More On ICU Bed/100k Population Figures

One thing I missed in Sunday's post about ICU beds in various medical systems is that the underlying Clinicians' Biosecurity News paper says that "there are about 46,500 medical ICU beds in the United States and perhaps an equal number of other ICU beds that could be used in a crisis" (emboldening mine). (The paper was published February 27, 2020, so still hot off the presses.) If we double that figure, it means the US has 93,000 ICU beds (assuming it is possible to adequately staff each one), or

93,000 ICU beds/331M population = 28 ICU beds/100k population

This is notably better than all European countries save Germany. However, they don't say how they arrived at that figure. A 2013 summary in Current Opinion In Critical Care claims the US has from 20.0-31.7 ICU beds/100k population, pointing to a 2008 summary in Critical Care Medicine:

 It seemed more likely to me that the industry itself might have better statistics, and indeed they do: the American Hospital Association says that the US has 97,776 ICU beds, which would mean

97,776 ICU beds/331M population = 29.5 ICU beds/100k population

While impressive, it seems reasonable to subtract out the neonatal ICU beds (22,860) and pediatric ICU beds (5,131). This gives us

69,785 ICU beds/331M population = 21.1 ICU beds/100k population

Overall, very good news, considering, but still inadequate to the demands if coronavirus needs spike.

No, Socialized Medicine Does Not Provide Superior Epidemic Planning

There have lately been a number of people using the COVID-19 epidemic as a justification for single-payer or socialized medicine. Particularly, Bernie Sanders has come out claiming that "it has never been more important to finally guarantee that health care as a human right by passing Medicare for All." Yesterday, I heard someone claim that the for-profit medical system we have in the US is less prepared than those of other countries, because its operators trim all non-exigent expenses down to average usage levels.

This of course is the purest nonsense, and anyone who has paid attention to the goings-on overseas would recognize this with just a little bit of research. Particularly, I wanted to look at one of the first things that will get used up in a real pandemic: intensive-care unit (ICU) beds. Eric Toner, M.D. and Richard Waldhorn, MD writing in Clinicians' Biosecurity News report an estimated 46,500 ICU beds in the United States versus low-case needs of 200,000 beds for a 1968 influenza breakout, and a high-end need of 2.9 million. Needless to say, the availability of ICU beds will become very stressed under epidemic conditions:

• The UK has 4,000 ICU beds, of which "about four-fifths are occupied" according to a recent BBC story. The UK's population is about 66 million, which translates to
  
  4,000 ICU beds / 66M = 6 ICU beds/100k
• Canadian ICU beds are broken down by hospital type, with occupancy rates of 86% for large urban facilities, and 90% for teaching hospitals, with rates as low as 50% for smaller/rural hospitals. I was unable to find an overall national occupancy rate, but it appears Canada has an occupancy rate at the very least comparable to the US if not greater. Canada's population is 38 million, over 3,715 ICU beds as of 2015, which means
  3,715 ICU beds / 38M = 8.3 ICU beds/100k
• The Society of Critical Care Management says that ICU occupancy in the US is 68% as of 2010, the last year figures were available. The US has 46,500 ICU beds distributed over a population of 331 million, so
  46,500 ICU beds/331M = 14 ICU beds/100k

In other words, the US has more beds, and more free capacity in the beds it does have, than two of the premier systems often touted as superior to the US. In fact, in general, the US's 14 ICU beds to 100,000 population ratio comes out looking positively rosy compared to most of the European systems (as of 2011):

(The figures above may actually overstate the ratios because the authors were unable to get standardized counts of critical versus acute care beds in many cases.) And it's not just ICU beds. As Noah Rothman points out in Commentary, public systems are struggling to cope with COVID-19. In Lombardy, Italy, the Italian Society of Anesthesia, Resuscitation, and Intensive Care has proposed an age limit for intensive care bed space. The UK's NHS has already run into ICU bed space problems and has inadequate ventilators, a situation that is "going to end in death". If there is a public system doing a better job (or capable of doing so) addressing COVID-19 planning, it hardly seems universal or even anything like a majority.

Update 2022-09-21: Google has seen fit to unpublish this on the grounds that it "violates Blogger Community Guidelines." This is pure political censorship.

The Bureaucracy Explosion In Medicine And Higher Education Is Killing Both

You can safely ignore virtually all of this New York Times editorial about medicine, save for one paragraph:

The health care system needs to be restructured to reflect the realities of patient care. From 1975 to 2010, the number of health care administrators increased 3,200 percent. There are now roughly 10 administrators for every doctor. If we converted even half of those salary lines to additional nurses and doctors, we might have enough clinical staff members to handle the work. Health care is about taking care of patients, not paperwork.

 This is the same problem besetting academia, with administrative staff growing at twice the rate of student populations. It is responsible for the staggering cost of both. And in both places, such bureaucrats must be laid off.

But who will do it?

Doximity Physician Pay Survey Raises More Questions Than It Answers

I recently got into it on Twitter with Leah Houston, M.D. regarding physician pay scales, and an alleged gender pay gap:

Serious question: what do you think of the looming physician-hours crisis? It seems to me this comes in (at least) two dimensions:

1) Insane levels of “paperwork”.
2) The feminization of the field. As of last year, a majority of incoming med school students were women. >

— Rob McMillin (@scareduck) April 11, 2019

Then, this:

Seriously? A “pay gap” that compares aggregate wages of male versus female doctors that fails to control for hours worked, continuity of employment, and specialization? For shame. This has been multiply debunked in the broad economy. No reason to think doctors are any different.

— Rob McMillin (@scareduck) April 11, 2019

(I was wrong about the control for hours, but see below.) The principal argument here comes from the 2019 Doximity physician pay report (PDF), but when you skip down to their methodology (p. 16), you see this:

Doximity’s study is drawn from self-reported compensation surveys completed by approximately 90,000 full-time, licensed U.S. physicians who practice at least 40 hours per week. Responses were mapped across metropolitan statistical areas, and the top 50 were ranked by the number of respondents in the data.

To control for differences in specialty, geography, and other provider-specific factors that might influence spending, we estimated a multivariate regression with fixed effects for provider specialty and MSA. We also controlled for how long each provider has practiced medicine and their self-reported average hours worked per week. This regression was estimated using a generalized linear model with a log link and gamma distribution. For the geographic and specialty rankings, we used the predicted values from this regression.

So, some questions:

1. Why does this not take into consideration interruptions in service years? Or, does "how long each provider has practiced medicine" refer to actual service time (opposite time since receiving certification)?
2. Was sex used for the multivariate analysis? If not, why not?
3. Why are self-reported hours not mentioned in the results? Considering the fracas of Relative Value Units, this would be valuable to know.
4. How many hours does an average male full-time physician work? How many for females?
5. When you say you queried "approximately 90,000 full-time, licensed U.S. physicians who practice at least 40 hours per week", is that physician-patient face time, or overall compensated time?

Overall, it does not seem to me that this looks closely enough at the data (and likely, does not ask the right questions) to arrive at any substantive conclusions as to whether there is a gender pay gap for physicians, even in the same specialty and market. 

Sunday Linkies

• The ACLU has come out in favor of M2F participation in biological women's sporting events, an announcement that was immediately panned by Martina Navratilova:

  I love you ACLU, but you are wrong on this. Unless you want to completely remake what Women’s Sports means, there can be no blanket inclusion rule. There is nothing stereotypical about this- it’s about fairness and it’s about science. Thank you.

  — Martina Navratilova (@Martina) March 13, 2019

  The ACLU's source for this claim is a data-free essay from ... Everyday Feminism.
• Reason ran a fine essay on sex differences in athletics that probably won't do much to change the current situation, larded as it is with loud advocates resting on spectral evidence that doesn't really address the differences between M2F transgender athletes and biological women. 
• A terrific thread from @FondOfBeetles showing how adolescent boys routinely break records set by the best women in track. Opening shot:

  In 2004, I was privileged to watch Kelly Holmes win the female Olympic 800m gold, in a run that kept everyone on tenterhooks until that final glorious sprint finish. Her finishing time was 1:56.38. 1/ pic.twitter.com/6EkVF5ZFxe

  — Dr FondOfBeetles (@FondOfBeetles) March 11, 2019

• A useful article from T Nation on the subject of transgender athletes:
  

  Most experts say that the average testosterone production for biological females ranges between 0.52 to 2.8 nmol/L. The Mayo Clinic put that range even lower (2). And while experts may vary in what they consider average among females, the consensus is almost always below 3 nanomoles/L.
  
  But remember, federations like the IOC require a male-born person to suppress and maintain testosterone production at 10 nanomoles/L.
  
  So even if a woman was genetically blessed with testosterone levels that reached 3 nmol/L, that would still be less than half of what a trans woman would be allowed to have during the competition. To look at it another way, her male-born competitor would have just over three times as much testosterone, even with hormone-altering drugs.

• Sex differences in the human brain show up before birth. The last refuge of the blank slate-ist is gone.
• Kirsten Gillibrand has zero endorsements. 
• Finland's government has collapsed following failed efforts to reform the country's healthcare delivery system.  This is interesting for a lot of reasons, not least because Finland has better per-capita spending on healthcare than France, which is often used as a model for US single-payer/M4A advocates (the light blue line below is Finland):
  
  
  

The USPTO Enabled The Theranos Scam

Ars Technica today reports on the USPTO's role in Theranos' con job. Enabled in very large part by Elizabeth Holmes' never-reduced-to-practice patent of a "microfluidic patch that could test blood for infectious organisms and could deliver antibiotics through the same microfluidic channels", the thing metastasized:

 The provisional application, filed in September 2003 when Holmes was just 19 years old, describes “medical devices and methods capable of real-time detection of biological activity and the controlled and localized release of appropriate therapeutic agents.” This provisional application would mature into many issued patents. In fact, there are patent applications still being prosecuted that claim priority back to Holmes’ 2003 submission.

...

...[M]ore than a decade after Holmes’ first patent application, Theranos had still not managed to build a reliable blood-testing device. By then the USPTO had granted it hundreds of patents. Holmes had been constructing a fantasy world from the minute she started writing her first application, and the agency was perfectly happy to play along.

An appalling story.

NYT Discards The Right Cause For "The Insulin Wars"

The New York Times somehow recognized that patent protection is behind the whack-a-mole madness of insulin prescriptions, yet mostly elides that as causal:

There are several reasons that insulin is so expensive. It is a biologic drug, meaning that it’s produced in living cells, which is a difficult manufacturing process. The bigger issue, however, is that companies tweak their formulations so they can get new patents, instead of working to create cheaper generic versions. This keeps insulin firmly in brand-name territory, with prices to match.

But the real ignominy (and the meat of the lawsuit) is the dealings between the drug manufacturers and the insurance companies. Insurers use pharmacy benefit managers, called P.B.M.s, to negotiate prices with manufacturers. Insurance programs represent huge markets, so manufacturers compete to offer good deals. How to offer a good deal? Jack up the list price, and then offer the P.B.M.s a “discount.”

Minus spurious patents, this kind of tomfoolery wouldn't happen. Patent reform as it applies to medicine, is absolutely a precondition to fixing pharma pricing.

Physicians Per Capita Continues Up In 2016 FSMB Survey

Good news on a subject I've harped on before: physicians per capita as a fundamental cause of the cost of medicine. Absent adequate supply, it almost doesn't matter what kind of payment system we have: medicine can't get cheaper without a bigger workforce. Accordingly, the Federation of State Medical Boards has published their 2016 survey results (PDF). The topline figure of 953,695 alleopathic and osteopathic physicians represents a 12% increase since 2010, and a 4.09% increase from 2014. This is a 2.01% annual growth rate, which is slightly off the pace of 2.14% rate I calculated in January, 2017 based on the 2014 survey (no longer available). Given the overall US population rate appears to be growing at about 0.7% annually, this is more than keeping pace with overall population growth, a good thing.

Physician immigration continues to be important, with Indian physicians, and physicians studying in the Caribbean countries, being the two most important sources:

India by itself provides about 23% of the immigrant physician population, and 5.1% of all US physicians. A majority of doctors studying in Caribbean countries are US citizens, and this has been true for years:

The largest single age group of physicians is those in their 60s, something that will have consequences as this group nears retirement — and as modern medicine becomes more bureaucratic:

Women physicians under 40 are now nearly double the number of men in the same age cohort, reducing available physician hours:

In all, mostly good news, but there's still an obvious iceberg ahead with pending retirements, Trumpian immigration restrictions, the crisis of part-time physicians, and Medicare internship throttling.

What Was The FDA's Statutory Authority For Granting Marketing Exclusivity On Colchicine?

Maybe this seems obscure, but it gets to the heart of something I've wondered about for quite some time: how did URL Pharma get a licensing exclusivity on colchicine? Colchicine is a drug made from the autumn crocus, Colchicum autumnale, and has been known since antiquity as a curative for gouty arthritis. From Wikipedia:

An unintended consequence of the 2006 U.S. Food and Drug Administration (FDA) safety program called the Unapproved Drugs Initiative — through which the FDA sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs^[27] — was a price increase of 2000 percent ^[28] for "a gout remedy so old that the ancient Greeks knew about its effects."^[28] Under Unapproved Drugs Initiative small companies like URL Pharma — Philadelphia drugmaker — were rewarded with licenses for testing of medicines like colchicine. In 2009, the FDA reviewed a New Drug Application for colchicine submitted by URL Pharma. URL Pharma did the testing, gained FDA formal approval and was granted rights over colchicine. With this monopoly pricing power, the price of colchicine increased.

In 2012 Asia’s biggest drugmaker — Takeda Pharmaceutical Co. — acquired URL Pharma for $800 million including the rights to colchicine (brand name Colcrys) earning $1.2 billion in revenue by raising the price even more.^[28]

Oral colchicine had been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.^[29] On July 30, 2009 the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares^[29]), and gave URL Pharma a three-year marketing exclusivity agreement^[30] in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee. URL Pharma raised the price from $0.09 per tablet to $4.85, and the FDA removed the older unapproved colchicine from the market in October 2010, both in oral and intravenous forms, but gave pharmacies the opportunity to buy up the older unapproved colchicine.^[31] Colchicine in combination with probenecid has been FDA-approved prior to 1982.^[30]

In August 2009, colchicine won FDA approval in the United States as a stand-alone drug for the treatment of acute flares of gout and familial Mediterranean fever.^[32][33] It had previously been approved as an ingredient in an FDA-approved combination product for gout. The approval was based on a study in which two doses (1.2 mg and 0.6 mg) an hour apart were as effective as higher doses in combating the acute flare of gout.^[11]

 The Unapproved Drugs Initiative page is singularly unhelpful when attempting to decipher where the FDA thought they were entitled to take this action, but the FDA's page on the colchicine enforcement action is, particularly citing Familial Mediterranean Fever as an excuse the justification for attaching "orphan drug" status to it (21 U.S.C. 360bb). This allowed URL Pharma to get marketing exclusivity for the drug, and all the rest. It's not clear that the Wikipedia page entry's blaming of Hatch-Waxman is appropriate.

Credit to @molratty on Twitter for background assistance.

Shooting The Messenger On Part-Time Female Physicians

Tell the truth these days (or come close to it) and your assured destruction at the hands of the feminist lynch mob will soon ensue. Take Dr. Gary Tigges, M.D., P.A., who recently said of the alleged gender gap in pay among physicians,

Yes, there is a pay gap. Female physicians do not work as hard and do not see as many patients as male physicians. This is because they choose to, or they simply don’t want to be rushed, or they don’t want to work the long hours. Most of the time, their priority is something else … family, social, whatever.

Nothing needs to be “done” about this unless female physicians actually want to work harder and put in the hours. If not, they should be paid less. That is fair.

Of course, this yielded a pointless apology from him, a dumb parody piece (uncharacteristically) from Gomerblog — and the usual horrified objections disconnected from any actual rebuttal. Take this one from the American Council of Science and Health, by Jamie Wells, M.D. Mostly indignant offense-taking, she finally settles down to marshal something resembling an argument. And by "resembling", I mean just that, because it isn't much of one. For instance:

Dr. Tigges' misguided statements, out of step with more than a decade of data that disputes his biased assertions demonstrating that female physicians are not only as good as their male counterparts but in many instances provide higher quality care with better outcomes, are commonly held beliefs throughout the healthcare system, particularly by those in management and administrative roles (see here and here).

But wasn't the issue compensation due to time spent in patient care, not administrators and managers? Okay, let's keep going. Maybe she provides something of substance anon.

Another example that is standard fare for those subscribing to the Tigges way of thinking is that more women physicians work part-time. The reasons for this are often mischaracterized as "their choice." This is often not the case. Practices don't have to cover benefits or pay as much for part-time, so they offer it instead which uniformly results in full-time work for part-time pay. Changing jobs or accepting the reality of seeing more for less until something better comes is a mainstay dilemma for countless women.

This word salad rebuts not at all Tigges' assertion that women see fewer patients. Perhaps it is not their fault. But so what? Earlier, she complains of "the perverse payment incentives of the RVU (relative value unit) system here which values low quality, high volume patient mill type medical practice." All these things may be true. But, again, they do not form a counterargument.  At last, she drags out the big guns, from something called Equity Quotient. There, we learn

• Of 446 major U.S. occupations, physicians have largest median gender-based pay gaps; in some subspecialties, as much as $90k (Wall Street Journal 2016)
  
• Over $9,000 per physician/per year is spent by healthcare organizations due to gender inequality — cost accrued from attrition, burnout and litigation (discrimination/sexual harassment).
  
• Total cost of recruitment, on-boarding, lost revenue, about $400k (up to $600k) for a single hospitalist

At last, an on-point citation with numbers! Unfortunately for Equity Quotient and Dr. Wells, the underlying 2016 Wall Street Journal story buttresses Dr. Tigges' assertion, not hers. The devil is in the details (paywall, emboldening mine):

The biggest gaps in many white-collar professions don’t easily lend themselves to legislative remedies. In fact, the Journal’s findings belie policy makers’ hope that the most-educated women would lead the way in shrinking the gap. Currently, more women than men graduate from college.

Wage transparency—requiring employers to report salary data—is “just not going to move the needle much,” says Claudia Goldin, a Harvard University economics professor and one of the country’s foremost scholars on gender and pay. Prof. Goldin found in a 2010 paper that men and women earned almost the same salaries right after receiving University of Chicago M.B.A.s. At least a decade after graduating, the women earned 57% of their male classmates.

The main factor, she and her co-authors concluded: Women became mothers, interrupted their careers and eschewed lengthy hours that generated higher paychecks. “These particular occupations,” Prof. Goldin says, “are not very forgiving of taking time off and having kids.”

The Journal’s analysis of Census Bureau data for the five years through 2014 found male doctors working full time earned about $210,000 annually on average. Female physicians made 64% of that, about $135,000 a year. Among personal financial advisers, men took in about $100,000 while women made about $62,000.

Many white-collar jobs give substantially larger financial rewards to those logging the longest hours and who job-hop often, phenomena that limit white-collar women who pull back for child-rearing. Researchers on the topic say ingrained workplace cultures also impede women’s earnings.

What those "workplace cultures" are, the unnamed researchers don't say later in the article, but one suspects it has to do with the expectation of long hours, among other things. As with the overall and principally bogus "pay gap", hours, continuity, and specialization produce higher returns. A multivariate analysis based on specialty, time spent on the job, and continuity of employment would be useful. Too bad we don't appear to have it.

Previously: The Crisis of Part-Time Physicians

How Big Data Is Raising Costs And Killing Doctors

This week, I interviewed two doctors starting a new practice in Little Rock using the Direct Primary Care model. We talked a good bit about a number of issues, but particularly, those of Electronic Medical Records (EMR), their distribution, and security. It came up that their days as employees of the University of Arkansas for Medical Sciences went something like this:

• 8:00 AM to 12:00 PM: see patients (with fit-ins possibly pushing that back to 1:00 PM)
• Lunch
• 1:00-2:00 PM to 6:00 PM: paperwork (ICD-10 coding, mainly)

That is to say, they were expensive secretaries whose time was better spent doing other things. Doctors are scarce as it is, and this makes a bad situation worse. It also meant that these two young women were unable to pick up their children from daycare, even given a ten-hour window! It is all too sadly typical:

A recent study in the Annals of Family Medicine used the E.M.R. to examine the work of 142 family medicine physicians over three years. These doctors spent more than half of their time — six hours of their average 11-hour day — on the E.M.R., of which nearly an hour and a half took place after the clinic closed.

Another study, in Health Affairs, tracked the activities of 471 primary care doctors over a three-year period, and also found that E.M.R. time edged out face-to-face time with patients.

This study came on the heels of another analysis, in the Annals of Internal Medicine, in which 57 physicians were observed directly for 430 hours. The researchers found that doctors spent nearly twice as much time doing administrative work as actually seeing patients: 49 percent of their time, versus 27 percent.

The insanity of such paperwork loads is obvious, and contributes mightily to physician burnout. According to a study from the Mayo Clinic, 1 in 5 doctors plan to curtail their clinical hours over the next two years, and 1 in 50 plan on leaving the field altogether. Big Data comes with real-world consequences. Remember that the next time you see some self-interested company pitching its wares as a means to improve outcomes or costs,  or some dimwit politicians endorsing it using fatuous acronyms.

Burning Down The Medical Village To Save It: The Folly Of Big Data In Medicine

Rena Xu's recent piece in The Atlantic on physician burnout is mostly interesting for its between-the-lines reporting. Yes, Big Data (i.e. medical coding) is driving a lot of physician burnout:

Regulations governing the use of electronic medical records (EMRs), first introduced in the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, have gotten more and more demanding, while expanded insurance coverage from the Affordable Care Act may have contributed to an uptrend in patient volume at many health centers. These changes are taking a toll on physicians: There’s some evidence that the administrative burden of medicine—and with it, the proportion of burned-out doctors—is on the rise. A study published last year in Health Affairs reported that from 2011 to 2014, physicians spent progressively more time on “desktop medicine” and less on face-to-face patient care. Another study found that the percentage of physicians reporting burnout increased over the same period; by 2014, more than half said they were affected.

But won't we need ever-more new physicians to deal with the aging US population? Yes, we will, but —

A quarter of U.S. physicians are expected to retire over the next decade, while the number of older Americans, who tend to need more health care, is expected to double by 2040. While it might be tempting to point to the historically competitive rates of medical-school admissions as proof that the talent pipeline for physicians won’t run dry, there is no guarantee. Last year, for the first time in at least a decade, the volume of medical school applications dropped—by nearly 14,000, according to data from the Association of American Medical Colleges. By the association’s projections, we may be short 100,000 physicians or more by 2030.

And this despite modest, recent upticks in new physicians, even despite Medicare's meddling in internship slots. In addition, the article cites the "Resident Physician Shortage Reduction Act ... [which] would add 15,000 residency spots over a five-year period." That's a 1.6% increase vs. the 2014 physician population of 916,264, but nothing compared to the gaping hole implied by 100,000 missing doctors. Mandated medical coding — the raw material of Big Data in medicine — contributes to a physician burnout we can scarcely afford.

But this kind of insanity is to be expected. The people who imagine they are helping very frequently do not subject themselves to the consequences of their "help" (viz., Jonathan Gruber, who is not a doctor). The meretricious belief that big data will somehow "bend the cost curve" is deeply embedded, including, especially, in service providers with something to sell. There are costs to acquiring that data, and that cost is, more administrative overhead (emboldening mine):

...[D]octors are most valuable when doing what they were trained to do—treating patients. Likewise, non-physicians are better suited to accomplish many of the tasks that currently fall upon physicians. The use of medical scribes during clinic visits, for instance, not only frees doctors to talk with their patients but also potentially yields better documentation. A study published last month in the World Journal of Urology reported that the introduction of scribes in a urology practice significantly increased physician efficiency, work satisfaction, and revenue.

And who pays for that increased revenue? Ultimately, it's the patients, of course, or the government (taxpayers) if it's Medicare/Medicaid.

The Supreme Court Blesses Inter Partes Review, And The Possibilities For Pharma Reform

One of my big complaints about medicine is the ongoing problems with patents (general complaints here, a more specific example here) needlessly driving the costs of pharmaceuticals higher. The Supreme Court recently delivered some good news on this front in the case of Oil States Energy Services v. Greene's Energy Group. Essentially, the 7-2 decision said that the USPTO can revoke its own granted patents in a process called Inter Partes Review.

The basic idea behind the IPR process was an admission that the USPTO is historically bad at properly reviewing patents before granting them. It grants a lot of bad patents. The IPR process allows anyone to present evidence to the PTO that it made a mistake and granted a patent that should never have been granted. If the PTAB is convinced, it can invalidate the patent. Seems pretty straightforward. Except that the usual patent lovers (mainly patent trolls and big pharma) insisted that this was some sort of unconstitutional taking of property, without the review of a court. This is wrong for a whole bunch of reasons -- starting with the incorrect view of patents as traditional "property."

 The reaction of the pharmaceutical business, which is often predicated on shabby patents, is highly negative, but it’s unclear whether there’s enough momentum behind the process, as “Pfizer, Merck, Novartis and Sanofi are among the companies to have used the IPR process” to invalidate patents. Unfortunately, because IPR is a strictly bureaucratic creature, it is also subject to regulatory capture, i.e. if Big Pharma (say) gets hold of it, it will actually result in worse outcomes than appeals before Article III judges. A study by BiologicsHQ shows that “despite widespread concerns about the PTAB operating as a patent death squad in IPRs, ‘such concern is not justified for drug patents.’” The study found that

According to the March 2017 IPR statistics issued by the PTAB, 53 percent of IPRs resolved as of March 31, 2017 were instituted; the rest were either denied institution or reached some other resolution prior to the institution decision. 35 percent of all resolved IPRs resulted in final written decisions and 23 percent led to findings of all claims unpatentable. Only 7 percent of all resolved IPRs led to final written decisions finding that no claim was unpatentable, and 5 percent led to mixed claim findings.

This suggests that only the most obscenely obvious patents will end up invalidated, and even among those patents that do go through the process, not all of them end up being instituted! But the numbers are even worse for pharmaceutical patents:

By contrast, drug patents fare better under PTAB scrutiny in terms of having claims upheld. Of the 4,563 resolved IPRs, BiologicsHQ reports that 222 petitions (5 percent) involved patents covering drugs listed in the Orange Book. Focusing on just the IPRs involving Orange Book patents, 44 percent were instituted and 38 percent reached a final written decision, but only 16 percent led to final written decisions where all claims were found unpatentable. No instituted claim was found unpatentable in 50 percent of final written decisions (19 percent of the total number of resolved Orange Book IPRs).

 (The Orange Book is the list of FDA-accepted drugs.) Far from being a salvation, IPR might prove to be an industry Trojan Horse. To be clear, there’s no immediate evidence that regulatory capture is currently running rampant at the USPTO,  but the outcomes certainly point in the same direction.

Sarah Kliff, Promoter Of Democratic Healthcare Fantasies

Vox's Sarah Kliff, last seen before 2016 election whistling past the Obamacare graveyard, now chirps about the number of Democratic health care proposals! Yay, team!

It’s notable to me that Democrats seem really keen on having another health care debate. They’re preparing for it by putting all these different options on the table, to sort through where a consensus might exist.

And the "options" really boil down to a Hobson's choice: how do you want your government-controlled health care delivered? All from the government right now (single-payer, a consistent loser at the polls)? Pretending that single-payer isn't the endgame right away (Medicare/Medicaid buy-in, i.e. the public option)? However you cut it, the belief in magical government intervention as an elixir is central to all of them. None of these will fix the physician shortage, nor will it fix the patent system, nor the regulatory moats around pharmaceuticals. Kliff doesn't concern herself with those kinds of details; her job is that of cheerleader. We know this because the second half of her article goes on to explain the wonders of the Murphy-Merkley plan, during which she writes the following:

The Choose Medicare Act envisions that individuals and companies would cover their costs for buying into Medicare, meaning actuaries would need to determine what those premiums would look like. There is some reason to expect these premiums would be lower than premiums for private insurance, because Medicare typically pays lower prices.

There are a lot of things to say about that, not least the shifting terrain that a large influx of new "insureds" would look like; recall that the Obamacare cohort was sicker than the general population, i.e. the incentives are for such people to seek out such care. There's hardly a reason to think a "public option" would save material costs, and considerable reasons to think it would do worse (i.e. the Democrats would be sure to goose the actuarial realities by way of further subsidies).

Another problem is the quip sometimes attributed to Stalin, that quantity has a quality all its own. Kliff is right that private payers pay more for their services than Medicare. But assuming Medicare expansion will fix costs also assumes that physicians will continue to accept Medicare patients. While data is hard to come by, Texas Medical Association figures showed a dramatic drop in the acceptance of new Medicare patients from 2000 (when 67% of physicians accepted all comers) to 2010 (only 31%). Moreover, given that Medicare represents a relatively small fraction of physician income (as of 2011, around 40% in Texas, see PDF page 5), expanding it would demand physicians take a substantial pay cut. That they might opt out of accepting new patients or stop seeing Medicare patients altogether. Second-order effects: we can haz them!

How An Idiotic Patent Turned $20 Worth Of Generic Drugs Into $5,430

So I went to see the surgeon today for a followup appointment following my knee surgery, a routine arthroscopy. He recommended I take an anti-inflammatory, 800 mg of ibuprofen, three times a day. Doses that large are not always well-tolerated; they have been known to cause gastric upset. Consequently, we get this:

Meet Duexis, a product of Horizon Pharma. Duexis consists of 800 mg of ibuprofen, and 26.6 mg of famotidine. Ibuprofen was patented in the UK in 1961, and expired in 1984; the US patent (3769425A) was granted in 1970, and would have expired in 1987. Originally sold under the trade name of Pepcid, famotidine has been off patent for 20 years, with generics appearing in 2001.

I checked at Sam's Club, and 200 count 20mg famotidine is currently $8.76, and 1,200 200 mg ibuprofen is available for $10.88. Assuming I take three 800 mg ibuprofen doses daily and three of the 20 mg famotidine, that would mean the latter is the limiting factor, and I could go about two months (66 days, plus two doses the next) on that. (The 1,200 ibuprofen would take me 100 days, a little over three months.)

A one month prescription of Duexis (30 days @ 3x/day) is $2,715 (per the Sam's Club pharmacy). Two months is $5,430.

Duexis is covered by US patent 8,501,228, which I assume is the reason for this insane pricing. (Horizon also granted Par Pharmaceutical a license to make a generic starting in 2023 as a result of a patent suit settlement.) This kind of apparently frivolous patent grant is disturbingly common:

When the patent reaches its expiry date, the comfortable monopoly evaporates, replaced by cut-throat competition. Incumbents have three ways of defending themselves. Marketing can create brand-specific demand, dulling the temptation to switch to low-price products. Ibuprofen illustrates this. Developed by the chemists at Boots itself in the 1960s, the patent expired in 1984. But a year earlier Boots had created Nurofen, branded ibuprofen. The clever mix of packaging and advertising protected its profits. The lucrative Nurofen brand was sold in 2006; Boots still stocks the product, which costs five times more than its generic equivalent.

A second strategy nudges customers towards newer drugs that are still protected by patent. Omeprazole, a drug to reduce stomach acid developed by AstraZeneca in the 1980s, shows how it works. Branded as Losec in Britain and Prilosec in America, it became one of the world’s bestselling drugs in the mid-1990s. With the patent set to expire in 2001 AstraZeneca faced a drop in profits. So the company took its drug and adapted it, creating a closely related compound, esomeprazole, which it sold as Nexium. Though a clear offshoot of the original medicine, this counted as a new drug and was given a patent. A big marketing campaign and attractive pricing helped shift demand away from Losec and towards Nexium. With the help of this strategy, sales between 2006 and 2013 amounted to almost $40 billion.

A third approach is to "pay the makers of generics not to compete". None of these are in the customer's interest.

Ironically, the surgeon pointed me at a manufacturer program that was going to cut me a break if I used their particular pharmacy — oh, joy! — I only have to pay a $10 copay! But this made me wonder if my insurance was going to pay it or some part of it. In which case, am I not indirectly paying for this usuriousness?

The Crisis of Part-Time Physicians

Something that came up elsewhere, but for which I was unaware of the magnitude of the problem: according to one unsourced estimate, around 30% of female physicians work part time. A better 2011 estimate in the Journal of the American Medical Association shows 21% of the physician workforce is part-time, with that figure plateauing as of 2015, of which 44% of female physicians worked part-time. Where this starts to get scary is in a recent Association of American Medical Colleges announcement that a slight majority of new med students are female, 50.7% of the overall total. Given that women exit internships into practice in prime reproductive years and are thus more likely to want time off for family, it suggests an upcoming crisis in terms of overall physician hours available: not all physicians are willing to work the same number of hours.

Sunday Bullets

• The Boy Scouts of America will start admitting female members.
• Allergan has apparently sold patents to a tribe, thus evading US patent law.The broken patent system finds yet another way to be even more broken.
• Harvey Weinstein was fired from the company bearing his name, and yesterday expelled from the Motion Picture Academy. Weinstein ironically funded the dreadful, unapologetic film The Hunting Ground, which goes to show you can't start the public rehabilitation process too early. But unlike Bill Cosby, whose studied "America's Dad" role belied the creeper beneath, Weinstein has no public goodwill, and was probably unknown to a large swath of the American public. 
• Michael Clegg has a good review of Angela Saini's Inferior: How Science Got Women Wrong at Quillette. Excerpt:
  

  I think Saini is right to be suspicious of an easy reach for the biological, especially if that is merely an invocation of prejudices about what is natural rather than a reference to the actual science. However, social explanation will always be challenged in accounting for deep, cross-cultural regularities in human behaviour. If authors want to advance such arguments as alternatives to the biological then they need to do so with caution. It is wrong to assume that social explanations are commonsensical and can be approached without theory, and it is wrong to assume that evidence in history doesn’t need the same care as evidence in science.

• Lynn Saxon deconstructs the typical view of bonobos as egalitarian, promiscuous, and nonviolent in The Naked Bonobo.
• Blade Runner 2049 is misogynistic because it shows women as prostitutes. Okay. Wired? Tired.

Bullety Stuff, Sunday Edition

• The narrative that Republicans are the principle reason why Obamacare isn't working is remarkably durable. Maybe Democrats should have created a system that wouldn't depend on their political enemies implementing it?
• The rise of the employer-provided "exclusive provider" health insurance plan. It eliminates out-of-network options for most things, but at a substantial savings ("double digit").
• Data Gone Odd looks at rape statistics (and particularly false reporting of rape) in a two-part series (part 1, part 2). As Scott Greenfield summarizes,
  
  

  The 2-10% false rape accusations stat is untrue. Actual stats:
  
  True-ish: 35.3%
  Definitively False: 5.9%
  Inconclusive: 58.8% https://t.co/6fMxzd3EaL

  — Scott Greenfield (@ScottGreenfield) July 16, 2017

• Perhaps the first recorded instance of publish or penis, i.e. the theory that getting cited in others' work "contribute[s] to 'white heteromasculinity'". 
• Steven Pinker thinks Harvard's attempt to shut down off-campus clubs starting in 2022 is a terrible idea. 
• Free speech is terrible, says progressive Christina Berchini.
• Even Vox Dep't: Nancy MacLean's hackish attack on the Public Choice school of economics backfires, Vox runs a wholly reasonable response, warning against reading everything as a conspiracy theory.

California's Single-Payer Delusion

I somehow managed to miss Colorado's rejection of a single-payer system by a stupendous 80-20% margin in last November's election, with overall tax hikes that would have amounted to a 7% increase on employers and 3% on employees. This followed Vermont's quiet rejection of single-payer on cost grounds back in 2014. Apparently this hasn't fazed California lawmakers, who continue to pretend that the most politically popular fantasy among naive Democrats isn't also impossibly expensive. Particularly, they appear to be soft-pedaling the reality that their proposed system will dwarf all other state expenditures by a factor of nearly four, leaving me to wonder who they will bludgeon to make the whole thing work.

Look, I get it — medicine is expensive, customer service sucks, and nobody can figure out pricing. But that doesn't mean shoveling the mess onto the state will fix those problems. It's not only naive to believe as much, it's incomprehensible: you can't fix costs without dealing with the physician shortage, patent abuse and regulatory moats, and a mess of other, related problems. Single-payer is basically saying, "hey, those things are terrible — and we should totally pay those guys their extortionate fees so nobody at the point of sale has to." It turns Martin Shkreli from a robber baron into just another guy making money in medicine.

Update 2017-05-23: Reason says the figure is only twice the overall state budget. Win!

We're Doomed Dep't: Now Docs In Their 60's Outnumber Those In Their 30's (Updated With Some Good News)

I cannot make this stuff up (PDF, see the 2014 population statistics on p. 4). I have written about this before; the insane problems of new physician minting will not go away, and apparently are not being attended to, titular but comically small efforts notwithstanding. In two years, about thirty thousand doctors entered their sixties, i.e. near retirement age, while physicians in their 30's actually diminished, both in absolute population and as a percentage of the overall population. The problems of healthcare costs can not be properly addressed until we get the physician shortage addressed.

Update 2017-01-14: Last night, in a Facebook conversation Jerry Thornton made the point that the headline good news was a 4% increase in the overall physician population from 2012 to 2014. It's useful to do some quick checks to make sure this is of significant import relative to the larger problem, i.e. that of overall physician-to-population ratio. From my earlier work, the OECD average is 30.6 physicians per 10,000 population, or 3.06x10^-3, expressed in scientific notation. How long will it take to get the US from where it is to there?

• 2012 estimated US population: 314 million. (Population is only known precisely in census years, but is estimated between them. Source page here.)
• 2014 estimated US population: 319 million. (From the same source above.)
• OECD most recent year physician-to-population ratio: 3.29x10^-3 physicians/population. (It's actually gone up.)
• US most recent year physician-to-population ratio: 2.56x10^-3 (from the prior link)
• US physician population, 2012: 878,194
• US physician population, 2014: 916,264

 Let's find the annual physician growth rate first.

916 264 = 878 194(1+x)²

Solving for x, the annual physician population growth rate, gets us

x = sqrt(916 264/878 194)-1 = 2.14x10^-2

Now, the general population is growing at the same time. How much? Let's do the same math:

p = sqrt(319/314)-1 = 7.93x10^-3

So when will these converge at the OECD average of 3.29x10^-3 physicians/population? (I ignore the growth in the OECD average physician-to-population ratio.) Note that the Journal of Medical Regulation census physician population divided by the US Census general population figure gives us 2.87x10^-3, which is higher than the OECD physician-to-population figure; we'll use that as a basis anyway, as both numbers are presumably more up-to-date, and won't make much of a difference relatively.

916 264 physicians * (1+2.14x10^-2)ⁿ/3.19x10⁸ population * (1+7.93x10^-3)ⁿ = 3.29x10^-3 physicians/population

Solving for n, the number of years until the US meets the OECD average physician-to-population ratio, we get 10.5 years, which is pretty fast as these timelines go. However, given OECD physician-to-population ratios are rising (almost certainly in response to population aging), it's probably somewhat misleading.

Update 2017-01-15: Even more interesting: feet-on-the-ground physicians vs. state populations for the 50 states ratio is 385 physicians per 100,000 population, which puts the US in the upper half, at least, and maybe the upper third. This makes me wonder about the OECD methodology; do they count expats in the denominator?