Anti-vaccine education – ignorance about science and 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 without 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 about science and about finance”

Italian court vaccine autism ruling – caused by unreliable expert

Italian court vaccine autism

On the 23 of September, 2014 a judge in the Labor Court of Milan awarded compensation (pdf, translated from Italian) to a child on the theory that the hexavalent vaccine manufactured by GSK – which protects children against polio, diphtheria, tetanus, pertussis, invasive disease Haemophilus influenzae type B and hepatitis B – caused the child’s autism. Essentially, the Italian court vaccine autism ruling seemed to state that vaccines caused autism.

The decision was based on an expert’s opinion that made several extremely problematic arguments, arguments that go against the scientific evidence. It has been criticized by the Italian scientific community (translated summary, pdf), and is, apparently, being appealed.

This post explains the reasoning of the decision, and why it is fundamentally flawed.

Continue reading “Italian court vaccine autism ruling – caused by unreliable expert”

Incompetent Italian court vaccine ruling – good comedy

 

Professor Dorit Reiss recently posted an article here about a 2014 ruling from an Italian court in Milan that awarded compensation to a child that was claimed to have developed a neurological deficit after receiving GSK’s hexavalent vaccine, which protects children against polio, diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type B and hepatitis B. Essentially, the decision was based on one so-called “expert” who seemed to think the tropes of the antivaccination world were scientifically based.

Professor Reiss pretty much debunks the legal arguments for that case by actually reviewing the court ruling rather than accept the word of various biased blogs and “news reports” out there in the world.

Of course, I’m not a legal scholar (nor do I play one on the internet), but Italy’s reputation as the center of legal interpretation of science is almost at the level of good comedy given its history. Italian court vaccine rulings would be great comedy if only it didn’t put children in harm’s way.

Remember, a previous Italian provincial court decided that vaccines cause autism, by accepting MrAndy Wakefield fraudulent claims over the consensus of science–vaccines do not cause autism. Update–an Italian appeals court overturns this Italian court vaccine ruling because of the lack of scientific evidence.

And let’s not forget about the Italian court that convicted six geologists for manslaughter because they could not accurately predict earthquakes (which no one can do, unless you’re a psychic). If this weren’t actually true, you’d think I was making this stuff up. Continue reading “Incompetent Italian court vaccine ruling – good comedy”

FDA approves first vaccine to prevent H5N1 avian influenza

H1N1_versus_H5N1_pathologyOn 22 November 2013, the US Food and Drug Administration (FDA) announced that GlaxoSmithKline’s vaccine against H5N1 avian influenza was approved for use should the virus threaten to become epidemic in human populations. GSK’s Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, has also received regulatory approval  in Europe and Canada under the brand names, Pumarix™ and Arepanrix™ H5N1, respectively. Though it is not available for commercial use, the vaccine will be added to the national stockpile and distributed by public health officials if such an epidemic were ever to arise.

“This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”

The evaluation of safety compared approximately 3,400 adults 18 years of age and older who received the vaccine to about 1,100 adults who received placebo in a multi-center study (a type of study that can be ethically performed when the risk of the preventable disease is expected to be near 0 during the time of trial). The most common side effect reported during the clinical studies among the vaccine recipients was injection site pain. Muscle aches, headache, fatigue and injection site redness and swelling were also common, but no serious side effects were observed. To determine the effectiveness of the vaccine, the immune response was evaluated in about 2,000 of the vaccinated adults. The results of the study established that approximately 91% of individuals between the ages of 18 and 64 years and 74% of individuals 65 years and older who received the two-dose regimen developed sufficient levels of antibodies that would prevent infection by the disease.

According to the Centers for Disease Control and Prevention (CDC), the H5N1 influenza has relatively rare. The CDC has reported that more than 600 human H5N1 cases have been reported to the World Health Organization from 15 countries in Asia, Africa, the Pacific, Europe and the Near East since November 2003.  Approximately 60 percent of individuals with documented H5N1 disease have died. Evidence has shown that the virus is highly pathogenic by causing a deadly pneumonia. In addition, there are several studies that have shown that H5N1 can be easily transmitted to humans from avian species through respiratory droplets.

The new vaccine, approved for use in people over the age of 18 who are at increased risk of exposure to the virus, is the first US-approved H5N1 vaccine that contains an adjuvant to boost the body’s natural immune response to the virus, and despite ongoing debate over the safety of such adjuvants, the new vaccine is “the first to show it can confer protection in the event of a pandemic,” Reuters reported.

This vaccine will save lives, many lives, in case of an avian flu epidemic. 

If you need to search for scientific information and evidence about vaccines try the Science-based Vaccine Search Engine.

Key citations:

GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior

Recently, the US Department of Justice ordered the pharmaceutical giant, GlaxoSmithKline (GSK), to pay $3 billion in criminal and civil liabilities in the largest healthcare fraud settlement in US history. Basically, GSK was caught promoting several drugs for unapproved uses, failing to report safety data, paying kickbacks to physicians, and price reporting. Let’s look at the fraud charges one by one.

Unapproved uses (or off-label uses). By law, pharmaceutical companies are only allowed to market drugs according to what is stated in their package labeling which is approved by the FDA. Off-label uses are the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. Physicians are legally allowed to prescribe drugs off-label (as long as it is not contraindicated), but the pharmaceutical company cannot directly or indirectly influence off-label use. In most cases, off-label use isn’t dangerous, nor is it particularly unethical.

GSK was accused of unlawfully promoting Paxil, an antidepressant, for treating patients under the age of 18, even though it lacked FDA approval for pediatric use. GSK participated in “preparing, publishing and distributing a misleading medical journal article that misreported a clinical trial of Paxil that demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” What was most troubling was that GSK did not balance its study with data from two other studies in which Paxil failed to demonstrate efficacy in treating depression in patients under 18. Typical of this type of marketing, GSK sponsored dinners, lunches, spas, and similar types of programs to promote the off-label use of Paxil in children. It’s also important to note that Paxil includes a “black box warning“, the strongest FDA warning for a pharmaceutical product, that states that antidepressants make increase suicidal ideation and behavior in patients under 18. Continue reading “GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior”