Is There Any Room Left For Empirical Research On Family Planning?

The United States' health care safety net relies heavily on states to implement and administer federally funded programs. As the expansion of Medicaid under the Affordable Care Act (ACA) has so clearly shown, this reliance is proving to be increasingly problematic as states diverge in their political contexts and as health care itself becomes politicized.

In the case of reproductive health care, the politicization and between-state divergence is particularly acute. This is well-documented for abortion restrictions, but it is increasingly true of family planning as well. For example, 23 states and both houses of the US Congress have considered or passed legislation barring Planned Parenthood affiliates from providing care with public funds. These proposals emerge from an animus for Planned Parenthood that may stem from the organization's political action as well as its strong association with the provision of abortion care.

The question we raise in this post is whether the politicization of this health care provider and reproductive health care in general has led to a situation where meaningful, empirically based debate over specific policies is no longer possible.

What Happened

We recently evaluated the impact of Texas' exclusion of Planned Parenthood from a fee-for-service family planning program (the Women's Health Program or WHP), publishing the results in The New England Journal of Medicine. The paper was widely covered in the press and on social media, and quickly criticized by Texas officials. Moreover, one of our co-authors was forced to resign for participating in the research. Here we describe our paper's origins and the response it received in the media and among Texas legislators. We then place the paper's reception in the context of increasing polarization among US states regarding reproductive health care, and question the room that remains in a state such as Texas for peer-reviewed empirical analysis.

In 2007, through a Medicaid waiver program, Texas began offering family planning services to women with incomes below 185 percent of the federal poverty line. The program always excluded providers of abortion care. But in 2011, the Texas state legislature directed the Texas Health and Human Services Commission (HHSC) to exclude from the program any organizations affiliated with abortion provision, including Planned Parenthood affiliates.

The federal government indicated that such an exclusion violated Medicaid's rules and ended the Texas waiver on January 1, 2013. In response, Texas replaced the federally supported program with an otherwise identical state-funded program that excluded Planned Parenthood affiliates. (As is discussed in more detail below, shortly after Texas took over the fee-for-service family planning program, the legislature introduced another new program that was widely seen as an effort to reverse a large cut that had been made to a different stream of state funding for family planning in 2011.)

In October 2012, a suit was filed challenging the exclusion of Planned Parenthood affiliates. In this challenge, the attorneys for the plaintiffs argued that the existing infrastructure could not accommodate the surge in demand that would result from excluding Planned Parenthood affiliates. Furthermore, they argued, specialized family planning providers were better equipped to meet women's desires for more effective methods of contraception like IUDs and implants. The attorneys for the state countered that care could continue uninterrupted because other, non-Planned Parenthood providers would take up the clients who had previously received care at Planned Parenthood affiliates.

In the courtroom, Dr. Richard Allgeyer, director of research for the HHSC served as expert witness for the state and one of us (Dr. Potter) served as an expert witness for the plaintiffs. At the trial, both Potter and Allgeyer provided projections of the impact of the exclusion. But all of us from both sides knew that measuring the exclusion's true impact was an empirical question that would require careful evaluation.

The legal challenge to the exclusion was unsuccessful. But in the months following the trial, we (Potter and Stevenson), attorney for the plaintiffs Pete Schenkkan, Allgeyer, and Allgeyer's colleague Imelda Flores-Vazquez, all collaborated on an analysis to determine which of the two sides' arguments was borne out. About three years later, the resulting paper was published. We found that the exclusion of Planned Parenthood from the Texas Women's Health Program was associated with a relative reduction of 35.5 percent in the provision of IUDs and implants and a relative reduction of 31.1 percent in the provision of injectable contraceptives. Among users of injectable contraception we found a 27 percent increase in Medicaid-paid deliveries.

As with many studies of politicized subjects, some news coverage of our paper was sensationalized, and it elicited responses from political actors. The most widely read news story, in the Los Angeles Times, accrued 250,000 page views in the first 24 hours and was the #1 trending story on reddit.com for the day the paper was released. Within hours of the paper's release on the NEJM web site, Texas state legislators began posting editorials and press releases calling it “deeply flawed” and “misleading.” Senator Jane Nelson sent a strongly worded public letter to the commissioner of Texas HHSC.

A week after Nelson sent her letter, Allgeyer retired from his senior position at the agency, an event widely regarded as the result of an ultimatum. While several liberal reporters and legislators responded to the legislators' unsubstantiated critique of the paper and Allgeyer's ouster, there was no response from any of the major medical organizations in the state, such as the Texas Medical Association and the Texas District (XI) of the American College of Obstetrics and Gynecology.

Funding Levels

In Texas, as noted above, the exclusion of Planned Parenthood from the WHP followed on the heels of a massive cut to a separate stream of state grant funding for family planning. That cut forced the closure of numerous clinics, reduced hours at others, and greatly restricted the access of uninsured women to the most effective (and most expensive) forms of contraception.

During this time, our project's peer-reviewed publications brought attention to these impacts. The clinic closures made the state look bad and raised the specter of a large increase in unwanted Medicaid births. Such concerns may have contributed to then-Governor Rick Perry's authorization of the state-funded replacement for the Medicaid-waiver program and Senator Jane Nelson's leadership in creating a new grant program to restore much of the previously cut family planning grant funding. In both of these new programs, eligibility was restricted to providers who could attest that they had no connection with providing abortion.

What results could be expected from this refunding? The financial resources were back in place, but a large fraction of the most experienced and well-trained providers had been removed from the state's programs, either because they were forced out of business by the initial round of cuts or because they were excluded by the Planned Parenthood affiliate ban. Clearly, the state of Texas has an interest in the outcome and Senator Nelson's letter stressed the need for “an objective assessment of how our programs are working-and how they are not working-in order to address any deficiencies that may exist.” But legislators could only have their cake and eat it too if an ample supply of alternate providers, both public and private, were available to step in to replace those who had been shuttered or excluded. Our paper provided a direct test of this proposition, and found it to be false.

What It All Means

As health policy analysts and citizens, we find the retaliation against our colleague, Dr. Allgeyer, concerning. As social scientists, we see the response to our paper as part of a larger social process in which reproductive health research, like climate science, is judged not on its scientific merits but on its conformation to political aims within a “culture war” arena. The larger question is whether research can play any role in braking the diverging trends between “red” states in which the dominant party has a large political stake in restricting abortion rights and eliminating Planned Parenthood, and “blue” states in which the dominant party has a political stake in maintaining abortion rights and keeping all providers eligible to participate in publicly funded family planning programs. This divergence is more often than not hidden from view in nationally representative data sets based on the National Survey of Family Growth, but it may have substantial influence on demographic indicators such as teen fertility, use of highly effective contraception, and unintended pregnancy.

We are left with several, possibly complementary, interpretations of the state legislators' aggressive response to our paper. The first is that perhaps moral reasoning (represented in the disapproval of Planned Parenthood's activities) and empirical reasoning are like oil and water and we cannot reasonably expect their integration. The second is that in politically sensitive matters, appearances may be uppermost. Any widely visible claim that contradicts a party's position must be attacked quickly as a matter of public relations. Either way, we appear to be witnessing a foreclosure of the space for collaboration between academic institutions and state government agencies, and a shrinking space for empiricism in debates over politicized health policies.

Of course, the most optimistic interpretation of events is to take Senator Nelson at her word when she expresses the desire for objective assessments of what is working and what is not in Texas' family planning programs. As reproductive health researchers concerned for the women of Texas and the integrity of health policy evaluation, we will continue to provide the objective assessments that Senator Nelson declares she wants. It is up to her and her fellow legislators and policymakers to act on this evidence.

Authors' Note

The authors' research was funded by a grant from the Susan T. Buffett Foundation.

The Patient and the Snake Oil Salesman

By JIM PURCELL

On June 11, 2016, James Madara, MD., addressed the American Medical Association's Annual Meeting with some wonderful hyperbole. Dr. Madara is the CEO of the AMA, and he likely felt some pressure to rally the troops (a/k/a physicians) and show that the AMA is advocating for their “side.” And it got attention, with articles trumpeting that Dr. Madara called digital products “modern-day 'snake oil'.” He indeed did.

We do need to give Dr. Madara a little leeway here.  The role of the AMA is to represent physicians, and he's the CEO.  That being said, consider for the moment that one of the major points Dr. Madara made was to tout how the AMA's predecessors over 100 years ago outed snake oil for the fraud it was, thereby protecting the consuming public.  While it was a while ago, the AMA should be rightly proud of that accomplishment.

However, what Dr. Madara did at the June AMA meeting, entertaining as it was, does not deserve equal accolades.

 Let's first look at the good parts.  What he was calling digital health snake oil were not ALL digital health products.  There are products in the market that are either vaporware or that can do outright harm, and he was referring to producers and literature that have oversold what digital products alone can do.  For better or worse, it is a largely unregulated arena, and use of such products does not mean never seeing a doctor again.  Duly warned.

Dr. Madara continued:  “The future is not about eliminating physicians, it's about leveraging physicians.”  I could not agree more.  We must get them to the sweet spot where they practice at the top of their license, unlike today.  Doing less with better results.  Moving away from volume production to patient outcomes.  But his focus on leveraging physicians brings me to my issue.

The medical profession by and large has ignored the convenience of patients.  We all know this.  The entire process of just seeing a physician is highly inconvenient.  There are, of course, exceptions, and they shine out as such.  But the center of the universe in our current system is…them.  Physicians might not actually realize that given the enormous pressures they are under.

But from the standpoint of an outside observer, it sure seems that way.  Everything about physician care revolves around maximizing what the physician can do in the extraordinarily limited amount of time he or she sees a patient.  That world circles around the physician rather than the patient.

That's not entirely the fault of physicians.  Our care delivery model and its financing (how payors pay for care) have ensured a model that is anything but patient-centric.

But back to the AMA speech.  The digital products Dr. Madara refers to, both good and bad, are attempts by the “market” to benefit patients–namely us.  They are efforts to educate us, empower us, and make our health care more convenient…for us.  We patients feel anything but empowered with our healthcare.  Thus, these digital products are the natural consumer response to a highly inconvenient, largely poor quality medical service in America today.

This should be, after all, about the patient's' convenience and outcomes.  From the AMA CEO's comments, it is very unclear whether he appreciates that, because his few nods to technology are limited to technology that advances the physician's convenience. For example:  “…digital tools that would simplify and better organize our lives…”  He's referring to physicians' lives–not ours.  He never mentions the convenience of patients.

Dr. Madara goes on to tout the “Steps Forward” digital modules which are made available via the AMA website.  Their purpose?  To “…address pain points highlighted by physicians….”  Not by patients.

The medical profession is light years behind virtually every other profession when it comes to customer convenience and interaction, much less the use of customer/patient-facing technology.  So it's unsurprising that the “customers” are taking matters into their own hands, and at least the digital world is reacting to supply the consumer demand.

Given physician uninvolvement, of course there will be some snake oil.  But up to now, most physicians have wanted nothing to do with this sort of technology. It's simply not a focus of the medical profession, and that is my point.  That must change, or the digital consumer revolution, which IS coming, will do it without their involvement, diminishing the truly important role physicians play.

Last but not least.  Dr. Madara takes shots at electronic medical records, lumping them in with digital snake oil remarks.  Here I take great issue on a number of levels.

 

• Physicians could have been more involved in their design.  For whatever reason, they were not.  Where was the AMA when EMRs were being designed and introduced?  The result is predictable.

• Physicians seem to accept the lack of interoperability as an inevitable part of the treatment landscape.  If ATMs can do it, so can EMRs (I'm told it's a bit more difficult in healthcare than in finance, but…).  It's outrageous that there's not more of an outcry on our lack of interoperability.

• The inordinate amount of time MDs spend on their computer, albeit apparently true, is a tired red herring.  Rather than make EMRs the whipping boy, design better EMRs and focus on better office workflows and business models.  Seasoned professionals in other areas (law, accounting, etc.) are not thusly hamstrung.  They find ways to make it work.  It's a sign of a broken business model if MDs are spending as much time entering data as treating patients.

The truth is that almost every physician cares deeply about patients.  But the AMA's comments might lead one to conclude to the contrary.  This could be seen as just one more instance where the profession continues to unilaterally dictate care paternalistically rather than collaboratively design it based upon greater patient and family input, and perhaps welcoming apps that do just that.

It would be a very healthy development indeed if the AMA were to focus more on facilitating patient convenience and outcomes and be a tad more receptive to the consumerized digital medical revolution that will soon be upon us, like or not.

Jim Purcell was the CEO of BCBSRI. Prior to that, he was a trial lawyer in healthcare, and today he mediates and arbitrates complex business disputes and is focused on workplace wellbeing. jamesepurcell.com (healthcare) and jimpurcelladr.com(mediation/arbitration).

 

Pancreatic neuroendocrine tumors (pancreatic NETs)

Pancreatic neuroendocrine tumors (pancreatic NETs): a type of tumor that arises from hormone-producing cells in the pancreas. Pancreatic NETs may be either benign or malignant and may produce hormones (termed a "functional" pancreatic NET) or not produce hormones (a "nonfunctional" pancreatic NET). Often, the tumor itself does not produce signs or symptoms, although the hormones produced by the tumor may cause symptoms.

• The main types of functional pancreatic NETs are gastrinoma, insulinoma, and glucagonoma. These produce the hormones gastrin, insulin, or glucagon, respectively. Most glucagonomas and gastrinomas are malignant, while most insulinomas are benign. Nonfunctional tumors also tend to be malignant.
  


• Other types of functional pancreatic NETs include tumors that produce vasoactive intestinal peptide (VIPomas) and somatostatinomas.
  


• Having the condition known as multiple endocrine neoplasia 1 syndrome (MEN1) increases the risk of developing a pancreatic NET.


• Some of the symptoms produced by the different kinds of pancreatic NETs include changes in
  hypoglycemia,
  diarrhea, stomach ulcers,
  dehydration, and
  weight loss, although the specific symptoms vary according to the type of hormone made by the tumor.
  


• There are a number of possible treatments, including surgery,
  chemotherapy,
  hormone therapy, and targeted therapy.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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Medicare's Long-Term Fiscal Peril Deserves More Attention

By STEVEN FINDLAY

This year's release of the annual Medicare Trustee's report on June 22-261 pages of mind-numbing healthcare and budget minutiae-coincided with the release of the House Republican's long-awaited alternative to Obamacare.   

Coincided, but not coincidence.  Republicans' sought to leverage the annual report's hand-wringing about Medicare's fiscal unsustainability-to draw attention to their proposals.     

Indeed, the GOP plan garnered the news spotlight.  But it's the Trustee's report that deserves closer attention and has more long-term import.   

Why?  For starters, the GOP health reform plan is going nowhere.  It's nice that Republicans finally went beyond their “repeal Obamacare” rhetoric.  But, as most of us now realize, the chances that Obamacare will ever get fully repealed and replaced are rapidly declining-for technical and political reasons.  If Hillary becomes president, it certainly won't happen over the next four years. 

Second, although the new GOP plan contains some ideas that may come into play as possible fixes to Obamacare and Medicare over the next 20 years, it is primarily a compilation of re-heated concepts and ideas that: (a) have failed for years-even decades-to garner broad support; (b) have inherent flaws in today's healthcare marketplace; and (c) would take us backward in coverage expansion, productivity and quality enhancement, and cost constraint.   

In contrast, this year's Medicare Trustee's report comes at a crucial moment.  We are 5 years into Obamacare implementation and its strengths and flaws are becoming clearer.  Health costs are again on the upswing.  The economic recovery remains weak, with Brexit adding to instability on that front.  And the long-term fiscal and federal budget (think taxes) challenge posed by Medicare, Medicaid and Social Security remain largely unaddressed.   

At a joint Brookings/American Enterprise Institute briefing on the report on June 23, a group of healthcare experts (of all political stripes) strongly agreed that Congress has been “sleepwalking into a major entitlement crisis” for more than a decade.  Conservatives/Republicans grumble about this a lot more than liberals/Democrats, but the Dems, too, get that the problem is serious.

To wit:

76 million baby boomers began moving into Medicare in 2011 at the rate of 10,000 a day.  By 2029, they'll all be in-with enrollment rising from 57 million today to 73 million in 2025 and 89 million in 2040. 

Medicare spending is projected to double over the next decade, from $683 billion in 2016 to $1.3 trillion in 2025.   

The average annual per beneficiary cost in the program is projected to rise from $12,925 in 2016 to $19,400 in 2025.   That reflects an average annual rate of increase over the next decade almost three times what it was in the years 2010 to 2015 (4.3% versus 1.5%).   (Importantly, overall per person per year health spending-for people of all ages-is forecast to grow at 4.9% over the next decade, about 1% faster than average GDP growth.) 

The Medicare hospital trust fund (Part A) will be insolvent by 2028, 2 years earlier than the Trustees projected last year.

Medicare spending will rise from 3.6% of GDP in 2016 to 5% in 2030 under current law.    (It was just over 2% of GDP in 2000.) (Health care spending overall is now 18% of GDP, and projected to rise to 20% by 2024.)   

On this last point, the Trustees assume in their projections that the cost constraints imposed on Medicare by the ACA and, more recently, MACRA (the law that replaced the SGR formula and creates an entirely new physician payment system which goes into effect in 2019) will be retained and not dramatically altered.  But, for illustrative purposes, the Trustees also calculated what would happen if, in their words, “adherence to the MACRA and ACA cost-reducing measures erodes” over the next decade and beyond.    

The results were dramatic:  Medicare spending alone could rise to 6.2% of GDP in 2040 and 9% in 2090.  Of course, such long-term projections-anything beyond 10 years-have a large margin of error, as the Trustees acknowledge.   

Indeed, their report notes:  “Scientific advances will make possible new interventions, procedures, and therapies. Some conditions that are untreatable today will be handled routinely in the future. Spurred by economic incentives, the institutions through which care is delivered will evolve, possibly becoming more efficient. While most health care technological advances to date have tended to increase expenditures, the health care landscape is shifting. No one knows whether future developments will, on balance, increase or decrease costs.”  (My emphasis in italics.) 

Even so, the overall point the Trustees make is profound: we not only have to stay the course on improving efficiency and productivity in health care while bringing the growth rate in costs down, we have to accelerate that effort.  And we can't wait until 2025 or beyond to do it.  If we do wait, health care costs will come to dominate the federal budget (they are already 20% of it) and crowd out other, necessary spending, and force wrenching changes.   

Here's are portions of the report that jumped out at me, edited for brevity and with my italics for emphasis:     

“The Board [of Trustees] assumes that the various cost-reduction measures [in the ACA and MACRA] will occur…. [and are] achievable if health care providers are able to realize productivity improvements at a faster rate than experienced historically. However, if the health sector cannot transition to more efficient models of care delivery and achieve productivity increases commensurate with economy-wide productivity, and if the provider reimbursement rates paid by commercial insurers continue to follow the same negotiated process used to date, then the availability and quality of health care received by Medicare beneficiaries would, under current law, fall over time compared to that received by those with private health insurance…. 

“The Trustees are hopeful that U.S. health care practices are in the process of becoming more efficient as providers anticipate more modest reimbursement growth rates, in both the public and private sectors, than experienced in recent decades. The methodology for projecting Medicare finances assumes a substantial long-term reduction in per capita health expenditure growth rates relative to historical experience, to which the cost-reduction provisions of the ACA and MACRA would add substantial further savings…..

“Notwithstanding recent favorable developments, current-law projections indicate that Medicare still faces a substantial financial shortfall that will need to be addressed with further legislation. Such legislation should be enacted sooner rather than later to minimize the impact on beneficiaries, providers, and taxpayers.”  

There's more to this story.  A follow-up blog will discuss the House GOP health plan's proposals on Medicare; the long-running debate over the role of Medicare Advantage; IPAB (the Independent Payment Advisory Board mandated in the ACA to control Medicare spending); and the politics of Medicare reform in the presidential campaign, triggered in part by a possible 20% or more increase in Part B premiums in 2017 for wealthier beneficiaries.      

 Steven Findlay is an independent journalist and editor who covers medicine and healthcare policy and technology.     

Traumatic asphyxia

Traumatic asphyxia: a medical emergency hat result in the loss of the ability to breathe brought on by intense compression of the chest. This leads to back-flow of blood from the right side of the heart into the veins of the neck and brain. Traumatic asphyxia is also known as Perte's syndrome. Symptoms and signs of traumatic asphyxia include swelling of the face and neck, bluish discoloration (cyanosis) of the head and neck, subconjunctival bleeding in the eyes, and small spot-like hemorrhages on the skin of the face, neck, and upper chest.

See also: asphyxia

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Assisted suicide

Assisted suicide: The deliberate hastening of death
by a terminally ill patient with assistance from
a doctor, family member, or another individual.

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We Bring Doctors' Knowledge To You

Retraction and the Rise of the Truth Jihadis

By SAURABH JHA, MD

A petition to the British Medical Journal (BMJ) asking for Makary's paper on medical errors to be retracted has received over 100 signatures. I, amongst others, criticized Makary's analysis. But I shall not be signing the petition.

I applaud the editor of the BMJ, and the section editor, for publishing Makary's analysis. The analysis was in the right journal in the right section. To be clear, I believe the editors did nothing wrong publishing the paper. The role of medical journals is not to tell us how to think, but what to think about, which the BMJ achieved.

Makary's analysis was provocative. I almost developed laryngeal edema reading it. The analysis advanced the discourse about medical errors. The analysis made doctors think, think beyond dull platitudes. The analysis broke the taboo of questioning the number of deaths from medical errors. Whether or not this was the intention of the authors is immaterial. The BMJ achieved a vigorous debate about medical errors. Not since the NEJM series on physician relationship with industr has any publication led to such intense discourse.

Some say that the paper should be retracted because it was a scientific paper, not an opinion, and as science it is even more dubious. This is not true. The paper was an “analysis.” Look up the definition of “analysis.” But were it research, so what? Methodology for this this type of research is flawed. If all research with fallible methods are retracted, that'll end medical research.

Some say that the paper should be retracted because the media runs with the story amplifying the error. The media is fickle. The media runs like decerebrate pigeons every time a nutritional study is published. The media doesn't know its posterior from elbow and I, for one, find this state of affairs comical. I find it hilarious when someone, who follows nutritional advice as punctiliously as a celibate nun listens to her pastor, is later told that it is all rubbish. Nothing gives me more pleasure than seeing mirthless optimizers taken down the garden path.

It is true that the media will be quoting “medical errors are the third leading cause of death” for years. However, the root cause of this chicanery is not Makary's analysis but the Institute of Medicine (IOM) report: To Err is Human, which stated that jumbo jets of hapless patients were crashing daily. The report created a new science and a professional empire. Should the IOM retract that report?

The problem with retraction was highlighted by my 10-year old son recently. Arguing with his younger brother he said “you must be feeling light because you left your brain back at school.” When I heard his gratuitous remark I was enraged, “Take your words back, now,” I yelled. After deep thought, and tears in his eyes, my son said “what good will that do? I already said them.” I gave him a time out for that reply. But his point was well taken – what is said can't be unsaid.

Retraction has become like corporal punishment. Spectators would flog to the stadiums in Taliban-controlled Afghanistan to watch with glee when adulterers were being stoned. When a medical journal retracts a study there is glee amongst spectators, the glee of an aspiring saint watching a sinner unfold. Read the comments in Retraction Watch, a consumer watchdog which keeps an eye on retractions.

Inquisitive scientists seeking the objective truth embrace uncertainty. There is, however, an emerging rank of science aficionados who treat objective truth like religion. These are the Truth Jihadis. They're indistinguishable from religious fanatics on PET scans. Truth Jihadis are not seeking the truth. They're seeking control. “I am for the truth” is the dullest of dullest platitudes. Science, an enterprise which grows by curiosity, not control, cannot be chaperoned by the incurious.

Calls for retraction have become yet another avenue of redress for an affluent society, which has exhausted the legal system, and which increasingly yearns for perfection, is intolerant of uncertainty and can't handle variation. Americans might introspect this November how they became more hyper regulated than the French, indeed more hyper regulated than Stalin or Mao thought it might have been possible to be hyper regulated.

When Bleyer and Welch published in the NEJM a study which showed that mammograms may have overdiagnosed breast cancer, the reaction amongst my peers was brisk and predictable. It started off with “how could this pass peer review?” – the incredulity cleverly according the skeptic with unchallenged sophistication. I asked a few, what should pass peer review? Was there a normative frame? Who developed the norm? I was met with silence.

Some asked the NEJM to retract the paper. Many called the study “fatally flawed.” One said, in a tone perfectly capturing sincerity and gravity, “this paper will kill women.” Nothing quite inspires righteousness more than believing you have God or statistics on your side.

If science has been hijacked by special interests it won't be rescued by social justice warriors. I recall an open letter signed by UK academics asking to boycott Israel's academia. Scientists and politicians, like pigs and farmers in Orwell's Animal Farm, have become indistinguishable.

The most famous retraction is Wakefield's discredited paper in the Lancet about the link between autism and vaccination. It must be understood why the paper was retracted. It was not retracted because the link was later shown to be wrong. As the editor of the Lancet, Richard Horton, reminded with frustration – science is self-correcting. It was not retracted because it unleashed havoc, including a congressional hearing. I'm always amazed how congress chooses the most dubious entities to debate over. It takes skill to be so consistently and exceptionally useless. The paper was retracted because Wakefield was struck off the General Medical Council, because he obtained the tissue samples of the children through deceit. The study was retracted because Wakefield had been dishonest.

The most disturbing part of the autism-MMR debacle is not that the Lancet published the study. It is that the Lancet had to retract the study before people believed the dubiousness of the link. Wakefield had to be discredited (he deserved to be), shown to be a bad man before people believed in vaccines again. It was not the scientific evidence that persuaded people, but the (bad) character of the researcher.

Thus, we cannot debate facts on their own merit but we must involve the person behind the facts. If he is sincere, “a good guy,” we must believe what he has to say. If the evidence is dubious he must be dubious, too. The religious undertones in the scientific enterprise are ironic. Pope Urban VIII is probably laughing in his grave.

It is a small logical step from saying that because dodgy scientists produce dodgy science, that dodgy science is produced by dodgy scientists. And an even smaller step from concluding that because dodgy research is later contradicted, that research which is later contradicted is dodgy. Retraction is a Spanish inquisition, of sorts. Calls for retraction are reminiscent of pitchfork-carrying righteous puritans in Salem. I'm getting tired of puritans.

It is precisely because Makary's analysis is flawed that it should not be retracted. For it to be retracted would be to set a standard for medical journals that is neither achievable nor desirable. Knowledge grows by error, not perfection. Perfection merely picks out the lowest-lying fruit which everyone can agree about. Makary's study received several online comments on the BMJ website. Voices were heard, which would not have been heard but for this paper. Were I the editor of the BMJ I'd open a bottle of champagne and celebrate a job well done.

Just-in-Time Healthcare Information

By HANS DUVEFELT, MD

One of the things that can cause physician burnout is the arcane way information flows in medical offices. In essence, due to EMRs we are the recipients of increasing amounts of unfiltered data without context.

Pre-EMR, team members sorted incoming data, which allowed us to deal with it more efficiently. We would have piles of things that needed a signature just as a formality, other piles for normal reports, smaller piles for abnormal reports, or whatever system worked best for us and our practices.

Because EMRs were created by people who never imagined that doctors themselves knew anything about how to maximize their own efficiency, results and reports now fill our inboxes in random order and demand our attention and our electronic signatures more or less immediately.

There is a better way. It is standard practice in manufacturing. They call it “Just in Time”.

First, let me describe the way it works now:

I saw Mrs. Keller three months ago for her diabetes. Next week, she will be back for her three month followup appointment. In the next few days, I will get her blood test results, each requiring my electronic signature. This time that might be her HbA1c and her annual urine microalbumin and a chemistry profile. I might also have received an eye doctor report from last week and a progress report from her podiatrist, neither one of which requires any action on my part. That means I must “steal” time from this week's patients to peruse and electronically sign off five items, which I will have to review again when I see her next week. I also have to remember to flag the eye doctor report for my medical assistant to enter in the flowsheet so we can keep up our quality reports.

In my mind, I multiply Mrs. Keller's five sign-offs by the number of followup visits I have every week. Even CT scans, MRIs and other imaging could be reviewed and signed off at the time of the followup visit; the radiology departments at all my area hospitals have routines in place to flag critical results.

Why should I look at everything twice? Why are physicians, the highest paid members of the health care team, essentially opening and sorting the mail?

I imagine how my day would flow if none of those five items cluttered my inbox, but popped up when I sat down with Mrs. Keller to talk about her diabetes or with Bill Watterson to talk about his partially torn meniscus.

In the lean, “Just in Time” manufacturing paradigm, factories don't store parts and raw materials needed for production. They save space, time and money by planning for what they will need and having these supplies arrive just before they are needed.

In medicine, information like test results and outside reports are the parts we need in order to produce treatment plans, which is the output in our “industry “.

Most of the time today, we get paid only for face-to-face visits, and not for “managing” patients' care. Even in the future, when Medicare starts paying us for outcomes, efficient information flow is essential. Imagine getting important information in random order versus delivered in context, when it is time to assess a patient's or an entire population's health status.

Between the skill and experience of our team members and the vast untapped potential of the expensive information systems we have, we could get to where we touch most incoming information only once, just when we need it. Imagine how much time, energy, frustration and money that could save us all.

Adiposity

Adiposity: a condition of being severely overweight, or obese. The term
"obesity" more frequently is used for this condition in the U.S. where obesity is usually defined by measuring a person's body mass index (BMI). There also
is a measurement of body fat used by some researchers known as the body adiposity index (BAI). Unlike the BMI, weight is not taken to account in the BAI, which is based on a person's height and hip circumference.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
We Bring Doctors' Knowledge To You

Are The FDA's New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated - including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

In 1991, the agency requested public comment on a definition, stating that “if the term 'natural' is adequately defined, the ambiguity surrounding use of this term that results in misleading claims could be abated.” But nothing came of the comments and in 1993, the FDA declined to define the term, citing “resource limitations and other agency priorities” (58 Fed. Reg. 2302, 2407 (Jan.6, 1993)).

Beginning in 2013, plaintiffs filed a large number of suits against food manufacturers, alleging that the use of the term “natural” was misleading under various state laws. And in late 2013, three courts in Northern California stayed several of these cases pending the FDA's determination of the issue. (I've written about this use of the primary jurisdiction doctrine here.) In January 2014, in a letter to these courts, the agency again declined to define the term, citing resource limitations. However, after receiving several citizen petitions on the issue in late 2015, the FDA once again requested public comment on whether it should define “natural,” and if so, how. When the comment period for this request closed on May 10, 2016, the agency had received 7,690 comments.

Implying Health

Although it did not define “natural” after the 1990 passage of the NLEA, the FDA did define the term “healthy.” The agency explained that some claims made on food labels suggest “that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices.” This, the agency said, implied nutrient content claims (21 C.F.R. § 101.13(b)(2)(ii)). And according to a regulation finalized in the early 1990s, the term “healthy” cannot be used in such a claim if the relevant food contained more than a certain amount of fat or sodium (21 C.F.R. § 101.65).

In March of 2015, the FDA sent a letter to the Chief Executive Officer of Kind, LLC, a company that manufactures protein bars, explaining that the product's labels violated the agency's regulations in several respects, most notably by the use of the term “healthy.” The bars contained too much saturated fat to be labeled healthy, according to the agency.

The company responded that the fat in its bars was derived from nuts, which are “generally considered to be good for you.” The extensive media coverage of the dispute focused on recent research showing that saturated fats, especially from foods such as nuts, may actually be healthy. The FDA and Kind reached a resolution in May of this year, and the FDA explained in a statement that the company could “use 'healthy and tasty' as part of its corporate philosophy, as opposed to using 'healthy' in the context of a nutrient content claim.” Moreover, the agency announced plans to ask for public comment on the redefinition of the term “healthy” soon.

Nutrition Facts 2.0

A prohibition on misbranding is one of the main tenets of the Food, Drug, and Cosmetic Act first enacted in 1938. Since then, the federal government has made the provision of accurate information a cornerstone of its food regulatory scheme.

In early 2014, the FDA published its proposed rule to update the Nutrition Facts label on most packaged foods listing the amount of calories and nutrients. In October of 2015, the then-Commissioner of the FDA, Dr. Margaret Hamburg, confirmed the agency's commitment to providing consumers with accurate information, stating in a letter that “[t]oday, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States.”

The Nutrition Facts label, finalized in May 2016, is an important part of this strategy. Large manufacturers will have to begin using the new label by July 26, 2018, while those with annual sales under $10 million have another year to comply the rule. Studies have shown that consumers actually use the Nutrition Facts label to make decisions about what to purchase and to eat. Forty two percent of respondents to the National Health and Nutrition Examination Survey in 2009-2010 used the Nutrition Facts label “always or most of the time,” compared to 34 percent in 2007-2008. The updated Nutrition Facts label is thus important and past due.

The new label updates serving sizes, which haven't been changed since 1993. And although there is the possibility that some people may think the FDA now sanctions larger servings, serving sizes are, by law (21 C.F.R. § 101.9(b)(1)), supposed to reflect what people actually eat, not what they should be eating. For better or for worse (probably worse), people eat more than they used to, and the new serving size requirements should help them understand the calories, fat, and nutrients in an average portion.

The FDA is also requiring manufacturers to begin listing some nutrients that we now know are important such as Vitamin D and potassium. The update also eliminates the required inclusion of other nutrients such as Vitamins A and C, which Americans now get enough of, and updates some daily values. Requiring manufacturers to list added sugars on the label is significant, because, as the agency explains in its highlights of the new label fact sheet, “[s]cientific data shows that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar.” The design of the label will also change, to make the information more accessible to consumers. You can see the original and the updated labels here.

The Aura Of Truth

The benefits of the agency acting to define “natural” and redefine “healthy” are less clear. Any consideration of the thousands of comments the agency received regarding whether and how it should define natural shows that such a definition would be more philosophy than science, and would represent a compromise among stakeholders. Questions of whether the term “natural” should encompass methods of production as well as ingredients, and whether genetically engineered ingredients can ever be considered natural, are only two of many on which much investment rests and about which interested parties may hold many different positions.

As far as deciding the meaning of “healthy,” a term that may seem more concrete than “natural,” the current debate illustrates how nutrition science is unsettled, and how quickly wisdom about certain nutrients can change. The ponderous regulatory process cannot keep up with the pace of changing scientific understanding. In addition, adding the FDA's imprimatur to these terms fosters consumers' overreliance on words, the specific content of which they may be unaware of or misunderstand. It is easier to buy food labeled “natural” or “healthy” than to take the time necessary to understand what kinds of products and ingredients are actually best for one's body.

In short, the Nutrition Facts labels correct an information imbalance, providing consumers with otherwise unavailable data, and allowing them to better assess their choices - definitions of terms such as “healthy” and “natural” do not. Any such definition will be a negotiated and artificial construct, imbued by the FDA with an aura of truth. The agency should spend its scarce resources elsewhere.

Time to Brexit the Health Care System?

By JOE FLOWER

Can't. Won't work. We're stuck with this. We have to fix it.

But “Brexit” was a great logo/hashtag/campaign meme, with echoes of “Britain, break it, exit” all in one. Falls right off the tongue, it does. And it described fairly exactly the mood behind it, one of breaking, getting out.

So in healthcare? Time to FFSexit - exit the fee for service business model. Nah, doesn't trip off the tongue. And it has echoes of “sex” and even “sexist.” Next!

Time to ITexit - exit the non-interoprative, non-communicative garbled EHRs and other information systems we have ended up with. Nope, nope. Sounds too much like inviting Texas to re-think this whole annexation thing.

Time to Vexit - exit the volume-based business model. Hmmm, no. Sounds vexatious, vexed.

Time to exit the fragmented, opaque, partial, byzantine, and outright cruel healthcare financing system we have now -FragOpParByzOutCrexit! Sigh.

Wait. Wait. Here's the core problem of this meme-pondering: We don't want to “exit” healthcare in any way.

The Congressional Republicans hope to exit the defined benefit Medicare system and make it a defined contribution system, presumably so that sooner or later they can drown the contribution in the bathtub. Republican state legislatures have found as many ways as possible to exit Medicaid, or its expansion.

But we the people can't exit the healthcare system because unlike political parties and ideologies, we actually have bodies, and those bodies need tending whether we like it or not.

The healthcare economy is hollow. You know the drill. It costs twice as much as it needs to for no good reason, overtreats to the tune of close to $1 trillion per year, at prices that have no real support in the cost basis or the market, still is a major cause of personal bankruptcies, and manages to cut vast numbers of people even people “covered” by high deductible plans, out of any treatment at all because it's so expensive to use the system.

We don't need to exit. We need to fix it. Fixit!

#healthcareFixit!

HIV

HIV: Acronym for the
Human Immunodeficiency Virus, the cause of AIDS (acquired immunodeficiency
syndrome). HIV has also been called the human
lymphotropic virus type III, the lymphadenopathy-associated virus and
the lymphadenopathy virus. No matter
what name is applied, it is a retrovirus. (A retrovirus has an RNA genome and a
reverse transcriptase enzyme. Using the reverse transcriptase, the virus uses its RNA as a template for making complementary
DNA which can
integrate into the DNA of the host organism).

Although the American
research Robert Gallo at the National Institutes of Health (NIH)
believed he was the first to find HIV, it is now generally accepted that the
French physician Luc Montagnier (1932-) and his team at the Pasteur
Institute discovered HIV in 1983-84.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
We Bring Doctors' Knowledge To You

Are The FDA's New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated - including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

In 1991, the agency requested public comment on a definition, stating that “if the term 'natural' is adequately defined, the ambiguity surrounding use of this term that results in misleading claims could be abated.” But nothing came of the comments and in 1993, the FDA declined to define the term, citing “resource limitations and other agency priorities” (58 Fed. Reg. 2302, 2407 (Jan.6, 1993)).

Beginning in 2013, plaintiffs filed a large number of suits against food manufacturers, alleging that the use of the term “natural” was misleading under various state laws. And in late 2013, three courts in Northern California stayed several of these cases pending the FDA's determination of the issue. (I've written about this use of the primary jurisdiction doctrine here.) In January 2014, in a letter to these courts, the agency again declined to define the term, citing resource limitations. However, after receiving several citizen petitions on the issue in late 2015, the FDA once again requested public comment on whether it should define “natural,” and if so, how. When the comment period for this request closed on May 10, 2016, the agency had received 7,690 comments.

Implying Health

Although it did not define “natural” after the 1990 passage of the NLEA, the FDA did define the term “healthy.” The agency explained that some claims made on food labels suggest “that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices.” This, the agency said, implied nutrient content claims (21 C.F.R. § 101.13(b)(2)(ii)). And according to a regulation finalized in the early 1990s, the term “healthy” cannot be used in such a claim if the relevant food contained more than a certain amount of fat or sodium (21 C.F.R. § 101.65).

In March of 2015, the FDA sent a letter to the Chief Executive Officer of Kind, LLC, a company that manufactures protein bars, explaining that the product's labels violated the agency's regulations in several respects, most notably by the use of the term “healthy.” The bars contained too much saturated fat to be labeled healthy, according to the agency.

The company responded that the fat in its bars was derived from nuts, which are “generally considered to be good for you.” The extensive media coverage of the dispute focused on recent research showing that saturated fats, especially from foods such as nuts, may actually be healthy. The FDA and Kind reached a resolution in May of this year, and the FDA explained in a statement that the company could “use 'healthy and tasty' as part of its corporate philosophy, as opposed to using 'healthy' in the context of a nutrient content claim.” Moreover, the agency announced plans to ask for public comment on the redefinition of the term “healthy” soon.

Nutrition Facts 2.0

A prohibition on misbranding is one of the main tenets of the Food, Drug, and Cosmetic Act first enacted in 1938. Since then, the federal government has made the provision of accurate information a cornerstone of its food regulatory scheme.

In early 2014, the FDA published its proposed rule to update the Nutrition Facts label on most packaged foods listing the amount of calories and nutrients. In October of 2015, the then-Commissioner of the FDA, Dr. Margaret Hamburg, confirmed the agency's commitment to providing consumers with accurate information, stating in a letter that “[t]oday, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States.”

The Nutrition Facts label, finalized in May 2016, is an important part of this strategy. Large manufacturers will have to begin using the new label by July 26, 2018, while those with annual sales under $10 million have another year to comply the rule. Studies have shown that consumers actually use the Nutrition Facts label to make decisions about what to purchase and to eat. Forty two percent of respondents to the National Health and Nutrition Examination Survey in 2009-2010 used the Nutrition Facts label “always or most of the time,” compared to 34 percent in 2007-2008. The updated Nutrition Facts label is thus important and past due.

The new label updates serving sizes, which haven't been changed since 1993. And although there is the possibility that some people may think the FDA now sanctions larger servings, serving sizes are, by law (21 C.F.R. § 101.9(b)(1)), supposed to reflect what people actually eat, not what they should be eating. For better or for worse (probably worse), people eat more than they used to, and the new serving size requirements should help them understand the calories, fat, and nutrients in an average portion.

The FDA is also requiring manufacturers to begin listing some nutrients that we now know are important such as Vitamin D and potassium. The update also eliminates the required inclusion of other nutrients such as Vitamins A and C, which Americans now get enough of, and updates some daily values. Requiring manufacturers to list added sugars on the label is significant, because, as the agency explains in its highlights of the new label fact sheet, “[s]cientific data shows that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar.” The design of the label will also change, to make the information more accessible to consumers. You can see the original and the updated labels here.

The Aura Of Truth

The benefits of the agency acting to define “natural” and redefine “healthy” are less clear. Any consideration of the thousands of comments the agency received regarding whether and how it should define natural shows that such a definition would be more philosophy than science, and would represent a compromise among stakeholders. Questions of whether the term “natural” should encompass methods of production as well as ingredients, and whether genetically engineered ingredients can ever be considered natural, are only two of many on which much investment rests and about which interested parties may hold many different positions.

As far as deciding the meaning of “healthy,” a term that may seem more concrete than “natural,” the current debate illustrates how nutrition science is unsettled, and how quickly wisdom about certain nutrients can change. The ponderous regulatory process cannot keep up with the pace of changing scientific understanding. In addition, adding the FDA's imprimatur to these terms fosters consumers' overreliance on words, the specific content of which they may be unaware of or misunderstand. It is easier to buy food labeled “natural” or “healthy” than to take the time necessary to understand what kinds of products and ingredients are actually best for one's body.

In short, the Nutrition Facts labels correct an information imbalance, providing consumers with otherwise unavailable data, and allowing them to better assess their choices - definitions of terms such as “healthy” and “natural” do not. Any such definition will be a negotiated and artificial construct, imbued by the FDA with an aura of truth. The agency should spend its scarce resources elsewhere.

Prescription Drug Monitoring Programs Help Reduce Opioid-Related Death Rates

Over the past two decades, the number of opioid pain relievers sold in the United States has risen dramatically, and the rate of opioid-related overdose deaths has also increased (see the map below for 2013 data by states.) In response, 49 states (all but Missouri, excluding the District of Columbia) have created prescription drug monitoring programs, to detect high-risk prescribing and patient behaviors.

A new study, released as a Web First by Health Affairs, a retrospective review of these programs, found that their implementation was associated with the prevention of one opioid-related overdose death every two hours on average nationwide. Additionally, the authors noted that states whose programs had robust characteristics-including monitoring greater numbers of drugs with abuse potential and updating their data at least weekly-had greater reductions in deaths - 1.55 fewer deaths per 100,000 population. In their study, the authors Stephen W. Patrick, Carrie E. Fry, Timothy Jones, and Melinda B. Buntin, used an interrupted time-series design with data derived from multiple public sources; their analysis unit was the state-by-state pair.

The Centers for Disease Control and Prevention's Prevention for States program has set the goal of making data from these programs more timely, but program funding has been inconsistent.

“Our findings provide support for bolstering prescription drug monitoring programs and establishing a consistent and predictable funding source for them,” the authors concluded. “As the use of these programs becomes more common and consistent, their effect on decreasing the prescription opioid epidemic is likely to grow.”

Patrick and Fry, are affiliated with Vanderbilt University School of Medicine, in Nashville, Tennessee; Jones is with the Tennessee Department of Health, in Nashville., and Buntin is with Vanderbilt University Medical Center.

This study, which will also appear in the July issue of Health Affairs, was funded by the National Institute on Drug Abuse of the National Institutes of Health.

The Mischief and the Good In Precision Medicine

By MERCEDITAS VILLANUEVA, MD

When The White House announced their Precision Medicine Initiative last year, they referred to precision medicine as “a new era of medicine,” signaling a shift in focus from a “one-size-fits-all-approach” to individualized care based on the specific characteristics that distinguish one patient from another. While there continues to be immense excitement about its game-changing impact in terms of early diagnoses and targeting specific treatment options, the advancements in technology, which underlie this approach, may not always yield the best medical results. In some cases, low cost approaches, based on sound clinical judgment, are still the better option.

For example, tuberculosis (TB) is an infectious disease that continues to pose global burden with 9.6 million new cases and 1.5 million deaths reported in 2014 alone. The large toll is partly due to lack of effective treatments (particularly for drug-resistant cases) but also due to delays in diagnosis. One might think that precision medicine technology leading to improved diagnosis would be effective at minimizing the related death toll but we shouldn't automatically assume that. It turns out that sometimes the latest technological advancements can be so sensitive that we detect organisms that are not causing disease.

I recently took care of a 50 year old man who was admitted to our hospital with fever and cough. Not a healthy man, he had liver cirrhosis, chronic obstructive pulmonary disease, and substance abuse. He also had a history of latent TB infection based on a positive TB skin test, but he never had active TB manifesting with clinical symptoms.   He never received prophylactic TB medications to prevent the development of active disease. Because of this history, his doctors sent a sputum sample for TB cultures, which usually take 6 weeks to grow the organism. The patient went home since he felt better with treatment for bronchitis.

In the meantime, the laboratory reported that the patient's sputum cultures were growing a “TB-like” organism.  The laboratory tested this culture using Gene Xpert, a precision medicine tool developed in 2010, which yielded a positive identification of drug resistant TB (along with non-TB mycobacteria). The patient was readmitted for TB treatment. Although the patient informed his doctors that he felt better, the question of active TB persisted.  Prior to treatment, his sputum samples were re-tested and all were negative using GeneXpert and traditional culture tests. The laboratory decided to further use Next Generation sequencing, another tool of precision medicine to test the original sample which had the positive identification. This test showed that a few TB bacteria were present and genomic testing showed the presence of drug-resistance.

The doctors decided to treat the patient with multiple medications for multi-drug resistant TB.   Over the next six months, the patient received an array of antibiotics that produced toxic side effects involving his kidneys, liver and lungs. The doctors conferred with the state health department and it was decided to continue treatment largely on the basis of the testing and the concern for potential infectiousness to the public.  When I became involved in this patient's care, he was doing poorly and I wondered if we were doing the right thing.

After all, the patient did not show classic signs of active TB (fever, bloody cough, weight loss).  Yet, our precision medicine tools revealed that resistant TB, albeit few in number, were present in his sputum. But did this constitute disease?  In infectious disease, there has always been the concept of “colonization,” where bacteria live on the human body but do not cause disease. But does this concept apply to TB?  The natural history of this infection describes a spectrum of TB ranging from harboring the bacteria in latent form to actual full-blown symptomatic disease when bacteria reach a critical number.  As our tests get more sophisticated, we may pick up earlier and earlier on conditions that do not actually represent disease as defined by the presence of symptoms.  But is there a benefit (to the patient and the public) in treating earlier in the absence of symptoms? Perhaps, but the more we treat, the more potential side effects can ensue.

In the end, our patient suffered multiple toxicities and his quarantine made him “feel like a prisoner.” Eventually, after consultation with local, state, and federal experts, including an institutional ethics consult, we decided to discontinue TB treatment in favor of monitoring him closely as an outpatient.  He died 6 months later.

I've always wondered if our prolonged attempt at TB treatment hastened his demise.  He never did show any signs of active TB prior to his death.

The Hippocratic oath is credited with the concept of primum non nocere or  “first do no harm.”   Further stated, physicians pledge that “I will according to my ability and judgment, prescribe a regimen for the health of the sick; but I will utterly reject harm and mischief.” To be sure, new precision medicine technologies can reset the clock on when we can first detect causes of disease and offer guidance on what types of treatment we can use. But how do we figure out how to draw the correct line between health and mischief?  As clinicians, we must learn to balance the promises of technology with a practical wisdom so that we do not put our patients in harm's way.

Merceditas Villanueva, MD is the Director of the Yale University School of Medicine AIDS Program and a Fellow with the Op Ed Project.

MD, Director

Yale University School of Medicine AIDS Program

 

Let's Stop Making Excuses For Egregious Medical Errors

To save the life of a child, a zoo sacrifices a prized, endangered gorilla. In exchange for one nearsighted Israeli soldier captured in Gaza, Israel released 1,000 Palestinian prisoners. (This example from the Middle East may not be surprising. In Judaism, it is commanded that “to save a life is as if one saved the world.”) And there are other examples of extreme bravery to save one life. That's how much societies value the life of each human being.

So how, then, do we explain our national acceptance of approximately 251,000 preventable deaths each year from medical error (according to a recent BMJ study)?

We can watch Saving Private Ryan and cheer the heroics of our armed forces as they rescue the remaining son of a family who suffered horrendous battlefield casualties during World War II.

But there is less sustained effort to do something about the hundreds of thousands of people who entrust their lives to medical facilities and suffer or die-not from their illness, accident, or surgery-but because someone did not observe sanitary precautions, or was careless in stocking the crash cart, marking a surgical site, delivering the right medications, or using a safety checklist. Somehow, we accept excuses about this tremendous casualty toll.

The nation is unforgiving when the National Aeronautics and Space Administration (NASA) loses one of its astronauts-a reflection of our national commitment to preserving life.

But we can't accept or process the extent of death by medical error, so we challenge the validity of the data. If 150,000 Americans die each year, or 440,000, does it matter?

Estimates at the “low” end still represent an unconscionable loss of life. We nurture inconsistency. We respect claims that hospital-acquired infections are inevitable, and that superbugs will always defeat us, but then demand that we wage war on the Ebola and Zika viruses.

Sometimes we place the blame on the patient-he or she should demand that health care workers wash their hands-in other words, demand that they do the right thing. We accept excuses from hospitals that perform complex procedures if they have high rates of medical errors because “their patients are sicker”; however, their resources to enforce safety are greater.

Why don't we stop excusing this terrible national tragedy and move with the alacrity of a SWAT team storming a burning building? Here are some measures that would work.

Demand Local Health System Leadership

Hospital and nursing home boards, management, and frontline supervisors should commit to dramatic reductions, within a year, in one or two of the nine leading causes of death: adverse drug events, catheter-associated urinary tract infections, central-line blood stream infections, patient falls in health care facilities, obstetric adverse events, pressure ulcers, surgical site infections, preventable blood clots, or ventilator-associated pneumonia.

The Centers for Medicare and Medicaid Services (CMS) is making this easy, with value-based payment initiatives that penalize providers for high rates of medical errors. So, act with alacrity! Enter a new era of transparency, by tracking progress month by month, unit by unit, and sharing best practices. Make reporting errors safe for employees, solve problems by getting to the root cause (forget workarounds), and reward high-performing staff members and unit directors. Use patient safety checklists and tools and technology to speed improvements.

Do this every year until there are dramatic reductions in all nine of the leading causes of death. Management at the highest level must continuously walk around and observe. It sends a clear message: this institution is deadly serious.

Commercial payers-like their Medicare counterpart-should favor provider organizations that are successful through their payment reform and shared savings programs. The amount of reimbursement should relate to sustained improvements.

We know that rapid, dramatic progress is possible. One of the Jewish Healthcare Foundation's (JHF's) supporting organizations, the Pittsburgh Regional Health Initiative (PRHI), recruited more than thirty hospitals in southwestern Pennsylvania and partnered with the Centers for Disease Control and Prevention (CDC) to systematically attack central-line associated bloodstream infections. Together, these institutions reduced central-line infections among intensive care unit patients by 68 percent. The PRHI also guided the VA Pittsburgh Healthcare System in developing a methicillin-resistant Staphylococcus aureus (MRSA) prevention protocol and interventions that led to an 85 percent reduction in MRSA infections in a postsurgical unit (see page 14). The MRSA prevention protocol became standard practice across the national Veterans Health Administration system. None of this happens without committed leadership.

Recognize and Reward Improvement Efforts

The people being needlessly harmed in our health care institutions are our neighbors, friends, and family. But those trying to deliver safe, high-quality health care are also our neighbors, friends, and family. We need to appreciate and support their efforts. We at the JHF are fortunate to have committed partners in Milton and Sheila Fine, whose Fine Foundation sponsors the Fine Awards for Teamwork Excellence in Health Care. Since 2008, Fine Award winners, representing the full spectrum of care settings, have demonstrated measurable, long-term improvement and have moved the quality bar within their organizations; achieved support from top administrators; and developed plans to sustain and spread their work. It's a model that should be replicated elsewhere.

Step Up Education and Training

Change happens at the point of care, where the people with “boots on the ground” connect with patients. If clinicians don't know how to solve problems rapidly in the course of their work, achieve high performance, and track progress, change won't happen. Doctors and nurses must lead the charge, so the role of education and ongoing training and coaching in safety science and quality engineering techniques should be given high priority in health professions schools. They aren't. And, by the way, add a dose of systems theory (which portrays the health care system as a complex entity consisting of many multidisciplinary, interdependent parts) and organizational behavior (covering topics such as introducing change, overcoming resistance to change, and building effective teams) as well.

Young professionals represent an untapped reservoir for building a network of mutually supportive change agents and reform activists. The JHF proudly provides online safety training to current practitioners and both funds and runs a series of multidisciplinary graduate student fellowships in patient safety and systems redesign. By late 2016, there will be more than 800 fellowship alumni.

Act on the Data

The Pennsylvania Department of Health publishes data on quality in skilled nursing facilities in the state, the Pennsylvania Healthcare Cost Containment Council (PHC4) publishes data on hospital-acquired infections (HAIs), and the Pennsylvania Patient Safety Authority provides data on medical errors in acute care settings, outpatient surgery settings, and long-term care settings. The data are available by facility.

Local health departments should more aggressively inform the public about the comparative data on medical error rates among local institutions. Insurance companies should provide their subscribers with useful comparisons in real time. Patients want comparative data on hip, knee, or cardiac surgeries precisely when they have to decide on a surgical team and site.

Media outlets must publicize outcomes data. Many already do so. The public needs to know which facilities are the safest and to call on the executive and governing boards of local hospitals and nursing facilities to accelerate the pace of progress.

Learn from the Past

We can learn from past successes. From anti-coagulation efforts to reduce clots, to universal precautions adherence to protect workers treating patients with AIDS, to vaccinations to prevent pneumonia, to fetal heart monitoring for better birth outcomes, to better life-support interventions for trauma victims, widespread and diligent applications of best practices have catalyzed movements to successfully fix major problems.

Take Ownership of the Problem

Death through medical error is a local problem, and it will have to be fixed at the point of care. Payment reforms can provide incentives and penalties; local workers must respond. It's time for all insurers to tier payments to favor the safest providers, and to provide clear, actionable data on comparative safety records to employers. Employers must pass this information on to employees if the public at large is to “choose wisely” in selecting providers and treatments. Health professions schools must provide sufficient education on safety science and quality engineering. Health systems have to develop an adequate problem-solving infrastructure and reward units and employees having excellent safety records. Clinicians must observe best practices diligently, every time.

There must be no excuse for further error. The media and our public health and civic leaders must give this issue the attention that it deserves.

We don't yet possess all of the answers necessary to eradicate heart disease and cancer­-the first and second leading causes of death in the United States-but we know how to eliminate medical errors. We just haven't shown the conviction and courage to do it. Until then, we're falling short of truly valuing every human life.

Chiggers

Chiggers: The larvae of one type of mites, of the family Trombiculidae. The larvae, or juvenile forms, feed on vertebrates such as humans, while the adult mites feed on soil. Chigger bites produce a red welt accompanied by an intense and unrelenting itch. Chiggers are so tiny that they can barely be seen with the naked eye. However, when they are present in a group, they may be noticed on the skin due to their red color. When chiggers bite humans, they inject a digestive enzyme into the host skin that destroys tissue. It is this tissue, and not blood, that serves as food for the chiggers. Chiggers have delicate mouth parts that typically can enter human skin only at areas where the skin has folds or wrinkles. Most chigger bites occur around the ankles, the back of the knees, the crotch, under the belt line and in the armpits. The chigger bite itself goes unnoticed, and the itching may last for days to weeks.

Picture of Chigger Eggs, Larvae, Nymph, and Adult

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