CDC Staffer Exposed to Ebola Amid Growing Concerns for Health Workers

The Ebola virus threat to health workers and international responders in West Africa saw no letup today, with news of the US Centers for Disease Control and Prevention (CDC) returning one of its deployed staff members after contact with a patient and Canada pulling a lab team after infections were detected at their hotel.

CDC Director Tom Frieden, MD, MPH, is in West Africa this week getting a first-hand look at the steep challenges the affected countries and international health responders face. In Monrovia, Liberia, he told CNN that the outbreak is worse than he feared. He said each day the outbreak continues increases the threat of exporting the disease to other countries.

“The sooner the world comes together to help Liberia and West Africans, the safer it will be,” Frieden told CNN.

CDC Staffer Had Low-risk Exposure

In a statement on Wednesday, the CDC said it brought an employee back on a charter jet following low-risk contact with an international health worker who recently tested positive for Ebola virus disease (EVD). The CDC staff member worked within 3 feet of and in the same room with the infected health worker for a prolonged period when the international worker was symptomatic and capable of spreading the virus to others.

The CDC said its staffer practiced good personal infection control. The individual is not sick, does not have any disease symptoms, and does not pose a threat to others. Also, the CDC said the staff member is rotating back to the United States, as scheduled, from the assignment in West Africa.

The agency said it is handling the case based on its interim guidance for monitoring and moving people who have been exposed to the Ebola virus, which stipulates that contacts can travel long distances only by private means during a 21-day interval after last contact.

The restriction addresses the possibility that a person could start having symptoms during travel and ensures that individuals would have quick access to care if they had symptoms. The CDC also recommends that travelers who have visited Sierra Leone, Guinea, or Liberia monitor their health for 21 days and seek medical care if they start experiencing EVD symptoms during that time.

Once the CDC staffer returns to the United States, he or she will not be on home restriction and could return to duties at the CDC during the 21-day symptom monitoring period, the group said.

Canada Pulls Lab Team from Sierra Leone Field Unit

In a related development, the Public Health Agency of Canada (PHAC) said that it has recalled a three-member mobile lab team that worked a field unit with a World Health Organization (WHO) employee who was recently infected with EVD, according to a Canadian Press report. The PHAC also said people at a hotel complex where the Canadian lab team was staying were diagnosed with EVD.

The PHAC said the Canadian lab workers are not sick but will be in voluntary isolation during their flight home and after they return to Canada.

The WHO said it was pulling its staff from a unit in Sierra Leone’s Kailahun district after one of its deployed workers, a Senegalese epidemiologist, was sickened by EVD. It also announced that it would send another team to the area to review how the worker was infected. The field site is located in a part of West Africa that has been called one of the outbreak’s most intense hot spots.

Christy Feig, WHO director of communications, told the Canadian Press that the unit where the epidemiologist and the Canadian lab team were working did not treat patients but rather supported operations at a nearby treatment center run by Doctors Without Borders.

Past WCMS President Rhoda Powsner Passes Away

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Rhoda Lee Moscovitz Powsner, MD, JD, MHSA, former President of WCMS, died in her sleep in Dedham, MA on August 21, 2014. A resident of Ann Arbor for almost 60 years, Dr. Powsner and her husband relocated to Massachusetts in 2013 to be near family. Dr. Powsner operated a cardiology practice in Ann Arbor from 1960 through 1985, when she became Chief Physician at Ford Motor Company’s World Headquarters in Dearborn until her retirement. A lifelong student, and very proud of her academic achievements, she earned her undergraduate degree from Adelphi University in New York, an M.D. from Yale Medical School in 1953, a J.D. from the University of Michigan Law School in 1981 and then, in her retirement, a Masters of Health Services Administration from the University of Michigan. Active in the medical-political community in Michigan, she worked tirelessly to advance the visibility and acceptance of women in the practice of medicine. Dr. Powsner served on the Board of Directors of the Michigan State Medical Society and was a member of the Michigan delegation to the American Medical Association. She served as President of the Washtenaw County Medical Society in 1992. She served as Executive Director of the Michigan Commission on Genetic Privacy and Progress. She also was a member on the Arbitration Advisory Committee to the State Insurance Commissioner. Dr. Powsner is survived by her husband of 64 years, Dr. Edward R. Powsner, and their children and grandchildren: Seth and his wife Elizabeth Yen; Rachel and her husband Ron Gurrera and their children Arianna and Daniel; Ethan and his wife Cynthia and their children Hilary, Sarah, and Carl; and, David and his wife Susan and their children Emily, Jonathan, Abigail, and Nathaniel. There will be a private burial service for the family. A memorial service will be held at a later date. Funeral arrangements are being handled by Muehlig Funeral Chapel, 403 S 4th Ave, Ann Arbor, MI (734) 663-3375. In lieu of flowers, donations may be made to the University of Michigan’s University Musical Society.

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Sunshine Act Deadline Pushed Back

After nearly two weeks of technical problems and a host of physician and industry complaints, the Centers for Medicare & Medicaid Services (CMS) has reopened its Sunshine Act portal (also known as the “Open Payments” system), where physicians can review data about their financial interactions with medical device and drug manufacturers. The agency has extended the deadline only until Sept. 8 for physicians to dispute their data and have it flagged as such before the information goes public.

Meanwhile, about one-third of the data reportedly has errors that CMS already has identified, and the agency said it would withhold this data from the initial public data release. Because there are outstanding concerns about the data’s accuracy, it is critical that physicians review their reports and seek any necessary corrections. CMS has said the Sept. 30 public release date remains firm.

The AMA and 112 specialty and state medical societies earlier this month urged CMS to postpone the release of physician financial data for six months, to March 31. The groups also called attention to the agency’s lack of communication surrounding the review and dispute process, which is confusing and time-consuming even when it is working properly. The groups also pointed to the short timeline for physicians—a mere 45 days to complete CMS’ convoluted registration process, review their data and submit any disputes.

CMS took the Open Payments system offline Aug. 3 “to resolve a technical issue,” according to a press release issued Aug. 15, which said the agency took “action after a physician reported a problem.” The agency reports that some manufacturers and group purchasing organizations erroneously submitted intermingled data, such as the wrong state license number or National Provider Identifier, for physicians with the same first and last names.

The agency extended the time for physicians to review their records to Sept. 8 to account for the 13 days the site was unavailable but didn’t change the date that records would be made available to the public. This compressed timeframe has raised concerns that the public data will be inaccurate.

“Reports that one-third of the data is not accurate and will be held back confirm our concerns about the data’s integrity and underscore the need for all parties involved to have more time to ensure accuracy and value,” said AMA President Robert M. Wah, MD, in a statement.

“The publication of inaccurate data can potentially harm the physician-patient relationship, which is why the AMA maintains its call for a six month delay of the data release in order to give CMS, pharmaceutical and device manufacturers, and group purchasing organizations more time to ensure information housed in the database is accurate,” Dr. Wah said. “Physicians [need] enough time to review and correct any wrong information before it is published.”

Although physicians can dispute their data until Dec. 31, it will not be marked as disputed in the public database.

Washtenaw County Schools Working to Reduce Elevated Vaccine Waiver Rates

Parents of children in Washtenaw County schools excuse their children from being vaccinated at a rate that is troubling local public health officials.

Washtenaw’s immunization waiver rate was the 20th highest out of 83 Michigan counties.

Database: See vaccination rates at Washtenaw County public and charter schools

Requiring that students at public and charter schools submit vaccination reports or waivers at the beginning of certain school years is one of the primary methods states use to ensure child immunization.

Students entering kindergarten, seventh grade, or changing school districts are required to submit report their vaccination records no later than the first day of school.

If the record is incomplete, parents can either ensure their children to receive the required vaccinations or sign a waiver form.

“Reporting means we need to know the status of at least 90 percent of the school by November 1 and that increases to 95 percent in February,” Washtenaw County Public Health immunization nurse coordinator Christina Karpinski said.

“The school secretaries are constantly working on getting this information from parents to make sure the kids are reported.”

Vaccination is tied to districts’ state school aid funding. The Michigan State School Aid Act of 1979 mandated that districts failing to meet the reporting deadlines would lose 5 percent of their state funding.

“What we work on as a health department is making sure that students are not just reported, but complete,” Karpinski said.

“People sometimes just sign the waiver because they think ‘I don’t have to get my kid vaccinated because everyone else did.’”

Karpinksi said that attitude can be dangerous, as lower levels of vaccination in a population can put everyone at risk.

Lower Vaccination Numbers, Higher Infection Numbers

Nationwide, public health officials are becoming increasingly concerned with low vaccination rates as measles infections are at their highest levels since the early 1990s. A number of cases of the potentially fatal respiratory infection have been documented in Ohio, but none have been reported in Michigan in the last 10 years.

“We need to keep our kids in school so they can optimize their educational opportunities,” vaccination policy expert Matt Davis, with the Child Health Evaluation and Research Unit at the University of Michigan, said.

“When kids get sick with vaccine preventable diseases that is an avoidable problem. We know how to keep kids healthy and in school and that’s by giving the recommended vaccines on the recommended schedule.”

Washtenaw County is in the midst of a second straight year with high pertussis, or whooping cough, levels in its schools. Public health officials said the outbreak was preventable and was caused by lower vaccination rates. Pertussis is characterized by the “whooping” cough that can make it extremely difficult for those with the infection to breath.

Washtenaw County vaccination rates fall behind state averages

One case of mumps, which can cause fever, headache and swelling of the brain and spinal cord has also been reported in the county in 2014.

School districts are responsible for notifying parents about the vaccination requirements and following up to ensure that records or waivers are completed.

“You let them know up front what the expectations are, what the due dates are, when we need the forms by and that they have to be inoculated by a certain date,” Teresa Cornelison, administrative assistant to the superintendent and secretarial supervisor at Ypsilanti Community Schools.

“We always let parents know up front what we need as part of our registration process and we train our people in the building what to look for in those immunization records so they can help parents on the spot.”

Most of the large school districts in the county had between seven and 12 percent of their students on waivers, with fully vaccinated students making up between 88 and 92 of the student population. The data is kept by the Washtenaw County Public Health Department and was obtained by The Ann Arbor News through a Freedom of Information Act request.

Manchester Community Schools had a higher waiver rate than most of the county at 17 percent, while Ypsilanti Community Schools had a waiver rate of just 1 percent across the district.

What the Districts Are Doing

The new Ypsilanti School district had a lower level of reporting than other districts in the county, with just 88 percent of students reporting as fully vaccinated or turning in the waiver form. However, all but 1 percent of those who did report were fully vaccinated.

Cornelison attributes those numbers to an emphasis at the secretarial level that vaccination is important.

“The waiver is not really something we offer up front,” she said.

“We say ‘your child needs to be inoculated’ and then we stay firm with it. It seems to work. If a person has a real objection they can of course fill out the waiver, but they may say ‘I don’t have a doctor here,’ so we help them with that. We help them get to the clinic through the county or direct them to a doctors office.”

Ann Arbor Public Schools has 88 percent of its students reporting as fully vaccinated and 9 percent have submitted waivers. District spokeswoman Liz Margolis said schools in the city work hard to get students either immunized or to fill out waiver forms.

“We aren’t making judgment calls,” she said. “Some schools will have a higher number of waivers than others and that’s just how it is. I think we can safely say we do see the impacts sometimes though.”

Saline Area Schools district nurse Karan Hervey said she has been very concerned about immunization rates dropping across the country and that she is leading a team effort to increase the rates in her district.

She said there will always be a small percentage of waivers that will never change but that she has focused on the cases that she can “turn around.”

“We try to be proactive instead of reactive here, and anticipate the needs of families and help them connect with the resources they need,” she said.

“In the past we might have said ‘we have a deadline to meet with the health department so just sign the waiver if you’re not vaccinated.’ But now we’ve reduced our waiver rate and we’ll continue to work on that.”

Saline Area Schools had an 8 percent waiver rate and 92 percent of students reported as fully vaccinated in 2014. Waiver rates at the district’s elementary and middle schools were all below 10 percent.

Waiver percentages varied widely in charter schools across the county. Ann Arbor Learning Community had 21 percent of its students on waivers and Honey Creek Community School had 32 percent, while New Beginnings Academy had just a 3 percent waiver rate.

Higher waiver rates were seen at high schools, where the only students reporting were ones who were new to the district. Karpinski said that the higher rates could in large part be attributed to foreign exchange students and other international students coming into the schools who had either different or incomplete immunization records and did not want further vaccination.

Six schools across the county had full immunization rates of 99 or 100 percent: Bryant Elementary School and the Roberto Clemente Center in Ann Arbor, the Central Academy Kindergarten, South Meadows Elementary in Chelsea, Saline Alternative High School and the Washtenaw County Juvenile Detention and Young Adult Programs.

NewLink Genetics: Ready to Test Ebola Vaccine

An Iowa drug developer is preparing to test a possible Ebola vaccine in humans, as scientists race to develop ways to prevent or fight a virus that has killed more than 1,000 people in a West African outbreak.

NewLink Genetics is planning an initial phase of testing involving up to 100 healthy volunteers and is talking with regulators about the study, said Brian Wiley, the company’s vice president for business development. He declined to say whether the drug developer has submitted an application for the research to the Food and Drug Administration.

Chief Financial Officer Gordon Link said Thursday the timing of the testing, which would involve up to 100 healthy volunteers, is uncertain.

“We’re getting a lot of assistance from a number of sources to accelerate this, so exactly how long it’s going to take is a little uncertain because people are greasing the paths as much as they can,” he said.

There is no proven treatment or vaccine for Ebola, and the current outbreak, which also has sickened nearly 2,000 people, is the largest in history. The outbreak was first detected in March in Guinea and spread to Liberia, Sierra Leone and Nigeria.

Other possible Ebola vaccines under development include one developed at the National Institutes of Health that is set to begin early-stage testing in humans this fall.

On Wednesday, Canadian drugmaker Tekmira Pharmaceuticals Corp. said it wasn’t ready to make its experimental Ebola drug available in Africa.

NewLink Genetics Corp. is planning to test a vaccine that was discovered by scientists working for the Canadian government. The U.S. drugmaker has an exclusive license to take it through clinical trials and then sell it if regulators grant approval.

NewLink said the vaccine has been 100 percent effective in preventing deadly Ebola infections in non-human primates, and it acts quickly enough to show effectiveness in animals that received a typically lethal dose of the virus.

The vaccine contains an antigen from the Ebola virus, and it essentially teaches a person’s immune system how to fight the virus.

“This is a very traditional vaccination process,” said Dr. Nicholas Vahanian, NewLink’s chief medical officer.

Researchers will be focused mainly on the vaccine’s safety in the initial round of testing, but they also will measure the antibodies the subject’s body produces to fight the virus.

“By measuring their immune response to the vaccine, you can predict the effectiveness,” Vahanian said.

The company also is working to line up manufacturing partners to make additional doses of the vaccine.

“It is not a particularly challenging vaccine to manufacture,” Vahanian said. “We are expending all our efforts to be able to secure additional manufacturing partners so we can meet high demand.”

A total of 1,500 doses have already been produced by a contract manufacturer in Germany, and the Canadian government purchased all of them. The government is setting aside some for NewLink to use in clinical research, and it also plans to donate between 800 and 1,000 doses to the World Health Organization, which is coordinating the international response to the latest outbreak.

Earlier this month, NewLink, which has no products on the market, announced a $1 million contract with the U.S. Defense Threat Reduction Agency to help fund research leading up to the human testing.

Shares of the Ames, Iowa, company soared more than 12 percent, or $2.86, to $26.30 in Thursday afternoon trading, while broader indexes climbed less than 1 percent.

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