Monday, June 18, 2018

FOX news stations in Oklahoma City & Cleveland aired stories that might seriously injure babies -- one fixed the problem; the other doubled down

How should a mainstream news organization respond after being made aware that a published story contains bad information that may seriously injure babies?

In somewhat identical situations, here's how FOX TV News affiliates in Oklahoma City and Cleveland responded.

One deserves to take a bow.

The other deserves to get sued.

source

On June 13, FOX25 News in Oklahoma City aired How to help someone who's choking by staff reporter Jordann Lucero.

Here's a screenshot from her story with my highlighting:


Via that part of her story, here's an interview with a member of the Oklahoma City Fire Department:


Here's the problem.

No legitimate medical organization or medical expert recommends performing stomach thrusts (aka abdominal thrusts aka the Heimlich maneuver) on babies.

 As I've reported, executives at the American Heart Association (AHA) and American Red Cross (ARC) wrote me that the treatment "may cause injuries" to babies.

(To my knowledge, the only organization that recommends and teaches the treatment is Cincinnati's Heimlich Heroes program, a dubious operation whose charter is to promote my dad's "legacy.")

source

After spotting Ms. Lucero's report I e-mailed AHA and ARC guidelines to Oklahoma City Battalion Chief and Public Relations Officer Benny Fulkerson.

A few hours later I received his reply:
Mr. Heimlich,

Sir, we just want to thank you for bringing this matter to our attention. After review, it has been determined that you are absolutely correct. The treatment demonstrated in the video was not in accordance with the AHA [American Heart Association] standard which we operate under. Please know that we feel terrible that this occurred, and we are working with Fox 25 to correct this information for their viewers. As a public safety organization, we take extremely seriously our role as an authority about all things related to fire and life safety. We do have amazing personnel who work very hard every day to serve our citizens. When we make mistakes, we take every measure to correct them and learn from them.

Again, thank you so much for contacting us about this. We are eager to get this information corrected.
I then received a thank-you from FOX25 New Director Adam Pursch who informed me that the story was being re-reported.

The re-reported story got it right:


I sincerely thanked Battalion Chief Fulkerson and Mr. Pursch for their professionalism and commitment to public safety.

I can't say the same re: the following mess.



Here's a transcript at about time stamp :35 from How to save a life: Help someone who is choking by staff reporter Adrienne DiPiazza, FOX8 News Cleveland, February 13, 2018:
DiPiazza: (The Akron Fire Department's Lt. Joe) Shumaker says don’t be afraid of hurting the baby, and forceful motions are the only thing that will help them breathe again.

Shumaker: “Can you cause some injury? Can you break a bone? Can you crack a rib? Perhaps, but in the end run the child will be breathing which is what we want as a result,” he said.
Who'd be irresponsible enough to stand behind the recommendation that first responders shouldn't worry about breaking a baby's bones?

Among others: Akron Mayor Daniel Horrigan, Fire Chief Clarence Tucker, and FOX8 News Director Andy Fishman.

Akron, OH, Mayor Daniel Horrigan & Fire Chief Clarence Tucker (source)

Last February I sent all of them the same information I sent last week to the responsible parties in Oklahoma City

However, rather than fixing the error in order to protect babies from potential injury or worse, they all backed up Lt. Shumaker who, in fact, is certified according to AHA standards:


Here's the grammatically-challenged reply I received from Mr. Fishman at FOX8 which more or less corresponds to the replies I received from the offices of the mayor and the fire department:
From: Fishman, Andy <Andy.Fishman@fox8.com>
To: Peter M. Heimlich <peter.heimlich@gmail.com>
Subject: Re: blogger inquiry
Date: Sun, 18 Feb 2018 14:00:09 +0000

Peter
As highly trained first responders, we [sic] trust and stand by the information provided to us by the Akron Fire Department.

Best Andy
I then asked him for the name and e-mail address of his station's general manager to which he responded:
From: Andy Fishman <Andy.Fishman@fox8.com>
To: Peter M. Heimlich <peter.heimlich@gmail.com>
Subject: Re: blogger inquiry
Date: Sun, 18 Feb 2018 14:29:54 +0000

Peter

We consider this matter closed

Best Andy
Per the item you're reading, I don't.

After I asked FOX8 Cleveland News Director Andy Fishman to put me in touch with his boss, he Twitter-blocked me

Thursday, June 7, 2018

Denver company going to the dogs (and cats), introduces suction plunger for choking pets -- any vets out there want to comment?

source

Dechoker LLC -- which in recent years has been selling a plunger device intended for sucking foreign body obstructions from the airways of humans -- now has a version for our four-legged friends.

The company -- which recently relocated to Denver, Colorado in the wake of a reported $2m securities fraud investigation by the North Carolina Secretary of State -- offers three sizes for dogs and a one-size-fits-all model for cats.

source

At this writing, two of the models -- medium and large sizes for fido -- are sold out.

But all four sizes appear to be available from a Bismarck, North Dakota company called Balkowitsch Enterprises, Inc.


source

According to a story aired last week by the NBC affiliate in Waterloo, Iowa, Heimlich alternative? KWWL investigates new medical device offered to Iowa school by staff reporter Amanda Gilbert, a local school district installed Dechokers, then removed them, apparently after viewing this interview with State EMS Medical Director David Stilley MD:



However, Dr. Stilley didn't share his opinion regarding the Dechoker for pets so if any veterinarians want to weigh in, feel free to e-mail me and I may publish submissions.

Friday, June 1, 2018

Happy "Heimlich Maneuver Day" -- but beware Cincinnati's reckless "Heimlich Heroes" first aid training program

source

source

Sounds nice except for this big problem.

Heimlich Heroes teaches the public to perform "the Heimlich" (abdominal thrusts) on infants.



To my knowledge, no legitimate medical organization or medical expert recommends the treatment for babies.

Why not?

According to e-mails I received from executives at the American Heart Association (Greg Donaldson) and the American Red Cross (Don Lauritzen), performing abdominal thrusts on infants "may cause injuries."

Further, to my knowledge there has never been any published research on the subject.

In other words, Heimlich Heroes has apparently taught 100,000 people that, when confronted with a life or death situation with your baby, you should perform an unapproved, experimental, potentially-harmful medical treatment.

Who would be reckless enough to recommend that?

As widely reported, my wife Karen and I helped expose my dad as a dangerous quack who, after he was fired for misconduct at his last medical job, spent the rest of his career as a celebrity doctor who used the press to circulate unfounded, experimental medical treatments that put lives at risk.

One was "the Heimlich" for choking infants, a claim he apparently pulled out of thin air.

Here's one good question.

Why is Cincinnati's nonprofit Deaconess Associations Inc. (DAI in the above graphic) funding and promoting this dangerous hokum?

Here's another.

Will a mainstream news outlet report this story before someone's baby is inadvertently injured or worse as a result of the Heimlich Heroes program?

source

Friday, May 4, 2018

Update in NC Secretary of State's $2+mil securities case re: anti-choking device company

source

For background see my March 26 item, "Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive.

According to the website of Dechoker LLC, the company has moved from Concord, North Carolina to Denver, Colorado. 

Updates via the North Carolina Secretary of State Securities Division:
On April 17, 2018, Alan Carver and Dechoker, LLC entered into a Consent Order with the Deputy Securities Administrator agreeing to cease offering unregistered securities and acting as unregistered dealers/salesmen in North Carolina. Click here to view the Consent Order. Also on April 17, 2018, the Deputy Securities Administrator entered a Final Order against Russell Wadell, Mark Shores, and Mark Honeycutt making permanent the Temporary Cease and Desist Order in the matter of Dechoker, LLC, Alan Carver, Russell Wadell, Mark Shores, and Mark Honeycutt entered on February 15, 2018. Click here to view the Final Order.
Via the same web page:
A summary cease & desist order is issued by the Securities Division when it appears that ongoing activity violates the North Carolina Securities Act or the North Carolina Investment Advisers Act and poses the threat of irreparable harm to the investing public. The cease & desist order commands those who receive it to stop any further violations and to comply with the requirements of the securities laws. At the time of issuance of a summary order, the persons named in the order have not had the opportunity to respond to its allegations. The order notifies those persons that they may request a hearing on whether the allegations are true. If no hearing is requested, the Division will issue a final order confirming the allegations as true. A final order terminates the controversy between the parties and concludes the issues in the proceeding, unless and until it is vacated or set aside. 
I. Here's the April 17 Consent Order with a couple of screenshots:
 





 
II. Here's the April 17 Final Order with a couple of screenshots:
 














Monday, March 26, 2018

"Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive

Via Anti-choking device business raided, accused of investment scheme a March 12, 2018 investigative report by Matthew Grant, FOX46 Charlotte, NC:
State investigators raided the Concord, NC office of (Dechoker LLC) last month seizing computers and financial records accusing the business of running an "investment scheme," according to the search warrant and other state records.

The company is accused of raising more than $2 million by defrauding more than 80 investors, mostly from North Carolina. The company did not have a license to work in the state or sell securities but did both illegally, according to the North Carolina Secretary of State.

...(Dechoker inventor Alan) Carver later pointed to a blog post on his website.

"Dechoker is a small organization with growing pains that all companies go through," the post reads.

I. Technical Precision Plastics (Mebane, NC) vs. Dechoker LLC, case no. 17CVS1088, Alamance County (NC) Superior Court, June 6, 2016 complaint:






II. Christopher Kellogg c. Dechoker LLC, case no. 16-CI-005356, Jefferson County, KY Circuit Court,10/26/16 plaintiff's complaint & 12/21/16 defendant's response:




Via FDA approves new lifesaving device based out of Louisville by Ann Bowdan, WLKY News (Louisville, KY), October 30, 2015:
(Recently) the Food and Drug Administration approved a new device being touted as an alternative method to the Heimlich.

The alternative device is called the Dechoker, and its headquarters is right here in Louisville.

"The Heimlich works on positive pressure and we work on negative pressure, or suction. In other words, it's a vacuum,” Dechoker CEO Christopher Kellogg said.

The concept for the Dechoker came while Navy Captain Alan Carver was taking a first aid course with his fellow seamen.

"They're 200 miles off the coast and the instructor says, ‘If the Heimlich doesn't work guys, then there isn't anything else,’” Kellogg said.

...Kellogg set up shop in Louisville as it was tested and approved.
[NOTE: The WLKY story provides no indication that Ms. Bowdan ever contacted the FDA. If she had, she might have learned that the agency simply registered the Dechoker, not "approved" it. In other words, the headline and lead of her story are wrong.]


III. Greenleaf Health Inc. (Washington, DC) vs. Dechoker LLC, case no. 2017CA003434CAAXWS, Pasco County, FL, Sixth Judicial Circuit Court:

Wednesday, March 21, 2018

UK government regulatory agency for medical devices releases determination letters sent last year re: two anti-choking devices


Via the website of the Medicines and Healthcare products Regulatory Agency (MHRA):
What we do

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
This week the MHRA released two identical August 30, 2017 determination letters re: the Dechoker and the LifeVac, two unrelated handheld anti-choking devices being marketed in the UK by Dechoker UK (Northampton) and LifeVac Europe Ltd (Devon) respectively. 

Both devices were developed by companies in the U.S., Dechoker LLC (recently relocated to Denver, CO) and LifeVac LLC (Springfield Gardens, NY).

Page down for copies of each letter. Here's the text.


30 August 2017

I am writing to you further to my letter of 19 May, when I requested additional information which was necessary for the MHRA to give full consideration to the regulatory issues relating to placing your product on the UK market. I am grateful to you for providing that information in a timely manner; we have now had the opportunity to consider the additional information and have reached a conclusion on how we propose to proceed.

In my letter, I referred to MEDDEV 2.7/1, a guide produced by the European Commission, that promotes a- common approach to clinical evaluation and specifically highlighted the section which referred to devices for unmet medical needs. One of our main concerns has been a lack of sufficient data demonstrating effective use of this device and we understand that due to the nature of the device, clinical trials would be extremely difficult. The proposals set out below are intended to allow you to gather clinical data in a controlled environment, with trained healthcare professionals, which will allow you to generate more robust results over time. These can then be incorporated into your clinical evaluation which, once sufficient evidence has been generated, may allow agreement of extending the availability of the device.

We are therefore requesting that you take all reasonable steps to ensure that your device should only be used in the following situations:
• By registered healthcare professionals or individuals with advanced life support training, only if currently recognised basic life support protocols have failed; or
• In situations where emergency services are unable to respond, for example on aeroplanes or ships, only if currently recognised basic life support protocols have failed; or
• On individuals in moulded wheelchairs, only if currently recognised basic life support protocols have failed.
Taking this into account, we would request that you alter your instructions for use, as well as any relevant supplementary marketing information to emphasise that your device should only be used under these conditions.

We would also request that you cease to market your device for use on children, in schools and in other public places such as restaurants and shopping centres.

I should advise that, based on the information provided to us thus far, we do not consider that your current plans for post-market surveillance, in particular the lack of structured post-market clinical follow-up, would be able to generate sufficient clinical evidence to expand the use of your device. The approach that we have proposed above should allow you to refine your plans for post-market surveillance; healthcare professionals will understand the experimental nature of your device and how it fits with basic life support and provide more structured post-market surveillance data.

I would like to thank you for your patience and co-operation in this matter. The MHRA believes the approach outlined in this letter, which at this stage is based on voluntary cooperation as opposed to formal regulatory action, strikes a balance that will allow you to continue your business but also gather information for clinical evaluation in a more controlled clinical environment that minimises the potential patient safety issues.

I would be grateful for a response to this letter by 20 September setting out your acceptance of the conditions in this letter and an outline of how you intend to comply with them.

Yours sincerely,

Graeme Tunbridge
Group Manager - Devices Regulatory Affairs
Tel: 0203 080 6901
Email: graeme.tunbridge@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ
United Kingdom
www.gov.uk/mhra
 



Tuesday, March 20, 2018

Re: anti-choking device in service at Union Community Schools, Iowa State Education Director: "This is a local issue" -- so I put it on the desk of the district superintendent

Three Dechoker devices in cabinet installed in Iowa's Union Community School District

On March 8, I blogged An Iowa school district recently installed Dechoker anti-choking device to respond to choking emergencies -- I've asked the state education department to review.

Based on a March 15, 2018 reply I received from Department of Education Director Ryan Wise -- see below -- when it comes to medical guidelines, apparently the state has zero oversight.

How much discretion do local districts have to determine what medical treatments are provided to their students? Are the districts equipped to make those determinations? Are students receiving the highest standard of care?


Read on...

From: Peter.Heimlich@gmail.com 
Subject: blogger inquiry
To: t_fleshner@union.k12.ia.us Cc: ryan.wise@iowa.gov
Date: Tue, 20 Mar 2018 14:10:53 -0400

Travis Fleshner
Superintendent
Union Community School District (UCSD)
200 Adams St.
La Porte City, IA 50651

Dear Mr. Fleshner,

Per the attached pdf [see below], I was referred to you - albeit indirectly - by Ryan Wise, Director of the IA Department of Education.

In a March 8, 2018 e-mail (published on my blog), I asked Mr. Wise to review the reported incorporation and installation of a plunger device called the Dechoker in your district's schools to be used to respond to a choking emergency.

Via my e-mail:

The Dechoker is not included the standards and guidelines of the American Heart Association, the American Red Cross, the American Academy of Pediatrics or, to my knowledge, any established medical organization. And a keyword search today for Dechoker on PubMed provided no results, so it appears the device has not been the subject of any research published in the literature.

In other words, the effectiveness and safety of the device appears to be unproven. Therefore, it's unclear on what basis the (UCSD) chose to equip its schools with the devices, hence this outreach.

...(It's also unclear if any district) officials obtained opinions from any medical experts or first aid organizations, or an opinion from the school district's risk manager. Would you please look into that and provide me with the results?
Via Mr. Wise's March 15 reply:
We have reviewed your inquiry and have determined that this is a local issue. The Department does not have authority over the district's decision to use these devices and there are no State rules that would prohibit the district's use of the devices.
Based on that determination, I'd appreciate your answers to some quick questions for a follow-up item I'm reporting.

1) Would you please provide me with copies of the documentation on which your district relied to determine that the Dechoker was an effective and safe treatment response to a choking emergency?

2) Did any district officials obtain opinions from any medical experts or first aid organizations, and/or an opinion from the school district's risk manager? If so, would you please provide me with details and documentation?

3) To my knowledge the Dechoker is not recommended by any established first aid organizations, therefore some might consider it to be an experimental medical device. With that in mind, have parents and guardians of students been provided the opportunity to approve or deny its use on their children? If so, would you please provide details and documentation? 

Thanks for your time/consideration and I look forward to receiving your answers. And if you have any questions for me, please don't hesitate to ask.

Sincerely,

Peter M. Heimlich
Peachtree Corners, Georgia 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
https://twitter.com/medfraud_pmh

cc: Ryan Wise