Saturday, September 18, 2021

 

The Sacklers as a Window into American Corruption & Dysfunction

In 1995, the Sackler family started producing and pushing oxycontin, a semi-synthetic opioid, via the Sackler-controlled company Purdue Pharma. Along the way they made billions of dollars in profits.

According to the CDC:

Nearly 500,000 people died from overdoses involving any opioid, including prescription and illicit opioids, from 1999-2019 ... The first wave began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids (natural and semi-synthetic opioids and methadone) increasing since at least 1999.

Most states of the United States have some form of the "felony murder rule". This means a perpetrator can be held be criminally liable for murder if s/he caused the death of another person in the course of committing a felony. The perpetrator need not have intended the death of the victim and, in some states, need not have been the proximate cause of the death.

For example, if you merely drove the get away car for an armed robbery where one of your accomplices murdered a bank teller then you may held responsible for the murder. (If narrowly written and applied I think the felony murder rule is perfectly fair and just.)

I bring this up to point out that in America if you kill one person—even if you didn't pull the trigger—you can be punished for the murder. On the other hand, if you are a member of the Sackler family who had a key role in the deaths of hundreds of thousands of Americans by opioid abuse then (so far) you won't be personally charged with any crime.

The Sackler family members who ran Purdue Pharma belong in prison. However, there are plenty of other culprits not directly connected to the Sacklers or Purdue Pharma who also belong in prison for their part in the opioid crisis and, as far as I know, none of them has been criminally charged, either.

To be clear, while the Sacklers et al. helped create the opioid crisis, the crisis itself is a form of collective suicide founded on America's nihilistic consumerism and culture of death. It's worth noting, too, that the death toll is mainly comprised of White Americans who are supposedly so privileged. This is undoubtedly fueled by unconcealed hostility to White people, generally, and White working-class people, in particular.

If you doubt this then try carrying a sign saying "It's Okay to be White" in public in any town or city in America and see what happens. Also, consider the remarks of Duquesne University Psychology professor Derek Hook who opined that “White people should commit suicide as an ethical act.” Hook says that he was speaking about suicide as the destruction of "Whiteness" but try publicly advocating that for any other racial, ethnic, or religious group.

Labels: , , , , , ,


Monday, June 28, 2021

 

Two COVID Tidbits

In late March of 2020 I wrote:

A 2016 report published by the National Academies repeatedly raised concerns about the SNS inventory and the logistics of distributing it in an emergency. The chair of the committee that prepared that report, Dr. Tara O'Toole, presciently told NPR in 2016:
"We have drastically decreased the level of state public health resources in the last decade. We've lost 50,000 state and local health officials. That's a huge hit," says O'Toole, who wishes local officials would get more money for things like emergency drills. "The notion that this is all going to be top down, that the feds are in charge and the feds will deliver, is wrong."
My point is that the inability and failure in the US to implement the successful model of South Korea to tamp down COVID-19 via widespread testing, contact tracing, and isolation of the exposed or infected was born of a longstanding failure of the values and priorities of the bipartisan political establishment and by the servile dependency and doltish complacency of the American people who keep electing them.
Almost a year to the day after I published that Health Affairs has published "US Public Health Neglected: Flat Or Declining Spending Left States Ill Equipped To Respond To COVID-19". The article is behind a pay wall so I haven't read it. The abstract says:

The COVID-19 pandemic has prompted concern about the integrity of the US public health infrastructure. Federal, state, and local governments spend $93 billion annually on public health in the US, but most of this spending is at the state level ... Although overall national health expenditures grew by 4.3 percent in this period, state governmental public health spending saw no statistically significant growth between 2008 and 2018 except in injury prevention. Moreover, state spending levels on public health were not restored after cuts experienced during the Great Recession ...

Axios reports: "The study found that public health spending dropped from $80.40 per capita in 2008 to $75.83 in 2018." It's worth pointing out that these figures understate the drop in public health spending. According to the U.S. Bureau of Labor Statistics CPI Inflation Calculator that $75.83 in June 2018 "has the same buying power as $65.85 in June 2008". Due to inflation, to maintain roughly the same per capita level as the 2008 public health spending would have required spending $92.59 per person in 2018.

###

Last month I wrote

... I consider it grotesquely unethical for government officials, vaccine manufacturers, and public health and medical professionals to conduct what is essentially a massive experiment* on hundreds of millions of people using relatively new vaccine technologies—mRNA and adenovirus vector vaccines—especially during a global pandemic. I am aware of no reason why Congress and health professionals couldn't and shouldn't have insisted that Operation Warp Speed funds be spent on conventional attenuated virus or viral protein vaccines.
In a June 24, 2021, article titled "The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better" Hilda Bastian reports in The Atlantic:

... the hype around the early-bird vaccines from Pfizer and Moderna has distorted perception. Their rapid arrival has been described in this magazine as "the triumph of mRNA"—a brand-new vaccine technology whose "potential stretches far beyond this pandemic."... It was easy to assume, based on all this reporting, that mRNA vaccines had already proved to be the most effective ones you could get—that they were better, sleeker, even cooler than any other vaccines could ever be.

But the fascination with the newest, shiniest options obscured some basic facts. These two particular mRNA vaccines may have been the first to get results from Phase 3 clinical trials, but that's because of superior trial management, not secret vaccine sauce. For now, they are harder and more expensive to manufacture and distribute than traditional types of vaccines, and their side effects are more common and more severe. The latest Novavax data confirm that it's possible to achieve the same efficacy against COVID-19 with a more familiar technology that more people may be inclined to trust.

Bastian continues:

... the success of the Novavax vaccine should be A1 news. The recent results confirm that it has roughly the same efficacy as the two authorized mRNA vaccines, with the added benefit of being based on an older, more familiar science ... Some of those people who have been wary of getting the mRNA vaccines may find Novavax more appealing.

The Novavax vaccine also has a substantially lower rate of side effects than the authorized mRNA vaccines ... Based on the results of Novavax's first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren't just less frequent; they're milder too ... Side effects are a big barrier for COVID-vaccine acceptance.

Bastian concludes:

But here's what we know today, based on information that we have right now:  Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it's the best COVID-19 vaccine we have.

Unfortunately, we don't have the Novavax vaccine yet and, as far as I know, Novavax hasn't applied to the FDA for emergency use authorization yet.

Labels: , , , , ,


Tuesday, May 11, 2021

 

The Safety of US COVID-19 Vaccines Revisited

After I finished my "The Safety of US COVID-19 Vaccines" post I learned that last week Tucker Carlson had done an episode on the same subject, including the use of VAERS data.

I don't typically agree with everything Carlson says and he is sometimes less careful than I think he should be. However, his segment on "How many Americans have died after taking the COVID vaccine?" is almost perfect. Don't trust me, watch it yourself.

What I want to focus on in this post is the outpouring of dishonest criticism from the rest of the mainstream media in the wake of Carlson's piece. In an all too typical example, rather than refute Carlson with relevant facts, National Review contributor Pradheep J. Shanker tweeted

Tucker, being an idiot, took that number of deaths, and says they are related to the vaccine.

This, of course, is nonsense. But again, gullible people will believe these things, because the math and science isn’t exactly crystal clear.

In fact, Carlson simply and accurately reported what is in the VAERS data. Here's a representative passage:

... So the question is how do those numbers compare to the death rate from the coronavirus vaccines now being distributed across the country? That’s worth knowing. 

We checked today. Here’s the answer, which comes from the same set of government numbers that we just listed: Between late December of 2020, and last month, a total of 3,362 people apparently died after getting the COVID vaccines in the United States. Three thousand, three hundred and sixty-two — that’s an average of 30 people every day. So, what does that add up to? By the way, that reporting period ended on April 23. We don’t have numbers past that, we’re not quite up to date. But we can assume that another 360 people have died in the 12 days since. That is a total of 3,722 deaths. Almost four thousand people died after getting the COVID vaccines. The actual number is almost certainly much higher than that — perhaps vastly higher. 

The data we just cited come from the Vaccine Adverse Events Reporting System — VAERS — which is managed by the CDC and the FDA. [VAERS] has received a lot of criticism over the years, some of it founded. Some critics have argued for a long time that [VAERS] undercounts vaccine injuries. A report submitted to the Department of Health and Human Services in 2010 concluded that "fewer than one percent of vaccine adverse events are reported"* by the [VAERS] system. Fewer than one percent. So what is the real number of people who apparently have been killed or injured by the vaccine? Well, we don’t know that number. Nobody does, and we’re not going to speculate about it ... 

The faux "fact checkers" at Politifact gave Carlson a rating of "false" on their "Truth-o-Meter". How did they justify their rating? Here a sample: "... VAERS data is considered unreliable for drawing causal conclusions. And dying after a vaccine is not the same thing as dying because of the vaccine."

I listened to the segment twice, Carlson did not draw a causal connection and never implied or claimed dying after a vaccine is the same thing as dying because of the vaccine. In short, Politifact's case against Carlson is a classic straw man argument—they thrash away at things Carlson didn't say.

Near the close of their article, Politifact says: "The CDC analyzed the VAERS death reports and concluded that there's no 'causal link to COVID-19 vaccines.' " I rate this claim mostly false. What the CDC actually says is: "A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines" (emphasis in original).

The CDC did NOT say "there's no 'causal link to COVID-19 vaccines' ", as Politifact claims. They said a causal link had not been established but they also did not rule out a causal link. It's also worth noting that the CDC provides no further information about who conducted their "review" or how it was conducted. There's no link to any documentation of the review.

* The report Carlson reference is from 2011, here's more context from it:

Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.

Labels: , , , , , , ,


Sunday, May 09, 2021

 

The Safety of US COVID-19 Vaccines

People sometimes ask me if I've gotten a SARS-CoV-2 vaccine yet. My answer is always no. This usually prompts a query as to why I haven't been vaccinated.

My standard answer is that I'm not an anti-vaxxer, I get a flu shot every year. However, I add, I consider it grotesquely unethical for government officials, vaccine manufacturers, and public health and medical professionals to conduct what is essentially a massive experiment* on hundreds of millions of people using relatively new vaccine technologies—mRNA and adenovirus vector vaccines—especially during a global pandemic. I am aware of no reason why Congress and health professionals couldn't and shouldn't have insisted that Operation Warp Speed funds be spent on conventional attenuated virus or viral protein vaccines. That said, until today I usually added that I thought the new technologies would probably prove safe.

* As the FDA notes all of the COVID vaccines in use in the US today have been approved under as investigational drugs under an Emergency Use Authorization. The FDA Letter of Authorization for the Pfizer vaccine says: "Pfizer-BioNTech COVID‐19 Vaccine is for use for active immunization to prevent COVID-19 ... It is an investigational vaccine not licensed for any indication." Its "Investigational New Drug application (IND) number" is 19736. According to the FDA: "Emergency Use IND  allows the FDA to authorize use of an experimental drug in an emergency situation ..."

Today, I actually looked at the CDC's and FDA's Vaccine Adverse Event Reporting System (VAERS) data for the first time. What I learned was pretty amazing.

As you can see from Table 1 below the number of deaths recorded as adverse events associated with COVID-19 vaccines is almost exactly the same as the number of death associated with all other vaccines since 2006 (all VAERS data reported in this post was selected by vaccination year).

Table 1. (VAERS data as of May 10, 2021 for 2006-2021)

Adverse Event Type
Vaccine Type Death Life
Threatening
Permanent
Disability
Sum
COVID-19 3,729 3,362 2,379 9,470
All Other Vaccines 3,733 9,648 9,174 22,555
Sum 7,462 13,010 11,553 32,025

From 2016 through April 30, 2021, there were 4,621 deaths reported as adverse events associated with all vaccines in the US (there's no table in this post for that data).

Table 2 covers 2016-2021 and compares deaths associated with the COVID vaccines and the non-COVID vaccine (Prevnar 13) associated with the most deaths in the same time period. For comparison purposes I also added in the flu vaccine type associated with the most deaths.

As you can see there are far more deaths associated with COVID vaccines even though they have been in use for only a few months. An apples-to-apples comparison would require other data, including the number of doses of each vaccine administered in the selected time period. However, I could not find that data for the non-COVID vaccines although the CDC said that in the 2020-2021 flu season the estimated number of quadrivalent flu vaccines expected to be available was 195 million.

Table 2. (VAERS data as of May 9, 2021; click on images to enlarge)

Table 3 gives the breakdown by COVID vaccine manufacturer of the following combined adverse events: Deaths, Life Threatening, and Permanent Disability. At first glance, it may look like the Janssen (Johnson & Johnson) vaccine is safer but as you can see from Table 4 far fewer doses of that vaccine have been administered.

Table 3. (VAERS data as of May 9, 2021)
 
Table 4. (CDC data as of May 9, 2021)

Combining the data from Tables 3 and 4 we find that there were 11,209 doses (numbers are rounded) of the Janssen vaccine administered for every associated serious adverse event recorded in Table 3. The corresponding count for the Pfizer and Moderna vaccines are 33,951 and 28,423, respectively.

It's interesting to me that I have not read or heard any mainstream reporting on the relatively large, as compared to other vaccines, number of deaths associated with COVID vaccines as adverse events. There are four things to bear in mind about the current numbers: First, an adverse event report is not proof that the vaccine caused the adverse event; Second, the number of adverse events associated with COVID vaccines is tiny compared to the number of adverse events caused by the virus itself; Third, many adverse events including deaths go unreported for a variety of reasons**; and, Fourth, the reporting of adverse events associated with COVID vaccines is just getting started. Who knows how things will look in five or ten years? Hopefully, there will be no great increase adverse events associated with COVID vaccines that emerges long term. Time will tell.

** According to the CDC's VAERS summary page: "VAERS data are from a passive surveillance system. Such data are subject to limitations of under-reporting, reporting bias, and lack of incidence rates in unvaccinated comparison groups." This echoes findings in a workshop summary published in 1994 by the National Academies Press: "As a passive surveillance system, VAERS suffers problems of both underreporting and overreporting. Although health care professionals are required to report some adverse events, specifically, those that are covered by the no-fault component of the Vaccine Injury Compensation Program, there are no provisions for enforcement. It is likely that many events that occur after the receipt of vaccines, like those that occur after the receipt of medications, go unreported."

###

There is a March 31, 2021, letter in the medical journal, Circulation Research, titled "SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2" that some COVID and COVID vaccine deniers/skeptics are using innaccurately to scare people about COVID vaccines. For example, HEALTHRANGER says:

The prestigious Salk Institute, founded by vaccine pioneer Jonas Salk, has authored and published a bombshell scientific article revealing that the SARS-CoV-2 spike protein is what's actually causing vascular damage in covid patients and covid vaccine recipients, promoting the strokes, heart attacks, migraines, blood clots and other harmful reactions that have already killed thousands of Americans ... Critically, all four covid vaccine brands currently in widespread use either inject patients with the spike protein or, via mRNA technology, instruct the patient's own body to manufacture spike proteins and release them into their own blood. This floods the patient's body with the very spike protein that the Salk Institute has now identified as the smoking gun cause of vascular damage and related events (such as blood clots, which are killing many people who take the vaccines).
However, in the very first paragraph of the Salk Institute news release it says:

LA JOLLA—Scientists have known for a while that SARS-CoV-2’s distinctive “spike” proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that the virus spike proteins (which behave very differently than those safely encoded by vaccines) also play a key role in the disease itself.

The authors of the letter itself conclude with this: "... our results suggest that the S protein-exerted EC damage overrides the decreased virus infectivity. This conclusion suggests that vaccination-generated antibody and/or exogenous antibody against S protein not only protects the host from SARS-CoV-2 infectivity but also inhibits S protein-imposed endothelial injury" (emphasis added). There is a hyperlink to an article in the paragraph I quoted above from the Salk Institute that goes into greater detail on this subject. I recommend reading it.

###

In the final analysis one ought always to be skeptical of powerful people and institutions but also of their critics. My read of the data and science is that the new vaccine technology, not the spike protein, is probably more to blame for the comparatively higher rates of adverse events associated with COVID vaccines. I will be cautious going forward but as of now I plan to receive the Novavax vaccine—a more conventional viral protein vaccine type—when it becomes available.

Last revised: 11 May 2021

See also: "The Safety of US COVID-19 Vaccines Revisited"

Labels: , , , , , ,


Monday, November 02, 2020

 

Comparison of Select COVID-19 Death Rates



COVID-19 Deaths Per 1,000,000 PopulationMedian Age of Population
Republic of China (Taiwan)
(pop. 23.6 million)
0.3
42.3
S. Korea
(pop. 51.8 million)
9
43.2
Japan
(pop. 125.5 million)
14
48.6
Norway
(pop. 5.5 million)
52
39.5
Germany
(pop. 80.2 million)
128
47.8
W. Virginia
(pop. 1.8 million)
256
42.4
Canada
(pop. 37.7 million)
270
41.8
Washington State
(pop. 7.6 million)
313
37.6
California
(pop. 39.5 million)
448
36.3
France
(pop. 67.8 million)
573
41.7
Italy
(pop. 62.4 million)
646
46.5
United Kingdom
(pop. 65.8 million)
689
40.6
United States
(pop. 332.6 million)
715
38.5
Michigan
(pop. 10.0 million)
773
39.7
San Marino
(pop. 34,232)
1,237
45.2
New York
(pop.  19.5 million)
1,732
38.7
New Jersey
(pop. 8.9 million)
1,856
39.8
Unless otherwise specified population estimates are for July 2020 and, along with median pop. age, are from the CIA's World Factbook. Death rates and U.S. state populations are from Worldometer. Median age for U.S. states is from World Population Review.
.

Labels: , , , ,


Sunday, November 01, 2020

 

Cuomo & COVID-19

Thanks to a fawning, largely uncritical media and a feckless, gullible public, Gov. Andrew Cuomo of New York was able to falsely position himself this year as the COVID-19 anti-Trump. In May, The Guardian published an op-ed titled "Andrew Cuomo is no hero. He's to blame for New York's coronavirus catastrophe". The authors noted:

Andrew Cuomo may be the most popular politician in the country. His approval ratings have hit all-time highs thanks to his Covid-19 response. Some Democrats have discussed him as a possible replacement for Joe Biden, due to Biden’s perceived weakness as a nominee. And there have even been some unfortunate tributes to Cuomo’s alleged sex appeal.

All of which is bizarre, because Cuomo should be one of the most loathed officials in America right now. ProPublica recently released a report outlining catastrophic missteps by Cuomo and the New York City mayor, Bill de Blasio, which probably resulted in many thousands of needless coronavirus cases ...

Federal failures played a role, of course, but this tragedy was absolutely due, in part, to decisions by the governor.

Nevertheless image triumphed once again over reality, as The Atlantic put it last August

The opening night of the Democrats’ virtual convention was the beginning of a coronation for Joe Biden, but it was also a victory march for Andrew Cuomo, New York’s governor and a supposed hero of the coronavirus pandemic. “For all the pain and all the tears, our way worked,” Cuomo declared in his five-minute speech. “And it was beautiful.”

“Beautiful” is an odd way to describe a virus that has killed more than 25,000 New Yorkers, or about 15 percent of the total number of Americans who have died from COVID-19. But Cuomo has long been a curious leader for Democrats to hold up as an emblem of successful leadership during the pandemic: He has somehow presided over the worst and deadliest coronavirus outbreak in the country while eluding the widespread criticism that has surrounded both President Donald Trump and New York City’s Democratic mayor, Bill de Blasio.

Earlier today I had bizarre conversation about one of Cuomo's many failures. In 2015, the New York State Task Force on Life and the Law (TFLL), its members appointed by Cuomo, released its "2015 Ventilator Allocation Guidelines".

The TFLL estimated that during the "peak week" of a severe "1918-like" pandemic scenario the state would have a ventilator shortfall of 15,783 units (p. 30). Instead of urging the state's leaders to come up with a plan to close the shortfall of ventilators and trained personnel to operate them the TFLL accepted a shortage of life-saving equipment as a fait accompli. The TFLL was focused on rationing ventilators without any analysis of whether the shortage could be ameliorated through advance preparation. Cuomo implicitly, if not explicitly, agreed he could live with the projected shortage and the deaths that would entail.

Their solution, then, was to create a triage plan that, by design, likely consigned hundreds, if not thousands, of patients to a needless death when the pandemic arrived this year. When I pointed out this to my friend she defended Cuomo asserting there was little or nothing he could have done differently. I replied he could have said: This is unacceptable, we need to figure out how to close this gap. She claimed, "That's not how government works." I'll never understand why some people make excuses for corrupt and/or inept politicians.

In 1984, the governor's father, Mario Cuomo, who was then himself governor of New York, gave one of his best known speeches at the Democratic national convention. His vision of government included the idea that people should be "protected in those moments when they would not be able to protect themselves." Andrew Cuomo echoed this notion when, in 2017, he asserted of the subway "crisis": "There is no time for delay and there is no tolerance for a lack of commitment on this issue ... The fundamental responsibility of government is to respond in a timely and effective way when people need help."

If Cuomo's TFLL could identify the problem then they could also have come up with a better solution. Moreover, Cuomo could have demanded one. No, he can't magically conjure ventilators or the money to buy them but experts have been predicting a serious viral pandemic for years. Cuomo (and governors and legislators across the country) had the ability and responsibility to ensure his state was better prepared for it.

Instead in March, Cuomo lied or betrayed a profound ignorance. As Colin Kalmbacher at Law & Crime wrote:

On Wednesday morning, during his quotidian Coronavirus press briefing, the three-term Democratic governor told an easily verifiable falsehood about New York’s state of health.

“No one has these ventilators and no one ever anticipated a situation where you would need this number of ventilators to deal with a public health emergency,” Cuomo said–explaining the Empire State’s recent move toward rationing the highly in-demand medical devices.

“So we have purchased everything that can be purchased,” he added. “We’re now in a situation where we’re trying to accelerate production of these ventilators, and a ventilator is a complicated piece of equipment.”

But Cuomo’s claim that “no one ever anticipated” the “number of ventilators to deal with a public health emergency” is directly undercut by a report from New York State itself–under his own administration–released halfway into Cuomo’s second term in office.

Like Cuomo, the New York State Commissioner of Health he appointed, Howard A. Zucker, was also given to uttering falsehoods. In a letter accompanying the TFLL's report he claimed: "Protecting the health and well-being of New Yorkers is a core objective of the Department of Health." So, Zucker knew about the anticipated ventilator shortage and the "death panel" solution to deal with it. 

Yet, in March of this year, Newsday reported

"I always felt if you can improve the life of others — whether an individual or many — you should," he [Zucker] said in an interview. "I learned practicing clinical medicine that I have to do everything possible ... it's our role in society."

"But I never expected this kind of situation," he said of the coronavirus threat."

Zucker has mostly flown under the radar compared to his boss but his COVID-19 performance prompted one editorial titled: "New York health chief Howard Zucker: Call him Dr. Death".

By April, Cuomo was throwing tens of millions of dollars around to try to buy ventilators at elevated prices from people who often couldn't deliver. If instead, he had ordered 15,783 ventilators in 2015 when his Task Force released its report then the state would likely have had a stockpile on hand during the COVID-19 crisis for less than 0.14% of the state's 2015-16 disbursements.

For the calculation above, I used a 2020 ventilator retail price via ProPublica of $12,495 per unit. I have no doubt that price is actually significantly higher than a competitive bidding process in 2015 would have obtained. If the state had spread the acquisition out over five years then the cost would have been less than 0.03% of the annual budget.

In any event, it seems both unsurprising and clear that few high-profile politicians of either major party actually concern themselves much with the victims of COVID-19, whom they largely regard as superannuated drags on the economy or otherwise disposable people. They don't say this out loud but their policies speak volumes. Instead of taking effective steps to save lives and safely re-open the economy, Democrats blame Trump, Republicans blame China (or engage in various forms of denial) and, in the meantime, the US has the largest COVID-19 death toll and one of the highest per capita COVID-19 death rates in the world.

Labels: , , , , , , , , ,


Saturday, March 28, 2020

 

A Few Thoughts on COVID-19 - Part II


One week ago, I wrote:
As of today, the global COVID-19 fatality rate (deaths divided by aggregate confirmed infections) is about 4.1%.

We know that the actual fatality rate is probably significantly lower than 4.1% because not everyone who has been infected has been tested.

There are a lot of other factors leading to uncertainty over the actual fatality rate from COVID-19 that I didn't write about. There is an excellent discussion of the "Coronavirus (COVID-19) Mortality Rate" that elaborates on those factors. I recommend it.

Today, the crude global COVID-19 fatality is about 4.6% per figures from the UW Novel Coronavirus (COVID-19) Infection Map. I still have every expectation that the final rate will be much lower than 4.6% globally, in Italy, the US, and elsewhere. However, because of the failures mentioned in my earlier post I still fear that "the progression of the COVID-19 in the US will likely resemble Italy's trajectory more closely than South Korea's or China's." Nothing that's happened in the last week has dissuaded me from that view although I remain hopeful something will change.

A week ago, I also wrote: "By the end of next week we may start to see how effective efforts to flatten the curve have been in Washington state." The Governor of Washington believes this may be the case but in my reading of the data it's still too soon to know for sure.

I want to elaborate a bit on the comparison I made between the US and South Korea. China, in my opinion, is the wrong place to look for comparisons. Although China has some aspects of a market economy, large and important entities are state-owned enterprises directly controlled by the Communist Party of China (CPC) and the remaining sectors are subject to indirect CPC control in the one-party authoritarian regime.

There is evidence that the Chinese government suppressed key information about the virus at least in the early stages. In contrast, South Korea has a modern, mostly private market economy with a political system that is, by one measure, at least as democratic as the United States' "flawed democracy" (but see here for a different ranking).

One of the big mistakes that many people will undoubtedly make in the aftermath of COVID-19 is to demand a larger, more centralized public health and medical system in the US. One of the big pitfalls of such thinking is that centralization creates the risk of severe consequences from a single point of failure.

We are actually seeing that play out in the US where state and local public health agencies and officials take their lead from the federal government and were slow to react appropriately to the threat of COVID-19. They were also hamstrung by their dependence on the Centers for Disease Control and Prevention (CDC) to roll out COVID-19 testing and misplaced reliance on supplies from the Strategic National Stockpile (SNS).

One counterargument is, yes, but if the federal government had done its job correctly then we wouldn't be in this situation. True enough but there are no guarantees that when a crisis develops there will be an able, humane leader at the helm of the large, centralized ship of state.

I am aware of no compelling evidence that, say a President Hillary Clinton, would have prepared for or handled the COVID-19 crisis markedly better than Trump. Speculatively, we can say she may indeed have risen to the challenge of COVID-19 but Clinton would have been under the same pressures by the investor class not to disrupt their profit-taking and to win re-election this year.

More crucially, the lapses in the CDC and the SNS, for instance, didn't develop under Trump alone. I have been unable to find a concise depiction of inflation-adjusted CDC annual budgets (there is this though) but it's clear that the Obama administration proposed significant cuts in 2011 (-11%). In 2013, the Obama administration again proposed more cuts in "biodefense and emergency preparedness programs" along with a $38 million reduction in the "allocation for the Strategic National Stockpile of emergency medical supplies".

And as NBC reports:

[The] U.S. strategic stockpile isn't intended to be the solution to a crisis. It's designed to be used as a stopgap during emergencies. The stockpile has limited resources, government officials and public health experts say, which weren't at full capacity even before the coronavirus was on the horizon.
And:
The stockpile wasn't at full capacity before the COVID-19 outbreak in the U.S., in part because it never fully replenished some of the critical supplies used in the 2009 H1N1 pandemic response ...
A 2016 report published by the National Academies repeatedly raised concerns about the SNS inventory and the logistics of distributing it in an emergency. The chair of the committee that prepared that report, Dr. Tara O'Toole, presciently told NPR in 2016:
"We have drastically decreased the level of state public health resources in the last decade. We've lost 50,000 state and local health officials. That's a huge hit," says O'Toole, who wishes local officials would get more money for things like emergency drills. "The notion that this is all going to be top down, that the feds are in charge and the feds will deliver, is wrong."
My point is that the inability and failure in the US to implement the successful model of South Korea to tamp down COVID-19 via widespread testing, contact tracing, and isolation of the exposed or infected was born of a longstanding failure of the values and priorities of the bipartisan political establishment and by the servile dependency and doltish complacency of the American people who keep electing them. Trump surely deserves a lot of blame for his failures but much of the finger pointing by, for example, Michigan Gov. Whitmer, is simply not grounded in fact and is counter-productive, self-interested blame-shifting by culpable partisans in the midst of a major crisis.

It bears stating that governments weren't invented for the well-being of commoners and only servile fools would willingly depend upon them for that. Governments were created to secure and enhance the power of the already powerful and to provide rhetorical cover for that domination. That is not to say they cannot potentially be transformed by people to more closely reflect the rhetoric of, say, "life, liberty, and the pursuit of happiness" but we should never forget that decent treatment of ordinary people is, at best, a means, not an end, of government.

If we are to have a centralized state or any state at all then, ceteris paribus, one that could competently stop an COVID-19 epidemic, for instance, would be preferable but this is a false dichotomy. There are other, better ways for humans to organize themselves free from the coercive state if only we will imagine and create them.

See also: "A Few Thoughts on COVID-19"

Labels: , , , , , , ,


Saturday, March 21, 2020

 

A Few Thoughts on COVID-19


Don't be deceived, COVID-19 is more lethal and more infectious than the normal annual influenza outbreaks. As one example, in roughly three weeks COVID-19 has already killed almost as many people in the Seattle area (King, Snohomish, and Pierce counties) alone as have died so far from the flu (lab-confirmed cases) in the entire State of Washington during the 2019-2020 flu season and COVID-19 shows no sign of slowing down yet. In part, this is because almost no one has any natural or vaccine-induced immunity to COVID-19 as it is "novel" and there is no vaccine for it.

Everywhere that COVID-19 has infected large numbers of people it has quickly overwhelmed the local health care system. That means the death toll from COVID-19 is added on to the existing, more routine causes of death from heart disease, cancer, influenza, accidents, etc. and the rapid influx of those sick from this new disease impairs the health care system's capacity to manage more typical cases of disease and trauma.

If unchecked by effective public health measures or natural immunity COVID-19 has exponential growth rates of infection and death (see also here and here and here) although the death curve is much flatter because the disease does not kill at nearly the same rate as it infects or sickens people. As of today, the global COVID-19 fatality rate (deaths divided by aggregate confirmed infections) is about 4.1%.

We know that the actual fatality rate is probably significantly lower than 4.1% because not everyone who has been infected has been tested. In South Korea, where there are high rates of testing and a very successful public health response, the fatality rate is about 1.2%. By contrast, the US 2018-2019 influenza fatality rate was about 0.1%. (There are a lot of factors, such as quality of the health care system, mean population age, smoking rates, etc., that influence fatality rates.)

Below, from the University of Washingon Novel Coronavirus (COVID-19) Infection Map, are two images (click to enlarge) showing the exponential growth of COVID-19 infections and deaths in the US and Italy.



The graphic below demonstrates that exponential growth of infection and death from COVID-19 can be arrested. South Korea had its first confirmed COVID-19 death on February 21 and in about three weeks it had stopped the initial exponential growth of infections. The number of COVID-19 deaths there is currently 102. China, too, after early missteps has reportedly stopped local transmission of COVID-19 altogether.



We did have earlier warnings to alert us to the potential of a dangerous viral pandemic. In addition to the Spanish Flu (1918; 25,000,000 - 100,000,000 deaths), there was the Asian flu (1957; 1,000,000 - 2,000,000 deaths), Hong Kong flu (1968; 1,000,000 - 4,000,000 deaths), SARS-CoV (2002; 774 deaths), H1N1 flu (2009; 151,000 - 575,000 deaths), and MERS-CoV (2012; 862 - 912 deaths). MERS is notable because it has a high fatality rate (~37%) and continues to infect and kill people every year. With few exceptions, the media, public health community, and politicians of all political stripes failed to alert Americans to the very real dangers of a viral pandemic and the country is, thus, woefully unprepared.

Unfortunately, I am afraid the progression of the COVID-19 in the US will likely resemble Italy's trajectory more closely than South Korea's or China's. I hope I will be proven mistaken in this.

American individualism is, in many ways, pathological and more communal attitudes and behavior are not necessarily antithetical to freedom or a healthy individualism. Whatever their downside, a more community-oriented culture was one factor that evidently contributed to the successful Chinese and South Korean responses to COVID-19.

If competently led, adequately staffed, and sufficiently provisioned, I think America's decentralized health care system could have responded in a coordinated and effective manner. This was not the case, however, and one result has been the very slow roll out of widespread COVID-19 testing that would have enabled the early isolation of infected people. The US also has a warped, hollowed out industrial base that has left it dependent on the importation of key health care supplies—masks, drugs, reagents, gloves, ventilators, etc.—that were seemingly not stockpiled and/or aren't being distributed in sufficient quantities.

Chinese health officials were able to successfully confine the COVID-19 outbreak to primarily one region of the country and then bring the resources of the rest of the country to bear in order to tamp down the disease. Unfortunately, for reasons described above, the US has failed to keep the outbreak of disease concentrated in one or two regions.

The result is that the COVID-19 is now, apparently, spreading exponentially in every US state. The first US death from COVID-19 was on February 29, 2020. Since that time Washington has had 82 more deaths, New York 43, California 24, Louisiana and Georgia 14 each, New Jersey 11, and Florida 10. COVID-19 deaths have been reported in several other states, too. The wide geographic dispersion of infections in the US will likely make it immensely difficult to bring COVID-19 under control quickly. Again, I hope I am proven wrong in this.

By the end of next week we may start to see how effective efforts to flatten the curve have been in Washington state. However, even if they have been effective the state has already fallen far short in comparison to South Korea. Consider the table below based on the 2018 populations.


COVID-19 Deaths Per 100,000 PopulationDays Elapsed Since First COVID-19 Death
Washington State
(2018 pop. 7.5 million)
1.1121
South Korea
(2018 pop. 51.6 million)
0.2029

So what is to be done? For those on the medical front lines of the struggle and those directly supporting them the path is pretty clear. The rest of us need to support those folks and each other. Don't panic, don't hoard. Don't worry about getting sick but do take scientifically supported steps to help prevent it.

For those who are able to do so, physical distancing and staying home as much as possible is probably the most critical task now. If you're not concerned about your own well-being then think about the others you might expose if you do get sick or the health resources you might take up that could have been used by someone who had a heart attack or a child hit by a car.

See also: "A Few Thoughts on COVID-19 - Part II"

Labels: , , , , , ,


Saturday, February 17, 2018

 

Color Vision


Watch what happens when these color blind men are able to see in color for the first time.


Labels: , ,


Saturday, February 25, 2017

 

On Diagnosing Trump

A large segment of the Left seems eager to advance the idea that Donald Trump is mentally unfit to be president of the US. I don't respect or admire Donald Trump, I never voted for him, and I never expected him (or Clinton) to be what I would consider a good or successful president.

However, I regard the public attacks on Trump's mental fitness as far more revealing of the depravity of some of his critics than of anything else. The public questioning of Trump's mental health by lay people and professionals who have never examined him in a clinical setting is little more than a scurrilous ad hominem attack in service of an unprincipled attempt to wield a tool of social control for for political purposes.

With respect to social control, people inclined to take seriously the ill-informed, politicized pronouncements of unethical mental health professionals that Trump is "mentally ill" may want to pause to reflect that it was not so long ago that these professions accepted surgical lobotomy and electroconvulsive "therapy" as common, if not routine, "treatments" for "mental illness". Despite a documented history of widespread and selective abuse they are far from rejected even today.

Psychiatry also gave us such enlightening concepts as "drapetomania"—the mysterious illness which caused slaves to try to escape their bondage. The wit who gave us that term was Samuel A. Cartwright, a physician who apprenticed with Benjamin Rush, the "father of American psychiatry". Then there's "The eugenic legacy in psychology and psychiatry". And don't forget that homosexuality was, according to the American Psychiatric Association (APA), also a mental illness until in 1973 (sort of) it wasn't. Finally, readers would do well to reflect on the weaponization of psychiatry in the Soviet Union and its correlates in the US.

Below are some thoughts of others who are concerned with the politicization of mental health by Trump opponents. The first excerpt is from Allen J. Frances who made his first appearance in this blog in 2013. I think Frances overstates the case against Trump and in so doing betrays his political bias nevertheless his main points are well-taken.
Fevered media speculation about Donald Trump's psychological motivations and psychiatric diagnosis has recently encouraged mental health professionals to disregard the usual ethical constraints against diagnosing public figures at a distance. They have sponsored several petitions and a Feb. 14 letter to The New York Times suggesting that Mr. Trump is incapable, on psychiatric grounds, of serving as president ...
Bad behavior is rarely a sign of mental illness, and the mentally ill behave badly only rarely. Psychiatric name-calling is a misguided way of countering Mr. Trump's attack on democracy. He can, and should, be appropriately denounced for his ignorance, incompetence, impulsivity and pursuit of dictatorial powers.
His psychological motivations are too obvious to be interesting, and analyzing them will not halt his headlong power grab. The antidote to a dystopic Trumpean dark age is political, not psychological.
The second excerpt is from a defense in the Journal of the American Academy of Psychiatry and the Law by Redinger et al. last September of the APA's "Goldwater Rule".
... diagnosing public figures via observations culled from the media represents poor diagnostic methodology ... Public figures, especially politicians, intentionally cultivate a public persona that may not accurately reflect their psychological state. Given the risk and potential harm of error, it would be imprudent for any psychiatrist to render an opinion of a public figure's subjective thoughts or motivations, conscious or unconscious, in the absence of a personal and value-free diagnostic interview.

The APA's Goldwater Rule exemplifies a necessary and justifiable professional norm that is intended to temper the potentially imprudent and self-indulgent motivations of psychiatrists to use the cloak of their profession to further a particular political ideology and neutralizes a fallacious appeal to their own authority. Justifications based on freedom of speech, conscientious objection, or the public interest fail to offset the likely harms to the psychiatrist, profession, and public figure.
The final excerpt is by Sera Davidow from the web site of Robert Whitaker, author of the illuminating Mad in America. Davidow underscores the mental health professions as instruments of social control along with the inherent subjectivity of the whole concept of mental illness.
[Trump]'s not 'mentally ill,' because this whole manner of categorization of human beings is just that subjective.

In other words, Trump is not 'mentally ill' because he is not a member of any of society's groups for which tools of control (like our diagnostic system) are most specifically designed. His brand of dangerous is party to some other kind of measure. A different set of standards. And while this tells us something about Trump, it tells us much more about ourselves ...

We need to stop calling Trump 'mentally ill' because it suggests that emotional distress and trauma (and all the rest that often gets wrapped up in and confused with this idea of 'disorder') are somehow scarier and worse than what Trump is actually doing. It's a distraction of the worst kind from what we can actually see and know.

We need to stop calling him 'mentally ill' because it misdirects us away from holding ourselves accountable for his election and the societal ills that led us to this point. We're far better off learning from our mistakes, and figuring out a way to back off of this crumbling ledge.

And we need to stop calling Trump 'mentally ill' because such labels are routinely applied inequitably and in ways that have harmed so many, and this present maelstrom only further encourages that trend. Psychiatric labels tell us little to nothing about how to be with or support one another, and give almost no information about what's actually going on. This is true of both president and neighbor. Friend or lover. Child or parent. Human being.

It certainly tells us nothing about how to get us out of our current bind.
See also: "Friday Feedback: Questioning A Leader's Mental Health" on MedPage Today.

Labels: , , ,


Monday, July 08, 2013

 

Mental Illness as Construct

"Here's the problem," Frances* said. "There is no definition of a mental disorder."

I mentioned that that hadn't stopped him from putting one into the DSM-IV, or the people who were then making the DSM-5 from fiddling with it.

"And it's bullshit," he said. "I mean you can't define it." [p. 23]

"the personality disorders are not at all clearly distinct from normal functioning or from each other," [p. 263; quoting Allen Frances; emphasis added]

What Insel heard "over and over again" on his tour [of "hospitals and universities around the country"] was that psychiatrists were tired of being trapped by the DSM. "we are so embedded in this structure," he told me. He and his colleagues had spent so much time diagnosing mental disorders that "we actually believe they are real. But there's no reality. These are just constructs. There's no reality to schizophrenia or depression." [p. 340]

"Whatever we've been doing for five decades," [Insel] told me, "it ain't working. And when I look at the numbers–the number of suicides, the number of disabilities, mortality data–it's abysmal, and it's not getting any better. All the ways in which we've approached these illnesses, and with a lot of people working very hard, the outcomes we've got to point to are pretty bleak–especially, he added, compared with the "extraordinary" progress in other fields, such as the 70 percent drop in mortality from cardiovascular disease since he went to medical school or the steep reductions in deaths from auto accidents and homicides. There are some people for whom some of what we do is enormously helpful," he said. But even so, "we don't know which treatments are working for which people." And this litany of failure, he said, "gets us back to your interest in nosology. Maybe we just need to rethink this whole approach." [pp. 351-352]

Source: Gary Greenberg. The Book of Woe: The DSM and the Unmaking of Psychiatry (Penguin, 2013).

Notes:
    *Allen J. Frances, MD is the former head of the Duke University School of Medicine's psychiatry department and was once referred to by The New York Times as "perhaps the most powerful psychiatrist in America." Frances served on the American Psychiatric Association's (APA) personality disorders work group for the 1980 DSM-III. He was chair of the APA task force responsible for the 1994 DSM-IV.
     †DSM is an abbreviation for the APA's Diagnostic and Statistical Manual of Mental Disorders.
     ‡Thomas R. Insel, MD, is the Director of the National Institute of Mental Health.


See also:

Labels: , ,


Friday, January 18, 2013

 

Antimatter and You

Positron emission tomography (PET) uses ionizing radiation to produce detailed, three-dimensional, functional images of living organisms. The images are produced using a radioisotope, a gamma radiation detector, and a computer system used to manage and display the data collected by the detector. The detector and computer combination may be thought of as a PET scanner.

The US National Oncologic PET Registry lists 2,272 facilities that are approved to conduct PET scans for cancer screening or monitoring. Thus, the use of these machines in the US, while perhaps not exactly routine, is not rare or exotic. But there is something exotic about PET scans--they depend upon matter-antimatter annihilation to produce their images.

Our everyday world is made up of matter and energy (which are convertible). Atoms are a basic unit of matter comprised of subatomic particles called protons, neutrons, and electrons (except the most common form of the element hydrogen has one proton, one electron, and no neutron). Likewise, antimatter is comprised of antiparticles which have the opposite charge and quantum spin of ordinary particles (there are no known naturally-occuring antimatter atoms).

Antimatter particles ("antiparticles") are extremely rare. According to physicist Brian Odom: "In molecular gas clouds in our galaxy, there is less than 1 antiproton for every 1015 protons." Nevertheless, antimatter is produced naturally by cosmic rays colliding with the Earth's atmosphere, lightning, and the beta decay of natural occurring radioisotopes, such as the Potassium-40 found in bananas.

Any way, let's get back to the PET scanner. The figure below illustrates how it works using an artifically-produced radioisotope, fluorine-18 (18F) as an example. If it is intravenuously administered in the form of the glucose ("blood sugar") analog 18-fluorodeoxyglucose then the 18F will be concentrated differentially based upon different rates of glucose metabolism. For example, cancer tumors typically have higher rates of metabolism than surrounding tissue.

18F has a half-life of 109.8 minutes. So, after 109.8 minutes half of the 18F atoms will have decayed into the rare, but stable, oxygen-18 isotope, usually (96.73% of the time) by emitting a positron (an antiparticle also called a "positive electron"). That positron will immediately collide with an electron (a negatively-charged matter particle). When it does the positron and electron will annihilate each other--mass is converted to energy--yielding two 511 keV gamma photons or gamma rays. These pass through the patient's body and are detected by the gamma ray detectors.


Labels: , ,


Monday, April 16, 2012

 

Part I: On the Efficacy of Psychotherapy & Psychopharmaceuticals for Depression

In Manufacturing Depression: The Secret History of a Modern Disease (Simon & Schuster, 2010) author Gary Greenberg cites studies from 1975 and 1980 and a 1995 Consumer Reports reader survey in support of the 1936 finding that "all forms of [psycho]therapy, competently practiced, were equally effective" (pp. 299-300). Greenberg summarizes:
The conclusion is inescapable: to the extent that therapy succeeds, it's not due to the particular help that's offered, but rather to the fact that something is offered in the first place, and by a person whom the patient expects, and believes, will help. Therapy, no less than drugs, works by the placebo effect.

This shouldn't be a surprise. To the extent that it is understood, the placebo effect seems to be the result of a patient's entering into a caring relationship with a healer, which is a much more explicit feature of psychotherapy than of general medicine. Nor should this be bad news. It just means that when therapists listen with empathy, when we offer support and understanding, when we help people to pick up their pieces and fashion a story out of them, to make as much sense of their lives as they can and to withstand the uncertainty of whatever is left over, when we provide a space in which they are free to be just as confused and demoralized and ambivalent as they really are—that when we do all that, and when we do it well, it really does help. It would no doubt be better to have a world in which we therapists weren't necessary, where narrative coherence wasn't so hard to come by and people weren't driven into private rooms to plumb the depths of their fears and their hopelessness, but that's not this world, so having those rooms, and the professionals who occupy them, is the next best thing. [pp. 300-301]
Regarding cognitive behavioral therapy in particular, Greenberg writes:
Other studies ... strengthen the finding that to the extent that cognitive therapy works for depression, it is not because its specific ingredients act on specific pathologies. Instead, according to the meta-analysts, cognitive therapy's success depends largely on the therapeutic alliance, therapist empathy, the allegiance of the therapist to his technique, and the expectations of the patient ... How therapy is conducted is more important ," as one researcher put it, "than what therapy is conducted." [p. 309]
Elsewhere Greenberg quotes a telling admission from the American Psychiatric Association's document, A Research Agenda for the DSM-V:
The major problem for mental disorders as currently defined is that their causes and pathophysiological mechanisms remain largely unknown. It is expected that, at some point in the future (perhaps decades from now), the pathophysiological states predisposing or contributing to major mental disorders will be identified ... once it is possible to define a mental disorder based on the identification of its underlying pathology, then it would surely make sense to follow the course of other medical conditions and have the presence of disorder be based solely on pathology and not on the effect this pathology exerts on the individual's functioning.
One take-home lesson from this is that by 2002 the psychiatric profession knew that the chemical imbalance theory of depression is speculative, not established fact.

Regarding the efficacy of psychopharmaceuticals, here's a quote from "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy" by Turner et al., a study Greenberg cites in his discussion of antidepressants:
Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.
In the paper's discussion section the authors write:
We found a bias toward the publication of positive results. Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome. We analyzed these data in terms of the proportion of positive studies and in terms of the effect size associated with drug treatment. Using both approaches, we found that the efficacy of this drug class is less than would be gleaned from an examination of the published literature alone. According to the published literature, the results of nearly all of the trials of antidepressants were positive. In contrast, FDA analysis of the trial data showed that roughly half of the trials had positive results.
To distill this: Drug companies suppress the results of clinical trials which show the drug they're trying to get approved for consumers is ineffective. So, if they don't dump the drug, they keep trying until they get a positive result they want to publish.

Greenberg also cites a 2002 article by Kirsch et al, "The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration". The authors studied clinical trials data for six popular antidepressants: fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), nefazodone (Serzone), and citalopram (Celexa). Here are the final two paragraphs of their article:
To summarize, the data submitted to the FDA reveal a small but significant difference between antidepressant drug and inert placebo. This difference may be a true pharmacological effect, or it may be an artifact associated with the breaking of blind by clinical trial patients and the psychiatrists who are rating the severity of their conditions. Further research is needed to determine which of these is the case.

In any case, the difference is relatively small (about 2 points on the HAM-D), and its clinical significance is dubious. Research is therefore needed to assess the additivity of antidepressant drug and placebo effects. If there is a powerful antidepressant effect, then it is being masked by a nonadditive placebo effect, in which case current clinical trial methodology may be inappropriate for evaluating these medications, and alternate methodology need to be developed. Conversely, if the drug effect is as small as it appears when drug/placebo differences are estimated, then there may be little justification for the clinical use of these medications. The problem, then, would be to find an alternative, as the clinical response to both drug and placebo is substantial. Placebo treatment has the advantage of eliciting fewer side effects. However, the deception that is inherent in clinical administration of placebos inhibits their use. Thus, the development of nondeceptive methods of eliciting the placebo effect would be of great importance.
In layperson's terms: We can't really tell from the clinical data if the billions of dollars worth of antidepressants prescribed to Americans every year are really helping them or not. The lead author, Irving Kirsch, published a book on the subject in 2010, along with a summary of sorts in The Huffington Post.

Kirsch was the lead author in a 2008 article, "Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration," also cited by Greenberg. The authors found:
Using complete datasets (including unpublished data) and a substantially larger dataset of this type than has been previously reported, we find that the overall effect of new-generation antidepressant medications is below recommended criteria for clinical significance. We also find that efficacy reaches clinical significance only in trials involving the most extremely depressed patients, and that this pattern is due to a decrease in the response to placebo rather than an increase in the response to medication.

Labels: ,


This page is powered by Blogger. Isn't yours?