Bad Actors Getting Your Health Data Is the FBI’s Latest Worry
In February 2015, the health insurer Anthem revealed that criminal hackers had gained access to the company's servers, exposing the personal information of nearly 79 million patients. It's the largest known healthcare breach in history.
FBI agents worry that the vast amounts of healthcare data being generated for precision medicine efforts could leave the U.S. vulnerable to cyber and biological attacks.
That year, the data of millions more would be compromised in one cyberattack after another on American insurers and other healthcare organizations. In fact, for the past several years, the number of reported data breaches has increased each year, from 199 in 2010 to 344 in 2017, according to a September 2018 analysis in the Journal of the American Medical Association.
The FBI's Edward You sees this as a worrying trend. He says hackers aren't just interested in your social security or credit card number. They're increasingly interested in stealing your medical information. Hackers can currently use this information to make fake identities, file fraudulent insurance claims, and order and sell expensive drugs and medical equipment. But beyond that, a new kind of cybersecurity threat is around the corner.
Mr. You and others worry that the vast amounts of healthcare data being generated for precision medicine efforts could leave the U.S. vulnerable to cyber and biological attacks. In the wrong hands, this data could be used to exploit or extort an individual, discriminate against certain groups of people, make targeted bioweapons, or give another country an economic advantage.
Precision medicine, of course, is the idea that medical treatments can be tailored to individuals based on their genetics, environment, lifestyle or other traits. But to do that requires collecting and analyzing huge quantities of health data from diverse populations. One research effort, called All of Us, launched by the U.S. National Institutes of Health last year, aims to collect genomic and other healthcare data from one million participants with the goal of advancing personalized medical care.
Other initiatives are underway by academic institutions and healthcare organizations. Electronic medical records, genetic tests, wearable health trackers, mobile apps, and social media are all sources of valuable healthcare data that a bad actor could potentially use to learn more about an individual or group of people.
"When you aggregate all of that data together, that becomes a very powerful profile of who you are," Mr. You says.
A supervisory special agent in the biological countermeasures unit within the FBI's weapons of mass destruction directorate, it's Mr. You's job to imagine worst-case bioterror scenarios and figure out how to prevent and prepare for them.
That used to mean focusing on threats like anthrax, Ebola, and smallpox—pathogens that could be used to intentionally infect people—"basically the dangerous bugs," as he puts it. In recent years, advances in gene editing and synthetic biology have given rise to fears that rogue, or even well-intentioned, scientists could create a virulent virus that's intentionally, or unintentionally, released outside the lab.
"If a foreign source, especially a criminal one, has your biological information, then they might have some particular insights into what your future medical needs might be and exploit that."
While Mr. You is still tracking those threats, he's been traveling around the country talking to scientists, lawyers, software engineers, cyber security professionals, government officials and CEOs about new security threats—those posed by genetic and other biological data.
Emerging threats
Mr. You says one possible situation he can imagine is the potential for nefarious actors to use an individual's sensitive medical information to extort or blackmail that person.
"If a foreign source, especially a criminal one, has your biological information, then they might have some particular insights into what your future medical needs might be and exploit that," he says. For instance, "what happens if you have a singular medical condition and an outside entity says they have a treatment for your condition?" You could get talked into paying a huge sum of money for a treatment that ends up being bogus.
Or what if hackers got a hold of a politician or high-profile CEO's health records? Say that person had a disease-causing genetic mutation that could affect their ability to carry out their job in the future and hackers threatened to expose that information. These scenarios may seem far-fetched, but Mr. You thinks they're becoming increasingly plausible.
On a wider scale, Kavita Berger, a scientist at Gryphon Scientific, a Washington, D.C.-area life sciences consulting firm, worries that data from different populations could be used to discriminate against certain groups of people, like minorities and immigrants.
For instance, the advocacy group Human Rights Watch in 2017 flagged a concerning trend in China's Xinjiang territory, a region with a history of government repression. Police there had purchased 12 DNA sequencers and were collecting and cataloging DNA samples from people to build a national database.
"The concern is that this particular province has a huge population of the Muslim minority in China," Ms. Berger says. "Now they have a really huge database of genetic sequences. You have to ask, why does a police station need 12 next-generation sequencers?"
Also alarming is the potential that large amounts of data from different groups of people could lead to customized bioweapons if that data ends up in the wrong hands.
Eleonore Pauwels, a research fellow on emerging cybertechnologies at United Nations University's Centre for Policy Research, says new insights gained from genomic and other data will give scientists a better understanding of how diseases occur and why certain people are more susceptible to certain diseases.
"As you get more and more knowledge about the genomic picture and how the microbiome and the immune system of different populations function, you could get a much deeper understanding about how you could target different populations for treatment but also how you could eventually target them with different forms of bioagents," Ms. Pauwels says.
Economic competitiveness
Another reason hackers might want to gain access to large genomic and other healthcare datasets is to give their country a leg up economically. Many large cyber-attacks on U.S. healthcare organizations have been tied to Chinese hacking groups.
"This is a biological space race and we just haven't woken up to the fact that we're in this race."
"It's becoming clear that China is increasingly interested in getting access to massive data sets that come from different countries," Ms. Pauwels says.
A year after U.S. President Barack Obama conceived of the Precision Medicine Initiative in 2015—later renamed All of Us—China followed suit, announcing the launch of a 15-year, $9 billion precision health effort aimed at turning China into a global leader in genomics.
Chinese genomics companies, too, are expanding their reach outside of Asia. One company, WuXi NextCODE, which has offices in Shanghai, Reykjavik, and Cambridge, Massachusetts, has built an extensive library of genomes from the U.S., China and Iceland, and is now setting its sights on Ireland.
Another Chinese company, BGI, has partnered with Children's Hospital of Philadelphia and Sinai Health System in Toronto, and also formed a collaboration with the Smithsonian Institute to sequence all species on the planet. BGI has built its own advanced genomic sequencing machines to compete with U.S.-based Illumina.
Mr. You says having access to all this data could lead to major breakthroughs in healthcare, such as new blockbuster drugs. "Whoever has the largest, most diverse dataset is truly going to win the day and come up with something very profitable," he says.
Some direct-to-consumer genetic testing companies with offices in the U.S., like Dante Labs, also use BGI to process customers' DNA.
Experts worry that China could race ahead the U.S. in precision medicine because of Chinese laws governing data sharing. Currently, China prohibits the exportation of genetic data without explicit permission from the government. Mr. You says this creates an asymmetry in data sharing between the U.S. and China.
"This is a biological space race and we just haven't woken up to the fact that we're in this race," he said in January at an American Society for Microbiology conference in Washington, D.C. "We don't have access to their data. There is absolutely no reciprocity."
Protecting your data
While Mr. You has been stressing the importance of data security to anyone who will listen, the National Academies of Sciences, Engineering, and Medicine, which makes scientific and policy recommendations on issues of national importance, has commissioned a study on "safeguarding the bioeconomy."
In the meantime, Ms. Berger says organizations that deal with people's health data should assess their security risks and identify potential vulnerabilities in their systems.
As for what individuals can do to protect themselves, she urges people to think about the different ways they're sharing healthcare data—such as via mobile health apps and wearables.
"Ask yourself, what's the benefit of sharing this? What are the potential consequences of sharing this?" she says.
Mr. You also cautions people to think twice before taking consumer DNA tests. They may seem harmless, he says, but at the end of the day, most people don't know where their genetic information is going. "If your genetic sequence is taken, once it's gone, it's gone. There's nothing you can do about it."
Sept. 13th Event: Delta, Vaccines, and Breakthrough Infections
This virtual event will convene leading scientific and medical experts to address the public's questions and concerns about COVID-19 vaccines, Delta, and breakthrough infections. Audience Q&A will follow the panel discussion. Your questions can be submitted in advance at the registration link.
DATE:
Monday, September 13th, 2021
12:30 p.m. - 1:45 p.m. EDT
REGISTER:
Dr. Amesh Adalja, M.D., FIDSA, Senior Scholar, Johns Hopkins Center for Health Security; Adjunct Assistant Professor, Johns Hopkins Bloomberg School of Public Health; Affiliate of the Johns Hopkins Center for Global Health. His work is focused on emerging infectious disease, pandemic preparedness, and biosecurity.
Dr. Nahid Bhadelia, M.D., MALD, Founding Director, Boston University Center for Emerging Infectious Diseases Policy and Research (CEID); Associate Director, National Emerging Infectious Diseases Laboratories (NEIDL), Boston University; Associate Professor, Section of Infectious Diseases, Boston University School of Medicine. She is an internationally recognized leader in highly communicable and emerging infectious diseases (EIDs) with clinical, field, academic, and policy experience in pandemic preparedness.
Dr. Akiko Iwasaki, Ph.D., Waldemar Von Zedtwitz Professor of Immunobiology and Molecular, Cellular and Developmental Biology and Professor of Epidemiology (Microbial Diseases), Yale School of Medicine; Investigator, Howard Hughes Medical Institute. Her laboratory researches how innate recognition of viral infections lead to the generation of adaptive immunity, and how adaptive immunity mediates protection against subsequent viral challenge.
Dr. Marion Pepper, Ph.D., Associate Professor, Department of Immunology, University of Washington. Her lab studies how cells of the adaptive immune system, called CD4+ T cells and B cells, form immunological memory by visualizing their differentiation, retention, and function.
This event is the third of a four-part series co-hosted by Leaps.org, the Aspen Institute Science & Society Program, and the Sabin–Aspen Vaccine Science & Policy Group, with generous support from the Gordon and Betty Moore Foundation and the Howard Hughes Medical Institute.
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
Don't Panic Over Waning Antibodies. Here's Why.
Since the Delta variant became predominant in the United States on July 7, both scientists and the media alike have been full of mixed messages ("breakthrough infections rare"; "breakthrough infections common"; "vaccines still work"; "vaccines losing their effectiveness") but – if we remember our infectious diseases history- one thing remains clear: immunity is the only way to get through a pandemic.
What Happened in the Past
The 1918 influenza pandemic was far the deadliest respiratory virus pandemic recorded in recent human history with over 50 million deaths (maybe even 100 million deaths, or 3% of the world's population) worldwide. Although they used some of the same measures we are using now (masks, distancing, event closures, as neither testing nor a vaccine existed back then), the deaths slowed only after enough of the population had either acquired immunity through natural infection or died. Indeed, the first influenza vaccine was not developed until 1942, more than 20 years later. As judged by the amount of suffering and death from 1918 influenza (and the deadly Delta surge in India in spring 2021), natural immunity is obviously a terrible way to get through a pandemic.
Similarly, measles was a highly transmissible respiratory virus that led to high levels of immunity among adults who were invariably exposed as children. However, measles led to deaths each year among the nonimmune until a vaccine was developed in 1963, largely restricting current measles outbreaks in the U.S. now to populations who decline to vaccinate. Smallpox also led to high levels of immunity through natural infection, which was often fatal. That's why unleashing smallpox on a largely nonimmune population in the New World was so deadly. Only an effective vaccine – and its administration worldwide, including among populations who declined smallpox vaccine at first via mandates – could control and then eventually eradicate smallpox from Earth.
Fully vaccinated people are already now able to generate some antibodies against all the variants we know of to date, thanks to their bank of memory B cells.
The Delta variant is extremely transmissible, making it unlikely we will ever eliminate or eradicate SARS-CoV-2. Even Australia, which had tried to maintain a COVID-zero nation with masks, distancing, lockdowns, testing and contact tracing before and during the vaccines, ended a strategy aimed at eliminating COVID-19 this week. But, luckily, since highly effective and safe vaccines were developed for COVID-19 less than a year after its advent on a nonimmune population and since vaccines are retaining their effectiveness against severe disease, we have a safe way out of the misery of this pandemic: more and more immunity. "Defanging" SARS-CoV-2 and stripping it of its ability to cause severe disease through immunity will relegate it to the fate of the other four circulating cold-causing coronaviruses, an inconvenience but not a world-stopper.
Immunity Is More Than Antibodies
When we say immunity, we have to be clear that we are talking about cellular immunity and immune memory, not only antibodies. This is a key point. Neutralizing antibodies, which prevent the virus from entering our cells, are generated by the vaccines. But those antibodies will necessarily wane over time since we cannot keep antibodies from every infection and vaccine we have ever seen in the bloodstream (or our blood would be thick as paste!). Vaccines with shorter intervals between doses (like Pfizer vaccines given 3 weeks apart) are likely to have their antibodies wane sooner than vaccines with longer intervals between doses (like Moderna), making mild symptomatic breakthroughs less likely with the Moderna vaccine than the Pfizer during our Delta surge, as a recent Mayo Clinic study showed.
Luckily, the vaccines generate B cells that get relegated to our memory banks and these memory B cells are able to produce high levels of antibodies to fight the virus if they see it again. Amazingly, these memory B cells will actually produce antibodies adapted against the COVID variants if they see a variant in the future, rather than the original antibodies directed against the ancestral strain. This is because memory B cells serve as a blueprint to make antibodies, like the blueprint of a house. If a house needs an extra column (or antibodies need to evolve to work against variants), the blueprint will oblige just as memory B cells will!
One problem with giving a 3rd dose of our current vaccines is that those antibodies won't be adapted towards the variants. Fully vaccinated people are already now able to generate some antibodies against all the variants we know of to date, thanks to their bank of memory B cells. In other words, no variant has evolved to date that completely evades our vaccines. Memory B cells, once generated by either natural infection or vaccination, should be long-lasting.
If memory B cells are formed by a vaccine, they should be as long-lasting as those from natural infection per various human studies. A 2008 Nature study found that survivors of the 1918 influenza pandemic were able to produce antibodies from memory B cells when exposed to the same influenza strain nine decades later. Of note, mild infections (such as the common cold from the cold-causing coronaviruses called 229E, NL63, OC43, and HKU1) may not reliably produce memory B cell immunity like more severe infections caused by SARS-CoV-2.
Right about now, you may be worrying about a super-variant that might yet emerge to evade all our hard-won immune responses. But most immunologists do not think this is very realistic because of T cells. How are T cells different from B Cells? While B cells are like the memory banks to produce antibodies when needed (helped by T cells), T cells will specifically amplify in response to a piece of the virus and help recruit cells to attack the pathogen directly. We likely have T cells to thank for the vaccine's incredible durability in protecting us against severe disease. Data from La Jolla Immunology Institute and UCSF show that the T cell response from the Pfizer vaccine is strong across all the variants.
Think of your spike protein as being comprised of 100 houses with a T cell there to cover each house (to protect you against severe disease). The variants have around 13 mutations along the spike protein so 13 of those T cells won't work, but there are over 80 T cells remaining to protect your "houses" or your body against severe disease.
Although these are theoretical numbers and we don't know exactly the number of T cell antigens (or "epitopes") across the spike protein, one review showed 1400 across the whole virus, with many of those in the spike protein. Another study showed that there were 87 epitopes across the spike protein to which T cells respond, and mutations in one of the variants (beta) took those down to 75. The virus cannot mutate indefinitely in its spike protein and still retain function. This is why it is unlikely we will get a variant that will evade the in-breadth, robust response of our T cells.
Where We Go From Here
So, what does this mean for getting through this pandemic? Immunity and more immunity. For those of us who are vaccinated, if we get exposed to the Delta variant, it will boost our immune response although the memory B cells might take 3-5 days to make new antibodies, which can leave us susceptible to a mild breakthrough infection. That's part of the reason the CDC put back masks for the vaccinated in late July. For those who are unvaccinated, immunity will be gained from Delta but often through terrible ways like severe disease.
The way for the U.S. to determine the need for 3rd shots among those who are not obviously immunocompromised, given the amazing immune memory generated by the vaccines among immunocompetent individuals, is to analyze the cases of the ~6000 individuals who have had severe breakthrough infections among the 171 million Americans fully vaccinated. Define their co-morbidities and age ranges, and boost those susceptible to severe infections (examples could include older people, those with co-morbidities, health care workers, and residents of long-term care facilities). This is an approach likely to be taken by the CDC's Advisory Committee on Immunization Practices.
If immunity is the only way to get through the pandemic and if variants are caused mostly by large populations being unvaccinated, there is not only a moral and ethical imperative but a practical imperative to vaccinate the world in order to keep us all safe. Immunocompetent Americans can boost their antibodies, which may enhance their ability to avoid mild breakthrough infections, but the initial shots still work well against the most important outcomes: hospitalizations and deaths.
There has been no randomized, controlled trial to assess whether three shots vs. two shots meaningfully improve those outcomes. While we ought to trust immune memory to get the immunocompetent in the United States through, we can hasten the end of this pandemic by providing surplus vaccines to poor countries to combat severe disease. Doing so would not only revitalize the role of the U.S. as a global health leader – it would save countless lives.