Owner of compounding company at the center of the 2012 meningitis outbreak acquitted of murder

A Boston jury convicted Barry Cadden, the owner and head pharmacist of the New England Compounding Center (NECC), of racketeering and mail fraud in connection with the 2012 nationwide fungal meningitis outbreak but acquitted him of 25 second-degree murder charges. His sentencing is scheduled for June 21, 2017; he faces a statutory maximum sentence of up to 20 years’ imprisonment on each of the mail fraud and racketeering counts.

Outbreak. In September 2012, the Centers for Disease Control and Prevention (CDC) began investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free methylprednisolone acetate (MPA) steroid injections from NECC. The CDC reported that 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 753 patients, the CDC reported that 64 patients in nine states died.

Indictment. In December 2014, the U.S. Attorney’s Office in Massachusetts announced a 131-count federal criminal indictment in connection with the outbreak. Cadden and NECC’s supervisory pharmacist, Glenn A. Chin, were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. Twelve other individuals associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes.

Prosecutors alleged that Cadden directed and authorized the shipping of contaminated MPA nationwide. In addition, he authorized the shipping of drugs before test results confirmed their sterility, failed to notify customers of nonsterile results, and compounded drugs with expired ingredients. NECC also used fictional and celebrity names on fake prescriptions to dispense drugs.

 

Highlight on Indiana: Lead and arsenic contamination causes health problems for children in East Chicago

Approximately 1,200 residents of the West Calumet public housing complex in East Chicago, Indiana, are looking for new homes after dangerously high levels of lead and arsenic in the area’s soil were detected. The Indiana State Department of Health (ISDH) is partnering with the East Chicago Health Department to offer free blood lead testing clinics for city residents, particularly those living in the West Calumet Housing Complex. However, a lawyer for some of the complex’s residents says it may already be too late; he reports that 85 children have tested for high lead levels.

East Chicago

East Chicago, Indiana, has about 30,000 residents. According to the Environmental Protection Agency, multiple manufacturing facilities in the area could have caused the contamination. The U.S. Smelter and Lead Refinery Inc. operated as a primary and secondary lead smelter in East Chicago from 1920 to 1985. Smelting operations generated waste materials including blast-furnace slag and lead-containing dust, and volatilized metals, including arsenic. Some of the waste materials were stockpiled south of the plant building and spread over an adjoining 21-acre wetland, and some lead-containing dust was deposited on area soils by the wind. Other potential sources of lead and arsenic contamination in the residential area include the former Anaconda Copper Company site, which manufactured white lead and zinc oxide, and the E.I. DuPont de Nemours Company facility, which manufactured the pesticide lead arsenate.

Soil contamination

In parts of the West Calumet Housing Complex, soil tested high for levels of lead and arsenic. Residents have been notified about these results, and warned not to allow children to play in dirt. The Agency for Toxic Substances and Disease Registry, advises parents to prevent children from playing in dirt or mulch, to wash toys regularly, and to wash children’s hands after they play outside. All residents should remove shoes before walking into their homes. Residents have also been advised to not disturb the mulch or dig or garden in their yards.

The Environmental Protection Agency initially planned to clean up the area by removing and replacing two feet of soil; however, after delays and accusations of not going far enough to protect residents, East Chicago Mayor Anthony Copeland ordered the removal of all complex residents.

Lead poisoning in children

According to the Mayo Clinic, lead poisoning can affect anyone of any age, but children under six are the most at risk. The signs and symptoms of lead poisoning in children may include:

  • Developmental delay
  • Learning difficulties
  • Irritability
  • Loss of appetite
  • Weight loss
  • Sluggishness and fatigue
  • Abdominal pain
  • Vomiting
  • Constipation
  • Hearing loss

Highlight on Iowa: Update on West Nile, Zika, and HIV diagnoses

The Iowa Department of Public Health (IDPH) recently announced the first human West Nile virus cases of 2016, that new HIV diagnoses were up 27 percent in 2015, and that 13 Iowans were infected with Zika in summer 2016.

West Nile

The IDPH announced that testing at the State Hygienic Laboratory (SHL) in Iowa has confirmed the first human cases of West Nile virus disease in 2016. A female child (0-17 years of age) and an adult male (41-60 years of age), both of Sioux County, were hospitalized due to the virus but are now recovering. “These cases serve as a reminder to all Iowans that the West Nile virus is present and it’s important for Iowans to be using insect repellent when outdoors,” according to IDPH Medical Director, Dr. Patricia Quinlisk.

Iowans are advised by the IDPH to: (1) use insect repellent with DEET, picaridin, IR3535, or oil of lemon eucalyptus (DEET should not be used on infants less than two months old and oil of lemon eucalyptus should not be used on children under three years old); (2) avoid outdoor activities at dusk and dawn; (3) wear long-sleeved shirts, pants, shoes, and socks whenever possible outdoors; and (4) eliminate standing water around the home.

Since West Nile first appeared in Iowa in 2002, it has been found in every county in Iowa, either in humans, horses, or birds. The virus peaked in 2003, when 141 were sickened and six died. In 2015, 14 cases of West Nile virus were reported to IDPH. The last death caused by West Nile virus was in 2010, and there were two deaths that year.

Zika

According to a August 12, 2016 Zika virus update from IDPH, the mosquitoes that are transmitting Zika virus in Central and South America and threatening parts of the southern United States are not established in Iowa, so the risk to Iowans occurs when they travel to Zika-affected areas. The Centers for Disease Control and Prevention (CDC) has issued Level 2 travel alerts to Zika-affected areas advising travelers to take measures to prevent mosquito bites. Thirteen Iowans have been confirmed to have Zika in summer 2016, but all were believed to be infected while traveling in affected regions.

HIV

The IDPH annual HIV Surveillance Report for 2015 finds there were 124 new HIV diagnoses in 2015, an increase of 27 percent from the 98 cases reported in 2014. This increase marks a return to the levels seen in 2013, and is a reversal from the drop in cases from 2013 to 2014.

The IDPH speculates that since 2014 was the first year of full implementation of the Affordable Care Act (ACA), it is possible that fewer HIV tests were performed because providers were dealing with the influx of new patients, leading to fewer confirmed cases. The 2015 increase may be because providers were more prepared for the increase in patients, and were more likely to perform HIV testing. This speculation is supported by the fact that the largest diagnoses decreases in 2014 and increases in 2015 occurred in private physician offices, hospital-based clinics, and community health centers (compared to public test sites, correctional settings, and blood banks).

Of the 2,367 diagnosed persons (both in and out of care) in Iowa, 76 percent were virally suppressed.  Nationally, an estimated 42 percent of persons diagnosed with HIV (both in and out of care) had attained viral suppression, so Iowa does very well by comparison.

In addition, the IDPH reports that the number of deaths among HIV-infected persons diagnosed in Iowa continues to decrease since peaking at 103 deaths in 1995. Since 2000, the number of deaths has fluctuated from a low of 20 to a high of 44.  Preliminary data indicate 20 HIV or AIDS-related Iowa deaths in 2015.

IDPH and its community partners are currently creating Iowa’s 2017-2021 Comprehensive HIV Plan, which will be released in fall 2016.

Highlight on Maine: Main CDC seeks to withhold outbreak information despite strong pushback

MaineHealth, the Maine Medical Association, Eastern Maine Health Systems, and other health care organizations opposed a proposed rule change by the Maine Center for Disease Control and Prevention (Maine CDC) that would allow the state agency discretion not to disclose the locations of infectious disease outbreaks. The rule change comes after two instances in recent years in which the agency refused to name the location of such outbreaks.

Maine CDC withholds information

In 2014, the Maine CDC was criticized for refusing to name the restaurant at which a hepatitis A outbreak occurred. In July 2015, the Portland Press Herald filed a lawsuit after the Maine CDC refused to disclose the locations of four chicken pox outbreaks over concerns that doing so would infringe on personal privacy.  The newspaper argued that, in releasing the location of the outbreaks, no individuals would be named. The lawsuit culminated in a settlement agreement in which the Maine CDC released the names of three schools and a day care facility where the outbreaks had occurred.

Strong opposition of proposed rule change

The proposed rule change would make it easier for the Maine CDC to withhold information about the location of outbreaks of communicable diseases. The Press Herald posited that the agency’s policy “runs counter to recommendations by public health experts, who say that knowing where outbreaks occur is beneficial to the public health because some people . . . are more susceptible to communicable diseases.” An attorney for the newspaper said that the proposal conflicts with state open records laws.

In addition to the Press Herald, organizations including MaineHealth, the Maine Medical Association, and Eastern Maine Health Systems submitted comments in opposition to the proposed change. According to the Press Herald, Dr. Jeffrey Aalberg, MaineHealth chief medical officer, said that the proposed change goes “beyond what is required” by a federal law that protects patient privacy. “The proposed rule would hinder our efforts to take critical public health action in the face of an imminent or possible public health threat. Lack of ready access to data regarding disease outbreaks, contaminated food or water, school or community immunization rates, or other significant events would prevent MaineHealth facilities and providers from delivering the level of care necessary to protect the health of our patients and communities, which include vulnerable populations like children and adults with serious chronic conditions,” he said.

If the Maine Attorney General’s Office evaluates the rule and finds it to be legal, it will go into effect four months after the comment period, which ended August 1, 2016.