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Do you have low T?

If you google “low testosterone” you’ll see lots of ads for testosterone replacement.  Some are from pharmaceutical companies that sell testosterone, others from obvious snake-oil salesmen.

Both types of ads list vague sets of symptoms, encourage you to believe that they are pathologic, and want to sell you something to make you better.  For example, the pharmaceutical company Solvay gives you a handy guide for speaking to your doctor, and a quiz to see if you have “low T”.  The quiz asks some questions that may be useful, but also asks very general questions about your sense of well being, and includes this gem:

I don’t feel sick, I just don’t feel like myself anymore. Could I have Low T?

The ad then gives this advice:

Because Low T signs and symptoms may not be clear and apparent, they may seem to be a normal part of aging or assumed to be caused by other health conditions. But talk to your doctor if you have symptoms of Low T. And ask to get tested. All it takes is a simple blood test that can be done during a routine checkup. If you do have Low T, your doctor may recommend treatments that can help bring testosterone up to normal levels and keep them there.

If you have diabetes, you should ask your doctor for a Low T test. The Endocrine Society recommends that all men with type 2 diabetes have their testosterone levels checked. Patients who have been diagnosed with diabetes have an increased chance of also having Low T.

Let’s step back for a moment.  What is being claimed is that low testosterone levels in males is a common cause of certain symptoms, and that testosterone replacement therapy can alleviate these symptoms.  To evaluate this claim from the perspective of science-based medicine, we need to ask specific questions. (more…)

Posted in: Science and Medicine

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Some Flu Vaccine Updates

It is always flu season somewhere in the world. As Australia’s flu season comes to a close, we are getting ready for ours in the Northern Hemisphere. This is a good time to start thinking about getting the flu vaccine, and as always there is a lot of flu vaccine news to sort through.

Mark Crislip has already reviewed the evidence for the efficacy of the seasonal flu vaccine. Like most questions in medicine, the evidence is deceptively complex, and Mark does an excellent job of sorting through it, so I won’t repeat it here.

This year the H1N1 pandemic flu virus will be incorporated into the seasonal flu vaccine, so there will not be two separate vaccines as there was last year. H1N1 remains the dominant strain of seasonal flu, and as predicted the pandemic has simply been incorporated into the seasonal flu pattern.

Here are some updates on flu vaccine news – first the good news:

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Posted in: Science and Medicine, Vaccines

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I’m not worthy! I’m not worthy! (For the Lorne Trottier Public Science Symposium)

Trottier Symposium 2010

In two weeks, yours truly will be participating in the 2010 Lorne Trottier Public Science Symposium at McGill University in Montreal. This year, the theme is Confronting Pseudoscience: A Call to Action. I’ll be speaking with Ben Goldacre and Michael Shermer on Monday, October 18 from 5 to 7 PM on the Threat of Pseudoscience. On Tuesday, October 19, the ever-amazing Randi will speak on investigating paranormal claims. Unfortunately, the organizers couldn’t get Randi on the same stage with us because he couldn’t make it to Montreal from TAM London in time for Monday night; so this is the next best thing. Randi deserves the stage to himself anyway.

Obviously, I can’t wait, although I must admit that I’m rather nervous. To share the stage with Michael Shermer and Ben Goldacre and to get to hang out with them plus Randi, well, that’s more than I could have hoped for or imagined. It leaves me feeling like Wayne in this clip, with Shermer, Goldacre, and Randi as Alice Cooper (very appropriate, given Randi’s history of having done the effects for Alice Cooper’s stage show back in the 1970s):

So, if you happen to be in the Montreal area or can get there on October 18 and/or 19, come on over to McGill. It’ll be a rousing good skeptical time. I don’t yet know what Ben Goldacre and Michael Shermer will be discussing, but I’ll be speaking about cancer quackery (although I probably won’t be able to resist a brief commentary on quackademic medicine). I’ll also be on Dr. Joe’s radio show on CJAD 1010.

Posted in: Announcements, Science and Medicine

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When (Anti-Vax) Politics Intrudes

Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.

Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.

Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.

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Posted in: Public Health, Science and Medicine, Vaccines

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Short Attention Span SBM

The bar on this blog is set high. The entries are often complete, with no turn left unstoned. Yet, not every topic needs the full monty with every post. The blog has extensive evaluations on many topics, and new medical literature doesn’t require another complete analysis. Many new articles add incrementally to the literature and their conclusions need to be inserted into the conversation of this blog, like a car sliding into heavy traffic. My eldest son just received his driver’s license, and car metaphors are on my mind. As are crash metaphors and insurance metaphors.

So in response to this need, a need only recognized by me, I give you Short Attention Span SCAM. Occasionally I will summarize a few recent studies and their key points as they relate to prior posts at SBM.

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Posted in: Acupuncture, Herbs & Supplements, Science and Medicine, Vaccines

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Christiane Northrup: more bad medicine

A question popped up on facebook the other day about Dr. Christiane Northrup, an OB/GYN who has been a frequent guest on Oprah.  I hadn’t heard much about her for a while, but a foul taste still lingered from previous encounters with her work.  So I went over to her website to see what fare she’s currently dishing up.  It isn’t pretty. (Cached version).

This month’s news item is titled “Angst Over Not Vaccinating Children is Unwarranted.” Regular readers will be expecting a typical antivax screed, and they won’t be disappointed, but I’d like to highlight some of the propaganda techniques Northrup uses to advance her dangerous lies.

She begins her story with this:

In June, 2010 there was an outbreak of pertussis (whooping cough) in California that reporters were calling the worst epidemic in 50 years.

There are two problems with this opening sentence.  The outbreak is ongoing, and it’s not “reporters” who are calling it “the worst epidemic in 50 years.”  The California Department of Public Health reports that the state has seen the largest number of cases in the last 55 years.  Of course the state was much smaller 55 years ago, so for comparison they give us an incidence rate: 10.3 cases/100,000 in 2010, the highest rate in 48 years (when the rate was 10.9 cases/100,000).  So far in California, there have been 9 deaths.  All of the deaths were in babies eight of whom were unvaccinated and one of whom had been vaccinated only days before becoming ill, not early enough to develop immunity.
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Posted in: Science and Medicine

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CFLs, Dirty Electricity and Bad Science

Governments and environmental advocates are promoting compact fluorescent lightbulbs (CFLs) as a way of reducing electricity use, saving money, and reducing our carbon footprint. CFLs are not a perfect technology – when turned on they take a moment to fully brighten and they contain a small amount of mercury which requires special procedures for disposal. CFLs are likely also to be a transitional technology, as more energy efficient light sources (such as LEDs) are already coming onto the market.  But CFLs are a safe and energy efficient alternative to incandescent bulbs.

It seems, however, with any new technology comes a wave of internet fearmongering, and CFLs are now a prime target. YouTube videos are circulating claiming that CFLs cause headaches, mercury toxicity, a host of symptoms from electromagnetic sensitivity, and something called “type 3 diabetes.”  Let’s take a look at the claims and the science.

Mercury in CFLs

There is a small amount of mercury in each CFL, necessary for the function of the bulb, about 4mg on average, with some newer bulbs having as little as 1.4mg. There is no exposure to mercury from using CFLs, as long as they are not broken. Even if a bulb is broken the exposure to mercury is negligible, far less than eating a tuna fish sandwich. But still, there are recommended procedures for cleaning up and disposing of a broken bulb to further minimize exposure, such as not using a vacuum, and ventilating the area. These procedures represent the cautionary principle in action, but make it easy to fearmonger about the risks of the mercury in the bulb.

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Posted in: Public Health, Science and Medicine

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How not to consult your biostatistician before doing an experiment

A friend of mine at work sent this video to me in great amusement.

I just hope he wasn’t making a comment on my behavior when it comes to dealing with our biostatisticians. I have, of course, seen investigators approach biostatistians this late in the game. Not that I’ve ever flirted with this sort of behavior, of course. At least the researcher in the video above actually consulted the biostatistician before doing the experiment, rather than after doing an experiment with inadequate statistical power to answer the question asked. On the other hand, I guess it doesn’t matter if the researcher doesn’t listen, does it?

Posted in: Humor, Science and Medicine

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

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

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

Background: the distinction between EBM and SBM

An important theme on the Science-Based Medicine blog, and the very reason for its name, has been its emphasis on examining all the evidence—not merely the results of clinical trials—for various claims, particularly for those that are implausible. We’ve discussed the distinction between Science-Based Medicine (SBM) and the more limited Evidence-Based Medicine (EBM) several times, for example here (I began my own discussion here and added a bit of formality here, here, and here). Let me summarize by quoting John Ioannidis:

…the probability that a research finding is indeed true depends on the prior probability of it being true (before doing the study), the statistical power of the study, and the level of statistical significance.

EBM, in a nutshell, ignores prior probability† (unless there is no other available evidence) and falls for the “p-value fallacy”; SBM does not. Please don’t bicker about this if you haven’t read the links above and some of their own references, particularly the EBM Levels of Evidence scheme and two articles by Steven Goodman (here and here). Also, note that it is not necessary to agree with Ioannidis that “most published research findings are false” to agree with his assertion, quoted above, about what determines the probability that a research finding is true.

The distinction between SBM and EBM has important implications for medical practice ethics, research ethics, human subject protections, allocation of scarce resources, epistemology in health care, public perceptions of medical knowledge and of the health professions, and more. EBM, as practiced in the 20 years of its formal existence, is poorly equipped to evaluate implausible claims because it fails to acknowledge that even if scientific plausibility is not sufficient to establish the validity of a new treatment, it is necessary for doing so.

Thus, in their recent foray into applying the tools of EBM to implausible health claims, government and academic investigators have made at least two, serious mistakes: first, they have subjected unwary subjects to dangerous but unnecessary trials in a quest for “evidence,” failing to realize that definitive evidence already exists; second, they have been largely incapable of pronouncing ineffective methods ineffective. At best, even after conducting predictably disconfirming trials of vanishingly unlikely claims, they have declared such methods merely “unproven,” almost always urging “further research.” That may be the proper EBM response, but it is a far cry from the reality. As I opined a couple of years ago, the founders of the EBM movement apparently “never saw ‘CAM’ coming.”

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

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