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Encouraging, But... PDF Print E-mail
Swift
Written by James Randi   

When the Federal Drug Administration (FDA) issues a "Class 1 recall" of a device, service, or medication being offered the public, that's serious. It means that they believe the item has a reasonable probability that it will cause "adverse health consequences or death."

Now, I don't think it took concentrated investigative powers of perception for the Administration to determine that anything called a "Vibrational Integrated Bio-photonic Energizer" - made by manufacturer VIBE Technologies of Greeley, Colorado, or the "HLX8" device made by Nebion of Los Angeles, California, might not perform as advertised. The VIBE device is sold to treat cancer, infections, and depression, while the HLX8 claims to treat: cancer - breast, bone, lung, and pancreatic, carpel tunnel syndrome, migraine, premenstrual syndrome, rheumatoid arthritis, shingles, sports injuries, sprains, and ruptured discs - an obviously wider range of ailments. Recalls were issued on both company's products.

Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said:

These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices... One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.

The FDA investigation of the VIBE claims began back in November of 2007, when they found that the company had not obtained FDA marketing approval or clearance for their device. On April 11, 2008, they issued a warning letter to them, and also cited the company for deviations from the Good Manufacturing Practice/Quality System regulations. More than a year passed before the FDA finally decided to close them down, while customers continued to purchase and use the product.

The FDA was aware of information suggesting that the VIBE device was used for cancer patients, and death occurred to one patient who used it, though the FDA has not verified that there is an association between that death and the device.

In June of 2008, the FDA inspected Nebion, and found that the company had not obtained FDA marketing approval or clearance for the HLX8 device, and they also uncovered substantial deviations from the Good Manufacturing Practice/Quality System regulation. As a result, Nebion recalled eight HLX8 devices, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval. The FDA has not received any reports of injuries or deaths linked to the HLX8 device.

Under federal law, any product that claims to diagnose a disease or condition, to cure, mitigate, treat or prevent a disease, or that is intended to affect the structure or function of the human body, is a product subject to the jurisdiction of the FDA and may require their approval or clearance prior to marketing it. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. Regular FDA clearance is for lower risk devices or materials that are shown to be as safe and effective as similar devices or materials already on the market.

In summary, neither VIBE Technologies nor Nebion were able to show the FDA that their devices are safe and/or effective at curing or treating diseases, as they had claimed, and they have been withdrawn from sale.

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Good, but....
written by Ian Mason, December 16, 2008
How much advertising space has been used on this phony apparatus? Wouldn't it be nice if the equivalent column inches were now used by Vibe/Nebion announcing the withdrawl of their product and why? Perhaps we should campaign for legislation in this area? An equivalent of a Press Complaints Coucil, where those who can prove that they have been unfairly treated in the printed media have a right to the same page space for a reply/rebuttal? In addition, if the media were compelled to give up valuable glossy pages to such announcements, they might begin to think twice about what they advertise.
If conmen were required to make public apologies, the public might develop a more skeptical attitude towards the quacks. If the quacks were hit where it hurts (the wallet) they might fade away. Get 'em both ways! Nowhere to run, nowhere to hide.
Keep up the good work.
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written by Able, December 16, 2008
I agree with you. When, after many years, a fine is finally handed down, some of that money should be used on advertising to enlighten people about the frauds, conmen and quacks who are out to take their money and sometimes their lives.
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written by Marcus, December 16, 2008
Ian, it would depend on the legislation as to whether the media were discouraged from carrying advertising for this sort of rubbish. It would seem fair that the companies producing and marketing the devices should bear the costs of publishing the retractions - in which case, canny magazine advertising editors would want to court such advertisers in the hope that they would be forced to pay for more adverts in future.
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written by cwniles, December 17, 2008
On one hand, it's disconcerting that these frauds were allowed to continue scamming people as long as they were but on the other hand, it is somewhat reassurring that the F.D.A. is out there actively shuttering bogus operations like these.
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written by Careyp74, December 17, 2008
Good point Marcus. It is hard to visualize the actual effects legislation would cause, but I could see your prediction coming true. Perhaps the newspapers should pay for the adverts, and the fines be used elsewhere. That would make the newspapers, who are already heading down the road to bankrupcy, to think more carefully about their sponsors.

BTW, the F.D.A. is called the U.S. Food and Drug Administration, not the Federal Drug Administration.
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written by Cuddy Joe, December 17, 2008
I'd suggest a simpler piece of legislation: You can't advertise and market unless you can prove to the advertiser that you've obtained FDA marketing approval.
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written by Trez, December 17, 2008
Perhaps we can point them in the direction of Cumberland Industries and their ADE651® device.

I reckon giving a trumped up dowsing rod to troops searching for hidden explosives could well result in adverse health consequences
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written by sibtrag, December 17, 2008
I certainly hope we do not see legislation deputizing advertisers and requiring them to determine whether a potential advertiser is following the law. I am happier with those tasks being delegated to subject experts at the FDA and legal experts in the courts. Newspapers and magazines do not have the expertise to determine which products require FDA (or other) approval and should not be exposed to such liability.

I do not mean that advertisers should abandon their standards of what advertisements are good and proper to allow in their publication, but rather that they should not be required to enforce the law.
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written by Cuddy Joe, December 17, 2008
They wouldn't be required to enforce the law, they'd be required to see written confirmation of FDA marketing approval before running an ad for a product/service of the given type. No need for ad section editors to take anybody down and handcuff them.
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written by cwniles, December 17, 2008
Good catch careyp74, I didn't even notice the typo regarding the FDA being referred to as the Federal Drug Admin. Someone oughtta fix that.
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written by LindaRosaRN, December 17, 2008
It's not always easy to know what the FDA is up to in any particular recall.

Manufacturer Gene Koonce sent out letters to VIBE operators in April '08, but the wording apparently didn't meet with FDA approval. Koonce sent out another letter that did around October 1st, this time to 840 VIBE owners, requesting that they respond (in ten days?), verifying that they would not make medical/functional claims for the VIBE and post a sign to that effect on the machine. The FDA is demanding 100% positive returns from these 840 people (who each paid $17,800 to 20,000 -- for about $15M total) for Koonce to satisfy the FDA that the public will be protected from quack claims. A quick check on the Internet show that there are many VIBE operators who are continuing to make medical/functional claims.

So I predict the FDA isn't quite finished with Koonce yet. As for the hundreds of VIBE operators who don't comply with the recall, the FDA can send them warning letters, seize their machines, or opt for other remedies.

The real pity is that the FTC and Colorado Attorney General are not involved in this case.
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written by BillyJoe, December 17, 2008
That name rings a bell, but I'm not sure which one.
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Personnal experience.
written by advancedGIR, December 18, 2008
I myself worked for a very big compagny in a division manufacturing medical radiography equipment and nearly all the products initially had "Good Manufacturing Practice/Quality System" issues notified by the FDA that we had to address during the development final stages and manufacturing prototyping. By itself, it is a perfectly normal step of development, even if the bureaucratic part sometimes feels like Sisyphus's rock.
However, I wouldn't want my worst ennemy to be under FDA scope when they discover you have tried to deceive or bypass them. Like a glacier, they may be slow, but they're unstoppable.
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The Bell
written by GusGus, December 18, 2008
Is the bell C. Everett Koop, former Surgeon General? Similar sounding name, medical reference...
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A Second Recall
written by LindaRosaRN, December 18, 2008
By the way, the FDA has just issued a second recall (Class 2). This time it's for the VIBE's alter ego -- the Quantum Pulse. When the FDA was closing in on the VIBE earlier this year, Gene Koonce apparently redubbed the machine the Quantum Pulse and set up a website for it to continue sales as usual (http://www.thequantumpulse.com).

The FDA may be slower than any of us would like, but in this case, it does seem to be doggedly thorough.
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