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…)
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.
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…)
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.
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:
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…)
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…)
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.
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…)
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.