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Clinicians please remain vigilant, and compassionate

DEA Laboratory Testing Reveals that 6 out of 10 Fentanyl-Laced Fake Prescription Pills Now Contain a Potentially Lethal Dose of Fentanyl

WASHINGTON – The U.S. Drug Enforcement Administration is alerting the public of a sharp nationwide increase in the lethality of fentanyl-laced fake prescription pills.  

The DEA Laboratory has found that, of the fentanyl-laced fake prescription pills analyzed in 2022, six out of ten now contain a potentially lethal dose of fentanyl. This is an increase from DEA’s previous announcement in 2021 that four out of ten fentanyl-laced fake prescription pills were found to contain a potentially lethal dose.

“More than half of the fentanyl-laced fake prescription pills being trafficked in communities across the country now contain a potentially deadly dose of fentanyl. This marks a dramatic increase – from four out of ten to six out of ten – in the number of pills that can kill,” said Administrator Anne Milgram. “These pills are being mass-produced by the Sinaloa Cartel and the Jalisco Cartel in Mexico. Never take a pill that wasn’t prescribed directly to you. Never take a pill from a friend. Never take a pill bought on social media. Just one pill is dangerous and one pill can kill.”

Last year, the DEA issued a Public Safety Alert on the widespread drug trafficking of fentanyl-laced fake prescription pills in American communities. These pills are largely made by two Mexican drug cartels, the Sinaloa Cartel and the Jalisco (CJNG) Cartel, to look identical to real prescription medications, including OxyContin®, Percocet®, and Xanax®, and they are often deadly. In 2021, the DEA seized more than 20.4 million fake prescription pills. Earlier this year, the DEA conducted a nationwide operational surge to target the trafficking of fentanyl-laced fake prescription pills and, in just over three months, seized 10.2 million fake pills in all 50 states. Through its One Pill Can Kill campaign, the DEA is working to alert the American public of the dangers of fake prescription pills. 

Fentanyl remains the deadliest drug threat facing this country. It is a highly addictive synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine.  Just two milligrams of fentanyl, the small amount that fits on the tip of a pencil, is considered a potentially deadly dose. According to the CDC, 107,622 Americans died of drug poisoning in 2021, with 66 percent of those deaths involving synthetic opioids like fentanyl.  The Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals largely sourced from China, are primarily responsible for the vast majority of the fentanyl that is being trafficked in communities across the United States.

For more information on the dangers of fentanyl, please visit Fentanyl Awareness (dea.gov).

RSV Cases are rising. Here’s what you need to know.

Before the Covid pandemic, most people caught respiratory syncytial virus before the age of 2. Now things have changed. You may have seen respiratory syncytial virus, or R.S.V., in the news recently, as rates of the virus have ticked up across the United States. R.S.V. usually circulates from late December to mid-February. But this year, an early spike in cases is resulting in markedly higher numbers of infections and hospitalizations. As rising R.S.V. rates coincide with the expected wintertime surge in Covid-19 as well as an early flu season, experts are worried about a “tripledemic” and the strain it could place on hospitals and emergency departments that are already stretched thin. What is R.S.V. and why is it on the rise? R.S.V. is a common winter virus that typically causes mild cold-like illness in most people, but can occasionally be very dangerous for young children and older adults, said Emily Martin, an associate professor of epidemiology at the University of Michigan School of Public Health. “The youngest infants have a high risk of coming into the hospital in what we call their first R.S.V. season,” Dr. Martin said. “If a child is born in the summer and they get exposed for the first time in the winter, they are at risk of having more serious disease. But many infants didn’t experience the first R.S.V. season on the regular schedule that they would have, particularly if they were born in or after 2020.” In a normal prepandemic year, 1 to 2 percent of babies younger than 6 months with an R.S.V. infection may need to be hospitalized. And virtually all children have gotten an R.S.V. infection by the time they are 2 years old. But many experts believe masking, social distancing, school closures and other precautions taken during the first year or two of the pandemic protected most children from exposure to the virus and other germs. “As a result, there are still many children who are less than 3 years old who’ve never been exposed to R.S.V.,” said Dr. James Antoon, an assistant professor of pediatrics at Monroe Carell Jr. Children’s Hospital

https://www.nytimes.com/article/rsv-symptoms-treatment.html?smid=url-share

Moderna Says New Covid Booster Strengthens Immune Response Against Subvariants

A study suggested that the updated booster shot produced higher levels of neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 than the first booster, the company said.

https://www.nytimes.com/2022/11/14/us/politics/moderna-booster.html?smid=url-share

WASHINGTON — A new study by Moderna suggests that its updated coronavirus booster strengthens a key component of the immune system’s defense against the Omicron subvariant that accounted for most infections in the United States in recent months.

The company announced the findings in a news release on Monday. The underlying data has not yet been published or peer-reviewed, but it has been reviewed by federal regulators.

The data indicates that Moderna’s new booster generates significantly higher levels of neutralizing antibodies against the subvariant, BA.5, and another Omicron subvariant, BA.4, than the previous booster, the company said. The federal government replaced the original boosters from Moderna and Pfizer-BioNTech with updated shots in September.

The study is the largest to date of one of the new shots, comparing hundreds of people who received either the updated booster or the original one.

While federal officials said they were heartened by the findings, the data underscored the problem in chasing a virus that invents new defenses against immunization faster than vaccine manufacturers can design and produce modified shots. The government is confronting a crowded landscape of fast-moving Omicron subvariants that threaten to evade the population’s immunity from vaccinations and previous infections.

When the government first decided on the makeup of the new booster this past summer, it targeted BA.4 and BA.5. The latter of those subvariants was responsible for a vast majority of infections in the United States in the summer and early fall, and it still accounts for about 30 percent of cases. Another fast-growing Omicron subvariant, BQ.1.1, could become dominant by Thanksgiving, said Dr. Stephen Hoge, the president of Moderna.

Dr. Hoge said the company’s lab tests suggested that the new booster also produced robust levels of antibodies against that surging subvariant, although far fewer than against BA.4 and BA.5. He cautioned that the BQ.1.1 tests were preliminary and involved only 40 participants.

Pfizer announced similar findings this month about the antibodies produced by its updated booster against BA.4 and BA.5. But neither Pfizer nor Moderna can say whether the revised shots result in less disease.

The Centers for Disease Control and Prevention is overseeing studies of the vaccines’ effectiveness, but those take significantly more time than studies of antibodies that form the body’s first line of defense. Results are not expected for months.

Among those who had a prior coronavirus infection, the company said, the updated shot produced about five times the level of antibodies against BA.4 and BA.5 as the old shot produced. Among those with no prior infection, the new shot induced more than six times the level of antibodies as the old shot. The results were consistent among both older and younger adults, Moderna said.

Those findings seem to dovetail with Pfizer’s study. Among 76 participants over age 55, the company said that the level of antibodies in those who had received its updated booster was four times as high as in those who had received the original one.

In Moderna’s study, Dr. Hoge said, the group that received another dose of the original booster and the group that received the new booster were comparable in age and rates of prior infection.

But there was a difference in when the two groups received their shots. A majority of those who received a second dose of the original booster got it in the spring, about four months after their last shot, Dr. Hoge said. Most of those who received the updated booster got it about nine months after their last shot.

Some outside scientists have questioned whether that factor could account for the higher antibody levels in people who received the updated booster — a criticism they also leveled against Pfizer’s study.

Neither company “controlled for length of time after the last dose,” Dr. Offit said, adding, “There are a lot of problems with that.” He said the longer interval after the third dose could have strengthened the immune system of participants who received the updated booster, leading to higher antibody levels.

Dr. Hoge said a detailed analysis of the data showed that the difference in timing of the doses did not explain the difference in antibody levels.

Test Result Emails

If you have not received an email with your test results within 24-48 hours, please remember to check your spam folder. If you still don’t see an email from Trilab, please contact us at info@trilabhealth.com for further assistance.

Masks Cut Covid Spread in Schools, Study Finds

In a so-called natural experiment, two school districts in Boston maintained masking after mandates had been lifted in others, enabling a unique comparison.

Masks have been a cultural flash point since the start of the pandemic, and mask mandates in schools have been especially incendiary. Critics have argued that there is no strong evidence to prove that masks slow the spread of Covid, and that in any case children weren’t wearing the right kinds of masks or weren’t wearing them properly.

Now a research paper details a so-called natural experiment that occurred when all but two school districts in the greater Boston area lifted mask requirements in the spring. Researchers took that opportunity to make a direct comparison of the spread of Covid in masking and non-masking schools.

The bottom line: Masking mandates were linked with significantly reduced numbers of Covid cases in schools.

https://www.nytimes.com/2022/11/10/health/covid-schools-masks.html?smid=url-share

COVID-19 was third leading cause of death in the United States in both 2020 and 2021

COVID-19 was the third leading cause of death in the United States between March 2020 and October 2021, according to an analysis of national death certificate data by researchers at the National Cancer Institute, part of the National Institutes of Health. The study appears July 5 in JAMA Internal Medicine. During the 20-month period studied, COVID-19 accounted for 1 in 8 deaths (or 350,000 deaths) in the United States. 

https://www.nih.gov/news-events/news-releases/covid-19-was-third-leading-cause-death-united-states-both-2020-2021#.YsWzAExKajM.twitter

The Concept of Classical Herd Immunity May Not Apply to Covid-19

There has been speculation about when in the coronavirus disease 2019 (COVID-19) pandemic we will be able to live with the virus in a manner that does not disrupt most peoples’ lives. Much of this discussion has focused on herd immunity thresholds. As commonly understood, herd immunity thresholds are reached when a sufficient proportion of the population is vaccinated or has recovered from natural infection with a pathogen such that its community circulation is reduced below the level of significant public health threat. For example, this threshold has been met with polio and measles circulation in the United States. However, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, is so different from polio and measles that classical herd immunity may not readily apply to it. Important differences include the phenotypic stability of polio and measles viruses, and their ability to elicit long-term protective immunity, compared to SARS-CoV-2. For these and other reasons, controlling COVID-19 by increasing herd immunity may be an elusive goal.

https://doi.org/10.1093/infdis/jiac109

Why COVID-19 tests are in short supply and results are delayed

Well, COVID testing across the US has been plagued by long lines and wait times topping three hours in some cities. And that has led to a lot of frustration ahead of the Christmas holiday. The seven day average, by the way, of testing across New York City alone has more than tripled since the low that we saw in July. More than 120,000 tests conducted on just one day, December 19, according to the latest data out of the city.

Let’s bring in Gerald Commissiong, Todos Medical CEO. And Gerald, you know, I’m looking at that number, there’s another set to that data, which says the amount of tests that were returned within one day, just 54%, and that is a 75% drop from that low we saw in July.

So what needs to be sorted out here? It feels like we’re two years into the pandemic, we shouldn’t be having these testing issues and yet here we are talking about long lines again.

GERALD COMMISSIONG: Well, you know, there are a number of issues that lead to long lines and testing. The first one, of course, is actually getting the swab into the nose and then getting that sample back to the lab. So when you think about that, the biggest issues that we’ve seen across the country are shipping.

So now COVID testing samples, if they’re being shipped to a location that’s not near where the sample’s collected, they’re competing with Christmas presents, with FedEx and UPS, to get to the destination. So that’s step one. Step two, is actually once the sample gets into the lab, how quickly can it get onto a machine.

And that’s the accessioning process. And oftentimes there’s a lot of automation issues because of HIPAA and other compliance for privacy that create long lines in terms of actually getting that information into the system. And then number three, once it’s on a machine, how quickly can the machine process those samples when there’s a huge crunch, and that boils down to automation.

And unfortunately, a lot of the labs that scaled up for automation last year for COVID testing, when the lull happened and there wasn’t really a lot of government support for ongoing surveillance testing, they went back to doing other tests, that are required for cancer screenings and other types of molecular testing.

And so their capacity to actually process those COVID tests is down. So when you combine those three things, you get long lines and you get long delays in getting tests. And until we really put this type of infrastructure in the routine testing, every day testing, so that there is an incentive for labs to keep this going for the long haul so that when there is a spike you don’t have these delays, because that’s the time when you need them the most, this is just going to continue.

AKIKO FUJITA: I know Todos Medical has your own testing as well. And we should note that it’s the only testing that allows you to see how many antibodies you have. We can get into that in just a bit. But in terms of being able to meet this demand that we’re seeing, what is your capacity look like and how are you ramping up production to be able to get those tests out?

GERALD COMMISSIONG: Yes, sure, so we have two different areas of our business. We have our own testing lab at Provista Diagnostics in Atlanta, Georgia, where we have capacity to do upwards of 20,000 tests a day. We invested heavily in automation. And we’ve really been upgrading our staff to be able to address each one of those bottlenecks that I just described.

So for us actually performing the test and getting results out, we’ve thought through a lot of that process and we’re doing that now in the Atlanta area. We also supply through Corona Diagnostics, which is a distribution business to other labs. Of all the reagents needed to run testing, we’ve obviously seen a huge uptick there in the last several weeks.

And really there are a couple of different things. We automate the labs. So we actually have two labs in the New York area that we have put in heavy automation Tecan machines so that they can do upwards of 10,000 tests a day and now they’re pressure testing that capacity, and it’s performing.

So those, what we call, fully loaded package labs, they’re able to turn around quickly because of the automation they have. The shortage of reagents and supplies that you heard the government tell testing labs is coming, we’ve solved that because we stocked up during the lull months.

So in our warehouse, we have those plastics that you see there. Those are going to be in big shortage, pipette tips also in big shortage, those typically come from China. And when China reduce their energy consumption for different industries, plastics take up huge amount of energy. And so plastic supply was reduced, we already have that.

So for us it’s about making sure that our labs have those pipette tips that you see there, have the necessary plastics to actually be able to put the stuff in. And this is going to become a bigger issue now that these oral antivirals are out. You can only take them within a certain number of days. So you need those test results quickly to get the prescription for these antiviral drugs, which we also have in development.

And so we think that this is a critical component. The government needs to invest in this continually to improve the infrastructure so that we don’t have these long delays in not only getting test results, but soon, in actually getting treatments to people that work better the sooner that you give them.

AKIKO FUJITA: There’s a lot of frustration it seems around the inconsistencies around the test results too. What the PCR test is showing versus what a rapid antigen test are showing. One potentially– one’s negative, one’s positive. You know, you mentioned your testing specifically looking at the amount of antibodies. Why is that important moving forward as we try to get through to this next phase in the pandemic?

GERALD COMMISSIONG: Yeah, so really there are three separate things. You know, antigen testing is a form of testing for the virus. There what you’re testing for is the result of the virus. So the virus takes over a cell and then it produces antigen. The antigen ends up on the surface of the cell a few days after you’ve been infected, which is why there’s a lag with these antigen test results.

The PCR test actually test for the presence of the virus itself before the antigen is present, which is why they’re more accurate. And then once you’ve been infected and you start to recover, or if you’ve been vaccinated, then you develop antibodies. And then the antibodies you’re looking for are the neutralizing antibodies. So not all the antibodies, but really the neutralizing antibodies, which are the same ones that you hear the FDA and others talk about increasing in numbers as evidence that the vaccines are working.

So with regard to antigen testing, these are the rapids that people are taking at home every day. The big issue, one is there’s not enough supply. So we know that the government just said they’re going to buy 500 million and distribute them. That’s not nowhere near enough, you know, that’s maybe enough for a month.

But that’s nowhere near enough to actually be able to address the issue. The problem with those people are searching on Twitter is you can be negative in the morning and positive a couple of hours later because the virus is developing to a point where you have enough antigen to show positive.

So from a practical standpoint, what does that mean? That means you can’t really rely on that result for more than a few hours. And when you actually look at the package insert on those antigen tests, they tell you you’ve got to take two in a row. So if you take two in a row two days apart, really you’re just telling yourself that you are probably negative yesterday or two days ago, not so much that you’re negative today.

That’s really the best we have. And when you compare that to PCR, it’s obviously not as good as PCR in the moment, but with PCR, you have the problem with turnaround time that you just suggested. So because you have the problem of turnaround time, you know, that antigen test may be more useful than a PCR test if you have a long turnaround time.

You know, all of those are bad options. The best option, of course, is a PCR test where you get a rapid result and that really needs to become the standard. That’s why this 24-hour resulting is critical and why we need to invest in local labs that can give you those results fast in a short period of time, because that’s what you need.

Then with regards to the antibodies, the antibodies is really all about how much protection do I have? You know, we’ve heard about, OK, you have X number of antibodies, you’re protected against Delta. Oh my God, Omicron came along. It’s much more virulent. It escapes those antibodies, so you need a much higher number of antibodies to be able to protect and to hold on to that Omicron variant in some form or fashion.

Well, you only get those with the booster. And for how long does that booster last? That’s really why you have to monitor those antibody titers to see when it’s likely that you need another booster to be protected.

AKIKO FUJITA: Gerald, we can talk about this for another hour. It is fascinating to learn the science behind all of this, and you know, your explanations are really helping to clear up a lot of confusion that I know our viewers have had. We hope to have you back on the show again soon. Gerald Commissiong, Todos Medical CEO, great to talk to you today.