Reflections from the Front: Conflicts of Interest

Reflections from the Front: Conflicts of Interest

Conflicts of interest are an ever present concern in scientific and medical research. One cannot listen to any CME lecture at your local hospital without being informed as to the speaker’s potential financial conflicts of interest.

Oncology research, in particular, poses some unusual risks. We long for breakthroughs in cancer treatment, but we sometimes forget the inherent conflicts of interest that arise when a treating physician also functions as a principle investigator.

I recently heard of an institution that was planning to compensate oncologists for each new person they were able to accrue into a protocol study. Dubious as to the ethics of this decision, I contacted several ethicist friends of mine, who each were equally concerned. A brief internet search revealed two pertinent documents. 

A white paper from Seton Hall Law School suggests, “In order to avoid a disincentive for physicians to conduct research, compensation for clinical trial work should include delineated reimbursement for expenses, such as screening interviews or tests and data monitoring and reporting, that do not arise in the clinical context.” In the next paragraph, however,  it states, “The federal government should bar the following: …any payment methodology that conditions payment for expenses attendant to screening potential participants on the individual enrolling in the trial, and all bonuses for recruiting or retaining a certain number of participants.”  [http://law.shu.edu/programscenters/healthtechIP/upload/health_center_whitepaper_nov2009.pdf]

“Informed Consent of Research Subjects,” by Partners Human Research Committee reads, “If subjects are to be enrolled from the investigator’s own patients, consent procedures must be put in place to ensure that subjects do not feel obligated to participate because the investigator is their treating physician. There is always concern about the possibility of patients feeling obligated to participate because it is their physician who is doing the asking…Researchers are asked to think about this issue and address it.” [http://healthcare.partners.org/phsirb/infcons.htm]

Here are two, of many, ways to address the conflict of interest associated with compensating physicians for accruing patients to study protocols:

1)      By including in the consent documentation a statement such as, “Physicians enrolling and managing patients under this protocol receive compensation to cover their additional duties.”  While this will not eliminate all conflict of interest, it will achieve transparency, as in the CME lecture scenario, above.

2)      By having the treating physician neutrally inform patients about possible studies when appropriate. If interested, patients would be referred to another independent professional who would review the protocol with the patient, and then having this second person sign off on having them enter the protocol. This would limit the degree of coercion currently possible under the typical consent procedure. The second physician could bill under a counseling or education code, or be nominally paid for their work by the parent organization. Thus, this would remove a disincentive for having the discussion—extra uncompensated work—and would allow for unbiased risk and benefit counseling. If the patient then enters the study, management could be performed by the original oncologist.

While it will never be possible to remove all hints of conflict of interest, we should strive to provide our patients with clean, un-coerced and non-coercive information on which to base difficult clinical choices.

 

 

Reflections from the Front: Throughts from a Marriage Expert

Reflections from the Front: Thoughts from a Marriage Expert

Dr. Emerson Eggerichs and his wife, Sarah publish and speak on Love and Respect, http://loveandrespect.com/, aiming to strengthen marriages by applying the principle that men and women have different needs in marriage. While both men and women want both love and respect, they preach women have a greater need for love, and men for respect.

They use several catchphrases to make their points, including: a) “Pink and Blue, not wrong, just different,” b) “Not communication, but mutual understanding,” and c) “80:20.”  As I thought on this, I rediscovered the obvious—books on marriage are primarily about relationships, and lessons learned there apply directly to patient care.

“Pink and Blue, not wrong, just different,” states that men and women see the world through different lenses. This certainly is true of physicians and patients. We need to constantly try to put ourselves in our patients’ shoes and ask if we are talking to ourselves, or engaging them from their perspective. Are we answering their true, but unspoken questions: How will this medicine affect my pocketbook? Are there non-medicinal interventions that would be more helpful? Could he say that in a more straightforward, comprehensible way? I wish my wife was here to hear this. Their positions and interests will differ from ours.

“Not communication but mutual understanding.” A Palliative Medicine principle for discussing painful diagnoses with patients is that if the news is hard to hear understanding will require more than one visit.  When someone hears that they have ALS, or their spouse has a terminal brain cancer, cognitive processes shut down, and further explanations of the disease are often pointless.  Websites or written educational material may be helpful after the initial shock wears off, but a follow-up visit in three days will promote greater understanding than an immediate 40 minute lecture. You may think you are communicating, but mutual understanding isn’t occurring.

“80:20,” is a reminder that most of the time (perhaps 80%) for many of us our marriages are rewarding and fun. When we become focused on the 20% that requires more obedience, effort and compassion, we can become irritable, disappointed, or envious of other relationships that appear to be more satisfying. As a physician this can happen to us as well. Paperwork, lawsuits, the occasional unpleasable patient, and long hours can make us lose our focus: medicine as a career is a good way to help people, no one is always happy with their work, and God called us to this vocation. We shouldn’t daydream about other life roles when he has given us a holy call. Instead of coveting another person’s spouse or home or car, we are focused on desiring their jobs, and ultimately denying that God is wiser and more loving that we could ever be.

Emerson and Sarah Eggerichs provide us with three mnemonics to improve our marriages and improve our service to Christ and others.

Reflections from the Front: Bad ideas

Reflections from the Front: Bad Ideas 

Drs. W. Sinott-Armstrong and F.G. Miller (Sinnott-Armstrong W, Miller FG. J Med Ethics (2012). doi:10.1136/medethics-2011-100351)  in a Featured Article in the Journal of Medical Ethics, entitled “What Makes Killing Wrong” write that : 

“What makes an act of killing morally wrong is not that the act causes loss of life or consciousness but rather that the act causes loss of all remaining abilities. This account implies that it is not even pro tanto [only to that extent] morally wrong to kill patients who are universally and irreversibly disabled, because they have no abilities to lose. Applied to vital organ transplantation, this account undermines the dead donor rule and shows how current practices are compatible with morality.” 

While I usually write on issues from the front, I make an exception for this reflection on an article from the literature, because of its profound implications for those of us on the front. 

This article is firmly entrenched in a view that makes no distinction between human life and other life. It employs circular logic–since we know that human life is of no greater value than other forms of life, we should treat it essentially as any other form of life–so we will. 

They predict the future–no meaningful life–for severely injured patients. Time and again, such prediction has been shown to be fraught with error. This is one of the major weaknesses of utilitarianism. It pretends to be able to predict outcomes of actions.  One of the deep truths in politics and society is the law of unintended outcomes. Well-meaning people make principled decisions that turn out very poorly because things don’t turn out as predicted. (Take Welfare laws, for instance.) 

They state “If [human] life were [sic] sacred then all life would be sacred,” but they don’t define sacred, or show good reason why this statement should be accepted. It is based on an atheistic evolutionary position (theistic evolution might still maintain that humans are distinct from animals in their moral worth) that says that since we all evolved from the slime, no human is of greater moral worth than any other living thing. Hard core environmentalists have a saying “A rat is a pig is a dog is a boy”, which allows them to ignore people affected by environmental decisions, in favor of trees, or darter fish, or whatever.  While trees are very important, people are inherently of more worth. 

They declare, but don’t effectively defend, that human worth is based solely on abilities. They never prove this point, but assume it. Most Protestants, Catholics and Jews, among others, maintain that human worth is based on our being created in God’s image, not in what we can or cannot do. 

It is hard at times to enter the public arena and be respectful of others from all positions. A typical flawed position is to state that since we can’t prove a religious position to be materially true it cannot be posited in a public debate. This is in itself, however, a faith statement, namely that God doesn’t count in these deliberations. A good book on this written a few years ago by Audi and Wolterstorff titled “Religion in the Public Square” provides an enlightening discussion of this complex issue. 

Ad hominem arguments come in various forms. These authors lump “traditionalists” (whoever they are) into one group and then paint them as backward. It is a subtle, but recurring ploy they use to preemptively denigrate the opinions of those likely to disagree with them. 

They assume that Donation after Cardiac Death (DCD) is a proven, morally acceptable position. This is still an open question and is widely debated. In 2009, Verheijde, Rady, and McGregor wrote an excellent review article (Philosophy, Ethics, and Humanities in Medicine 2009, 4:15) on the flaws of this position and called for a moratorium on DCD. When bad ideas are initially discussed people are revolted. Later, they are intrigued, then engaged, then supportive. Finally they act as if the idea is so clearly self-evident that it need not be defended. I’m not sure if DCD is a terrible idea or not, but it is not the clear best solution to our organ shortage.

 

 

 

 

Reflections From the Front: Tough Discussions

Lessons from the Front: Tough Discussions

I heard a fascinating talk today from John Hill, MD, a Carle Foundation Hospital critical care physician who discussed end of life issues with patients and families in the ICU. At times, he reminded us, we need to reframe the families’ questions. It isn’t “Doing everything” or “Not doing anything”, but arriving at realistic goals shared by the patient or their surrogates and the treating team.  Graciously navigating the recurrent renegotiation of goals based on the daily changes in the physical status of the patient is the next, and often more complex part of the process.

Advance Directives have some limited benefits in regard to outlining specific courses of action, but their most valuable role is in establishing who the appropriate proxy is for discussions if the patient is unable to speak for him or herself. Many, unfortunately, stop short at naming a proxy but do not have the necessary discussions with their surrogates about what their true wishes for end of life care are.

Prognostication is always difficult, particularly when “it is about the future”, per Niels Bohr. (I had always thought Yogi Berra said that.) This is one thing that makes these discussions so uncertain. As a physician or nurse at the bedside, nothing beats daily communications with the family to establish rapport and trust to facilitate conversations. The natural inclination for some of us, however, particularly when we are not accomplishing the hoped-for turnaround in clinical status, is to withdraw from daily ongoing family discussions. When a physician withdraws, the family gets its information from multiple, often discordant sources, worsening communication.

Withdrawing from family interactions is often a natural tendency, particularly if we aren’t helping the patient to improve. A few years ago, I was, despite my best efforts, slow in establishing a correct diagnosis in a patient with Amyotrophic Lateral Sclerosis.  My delay in diagnosis made no difference in long-term outcome, but severely impaired the husband’s confidence in my care. As this sweet lady lay dying in the hospital from a complication of her ALS, I had to daily screw up my courage, and whisper a quick prayer for wisdom before venturing back in to see her and her family.  I could have signed off the case, leaving further care to the primary care team, since I had no medical intervention to offer, but my conscience wouldn’t let me. [I didn’t bill for my last few weeks of visits with the patient.] I will never forget some of the more subtle presentations of this rather common disease, nor will I forget the way God answered my prayers for courage and wisdom in meeting the family daily.

Dr. Hill’s take home lessons?

1)      Tough conversations regarding prognosis and patient wishes are easy to avoid, but we shouldn’t give in to this temptation.

2)      The quality of the relationship and discussion with the proxy has a profound impact on the ability of the surrogate to assist the medical team in decision making.

3)      Withdrawing from a patient and family due to our own feelings of inadequacy is not only bad medicine, it is cowardly and unethical.

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Reflections From the Front: Knowing When to Say When

Reflections From the Front: Knowing When to Say When

Palliative Medicine. Many physicians become so focused on their piece of technological turf that they don’t put the patient and the real clinical issues in appropriate perspective. Often the best course of action is no further technical intervention, but a change of focus to relationships, comfort and symptom management.

I wrote this anonymized poem as I was thinking about our patient. I changed the sex, and tried to be a little vague with the medical details, but wanted to capture the main point of our encounter.

A Step Back

(The Technological Imperative)

The old man hits the wards with nasopharyngeal cancer with “mets” to the brain.

Despite any conceivable intervention, his prognosis is in weeks, not months.

And, thanks to his increased brain pressure and morphine, he is feeling no pain.

 

When he presents with systemic infection from an infected ventricular shunt,

We say

“We can fix this.”

We can SurgicallyremovethetubeTreatwithantibioticsGotosurgerytoreplacethebraintubeGobacktotheICUwithaventilatorDorepeatedspinaltapsTreatanynewcomplicationsAndhopethenewshuntremainsinfection-free.

All of which will take three weeks, and during which time

He won’t wake up enough to say Good-Bye.

Fortunately for him, he took a nosedive, and he and we were saved from ourselves.

 

Reflections from the Front: Pre-Marital Counseling

Reflections from the Front: Pre-Marital Counseling

The Doctor-Patient relationship, autonomy. Some times our patients invite us into places where angels fear to tread. We can’t rush in. But if invited in, we must consider carefully the sacred responsibility and the cowardice of refusing to attempt to help. God and society have granted us this position as a trust. We have no right to abuse this trust by acts of omission or commission. (CSP Vol. 43 No 2, 2000)

 

I am a neurologist.

I don’t do pre-marital counseling.

Yet, here they were in front of me: Tom and Sally.

 

Tom had been my patient for years.

He was partially deaf, and mildly retarded.

I treated his intractable seizures, and Migraine headaches.

Recently, we had proven that these all were part of a larger syndrome*—

That would kill him in the next few years.

He had called and asked if I would meet with them.

 

Sally was new to me.

She had cerebral palsy, with impaired legs, but a good mind.

Sally was plain, and vaguely eccentric.

But she had a good sense of humor.

 

Tom was her first boyfriend.

They talked on the phone for hours.

They both claimed to be in love.

They both had thought and prayed about this decision for weeks.

But Tom’s mother was quietly opposed.

 

What did I think?

They really wanted to know.

 

We talked for over an hour.

Were they unrealistic?

Were they blinded by their first love?

Could they imagine the pain they would share?

I probed as gently as I could.

 

No cliché–I felt honored and immensely humbled.

 

“No,” I told them.

“I don’t think you are blind or unrealistic.

But I think you have no idea how much pain you are in for.”

 

(Do any of us when we deeply love someone?)

 

Tom died in stages over the next two years.

But not before they shared true intimacy,

            Marital sexual union, and

                        Some good times together.

 

Sally said:

            “It was terrible, but wonderful.”

 

I thought:

            “How like the best of marriages.”

 

[* Tom had MELAS, Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-like Episodes. MELAS is a maternally inherited, progressive, incurable disease.]

 

Reflections From the Front: Doctors and Patients

Autonomy versus Paternalism. Some people think doctors are arrogant, and that they revel in their power. Ask most practicing physicians, however, and they will be quick to tell you of their impotence to change established patterns of behavior in their patients. Their limited impact is primarily through the art of gentle persuasion. This frequently involves thinking twice before speaking once. (Originally published in Carle Selected Papers, Vol. 44, No 1, 2000) 

Persuasion 

The 42-year-old morbidly obese

Mildly disheveled, smelly woman

In a Jack Daniels T-shirt

Wheezed smokily into my Neurology office

To discuss her knee pain and chronic fatigue. 

She said:

“We don’t have money for the medications.

Who has time to exercise?

I’d love to quit smoking, but I’ve tried and I can’t.

I only drink to be sociable.” 

I thought:

“Your medicine money went for Budweiser and Marlboros.

We make time for what we must.

You could socially walk with your friends—

                        Around the block,

            Not to the fridge.” 

I said:

“Your hypertension and diabetes could prevent you from enjoying your grandchildren.

We don’t want that.

We could probably get your internist, Dr. Kazlowski to help you stop smoking.

                        That might help.

Believe me, I know it’s hard to lose weight.

                        Perhaps she could help us with that as well.” 

She thought:

“This uppity, rich, white guy doesn’t know me.

If he had to put up with my husband,

                        He would drink and smoke, too.

If he had as little time as I do,

                        He wouldn’t nag me about walking.” 

However….

            Ten minutes later

            After four rounds of excuses

            Politely entertained, but gently redirected, 

She said:

“I do love my grandbabies.

Dr. Kazlowski is all right, I guess.

I’ll think about what you said.

So… see you next month, Doc?”

 

Reflections from the Front: For Whose Good?

Reflections From the Front: For Whose Good?

On October 26, the New York Times published a news story, http://www.nytimes.com/2011/10/26/health/policy/26vaccine.html?scp=2&sq=hpv%20vaccine&st=cseabout a recent recommendation from the Centers for Disease Control and Prevention that boys and young men should be vaccinated against human papillomavirus, HPV, to protect them from anal and throat cancers resulting from sexual activity. It is much less expensive to vaccinate only the boys who will engage in homosexual sex, but since this is hard to predict, the argument goes, we need to vaccinate them all.

Interestingly, the CDC came out with a similar recommendation for girls in  2006, but fewer than half of the girls between 13 to 17 have received even one dose, and less than a third have received all three required for efficacy.

The cost of administering the vaccine per year would be around $140 million, but the initial costs of catching up on the unvaccinated boys might approach $1 billion. The vaccine would combat several but not all strains of HPV; to provide greatest protection, it would ideally be given prior to any sexual activity. Since by age 15 one of five teens are no longer virgins, the aim would be to vaccinate prior to any sexual activity.

An October 29th editorial, http://www.nytimes.com/2011/10/29/opinion/the-hpv-vaccine-is-for-their-own-good.html?scp=1&sq=hpv%20vaccine&st=cse, tells us that it is “For Their Own Good”, and strongly encourages that all 11 to 12 year-olds receive the vaccine.

The editorialist cannot help himself. He takes a gratuitous swipe at conservative politicians (identified as Republicans in the first article), and conservatives in general for their reluctance to endorse the vaccine recommendations wholeheartedly. It is always easier to employ ad hominem arguments than it is to seriously address counterarguments to one’s own position. He fails to address:

1)       If this is such a great idea, why is the vaccination rate so low among girls, 5 years after the CDC’s endorsement? Are two-thirds of all Americans conservative, religious Luddites?

2)       Are there alternative ways to decrease the spread of HPV? What are their risks and benefits?

3)       There is no mention of abstention education, which has been proven to reduce sexual activity prior to marriage. http://www.cmda.org/wcm/CMDA/PublicPolicy2/Press_Room1/NewsReleases/2010_News_Releases/Landmark_abstinence_study_.aspx

4)       Contrary to the types of statistics generated by Alfred Kinsey, thoroughly debunked but still occasionally quoted as an authority, a true estimate of homosexual behavior in American males is probably between 1-5%. Is it really reasonable to vaccinate 95-99% of American boys for a disease that is very rare in their population?

Simplistic prescriptions for complex ailments are seldom satisfactory.

TIUBlogNumber4Vaccines.doc

Reflections from the Front: We All Answer to Someone

Reflections from the Front: We All Answer to Someone

“Surgeons routinely fail to disclose financial ties” is the title of a  Journal Sentinel article by John Fauber, http://www.jsonline.com/features/health/102811174.html. Fauber outlines how over the last several years a number of leading orthopedic surgeons received millions of dollars in “consultation fees”, to use and promote products from specific manufacturers. Hospitals and patients were unaware of the conflicts of interest. These types of violations are illegal under current anti-kickback laws, but nonetheless in 2007, “41 surgeons and researchers got $114 million from the five firms (limited study), an average of $2.8 million each.”

In www.neurotodayonline.com August 4, 2011, Volume 11, Issue 15, Kurt Samson details an unethical practice referred to as “seeding”. In seeding, the drug company secures high profile researchers to participate in studies which they believe legitimate.  With the new drug on the guru’s front burner, the hope is that in the course of their professional presentations they mention their new trials. The aura of “They’re using it in trials at the Cleveland Clinic” provides legitimacy by association. It works for high prescribers as well. If busy clinicians become involved in the trial, they may also begin prescribing the medication for their other patients as well. The fulcrum of the duplicity as discovered in a recent court case against Parke-Davis, was to pretend  the results of the trial were important for proof of safety or efficacy, when  these facts had already been proven. This was purely a marketing ploy.

During the early days of the stem cell controversy in America, in discussing embryonic versus adult stem cell research funding, outspoken scientists claimed that the science of the research was so complex that no non-scientist’s opinion was worth hearing on the ethical aspects of the question. The obvious conflicts of interest, who is receiving funding from whom, to what ends, were ignored. Over time the overblown claims of the embryonic researchers have been proven to be just that. I witnessed a researcher claim in a symposium in our medical school that the future of stem cell research depended primarily on embryonic experiments. Later, in private, when I questioned him, his response was, “Anyone knows that thus far the adult stem cell research has been far more productive, but I don’t want anyone telling me what I can do my research on.”

My points?  1) Follow the money, 2) Accountability, with checks and balances is important in research and education (government, religion, etc.), and 3) We are all fallen human beings. Contrary to what President Clinton said while in the White House, as humans we are not all “basically good people.” Made in the image of God, we are nonetheless fallen; power corrupts, and researchers need to be answerable not only to academia, but to society at large. These issues are too important to leave to scientists, and the church is far too important a voice to abstain from accountability discussions. We must remain attentive and involved in the forum.

 

TIU Blog 2011 Number 3

Reflections from the Front: End-of-Life Care

Reflections from the Front: End-of-Life Care

In the past sixteen months three members of my immediate family have died. Heart Disease, Dementia and Cancer claimed the lives of my father, my mother and my wife. If it were not for the resurrection, we would be totally bereft. As it is, we grieve, “but not as those who have no hope.”

In their last days, with each family member, we made the decision to not pursue all possible treatments at any cost, but instead only reasonable treatments, that would help mitigate pain and suffering, and whose benefits clearly outweighed the likely downsides to treatment. In regard to specific decisions, however, this may be easy to say, but not so easy to do.

Particularly for the Christian who continually prays for God’s miraculous interventional healing, it is tempting to continue to push, based on the possibility that God will intervene “soon”, if we have faith, and don’t give up the fight. Deciding when to transition care from a cure-orientation to a palliative care approach, can, at times, be especially difficult when the patient and the whole family are not at the same place at the same time.  The person who perhaps prophetically realizes that God’s healing may not come on this present earth may be perceived as being less committed, less loving, and less faith-filled. Perhaps; but perhaps they have an insight from the Lord.

Dr. John Dunlop, Internist and Geriatrician, recently wrote an outstanding, yet easy-to-read book– Finishing Well to the Glory of God, (2011, Crossway Books, Wheaton, Illinois,) covering just these issues. I highly recommend his book, which I found personally helpful. I would also recommend the website: http://www.cancer.gov/cancertopics/factsheet/Support/end-of-life-care

Discussions in the abstract, quoting probabilities of life, death, pain and disability can be almost mathematical. For populations these predictions have been found to be relatively accurate. For the patient or family member directly in front of you, they are much less helpful. When your time comes to deal with these issues as a provider, friend, or family member, I recommend Dr. Dunlop’s book, appropriate, accurate medical data, continuous prayer, and reliance on the Holy Spirit to help you walk through this minefield. I also recommend patience and love for your family circle members who aren’t where you are and a spirit of humility, forgiveness and grace as you make tough decisions.