Your Friday Dose of Woo on Saturday: Apparently the FDA doesn’t get the “VIBE”

i-e7a12c3d2598161273c9ed31d61fe694-ClassicInsolence.jpgDue to my activities at the Society of Surgical Oncology meeting in San Antonio, somehow I didn’t manage to crank out a bit of that Insolence, Respectful or Not-So-Respectful, that you all crave. So, given that this is Friday, I thought I’d to a “rerun” of a bit of classic woo. This one’s a little newer than the reruns I usually do, only two and a half years old. So, if you’ve been reading less than two years, it’s new to you!

In the nearly two years of its existence, I have strived to feature only the finest and most outrageous woo that I can find. It’s mostly been medical quackery but sometimes it’s other topics as well. Oddly enough, the vast majority of the woo featured nearly every week never attracts the attention of any regulatory bodies. Given the hilariously, extravagantly pseudscientific or spiritual claims made to support some of these devices, it’s hard to image how so many of them never attract the loving attention of the Food and Drug Administration or the counterpart of the FDA in other countries in which these devices are marketed, but, by and large, they don’t.

Until now. Pity the poor manufacturer of the VIBE Machine.

First, let’s review what the VIBE Machine does, as described about two months ago right here on this very blog:

Human DNA conformational changes have been previously used to measure energetic influences of subtle energy generated by healers. This new bio-assay measures direct resonances with the physical DNA as well as underlying quantum process associated with hydrogen bond formation. Experiments reported here were designed to measure possible correlations between psychotronic and biochemical measurement of DNA in real time as physical DNA rewound following thermal denaturation. Physical measurements of DNA were made in NY using a spectrophotometer and radionic measurements were made in Ohio using the Harmonic Translator. An active phone line created a connection between the two locations and allowed exact timing for simultaneous measurements using both devices.

And:

One way to efficiently and safely raise cell voltages is with a device called a VIBE machine. An earlier type was invented by Georges Lakhovsky in the early 1900’s. Dr. Lakhovsky discovered that healthy cells acted like little batteries and discovered how to recharge them (raise their voltages). He found that transmitting energy in the range between 750,000 hertz and 3,000,000,000 hertz raised the cell’s voltage. Dr. Lakhovsky had great results with all types of physical imbalances.

Not only was his unit able to return sick cells (and people) to health, but also those who used it regularly noticed that they rarely became sick. He proved the principle that life forms can absorb radio wave energy. The VIBE uses that principle to strengthen the healthy cells of the body, so that they can resist physical imbalances. Knowing the right frequencies and putting them out simultaneously does not necessarily destroy an infection, but we believe it charges the cell making it strong enough to resist the infection.

Fuse this with a bit of Secret-style wishful thinking, and you have woo deserving of being featured here on Friday!

As you may also recall, the manufacturer had changed his website in the time since the VIBE was added to my Folder of Woo and when I actually wrote about it, necessitating a trip to the Wayback Machine to demonstrate that, yes, the woo as I described it was really and truly once on the VIBE Machine website. Hilariously, what now greets visitors to the VIBE Machine website at the very top of the web page is a message:

Currently the V.I.B.E. Machine is going through FDA clearance…

In the meantime, learn how to heal your mind-body

with ancient techniques in our Manifesting Manual below!

No doubt this was in response to this warning letter from the FDA sent to Gene Koonce, the President of VIBE Technologies, LLC in Greeley, CO:

During an inspection of your firm located in Greeley, Colorado, on November 5 through November 16, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the V.I.B.E., Vibrational Integrated Bio-photonic Energizer (VIBE) Machine. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

Quite frankly, this is seriously down the rabbit hole. Just a perusal of the ridiculous and overblown claims made for the VIBE Machine should be enough to demonstrate that it can’t possibly do what was claimed for it. If it could, as is the case for homeopathy, large swaths of what we know about physics, chemistry, and biology would have to be not just wrong, but spectacularly wrong. For the FDA to write a letter like this shows that, truly, bureaucrats have trouble calling B.S. bluntly when they see it. Comments Linda Rosa:

The Colorado director of the National Council Against Health Fraud, Linda Rosa of Loveland, said she has been studying the VIBE because it has become known in the community.

She routinely goes through the administration’s warning letters so that she can add some to the Web site Quackwatch.org, she said.

The VIBE machine concerns her because of its “outrageous” price, which is about $18,000, and because “it looked very much like other quack devices that have been on the market for decades,” she said.

Indeed it does. But Mr. Koonce vows to soldier on:

Greeley resident Gene Koonce, owner of VIBE Technologies LLC, said he already is in compliance with the administration and is working to clear the VIBE machine as a medical device, so he can make medical claims.

The cited violations were found by an FDA investigator who visited the Greeley office in November.

“The FDA did not deem it as any type of fraud; they deemed it as a medical device,” Koonce said.

That’s right; if you make medical claims for a device, it’s a medical device and you have to back up those claims with strong evidence. Or at least you should have to, and the Quack Miranda Warning shouldn’t shield you.

Unfortunately, even the FDA’s attention can’t seem to stop quacks who have already purchased the VIBE Machine from continuing to charge marks to use it:

While under FDA investigation, Koonce cannot sell or market the device.

Businesses that already own the machine can still use it, as long as they don’t make medical claims, Koonce said.

Business at Loveland’s V.I.B.E. Villa, 1966 W. 15th St., is continuing as usual, said co-owner Callie Stewart.

“We just can’t use words like cure, treat or heal — things we’ve always had to be careful about,” she said.

Of course they can’t, and of course they have.

This of course begs the question of what, exactly, Callie Stewart tells patients while pitching the VIBE Machine, if she doesn’t say it can treat or heal anything. Without those claims, it’s just a box with a glowing light. It’s all just more evidence of the code language of woo, in which woo-meisters substitute terminology and words that everyone interested in their quackery understand to be health claims but that avoid the use of distinct claims. Truly, up is down and down is up in the wacky world of woo, and regulatory agencies appear distressingly impotent in the face of even the most outrageously priced and dubious devices.