.

Medical Technology and Patient Safety

The week ended with Part II of my series on medical technology and whether all the new toys, bells and whistles of our modern healthcare system are truly advancing safe, efficient and effective delivery of healthcare. The week’s piece focuses on perhaps one of the largest advances in the healthcare industry – electronic medical records (EMR).

The blog, Medical Technology and Patient Safety – Part II – EMR’s (electronic medical records), brings a lawyer’s perspective to this topic. Much has already been written – and frankly will continue to be written – about EMR’s by the medical profession. Controversy has filed the pages of journals and at times probably slowed traffic on the internet (okay – maybe that’s a bit of an exaggeration) since this new marvelous technological advance was rolled-out in our medical institutions.  Those writing and fighting about it have been the end-users themselves – the medical professionals, who have to deal with the issues and flaws that have surfaced with this wonderful new technology. I thought it was about time to tell you how this plays out by another end-user – the lawyer who now deals with EMR’s. This piece is also intended as the foundation for what we as lawyer have seen play-out in terms of patient safety and health as a result of EMR implementation.

Sneak Peak of the Week Ahead

I anticipate that next week we’ll be seeing Jason Penn with his first blog on a recent report about numerous safety violations by hospitals in our practice jurisdictions – Maryland and Washington, D.C. Mike Sanders will be bringing to our readers aN old but back-in-the-news report on super infections, which still seem to be – unfortunately – thriving in our nation’s hospitals. We’ll start off this coming week with a piece by Theresa Neumann, our highly acclaimed in-house physician’s assistant expert, on spinal stroke. We all know about strokes that can damage the brain. Theresa will be sharing her insights on an equally devastating stroke of the spinal cord. I also suspect – shhh – that we’ll be reading more from Sarah Keogh this coming week. If the practice of law doesn’t get too much in the way, I am also hoping to share with you some real life examples – from a lawyer’s perspective – of just how EMR’s may not be advancing the causes of patient safety and health.

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Lap-Band (Weight Loss) Surgery: is it for you? FDA clears new Allergan system and opens door to more patients

Monday, February 21st, 2011

The FDA recently approved Allergan’s Lap-Band weight loss surgery (which is a form of what is known as bariatric surgery). By its 8-2 vote, the FDA cleared the way for patients who are significantly less obese (BMI of 30) than those who would have qualified for weight loss surgery before this recent approval.

Knowing that this controversial clearance vote was on the horizon, major news networks aired stories on the pro’s and con’s of “broadening the base” of patients, who would now qualify. Here’s a report by ABC News’ Diane Sawyer in December 2010. (Sorry about the lead-in ad. If it were not a good report, I would have found something “ad-less” to present the issue!)

With the FDA’s announcement came somewhat of a firestorm of criticism. As reported locally in the Baltimore Sun (actually written by Thomas H. Maugh II of the Los Angeles Times), the approval has raised “concerns” by many in the medical community, who fear that this surgery will now be seen as a “quick fix” to the obesity plague in this country.

“I’m very concerned,” said Dr. Ted Khalili, former director of bariatric surgery at Cedars-Sinai hospital and founder of the Khalili Center for Bariatric Care in Beverly Hills. “You can’t be driving down a street and have a flashbulb go off and think that this will be an easy fix.”

What Dr. Khalili seems to be referring to is a marketing drive that directs patients to clinics that perform the procedure using the Allergan device. Here’s (to the right) a photo that shows exactly what this is all about.

Patient deaths following procedure lead to litigation in California

Maugh reports in his piece in the LA Times that four patients have died following the Allergan lap-band procedure. Lawsuits have followed. In a related article by another Los Angeles Times reporter, some details emerge.

Laura Faitro of Simi Valley died July 26, 2010, five days after surgery at Valley Surgical Center in West Hills. Three other patients have died shortly after surgery at an associated center in Beverly Hills, relatives have alleged in lawsuits and interviews.

Supporters speak out as well

While there are many who have decried the FDA’s approval and the lowering of the qualification standards to undergo this new lap-band procedure, there are certainly those who are in support of its potential therapeutic effects:

For those with Type 2 diabetes, the Lap-Band could be an immediate fix. “This operation takes about an hour, and two days in the hospital, and these people go off their diabetes medication. It’s unbelievable,” Dr. Walter J. Pories, a professor of surgery at East Carolina University and a leading researcher on weight-loss surgery, said in this L.A. Times report.

All surgery – including this new lap-band procedure – has significant risks

Whether one should consider taking advantage of this new procedure is a matter between the patient and his/her surgeon. After advising that not all risks or complications of undergoing this new procedure are listed in its website overview, the product’s manufacturer, Allergan, provides the following information:

Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.

Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

While many people seem to be intrigued by a “quick fix” surgical method of weight loss, some necessary clearance hurdles stand in the way – and should! Allergan is requiring all surgeons who want to order and perform surgery with the manufacturer’s new device “to first complete a comprehensive proctorship and training program, have advanced laparoscopic skills and (we believe this is key) have the staff and resources needed to comply with the long-term follow-up requirements of obesity procedures.”

I would add here that in our experience of handling lawsuits involving catastrophic injuries and death claims following bariatric procedures, issues relating to selection of proper surgical candidates and post-procedure follow-up and compliance have many times been at the core of these cases.

Not a “quick fix” replacement for exercise, diet and possible medication

As anyone who has been involved in any manner with issues relating to bariatric, weight-loss surgery, this is not the first step to be taken toward losing weight. Sure, it sounds enticing to go into a clinic or hospital, have a one hour procedure, and all your weight issues are a thing of the past. First of all, that is not how this works at all. Pre-procedure clearance does and must be taken seriously and not be a mere sham.

There is no doubt that there is a financial benefit for the providers of this procedure; it is reported that it will cost approximately $25,000 for the device, surgeon and operating room costs. It is also said that many insurance policies may cover all or part of this cost. That being said, even Allergan cautions that this is not a drive-by way to achieve weight loss. Read its Lap-Band System Fact Sheet and Lap-Band Labeling and Safety Information if you are interested in knowing more about the indications, alternatives, risks, benefits and advantages of this newly approved system. In addition, make certain that the surgeon you are consulting meets the qualifying standards of the manufacturer. Ask questions – it’s your body, your life.

As a side note, in case you are wondering if your BMI qualifies you for consideration of this procedure, here’s a handy BMI calculator made available online by the National Heart Blood Lung Institute – Calculate your BMI.

Know anyone who has had this or other forms of weight loss surgery?

If you or someone you know has undergone a procedure involving this new device by Allergan, share your story with our readers. If you or someone you know has undergone bariatric surgery, we also invite you to please share your story of how this worked for you or those you may know. Has it changed your or their life? If so – for the better or worse?

A Surgeon’s Sleep Deprivation and Elective Surgery – Not a good (or safe) combination

Friday, January 14th, 2011

The New England Journal of Medicine published a Perspective on December 30, 2010, that screams common sense and should be embraced as a starting point to implement some new patient-safety standards of practice.

Place yourself in the position of a patient getting ready to undergo an elective (i.e. non-emergency) surgical procedure. You’re wheeled into the operating room for your surgery and are greeted by your surgeon in the process. Your mind is focused on just coming out alive and better than when you went in. What you don’t know, however, is your surgeon has been up all night handling a busy call schedule. If you knew he/she was dead tired as any human being would be under the circumstances, would you really want this surgeon operating on you? If you don’t care, then this post is really of no interest to you. If you do care, then read on.

Well, you’re still reading…so you must have some level of concern for your safety. Good for you because here’s a startling number in terms of adverse incidents when involving sleep deprived surgeons:

Researchers have documented the adverse effects of sleep deprivation and sleep disorders on individual performance. In surgery, there is an 83% increase in the risk of complications (e.g., massive hemorrhage, organ injury, or wound failure) in patients who undergo elective daytime surgical procedures performed by attending surgeons who had less than a 6-hour opportunity for sleep between procedures during a previous on-call night.

Note that this relates to elective surgery – you elected to have it; it is not an emergency. Sure, if the surgery has to be rescheduled, that’s a major inconvenience and not emotionally satisfying after you have prepared yourself for the “magic hour” when you are to be taken to the operating room. In most surgeries, you have not been allowed to eat since midnight (NPO status) if you are going to be anesthetized during your surgery. But let me ask – would you rather be inconvenienced or suffer from “a massive hemorrhage, organ injury, or wound failure” – to name but a few of the things that could go wrong at the hands of a sleep deprived surgeon?

The NEJM article reports that “most patients would be concerned about their safety if they knew their doctor had been awake for the prior 24 hours.” I really don’t think they needed a survey to reach that conclusion. Do you?

So how is this risky situation supposed to be avoided? Are you supposed to ask your surgeon: “So did you get a good night’s sleep?” Or – “How you feeling today, Doc? Well rested?” While some more assertive patients might take this approach, way too many, I’m afraid, would just “trust” their doctor to know  better than to operate under such a condition and advise the patient now is not a good time for him/her to do the surgery. In an ideal world, that’s what should happen – but we don’t inhabit such a world now do we? For whatever motivation – some good; some not so good, I sincerely doubt this is going to happen and certainly should not be the standard. In fact, the following excerpt from the NEJM piece addresses this very issue – at least in part:

Chronic sleep deprivation degrades one’s ability to recognize the impairments induced by sleep loss.5 Sleep-deprived clinicians are therefore not likely to assess accurately the risks posed when they perform procedures in such a state, and they should not be permitted to decide whether or not to proceed with elective surgery without obtaining the patient’s informed consent.

That’s a start, but frankly, I’m not really a big advocate of this approach. Obtaining my informed consent? So what happens – I’m told as I’m awaiting my surgery that my doctor has been up all night and the prior day. He then asks, “Are you willing to have your surgery anyway?” I then ask: “Well how are you feeling? Are you up to doing this?” If I get an affirmative response, why should the burden be on me (read: YOU in this scenario) to make a decision if it’s alright to proceed?

I much prefer the primary suggestion of the authors:

As a first step, we recommend that institutions implement policies to minimize the likelihood of sleep deprivation before a clinician performs elective surgery and to facilitate priority rescheduling of elective procedures when a clinician is sleep-deprived. In addition, patients should be empowered to inquire about the amount of sleep their clinicians have had the night before such procedures.

While I say I “prefer” this approach of “implementing policies to minimize the likelihood of sleep deprivation,” I would modify this “recommendation” to read – “to implement policies to eradicate the likelihood of sleep deprivation or in those instances where certain “sleep guidelines” have not been met, to mandate the rescheduling of this elective surgery. Note that the latter part of this “first step” recommendation puts the burden back on the patient “to inquire about the amount of sleep their clinicians have had the night before such procedures.” Same issues; same problems. The patient should not be put in this position. The hospitals ought to be protecting the patient in such situations, not empowering them – whatever that means!

This is a problem whose solution is not that complex. It is a problem whose solution is way too long overdue. I would urge the medical profession and hospital  administrators to stop trying to be “balanced” on this issue. Sure it’s an inconvenience for all concerned. No doubt this can wreak havoc in terms of a hospital’s operating room scheduling. Too bad! Figure out ways to deal with “call schedules” then. Don’t place the onus on the patient. The health industry claims it is constantly in search of ways to improve safety. Well isn’t this a pretty simple issue to tackle if that’s the case?

What are your thoughts on this issue? Would you be concerned if the person holding the surgical instrument for your procedure has sleep deprivation? Would you ask the questions about their sleep patterns or how much sleep they got the night before? Should this be a patient’s burden? What policies make sense? Share your thoughts with our readers. Maybe – just maybe – the right people might read your comments and come up with some solid policies to protect all of us in such circumstances.

Image: peoplespharmacy.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

$8 Million Verdict in Fosamax trial – Jawbone Destroyed By Drug

Thursday, July 22nd, 2010

A landmark verdict against the pharmaceutical giant Merck was recently rendered in a Fort Walton Beach Florida courtroom.  It should raise wide-spead public concern over the safety of drugs called bisphosphonates prescribed for mostly women as treatment for osteoporosis and osteopenia.  Bisphosphonates  are a drug classification that includes Fosamax, Fosamax + D, Aredia, Boniva, Didronil, Actonel, Actonel + Ca, Reclast, Skelid,  and Zometa.

Limited news reports tell the story of Shirley Boles, a 72 year old great grandmother and retired sheriff’s deputy, who was taking the drug Fosamax for osteopenia.  The condition of osteopenia is a normal thinning of the bones as a person ages.  It does not typically result in bone fractures unless it progresses to the disease osteoporosis. Current medical practices recommend treatment to prevent the development of osteoporosis.

Ms.  Boles also had a history of periodontal disease and smoking. She began experiencing jaw problems after taking Fosamax over a 10 year period of time.  She ultimately needed extraction of two teeth. Following the extraction, a very serious  condition called osteonecrosis of her jaw was diagnosed. In essence, the bone in her jaw disintegrated and died.  Jurors witnessed the physical decaying bone matter and infection seen from two drains in her chin. They heard how Ms.  Bales only eats soft food and will need to undergo repeated surgeries to replace her dead jawbone.

How the condition osteopenia went from a research term to an actual disease classification for some people and not others, and how Merck advanced their money-losing drug Fosamax to treat the new disease is a fascinating read.

NPR broke the story during Christmas 2009.  That same month, it was also reported that 10 million people in the United States had osteoporosis and most were women.  That same year,  45 million bisphosphonate prescriptions were written in the US generating $4.9 billion. Given the holiday season, one must wonder how many people actually became aware of this story.

The tale actually begins with the publication of an article released by the Wall Street Journal in December 8, 2004.  The story noted that in 2001, the Chief of Oral Surgery at the Long Island Jewish Medical Center, Dr. Salvatore Ruggiero, began recognizing a distinct pattern of osteonecrosis and jawbone death in 8 cancer patients taking the drug Aredia to combat bone loss.  He reported his cases to the FDA. He continued to track 90 of his subsequent patients, who developed jawbone osteonecrosis while taking Aredia and Zometa.  During this period, other oral surgeons were also reporting the same findings, including the Chief of Oral and Maxillofacial Surgery at the University of Miami’s Miller School of Medicine, Dr. Robert Marx.

The drug company Novartis, which makes Aredia and Zometa, first reported the side effect of osteonecrosis of the jaw (ONJ) on drug inserts in 2003.  By 2004, Novartis had received 500 reported cases in cancer patients taking Aredia and Zometa.  In September 2004, the FDA issued their first warning associated with intravenous bisphosphonates. In June 2006, the National Osteoporosis Foundation put out a Scientific Statement that ONJ associated with bisphosphonate therapy was seen 95% of the time in cancer patients and only rarely in the general osteoporosis patient population.

Ms. Boles did not have cancer.

The American Society of Oral and Maxillofacial Surgeons (ASOMS) put out a clinical position paper in September 2006. Their clinical research found increased risk factors for ONJ in those receiving both intravenous AND oral bisphosphonates.  There was a definite risk increase in patients taking the drugs for more then 3 years, but ASOMS concluded more study was needed. In addition, ASOMS noted a seven-fold increase in patients who had a history of periodontal disease and oral abscess. Diabetes, smoking, and alcohol also increased risk.

Current drug inserts and patient information do not list (ONJ) in drug contraindications or warnings.  However, under general precautions the inserts say ONJ can “occur spontaneously in association with tooth extractions, dental implants, and bony surgery.  It can also occur in cancer patients receiving cancer treatments.  Persons at risk include those with poor oral hygiene, periodontal disease, pre-existing dental disease, anemia, coagulopathy, and ill-fitting dentures.”

In 2009, an article was published in the Journal of the American Dental Association involving the University of Southern California dental clinics.  The results were even more alarming.  The researchers found out of 208 patients taking the drug Alendronate, also known as Fosamax and sold by Merck, nine had active ONJ.  This represented 1 in 23 patients, 4% of the general dental clinic population.  The researchers concluded the incidence may be much higher then previously reported, and the risk appears great even in short term users.  The study author noted there was a 10 year half-life of the drug remaining in bone tissue.  So dentists and patients need to be alerted to the risk remaining over a period of time.

Faulty drug design was the basis for Mrs. Boles $8 million dollar verdict.  Merck plans to appeal.  In the meantime, how many woman taking bisphosphonates remain uninformed of this potential risk?

Why don't patients ask questions of their doctor?

Monday, May 31st, 2010

My wife came back from a doctor’s appointment the other day, and immediately, I noticed that she looked puzzled and somewhat confused. So, I asked her about her appointment.  She went over her discussion with the doctor as I kept probing with questions about their conversation.  I found myself asking the following question more than any other: “Well, did you ask him about…?” Before too long, doing what I do for a living, I could not help but wonder why patients aren’t more inquisitive. Is there something about the patient-doctor relationship that makes patients not want to ask questions of their physicians?

Surely, the primary responsibility for gathering information about the patient’s medical conditions is and should be with the physicians. After all, their knowledge of medicine is vastly superior to that of the average patient. Still, when a patient has questions, there is often no good reason not to ask them. Consider a physician who orders hormone replacement for a female patient with a history of blood clots or hypercoagulability of which the physician is unaware. Consider another patient who develops a series of complications after a surgical procedure but who decides to tough-it- out and not ask any questions during follow-up appointments with the physician. In both of these examples, the patient risks developing potentially life-threatening conditions, and, if the patient knows or suspects that possibility for whatever reason, it is probably not a good idea to assume that the doctor will be the one to ask the right questions. So, why are patients sometimes reluctant to ask more questions about their medical care or condition?  I don’t presume to know the answer, but I suspect, in part, it has to do with the patient’s expectations.

For example, when I am pain, I don’t really want to have an extensive Q & A session with my doctor. I just want treatment!  It is simply mentally relaxing to just let go and have someone else take care of me. In addition, my knowledge of medicine is superficial at best. I don’t feel comfortable asking questions if I don’t know what I am talking about. My ego would rather have me in pain than allow me to question a doctor at the risk of looking like a fool.

On a subconscious level, I am probably also dealing with preconceived notions about doctors.  As long as I can remember, I have been told that doctors are intelligent and in control. After all, who else is capable of getting into medical school and then have the stamina to survive some seven to ten years of medical training? All of this makes me think that my doctor can only make the right decisions about my medical care. And then there is the medical office or the hospital. The smells, the patients (most with problems far worse than I have), the complicated machines that look like they belong in a sci-fi movie don’t exactly add-up to a familiar, comfortable environment.  I am in pain, uncomfortable, and somewhat intimidated – not exactly an environment conducive of critical thinking.

Well, if this is how other people feel, I think that might explain why patients are sometimes not as inquisitive as they should be.  What do you think?  If you are a patient or a physician, your feedback is much appreciated. Of course, everyone is welcome to comment.

Contributing author: Jon Stefanuca

Editor’s Note: This piece was written by Jon Stefanuca. My own wife has an advanced degree in pathology, did surgical pathology and autopsies. She DOES ask questions! Do you really need a medically-related degree, however, to ask the basic questions so that you have a clue what you’ve just agreed to by way of medical care? I think not. Moral of the story: be your own patient advocate! If you need help, then have a family member or a close friend accompany you if you have any doubt.

Best Hospital Rankings – A reply to Dr. K – what's best for YOU?

Thursday, May 13th, 2010

As readers of our blog know, Dr. Kevin’s blog serves as the source for a number of our posts. Recently, Dr. Kevin posted somewhat of a spin-off -Top hospital rankings doesn’t mean the best medical care | KevinMD.com – of a post he had done earlier about “Top Doctors” does not equal (necessarily) “Best Doctors.” Then today, as I was going through my News Feed on Facebook, lo and behold, here it is again.  I agreed wholeheartedly with him then and  now, and I find myself saying “Amen” to his post.  Problem is – what is the answer, Dr. K?

Check out his blog. He identifies the issue, but does he really suggest the answer? My humble opinion: afraid not!

Let’s explore some ‘tips and tricks’ for you to get close to the right answer. I say ‘close’ because there really is not a perfect answer. If you get great care and all goes well, then that was the best hospital for you and your problem. These after-the-fact answers are always 100% accurate when seen through the best medical instrument available – the retrospectroscope. If you are interested in some tips and tricks for picking an institution for future, non-emergent care, read on.  Let’s see if we can provide you some guidelines for your selection process.

Having been involved with issues relating to the care rendered at numerous hospitals in Washington, D.C., Baltimore and far beyond for many years, I have my own personal opinions where I would go to be treated and where I most assuredly would not go.  In fact, I have often joked that I need to get a medical alert bracelet reading – ‘in event you find me unresponsive do NOT take me to Hospital X (fill-in the blank).”

Lawyers doing medical malpractice have a pretty darn good sense of which hospitals give the best care.  Does the general public? As Dr. Kevin points out, reputation and marketing of that reputation is not the end-all-be-all of defining which hospital (also insert ‘doctor’) gives the “best medical care.”

There’s a certain hospital here in Baltimore that is constantly listed as the “Best.” While that institution does have some of the ‘best’ doctors and allied health specialists, it is also well known to provide substandard care at an alarming rate. The local maxim goes – “If I wind-up having a rare disease, that’s the place I want to go for treatment; however, if it’s garden variety, no way – no how!” Why? Just too busy, too arrogant, not patient- friendly, too willing to turn patient care over to resident-staff-only surveillance and so on. Maybe they are just bored by the ordinary health issue – not complex enough. Who knows?

But here’s the catch – just as ‘top hospital’ rankings doesn’t mean (necessarily) best medical care, nor does overblown reputation mean that there aren’t some, if not many, outstanding physicians at these same institutions. Titles, marketing banners and magazine covers simply do not answer the search for the best institution for your care.

Let’s face it, in an emergency situation you are going to the nearest available institution at least until you are stabilized medically. Whether you elect to stay there for ongoing care may well be a different issue. The more common situation you will probably face is when you are going to undergo elective procedures or care.

Since you are reading this blog, you undoubtedly have a computer. Have you done your homework? Going online to learn more about your medical condition is a good place to start. No, I’m not suggesting you check-out what ranking your doctor or his/her hospital has; that information is precisely at the heart of the problem.

Let’s take one example of putting research into the decision-making process. An obese patient determines that he/she would benefit by bariatric (weight loss) surgery. Putting aside those who see this as a quick-fix alternative to Jenny Craig or Weight Watchers, John Doe (J.D.) – our hypothetical patient – might consider researching the various forms of bariatric surgery. Does J.D. know if he should have gastric bypass surgery or gastric banding? If gastric bypass, does his doctor specialize in open procedures or laparoscopic surgery? Does he know the different approaches a doctor can take? What are the risks of malabsorption or the post-operative complications associated with that form of surgery? Had J.D. just typed in “bariatric surgery” in whatever search engine he likes, he would see there is a world of information out there about the types of bariatric surgery, the risks associated with such surgery and so on. Did that handout he received from his doctor really fully educate him on the alternatives to what was recommended to him?

Okay – let’s focus on J.D.’s surgeon. Does he/she have a ‘preference’ for doing open versus laparoscopic procedures? When is the last time, if ever, he/she did one laparoscopically? Consider: did J.D. think that might be the reason why he/she is recommending J.D. undergo an open Roux-en-Y? Is this really in J.D.’s best interest?

Let’s put you in J.D.’s shoes. Would you ask your prospective surgeon what his/her complication rate is? How about  mortality rate? If you think surgeons don’t know their morbidity/mortality rates, think again. What is the most frequent complication your surgeon  encounters following the surgery or treatment you are considering? Are you, for some reason, at greater risk than other patients for encountering this risk?

Hopefully by now you get the drift. This is your body – protect it! Last time I checked, we’re only here one time around. If your doctor makes you feel ‘uncomfortable’ because of his/her reaction to your questions or  the time it takes for  you to understand what you are agreeing to undergo surgically or medically, that might just be a telltale sign to move on.

Best Doctor/Best Hospital? Hopefully, by doing your homework and having a meaningful discussion with your doctor and understanding better the hospital where this will all be taking place, you will determine exactly who is the “best doctor’ and which is ‘the best hospital‘  for YOU! At least this approach will give you a better chance of a good outcome and experience than making your choice based on a title, magazine cover or a banner hanging on the hospital’s facade.

By the way, the same can be said of lawyers. Are we listed as the ‘best’ and ‘super’? We sure are, but you should ask us (or any lawyer you have occasion to meet) the same type of tough questions. Be pro-active. You’ll be better-off for it.

Have you ever wondered how people get in clinical trials? Well, you should check this out.

Monday, April 26th, 2010

Are you aware of clinical trials that may be in your neighborhood? I just happened to come across this link to clinical trials.  Perhaps you are a lot more savvy than I (which would not surprise me one bit), but you can get ongoing information on these clinical trials by going to a website called Clinical Connection.

For example, there’s one in Baltimore for overweight folks being conducted at Harbor Hospital involving a new investigational medication.

In fact, if you go to this link, you will see that there are over 15 clinical trials for all types of conditions in the Baltimore area alone. If you are willing to travel 50 miles or less, there are even more in which you can enroll.

Do you have moderate or severe pain from osteoarthritis of the hip or knee?  Well Annapolis just might the place for you to visit and try out a new drug.  You have to be  over 18 years of age and according to the website, “study participants may be compensated for time and travel. All study-related care is provided at no cost and health insurance is not required to participate.”  I don’t know what “may be compensated” means – but if you are interested, check it out.

On the national level, the home page of Clinical Connection says there are 105,555 clinical trials underway – and there’s probably at least one in your neighborhood.

Do you suffer from chronic low back pain of greater than 3 months duration? That’s right – there’s a trial for you taking place at 7 locations, including California, Arizona, Florida, Washington and Nevada.

You name the condition – there just may be some free study out there waiting for you to volunteer.

These programs undoubtedly have very extensive packets of information about the study guidelines and the risks and benefits of the drug or therapy under study.  These trials are called clinical trials since the manufacturer has presumablyjumped over the hurdles of early non-clinical research in order to take the next step – how does our product work with real people?

Make sure you understand what you are signing up for before doing so.  Who knows, it may turn out that you get some real benefit from participating – hopefully you will not be a statistic in terms of adverse outcome. Just take time to understand what you are getting yourself into and what rights you are waiving.  If you’re good to go, we wish you well!

"Top doctors may not always be the best physicians" via @KevinMD – A Commentary and Some Tips

Monday, April 26th, 2010

OK – so I’m a bit late with this one – since it was posted on April 21st – but sometimes even an ‘old’ post is worth a comment or two.

Dr. Charles writes in his post Top doctors may not always be the best physicians

Some of these doctors are excellent, but many are simply “notable.” They may be well-connected, in leadership positions, or presidents of this or that society. Many are excellent self-promoters, branding themselves through the name brand institutions they work for and the billboards that increasingly advertise their faces. Many are simply well-known or popular among their peers.

Well, he’s spot on with that one.  Of topical interest perhaps in the legal arena is that unless the opposing lawyer isasleep, objections in a courtroom to the question – “Doctor, have you ever been listed in (fill-in the name of the local magazine that rates physicians) as a ‘Top Doctor’?” are universally sustained by the judge.  Maybe judges understand better than the public that ‘Top Doctor’ status may not really be relevant to a physicians ‘expertise’ in a given subject area.

Before going any further, let it be said, however, that many times “Top Doctor(s)” are just that – they are some of the best  in their given specialty or subspecialty.  But how does the public know which ones are the entrepreneurial self-promoters and which ones are the real deal?  I might suggest that if you read Dr. Charles’ piece that you not stop until you read the ‘Comments.’  Here’s just a sample:

This from a gentleman named Kevin Falchuk, who provides the disclaimer – “I think you make excellent points, and this is coming from me, the President of a company called Best Doctors. We’re responsible for creating some of these lists.”

With that said, Mr. Falchuk notes:

[T]he issue in medical care isn’t your doctor’s reputation. Instead, it’s the extent to which he or she is able to spend time with you, think about your problems, and render good advice.

Let me add a few other suggestions:  While you are spending time with your doctor, if you are dealing with a life-threatening or potentially life-altering condition and not just the common cold, you may want to find out what his/her experience is in dealing with your condition.  In the right situation ask – is a referral to a specialist advisable? Perhaps a second opinion? If a course of treatment is recommended, are their alternatives?  What are the risks and benefits to each approach?  Does the recommended treatment have any known and likely side-effects?  Is there anything in your medical history that puts you at greater risk for known complications?

While it is never a good idea for a lay person to diagnose himself/herself, if you are recommended a course of treatment or a surgical procedure, perhaps you might consider educating yourself on what’s out there as far as information about the risks, benefits and alternatives of a procedure or treatment plan.  If you do and you have questions, contact your physician and ask about your concerns. However, sage advice on this approach might be – “If you trust Google more than your doctor then maybe it’s time to switch doctors.” Jadelr and Cristina CordovaChasing Windmills, 08-21-06

I suspect that somewhere during the course of the informed consent discussion with your physician, you or a family member will get a pretty good sense of whether the physician with whom you are speaking is the person for you and truly is one of the Best Doctors for your condition and treatment.

There’s a lot of talk about the medical profession learning how to improve on patient satisfaction. Why should you care if others think your doctor is tops or the best in some magazine?  While this may be a way to initially chose from the dozens of specialists in any given area, it should not be the end of the search.  Choice of physicians – as with any group – yes, even lawyers – is there for you.  Once you are in that physician’s office, only you can decide if he/she is the best doctor for you and you alone.  Also – keep in mind that not all the best doctors (or lawyers, or candlestick makers) are listed in such publications.  Whether your doctor is or is not is perhaps of no moment.  I have always believed in a system that is based on common sense – be an educated patient, ask questions, listen to the answers and follow your brain and your heart. While it does not guarantee a great outcome, you will have at least done what you can do to make sure that – your doctor is the best doctor for you!