Why don’t condom labels say anything about HPV?

The long answer is much more complex. For one, the information on condom warning labels is “enforced” by the Food and Drug Administration (FDA). They’re the ones who are supposed to make sure that the information is medically accurate. So, why don’t they tell you that the condom doesn’t protect against HPV? It’s a messy story:

In 1999, the director of the National Cancer Institute reported to Congress that “Condoms are ineffective against HPV” and that “additional research efforts by NCIL on the effectiveness of condoms in preventing HPV transmission are not warranted.”[1]

On October 3, 2000, the “Cervical Cancer Public Awareness Resolution” was presented before the US House of Representatives. In it, Congressman Tom Coburn, who had a full-time practice in obstetrics and family medicine, said, “Along with that comes the very sad fact that our institutions that we should be trusting in this area have failed us. The Center for Disease Control has failed, because the full name of the Center for Disease Control is the Center for Disease Control and Prevention. The NIH has released a statement, as well as NCI, and on their Web site you can find that this disease is caused by human papilloma virus and that a condom fails to protect. We are so sold on this concept of ‘safe sex’ in this country that we refuse to accept the etiology and pathogenesis of this disease, and we refuse to be honest with the American public in that a condom cannot protect them from this. The thing that is exciting to me about this resolution coming up is it perhaps will have some honesty coming out of the institutions that are funded with the taxpayers’ money in this country, both the NIH and the NCI, as well as the CDC.”[2]

Coburn added that they had a breast and cervical cancer treatment bill that was “being held up at this time on the basis of the Senate conferees not wanting to agree to the language in that in regards to HPV and cervical cancer.” He pleaded to the Speaker of the House, ” Mr. Speaker, I would like to ask the body that they would put pressure on their fellow Senators that they might accede to this. The fact is, the reason we have this awareness up is we want women to get treated. This is a disease that is absolutely curable. It is not like breast cancer; we cannot always cure breast cancer. This disease, if diagnosed properly and treated, is 100 percent curable. Knowledge and the fact that we are allowing a safe sex message of condoms preventing this disease to continue will do nothing but harm women….The fact is, it is harmful to women to let that lie continue.”

Later that year, the United States Congress approved Public Law 106-554. This law directed the Centers for Disease Control (CDC) and FDA to educate the public about HPV. Part of the bill required that educational material regarding STDs like HPV shall “contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address.” The CDC was given until December 21, 2003 to issue a report “including a detailed summary of the significant findings and problems and best strategies to prevent future infections, based upon available science.”

December 21st came and went, and nothing was done. Indiana Representative Souder (the Chairman of the Subcommittee on Criminal Justice, Drug Policy, and Human Resources), pressed them on it and they finally released the January 2004 report to Congress: “Prevention of Genital Human Papillomavirus Infection.” In it, the CDC admitted, “The available scientific evidence is not sufficient to recommend condoms as a primary prevention strategy [against HPV]”. However, it remains to be seen if the CDC will actually implement an effective public policy to inform Americans of this.

On February 12, 2004, Rep. Souder wrote a letter to the Commissioner of the FDA, Mark McClellan, M.D., Ph.D., asking him to re-examine the misleading information given on condom labels. In this letter, he reminded the FDA of the findings in the CDC report the previous month, and wrote, “A meta-analysis reviewing ‘the best available data describing the relationship between condoms and HPV-related conditions’ from the past two decades published in the November 29, 2002 edition of the journal Sexually Transmitted Diseases found, ‘’There was no consistent evidence of a protective effect of condom use on HPV DNA detection, and in some studies, condom use was associated with a slightly increased risk for these lesions.’ Three years after Public Law 106-554 was signed by President Clinton, condom labels still do not warn consumers about the lack of protection against HPV infection. The Subcommittee urges FDA to act on the release of CDC’s HPV prevention report and immediately relabel condoms to alert consumers that condoms do not provide effective protection against HPV infection.”[3] However, Dr. McClellan remained the commissioner of the FDA for only a month after this letter was written, so not much was done under his watch.

Since then, the FDA has not done a great deal. They said that they’re “certainly committed to looking at this and making the requisite changes.”[4] They’ve added that they’re “preparing new guidance on condom labeling,” “exploring new opportunities to best inform condom users about important limitations of the device,” and “proposing to amend the classification regulations for condoms.”[5] In other words, condom labels still had not changed. Dr. Tom Coburn, who is a physician, congressman, and co-chairman of the Presidential Advisory Council on HIV and AIDS said, “The FDA has been dragging its feet for three and a half years.”[6]

Opponents of abstinence education disagree with Coburn. For example, Henry Waxman (D- CA), argues “we want to be sure that we do not end up with an unintended effect of confusing people about the situations when condoms do work—in HIV transmission to name only one—and actually reduce their use.” Furthermore, he added, condom labels that “include information on HPV can result in so much information on such a small package that it reduces the effectiveness of any information.”[7] Waxman apparently thinks that self-control is an unrealistic option for human beings. He assumes that if people knew the truth about condoms, they’d just throw them away and continue having sex.

In June 2005, Senator Coburn placed a hold on President Bush’s nomination for a new federal drug agency chief, hoping it would force the FDA to enforce a federal condom labeling law that requires all condom packaging to warn consumers that condoms are not effective in preventing HPV. Then, in September 2006, President Bush asked National Cancer Institute Director Andrew von Eschenbach to serve as acting agency commissioner of the FDA. Prior to his confirmation hearing, Dr. Eschenbach was asked if he would ensure that condom labels would be updated. He displayed his familiarity with the ineffectiveness of the condom, and added that it may offer some risk reduction for HPV related diseases. He then added that in November of 2005, the FDA drafted a document with proposed language for a new condom label. As a result of this document, Eschenbach said, “FDA received roughly 400 comments on the proposed rule. Almost all comments suggested the proposed labeling language was confusing and difficult for consumers to understand. As a result, the Agency intends to undertake additional labeling comprehension studies to help insure that the final labeling recommendations issued by the Agency are understandable to users.”[8]

Regarding the proposed new condom labels, Senator Coburn remarked, “In the five years it took the FDA to implement this law, over 27 million Americans have become infected with HPV, over 50,000 women have been diagnosed with invasive cervical cancer, and nearly 20,000 women have died from the disease. Despite these tragic numbers, very few Americans are still not aware of HPV or its link to cervical cancer and the FDA seems to be content with providing inconclusive claims of effectiveness that may endanger women be providing a false security against cervical cancer.”[9]

In November of 2006 (six years after the law was created requiring medically accurate condom labels) nothing had changed. So, Senator Coburn requested an investigation by the Government Accountability office of the failure of the FDA in this matter. In it, he stated, “I am requesting that GAO investigate the failure of the Food and Drug Administration (FDA) to comply with the provision of the same law that requires the agency to ‘reexamine existing condom labels that are authorized pursuant to the Federal Food, Drug, and Cosmetic Act to determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases, including HPV.’ It has been six years since this law was signed and FDA has yet to issue guidance to ensure condom labels meet this criteria. As you noted in your letter, ‘Section 317P of the Public Health Service Act addresses human papillomavirus specifically.’ Yet, condom labels do not currently mention the lack of effectiveness of condoms in protecting against HPV infection, which has been conclusively documented over the past decade.”[10]

This battle has been raging for years, without ever garnering the attention of the liberal media. When the CDC report on HPV was released, among major media outlets, only the Washington Post mentioned anything about it. In August of 2001, groups representing over 10,000 doctors accused the CDC for covering up the government’s own research about condom infectiveness (in particular, the NIH report). In the statement, which was released by the Physicians Consortium, former Congressman Tom Coburn, M.D., Congressman Dave Weldon, M.D. and others, it stated that the CDC has “systematically hidden and misrepresented vital medical information regarding the ineffectiveness of condoms to prevent the transmission of STDs. The CDC’s refusal to acknowledge clinical research has contributed to the massive STD epidemic.”[11]

The Physicians Consortium claimed that the CDC not only failed to educate the public about their findings, but tried to conceal the paper and delay its release. They added that the CDC demanded revisions of the report in order to cause “unwarranted confusion and misinformation to what otherwise is a clear-cut repudiation of condom effectiveness.”

Despite knowing about HPV and condom ineffectiveness, the CDC remained quiet. In a NIH “Consensus Statement” on Cervical Cancer, it was reported that “The data on the use of barrier methods of contraception to prevent the spread of HPV…does not support this as an effective method of prevention.”[12] That was in 1996! The CDC’s silence has been so inexcusable that the Physicians Consortium held a Capitol building press conference calling for the resignation of the (then) Director of the CDC, Dr. Jeffrey P. Koplan. Odds are, you didn’t see that on the evening news.

Finally, in December of 2008, the FDA issued a new document that outlines how condom labels should be updated. It stated that the condom label should inform customers that “Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.” You’ll notice that the language shifted away from the effectiveness of the condom to a vague assertion of what it’s “intended” to to. In order to read anything about HPV, you need to browse through the condom’s information packet, which admits, “Latex condoms are less effective against STIs such as Human Papillomavirus (HPV) and herpes. These STIs can also be spread by contact with infected skin that is not covered by the condom.”

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[1]. Richard D. Klausner, M.D., Letter to the U.S. House Commerce Committee, February, 1999.
[2]. Cervical Cancer Public Awareness Resolution (House of Representatives – October 03, 2000) http://thomas.loc.gov/cgi-bin/query/z?r106:H03OC0-0045:
[3]. “Rep. Souder Asks FDA for Action on Condom & HPV Information Law,” abstinence.net (12 February 2004).
[4]. FDA official Daniel Schultz, as quoted in “Condom Labels Called Inadequate,” Sylvia Smith, Fort Wayne Gazette, March 12, 2004.
[5]. Emphasis mine
[6]. “FDA Weighs Condom Warning Label,” by Keith Powers, Family News, March 15, 2004.
[7]. Ilka Couto and Cynthia Dailard, “Wanted: A Balanced Policy and Program Response to HPV and Cervical Cancer,” The Guttmacher Report on Public Policy 2:6 (December 1999).
[8]. “Latest News: Andrew C. Von Eschenbach, M.D., Confirmation, Questions for the Record,” Abstinence Clearinghouse E-mail Update (September 9, 2006), reply to Question 14.
[9]. Press Release, “Dr. Coburn Says New FDA Condom Regulations Make Inconclusive, Exaggerated Claims About Condom Effectiveness,” coburn.senate.gov, Washington, D.C. (November 10, 2005).
[10]. Senator Tom A. Coburn, M.D., Letter to Gary L. Kepplinger, General Counsel, U.S. Government Accountability Office, Washington, DC 20548, (November 1, 2006).
[11]. Austin Ruse, “Physicians Groups Charge US Government with Condom Cover-up, “Friday Fax, Vol 4 (Aug 17, 2001) No 35 (see http://www.c-fam.org).
[12]. National Institutes of Health Consensus Development Conference Statement on Cervical Cancer, April 1–3, 1996.