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The following list contains the notes and the known issues that apply for the Flex Appliance 2.1 software:
When you upgrade and commit to version 2.1, the Flex Appliance Console shows an error displaying the node information for a couple minutes after the commit. The error resolves on its own once all services are online. If you see node errors, wait a couple minutes and check again.
During an instance upgrade, an issue can occur that causes the following error to display in the Activity Monitor:
"Create snapshot failed with error exec: Stdout already set"
This issue is fixed in the 2.1.1 update. If you encounter this issue in version 2.1, retry the upgrade. If the problem persists, restart all nodes on the appliance and try again.
When you create an instance or configure a proxy server for Call Home, an issue can occur with the file uploads if you upload a file with incorrect data. If you edit the file to correct the issue and then attempt to upload it again, the upload still fails.
This issue is fixed in the 2.1.1 update. If you encounter this issue in version 2.1, exit the operation and start it again.
The set alerts hardware-threshold command was added this release to set threshold values for alerts. However, alerts are not currently sent for the metrics that can be set with this command.
The support data-collect command may show the following error:
"*** Error in `qaucli': double free or corruption"
This error can be safely disregarded. The command still generates a DataCollect package.
During an instance upgrade on a Veritas 5150 Appliance, the upgrade precheck may fail with the following error message:
"V-492-101-102: Not enough space; request size of 256000 MB is greater than remaining space of <available space> MB. The log volume and the internal data volumes are included in space calculations."
If you encounter this issue, resize one or more of your application instances to make sure that there is 250 GB of available storage space. Then retry the upgrade.
During a firmware upgrade, an issue can occur with the storage shelf controller that causes an upgrade failure message to appear. If you see a failure message, it may have appeared in error, and the upgrade may still have worked. Run the following command to confirm the firmware version:
show hardware-health primaryshelf component=controller
If you upgrade to version 2.1 and then roll back, an issue can occur that causes the Flex Appliance Console to be unable to load. If you encounter this issue, restart all appliance nodes and then try again to access the console.
If you have a multi-node appliance, do not restart both nodes at the same time.
For this release, while an update is in progress, do not perform any other operations in the Flex Appliance Shell or the Flex Appliance Console.
If you change the BIOS date and time on a Veritas 5250 Appliance after initial configuration, you can no longer access the Flex Appliance Console.
This issue is fixed in the 2.1.1 update. If you encounter this issue in version 2.1, change the BIOS date and time back to what it was before.
When you create a bond, do not supply it a bond name that is all numbers. If you do so, you can no longer create any additional bonds on the appliance.
If you were not aware of this limitation and have already created a bond name that is all numbers, contact Technical Support for assistance. Ask your representative to reference article 100050464.
Accelerator backups on Flex Appliance application instances fail if there is not enough space for the logs. For example, the logs for NDMP backups could require up to a Terabyte of storage space.
On a primary server instance, the logs are stored in the same location as the NetBackup catalogs. To resolve this issue on a primary server instance, resize the NetBackup catalog and make sure to allocate enough storage for the Accelerator logs as well.
On a media server instance, the logs are stored in the /mnt/nblogs
directory, which has a default size of 250 GB. This directory cannot currently be resized through the Flex Appliance Console.
On version 2.1.1, you can resize the directory with the PUT /instances/<instance-id>/volumes
API. See the Flex Management Server API documentation on Veritas SORT for details.
If you are on version 2.1, contact Veritas Support and ask your representative to reference article 100049971 to resize the directory.
Due to an underlying performance issue, the monitoring and alerting feature for the ROC Temperature (RAID on Chip for RAID Adapters) is disabled in this release for the Veritas 5250 Appliance. This feature will be reinstated and available for 5250 models in a future software release.
When you install application add-ons on an instance, the Flex Appliance Console lets you select different versions of the same OST plug-in. However, this configuration is not supported, and if you select more than one version of the same plug-in, the Install add-ons page shows duplicate entries. Only install one version of each OST plug-in on an instance. If you need to change the version of an OST plug-in that is already installed, first uninstall it, and then install the new version.
If the host0 or host1 port is not connected to the appliance node during initial configuration, the following error message appears that does not provide complete information:
"Network card for <interface name> is missing. Make sure that all network interfaces are connected to the appliance."
If you encounter this message, verify that all ports are connected according to the initial configuration guidelines. See Initial configuration guidelines and checklist. Then restart the node to continue the configuration.
When you create a new application instance, the Application instances section of the System topology page may show the instance status as Partially Deleted while the creation is in progress. The Partially Deleted status displays in error and can be safely ignored. You can track the instance creation progress from the Activity Monitor, and the instance status changes to Online when the instance creation has completed successfully.
If you have a tenant whose name or location contains special characters when you upgrade to version 2.1, tenant operations fail after the upgrade. To resolve this issue, edit the tenant name and location so that they do not have special characters.
The following error message may display in the Flex Appliance Shell during an upgrade or a factory reset:
dracut:Failed to install module bnx2
This message displays in error and can be safely disregarded.
If you have a multi-node appliance and one of the nodes is turned off for any reason, do not restart the other node until they are both online. If a node is restarted while the other node is off, the Flex Appliance Console fails to load.
If you encounter this scenario, contact Veritas Technical Support and ask your representative to reference articles 100046118 and 100051413.
When you create an instance, if you enter the IP address before you select a network interface, the IP address field displays the following error message:
"IP address does not belong to the selected network's subnet."
This message still displays after you select the network interface that corresponds to the IP address. To clear the message, click inside the IP address field and then click or tab outside of it.
After some operations in the Flex Appliance Shell, an "Operation successfully" message may display even if a failure occurred. Read all of the messages that display at the end of each task to make sure that no further action is required.
Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.
Howie Forman: And I’m Howie Forman. We are physicians and professors at Yale University and we’re trying to get closer to the truth about health and healthcare. This week, we will be speaking with Professor Gregg Gonsalves, but first we like to check in on current health news.
Harlan Krumholz: Yeah. So I’ll take that, Howie. So I wanted to ask you, you know anybody who’s got COVID?
Howie Forman: Huh, I feel like I’m the only person in my circle who has not yet been infected. I did go for my booster today, but not necessarily because I personally wanted to but because the university is sort of making me get a booster.
Harlan Krumholz: But there’s a lot of people around us who have COVID, right? And not only—
Howie Forman: Oh my God.
Harlan Krumholz: ... people who have had COVID, but there are people I know, lots of people who had COVID and now have it again. Have you noticed that?
Howie Forman: Yes, absolutely.
Harlan Krumholz: So anyway, people are writing about this. There was a nice piece by Eric Topol. By the way, just for our listeners, I mean, Eric has just done extraordinary service throughout the pandemic. We’re going to have him on the podcast. I thought, that’ll be amazing.
Howie Forman: Yes. I’m so thankful for that.
Harlan Krumholz: People can hear Eric. And his Twitter, terrific to follow and he also has something nice on Substack where he really reviews things. He had a recent one that came out. Eric was writing about a paper that was just published out of the VA. And recently they posted a pre-print. Just for people listening, a pre-print hasn’t been peer-reviewed or published in a journal yet. But they looked at about 250,000 people with one infection, about 40,000 people with two infections, and almost, a little more than 5 million people who are uninfected controls. And they looked to see what’s up with these reinfections? Are they more or less dangerous? What happens to people? And it was interesting because these reinfections, it seemed, were associated with higher risk over time. And so the people who had more infections, and almost like what we call a dose response, that is, the more infections you had, the riskier it was.
And even though this is among variants that we think are becoming less dangerous over time, but actually in the VA, they’re describing it as actually being a bigger problem. And even with regard to mortality as well. Now, people may wonder like, actually, why are these reinfections becoming so much more common? And you may be memorizing about these variants. I know people’s eyes glaze over with all these number of Omicron, BA.2, BA.2.12.1. I mean, it starts to get numbing after a while. But what I think is important for people to know is that there’s a new variant that has been coming out, that BA.4/5 that seems to be accounting for about a third of the infections right now in the United States. It’s new. And people talk about this “immune evasion,” that these variants are able to dodge our immune system that even if you’ve been vaccinated or if you’ve been previously infected that because of the mutations that are occurring particularly on the spike protein, the part that’s sticking out, and that’s what a lot of the antibodies are to, that spike, that these mutations are changing it just enough so that it’s dodging our immune system.
And that’s why you’re seeing so many different people who are able to, have been priorly infected; they think they’re protected. But in fact, this sneaky little virus is finding ways to spread among the population. And this VA study is in counter-distinction to a lot of the studies that came out that suggested that the accurate variants are not as dangerous, but the thing is, they’re infecting more people. And so the result of infecting more people, even if it’s slightly less dangerous as a virus, may actually be causing harm that’s greater.
We’d written about this, and other people have seen it. I think the one thing to comment on too is Eric at the end of this makes a very strong statement that... And I think reflecting a little bit on Congress has yet to pass the COVID-19 bill. I mean, so a lot of the funding for future public health is still in question. And he says the lack of priority in resource allocation stems from the illusion that the pandemic is behind us, which is obviously off base.
Howie Forman: Yep.
Harlan Krumholz: Anyway, we should get on to Gregg, because this will be a great interview.
Howie Forman: I’m delighted to introduce Professor Gregg Gonsalves. Gregg Gonsalves is an associate professor of epidemiology at the Yale School of Public Health. His work involves modeling infectious disease and substance use while also investigating public policy and health equity. Professor Gonsalves has worked on HIV/AIDS and various global health issues with organizations such as the AIDS Coalition to Unleash Power or ACT UP, the Treatment Action Group, Gay Men's Health Crisis, and many more. He is the epitome of an interdisciplinary colleague, working with our law school as an adjunct associate professor of law and the co-director of the Global Health Justice Partnership, a Yale Law School and School of Public Health initiative to respond to problems in health justice, and also works with faculty at our School of Management and beyond.
He is a 2018 winner of the MacArthur Fellowship or “Genius Grant,” as it is commonly known. I first came to know him when he came to Yale’s campus to obtain his bachelor’s degree in 2008 as a 44-year-old man through the Eli Whitney Students Program. Since that time, he has also obtained his PhD from our School of Public Health and obviously enriched our campus with his passion, his deep abiding belief in informing policy with science and evidence, and his commitment to social justice and equal rights for all.
First, let me just start off by saying how much I appreciate you joining us. You have consistently stood up for those who either can’t or won’t be noticed if they do with so much injustice in the world. How do you prioritize your efforts?
Gregg Gonsalves: Well, you said it was a simple question you were going to ask, but it’s pretty difficult. I was on a prep call for a webinar with Partners In Health that’s happening next week. And there are people there who are going to talk on abortion rights and reproductive justice on gun control and on immigration. We had a conversation about, how do you prioritize all of that? I said, “We agreed we should put it under one big umbrella that counts as public health and not try to sort of triage and rank things in order of importance,” because that’s what they like to do, they like to pick you off, right? To say that you work on one issue, and you don’t need to think about the rest of the broad scope of what public health entails in America. And so I would say I do what I know best, which is stuff around HIV, substance use, and infectious diseases, but I’m trying to listen to my colleagues and promote my colleagues’ work on all the other fields that I think are sort of under our big tent at public health.
Howie Forman: Can you comment a little bit on—two things, I guess. One is that you dropped out of college. I would love to know why and when you did that the first time. But the second is that when I first met you, I remember realizing that you and I were contemporaries and you’d come back to college to do your undergraduate degree in evolutionary biology and developmental biology, I think. And you were already so successful, Gregg. I mean, I described it in the bio, but it understates your impact on how we affected change—or how you affected change—during the HIV/AIDS crisis. First of all, how did that happen? And second of all, what can you tell people who think that at the age of 44, it’s too late to go back to school or too late to make a career pivot like that?
Gregg Gonsalves: So we’re contemporaries, and I think you’ll understand this is at... I graduated from high school in 1981. Two events happened around that time, the election of Ronald Reagan and the beginning of the AIDS epidemic. And coming out as a young gay man and a conservative suburban New York family of second-generation immigrants was incredibly difficult. I’d been “the best little boy in the world” and done well at school, was going off to consider a research career in comparative literature. I studied Russian, and none of it made sense. I felt this compulsion to sort of rethink my life in the context of what was happening around me, and I dropped out of school. I ended up meeting somebody who was HIV-positive, the first HIV-positive person I knew, and went looking for information and ended up in ACT UP and then sort of found my people, found my tribe.
And that’s why I ended up never returning to school until I was 44. I thought coming to Yale was going to be like a sabbatical from work. Like it would just be sort of this nice time to sort of reflect. Being in biology courses with Yale undergraduates was slightly terrifying because they’re all heading to medical school, and I was sitting there 44 years old with like a lot of distance between me and the last science course I took. But it was fun.
It was incredibly thrilling. Steve Stearns, who was my advisor as an undergraduate, and Paul Turner, who was basically my co-advisor, really opened up this new world to me about evolution and infectious diseases, which was totally fascinating. I almost left and went to do a lab-based PhD in Europe on sort of immunogenetics and immunodeficiency viruses.
But it’s funny because it didn’t occur to me that that was... I’d never took a linear path from A to B in my life, so it didn’t occur to me that it was odd to go back to school at 44. My mother, who was 88 years old, was a schoolteacher in New York City for many, many years. And then in her 60s, well, she retired from the New York City public school system and became a politician, a Republican politician on Long Island and only retired five or six years ago. So it’s interesting. I watched my mother sort of pivot after retirement into a huge sort of local political career, which gave me the sense, I guess, like in retrospect that like, if she can do it, I probably can too.
Harlan Krumholz: But how did you come to apply to Yale at that point? I mean, what was the thing that made you think, “I’m going to apply to Yale”?
Gregg Gonsalves: So I was sitting in South Africa in my apartment in Cape Town, and I’d been doing this work for 25 years, and I loved it. I mean, the job I had then was really dealing with the Thabo Mbeki administration in South Africa and their refusal to supply oral therapy to people in the country, but also to sort of go into countries around the region with my colleagues at the Treatment Action Campaign and teach people about the virology, immunology of HIV, about clinical trials and all this stuff. I realized I could do this forever, or I could take a break and try to do something else. I was looking around the internet for programs that would take older undergraduates. I saw the Yale one and I said, “Oh, I’ll just apply.” And I said, “If I get in, I’ll go. If not, I’ll just keep doing what I’m doing.” One day I got a letter in Cape Town and decided to get on a plane and come back to the U.S.
Harlan Krumholz: Wow.
Howie Forman: And the rest is history. I just want to ask you know, I think for some of our listeners, we’re now 41 years into the HIV/AIDS epidemic right now. There was that window of time for the first 15, 18 years where it was not only just lethal, but it was filled with misinformation. Just filled with it. I think for a lot of people going through the COVID pandemic right now, there’s this expectation that after two years we should know everything. I think back—even now, we’re learning so much about HIV, and we’ve had several guests talk about this already, but I think back to that period of time where the information flow was so high for so long and so many myths were being dispelled. What is the role for activists during... I mean, right now in the COVID pandemic, what’s the role for people to be pushing back against misinformation, to be defending stigmatized populations? How do you see that looking back on that period in time?
Gregg Gonsalves: So, it’s interesting. Misinformation on the AIDS epidemic started in the beginning, and the idea that HIV didn’t cause AIDS was propounded by Peter Duesberg who was a National Academy of Medicine member. Kary Mullis, who was a Nobel Prize winner, who sort of discovered or developed PCR. And it’s being propagated around the country, was turbocharged by Thabo Mbeki in South Africa, and around 2000, a group of us set up something called AIDSTruth. It was clinicians. It was basic geneticists and biologists, and it was AIDS activists. We basically deconstructed all the sort of myths, put up all the sort of scientific evidence and did it in a simple, engaging format so people could understand what was going on. With COVID-19, everything is just sort of nuclear-scale misinformation. And for 2020, lots of it was coming out of the White House.
We were talking about people like Jay Bhattacharya, John Ioannidis, and Scott Atlas and others. We have people within our own institutions now who are propelling misinformation forward. Myocarditis in young children and vaccines. The scale of the misinformation now is really, really, really, really pervasive and coming from the highest levels of government. The governor of Florida for instance is a pretty strong proponent of not giving vaccines to children, has made comments about the state of the pandemic, and his own state surgeon general has been a problematic figure in terms of passing misinformation.
We need to speak out. We’re not just clinicians and scientists. We are citizens in a country that we need to supply back to. And part of that is sort of setting the record straight about what’s true and what’s not true. What’s science and what’s myth and fabrication.
Howie Forman: Your work with HIV, and now your commentary work with monkeypox, in one of the articles, you’ve mentioned something, or quoted as saying something about how “we have to become more comfortable talking about sex.” Here we are at a time where the LGBTQ community is being further marginalized in large parts of the country right now where we’re taking steps backward in terms of freedoms and particularly women’s agency, but really the agency of anybody with regard to reproductive health and sexual health.
How do we move the needle in a way that’s productive for society? Monkeypox is not anywhere near the level of concern that COVID was, but there is concern and you’ve raised this sort of weight between us being able to contain it versus just mitigating it, which would be a failure.
Harlan Krumholz: By the way, should we still be saying “monkeypox” or is there a new name yet for it?
Gregg Gonsalves: Well, I think the new names are going to be around the Congo and West African variants. But this is not COVID. There’s a real chance that this virus could establish itself among gay men, bisexual men. And that’s a choice, right? A few weeks ago I wrote a piece that talked about a thousand cases worldwide. Now, we have 3,000 cases worldwide in 41 countries. It’s spread by close physical contact in the context of the current outbreak, outside of its endemic regions, it’s happening among many intersections with men. And while it’s not a sexually transmitted disease, it’s happening in the context of social and sexual networks.
So, many of us have been very careful to not stigmatize gay men or to stigmatize sex or to turn into sort of modern-day Nancy Reagans and “just say no” to sex and gay pride. But we do have to say that this virus is now spreading quietly and broadly among the gay community. We have 21 cases in New York now. And it’s going to have to talk very frankly about safe sex, safe socializing over the next few months until we can get it under control.
We’re on the cusp of potentially having this sort of sustained in the gay community over the next few months and years, which would be a shame, because we have the tools. We have a vaccine to stamp it out. We have the ability to treat it. But if we keep making the same mistakes as COVID and HIV, we’re going to be in a situation where we’re dealing with another sort of persistent virus among gay men.
Harlan Krumholz: Do you want to maybe just take a second for listeners... many people may have been sort of paying a little bit of attention to this, but not as much. What are the things you think from a public health point of view that people should know about monkeypox? And who’s at risk and what they’re at risk for? I mean what do you wish that everybody knew?
Gregg Gonsalves: So one is, it’s a disease that’s been around for a long time, endemic in Western Central Africa, and we’ve ignored it because we ignored diseases that affect poor people in foreign countries. That’s basically why we have neglected tropical diseases, because they’re neglected by us. The context of this pandemic, its outbreak? It has been initially seen in a cohort of gay men who are part of raves in the Canary Islands and in Portugal, but has now spread to 41 countries largely among men, bisexual men, but not exclusively. Again, it’s spread by close physical contact. It’s not about safer sex at all. It’s about refraining from sexual contact, sharing of clothing, other objects.
Harlan Krumholz: How about a handshake?
Gregg Gonsalves: If you have a lesion on your hand, you’re going to shake somebody’s hand, touch your eye, you’re going to have monkeypox.
Harlan Krumholz: So, potentially.
Gregg Gonsalves: Potentially, there’s some idea that the presentation of this in this outbreak has been around sort of the inter-genital region, but it’s not exactly the case. There’s been disseminated sort of lesions across the body and you’re highly infectious until those lesions scab up and fall off. So this is why people are so panic that this is going to entrench itself—
Harlan Krumholz: What’s the biggest harm of it? What can it do at its extreme?
Gregg Gonsalves: At its extreme, this strain has not been responsible for that many deaths at all in West Africa. The Congolese version, which will soon be renamed, has a higher fatality rate. And right now we haven’t had any deaths from it. If it gets into immunocompromised populations, it gets into children, we don’t know what’ll happen. A colleague of mine, Demetre Daskalakis, who’s at the Centers for Disease Control, has said, “Think of this like MRSA. It’s in the gay community now, but MRSA went from the gay community to health clinics.”
Harlan Krumholz: And MRSA, just for definition, for, you want to just—Methicillin-resistant...
Gregg Gonsalves: Methicillin-resistant Staphylococcus aureus. It’s a bacterial infection of the skin that’s drug-resistant. There’s an outbreak in gay men, and then it showed up in health clubs. And so just because it’s now limited to the gay community and a subsection of the gay community, it doesn’t mean it’s not going to sort of emerge in large-population temperatures like New York and others in other populations. And then it’s hard to know if it’ll sustain itself.
The big fear is that it gets into people who potentially are HIV-positive but don’t know their status. There’s lots of reasons why you might see a more severe presentation even though right now we’ve had no deaths really among most of the cases that are circulating around the world. At least outside of its endemic region.
Howie Forman: Well, one of the things we haven’t talked about, that you’re enormously prolific and productive in writing lay pieces not just for the scientific literature, but pieces in political science magazines, in Washington Post and The New York Times and so on, how do you pick and choose for that and what you’re going to decide to write for the public? Because public health communications I think is so important, but there’s only so much time you have for that, and you’ve done a lot of it.
Gregg Gonsalves: Well, I mean, Harlan and Joe and a bunch of us have written a lot on FDA stuff. So there’s things I care about, drug regulation and the regulatory state, particularly the regulation of drugs and devices and biologics. So I’ve written a lot about that. A lot on COVID. A friend of mine, Zain Rizvi, who was at the Law School a few years ago and who’s now at Public Citizen in D.C., are writing a piece on monkeypox vaccines right now.
I got a gig as The Nation’s public health correspondent last year, and my editor sort of tends to poke me on certain issues but gives me wide latitude to write what I want. I mean, after COVID, it’s hard to think about if I’ll sustain that level of sort of commitment to public writing. The more episodic work I’ve done over the past is probably more of a template for what I think I’ll do in the future.
Harlan Krumholz: Any parting words for students coming up and who look at a career like yours, nonlinear, highly impactful, to supply them courage, to be able to supply them the ability to make choices, not that others expect of them, but ones that they really can follow their hearts and what they really want to do? We appreciate you being on today, but that’s one of the things I think about you is that it’s an inspiring path in one where you did have the courage, the bravery to move forward in ways that maybe were a little unconventional, but highly impactful.
Gregg Gonsalves: I mean, people make lots of spectacular achievements going from A to B, but I’ll never forget when Gerry Friedland, who’s a colleague of all of ours, gave a lecture to the medical students a few years ago and drew a squiggling line on the board and didn’t tell anybody what it was. And then he talked about his life. Gerry was going to be a sociology PhD, went off to the Peace Corps, met Allan Rosenfield, who became the dean of the School of Public Health at Columbia. But as the doctor of record for the Black Panthers.
So there’s lots of people we know that are among us who’ve taken sort of circuitous routes to where they are today. And I think it’s, trust your gut. A lot of Yale undergraduates when I was here were so afraid of sort of stepping off the well-trodden path of success that they’d had in high school and that they assumed they were going to go to Yale, go to medical school and go to law school. There’s a very strong pressure to conform, which despite the creativity and innovation at this place can weigh down young people.
And I’d say, trust your gut, because in the end you have to live with yourself, not your parents or your professors or your peers. And so I don’t think I would do things differently if I had to do it all over again, even though it was a little bit of a wild ride of a life.
Howie Forman: I do want to say one thing in parting words, we haven’t mentioned before, but you’ve alluded to it, you have been an incredible mentor and collaborator with our students on campus and some of whom have graduated from campus. And when I talk to students that have graduated from here, some of whom are already faculty members, many of them will still say like the paper they’re most proud of is the paper they did with you. So I just want to thank you on behalf of them and our listeners for what you’ve been able to do to help develop careers.
Harlan Krumholz: Yeah. Thank you, Gregg. And thanks for joining.
Gregg Gonsalves: Thank you for having me. No, thanks for having me in, Harlan and Howie.
Harlan Krumholz: Howie, that was great. So let’s move on to the next segment where we can hear what’s keeping you up or are occupying your attention these days.
Howie Forman: Yeah. So you had a great thread on Twitter this week about the horrible financial impact that healthcare has on a relatively large chunk of society based on a Kaiser Health News article by Noam Levey. It indicated that over 100 million people, almost one in every three in America, are saddled with medical debt, and that’s not new. Even in the decade after Obamacare, which was supposed to be the “affordable healthcare act,” out-of-pocket health spending is very high. It’s enormously impactful to even upper-income groups. All it takes is one catastrophic illness or condition and you could be saddled with lifelong debt or worse, including bankruptcy.
So I wanted to pivot from that thread, which I thought was a very important story, but to the other end of the spectrum, our recent guest Dean Sherry Glied of the Wagner School at NYU just published a paper in Health Affairs that confirms that our two-decade experiment with health savings accounts or HSAs has mostly failed. These are the accounts that people have combined with a high-deductible health plan, and we may call them consumer-directed health plans.
A lot of people have them now. They bring no efficiency gains. In other words, these plans—of which by the way 30% of what most employees are choosing now, so it’s a large part of the population—do not lead you to spend money more wisely. They just allow for a tax break primarily for higher-income individuals. It’s a regressive policy. And full disclosure: I, along with tens of millions of others, benefit from this policy.
I’ve used an HSA or prior to that, a flexible spending account for a while. Our government, in a purported effort to make healthcare spending more efficient, has instead just codified another means for an individual to reduce their federal tax obligations. And in this case, it’s to the tune of about $12 billion per year, which is not chump change. So at the very same time that so many lower-income individuals struggle to pay off healthcare debt, we are lavishing more tax breaks on the better-off with no seeming policy reason other than a lower tax burden. And Sherry Glied, Dean Glied thinks this policy should be undone, and I agree.
Harlan Krumholz: You know, that’s a really interesting point, and I’m glad you raised it. I’ll get back to the Twitter stream that I put together, the reflection on that article. Look, I’m always impressed by the studies that show that about half of America doesn’t even have $500 to manage a financial emergency. And our healthcare system imposes such profound financial harm on people. Leading people to avoid care, leading people who need care to be saddled with debt. It’s a side effect of our system.
Look, what I said was, no matter what, we should identify this as a major problem. Whether you’re for or against universal healthcare, whether you’re for, against a particular solution, then tell me what your solution is, because we can’t have a country where getting sick leads you to have your house foreclosed on, for your inability to put food on the table, for you to have anxiety, for you to have such worries.
I mean, it’s just simply not the kind of society that we should want to live in. And for the richest nation, the world, to have a record like this? We doctors are imposing harm every day because every bit of care for people who can’t afford, it leaves them weaker and in a position where they’re struggling as a result of this. We can promote health, but actually we’re not promoting well-being because they’re in these disastrous situations. And for some people it’s devastating.
Howie Forman: Yeah, it’s so frustrating.
Harlan Krumholz: I think I want a culmination. What is the solution? I mean, so universal healthcare is one solution. The government actually takes on the responsibility. That’s what happens in most advanced societies. If we’re unprepared to do that, then what are we prepared to do? But this status quo can’t continue.
Howie Forman: Yeah. No, I agree. And look, it’s taken me... It’s a long evolution for me because I was very... In the 1990s, when I finished business school, I was extremely pro-market. I really thought the market could solve most problems. And now I’ve come pretty much 180 degrees where I feel like we’ve given the market every possible opportunity to fix some of these big problems, and it’s not able to. But on the other hand, I’m also much more aware now than ever before that the political realities to fixing this are so challenging.
So I personally think that we as professionals within healthcare systems have to help reshape the way we deliver care even if our government institutions aren’t able to do it.
Harlan Krumholz: And people are afraid for change, but they have to realize the harm imposed by the status quo. And so we have... It’s true things can always get worse, but they’re not great now for a vast majority of Americans who are saddled with debt as a result of receiving healthcare. So we need to be able to fix that.
Howie Forman: Yep.
Harlan Krumholz: You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.
Howie Forman: So how did we do? To supply us your feedback or to keep the conversation going, you can find us on Twitter.
Harlan Krumholz: I’m @hmkyale. That’s H-M-K Yale.
Howie Forman: And I’m @thehowie. That’s at T-H-E-H-O-W-I-E. Aside from Twitter and our podcast, I’m fortunate to be the faculty director of the health care track and founder of the MBA for Executives program at the Yale School of Management. Feel free to reach out via email for more information on our innovative programs, or you can check out our website at som.yale.edu/emba.
Harlan Krumholz: How many people do you think have gotten an MBA under your auspices about since the whole time you’ve been at Yale?
Howie Forman: Oh, hundreds and hundreds.
Harlan Krumholz: Hundreds.
Howie Forman: And a few hundred physicians alone. Yeah.
Harlan Krumholz: Yeah, that’s amazing. Health & Veritas is produced with the Yale School of Management. Thanks to our researcher, Jenny Tan, and to our producer, Miranda Shafer. Talk to you soon, Howie.
Howie Forman: Thanks, Harlan. Talk to you soon.
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Shortly after San Francisco renters celebrated a law that expands tenants’ rights, one of the city’s biggest landlords fired back, notifying its residents that they can be evicted for attempting to organize.
At the end of June, GreenTree Property Management, a subsidiary of corporate landlord Veritas Investments, emailed its residents nine pages of “Updated House Rules” and noted that violating any of them may result in an eviction. The rules prohibit multiple actions vital to organizing, including distribution of “literature” in common areas, the hanging of signs or posters on any doors or windows, and “soliciting” more than four times a year.
The document explicitly states Veritas’ new rules are a response to a new tenants’ law.
Strict new dictums with harsh consequences have disturbed and concerned residents who’ve lived in Veritas properties for years, and signed far less restrictive agreements. W. Blake Gray, a tenant of a building recently acquired by GreenTree and a journalist, found new noise restrictions especially egregious. The rule allows someone to be evicted based on a single “boisterous party,” which is determined by management’s “sole discretion.”
“You are essentially giving the largest landlord in San Francisco the power to evict based on the say-so of the resident manager,” Gray said. “I don’t want to live next to someone who has loud parties, but there has to be a warning process.”
Gray replied to his property manager’s email and said he believed the rules to be illegal. “They wrote the most horrible set of rules and rights they could think of,” he said.
Though only a court could decide on the legality of the rules, many of the rules do appear legal according to a tenants lawyer. But some are more shaky. For example, the solicitation limit appears to adhere to San Francisco Administrative Code Chapter 49A.2, subsection b, which states “the landlord may establish other reasonable requirements … of such literature distribution, including a limitation of distribution.” An earlier version of that section had limited organizing to four times a year, but that had been explicitly removed in the new tenants’ law passed this year, making it unclear if a limit would be legal.
Still, “only a court would be able to make a determination on [legal] reasonableness” for specific cases, said Christina Varner, the executive director of the San Francisco Rent Board, the city’s Rent Ordinance oversight body.
To Veritas consultant Daniel Baldocchi, it’s clear the company is acting within its rights. “It’s more establishing rules around the organizing so it’s … reasonable,” Baldocchi said. He added that much of the language was borrowed directly from San Francisco Apartment Association housing guidance.
On the other hand, the rule about posting signs on doors appears to be illegal, said tenant attorney Joseph Tobener, who said this is the first time he has seen a rule restricting organizing in his 20 years of practice. He said a landlord cannot prohibit the posting of political signs.
“In my experience, GreenTree often pushes to the edge of what is legally allowed, and frequently crosses the line,” Tobener said.“These house rules are yet another example of this.”
The GreenTree document that these updated rules supersede any rules in tenants’ prior leases: “Failure to comply… may constitute a just cause for eviction.” This jolted the scores of GreenTree residents who received the email.
Existing tenants, however, cannot be evicted for violating these “updated house rules” unless they sign a document accepting the new lease terms, according to Section 12.20 of the Rent Board Rules and Regulations. Nowhere is that protection noted on the updated rules document sent to GreenTree tenants, which some residents complained was only available in English.
Debbie Nunez, a Veritas renter and member of the Veritas Tenants Association, feared that non-English-speaking tenants might misunderstand and readily accept the terms. “They are really masters of semantics, when they say ‘updates.’ [The new rules] contain things that could or would materially change an individual’s lease agreement,” she said. “Excuse my French — I call bullshit.”
If the rules are included in new tenants’ leases, they could possibly be legally evicted for violating the rules over a breach of lease, said Varner. These rules would make new leases much more restrictive than the original ones signed by longstanding tenants like Nunez and Gray.
Both of these tenants have no doubt that the rules were written explicitly to dilute organizing efforts and, as Nunez put it, to “interfere with the newly granted [tenants’] rights.”
And she is right that GreenTree’s Updated House Rules stipulate that it is a direct response to a recently passed city law that grants tenants the ability to “unionize” — a law that residents in 20 Veritas San Francisco buildings have attempted to use.
“Some of the changes you will find in this update to the House Rules are in response to new legislation,” begins the Updated House Rules document sent to residents. “This legislation grants tenant associations greater ability to organize and to confer with their building’s management team … ”
Although the updated rules intended to respond to increased tenant power, it seems to have stoked it. Nunez said she thinks other residents will “stand up” once they realize what Veritas is doing.
Gray hasn’t joined a tenants group, “but this made me want to do it … Maybe we want the power to stand up to a big corporation like Veritas.”
This article was corrected on July 7 to reference and link to the updated administration code. An earlier version referred to an outdated version.
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Data protection heavyweight Veritas is aiming to rework its core software offering NetBackup around autonomous functionality.
Its Autonomous Data Management project will see the development of, for example, autonomous provisioning capabilities where backup software seeks out data to be protected across on-premise capacity and in the cloud and stores it optimally in the appropriate tier.
So, Autonomous Data Management would designate backup data to differing tiers of storage, from those that are close to production for rapid restore and use, to those that are archived off for long-term retention. The artificial intelligence (AI) would rate the importance of data in terms of its access requirements, disinfect corrupted files where necessary, and restore files to the appropriate place for future use.
“The problem for CIOs is the struggle to keep up with all the applications deployed in the enterprise, and that is aggravated by the proliferation of data in a multitude of cloud services,” said Doug Matthews, senior VP of products at Veritas.
“If you don’t understand the data you manage, you won’t be able to define the rules to protect it. Our aim is to eliminate the effort needed to manage data,” added Matthews during an interview with Computer Weekly’s sister website in France, LeMagIT, during a accurate IT Press Tour event.
NetBackup 10 was launched in March 2022 with numerous enhancements that included some policy-based automation for provisioning, notably in AWS and Azure environments. However, full autonomisation of these kinds of functionality will not be complete until the next version in 2024.
Matthews clarified the distinction. “With automation, you define the rules and they apply themselves,” he said. “In autonomic mode, the rules are deduced according to metrics derived from your production workloads and which are constantly reassessed. All you have to do is label your resources via the interface and the software does the rest.”
Currently, Veritas has only presentations and small-scale prototypes to demonstrate its progress. But it said the challenges are so important to its customers that it plans to prepare them for an early switch to the era of autonomic processes.
Veritas is a long-established giant among backup product suppliers, with very large accounts well represented among its client list. These include the biggest global banks, telcos and pharmaceutical companies, all of which are heavily-regulated sectors where letting a machine work its way through enterprise data is not necessarily seen as best practice.
“The reality of increasingly complex cloud deployments means that enterprises are putting themselves in danger if they rely on managing backup manually,” said Matthews. “Now, only AI can guarantee that you won’t restore corrupted data. In two years, none of our customers have lost data after a cyber attack, thanks to NetBackup. We are moving towards autonomisation to maintain that reputation.”
The company believes it can convince its customers to look beyond any regulatory concerns. Protecting against ransomware is a key argument it deploys, but eco-responsibility is another. Veritas cited a US study which calculated that to store a PB of data in the cloud for a year emits 3.5 tonnes of CO2. Addressing this concern, it claimed that its algorithms can significantly reduce data volumes, and that this will diminish CO2 outputs beyond that possible by an IT team and without excessively complex management.
Autonomous Data Management is likely to allow savings to be made, it said, not only in terms of the ability to purchase capacity in smaller volumes, but also by being able to select from better cloud tariffs.
According to Matthews, AI is the key to data protection that can adapt to changing circumstances in real time and instantly call up the correct response.
Having said that, AI is efficient only if it is trained sufficiently. Veritas said it plans to build a data lake of metadata that references the ways its customers protect their data, and that will serve as training data for its machine learning engine. Matthews stressed that no customer data will leave its site to feed the data lake.
“We have worked for two years on this AI engine and as far as we know, we are the only one to have gone in the direction of an autonomous system,” said Matthews. “That means we are the only one that will offer such a solution to enterprise customers.”
He predicted that Veritas’s turnover would grow by 8% to 10% a year when Autonomous Data Management has been fully productised, probably as part of NetBackup 11.
INTRODUCTION
Section:
Falling costs of genetic testing in combination with growing public interest in personal genomics has driven the expansion of direct-to-consumer (DTC) genetic testing. Today’s market encompasses a broad range of offerings, from tests that pair users with wines to tests that reveal serious disease risks.1 This review focuses on one area of the rapidly expanding DTC market—genetic testing for cancer susceptibility. Within this space, DTC offerings vary considerably in size and scope. The narrowest is a test that screens for three specific mutations in two genes and the broadest is a whole-genome sequencing service that analyzes dozens of genes for mutations that could affect cancer risk.
Traditionally, DTC genetic tests were advertised—and sold—to consumers without involving a health care professional; however, in accurate years, a new model of testing has come to dominate the market. In this model, tests are advertised to consumers but ordered by licensed physicians.2-5 A number of companies even allow consumers to choose between having tests ordered by their own physician or by a company-provided independent physician.
In both the academic literature and the popular media, there is a lack of clarity about which genetic tests count as DTC offerings.6 This uncertainty, as Hogarth et al7 explain, stems from ambiguity about the meaning of direct-to-consumer, a term that “has been used variously to refer to both advertising and sale of genetic tests.” According to the US National Institutes of Health (NIH), DTC genetic tests “are marketed directly to customers via television, print advertisements, or the Internet, and . . . can be bought online or in stores.”8(p163) Under this expansive definition, tests that are advertised to consumers but ordered by licensed physicians—often referred to as the hybrid model—fall within the ambit of DTC genetic testing.2,5
CONTEXT
Key Objective
To provide an overview of available direct-to-consumer (DTC) genetic tests for cancer susceptibility and to identify six aspects of the testing process that could affect consumers’ ability to make informed decisions about testing and interpret their results.
Knowledge Generated
Recent years have seen DTC genetic testing for cancer susceptibility change dramatically. Specifically, a new model now dominates the market where tests are advertised to consumers but ordered by physicians. Moreover, many of today’s tests are distinguished from earlier DTC offerings for cancer susceptibility by their scope and potential clinical significance. This review provides a comprehensive overview of available DTC genetic tests for cancer susceptibility and identifies aspects of the DTC testing process that could affect consumers’ ability to make informed decisions about testing and understand their results. Given how the DTC genetic testing market for cancer susceptibility has changed in accurate years, it is essential that health care professionals and researchers working in this space appreciate both the range of tests being offered and the challenges that consumers may face as they navigate this evolving landscape.
Relevance
On the basis of our review of companies’ Web sites, consumers would benefit from more information about certain aspects of the testing process. Providing this information would help consumers make informed decisions about whether to use a particular DTC genetic testing service and, should they choose to pursue testing, understand the implications and limitations of their results.
Other than the shift toward physician-ordered testing, many of today’s tests are distinguished from their predecessors by their scope and potential clinical significance. Previously, in the mid-to-late 2000s, most DTC tests used single-nucleotide variation profiling to assess cancer risk, a process that involves screening a DNA demo for single-nucleotide polymorphisms (SNPs)—single base-pair differences that occur at specific positions in the genome—that may affect cancer risk.9,10 Single-nucleotide variation profiling, however, tends to have low predictive value for disease risk and limited usefulness in improving health outcomes (ie, clinical utility).
Today’s DTC companies have largely moved away from using single-nucleotide variation profiling. Instead, they tend to analyze specific genes for mutations that increase cancer risk. Yet this change has not eliminated uncertainty in cancer susceptibility genetic testing. For many of the genes included in larger tests, a positive result may be associated with uncertain risk estimates and/or unclear medical management strategies.11,12
Given how the DTC genetic testing market for cancer susceptibility has changed in accurate years, it is essential that health care professionals and researchers working in this space appreciate both the range of tests being offered and the challenges that consumers may face as they navigate this evolving landscape. Part I of this paper provides an overview of available DTC genetic tests for cancer susceptibility as of July 2019. For each test, we discuss cost; who orders it; whether variants of uncertain significance (VUS) are returned; availability of genetic counseling; intended users; whether consumers are recontacted about variant reclassifications; whether the test is characterized by the company as being diagnostic, actionable, and clinically valid; molecular technique used to analyze DNA; and whether the test is Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited.
In Part II, we identify six aspects of the testing process that we believe could affect consumers’ ability to make informed decisions about testing and understand the implications—and limitations—of their results.13 These are: how companies use certain terms (eg, medical grade or clinical grade); how companies use consumers’ health information during the ordering process; the extent of genetic counseling provided by companies; companies’ procedures for returning results; the role of company-provided ordering physicians; and companies’ procedures for communicating variant reclassifications. On the basis of our review of companies’ Web sites, we believe that consumers would benefit from more information about these aspects of testing.
PART I: DTC GENETIC TESTS FOR CANCER RISK
Section:
Here we describe the array of DTC genetic tests for cancer susceptibility that were on the market as of July 2019 (Table 1). Given the Internet-based nature of DTC genetic testing, today’s consumers primarily receive and interact with DTC companies’ offerings through their Web sites. Thus, to better capture the information that consumers are likely to access when deciding whether to use a test, we only include information about testing services that is, or was, available on companies’ Web sites. It is worth noting that some companies do not explicitly define the terms diagnostic, actionable, or clinically valid. Whereas we describe how each company characterizes these terms and indicate when definitions are absent, inasmuch as our objective is to convey what companies report on their Web sites, we do not evaluate the accuracy of their claims.14
23andMe
In 2013, the US Food and Drug Administration (FDA) issued a warning letter to 23andMe (Sunnyvale, CA) ordering the company to discontinue marketing its Personal Genome Service, which included reports for several hundred diseases and conditions, an SNP-based risk score for breast cancer, and a limited BRCA1/BRCA2 test.15 According to the FDA, 23andMe had failed to demonstrate that its service could correctly identify genetic disease risks, made misleading claims about the health benefits of tests, and failed to comply with the premarket review process for medical devices.16
Since that time, 23andMe has substantially revised its services. In March 2018, the FDA authorized 23andMe to market a BRCA test that screens for three specific BRCA1/BRCA2 variants, making it the first FDA-authorized DTC genetic test to report on cancer risk.17,18 Although there are more than 1,000 known BRCA1/BRCA2 mutations that are associated with an increased risk of breast and ovarian cancer, 23andMe’s test only screens for three founder mutations—two in the BRCA1 gene (BRCA1 c.68_69delAG and BRCA1 c.5266dupC) and one in the BRCA2 gene (BRCA2 c.5946delT)—that are found almost exclusively in individuals of Ashkenazi Jewish descent.17 The test, therefore, is unlikely to be useful to individuals from other ethnic backgrounds.19,20 As 23andMe acknowledges, its BRCA screen is not comprehensive and does not rule out the possibility that an individual carries one of the many BRCA1/BRCA2 mutations not covered by its report.21
In January 2019, 23andMe received FDA clearance to expand its cancer susceptibility testing to report on two MUTYH genetic mutations that are implicated in MUTYH-associated polyposis, an autosomal recessive hereditary colorectal cancer syndrome.22 The two variants that are included in the test—p.Y179C and p.G396D—are the most common pathogenic MUTYH mutations in individuals of northern European descent, although there are more than 100 pathogenic MUTYH variants.23 In the general northern European, Australian, and US population, the heterozygous carrier frequency for a pathogenic MUTYH variant is 1% to 2%.2 Individuals with a single MUTYH mutation are thought to have a slightly increased risk of colorectal cancer relative to the general population lifetime risk—approximately 4%.25-27 In contrast, individuals carrying mutations in both MUTYH alleles have a much higher cumulative risk of colorectal cancer—approximately 80% by age 70.28
23andMe’s BRCA report is included with its Health + Ancestry Service.29 Excluding special offers, the service costs $199. Consumers order their own tests and receive their results through an online account. If a consumer does not wish to view his or her BRCA result, they can opt to exclude it from the report. Although the company does not provide genetic counseling, consumers are encouraged to consult with a genetic counselor before and after testing. 23andMe uses genotyping to analyze DNA. The company states that its BRCA test meets FDA requirements for clinical validity, which it defines as “the degree to which a test accurately identifies or predicts a disease of interest.”30 23andMe maintains that its BRCA test “is not intended to diagnose any disease and does not describe a person’s overall risk of developing any type of cancer.”22 It also maintains that the test is not medically actionable and that “[r]esults should be confirmed in a clinical setting before taking any medical action.”22 All DNA samples are processed in CLIA-certified and CAP-accredited laboratories.
Veritas Genetics
Veritas (Santa Clara, CA) offers a whole-genome sequencing service called myGenome Standard that costs $599. For an additional $1,000, consumers can upgrade to myGenome Premium, which includes more diseases and carrier conditions. myGenome (standard and premium) can be ordered by the consumer’s own provider or, for an additional $129, by an independent physician affiliated with the telegenomics company Genome Medical. When the results are ready, Veritas notifies the consumer and the ordering provider, both of whom can then access the report through Veritas’ Web portal. If interested, consumers can pay an additional $99 to receive their raw data.
For myGenome (standard and premium), pathogenic and likely pathogenic results are reported, and benign, likely benign, and VUS results are not typically returned. Veritas does not state whether it will contact the ordering provider or the consumer about variant reclassifications. Through Genome Medical, Veritas offers a complimentary 30-minute return of results genetic counseling session for clinically actionable findings. Consumers can also pay $299 for Comprehensive Genetic Counseling, which includes access to pretest counseling and a 60-minute post-test session to review results.
According to Veritas, its service is intended to be a screening test for healthy individuals; however, myGenome is not meant to be diagnostic because “there is a chance that some of the variants that are associated with health conditions or disease risk could be missed.”31 As such, the test “should not be used to diagnose a known or suspected heritable disease in [the consumer] or [the consumer’s family].”32 Veritas does not state whether myGenome is a clinically valid test. It does, however, characterize myGenome as providing information that may “affect [the consumer’s] health and [is] actionable, be it with changes in diet and activity level, medical screenings, or enhanced vigilance.”33 Nevertheless, it is not clear that Veritas’ findings, at least by themselves, are intended to inform clinical care.34 This interpretation is supported by the company’s informed consent document, which states that “all variants considered clinically relevant in [the consumer’s] report should be confirmed with secondary testing before changes to [the consumer’s] healthcare are made.”32 Veritas uses next-generation sequencing to analyze DNA. The company’s US laboratory is CLIA certified and CAP accredited.
Invitae Corporation
Invitae (San Francisco, CA) offers a cancer susceptibility panel—Invitae Cancer Screen—that consists of 61 genes associated with 10 types of cancer (breast, colorectal, gastric, ovarian, pancreatic, prostate, renal cell, thyroid, uterine, and cutaneous melanoma). In addition, Invitae offers cancer susceptibility testing as part of its Genetic Health Screen, which consists of a 147-gene panel that also analyzes genes related to cardiac diseases and other inherited conditions. Neither test is intended to be diagnostic; both are considered proactive services that are intended for healthy adults without a strong personal or family history of cancer.
Invitae’s Cancer Screen and Genetic Health Screen cost $250 and $350, respectively, and can be ordered by the consumer’s own provider or by a company-provided physician. The ordering provider is notified via e-mail when the results are ready and receives a written report. Consumers who have their test ordered by an independent physician receive an e-mail when the results are ready, at which time they can review their results and schedule an appointment with one of Invitae’s genetic counselors. Post-test genetic counseling is available at no additional cost.
Invitae uses next-generation sequencing and does not report VUS findings for proactive tests. However, if a VUS is reclassified to likely pathogenic or pathogenic, Invitae will inform the ordering physician and issue an updated report. Invitae does not say whether it will contact the ordering physician and issue an amended report for other variant reclassifications. The company also does not state whether either proactive test is clinically valid, although it does provide links to validation studies.35 Regarding actionability, Invitae maintains that consumers can “take action based on [their] results” and “work with [their] provider to consider: increased or earlier screenings, lifestyle modifications, and early intervention to prevent the onset of disease.”36 Invitae’s laboratory is CLIA certified and CAP accredited.
Color Genomics
Color Genomics (Burlingame, CA) offers a test called Color Extended that analyzes genes related to cancer, cardiac disease, and medication response. The test costs $258.95 and includes 30 cancer predisposition genes associated with eight types of cancer (breast, ovarian, uterine, colorectal, melanoma, pancreatic, stomach, and prostate). Color Extended can be ordered by either the consumer’s own provider or by a company-provided independent physician at no additional charge. If the consumer’s own provider orders the test, the provider can choose whether the results are released to the consumer as soon as they are ready or after a delay. For tests that are ordered by an independent physician, information about the process for returning results is not available on the company’s Web site. Consumers who wish to discuss their results can access complimentary genetic counseling.
Color uses next-generation sequencing and reports VUS findings. If a VUS result is reclassified, Color will attempt to recontact the consumer. The company does not state whether Color Extended is a clinically valid test in its entirety. However, there is a section on the Web site where Color discusses the clinical validity of its tests with respect to certain conditions.37 Color Extended is described as being actionable, meaning that the consumer can “work with [their] healthcare provider to create a personalized screening and prevention plan, designed to reduce [their] risk of developing cancer.”38 Color maintains that its test is not diagnostic because “[p]ositive results do not necessarily mean that [the consumer] [has] that hereditary disorder or that [the consumer] will develop the disorder in [their] lifetime” and “[n]egative results do not eliminate [the consumer’s] risk of developing a disorder, and do not guarantee that [the consumer] will be healthy or will never develop any of the disorders that Color tests for.”39 Color’s laboratory is CLIA certified and CAP accredited.
Helix
Helix (San Carlos, CA) offers two tests—GenePrism and Prostate Cancer Genetic Risk Score—that evaluate cancer susceptibility. Whereas both tests are sold by Helix, GenePrism is administered by PerkinElmer Genomics, and Prostate Cancer Genetic Risk Score is administered by NorthShore University HealthSystem. The tests can only be ordered by a physician who is affiliated with the relevant partner company.
GenePrism analyzes the 59 genes included in the American College of Medical Genetics and Genomics’ list of actionable genes, of which 26 are associated with an increased risk of cancer.40 The test costs $299.99, including a $30 fee that covers the ordering physician and genetic counseling services. The test is “intended to provide proactive health insights for those who do not have a significant family history associated with the health conditions that it includes.”41 The consumer is notified by e-mail when the results are ready to be accessed through the GenePrism Web site. Helix does not explicitly state whether the test is clinically valid. GenePrism is not a diagnostic test and “is not intended to diagnose any medical conditions” and “will not tell you if you currently have one of the conditions covered by the test, or if you definitely will or will not develop the condition in the future.”41 The test does not report VUS results. Helix describes the test as actionable, which, according to the company, means that “if [the consumer] learn[s] of a genetic risk from the test, [the consumer’s] risk is significantly increased over the general population, and there are actions [the consumer] or [the consumer’s] doctor can take to reduce [the consumer’s] risks based on established medical recommendations.”41 Helix does not explain its procedures for recontacting consumers about variant reclassifications, although the company does maintain that “[r]esults may change as research continues to allow us to better interpret what these and other genes mean for health.”41
Prostate Cancer Genetic Risk Score is an outlier among DTC cancer susceptibility tests. Unlike other tests that focus on single-gene mutations, Helix’s test provides a polygenic risk score based on an analysis of numerous SNPs that affect prostate cancer. The test costs $239.99, which includes a $40.00 fee that covers the ordering physician and genetic counseling services. Helix does not state whether the test is intended for individuals with a personal and/or family history of prostate cancer. Results are returned through secure e-mail. Helix maintains that the test is not a diagnostic product because “[a]n estimate of [the consumer’s] risk does not determine if [the consumer] will or will not get prostate cancer.”42 Helix does not state whether the test is clinically valid or whether results are medically actionable.
Helix uses next-generation sequencing to analyze DNA. For both GenePrism and Prostate Cancer Genetic Risk Score, genetic counseling is available through Genome Medical at no additional charge. Helix’s laboratory is CLIA certified and CAP accredited.
PART II. ASPECTS OF TESTING THAT COULD AFFECT INFORMED DECISION MAKING AND THE INTERPRETATION OF RESULTS
Section:
Meaning of Terms
In describing their offerings, several companies use terms that they do not clearly define. For example, Invitae characterizes its proactive tests as medical grade and diagnostic grade. Except to say that its proactive tests “offer the same clinical quality as a diagnostic test,” the company does not explicitly define either of these terms.43 Similarly, Color characterizes its offering as an “affordable clinical-grade test,” but does not specify what the term clinical grade means. Of note, despite describing these tests as medical, diagnostic, or clinical grade, both Invitae and Color maintain that their services are not intended to be diagnostic.39,43 Consumers who are unclear about the meanings of these terms, none of which are scientific or medical designations, may struggle to understand why a test that is marketed as medical-, diagnostic-, or clinical grade should not be used in a diagnostic capacity.
In addition, given that tests are often characterized as being medical, diagnostic, or clinical grade, consumers may wonder whether their results could expose them to potential insurance discrimination. According to the Genetic Nondiscrimination Act (GINA), it is illegal for US health insurance providers to use genetic information, including from DTC tests, to deny coverage or increase premiums. GINA, however, does not apply when an employer has fewer than 15 employees or to other forms of insurance (eg, disability insurance, long-term care insurance, and/or life insurance).44 Although all of the companies seem to provide some information on their Web sites about genetic discrimination, discussions about how consumers’ results could affect their access to different types of insurance is often covered during pretest counseling, which may be lacking in the DTC setting.
Companies could also be more transparent about whether their tests can accurately predict an individual’s risk of developing a particular disease—that is, whether they are clinically valid. Most DTC cancer susceptibility genetic tests analyze an array of genes that encompass a wide range of risk estimates. Whereas some of the genes included in these tests have well-established risk estimates, not all do. For example, Color and Veritas’ tests include the MITF gene.45,46 Although MITF mutations are suspected to increase the risk of melanoma and renal carcinoma, the extent to which a mutation carrier’s risk is elevated remains unclear.45,47 Overall, consumers might benefit from greater clarity about which genes in a test are considered clinically valid. Providing this information in a transparent and accessible manner could help consumers decide whether to pursue a test that may include genes with low predictive value for cancer risk.
Use of Consumers’ Health Information
Companies with testing services that can be ordered by a company-provided physician often ask consumers to answer a set of questions about their personal and family health history; however, it is not always clear how ordering physicians use this information. For example, Veritas maintains that consumers’ responses to these questions “are necessary to sequence [their] DNA and also helps [Veritas] better interpret [their] results.”48 Nevertheless, Veritas does not clarify how this information factors into the ordering process. As consumers consider whether to purchase a test, they may be interested in learning how their health information will be used. In particular, they might want to know whether the physician will follow up to discuss their health history before ordering testing. Consumers might also wonder whether company-provided physicians ever decline to order testing and, if so, for what reasons.
Genetic Counseling
Although all of the companies that offer physician-ordered DTC genetic tests seem to provide genetic counseling in some capacity, the extent, timing, and cost of these services is sometimes unclear. For example, Invitae maintains that “[o]ur team of board-certified genetic counselors is available on demand by phone during business hours to assist you with general questions about genetic testing and your results.”49 What remains unclear (for Invitae and some of the other companies) is the extent to which pretest counseling is comprehensive and individualized. In the clinical setting, pretest counseling is widely regarded as an important part of obtaining informed consent to testing.50,51 Companies could therefore help consumers make informed choices about whether to pursue DTC testing by including more information on their Web sites about pretest counseling.
Currently, companies differ in terms of how they provide genetic counseling. Helix, for example, outsources its genetic counseling to Genome Medical, which is a distinct corporate entity from Helix.41 Other companies, such as Invitae, offer in-house counseling that includes pretest counseling.49 This arrangement raises potential ethical concerns about whether a conflict of interest arises when companies provide pretest counseling services for their own tests.52,53
Procedures for Returning Results
Most of the companies that offer tests through the physician-ordered model do not include a detailed description of their process for returning results. On the basis of the companies’ online materials, it may not be clear whether procedures vary depending on the clinical significance of consumers’ results. Are positive and VUS results disclosed over the phone by a genetic counselor, while negative results are delivered through an online portal? Again, providing more information could help consumers make informed decisions about whether they are comfortable with a company’s model for returning results.
Role of Company-Provided Physicians
For some of the companies that offer company-provided independent physicians, it is unclear what role, if any, these physicians play beyond simply ordering tests. It is also not clear how companies conceive of the relationship between consumers and these physicians, some of whom may belong to an external physician network or separate company.54 For example, Helix states that the company “will share [the consumer’s] contact information and health history with PerkinElmer Genomics so a physician they designate can review and make sure this product is right for [the consumer].”41 Consumers may wonder whether they can contact the ordering physician with additional questions about the test or their results. Notably, will the ordering physician assume responsibility for a consumer’s follow-up care or refer the consumer to another provider? As of now, these questions are not easily answerable from companies’ online materials.
Variant Reclassification
As scientific understanding of variant pathogenicity evolves, genetic test results may be amended. Some changes could have significant clinical implications for disease risk and medical management (eg, a VUS that is upgraded to pathogenic). Nevertheless, information about companies’ procedures for handling amended results may not be readily available. Color’s Informed Consent, for instance, lacks specific information about how the company manages variant reclassification beyond stating that it may “at its sole discretion, amend or modify [the consumer’s] Test report” and will “attempt to notify (the consumer) of any material amendments or modifications.”39 Some companies, however, do not provide any information about variant reclassification. Helix’s informed consent, for instance, notes that “future information may change your results,” but does not specify whether the company monitors for variant changes or notify consumers about them.55 Given the potential clinical significance of variant reclassifications, consumers could benefit from more information about companies’ procedures for tracking variant changes and sharing amended results.
In conclusion, genetic testing for cancer susceptibility, once limited to the clinical setting, is now widely available through Web-based DTC genetic testing companies. To better understand whether test takers are knowledgeable about companies’ testing procedures, there is an urgent need to collect and study consumer outcome data.13 As the DTC market continues to evolve, outcome data should inform companies’ products and practices to ensure that consumers are equipped to make informed decisions throughout the testing process and understand their results.
CNBC’s ‘Halftime Report’ investment committee, Steve Weiss, Jim Lebenthal, Joe Terranova and Liz Young discuss the state of the market and futures.
04:08
Mon, Jul 11 202212:38 PM EDT
While designing Global Medical Device Testing Market research report, marketing administration has carefully considered the minds of their target markets, their feelings, their preferences, their attitudes, convictions and value systems with a formalized and managerial approach. For the accomplishment of business at local, regional and international level, this high quality global market research is an ultimate solution. The research studies accomplished in the world class Global Medical Device Testing Market business report helps to guess several important aspects that includes but are not limited to investment in a rising market, success of a new product, and expansion of market share.
Data Bridge Market Research analyses that the medical device testing market to be grow at a CAGR of 10.8% in the forecast period of 2022-2029 and is likely to reach the USD 28.89 billion by 2029.
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The process of checking the design and production efficiency of diverse active and non-active medical equipment is known as medical device testing. Prototype, biocompatibility, chemistry, microbiology, and sterility testing, packaging validation, electrical, mechanical, and functional safety evaluations, and software testing are all part of this process. Cardiovascular, neuro, and orthopaedic devices, as well as dental implants and material components, are subjected to these examinations. Consumers can also get in-house or outsourced testing, inspection, and certification services from the service providers. These services ensure that the equipment is trustworthy and safe to use in clinical and emergency situations.
The rise in the demand for more strict regulatory standards in new medical devices will act as major driver accelerating the medical device testing market’s growth rate. Another significant factor resulting in the expansion of market is the growing demand for validation and verification of medical devices. Furthermore, surging trend of outsourcing medical device testing services and imposition of rigorous government regulations are the major drivers that will enhance the growth of market. Likewise, rise in the complications in product design, widespread adoption of outsourced testing services and rapid urbanisation will show positive impact on the market’s growth rate. Growing healthcare expenditure and rise in the level of disposable incomes in developing and developed countries will influence the growth rate of medical device testing market.
Moreover, the addition of mobile and medical devices and advancement in medical technology will provide beneficial opportunities for the medical device testing market growth. Additionally, the rise in the development of internet of things (IoT) and artificial intelligence in various medical devices will further expand the medical device testing market’s growth rate in the future.
On the other hand, high cost of medical devices and long lead time for overseas qualification tests are factors that will obstruct the market growth. Also, complex nature of global supply chains will challenge the medical device testing market. However, lack of healthcare professionals and the less awareness will act as restrain and further impede the growth rate of market.
This medical device testing market report provides details of new accurate developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on medical device testing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Some of the major players operating in the medical device testing market are Charles River Laboratories International, Inc., Biomedical Device Labs, SGS SA, Bureau Veritas, Intertek Group plc, TUV SUD South Asia Pvt. Ltd., TÜV RHEINLAND, UL LLC, Eurofins Scientific, ASTM, Element Materials Technology, Avomeen, Gateway Analytical, MEDISTRI SA, Pace Analytical Services, LLC, WuXi AppTec, TOXIKON, Source BioScience., NSF International., Stable Micro Systems, and Surpass, Inc., among others.
Browse the complete table of contents at – https://www.databridgemarketresearch.com/toc/?dbmr=Global-Medical-Device-Testing-Market
Global Medical Device Testing Market Scope and Market Size
The medical device testing market is segmented on the basis of services, sourcing, device class and technology. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.
Based on services, medical device testing market is segmented into testing, inspection and certification.
Medical device testing market is segmented based on sourcing into in-house and outsourced.
Based on device class, medical device testing market has also been segmented into class I, class II and class III.
Medical device testing market has also been segmented based on technology into active implant medical device, active medical device, non-active medical device, in-vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device and other. Other segment is further segmented into mobile devices, medical devices with ancillary medicinal substances, medical devices utilizing animal origin.
To Gain More Insights into the Market Analysis, Browse Summary of the Research [email protected] https://www.databridgemarketresearch.com/reports/global-medical-device-testing-market
Global Medical Device Testing Market Scope and Market Size
The medical device testing market is segmented on the basis of services, sourcing, device class and technology. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.
Based on services, medical device testing market is segmented into testing, inspection and certification.
Medical device testing market is segmented based on sourcing into in-house and outsourced.
Based on device class, medical device testing market has also been segmented into class I, class II and class III.
Medical device testing market has also been segmented based on technology into active implant medical device, active medical device, non-active medical device, in-vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device and other. Other segment is further segmented into mobile devices, medical devices with ancillary medicinal substances, medical devices utilizing animal origin.
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DECATUR, Ill. (WAND)- HSHS St. Mary’s Hospital has appointed a new chief medical officer.
Vinil Bhuma, MD, MBA, CPE, FAAFP, FACMQ, SFHM will start his new role July 11, 2022.
“We are excited to officially welcome Dr. Bhuma to our leadership team today. We look forward to advancing the mission of our organization together,” said Theresa Rutherford, HSHS St. Mary’s Hospital President and CEO. “His many years of experience and expertise will benefit our health care services and community. We also thank Dr. Ryan Jennings, CMO of our sister ministries, for successfully supporting St. Mary’s as we sought to fill the CMO position permanently.”
According to the Hospital, Dr. Bhuma came to St. Mary’s Hospital from UnityPoint Health-Trinity Regional Medical Center in Fort Dodge, Iowa where he was chief medical information officer as well as the president of the medical staff.
Dr. Bhuma served as chair of the board of health and medical director for the Webster County Health Department in Iowa, and on a national level, is the current chair for the accreditation advisory board for the Det Norske Veritas (DNV) accreditation organization and vice-chair of the professional certification board for Healthcare Information and Management Systems Society (HIMSS).
Prior to his service at Trinity Regional Medical Center, Dr. Bhuma was a medical director at Good Samaritan Hospital in Vincennes, Indiana, specialized as a hospitalist, and served patients at Memorial Hospital in South Bend, Indiana and Aspirus Wausau Hospital in Wausau, Wisconsin.
Dr. Bhuma completed his residency at the University of Alabama at Birmingham Family Medicine Residency in Huntsville, Alabama where he was also chief resident for a year.
In addition, he has a Master of Business Administration from Kelley School of Business at Indiana University in Indianapolis, Indiana.
“I look forward to serving the Decatur community,” said Dr. Bhuma. “My new hospital colleagues and new community neighbors have already welcomed me so warmly. I know my family and I will create roots and experience joy here in the coming years.”
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