Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

One of the cherished strategies of the antivaccine group is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other cases) to “prove” that vaccines are dangerous. Vaccine deniers consider the package insert to be golden tablets of the Truth™. It’s ironic that these antivaccine groupies rail against Big Pharma, as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. Irony abounds.

Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to a section in any of the many vaccine package inserts (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. Or that it doesn’t work.

The snarky Orac has proclaimed it “Argument by Package Insert” – it’s almost at the level of logical fallacy. David Gorski has just given it the Latin name, argumentum ad package insert, so it’s now officially a logical fallacy, at least for vaccine discussions.

Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. However, vaccine package inserts are not documents that serve as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. Continue reading “Argument by Vaccine Package Inserts – they’re not infallible”

Debunking myths about vaccine testing and safety

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

Continue reading “Debunking myths about vaccine testing and safety”

Big Pharma and development of drugs – debunking myths

As I’ve written more times than I can imagine, in the hierarchy of scientific evidence, the best primary evidence for the usefulness of any therapeutic method (including medications) are clinical trials, with double-blind, randomized ones considered the gold standard.

Despite the fact that clinical trials form the foundation of all medical evidence, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device flies through this process, with Big Pharma’s desires taking precedence over science.

Big Pharma and development of drugs are a bone of contention, even to those who don’t jump on board the various conspiracies about the pharmaceutical industry. There is a myth that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies), and does whatever it wants.

But let’s look at it carefully, including how most drugs are developed and brought to the market. Let’s try to separate the myths of Big Pharma and development of drugs from the facts.

Continue reading “Big Pharma and development of drugs – debunking myths”

Male birth control side effects – no, men are not wimps

male birth control

A new male birth control method, which utilizes a hormonal injection, was designed to slow or block sperm production. However, according to various media reports, this new birth control method won’t be available anytime soon because men are weaklings, unable to handle the side effects, such as moodiness and acne, which women on birth control tolerate. As a result of these side effects the study was terminated.

In between all of the political news that seems to be monopolizing all of our social networking feeds, you probably saw a few articles that said that a male birth control clinical trial was terminated because “men can’t handle side effects women face daily.” Other reputable websites, like the Atlantic, ran headlines pushing the same trope, stating that “a clinical trial of contraceptives for men was halted because of side effects—side effects that women have dealt with for decades.”

But it didn’t stop there. My Twitter and Facebook feeds were flooded with memes that pushed the male birth control clinical trial proves men are wimps compared to women. To be clear, I think that male birth control is a great idea, and sociologically, it forces men to share in the burden of contraceptives. Cynically, I’ll bet that right wingers will be less controlling of male birth control than they are with women’s reproductive rights. But hey, I’m nothing if I’m not a cynic.

The problem with the memes and tropes is that they’re completely wrong. The study was halted because one of the two independent committees that monitor this trial’s safety data (something that happens with all drugs undergoing clinical trials in the USA) was concerned about the high number of adverse events the men experienced. Furthermore, the incidence of adverse events was higher than what is experienced by women using hormonal birth control.

Lucky for us, the data from this study was published in a peer reviewed journal, so we can take a look at what actually happened.

Continue reading “Male birth control side effects – no, men are not wimps”

A failed vaccine clinical trial – it happens

There is a trope that Big Pharma has an open door to push whatever drug they want onto the unwitting public, whenever they want, irrespective of any safety and effectiveness data. For those who actually work in Big Pharma, this causes more nervous laughter than any other trope, because they know how hard and complicated it is to actually do so.

I’ve written previously that less than 10% of hyped pre-clinical data ever makes it through clinical trials so that it might be considered valuable evidence for clinical decisions. And less than 10% of drugs, such as cancer treatments, ever make it from the first step through the last step (often called pivotal studies) of clinical trials to gain regulatory approval (pdf).

So if Big Pharma is lying to the public about the quality of their drugs (and by extension, vaccines), and then bribing the FDA to cover up these lies, they are laughably incompetent. I guess if they really were that inept, it’s a good thing.

But now we come to a failed vaccine clinical trial – what does that tell us about vaccine development. Continue reading “A failed vaccine clinical trial – it happens”

Vaccines aren’t tested – myth vs. science (updated)

There are so many silly memes that have arisen from the vaccine deniers, most of which have been thoroughly debunked. Everything from the well-worn (and worn-out) “vaccines cause autism” fable, which I have quashed here, to the “these diseases aren’t dangerous”, which, of course, couldn’t be farther from the truth.

One of the more annoying of the tales pushed by the vaccine refusers is that vaccines aren’t tested thoroughly before being used on unsuspecting infants. I do not know where this started, or why it started, but like much in the anti-vaccination world, it really doesn’t matter. It just passes from one person to another across google, and individuals with no research background hold this particular belief as if it were the Truth™.

Not only are vaccines thoroughly tested for safety and efficacy before being marketed, they also are rigorously tested in various combinations with other vaccines. And I’m not Cherry Picking a few articles to support my point of view, unless by cherry-picking you mean I’m picking the best articles from the highest quality journals in medicine.
Continue reading “Vaccines aren’t tested – myth vs. science (updated)”

Pseudoscience and science – alternative medicine is bullshit

Editor’s note: This article combines elements of several articles about pseudoscience published in 2012 and 2013. It’s been revised to include some newer information and split into several parts to improve readability. See Part 1 here.

This is part 2 of the Pseudoscience and science series.

Pseudoscience and science – the former is bullshit. And the latter is fact based on robust, unbiased evidence. Mostly pseudoscience can be ignored, even if it smells bad.

Pseudoscience is enticing because it’s easy to understand. It’s not nuanced, and it general speaks in black and white terms, often false dichotomies. That view is most prevalent in medicine.

Real doctors will say “this treatment for XYZ cancer is going to be difficult. You’ll lose your hair. You’ll feel sick all the time. You might be in pain. But it gives a 73% chance of putting the cancer into remission, and you have a reasonable chance of living at least five years.”

The pseudo-medicine pusher will say, “drink this juice and have a coffee enema. No side effects. And I guarantee that the cancer will disappear.”

The second choice is so enticing. So easy. But most of us know that treating most cancers is hard. We try to find another way, and hope for the best. Maybe you can choose the junk medicine approach, and get lucky with a spontaneous remission. Or maybe the real medicine worked well enough to cause the remission.

 

Of course, pseudoscience can make broad claims without the rigorous research required to make those claims. The charlatans who push junk medicine get to say whatever they want, with no consequences usually.

Alternative medicine is bullshit – it is firmly grounded in pseudoscience.

Continue reading “Pseudoscience and science – alternative medicine is bullshit”

The one vaccine clinical trial design to rule them all

If you spend time observing the “vaccine debate” (it’s not a debate), you’ll hear every dumb argument to deny science. But one thing that you’ll see repeatedly from the antivaccination cults are that they would support vaccinations if there were better vaccine clinical trial design.

The problem with the cult’s demand for better vaccine clinical trial design is really one of several moving targets for their denialism, relying on a form of the Argument from ignorance, claiming that if we can’t absolutely “prove” that vaccines are safe, then it must be absolutely unsafe.

For example, there are literally thousands of articles,  ( an example here and was discussed here), that actually provide overwhelming evidence of the safety and effectiveness of vaccines using real science, real statistics, and real hard work. The antithesis of the fake science, bogus statistics, and 2 hours of Google.

Continue reading “The one vaccine clinical trial design to rule them all”

Study concludes that homeopathy cures tonsillitis–probably not

massive-homeopathic-overdose-homeopathyHere we go again. “Researchers” trying to show that a pseudoscientific concept is real medicine, but failing so badly that only true believers would qualify it as real “evidence.”

In this case, homeopaths from the Department of Homeopathy at the University of Johannesburg (seriously, a Department of Homeopathy?) in South Africa recently published a study that claimed a concoction of homeopathic potions, in pill form, treats tonsillitis, an infection and inflammation of a set of lymph nodes called tonsils in the back of the throat, better than a placebo. The researchers concluded that “the homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis.”

Convincing conclusion. That’s it, next time my children have tonsillitis, I’m going to run down to my local homeopathic lotion and potion magician, and I’ll buy out the store.

Or maybe not. I’ll probably save my money from lining the pockets of that homeopathic wizard, and I’ll send the kids to a real physician who practices evidence-based medicine. And get real treatment.

Why am I so negative about a real peer-reviewed study published in a medical journal? For lots of reasons. Continue reading “Study concludes that homeopathy cures tonsillitis–probably not”

The Irish Catholic children’s home scandal–it’s NOT about vaccines

children-at-st-marysThere’s an appalling story out of Ireland that has dominated the news for the past few days. Over a period of 35 years, St Mary’s Mother and Baby Home, a Catholic home for unwed mothers in County Galway (on the west coast of Ireland), apparently buried some children in a sewer system after dying in that home. You might have heard from some irresponsible journalists that over 800 children were buried in the septic tank, without questioning whether 800 bodies could actually be buried in the septic system, and without determining when the home was moved to a County sanitary sewer system, making it impossible to dump dead children in the septic tank. OK, that’s a small point.

According to the individual who actually uncovered this atrocity, Catherine Corless, an academic historian, she claims, through her research of birth records and other information, around 800 children died at this home over 36 years. The Irish Times reports, “between 1925, when the home opened, and 1937 the tank remained in use. During that period 204 children died at the home. Corless admits that it now seems impossible to her that more than 200 bodies could have been put in a working sewage tank.” OK, it’s sad and maddening that 22 children died every year at this home, even if infant mortality rates were substantially higher back then because of malnutrition and vaccine preventable diseases (like measles, mumps, polio, rotavirus and others) that would run rampant through closed quarters like that.

So the first myth we need to debunk is that there are 800 bodies buried in a septic tank–there aren’t. But, like I’ve said, that’s really just a minor point (setting aside the atrocity itself, which we’ll address later), because there are some other issues that have arisen with this story that also need to be discussed honestly. Continue reading “The Irish Catholic children’s home scandal–it’s NOT about vaccines”