1976 General Accounting Office Report on Diathermy
The September, 1976, report titled "Stronger Measures Needed To Insure That Medical Diathermy Devices Are Safe And Effective" (HRD-76-153) provides a lot of factual information regarding the protracted controversy over the Diapulse device beginning only a year or so after the company was formed.
The General Accounting Office (now called the General Accountability Office) undertook the investigation which resulted in the report as the request of Senator Abraham Ribicoff of Connecticut. Ribicoff asked the GAO to investigate because he had received a complaint from Diapulse Corporation.
The GAO investigators, led by Al Jojokian, attempted to do a thorough and probably unbiased investigation. Around the time the report was issued, I spoke with the GAO investigators. They told me the Robert J. Kennedy had told them that Diapulse would never be approved for anything. Indeed, it was only after the K-D-B had retired and the Second Circuit Court upheld Judge Mishler's verdict that CDRH finally gave Diapulse a label in 1987.
To view the entire report, click here