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Biological Chemistry

Zika, Bial, And Theranos

by Bibiana Campos Seijo
February 1, 2016 | A version of this story appeared in Volume 94, Issue 5

The outbreak of the Zika virus has dominated the news in the past couple of weeks.

The stories and images we have seen in the media about the Zika virus (see page 8) and its effects in babies are devastating and point at a health crisis of major proportions. The U.S. Centers for Disease Control & Prevention has cautioned that more studies are needed to confirm the link between the virus and infant microcephaly—a rare condition in which infants are born with abnormally small heads—but the connection is strong enough that they have warned pregnant women against traveling to countries where the virus is present. The travel advisory warning covers countries in the Caribbean and Central and South America including Brazil, where the alarm was first raised. Health officials had been monitoring a sharp increase in cases of microcephaly in the northeast of the country, an area that had been going through a Zika outbreak.

On its own, the Zika virus is not life-threatening and causes flulike symptoms. But in their investigations, the researchers identified the Zika virus in the amniotic fluid of two pregnant women whose fetuses were found to have microcephaly, pointing at a connection between the virus and the condition. It is not known at this point whether the virus alone causes microcephaly or whether the condition develops only if the mother has had a previous infection.

More research is needed, but Brazilian authorities lack the most up-to-date technology to test for the virus efficiently. This means that Zika cases in the country can only be detected during the acute phase of infection, which typically lasts five to six days. Given the speed with which this virus has propagated—it originated in Uganda and is thought to have traveled to Brazil in 2014, and cases in El Salvador have escalated since it was first reported there in late November—and the threat it poses to pregnant women, there is a great sense of urgency and the international community must respond. Latin America continues to struggle with mosquito-borne diseases, and this vulnerability needs to be addressed.

The other news that grabbed the headlines recently is the clinical trials tragedy in Rennes, France. Six individuals taking part in Phase I clinical trials—conducted by the company Biotrial on behalf of Portuguese firm Bial—were hospitalized, with one being pronounced dead, four still requiring hospitalization, and a sixth individual being released after not showing secondary effects. These were healthy, paid volunteers who were helping evaluate a drug candidate’s safety profile. At press time, the nature of the candidate had been leaked but not yet confirmed by Bial, and the investigation is still ongoing. There had been no major incidents for a number of years in Europe, and this came as a shock. I’d like to praise the commentary provided by the online community of scientists, who did an outstanding job of seeking and providing information where available and also speculating in a constructive—but not necessarily correct—way over the different pathways the drug may have followed in the body to cause such an adverse reaction.

Lastly, I wanted to update you on news that I was writing about last year. In my Nov. 2, 2015, editorial, I admitted to being shocked by the large amount of money that had been quoted for the valuation of start-up Theranos. The company had made the headlines because FDA had issued a report indicating it had found flaws in Theranos nanotainers—small blood-sampling devices that require only a few drops of blood to carry out a bunch of lab tests quickly and effectively without the use of needles—and quality-control procedures. Now, the company is under review by another federal regulator, the Centers for Medicare & Medicaid Services. CMS has just issued a letter specifying some deficiencies that Theranos has 10 days to correct or risk losing certification for the lab in question. By the time you read this, we may already know the outcome, and I hope it is positive for the sake of the company and its workers as well as for the credibility and reputation of its founder, Elizabeth Holmes.

Views expressed on this page are those of the author and not necessarily those of ACS.

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