Category: Ethics

How Preposterous News Propagates

Every so often – perhaps more frequently, if you’re continuously canvassing the literature – there’s a rapturous press release regarding a new medical innovation that seems too good to be true.  And, you wonder, how does the lay media get it so wrong?

This study reviewed a consecutive convenience sample of published literature, looking for articles resulting in press releases.  Then, they looked for elements of the article that made it into the press release, as well as the relative accuracy of the release compared with the overall findings of the article.  Essentially, what they found is that press releases were most likely to have “spin” if the conclusion of the article abstract misrepresented the study findings with “spin”.

The authors also have an interesting summary of the sort of “spin” found in abstracts that misrepresent study findings.  These include:

 • No acknowledgment of nonstatistically significant primary outcome
 • Claiming equivalence when results failed to demonstrate a statistically significant difference
 • Focus on positive secondary outcome
 • Nonstatistically significant outcome reported as if they were significant

…and several others.

“Misrepresentation of Randomized Controlled Trials in Press Releases and News Coverage: A Cohort Study”

Could Ordering Reprints Help You Get Published?

Medical journals, to a certain extent, require independent sustainable business models.  The full-time editorial staff, the administrative personnel, and the printing costs must be defrayed by elements such as advertising, subscription fees, or other largess.  One of these sources of largess – particularly for journals with high impact factors – is the ordering of reprints.  After gifts, the major promotional material circulated by pharmaceutical companies among physicians is reprints of publications.

This recent study in the BMJ queried the most prominent medical journals regarding their reprints, hoping to gauge the scope of the reprint requests, as well as the financial windfall these might represent.  JAMA, NEJM, and Annals of Internal Medicine all declined to provide data, so these authors were left with the Lancet and the BMJ family of journals.  Of the most-frequently reprinted articles in these journals, they were far more likely to be industry-sponsored, and represented significant sources of income for the journals – up to a $2.4 million USD order from the Lancet.

There are significant limitations to this study, but, clearly, the revenue stream from reprints may be substantial enough that it may further influence and bias the publication of medical literature.

“High reprint orders in medical journals and pharmaceutical industry funding: case-control study”
http://www.bmj.com/content/344/bmj.e4212

Defensive Medicine is Defensive

Sometimes, people order a CTA chest to evaluate for pulmonary embolism because they’ve used the available evidence to risk-stratify the patient for a pulmonary embolism, and it’s an important diagnosis to make.  Sometimes, people order CTAs of the chest to evaluate for pulmonary embolism out of defensive practice, in order to avoid missing a pulmonary embolism.

There are some holes in this paper, considering how few patients in their cohort received the study intervention.  However, the general statistical gist was is that physicians who indicated that defensive medicine played a role in their ordering decisions had a much lower yield on their CTA for PE.  Conversely, elevated Wells/Geneva scores were associated with higher yield CTA.  Positive d-Dimers and patient request were non-significantly positively associated with increased CTA yield.

Not precisely an earthshaking paper, but it does weakly reinforce what we probably already suspected – defensive medicine harms the patient and the healthcare system.

“Ordering CT pulmonary angiography to exclude pulmonary embolism: defense versus evidence in the emergency room”
www.ncbi.nlm.nih.gov/pubmed/22584801

“Consequences” of Conflict of Interest Disclosure

As if physicians are children, and truths must be hidden from them, three consultants of the healthcare industry have published a commentary in JAMA regarding the possible adverse effects of conflict of interest disclosure. 
They provide cautionary justification for their belief that physicians who have conflicts of interest will overstate or exaggerate their results.  They believe this will happen either as a compensatory mechanism to overcome any skepticism created their reported COI, or because physicians will use their disclosure as an excuse to provide biased results “because the [audience] has been warned.”  They also feel that disclosures of conflicts of interests to patients might make them anxious, which would impact the therapeutic relationship built on trust.  And, finally, they believe that all this hullabaloo about disclosure distracts from the real COI issues associated with fee-for-service and other financial arrangements that should be prioritized for reform.  I tend to think these are narrow, paternalistic arguments that downplay the critical importance of transparency.
Additionally, given a ten citation limit, they cite their own prior articles six times.  I’m not sure if this is an effective strategy to build trust in their evidence or the legitimacy of their message.
But it got them in JAMA.
“The Unintended Consequences of Conflict of Interest Disclosure”

You Should Behave on the Internet

This is an interesting little research letter in JAMA regarding the incidence of state medical board review of unprofessional online behavior.  Of the 48 boards responding, 44 indicated that at least one complaint had been reviewed secondary to inappropriate online behavior.

The most commonly reviewed instances were inappropriate patient communication, online misrepresentation of credentials, and “inappropriate practice.”  The most common responses noted by the survey were disciplinary proceedings, sanctions, and informal warnings – and half of medical boards reported license restriction, suspension, or revocation in response to proceedings.

Behave on the internet!

“Physician Violations of Online Professionalism and Disciplinary Actions: A National Survey of State Medical Boards”
www.ncbi.nlm.nih.gov/pubmed/22436951

The Future of Medicine…is Defensive

At Northwestern University in Chicago, anyway – and probably externally valid to other institutions, as well.

This is a survey of 194 fourth-year medical students and 141 third-year residents regarding whether they observed or encountered “assurance” practice (extra testing of minimal clinical value) or “avoidance” practice (withholding services from patients perceived as high risk).  65% of medical students and 54% of residents completed the survey – decent numbers, but low enough to introduce sampling bias.

The numbers, of course, are grim – 92% of medical students and 96% of residents reported encountering “assurance” practice at least “sometimes” or “often”, while 34% of medical students and 43% of residents had encountered “avoidance” practice at least “sometimes” or “often” – nearly all of those being “sometimes”.  These behaviors are apparently learned from their superiors – approximately 40% of medical students and 55% of residents were explicitly taught to consider practicing defensive medicine.

Interestingly, medical students, internal medicine residents, and surgical residents all reported nearly identical levels of “often”/”sometimes”/”rarely” regardless of the behavior sampled – although surgical residents were more frequently taught to be defensive than medicine residents.

Must be a tough legal quagmire up in Chicago.

“Medical Students’ and Residents’ Clinical and Educational Experiences With Defensive Medicine”
http://www.ncbi.nlm.nih.gov/pubmed/22189882

Progress In Combating Publication Bias

…if from abysmally terrible to embarrassingly bad represents progress.

A certain subgroup of trials registered with ClinicalTrials.gov are required to report their results within one year of conclusion of study.  These mandatory-reporting requirements include clinical trials of FDA-approved drugs, devices, or biological agents that have at least one study site in the U.S.  In the future, this will expand to include unapproved drugs.  These requirements, ideally, should help reduce publication and sponsorship bias by ensuring result availability regardless of ability to obtain publication or the desire of a pharmaceutical corporation to publish negative results.

And, so far, these authors discover that it is a tremendous success – trials subject to the mandatory reporting complied with the requirement in twice as many of identified trials as compared with registered trials that were not required to report results.

Unfortunately, twice as many was only 22% compared with 10%.  So, there’s still quite a ways to go before we have full transparency in clinical trial reporting – but it’s “progress.”

“Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study”
http://www.bmj.com/content/344/bmj.d7373

Lies, Damned Lies, and Tamiflu (oseltamivir)

Receiving quite a bit of press yesterday, and rightfully so, the Cochrane Collaboration published their analysis of oseltamivir – the miracle influenza antiviral that (at great cost) is part of our nation’s strategic stockpile for an influenza pandemic.  The story is interesting both regarding what they found, and what they didn’t find.

As for the data from the review, the numbers are similar to what we’ve been basing our practice upon – oseltamivir significantly shortens the length of time until symptom improvement from 160 hours to 139 hours.  However, it did not demonstrate any difference in hospitalization rates.  Additionally – whether through study bias or by direct medication effects – the oseltamivir groups were significantly less likely to have a confirmed diagnosis of influenza.

So, this suggests that it’s a little troubling that we’ve gone to all the expense to stockpile this expensive medication that does not appear to reduce hospitalizations from influenza – and it remains an individual decision whether that extra day of symptom improvement is worth exposure to the side effects of the medication.  But the reason this is national news is that Roche pharmaceuticals refused to supply the promised clinical data requested by the Cochrane Collaboration; the published analysis is based on 15 oseltamivir studies with complete information, and excludes 42 other studies with discrepancies in the data.  This sort of behavior is just another representative sample of the unethical, but completely understandable, profit-motivation of pharmaceutical corporations protecting their financial interests.

I would be greatly surprised if the clinical data Roche is holding onto supports oseltamivir efficacy.

“Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children – a review of clinical study reports”
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965/abstract

“Flu Drugs: Search for evidence goes on”

Too Many Traumatic Arrests Are Transported

Traumatic arrest in the field – except in the narrowest of circumstances – has universally dismal outcomes.  Yet, As the authors of this study observe, a great number of these patients continue to be transported to hospitals.

This is a retrospective review of a prospective trauma registry at Sinai in Chicago in which all traumatic patients with pre-hospital arrest were considered.  Patients were excluded for pediatrics, medical causes, drowning/electrocution injuries, and if the prehospital time was less than 15 minutes.  Essentially, they were looking at guidelines from the ACS Committee on Trauma for termination of resuscitation in the out of hospital setting – pulseless, apneic, no organized ECG activity, or unresponsive to 15 minutes of resuscitation.

They identified 428 patients in their cohort – and found that 294 of them were transported in violation of guidelines.  Of the inappropriately transported patients, 93% were declared dead in the ED and the remaining 6.8% (20 patients) survived the ED.  Of those 20, 12 died in surgery, 8 made it to the ICU, and 7 died.  A single, neurologically devastated, patient survived to discharge to a long-term care facility with a GCS of 6.

The total hospital charges incurred for the futile resuscitation of these patients totaled $3.8 million – a figure that excludes the EMS charges as well as the long-term care facility charges for the patient with GCS 6.

And this is just a single hospital.

“The Consequences of Noncompliance With Guidelines for Withholding or Terminating Resuscitation in Traumatic Cardiac Arrest Patients”
http://www.ncbi.nlm.nih.gov/pubmed/21986740

The Risks of Missing Dialysis

Hemodialysis patients have an elevated risk of death – and it’s even higher for patients on scheduled dialysis during their “weekend.”

Most scheduled plans are every other day Mon-Wed-Fri or Tue-Thu-Sat, which leads to a two-day interval between dialysis – resulting in an extra day of fluid retention and electrolyte abnormalities.  Bad hearts + extra fluid results in a much higher incidence of essentially any kind of mortality or morbidity associated with cardiovascular causes – significantly more myocardial infarction, congestive heart failure, stroke, and dysrhythmia.  Overall, there were 22.1 vs. 18.0 deaths per 100 person-years on the long-interval days than the others.  Retrospective registry data-mining, but it probably illuminates a logical truth.

This particular article caught my eye because we have a significant population at our county facility that comes for “compassionate dialysis”.  Non-U.S. citizens that do not qualify for scheduled dialysis, they “live” a tortured existence in which they can only receive “emergency dialysis”, as in, we routinely wait until they’re at the precipice of death – with strict criteria of pulmonary edema, K+ > 6.0, bicarbonate less than 10, etc. – before pulling them back a small increment and sending them home to repeat the cycle in another week.  Barbaric.  I can’t even imagine what their outcomes are like….

“Long Interdialytic Interval and Mortality among Patients Receiving Hemodialysis”
http://www.ncbi.nlm.nih.gov/pubmed/21992122