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Gold mine or dumpster dive? A closer look at adverse event reports

All informed health decisions are based on an evaluation of expected risks and known benefits. Nothing is without risk. Drugs can provide an enormous benefit, but they all have the potential to harm. Whether it’s to guide therapy choices or to ensure patients are aware of the risks of their prescription drugs, I spend a lot of time discussing the potential negative consequences of treatments. It’s part of my dialogue with consumers: You cannot have an effect without the possibility of an adverse effect. And even when used in a science-based way, there is always the possibility of a drug causing either predictable or idiosyncratic harm.

An “adverse event” is an undesirable outcome related to the provision of healthcare. It may be a natural consequence of the underlying illness, or it could be related to a treatment provided. The use of the term “event” is deliberate, as it does not imply a cause: it is simply associated with an intervention. The term “adverse reaction,” or more specifically “adverse drug reaction,” is used where a causal relationship is strongly suspected. Not all adverse events can be be causally linked to health interventions. Consequently, many adverse events associated with drug treatments can only be considered “suspected” adverse drug reactions until more information emerges to suggest the relationship is likely to be true.

Correlation fallacies can be hard to identify, even for health professionals. You take a drug (or, say, are given a vaccine). Soon after, some event occurs. Was the event caused by the treatment? It’s one of the most common questions I receive: ”Does drug ‘X’ cause reaction ‘Y’?” We know correlation doesn’t equal causation. But we can do better than dismissing the relationship as anecdotal, as it could be real. Consider an adverse event that is a believed to be related to drug therapy: (more…)

Posted in: Epidemiology, Pharmaceuticals

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Feet of Clay

It has been tough in Portland this year. The Trailblazers, our NBA, and only professional team, started out on a tear, then went right down the toilet. It is painful to see such promise dribbled away. Sigh. Why is elation always followed by disappointment? Everyone and everything has feet of clay. Except Cassius Marcellus.

At the beginning of March the NEJM had a wonderful essay, What’s the Alternative? The Worldwide Web of Integrative Medicine by Ranjana Srivastava. The essay concerns a patient who is ‘diagnosed’ with cancer at an integrative medicine exhibition and the resultant diagnostic and therapeutic debacles that follow.
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Posted in: Health Fraud, Medical Academia, Pharmaceuticals

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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Generic Drugs: Are they Equivalent?

With healthcare costs continuing to rise, generic drugs are looking more attractive than ever. The prospect of getting the same drug at a lower cost is tempting to anyone with a large drug bill — patient or insurer alike. The savings are massive: Lipitor lost patent protection last month — it was a $10 billion drug, and the generic versions are priced at a fraction of the original cost. In 2012, Plavix and Seroquel, two other blockbusters, will lose patent protection too — that’s another $10 billion in drug costs that will shrink. This “patent cliff” will shrivel about $255 billion in worldwide patented drug sales over the next five years. If you’re taking a prescription drug and not already on a generic, you probably will be soon. And depending on where you live, you may be automatically switched to a generic version of your prescription drug as soon as it’s available.

Pharmacists are responsible for most of the switches from brand to generic drugs. In Ontario, where I work, regulations specify which drugs and brands may be automatically substituted — that is, without patient or prescriber consent.  This doesn’t mean a  lack of transparency, however, so I spend a lot of time speaking with patients about generic drugs. Misconceptions are common, ranging from manufacturing standards (“they’re weaker!”) to efficacy (“the drugs don’t work!”). I’ve seen a number of questions and comments about generic drugs in the comments section here at SBM as well. So today’s post is an overview of the science of evaluating generic drugs. Specifically, I want to review the concept of bioequivalence, the confirmation of which assures us of the interchangeability of different drugs — that is, one can be substituted for another. (more…)

Posted in: Basic Science, Pharmaceuticals

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Reducing the Risk of Adverse Drug Events

Critics of mainstream medicine often point to the dangers of drugs. I previously wrote about “Death by Medicine,” where I explained the fallacy of fixating on harmful effects of drugs without putting them into perspective with all the good drugs do. Yes, patients have died from severe allergic reactions to penicillin, but penicillin has also saved countless lives.

A recent article in The New England Journal of Medicine looks at emergency hospitalizations for adverse drug events in elderly Americans. It confirms that adverse reactions are a serious problem, but some of its findings are surprising.
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Posted in: Pharmaceuticals

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Hypothyroidism: The facts, the controversies, and the pseudoscience

As glands go, we don’t give the butterfly-shaped thyroid that straddles our trachea too much  thought — until it stops working properly. The thyroid is a bit like your home’s thermostat: turn it high, and you’re hyperthyroid: heat intolerant, a high heart rate, and maybe some diarrhea. Turn it down, and you’re hypothyroid: cold, tired, constipated, and possibly even depressed. Both conditions are associated with a long list of more serious health consequences. Between the two however, hypothyroidism is far more prevalent. The mainstay drug that treats it, levothyroxine (Synthroid), is one of the most prescribed in the world.

One of my more memorable pharmacy experiences involved levothyroxine. The store had recently changed its prescription labelling standards: It switched from listing the brand name, to only including the generic name (with the manufacturer in parentheses). Few patients noticed. But one elderly patient, taking Synthroid, was furious, and accused me of making a dispensing error. I assured her that levothyroxine was the active ingredient in Synthroid, and she was getting the exact same product as her last visit — but she would have none of it. Her symptoms had worsened, she said, because the medication wasn’t the same. “I want Synthroid — this levothyroxine stuff does not work,” she screamed at me across the counter. No amount of reassurance would satisfy her — I think we eventually resorted to custom, typewritten labels.

I mention this anecdote not to dismiss the symptoms of hypothyroidism as sensitive to placebo effects — hypothyroidism is a real condition with objective monitoring criteria. But this episode was one of my earliest lessons in understanding how perceptions  can shape expectations of effectiveness — something that I’ll come back to, when we look at the controversies of this common condition. Any the treatment of hypothyroidism is not without its controversies – most of which occur outside the realm of medicine, and can more accurately be labelled pseudoscience. (more…)

Posted in: Nutrition, Pharmaceuticals, Science and Medicine

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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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Posted in: Basic Science, Cancer, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?

Last week, I wrote a magnum opus of a movie review of a movie about a physician and “researcher” named Stanislaw Burzynski, MD, PhD, founder of the Burzynski Clinic and Burzynski Research Institute in Houston. I refer you to my original post for details, but in brief Dr. Burzynski claimed in the 1970s to have made a major breakthrough in cancer therapy through his discovery of anticancer substances in the urine that he dubbed “antineoplastons,” which turned out to be mainly modified amino acids and peptides. Since the late 1970s, when he founded his clinic, Dr. Burzynski has been using antineoplastons to treat cancer. Over the last 25 years or so, he has opened a large number of phase I and phase II clinical trials with little or nothing to show for it in terms of convincing evidence of efficacy. Worse, as has been noted in a number of places, high doses of antineoplastons as sodium salts are required, doses so high that severe hypernatremia is a concern.

Although antineoplastons are the dubious cancer therapy upon which Dr. Burzynski built his fame, they aren’t the only thing he does. Despite the promotion of the Burzynski Clinic as using “nontoxic” therapies that “aren’t chemotherapy” by “natural medicine” cranks such as Joe Mercola and Mike Adams, Dr. Burzynski’s dirty little secrets, at least as far as the “alternative medicine” crowd goes, are that (1) despite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy and (2) Dr. Burzynski uses a lot of conventional chemotherapy. In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted. No longer are antineoplastons the center of attention at his clinic. Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.” In fact, it’s right there in the first bullet point on his clinic’s webpage, underlined, even! Antineoplastons aren’t even listed until the third bullet point.

But what is “personalized gene-targeted cancer therapy,” according to Dr. Burzynski? Here is how it is described:
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Posted in: Basic Science, Cancer, Clinical Trials, Pharmaceuticals

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November Hodgepodge

There have not been a lot of topics of late that warrant extensive analysis and discussion.  But there are a number of little topics of interest, each worthy of a few paragraphs of discussion, archetypes of issues in medicine, science based and otherwise.

Xigirs. No, it is not whale vomit, but close.

Last month Xigris  was pulled from the market by Lilly.  Yes, I understand the shock. Xigris, we hardly knew ye.   Xigris is the brand name for drotrecogin alfa, or activated protein C.  It is an enzyme in the clotting cascade that is/was given for the treatment of sepsis. (more…)

Posted in: Acupuncture, Energy Medicine, Pharmaceuticals, Science and Medicine

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Birth Control

From a message posted on Facebook:

 Is the pill safe? The International Agency for Research on Cancer in a 2007 study made by 21 scientists reported that the pill causes cancer, giving it the highest level of carcinogenicity, the same as cigarettes and asbestos. It also causes stroke, and significantly increases the risk of heart attacks. Several scientific journals have stated that the natural way of regulating births through the Billings Ovulation Method has no side-effects, and is 99.5 % effective.

The Billings Ovulation Method (BOM) is a method of natural family planning where women are taught to recognize when they have ovulated by examining their cervical mucus, allowing them to avoid intercourse during fertile periods or conversely, to have intercourse during fertile periods when pregnancy is desired. We used to call people who used the rhythm method “parents,” but BOM is more reliable than older abstinence methods.

I’m a big fan of oral contraceptives. They contributed to women’s liberation by giving us a reliable method of planning, delaying, or avoiding pregnancy.  They also have medical uses that go beyond contraception. Birth control pills (BCPs) have had such an important impact that they are known as simply “The Pill.” We have always known they were not 100% risk free; but we also know they are less risky than pregnancy itself. There are other methods of birth control; but they are generally less effective and less convenient.  For those who want permanent solutions, tubal ligation and vasectomy are available; but even they have occasional failures. What does science tell us about the effectiveness and safety of BCPs as compared to other methods?  (more…)

Posted in: Obstetrics & gynecology, Pharmaceuticals

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