3/13/2014

Some of you may have seen an article on the front page of the business section of the New York Times today entitled “FDA Panel Recommends Replacement for the Pap Test.” Understand that this is simply an Advisory Committee to the FDA and this recommendation may or may not be adopted by the FDA itself. Furthermore, as pointed out in the article, this does not mean that various societies like the American College of Obstetricians and Gynecologists will automatically change their guidelines. I am compelled to make a few observations: 

  • The article makes reference to the fact that HPV testing is more objective and Pap smear evaluations are subjective. This is in fact true, and one of the main reasons that I send all of your Pap smears to the NYU cytology lab, rather than using large commercial labs like Quest or National Health Laboratories, is that I feel the quality control here at NYU is superior. This is not unlike the comments I made about mammography after the recent article concerning mammograms (which by the way were done in Canada 30 years ago with outdated equipment). Any of these tests are only as good as the people who perform and interpret them.
  • While it is true that a negative HPV test would be somewhat reassuring, the incidence of positive tests is so high, especially in women under 30, that this will lead to a great deal of unnecessary anxiety and intervention with testing. As I have told many of you THEY ARE TURNING HPV INTO THE DISEASE. THE DISEASE IS CERVICAL CANCER.
  • The article correctly points out that the Pap smear has resulted in a huge reduction in deaths from cervical cancer between 1955-1992, but that rate has not declined further. In my opinion that is because 50% of these are related to patients who have never had a Pap smear, another 10% in patients who have an abnormal smear but do not follow up.
  • They quote the number that worldwide 70% of cervical cancers are associated with HPV subtypes 16 and 18, which are the ones this test detects. This data comes from all over the world and relates back to data collected in the mid 1990’s. In the United States, in an article published in 2007, in American women, of all the high risk DNA types of HPV, number 16 and 18 were number 6 and 10 in prevalence. What about all the other high-risk types?
  • The new test, which they are recommending approval of, is made by Roche. Interestingly enough, Roche is the company that makes Gardasil, the vaccine being pushed onto most young women and now even young men by pediatricians. You may recall that a lobbyist for Roche was related to the Governor of Texas and that state came very close to mandating vaccinations for all young girls.

Abandoning Pap smears for HPV DNA testing will result in a flurry of false positives, increase patient anxiety, increase invasive testing and is, in my opinion, not what I would recommend. Good Pap smear screening, with HPV testing where indicated as we currently perform, is in my opinion more than adequate. In more than 25 years of practice, I have had one case of invasive cervical cancer (and that woman walked into my office with the disease).

 

As always, I remain yours in health.