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There is so much wrong with this press release, that it might be used as an example of what to avoid, when making statements about medical treatment.
January 12, 2011 – CIRC Trial Concludes Successfully[1]
This raises a question.
What does concludes successfully mean?
Back in 2006, there was ASPIRE,[2] which was stopped early due to dramatically worse outcomes for the patients treated with the AutoPulse®. The great news is that this time the AutoPulse® did not appear to result in dramatically worse outcomes. Yay! Yippee! Yahoo!
Yawn.
What do the results show?
We don’t have the results, yet. They haven’t even completed entering the data. All we have is something that did not get kicked out of the study for being too dangerous for use on dead people, which is what happened last time.[2]
Double yawn.
What comes after the title, even before the dateline?
INVESTOR CONTACT:
A. Ernest Whiton
Chief Financial Officer
ZOLL Medical Corporation
+1 (978) 421-9655MEDIA CONTACT:
Diane Egan
ZOLL Medical Corporation
+1 (978) 421-9637
degan@zoll.com[1]
This is not a medical press release, but something to get investors to buy more stock. That is part of what the investor relations department does. They are also able to provide a lot of information about the company.
This press release is being sent around to medical people as evidence that the AutoPulse® is the answer to the prayers of someone who just found her father collapsed, unresponsive and pulseless, in the living room.
So, what does the press release say about the performance of the AutoPulse®?
First, there is a sub-headline –
CIRC (CIRCULATION IMPROVING RESUSCITATION CARE)TRIAL CONCLUDES SUCCESSFULLY
First Large Scale Resuscitation Trial to Reach a Statistically Significant Result[1]
More yawning.
January 12, 2011─CHELMSFORD, MASS.–ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today the successful conclusion of the ZOLL-sponsored CIRC trial. The trial’s Data Safety Monitoring Board (DSMB) closed enrollment when an analysis of the data showed the load-distributing band (AutoPulse® Non-invasive Cardiac Support Pump) to be equivalent to manual chest compressions.[1]
As good as CPR?
WTF?
There is something else that is as good as CPR. It is called CPR.
Zoll, manufacturer of AutoPulse, has given the county 72 of the $15,000 machines. Each band is disposable and costs $125 to replace. Hillsborough Fire Rescue also gets $149,000 annually for training and personnel costs associated with the trial.[3]
“On behalf of all the CIRC investigators, we are excited about the conclusion of enrollment and look forward to presenting complete results later this fall. . . . ” said Dr. Wik.[1]
They have concluded enrollment and will not be able to present their results for at least 9 months.
This is kind of like a couple that is trying to conceive celebrating the birth of their child just because they had intercourse. This is more than a little premature.
Dr. Wik added, “EMS around the world will look at the CIRC result as positive for AutoPulse. They know how difficult it is to perform manual CPR on a regular basis. My gut feeling is that the CIRC results will increase AutoPulse interest.”[1]
OK. CPR is not easy, but does that mean that we should spend $15,000 for each ambulance and $125 for each patient, just to make things a little bit easier?
PS Be wary of scientists offering gut feelings.
I try not to think with my gut. If I’m serious about understanding the world, thinking with anything besides my brain, as tempting as that might be, is likely to get me into trouble. Really, it’s okay to reserve judgment until the evidence is in.[4]
So why are we having a press release when the evidence is not in?
Richard A. Packer, CEO of ZOLL commented, “We are pleased to see the CIRC trial successfully concluded and the AutoPulse equivalent to a Class I AHA recommended therapy. While we would have liked to have seen a superior outcome, this finding unequivocally confirms the AutoPulse’s role in improving resuscitation.”[1]
To clarify what he means. CPR is a Class I recommendation –
Generally for Class I recommendations, high-level prospective studies support the action or therapy, and the benefit substantially outweighs the potential for harm.[5]
The AutoPulse® does not appear to be statistically worse than CPR, but this is premature, since they haven’t even finished entering the results into their database.
Mr. Packer continued, “It will be some time before the complete picture unfolds as there are still some 400 patients that have yet to be entered into the database, and numerous sub-analyses to be completed. We look forward to publication of the trial’s details.[1]
We look forward to actual results, but right now we are celebrating not being kicked out of the study early as a danger to dead patients.
We believe the CIRC trial is the largest privately funded trial ever undertaken in the field of resuscitation. We introduced this technology to the market on the strength of earlier studies and with FDA clearance.”[1]
We have spent so much on this that we can’t image anything less than success.
“The AutoPulse is currently included in the just released 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science as a Class IIb intervention with a recommendation for additional studies,” he added. Mr. Packer concluded, “This outcome, had it been available, could have improved the recommendation related to the AutoPulse in the Guidelines.[1]
That still depends on what the outcome of this study actually is. We won’t know what the results are for about a year.
Suppose this expensive device is as good as CPR.
Does being as good as CPR mean that the AutoPulse® deserves a Class I recommendation?
Absolutely not.
Then there is this from the standard disclaimer required for investment advice – remember that this press release is not medical advice, this is investment advice –
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.[1]
In other words, wait for the research to be published, otherwise you may end up just another example of PPR (Premature Press Release).
–
Does anyone remember Cold Fusion?[6]
There may be something useful to be gained from work on cold fusion, but the stigma as a result of the exaggerated claims made at a press conference continues to discourage many scientists from working on cold fusion.
Misleading expectations can produce a very negative backlash.
I will write more about the original study (ASPIRE[2]) that found the AutoPulse® to be unsafe for use on dead people.
–
I also wrote Extensive injury after use of a mechanical cardiopulmonary resuscitation device.
This patient treated with the AutoPulse® was not a trauma patient, but the injuries produced are examples of severe multi-system trauma. Why wouldn’t the patient get better when treated with a device that produces these injuries?
Maybe waiting for good evidence is a very good idea.
–
Footnotes:
–
[1] January 12, 2011 – CIRC Trial Concludes Successfully
Zoll
Press Release
–
[2] Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial.
Hallstrom A, Rea TD, Sayre MR, Christenson J, Anton AR, Mosesso VN Jr, Van Ottingham L, Olsufka M, Pennington S, White LJ, Yahn S, Husar J, Morris MF, Cobb LA.
JAMA. 2006 Jun 14;295(22):2620-8.
PMID: 16772625 [PubMed – indexed for MEDLINE]
Free Full Text from JAMA with link to Free Full Text PDF
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[3] Life or death question: Is man or machine better at CPR?
Rebecca Catalanello, Times staff writer
In Print: Saturday, January 10, 2009
St. Petersburg Times
Article
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[4] The Demon-Haunted World : Science as a Candle in the Dark (1995)
by Carl Sagan
Ch. 11 : The Dragon in My Garage, p. 180
Quote from Wikiquote
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[5] AHA Classes of Recommendations and Levels of Evidence
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 2: Evidence Evaluation and Management of Potential or Perceived Conflicts of Interest
Medications for Arrest Rhythms
Development of the AHA Guidelines
Free Full Text Article with links to Free Full Text PDF download
–
[6] Cold Fusion
Wikipedia
Article
.
something i’ve wondered about… immediately getting on the chest for compressions is so important that the AHA has changed the ABC’s to CAB’s to avoid the delay of seconds involved in “look listen and feel” and the two rescue breaths… well, the Autopulse has to be applied to the patient, and from what i understand, while this may not take minutes to do, it does take a measure of time at which efficient compressions are not being done..it would seem to cause at least as much of a delay that the AHA is trying to avoid while changing the guidelines… it is an issue that i rarely see addressed regarding these devices.
I have yet to see an EMS system using an automated compression device with Bystander-Witnessed VF Discharged Alive rate > 40%. Richmond, VA which showed “big” improvements in survival after using the AutoPulse http://emswiki.com/index.php/AutoPulse only has a 19% discharged alive rate for Bystander-Witnessed VF. http://emscompare.org/media/public_records_requests/richmond_09.pdf
The ASPIRE trial is a strange one. It just so happens the Seattle site which saw the decreased survival also was the one site that made a protocol change. 17 minutes into http://www.emsonline.net/ts/tuesday_2010.asp?date=1207&whichVid=TS_12-2007_Cobb_Reflections.flv is a discussion of the trial by one of the trial coordinators. ZOLL and the trial coordinators have been “fighting” it out in the journals http://www.ncbi.nlm.nih.gov/pubmed/20708892