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”

The myth of Big Pharma vaccine profits – it’s not what they say it is

Several of the ongoing memes, tropes and fabrications of the vaccine deniers is somehow, somewhere, in some Big Pharma boardroom, a group of men and women in suits choose the next vaccine in some magical way, and foist it upon the world just to make billions of dollars through vaccine profits. Of course, while magically concocting this vaccine brew, these pharmaceutical execs ignore ethics and morals just to make a profit on hapless vaccine-injured victims worldwide.

The Big Pharma vaccine profits conspiracy trope ranges across the junk medicine world. Homeopathy, for example, claims that Big Pharma suppresses the data that shows water cures all diseases. Like Ebola.

But the Big Pharma vaccine profits conspiracy is still one of most amusing myths of the antivaccination world.

 

Continue reading “The myth of Big Pharma vaccine profits – it’s not what they say it is”

Developing and supporting a scientific consensus

In my writing, I often refer to the scientific consensus, which is the collective opinion and judgement of scientists in a particular field of study. This consensus implies general agreement, though disagreement is limited and generally insignificant.

The major difference between a scientific theory and a scientific consensus is that the theory is essentially fact. It is so predictive, it is supported by so much evidence, and it is so well accepted, it takes an almost ridiculous amount of data to refute it, though it is possible.

In the hierarchy of scientific principles, we often mention scientific theories which “are large bodies of work that are a culmination or a composite of the products of many contributors over time and are substantiated by vast bodies of converging evidence. They unify and synchronize the scientific community’s view and approach to a particular scientific field.” A scientific theory is not a wild and arbitrary guess, but it is built upon a foundation of scientific knowledge that itself is based on evidence accumulated from data that resulted from scientific experimentation.

We want to focus on the scientific consensus, describing what it is. Take a deep breath, because this is a complicated one.

Continue reading “Developing and supporting a scientific consensus”

Import Canadian drugs – another half-baked idea that won’t work

Import Canadian drugs

That old Senate gadfly, Bernie Sanders, tried to win points as the self-proclaimed leader of the Democratic party by proposing a naive and impractical amendment to the Senate health care law to allow Americans to import Canadian drugs. The amendment specifically stated that it would “establish a deficit-neutral reserve fund relating to lower prescription drug prices for Americans by importing drugs from Canada.”

The Amendment failed but not in the way you could imagine. Actually, 12 Republican Senators supported it, which in this environment of politics is nearly a miracle. You’d think that it would have passed, but it didn’t. Thirteen Democrats voted against the Amendment, which caused it to fail.

The liberal internet decided to come down hard on Senator Cory Booker of NJ, because just a day before he had the intestinal fortitude to stand up to the nomination of the backwards Jefferey Sessions for Attorney General, so how dare the perfect liberal not be perfect on everything. Senator Booker voted against the amendment for good reasons, though the crazy liberal media is fairly angry at him. And of course, the meme-makers had to pull out the old Big Pharma Shill Gambit, accusing all thirteen Democrats of being pawns of Big Pharma.

To be fair to Senator Booker, his office issued a statement to the media after the vote. It said he supports the importation of prescription drugs but that “any plan to allow the importation of prescription medications should also include consumer protections that ensure foreign drugs meet American safety standards. I opposed an amendment put forward last night that didn’t meet this test.”

In other words Sen. Booker and others are saying that, before we import Canadian drugs, let’s make sure they are safe. Yes, Canada’s drug distribution is fairly safe, but it’s not perfect. There are a lot of issues of safety that should be considered (and Sanders did not, because I’m beginning to be convinced his analytical skills are weak). But there’s a bigger concern – would Canada allow this to happen, and why would they? And that is the concern that Sanders failed to acknowledge.

Let me be absolutely clear. The USA needs some sort of drug pricing regulation, although I doubt it will happen under the Trump administration for lots of reasons.

Setting aside the positives and negatives of this amendment, let’s take a look at whether we can or should import Canadian drugs. Continue reading “Import Canadian drugs – another half-baked idea that won’t work”

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”

Anti-vaccine education – ignorance and bullshit about finance

anti-vaccine education

We all  know about anti-vaccine education. They are ignorant about science. They’re unknowledgeable about clinical trials. They’re uneducated about the vaccine court. And they rely upon package inserts, written by Big Pharma of course, as their proof of whatever.

Now, it’s clear that human nature is such that when one takes a position, say on vaccines, they kind of lock in on it, despite the evidence. And the vast majority of unbiased, non-cherry-picked evidence leads to only one simple conclusion – vaccines are relatively safe and effective. A truly open-minded person, say a scaly extinct dinosaur, examines and re-examines their position in light of all of the evidence.

But it’s not just science where the anti-vaccine crowd gets it all wrong. I’ve written before about vaccine profits – if Big Pharma were as evil and nefarious as the science deniers claim, then vaccines would slowly disappear from the market. Why? Because the industry would make boatloads more money selling everything else to hospitals and physicians to treat long-disappeared vaccine preventable diseases.

And there’s more. I completely overlooked the major problem with huge epidemics, which don’t exist today – there are insufficient hospital beds in all developed countries (and it goes with out saying, it’s worse in poorer countries) to care for the hundreds of thousands or millions of kids who get sick. Every new bed in a hospital probably sends $1 million in revenues to Big Pharma (or more broadly Big Medical, which includes devices, equipment, and other products). The windfall to Big Medical/Big Pharma would be so huge that if ending vaccination were a real thing, I’d be going long in Big Pharma stocks, and waiting for the delivery of my brand new shiny Ferrari.

Related to the ignorant anti-vaccine education on Big Pharma profits, their utter lack of understanding about personal finance and investing is almost laughable. Especially, since it’s one of their core ad hominem attacks on several pro-science writers. Let’s look at one.

Continue reading “Anti-vaccine education – ignorance and bullshit about finance”

Martin Shkreli – skyrocketing prices of an anti-parasitic drug

Martin Shkreli

This article is #12 of the 12 most popular posts on Skeptical Raptor during 2015. Stay tuned, I’ll be reposting the rest of them through New Year’s Day.

It is a story about Martin Shkreli and Turing Pharmaceutical skyrocketing the price of pyrimethamine. Of course, he just got arrested for securities fraud, so it’s clear that Shkreli’s character is precisely what we thought it was.

Over the weekend, my newsfeed on Twitter and Facebook exploded with outrage and indignation about a story that was published in AddictingInfo.org and other outlets regarding skyrocketing prices of an anti-parasitic drug – pyrimethamine (trade name Daraprim) – which is used to treat parasitic infections, like toxoplasmosis and malaria.

Pyrimethamine is frequently used in AIDS patients whose suppressed immune systems allow frequent parasitic infections like toxoplasmosis. As opposed to the AddictingInfo headline, stating that pyrimethamine is a “60 year old cancer drug,” there is no evidence that it was ever a “cancer drug.” It may have been used as such 60 years ago, but today it is not.

So let’s review some of the issues around this drug, and what are facts, and what are most certainly not. But one more thing, does this price increase really matter?

Continue reading “Martin Shkreli – skyrocketing prices of an anti-parasitic drug”

Another flu vaccine myth – Big Pharma profits

another flu vaccine myth

There is a more general article – about the myth of Big Pharma vaccine profits – which has recently been updated and republished. 

The 2015-16 flu season is upon us, and that means it’s flu vaccine time again. And flu vaccine myth time. There is another flu vaccine myth – Big Pharma profits – that needs to be debunked.

Despite the availability of several flu vaccines, many people think that the flu is a painless, harmless disease, a belief belied by evidence. Wrong.

To put flu in perspective, in the USA, depending on the severity of the flu season, from 3,000 (which happened 25 years ago, and hasn’t been that low since) to 49,000 people die every year. Worldwide, about 250,000 to 500,000 people die from the flu every year. A flu pandemic, like the one in 1918, killed 50-100 million humans, much more scary than Ebola.

Of course, a fairly large group of people, including some who are pro-science (read, pro-vaccine), will fall into the arms of their favorite flu vaccine myth, and then refuse to get the flu vaccine. Given the dangers of the flu, and given the loss in productivity, income, and lives, you’d think that the flu vaccine would be near the top of health care needs for the average person.

My fellow blogger, Tara Haelle, spent numerous hours putting together the Top Myths about the flu vaccine. She debunks these myths completely out of the water. But antivaccination myths are never static, there’s always a new variant. Continue reading “Another flu vaccine myth – Big Pharma profits”

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”

Big Pharma vaccine profits – the real conspiracy

Editor’s note: The original version article was published in May 2013. A new updated version has been published using new and revised data. It has also been updated to improve readability and to add some new research into the burden of vaccine preventable diseases. The calculations for those costs  have also been revised. The comments for this article are now closed – please comment at the new article.

One of the ongoing memes, tropes and fabrications of the vaccine deniers is somehow, somewhere, in some Big Pharma boardroom, a group of men and women in suits choose the next vaccine in some magical way, and foist it upon the world just to make billions of dollars. And while magically concocting the vaccine brew, these pharmaceutical execs ignore ethics and morals just to make a profit on hapless vaccine-injured victims worldwide.

The Big Pharma profits conspiracy trope ranges across the junk medicine world. Homeopathy, for example, claims that Big Pharma suppresses the data that shows water cures all diseases. Like Ebola.

But the Big Pharma vaccine profits conspiracy is still one of most amusing myths of the antivaccination world. Continue reading “Big Pharma vaccine profits – the real conspiracy”