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Thursday, February 13, 2020

Kidney disease treatments inadequate, results hard to measure

Chronic kidney disease (CKD) affects 14 percent of adults in the U.S. There are several stages of CKD, but when it progresses to kidney failure, outcomes are quite poor, with those patients dying at a higher rate than patients with most advanced cancers. Patients who go on dialysis face both an exhausting treatment regimen and a high rate of death with 50 percent of patients dying within three years. Last July, the U.S. Department of Health and Human Services launched the Advancing American Kidney Health initiative to try to improve kidney care. But this raised an important question in the medical community: How do you measure the quality of kidney care and the success of new innovations? A study published in the Journal of the American Society of Nephrology evaluated national kidney disease quality metrics—the benchmarks used today to measure kidney disease progression, patient outcomes and more—and found that more than half were of middle or low quality.
“As a nephrologist, I see patients with and end-stage renal disease, and when we discuss dialysis, they ask me, ‘Is that all there is? Why aren’t there innovative treatments for kidney disease like there are for other diseases?'” said corresponding author Mallika Mendu, MD, MBA, medical director for Quality and Safety at Brigham and Women’s Hospital, director of Quality for the Brigham Renal Division, and a practicing nephrologist. “One of the reasons is that success is contingent on getting the details right. When we measure quality of care to determine if a treatment is working for a patient, we need to be certain we’re measuring the right thing.”
Mendu and other members of the American Society of Nephrology Quality Committee evaluated 60 existing kidney quality metrics from multiple kidney and quality organizations. These included metrics for CKD prevention, slowing CKD progression, kidney replacement planning, and dialysis management, among others. The team evaluated the measures based on a set of criteria, including whether the metric led to meaningful improvements and appropriate care, whether it was based on high-quality evidence, and more. Based on their defined criteria, they found that 29 of the metrics (less than half) had high validity, 23 had medium validity and 8 had low validity.
The team advocates for shifting the focus to metrics that matter most to the patient and most accurately reflect kidney health or progression, for example the “optimal starts” which measures how many patients start dialysis as an outpatient on home dialysis or receive a transplant before they need dialysis.
“We think about quality and safety metrics on a daily basis, but we need to understand which metrics truly reflect and drive the care improvements that matter to our patients,” said Mendu. “Being in the quality and safety space has given me an appreciation for why defining metrics accurately matters so much. When done well, metrics can foster improvements in care. We think the findings from our study will help to inform policy, regulation and legislation moving forward. We believe that this study is timely in light of the Advancing American Kidney Health initiative, which has the potential to advance care if success is defined and measured accurately.”

Explore further
Study examines quality of life in patients with kidney disease in India

More information: Mendu, M et al. “Measuring Quality in Kidney Care: An Evaluation of Existing Quality Metrics and Approach to Facilitating Care Delivery Improvements” Journal of the American Society of Nephrology (2020). DOI: 10.1681/ASN.2019090869

Bio-Rad Labs EPS misses by $0.13, misses on revenue

Bio-Rad Labs (NYSE:BIO): Q4 Non-GAAP EPS of $2.32 misses by $0.13; GAAP EPS of $18.31.
Revenue of $624.43M (+1.2% Y/Y) misses by $17.03M.
https://seekingalpha.com/news/3541989-bio-rad-labs-eps-misses-0_13-misses-on-revenue

What The Left Doesn’t Understand About Health Care Prices

In just about every critique of the U.S. health care system, the subject of prices is front and center. See for example, It’s the Prices Stupid: Why the United States Is So Different from Other Countries and the more recent update.
We pay the highest prices in the world, we are told. There is some truth in that, but there are qualifications you need to know about which I will address below.
So, what do radical progressives want to do about the problem of high prices? They want to nationalize the entire health care system.
If that doesn’t sound strange to you, it should. But perhaps you don’t pay a lot of attention to liberal blogs and leftwing thought.
For the most part, the left doesn’t think that any price in any market plays a useful social function. Whenever they decide a price is too high, they call for government intervention to push the price down. If they decide a price is too low, they call for government intervention to push the price up. Because they don’t think prices serve any positive function, they often ignore the unintended and undesirable consequences of intervention.
But almost no one today (outside of hard-core Marxists on university campuses) wants government to nationalize every industry.
Let’s say housing prices are too high. The left calls for rent control. They don’t advocate having government take over the entire housing industry.
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Or let’s say wages on the bottom rung are too low. The left calls for minimum wage laws. They don’t advocate having government nationalize every business that hires low-wage labor.
Why is health care different? If you really think the problem is high health care prices and you want to do something about it, why not impose price controls? For example, the government might say that every doctor, every hospital, and every other provider cannot charge more than the Medicare rate.
By the way, that is exactly what Bernie Sanders is promising. The puzzle is: Why does he want government to control the whole system? Imposing Medicare prices on health care would be as easy as imposing rent controls or minimum wage laws. Running the whole health care system is hard.
Here is another puzzle. Although it’s not stressed as much, implicit in almost all leftwing rhetoric about health care is the idea that providers make too much money. After all, high prices produce high revenues and that produces high incomes.
But remember, the left thinks the entire economic system is rigged to favor the rich and hurt the poor. And what is their stock solution? They don’t advocate nationalizing the entire economy. Instead, they advocate taxing the rich and giving to the poor.
We could do that in health care too. In fact, it would be easy. We could place a surtax on incomes of all providers—doctors, hospitals, nurse practitioners, etc. And we could extend a subsidy to every taxpayer who reports a medical expense.
Nationalizing the entire health care system would be enormously difficult and complex. But taxing providers and subsidizing patients in the way I just described would be as easy as pie.
So why doesn’t the left turn to the tried-and-true interventions it has always advocated instead of wanting to turn the entire health care system upside down?
I think I found the answer years ago when I formulated:
Goodman’s Law: When people begin to think about health care, their IQ drops by 15 points.
Or, put differently, when people start thinking about health care, they just quit thinking.
Now it’s always possible that the left will come to its senses. They might even latch onto the two interventions I described above. What’ s wrong with that?
As loyal readers know, my view is that the problem with our health care system is not that it is market-based. To the contrary, we have so suppressed the market that no one ever sees a real price for anything. The answer to that is to liberate the market. Buyers and sellers should see real prices for every service.
Price controls and transfer taxes and subsidies would do the opposite of that. They would further ensure that no price is a real price and that every buyer and every seller faces perverse incentives.
What I usually talk about is what the left never talks about: How do we make the market work for us in health care the way it works so very well everywhere else?
Now back to international comparisons, as I promised.
It turns out that although our nominal prices are high, that doesn’t mean that health care costs more in the economic sense of the word.
Remember, if every price is a phony price, when you add up all those prices, the total number is a phony number. Comparing phony numbers internationally doesn’t tell us anything interesting.
The real cost of health care to any nation is the real resources used to produce it. How many doctors are there per capita? How many nurses? How many hospital admissions. How many hospital days?
Believe it or not, when you count up real resources, we are not the most expensive system in the world. In fact, we are in the middle of the pack.
https://www.forbes.com/sites/johngoodman/2020/01/17/what-the-left-doesnt-understand-about-health-care-prices/#1cd0b4a1664e

DexCom EPS beats by $0.43, beats on revenue

DexCom (NASDAQ:DXCM): Q4 Non-GAAP EPS of $1.15 beats by $0.43; GAAP EPS of $1.00 beats by $0.37.
Revenue of $462.8M (+36.9% Y/Y) beats by $5.68M.
Shares +3%.
https://seekingalpha.com/news/3541909-dexcom-eps-beats-0_43-beats-on-revenue

Ultragenyx Q4 revenue up 118%

Ultragenyx (NASDAQ:RARE) Q4 results:
Revenue: $35.6M (+118%); product sales: $7.2M (+107%).
Net loss: ($93.8M); loss/share: ($1.62).
2020 guidance: Crysvita revenue: $125M – 140M.
https://seekingalpha.com/news/3541919-ultragenyx-q4-revenue-up-118

FDA requests removal of weight loss med Belviq

Citing its potential cancer risk, the FDA has requested the removal of Arena Pharmaceuticals’ (ARNA -1.1%) Belviq (lorcaserin) from the U.S. market.
Licensee Eisai (OTCPK:ESALY N/A) has submitted a filing to voluntarily withdraw the drug.
Update: Arena sold the rights to Eisai in 2017 for $23M in cash and over $80M in cost relief.
https://seekingalpha.com/news/3541893-fda-requests-removal-of-weight-loss-med-belviq

Who to blame for opioid crisis? In Florida, Walgreens, CVS point to doctors

In lawsuits around the U.S. that blame major pharmacy chains, such as Walgreens and CVS, for the country’s opioid crisis, the healthcare giants appear to be following a similar legal strategy: Blame the doctors instead.
In Florida earlier this month, Walgreens and CVS filed a third-party complaint that says that 500 anonymous physicians—Dr. John and Jane Doe—are responsible for fueling that state’s opioid epidemic, not the pharmacists who filled the opioid prescriptions.
It comes after a group of major pharmacy chains that included CVS and Walgreens, filed legal action in an Ohio court in January to shift the responsibility to physicians in a major federal opioid trial that claims the large companies are culpable for prescribing the drugs that have fueled the opioid crisis.
In those filings, the pharmacy chains, which also included Walmart, Rite Aid, HBC and Discount Drug Mart, said it was actually hundreds of Ohio physicians and other healthcare practitioners who write the prescriptions that bear the blame for providing opioids to patients—not the pharmacists who filled those prescriptions.

Florida’s Attorney General Ashley Moody was having none of that legal argument. “This stunt is simply a tone-deaf distraction by two of the wrongdoers in the national opioid crisis that is claiming 15 lives in Florida every single day,” Moody said in a statement.
She filed a motion to strike or sever the third-party complaint (PDF) filed by CVS Pharmacy Inc. and the Walgreen Company, pharmacy retailers who were named as co-defendants in a suit brought by the Attorney General’s office against Purdue Pharma, the maker of OxyContin, and other manufacturers, distributors and chain pharmacies.
In her motion to throw out the third-party complaint in Florida, Moody said CVS and Walgreens have records that include the names of the doctors who wrote the opioid prescriptions, “Yet, CVS and Walgreens have not named a single prescriber and, instead, have filed this pleading against 500 John and Jane Doe defendants,” she wrote. “Our complaint alleges that these national pharmacies are responsible for knowingly flooding Florida with billions of dangerous and addictive pills all while the opioid crisis continued to spiral out of control.”
Like several other states seeking to recoup millions of dollars spent battling the costly opioid epidemic, Florida filed a lawsuit in 2018 that named the two retail pharmacy giants as defendants.

The defendants should have known they were fueling an opioid epidemic, the lawsuit said. A Walgreen’s drug distribution center sent 2.2 million opioid tablets to a single pharmacy in tiny Hudson, Florida, in 2011 a roughly six-month supply for each of its 12,000 residents, the lawsuit said. CVS distributed more than 700 million opioid doses in Florida between 2006 and 2014, it said.
In response, Walgreens and CVS filed a third-party complaint in January saying they are not liable for the opioid crisis and asking the court to focus on the physicians who prescribe the drugs.
“Pharmacists do not write prescriptions and do not decide for doctors which medications are appropriate to treat their patients,” the complaint says. “While pharmacists are highly trained and licensed professionals, they did not attend medical school and are not trained as physicians. They do not examine or diagnose patients. They do not write prescriptions.”
https://www.fiercehealthcare.com/practices/laying-blame-for-opioid-crisis-florida-walgreens-and-cvs-point-finger-at-physicians