Sunday, October 4, 2015

My letter today to the FDA re: two unapproved choking rescue devices: "LifeVac" and "Heimlich Helper" -- and don't miss the promo videos! [UPDATE: FDA public health advisor screwed up, admits she gave me wrong information]

10/8/15 UPDATE: This item and my October 4 letter to the FDA were based on a September 29 e-mail I received from FDA public health advisor Bonnie J. Alderton stating "(LifeVac's manufacturer) has registered their establishment with the FDA and listed the device they intend to market. However, the device currently does not have FDA marketing clearance."

Turns out Alderton screwed up as she admitted in this October 6 e-mail (page down for a copy):

Upon further investigation, I have learned these devices, while they are Class II, are EXEMPT from the premarket notification (510K) process. Therefore, they are only required to register their establishment and list their product...Again, Lifevac has registered and listed with FDA, however I find no record of registration or listing for Big John Products.
No thanks to Alderton for wasting everybody's time, but I predict more to come in the "LifeVac" and "Heimlich Helper "stories.

My original item is between the hash marks.


Click here to download a copy of my October 4, 2015 letter to the FDA. Page down for promo videos for each device.

Re: the "LifeVac," per my letter, reportedly the Sarasota Police Department and two municipal fire departments on Long Island -- Jericho and Brentwood -- have purchased the device and presumably are using it on the public.

According to the "LifeVac" promo video, the device creates enough suction to lift a bowling ball...

The "Heimlich Helper" promo video stars actor/comedian Marc Price who played "Skippy" on the TV show Family Ties.



Wednesday, September 30, 2015

Katz out of the bag: Did prominent Yale doc/prof/columnist shill review a book he wrote under a pseudonym? I've asked Amazon to take a look


It's no secret that attracts shill book reviewers.

In Spring 2010, a couple of years before her death, my mother Jane Heimlich's memoir was published. I caught a Clearwater, Florida press agent posting dozens of glowing 5-star shill reviews on for my mom's book and for scores of other authors she represented.

That turned into Scamazon, a three-part story I reported (sans a byline) for the now-defunct Cincinnati Beacon (Part I, Part II, Part III) that was picked up by other media outlets in the US (click here, here, and here) and France (click here). The Clearwater publicist's Amazon account was deleted and the Public Relations Society of America issued a two-page ethics statement.

Then last year I reported The Shill is Gone about how I caught my father's New York publicist posting glowing Amazon reviews for his memoir and for books by other authors she represented. After I brought the information to Amazon, they scrubbed her reviews.

I think I've got another one, this prominent Yale MD/professor/author. He's also a longtime Huffington Post columnist and for years he's had a weekly column in the New Haven Register.

E-mailed this afternoon...

Subject: blogger inquiry re: book review
From: Peter Heimlich 

Date: 9/30/2015 3:47 PM
Public Relations

To whom it may concern:

I'm blogging an item about what may be a problematic book review posted on your site. I'd appreciate you reviewing the following information and answering two quick questions.

Here's a screen shot I just took of a February16, 2014 Amazon review by David L. Katz of a book of fiction entitled reVision: Lore of the Corners Trilogy, Book 1 by Samhu L. Iyyam:


Here are screenshots I just took from a February 18, 2014 Huffington Post column entitled To See By Common Light by David Katz MD -- red rectangles added by yours truly.

The red-lassoed text above is identical to the Amazon review published two days before. Therefore, Amazon user David L. Katz may be Huffington Post columnist David L. Katz MD, a prominent author, physician, and professor at Yale.

Here are my questions. Would you please determine if the reviewer is Dr. Katz? And if so, does his Amazon review of reVision comply with your company's guidelines?

Thanks for your time/consideration and I look forward to your reply, preferably by Tuesday, October 6. If you need more time, please advise and I'll do my best to accommodate.

Cheers, Peter

Peter M. Heimlich
ph: (208)474-7283

And via Dr. Katz's 60-page(!) CV:

Finally, in his February 18, 2014 Huffington Post column praising reVision, Dr. Katz didn't identify himself as the book's author. That fact was added on April 1, 2014, apparently by the HuffPo.

When and how did the HuffPo learn about the apparent deception and who appended his column? 

And considering the apparent deception, should the column have been retracted with an explanation?

I'll ask the HuffPo and will report the results. 


Big hat tips to Dr. Jason Fung for tagging the HuffPo column and to Low-Carb Barb for catching the Amazon review.

[This item has been updated.]

Tuesday, September 22, 2015

Peer-reviewed journal asked to retract controversial "Heimlich for drowning rescue" study


I was copied on a retraction request sent yesterday to Stephen J. Langendorfer PhD, editor of the peer-reviewed International Journal of Aquatics Research and Education (IJARE) which in May 2010 published a controversial research study by John Hunsucker PhD and Scott Davison of the Houston-area lifeguard training company, the National Aquatic Safety Company (NASCO).

The request was sent to Dr. Langendorfer, a professor and department head at Ohio's Bowling Green State University by Ed Castillo, President/Chief of Operations of Golden State Lifeguards in Woodland Hills, California.

Via the abstract of the NASCO study:
This paper discusses the development and effectiveness of a protocol for lifeguards in enclosed aquatic facilities with special emphasis on scanning, rapid rescue, and applying a resuscitation procedure in the water immediately after contacting a drowning victim. We call this set of procedures In-The-Water-Intervention (IWI). Testing showed abdominal thrusts (ATs) adapted for the protocol were the most effective IWI procedure that could reliably be performed in deep water by 16–18-year-old lifeguards. Data analysis was done on a waterpark attendance of 63,800,000 with 56,000 rescues and 32 respiratory failures including four deaths.
As Sidebar readers know, performing abdominal thrusts (the Heimlich maneuver) to resuscitate drowning victims has been universally discredited as ineffective and potentially harmful by leading medical and water safety organizations, and NASCO's promotion of the treatment has been the subject of numerous media reports around the county.

Per Castillo's letter, in response to the NASCO study, IJARE published a scathing analysis and rebuttal these prominent medical and water safety experts: Peter Wernicki MD, Peter Chambers DO, Roy Fielding, Terri Lees, David Markenson MD, Francesco Pia PhD, and Linda Quan MD.

Via the rebuttal:
The authors’ two-part goal was to describe a protocol they named “in-water intervention” (IWI) that uses abdominal thrusts (ATs) and to report on its effectiveness at assisting drowning victims in waterparks. We identify serious shortcomings in the paper’s methodology, interpretation and use of the literature, and ethical principles. We conclude that their primary assertions were unsubstantiated by the evidence they presented.

...The most disturbing aspect of this study is that Hunsucker and Davison ignored the ethical principles governing the conduct of human subject research. The study failed to adhere to all three recognized principles of human subject research - autonomy, beneficence, and justice as outlined in the Belmont Report (National Commission 1979) and codified in all current regulations regarding human subject research. It appears that experimentation was conducted on unknowing human subjects (failure to adhere to autonomy). It involved the use of a disproved and potentially dangerous procedure that ignored the international standard of care - CPR (failure to recognize beneficence). To make matters even worse, the majority of the victims treated in the study were children (failure to adhere to justice). Apparently, no institutional review board was involved, consent was not obtained, and procedures for the conduct of human research in the absence of prospective informed consent were not followed. The authors seemed to justify and conduct the experiment on their own without any oversight or outside review. There was no informed consent given by the victims/patrons, but it is also unclear if the lifeguards, instructors, facilities, or their insurers were aware that they were participants in an unsanctioned study. By failing to employ appropriate methodology, statistical analysis, and conduct of the study as previously described, the study cannot be of benefit and thus fails even the minimal required test of human subject research - that a study has social value and scientific validity.
Castillo also asked Dr. Langendorfer to obtain the names of "the waterparks which provided data to the authors (since they) may have participated in violative human subjects research" and to obtain details about the "32 respiratory failures including four deaths."

Page down to read or click here to download a copy of Castillo's letter which includes this link to a pdf file consisting of the NASCO study, the rebuttal, a response to the rebuttal, a related editorial by Dr. Langendorfer, and a strong letter to the editor from B. Chris Brewster of San Diego, President of the United States Lifesaving Association.

And if you're interested in the subject of retractions by professional journals, be sure to check out

Monday, September 21, 2015

Choking on Jane Brody's recent Heimlich article; my inquiry today to the NY Times public editor


Re: her September 14, 2015 New York Times article, What Comes After the Heimlich Maneuver, can "trusted authority on health" Jane Brody back up her own claims?

Ms. Brody didn't reply to my e-mails, so I've asked Margaret Sullivan, the paper's public editor, to jump in.

Click here to download a copy.

Thursday, September 17, 2015

Should two Cincinnati nonprofits promoting unapproved, experimental medical treatments be granted tax-exempt status? Today I asked the IRS and the OH Attorney General

Via the website of the Heimlich Institute, hosted by Deaconess Associations

As Sidebar readers know, for decades Cincinnati's Heimlich Institute has funded and promoted violative offshore human experiments in which patients suffering from cancer, Lyme Disease, and AIDS have been infected with malaria, a crackpot cure my father called "malariotherapy."

For decades my father's organization also put the public at risk by hyping a string of baseless, experimental, thoroughly-discredited medical treatments such as claiming the Heimlich can revive drowning victims, stop asthma attacks, and cure cystic fibrosis.

His so-called institute -- which, according to IRS filings, hasn't had any employees for nearly a decade, currently has $1000 in assets and is apparently nothing but a website -- has been a subsidiary of Deaconess Associations Inc., a healthcare conglomerate in the Queen City, since June 1998.

A few years ago, Deaconess launched a new venture, a first aid training program called Heimlich Heroes, intended to teach the Heimlich maneuver to kids around the country.

As Sidebar readers also know, Heimlich Heroes is teaching kids -- here we go again -- to perform "the Heimlich" to revive unconscious choking victims, an untested experimental medical treatment that's not recommended by the American Red Cross or the American Heart Association.

Like his other bogus medical claims, apparently my father pulled this out of thin air.

So what happens if a Heimlich Heroes-trained kid hurts or kills someone using the treatment?

I'd rather not find out, so today I filed complaints against Deaconess and the Heimlich Institute -- both 501(c)(3) nonprofits registered with the state of Ohio -- with the IRS and the Ohio Attorney General's Charitable Law Bureau. (In June I filed similar complaints regarding the American Heritage Girls, a "Christ-centered alternative" to the Girl Scouts of America that's partnering with Heimlich Heroes.)

Page down or click here to download a pdf of both letters.

Wednesday, August 19, 2015

Filed yesterday, Carol Spizzirri's response to plaintiff's complaint in Melongo v. Spizzirri et al

Click here for plaintiff Annabel Melongo's November 15, 2014 Second Amended Complaint and other key case documents.

Click here for media reports about the Melongo case.

Click here for media reports about Carol Spizzirri and the Save-A-Life Foundation.

Monday, August 10, 2015

NBC Today Show reports NYC doc's wrong, possibly dangerous medical recommendations -- and no one will clean up the mess

Please watch this clip from an NBC Today Show segment, How to save the life of someone who's choking by reporter Jeff Rossen and producer Jovanna Billington -- the web page says July 17, 2015, but it aired Tuesday July 14th:

Long story short, Dr. Holly Andersen's claim about back blows is contradicted by the recommendations of the American Red Cross and the American Heart Association.

For years, along with most of the world's first aid organizations, the ARC and AHA have recommended back blows as an effective treatment for responding to a choking emergency.

Further, as widely reported, for about a decade the ARC has recommend back blows as the first treatment response:

As for her claim that rescuers should perform a Heimlich maneuver using one arm, I've been researching my father's career for over a decade and I've never heard of that.

I don't know where she came up with those recommendations, but since she provided medical information on national TV that was wrong and could conceivably harm kids and adults, I assumed Dr. Andersen and NBC would want to correct the errors.

So I shared the above information with New York Presbyterian Hospital's media department, and asked them to ask Dr. Andersen if she thought NBC should correct the errors.

Here's their reply:
From: Jacqueline Shutack
Subject: Re: [PR-NYP] blogger inquiry
Date: Wed, 22 Jul 2015 11:44:01 +0000

Hi Peter.

Dr. Anderson is unavailable to comment.


Jackie Shutack Wong
Media Associate
NewYork-Presbyterian Hospital
Stephen J. Corwin MD (source)

I then sent a couple of courteous e-mails to Dr. Anderson and to Stephen J. Corwin MD, the hospital's CEO, asking if they wanted to comment.

I received multiple confirmations of receipt from both, but no other communications, so presumably their version of the Hippocratic Oath is, "First, admit no mistakes."

As for NBC, I sent self-described National Investigative Correspondent Jeff Rossen multiple courteous, well-documented e-mails explaining that his report included false and questionable medical recommendations.

Although each time I received prompt confirmations of receipt -- here's the most recent -- I received no further communications from him.


Since Rossen was apparently hiding under his desk, I sent a courteous, well-documented e-mail to NBC News Division head Andrew Lack, asking him to jump in.

Page down to read that e-mail, but here are some pulls:
(If Dr. Andersen's) going to appear on national TV as an expert, it's her responsibility to know what she's talking about and it's apparent she failed to adequately prepare. So why give her a pass, meanwhile leaving your audience with incorrect information?
...Based on my experience, if good journalists make an error, they welcome publishing corrections for at least two reasons. One, they want to get it right because they have pride in the accuracy of their reporting. Two, they care about maintaining their audience's trust. Based on Mr. Rossen's silence, apparently none of that matters to him, hence this outreach.
I received this confirmation of receipt but no further communication.

But wait, there's more.

Rossen and Billington apparently weren't even paying attention to their own story.

If they had, shouldn't they have noticed this intro clip in the piece?

It shows an officer responding to a choking three-year-old and performing -- yep --a series of back blows, thereby, according to Rossen, "saving the boy's life."

Finally, this historical tie-in, a brief interview with retired Today Show weatherman Frank Field in which explains his crusade to promote the Heimlich maneuver shortly after my father introduced the treatment in 1974: