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”

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”

The one study to rule them all–the vaccine denier’s dream

If you spend any time in the “debate” (actually, one side has scientific evidence and the antivaccination side denies all science, so to avoid falling for a false equivalency, debate gets scare quotes), you’ll hear every dumb argument to deny science. But one thing that you’ll see repeatedly from the vaccine deniers is that they would support vaccinations if there were better clinical trials.

The problem with the vaccine denier’s clinical trial proposals is that they are a moving target, 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 dozens of articles, including one of the latest (published here and discussed here).

The actual process for vaccine clinical trials.
The actual process for vaccine clinical trials.

My good friend Allison Hagood, co-author of Your Baby’s Best Shot: Why Vaccines Are Safe and Save Lives, wrote a commentary about the antivaccine community’s perfect clinical trial. Follow along! (Allison’s commentary is presented in whole, but I’ve edited the formatting and added links where necessary).

Continue reading “The one study to rule them all–the vaccine denier’s dream”

Multivitamins–big money, no effect on cardiovascular disease

A few months ago, I wrote about the role of supplements, mainly vitamins and other nutrients, in preventing cancer. Conclusion: they didn’t. To quote Martinez et al., who published a review of dietary supplements and vitamins in cancer prevention

Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk. 

All those expensive supplements, most of which have broad and unproven claims made about them, do precious little for cancer. And some actually increase the risk of certain types of cancer. Continue reading “Multivitamins–big money, no effect on cardiovascular disease”

Vaccine to block gluten sensitivity in celiac disease

Celiac disease (also known as coeliac disease in British English speaking countries) is an autoimmune disorder that afflicts the small intestine of certain  individuals who are genetically predisposed to it. The disease afflicts between 1 in 1,750 and 1 in 105 people in the United States (or about 200,000 to 3,000,000 people) and usually, but not always, results in chronic diarrhea, low pediatric weight gain, and fatigue. This disease is caused by a reaction to a gluten protein found in wheat, and similar proteins found common grains such as barley and rye

Upon exposure to gluten, the immune system causes an inflammatory reaction of the lining the small intestine. This interferes with the absorption of nutrients. The only known effective treatment is a lifelong gluten-free diet. This disease should not be confused with wheat allergy, which is also caused by a reaction to wheat proteins. Continue reading “Vaccine to block gluten sensitivity in celiac disease”

Debunking the “vaccines aren’t tested” myth

There are so many silly memes that have arisen from the anti-vaxxers, all of which have been thoroughly debunked. Everything from the well-worn (and worn-out) “vaccines cause autism” fable, 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 denialists 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™. Continue reading “Debunking the “vaccines aren’t tested” myth”

Placebos cannot replace antipsychotics

As I’ve discussed previously, placebo effects are mostly a myth, and if a new drug has an effect barely above that of a mythical placebo effect, it’s considered a failure. In a recent article in Reuters Health, Rising placebo response seen in schizophrenia trials, Amy Norton states that clinical trials of anti-schizophrenia drugs, in a class of drugs called antipsychotics, are finding lesser effects because patients are responding positively to placebos (that presumably does not contain anything but sugar).

Treating schizophrenia or any psychosis is difficult because different patients respond in different ways to each drug. For some individuals, these drugs can treat many of the symptoms of schizophrenia, including hallucinations and delusions, which allows them to live relatively normal lives. But for some individuals these same drugs have significant side effects, including sedation, weight gain, and hyperglycemia (which can be serious for a diabetic). Eventually, individuals stop using the drugs because of the side effects and their psychotic symptoms return. Continue reading “Placebos cannot replace antipsychotics”