August 25, 2017

AHF: Congenital Syphilis a Growing Crisis; CDC Must Act Aggressively on Prevention, Treatment

READ TIME: 5 MIN.

In response to data revealing a growing crisis of congenital syphilis across the U.S., advocates from AHF today call on the Centers for Disease Control and Prevention (CDC) to act far more aggressively on prevention, education and treatment on the potentially deadly disease. AHF also today reiterates a separate call on the FDA to investigate an ongoing shortage of Pfizer's Bicillin L-A, the key syphilis drug used in the treatment of pregnant women.

According to the October 2016 Sexually Transmitted Surveillance (STDs) report covering data for the year 2015 (the most recent year data are available for), data on rates of congenital syphilis in the United States include the following key statistics:

  • The number of congenital syphilis cases in 2015 (487 cases) is the highest it has been since 2001 (506 cases).

  • According to the CDC, "Up to 40% of babies born to women with untreated syphilis may be stillborn, or die from the infection as a newborn."

  • African Americans experience the highest rates (35.2 per 100,000 population) compared to every other race/ethnicity in 2015.

    In addition, the New York Times reported today that, "Nearly five times as many babies across the country are born with syphilis as with H.I.V." (NYT 'Hunting a Killer: Sex, Drugs and the Return of Syphilis' August 23, 2017 Jan Hoffman)

    "For years, syphilis rates across the U.S. have been exploding, with rates of congenital syphilis, in particular, now at crisis level. At the same time, over the past year, there have been three separate instances when there were complete stock outs or shortages of the only drug recommended for treatment of pregnant women. It is high time for the CDC to aggressively step up its game to combat, prevent and treat syphilis and congenital syphilis, and also time for the FDA to investigate the shortages of Bicillin L-A," said Michael Weinstein, President of AIDS Healthcare Foundation.

    AHF first sounded the alarm about the dangerous Bicillin shortage in May 2016 and then again in December 2016. Yet, the FDA and the CDC simply repeated the explanation from Pfizer, the producer of Bicillin, that manufacturing contamination caused the shortage.

    The shortage has recurred again in May 2017, leaving health providers, particularly those treating pregnant women, scrambling for supplies of the drug. That month, the New York Department of Health issued an advisory to update the community of the status of the continuing shortages of Bicillin L-A.

    Also in response to Pfizer's repeated shortages of Bicillin L-A., Dr. Tyler B. Evans, MD, MS, MPH, AAHIVS, DTM&H, AIDS Healthcare Foundation's National Director of Infectious Disease (and Medical Director of AHF's Hollywood HealthCare Center), wrote to Dr. Scott Gottlieb, the then newly appointed Commissioner of the FDA. In a letter dated May 18, 2017, Dr. Evans wrote:

    "The infection rates of primary and secondary syphilis are at a record high. From 2014-2015, the national rate has increased 19 percent. The CDC continues to recommend Bicillin as the first line regimen for treatment because it is one of the most effective tools in addressing this public health crisis. Treatment alternative such as Doxycycline can't be considered as a reasonable replacement as Doxycycline can't be administered to pregnant women and because the dosage requirements create serious adherence challenges for patients. AHF first sounded the alarm about the dangerous Bicillin shortage in May 2016 and then again in December 2016. Yet, the FDA and the Centers for Disease Control and Prevention simply repeated the explanation from Pfizer, the producer of Bicillin, that manufacturing contamination caused the shortage.

    At a time when the rates of syphilis infections are surging across the United States, threatening the public health, we urge you to launch a high-level investigation including the consideration of sanctions against the manufacturer if it doesn't immediately resolve these so-called manufacturing problems. We find it hard to accept that Pfizer which holds the exclusive patent for this medication, with its size, scale and resources, hasn't successfully addressed the supply chain bottlenecks for Bicillin. If Pfizer is unwilling or unable to meet the ongoing demand for Bicillin, shouldn't the FDA consider overriding the exclusivity of its patent so that a more responsive manufacturer may meet the demand for this medication vital to the public health and welfare of the United States?"

    FDA has yet to respond to Dr. Evans' letter.

    Other noteworthy statistics from the October 2016 Sexually Transmitted Surveillance (STDs) report include the following:

  • Louisiana reported the highest rates of congenital syphils (83.9 per 100,000 population) compared to every other state in 2015.

  • California reported the most cases (141 cases) compared to every other state in 2015.

  • The Western region reported the highest rates (18.5 per 100,000 population) in 2015, and the Southern region reported the most cases (217 cases) in 2015.

  • In Louisiana, the rate has increased from 29.1 in 2011 to 83.9 per 100,000 population in 2015. In the same time frame, the number of cases has increased from 18 to 53.

  • In California, the rate has increased from 8.0 in 2011 to 28.5 per 100,000 population in 2015. In the same time frame, the number of cases has increased from 40 to 141.

    According to CDC estimates, there are 20 million new STD infections each year in the United States, costing the healthcare system nearly $16 billion in direct medical costs. The agency also reports more than 110 million current cases of sexually transmitted infections in U.S. men and women.

    AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 784,000 individuals in 39 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe.

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