Tag Archives: FDA

Let’s Do “First Doses First”

06 Wednesday Jan 2021

Posted by in Coronavirus, Vaccinations

≈ Leave a comment

Tags

, , , , , , , , , ,

Both the Pfizer and the Moderna COVID vaccines require two doses, with an effectiveness of about 95%. But a single dose may have an efficacy of about 80% that is likely to last over a number of weeks without a second dose. There are varying estimates of short-term efficacy, and but see here, here, and here. The chart above is for the Pfizer vaccine (red line) relative to a control group over days since the first dose, and the efficacy grows over time relative to the control before a presumed decay ever sets in.

Unfortunately, doses are in short supply, and getting doses administered has proven to be much more difficult than expected. “First Doses First” (FDF) is a name for a vaccination strategy focusing on delivering only first doses until a sufficient number of the highly vulnerable receive one. After that, second doses can be administered, perhaps within some maximum time internal such as 8 – 12 weeks. FDF doubles the number of individuals who can be vaccinated in the short-term with a given supply of vaccine. Today, Phil Kerpen posted this update on doses delivered and administered thus far:

Dosing has caught up a little, but it’s still lagging way behind deliveries.

As Alex Tabbarok points out, FDF is superior strategy because every two doses create an average of 1.6 immune individuals (2 x 0.8) instead of just 0.95 immune individuals. His example involves a population of 300 million, a required herd immunity level of two-thirds (higher than a herd immunity threshold), and an ability to administer 100 million doses per month. Under a FDF regime, you’ve reached Tabarrok’s “herd immunity” level in two months. (This is not to imply that vaccination is the only contributor to herd immunity… far from it!) Under the two-dose regime, you only get halfway there in that time. So FDF means fewer cases, fewer deaths, shorter suspensions of individual liberty, and a faster economic recovery.

An alternative that doubles the number of doses available is Moderna’s half-dose plan. Apparently, their tests indicate that half doses are just as effective as full doses, and they are said to be in discussions with the FDA and Operation Warp Speed to implement the half-dose plan. But the disadvantage of the half-dose plan relative to FDF is that the former does not help to overcome the slow speed with which doses are being administered.

Vaccine supplies are bound to increase dramatically in coming months, and the process of dosing will no doubt accelerate as well. However, for the next month or two, FDF is too sensible to ignore. While I am not a fan of all British COVID policies, their vaccination authorities have recommended an FDF approach as well as allowing different vaccines for first and second doses.

COVID Testing: Cycle Thresholds and Coffee Grounds

19 Saturday Dec 2020

Posted by in Coronavirus, Public Health, Uncategorized

≈ 2 Comments

Tags

, , , , , , , , , ,

Here’s some incredible data on PCR tests demonstrating a radically excessive lab practice that generates false positives. I’m almost tempted to say we’d do just as well using a thermometer and the coffee ground test. Open a coffee tin and take a sniff. Can you smell the distinct aroma of the grounds? If not, and if you have other common symptoms, there’s a decent chance you have an active COVID infection. That test is actually in use in some parts of the globe!

The data shown below on PCR tests are from the Rhode Island Department of a Health and the Rhode Island State Health Lab. They summarize over 5,000 positive COVID PCR tests (collected via deep nasal swabs) taken from late March through early July. The vertical axis in the chart measures the cycle threshold (Ct) value of each positive test. Ct is the number of times the RNA in a sample must be replicated before any COVID-19 (or COVID-like) RNA is detected. It might be from a live virus or perhaps a fragment of a dead virus. A positive test with a low Ct value indicates that the subject is likely infected with billions of live COVID-19 viruses, while a high Ct value indicates perhaps a handful or no live virus at all.

The range of red dots in the chart (< 28 Ct) indicates relatively low Ct values and active infections. The yellow range of dots, for which 28 < Ct <= 32, indicates possible infections, and the upper range of green dots, where Ct > 32, indicates that active infections were highly unlikely. It’s important to note that all of these tests were recorded as new COVID cases, so the range of Ct values suggest that testing in Rhode Island was unreasonably sensitive. That’s broadly true across the U.S. as well, which means that COVID cases are over-counted by perhaps 30% or more. And yet it is extremely difficult for subjects testing positive to learn their Ct values. You can ask, but you probably won’t get an answer, which is absurd and counterproductive.

Notice that the concentration of red dots diminished over time, and we know that the spring wave of the virus in the Northeast was waning as the summer approached. The share of positives tests with high Ct values increased over that time frame, however. This is borne out by the next chart, which shows the daily mean Ct of these positive tests. The chart shows that active infections became increasingly rare over that time frame both because positive tests decreased and the average Ct value rose. What we don’t know is whether labs bumped up the number of cycles or replications to which samples were subjected. Still, the trend is rather disturbing because most of the positive cases in May and the first half of June were more likely to be virus remnants than live viruses.

It’s also worth noting that COVID deaths declined in concert with the upward trend in Ct values. This is shown in the chart below (where the Ct scale is inverted). This demonstrates the truly benign nature of positive tests having high Ct values.

This is also demonstrated by the following data from a New York City academic hospital, which was posted by Andrew Bostom. It shows that a more favorable “clinical status” of COVID patients is associated with higher Ct values.

It’s astounding that the U.S. has relied so heavily on a diagnostic tool that gets so many subjects wrong. And it’s nearly impossible for subjects testing positive to obtain their Ct values. Instead, they are subject to self-quarantine for up to two weeks. Even worse, until recently there were delays in reporting the results of these tests of up to a week or more. That made them extremely unhelpful. On the other hand, the coffee ground test is fast and cheap, and it might enhance the credibility of a subsequent positive PCR test, if one is necessary … and especially if the lab won’t report the Ct value.

The PCR test has identified far too many false infections, but it wouldn’t have been quite so damaging if 1) a reasonably low maximum cycle threshold had been established; 2) test results had not been subject to such long delays; and 3) rapid retests had been available for confirmation. The cycle threshold issue is starting to receive more attention, quite belatedly, and more rapid tests have become available. As I’ve emphasized in the past, cheap, rapid tests exist. But having dithered in February and March in approving even the PCR test, the FDA has remained extremely grudging in approving newer tests, and it persists in creating obstacles to their use. The FDA needs to wake up and smell the coffee!

Most Hospitals Have Ample Capacity

05 Saturday Dec 2020

Posted by in Coronavirus, Health Care

≈ 1 Comment

Tags

, , , , , , , , , , , , , , , , , , , , , , , , ,

Let’s get one thing straight: when you read that “hospitalizations have hit record highs”, as the Wall Street Journal headline blared Friday morning, they aren’t talking about total hospitalizations. They reference a far more limited set of patients: those admitted either “for” or “with” COVID. And yes, COVID admissions have increased this fall nationwide, and especially in certain hot spots (though some of those are now coming down). Admissions for respiratory illness tend to be highest in the winter months. However, overall hospital capacity utilization has been stable this fall. The same contrast holds for ICU utilization: more COVID patients, but overall occupancy rates have been fairly stable. Several factors account for these differing trends.

Admissions and Utilization

First, take a look at total staffed beds, beds occupied, and beds occupied by COVID patients (admitted “for” or “with” COVID), courtesy of Don Wolt. Notice that COVID patients occupied about 14% of all staffed beds over the past week or so, and total beds occupied are at about 70% of all staffed beds.

Is this unusual? Utilization is a little high based on the following annual averages of staffed-bed occupancy from Statista (which end in 2017, unfortunately). I don’t have a comparable utilization average for the November 30 date in recent years. However, the medical director interviewed at this link believes there is a consensus that the “optimal” capacity utilization rate for hospitals is as high as 85%! On that basis, we’re fine in the aggregate!

The chart below shows that about 21% of staffed Intensive Care Unit (ICU) beds are occupied by patients having COVID infections, and 74% of all ICU beds are occupied.

Here’s some information on the regional variation in ICU occupancy rates by COVID patients, which pretty much mirror the intensity of total beds occupied by COVID patients. Fortunately, new cases have declined recently in most of the states with high ICU occupancies.

Resolving an Apparent Contradiction

There are several factors that account for the upward trend in COVID admissions with stable total occupancy. Several links below are courtesy of AJ Kay:

  • The flu season has been remarkably light, though outpatients with symptoms of influenza-like illness (ILI) have ticked-up a bit in the past couple of weeks. Still, thus far, the light flu season has freed up hospital resources for COVID patients. Take a look at the low CDC numbers through the first nine weeks of the current flu season (from Phil Kerpen):
  • There is always flexibility in the number of staffed beds both in ICUs and otherwise. Hospitals adjust staffing levels, and beds are sometimes reassigned to ICUs or from outpatient use to inpatient use. More extreme adjustments are possible as well, as when hallways or tents are deployed for temporary beds. This tends to stabilize total bed utilization.
  • The panic about the fall wave of the virus sowed by media and public officials has no doubt “spooked” individuals into deferring care and elective procedures that might require hospitalization. This has been an unfortunate hallmark of the pandemic with terrible medical implications, but it has almost surely freed-up capacity.
  • COVID beds occupied are inflated by a failure to distinguish between patients admitted “for” COVID-like illness (CLI) and patients admitted for other reasons but who happen to test positive for COVID — patients “with” COVID (and all admissions are tested).
  • Case inflation from other kinds of admissions is amplified by false positives, which are rife. This leads to a direct reallocation of patients from “beds occupied” to “COVID beds occupied”.
  • In early October, the CDC changed its guidelines for bed counts. Out-patients presenting CLI symptoms or a positive test, and who are assigned to a bed for observation for more than eight hours, were henceforth to be included in COVID-occupied beds.
  • Also in October, the FDA approve an Emergency Use Authorization for Remdesivir as a first line treatment for COVID. That requires hospitalization, so it probably inflated COVID admissions.
  • The CDC also announced severe penalties in October for facilities which fail to meet its rather inclusive COVID reporting requirements, creating another incentive to capture any suspected COVID case in its reports.

In addition to the above, let’s not forget: early on, hospitals were given an incentive to diagnose patients with COVID, whether tested or merely “suspected”. The CARES Act authorized $175 billion dollars for hospitals for the care of COVID patients. In the spring and even now, hospitals have lost revenue due to the cancellation of many elective procedures, so the law helped replace those losses (though the distribution was highly uneven). The point is that incentives were and still are in place to diagnose COVID to the extent possible under the law (with a major assist from false-positive PCR tests).

Improved Treatment and Treatment

While more COVID patients are using beds, they are surviving their infections at a much higher rate than in the spring, according to data from FAIR Health. Moreover, the average length of their hospital stay has fallen by more than half, from 10.5 to 4.6 days. That means beds turn over more quickly, so more patients can be admitted over a week or month while maintaining a given level of hospital occupancy.

The CDC just published a report on “under-reported” hospitalization, but as AJ Kay notes, it can only be described as terrible research. Okay, propaganda is probably a better word! Biased research would be okay as well. The basic idea is to say that all non-hospitalized, symptomatic COVID patients should be counted as “under-counted” hospitalizations. We’ve entered the theater of the absurd! It’s certainly true that maxed-out hospitals must prioritize admissions based on the severity of cases. Some patients might be diverted to other facilities or sent home. Those decisions depend on professional judgement and sometimes on the basis of patient preference. But let’s not confuse beds that are unoccupied with beds that “should be occupied” if only every symptomatic COVID patient were admitted.

Regional Differences

Finally, here’s a little more information on regional variation in bed utilization from the HealthData.gov web site. The table below lists the top 25 states by staffed bed utilization at the end of November. A few states are highlighted based on my loose awareness of their status as “COVID “hot spots” this fall (and I’m sure I have overlooked a couple. Only two states were above 80% occupancy, however.

The next table shows the 25 states with the largest increase in staffed bed utilization during November. Only a handful would appear to be at all alarming based on these increases, but Missouri, for example, at the top of the list, still had 27% of beds unoccupied on November 30. Also, 21 states had decreases in bed utilization during November. Importantly, it is not unusual for hospitals to operate with this much headroom or less, which many administrators would actually prefer.

Of course, certain local markets and individual hospitals face greater capacity pressures at this point. Often, the most crimped situations are in small hospitals in underserved communities. This is exacerbated by more limited availability of staff members with school-age children at home due to school closures. Nevertheless, overall needs for beds look quite manageable, especially in view of some of the factors inflating COVID occupancy.

Conclusion

Marc Boom, President and CEO of Houston Methodist Hospital, had some enlightening comments in this article:

“Hospital capacity is incredibly fluid, as Boom explained on the call, with shifting beds and staffing adjustments an ongoing affair. He also noted that as a rule, hospitals actually try to operate as near to capacity as possible in order to maximize resources and minimize cost burdens. Boom said numbers from one year ago, June 25, 2019, show that capacity was at 95%.”

So there are ample beds available at most hospitals. A few are pinched, but resources can and should be devoted to diverting serious COVID cases to other facilities. But on the whole, the panic over hospital capacity for COVID patients is unwarranted.

The FDA Can Put Virus Behind Us, Sans Vaccine

19 Wednesday Aug 2020

Posted by in Liberty, Pandemic, Vaccinations

≈ 1 Comment

Tags

, , , , , , , , , , , , , , , , , , , , , , , , , , ,

Most of the news about COVID vaccine development is positive, but there are still huge doubts about 1) whether an effective vaccine(s) will ever be available; 2) when it will be available; 3) in what quantities (supply chains for vaccines present issues that most lay persons would never imagine) ; 4) the best approaches to allocation across young/healthy vs. old/vulnerable; 5) how long it will provide protection (the news is good on lasting immunity as well); and 6) whether people will actually take it. Given all these uncertainties, it’s worth considering an approach to stanching the coronavirus that won’t require a vaccine while still allowing a return to normalcy: cheap, rapid tests available to consumers on a daily basis in their homes or in businesses.

The full benefits of cheap, rapid tests can take people a while to wrap their heads around. In fact, there are skeptics who’s views on any and all testing are colored by suspicions that increased testing is some sort of conspiracy to spread fear and keep the economy hobbled. It’s true that increased testing drove much of the increase in COVID cases this summer, which caused the mainstream media to delight in spinning alarmist narratives. Fair enough, but that misses the point, which I’ll try to elucidate below. I credit a John Cochrane post for bringing this to my attention.

A successful vaccine breaks the so-called “transmission chain”, but so does frequent testing to identify infectious individuals on an ongoing basis so they can self-quarantine. As Alex Tabarrok has emphasized, we should worry about identifying infectious individuals, as opposed to infected individuals. They are not the same. Cheap, rapid, and easy-to-administer tests have already proven to be fairly accurate during the infectious stage. The idea is for individuals to self-test every day and stay home if they are positive. Or, employers can test workers every day and send them home if they are positive. Frequent testing also makes it simpler to trace the source of an infection and may reduce the importance of tracing.

To those who say this represents an affront to personal liberty, and I’m very touchy on that subject myself, recall that even now people are being screened in their workplaces using thermometers, questionnaires, or on the basis of any frogginess perceived by supervisors and co-workers. Those “tests” are far less accurate in identifying COVID-19 contagiousness than the kinds of cheap tests at issue here, and they are certainly no less intrusive. Then there are the many businesses facing restrictions on their operations: how “accurate” is it to keep everyone at home by locking down places of business? How intrusive is that? Those restrictions are indefensible, and especially with the advent and diffusion of cheap, rapid tests.

Of course, people might cheat and not report positives. Tests could be administered at workplaces to avoid that possibility, or at points of admission to businesses and facilities, but a few minutes of delay would be necessary. I would not support a centralized database of daily test results. If nothing else, relying on the good faith of individuals in reporting their results would be a giant leap forward in breaking the transmission chain now, rather than counting on the possibility of a successful virus in the indefinite future. And we might then avoid the whole pro-vax/anti-vax imbroglio that already foments, which raises major questions bearing on individual liberty.

Then there is the question of positive tests within multi-person households. Should the entire family or household self-quarantine? I say no, not if the others are negative, but then the others should test twice before going out, which dramatically reduces the probability of a false negative, and they should probably test more frequently, perhaps several times a day.

There are other important details to address: Who will pay for the tests? Will workers be paid to stay home if they test positive? How long will they be required to stay home? How will repeated tests be treated? I don’t want to get into detail on all of these points, but cheap, fast tests can help overcome many of these difficulties, and I believe many of the details can and should be worked out privately.

Unfortunately, the FDA has approved only two rapid tests, and they are not very rapid and not cheap enough. Only one had been approved up until last weekend because the FDA found the accuracy to be lacking … compared to PCR tests! But the FDA finally issued an Emergency Use Authorization for a saliva-based test (SalivaDirect) developed at Yale, partly funded by the NBA and the Players Association. The test still requires processing at a lab, so it’s really not convenient enough and not fast enough. Here is Zach Lowe on the cost:

“The cost per sample could be as low as about $4, though the cost to consumers will likely be higher than that — perhaps around $15 or $20 in some cases, according to expert sources.”

Not bad, but it’s much higher than more rapid, paper tests developed by Harvard’s Wyss Institute for Biologically Inspired Engineering and a company called E25Bio. Both of those are expected to cost about $1 per sample and can be completed anywhere. That’s a price that can work. And there are other promising candidates.

The benefits of tests that are rough, ready, and cheap will be huge. Such tests will also enable retesting, which helps to overcome the dilemmas of false positives and negatives. False negatives might be of greater concern to the FDA, but again, false negatives are less likely during the contagious stage of an infection, and the tests will be accurate enough that transmission risk will be drastically reduced.

The FDA needs to move beyond its stodgy insistence on achieving laboratory levels of accuracy. It’s unlikely that a single test source will be adequate to stanch the transmission chain, so the agency should rush to approve as many cheap, rapid tests as possible, with as many advisories and patient warnings regarding test results and follow-up instructions as it deems necessary. Remember, these tests are much better than thermometers!

COVID Politics and Collateral Damage

26 Sunday Jul 2020

Posted by in Pandemic, Public Health

≈ 2 Comments

Tags

, , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Policymakers, public health experts, and the media responded to the coronavirus in ways that have often undermined public health and magnified the deadly consequences of the pandemic. Below I offer several examples of perverse politics and policy prescriptions, and a few really bad decisions by certain elected officials. Some of the collateral damage was intentional and motivated by an intent to inflict political damage on Donald Trump, and people of good faith should find that grotesque no matter their views on Trump’s presidency.

Politicized Treatment

The smug dismissal of hydroxychloraquine as Trumpian foolishness was a crime against humanity. We now know HCQ works as an early treatment and as a prophylactic against infection. It’s has been partly credited with stanching “hot spots” in India as well as contributing strongly to control of the contagion in Switzerland and in a number of other countries. According to epidemiologist Harvey Risch of the Yale School of Public Health, HCQ could save 75,000 to 100,000 lives if the drug is widely used. This is from Dr. Risch’s OpEd in Newsweek:

“On May 27, I published an article in the American Journal of Epidemiology (AJE) entitled, ‘Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.’ That article, published in the world’s leading epidemiology journal, analyzed five studies, demonstrating clear-cut and significant benefits to treated patients, plus other very large studies that showed the medication safety. …

Since [then], seven more studies have demonstrated similar benefit. In a lengthy follow-up letter, also published by AJE, I discuss these seven studies and renew my call for the immediate early use of hydroxychloroquine in high-risk patients.”

Risch is careful to couch his statements in forward-looking terms, but this also implies that tens of thousands of lives could have been saved, or patients might have recovered more readily and without lasting harm, had use of the drug not been restricted. The FDA revoked its Emergency Use Authorization for HCQ on June 15th, alleging that it is not safe and has little if any benefit. An important rationale cited in the FDA’s memo was an NIH study of late-stage C19 patients that found no benefit and potential risks to HCQ, but this is of questionable relevance because the benefit appears to be in early-stage treatment or prophylaxis. Poor research design also goes for this study and this study, while this study shared in some shortcomings (e.g., and no use of and/or controls for zinc) and a lack of statistical power. Left-wing outlets like Politico seemed almost gleeful, and blissfully ignorant, in calling those studies “nails in the coffin” for HCQ. Now, I ask: putting the outcomes of the research aside, was it really appropriate to root against a potential treatment for a serious disease, especially back in March and April when there were few treatment options, but even now?

Then we have the state governors who restricted the use of HCQ for treating C19, such as Gretchen Whitmer (MI) and Steve Sisolak (NV). Andrew Cuomo (NY) decided that HCQ could be dispensed only for hospital use, exactly the wrong approach for early stage treatment. And all of this resistance was a reaction to Donald Trump’s optimism about the promise of HCQ. Yes, there was alarm that lupus patients would be left without adequate supplies, but the medication is a very cheap, easy to produce drug, so that was never a real danger. Too much of the media and politicians have been complicit in denying a viable treatment to many thousands of C19 victims. If you were one of the snarky idiots putting it down on social media, you are either complicit or simply a poster child for banal evil.

Seeding the Nursing Homes

The governors of several states issued executive orders to force nursing homes to accept C19 patients, which was against CMS guidance issued in mid-March. The governors were Andrew Cuomo (NY), Gretchen Whitmer (MI), Gavin Newsom (CA), Tom Wolf (PA), and Phil Murphy (PA). This was a case of stupidity more than anything else. These institutions are home to the segment of the population most vulnerable to the virus, and they have accounted for about 40% of all C19 deaths. Nursing homes were ill-prepared to handle these patients, and the governors foolishly and callously ordered them to house patients who required a greater level of care and who represented an extreme hazard to other residents and staff.

Party & Protest On

Then of course we had the mayor of New York City, Bill De Blasio, who urged New Yorkers to get out on the town in early March. That was matched in its stupidity by the array of politicians and health experts who decided, having spent months proselytizing the need to “stay home”, that it was in their best interests to endorse participation in street protests that were often too crowded to maintain effective social distance. That’s not a condemnation of those who sought to protest peacefully against police brutality, but it was not a good or consistent recommendation in the domain of public health. Thankfully, the protests were outside!

Testing, Our Way Or the Highway

The FDA and CDC were guilty of regulatory overreach in preventing early testing for C19, and were responsible for many lives lost early in the pandemic. By the time the approved CDC tests revealed that the virus was ramping up drastically in March, the country was already behind in getting a handle on the spread of the virus, quarantining the infected, and tracing their contacts. There is no question that this cost lives.

Masks… Maybe, But Our Way Or the Highway

U.S. public health authorities were guilty of confused messaging on the efficacy of masks early in the pandemic. As Joel Zinberg notes in City Journal, Anthony Fauci admitted that his own minimization of the effectiveness of masks was motivated by a desire to prevent a shortage of PPE for health care workers:

“In discouraging mask use, Fauci—for decades, the nation’s foremost expert on viral infectious diseases—was not acting as a neutral interpreter of settled science but as a policymaker, concerned with maximizing the utility of the limited supply of a critical item. An economist could have told him that there was no need to misinform the public. Letting market mechanisms work and relaxing counterproductive regulations would ease shortages. Masks for health-care workers would be available if we were willing to pay higher prices; those higher prices, in turn, would elicit more mask production.”

Indeed, regulators made acquisition of adequate supplies of PPE more difficult than necessary via compliance requirements, “price gouging” rules, and import controls.

Bans on Elective Surgery

Another series of unnecessary deaths was caused by various bans on elective surgeries across the U.S. (also see here), and we’re now in danger of repeating that mistake. These bans were thought to be helpful in preserving hospital capacity, but hospitals were significantly underutilized for much of the pandemic. Add to that the fright inspired by official reaction to C19, which keeps emergency rooms empty, and you have a universe of diverse public health problems to grapple with. As I said on this blog a couple of months ago:

“… months of undiagnosed cardiac and stroke symptoms; no cancer screenings, putting patients months behind on the survival curve; deferred procedures of all kinds; run-of-the-mill infections gone untreated; palsy and other neurological symptoms anxiously discounted by victims at home; a hold on treatments for all sorts of other progressive diseases; and patients ordinarily requiring hospitalization sent home. And to start back up, new health problems must compete with all that deferred care. Do you dare tally the death and other worsened outcomes? Both are no doubt significant.”

Lockdowns

The lockdowns were unnecessary and ineffectual in their ability to control the spread of the virus. A study of 50 countries published by The Lancet last week found the following:

“Increasing COVID-19 caseloads were associated with countries with higher obesity … median population age … and longer time to border closures from the first reported case…. Increased mortality per million was significantly associated with higher obesity prevalence … and per capita gross domestic product (GDP) …. Reduced income dispersion reduced mortality … and the number of critical cases …. Rapid border closures, full lockdowns, and wide-spread testing were not associated with COVID-19 mortality per million people.”

That should have been obvious for a virus that holds little danger for prime working-age cohorts who are most impacted by economic lockdowns.

Like the moratoria on elective surgeries, lockdowns did more harm than good. Livelihoods disappeared, business were ruined, savings were destroyed, dreams were shattered, isolation set in, and it continues today. These kinds of problems are strongly associated with health troubles, family dysfunction, drug and alcohol abuse, and even suicide. It’s ironic that those charged with advising on matters pertaining to public health should focus exclusively on a single risk, recommending solutions that carry great risk themselves without a second thought. After all, the protocol in reviewing new treatments sets the first hurdle as patient safety, but apparently that didn’t apply in the case of shutdowns.

Even as efforts were made to reopen, faulty epidemiological models were used to predict calamitous outcomes. While case counts have risen in many states in the U.S. in June and July, deaths remain far below model predictions and far below deaths recorded during the spring in the northeast.

One last note: I almost titled this post “Attack of the Killer Morons”, but as a concession to what is surely a vain hope, I decided not to alienate certain readers right from the start.

 

 

Trump and Coronavirus

26 Tuesday May 2020

Posted by in Pandemic, Public Health, Risk Management, Stimulus, Trump Administration

≈ 1 Comment

Tags

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

It’s a bit early to fully evaluate President Trump’s performance in dealing with the coronavirus pandemic, but there are a number of criteria on which I might assign marks. I’ll address some of those below, but in so doing I’m reminded of Jerry Garcia’s quip that he was “shopping around for something no one will like.” That might be how this goes. Of course, many of the sub-topics are worthy of lengthier treatment. The focus here is on the pandemic and not more general aspects of his performance in office, though there is some unavoidable overlap.

General “Readiness”

Many have criticized the Trump Administration for not being “ready” for a pandemic. I assign no grade on that basis because absolutely no one was ready, at least not in the West, so there is no sound premise for judgement. I also view the very general charge that Trump did not provide “leadership” as code for either “I don’t like him”, or “he refused to impose more authoritarian measures”, like a full-scale nationwide lockdown. Such is the over-prescriptive instinct of the Left.

Equally misleading is the allegation that Trump had “disbanded” the White House pandemic response team, and I have addressed that here. First, while the NSC would play a coordinating role, pandemic response is supposed to be the CDC’s job, when it isn’t too busy with diseases of social injustice to get it done. Second, it was John Bolton who executed a reorganization at the NSC. There were two high profile departures from the team in question at the time, and one one was a resignation. Most of the team’s staff remained with the NSC with the same duties as before the reirganization.

Finally, there was the matter of a distracting impeachment on false charges. This effort lasted through the first three years of Trump’s administration, finally culminating in January 2020. Perhaps the Administration would have had more time to focus on what was happening in China without the histrionics from the opposition party. So whatever else I might say below, these factors weigh toward leniency in my appraisal of Trump’s handing of the virus.

Messaging: C

As usual, Trump’s messaging during the pandemic was often boorish and inarticulate. His appearances at coronavirus briefings were no exception, often cringeworthy and sometimes featuring misinterpretations of what his team of experts was saying. He was inconsistent in signaling optimism and pessimism, as were many others such as New York Governor Andrew Cuomo and New York City Mayor Bill De Blasio. It shifted from “the virus is about like the flu” in February to a more sober assessment by mid-March. This was, however, quite consistent with the messaging from Dr. Anthony Fauci over the same time frame, as well as the World Health Organization (WHO). Again, no one really knew what to expect, so it’s understandable. A great deal of that can be ascribed to “the fog of war”.

Delegation and Deference: B

Trump cannot be accused of ignoring expert advice through the episode. He was obviously on-board with Fauci, Dr. Deborah Birx, Dr. Robert Redfield, and other health care advisors on the “15 Days to Slow the Spread” guidelines issued on March 16. His messaging wavered during those 15 days, expressing a desire to fully reopen the nation by Easter, which Vice President Michael Pence later described as “aspirational”. Before the end of March, however, Trump went along with a 30-day extension of the guidelines. Finally, by mid-April, the White House released guidelines for “Opening Up America Again“, which was a collaboration between Trump’s health care experts and the economic team. Trump agreed that the timeline for reopening should be governed by “the data”. There is no question, however, that Trump was chomping at the bit for reopening at several stages of this process. I see value in that positioning, as it conveys an intent to reopen asap and that people should have confidence in progress toward that goal.  

International Travel Bans: A

If anyone wonders why the world was so thoroughly blindsided by the coronavirus, look no further than China’s failure to deliver a proper warning as 2019 drew to a close. Wuhan, China was ground zero; the virus spread to the rest of the world with travelers out of Wuhan and other Chinese cities. The White House announced severe restrictions on flights from China on January 31, including a two-week quarantine for returning U.S. citizens. In retrospect, it wasn’t a minute too soon, yet for that precaution, Trump was attacked as a racist by the Left. In early February, WHO actually said travel bans were unnecessary, among other missteps. Other bans were instituted on entry from Iran and Brazil, as well as entry from Europe in early March, as countries around the globe closed their borders. Trump’s actions on incoming travelers were prescient, so I’ll score this one for Trump. Some of these travel restrictions can and should be eased now, and certainly that is expected in coming months, so we’ll see how well that process is managed.

Deference to States: A-

As a federalist, I was pleased that Trump and his team left most of the specifics on closures and bans on public gatherings up to state and local governments. That allowed more targeted mitigation efforts as dictated by local conditions and, to some extent, public opinion. This is a classic case of “laboratory federalism” whereby the most effective policies can be identified, though as we’ve seen, there’s no guarantee less successful states will emulate them. I grade Trump well on this one.

On reopening, too, Trump has been a consistent advocate of allowing flexility where local conditions permit, though he wrongly claimed he had “total authority” over ending social distancing rules. It’s hard to square that remark with his general stand on the issue of autonomy except as a tactic to strong-arm certain governors on other points.   

CDC/FDA Snafus: D

I applaud the Administration for its emphasis on the salutary effects of deregulation, but Trump went along with some major pieces of “expert advice” that were not only poor from regulatory perspective, but an affront to federalism. One was a directive issued by the CDC to delay “all elective surgeries, non-essential medical, surgical, and dental procedures during the 2019 Novel Coronavirus (COVID-19) outbreak“. (See my post “Suspending Medical Care in the Name of Public Health“.)

This is exactly the kind of “one size fits all” regulatory policy that has proven so costly, sacrificing not just economic activity but lives and care for the sick, creating avoidable illnesses and complications. The idea was to assure that adequate health care resources were available to treat an onslaught of coronavirus patients, but that was unneeded in most jurisdictions. And while the contagion was in it’s early “exponential” phase at the time, a more nuanced approach could have been adopted to allow different geographic areas and facilities more discretion, especially for different kinds of patients, or perhaps something less than a complete suspension of care. In any case, the extensions into May were excessive. I must grade Trump poorly for allowing this to happen, despite what must have been extreme pressure to follow “expert advice” on the point and the others discussed earlier.

That’s not the only point on which I blame Trump for caving to the CDC. In a case of massive regulatory failure, the CDC and FDA put the U.S. well over a month behind on testing when the first signs of the virus appeared here. Not only did they prohibit private labs and universities from getting testing underway, insisting on exclusive use of the CDC’s own tests, they also distributed faulty tests in early February that took over a month to replace. The FDA also enforced barriers to imported N95-type masks during the pandemic. Trump tends to have a visceral understanding of the calcifying dangers of regulation, but he let the so-called “experts” call the shots here. Big mistake, and Trump shares the blame with these agencies.  

Health Resources: B-

Managing the emergency distribution of PPE and ventilators to states did not go as smoothly as might have been hoped. The shortage itself left FEMA with the unenviable task of allocating quantities that could never satisfy all demands. A few states were thought to have especially acute needs, but there was also an obligation to hold stockpiles against potential requests from other states. In fact, a situation of this kind creates an incentive for states to overstate their real needs, and there are indications that such was the case. Trump sparred with a few governors over these allocations. There is certainly blame to be shared, but I won’t grade Trump down for this.

Vaccines and Treatments: C+

 

The push to develop vaccines might not achieve success soon, if ever, but a huge effort is underway. Trump gets some of the credit for that, as well as the investment in capacity now to produce future vaccine candidates in large quantities. As for treatments, he was very excited about the promise of hydroxychloraquine, going so far as to take it himself with zinc, a combination for which no fully randomized trial results have been reported (the recent study appearing in the Lancet on HCQ taken by itself has been called into question). Trump also committed an unfortunate gaffe when the DHS announced the results of a study showing that sunlight kills coronavirus in a matter of minutes, as do bleach and other disinfectants. Trump mused that perhaps sunlight or some form of disinfectant could be used as a treatment for coronavirus patients. He might have been thinking about an old and controversial practice whereby blood is exposed to UV light and then returned to the body. Later, he said he used the term “disinfectant” sarcastically, but he probably meant to say “euphemistically” …. I’m not sure he knows the difference. In any case, his habit of speculating on such matters is often unhelpful, and he loses points for that.

Fiscal Policy: B

The several phases of the economic stimulus program were a collaboration between the Trump Administration and Congress. A reasonably good summary appears here. The major parts were the $2.3 trillion CARES Act in late March and a nearly $500 billion supplemental package in late April. These packages were unprecedented in size. Major provisions were direct cash payments and the Paycheck Protection Program (PPP), which provides loans and grants to small businesses. The execution of both was a bit clunky, especially PPP, which placed a burden on private banks to extend the loans but was sketchy in terms of qualifications. The extension of unemployment compensation left some workers with more benefits than they earned in their former jobs, which could be an impediment to reopening. There were a number of other reasonable measures in these packages and the two smaller bills that preceded them in March. A number of these measures were well-targeted and inventive, such as waiving early withdrawal penalties from IRA and 401(k) balances. The Trump Administration deserves credit for helping to shape these efforts as well as others taken independently by the executive branch. 

Trump’s proposal to suspend payroll taxes did not fly, at least not yet. The idea is to reduce the cost of hiring and increase the return to work, if only temporarily. This is not a particularly appealing idea because so much of the benefits would flow to those who haven’t lost their jobs. It could be improved if targeted at new hires and rehires, however.

Trump’s proposal to grant liability waivers to reopened private businesses is extremely contentious, but one I support. Lockdowns are being eased under the weight of often heavy public and private regulation of conduct. As John Cochrane says in “Get Ready for the Careful Economy“: 

“One worry on regulation is that it will provide a recipe for a wave of lawsuits. That may have been a reason the Administration tried to hold back CDC guidance. A long, expensive, and impractical list of things you must do to reopen is catnip when someone gets sick and wants to blame a business. Show us the records that you wiped down the bathrooms every half hour. A legal system that can sue over talcum powder is not above this.”

Indeed, potential liability might represent a staggering cost to many businesses, one that might not be insurable. Accusations of negligence, true or false, can carry significant legal costs. Customers and employees, not just businesses, must accept some of the burden of risks of doing business. I give Trump good marks for this one, but we’ll see if it goes anywhere.

Some of the proposals for new stimulus legislation from democrats are much worse, including diversity initiatives, massive subsidies for “green” technologies, and bailouts for state and local government for unfunded pension liabilities. None of these has anything to do with the virus. The burden of pension shortfalls in some states should not fall on taxpayers nationwide, but on the states that incurred them. The Trump Administration and congressional Republicans should continue resisting these opportunistic proposals.

The Grade

Without assigning weights to the sub-topics covered above, I’d put the overall grade for Trump and his Administration’s handling of matters during the pandemic at about a B-, thus far. When it comes to politics, it’s often unfair to credit or blame one side for the promulgation of an overall set of policies. Nevertheless, I think it’s fair to say that Trump, could have done much better and could have done much worse. We will learn more with the passage of time, the continued evolution of the virus, the development of treatments or vaccines, and the course of the economy.

 

 

 

 

 

 

 

Coronavirus Controversies

11 Saturday Apr 2020

Posted by in Health Care, Leftism, Pandemic

≈ 1 Comment

Tags

, , , , , , , , , , , , , , , , , , , ,

The coronavirus and the tragedy it has wrought has prompted so many provocative discussions that it’s hard to pick just one of those topics for scarce blogging time. So I’ll try to cover two here: first, the question of whether coronavirus deaths are being miscounted; second, the politically-motivated controversy over the use of hydroxychloraquin to treat severe cases of Covid-19.

Counting Deaths

I’ve been suspicious that Covid deaths are being over-counted, but I’m no longer as sure of that. Of course, there are reasons to doubt the accuracy of the death counts. For example, there is a strong possibility that some Covid deaths are simply not being counted due to lack of diagnoses. But there are widespread suspicions that too many deaths with positive diagnoses are being counted as Covid deaths when decedents have severe co-morbidities. Members of that cohort die on an ongoing basis, but now many or all of those deaths are being attributed to Covid-19. A more perverse counting problem might occur when public health authorities instruct physicians to attribute various respiratory deaths to Covid even without a positive diagnosis! That is happening in some parts of the country.

To avoid any bias in the count, I’ve advocated tracking mortality from all co-morbidities and comparing the total to historical or “normal” levels to calculate “excess deaths”. One could also look at all-cause mortality and do the same, though I don’t think that would be quite on point. For example, traffic deaths are certainly way down, which would distort the excess deaths calculation.

Despite the vagaries in counting, there is no question that the coronavirus has been especially deadly in its brief assault on humans. New York has experienced a sharp increase in deaths, as the chart below illustrates (the chart is a corrected version of what appeared in the Reason article at the prior link). The spike is way out of line with normal seasonal patterns, and it obviously corresponds closely with deaths attributable to Covid-19. It is expected to be short-lived, but it might taper over the course of several weeks or months, Once it does, I suspect that the cumulative deaths under all those other curves in the chart will exceed Covid deaths substantially. Also note that the yellow line for the flu just stops when Covid deaths begin, suggesting that the red line probably incorporates at least some “normal” flu deaths.

Once the virus abates, we’ll be able to tell with a bit more certainty just how deadly the pandemic has been. It will be revealed through analyses of excess deaths. For now, we have the statistics we have, and they should be interpreted cautiously.

Hydrochloraquin

A more boneheaded debate centers on the use of the anti-malarial drug hydroxychloraquin (HCQ) to treat coronavirus patients. There have been many successes, particularly in combination with a Z-Pak, or zinc. Guidelines issued by the American Society of  Thoracic Surgeons last week call for HCQ’s use in advanced cases of coronavirus infection. These and other therapies are being tested formally, but many are prescribed outside any formal testing framework. Remdesivir has been prominent among these. Plasma therapy has been as well, and several other possible treatments are under study.

With respect to HCQ, it’s almost as if the Left, much of the media, and a subset of overly “prescriptive” medical experts were goaded into an irrational position via pure Trump Derangement. Just Google or Bing “Hydroxychloraquine Coronavirus” for a bizarre list of alarmist articles about Trump’s mention of HCQ. To take just two of the claims, the idea that Trump stands to earn substantial personal profits from HCQ because he holds a few equity shares in a manufacturer of generic drugs is patently absurd. And claims that shortages for arthritis, lupus, and malaria patients are imminent are unconvincing, given the massive stockpiles now accumulated and the efforts to ramp-up production.

So much lefty hair is on fire over a potential therapy that is both promising and safe that the media message lacks credulity. But more ominously, the Democrat governors of Michigan and Nevada were so petulant that they banned HCQ’s use in their states, though at least Nevada’a governor rescinded his order. It’s almost as if they don’t want it to work, and don’t want to give it a chance to work. Or do I go too far? No, I don’t think so.

Victoria Taft has a good summary of the media backlash against President Trump’s hopeful statements about HCQ. Not only was the FDA’s authority over the use of HCQ misrepresented, there was also a good bit of smearing of various researchers who’d found preliminary evidence of HCQ’s effectiveness. Let’s be honest: the quality of medical research is often inflated by the research establishment. And the media eat up any study with findings that are noteworthy in any way. Over the years, a great deal of medical research has been based on small samples from which statistical hypothesis tests are shaky at best. That’s one reason for the legendary replication problem in medical research. In the case of HCQ, there has been widespread misuse of the term “anecdotal” in the media, prompted by experts like Dr. Anthony Fauci, who should know better. The term was used to describe clinical tests on moderately large groups of patients, at least one of which was a randomized control trial.

Every day we hear stories from individual patients that they were saved by HCQ. These are properly called anecdotal accounts. But we also hear from various physicians around the country and world who claim to be astonished at HCQ’s therapeutic efficacy on groups of patients. This link gives another strong indication of how physicians feel about HCQ at this point. These are not from RCTs, but they constitute clinical evidence, not mere “anecdotes”.

By virtue of state and federal right-to-try laws, terminally ill patients can choose to take medications that are unapproved by regulators. Beyond that, FDA approval of HCQ specifically for treating coronavirus was unnecessary because the drug was already legal to prescribe to cover patients as an “off-label” use. That’s true of all drugs approved by the FDA: they can be prescribed legally for off-label uses. When regulators like Dr. Fauci, and even practicing physicians like Dr. Jeffrey Singer (linked below) claim that the FDA hasn’t approved HCQ specifically for treating Covid, it is a technicality: the FDA can certainly “approve” it for that specific use, but it’s already legal to prescribe!

While it won’t end the silly argument, which is obviously grounded in other motives, Dr. Singer brings us to the only reasonable position: treatment of Covid with HCQ is between the patient and their doctor.

 

 

Left’s Pandemic Response: Politics As Usual

17 Tuesday Mar 2020

Posted by in Health Care, Pandemic, Regulation

≈ 2 Comments

Tags

, , , , , , , , , , , , , , , , , , , ,

The Left asserts that President Trump dismissed and dismantled the nation’s Pandemic Response Team. That’s bullshit. So is the claim that the CDC was defunded. The news media and certain pundits have helped to feed this narrative. Or, as Glenn Reynolds calls those pundits, “Democrat operatives with bylines”.

First of all, the team in question was not at the CDC, a fact that hasn’t always been clear from the commentary on this issue. It was a team of White House overseers at the National Security Council’s “Directorate for Global Health Security and Biodefense”. What happened was this: the senior director of that team resigned after John Bolton was appointed to head the NSC. Bolton might have wanted him out, but what we know is the director resigned. Subsequently, that team was folded into another directorate as part of an long-overdue consolidation. Health experts from the team remain on the NSC staff today. Yet Sen. Sherrod Brown (D-OH)—and many others since—had the temerity to charge that Trump had fired “the entire Whilte House pandemic team”. Well, at least he didn’t imply that it was the CDC.

Tim Morrison wrote the following in the Washington Post yesterday:

“Because I led the very directorate assigned that mission, the counterproliferation and biodefense office, for a year and then handed it off to another official who still holds the post, I know the charge is specious. …

When I joined the National Security Council staff in 2018, I inherited a strong and skilled staff in the counterproliferation and biodefense directorate. This team of national experts together drafted the National Biodefense Strategy of 2018 and an accompanying national security presidential memorandum to implement it; an executive order to modernize influenza vaccines; and coordinated the United States’ response to the Ebola epidemic in Congo, which was ultimately defeated in 2020.”

This assessment at Brietbart.com quotes former senior NSC official Richard Goldberg:

“Weird. A year later I was inside the NSC working with talented global health/biodefense professionals who coordinated an incredibly effective response to Ebola. They’re still there. Working hard. On .”

It’s true that Bolton sought to eliminate red tape, duplication, and bureaucracy within the NSC, and that was wholly justified. According to Morrison, the NSC staff quadrupled from the 1990s through the second Obama term. Pandemics are supposed to be the CDC’s purview, but the proliferation of administrative layers is what happens as government grows uncontrollably. Leslie Eastman at Legal Insurrection questions whether the U.S. needs a permanent “Pandemic Response Team” in the White House. She quotes GOP Chairwoman Ronna McDaniel:

“JAN 7: CDC established a coronavirus incident management system, two days before China announced the outbreak. … Pelosi began Week 3 of withholding her sham impeachment articles. 

JAN 21: The CDC activated its emergency operations center to provide ongoing support to confront coronavirus. …What were Congressional Democrats focused on? Writing their opening arguments for their bogus impeachment trial.”

Well, bully for the CDC. As for “defunding the CDC”, the facts are this: the proposed budget submitted to Congress by the Trump Administration in February, but never passed, did indeed include cuts to the CDC’s budget, which has grown over the years as it expanded its mission from fighting infectious diseases to matters like obesity, racism, and questions of social justice. The cuts proposed by Trump, however, were primarily to state grants. Actually, the proposal called for increased CDC staffing, and it funded all programs related to infectious diseases. But no matter, because that proposal is unlikely to become part of any appropriations bill that would pass Congress.

True to form, the Left plays politics in the middle of a national crisis. When the Trump Administration told airlines that it was considering banning flights from China in late January, it was called racist. Now, of course, he hasn’t done enough. A huge irony, however, is that Trump’s biggest mistake was in trusting the FDA and the CDC’s authority to develop and regulate testing for the coronavirus. They botched it. In a classic case of over-regulation, they prohibited hospitals and labs from conducting tests developed privately or by academic researchers, insisting that everyone wait for the “approved” test to be distributed. Then, the test they released in early February was flawed, costing additional weeks before testing was available.

 

Rx Drug Prices Are Falling, But You’re Aging

08 Friday Nov 2019

Posted by in Health Care, Prescription Drugs, Price Controls

≈ Leave a comment

Tags

, , , , , , , , , , , , ,

Ask anyone on the street about prescription drug prices, or ask anyone in the press, and you’ll probably hear they are out of control. That contention is false. The conventional wisdom is typified by this exaggerated BS about insulin pricing … actually, you can find a vial of the kind I used for many years for about $25 without much difficulty.

Individual experience differs, of course. Yes, there are new drugs on the market that are exorbitant; there are older drugs still under patent that are pricey too. Those represent a fairly small part of the total market, however, and one on which policymakers should tread lightly if they hope to foster the development of new, life-saving drugs. Newer insulin varieties are not in that class, and those varieties don’t always incorporate meaningful improvements for patients.

Getting Old Is Hell

In fact, prescription drug prices have been declining for a number of years. The real problem is we’re always getting older! In a report from the Progressive Policy Institute, Michael Mandel describes what he calls the prescription drug escalator. Alex Tabarrok has a good summary of the article. The chart at the top of this post, from Mandel, shows that the number of drugs prescribed rises steadily with one’s age. The total bill rises along with age, which may create the perception that you’re paying higher prices. Unsurprisingly, more of each health-care dollar spent out-of-pocket  (OOP) goes to prescribed medications as you age, and more goes to prescription drugs as health declines. As Mandell says, the increases experienced by individuals are a matter of utilization as opposed to pricing..

Generic Dominance

Tabarrok notes that generic drugs account for somewhere between 80-90% of all prescriptions, and generic costs have been falling for some time. He links to one of his earlier posts on generics and to this study by the National Bureau of Economic Research, which states:

“… direct-out-of-pocket CPI for generic prescription drugs decline[d] by about 50% between 2007 and 2016 …”

Average OOP prescription costs peaked in 2006, according to Mandel’s data. Tabarrok quotes Mandell:

“May 2019 research report from the Agency for Healthcare Research and Quality reported that average out-of-pocket spending for prescribed medications, among persons who obtained at least one prescribed medication, declined from $327 in 2009 to $238 by 2016, a decrease of 27 percent. Data from the Bureau of Labor Statistics Consumer Expenditure Survey shows that average household spending on prescription drugs fell by 11% between 2013 and 2018.

Moreover, OECD data shows that average out-of-pocket spending on prescribed medicines in the United States ($143 per capita in 2017) is actually lower than countries such as Canada ($144), Korea ($156), Norway ($178), and Switzerland ($215).”

The declines in OOP drug costs came despite a shift in health-care payment responsibilities from insurers to consumers in recent years — OOP costs would have declined much more had the shift not occurred, according to Mandel. As he says, consumers now have more “skin in the game”, and apparently they act on it.

Another basis of the misperception about escalating drug prices has to do with the way they are reported. Mandel says:

“List prices are the published prices that manufacturers charge to wholesalers. Net prices reflect the revenues that drug manufacturers receive, net of rebates and discounts to prescription benefit managers, insurance companies, and hospitals.

Studies of list prices invariably show very strong growth. For example the IQVIA Institute for Human Data Science found that the list price of the average brand rose from $364.92 to $657.08 since 2014, an 80% increase. Similarly, a widely cited recent study based on list prices found that from 2008–16, the costs of oral and injectable brand-name drugs increased annually by 9.2 percent and 15.1 percent, respectively. … By contrast, net prices and net pharma revenue have been growing much more slowly, once rebates and discounts are accounted for.” 

The Pricey Segment

There are a variety of circumstances that bear on the pricing of individual drugs. Clearly, non-generic drugs are subject to more upward price pressure and give rise to anecdotes that feed misperceptions about the overall trajectory of drug prices. These are either new drugs or older ones sold under extended patents, which are sometimes granted for even minor changes in a drug’s chemical makeup.

Some new drugs are life-saving breakthroughs targeting rare diseases. The unfortunate truth is that drug development is a very costly enterprise, often stretching well over a decade in the U.S. under the FDA’s approval process. Moreover, U.S. consumers actually subsidize the cost of drugs for European consumers, where drugs are typically subject to price ceilings or are directly negotiated by government. By the time drugs go to market, development is treated as a fixed cost; even the low prices in Europe cover the marginal cost of production, so pharmaceutical manufacturers don’t mind selling there as long as their development overhead is paid by someone. That’s the rub.

Drug development costs are heavily influenced by public policy, often to the detriment of consumers. The FDA’s drug approval process is in dire need of reform, and patent extensions should be severely curtailed. As an advocate of free trade, I also favor a lifting of restrictions on imports of drugs to the U.S.

Conclusion

You’re likely to see more physicians as you age, they’re likely to prescribe more drugs, and you’re likely to pay more for prescriptions OOP. That’s the escalator in action. You can minimize the slope of your personal prescription escalator by taking good care of yourself and using generics when possible, but the slope is often beyond a person’s control. Nevertheless, over the past 13 years in the U.S.,  most of those experiencing higher OOP costs have this escalator, i.e., aging, to thank… it’s drug utilization, not pricing.

A relatively small but important share of the market has experienced price escalation. Newer, highly specialized drugs can carry high price tags. Patents give drug manufacturers considerably more pricing power, and drug companies have sought to maintain “evergreen” patents by manipulating their formulations. U.S. import quotas and restrictive pricing abroad have left consumers in the U.S. holding the bag for a large share of drug development costs. These shortcomings can be addressed via streamlined drug approval, patent reform, and lifting import restrictions.

A critical policy prescription is to liberate market forces and foster competition in the pharmaceuticals industry. Price controls in the U.S. would eliminate all incentives for new breakthroughs, leading progress in many areas of treatment to a stand-still. Price controls merely substitute the arbitrary decisions of politicians and bureaucrats for the market’s ability to balance dynamic consumer needs, medical expertise, and the costs faced by sellers.

 

 

Opioids and The War On Pain Treatment

08 Friday Mar 2019

Posted by in Prohibition, War On Drugs

≈ 1 Comment

Tags

, , , , , , , , , , , , , , , , , , , , ,

I repeatedly hear the bogus claim that prescription pain killers are a primary cause of opioid addiction. Twice this week I heard Geraldo Rivera prattling about it, blaming the drug companies for the opioid epidemic, expressing his view of the righteousness of the many lawsuits faced by Purdue Pharma and other firms. But these cases are hardly sure wins for the plaintiffs, and for good reason. The idea that pharmaceutical companies misleadingly promoted the effectiveness of drugs like Oxycontin for pain relief, and minimized their addictive potential, might appear credible, but there are a number of factors that argue strongly against these claims. Of course, opioids are legal prescription drugs, approved for pain relief by the FDA, and are generally marketed by drug companies under guidelines established by the FDA at the time of approval. And sadly, the narrative promoted by Rivera and many others is at tension with the needs of patients suffering from chronic pain.

In fact, opioids are effective for temporary and chronic pain relief, and they have been used for those purposes for many decades. In “The Other Opioid Problem“, anesthesiologist Dr. Ted Noel asserts that few chronic pain patients have overdosed or been killed by ODs. According to Scientific American:

“A Cochrane review of opioid prescribing for chronic pain found that less than one percent of those who were well-screened for drug problems developed new addictions during pain care; a less rigorous, but more recent review put the rate of addiction among people taking opioids for chronic pain at 8-12 percent [but less than 1% abuse].”

Those prescribed opioids for temporary relief after an injury or surgical procedure are even less likely to develop an addiction. The large majority of addicts are self-selected out of a population of individuals who want to get high. And most of them feed their addictions on opioids obtained illegally, often from imported heroin and fentanyl. Yes, opioids are stolen from legitimate patients, pharmacies, or elsewhere, and sometimes they are prescribed illegally by unscrupulous physicians. That might be the way many addicts get started, but most of the illegal opioid supply in the U.S. is imported heroin and fentanyl.

A causal linkage between opioid prescriptions, addiction and opioid deaths would imply a strong, positive correlation between prescription and death rates. However, Jacob Sullum reports that there is no correlation across states between prescription rates and death rates from opioids. As Sullum notes, this result offers “more reason to doubt that pain pill restrictions will save lives”.

In fact, in a separate article, Sullum writes of other evidence strongly suggesting that those restrictions may have counterproductive effects on opioid deaths, in addition to denying some patients access to the pain pills they legitimately need for treatment. According to Sullum, all 50 states have Prescription Drug Monitoring Programs (PDMPs) that monitor controlled substances and keep tabs on prescribers and pharmacies. These have succeeded in discouraging opioid prescriptions, but research appearing in the Annals of Internal Medicine suggests that the programs might be doing more harm than good:

“Fink et al found six studies that included heroin overdoses, half of which reported a statistically significant association between adoption of PDMPs and increases in such incidents. … To the extent that PDMPs succeed in making pain pills harder to obtain, they encourage nonmedical users to seek black-market substitutes. ‘Changes to either the supply or cost of prescription opioids after a PDMP is instituted,’ Fink et al. observe, ‘might reasonably drive opioid-dependent persons to substitute their preferred prescription opioid with heroin or nonpharmaceutical fentanyl.’

The FDA has enforced quotas on the production of legal opioids. According to the CATO Institute:

“The tight quotas on opioid production contributed to the acute shortage of injectable opioids being felt in hospitals across the nation. It is not only making patients suffer needlessly but places them at increased risk for adverse drug reactions or overdose.”

The FDA’s restrictions were eased somewhat after complaints from the medical community, but the harm continues. At the time of CATO’s report, opioid prescriptions had declined by 41% since 2010, while the overdose rate continued to escalate.

This pattern is all too familiar to those who have been arguing against drug prohibition for years. The flood of fentanyl into the country, and into what is sold as street heroin, is a direct consequence of prohibitions on supplies of legal heroin and other narcotics. But breaking through the puritanical and bumptious mentality of drug warriors is almost impossible. The worse the situation gets, the tighter they turn the screws, doubling down on the policies that have repeatedly failed in the past. Here I repeat the concluding paragraph of a Sacred Cow Chips post from January 2018 on the opioid epidemic:

“There are solutions to the deadly nature of the opioid epidemic, but prohibition is not one of them and never will be. If anything, prohibition in varying degrees has aggravated the dangers of opioids. To truly solve the problem, we should eliminate restrictions on the production and distribution of legal opioids for pain management, legalize heroin, and stop interfering in markets. That would be merciful for patients in real pain, make recreational use of opioids dramatically safer, and put an end to the gangland violence associated with underground competition. Second, redirect those resources into … harm reduction programs. [Jeffrey] Miron notes that legalization has worked in other countries, like Portugal and France, to reduce overdoses and opioid deaths. As a political matter, however, these steps might not be feasible unless we get over the cultural bias stigmatizing recreational opioid use as ‘evil’, and the idea that laws and enforcement can actually prevent people from trying to get high.