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Are you sure you’re allergic to penicillin?

As a pharmacist, when I dispense medication, it’s my responsibility to ensure that the medication is safe and appropriate for the patient. There are numerous checks we go through including verifying the dose, ensuring there are no interactions with other drugs, and verifying the patient has no history of allergy to the product prescribed. Asking about allergies is a mandatory question for every new patient.

Penicillin is one of the oldest antibiotics still in use despite widespread bacterial resistance. Multiple analogs of penicillin have been developed to change its effectiveness, or improve its tolerability. And other classes of antibiotics (e.g., cephalosporins) share some structural features with penicillin. These products are widely used for both routine and serious bacterial infections. Unfortunately, allergies to penicillin are widely reported. Statistically, one in ten of you reading this post will respond that you’re allergic to penicillin. Yet the incidence of anaphylaxis to penicillin is estimated to be only 1 to 5 per 10,000. So why do so many people believe they’re allergic to penicillin? Much of it comes down to how we define “allergy.”

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Posted in: Basic Science

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Treating The Common Cold

For the last week I have had a cold. I usually get one each winter. I have two kids in school and they bring home a lot of viruses. I also work in a hospital, which tends (for some reason) to have lots of sick people. Although this year I think I caught my cold while traveling.  I’m almost over it now, but it’s certainly a miserable interlude to my normal routine.

One thing we can say for certain about the common cold – it’s common. It is therefore no surprise that there are lots of cold remedies, folk remedies, pharmaceuticals, and “alternative” treatments. Finding a “cure for the common cold” has also become a journalistic cliche – reporters will jump on any chance to claim that some new research may one day lead to a cure for the common cold. Just about any research into viruses, no matter how basic or preliminary, seems to get tagged with this headline.  (It’s right up there with every fossil being a “missing link.”)

But despite the commonality of the cold, the overall success of modern medicine, and the many attempts to treat or prevent the cold – there are very few treatments that are actually of any benefit. The only certain treatment is tincture of time. Most colds will get better on their own in about a week. This also creates the impression that any treatment works – no matter what you do, your symptoms are likely to improve. It is also very common to get a mild cold that lasts just a day or so. Many people my feel a cold “coming on” but then it never manifests. This is likely because there was already some partial immunity, so the infection was wiped out quickly by the immune system. But this can also create the impression that whatever treatment was taken at the onset of symptoms worked really well, and even prevented the cold altogether.

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Posted in: Herbs & Supplements

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Childbirth Without Pain: Are Epidurals the Answer?

Is unmedicated natural childbirth a good idea? The American College of Obstetrics and Gynecology (ACOG) points out that

There is no other circumstance in which it is considered acceptable for a person to experience untreated severe pain, amenable to safe intervention, while under a physician’s care.

It is curious when an effective science-based treatment is rejected. Vaccine rejecters have been extensively discussed on this blog, but I am intrigued by another category of rejecters: those who reject pain relief in childbirth. They seem to fall into 3 general categories:

  1. Religious beliefs
  2. Heroism
  3. Objections based on safety

1. “In pain you will bring forth children” may be a mistranslation, and it certainly is not a justification for rejecting pain relief. Nothing in the Bible or any other religious text says “Thou shalt not accept medical interventions to relieve pain.” Even the Christian Science church takes no official stand on childbirth and its members are free to accept medical intervention if they choose.

2. The natural childbirth movement seems to view childbirth as an extreme sport or a rite of passage that is empowering and somehow enhances women’s worth. Women who “fail” and require pain relief or C-section are often looked down upon and made to feel guilty or at least somehow less worthy.

3. I’m not impressed by religious or heroic arguments, although I support the right of women to reject pain relief on the autonomy principle. What inquiring science-based minds want to know is what the evidence shows. Does avoiding medical treatment for pain produce better outcomes for mother and/or baby? It seems increasingly clear that it doesn’t. A new book, Epidural Without Guilt: Childbirth Without Pain, by Gilbert J. Grant, MD, helps clarify these issues.

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Posted in: Book & movie reviews, Obstetrics & gynecology

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Why haven’t we cured cancer yet?

Why haven’t we cured cancer yet?

If we can put a man on the moon, why can’t we cure cancer?

If we can harness the atom, why can’t we cure cancer?

How many times have you heard these questions, or variants thereof? How many times have you asked this question yourself? Sometimes, I even ask this question myself. Saturday was the two year anniversary of the death of my mother-in-law from a particularly nasty form of breast cancer, and, even though I am a breast cancer surgeon, I still wonder why there was nothing in the armamentarium of science-based medicine that could save her from a several month decline followed by an unpleasant death. That’s why, to me at least, the timing of the publication of a study examining the genome of prostate cancer that was published in Nature and summarized in this Science Daily news story was particularly apt. Performed as part of the National Cancer Institute’s Cancer Genome Project, the study undertook complete genome sequencing of seven advanced and aggressive prostate cancers. The results, as ERV put it, revealed what can be describe as a “train wreck.”

Personally, I’d describe it as looking as though someone threw a miniature grenade into the nucleus of a prostate epithelial cell. You’ll see what I mean shortly.

Of course, although that image does give you an idea of the chromosomal chaos in the heart of prostate cancer cells, it is inaccurate in that it implies a sudden explosion, after which the damage is done, and if there’s one thing we know about cancer it’s that in most cases it takes many years for a normal cell to progress to a cancer cell fully capable of metastasizing and killing its host. I’ve written in detail about the complexity of cancer before, of course, and have even pointed out before that when President Nixon launched the “war on cancer” 40 years ago scientists had no idea how difficult it would be. Indeed, before I discuss the current study, it’s probably useful to reiterate a bit why, in order to put the study in context.
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Posted in: Cancer, Science and Medicine

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The Flu Vaccine and Narcolepsy

Last year it was reported that there was a possible increase in narcolepsy, a sleep disorder characterized by excessive sleepiness, in children who had received the Pandemrix brand of H1N1 flu vaccine in Sweden, Finland, and Iceland. However a review of the data did not find a convincing connection, although concluded there was insufficient data at present and recommended further surveillance. A narcolepsy task force was formed in Finland, and now we have their preliminary report.

They conclude that the evidence suggests there is a connection:

Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

The World Health Organization (WHO) has reviewed these results and concluded:

WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines. An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

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Posted in: Neuroscience/Mental Health, Vaccines

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Ear Infections: To Treat or Not to Treat

Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.

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Posted in: Clinical Trials, Pharmaceuticals

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The NCCAM Strategic Plan 2011-2015: The Good, The Bad, and The Ugly

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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Randi issues a challenge

Lest I be left out of the fun, I can’t help but point out that yesterday the Amazing One himself, James Randi, issued a challenge to manufacturers of homeopathic remedies and retail pharmacies that sell such remedies, in particular large national chains like Walgreens and CVS and large national chains that include pharmacies in their stores, such as Walmart and Target. This was done in conjunction with the 10:23 Challenge, which is designed to demonstrate that homeopathy is nonsense. All over the world, skeptics and supporters of science-based medicine gathered to engage in overdoses of homeopathic medicines in order to demonstrate that there is nothing in them.

As much as I like Randi, unfortunately, I doubt that the prospect of winning $1 million will make much difference to huge companies like Boiron (a French company that manufactures popular homeopathic remedies), Walmart, or Walgreens, but I do like the spirit of the protest, in particular how it drives home a very simply message about homeopathy: There’s nothing in it.

Posted in: Homeopathy

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Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay later…

Review

This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim, and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.

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Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Medical Academia, Medical Ethics, Science and Medicine

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