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The legal establishment of Winkler County, Texas conspires to punish whistle blowing nurses

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
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Posted in: Medical Ethics, Politics and Regulation

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Yes, Jacqueline: EBM ought to be Synonymous with SBM

“Ridiculing RCTs and EBM”

Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or efficacy of a treatment—other than to declare the treatment unproven.

A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post entitled #NotSoFunny – Ridiculing RCTs and EBM.

Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

Jacqueline had this to say about the parachute article:

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.

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Posted in: Clinical Trials, Medical Academia, Medical Ethics, Science and Medicine

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Energy Healing In Maryland

I had an interesting conversation with a reporter today. She called me to get a “medical/skeptical” counterpoint for an article she is preparing on energy healing. Although I don’t know if she’ll faithfully represent what I had to say, we had an entertaining exchange and so I decided to capture the essence of it here. I’m curious to see which parts of our conversation remain in her final article, due out on February 19th. (Stay tuned for that).

Apparently a local hospital in Maryland is now offering nurse-guided therapeutic touch and Reiki healing for inpatients. She decided to interview the practitioners involved, and turned to me for comment. I did not have the benefit of preparing in advance or having references handy – so I gave it my best shot. I’d be interested to know how you might have responded differently.

1. Is there any scientific evidence that energy healing works? (more…)

Posted in: Energy Medicine, Science and the Media

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Study shows antidepressants useless for mild to moderate depression? Not exactly.

As Harriet Hall has written (http://www.sciencebasedmedicine.org/?p=353), psychiatry bashing is a popular media sport. There seems to be a bias against treatment of psychiatric disabilities, and a common claim is that antidepressants are no better than placebo. The New York Times illustrated both the perpetuation of the myth that antidepressants are ineffective, and the increasing and disturbing tendency of major media organizations to confuse the wholesale acceptance of medical press releases with medical journalism.

In Popular Drugs May Help Only Severe Depression The New York Times credulously publicized the findings of a recent study that claimed to show that antidepressants are ineffective in treating mild and moderate depression. Yes, that’s what the study showed, but the study itself is so limited, so fraught with problems, and the conclusions are so misleading that the article is a terrible disservice.

Before we consider what the study showed, let’s think about what kind of evidence we’d need to conclude that antidepressants don’t work.

First, although there are different types of antidepressants, the term used colloquially refers to antidepressants of a specific type, SSRI’s or selective serotonin reuptake inhibitors. There are other, older types of antidepressants that are rarely used today because of their unpleasant side effects. Hence any study that claims to show that “antidepressants” are ineffective, must look at SSRIs.

Second, there are literally thousands of studies of SSRIs, and it would be helpful to aggregate the results. Aggregating results can be done in a type of paper known as metaanalysis. Metaanlysis adds the results of multiple similar studies to find trends that might not be apparent in individual small studies. But a metaanlysis is subject to several important limitations that must always be considered. The most important limitation is that the authors of the metaanalysis choose the papers to be included. Bias can be introduced by examining only papers that have a desired outcome; that can be accomplished by restricting the inclusion criteria in arbitrary ways.

Let’s look at the study, Antidepressant Drug Effects and Depression Severity. According to the abstract:
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Posted in: Science and Medicine

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The Lancet retracts Andrew Wakefield’s article

In 1998 Andrew Wakefield and 11 other co-authors published a study with the unremarkable title: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Such a title would hardly grab a science journalist’s attention, but the small study sparked widespread hysteria about a possible connection between the mumps-measles-rubella (MMR) vaccine and autism spectrum disorder (ASD).

The study itself has not stood the test of time. The results could not be replicated by other labs. A decade of subsequent research has sufficiently cleared the MMR vaccine of any connection to ASD. The lab used to search for measles virus in the guts of the study subjects has been shown to have used flawed techniques, resulting in false positives (from the Autism Omnibus testimony, and here is a quick summary). There does not appear to be any association between autism and a GI disorder.

But it’s OK to be wrong in science. There is no expectation that every potential finding will turn out to be true – in fact it is expected that most new finding will eventually be found to be false. That’s the nature of investigating the unknown. No harm no foul.

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Posted in: Science and Medicine

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Do Cell Phones Prevent Alzheimer’s?

Scientific studies are not meant to be amusing, but I laughed out loud when I heard about this one. After all the concern about possible adverse health effects from cell phone use, this study tells us cell phone use can prevent Alzheimer’s, treat Alzheimer’s, and even improve cognitive function in healthy users.

They studied transgenic mice programmed by their genes to develop Alzheimer’s-like cognitive impairment; they used a group of non-transgenic littermates as controls. For an hour twice daily over several months they exposed the entire mouse cage to EMF comparable to what is emitted by cell phones. They tested cognitive function with maze tests and other tasks that are thought to measure the same things as human tests of cognitive function. The authors claim to have found striking evidence for both protective and disease-reversing effects. (more…)

Posted in: Neuroscience/Mental Health

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Success in the fight against childhood diarrhea

Rotavirus is the world’s most common cause of severe childhood diarrhea.  In the U.S. alone, rotavirus disease leads to around 70,000 hospitalizations, 3/4 million ER visits, and nearly half-a-million doctor office visits yearly.  But it rarely causes death.

The same is not true for the developing world.  Rotavirus disease is estimated to kill around a half-million children a year world wide.   Finding a way to mitigate this is an active public health concern, with the World Health Organization specifically recommending rotavirus vaccinations in areas where the virus has a significant public health impact.

Rotavirus causes a severe diarrheal illness. It is passed via a fecal-oral route, meaning that contaminated food, surfaces, and water can all be sources.   In developed countries like the US, rotavirus disease is unpleasant and inconvenient.  Since rotavirus spreads more readily in areas without access to clean water and medical care, it takes a greater toll in these areas, and children afflicted are at risk of death due to dehydration.  The US has seen a decline in rotavirus disease in the last few years, an effect that appears to be due to increased vaccination and a herd immunity effect.

Given the large number of pediatric rotavirus deaths in developing countries, the World Health Organization (WHO) has made vaccination a priority. Two articles in this week’s New England Journal of Medicine report on the progress of the fight against rotavirus.

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Posted in: Science and Medicine, Vaccines

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The General Medical Council to Andrew Wakefield: “The panel is satisfied that your conduct was irresponsible and dishonest”

BACKGROUND

In my not-so-humble opinion, the very kindest thing that can be said about Andrew Wakefield is that he is utterly incompetent as a scientist. After all, it’s been proven time and time again that his unethical and scientifically incompetent “study” that was published in The Lancet in 1999 claiming to find a correlation between vaccination with MMR and autistic regression in autistic children with bowel symptoms was at best dubious science and at worst fraudulent. For one thing, as investigative journalist Brian Deer found, Wakefield was in the pocket of trial lawyers, who were interested in suing vaccine manufacturers, to the tune of £435,643 in fees, plus £3,910 expenses beginning even before his infamous “study” started accruing patients. Even though the study itself used the typical careful and relatively neutral language that we all expect from scientists, Wakefield himself was not nearly so circumspect. In a press conference announcing the Lancet study, he said:

He told journalists it was a “moral issue” and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella.

“Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,” Dr Wakefield said at the time.

And so began one of the most contentious health stories of this generation.

Wakefield’s Lancet paper, even interpreted as sympathetically as possible, concluded nothing that justified such language. Yet his rhetoric, along with sensationalistic and credulous British journalists, ignited a firestorm of fear over the MMR that has not yet subsided now, over a decade later. Vaccination rates plummeted in the UK, and measles, a disease once thought to be under control, has surged back and become endemic again. It is a feat that Jenny McCarthy and Jim Carrey appear to be trying to replicate right here in the U.S. with their wonderfully Orwellian-named Green Our Vaccines activism and ceaseless promotion of anti-vaccine messages.

More recently, at the Autism Omnibus hearings, we learned from a world expert in the polymerase chain reaction, Dr Stephen Bustin, that the techniques used in the laboratory running PCR on the clinical specimens from Wakefield’s clinical trial were so shoddy, so devoid of routine controls necessary in any PCR experiment, that the measles sequences reported as amplified in Wakefield’s followup to his Lancet study were false positives derived from plasmids with measles sequences in them contaminating the laboratory. Then, in late 2008, Mady Hornig and colleagues at Columbia University published an attempted replication of Wakefield’s study. They failed. There was no association between vaccination with MMR and autistic regression, nor could Hornig find any evidence that measles in the gut was any more common in the autistic children studied than in the neurotypical controls. This study was particularly devastating to Wakefield because it was carried out by a researcher who had previously been sympathetic to the myth that vaccines cause autism, as evidenced by her infamous “rain mouse” study and, even more close to home, using the same laboratory that had performed Wakefield’s PCR, which had apparently cleaned up its act in the years following its work on Wakefield’s specimens.

When it comes to the science, there is no doubt. No reputable scientist has been able to replicate Wakefield’s findings, and there is a remarkable convergence and agreement of findings of major studies looking for a correlation between MMR vaccination and autism: There ain’t one. Indeed, closing out 2009 was the publication of yet another study that failed to find any correlation between MMR and autism, or, as I put it at the time, yet another nail in the coffin of the myth that the MMR vaccine causes autism. Andrew Wakefield’s repeated claims that the MMR can cause or “trigger” autism in some children is deader than dead as a scientific hypothesis and without a basis in scientific or clinical evidence. True, Wakefield tried to counter with a horribly unethical and badly designed primate study that seemed custom-designed to be used in court rather than in the court of scientific inquiry. It didn’t help and only made Wakefield’s Thoughtful House, Wakefield’s Fortress of Solitude in Texas to which he retreated in the wake of the revelations about his conduct, look even worse. Even a credulously “balanced” TV story by NBC news and Matt Lauer couldn’t hide the dubiousness nature of what goes on there.

Of course, while the science refuting Wakefield’s pseudoscience and evidence showing Wakefield to be incompetent and unethical continued to roll in, a little less than a year ago, it got even worse for him. Brian Deer reported that Wakefield very well may have engaged in scientific fraud in the “research” (and I do use the term loosely) that led to the publication of his Lancet paper in 1999. Through it all, the General Medical Council began an inquiry into whether Andrew Wakefield behaved unethically in the “research” that resulted in his 1999 Lancet report. It should be pointed out that the investigation of the GMC began before Deer’s latest revelation of potential fraud; rather it was far more concerned with how Wakefield ran his study and recruited patients. Nonetheless, the revelations nearly a year ago about Wakefield’s playing fast and loose with research methodology could not help but contribute to the sense that the Good Ship Wakefield had been torpedoed below the water line and was taking on water fast.

As the investigation and hearings wound on seemingly endlessly for two and a half years, Wakefield’s supporters intermittently waged an increasingly histrionic and ridiculous propaganda offensive to try to preemptively discredit the GMC’s findings. As it became clear that finally after all this time the GMC was on the verge of announcing its ruling, I noticed that the anti-vaccine crank blog Age of Autism was ramping up an increasingly bizarre and unhinged last minute propaganda campaign, complete with reposting a hilariously inapt post by Mark Blaxill comparing Wakefield to Galileo and the GMC to the Inquisition, complete with references to Stalin and Mao (I suppose I should be relieved that Blaxill refrained from playing the Hitler card); a defense of “that paper” by Wakefield himself; claims that parent witnesses had been “silenced” at the GMC hearings; and a whole series of posts by John Stone trying to discredit the GMC.

And then on Thursday, the GMC ruled.

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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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The Tamiflu Spin

I will start, for those of you who are new to the blog, with two disclaimers.

First, I am an infectious disease doctor. It is a simple job: Me find bug. Me kill bug. Me go home. I spend all day taking care of patients with infections. My income comes from treating and preventing infections. So I must have some sort of bias, the main one being I like to do everything I can to cure my patients.

Second, in 25 years I have, to my knowledge, accepted one thing from a drug company. The Unisin (that’s how I spell it) rep, upon transfer from my hospital, sent me a Fleet enema with a Unisin sticker on it. I show it proudly to all who enter my office. I do not even eat the drug company pizza at conference, and I cannot begin to tell you painful that is.

As we leave (I hope) the H1N1 season and enter seasonal flu season, there has been a flurry of articles, originating in the British Medical Journal , questioning whether oseltamivir is effective in treating influenza. The specific complaint at issue is whether or not oseltamivir prevents secondary complications of influenza like hospitalization and pneumonia. Although you wouldn’t guess that was at issue from the reporting.  As always, there is what the data says, what the abstract says, what the conclusion says, and what other people say it says.  Reading the medical literature is all about blind men and elephants.

There is, evidently, going to be an investigation by the European Union Council of Europe  into whether or not the H1N1 pandemic was faked to sell more oseltamivir. Sigh.
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health, Science and the Media

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Reflexive doubt

Those of us who study, practice and write about medicine cherish the hope that explaining the science behind medicine (or the lack of science behind “alternative” treatments) will promote a better understanding of medicine. Certainly, I would not bother to write about medical topics if I did not believe that promoting science based medicine would lead to increased understanding of medical recommendations and decreased gullibility in regard to “alternative” remedies. Nonetheless, lack of scientific knowledge is not the only reason for the current popularity of “alternative health. Indeed, many advocates and purveyors of “alternative” health are impervious to the scientific evidence. What else might be going on?

Belief in “alternative” medicine is a complex social phenomenon. Like any complex social phenomenon, the explanation cannot be reduced to a simple answer. But I would argue that there is an important philosophical component, developed by and promoted by advocates of “alternative” health. That philosophical component is the rise of reflexive doubt. Simply put, among a significant segment of society, it has become a badge of honor to question authority.

As an obstetrician, I am most familiar with its expression among childbirth activists. They recognize that many people hold the common sense belief that modern obstetrical practice has made birth safer, and have worked ceaseless at undermining this common sense view. Craig Thompson, a professor of marketing, has examines this tactic in his paper What Happens to Health Risk Perceptions When Consumers Really Do Question Authority?:
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