Stop Screening for Cervical Cancer with Ineffective, Unapproved Test

Target: Women and women’s health care providers

Goal: To protect women’s health by ensuring that only approved tests are used to detect human papilloma virus, the major cause of cervical cancer.

Over 12,000 women in the U.S. will be diagnosed with cervical cancer this year. As most women know, their best chance for early detection is through regular screening for the human papilloma virus (HPV), which is the leading cause of cervical cancer. Hundreds of women, however, may go undiagnosed due to the use of an unapproved test that produces false negatives for HPV. The test, known as SurePath, is produced by the Becton Dickinson company, and while it is approved for Pap tests, the Food and Drug Administration (FDA) has denied its approval for HPV testing three times in the last 10 years. Both the FDA and Becton Dickinson are well aware of the risk of false negatives, but the company only notified laboratories—not women’s health care providers—about the problem last year. Of all HPV tests given to women every year, SurePath is used a third of the time, which is about 3 million tests. The widespread use of the unapproved test can lead to dire consequences for countless women, including failing to treat the cancer in its early stages, undergoing hysterectomy and other surgeries, and death.

A recent investigation shows that many gynecologists are unaware of the issues with SurePath, most likely because the FDA and Becton Dickinson only alerted laboratories about the risk of false negatives. It is unclear why many of the largest national labs use SurePath to detect HPV, besides the fact that SurePath kits are slightly less expensive than other approved tests. Several major labs that use SurePath for HPV testing claim to have performed their own internal validation, even though many alternative tests with FDA approval are available.

The health and lives of women should not be subjected to the laboratories’ choice of a cheaper test, especially when that test could give them and their doctors false information. Considering the fact that approximately 4,200 women will die from cervical cancer this year, why would anyone want to take that risk? Sign the petition below to women and their health care providers of the risk involved using SurePath.

PETITION LETTER:

Dear women’s health care providers, the American Gynecological and Obstetrical Society, and women everywhere,

Over 12,000 women in the U.S. will be diagnosed with cervical cancer this year. As we now know, the best chance for early detection is through regular screening for the human papilloma virus (HPV), the leading cause of cervical cancer. What most women and their health care providers do not know, however, is that many major laboratories routinely use a test that has not been approved by the Food and Drug Administration. The test, known as SurePath, is produced by the Becton Dickinson company and often results in false negatives when used for HPV detection. While it is approved for Pap tests, the FDA has denied its approval for HPV testing three times in the last 10 years.

Despite its lack of approval, SurePath accounts for about a third of all tests used to detect HPV in the U.S. This has dire consequences for women across the country, including inability to access early treatment, undergoing radical surgeries, and untimely death. Considering the new guidelines that now recommend less frequent Pap and HPV testing, the risk could easily be compounded.

Last year, Becton Dickinson and the FDA did write a bulletin with warnings of the false negatives produced by SurePath, but they only sent it to testing labs. Many labs have continued to use the SurePath test over the slightly more expensive approved tests, which is why we want to alert you and your patients about the hazards involved with SurePath for HPV testing. Doctors, ensure that your labs use only FDA approved HPV tests. Women, determine what kind of tests your doctor uses, and if you have received a negative HPV result, ask your doctor how the specimen was obtained. Considering the fact that approximately 4,200 women will die from cervical cancer this year, why risk it?

Sincerely,

[Your Name Here]

Photo credit: Chance Agrella via Freerange Stock

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