The Diapulse Case - Legal and Regulatory Aspects - 1985 - click here This above summary, written in December, 1985, chronicles the dispute between Diapulse Corporation of America and the FDA over two decades.
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The FDA has a real problem distinguishing "diathermy" from "pulsed electromagnetic therapy (PEMT)."
There ia a very long history, much of it involving a device known as Diapulse®. (Diapulse is a registered trademark of Diapulse Corporation of America.)
Diapulse® differs from a conventional diathermy in that its output is pulsed instead of continuous shortwave. One effect of pulsing is to reduce the average power delivered to the patient; in the case of Diapulse® the maximum average power is only 37.5 watts with a peak power setting of 975 watts ("Penetration" = 6). While care must be exercised to avoid injury to patients exposed to conventional diathermy, there is no such concern with Diapulse. No adverse effects have been reported even with exposures exceeding an hour at the highest setting.
Effectiveness of the therapy, not safety, is the real issue for the FDA. In the 1960s and 1970s, FDA "experts" refused to acknowledge the possibility that pulsed electromagnetic energy could produce non-thermal effects in biological systems. The agency's principal expert for quack medical devices was a physicist, Robert John Kennedy. Kennedy didn't know of any physiological effect from exposure of living systems to radio waves aside from those produced by heating. Kennedy's boss in the Medical Review Group, Joseph B. Davis, M.D., agreed with Kennedy and the two of them held sway in the FDA for many years. Commissioners of FDA testifying to Congress mentioned Diapulse by name as a quack device as part of their argument supporting the need for medical device legislation. (This fact had been predicted years before by attorney Bradshaw Mintener - for details follow the link at the top of this page - Legal and Regulatory Aspects.)
Kennedy consistently maintained that Diapulse® is a diathermy device because of its similarity to diathermy. Then, since Diapulse® did not produce enough power to produce the minimum temperature rise in treated tissue considered therapeutic for diathermy and he was unaware of any nonthermal effect, Kennedy concluded Diapulse® was a quack device. Then, having persuaded his bosses at the FDA that Diapulse® was a quack device, Kennedy and Davis had to reject every study of Diapulse® proffered by the company. They came up with flimsy excuses at times. (Early examples of "creative writing"?)
1976 GAO report (HRD-76-153)
Diapulse Corporation sought relief from FDA's bullying tactics by appealing to Senator Abraham Ribicoff of Connecticut. Ribicoff requested the General Accounting Office to investigate. Chapter four of the report provides a history, including the following statement. "The Corporation initially contacted FDA by letter dated December 1, 1958, to inquire about FDA's requirements for examining and approving the Diapulse machine for marketing. The Corporation offered to give FDA information concerning the names and addresses of doctors under whose supervision research was being conducted on the Diapulse device. On December 30, 1958, FDA requested the Corporation to provide the information it offered and stated that a complete reply would be made at a later date. Based on the records we reviewed, FDA did not give the Corporation a complete reply to its inquiry nor did the Corporation give FDA complete information on the Diapulse device research."
The relationship between Diapulse Corporation and the FDA continued to spiral downward. FDA didn't provide the information requested by Diapulse and Diapulse declined to reveal the complete list of researchers. The GAO report states "The Corporation told us that it was reluctant to supply all of the names because it was concerned about the inhibiting effect that FDA investigators might have had on the researchers." Later events would confirm the wisdom of this reluctance - see the section below titled Government Bullies a University Research Professor for an account of one such incident.
The GAO investigation didn't lead to the relief that Diapulse Corporation had hoped for. The title of the report: "Stronger Measures Needed to Insure That Medical Diathermy Devices Are Safe And Effective" says it all.
Around the time the GAO investigation was concluding, I spoke with Al Jojokian and two other men who had worked on the investigation. They said that Robert Kennedy had told them that Diapulse would never be approved for anything.
As noted above, the GAO report indicated that Diapulse Corporation made the initial contact with the FDA in December, 1958, only months after the company was incorporated. Doesn't it seem strange that the Corporation would put itself on the FDA's radar if they knew their device was ineffective? It seems to me that real quacks and scam artists scrupulously avoid contact with a government agency that might find their activities suspicious.
Why did Robert Kennedy insist that Diapulse is a diathermy device when the Corporation consistently maintained that their device is not diathermy and does not rely on heating to achieve its benefits? Kennedy was a man of strong opinions. He could be quite persuasive with people who couldn't match his credentials in physics. Most of Kennedy's work at the FDA was centered on quack devices and he was held in rather high esteem.
Kennedy worked with a physician, Joseph B. Davis, M.D., who headed the Medical Review Group. Together, they considered the pulsing used by Diapulse as a marketing ploy to hoodwink the doctors into buying Diapulse machines.
Diathermy Reports Sponsored by FDA
Dr. Davis arranged FDA contracts to fund reports on diathermy by the University of Washington in 1974 ("Lehmann report") and Marquette University in 1983 . Both reports concluded there was no evidence that any beneficial effects from pulsing could not also be achieved with continuous wave diathermy.
Even today, FDA puts Diapulse and the other devices which have been found to be substantially equivalent to Diapulse are covered at 21 CFR 890.5290(b) as "Shortwave diathermy for all other uses." It's a sign of FDA's inconsistency: Diapulse, condemned for years as quackery because it did not produce enough power to meet FDA's criteria for diathermy, has been joined by other devices with power levels orders of magnitude smaller, which FDA cleared as substantially equivalent. Perhaps, by FDA's reasoning, they are all substantially equivalent because they consider them to be equally ineffective.
Experimental Evidence That Pulsing Does Make a Difference
A British surgeon, David Wilson, conducted two studies on sprained ankle. The first, published in the British Medical Journal in 1972, was double-blind. Wilson found, to his surprise, that patients treated with active Diapulse recovered quicker with less pain and edeme that those given sham Diapulse treatments. His second study, published in the same journal to years later, compared DIapulse to conventional shortwave diathermy. Diapulse was superior. Wilson was sufficiently convinced that Diapulse was effective that he continued his studies of Diapulse. He was an early proponent of the view that central nervous tissue is capable of regeneration, a phenomenon of extreme importance, e.g., cases of spinal cord or brain injury. See the Annotated Bibliography for details.
Survey of Doctors Whose DIapulse Machines Were Confiscated
In 1985, I conducted a survey of doctors whose Diapulse machines had been seized by the government.
To see the questionnaire and the survey results click here To see the report click here
Government Bullies a University Research Professor
A university scientist studied the effect of Diapulse therapy. His research found that surgical wounds healed more quickly and had greater strength when treated with Diapulse. When he was called upon to testify in court on behalf of other Diapulse advocates. he got a visit from government representatives. His letter, written to me in 1985, explained what happened.
"The FDA came to my office and told me that the machine had been
condemned because of faulty advertising, or whatnot, and told
me that, if I did not give this up, my house, my practice and
my family would be in jeopardy. They definitely threatened me
and convinced me that many bad things would happen if we did
not desist. In addition, they confiscated my machine."
At the request of his family lawyer, his identity is being withheld.
To see the correspondence, click here.
Copyright 2013 - Leroy L. Hamilton