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Science Policy Around the Web – September 12, 2017

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By: Saurav Seshadri, PhD

Vaccination Medicine Vaccine Ampoules

Source: maxpixel

Infectious Diseases

Is a Zika vaccine worth the effort?

A collaboration between pharmaceutical giant Sanofi and the US Army to develop a vaccine for the Zika virus has come to an end.  About a year ago, Sanofi received $43.2 million in funding from the Biomedical Advanced Research and Development Authority (BARDA, a division of DHHS) to move a Zika vaccine candidate, generated by the Walter Reed Army Institute of Research, into Phase II development.  BARDA has now decided to ‘de-scope’ the project, leading Sanofi to abandon its efforts to develop or license the candidate.

The number of cases of Zika has declined sharply since its peak in early 2016.  While this ‘evolving epidemiology’ has hampered Zika-related clinical research and drug development, it may actually be a welcome relief for Sanofi. The French company has endured months of political pressure to agree to pricing assurances for any vaccine produced from the collaboration, with lawmakers, including Senator Bernie Sanders, arguing that it would be a ‘bad deal‘ for a private company to profit from research funded in part by American taxpayers.  In particular, the exclusivity of Sanofi’s license,  uncommon for such agreements, has been singled out as ‘monopolistic’.  Sanofi has been defending itself vigorously against this characterization, pointing out that it took on significant risk itself for a vaccine that was far from approval, and that it has already discussed reimbursing the US government for its investment through milestone and royalty payments.  Ultimately, ending the collaboration puts this PR-damaging debate to rest, while also providing Sanofi a face-saving opportunity to avoid committing to a drug with limited prospective demand and profitability (as recently transpired with the dengue fever vaccine Dengvaxia, which only reached 55 of its projected 200 million euros in sales in 2016).

In its statement, Sanofi says that it continues ‘to believe that public-private partnerships are the right model to address…public health challenges’ posed by infectious diseases.  Indeed, several pharmaceutical companies responded to the WHO’s declaration of Zika as a public health emergency in 2016; of these, Takeda and Moderna appear to still have ongoing large-scale collaborations with BARDA to develop Zika vaccines.  While the drop in Zika prevalence is clearly a good thing, it’s unclear how it will affect the economic and scientific feasibility of such collaborations in the future.  One solution is to promote vaccine development before an outbreak occurs: groups such as the Coalition for Epidemic Preparedness Innovations (CEPI) hope to facilitate this approach, but the need to allocate limited resources makes its practicality questionable.  However, the alternative is usefully illustrated by the Ebola epidemic of 2014.  Despite concerted global efforts that led to successful vaccine development by Merck, current outbreaks are small enough that the deployment of vaccines may not even be warranted.  Barring an overhaul of regulatory processes and/or financial priorities, it seems likely that when the next epidemic emerges, we’ll be playing catch-up again.

(Eric Sagonowsky, FiercePharma)

Neuroscience

Is every human brain study a clinical trial?

Basic research into the mechanisms underlying cognition and their impairment in a range of brain disorders is the primary focus of hundreds of neuroscience laboratories.  While such studies feed into drug discovery for diseases such as autism, schizophrenia, and bipolar disorder, since they do not directly involve testing any treatments, they are not commonly considered to be clinical trials.  This perception became technically incorrect in 2014, following an NIH announcement broadly redefining ‘clinical trial’ to include any study in which ‘one or more human subjects’ receive an intervention and ‘health-related biomedical or behavioral outcomes’ are observed.  Last year, the NIH revised its data reporting policies for such trials.  These more stringent policies are now being implemented, and will affect grant applications submitted in 2018.

Several members of the scientific community have begun to voice their concern about the changes.  The Association for Psychological Science (APS) and Federation of Associations in Behavioral & Brain Sciences (FABBS) have both sent critical letters to the NIH. A petition by neuroscience researchers pushing back against the policy has garnered over 3,400 signatures.  Opponents argue that the requirements imposed by the ‘clinical trial’ label are overly burdensome and would impede basic research.  These requirements include timely study registration and public disclosure of results through ClinicalTrials.gov. Further, they demand that all staff receive Good Clinical Practices training. Investigators dread the bureaucracy that will be involved in complying with these mandates.  Perhaps most concerning for scientists is the constraint that new proposals must respond to a Funding Opportunity Announcement, which have specific stipulations about study objectives, design, oversight, and evaluation.  While these rules are intended to promote scientific rigor and transparency, the more immediate effects may be to stifle exploration and creativity and to deter basic researchers who may not know how to tailor their applications to reflect clinical values.

For its part, the NIH is steadfast that the broad redefinition is ‘intentional’ and that current standards of data reporting are ‘unacceptable’.  Policymakers argue that they are simply asking scientists to inform the public about the existence and outcome of their research.  While this sounds unimpeachable in theory, scientists are already reporting practical challenges: for example, asking potential study participants to sign a clinical trial consent form can scare them away.  While the NIH is making efforts to provide guidance to the community, it is running out of time to stamp out confusion before next January, let alone achieve enthusiastic compliance.  Neuroscientists are likely to face setbacks in funding and progress as a result.

(Sara Reardon, Nature News)

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Written by sciencepolicyforall

September 12, 2017 at 5:52 pm

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