November 09 | 2020
Biden’s Administration Should Immediately Prioritize These Five Pandemic Tasks
Dr. Adalja is focused on emerging infectious disease, pandemic preparedness, and biosecurity. He has served on US government panels tasked with developing guidelines for the treatment of plague, botulism, and anthrax in mass casualty settings and the system of care for infectious disease emergencies, and as an external advisor to the New York City Health and Hospital Emergency Management Highly Infectious Disease training program, as well as on a FEMA working group on nuclear disaster recovery. Dr. Adalja is an Associate Editor of the journal Health Security. He was a coeditor of the volume Global Catastrophic Biological Risks, a contributing author for the Handbook of Bioterrorism and Disaster Medicine, the Emergency Medicine CorePendium, Clinical Microbiology Made Ridiculously Simple, UpToDate's section on biological terrorism, and a NATO volume on bioterrorism. He has also published in such journals as the New England Journal of Medicine, the Journal of Infectious Diseases, Clinical Infectious Diseases, Emerging Infectious Diseases, and the Annals of Emergency Medicine. He is a board-certified physician in internal medicine, emergency medicine, infectious diseases, and critical care medicine. Follow him on Twitter: @AmeshAA
Democratic U.S. presidential nominee and former Vice President Joe Biden puts his face mask back on after answering questions following a speech on the effects on the U.S. economy of the Trump administration's response to the coronavirus disease (COVID-19) pandemic during a campaign event in Wilmington, Delaware, U.S., September 4, 2020.
REUTERS/Kevin Lamarque
The response to the COVID-19 pandemic will soon become the responsibility of President-elect Biden. As is clear to anyone who honestly looks, the past 10+ months of this pandemic have been a disastrous litany of mistakes, wrong actions, and misinformation.
The result has been the deaths of 240,000 Americans, economic collapse, disruption of routine healthcare, and inability of Americans to pursue their values without fear of contracting or spreading a deadly infectious disease. With the looming change in administration, many proposals will be suggested for the path forward.
Indeed, the Biden campaign published their own plan. This plan encompasses many of the actions my colleagues and I in the public health and infectious disease fields have been arguing for since January. Several of these points, I think, bear emphasis and should be aggressively pursued to help the U.S. emerge from the pandemic.
Support More and Faster Tests
When it comes to an infectious disease outbreak the most basic question that must be answered in any response is: "Who is infected and who is not?" Even today this simple question is not easy to answer because testing issues continue to plague us and there are voices who oppose more testing -- as if by not testing, the cases of COVID cease to exist. While testing is worlds better than it was in March – especially for hospital inpatients – it is still a process fraught with unnecessary bureaucracy and delays in the outpatient setting.
Just this past week, friends and colleagues have had to wait days upon days to get a result back, all the while having to self-quarantine pending the result. This not only leaves people in limbo, it discourages people from being tested, and renders contact tracing almost moot. A test that results in several days is almost useless to contact tracers as Bill Gates has forcefully argued.
We need more testing and more actionable rapid turn-around tests. These tests need to be deployed in healthcare facilities and beyond. Ideally, these tests should be made available for individuals to conduct on themselves at home. For some settings, such as at home, rapid antigen tests similar to those used to detect pregnancy will be suitable; for other settings, like at a doctor's office or a hospital, more elaborate PCR tests will still be key. These last have been compromised for several months due to rationing of the reagent supplies necessary to perform the test – an unacceptable state of affairs that cannot continue. Reflecting an understanding of the state of play of testing, the President-elect recently stated: "We need to increase both lab-based diagnostic testing, with results back within 24 hours or less, and faster, cheaper screening tests that you can take right at home or in school."
Roll Out Safe and Effective Vaccine(s)
Biden's plan also identifies the need to "accelerate the development of treatments and vaccines" and indeed Operation Warp Speed has been one solitary bright spot in the darkness of the failed pandemic response. It is this program that facilitated a distribution partnership with Pfizer for 100 million doses of its mRNA vaccine -- whose preliminary, and extremely positive data, was just announced today to great excitement.
Operation Warp Speed needs to be continued so that we can ensure the final development and distribution of the first-generation vaccines and treatments. When a vaccine is available, it will be a Herculean task that will span many months to actually get into the arms (twice as a 2-dose vaccine) of Americans. Vaccination may begin for healthcare workers before a change in administration, but it will continue long into 2021 and possibly longer. Vaccine distribution will be a task that demands a high degree of competence and coordination, especially with the extreme cold storage conditions needed for the vaccines.
Anticipate the Next Pandemic Now
Not only should Operation Warp Speed be supported, it needs to be expanded. For too long pandemic preparedness has been reactive and it is long past time to approach the development of medical countermeasures for pandemic threats in a proactive fashion.
What we do for other national security threats should be the paradigm for infectious disease threats that too often are subject to a mind-boggling cycle of panic and neglect. There are an estimated 200 outbreaks of viral diseases per year. Luckily and because of hard work, for many of them we have tools at our hands to control them, but for the unknown 201st virus outbreak we do not –as we've seen this year. And, the next unknown virus will likely appear soon. A new program must be constructed guaranteeing that we will never again be caught blindsided and flatfooted as we have been with the COVID-19 pandemic.
A new dedicated "Virus 201" strategy, program, and funding must be created to achieve this goal. This initiative should be a specific program focused on unknown threats that emanate from identified classes of pathogens that possess certain pandemic-causing characteristics. For example, such a program could leverage new powerful vaccine platform technologies to begin development on vaccine candidates for a variety of viral families before they emerge as full-fledged threats. Imagine how different our world would be today if this action was taken after SARS in 2003 or even MERS in 2012.
Biden should remove the handcuffs from the Centers for Disease Control and Prevention (CDC) and allow its experts to coordinate the national response and to issue guidance in the manner they were constituted to do without fear of political reprisal.
Resurrect Expertise
One of the most disheartening aspects of the pandemic has been the denigration and outright attacks on experts in infectious disease. Such disgusting attacks were not for any flaws, incompetence, or weakness but for their opposite -- strength and competence – and emanated from a desire to evade the grim reality. Such nihilism must end and indeed the Biden plan contains several crucial remedies, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense, a crucial body of experts at the White House that the Trump administration bafflingly eliminated in 2018.
Additionally, Biden should remove the handcuffs from the Centers for Disease Control and Prevention (CDC) and allow its experts to coordinate the national response and to issue guidance in the manner they were constituted to do without fear of political reprisal.
Shore Up Hospital Capacity
For the foreseeable future, as control of the virus slips away in certain parts of the country, hospital capacity will be the paramount concern. Unlike many other industries, the healthcare sector is severely constrained in its ability to expand capacity because of regulatory and financial considerations. Hospital emergency preparedness has never been prioritized and until we can substantially curtail the spread of this virus, hospitals must remain vigilant.
We have seen how suspensions of "elective" procedures led to alarming declines in vital healthcare services that range from childhood immunization to cancer chemotherapy to psychiatric care. This cannot be allowed to happen again. Hospitals will need support in terms of staffing, alternative care sites, and personal protective equipment. Reflecting these concerns, the Biden plan outlines an approach that smartly uses the Departments of Defense and Veterans Affairs assets and medical reserve corps, coupled to the now-flourishing telemedicine innovations, to augment capacity and forestall the need for hospitals to shift to crisis standards of care.
To these five tasks, I would add a long list of subtasks that need to be executed by agencies such as the Centers for Medicare and Medicaid, the Food and Drug Administration, and many other arms of government. But, to me, these are the most crucial.
***
As COVID-19 has demonstrated, new deadly viruses can spread quickly and easily around the globe, causing significant loss of life and economic ruin. With nearly 200 epidemics occurring each year, the next fast-moving, novel infectious disease pandemic could be right around the corner.
The upcoming transition affords the opportunity to implement a new paradigm in pandemic response, biosecurity, and emerging disease response. The United States and President-elect Biden must work hard to to end this pandemic and increase the resilience of the United States to the future infectious disease threats we will surely face.
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Dr. Adalja is focused on emerging infectious disease, pandemic preparedness, and biosecurity. He has served on US government panels tasked with developing guidelines for the treatment of plague, botulism, and anthrax in mass casualty settings and the system of care for infectious disease emergencies, and as an external advisor to the New York City Health and Hospital Emergency Management Highly Infectious Disease training program, as well as on a FEMA working group on nuclear disaster recovery. Dr. Adalja is an Associate Editor of the journal Health Security. He was a coeditor of the volume Global Catastrophic Biological Risks, a contributing author for the Handbook of Bioterrorism and Disaster Medicine, the Emergency Medicine CorePendium, Clinical Microbiology Made Ridiculously Simple, UpToDate's section on biological terrorism, and a NATO volume on bioterrorism. He has also published in such journals as the New England Journal of Medicine, the Journal of Infectious Diseases, Clinical Infectious Diseases, Emerging Infectious Diseases, and the Annals of Emergency Medicine. He is a board-certified physician in internal medicine, emergency medicine, infectious diseases, and critical care medicine. Follow him on Twitter: @AmeshAA
November 30 | 2022
Sexually Transmitted Infections are on the rise. This drug could stop them.
Cases of gonorrhea, chlamydia and syphilis soared last year, but researchers are finding that a drug known as doxy seems to reduce the number of infections.
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Sexually transmitted infections (STIs) are surging across the U.S. to 2.5 million cases in 2021 according to preliminary data from the CDC. A new prevention and treatment strategy now in clinical trials may provide a way to get a handle on them.
It's easy to overlook the soaring rates of gonorrhea, chlamydia, and syphilis because most of those infections have few or no symptoms and can be identified only through testing. But left untreated, they can lead to serious damage to nerves and tissue, resulting in infertility, blindness, and dementia. Infants developing in utero are particularly vulnerable.
Covid-19 played havoc with regular medical treatment and preventive care for many health problems, including STIs. After formal lockdowns ended, many people gradually became more socially engaged, with increases in sexual activity, and may have prioritized these activities over getting back in touch with their doctors.
A second blow to controlling STIs is that family planning clinics are closing left and right because of the Dobbs decision and legislation in many states that curtailed access to an abortion. Discussion has focused on abortion, but those same clinics also play a vital role in the diagnosis and treatment of STIs.
Routine public health is the neglected stepchild of medicine. It is called upon in times of crisis but as that crisis resolves, funding dries up. Labs have atrophied and personnel have been redirected to Covid, “so access to routine screening for STIs has been decimated,” says Jennifer Mahn, director of sexual and clinical health with the National Coalition of STD Directors.
A preview of what we likely are facing comes from Iowa. In 2017, the state legislature restricted funding to family health clinics in four counties, which closed their doors. A year later the statewide rate of gonorrhea skyrocketed from 83 to 153.7 cases per 100,000 people. “Iowa counties with clinic closures had a significantly larger increase,” according to a study published in JAMA. That scenario likely is playing out in countless other regions where access to sexual health care is shrinking; it will be many months before we have the data to know for sure.
A decades-old antibiotic finds a new purpose
Using drugs to protect against HIV, either as post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP), has proven to be quite successful. Researchers wondered if the same approach might be applied to other STIs. They focused on doxycycline, or doxy for short. One of the most commonly prescribed antibiotics in the U.S., it’s a member of the tetracycline family that has been on the market since 1967. It is so safe that it’s used to treat acne.
Two small studies using doxy suggested that it could work to prevent STIs. A handful of clinical trials by different researchers and funding sources set out to generate the additional evidence needed to prove their hypothesis and change the standard of care.
Senior researcher Victor Omollo, with the Kenya Medical Research Institute, noted, “These are prevention interventions that women can control on their own without having to seek or get consent from another person,” as is the case with condom use.
The first with results is the DoxyPEP study, conducted at two sexual health clinics in San Francisco and Seattle. It drew from a mix of transgender women and men who have sex with men, who had at least one diagnosed STI over the last year. The researchers divided the participants into two groups: one with people who were already HIV-positive and engaged in care, while the other group consisted of people who were on PrEP to prevent infection with HIV. For the active part of the study, a subset of the participants received doxy, and the rest of the participants did not.
The researchers intentionally chose to do the study in a population at the highest risk of having STIs, who were very health oriented, and “who were getting screened every three months or so as part of their PrEP program or their HIV care program,” says Connie Celum, a senior researcher at the University of Washington on the study.
Each member of the active group was given a supply of doxy and asked to take two pills within 72 hours of having sex where a condom was not used. The study was supposed to run for two years but, in May, it stopped halfway through, when a safety monitoring board looked at the data and recommended that it would be unethical to continue depriving the control group of the drug’s benefits.
Celum presented these preliminary results from the DoxyPEP study in July at the International AIDS Conference in Montreal. “We saw about a 56 percent reduction in gonorrhea, about 80 percent reduction in chlamydia and syphilis, so very significant reductions, and this is on a per quarter basis,” she told a later webinar.
In Kenya, another study is following a group of cisgender women who are taking the same two-pill regimen to prevent HIV, and the data from this research should become available in 2023. Senior researcher Victor Omollo, with the Kenya Medical Research Institute, noted that “these are prevention interventions that women can control on their own without having to seek or get consent from another person,” as is the case with condom use, another effective prevention tool.
Antibiotic resistance
Antibiotic resistance is a potentially big concern. About 25 percent of gonorrhea strains circulating in the U.S. are resistant to the tetracycline class of drugs, including doxy; rates are higher elsewhere. But resistance often is a matter of degree and can be overcome with a larger or longer dose of the drug, or perhaps with a switch to another drug or a two-drug combination.
Research has shown that an established bacterial infection is more difficult to treat because it is part of a biofilm, which can leave only a small portion or perhaps none of the cell surface exposed to a drug. But a new infection, even one where the bacteria is resistant to a drug, might still be vulnerable to that drug if it's used before the bacterial biofilm can be established. Preliminary data suggests that may be the case with doxyPEP and drug resistant gonorrhea; some but not all new drug resistant infections might be thwarted if they’re treated early enough.
“There are some tradeoffs” to these interventions, Celum says, and people may disagree on the cost of increased resistance balanced against the benefits of treating the STIs and reducing their spread within the community.
Resistance does not seem to be an issue yet for chlamydia and syphilis even though doxy has been a recommended treatment for decades, but a remaining question is whether broader use of doxy will directly worsen antibiotic resistance in gonorrhea, or promote it in other STIs. And how will it affect the gut microbiome?
In addition, Celum notes that we need to understand whether doxy will generate mutations in other bacteria that might contribute to drug resistance for gonorrhea, chlamydia or syphilis. The studies underway aim to provide data to answer these questions.
“There are some tradeoffs” to these interventions, Celum says, and people may disagree on the cost of increased resistance balanced against the benefits of treating the STIs and reducing their spread within the community. That might affect doctors' willingness to prescribe the drug.
Turning research into action
The CDC makes policy recommendations for prevention services such as taking doxy, requiring some and leaving others optional. Celum says the CDC will be reviewing information from her trial at a meeting in December, but probably will wait until that study is published before making recommendations, likely in 2023. The San Francisco Department of Public Health issued its own guidance on October 20th and anecdotally, some doctors around the country are beginning to issue prescriptions for doxy to select patients.
About half of new STIs occur in young people ages 15 to 24, a group that is least likely to regularly see a doctor. And sexual health remains a great taboo for many people who don't want such information on their health record for prying parents, employers or neighbors to find out.
“People will go out of their way and travel extensive distances just to avoid that,” says Mahn, the National Coalition director. “People identify locations where they feel safe, where they feel welcome, where they don't feel judged,” Mahn explains, such as community and family planning clinics. They understand those issues and have fees that vary depending on a person’s ability to pay.
Given that these clinics already are understaffed and underfunded, they will be hard pressed to expand services covering the labor intensive testing and monitoring of a doxyPEP regimen. Sexual health clinics don't even have a separate line item in the federal budget for health. That is something the National Association of STI Directors is pushing for in D.C.
DoxyPEP isn't a panacea, and it isn't for everyone. “We really want to try to reach that population who is most likely going to have an STI in the next year,” says Celum, “Because that's where you are going to have the biggest impact.”
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Bob Roehr is a biomedical journalist based in Washington, DC. Over the last twenty-five years he has written extensively for The BMJ, Scientific American, PNAS, Proto, and myriad other publications. He is primarily interested in HIV, infectious disease, immunology, and how growing knowledge of the microbiome is changing our understanding of health and disease. He is working on a book about the ways the body can at least partially control HIV and how that has influenced (or not) the search for a treatment and cure.
November 25 | 2022
The Friday Five: The plain solution to holiday stress?
In this week's Friday Five, research on how to improve your working memory, the plain old solution to stress, rise of the robot surgeon, tomato brain power, the gut connection to health after strokes - and more.
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The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
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Here are the promising studies covered in this week's Friday Five:
- How to improve your working memory
- A plain old solution to stress
- Progress on a deadly cancer for first time since 1995*
- Rise of the robot surgeon
- Tomato brain power
And in an honorable mention this week, new research on the gut connection to better brain health after strokes.
* The methodology for this study has come under scrutiny here.
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Matt Fuchs is the host of the Making Sense of Science podcast and served previously as the editor-in-chief of Leaps.org. He writes as a contributor to the Washington Post, and his articles have also appeared in the New York Times, WIRED, Nautilus Magazine, Fortune Magazine and TIME Magazine. Follow him @fuchswriter.