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From ACC 2008: Home Automated External Defibrillator Trial (HAT); how does government select what trials to fund?

Posted Apr 04, 2008 at 10:59 AM, EDT

Findings from the Home Automated External Defibrillator Trial (HAT) released at ACC show no advantage to owning a personal AED for post-MI patients in lives saved compared to the control arm. This raises several questions: When would an AED work? In the home setting, how would a family member detect malignant ventricular arrythmia? Given these difficulties, isn’t the negative outcome of the trial predictable? And given this, how does government select what trials to fund?
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I agree with you.  In a time of decreased government spending on health care, I think they need to choose studies very carefully.  The number of people they would need to enroll in an AED study to find a positive result is huge and the public impact would be relatively small.  I think more NIH funded studies like ALLHAT are appropriate for patients as well as for appropriately reducing medical spending.  The inexpensive medications studied could significantly decrease cardiovascular events as well as reduce Medicare, insurance, and patient spending on medications.  Why use a newly FDA approved beta blocker or ARB if equally or more effective generic medications are available.

 

I think there is a roll for NIH funded studies and it could significantly improve public health and spending by providing a non industry related source of funding, but they should be picked more carefully. It would be interesting to hear the inside story on how the HAT study was chosen.

 


Posted by Mike McWilliams, Apr 12, 2008 Publié le Mike McWilliams, 04.12.2008
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Dr. Topel,  I also would like to know the process that is taken to decide on a study, especially those government funded. Are the decisions made by good scientific checks and balances, or is money doing the talking.  I'm an RN and have always admired your persistance to focus on the direction we are taking our research.  As a cardiac nurse, it seems that placing an AED in the home would be expecting a lot from the family members, among numerous other issues that would surround this study.  I don't understand how the cost could be justified? Are there not many other studies that would be more beneficial to us? I hope you continue to persist in questioning these types of studies.  For the record, you were always an informative physician  in the cath lab, and your true colors showed when you took time to share your knowledge with the nurses as well as the fellows. Keep it up!


Posted by Debra , Apr 13, 2008 Publié le Debra , 04.13.2008
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Thanks, Debra and Mike.

It is asking for a lot to expect an AED to save lives in the home, with many sudden cardiac deaths occuring outside the home, or unwitnessed in the home. It's great to have validated the lack of benefit by HAT, but given the low likelihood of a positive trial, I agree that this initiative might not be considered high priority for NIH funding.


Posted by eric topol, Apr 14, 2008 Publié le eric topol, 04.14.2008
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Dear Eric:

In the 2 examples you quote (HAT and the chelation study), the PI had previously completed a successful, relatively high-impact NHLBI-sponsored trial (SCDHeFT and MOST). Thus, they were in a politically strong position to get funding for a new study (they knew the inner working of the bureacracy, the people making the decisions, and had high credibility). Unfortunately the hypothesis and science behind the new studies was weak and the results will probably be irrelevant.

 It would be interesting to tabulate all examples of this phenomenon of public sponsoring of irrelevant trials  to see if my theory holds.

The grant application should include a caveat similar to mutual funds: "Past performance does not guarantee future results".


Posted by Sergio Pinski, May 18, 2008 Publié le Sergio Pinski, 05.18.2008
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Eric J Topol MD
Director, Scripps Translational Science Institute
The Gary and Mary West Chair of Innovative Medicine
Chief Academic Officer, Scripps Health
La Jolla, CA