Voltaren (diclofenac) gives you heart attacks -- or does it?

Alternative U.S. brand names: Cambia, Cataflam, Zipsor, Zorvolex.

Between 1970 and 1990, I spent 20 years energetically involved in psychological research, with over 200 papers published in the academic journals to show for it eventually.  I stopped doing it and turned to studies of history instead when I became convinced that I was just about the only one doing serious psychological research.  I concluded that almost all of my colleagues were just playing clever games.  They were routinely failing to take the basic methodological precautions -- such as random sampling -- that that would enable their results to have any degree of generalizability.

Now many years later that conclusion has been resoundingly confirmed by the "replication crisis" -- the finding that up to 70% of the findings from psychological research failed to show up again when the relevant research was repeated, which was a complete blow to any claims of generalizability for the research findings concerned.

From quite early on, however, I had always had an interest in medical research.  I assumed that with the stakes being higher there the level of caution in the research would be better.  I even contributed a few papers to the medical literature myself.  And from 2005 to 2014  I ran a blog that took critical looks at the latest medical research.  I again found what I had found in psychological research -- a great lack of the precautions which would give you any confidence in the findings.  In fact, psychological research seemed more robust, in that larger effect sizes were generally demonstrated.  The tiniest effect in medical research seems to generate vast claims.  And the replication crisis has hit medical research too -- confirming that most medical findings are not representative of reality either.

And I am afraid that the latest piece of research (below) that I look at is just as hopeless. The authors did a lot of work and had available an excellent body of data but they took almost no methodological precautions whatever.  For epidemiological research to be assigned any confidence, alternative explanations for its correlations have to be ruled out.  That can never be conclusively done but reasonable confidence can be reached.  And at a minimum, the Big Five personality variables have to be controlled for plus the big seven demographic variables (Race, sex, age, education, income, IQ and self-assigned social class).  Any one of those factors can intrude into the findings.

Needless to say, I know of NOT ONE piece of medical research which has used all those controls.  One might have hoped that many studies would at least have incorporated controls for the big two demographics -- Income (where poverty has wide-ranging negative effect on health) and IQ (where high IQ has wide-ranging positive effects on health).  I know of only one study where those two variable were considered -- as part of a wide range of demographic variables. That study found that IQ accounted for more of the variance than all of the rest of the demographics put together.  So the importance of basic controls is beyond dispute.

The study below is also epidemiological.  It is an "emulated trial design" so displayed some caution but is almost totally lacking in real controls.  And, as such, one or more pesky "third" factors could have intruded into the results. The authors seem to have been so excited by the wonderful statistics made available to them by the authoritarian Danish state, that they abandoned basic caution.  Not even demographic controls seem to have been applied.

The issue with this study, as with many epidemiological studies, is to ask WHO it was who fell into the target group.  WHY did some people take Voltaren while other people took other drugs?  What put people into the category of Voltaren users?  Were they, for instance, poor people?  The study authors are silent on such questions.  Had they showed a reasonable level of research caution, they would at least have looked at the demographics for Voltaren use.  Had they found that Voltaren users were mostly poor people, we could have concluded that the study was just one of many which routinely show poor people to have worse health.  The absence of such information means, I am sorry to say, that the results are uninterpretable.

I know nothing about how Voltaren is perceived in Denmark and who takes it.  My only stay in Denmark lasted only for a matter of hours.  But I can offer an hypothesis for what lay behind the study results below based on my knowledge of how Voltaren is perceived in Australia, where I happily live.

And a crucial (and correct) thing that everybody tells you here  is that you cannot use Voltaren for much more than a week without risking an upset stomach.  And so good middle class people like me observe that warning. If we take it at all we take it only briefly.  But medical warnings often go in one ear and out the other, particularly -- you guessed it -- among poor people.  So I guess that Voltaren is used at some sort of conventional rate by incautious people, whereas more cautious (smarter?) people use other drugs.

So I suspect that the bad health outcomes in Voltaren users reflect the characteristics of its users rather than the characteristics of the drug.  There is no way of separating the two interpretations


Diclofenac use and cardiovascular risks: series of nationwide cohort studies

Morten Schmidt et al.

Abstract

Objective: To examine the cardiovascular risks of diclofenac initiation compared with initiation of other traditional non-steroidal anti-inflammatory drugs, initiation of paracetamol, and no initiation.

Design: Series of 252 nationwide cohort studies, each mimicking the strict design criteria of a clinical trial (emulated trial design).

Setting: Danish, nationwide, population based health registries (1996-2016).

Participants: Individuals eligible for inclusion were all adults without malignancy; schizophrenia; dementia; or cardiovascular, kidney, liver, or ulcer diseases (that is, with low baseline risk). The study included 1 370 832 diclofenac initiators, 3 878 454 ibuprofen initiators, 291 490 naproxen initiators, 764 781 healthcare seeking paracetamol initiators matched by propensity score, and 1 303 209 healthcare seeking non-initiators also matched by propensity score.

Main outcome measures: Cox proportional hazards regression was used to compute the intention to treat hazard ratio (as a measure of the incidence rate ratio) of major adverse cardiovascular events within 30 days of initiation.

Results: The adverse event rate among diclofenac initiators increased by 50% compared with non-initiators (incidence rate ratio 1.5, 95% confidence interval 1.4 to 1.7), 20% compared with paracetamol or ibuprofen initiators (both 1.2, 1.1 to 1.3), and 30% compared with naproxen initiators (1.3, 1.1 to 1.5). The event rate for diclofenac initiators increased for each component of the combined endpoint (1.2 (1.1 to 1.4) for atrial fibrillation/flutter, 1.6 (1.3 to 2.0) for ischaemic stroke, 1.7 (1.4 to 2.0) for heart failure, 1.9 (1.6 to 2.2) for myocardial infarction, and 1.7 (1.4 to 2.1) for cardiac death) as well as for low doses of diclofenac, compared with non-initiators. Although the relative risk of major adverse cardiovascular events was highest in individuals with low or moderate baseline risk (that is, diabetes mellitus), the absolute risk was highest in individuals with high baseline risk (that is, previous myocardial infarction or heart failure). Diclofenac initiation also increased the risk of upper gastrointestinal bleeding at 30 days, by approximately 4.5-fold compared with no initiation, 2.5-fold compared with initiation of ibuprofen or paracetamol, and to a similar extent as naproxen initiation.

Conclusions: Diclofenac poses a cardiovascular health risk compared with non-use, paracetamol use, and use of other traditional non-steroidal anti-inflammatory drugs.

SOURCE 

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Leftism as a Secular Religion

Dennis Prager

One of the most important books of the 20th century—it remains a best-seller 59 years after it was first published—is “Man’s Search for Meaning” by Viktor Frankl.

Marx saw man’s primary drive as economic, and Freud saw it as sex. But Frankl believed—correctly, in my opinion—that the greatest drive of man is meaning.

One can be poor and chaste and still be happy. But one cannot be bereft of meaning and be happy—no matter how rich or how sexually fulfilled one may be.

The greatest provider of meaning for the vast majority of human beings has been religion. In the West, Christianity (and on a smaller scale, Judaism) provided nearly all people with the Bible, a divine or divinely inspired text to guide their lives; a religious community; answers to life’s fundamental questions; and, above all, meaning: A good God governs the universe; death does not end everything; and human beings were purposefully created.

In addition, Christianity gave Christians a project: Spread the Good News, and bring the world to Christ. And Judaism gave Jews a project: Live by God’s laws of ethics and holiness and be “a light unto the nations.”

All this has disappeared for most Westerners. The Bible is regarded as myth, silly at best, malicious at worst—there is no God, certainly not the morality-giving and judging God of the Bible; there is no afterlife; human beings are a purposeless coincidence with no more intrinsic purpose than anything else in the universe. In short: This is all there is.

So, if the need for meaning is the greatest of all human needs and that which supplied meaning no longer does, what are millions of Westerners supposed to do?

The answer is obvious: Find meaning elsewhere. But where? Church won’t provide it. Nor will marriage and family—increasingly, secular individuals in the West eschew marriage, and even more do not have children. It turns out, to the surprise of many, that marriage and children are religious values, not human instincts.

In the West today, love and marriage (and children) go together like a horse and a carriage for faithful Catholics, Orthodox Jews, religious Mormons, and evangelical Protestants—not for the secular. I know many religious families with more than four children; I do not know one secular family with more than four children (and the odds are you don’t either).

The answer to the great dearth of meaning left by the death of biblical religion in the West is secular religion. The first two great secular substitutes were communism and Nazism. The first provided hundreds of millions of people with meaning; the latter provided most Germans and Austrians with meaning.

In particular, both ideologies provided the intellectual class with meaning. No groups believed in communism and Nazism more than intellectuals. Like everyone else, secular intellectuals need meaning, and when this need was combined with intellectuals’ love of ideas (especially new ideas—”new” is almost erotic in the power of its appeal to secular intellectuals), communism and Nazism became potent ideologies.

With the fall of communism and the awareness of the extent of the communist mass murder (about 100 million noncombatants) and mass enslavement (virtually all individuals in communist countries—except for Communist Party leaders—are essentially enslaved), communism, or at least the word “communism,” fell into disrepute.

So, what were secular intellectuals to do once communism became “the god that failed”?

The answer was to create another left-wing secular religion. And that is what leftism is: a secular meaning-giver to supplant Christianity. Left-wing religious expressions include Marxism, communism, socialism, feminism, and environmentalism.

Leftism’s guiding principles—notwithstanding the principles of those Christians and Jews who claim to be religious yet hold leftist views—are the antitheses of Judaism and Christianity’s guiding principles.

Judaism and Christianity hold that people are not basically good. Leftism holds that people are basically good. Therefore, Judaism and Christianity believe evil comes from human nature, and leftism believes evil comes from capitalism, religion, the nation-state (i.e. nationalism), corporations, the patriarchy, and virtually every other traditional value.

Judaism and Christianity hold that utopia on Earth is impossible—it will only come in God’s good time as a Messianic age or in the afterlife. Leftism holds that utopia is to be created here on Earth—and as soon as possible. That is why leftists find America so contemptible. They do not compare it to other nations but to a utopian ideal—a society with no inequality, no racism, no differences between the sexes (indeed, no sexes), and no greed in which everything important is obtained free.

Judaism and Christianity believe God and the Bible are to instruct us on how to live a good life and how the heart is the last place to look for moral guidance. Leftists have contempt for anyone who is guided by the Bible and its God, and substitute the heart and feelings for divine instruction.

There may be a clash of civilizations between the West and Islam, but the biggest clash of civilizations is between the West and the left.

SOURCE

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Democrat-led cities now "Third world"

AGEING and defunct infrastructure in some of America’s cities has lead to a lack of basic services, leaving residents in what some have described as “third world” conditions.

About 50,000 Detroit public school students across 106 schools will start the school year this week without access to flowing drinking water from taps and bubblers after the discovery of elevated levels of lead or copper in the water supply.

It is the latest setback in the state of Michigan which is already dealing with the consequences of contaminated tap water in Flint and other communities.

With the taps turned off, Detroit students and staff will be relying on bottled water that will cost about US$200,000 over two months, after which the district will probably seek bids for a longer-term contract, said Detroit Public Schools Superintendent Nikolai Vitti.

Given the problems in other parts of the state, some students have long avoided the public water fountains. “There has been an undertone of not trusting the water to begin with,” Mr Vitti told The Associated Press.

The old plumbing and water infrastructure is decaying, becoming dangerous and local cash-strapped governments are struggling to find a solution.

Detroit is not the first major school district to switch to bottled water. The 49,000 student district in Portland, Oregon, turned off its fixtures in 2016 after a scandal over high levels of lead in the water at almost every school — a problem that took two years to fix.

Water at most schools in the 80,000-student Baltimore districts have been shut off for more than a decade.

Last year, Detroit mother LeeAndria Hardison, 39, saw brown water coming from fountains at the school attended by her teenage son.  “I’ve been sending water to school every day with his name on it — five bottles of water in a cooling pack,” she said. “He was only allowed to drink that water.”

The entities that provide and distribute Detroit’s drinking water — the Great Lakes Water Authority and the Detroit Water and Sewerage Department — said it meets and surpasses federal and state standards, and the district’s problems are due to ageing plumbing.

In response to a Reuters story about the water crisis in Detroit, one US resident whose Twitter profile describes her as living in Nashville, expressed dismay at her country. “WTF is wrong with country? We give tax cuts to the rich that explode the deficit & in Detroit we have kids in schools with no water. We are becoming a third world country. The greed is mind boggling,” she wrote on Twitter.

She is far from the only one to make the third world comparison.  Actor Alyssa Milano shared a Washington Post story about Detroit schools turning off their potentially dangerous water and was met with comments of equal anger from social media users.

“Corrupt and incompetent Democratic leadership for generations has turned the city of Detroit into a third world sh**hole,” replied a man from Ohio.

In Flint, Michigan, residents have been dealing with the issue of toxic water for more than four years.

The consequences of the problem are laid bare in a new book by journalist Anna Clark titled The Poisoned City: Flint’s Water and the American Urban Tragedy. “America is built on lead. Networks of ageing pipes made from the bluish-grey metal bring water into millions of US homes,” she wrote. “But when lead, a poison to the nervous system, gets into drinking water — as happened in Flint, Michigan — the heavy metal can cause irreparable harm.”

In the US, only eight states require lead-in-water testing in schools and Michigan is not among them.

Stephanie Chang, a Detroit Democrat, said the inaction is disappointing given the serious health consequences of being exposed to lead. “It only makes sense to test water on a regular basis in our schools and in childcare centres and in other places where there are vulnerable populations,” she said.

SOURCE

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For more blog postings from me, see  TONGUE-TIED, EDUCATION WATCH INTERNATIONAL, GREENIE WATCH,  POLITICAL CORRECTNESS WATCH, AUSTRALIAN POLITICS, and Paralipomena (Occasionally updated),  a Coral reef compendium and an IQ compendium. (Both updated as news items come in).  GUN WATCH is now mainly put together by Dean Weingarten. I also put up occasional updates on my Personal blog and each day I gather together my most substantial current writings on THE PSYCHOLOGIST.

Email me  here (Hotmail address). My Home Pages are here (Academic) or  here (Pictorial) or  here  (Personal)

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