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Sunday, August 14, 2022

Navy SEAL Kaj Larsen’s Guide to Becoming a Better Swimmer

 Kaj Larsen freely admits that he often feels more at home underwater than on dry land.

Raised next to the ocean in Capitola By-the-Sea, Larsen grew up surfing, playing water polo, and lifeguarding before joining the Navy SEALs. As a member of the maritime component of U.S. special operations, he only expanded his mental and physical ability to succeed while submerged.

As a Lieutenant, Larsen led a team of special warfare personnel in covert operations overseas. He was deployed as a detachment Commander in support of the Global War on Terrorism, and continues his service to this day as a SEAL reserve officer, assigned to the U.S. Special Operations Command. Larsen is also a two-time national champion open-water swimmer, and has offered his talents to missions with Team Rubicon Global. Throughout the year he participates in charity events like the Navy SEAL Hudson River Swim to raise money and visibility for veterans.

We recently sat down with Larsen to chat about the experiences that led him to be a great waterman, and how the rest of us can attack the surf more like a Navy SEAL.

Courtesy of Kaj Larsen

InsideHook: Do you remember your first experience in the water?

Kaj Larsen: My introduction to the water came very early from my parents. My mother took me out to look at the waves on the day I was born. My father was a great athlete, swimmer, and a Marine. He subscribed to this ancient Russian baby-raising technique, which states that babies aren’t afraid of the water during their first six months of life. So, much to my mother’s shock, he brought me into the pool when I was around three months old. I survived that early initiation, and actually was fine when he took me down to the bottom. I think those early experiences definitely influenced who I’m, as well as growing up in the Santa Cruz area where there is a strong tradition of watermen. From there I suppose it was a natural evolution that I joined the Navy SEALs.

What was it like doing water training to join the Navy SEALs at Basic Underwater Demotion/SEAL Training (aka BUD/S)?

The water portion was my favorite part of BUD/S, but during that training you do have this complex relationship with the water. The ocean can be beautiful and calming, but it can also be extraordinarily dangerous. One of the most punishing challenges that they put you through is called “Surf Torture,” where you are linked arm-in-arm with the rest of your class while the cold waves crash on you, plummeting your body temperature. This continues until you’re near-hypothermic and can’t stop shivering. There is so much made of all the physical challenges, like the log carrying or the obstacle course, but that cold water is what saps most guys’ will to keep fighting. It’s those evolutions where guys are cold, wet, and hungry that really get them running to ring the bell and give up. They can be so tough and punishing that I’ve seen guys coming out of the experience with aqua-phobia or some sort of fear of the water. 

Can you describe the kinds of swims and underwater drills you were required to do in BUD/S?

One of the tests is a 50-meter underwater swim that starts out with a summersault. The passing standard doesn’t require you to get out of the pool yourself, you just need to make the wall. Most people who do this test are pretty much tapped by the time they make it to the wall. There are a lot of occasions where guys will black out once they make the wall and need to be pulled out to be given oxygen to recover. The second phase of BUD/S is the dive phase and there is a part of that called pool competency. The instructors take you through seven levels of effort and you have to pass all of them to move onto combat diving. One of the constant elements throughout is a drill they call “sharking” where they are basically beating you up underwater. They’ll try to throw you off your game underwater, hitting you and tying your regulator up into knots so that you can demonstrate your ability to keep calm underwater with out oxygen. 

Did you have a particular challenge during that training that was the most difficult for you personally and required you to push yourself to an extreme?

I was the best waterman in the class, winning pretty much every swim in BUD/S. But that ability didn’t make the very technical challenges any less difficult. I remember during the final effort I had two instructors messing with me while I was breathing through a double-hosed regulator in a 15-foot pool. They tied my regulator in a very specific knot, forcing me to work with no air available to get it untied. So apparently during this test the diver, aka me, is supposed to recognize that the knot is impossible to untie and give up. It’s a pretty serious knot called the “whammy knot”. I remember the feeling that I had in that moment, and it was that I didn’t want to fail. Failure was not an option. So the instructors came down, hit me, ripped my mask off, beat me up a bit, and then turned my air off that way. I was so afraid of failing in that moment that I stayed down there on a two-minute breathe hold until I did eventually untie the knot. So, basically, even though I didn’t complete the mission as they expected, I did pass. That was probably one of the most challenging moments I’ve had during training. 

Is there a particular way of swimming that you perform in the SEALs that can’t be found elsewhere?

One of the more important swimming methodologies that we learn in the SEALs is the combat sidestroke. We learn it because it’s a very efficient way of moving through the water, and less visible than other strokes for when we need to swim on the surface. I helped some of my fellow SEALs learn it in BUD/S and there are a lot of videos out there where you can see how it plays on the surface.

Over these years of training in the water, what do you believe are the best practices for becoming a better swimmer?

There are two basic components to succeeding underwater: the physical and the mental. The physical element starts with breath-hold training and breathwork, which can be improved like any aspect of physical performance. I first began really contemplating breathwork not in relation to diving, but instead during my marksmanship training in the military. One of the things that we do in sniper training is steady the body for a better shot by sticking to a specific breathing pattern. I expanded that philosophy naturally into my swimming as well.

There are also technical things that you can do, like holding your breath while exerting. There are charts and exercises that you can follow to increase your CO2 or carbon dioxide tolerance. People forget it’s not the lack of oxygen that signals the body’s need to breathe, it’s actually the build up of carbon dioxide. Back in the old days of free-diving we used to just scrub the carbon dioxide off our bodies, the problem being after a few minutes if you continued to push yourself you would pass out. That was a dangerous way to free dive and we don’t do it that way anymore.

But there are stretching techniques that you can employ to expand this bird cage or ribs that hold our lungs. I find it interesting that breathing is the very first and the very last act of our lives, yet we rarely think about the breathing that happens between. Humans have the ability to breath consciously and unconsciously, which not every animal has. Dolphins for example only breathe consciously, they have to think about every breathe they take and when they sleep the one hemisphere of the brain stays active to make sure they breathe. One of the ways that you can improve is to start focusing on the breathing and being more present for those breaths. Almost everything you do in life can be made better by taking a conscious breath. 

Is there any kind of specific workout that you do inside the gym and outside of the water that directly translates to performing better during your swims?

I would say any kind of cross-training is going to benefit you in athletic endeavors like swimming. Being lighter, leaner, faster, stronger is going to have tremendous horizontal transfer into swimming better. I’ll incorporate breath holds into my sprints during my workouts. There are a lot of people who have strong enough legs to do a ten-kilometer run, but they’re limited by their conditioning. The same circumstances apply to swimming. Movements like pull-ups and rowing are great for improving your swimming because of their emphasis on the latissimus dorsi and the similar motions made by the body. Explosiveness should also be included into the training. There is always the caveat that you don’t want to show up to the water looking like the Hulk. Ideally your physicality is more lean and torpedo-like. 

How about the mental aspect you mentioned?

I’d say the most important key in any water environment is your state of mind and ability to relax underwater. The majority of people who drown do so because they lose their composure. They get in this vicious cycle where their mind is convincing them they need more oxygen than they really do. That is when they start to get more frenetic and they start burning though the oxygen that they do have. Being calm underwater is not just the secret to success, but also the secret to survival. 

Do you have any rules that you follow no matter what when pushing yourself underwater?

The first rule to doing anything like free-diving or breath-hold training is to adhere to the buddy system. There have been too many instances where people have done hypoxic training until they passed out and died because nobody was with them. In the SEAL Teams we preach that you never leave your swim buddy. The second rule is to know your environment, nobody should be venturing out into big surf before first spending plenty of time in small surf. There are granularities and micro-components of the ocean that are not readily visible to the layman’s eyes. Like how a wave’s color can change from blue to green because of the way the light filters through it right before it’s going to break. Most people just see a one huge body of water when they look at the ocean, and not all of the dynamism. Really good watermen can read all of those micro-expressions and use them to position themselves in the most advantageous place. 

The ability to withstand cold water scenarios is drilled quite a bit with exercises like the “Surf Torture”… have you seen benefits to that kind of practice since?

The adaptability of the human condition never ceases to amaze me. The fact is, if you put yourself in cold water scenarios often you are going to be better at tolerating it. I don’t think that it’s only about increasing your ability to withstand cold water mentally, but there are also significant benefits physiologically. That is why I subscribe to ice baths. There are benefits like cold shock proteins and heat shock proteins. I was really exposed to this more deeply thanks to Laird Hamilton, who was the one who got me into the practice of going back and forth between ice baths and hot saunas to engage those proteins.

Do you have any places that you go these days to elevate your training underwater?

The kind of underwater training that I practice is still pretty esoteric. I hope that that kind of training will become more widely available. There are a couple great examples like Laird’s program XPT which includes great breath work. Laird has been my guru through many new practices that I’ve incorporated into my life. I also have a couple of friends — Don Tran and Prime Hall — who started a program called Deep End Fitness, which has a game associated with it called Underwater Torpedo League. It’s basically football meets lacrosse, and you throw this football around while submerged. 

For those really trying to take on the ocean for the first time, do you have any advice on how to attack the surf better?

The first step you should take is to go under the surf and grab the sand. Get as low as possible and watch that wave pass over you. If you keep your eyes open you will be more aware of when to get flatter, and closer to the bottom like a halibut. Far too many people try to go up over the wave when the safest place to be is below that crest when it’s on you. The pro tip is to keep your eyes open because you can actually see the cloud coming underneath the wave that’s breaking and that’s where you are going to be feeling the turbulence. That’s what’s going to smash you down and pull you into the shore. Much like how everything is better when you are focusing on your breath, you are better prepared to take on everything when your eyes are open. 

https://www.insidehook.com/article/health-and-fitness/become-better-swimmer

Following the Money 'Related company' transactions in New York’s nursing home industry

The tragic impact of the coronavirus pandemic in New York’s nursing homes has revived debate about how the industry operates, including how it handles the Medicaid and Medicare money that makes up the bulk of its revenue.

A particular concern relates to the proliferation of “related companies” in the nursing home business.

It’s increasingly common, in New York as in other states, for nursing homes operators to structure themselves as networks of interlocking companies. They typically establish a separate company to own each facility in their chain, and sometimes create additional companies to hold the real estate. Other side businesses supply shared services such as physical therapy, payroll processing or liability insurance.

In many cases, these various companies are owned by the same set of people – or by their family members and business partners – and outwardly function as a single organization.

These practices have become a focus of criticism from watchdog groups and some policymakers. They contend that nursing homes operators use “related company” transactions to divert money away from patient care and disguise the true profitability of their businesses.

In recognition of these risks, federal officials have directed nursing homes to keep their payments to related companies in line with market prices.

According to CMS reporting guidelines, payments to related companies “must not exceed the amount a prudent and cost-conscious buyer would pay for comparable services, facilities, or supplies that could be purchased elsewhere.” Critics contend that this guideline is widely disregarded.

Industry officials defend the use of related companies as a strategy for limiting exposure to lawsuits, managing tax bills or saving money on supplies by buying in bulk. They point out that the transactions are subject to extensive disclosure requirements, potential audits by the Office of Medicaid Inspector General and in some cases advance review by the Health Department.

A review of nursing home financial reports gathered by the state sheds light on this policy debate.

The reports for 2020 show that some related companies barely broke even or lost money while others realized double-digit margins. Profit rates were especially high among the real estate firms that held title to the facilities and collected rent from the operating companies.

Overall, the use of related companies was widespread and growing, and they accounted for about two-thirds of operators’ net income.

Key patterns and trends include:

  • Seventy-two percent of the state’s for-profit nursing homes do at least some business with companies that have common or overlapping ownership.
  • The homes’ payments to related companies totaled more than $1 billion, or 16 percent of their operating expenses.
  • These secondary businesses typically made most of their money – and in some cases all of their money – from nursing homes with related ownership rather than arm’s-length business deals.
  • The aggregate profit margin for these secondary companies was 19.5 percent, compared to 2.3 percent for their affiliated nursing homes.
  • Owners who engaged in related-company transactions collectively made more money from side businesses than from the nursing homes themselves.
  • In New York City and Long Island, nursing homes renting their facilities from related companies paid an average of 50 percent and 42 percent more per patient-day, respectively, than those renting from unrelated landlords.
  • On average, for-profit nursing homes doing business with related companies spent less on staffing and received lower federal quality ratings than not-for-profit or government-owned facilities. However, they spent more on staffing and received higher quality ratings than for-profit homes with no related-company business.
  • Related-company spending by New York nursing homes jumped 164 percent between 2011 and 2020, the second-fastest growth rate of any state.

As the primary regulator and source of funding for nursing homes, the state should make sure that its policies encourage operators to provide the best possible care with the money available.

The patterns discussed in this report raise concern that the current system fails to adequately incentivize care quality, leaving it vulnerable to business strategies that prioritize financial maneuvering over the best interests of patients.

The big picture

Related-party transactions are commonplace in New York’s nursing home industry, particularly among for-profit facilities.

In 2020, 72 percent of the state’s for-profit nursing homes disclosed business with one or more related companies or organizations (see Table 1). (Another 49 not-for-profit homes disclosed related-party payments, but all went to not-for-profit parent organizations or health systems. Because of the different nature of these transactions, they were omitted from this report’s analysis.)

 

Payments from for-profit nursing homes to related companies totaled almost $1.1 billion, or 16 percent of their total expenses for the year.

In aggregate, the nursing homes involved in these transactions reported $153 million in profit from $6.7 billion in revenue, a 2.3 percent margin.

The related companies doing business with those same homes reported $306 million in profit from $1.6 billion in revenue – including income from buyers with independent ownership – for a margin of 19.5 percent.

In other words, the owners made twice as much money from related businesses as they did from the nursing homes themselves.

The details of one ownership group

A closer look at the inner workings of one nursing home chain provides one illustration of how these transactions work.

Efraim Steif and Uri Koenig jointly own 17 nursing homes across Upstate – from Spring Valley in Rockland County to Wellsville in Allegany County – with a total of 3,100 beds.

In 2020, the Steif-Koenig facilities reported $292 million in operating revenue. Forty-nine percent of their income came from Medicaid, the state-federal health plan for the low-income and disabled, and 19 percent from Medicare, the federal health plan for the elderly.

Nine of the homes reported ending 2020 in the black, while eight lost money. Their aggregate profit was $1.7 million, or less than 1 percent of revenues.

At the same time, the 17 homes did business with a dozen related companies, including 11 in which Steif, Koenig or both held ownership stakes (see Table 2). The homes spent $57 million on rent, services and goods from the related companies, which was 20 percent of the homes’ combined operating expenses.

 

Some of these ancillary companies roughly broke even while others reported profit margins as high as 63 percent. In aggregate, their profits amounted to just over $10 million. Based on their reported ownership percentages, Steif’s share of those profits would have been $7.2 million and Koenig’s $2.8 million.

These figures seem to be incomplete. One of the Steif-Koenig facilities, the Van Duyn Center for Rehabilitation and Nursing in Syracuse, reported paying $5.4 million in rent to a limited liability company that owns its building – which, based on federal reporting, appears to be owned by Steif. Although Van Duyn declared the payment as a related-party transaction, it did not disclose the finances of the recipient, making it unclear how much the real estate company realized as profit.

In addition, Steif and Koenig both draw salaries from multiple homes in their network. Eleven facilities listed Steif as a paid employee, paying him $1.1 million for a combined 140 hours per week. Koenig was paid just under $1 million for 60 hours a week at 10 facilities (see Table 3).

 

Overall, during the worst year of the pandemic, the two partners netted at least $13.8 million in profits and salaries from their combined nursing home businesses.

Steif and Koenig’s business practices have come under scrutiny from Attorney General Letitia James, who is investigating complaints of neglect and abuse at the Van Duyn Center.

In court papers, James’ office said it is probing whether Van Duyn was understaffed “because the owners … diverted through related-party transactions – for purposes of personal profit – substantial Medicaid funds that were intended for patient care.” 

The company has denied James’ charges.

“Any allegation that Van Duyn’s ownership diverted funds that were intended to be used to hire staff is entirely false,” Van Duyn officials said in a statement to the Syracuse Post-Standard. “It is common industry practice for nursing homes to share support services such as information technology, billing, quality assurance, payroll and financial management that are often contracted from companies that may share ownership.”

The national picture

The federal government also requires nursing homes to disclose related-company transactions as part of annual financial reports to the Centers for Medicare and Medicaid Services (CMS). Although the federal reports are less detailed than the state’s, they give a sense of how New York fits into the national picture. 

They show that for-profit related-party transactions are growing faster in New York’s nursing home industry than in all but a handful of other states.

This is partly because the share of New York nursing homes owned by for-profit companies has been growing, from 55 percent in 2011 to 66 percent in 2020.

However, spending on related-party transactions has risen even faster. Between 2011 and 2020, the dollar amount paid to for-profit related companies in New York shot up by $613 million or 164 percent, which was the highest dollar increase and the second-highest percentage increase in the U.S.

In 2011, payments by for-profit homes to related companies accounted for 3 percent of total nursing home expenses in New York, about half the national rate. As of 2020, that percentage had doubled to 6 percent, catching up to the U.S. average.  

Staffing patterns 

Employment data reported to the state show that for-profit nursing homes as a group spend proportionally less on staffing than either not-for-profit or government-owned facilities.

However, it’s not clear that related-party transactions account for this gap.

As seen in Chart 1, for-profit homes of all types spend less per patient-day on wages and benefits than not-for-profit and government-owned facilities. (The compensation rate for government facilities is especially high, largely because of much heavier spending on employee benefits.) 

 

Within the category of for-profit homes, however, facilities with related-company transactions spent 7 percent more on compensation per patient-day than those without such transactions. 

The former group also scores better than the latter in the federal quality rating system – which is based in part on staffing levels (see Chart 2). 

 

 

Rent patterns 

Rent constituted a majority of all related-company spending. In 2020, 237 for-profit nursing homes spent a total of $605 million on rental payments to real estate companies with shared ownership.  

In many cases, the real estate companies collecting that rent reported realizing large margins. 

The Dry Harbor Nursing Home, for example, rented its 360-bed facility in Queens from a company called Dry Harbor Realty LLC. According to federal records, the home and the realty company are owned by the same person, Jonathan Strasser.  

In 2020, the nursing home reported paying Dry Harbor Realty $11.4 million in rent, which was one-fifth of its operating expenses for the year. 

While the home ended the year with a profit of $1.5 million, the realty company showed a profit of $7.7 million – or 66 percent of what it was paid in rent. 

Exploring the data

Although the state gathers extensive data on self-dealing by nursing homes, the results of that reporting rarely come up in policy discussions.

In December 2019, for example, then-Governor Andrew Cuomo signed legislation requiring, among other things, that nursing home operators notify the Health Department “of any common or familial ownership of any corporation, other entity or individual providing services to the operator or the facility.” The fact that homes were already reporting at least some of that information was not mentioned in the bill language or its supporting memorandum.

In a January 2021 report on COVID-19 in nursing homes, the attorney general’s office faulted some owners for using related-company payments to increase their profits at the expense of patient care. The report called for “additional and enforceable transparency” about such transactions but did not discuss existing reporting requirements or explain why they were inadequate.

One reason the reporting hasn’t gotten more attention is the unwieldy way in which it is published. The Health Department posts its nursing home financial reports in the form of raw data that are unusable without considerable decoding and sifting. The accompanying data “dictionary” lists more than 500,000 possible fields, and the typical nursing home’s report uses several thousand of them.

With the help of industry experts, the Empire Center extracted key information from the state’s 2020 data set, including how much each nursing home paid to related companies, how much profit those companies realized, and how ownership overlapped. The center has posted spreadsheets of that information on its website as a research tool for policymakers, journalists and interested citizens.

Policy implications

The patterns documented in this report raise questions about the state’s oversight of an important sector of the health-care industry.

A rising share of the state’s nursing home operators are outsourcing expenses to other companies in which they also have ownership stakes – a practice that carries a risk of waste and abuse.

Government policy says such payments to related companies must be “prudent and cost-conscious,” but the hefty profit margins realized by some of the ancillary firms raise doubt that this standard is being consistently followed.

Meanwhile, the homes involved in the transactions generally have lower staffing levels and quality ratings than the state average.

This type of self-dealing is increasingly common among nursing homes across the country, but the practice is growing faster in New York than in almost any other state.

And all of this has unfolded under the eyes of state officials, who gather detailed information on related-company transactions, but seemingly make little use of it to shape policy or inform the public.

Given the stakes for the tens of thousands of vulnerable New Yorkers – and for the taxpayers who finance the bulk of their care – the state should review its oversight of related-company transactions in the nursing home industry.

The underlying driver of industry practices is a system of regulations and reimbursement policies largely controlled by the state – a system that appears to lack adequate incentives for delivering high-quality care at a reasonable cost. Short of a total overhaul of that system, smaller-scale reforms could be constructive.

As a first step, the Health Department should publish a summary of its extensive data on nursing home finances in a way that’s accessible and usable for policymakers, watchdogs and average citizens. It should also prepare annual reports that summarize patterns and highlight trends.

Second, the department should commission a public study of nursing home economics – including an analysis of how business practices are shaped by state laws and regulations.

This study should examine in particular whether the state’s method for setting Medicaid reimbursements – which includes a component to cover capital costs – creates an incentive for homes to pay excessive rent.

The study should also consider how to improve the monitoring of related-party transactions to avoid waste and abuse. Should the state dedicate more resources for auditing the financial reports? Or should it establish clearer guidelines for which transactions qualify as “prudent and cost-conscious”?

Finally, lawmakers should be wary of unintended consequences. As part of its response to the pandemic last year, the Legislature required homes to spend at least 70 percent of their revenue on patient care, including 40 percent on “resident-facing staffing,” while capping profit margins at 5 percent per year.

This policy – which took effect in January – has the potential to encourage more outsourcing to related companies, because it incentivizes owners to realize profits through ancillary companies rather than from the nursing homes themselves.

The state has the data it needs to develop smarter, more effective oversight of its nursing home industry. It should be putting that data to use on behalf of the residents who live in those facilities and the taxpayers who shoulder most of the costs. 

Bill Hammond is the Empire Center’s senior fellow for health policy. Hammond tracks fast-moving developments in New York’s massive health  industry, with a focus on how decisions made in Albany and Washington affect the well-being of patients, providers, taxpayers and the state’s economy.

Pandemic Priorities

 It’s been over two years since the COVID pandemic began, and a great deal of progress has been made. But how much have we learned? We have a vaccine available, now for people of almost all ages. It’s an extraordinary achievement, but how effective is it in the end? And perhaps more importantly, what do we now know about how to handle future pandemics? These are the sort of questions that are heavy on Dr. Vinay Prasad‘s mind (and mine!). In this episode, EconTalk host Russ Roberts welcomes Prasad back to explore these questions and more.

Now we’d like to hear what struck you in this conversation. Use the prompts below to spark comments here, or use them to start a new conversation offline. The conversation is what we’re here for,

 

 

1- Prasad is clear that he believes the COVID vaccine to be a remarkable achievement which clearly benefitted us in this pandemic. What does he mean, then, when he says we may now face diminishing returns from the vaccine, especially in younger people?

 

2- Prasad says we now have two buckets of risk with regard to vaccination. The first is the “original antigenic sin” bucket, the second is the risk involving myocarditis. How do these buckets differ, and how does Prasad believe we should approach each? And importantly, what role does he think randomized control trials should play?

 

3- Roberts asks Prasad what “things public health distorted that will plague us over time.” How does Prasad respond? How have these issues affected the way you think about the pandemic?

 

4- Next, Roberts asks Prasad whether the most aggressive lockdowns prevented the most deaths? (FWIW, Prasad dubs this “one of the greatest economics questions of the next quarter century.”) How can we know if a lockdown helped or hurt a country, according to Prasad? What might we do to learn more?

 

5- The conversation concludes with a discussion of the impact of COVID on children, particularly mask mandates. According to Prasad, what do we know and what do we not know about them? To put it mildly, Prasad is very unhappy with the lack of randomized trials, which he thinks would be easy to accomplish. Why does he think that, and what does he mean when he says, “I think a nation that is willing to, I mean, print $5 trillion in money and lose $20 trillion in GDP [Gross Domestic Product], but is not willing to spend, you know, $10 million, a hundred million, on running sort of just basic public health randomized trials? I think that, to me, is a problem.”

https://www.econtalk.org/extra/pandemic-priorities/

Saturday, August 13, 2022

Boil water advisory affects 935,000 residents in metro Detroit area

 A boil water water advisory was issued Saturday in 23 Detroit metro-area communities, affecting 935,000 residents, after a water main break was discovered.

The Great Lakes Water Authority found the break on a 120-inch water transmission main that distributes drinking water to 23 communities across Oakland, Macomb and Wayne counties, the Detroit Free Press reported.

The GLWA provides drinking water to nearly 40% of Michigan’s population.

Crews identified the leak to be one mile west of GLWA’s Lake Huron Water Treatment Facility.

Once the leak is isolated, crews will establish emergency connections to other system mains and restore some water to the affected communities.

Until the issue is fixed, residents in those affected areas shouldn’t drink the system’s water without boiling it for at least one minute to kill bacteria, then let it cool down.

The GLWA says it is investigating the cause of the break.

https://nypost.com/2022/08/13/boil-water-advisory-affects-935000-residents-in-metro-detroit/

FDA defended new monkeypox vaccine strategy to vaccine maker

 The US Food and Drug Administration defended the federal government's recent decision to stretch out its limited supply of the Jynneos monkeypox vaccine by giving individuals smaller doses using a different method of injection, pointing out in a letter to the company that manufactures the vaccine that a 2015 clinical study showed "a very similar immune response" to the new method as well as the previously used one.

In a letter Friday to Bavarian Nordic CEO Paul Chaplin, two top FDA officials responded to concerns Chaplin had raised earlier this week. They wrote that the agency recently determined that the benefits of stretching its limited supply of the two-dose Jynneos vaccine by giving individuals smaller doses outweighed the known possible risks.
The decision came after the FDA ruled out -- at least for now -- the use of alternative vaccines, as well as the option of delaying the second vaccine dose by three to six months, the agency said.
    The FDA's letter, obtained by CNN Saturday, was signed by FDA Commissioner Dr. Robert Califf and Dr. Peter Marks, the director of the FDA's Center for Biologics and Evaluation Research.
    The letter cited a 2015 clinical study, which Chaplin co-authored, in which "individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously."
      "The results of this study demonstrated that intradermal administration produced a very similar immune response to subcutaneous (SC) administration," the letter said. While the intradermal injection method "did result in more redness, firmness, itchiness and swelling at the injection site, but less pain," the letter continued, "these side effects were manageable."
      The FDA also detailed other options that the agency had considered. But the use of alternative vaccines to prevent monkeypox "was determined to be either impractical or inadvisable at this time," according to the letter. Specifically, the ACAM2000 vaccine, which is FDA approved for prevention of smallpox, "may not be appropriate now for a potentially immunocompromised population," the letter said.
        The FDA also looked into the option of delaying the second vaccine doses by three to six months, rather than giving the second dose the recommended 28 days after the first.
        But the agency ultimately determined that there was not any data to demonstrate that this method would provide sufficient protection, and that delaying the second dose could also give people "a false sense of reassurance that they were protected against monkeypox when the actual level of protection would be unknown and quite possibly inadequate," the letter said.
        The federal government's announcement this week authorizing health care providers to give smaller doses of Jynneos came in an attempt to better meet the high demand for the vaccine. Top Biden administration health officials have made clear in recent days that given the speed of the spread of monkeypox -- which it earlier this month declared a public health emergency -- the US did not have enough vaccine supply to meet demand. This week's decision to stretch out the available Jynneos vaccines was aimed at addressing the limited supply.
        Dr. Marks of the FDA said Thursday that there were an estimated 1.6 million to 1.7 million people in the US who are now eligible for the two-dose Jynneos vaccine. According to the US Department of Health and Human Services, around 634,213 vials have been sent to jurisdictions as of Friday.
        The low-dose intradermal strategy immediately prompted concern among some public health experts, including about the limited amount of research surrounding the new method.
        "This approach raises red flag after red flag, and appears to be rushed ahead without data on efficacy, safety, or alternative dosing strategies," David Harvey, executive director of the National Coalition of STD Directors, said in a statement this week.
          Chaplin, the CEO of Bavarian Nordic, also raised concerns. CNN reported that Chaplin wrote in a letter Tuesday to Califf and HHS Secretary Xavier Becerra that he had concerns about the "very limited safety data available" on the newly announced vaccination strategy, and that a relatively high percentage of people in the clinical study -- 20% -- did not get their second shot.
          "While we have certain reservations, we are trying to find the best way to support the [emergency use authorization] by collecting additional data and aligning on the responses to assist state officials in the rollout," Chaplin wrote. "We are also investing in expanding the manufacturing capacity at both BN and external facilities, with likely more announcements soon to come."

          Stem Cell Lines Riddled With Undetected Mutations

           

          Most of the human induced pluripotent stem cells stored at major cell line repositories and used in research harbor thousands of DNA errors, a study finds, highlighting the need for improved quality control measures.


          Stem cell research that uses pluripotent stem cells derived from human skin or blood cells has led to numerous discoveries, aided drug development, and proven useful in gene therapies. However, many of these human induced pluripotent stem cell (hiPSC) lines banked in repositories or developed in labs likely harbor thousands of undetected mutations, casting doubt on how generalizable the findings made with them can be, according to research published yesterday (August 11) in Nature Genetics. According to study coauthor and Cambridge Biomedical Research Campus medical geneticist Serena Nik-Zainal, the study reveals that the level of quality control involved in such stem cell research may not be up to snuff.

          Researchers make hiPSCs by harvesting somatic cells—often from skin—from a person and then reprogramming them to enter an embryonic-like state. Nik-Zainal says that she and her colleagues were clued in to the widespread presence of mutations years ago when they noticed that multiple hiPSCs derived from the same patient appeared quite different from one another. Ultimately, they found that ultraviolet (UV) radiation, possibly linked to sunlight exposure prior to harvesting the cells, was causing significant levels of DNA damage to skin-derived hiPSCs—sometimes inducing tens of thousands of mutations. Still, the cells had been cleared for use by major repositories.

          “Those ‘normal’ cell lines have as many mutations as [some] cancers,” Nik-Zainal tells The Scientist. “It was pretty striking.”

          In the new study, which Nik-Zainal says began more than a decade ago, she and her colleagues ran whole genome sequencing on the stem cell lines stored and made available to researchers in two major repositories: HipSci, one of the largest iPSC banks in the world, and Insignia. The sequencing revealed that 72 percent of the skin cell–derived hiPSCs in the HipSci bank showed signs of mutations. Meanwhile, 27 percent of the blood-derived hiPSCs stored with Insignia and 18 percent of blood hiPSCs in HipSci contained multiple mutations in the BCOR gene, which is implicated in several types of cancer.

          See “New Resource for Banked iPSCs

          Further analysis revealed that mutations, especially the BCOR mutations in the blood-derived lines, can occur after reprogramming, meaning they didn’t originate from the human donors but rather arose as the cells replicated in the lab, likely through selective pressures the cells experience while growing and dividing in a dish.

          “It’s a problem, but it’s solvable,” says Jeanne Loring, a stem cell researcher at the Scripps Research Institute who didn’t work on the study. “It’s a call that’s finally, increasingly being communicated: to analyze the cells you’re going to use by genomic analysis.”

          As it stands now, scientists using these hiPSCs for research or clinical applications only need to screen and characterize their cell lines, whether they’re developed in-house or taken from a repository, to whatever extent is required by a journal or the reviewers assessing their work. In order to deposit a cell line someplace like HipSci, researchers only have to demonstrate that the stem cells don’t have any missing or duplicated chromosomes or other largescale genetic errors—analyses that would miss the myriad single-nucleotide mutations identified in the new paper.

          Stem cells derived from adult somatic cells “will carry the mutational history of their past, as well as of any new mutations that occur when you are reprogramming them or growing them in culture,” Nik-Zainal says.

          She and Loring both suggest that these overlooked mutations could absolutely invalidate the findings of basic or clinical studies that have already been published. But “it’s not like you’re a bad scientist if your cells acquire mutations,” says Loring. “There isn’t a way to avoid it,” except by stopping cells from dividing altogether, “which is not what you want,” she adds.

          A cell line can harbor thousands of mutations and still be usable for research as long as those mutations are concentrated in irrelevant noncoding areas or don’t hit important genes, Nik-Zainal says.

          Loring says that researchers need to act as a sort of proxy for the immune system, monitoring cells and pruning those with unwanted mutations. Otherwise, she says, the lines will mutate in ways that promote their own survival in culture, but that might not further whatever scientific or therapeutic purposes a researcher had in mind.

          Nik-Zainal says that her work has prompted criticism from researchers in the field who seem resentful over the implication that they may need to implement whole genome sequencing as a new quality control measure. Despite being an order of magnitude less expensive than it was a decade ago, this type of sequencing remains technically complicated and difficult to perform without specialized training. However, she suggests that more thorough screenings may become more commonplace. “The day of now being able to absolutely screen using whole genomic sequence of every line is upon us,” she tells The Scientist. “We’re at an inflection point.”

          See “Underdog Enzyme Likely Responsible for Mutations in Most Cancers

          Nik-Zainal says she’s already sent her findings to the UK Regenerative Medicine Platform, which supports stem cell research, among other initiatives, and that it was receptive to the issues she identified. Meanwhile, Loring says that she’s seen the issue of hiPSC mutations, which she calls “evolution in the incubator,” discussed at recent conferences and meetings.

          “I think [this study] will help,” Loring says. “I think it adds strength to the argument that this kind of analysis should be done.”

          Loring emphasizes that the field ought to adopt new standards, whether they’re imposed by journals, stem cell banks, or regulatory agencies—especially when it comes to using mutated hiSPCs in clinical research or gene therapies. She says she’s hopeful that cell line screening and characterization at the whole genome level will become commonplace as more researchers gain the necessary technical skills and the problem becomes more well-known.

          Even if no new standards are imposed, Nik-Zainal suggests that whole-genome sequencing might be necessary for researchers who want to ensure that their research is valid: “If your whole experiment is dependent on demonstrating something in a cell line and you cannot account for the status of your cell line, that’s probably not good enough.” That’s especially true for clinical work, she says. “I would not want to have cells that had a major mutation being inserted into me—I would like to know.”