Author Archives: Erika Check Hayden

US research ethics agency upholds decision on informed consent

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United States regulators are standing by their decision that parents were not properly informed of the risks of a clinical trial in which premature babies received different levels of oxygen supplementation.

From 2005 to 2009, the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) trial randomly assigned 1,316 premature babies to receive one of two levels of oxygen supplementation in an effort to test which level was best. Even though the lower level was associated with increased risk of brain damage and possibly death, and the higher level with blindness, the study leaders said that they did not disclose these risks to parents because all ranges of oxygen used in the trial were considered to be within the medically appropriate range at the time.

The study was supported by the US National Institutes of Health (NIH). On 7 March 2013, the US Office of Human Research Protections (OHRP) issued a letter determining that the trial investigators had not adequately informed parents about the risks to their babies in the SUPPORT trial. The NIH and many researchers disputed the decision, arguing that it would impede “comparative effectiveness research” studies that are designed to test the best use of approved interventions. Parents of children in the trial, however, and others supported the OHRP’s determination that parents hadn’t received adequate information. The two sides clashed at a meeting convened by the NIH and the OHRP in August 2013.

Today, 24 October 2014, the OHRP has issued guidance reiterating and clarifying its position on what types of risks must be disclosed to study subjects in comparative effectiveness research studies such as SUPPORT. The agency has determined that risks of the intervention must be disclosed to study participants even if the risks are considered acceptable according to current medical guidelines, if the study intends to evaluate these risks and if the patients’ risks will change when they enrol in the study.

The OHRP said that even though both the low and high levels of oxygen supplementation were considered within the acceptable range, “the key issue is that the treatment and possible risks infants were exposed to in the research were different from the treatment and possible risks they would have been exposed to if they had not been in the trial”.

“[F]or the great majority of infants in the trial, it is likely that their participation altered the level of oxygen they received compared to what they would have received had they not participated,” the OHRP added.

The agency said further that if a trial is designed to compare the risks of potential side effects of a treatment already in use, then the risks are “reasonably foreseeable” and that prospective study participants should be made aware of it.

“If a specific risk has been identified as significant enough that it is important for the Federal government to spend taxpayer money to better understand the extent or nature of that risk, then that risk is one that prospective subjects should be made aware of so that they can decide if they want to be exposed to it,” OHRP said.

The guidance is open to comments until 24 December.

First US Ebola case diagnosed

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A man has been diagnosed with Ebola virus disease in Dallas, Texas.

The man diagnosed with the illness on 30 September is the first in the United States, and the first person ever diagnosed outside Africa with the Zaire species of Ebola virus, which has killed more than 3,000 people in Africa in the current outbreak. A handful of Ebola patients have been treated in the United States during the current outbreak after being diagnosed with the disease in Africa.

The patient travelled from Liberia to the United States on a flight that landed on 20 September, began experiencing symptoms on 24 September, sought care on 26 September and was admitted to an isolation ward at Texas Health Presbyterian Hospital Dallas on 28 September. The US Centers for Disease Control and Prevention (CDC) in Atlanta and a state health department lab in Austin, Texas, both diagnosed Ebola in samples from the patient.

CDC director Thomas Frieden said that the patient was in the United States visiting family and did not appear to be involved in the Ebola outbreak response in Africa.

Frieden said that public-health officials began tracing the contacts of the individual today, and do not think that passengers who were on his flight are at risk of infection with Ebola. Frieden said that officials have identified “several family members and one or two community members” who had contact with the patient after he became sick and so therefore may have been exposed to the virus. Officials will monitor them for 21 days, the period of time in which they will show symptoms if they have been infected with Ebola.

“Ebola doesn’t spread until someone gets sick, and he didn’t get sick until four days after he got off the airplane, so we do not believe there was any risk to anyone who was on the flight,” Frieden said.

“I have no doubt that we will control this importation, or case of Ebola, so that it does not spread widely in this country,” Frieden said. “It does reflect the ongoing spread of Ebola in Liberia and West Africa where there are a large number of cases.”

Frieden said further that doctors were considering providing experimental treatments to the patient such as injections of blood or serum from other Ebola survivors.

“That’s being discussed with the hospital and family now and if appropriate, they would be provided to the extent available,” Frieden said.

Few other details about the patient were provided, though officials did say that he is “ill and in intensive care”.

 

Scripps president resigns after faculty revolt

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The president of the Scripps Research Institute intends to leave his post, according to a statement from Richard Gephardt, the chair of the institute’s board of trustees. The announcement came in the wake of a faculty rebellion against the president, Michael Marletta, who had attempted to broker a deal in which the research lab, in La Jolla, California, would be acquired by the Los Angeles-based University of Southern California (USC) for US$600 million.

In the statement, posted on 21 July, Gephardt said that Marletta “has indicated his desire to leave” Scripps and that the board “is working with Dr Marletta on a possible transition plan”.

Scripps Research Institute president Michael Marletta resigned after clashing with faculty over a proposed merger.

Scripps Research Institute president Michael Marletta resigned after clashing with faculty over a proposed merger.{credit}Scripps Research Institute{/credit}

Scripps faculty members see Marletta’s departure as a victory. They had been angered by the terms of the USC deal, which was scrapped on 9 July, and by the fact that Marletta did not consult with faculty during his negotiations with USC. Faculty members told the Scripps board of trustees earlier this month that they had an almost unanimous consensus of no confidence in Marletta.

“I think we are more optimistic than we have been in many years, because we feel like we have some control over our own fate,” says Scripps biologist Jeanne Loring.

Loring said that at a meeting with a majority of Scripps faculty on 21 July, Gephardt indicated that the board had thought that Marletta was communicating with the faculty as he negotiated the USC deal. Gephardt also promised that faculty would involved in choosing Marletta’s successor.

Whoever replaces Marletta must find a way to close a projected $21-million budget gap this year left by the contraction of funding from the US National Institutes of Health (NIH) and by the virtual disappearance of support from pharmaceutical companies, who had provided major support for Scripps until 2011.

How Scripps solves its funding issue will be watched by other independent institutes, which have been hard hit by the contraction in NIH dollars. Scripps’ neighbour institutes have brought in hundreds of millions of dollars in philanthropy, and many involved see that as part of the solution for Scripps as well. But, Loring says, “the funding that other institutes have got from philanthropy is going to be a short-term solution, because even though it seems like an awful lot of money, they have to spend it, so they will eventually be facing the same issues.”

Follow Erika on Twitter: @Erika_Check.

 

Promising sequencing contender Oxford Nanopore and market leader Illumina sever financial ties

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Two closely watched genetic sequencing technology firms who had been unhappily affiliated have now divorced. UK-based Oxford Nanopore announced on 15 November that it has raised £56.4 million — mostly by selling the 13.5% of its shares that had been owned by San Diego-based Illumina since 2009.

Illumina had purchased the shares for $18 million in pursuit of an alliance that would give it a foothold in nanopore sequencing technology, in which different genetic bases are identified by changes in electric conductance caused when they are fed through a nanoscale pore. The technology is seen as highly promising because it offers the potential for very rapid sequencing at low cost. But after Oxford announced in 2012 that it was commercializing a version of its technology that is slightly different from the one in which Illumina invested, the two companies severed commercial ties and Illumina licensed a competing nanopore technology.

Oxford also said that it will begin allowing scientists to register to test its MinION portable genetic sequencer on 25th November in a “substantial but initially controlled programme designed to give life science researchers access to nanopore sequencing technology at no risk and for a refundable deposit of $1,000.”

The impetus for Oxford’s divestiture of Illumina shares isn’t yet clear. As computational biologist Mick Watson of the University of Edinburgh writes on his blog, Illumina may have figured that it would never make much money from the investment, as Oxford is now staking out a competitive position. “The simple answer may be that Illumina had nowhere to go with this,” Watson writes. “Therefore this is probably the logical conclusion — sell the shares and compete, try and beat [Oxford Nanopore] at their own game.”

So far, financial analysts give Illumina the edge in this game: “We continue to believe that [Illumina] has the dominant platform for the foreseeable future,” wrote Goldman Sachs analyst Isaac Ro in a research note on 15 November.

Scientists who have tested MinION so far have agreed, though they been impressed with the technology. Geneticist Yaniv Erlich of the Cambridge, Mass. Whitehead Institute for Biomedical Research wrote earlier this month that “MinION (and presumably its GridION scale-up) is far from being a threat to Illumina.”

Follow Erika on Twitter @Erika_Check.

California governor vetoes egg-payment law

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California Governor Jerry Brown has vetoed a proposed law that would have allowed payments to women who give their eggs to scientific researchers, a move that may deter other states from attempting to ease similar bans.

The measure gained attention in May after an Oregon researcher, Shoukhrat Mitalipov, published a paper showing that he could derive stem cell lines from cloned human embryos. Mitalipov paid the women who donated the eggs US$3,000–7,000 apiece, removing a significant bottleneck in the cloning process: the availability of human eggs, which must be harvested in a time-consuming and uncomfortable procedure.

In his veto message on 13 August, Brown cited ethical concerns: “Not everything in life is for sale nor should it be,” Brown wrote. The American Society for Reproductive Medicine in Birmingham, Alabama, co-sponsored the proposed law. A coalition of conservative and watchdog groups opposed it and lauded the veto.

“It would be unconscionable to expand the commercial market in women’s eggs without obtaining significantly more information about the risks of retrieving them,” said Diane Tober, associate executive director at the Center for Genetics and Society in Oakland, California, in a statement.

Even if Brown had signed the proposed law, separate rules still prohibit the state’s California Institute for Regenerative Medicine from funding research on stem cell lines created with eggs from paid donors. The agency’s leadership has asked for an amendment of those rules, but that move is stalled for now.