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Archive for Pharmaceuticals

What’s all that other stuff in my medicine?

If you read enough supplement advertisements, like I do, you’ll often see the purity of  a product often cited as one of its merits. It’s usually some phrase like:

Contains no binders! No fillers! No colours! No excipients! No starch! No gluten! No coatings! No flow agents!

It’s a point of pride for supplement manufacturers to advertise that their product contains nothing but the labelled ingredient. And that’s also seen as an important benefit to many that purchase supplements. The perception from many consumers (based on my personal experience) seems to be that products are inferior if they contain non-drug ingredients. By this measure, drug products are problematic. Pharmaceuticals all contain an array of binders, coatings, supplements and fillers.  Even (gasp) artificial ingredients and sweeteners! And they’re often, though not always, disclosed on the package label.

But rather than being a negative feature, these supplementary, non-medicinal ingredients play a critical role in ensuring that drug products are of consistent and reproducible quality. Without them, we’d have products that are potentially unstable, we’d be unclear if they were actually being absorbed, and we wouldn’t know if they actually delivered any active ingredients into the body. In short, we’d be in the same situation we’re currently in with many herbal remedies and other types of supplements.

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Posted in: Pharmaceuticals

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Understanding and Treating Colic

Parenting an infant can be totally overwhelming. One of the earliest challenge many face is learning to deal with periods of intractable crying. I often speak with sleep deprived parents when they’re looking for something — anything — to stop their baby from crying. They’ve typically been told by friends of family that their baby must have “colic” and they’ve come to the pharmacy, looking for a treatment. Colic is common, affecting up to 40% of babies in the few months of life.

While distressing, colic is a diagnosis of exclusion — that it, it is given only after other causes have been ruled out (hunger, pain, fatigue, etc.). The most common definition for colic is fussing or crying for more than 3 hours per day, more than 3 days per week, for more than 3 weeks. These criteria, first proposed by Morris Wessel in 1954, continue to be used today. However, scientific evidence to explain the cause is lacking. Ideas proposed include:

  • changes in gastrointestinal bacteria/flora
  • food allergies
  • lactose intolerance
  • excess gas in stomach
  • cramping or indigestion
  • intolerance to substances in the breast milk
  • behavioural issues secondary to parenting factors

Despite its intensity, colic resolves on its own with no interventions. By three months of age, colic has resolved in 60% of infants. By four months, it’s 90%. It sounds harmless and short-lived, but colic’s ability to induce stress in parents cannot be overstated. Parents may be angry, frustrated, depressed, exhausted, or just feel guilty, ascribing their baby’s cries to some parenting fault. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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Comparative Drug Research

The latest issue of the BMJ contains an editorial recommending that regulators (this is in the UK, but the argument applies in the US and elsewhere) should require pharmaceutical companies to provide research on direct comparison to existing therapies as part of the approval process. The authors, Sorenson, Naci, Cylus, and Mossialos, write:

When a drug comes to market, evidence on the comparative risks and benefits is needed to help regulatory authorities to safeguard public health from inferior and unsafe treatments, to ensure that health technology assessment agencies and payers make funding decisions based on the best available evidence of different treatments, and to aid clinicians’ and patients’ understanding of what therapies work best and their appropriate position in the treatment pathway.

They make a persuasive argument, but there are some interesting angles to this topic.

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Posted in: Pharmaceuticals

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Who’s to Blame for Drug Shortages?

All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a dozen drugs stopped being produced. This lead to extensive media coverage, speculating on the causes and implications of what seems like a growing problem. So who’s to blame? (more…)

Posted in: Pharmaceuticals, Politics and Regulation

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.0: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD

Review

The recent albuterol vs. placebo trial reported in the New England Journal of Medicine (NEJM) found that experimental subjects with asthma experienced substantial, measured improvements in lung function after inhaling albuterol, but not after inhaling placebo, undergoing sham acupuncture, or “no treatment.” It also found that the same subjects reported having felt substantially improved after either albuterol or each of the two sham treatments, but not after “no treatment.” Anthropologist Daniel Moerman, in an accompanying editorial, wrote, “the authors conclude that the patient reports were ‘unreliable,’ since they reported improvement when there was none”—precisely as any rational clinician or biomedical scientist would have concluded.

In Part 1 of this blog we saw that Moerman took issue with that conclusion. He argued, with just a bit of hedging, that the subjects’ perceptions of improvement were more important than objective measures of their lung function. I wondered how the NEJM editors had chosen someone whose bibliography predicted such an anti-medical opinion. I doubted that Editor-in-Chief Jeffrey Drazen, an expert in the pathophysiology of asthma, had ever heard of Moerman. I suggested, in a way that probably appeared facetious, that Ted Kaptchuk, the senior author of the asthma report, might have recommended him. (more…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Health Fraud, Herbs & Supplements, History, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Science and Medicine, Science and the Media

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Oh yeah? Thalidomide! Where’s your science now?

Online discussions on the merits of alternative medicine can get quite heated. And its proponents, given enough time, will inevitably cite the same drug as “evidence” of the failings of science. Call it Gavura’s Law, with apologies to Mike Godwin:

As an online discussion on the effectiveness of alternative medicine grows longer,  the probability that thalidomide will be cited approaches one.

A recent comment on my own blog, regarding the homeopathic product Traumeel, is typical:

If the scientific method is all that separates an accepted claim, ie Thalidomide, Vioxx, Bextra, Darvon, from mere anecdote, of what benefit is the Science?

As a non-scientist consumer, I’ll take the anecdotes and my own experience. Thank you.

If scientists want to be taken seriously, they must stop selling themselves to the highest bidder becoming corporate whores without a shred of decency. To my mind, that’s how the claims for Thalidomide, Vioxx, Bextra, Darvon were accepted, making the scientific method utterly worthless.

To this commenter, “science has been wrong before.” And that invalidates science, and apparently validates homeopathy. It’s a fallacious argument. But does thalidomide actually represent a failing of science-based medicine? No, not even close. It’s so wrong, it’s not even wrong. Thalidomide is good example of the importance of science-based medicine and why allowing alternative medicine to be sold in the absence of good science is a concern. (more…)

Posted in: History, Pharmaceuticals, Politics and Regulation, Science and Medicine

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Tylenol: Safe painkiller, or drug of hepatic destruction?

What do Tylenol, Excedrin Extra Strength, Nyquil Cold & Flu, Vicodin, and Anacin Aspirin Free have in common? They all contain the drug acetaminophen. Taking multiple acetaminophen-containing drugs can be risky: while acetaminophen is safe when used at appropriate doses, at excessive doses, it is highly toxic to the liver. Take enough, and you’ll almost certainly end up hospitalized with liver failure. Acetaminophen poisonings, whether intentional or not, are a considerable public health issue. In the USA, poisonings from this drug alone result in 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year. [PDF] This makes acetaminophen responsible for more overdoses, and overdose deaths [PDF], than any other pharmaceutical product.

Last week, Johnson & Johnson announced that it’s lowering the maximum recommended daily dose for its flagship analgesic, Extra Strength Tylenol, from 8 tablets per day (4000mg) to 6 tablets per day (3000mg). Why? According to the manufacturer,

The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.

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Posted in: Pharmaceuticals, Politics and Regulation, Science and Medicine

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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word ”doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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Antidepressants and Effect Size

Antidepressant drugs have been getting a bad rap in the media. I’ll just give 3 examples:

  • On the Today show, prominent medical expert :-) Tom Cruise told us Brooke Shields shouldn’t have taken these drugs for her postpartum depression.
  • In Natural News, “Health Ranger” Mike Adams accused pharmaceutical companies and the FDA of covering up negative information about antidepressants, saying it would be considered criminal activity in any other industry.
  • And an article in Newsweek said  “Studies suggest that the popular drugs are no more effective than a placebo. In fact, they may be worse.”

Yet psychiatrists are convinced that antidepressants work and are still routinely prescribing them for their patients. Is it all a Big Pharma plot? Who ya gonna believe? Inquiring minds want to know:

  • Are antidepressants more effective than placebo?
  • Has the efficacy of antidepressants been exaggerated?
  • Is psychotherapy a better treatment choice?

The science-based answers to the first two questions are clearly “Yes.” The best answer to the third question is “It depends.” (more…)

Posted in: Neuroscience/Mental Health, Pharmaceuticals

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The Neurontin Seeding Trial

Any institution that is based upon science is also dependent upon the integrity of the scientific process, and must guard that integrity jealously. That is certainly one of the missions of Science-Based Medicine. A particular challenge is that medicine is a massively expensive enterprise, and growing in both absolute and relative terms. This means that there is a great deal of money at stake (to be potentially earned and spent) and this fact constantly threatens to distort the process of science that is supposed to underlie medicine.

In particular, wherever there are millions or billions of dollars to be made, the motivation to find clever and subtle ways to distort the scientific process is huge. We find such behavior among any industry that has a medical product or service to sell. A recent example of this behavior was recently published in the Archives of Internal Medicine – Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial.

Krumholz et al. reviewed the documents resulting from Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert and concluded:

The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

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