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Science-Based Medicine 101: How To Establish A Source’s Credibility

I thought I’d do a little SBM 101 series for our lay readers. Forgive me if this information is too basic… at least it’s a place to start for those who are budding scientists and critical thinkers. :)

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Which news source do you trust more: The New York Times or The National Enquirer? Which news reporter would you trust more: Charlie Gibson or Jerry Springer? As it turns out, medical journals and science researchers run the gamut from highly credible and respected to dishonest and untrustworthy. So as we continue down this road of learning how to evaluate health news, let’s now turn our attention to pillar number one of trustworthy science: credibility.

In medical research, I like to think of credibility in three categories:

1. The credibility of the researcher: does the researcher have a track record of excellence in research methodology? Is he or she well-trained and/or have access to mentors who can shepherd along the research project and avoid the pitfalls of false positive “artifacts?” Has the researcher published previously in highly respected, peer reviewed journals?

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Posted in: Science and Medicine, Science and the Media

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Why False Positive Results Are So Common In Medicine

Have you ever been surprised and confused by what seem to be conflicting results from scientific research? Have you ever secretly wondered if the medical profession is comprised of neurotic individuals who change their mind more frequently than you change your clothes? Well, I can understand why you’d feel that way because the public is constantly barraged with mixed health messages. But why is this happening?

The answer is complex, and I’d like to take a closer look at a few of the reasons in a series of blog posts. First, the human body is so incredibly complicated that we are constantly learning new things about it – how medicines, foods, and the environment impact it from the chemical to cellular to organ system level. There will always be new information, some of which may contradict previous thinking, and some that furthers it or ads a new facet to what we have already learned. Because human behavior is also so intricate, it’s far more difficult to prove a clear cause and effect relationship with certain treatments and interventions, due to the power of the human mind to perceive benefit when there is none (placebo effect).

Second, the media, by its very nature, seeks to present data with less ambiguity than is warranted. R. Barker Bausell, PhD, explains this tendency:

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Posted in: Science and the Media

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Woosceptibility: A Brief Interview With James Randi

James Randi, perhaps better known as “The Amazing Randi” has spent most of his life performing magic shows. In 1996 he created the James Randi Educational Foundation (JREF) designed to expose the fraudulent claims made by psychics, faith healers, and snake oil salesmen. The ultimate goal of the JREF is to create a new generation of critical thinkers – people who will not be hoodwinked by the aforementioned hucksters.I had the good fortune of interviewing Mr. Randi briefly at the recent conference known as “The Amazing Meeting.” I was eager to pick his brain about human behavior and magical thinking. This is what I learned…

Randi identified certain groups of people who seem to be more susceptible to magical thinking and/or belief in the paranormal. According to him, the top two are:

1. News reporters. Although at first I wasn’t sure if Randi meant that reporters like a good story versus they believe a good story – he told me that in his experience, they were some of the most gullible people on earth. In fact, they were more interested in implausible stories than true ones – and Randi said that the more fantastical his explanation for phenomena, the more likely they were to believe it and write about it.

2. Academics. This surprised me since I assumed that this group would actually be less susceptible. Randi suggested that they are more likely to be taken in because they are single-minded about phenomena. They are over confident in their ability to understand how things work, and when something cannot be explained in their framework, they’re willing to attribute it to the paranormal.

Who are the least susceptible? Children. Why? Because they are simple thinkers, and harder to distract. The art of magic is in distraction of the sophisticated mind. Children tend to be very concrete, so they don’t expect things to happen with hand-waving and flourishes. They keep their eye on the coin (or other item being transferred from hand to hand), and are more likely to know where it is at all times.

To wrap up our short interview, I asked Randi if he could explain why people believe in magic, fantasy, and the paranormal? He responded plainly:

Ultimately it’s not about intelligence or lack thereof. It’s about people not wanting to accept that life is random, suffering is inevitable, and there is no good reason for bad things happening.

What do you make of Randi’s observations?

Posted in: Faith Healing & Spirituality, Health Fraud, Neuroscience/Mental Health

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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Could Francis Collins’ Faith Create Conflicts For His Potential Directorship of NIH?

Francis Collins, M.D., Ph.D., is probably best known for his leadership of the Human Genome Project, though his discoveries of the Cystic Fibrosis, Huntington’s, and Neurofibromatosis genes are also extraordinary accomplishments. Dr. Collins is a world-renowned scientist and geneticist, and also a committed Christian. In his recent best-selling book, The Language Of God, Dr. Collins attempts to harmonize his commitment to both science and religion.

Some critics (such as Richard Dawkins) have expressed reservations about Dr. Collins’ faith, wondering if it might cloud his scientific judgment. Since Collins is rumored to be the most likely candidate for directorship of the NIH, and because I wanted to know if Dawkins et al. had any reason for concern, I decided to read The Language Of God.

First of all, Christians are a rather heterogeneous group – with a range of viewpoints on evolution, science, and the interpretation of Biblical texts. On one extreme there are Christians (often referred to as “young earth creationists” or simply “creationists”) who believe in an absolutely literal interpretation of the Genesis story, and see evolution as antithetical to true faith. Dr. Collins suggests that as many as 45% of Christians may actually be in this camp.
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Posted in: Basic Science, Book & movie reviews, Evolution

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Barriers To Adoption of Science-Based Medicine

I have a confession to make – it’s not easy keeping up with the other “Joneses” on this blog. My colleagues do a terrific job with thoroughly referenced analyses of key issues in medicine – and I sometimes struggle to think of topics that they haven’t already covered in more depth than I can. So today I asked my friends on Twitter if they had any suggestions for this week’s post.

One Twitter respondent asked me for my “perspective on the biggest barriers to better funding and adoption of science- based medicine.” As I contemplated that question, an experience leapt immediately to mind…

I attended a recent press conference held at a major Washington, DC think tank. An all-star cast was assembled, including Senator Baucus and Peter Orszag, to discuss the subject of comparative effectiveness research (CER). The most memorable part of the conference, however, was when one of the CER policy “experts” took the podium and actually said this (I’m going to paraphrase slightly):

The problem with science is that it’s too narrow. We’d have a lot more information to go on if we got rid of the narrow inclusion criteria in clinical trials. The exclusivity is not an irreversible flaw in the method – we just need to open up trials to larger groups of people of all kinds of different backgrounds so we can get better information.

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Posted in: Politics and Regulation

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Counterfeit Drugs: A Growing Global Health Crisis

A resistant strain of bacteria –created by partially effective counterfeit antibiotics – doesn’t need a VISA and passport to get to the U.S.

-    Paul Orhii, National Agency for Food and Drug Administration and Control, Nigeria

I attended a conference in DC yesterday called, “The Global Impact of Fake Medicine.” Although I had initially wondered if homeopathy and the supplement industry would be the subjects of discussion, I quickly realized that there was another world of medical fraud that I hadn’t previously considered: counterfeit pharmaceuticals.

Just as designer goods have low-cost knock-offs, so too do pharmaceuticals and medical devices. Unfortunately, counterfeit medical products are a higher risk proposition – perhaps causing the death of hundreds of thousands of people worldwide each year.

It is difficult to quantify the international morbidity and mortality toll of counterfeit drugs – there have been no comprehensive global studies to determine the prevalence and collateral damage of the problem.  But I found these data points of interest (they were in the slide decks presented at the conference):
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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Will The Real, Silent Majority Please Stand Up – To Oprah and Jenny McCarthy?

Much to my surprise and delight, my recent blog post about Jenny McCarthy’s  “educational” video was picked up by several other blogs and websites, resulting in a small flood of emails applauding my efforts to expose dangerous pseudoscience. I had braced myself for what I assumed would be an onslaught of hate mail (what else would irrational folks do about a sensible warning message?) and found that instead I received a small number of high-fives from advocates and health organizations committed to cutting through the rhetoric and providing accurate information about vaccines. Perhaps the hate is still in the mail?

I began wondering who is in the majority on the issue of vaccines – those who want to study concerns carefully and accept what the science shows, or those who are fixated on blaming vaccines for diseases they don’t cause, despite all evidence to the contrary.

Since the latter are louder than the former, one does tend to feel as if the world has gone a bit nutty. And when celebrities like Oprah Winfrey promote the unfounded anti-vaccine rhetoric of Jenny McCarthy, sensible parents across the country begin to shudder. But when will this shuddering lead to action?
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Posted in: Science and the Media, Vaccines

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Science And The Game Of 20 Questions

An audience member at a recent NYC Skeptics meeting asked me how I handled conflict surrounding strongly held beliefs that are not supported by conclusive evidence. As a dentist, he argued, he often witnessed professionals touting procedure A over procedure B as the “best way” to do X, when in reality there are no controlled clinical trials comparing A and B. “How am I to know what’s right in these circumstances?” He asked.

And this is more-or-less what I said:

The truth is, you probably can’t know which procedure is better. At least, not at this point in history. The beauty of science is that it’s evolving. We are constantly learning more about our bodies and our environment, so that we are getting an ever-clearer degree of resolution on what we see and experience.

It’s like having a blurry camera lens at a farm.  At first we can only perceive that there are living things moving around on the other side of the lens – but as we begin to focus the camera, we begin to make out that the animals are in the horse or cattle family. With further focus we might be able to differentiate a horse from a cow… and eventually we’ll be able to tell if the horse has a saddle on it, and maybe one day we’ll be able to see what brand of saddle it is. Each scientific conundrum that we approach is often quite blurry at the onset. People get very invested in their theories of the presence or absence of cows, and whether or not the moving objects could in fact be horses. Others say that those looking through the camera contradict one another too much to be trusted – that they must be offering false ideas or willfully misleading people about the picture they’re describing.

In fact, we just have different degrees of clarity on issues at any given point in time. This is not cause for alarm, nor is it a reason to abandon our cameras. No, it just gives us more reason to continue to review, analyze, and revise our understanding of the picture at hand. We should try not to make more out of photo than we can at a given resolution – and understand that contradicting opinions are more likely to be evidence of insufficient information than a fundamental flaw of the scientific method.
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Posted in: Science and Medicine

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