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Thursday, August 24, 2023

Medicare Drugs on Chopping Block

The Biden administration is expected to announce, by Sept. 1, the first 10 prescription drugs it will target in its newly authorized drug price “negotiation” regime.

Under the Inflation Reduction Act (more properly dubbed the Innovation Reduction Act), the Centers for Medicare and Medicaid Services will announce the 10 drugs under Medicare Part D that the agency will subject to its Drug Price Negotiation Program.

These drugs will be “single-source drugs with the highest Medicare spending,” with some exemptions. Reuters published a list of the most likely targets.

However, the Inflation Reduction Act, passed by Congress and signed by President Joe Biden a year ago, threatens to impose an enormous excise tax on the selected drugs to force pharmaceutical developers to participate.

Boehringer Ingelheim just became the seventh company to file a lawsuit against the U.S. Department of Health and Human Services.  The suits claim the drug price program is unconstitutional on several grounds, including that it violates the First Amendment (compelled speech), Fifth Amendment (due process and unlawful taking), and the Eighth Amendment (excessive fines) as well as other constitutional harms.

Two plaintiffs have filed motions seeking injunctive relief to stop HHS from implementing the program through its Centers for Medicare and Medicaid Services.

The Impact

Doug Holtz-Eakin, an economist who heads the American Action Forum, details the impact of the misguided program, which he says “features price controls and draconian taxes.”

Holtz-Eakin argues that although Biden and other Democrats advertised the Inflation Reduction Act as “substantially” reducing drug costs for a wide swath of Medicare beneficiaries, in fact, fewer than 10% of seniors will benefit at all.

For those who do see savings, he argues, they will be modest. Fully 69% of those who see any savings will pocket less than $300.

University of Chicago economist Tomas Philipson has extensively studied the law’s expected impact. He estimates that because of the price control regime, 135 fewer drugs will be brought to market, amounting to $18 trillion in health-related losses through 2039.

The impact on patients will be significant, decimating drug development as pharmaceutical companies pull funding for promising drugs from the research pipeline, Philipson predicts.

“This drop in new drugs is predicted to generate a loss of 331.5 million life years in the U.S., 31 times as large as the 10.7 million life years lost from COVID-19 in the U.S. to date,” Philipson writes.

Each year, the Centers for Medicare and Medicaid Services will add more and more drugs to its target list. Americans can expect to see fewer new cures and treatments along with the same restrictions and rationing that patients face in countries that have government-run, price-controlled health systems.

“Of all drugs launched worldwide between 2011 and 2018, 89% were available in the U.S. while only 48% were available in France. Bureaucrats may be well-intentioned, but markets are always better at setting prices,” Philipson writes.

Freezing Innovation

And all of this is being done so that the Biden administration  can “save” an estimated $238 billion over a decade, money that it does not plan to reinvest in Medicare to stave off the program’s pending bankruptcy, but rather to fund its radical agenda, especially its climate change initiatives.

The drug price control scheme will freeze today’s innovation in place because it punishes companies that continue to improve a drug and find new disease applications—applications that are the source of the majority of cancer drugs.

Erica York, senior economist with the Tax Foundation, explains that it currently takes an average of 10 years and more than $2 billion to develop and bring a new drug to market. The industry invested more than $100 billion in research and development in 2021, but leaders already are pulling funding for new drugs.

Peter Thompson, private equity partner at OrbiMed Advisors LLC, said during a recent BIO Investor Forum that the 2022 law already is “directly hampering science.”

Drug companies are in the crosshairs of the Inflation Reduction Act no matter what they do. The law forces them to state that they “agree voluntarily” to whatever price the government offers for their drugs—with no minimum price. 

And companies will face enormous and punitive fines if they don’t comply. New Jersey-based Merck states in its lawsuit that manufacturers who don’t participate in negotiations “must pay an escalating excise tax that starts at 186% and eventually reaches 1,900% of a drug’s daily revenues.”

The company estimates that refusal to negotiate for even just one drug could incur fines of tens of millions of dollars on the first day—increasing to hundreds of millions of dollars per day thereafter.

Lives at Risk

This exposes the falsehood of the “negotiation.” In a private negotiation, the playing field is level. Under this scheme, though, the government sets the terms and enforces the penalty.

It’s as if the government fielded a baseball team and also acted as umpire. The playing field here is not equal.

It’s important for Americans to know these facts before the Centers for Medicare and Medicaid Services decimates drug development in the U.S. 

Congress has held numerous hearings to investigate the expected impact of the new law. It must continue its oversight and use its authority where possible to curtail the Biden administration’s plans as the law makes its way through the courts.

With fewer cures and treatments, lives are at risk.

https://www.dailysignal.com/2023/08/22/medicare-drugs-on-chopping-block/

Healthcare software firm Waystar eyes $8 billion valuation in U.S. IPO

 Waystar Inc, a private equity-owned vendor of software that helps hospitals and doctors' practices manage their finances, has tapped banks for an initial public offering that could value it at as much as $8 billion, including debt, according to people familiar with the matter.

Waystar's owners, buyout firm EQT AB and Canada Pension Plan Investment Board (CPPIB), have hired Goldman Sachs Group Inc and JPMorgan Chase & Co to advise on the listing, the sources said.

The IPO could come later this year or early next year, subject to market conditions, the sources added, requesting anonymity because the matter is confidential. The valuation attained will also be subject to market conditions, the sources added.

EQT, CPPIB and Goldman Sachs declined to comment. Waystar and JPMorgan did not respond to a request for comment.

Waystar was formed in 2017 through the merger of Navicure and ZirMed. The company develops payment software helping clients such as large hospital systems with the collection of bills from patients.

Waystar was valued at $2.7 billion when EQT and CPPIB acquired a majority stake in the company in 2019 from Bain Capital, which stayed on as a minority investor. All three firms are represented on Waystar's board of directors.

Under EQT and CPPIB's ownership, Waystar has gained scale by acquiring some of its competitors, including eSolutions in 2020, which boosted its presence in the lucrative government health insurance market for the elderly, known as Medicare. The company now works with 1 million healthcare providers and handles more than 2.5 billion transactions annually, according to its website.

Fitch analysts, who track Waystar's outstanding debt, said the company stands to benefit from the expansion of the healthcare industry as the population ages and spending increases. The Centers for Medicare and Medicaid Services (CMS) expects national health expenditure to grow at an annual clip of 5.4% through 2031.

https://www.aol.com/news/exclusive-healthcare-software-firm-waystar-211907219.html

Highly mutated COVID variant found in new countries but pandemic in 'a different phase’

 A highly mutated COVID variant called BA.2.86 has now been detected in Switzerland and South Africa in addition to Israel, Denmark, the U.S. and the U.K., according to a leading World Health Organization official.

The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 - a number roughly on par with the Omicron variant that caused record infections compared to its predecessor.

It was first spotted in Denmark on July 24 after the virus infecting a patient at risk of becoming severely ill was sequenced. It has since been detected in other symptomatic patients, in routine airport screening, and in wastewater samples in a handful of countries.

A dozen scientists around the world said while it was important to monitor BA.2.86, it was unlikely to cause a devastating wave of severe disease and death given immune defenses built up worldwide from vaccination and prior infection.

"It's still low numbers," Maria Van Kerkhove, COVID-19 technical lead at the WHO, said in her first interview regarding BA.2.86.

That the known cases are not linked suggests it is already circulating more widely, particularly given reduced surveillance worldwide, she said.

Scientists are testing how well updated COVID-19 vaccines will work against BA.2.86. Kerkhove noted that vaccines have been better at preventing severe illness and death than re-infection.

“We are in a very different phase (of the pandemic) than if this popped up in the first year,” said Marion Koopmans, a Dutch virologist who advises the WHO.

Dr. Nirav Shah, principal deputy director of the U.S. Centers for Disease Control and Prevention, said the agency and others spotted the new variant last week, held meetings with scientists throughout the weekend, and issued a risk assessment on Wednesday. There have been nine such cases detected as of Aug. 23 and the variant was also found in wastewater in Switzerland.

China quietly recruits overseas chip talent as US tightens curbs

  For a decade until 2018, China sought to recruit elite foreign-trained scientists under a lavishly funded program that Washington viewed as a threat to U.S. interests and technological supremacy.

Two years after it stopped promoting the Thousand Talents Plan (TTP) amid U.S. investigations of scientists, China quietly revived the initiative under a new name and format as part of a broader mission to accelerate its tech proficiency, according to three sources with knowledge of the matter and a Reuters review of over 500 government documents spanning 2019 to 2023.

The revamped recruitment drive, reported in detail by Reuters for the first time, offers perks including home-purchase subsidies and typical signing bonuses of 3 to 5 million yuan, or $420,000 to $700,000, the three people told Reuters.

China operates talent programs at various levels of government, targeting a mix of overseas Chinese and foreign experts. The primary replacement for TTP is a program called Qiming overseen by the Ministry of Industry and Information Technology, according to national and local policy documents, online recruitment advertisements and a person with direct knowledge of the matter who, as with others, spoke on the condition of anonymity because of the issue's sensitivity.

The race to attract tech talent comes as President Xi Jinping emphasises China's need to achieve self-reliance in semiconductors in the face of U.S. export curbs. Regulations adopted by the U.S. Commerce Department in October restrict U.S. citizens and permanent residents from supporting the development and production of advanced chips in China, among other measures.

Neither China's State Council Information Office nor the ministry responded to questions about Qiming. China has previously said its overseas recruitment through the TTP aimed to build an innovation-driven economy and promote talent mobility, while respecting intellectual property rights, according to the state-run Xinhua news agency.

Fukushima wastewater released into the ocean, China bans all Japanese seafood

 Japan started releasing treated radioactive water from the wrecked Fukushima nuclear power plant into the Pacific Ocean on Thursday, a polarising move that prompted China to announce an immediate blanket ban on all aquatic products from Japan.

China is "highly concerned about the risk of radioactive contamination brought by... Japan's food and agricultural products," the customs bureau said in a statement.

The Japanese government signed off on the plan two years ago and it was given a green light by the U.N. nuclear watchdog last month. The discharge is a key step in decommissioning the Fukushima Daiichi plant after it was destroyed by a tsunami in 2011.

Plant operator Tokyo Electric Power (Tepco) said the release began at 1:03 p.m. local time (0403 GMT) and it had not identified any abnormalities.

However, China reiterated its firm opposition to the plan and said the Japanese government had not proved that the water discharged would be safe.

"The Japanese side should not cause secondary harm to the local people and even the people of the world out of its own selfish interests," its foreign ministry said in a statement.

Tokyo has in turn criticised China for spreading "scientifically unfounded claims."

It maintains the water release is safe, noting that the International Atomic Energy Agency (IAEA) has also concluded that the impact it would have on people and the environment was "negligible."

Japan has requested that China immediately lift its import ban on aquatic products and seeks a discussion on the impact of the water release based on science, Prime Minister Fumio Kishida told reporters.

Japan exported about $600 million worth of aquatic products to China in 2022, making it the biggest market for Japanese exports, with Hong Kong second. Sales to China and Hong Kong accounted for 42% of all Japanese aquatic exports in 2022, according to government data.

China customs did not give details on the specific aquatic products impacted by the ban and did not immediately respond to a request for comment.

DECADES LONG PROCESS

The Fukushima Daiichi plant was destroyed in March 2011 after a massive 9.0 magnitude earthquake generated powerful tsunami waves causing meltdowns in three reactors.

The first discharge totalling 7,800 cubic metres - the equivalent of about three Olympic swimming pools of water - will take place over about 17 days.

According to Tepco test results released on Thursday, that water contained about up to 63 becquerels of tritium per litre, below the World Health Organization drinking water limit of 10,000 becquerels per litre. A becquerel is a unit of radioactivity.

The IAEA also released a statement saying its independent on-site analysis had confirmed the tritium concentration was far below the limit.

"There are not going to be any health effects… There is no scientific reason to ban imports of Japanese food whatsoever," said Geraldine Thomas, former professor of molecular pathology at London's Imperial College.

But Japanese fishing groups, hit with years of reputational damage from radiation fears, still oppose the plan.

"All we want is to be able to continue fishing," the head of the Japan Fisheries Co-operative said in a statement that touched on the "mounting anxiety" of the community.

Separately from China, Hong Kong and Macau have announced their own ban starting Thursday, which covers Japanese seafood imports from 10 regions.

South Korean Prime Minister Han Duck-soo said import bans on Fukushima fisheries and food products will stay in place until public concerns were eased.

Japan will conduct monitoring around the water release area and publish results weekly starting on Sunday, Japan's environment minister said. The release is estimated to take about 30 years.

PROTESTS

In Hong Kong, Jacay Shum, a 73-year-old activist, held up a picture portraying IAEA head Rafael Grossi as the devil.

"Japan's actions in discharging contaminated water are very irresponsible, illegal, and immoral," said Shum, who was among a group of about 100 marchers. "No one can prove that the nuclear waste and materials are safe. They are completely unsafe."

South Korean police arrested at least 16 protesters who entered the Japanese embassy in Seoul, although South Korea's government has said its own assessment found no problems with the scientific and technical aspects of the release.

North Korea's foreign ministry demanded that the water discharge be immediately halted, calling it a "crime against humanity", state media reported.

A few dozen protesters gathered in front of Tepco's headquarters in Tokyo holding signs reading "Don't throw contaminated water into the sea!"

"The Fukushima nuclear disaster is not over. This time only around 1% of the water will be released," 71-year-old Jun Iizuka, who attended the protest, told Reuters. "From now on, we will keep fighting for a long time to stop the long-term discharge of contaminated water."

https://www.yahoo.com/news/japan-set-release-fukushima-water-220241691.html

Human Frailty Is a Cash Cow

 Doctor, if you are caring for patients with diabetes, I sure hope you know more about it than I do. The longer I live, it seems, the less I understand.


In a free society, people can do what they want, and that's great except when it isn't. That's why societies develop ethics and even public laws if ethics are not strong enough to protect us from ourselves and others.

Sugar, Sugar

When I was growing up in small-town Alabama during the Depression and World War II, we called it sugar diabetes. Eat too much sugar, you got fat; your blood sugar went up, and you spilled sugar into your urine. Diabetes was fairly rare, and so was obesity. Doctors treated it by limiting the intake of sugar (and various sweet foods), along with attempting weight loss. If that didn't do the trick, insulin injections.

From then until now, note these trends (Table).

Table. Annual Per Capita Sugar Consumption, Obesity Rates, and Prevalence of Type 2 Diabetes in the United States, 1950-2020

YearPer capita
sugar consumption (lb)
Obesity ratePrevalence of type 2 diabetes
195010413.4%0.6%
196011216.0%1.0%
197011719.1%1.4%
198012323.3%2.4%
199012926.2%3.9%
200013530.5%6.2%
201014133.7%8.5%
202014642.4%11.3%

Type 2 diabetes was diagnosed even more infrequently before 1950:

  • 1920: 0.2% of the population

  • 1930: 0.3% of the population

  • 1940: 0.4% of the population

In 2020, although 11.3% of the population was diagnosed with type 2 diabetes, the unknown undiagnosed proportion could be much higher.

Notice a correlation between sugar consumption and prevalence of diabetes? Of course, correlation is not causation, but at the same time, it sure as hell is not negation. Such concordance can be considered hypothesis-generating. It may not be true causation, but it's a good bet when 89% of people with diabetes have overweight or obesity.

What did the entire medical, public health, government, agriculture, nursing, food manufacturing, marketing, advertising, restaurant, and education constituencies do about this as it was happening? They observed, documented, gave lip service, and wrung their hands in public a bit. I do not believe that this is an organized active conspiracy; it would take too many players cooperating over too long a period of time. But it certainly may be a passive conspiracy, and primary care physicians and their patients are trapped.

The proper daily practice of medicine consists of one patient, one physician, one moment, and one decision. Let it be a shared decision, informed by the best evidence and taking cost into consideration. That encounter represents an opportunity, a responsibility, and a conundrum.

Individual health is subsumed under the collective health of the public. As such, a patient's health is out of the control of both physician and patient; instead, patients are the beneficiaries or victims of the "marketplace." Humans are frail and easily taken advantage of by the brilliant and highly motivated strategic planning and execution of Big Agriculture, Big Food, Big Pharma, Big Marketing, and Big Money-Driven Medicine and generally failed by Big Government, Big Public Health, Big Education, Big Psychology, and Big Religion.

Rethinking Diabetes

Consider diabetes as one of many examples. What a terrific deal for capitalism. First, the system spends decades fattening us up; then, it makes massive amounts of money off of the myriad complications of the fattened populace; then it discovers (invents) long-term, very expensive, compelling treatments to slim us down, with no end in sight, and still without ever understanding the true nature of diabetes.

Gary Taubes's great new book, Rethinking Diabetes: What Science Reveals About Diet, Insulin, and Successful Treatments, is being published by Alfred A. Knopf in early 2024.

It is 404 pages of (dense) text, with 401 numbered references and footnotes, a bibliography of 790 references, alphabetically arranged for easy cross-checking, and a 25-page index.

Remember Taubes's earlier definitive historical treatises: Good Calories, Bad Calories (2007), Why We Get Fat (2010), The Case Against Sugar (2016), and The Case for Keto (2020)?

This new book is more like Good Calories, Bad Calories: long, dense, detailed, definitive, and of great historical reference value, including original research information from other countries in other languages. The author told me that the many early research reference sources were only available in German and that his use of generative artificial intelligence as an assistant researcher was of great value.

Nonphysician author Taubes uses his deep understanding of science and history to inform his long-honed talents of impartial investigative journalism as he attempts to understand and then explain why after all these years, the medical scientific community still does not have a sound consensus about the essence of diabetes, diet, insulin, and proper prevention and treatment at a level that is actually effective — amazing and so sad.

To signal these evolved and evolving conflicts, the book includes the following chapters:

  • "Rise of the Carbohydrate-Rich and Very-Low-Carbohydrate Diets"

  • "The Fear of Fat and High-Fat Diets"

  • "Insulin and The End of Carbohydrate Restriction and Low Blood Sugar"

Yes, it is difficult. Imagine the bookend segments: "The Nature of Medical Knowledge" and "The Conflicts of Evidence-Based Medicine." There is also a detailed discussion of good vs bad science spanning three long chapters.

If all that reads like a greatly confused mess to you then you're beginning to understand. If you are a fan of an unbiased explication of the evolution of understanding the ins and outs of scientific history in richly documented detail, this is a book for you. It's not a quick nor easy read. And don't expect to discover whether the newest wonder drugs for weight loss and control of diabetes will be the long-term solution for people with obesity and diabetes worldwide.

Obesity and overweight are major risk factors for type 2 diabetes. About 90% of patients with diabetes have either overweight or obesity. Thus, the complications of these two conditions, which largely overlap, include atherosclerotic cardiovascular diseasemyocardial infarction; stroke; hypertensionmetabolic syndrome; lower-extremity gangrene; chronic kidney disease; retinopathy; glaucoma; cataracts; disabling osteoarthritis; breast, endometrial, colon, and other cancers; fatty liver; sleep apnea; and peripheral neuropathy. These diseases create a major lucrative business for a wide swathe of medical and surgical specialties, plus hospital, clinic, device, pharmaceutical, and food industries.

In summary, we've just been through 40 years of failure to recognize the sugar-elephant in the room and intervene with serious preventive efforts. Forty years of fleshing out both the populace and the American Medical-Industrial Complex (AMIC). Talk about a sweet spot. The only successful long-term treatment of obesity (and with it, diabetes) is prevention. Don't emphasize losing weight. Focus on preventing excessive weight gain, right now, for the population, beginning with yourselves. Otherwise, we continue openly to perpetuate a terrific deal for the AMIC, a travesty for everyone else. Time for some industrial grade penance and a course correction.

Meanwhile, here we are living out Big Pharma's dream of a big populace, produced by the agriculture and food industries, enjoyed by capitalism after failures of education, medicine, and public health: a seemingly endless supply of people living with big complications who are ready for big (expensive, new) medications to fix the world's big health problems.

George D. Lundberg, MD,

Editor in Chief, Cancer Commons

https://www.medscape.com/viewarticle/995726

Kidney Stones on the Rise: Where Are the Specialists?

 A dearth of kidney stone specialists is colliding with a rise in the number of patients who need specialized care.

While increasing the number of nephrologists who specialize in kidney stones is necessary, nonspecialists need to play a larger role in recognizing and preventing kidney stones.

Primary care and emergency room physicians can be the front lines of counseling patients who do not have underlying genetic causes of kidney stones on how to prevent a recurrence, according to Irina Jaeger, MD, a urologist at University Hospitals and an assistant professor of urology at Case Western Reserve University School of Medicine, both in Cleveland, Ohio. 

"A lot of this care can be implemented by our primary care physicians, such as counseling on decreasing sodium in the diet and increasing fluid intake, which benefits so many different health conditions as well as stones," said Gregory E. Tasian, MD, MSCE, an attending pediatric urologist at Children's Hospital of Philadelphia, Pennsylvania. "If we can think about this holistically, we can really make strides." 

Focus on Prevention

Taking a holistic approach, Tasian added, will require rethinking how health teams approach patient care and manage kidney stones. 

"We think of stones as episodic events that are painful, and then pass," he said. "But it's really a disorder of mineral metabolism."

Understanding these episodes as a chronic disease can also explain why nephrolithiasis often goes hand in hand with higher instances of heart attack and strokehypertension , and bone breaks, he added.

Simple measures like staying hydrated and consuming citrate in the form of lemon water or lemonade can help patients prevent recurring kidney stones, Jaeger said.

But patients who have had a stone also need to see a specialist to rule out any underlying causes. Kidney stones are routinely viewed as episodic events that don't pose much of a health threat, but between 30% and 50% of people diagnosed with stones will experience a recurrence within 5 years. Educating patients on how they can prevent future episodes is a crucial part of care. 

"Even if they are passing the stones on their own without surgery, they should really be evaluated by a urologist or a nephrologist," Jaeger said. 

David Goldfarb, MD, clinical director of the Division of Nephrology at NYU Langone Health, in New York City, said that access to nephrologists who specialize in kidney stones is a critical piece of prevention. While urologists can treat stones, nephrologists get to the bottom of why the stones occurred in the first place and help patients prevent further stones from forming.

"The majority of urologists in the U.S. don't do much in regard to prevention," he said. "There needs to be more nephrologists." 

Kidney stones now appear to be increasingly common in patient populations that previously did not have the condition. 

study published in 2016 in the Clinical Journal of the American Society of Nephrology found that the annual incidence of kidney stones increased 16% from 1997 to 2012, with the biggest increase seen among teenagers. Stones were 52% more common among girls and women than among men, but the condition is also becoming more common in men starting at age 25. Meanwhile, Black Americans of all ages saw greater rates of kidney stone development than their White counterparts. 

Fewer residents are also choosing to specialize in nephrology, with a decrease in the choice of fellowship of 50% from 2009 to 2019, according to a 2023 report by the American Society of Nephrology.

2019 survey of nearly 4200 residents found that only 60% of nephrology fellowship positions were filled in 2018, and the majority of those residents reported a lack of interest in the kidney as being the most critical factor in not selecting the specialty. Others reported lack of exposure to nephrology overall.

Diagnosing the Root Cause

Getting to the root cause of how further kidney stones can be prevented usually requires a nephrologist, according to Jaeger.

"As a urologist, 90% of what we do is surgery," Jaeger said.

Although urologists are trained in analyzing 24-hour urine tests, which can reveal risks that can be addressed by preventive changes, many urologists tap a specialized nephrologist, who may analyze the samples with a keener eye. 

"When individuals pass a stone, fewer than 10% seek care with a specialist after that and that's a missed opportunity to prevent future stones," Tasian said. 

Not all nephrologists specialize in stones, but they may be better equipped to recognize when a patient needs to see someone who does. Failing to involve a nephrologist who specializes in kidney stones can have grave consequences for patient health. 

Goldfarb is currently caring for a patient with a kidney transplant that had begun to lose function. Clinicians who originally cared for the patient took a kidney biopsy, which showed fragments of calcium oxalate, a common type of kidney stone, in her native kidneys.

After receiving a kidney transplant, her health began to decline again and a second biopsy found that the new kidney was forming the same type of stones. Her nephrologist knew this meant she likely had a genetic disorder and referred her to Goldfarb, who specializes in underlying genetic causes of kidney stones. A genetic test revealed that the patient had primary hyperoxaluria

"She would have been treated completely differently if that had been recognized as the cause of her original kidney disease," Goldfarb said. "Now her kidney transplant is getting kidney stones and I'm working with her to prevent that."

Under Goldfarb, the patient will have access to a new experimental drug, called nedosiran, specifically for primary hyperoxaluria, which is currently in clinical trials

"The kidney doctor that made the diagnosis correctly and referred her to me isn't a kidney stone specialist; he is a general nephrologist who has taken an interest in the topic of kidney stones, recognizing there is sometimes some nuance and specialty of issues related to this," Goldfarb said.

https://www.medscape.com/viewarticle/995778