The CDC/AAP Project

The American Academy of Pediatrics is reconsidering their policy statement on neonatal circumcision. The United States Centers for Disease Control had a meeting late last year to consider the implications of the African circumcision studies viz HIV/AIDS for the United States.

At the CDC meeting, consideration was given to a study by Millett et al. [pdf document, link to abstract here] that confirmed the Sydney study that male circumcision has no value for gay men, who are the major risk group in the United States. Then there was this presentation that seems to recommend mass infant male circumcision anyway on a wildly speculative cost-effectiveness basis. No human rights issues were discussed or apparently even contemplated in recommending genital surgeries on children. The meeting attendees left with a proposal to formulate a policy and work closely with AAP to promote said policy. It isn't clear what that policy will be yet.

The essential issue is: Do you want public policy makers to assert any price, no matter how costly or unethical, is worth a potential, incremental reduction in HIV risk? Do you want public policy makers to make it easier for misinformed, misguided, or poorly educated parents to choose circumcision for their children with no immediate value and certain physical and psychological costs and risks?

In regards to your letter to the AAP, consider the following issues in your letter:

• If you are a medical professional and have observed circumcisions or dealt with complications, be sure to mention this.
• If you have a child, partner, or friend with circumcision complications, be sure to mention them.
• If it is a recent circumcision with complications, done in the USA, be sure to mention place/date, so it is clear that these complications are happening in current medical practice.
• Start your letter with "Dear sir:".
• Less than one page is best, just make your point!

THANK YOU to Camellia May for this contribution.

UPDATE2: Some people have received form letters from the CDC regarding this issue. We still have time to press the point. I have reorganized the names, addresses and emails of individuals you may contact regarding the impending endorsement by the Federal Government of male circumcision in order to make it easier to check who you have contacted. This is your government getting deeper into the business of genital mutilation and forced circumcision of children. Form letter added below.

UPDATE: At the end of this post is a list of key people to contact at the CDC and the AAP. Your voice is important. Please write the people speaking in your name.

I urge everyone who believes it is a mistake and a tragedy for the Centers for Disease Control to recommend neonatal circumcision to fight the spread of HIV/AIDS to write a letter to the director of that agency today. I also urge you to cc your Senate and Congressional representative. Further down, you will find names, addresses and email addresses of individuals you should contact.

This is my letter.

December 10, 2007

Julie Louise Gerberding, M.D., M.P.H. [follow link for background on the director]
Director, Centers for Disease Control and Prevention
Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Rd Atlanta, GA 30333

RE: Recommendations viz neonatal male circumcision and HIV

Dear Dr. Gerberding:

I have learned with grave concern that you and the Centers for Disease Control are considering recommending neonatal circumcision as public health policy in the effort to stem the spread of HIV/AIDS in the United States. I oppose this recommendation in the strongest possible way.

Neonatal circumcision has run into national grassroots opposition from a sizable and highly active group of people for at least the last 25 years. This opposition on human rights grounds has resulted in the major medical organizations gradually moving away from support of a marginal procedure that damages sexual response and violates the individual human rights of the infants on the receiving end.

Whatever marginal gain individuals may receive from male circumcision must be in the context of informed consent and voluntariness. Infants can provide neither. The variables involved in the effectiveness of such a procedure over the longer term are many, including the changing dynamics of the disease, changes in provision of healthcare impacting cost-effectiveness, the possibility of new treatments, prevention technologies, and eventually a vaccine. Male circumcision has not served the United States well heretofore in comparison with non-circumcising countries and regions where the HIV/AIDS rate is much lower, e.g. Japan, most of Europe, and Latin America.

I urge you to reject neonatal male circumcision as public health policy in order to safe guard your credibility with the American people and throughout the world. The United States can ill-afford another dubious policy with scant input from American stakeholders.

Very truly yours,

/DWilton/

DAVID WILTON, Esq.
Editor
http://www.circumcisionandhiv.com/

---

Below are addresses and emails for key people at the CDC and the AAP. Please both e-mail and snail mail letters to the addresses below.

Julie Louise Gerberding, M.D., M.P.H.
Director, Centers for Disease Control and Prevention
Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333
julie.gerberding@cdc.hhs.gov

Timothy Mastro, M.D.
Division of HIV/AIDS Prevention
US Centers for Disease Control
Mail stop D21
Corporate Boulevard
Atlanta, GA 30329-1902
timothy.mastro@cdc.hhs.gov

Committee on Bioethics
American Academy of Pediatrics
bioethics@aap.org

Renée Jenkins, M.D.
President
American Academy of Pediatrics
Professor and Chair
Department of Pediatrics and Child Health
Howard University Hospital
2041 Georgia Ave, NW, Room 6B02
Washington, DC 20060
executivecommittee@aap.org
rjenkins@aap.org

Jay Berkelhamer, MD, FAAP
Past-President
American Academy of Pediatrics
Children's Health Care of Atlanta
1600 Tullie Circle
Atlanta, GA  30329
Jay.Berkelhamer@choa.org

David T. Tayloe, Jr., MD
President-Elect
American Academy of Pediatrics
2706 Medical Office Place
Goldsboro, NC 27534
dtayloe@aap.org

Errol Alden, MD
Executive Director
American Academy of Pediatrics
141 Northwest Point Blvd,
Elk Grove Village, IL 60007
EAlden@aap.org

Peter H. Kilmarx
Branch Chief
US Centers for Disease Control
Corporate Square, E45
Corporate Blvd.
Atlanta, GA 30329
peter.kilmarx@cdc.hhs.gov

NEW! Dr. Andrew Freedman,
Pediatric Urologist
Cedars-Sinai Medical Center
8635 W. Third St., Suite 1070
Los Angeles, CA 90048

Dr. Freeman is apparently also on the AAP Circumcision Task Force

NEW! Dr. Doug Diekema
Pediatrician
Department of Emergency Services
Children’s Hospital and Medical Center
4800 Sand Point Way NE
Seattle WA 98105
diek@u.washington.edu

This may be an additional address: 1100 Olive Way MPW 8-2, Seattle, WA 98101-0000

Dr. Diekema is the AAP Chairperson for the Committee on Bioethics and is on the AAP task force developing the new policy.

Additional CDC Committee Member Emails:

Patrick Sullivan
patrick.sullivan@cdc.hhs.gov

Thomas Peterman
thomas.peterman@cdc.hhs.gov

Allan Taylor
allan.taylor@cdc.hhs.gov

Allyn Nakashima
allyn.nakashima@cdc.hhs.gov

Mary Kamb
mary.kamb@cdc.hhs.gov

Lee Warner
lee.warner@cdc.hhs.gov

Stephanie Bailey
stephanie.bailey@cdc.hhs.gov

Stephen Blount
stephen.blount@cdc.hhs.gov

Kevin Fenton
kevin.fenton@cdc.hhs.gov

fvo9@cdc.gov (?)

Additional AAP Committee Member Emails:

DWalter@aap.org (?)
rsuchyta@aap.org (?)

Several different versions of form letters have been received from the CDC so far. Here is one of them:

Department of Health & Human Services
Public Health Service
Centers for Disease Control and Prevention

February 6, 2008

[Addressee omited]

Dear Ms. [name omited]:

Thank you for your recent correspondence to the Centers for Disease Control and Prevention (CDC) regarding male circumcision as it relates to HIV prevention in the United States. The potential role of adult and neonatal male circumcision in addressing health outcomes in the United States, including HIV infection, is currently an important consideration for public health.

In the past year, male circumcision has been identified as an effective HIV prevention method, based on clinical trials in Africa. Researchers found that circumcised men were at least 51% less likely than uncircumcised men to acquire HIV during sex with women. While there are distinct differences between the HIV/AIDS epidemics in Africa and the United States, it is critical that we examine the potential role of male circumcision in HIV prevention efforts in the United States.

CDC acknowledges that male circumcision is associated with reduced risk for HIV acquisition via heterosexual exposure, and that additional consideration is needed to determine its relevance to the epidemic in the United States. We are committed to ensuring that evidence-based HIV prevention strategies are promoted. CDC is continuing to receive input on this issue, and we appreciate the information you have provided. We believe that a comprehensive approach to HIV prevention is the best way to reduce the impact of HIV on America's communities.

CDC is committed to working with public health partners to evaluate the role of male circumcision for HIV prevention in the United States. In April 2007, CDC consulted with a broad range of experts to explore the role of male circumcision in preventing HIV transmission in the United States. Participants examined the best scientific evidence to assess the relevance of male circumcision to the epidemic in the United States and explored factors such as potential cost-effectiveness, cultural and safety concerns, and integration with existing prevention methods. CDC believes it is critical to examine the best scientific data and take into account a variety of perspectives on health policies as we develop recommendations on male circumcision. Once CDC has developed draft recommendations, they will be published in the Federal Register to provide an opportunity for the public to comment through a formal public review period.

CDC continues to support a combination of evidence-based prevention strategies. We believe that the promotion of safer sexual behaviors, including condom use, should continue and will contribute substantially to reducing HIV infection rates, especially when combined with other effective interventions. We are also taking into account the potential risks and harms of male circumcision, and are aware of concerns regarding human rights and changes in sexual sensation resulting from male circumcision.

Thank you again for contacting CDC and for your continued commitment to HIV prevention.

Sincerely,

Timothy D. Mastro, M.D.
Deputy Director for Surveillance, Epidemiolgy, and Laboratory Science Division of HIV/AIDS Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Comments

[cute little fireman]

"a vanishingly small incremental reduction in HIV risk"

Come on guys by all means oppose circumcision but don't stoop to lies and disinformation. The protective effect for female to male HIV infection through male circumcision is 60% and that is not "vanishingly small". Sheez.

[David]

It is vanishingly small when you take into account the very real problems with the research. The reduction of risk at 60% is hopelessly optimistic in a real world setting. It applies to a research cohort, not individuals. The over all reduction was 60% in a highly controlled trial. If the researchers could say that the reduction in risk was that great, there were be no reason to believe that increased sexual activity by the cohort would erase the gains. And of course, there would be no need to continue the message that you have to use condoms all the time even if circumcised. The real world will not produce a 60% reduction in HIV infections. We have seen this in other observational research. (And didn't one of the studies show only a 40% reduction in risk? That's a huge spread.)

If you believe the 60% reduction in risk, you are doing what the researchers did: focusing only on the results of a highly controlled trial and claiming the results are valid outside controlled conditions. The only way to know if this will be true is further research. I know of no calls for further research to verify that a 60% efficacy (clinical) rate will translate into a 60% effectiveness (real world) rate. In fact, it is not even clear that the subjects of this research will be followed to see how they fair.

And btw, "vanishingly small" is no hyperbole when you consider that we are talking about a policy statement of the AAP that presumably only applies to the US and to neonates in particular. The US does not have a generalized epidemic. The principal method of transmission is not heterosexual female to male intercourse. Viewed in that light, for any particular individual the protection from circumcision, even if you accept the 60% number, in no way approaches the claims of its promotors.

[J]

No I think that David's description is scarcely an exaggeration. Have you ever heard the saying, “The big print giveth, the small print taketh away.”? The thing is this 60% figure that keeps getting thrown around represents the relative risk reduction not the absolute risk reduction. The authors, press, and funders throw that around for one simple reason, it look far more impressive. For example in one of the studies the figures were 22 (1.5%) 47 (3.2%) over about 1400 which leads to a absolute risk reduction of less than 2%, and that was the high mark. The problem is you don't want a headline reading “Circumcision reduced absolute risk of contracting HIV by 2%”. A headline like that doesn't get you recognition, further funding, or the front page of major papers. Now if the results were instead 40% and 80% we would have a 50% relative risk reduction, a 40% absolute risk reduction, and perhaps something to talk about, in Africa.

Lets also remember that these studies were conducted in a pandemic zone where we have infection rates which are in the neighborhood of 15 – 35% (or more) and I would imagine that just about everyone and everything in those countries are considered 'utra-high risk'. I also don't believe that the bulk of the population group studied in Africa could possibly be compared to those in the west with respect to education, standard of living, and other important factors. Consider that there are still people in some of these African countries who believe the most absurd notions like they can cure themselves by having sex with a virgin, the younger the better. Now some bureaucrat is going to tell me we have reached the limits of what education is going to achieve? So, out of this 'perfect storm' there is, optimistically, an actual reduction of less than 2% if all goes perfectly. Project that optimistic projection into the west and we are likely talking about tenths, perhaps even hundredths of a percent difference. This is quite possibly why simple observational studies failed to show any real correlation, even in Africa the data was all over the board.

This kind of approach is historically common with those pushing circumcision and groping for a justification. For example, girls are several times more likely to contract UTIs than boys and it isn't considered a serious condition; however, for boys a surgical operation is suggested. Or penile cancer the incident of which approaches lottery odds. Which makes me wonder what are the little pamphlets going to look like in Africa. Are they going to have a bullet that says: Absolute Risk Reduction: 2% or Relative Risk Reduction: 60% or perhaps just Risk Reduction 60%. Indeed if you were truthful in your full disclosure you would have to discuss both of these and their relevance. Perhaps 2% in South Africa is a good number but in the west if your telling me that the absolute risk reduction is .1 or .2 or something, likely less for most westerners, and I still need the condom, there will be no sale which I think could be the case if you told men in South Africa about the 2%. Quite frankly perhaps the greatest danger an intact boy or man faces in the US are the doctors themselves, many of whom may have possibly gone most of there careers with out seeing one. Although this is slowly changing even today boys in particular are most at risk in this regard.

So I don't think David is lying when he says "a vanishingly small incremental reduction in HIV risk". The truth of the matter is that a campaign like this runs a significant risk of both sending the message of absolute protection and siphoning money away from more effective programs. If you are concerned about pinning people for 'lying' to support a cause I would recommend you speak with some of the study authors who were at one point quoted in the press claiming circumcision is a virtual condom, circumcision has the effect of a high efficiency vaccine. Here is a link to my 'vaccine' assertion:
http://www.medpagetoday.com/InfectiousDisease/HIVAIDS/tb/1992 I think that was Auvert. Or more recently out of Sydney the headlines "Circumcision Key to Slowing Aids", or something along those lines. That is deceptive; while WHO attempted to soften that language the damage is done.

[Jake]

In trials such as these, the absolute incidence of HIV in the groups (and hence the absolute risk reduction) will depend upon the duration of the trial and the incidence of HIV in the environment. All things being equal, a longer trial will result in more cases of disease. Similarly, a trial in a high-risk environment will observe more cases than one in a lower-risk environment.

Circumcision, once performed, lasts indefinitely. The fixed duration of the trials is artificial: there is no reason to believe that the protective effect suddenly stops once the trials complete (indeed, in all three trials, the protective effect was remarkably stable over time). A simplistic attempt to estimate absolute risk reduction fails to take this into account.

Some 30-40 observational studies in numerous countries indicate a remarkably consistent protective effect, and this is confirmed by the three, more rigorous, randomised controlled trials. These trials were performed in different environments, but the relative risks were remarkably consistent in all three.

In such a situation, then, the absolute risk reduction is not a very descriptive - or indeed helpful - figure. Much more useful is the relative risk, from which one can estimate the overall ARR in any population.

Perhaps it's time to accept the facts. You can - quite consistently - believe that circumcision is wrong and yet accept the evidence. Protesting that the science must be wrong, however, is a good way to make yourself look foolish and cause yourself to be ignored.

[David]

... except that the observational studies did not look at associations between circumcision and practices likely to deter high risk behavior, such as sequestration of women, disapproval and severe restrictions on commercial sex work, lack of a cultural practice of multiple concurrent sex partners. Less permissive societies in which circumcision was observed correlate with lower rates of HIV. Wherever similar cultural attitudes and practices are observed, the correlation falls away. Examples are Lesotho and Swaziland, within Zambia, even South Africa.

Now, it may be true that circumcision results in a lower initial uptake of HIV infection. But over time, the numbers of infection will catch up with the intact group because the numbers of men taking risks are probably about equal in each group. If this wasn't true, HIV would have raced through whole populations already.

Btw, this discussion really isn't related to circumcision in the North American context. I encourage you to take it to the post for today which relates exactly this issue.

[Jake]

"But over time, the numbers of infection will catch up with the intact group because the numbers of men taking risks are probably about equal in each group."

If that were true, then any intervention - condoms, circumcision, you name it - would be hopeless. Fortunately, risks can be reduced.

[David]

Yes, risks can be reduced with the right interventions. However, circumcision is an intervention that is severely limited in its effectiveness for those who continue to engage in risky behavior. Btw, I posted on this a couple of days ago. Mathematical studies, even accepting their problems, have borne this out.

Wearing a condom is not comparable to circumcision. Not even close. Equating the two is a rhetorical technique to confuse the discussion.

I'm closing comments temporarily to encourage moving this discussion to today's post on the front page. Feel free to link back to this page for context in any new comment. Thanks.