A Drug for Sleep Apnea – A Marketing Miracle

A Drug for Sleep Apnea – A Marketing Miracle

Winston

Yes, yes, Winston, I have heard about the new medication approved by the FDA.  It has been heralded as the first drug approved for the treatment of Obstructive Sleep Apnea.  “Is it so?”  you ask.  It is, but as an infamous man once said, “It all depends on what the definition of is, is.”

The approval is the FDA giving it an indication for use in obese patients with moderate to severe obstructive sleep apnea.  With that approval, it becomes the first medication to have an indication for use in Obstructive Sleep Apnea.  This is the fact that has been in multiple news outlets and led to many questions of sleep doctors by our patients.  It is important to know more about the details.

The approval followed a multi-million dollar, manufacture sponsored study that was published in the New England Journal of Medicine (NEJM).  The study focused on using the weight loss drug in obese individuals with Obstructive Sleep Apnea.  Unsurprisingly, the weight loss induced by the medication resulted in improvement in the apnea condition.  The treated patients were compared to those treated by diet alone who lost little weight during the study.  It was not compared to other weight loss drugs.  The article received wide acclaim and attention.

What was known about excessive body weight, weight loss and Obstructive Sleep Apnea before this study?  I have an interest in the subject and have followed the work in the field since seeing my first patient with sleep apnea while serving in the Army.  He was thin as a rail, by the way.  Current knowledge is that we know slightly more than half of all newly diagnosed apnea patients have problems with their weight.  We know that of those patients who experience significant weight loss, apnea is eliminated in 18-20% of the obese patients.  The others are usually improved, but apnea is not eliminated.

My review of the NEJM article can be summarized briefly.  The drug causes weight loss (previously known) and the weight loss improved apnea in many with it.  Does it work any better than weight loss by any other means: diet, counseling or other weight loss drugs?  Who knows?  The study does not address the issue.  Does it improve apnea over and above the effect of losing weight?  Who knows?  The study does not address the issue.

What did the article do?  I don’t think it provided any new information. It most likely – I speculate here – influenced the FDA to add the Sleep Apnea with obesity indication to the medication’s approved usage.  I suspect that the several million dollars spent for the study resulted in far more notoriety and media attention than any amount of advertising money could buy.  Additional facts for you to consider are the cost of the medication and the duration of treatment it requires.  A quick Internet search shows it to cost between 900 and 1,000 dollars a month on a well-known discount site.  The duration of treatment is potentially life long.

No Winston, it is not proven to be a drug for apnea: just another very expensive drug for weight loss.

What has transpired?  A modern, marketing miracle.

LOOKING GOOD on PAPER – Medical Reports II

LOOKING GOOD on PAPER – Medical Reports II

I am sorry to go on like this Winston, but let’s face it; we are all concerned with our image. It is a basic human trait. Doctors are not immune. When I last wrote, my feelings were running high regarding the reports all doctors are responsible for completing. I stressed the importance of topic or idea segmentation to improve communication, but good communication requires much more.

All reports need more than just the appropriate formatting. What do we include? Of course the type of report dictates its contents. Test interpretation results, by their nature, report the data generated. Hopefully, these are skillfully separated into pertinent presentations or discussions of individual parameters. For the tests performed, a summation of the results should follow with any appropriate, suggested next steps.

Most medical reports are the results of our direct interaction with patients. Histories, physicals, consultations, progress notes, surgical reports and summaries of clinical notes are examples. While these reports are segmented in a long defined manner, they are often subject to abuses of several easily identifiable types.

The segmentation of doctors’ reports summarizing patient interactions is over 50 years old. New physicians are trained to segment their reports.  Traditionally, such reports are divided into the chief complaint, history of the present illness, past medical history, medications, allergies, system review, physical examination, available test data, analysis, impression of the potential diagnosis and the plan for the patient’s future. It seems a lot, and it is, but it is what we do. A great deal must be accomplished in the time we allocate to meet with the patient. 

Changes in the notes documenting patient interactions have been suggested in the past few decades; most notably the problem oriented segmentation of such reports.  Segmenting reports to specific problems has been suggested to improve the identification and analysis of each problem. These approaches have has varying degrees of acceptance and have definitely improved communications of information.   But abuses creating reports continue.

In reports, the all-encompassing segment on analysis is too frequently a single paragraph where the facts of the case are reviewed, an appropriate diagnosis assessed and recommendations presented. When prepared by a thorough physician, this portion of the report will be subdivided as appropriate for the facts of the case to discuss each individual item.  The specific recommendations will be provided separately. 

There are common techniques used in creating these reports that stand out as inappropriate when overused.  I refer to the users of these techniques as the ‘filler’, the ‘ black and white,’ and the ‘obfuscator.’

A ‘filler’ delights in computer generated reports.  At the appropriate place in his report, the ‘filler’ will copy and paste entire test results, consults, radiology or laboratory reports into their own.  Another common filler technique is to insert a computer generated medical list completed by a nurse or assistant that is so easy to do and so official looking.  All the while, to the educated eye, the presentation is screaming that they couldn’t identify what was important from the inserted report so they just included it all in their own. You can almost hear them say, “Look at my impressive comprehensive report.” Certainly the lengths of the reports are impressive.  I recently received a consultation on one of my patients where the doctor used the filler technique to the maximum.  The dictated computer report was 16 pages long.

The person using the ‘black and white’ approach is the binary report creator: lots of data and no nuances. The ‘black and white’s’ history will include yes and no answers for symptoms, give number results for standard questionnaires and closely follow current medical guidelines. This is particularly true for any therapeutic recommendations on the reports.

 The ‘obfuscator’ will fill their assessments with facts and lengthy discussions of potential diseases and conditions, while not providing a consensus on issues of concern to the patient. Could it be they do not have an opinion, do not have a clue or just do not want to express an assessment of the patient’s issues?  Maybe it is a “look how smart I am” assessment.

All of us use these techniques to some degree in our reports. Most medical reports tend to be repetitious and dull, but like a story, they can benefit from a logical progression in the presentation and understandable writing.  Brevity, to a point, leads to clarity of communication.

I am sorry to go on like this Winston, but let’s face it; we are all concerned with our image. It is a basic human trait. Doctors are not immune. When I last wrote, my feelings were running high regarding the reports all doctors are responsible for completing. I stressed the importance of topic or idea segmentation to improve communication, but good communication requires much more.

All reports need more than just the appropriate formatting. What do we include? Of course the type of report dictates its contents. Test interpretation results, by their nature, report the data generated. Hopefully, these are skillfully separated into pertinent presentations or discussions of individual parameters. For the tests performed, a summation of the results should follow with any appropriate, suggested next steps.

Most medical reports are the results of our direct interaction with patients. Histories, physicals, consultations, progress notes, surgical reports and summaries of clinical notes are examples. While these reports are segmented in a long defined manner, they are often subject to abuses of several easily identifiable types.

The segmentation of doctors’ reports summarizing patient interactions is over 50 years old. New physicians are trained to segment their reports.  Traditionally, such reports are divided into the chief complaint, history of the present illness, past medical history, medications, allergies, system review, physical examination, available test data, analysis, impression of the potential diagnosis and the plan for the patient’s future. It seems a lot, and it is, but it is what we do. A great deal must be accomplished in the time we allocate to meet with the patient. 

Changes in the notes documenting patient interactions have been suggested in the past few decades; most notably the problem oriented segmentation of such reports.  Segmenting reports to specific problems has been suggested to improve the identification and analysis of each problem. These approaches have has varying degrees of acceptance and have definitely improved communications of information.   But abuses creating reports continue.

In reports, the all-encompassing segment on analysis is too frequently a single paragraph where the facts of the case are reviewed, an appropriate diagnosis assessed and recommendations presented. When prepared by a thorough physician, this portion of the report will be subdivided as appropriate for the facts of the case to discuss each individual item.  The specific recommendations will be provided separately. 

There are common techniques used in creating these reports that stand out as inappropriate when overused.  I refer to the users of these techniques as the ‘filler’, the ‘ black and white,’ and the ‘obfuscator.’

A ‘filler’ delights in computer generated reports.  At the appropriate place in his report, the ‘filler’ will copy and paste entire test results, consults, radiology or laboratory reports into their own.  Another common filler technique is to insert a computer generated medical list completed by a nurse or assistant that is so easy to do and so official looking.  All the while, to the educated eye, the presentation is screaming that they couldn’t identify what was important from the inserted report so they just included it all in their own. You can almost hear them say, “Look at my impressive comprehensive report.” Certainly the lengths of the reports are impressive.  I recently received a consultation on one of my patients where the doctor used the filler technique to the maximum.  The dictated computer report was 16 pages long.

The person using the ‘black and white’ approach is the binary report creator: lots of data and no nuances. The ‘black and white’s’ history will include yes and no answers for symptoms, give number results for standard questionnaires and closely follow current medical guidelines. This is particularly true for any therapeutic recommendations on the reports.

 The ‘obfuscator’ will fill their assessments with facts and lengthy discussions of potential diseases and conditions, while not providing a consensus on issues of concern to the patient. Could it be they do not have an opinion, do not have a clue or just do not want to express an assessment of the patient’s issues?  Maybe it is a “look how smart I am” assessment.

All of us use these techniques to some degree in our reports. Most medical reports tend to be repetitious and dull, but like a story, they can benefit from a logical progression in the presentation and understandable writing.  Brevity, to a point, leads to clarity of communication.

Writing Medical Reports 

Writing Medical Reports