Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

One of the cherished strategies of the anti-vaccine religion is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other areas) to “prove” that vaccines are dangerous. These vaccine deniers consider the package insert to be the golden tablets of the Truth™.

Yes, it is cynical that these anti-vaccine groupies rail against Big Pharma as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. And there is another broken irony meter.

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”

Cure cancer in one year according to Israeli scientists – just bovine feces

cure cancer

If you’ve been cruising Facebook, Twitter, or Google+ lately, you’d have seen some breathless headlines claiming that Israeli scientists have discovered a miracle cure for cancer. And it will be ready in one year.

What a load of rubbish, balderdash, codswallop, claptrap, and nonsense.

I’d end the article right there because nothing more really needs to be written. But you come here for the snark, but stay for the science. Or come here for the science, and stay for the snark. Either way, I need to spend a few minutes of your time, and a couple of thousand words, to put this pile of equine excrement into a waste pit.

So let’s take a look at how some Israeli scientists will cure cancer. Spoiler alert – they can’t. Continue reading “Cure cancer in one year according to Israeli scientists – just bovine feces”

Vaccine clinical trials – the anti-vaxxer pseudoscience is wrong again

Of all of the ridiculous tropes, memes, and lies about vaccines pushed by the pseudoscience of the anti-vaccine religion, vaccine clinical trials are the most annoying. They simply get it wrong on so many levels.

The anti-vaccine myths have popped again in a letter to the US Department of Health and Human Services (HHS) from Del Bigtree, the producer of the fraudmentary Vaxxed, who has approximately zero credibility on vaccines. He, and his anti-vaccine organization, Informed Consent Action Network, is nothing more than a sycophant to Mr. Andrew Wakefield, serving to push Wakefield’s fraudulent claims about vaccines for money and profit.

The aforementioned letter is an 88-page, yes, 88-plodding-pages, treasure trove of cherry-picking, pseudoscience, appeals to authority, other logical fallacies, lies, ignorance, misinformation, and delusion about vaccines. This is a letter is a follow-up to a response from HHS to Bigtree’s original laughable letter to HHS from January 2018.

Since my tearing down an 88-page rant would take 100,000 words, unless I showed some brevity and simplified my response to “Bigtree is a dumbass,” I thought I’d focus on a few key points over a few days. Of course, I might get bored and give up after this one article.

Given all that, I’m going to focus on Bigtree’s vast ignorance of vaccine clinical trials. He gets it all wrong. He doesn’t understand it. And, he is a dumbass. Not necessarily in that order. Continue reading “Vaccine clinical trials – the anti-vaxxer pseudoscience is wrong again”

Debunking myths about vaccine testing and safety

vaccine testing

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”

Testing vaccines – another anti-vaccine myth requiring debunking

testing vaccines

There are so many myths, tropes, and memes pushed by the anti-vaccine religion that it’s almost a full-time job to keep up with it all. One of the most ridiculous is that vaccines aren’t tested, especially in clinical trials. This is ridiculous on so many levels, the most important of which is that testing vaccines are critical to receiving regulatory approval across the world.

The anti-vaccine religion believes 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 social media, and individuals with no research background hold this particular belief as if it were the Truth™.

On the contrary, testing vaccines is a thorough process – each vaccine is tested for safety and effectiveness before being marketed. 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 “Testing vaccines – another anti-vaccine myth requiring debunking”

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”

Pharmaceutical drug development – providing facts about vaccines

pharmaceutical drug development

I might be over-exaggerating, but I’ve always thought that the anti-vaccine religion believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Despite the fact that pharmaceutical drug development is so complicated and failure-prone, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device fly through this process, with Big Pharma’s lust for profits taking precedence over science.

The myths about pharmaceutical drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is 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 the process of pharmaceutical drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths of from the facts of pharmaceutical drug development.

Continue reading “Pharmaceutical drug development – providing facts about vaccines”

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”

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”