Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Tuesday, January 19, 2021

Is a Greenville, SC, chiropractor/social media star using patients to test an experimental medical device? I've asked the state to review [UPDATES: 1) Vendor of the "Y-Strap" wrote me that the device is not marketed to be used for any medical treatment; 2) The FDA's taking a look; 3) South Carolina is investigating with a pending decision by Chiropractic Board]

January 16, 2020

Click here to direct download a copy of my January 14, 2020 letter to South Carolina's licensing agency requesting of review of chiropractor Joseph Cipriano's use of the "Y-Strap decompression tool."

The Y-Strap is a black, mostly fabric harness that looks like something from an S&M dungeon. In Joseph Cipriano’s YouTube videos, it's placed behind the necks of prone patients who, in the moment before the crack, typically tense as if bracing for a crash.

Cipriano, a chiropractor based in Greenville, South Carolina, has become a YouTube sensation in the past 18 months, taking his channel from inception last March to more than 850,000 subscribers ...“I literally watched every video I could find on the Y-Strap first,” says Xavier, a patient of Cipriano’s. “It’s pretty daunting to think you’re allowing someone to pull apart your spine like a Lego.”

“Coowaa,” goes the sound as Cipriano yanks the Y-Strap and patient's skull away from their body: a mix of them being dragged and cracks that ricochet down the spine, caused by bubbles forming in the synovial fluid around joints. The noise is followed by either laughter, a grimace, or an emotional release that can include crying. “I feel like I just grew two inches,” says one woman.
Via my letter (which includes links and text from the WiredUK article and another article recently published in Vice):
As a result of research by my wife and me into my father's bizarre career, I developed an interest in experimental medical treatments/devices, medical ethics (including the use of human subjects in unsupervised medical research), and oversight responsibility of public health authorities. The following situation in your state appears to include all of those topics.

...This is to request that your office review the following information and provide me with a determination if (Greenville, SC, chiropractor Joseph) Cipriano’s treatment of his patients using a device called the “Y-Strap decompression tool” is in compliance with your agency’s guidelines.
Superior Balance SL is a company in Seville, Spain, that markets the "Y-Strap" in the US and other countries. Via my letter (on which I courtesy-copied Jeffery Shuren MD JD who heads the US Food & Drug Administration's medical devices division):
I searched https://y-strap.com and https://www.drjosephcipriano.com and the FDA’s database of registered devices and failed to locate any information regarding whether the “Y-Strap” is registered with that agency, so yesterday I phoned Superior Balance SL in Seville and a company representative informed me that the device is not registered with the FDA.

When I asked if the device has been the subject of any published studies, the representative replied, “The Y-Strap hasn’t been the subject of any clinical trials. Because there is no clinical proof that it works, we don’t sell it as a medical product.”

Therefore, Mr. Cipriano appears to be using his patients to test the medical benefits of the “Y-Strap.” In your review, would you please determine which if any Institutional Review Board is overseeing his research?
Big hat tip to Myles Power for tweets that introduced me to this story. He also steered me to videos from which I made these clips of Cipriano using the "Y-Strap" to aggressively yank the necks of his patients. (I included the videos in my letter to the state agency that licenses him to practice in the Palmetto State.)








UPDATE: On January 20, Tomas Lopez, president of the Seville, Spain company that markets the "Y-Strap" sent me a complaint email requesting I change this blog item. In a same-day reply, I declined and sent him some questions. I haven't received a reply.

Via his email:
(We) do not market (marketing) [sic] our product as a medical product...

We never say they are intended to diagnose, treat, cure, nor prevent any disease or health condition.

Click here for both emails which I'm sharing shared with South Carolina's licensing agency and the FDA.

UPDATE: On January 27, the FDA wrote me that they're taking a look at my concerns about the "Y-Strap."

UPDATE: On June 8, 2020, Erica Williams at the SC Dept. of Labor Licensing and Regulation's Office of Investigations and Enforcement emailed me that my request has been assigned to investigator Kevin Pate.

UPDATE: On January 19, 2021, Mr. Pate emailed me, "The complaint before the SC Board of Chiropractic Examiners (2019-23) is still pending. The investigative aspect of the case has been completed but the Board has yet to render a decision...At this point I cannot provide a date for a Board decision as the case has been designated for additional review. The Board meets next month (February 4th) and it will not be on the docket at that meeting. I would hope the case would be ready for the following Board meeting in the Spring."


Saturday, March 10, 2018

Two Scoops: In $2m+ securities probe, state agents seized computers, files of Concord, NC company selling anti-choking device -- meanwhile in Louisville, the company's being sued by its former CEO [UPDATE: North Carolina TV investigative reporter picks up my story]

UPDATE 3/13/14: Last night via Anti-choking device business raided, accused of investment scheme, investigative reporter Matthew Grant at FOX46 in Charlotte, NC,  picked up my scoop and moved it forward, My 3/10/18 item is below the video.



source

In the course of researching my dad's bizarre career and his namesake anti-choking maneuver, I've occasionally reported about anti-choking devices that have been marketed over the years, for example, the Heimlich Helper, the LifeVac, and the Dechoker.

Click the links and you'll see that I've reported mostly about the LifeVac because, based on casual observation, that device has been more aggressively promoted via press releases, media reports, and social media. More promo materials means more for me (or anyone else) to report.

Two unrelated legal cases -- one in North Carolina, the other in Louisville, Kentucky -- involving the company marketing the Dechoker appear likely to provide me with more reporting opportunities.  

I. On February 21, I reported Re: $2 million investment scheme, North Carolina Secretary of State's Securities Division issues temporary cease & desist order to Concord company selling Dechoker anti-choking device -- meanwhile the company's UK division claims the device has saved 14 lives(!)

The date of the temporary cease and desist order was February 15, 2018.

To my knowledge unreported until now, according to a search warrant issued by the Superior Court of Wake County, that same day agents of the North Carolina Secretary of State's Securities Division seized computers and files from the offices of Dechoker LLC located at 4454 Raceway Drive in Concord.


Here's the 36-page search warrant with supporting records -- click here to download a copy.



This was posted yesterday on the website of Dechoker LLC:



 

II. Via FDA approves new lifesaving device based out of Louisville by anchor/reporter Ann Bowdan, WLKY-TV News,WLKY October 30, 2015:

(Recently), the Food and Drug Administration approved a new device being touted as an alternative method to the Heimlich [for responding to a choking emergency].

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.

..."Obviously there's a health care hub here and the city of Louisville has been absolutely wonderful to work with open arms," Kellogg said.

...But there are some skeptics.

Peter Heimlich, the son of Henry Heimlich, who created the Heimlich maneuver, questions the validity of the FDA’s approval of the device.

He believes more published research is needed. 
The headline and lede of Bowdan's story -- that the Dechoker was approved by the FDA -- appears to have originated with Dechoker LLC:


I'll ask the FDA and report the results.

To my knowledge unreported until now, a year after the WLKY report aired, Christopher Kellogg filed a lawsuit against Dechoker LLC in Jefferson County, Kentucky, Circuit Court claiming breach of contract, unpaid salary, and other allegations.

According to court records accessed today:


Here's the October 26, 2016 complaint and December 21, 2016 response. Click here to download copies.

Monday, April 18, 2016

ABC7 Sarasota: Police department spent $6,500 for controversial anti-choking plunger

This investigative report by reporter Kate Flexter aired on the ABC-TV affiliate in Sarasota, FL, on the 7pm News on April 7, 2016. Below the screen, I've included a partial transcript.



The LifeVac is designed to remove a blockage in someone's throat during a choking incident when all other lifesaving attempts have failed.

...The issue is the device has not technically been approved by the Food and Drug Administration because it doesn't have to be. The FDA tells ABC7 that LifeVac is registered as a moderate-risk device which makes it "exempt from the clearance and approval process."

But some doctors we talked to say it should be tested more thoroughly and is potentially dangerous. We showed the training video for the device to the head of pediatrics at the Florida Hospital in Tampa, Dr. James Orlowski.

Orlowski: “It seems that the pressure that they use before sucking back could potentially drive the object further down into the airway.”

Dr. Orlowski says the pressure created by the device could potentially cause damage to other parts of the body in the process.

Orlowski: “If it can hold up a bowling ball, it can probably do a lot of damage to the airway and to other organs.”

Up until last week, no study on the device had been published in a peer-reviewed medical journal. And for the study published in the American Journal of Emergency Medicine last week, the device was only tested on cadavers.

...(Last year the Sarasota Police Department) purchased 100 LifeVacs for $4,000 and spent about $2,500 on training officers. The department now has a LifeVac in each patrol car...

Sarasota is one of only two police departments in the nation that uses LifeVac. In a 2015 interview, (LifeVac inventor Arthur) Lih was quoted in the Florida publication Business Observer saying, “Sarasota has been the most receptive part of the country. This is our petri dish.”

Dr. Orlowski says using a community as a petri dish is disconcerting.

Orlowski: “I would have concerns with public services jumping onto something like this without looking into it more carefully and making sure that it can do what it’s supposed to do without doing any harm.”

The video's embedded on ABC7's Facebook page.

Here's the first comment from a viewer.


If Mr. Banagan sounds well-informed about the LifeVac, he ought to be:

source

source

After Ms. Flexter's report, ABC7 anchor/managing editor Alan Cohn hosted this round table discussion with Dr. Orlowski and LifeVac advocate osteopath William A. Holt of Port Charlotte, FL.



If Dr. Holt sounds well-informed about the LifeVac, he ought to be.

Via LifeVac's website: