The US Food and Drug Administration is working hard toward a 21st century roadmap on alternative testing methods and antibiotics for human sexually transmitted infections
Although there is no set timeline, FDA officials say the programme is a priority. It would be funded from US$5 million it has requested as part of its 2023 budget to develop a ‘comprehensive strategy’ on alternative testing methods. Paul Locke, an environmental health scientist and lawyer at the University of Baltimore who specializes in alternatives to animal testing, says that the FDA is taking a critical step towards making sure the US government stays up to speed with the latest science. He is excited about what the FDA is doing. “They’ve put a stake in the ground and said, ‘Hey, we want to be there using these tools, they’re consistent with our mission and they’re consistent with what twenty-first-century science looks like.’”
“A key for bringing about change is to do so among the multiple major regulatory agencies,” says David Strauss, director of the FDA’s Division of Applied Regulatory Science. Drugdevelopment programmes are global and companies want to sell their products in many countries around the world.
He says there is a lot of moving pieces. “The FDA has started the ball rolling, but we need more work to make sure we can use these new methodologies appropriately.”
Researchers are sweeping beaches and using satellites to gather data that will support a landmark anti-plastic pollution treaty. There are preventive antibiotics for sexually transmitted infections and the future of animal-to-human transplants.
A health department in the United States has become one of the first to recommend that people who are at high risk of getting a sexually transmitted infection (STI) take a preventive dose of antibiotics after unprotected sex. There are studies that show the strategy can reduce sexually transmitted infections. Some scientists fear it will contribute to antibiotic resistance. Guidelines about use are important because they inform people about the safety of a strategy they are already using. The tool should be accessible if it makes sense for people, says Jenell Stewart.
The number of deaths from bug infections was close to 8 million in 2019, making them the second biggest killer after heart disease. Death rates differed widely by region, from 230 deaths per 100,000 people in sub-Saharan Africa to 52 deaths per 100,000 across western Europe, North America and Australasia. “These new data for the first time reveal the full extent of the global public health challenge posed by bacterial infections,” says study co-author Christopher Murray.
Incentives for climate change: the first pig organ transplant trials and how to get the most out of the waiting list for organ transplants
In the wake of the 27th United Nations climate conference (COP27) in Egypt, diplomats, activists and scientists are pondering how to make such events more impactful. Some stakeholders suggest that COPs could focus less on targets and more on how to incentivize drastic reductions in greenhouse-gas emissions, with rich countries leading the way.
The first pig organ transplant trials this year have raised the expectations for other transplants. In January, a man who was too ill to qualify for a human or artificial heart was granted emergency authorization to receive a pig heart. He lived for almost two months after the procedure. Other tests have seen genetically modified pig kidneys transferred into people who had been declared legally dead. Proponents of more clinical trials think that xenotransplantation can help to get more people on the waiting list for organ transplants. “I think we need to take that step forward and go to the clinic,” says transplant surgeon Wayne Hawthorne. But the mood is cautious. If there is a problem, you can limit the field.
Source: https://www.nature.com/articles/d41586-022-04128-y
When Latour’s Speech About the Plastics Problem in Africa prompted the Nairobi Protocol to be signed by all 50 nations in the 21st century
In March, after nearly 30 years of researchers warning that plastics were a growing global problem, 175 nations voted in Nairobi to create a legally binding international plastics treaty. Negotiations commence in Uruguay on November 28. To ensure that a treaty is effective, we need to know who is responsible for the material that ends up in our mouths. Researchers are contributing by collecting tiny plastic particles from beaches, measuring light -reflecting off debris with satellites and dropping GPS-tagged bottles into India’s Ganges River.
Steve Woolgar wrote about the impact of Bruno Latour in his 1979 book Laboratory Life. Woolgar writes, “He wrote about profound issues with a disarming lightness.” In 2003 at the University of Oxford, a junior researcher tried to point out a logical contradiction in Bruno’s speech. Bruno exclaimed, “But I am French!” to rapturous applause. Latour has died aged 75.
“I think there’s a lot of ‘equity washing’ — if I can invent a term — which really pisses me off,” writes Dolors Armenteras Pascual, a biodiversity conservation researcher in Colombia, in a short, straight-talking call for more equitable partnerships with collaborators from the global north. Nothing changes, because researchers or institutions add superficial, in-name-only equity efforts to their departments. She suggests avoiding tokenism, building long-term collaborations and not being extractive.
Source: https://www.nature.com/articles/d41586-022-04128-y
The HHS Advisory Panel on a Pandemic-Induced Influenza in Microbiology, a Critical Report on the Epidemic and Vaccines
A prototype navigation system overcomes obstacles. The system uses a telecommunications technique known as orthogonal frequency-division multiplexing (OFDM) to combine multiple mobile-phone signals. The transmitters are connected to the optical cables so that they are synchronized.
Gronvall and others also question the report’s recommendation that the HHS evaluate the safety of research involving pathogen surveillance and vaccine development, which are currently exempt from these regulations. “What got us out of the pandemic as quickly as it did was all the scientists who jumped in,” says Michael Imperiale, a microbiologist at the University of Michigan in Ann Arbor. I don’t want to see people jumping through hoops because they want to do important experiments.
The report will be forwarded to the US Department of Health and Human Services when it’s finished, as HHS crafts new guidelines. The level of details will be provided by the HHS. It is not clear when that will happen.
After the acting policy chair of the institute said that rejecting the report would require a new gathering, the panel members unanimously decided to approve the report with modifications. But when or how those modifications would be made, or which of the panel’s many concerns they would address, was not clear.
The agency lifted its ban on research involving certain pathogens in December of 2017: HHS proposed a new framework that extended reviews of research related to the potential to start a flu epidemic. Three projects that involved research into the flu, have gone through the official review process by the HHS.
An epidemiologist at the Harvard T.H. Chan School of Public Health is concerned by that low number. “The big loophole at this stage is that most things never get to the stage of being reviewed,” he says. He points to a study in which a variation of the coronaviruses was inserted into an earlier strain of the virus in order to find out if there was a cause for the death of mice. Neither underwent the HHS’s extended review process.
“Before COVID, we were thinking of [pandemics as] something in the future that may happen,” says Arturo Casadevall, a microbiologist at Johns Hopkins University in Baltimore, Maryland. The amount of damage has been mind blowing.
Source: https://www.nature.com/articles/d41586-023-00257-0
On the role of transparency in NIH-funded research, and what it tells us about the risks and benefits of research done in other countries
The new report’s recommendations include increased transparency in the review process, a role for research institutions in evaluating the risks and benefits of proposed experiments and improved regulation of NIH-funded research performed in other countries.
Lipsitch says this vague wording is useful — after all, scientists don’t always initially know where their research is going to lead. “We’re talking about low-probability, but high-consequence, events,” he says. He remains concerned, though, that the wording could also allow high-risk research to proceed without extended review, depending on how the phrase is interpreted.
On the other hand, Gronvall worries that “reasonably anticipated” could be interpreted so broadly that it could delay a wide swathe of experiments, such as those involved in vaccine development during an outbreak, or even those used in synthetic biology to engineer bacteria so that they produce biomaterials. “Almost all things are dual-use,” she says. “By not doing this research, we’re not making ourselves safer.”
At the NSABB meeting, board member Mark Denison, an infectious-disease expert at Vanderbilt University Medical Center in Nashville, Tennessee, also mentioned the difficulty of determining what experiments could be risky. If identifying the function of a common protein might reveal that a mutation could make it more dangerous, for instance, would that identification constitute a risk? “We need a better definition of gain-of-function,” he said.
Gronvall’s concerns echo those of a separate, 18 January report from the US Government Accountability Office (GAO), which recommended that HHS develop a clear, public standard for what “reasonably anticipated” means. The GAO called for more transparency around the HHS’s evaluation process, and said that the US Centers for Disease Control and Prevention should evaluate whether exemptions for public-health emergencies constitute a risk.
One year ago, the Advanced Research Projects Agency for Health was launched by the administration of US President Joe Biden. The agency, armed with a US$2.5 billion budget, aims to shake up the conventional model of funding biomedical research — which some deem too slow and conservative — by funding high-risk, high-reward projects.
Renee Wegrzyn, who Biden selected to be ARPA-H’s inaugural director, is being closely watched because of her desire to address the concerns and establish the agency’s agenda. The agency will have offices in three locations across the United States, one in the Washington DC area, and two more to be announced later this year.
Scalable Solutions and Resilient Systems in the Early Stages of Medicare: The Phenomenological and Social-Science Challenges at the RHIC
It is an exciting time for us. I am very excited about the fact that our business team is in place. Now we’re bringing our technical team members [such as programme managers] on so that they can really hit the ground running. We finally have the critical mass to be open for business.
Scalable solutions is making sure that we can scale some of the therapies and diagnostics that we intend to pursue, And it is making sure that we reach the American people at scale. Many rural communities are looking at hospital closings because they are closer to a centre of care. How do we get technology into people’s homes?
Proactive health is about keeping people from becoming patients in the first place. Think detection and diagnostics, but also behavioural and social-science innovations that help the person quit smoking, or avoid things we know lead to disease over the long term.
The final area, resilient systems, is thinking at a much broader systems level. The things that can be interwoven to help us be resilient against future crises are not yet known. The investments that we have yet to see at scale in other parts of government.
Source: https://www.nature.com/articles/d41586-023-00817-4
Why should ARPA-H be a catalyst for vaccine development? New Heilmeier questions for programme managers in antiretroviral antiproliferation
mRNA vaccines had initially been developed with research at and funding from the NIH. The vaccine makers Moderna and Pfizer were funded by the Pentagon so that they could speed up getting those to market. It’s a really great example of how an ARPA might be a catalyst. It’s not meant to be the forever funder of these technologies, but that type of resourcing can really just quickly get a health advance to the public and into the hands of the people who need it most. I want to make clear, too, that under no circumstance does moving fast mean compromising on safety or efficacy — that is of utmost importance.
We’re not going to be a grant-based organization. These are cooperative agreements, contracts and other transactional authorities, so that ARPA-H has a seat at the table.
We are more than a copy-paste of the model. We aren’t going to have a conventional peer-review process. The programme manager is going to be the decision-maker. (Programme managers at ARPA-based agencies help to set priorities and see projects through from idea to implementation.) We’ve also adopted the Heilmeier questions. George Heilmeier was an early director of DARPA, and he laid out eight questions that programme managers use to evaluate projects. We have adopted those, but we’ve adapted them to make them unique to us: we’ve added two more questions. One is very focused on cost and accessibility but also user experience, we want to make sure that we don’t create the next device or Diagnostic that will sit on the shelf. How might your new technology be misinterpreted?
The programme manager’s idea from their job talks is something we already know about. They come, and they refine that idea into a full programme with milestones and metrics that we’re going to pursue and announce to the public. The last step before they announce it to the world is to pitch it to me, in the director’s office, and to ask for a bank account. They have to really answer the 10 [fundamental] questions, including, how are you going to address accessibility and cost, and are you helping the patients that stand to benefit the most from your programme? If they can’t answer those questions well, and they don’t have a strategy and a plan for those issues, they don’t get the bank account.