The Placebo Effect

One of the main reasons for failure of new drugs in clinical trials is the placebo effect. Placebos given to patients in controlled clinical trials elicit measurably beneficial effects that are good enough to make the drug look statistically no better than the placebo. The drug then fails and tens or hundreds of millions of dollars in investment returns nothing but the valuable information associated with the failure, which isn’t a marketable product. Strong placebo effects even pop up in diseases like Parkinson’s Disease where normal disease progression would be expected without some form of therapeutic drug.

Placebo effects are biological, not magical

The study of placebo effects are still early, but progress is being made. In Parkinson’s, placebo effects are believed to arise partly from release of dopamine in the brain: “We show here that the placebo effect in Parkinson’s disease is due, at least in part, to the release of dopamine in the striatum. We propose that the placebo effect might be related to reward mechanisms. The expectation of reward (i.e. clinical benefit) seems to be particularly relevant. According to this theory, brain dopamine release could be a common biochemical substrate for the placebo effect encountered in other medical conditions, such as pain and depression. Other neurotransmitters or neuropeptides, however, are also likely to be involved in mediating the placebo effect (e.g. opioids in pain disorders, serotonin in depression).”

Placebo effects are being correlated with genetic traits. For example, in irritable bowel disease, a small gene variant in the catechol-O-methyltransferase gene (val158met) is correlated with an increased placebo response. That gene is relevant to metabolism of the neurotransmitter dopamine. Research on placebo effects also includes health care provider social behavior (bedside manner). Placebo effects can be powerful in mental disease treatments: “The placebo effect—the ability of expectations about a treatment to lead to clinical improvement—is well established as a powerful force in mental health interventions. The placebo effect is responsible for a substantial portion of the efficacy of antidepressant medications and other important elements of psychiatric care.”

Placebo effects are also prominent in pain therapies: “The placebo effect is a powerful mechanism for modulating clinical outcomes. Linked to psychoneurobiological changes, placebo effects result from the expectancies of the patient, proxy, and provider (1, 2) and are distinct from regression to the mean, spontaneous remission, and fluctuations in symptoms. In randomized clinical trials, the inclusion of a no-intervention arm (3) and possibly a measurement of expectations (4) are critical design elements that can help separate placebo effects from these potential confounds (5). This phenomenon has been particularly well investigated in the areas of experimental and clinical pain, but placebo effects can influence any treatment and any condition (6).” (emphasis added)

Chi, acupuncture, nutritional supplements & Goop

People report feeling better from a vast number of ailments and diseases. Products are sold that infer or outright claim to be good to treat all sorts of diseases and symptoms. Most of it is based on pseudoscience and/or outright fraud. For example, acupuncture claims to be based on inserting thin needles in precise locations on the body to affect the flow of Chi or life force in clinically beneficial ways. Despite the claim, (1) there are no precise locations that experts use to affect the flow of Chi, and (2) Chi doesn't exist. Efforts to proves it exists have failed. Paltrow’s products marketed under the Goop brand name may elicit placebo effects in at least some people based on pseudoscience at best.[1] Nutritional or dietary supplements usually have no useful ingredients other than minerals and vitamins that are considered to be actual necessary nutrients.

I don’t care about science, I want to buy it anyway

Some people don’t care that the product they buy doesn't work beyond being a placebo. Others reject science arguments because they believe their product really “works.” Often they just want to be left alone about it and free to buy whatever they want.

There’s a lot to buy.[2] The global market for dietary supplements alone is projected by one study to be about $350 billion by 2026. Paltrow’s Goop products can be expensive. A 2002 study estimated that US consumers paid about $34 billion for complementary and alternative medicine (CAM) therapies, acupuncture, reflexology, aromatherapy, herbal therapy, etc., but the clinical benefits were not quantified due to a lack of good data for analysis: “Nevertheless, there are still too few good quality evaluations to draw many conclusions about the cost-effectiveness of specific CAM therapies for particular conditions.”

In view of existing evidence, it is reasonable to believe that essentially all benefit that people report for products and therapies that are not FDA approved come from the placebo effect. It is also reasonable to believe that people will continue buying various non-FDA approved products in the belief of benefits that arise from something other than the placebo effect.


Footnotes:
1. Scientific belief that benefits from Chi, acupuncture, nutritional supplements and Goop are based on placebo effects have been rejected by some people. That belief is criticized as closed-minded worship of a fallible and flawed Western science that does not fully understand all of the things it pretends to know. Some of that criticism is true because Western medical science doesn't understand everything, but at least it doesn’t claim to. However, that limitation does not negate the placebo effect or show evidence that convincingly demonstrates effectiveness of alternative treatments beyond placebo effects.

The ‘not enough evidence’ criticism has been rejected as raising the bar higher for alternative approaches compared to FDA approved drugs. The rebuttal to that is that higher levels of evidence can be reasonably asked for inherently inexplicable theories, such as Chi, and treatments or products that operate without any basis in science other than placebo effects. After all, no one has measured Chi, despite years of trying. Such a finding would be a major new scientific finding that would ripple through biomedical research if not most all other sciences as well. So far, no such finding has been published. Almost all placebo controlled clinical trials with nutritional supplements have failed, which is why none are FDA-approved.

2. All non-FDA approved nutritional or dietary supplements and homeopathy products are required to include this disclaimer related to any medical or clinical benefits the product is claimed to have:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

In other words, such products do not have to do anything medically useful and they cannot make any such claim. They may elicit a placebo response in some consumers.

US election 2020: The race to take on Trump enters crucial phase

Election season is getting under way and the race to become the Democratic challenger to Donald Trump is hotting up.

Last summer, there were nearly 30 serious candidates vying for the attention of the party's supporters, but fewer than a dozen are still standing.

Joe Biden and Bernie Sanders are the relatively well-known frontrunners, but some of the chasing pack were mostly unknown outside the Washington DC bubble before running.

The group features the usual mix of seasoned politicians, but it also includes a couple of billionaires, two military veterans and a tech entrepreneur.

Here's our rundown of the candidates left in the race, with a take from the BBC's Anthony Zurcher on each.

Who are they? What are their key issues? What's their secret weapon against President Trump? We've got it all covered.

Who will take on Trump in 2020?

For further analysis and a breakdown of the candidates:

https://www.bbc.com/news/world-us-canada-47309795

Capitalism Gone Awry??

My short, albeit “biased” question:

What kind of greedy bastard (or bitch… I’m an Equal Opportunity Employer ;) has a problem with Elizabeth Warren’s “wealth tax” of 2-cents on the dollar for earnings starting over the $50,000,000 mark, per year? (That’s millions, in case you got lost in the zeros.)

Seriously, explain that kind of greed to my curious mind. Thank you.

Trump's Revenge

As noted here a couple of days ago, now that the impeachment is over, the president can turn to important matters such as extracting revenge against people who testified in the House impeachment proceedings and slandering and attacking political opposition and the press. The tyrant kleptocrat wannabe, corrupt-liar Trump, is now free to flex his muscle and wreak his vengeance. In this, he will be aided and abetted by the silence and complicity of the corrupt, spineless GOP in congress.

Major reliable news outlets are reporting that the president has removed two people in revenge for their testimony in the House. An AP article, Payback: Trump ousts officials who testified on impeachment, reports:

“WASHINGTON (AP) — Exacting swift punishment against those who crossed him, an emboldened President Donald Trump ousted two government officials who had delivered damaging testimony against him during his impeachment hearings. The president took retribution just two days after his acquittal by the Senate.

First came news Friday that Trump had ousted Lt. Col. Alexander Vindman, the decorated soldier and national security aide who played a central role in the Democrats’ impeachment case. Vindman’s lawyer said his client was escorted out of the White House complex Friday, told to leave in retaliation for ‘telling the truth.’ ‘The truth has cost Lt. Col. Alexander Vindman his job, his career, and his privacy,’ attorney David Pressman said in a statement. Vindman’s twin brother, Lt. Col. Yevgeny Vindman, also was asked to leave his job as a White House lawyer on Friday, the Army said in a statement. Both men were reassigned to the Army.

Next came word that Gordon Sondland, Trump’s ambassador to the European Union, also was out. ‘I was advised today that the President intends to recall me effective immediately as United States Ambassador to the European Union,’ Sondland said in a statement. The White House had not been coy about whether Trump would retaliate against those he viewed as foes in the impeachment drama. White House press secretary Stephanie Grisham said Thursday that Trump was glad it was over and ‘maybe people should pay for that.’

Alexander Vindman’s lawyer issued a one-page statement that accused Trump of taking revenge on his client. ‘He did what any member of our military is charged with doing every day: he followed orders, he obeyed his oath, and he served his country, even when doing so was fraught with danger and personal peril,’ Pressman said. ‘And for that, the most powerful man in the world — buoyed by the silent, the pliable, and the complicit — has decided to exact revenge.’

News that both Vindman twins had been ousted led Rep. Paul Gosar, R-Ariz., to tweet, ‘The White House is running a two for one special today on deep state leakers.’”

Honesty and truth are under open, direct attack 

The obvious here bears saying it clearly: The president will fire or get rid of you if you work for him but are honest and tell truths he does not want told. That means that the president wants his people to lie for him when he sees it in his personal interest. This is more evidence of the president’s hostility toward inconvenient or embarrassing facts, truths and logic. This deeply immoral aspect of our president cannot be much clearer.

And it is true that he and his hate and rage filled mind has been buoyed by the silent, the pliable, and the complicit, including immoral people like Paul Gosar.

Constitutional Rot vs. Constitutional Crisis

Uncle Fester: Dementia, what a beautiful name. 
Dementia: It means “insanity.” 
Uncle Fester: My name is Fester. It means “to rot.”


Constitutional scholar Jack Balkin (Professor, Yale Law School) wrote a short chapter for the 2018 book Constitutional Democracy in Crisis?, edited by Mark A, Graber et al. Balkin’s chapter 2, Constitutional Crisis and Constitutional Rot, explains the difference between the two concepts. The topic is timely because many people are concerned that the US is in or near a constitutional crisis in view of President Trump’s institutionally corrosive and socially divisive rhetoric and actions. Constitutional rot is a concept that most people are not aware of, while constitutional crisis is mostly misunderstood. Knowing the difference helps put America’s political situation in much better context.

Constitutional crisis defined: Balkin and another scholar Sanford Levinson, have described what a constitutional crisis (CC) is and is not in a constitutional democracy. That is summarized in Balkin’s chapter 2. There are three different kinds of CC. The Type One CC occurs when politicians and/or military officials announce they will not obey the constitution any more. That can happen when politicians and/or military officials refuse to obey a court order. Once refusal to adhere to constitutional rules has occurred, the constitution has failed.

The Type Two CC occurs when the constitution prevents political actors from trying to prevent an impending disaster. This is rare because the courts tend to find ways to allow political actors to avoid disasters. The Type Three CC occurs when many people refuse to obey the constitution. In these scenarios, there can be street riots, or, states or regions try to secede from the nation. This involves "situations where publicly articulated disagreements about the constitution lead political actors to engage in extraordinary forms of protest beyond mere legal disagreements and political protests: people take to the streets, armies mobilize, and brute force is used or threatened in order to prevail."

Balkin goes on to argue that most time when the term CC is used, it is hyperbole. Constitutions rarely break down.

Constitutional rot (CR): By contrast with a CC, CR arises when norms that held power in check fall, partisans play constitutional hardball and fair political competition comes under attack. We are seeing this now. For example, it was constitutional hardball by Mitch McConnell to ignore President Obama’s Supreme Court nomination of Merrick Garland. In CR, politicians favor short-term political gains over long-term damage to the constitutional system. As CR progresses, the political system becomes less democratic. State power becomes less accountable and less responsive to the public, while politicians become more beholden to backers who keep them in power. In essence, the country drifts into oligarchy.

While that is happening, the public loses trust in government and the political system because they have been abandoned: “When constitutional rot becomes advanced, and the public’s trust in government is thoroughly undermined, people turn to demagogues who flatter the public and who stoke division, anger and resentment. Demagogues promise they will restore lost glories and make everything right again. They divert the public’s attention to enemies and scapegoats within and without the republic. They divide the public in order to conquer it. They play on people’s fears of loss of status. They use divisive rhetoric to distract attention, maintain a loyal set of followers, and keep themselves in power. There are always potential demagogues in a republic, but healthy republics restrain their emergence and ascension. When demagogues manage to take power and lead the nation, however, CR has become serious indeed.”

Does any of that sound familiar?

The four horsemen of CR: Balkin describes the four horsemen of CR as (1) loss of trust in government and fellow citizens, (2) polarization that leads to people seeing fellow citizens as enemies of the state[1], (3) increasing economic inequality which foments anger, resentment and a search for scapegoats, and (4) policy disasters such as the Iraq war and the 2008 financial crisis, which undermine public trust in political leadership and constitutional governance. He argues that each one of these tends to feed into the one or more of the other factors. For example, polarization deflects public attention to symbolic and zero-sum conflicts, which allows wealthy interests to entrench their power and foster oligarchy. In turn, that tends to undermine public faith in a government that is drifting away from them and their interests. Rot begets more rot.

Balkin sees hardball politics and attendant destruction of norms of fair politics as leading to “a gradual descent into authoritarian or autocratic politics.”

Regarding our current situation, Balkin sees it like this: “The United States is not currently in a period of constitutional crisis. But for some time--at least since the 1990s--it has been in a period of increasing constitutional rot. The election of a demagogue such as Trump is further evidence that our institutions have decayed, and judging by his presidential campaign and his first year in office, Trump promises to accelerate the corruption.”

It sounds like we are in for more CR and maybe even a deep descent into corrupt, anti-democratic authoritarian politics ad full-blown CC. How gradual the process may be and how far it might go are matters open for debate. It appears to me that the process is moving rather crisply toward a nasty CC, but that is just one person’s opinion.


Footnote:
1. As discussed here before, a January 2018 survey of experts ranked the president as least great of all US presidents, but more importantly for this discussion, they ranked him as the most polarizing.

B&B orig: 5/24/19; DP orig 6/3/19

Getting rid of online comments doesn’t mean the end of dialogue.

 But it does mean the start of civility.

Capital-Star Opinion contributor Lloyd E. Sheaffer, a retired English and Humanities teacher:

https://www.penncapital-star.com/commentary/getting-rid-of-online-comments-doesnt-mean-the-end-of-dialogue-but-it-does-mean-the-start-of-civility-lloyd-e-sheaffer/

“This behavior is a common precursor to socialism/communism.” (AmericanOne)  “Without the comments, how are we ever going to learn the truth?” (Clinocchio)   “Silencing the masses and censoring the intelligent. I’m shocked.”  (Swampman32) 

These are just three of the nearly 900 comments to the announcement that the local news site pennlive.com is discontinuing comments on its website.

“One of the biggest flashpoints for controversy in PennLive’s 20-plus-year history hasn’t been the news. It’s been the comments. Despite the invested time, money and effort, it’s also failed to dampen a pervasive tone of incivility and mean-spiritedness,” Cate Barron, the vice president of content at PA Media Group, PennLive’s parent company explained.

I know what she means.

Prior to being invited to share my musings for the Pennsylvania Capital-Star, my opinion pieces were posted monthly on Pennlive.com and published in The Patriot-News for over six years.

The Capital-Star’s Editor, John L. Micek, then PennLive’s opinion editor, asked me to submit a monthly column, one that reflected my views on matters of social importance.

He sought a community voice to spur conversation and thought. During those years I wrote about, among other matters, school and other academic topics; I expressed myself on the terrific care I received in local hospital after emergency surgery; I spoke against charter and home schooling; I called for citizens to elect servant leaders rather than career politicians and demagogues. Never were my perspectives malicious or designed to engender controversy.

But then came the comments. For instance, I was labeled a Communist (of course) more than a few times. I was accused of never having had a real job because I was a public school teacher. Contrarily, one commenter claimed I knew nothing about public schools and should keep my opinions to myself; in that instance I did break my rule about not replying to anonymous comments and responded that, per my printed bio, I had taught for 33 years in a public high school.

So much for Micek’s hope for thoughtful conversation. Incivility and mean-spiritedness became de rigueur for those posting under daft noms de guerre instead of their real names.

The comments became more vitriolic when my columns took on a more political tone as I wrote about the current narcissistic, fact-challenged president and his policies that grated against my personal values. His minions responded with predictable acrimony. Boorishness reigned from the right, reactionary remarks that academic studies had already predicted would occur.

A study about incivility in online discussions notes, “Our findings also show that these effects [what social scientists have labeled “nasty effects”] are strongest for those who hold strong conservative ideological viewpoints. Thus, our study points to the increased polarization that can occur along existing divisions in society when incivility is present in online comments.”

The effects of online incivility spread beyond the world of digital trolls and flamers.

From a New York Times article on the decreased civility in our nation come these findings: “Unfortunately, we’ve seen a decline in civility and an uptick in incivility,” said Christine Porath, a Georgetown University professor and author of “Mastering Civility,” a book on behavior in the workplace.

“It seems like people are not only reciprocating, but we tend to stoop lower rather than higher. It’s really putting us in an unfortunate place,” Porath said the current harsh climate was affecting people beyond politics, injecting itself into everyday life at home and work. ‘We know that incivility is contagious,” she said. ‘It’s like a bug or virus. It’s not only when people experience incivility, it’s when they see or read about it.”

It seems, then, that the decision to end online comments being made by news sites across the nation might add to the greater health and well-being of their communities and beyond.

Another article about social media and incivility reports, “Civil discourse is a key to a healthy democracy,” said Pam Jenkins, president of Weber Shandwick Global Public Affairs. “The public has identified our civility problem, and it is now up to all of us to encourage the solutions that will make our government and society work better.” The authors offer some suggestions how to encourage more civility in these uncivil times:

• Parents teaching civility to their children
• Making an effort to be civil when treated uncivilly
• Encouraging family, friends and coworkers to be civil
• Voting for political leaders who behave in a civil way
• Committing to one act of civility – say or do something nice – regularly
• Speaking up against, or doing something about, incivility

One point I want to emphasize about this entire issue is that in no case is anyone discouraging genuine, productive discussion or sincere discourse among those with opposing views.

In fact, news sites such as pennlive.com continue to offer numerous ways to for readers to comment on articles and op-eds.

For instance, Barron writes in her article, “Despite this major change, we want to emphasize that we remain eager for your feedback — now more than ever. Readers will still be able to comment on the many stories we post daily on Facebook, Twitter and other social platforms. As always, you can click the byline on any story to email that reporter.”

Micek shares a similar position.

“The Pennsylvania Capital-Star is always open to hearing from its readers. They can reach out to us on our Twitter and Facebook pages, as well as through email,” he told me. “Our parent organization, The States Newsroom Project, made the decision late last year to shutdown online commenting on our articles and commentary pieces. The commenting environment had not only become excessively vitriolic, it was also prone to chronic spam. And because our newsrooms are so small, it was not a productive use of time our effort to moderate offensive posts and to clean out the junk comments. In our year of existence, we’ve loved interacting with readers and supporters across Pennsylvania, and our door is always open to them.”

In my classroom years I always encouraged my students to share diverse ideas, to challenge each others’ views, to consider objectively the value of opposing perceptions. They grew intellectually, and sometimes emotionally or socially, through these respectful exchanges. I am sad that so many of our children and youth are being exposed to rancor and animosity instead of courtesy and graciousness.

Let us all work to exchange ideas and debate important issues with comity rather than hostility.

We can — and must — do better.