FDA CHALLENGED BY HiFi DNA TECH TO PROVIDE PROOF THAT HPV TYPES 6 & 11 CAUSE VULVAR AND VAGINAL CANCERS

TRUMBULL, CT -- A Connecticut cancer pathologist/physician/scientist with extensive experience in the field for the past half century has formally challenged the FDA to back claims on its website that human papillomavirus (HPV) genotypes 6 and 11 cause vulvar and vaginal cancers in women.

HiFi DNA Tech president Sin Hang Lee, MD, requested the FDA publish the data to support its assertion that now “HPV types 6 and 11 cause 20-50% of vulvar cancers and 60-65% of vaginal cancers,” in a letter addressed to FDA Commissioner Dr. Margaret Hamburg. The FDA assertion was made in an advisory “For Consumers,” last updated Feb. 23, 2010.

Dr. Lee said that in his and other scientists’ experience HPV types 6 and 11 have almost never been associated with what is called “anogenital” cancers. “If the FDA data showed a link between these two HPV types and cancers in the vulva and vagina, the genotyping method of the FDA’s references ought to be re-examined and rigorously validated,” he said. Dr. Lee, also a full-time pathologist at Milford Hospital and director of Milford Medical Laboratory, is a proponent of using DNA sequencing for accurate HPV genotyping to reduce the harmful unnecessary cervical biopsies on women.

“Now when consumers are encouraged to take a more active role in their health care decisions and are responsible for digesting substantial amounts of information, the material provided by the FDA should be evidence-based.” said Dr. Lee.

To this date, the FDA has not published the positive predictive value (PPV) of the FDA-approved HPV tests in determining the need for referral of women to colposcopic biopsies, as requested.  

Contact person: Ken Warren at 203-891-9001