Trump's Claims Are Dangerous: COVID-19 & Hydroxychloroquine

Andre Picard
Globe and Mail
Originally published 9 April 20

Here is an excerpt:

The principal argument the President has used in support of hydroxychloroquine is the rhetorical statement: “What do we have to lose?” (He repeated that phrase five times at his Saturday media briefing.) “I’m not a doctor but I have common sense,” Mr. Trump added.

“Common sense” is not evidence. And “what have we got to lose?” is certainly no way to practise medicine – or policy-making for that matter.

Physicians in China started using hydroxychloroquine to treat COVID-19 patients early in the pandemic. There was certainly some logic to this move. The drug has antiviral properties and showed some promise in vitro but that doesn’t mean it will work in vivo.

It remains a desperation drug, something to try when the rest of the very limited armamentarium has been exhausted.

The evidence of benefit in patients is mostly anecdotal, based on highly publicized but scientifically weak studies. Controversial microbiologist Didier Raoult has made wild claims about the effectiveness of hydroxychloroquine but his study, published in the International Journal of Antimicrobial Agents, is little more than anecdotal.

Similarly, Vladimir Zelenko, a small-town doctor in New York State, has gained internet fame promoting a cocktail of three drugs – hydroxychloroquine, the antibiotic azithromycin and zinc sulphate. There is no real evidence for claims that he has cured hundreds of cases of COVID-19, but that hasn’t stopped Mr. Trump from promoting the regimen.

There needs to be proper studies done, with control groups – meaning one group gets the drug(s) and the other does not, and the outcomes are compared. Like it or not, that takes time.

Impatience is not an excuse to make unsubstantiated claims.

The info is here.

N.I.H. Tells Researchers to End Sex Bias in Early Studies

By Roni Caryn Rabin
The New York Times
Originally published May 14, 2014

Amid growing evidence that many drugs are not as effective in women as in men, the National Institutes of Health on Wednesday warned scientists that they must take steps to alter longstanding basic research methods.

The N.I.H. has already taken researchers to task for their failure to include adequate numbers of women in clinical trials. The new announcement is an acknowledgment that this gender disparity begins much earlier in the research process.

Even in the most preliminary stages of investigation, many scientists for decades have tested their theories only in male lab rats or only in male tissues and cells. Now the N.I.H. wants scientists that it funds to include female lab animals and female cell lines.

The entire article is here.

Breaking the Seal on Drug Research

By KATIE THOMAS
The New York Times
Published: June 29, 2013

Here are som excerpts:

For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.

Problems with data about high-profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.

To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.

“This problem has been very well documented for at least three decades now in medicine, with no substantive fix,” said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. “Things have changed almost unimaginably fast over the past six months.”

Much of that change is happening because of what Dr. Goldacre calls an “accident of history.” In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu’s efficacy transformed Dr. Doshi and others into activists for transparency — and turned the tables on drug makers. Until recently, the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn’t.

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Earlier this month, Dr. Doshi opened what he hopes will be a new chapter in his quest for greater understanding of clinical trials. He and several other researchers published what amounted to an ultimatum to drug companies: publish your data, or we’ll do it for you.

The entire story is here.

Four Common Antipsychotic Drugs Found to Lack Safety and Effectiveness in Older Adults

Science Daily
Originally published November 27, 2012

In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications -- schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs.

In a new study -- led by researchers at the University of California, San Diego School of Medicine, Stanford University and the University of Iowa, and funded by the National Institute of Mental Health -- four of the antipsychotics most commonly prescribed off label for use in patients over 40 were found to lack both safety and effectiveness. The results will be published November 27 in The Journal of Clinical Psychiatry.

The study looked at four atypical antipsychotics (AAPs) -- aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) -- in 332 patients over the age of 40 diagnosed with psychosis associated with schizophrenia, mood disorders, PTSD, or dementia.

"Our study suggests that off-label use of these drugs in older people should be short-term, and undertaken with caution," said Dilip V. Jeste, MD, Estelle and Edgar Levi Chair in Aging, Distinguished Professor of Psychiatry and Neurosciences, and director of the Stein Institute for Research on Aging at UC San Diego.

The entire story is here.

Thanks to Tom Fink for this information.

A Recent Study of Atypical Neuroleptics: “The Results of our Study are Sobering”

Sandra Steingard, M.D.
Mad In America
Originally published December 3, 2012


This week, MIA highlighted a recently published study of the four most commonly prescribed neuroleptics.  As noted in the post, the major outcome was that these drugs were not found to be effective or safe.

This important study, co-authored by Dilip Jeste the current president of the American Psychiatric Association, is worth reviewing in greater detail.

The study was modeled to capture clinical practice.  Entry to the study was broad and not limited to a specific diagnostic category.  It is characterized as a study of “older adults” and I admit to some chagrin that this meant anyone over 40.  Diagnoses included schizophrenia, schizoaffective disorder,  and psychosis associated with mood disorder, PTSD or dementia.  It was open to individuals who were either already taking an atypical neuroleptic or had a psychiatrist who was recommending this.

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What was most striking to me is this line from the study: there was

“no significant change in psychopathology with any of the study atypical antipsychotics“

They did not even report the numbers in their report.

The entire information is here.

Thanks to Tom Fink for this information.

If Medications Don’t Work, Why Do I Prescribe Them Anyway?

By Steve Balt, Psychiatrist
Thought Broadcast Blog
Originally posted January 4, 2013

I have a confession to make.  I don’t think what I do each day makes any sense.

Perhaps I should explain myself.  Six months ago, I started my own private psychiatry practice.  I made this decision after working for several years in various community clinics, county mental health systems, and three academic institutions.  I figured that an independent practice would permit me to be a more effective psychiatrist, as I wouldn’t be encumbered by the restrictions and regulations of most of today’s practice settings.

My experience has strengthened my long-held belief that people are far more complicated than diagnoses or “chemical imbalances”—something I’ve written about on this blog and with which most psychiatrists would agree.  But I’ve also made an observation that seems incompatible with one of the central dogmas of psychiatry.  To put it bluntly, I’m not sure that psychiatric medications work.

Before you jump to the conclusion that I’m just another disgruntled, anti-medication psychiatrist who thinks we’ve all been bought and misled by the pharmaceutical industry, please wait.  The issue here is, to me, a deeper one than saying that we drug people who request a pill for every ill.  In fact, it might even be a stretch to say that medications never work.  I’ve seen antidepressants, antipsychotics, mood stabilizers, and even interventions like ECT give results that are actually quite miraculous.

But here’s my concern: For the vast majority of my patients, when a medication “works,” there are numerous other potential explanations, and a simple discussion may reveal multiple other hypotheses for the clinical response.  And when you consider the fact that no two people “benefit” in quite the same way from the same drug, it becomes even harder to say what’s really going on. There’s nothing scientific about this process whatsoever.

And then, of course, there are the patients who just don’t respond at all.  This happens so frequently I sometimes wonder whether I’m practicing psychiatry wrong, or whether my patients are playing a joke on me.  But no, as far as I can tell, I’m doing things right: I prescribe appropriately, I use proper doses, and I wait long enough to see a response.  My training is up-to-date; I’ve even been invited to lecture at national conferences about psychiatric meds.  I can’t be that bad at psychiatry, can I?

The entire blog post is here.

Ghostwritten medical articles called fraud

CBC News

It's fraudulent for academics to give their names to medical articles ghostwritten by pharmaceutical industry writers, say two Canadian law professors who call for potential legal sanctions.

Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues, said Trudo Lemmens, a law professor at the University of Toronto. The integrity of medical research is also harmed by ghostwritten articles, he said.

Ghostwriting is part of marketing that can distort the evidence on a drug, Lemmens said. Industry authors are concealed to insert marketing messages and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analyzing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in Tuesday's issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.

The institutions have divided loyalties, the authors say, which may explain why they've been slow to act. For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

A legal response could act as a powerful deterrent, Stern said.

"Our theory does not depend on the accuracy of the data," Lemmens said in an email. "False representation of authorship is in our view fraud, regardless of the accuracy of the reporting."

Doctors and patients perceive published studies to be independent assessments made by academic experts, the authors noted.

Ghostwritten publications are used in court to support a manufacturer's arguments about a drug's safety and effectiveness, and academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with the publications on their CV, Lemmens said.

The entire story can be found here.