HPV Update

HPV Update -- October 2000 Date: Sun, 29 Oct 2000 15:59:41 -0500

HPV Education and Prevention Plan is Deleted from Cervical Cancer Bill
The House of Representatives agreed October 12 to strip from a cancer treatment bill a provision to educate the American public and health care providers about human papillomavirus (HPV). The proposal would have, in part, required condom manufacturers to label packages with warnings that condoms do not prevent the transmission of HPV. Rep. Tom Coburn, M.D. (R-OK), had pushed for incorporating the condom-labeling provision in H.R. 4386, which would allow states to extend Medicaid coverage for breast and cervical cancer treatment to low-income women.

In May, the House voted 421-1 to pass the bill with the labeling requirement included. The Senate stripped the provision from the bill and, in early October, sent it back to the House. The House was prepared to restore the language and return the measure to the Senate. During floor debate, several women members of the House assured Coburn that they would work with him to have his proposal included in other legislation this year. "We recognize that what he is doing is important," said Rep. Louise Slaughter (D-NY).

A new proposal for HPV prevention and education is expected to be included in the fiscal 2001 appropriations bill for the Labor, Health and Human Services, and Education departments. The new proposal directs the Food and Drug Administration to ensure that condom labels "are medically accurate and not misleading" regarding HPV. Coburn argued that warning labels were necessary because condoms do not protect against strains of HPV that are associated with nearly all cervical cancer deaths in the United States. He called safe-sex messages "a lie."

The American Cancer Society declined to endorse Coburn's original plan for condom labeling. It instead favors widespread, regular Pap screenings for the early detection and treatment of cervical cancer. AIDS Policy and Law, 10/27/2000

ACOG Claims Credit for Deleting HPV Prevention and Education Proposal
The American College of Obstetricians and Gynecologists is taking credit for the Senate's decision to delete the HPV prevention and education provisions from the Breast and Cervical Cancer Treatment Act. "ACOG worked closely with the Senate to ensure that the HPV provisions were not included in the Senate bill," according to the group's Legislative News update. Despite its stated purpose to advocate for women's health, ACOG has worked with the condom manufacturers over the past year to stop the Congressional efforts to educate the public and health care providers about HPV and its link to cervical cancer. ACOG has claimed that labels stating the ineffectiveness of condoms in preventing HPV infection "could be confusing and misleading to the general public and could have the unintended consequence of actually reducing use of condoms," a position the author of the proposal, Rep. Tom Coburn, M.D. (R-OK), said "assumes that people are stupid." ACOG Legislative News, 10/6/2000; CongressDaily, 10/5/2000

Women's Caucus Urges Support for HPV Prevention & Education Proposal
The bipartisan Congressional Women's Caucus last week wrote a letter to House Speaker Dennis Hastert (R-IL) expressing its "support for language addressing the human papillomavirus." Stating that the caucus "recognize[s] that HPV is associated with nearly all cancers of the cervix," the letter continues, "we support efforts to educate all Americans about HPV so that women can make fully informed choices that will affect their health." The caucus members also pledge their support of educating health care providers about HPV "so they are fully prepared to identify and care for those who are infected." The letter concludes by asking for Hastert's support in enacting an HPV education and prevention proposal. Deborah Arrindell, senior director of public policy at the American Social Health Association, stated that "we support the efforts of Congress to increase education and awareness about HPV and emphasize the importance of screening. Increased awareness about HPV and cervical cancer prevention will reduce unnecessary deaths from this preventable cancer." Kaiser Daily Reproductive Health Report, 10/26/2000

Senators Accused of "Keeping Women in the Dark" about HPV
In a statement released last week, the Family Research Council accused several senators of "working to keep women in the dark" about human papillomavirus after learning that some senators are delaying the passage of the FY2001 Labor-HHS- Education funding bill in part because of a provision concerning education and prevention of HPV. "Why are key senators actively working against provisions in the health care funding bill that would educate Americans -- especially women -- about the most prevalent sexually transmitted disease in this country?" FRC Policy Analyst Yvette Schneider asked. Rep. Tom Coburn, M.D. (R-OK) drafted the provision which would require that condom labels be "medically accurate" about their lack of effectiveness in protecting against HPV. The provision has met opposition from Sen. Tom Harkin (D-Iowa), ranking Democrat on the Appropriations Subcommittee on Labor-HHS, and the American College of Obstetricians and Gynecologists, which is lobbying against it. Schneider commented, "ACOG is supposed to be advocating measures that protect and improve women's health. So, why are they so adamantly opposed to ... Coburn's proposal?" HPV affects approximately 24 million Americans and is associated with nearly all cervical cancer.

To address the Senate opposition, Rep. Coburn sent a letter to Harkin "clarify[ing] any confusion" about his HPV proposal in response to a CongressDaily story which "inaccurately described" the provision as "requiring[ing] a warning label on condoms stating that they do not protect against the spread" of HPV, which Harkin called a "sticking point" for the bill. Coburn stated that the language does not call for a warning label; instead the provision "merely states that the FDA must ensure that the existing condom labels are 'medically accurate and not misleading,'" he wrote, adding, "It also directs the CDC to conduct studies to determine the prevalence of HPV and develop HPV prevention and education programs for the public and health care providers." The Kaiser Daily Reproductive Health Report, 10/25/2000

FDA Re-evaluating Accuracy of Condom Labels
"The Food and Drug Administration (FDA or the Agency) is in the process of taking a comprehensive look at condom labeling, including the primary display panel, the back panel, the package insert, and the foil pack," according to a letter from Melinda Plaisier, FDA's Associate Commissioner for Legislation to Congressman Tom Coburn, M.D. According to the letter, a Public Health Service conference entitled "Scientific Evidence on Condom Effectiveness and STD Prevention" took place on June 12- 14, 2000 to examine the available data on condom effectiveness. "The conference panel reviewed more than 100 published studies and heard from a variety of experts in the field," Plaisier writes. "Although studies show that condoms provide significant protection against some STDs (including and especially HIV/AIDS), currently available data do not clearly answer the question of whether or to what extent condoms protect against transmission of HPV. A summary of the June workshop is being prepared by the National Institutes of Health and should be available shortly. Our review of condom labeling will address this and many other questions." FDA letter, 10/20/2000

Physicians Consortium Calls on Condom Makers To Stop Misinformation Campaign, File Complaint with the FDA
The Physicians Consortium, a national organization of over 2,000 physicians, is asking the condom industry to stop the "misinformation campaign" about condom effectiveness. In a letter to Harry Boon, the CEO of Ansell Healthcare, the Consortium writes that "the condom industry has not been willing to fully disclose that barrier contraception is ineffective in controlling the spread of HPV." Ansell manufacturers LifeStyles condoms. The Consortium letter points out that an Ansell press release dated August 1, 2000 contained "the fraudulent statement" that LifeStyles condoms offer protection against HPV. The Physicians Consortium "is calling upon Ansell Healthcare to issue to every recipient of the August 1 press release a statement clarifying in detail the fraudulent information contained in that press release."

The Consortium letter also addresses the company's promotion of condoms containing the spermicide nonoxynol-9 (N-9) which studies have shown increases the risk of HIV infection. The Consortium letter inquires of Ansell "are you aware of the recent study that N-9 may increase the risk of HIV transmission?" "As practicing physicians who deal daily with the ravages of STDs, we have been pushed beyond our level of tolerance by the misinformation campaign of the condom industry. Therefore we are filing an official complaint against Ansell Healthcare with the Food and Drug Administration. It is time for women and men to be provided complete information about the limitations of condoms." The Physicians Consortium letter, 9/27/2000

HPV Test Catching On as the More Definitive Cervical Cancer Screening
A more definitive cervical cancer screening test that helps reduce uncertainty in diagnosing the disease is gaining support from doctors and health insurers. Aetna, the nation's largest health insurer, on Wednesday became the latest plan to cover the new DNA test that checks for the presence of a virus that studies show causes more than 99 percent of cervical cancers. The test is used when a Pap smear proves inconclusive, which happens about 5 percent of the time. Kaiser Permanente, United Healthcare and most Blue Cross and Blue Shield plans already cover the test for human papillomavirus, or HPV, according to the test's maker, Digene Corp. of Gaithersburg, Maryland. About 400,000 U.S. women had the HPV test in the past year, a Digene spokeswoman said. If the test shows no sign of HPV, a woman is assured she doesn't have cancer. If the HPV virus present, there is a greater likelihood the woman has cancer and she is sent for additional testing which most likely include a biopsy. ``Aetna is a bellwether for the adoption of HPV testing as a standard of care in cervical cancer screening,'' said Evan Jones, Chairman and CEO of Digene Corporation.

About 50 million Pap smears are performed annually in the United States. Before the HPV test was approved by the Food and Drug Administration in 1999, women who had an inconclusive Pap test would have to get another Pap test or an outpatient procedure that would likely include a biopsy. The results of a biopsy could take two weeks, a period in which the woman would not know if she had cancer. An HPV test can be done typically in a lab the same day as a Pap test, and it is done using the same Pap smear. Aetna is working with its clinical labs for them to automatically do the HPV test when the Pap test proves inconclusive, or mildly abnormal. ``For the patient this is a tremendous value, because the anxiety of being told you have an abnormal Pap is taken away,'' said Dr. Arnold Cohen, Aetna's medical director for women's health. Cohen estimated that about 60 percent of HPV tests done after an inconclusive Pap test will show no signs of the virus that causes cervical cancer. Thus, for Aetna and other health insurers, the HPV test eliminates the cost of paying for further office visits and a biopsy. According to the American Cancer Society, an estimated 12,800 cases of cervical cancer will be diagnosed this year and 4,600 women will die of the disease. Some experts say the HPV test can help make sure women are diagnosed earlier when the disease is more easily treated. ``This is a real breakthough, a great advance in cervical cancer screening,'' said Dr. Mark Schiffman, who is studying the impact of HPV testing at the National Cancer Institute But how widely the screening is used will depend on whether Digene makes the price affordable, especially for public health clinics, he said. The cost for the HPV test to check for cancer is about $50. In comparison, the conventional Pap test costs about $10. Another type of cervical cancer screening test, which was approved in the mid 1990s, is the ThinPrep or Prep Pap test. In those tests, which cost about $30, a computer rather than a laboratory technician scans the Pap smear slide for abnormalities. Studies show this test typically can better identify abnormal cells than the conventional Pap test. Associated Press, 9/20/2000

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