Archive for the ‘Patricia Salber’ Category

Better Health’s Grand Rounds Volume 7, Number 44

CFAH Staff
Tuesday, July 26th, 2011

Welcome to Better Health’s Grand Rounds Volume 7, Number 44! This is our second time hosting Grand Rounds and we’re excited about sharing the posts we received.  The theme of this week’s collection came from a recent Health Affairs blog post by CFAH president, Jessie Gruman, Patient Advocates: Flies In The Ointment Of Evidence-Based Care, which addresses a few of the many challenges of basing health care practices, policies, and decisions on evidence of effectiveness.

We have posts that wrestle with conflicts of interest in reporting on evidence, obstacles to the delivery of evidence-based care, using evidence in practice and care decisions, and providing patient-centered care.  We believe this topic is important to all those involved in health care, from patients and doctors to hospital administrators and policy makers.  Thank you to everyone who submitted a post.  We hope you enjoy this week’s collection.

Consider the Source

Evidence of clinical effectiveness/harm is revealed over time by additional “white-coat” research and via the real-life experiences of patients and clinicians.  Identifying how and by whom evidence is revealed is an important part of evaluating its reliability and accuracy…and towards following the winding path towards effectively applying evidence to practice.

Elaine Schattner, in her post on Medical Lessons, Patients Words, Unfiltered, Medical Journalism and Evidence, shares her concerns that:  1) journalists often select patients’ voices to support pre-determined points of view;  2) making rational decisions based on data is often more complicated than surface appearances; and while 3) evidence should be the foundation of care…we also must acknowledge that outliers exist.

In Direct-to-Consumer Advertising and the Role of Advocacy Organizations: Two Threats to Evidence Based Testing, Josh Freeman, from Medicine and Social Justice, reviews two recent JAMA “commentaries” that addressed challenges to the implementation of evidence-based practice guidelines from two very different but very powerful forces. The marketing of health care technology and treatment directly to consumers and patient activists present both obstacles and opportunities to advance the delivery of evidence-based care.

How did this Heart Drug get Approved in the First Place?, asks Carolyn Thomas, in her post on The Ethical Nag: Marketing Ethics for the Easily Swayed, referring to the drug Nesiritide.  A heart attack survivor, Carolyn “figured the purpose of the drug approval process is to ensure that testing the effects of new drugs on patient outcomes has already been done before approval is granted.”  Pat Salber, of The Doctor Weighs In, also tackles this in her post: Niseritide, the “Lost Decade”, and the Pinto.

Obstacles to Delivering Evidence-based Care

One challenge to the delivery of evidence-based care is the interpretation and application of evidence by individual clinicians.  A Country Doctor, in his post, Patient Centered or Evidence Based Medicine – Can we really have both?, notes that every physician has to evaluate the evidence and determine how to apply it to each patient’s unique situation.

From Joel M. Topf, of Precious Body Fluids, comes, The Problem with Numbers, the Curse of Intermediate End-points, expressing his concern that medical interventions are increasingly oriented around improving the “numbers” – what he defines as intermediate endpoints – rather than real goals of preventing morbidity and mortality in addition to effectively addressing patient concerns and symptoms.  He worries that medications “are pursued and approved only for their ability to fix the numbers.”

The frenzied pace of many medical practices can also be a barrier to providing optimal care, says Steve Wilkins, of Mind the Gap, in Lack of Time and Reimbursement—Is That Why Physicians Don’t Do a Better Job Communicating With Patients? Steve points out that although doctors claim that there is not enough time for patient education, evidence shows that such conversations improve patient outcomes.

InsureBlog‘s Kelley Beloff makes a similar argument in Wait Times in the Medical Office, proposing that patients should consider why doctors run late before making judgments or feeling frustrated.  Kelley writes, “The standard patient appointment time is 15 minutes.  How many of us could do our entire job in 15 minute increments, 25 to 28 times a day?”

Are We Using Evidence Effectively?

Val Jones of Better Health tells us Why She’s Afraid For Anyone to Enter the Healthcare System…Ever.  Val’s post offers resources for patients, caregivers and health care professionals to ensure they are “on the right diagnostic pathway, getting the most appropriate care that suits their needs and preferences, and protecting them from errors and missteps.”

Rheumatologist Irwin Lim, in One Fracture, Two Fracture, Three Fracture…Enough! writes about the need for targeted interventions for high-risk groups…especially patients with osteoporotic fractures that “are getting a surgical fix or a cast, but not assessed and therefore, not treated for osteoporosis…this causes pain, suffering, disability and loss of independence. It also costs….a lot of…money.”

Harold Pollack at Kaiser Health News says in, It’s Not Just About the Money: Cost Control in Cancer Care, that providing evidence-based care is greatly impacted by incentives promoting aggressive care.  He writes that “We all must face these issues to control costs…We can treat our loved ones, and ultimately ourselves, more effectively, more efficiently, and more decently than we often do.”

Family physician Ed Pullen at DrPullen.com struggles with how to best reduce morbidity risks when facing contradictory recommendations for care.  For example, he wonders how to weigh concerns about PSA screening asking “Is there more morbidity related to treating cancer long before symptoms develop, or is there more morbidity from treating cancer after symptoms appear?”

On Pizaazz, Glenn Laffel argues that while no one would dispute screening and prevention as potentially useful tools in the effort to improve the quality of care and reduce unnecessary costs, not all such programs actually work.  Screening for prostate cancer, spiral CT screening for lung cancer, colonoscopies, and ECG screening for high school students, to name a few.  He says, “Some screening and prevention programs are not effective at all.  Others are effective, but prohibitively expensive.”

Gary Schwitzer, of HealthNewsReview, in two posts about using robotics for surgical procedures, raises questions about its use despite many questions about its benefits, harms, and increased costs.  Gary asks, “How are patients to make informed health care decisions and weigh evidence fairly if the information presented is not whole?”

Alexander Friedman adds in his post, My Patient Needed to be Delivered, that cesarean section rates are on the rise due to standard use of fetal heart monitors.  Friedman says that although it’s an “appallingly poor test,” nearly all American mothers are monitored during labor.  Yet, in his experience, almost every time he performs a C-section based on the warnings of distress from the monitor, the baby is delivered “pink, healthy, and a little bit angry…our medical culture prizes technology and tests, even if they don’t work and can cause harm.”

With several recent deaths in Oregon from attempting at-home breech deliveries, Jonie Dawning, an experienced midwife, believes that too many midwives are unaware of the potential risks involved.  In her letter to the Oregon State Legislature, she makes the case for an evidence-based care and policy approach.

Wilderness medicine expert Paul S. Auerbach acknowledges that antibiotics are overused to treat childhood ear infections. But when in an outdoor or wilderness setting, where there is no medical professional to help make the decision, he advises that it is certainly reasonable to administer antibiotics.

Using Evidence for End of Life Care Decisions

In response to a recent NYTimes piece on rising Medicare hospice costs and the role of fraud in the phenomenon, Chris Langston, of The John A. Hartford Foundation HealthAGEnda blog, offers a primer on hospice in the first of a two-part series. With the current budget-cutting environment, Langston “worries that we will make a mistake that will deprive people at the end of their lives of valuable services and that we could even unintentionally increase total health care costs while trying to lower them.”

On GeriPal, Eric Widera shares that “despite a lack of evidence to show any benefits to prevent aspiration pneumonias or pressure ulcers, improving comfort, or prolonging life, feeding tubes are still inserted in patients with advanced dementia.” Widera wonders if family members have unreasonable expectations about the benefits of feeding tubes and specifically if they know that “40 percent of tube fed individuals must be restrained to keep feeding tubes in place.”

Ryan DuBosar, on ACP Hospitalist blog, highlights a recent report from the Center to Advance Palliative Care, noting that nearly two-thirds of all hospitals now have a palliative care program and larger hospitals have even more access. These palliative care teams can help patients and their caregivers when facing a serious illness and making difficult choices.

Receiving Patient-Centered Care…Not Always as Expected

Clinicians, family members and sometimes even strangers can all play a role in providing patient-centered care.  Sometimes you get the support you need…at other times, there is a gap between what you need and what you receive.

Amy Berman, of the John A Hartford Foundation HealthAGEnda blog, shares her experience with what she believes was an overly aggressive treatment recommendation in Can Good Care Produce Bad Health?.  She says, “It doesn’t matter if care is cutting-edge and technologically advanced; if it doesn’t take the patient’s goals into account, it may not be worth doing.”

Posting a sick kid’s photo on Facebook led to the swift diagnosis of a dangerous, fast-moving illness. David E. Williams, in the Health Business Blog, explores the role of social media and crowd-sourcing in his post, Diagnosing an Illness with Facebook.

Beth L. Gainer, of Calling the Shots, recognizes the compassion and support she received from unexpected sources after she received her breast cancer diagnosis and during her treatment in her post, Heroic Moments.

We hope you enjoyed this week’s Grand Rounds.  It was wonderful to read so many posts related to such an important and lasting issue.  Thank you to everyone who submitted a post and to those whose posts we happened upon and included above.  Please be sure to check out next week’s host, James Logan, MD at http://jamesloganmd.com.

Guest Blog: Niseritide, the “Lost Decade”, and the Pinto

Patricia Salber
Thursday, July 21st, 2011

Patricia Salber, MD, MBA, is the founder and host of The Doctor Weighs In.  She is a board certified internist and emergency physician.    She is currently Principal at PRS Healthcare Consultants, focused on helping organizations get ready for the post-health care reform world with a special emphasis on population health improvement.

Eric Topol, MD wrote an interesting commentary in the July 7, 2011 issue of the New England Journal of Medicine, titled “The Lost Decade of Nesiritide.” Nesiritide is a drug for heart failure symptoms (e.g., shortness of breath) that was approved by the FDA in 2001. Since that time, according to Dr. Topol, “well more than $1 Billion was wasted on purchasing the drug.”

It turns out that the FDA approved the drug was based on a relatively small, not particularly well done clinical trial that showed improvement in self-reported symptoms of shortness of breath 3 hours after the drug was administered. Once the drug was approved, the drug was marketed like crazy. For profit outpatient heart failure “tune up” clinics opened so that heart failure patients could get weekly intravenous infusions of the drug.

Over the ensuing decade, small studies were published that suggested Nesiritide was associated with a worsening of kidney function and perhaps an increased rate of death. These studies led to a recommendation that a large clinical trial be conducted so issues of safety and efficacy could be more definitively determined.

As a result a large international clinical trial of the drug was conducted from May 2007 to August 2010. It involved 7141 patients in 398 centers around the world. The results of the study, published in the same issue of the NEJM as Dr. Topol’s commentary, failed to find any statistically significant benefit of the drug on heart failure symptoms. It also failed to find any worsening of kidney function, but it did identify increase in rates of hypotension (low blood pressure). The authors conclude “one the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure.”

Thus, over a ten year time span, Neseritide was infused into the veins of many, many patients with heart failure, costing payers (insurers and, in the case of public programs like Medicare, tax-payers) over a $1 billion, without bringing any significant benefit to the end-user (AKA, the patient). Of course, not everyone lost as a result of this wasteful spending – that $1 billion benefitted the manufacturer(s), shareholders, owners of the “tune up” clinics and everyone else along the supply chain.

Dr. Topal calls this the “Lost Decade of Nesiritide” likening it to the “lost decade” of the Japanese economy in the 90s and perhaps the “lost decade” the US economy may be in the midst of experiencing. He is probably right. We spent the money. We did not get the expected health benefits. Nothing to be done? Right?

I suspect somewhere in the bowels of the manufacturers’ files are calculations on how much money could be made on the drug regardless of its marginal – if any – benefit. This tale reminds me a bit of the story of the Ford Motor Company executives who calculated the cost-benefit ratio of keeping quiet about the known flaw in the gas tank design of the then popular Pinto.

Costs related to paying for burns from ruptured gas tanks:*
Savings: 180 burn deaths, 180 serious burn injuries, 2,100 burned vehicles.  

Unit Cost: $200,000 per death, $67,000 per injury, $700 per vehicle.

Total Benefit: 180 X ($200,000) + 180 X ($67,000) + $2,100 X ($700) = $49.5 million.
Costs resulting from paying for an $11 insert to prevent the gas tanks from rupturing:
Sales: 11 million cars, 1.5 million light trucks. 

Unit Cost: $11 per car, $11 per truck.

Total Cost: 11,000,000 X ($11) + 1,500,000 X ($11) = $137 million.*Table adapted from http://www.engineering.com/Library/ArticlesPage/tabid/85/articleType/ArticleView/articleId/166/Ford-Pinto.aspx

Ford ultimately paid much more than the $137 million it would have cost to prevent the gas tank ruptures to settle lawsuits, recall the cars, and fix the problem – the insertion of a plastic barrier between the gas tank and the exterior.

If the Nesiritide story was more like the Pinto story, we would see efforts to recoup that lost $1 Billion. But fortunately patients weren’t seriously harmed by the administration of the drug, so there won’t be any lawsuits for damages and there won’t be any public outrage. After all, we are used to waste in health care – we have been talking about it – and documenting it – for years.

So the manufacturers and “tune up” clinics will keep their profits from a drug they most likely knew was not worth the price they were charging. The large scale study that refutes the drugs benefit will eventually lead to a slow decline in the use of the drug as insurers change their policies regarding reimbursement for the drug and…the business of medicine will keep on going, mostly unchanged by yet another expose of poor oversight practices that let waste flourish in our non-system.

An FDA with teeth – one that would have the strength to not approve a drug on the basis of only one, not particularly well-done study – or at the very least was able to tie an interim approval to the rapid design and implementation of a more definitive study – is probably too much to wish for in this era of hatred of all things regulatory. What’s to be done….?

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