Wednesday, February 29, 2012

Patient Advocacy, Informed Consent and Physician Bias - oh my...

Arizona nurse Amanda Trujillo was fired in April 2011 after providing education to and making a pallative care request for her end-stage liver disease patient. Apparently this patient was scheduled for pre-transplant evaluation, and the physician was none too happy that Trujillo's patient advocacy thwarted the plan. ("threw a well witnessed tantrum in the nurses station", according to one report).

While I have no dog in this particular hunt, so to speak, I find it notable the patient had end-stage liver disease. Practically every published study I read (thousands at this point) make some statement in the abstract about 'living donor transplants' as the 'best treatment' for end-stage kidney and liver disease. It's made me wonder if this pervasive belief affects a physician's communication with patients, if s/he inadvertently steers the patient toward the physician-preferred treatment rather than respecting the patient's autonomy.



Naturally this question manifests itself in the hate mail I receive which often accuses me of causing would-be recipients' deaths because I don't present living donation as all rainbows and lollipops (as if a transplant is a panacea), but it is more effectively demonstrated in the myriad public solicitations dotting newspapers, blogs, social media and the like. In addition to the heart-string-tugging depiction of the would-be recipient's character, we get a statement or two about how 'safe' living donation is, or how 'a kidney is a spare', or the 'liver regnerates'. Often with a "they make sure you're healthy first" and "all costs covered" comment meant to instill trust in the people who benefit financially from the proffered liver or kidney.

But there is never, and I do mean never, any word about risk, or death, or depression, or lack of friggin data, which leads me to I ask myself: why do these kidney/liver want ads always say almost exactly the same thing? And my conclusion is: because this is what would-be recipients are being told.



Case in Point: Dr. Peter Laird:

When I was entering the confines of the world of ESRD, the mantra I heard over and over again was I had to have a transplant from my entire nephrology medical team and essentially every one of my colleagues in the Internal Medicine and Family Practice departments...I diligently researched the extensive risks of renal transplant especially in light of my prior cancer history... On my own insistence, I requested a dermatology evaluation understanding the increased risk of skin cancer post transplant, and that is when they discovered a very early malignant melanoma.  With two cancer scares in my life completely cured  by early surgical removal, I am not willing to add any further increased risk of future cancers from the immunosuppressive regimen after transplant.

Even prior to withdrawing from consideration of the renal transplant list..., I had decided to fore-go a preemptive transplant offered to me by my wife and daughter...I determined that renal disease was my burden to bare and I would not place another healthy individual at risk for what is my disease after all...In addition to my recognition of the risks of transplant and the risks of donation for my loved ones, I became aware of the data for daily dialysis showing equal outcomes compared to cadaveric renal transplant. Pauly et al demonstrated this in a widely publicized paper in 2009. Unfortunately, the majority of patients are told that transplant has superior survival to dialysis, which is only true if comparing to in-center dialysis alone.

Even Laird, a physician, couldn't rely on his providers, or his doctor peers, to give him comprehensive information regarding his condition and treatment options. He took it upon himself to educate and advocate, and I'm sure to some extent, overcome the resistance of his pro-transplant medical providers, to embark on the treatment he deemed best for his overall quality of life.



Not long ago, I received an email from a woman whose kidney disease had advanced to the point where her doctors suggested she begin to think about a transplant. Somehow in her research, she stumbled upon LD101, which motivated her to thank me for giving her all the information her physicians didn't. Hovering around the average age of an individual with end-stage renal disease, she admitted her father had died far younger than she of the same diagnosis, and she simply wasn't going to hurt someone else for her benefit.



On Living Donor 101, I argue that it's not only prospective living donors that are being denied their legal and ethical right to informed consent, but would-be transplant recipients too. While prospective living donors are told about 'alternative treatments' for the recipient, there is no requirement for the would-be recipient to be informed about the risks of donation to the living donor. Since the bias toward living donor transplants is so strong, the course of treatment (transplant) is assumed. As indicated by the Trujillo incident, such an assumption can be false. Patients want the information to make an educated decision. And if autonomy is the guiding principle of the doctor-patient relationship, then there is no good reason for denying them the opportunity. Even if the choice differs from the doctor's.



[note: I don't think I've ever received hate mail from a recipient, at least not on their behalf. It usually originates from the loved ones of recipients, or folks involved with finding donors for would-be recipients. The former includes some living donors, who lash out in denial of the harm done to them by their generous deed]

Sunday, February 26, 2012

Open Letter to Ann Work: A Kidney is Not a Spare

Ms. Work,

I just read your story on Ms. Silvestri's living kidney donation (found here), and found the misconceptions and errors contained therein to be highly disturbing.



1. A kidney is not a spare. While one can function without an arm, or eye, no one would consider the second a 'spare' and no one would ever consider one as beneficial as two. The remaining kidney does not 'grow', but hyperfiltrates, meaning the actual cells of the organ swell under the pressure of doing double the work. This adaptation leaves the kidney and its nephrons more vulernable to toxins, disease, damage and age.

Consider what happens to a balloon when air is forced into it.



2. While the intended recipient's insurance pays for the evalution or surgery, many living donors have reported bearing the cost of complications or mental health services post-donation. Many insurance policies will have a time or money limit on their living donor benefit, which leaves the living donor with permanent nerve damage or adrenal dysfunction responsible for their own care. Mental health services are never covered.



3. Yes, it is illegal to sell OR BUY a kidney in the US, but recent reports have indicated the transplant industry's lax attitudes on the matter. See Dan Rather's "Kidney Pirates", as well as Nancy Schepler-Hughes profile on the Rosenbaum trafficking case here: http://www.counterpunch.org/2011/11/30/the-rosenbaum-kidney-trafficking-gang/



4. A kidney donor in need of a kidney does NOT go to the 'top of the list'. That individual is given four LOCAL priority points, which amounts to approximately one year of wait time on the list. See here: http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_172.pdf



5. Where is the proof that "99% of donor weather their surgery with ease"?

4.4 living kidney donors die each year in the US within 12 months of surgery. 20% experience complications. 20-30% suffer from depression, anxiety, grief, anger and PTSD.

There are no national standards of living donor evaluation, selection, or treatment. Each US transplant center makes up its own rules.

There is NO comprehensive short or long-term data. The first LKD occured in 1954, yet no identifying info was collected on LDs until 1994. In 2000, the Secretary of Health mandated one year of follow-up on all living donors (2 yrs as of 2006) yet 30% are still reported 'lost', and not a single transplant center has been penalized for noncompliance.



I understand, Ms. Work, that your information was most likely gleened from the local organ procurement organization, a nearby transplant center or surgeon, or even the websites of OPTN or UNOS. But they all benefit from living donor transplants, financially and otherwise. Before penning your next living donor related article, I urge you to consider sources outside of the transplant industry, folks and groups that prioritize the protection and care of living donors. They will have the most insight.



Sincerely,

LD101

Monday, February 20, 2012

Reports of Liver Donor's Early Deaths Are Grossly Inaccurate

Another lesson in why it's important not to trust headlines, especially when the content originates from an organization's PR department.


4111 live liver donors in the United States between April 1994 and March 2011 for a mean of 7.6 years;

And herein lies the problem. If an individual donates their liver at age 30 when average life expectancy is 76-ish, the fact they haven't kicked off in 16 years or less proves nothing.

Yet....


Long-term mortality of live liver donors was comparable to that of live kidney donors and NHANES participants.

Unless the definition has changed, 7 years or even 11 years is NOT long-term. That only applies to anything over 20 or so years.

But here's a nice paragraph:


In general, our understanding of catastrophic complications arising from live liver donation has been partly informed by the media, case reports, and center-specific studies. Although a multicenter consortium, an analysis of health care registry data, and a nationwide survey have attempted to address the shortcomings in the literature, these efforts have been limited by selection and ascertainment biases, small sample size, and the lack of a generalizable denominator for accurate risk estimation.


But then there's this:

...the risks associated with live donor nephrectomy are well characterized

I'm sorry - WTF?? We don't have so much as social security numbers on the first 40 yrs of living kidney donors, we've only required one to two years of follow-up on the last 10, and of those, 30% are reported 'lost'. So we have no data.

Let me repeat that - WE HAVE NO DATA.


I encourage you to read the entire study, available here. Just understand the authors include both right and left lobe donors, when the two procedures have been shown to have vastly different risk levels (see our pages on live liver donors for more). Most of all, be suspicious if you run across any news articles that purport the safety of live liver donation. This article does nothing of the sort, despite the wishes of its authors.





Muzaale, A., Dagher, N., Montgomery, R., Taranto, S., Mcbride, M., & Segev, D. (2012). Estimates of Early Death, Acute Liver Failure, and Long-term Mortality Among Live Liver Donors Gastroenterology, 142 (2), 273-280 DOI: 10.1053/j.gastro.2011.11.015

Wednesday, February 15, 2012

Parkland Memorial Comprises Patient Safety

The Dallas Morning News released a copy of a CMS report on Parkland Memorial Hospital in Dallas after hospital officials refused to release it to the public, fearing lawsuits. CMS' investigation, meanwhile, was conducted after Parkland "failed a series of inspections prompted by the death of an illegally restrained psychiatric patient".

The CMS investigation cost about $7 million in tax payer money.

Patient rooms were found to contain overflowing trash bins, excrement and blood. Hundreds of medications were improperly administered to patients. Dozens of beds remained empty despite crushes of patients seeking emergency care. Senior leaders kept critical information from the hospital’s board of managers. One patient died, apparently after receiving a drug without doctors’ orders.

The report also identified a number of cases of patient harm since just last November, a “surprising” finding, the monitors said. Parkland was already under such intense outside scrutiny, and the continued problems suggested corrective actions the hospital pledged “have not been effective in creating a safer care environment.”

The report cited "violations of more than 50 CMS standards — roughly half of all CMS rules governing federally funded hospitals."

In examining Parkland’s daily operations, the monitors also found fault with faculty doctors from UT Southwestern Medical Center, the hospital’s academic medical partner. UTSW’s faculty comprises most of Parkland’s physician workforce and supervises the resident doctors-in-training who deliver much of the care at the teaching facility.

The safety monitors said problems in the residency program, jointly managed by the two institutions, are a factor in Parkland’s care issues. Unsupervised residents botched several invasive procedures, for example, including draining chest fluid from the wrong site.



Other than the obvious, why does this warrant a mention? Because Parkland has a kidney and pancreas transplant program.

I looked up Parkland's data on OPTN's website. Below is a screenshot (click for full size):





In 2011, Parkland performed three (3) living kidney donor transplants.

One (1) each in 2009 and 2010.

Nine (9) in 2008.

One (1) in 2007.

Five (5) in 2006.

One (1) in 2005.

According to Transplant Living* (a site run by UNOS, the contractor for OPTN):

If the center wishes to perform laparoscopic donor nephrectomies, a qualifying renal donor surgeon must be on site and must have:
  • (i) Acted as primary surgeon or first assistant in performing no fewer than 15 laparoscopic nephrectomies within the prior 5-year period.


Do we think Parkland only has ONE surgeon that performed all of these living donor nephrectomies? Cuz that's problematic otherwise (It's problematic either way, imo).



As of this writing, there is no statement on OPTN's website about Parkland or the CMS investigation.



Please, do yourself a favor and read the entire article: http://www.dallasnews.com/investigations/patient-safety/20120214-parkland-safety-report-says-problems-persist.ece

http://www.healthjournalism.org/blog/2012/02/cms-ordered-report-withheld-by-hospital-reveals-hundreds-of-deficiencies/

Sunday, February 12, 2012

Sodium and Living Kidney Donors

Sure, everyone should pay attention to their sodium consumption, but living kidney donors are at a greater risk due to reduced nephrons. According to Brenner, this reduction limits the body's ability to secrete sodium and can result in hypertension. High blood pressure, in turn, leads to heart disease, stroke and other vascular diseases.

According to the CDC's newest report, 90% of Americans eat more sodium than is recommended for a healthy diet.

Mean daily sodium consumption was 3,266 mg. Approximately 44% of sodium consumption came from foods in the following 10 categories:


  • bread and rolls (7.4%),
  •  cold cuts/cured meats (5.1%), 
  • pizza (4.9%), 
  • fresh and processed poultry (4.5%), 
  • soups (4.3%), 
  • sandwiches like cheeseburgers (4.0%),†† 
  • cheese (3.8%), 
  • pasta mixed dishes (e.g., spaghetti with meat sauce) (3.3%), 
  • meat mixed dishes (e.g., meat loaf with tomato sauce) (3.2%), 
  • savory snacks (e.g., chips and pretzels) (3.1%)




    Table

    Most sodium consumed (65.2%) came from foods obtained from a store (e.g., supermarket or convenience store). Restaurants were the source of 24.8% of the sodium consumed.

    Two leading contributors to sodium consumption (pizza and poultry) are more often obtained from restaurants and locations other than stores.


    What to do?


    • eat more fresh vegetables and fruits, or frozen veggies without sauce
    • read nutritional labels
    • look for low/reduced sodium options at restaurants and in grocery stores


    http://www.cdc.gov/Features/VitalSigns/Sodium/

    Friday, February 10, 2012

    More Kidney Donation Spin From the Transplant Industry

    An article entitled "Kidney Donors Not at Higher Risk of Needing Acute Dialysis" showed up in my google alert today.

    Read the press release - er, neutral media coverage - here.




    Here was my response (if they so choose to publish my comment):

    This is a worthless study meant to do nothing but further the misconception that living kidney donation is safe.

    According to OPTN's own data, more than 300 living kidney donors have been wait listed since 1994 in need of their own kidney transplant. From the few studies done on LKDs diagnosed with end-stage renal disease, we know the time from donation to be anywhere from 13-21 years. In addition, Kido (2009) noted that ESRD developed irrespective of pre-donation kidney function, or presence/absence of risk factors such as proteinuria, hypertension or diabetes.

    A living kidney donor's biggest long-term risk isn't kidney failure, but cardiovascular disease. According to one study, five years after a nephrectomy (kidney removal), patients had a 25% increased risk of cardiac death. According to another, most patients in the early stage of chronic kidney disease (including kidney donors) do not progress to end-stage renal disease because they die of a cardiac event first.

    Ron Herrick, the first living kidney donor, had a stroke in 2002, spent the last decade of his life on dialysis, and died following cardiac surgery in 2010. It's past time we stop misrepresenting the risk of living kidney donation. The public are not medical supply. Living donors are people too.


    For more info on LKDs wait listed for a kidney transplant:

    http://livingdonorsarepeopletoo.com/living-kidney-donors-listed-for-transplant-part-i/

    http://www.livingdonor101.com/kidney-failure-risk.shtml

    For more on LKDs and cardiac risk:

    http://www.livingdonor101.com/risks.shtml

    Tuesday, February 07, 2012

    Uproar Over 'Denied' Kidney Transplant Completely Overlooks Living Donor

    The story of Jesus Navarro, the undocumented immigrant (aka illegal resident-slash-alien, whatever term seems to be in vogue these days), who was denied a kidney transplant due to his not-legal residential status and uncertain ability to obtain follow-up care and anti-rejection medications, has been big news of late. I chose not to comment because it seemed like a futile effort - and because I've been busy training poll workers not to bork the upcoming election in March.

    But then I got an email from change.org about a petition to help Mr. Navarro obtain his transplant. I wouldn't have been bothered except for the misinformation and oh-so-constant theme.

    Here's the first paragraph:

    Jesus Navarro could die without a kidney transplant. His wife is a match, she wants to donate her kidney to save her husband's life, and Jesus even has health insurance to cover the transplant.



    And here was my response to change.org (which will probably go into the junk/spam folder or be returned as undeliverable):


    I would encourage more research on this matter. Mr. Navarro lost his job and consequently his private insurance (he lost it because his company was caught up in an immigration sweep):

    http://abcnews.go.com/US/dying-dad-jesus-navarro-denied-kidney-transplant-immigration/story?id=15494070#.TzBLTMVSQWM

    It also might serve your organization well to understand that a transplant is not a cure, and without proper medical follow-up (including funds for anti-rejection meds, which are very expensive), Mr. Navarro's body will reject the transplanted kidney and he will be back where he started.

    Mr. Navarro's wife has offered to be his living kidney donor, yet no media outlet (including change.org) has asked whether she has employment or private insurance. No one has the least bit of concern that 4.4 living kidney donors die each year in the US within 12 months of surgery, 20% experience complications, 20-30% suffer from depression, anxiety and PTSD, and not a single US transplant center offers aftercare or support.

    The public (and media) perception is that kidneys are like pints of blood when in fact, there are NO national standards of living donor evaluation, selection or treatment, and there is NO data on living donors' health or well-being. Hard to believe, I know, but the first living kidney donor transplant was performed in 1954, no identifying information on living donors was collected until 1994, and even though the Sec of Health mandated one year of follow-up on all living donors in 2000 (two yrs as of 2006), 30% of living donors are reported 'lost' by one year and NO transplant programs have been penalized for non-compliance.

    So while everyone is in an uproar about Mr. Navarro being denied a kidney transplant in the US (when he could receive one in Mexico), no one has bothered to throw one errant thought to what will happen to his wife, or any other of the 6600 people in the US who become living donors every year. Which is the bigger atrocity?




    What I didn't say and could have is that Mr. Navarro now has a 'sponsor' willing to pay all of his medical bills. Mr. Kagan is a kidney recipient himself, WHOSE DONOR WAS AN ILLEGAL ALIEN (undocumented immigrant, whatever).

    To quote:

    "A person ... had absolutely nothing and was willing to give his kidney to me," said Kagan, the co-owner of a Berkeley technology firm.


    It's interesting that Mr. Kagan's living kidney donor was A. not a relative and B. in the country illegally. He does not name this person, and this person has yet to come forward in any way or participate in Mr. Kagan's vocal support for Mr. Navarro. Why is that?

    - Is he no longer in the country?
    - Did he receive payment for the kidney?
    - Is he dead??

    For the record, I have no way of knowing any of these things, but Mr. Kagan's bias on this issue is pretty evident, and it's not in the direction of ensuring any living donor is protected in any way.

    Of course, he's not alone. No one involved in this scenario or discussion appears to give one whit about what happens to Mrs. Navarro. The only goal is to get Mr. Navarro his precious transplant.

    Unfortunately, what else is new?

    Monday, February 06, 2012

    Tax Deductions Are Not the Answer

    I ran across an article today about a bill introduced in New Jersey's Senate allowing living organ donors to take a tax deduction of up to $10,000 for living donor related expenses. The article, written by Carly Q. Romalino, contains a quote by John Green, community relations director with Gift of Life Donor program:

    “Altruistic donors, they can really help decrease the number of people on the waiting list especially in New Jersey.”


    Yep, that's right. This bill is solely meant to motivate the public to kick out a kidney to a complete stranger.

    Did I mention this person is employed by the state's Organ Procurement Organization, which is NOT ALLOWED BY FEDERAL POLICY to meddle into the affairs of living donation? Yet here we are.


    And the Senator who proposed this bill - Fred Madden - he admits: Through his work on the health committee...he’s noticed there is some consistency “that the donor goes through a tougher transition when they donate the organ.”


    Let me get this straight: he knows that living donation isn't a skipping-merrily-into-the-sunset proposition, yet instead of proposing a bill that might 'ease the transition*' (whatever that mans), he wants to sideways, backways encourage people to do it anyway by subtly bribing them?

    Shameful.



    If you'd like to contact Senator Fred Madden and encourage him to use his position to ensure living kidney donors are protected and respected, here's his contact information:

    District Office: 129 Johnson Road, Suite 1, Turnersville, NJ 08012 (856) 232-6700
    District Office: 1031 Little Gloucester Rd., Suite 3, Blackwood, NJ 08012 (856) 401-3073



    *Support services, aftercare, mental health provisions... Oh, I know a REAL and ACTUAL psychosocial evaluation intended to prevent harm to living donors instead of the current "You know this is major surgery, right? You know it's illegal to take payment, right?" pathetic excuse we have now.

    Wednesday, February 01, 2012

    Protecting Kidney Function with Fruits and Vegetables

    Here's the deal: there is growing evidence that baking soda can help preserve kidney function in folks with early stage chronic kidney disease.


    I imagine a whole bunch of question marks sprouting over my readers' heads right about now. Here's a more scientific explanation:


    Many foods have high acid content, and these acids can be damaging to the glomerules of the kidney. As we all recall from our high school science class, alkaline (base) substances are the chemical (ph) alternate to acids.


    Baking soda's technical/chemical name is Sodium Bicarbonate - an alkaline.


    But because sodium is also damaging to the kidneys, and can cause or worsen hypertension (high blood pressure), the use of baking soda to mitigate acid damage is questionable. Our reseachers wondered if the addition of base/alkaline foods would reduce dietary acid and help prevent kidney damage compared to baking soda therapy.



    The foods in question:

    Fruits such as apples, apricots, oranges, peaches, pears, raisins, and strawberries.

    Vegetables such as carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini.



    30 days of this treatment 'significantly and comparably decreased kidney injury' in those with stage 2 Chronic Kidney Disease (GFR<60), the same result as baking soda, but without the annoying sodium problem. Unfortunately, folks with Stage 1 CKD didn't appear to benefit, and neither did those with more severe stages of chronic kidney disease. If you'd like to read all the grisly and long-winded details, here you go.


    Goraya, N., Simoni, J., Jo, C., & Wesson, D. (2011). Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy Kidney International, 81 (1), 86-93 DOI: 10.1038/ki.2011.313