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Misleading VAX-D® Advertisement

In March 2000, a chiropractor and an osteopath who practice together placed this ad in The Morning Call (Allentown, Pennsylvania):

Breakthrough for BACK PAIN!!

Correction of Herniated and
Degenerated Disks without Surgery!

VAX-D Therapy uses a specialized state-of the-art therapeutic table designed to gradually relieve the pressure on the nerves and structures of the spine. This is a non-invasive procedure that relieves stress on the spine, reversing the pressure on the affected disc. This procedure has also been proven effective in post-surgical patients. Most patients respond within 15 visits to this type of painless therapy.

This procedure is covered by most insurance policies.

"I have devoted my life to finding lower back pain. After researching this device for 15 years, and through two clinical studies VAX-D has attained a 75% success rate in treating back pain."

Alan Dyer, Phm.B, Sc., Ph.D., M.D.
Inventor, Deputy Minister of Health, Canada

 

The ad violates the FDA's instructions to the manufacturer concerning what claims can be legally made. During the 510K clearance procedure, the agency clearly indicated that:

  • The claim that VAX-D can correct a herniated or degenerated disc could not be made without premarket approval based on satisfactory evidence given to the FDA. The manufacturer submitted no such evidence.
  • It would be improper to suggest that VAX-D relieves pressure on the nerves without making it clear that this is not the same type of decompression that can be achieved with surgery.
  • Generalizations regarding the course of treatment cannot be made because of the diversity of pathologic conditions and the uniqueness of the individual's underlying clinical condition. The manufacturer agreed not to make any such claim.
  • No claim can be made about success rates without premarket approval based on satisfactory evidence given to the FDA. No such evidence has been submitted to the FDA. [In addition, the "75% success rate" claim is based on studies that were poorly designed.]

Identifying Dr. Dyer as "Minister of Health, Canada, is misleading because: (a) he was Minister of Health of one province, not the entire country; (b) no time frame is given, so that it might appear that he is still minister of health; and (3) the identification falsely suggests that he made the statement while he was Minister of Health.

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This article was posted on April 26, 2000.