Showing posts with label prophylaxis. Show all posts
Showing posts with label prophylaxis. Show all posts

Monday, December 29, 2014

WASHINGTON DC: FDA appproves Gardasil-9

Another nail in the coffin of surgery as prophylaxis

US Food and Drug Administration
December 10, 2014

FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV

The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
...

The safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.

TARRYTOWN, NY: CDC "out of touch with the rest of the developed world"

Intact America
December 2, 2014

CDC "out of touch with the rest of the developed world"

TARRYTOWN, NY—Intact America, an organization that opposes the forced genital cutting of babies and children, sharply criticizes today’s Centers for Disease Control (CDC) proposed guidelines for circumcision.

The CDC is calling for doctors to tell the parents of male infants, children and adolescents that circumcision has been found to reduce the transmission to men of HIV and other sexually transmitted infections (STIs). The guidelines were released on December 2, 2014, opening a public comment period that will end on January 16, 2015.

“Beyond stating and restating its support for medically unnecessary circumcision, the Centers for Disease Control fails to provide any solid evidence to bolster the case for circumcision as a valid measure for disease prevention,” said Georganne Chapin, an attorney and executive director of Intact America. “The studies cited by the CDC purporting to show that circumcision reduces transmission of STIs were conducted in poor rural areas of sub-Saharan Africa over eight years ago. These studies have never been replicated elsewhere—let alone in the United States—and have no relevance to children or men in the developed world.”

“There have been no systematic studies conducted anywhere about the short-or long-term adverse consequences resulting from circumcision," says director Chapin. "Through thousands of personal stories from boys, men and their parents we know that circumcision causes myriad complications, some requiring surgical correction. Adult consequences include poor body image, painful sex, psychological problems, and erectile dysfunction. The CDC's continued persistence in recommending what they know to be an unnecessary surgery is questionable. It is happening in the face of increased public awareness about circumcision’s harms, declining U.S. circumcision rates, and the growing reluctance of states and insurers to pay for this medically unnecessary surgery.”

Intact America notes that the CDC’s proposed guidelines make no mention of the spontaneous and growing protests around the U.S. and Canada by men who are speaking out angrily about having been forced as children to undergo circumcision.

“As a public health organization, the CDC should be calling for a study of the true risks and complications from circumcision that occur over the lifetime of boys and men,” says Chapin, “before it promotes its evidence-free claim that the benefits of newborn circumcision outweigh its harms.”

The American Academy of Pediatrics released a statement in 2012 promoting the benefits of infant circumcision and calling for insurers and state Medicaid programs to pay for the surgery, performed in the U.S. often without anesthesia. This report is at sharp odds with the ethical and medical stance taken by physicians here and in Europe concerning the removal of healthy sexual tissue from children who cannot consent.

In early 2013 in the journal Pediatrics, a large group of physicians, medical organizations, and ethicists from European, Scandinavian, and Commonwealth countries issued a strongly-worded statement , calling American medicine’s support for infant circumcision “culturally biased,” and “different from [the conclusions] reached by physicians in other parts of the Western world, including Europe, Canada and Australia."

In October 2014, Britain’s National Health Service affirmed its previous position stating that, "…most healthcare professionals now agree that the risks associated with routine circumcision, such as infection and excessive bleeding, outweigh any potential benefits."

ATLANTA, GA: CDC taking submissions on male genital cutting

RollCall
December 1, 2014

To Cut or Not to Cut: CDC Poised to Offer Circumcision Guidance

by Paul Jenks
The Centers for Disease Control and Prevention on Tuesday will unveil new guidance on health outcomes relating to elective male circumcision. The agency has been developing counseling guidance for health care providers based upon recent clinical trials and reports that have demonstrated some effectiveness of circumcision in reducing the risk of HIV and several sexually transmitted diseases. The report will also address social, ethical and religious factors relating to circumcision. A notice opening up a 45-day comment period on the looming guidance text will be published on Tuesday.

A recent federal survey indicated 88 percent of non-Hispanic white men and 79 percent of non-Hispanic black men are circumcised but the rates are lower for other ethnicities. [Those are prevelance - proportion of males who are cut - figures, but the incidence - proportion of babies being cut today - is much lower.] However, the study also notes that many of those surveyed did not correctly identify whether they are circumcised.