A Study About Drinking Raises Ethical Questions

If ER patients won’t tell you what they were drinking, pretend to be a doctor.

That seems to be the main message of a study, paid for with federal tax dollars, by the Center on Alcohol Marketing & Youth (CAMY).

But is it ethical to appear to be a doctor, when one is simply a researcher gathering data for a study?  That’s just one of the questions raised by the study.

David Jernigan, who runs CAMY, and associates thought it would be interesting to see what beverages were consumed by people who had to go to a hospital emergency room.  There have been studies which looked at what types of beverages were consumed — beer, wine or spirits, alcoholic energy drinks, fortified wines, etc.

This is, in our opinion, nice to know information:  It’s not surprising that people who drink several cans of a fortified malt liquor will be more likely to be seen in an ER setting than a person who drinks one or two light beers, or a couple of glasses of wine.   Common sense would suggest that a person who drinks a fortified malt liquor is more likely to be seen, but it’s always useful to confirm that suspicion.

Jernigan wanted to extend this thinking:  What brands were most likely to be consumed by people who visited a hospital ER?  Are alcoholic energy drinks really dangerous, or was some other sort of product a bigger risk?

In our opinion, those are interesting questions.  But it’s fair to ask, why should we care?  Is our purpose to gather data, for instance, so consumers will know it is safer to drink a regular beer than to drink a malt liquor?  Or do we want to tell consumers which is safer to drink — beer or liquor?

Study Objectives

Jernigan set out to determine (1) whether ER patients would disclose what they had been drinking, and (2) what brands and types were involved.

So he decided to do a pilot study, similar to a bev/al exec who wants to know if a new product will sell will use a test market.  Actually, marketers don’t use one test market, they use several.

And that was the first problem with Jernigan’s study.  CAMY has found a home at Johns Hopkins University School of Public Health, so Jernigan decided to do his pilot study at just one location — the Johns Hopkins Hospital Emergency Department in East Baltimore.

Why he didn’t choose to do a similar study elsewhere isn’t explained.  He could have looked to Boston, for instance.  One of his co-authors is a doctoral student in epidemiology at the Boston University School of Public Health.

But he didn’t, which means the applicability of his research is very limited.

Not Your Grandfather’s Baltimore

Baltimore is the 24th largest city in the U.S., and the Port of Baltimore is the second largest in the Mid-Atlantic, situated closer to Midwestern markets than any other major East Coast seaport.

The city was once a manufacturing center.  For almost 125 years, for example, Sparrows Point just outside Baltimore itself was synonymous with steel, supplying the steel that built  the battleships that won World War II and the Golden Gate Bridge.  That ended in 2012, when the Sparrows Point steel mill was closed.

Now, nearly a quarter of all jobs in the Baltimore region are science, technology,  engineering and.  The city ranks 8th of 100 U.S. metropolitan areas for its concentration of STEM jobs.

Low-Income, Crime Ridden

Eastern Baltimore, where Johns Hopkins is located, once was a vibrant, largely Polish middle-class neighborhood.  Today it is almost exclusively a low-income, crime-ridden, African-American neighborhood.

Blocks of abandoned buildings and its chronic problem with drug trafficking made this area a frequent on-site film location for Homicide: Life on the Street, an NBC television series based on a bestselling book by David Simon, former reporter for The Baltimore Sun in 1997-2001, and the sequels The Corner and The Wire, an HBO cable television drama produced from 2002 to 2008.

Any results as to brands that Jernigan obtained would logically be largely a result of this neighborhood.  By choosing that location, Jernigan virtually guaranteed that he would find low-cost, get-drunk-quick drinks.

Had he chosen to drive 34 miles to a Johns Hopkins hospital on Wisconsin Avenue in Bethesda, Md., he might have found patients using more expensive, top-shelf products, whether craft beers, or top-of-the-line spirits.

Intake Interview

The Baltimore hospital’s ER intake interview asked if the patient drank alcohol, not specific to whatever injury brought him to the hospital, but just whether he drank alcohol.  That wasn’t adequate for Jernigan’s purposes.  He could have had the intake form modified to ask his questions, but instead he developed a procedure where his research team would review intake questionnaires, ask the doctor if the patient was sufficiently sober to provide informed consent.

The study doesn’t discuss whether this procedure which involved researchers seeing individual patient information, violates HIPAA privacy rules.

At any rate, if the patient was deemed able to provide informed consent, the CAMY researchers would then ask the patient whether he had been drinking before the injury.  Those who had not been drinking weren’t asked any additional questions.  If the patient was under 21, and was accompanied by a parent or guardian, the parent or guardian was asked to leave the room to ensure no parental influence.

According to the study, this procedure was reviewed and approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board.  Over a 14 month period, the researchers completed 105 interviews.

Putting on White Coats

Early on, they found many of the patients refusing to answer their questions.  So Jernigan came up with a solution:  His researchers donned the same sort of white coats worn by doctors.  According to the study, this was done with the permission of the emergency department, and, “following this change in study procedure, refusals were rare.”

Any police officer knows that when he asks people how much they’ve had to drink, he often gets results that are wildly different from what is indicated by a breath-test device.  And yet much of Jernigan’s conclusions used exactly this methodology:  Ask patients what, and how much, they had been drinking before the injury.

In the study, Jernigan reports that the  interview found “a lower proportion of beer and other (sic) malt liquor consumed, compared to the national market share of beer and other malt liquor.  The proportion of distilled spirits consumed in the ER sample was higher than the market share for distilled spirits in the U.S.”  The proportion of RTDs was higher than the national market, and the proportion of wine was lower than the national market.

Vodka was consumed at a rate nearly twice that of the national distilled spirits market, bourbon was slightly lower than the national rate; cordials/liqueurs, rum, tequila and whiskey were “all under-represented in the ER sample as well, when compared to their share in the national DS market.”  Brandy/cognac and gin were over-represented in the ER sample.

Jernigan then turned to analyzing the brands represented in the sample.  He reported that “Budweiser beer was the alcohol brand consumed in the highest quantity in the ER sample, representing 15% of all beer consumed.”  He noted that in the national market, Budweiser accounts for only 9.1% of beer consumed.

Steel Reserve represented 14.7% .  “This differs significantly from the national market where Steel Reserve represents only 0.8% of the market.”  Jernigan went on to observe that the top five brands of alcohol consumed in the highest quantities were all beer, followed by Barton’s vodka.

Did CAMY Act Unethically?

The study raises several questions in our minds.  The first, and most important, is whether it is improper and unethical for a researcher to masquerade as a doctor while gathering information for a study.

Your first thought might be, as ours was, “What?  They deceived patients to believe they were talking to doctors?  Isn’t that unethical?”

The study makes clear that the ER doctors approved the use of the white coats.  It doesn’t mention the Bloomberg School’s Institutional Review Board, which suggests to us the IRB didn’t review this part of the study.

We asked several medical ethicists for their opinions on this, and they declined to respond.  Our own view is that this is highly improper.  It was, in a way of speaking, fraud — the intentional misrepresentation of a material fact, knowingly made.  But it wasn’t legal fraud because there wasn’t any resulting injury.

It is also an example of consequentialist ethics, a belief that what really matters are outcomes, that the “end justifies the means;” in this context, that it’s okay to lie if that’s what it takes to make the study work.

 Singling Out Beer

The second ethical question deals with how Jernigan handled beer and spirits.  Looking at beer, he found the “proportion of beer and other (malt) liquor consumed” was lower than the “national market share of beer and other malt liquor.”  But, he said, “the proportion of distilled spirits in the ER sample was higher than the national market.”

When Johns Hopkins put out a press release about the study, it focused on beer, leading off by mentioning four beer brands.  The question is, why?  Maybe Jernigan views beer as the bigger problem, but neither the study nor the press release makes that case.

It also seems as though Jernigan is pushing any problems related to spirits under the rug.

Why Publicize Such a Limited Study?

And that raises a third question:  Why did Johns Hopkins School of Public Health decide to put out a press release about such a limited study.  It’s awfully hard to draw any conclusions about a sample of just 105 persons over a 14 month period.

And yet Johns Hopkins put out a release with the sensationalistic headline:  “Pilot Study Finds ER Patients Drinking High-Octane Beer.”   The release generated a lot of press coverage; at least 38 news sources and NBC News ran stories based on the study, a Google News search indicates.  A cynic might conclude the whole point was to gain a lot of publicity.

The study was funded by the Centers for Disease Control & Prevention.



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