No admission

Let's establish something right from the outset.

Vaccines do NOT cause autism.

Clear enough?  If you are in any doubt, here's a site that provides links to exhaustive studies and meta-analyses that not only show no causative relationship between vaccines and autism, but that there is not even a correlation.

I.e., Andrew Wakefield was lying, and the anti-vaxxers are willfully putting their own children at risk of potentially deadly diseases that are entirely preventable.  As I've said now about 582 times.

The reason this comes up yet again is a webpage that I've now seen posted three times, with the title, "NOW IT'S OFFICIAL: FDA Announced That Vaccines Are Causing Autism!"

The article goes on to say the following:

You may be wondering: Why some of the doctors don’t say anything about the risk of DTaP Vaccine? 

That is a question that many of us, still wondering! Maybe they just is just not convenient for them that we know about the risk of these vaccine. 

To take the vaccine debacle further, most of the mandated vaccines for infants and children, contain many of the above ingredients, which must be stopped from being injected into infants, toddlers, teens and even adults! 

It’s time for Congress to rescind the “Get out of Jail Free” card for vaccine makers and stop the aggressive onslaught of the Autism Spectrum Disorder that is depriving children of a fulfilling life and ruining families emotionally, financially, and physically to the point of parents divorcing because of the stresses of ASD in a family.

The reason that "some of the doctors" (exclusive of frauds like Andrew Wakefield) aren't saying anything about the risk of autism from DTaP and other vaccines is that there is none.  There may well be kids who were diagnosed as autistic following their vaccinations; after all, most vaccines and most autism diagnoses both occur during early childhood.  But to associate the two is the Post Hoc, Ergo Propter Hoc Fallacy -- "after this, therefore because of this."

Let me say it again: multiple studies with huge sample sizes have found that the incidence of autism is no higher in vaccinated children than it is in unvaccinated children.  And vaccinating your children will keep them getting diseases like diphtheria, which back in the days before immunization, killed children by the thousands by making them, literally, slowly suffocate to death.

[image courtesy of the Wikimedia Commons]

So needless to say (or it should be), the FDA didn't announce any such thing.  If you bother to read the article, or (better yet) take a look at the FDA post that generated it, what you find is that the information the government published on the DTaP (diphtheria, tetanus, and pertussis) vaccine listed autism along with a dozen or so "reported adverse effects" -- but then said, and I quote, "Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine."

The important part is "reported voluntarily."  In other words, all you'd have to do is have a single parent call the FDA and lodge an official complaint that their child became autistic due to the DTaP vaccine, and it would be justifiably included on this list.  Nowhere does it says that the claim -- any of them on the list, in fact -- had been evaluated by a physician, or even confirmed to be the truth.  This isn't even at the level of anecdote.

This is at the level of "my aunt's best friend's gardener's second cousin's third-grade teacher said it was so."

If you think that I'm just a blogger with an axe to grind on this topic -- not entirely untrue, I must admit -- here's the piece that Snopes did on the subject.

It's unfortunate the FDA did that -- not that I'm in favor of suppressing information, bear you, but the last thing we (or they) really need is the anti-vaxxers to come howling out of the woodwork.  Not that they ever gave up, really, and it's amazing how much their campaign has worked, even among people who are otherwise pretty sensible.  I've seen more than one person claim they'd never get a flu shot because the year before, the vaccine gave them the flu (impossible, as the flu vaccine contains dead virus particles) and that there's no way they'd have their child receive the HPV vaccine because it can potentially cause brain damage (total bullshit, and especially horrifying given that the eradication of HPV would virtually eliminate the risk of six different particularly deadly cancers).

The message should be loud and clear.  Claiming that the risks of vaccination outweigh the benefits, or that the risk is even significant, is quite simply wrong.  Refusing to vaccinate your own children constitutes child endangerment, not to mention putting at risk children who can't receive vaccines for legitimate medical reasons (e.g. having a damaged immune system).

This debate is over.  It's time for the anti-vaxxers to stop screeching about coverups and shills and conspiracies by Big Pharma, and admit that they were wrong from the outset.

And along the way, admit that this has never been about evidence; it's about irrational fear and a never-say-die adherence to personal bias.

Milk of human kindness

I'm not a big believer in schadenfreude -- taking pleasure in other people's misfortune.  The habit of compassion is just too strongly ingrained in me.  But there are times that a person who richly deserves it receiving swift comeuppance is simply impossible to ignore.

Take, for example, the West Virginia lawmakers who passed a bill last week to legalize the sale of raw milk.  Raw milk was eliminated from the market in 1987, when the FDA mandated the pasteurization of all milk and milk products.  For good reason; there are a lot of bacteria in raw milk, and in fact the consumption of raw milk was a major pathway for the transmission of such horrible diseases as brucellosis and tuberculosis.

The FDA's statement on the topic is unequivocal:

Milk and milk products provide a wealth of nutrition benefits. But raw milk can harbor dangerous microorganisms that can pose serious health risks to you and your family. According to an analysis by the Centers for Disease Control and Prevention (CDC), between 1993 and 2006 more than 1500 people in the United States became sick from drinking raw milk or eating cheese made from raw milk. In addition, CDC reported that unpasteurized milk is 150 times more likely to cause foodborne illness and results in 13 times more hospitalizations than illnesses involving pasteurized dairy products. 

Raw milk is milk from cows, sheep, or goats that has not been pasteurized to kill harmful bacteria. This raw, unpasteurized milk can carry dangerous bacteria such as Salmonella, E. coli, and Listeria, which are responsible for causing numerous foodborne illnesses. 

These harmful bacteria can seriously affect the health of anyone who drinks raw milk, or eats foods made from raw milk. However, the bacteria in raw milk can be especially dangerous to people with weakened immune systems, older adults, pregnant women, and children. In fact, the CDC analysis found that foodborne illness from raw milk especially affected children and teenagers.

But there are always people who are (1) doubters of hard science, and (2) resent any government interference in their god-given right to do stupid stuff.  And when these two characteristics meet, we have problems.

So the lawmakers in West Virginia passed their bill allowing the sale of raw milk, and the delegate who sponsored the bill, Scott Cadle, decided to toast their success by drinking some.

The whole lot of them were laid low a day later by nausea, vomiting, and diarrhea.

[screen capture from video]

Of course, that's not enough for people who ignored all of the FDA's warnings to begin with.  Delegate Pat McGeehan, in between elbowing his fellow lawmakers out of the way to reach the bathroom in time, said, "I highly doubt raw milk had anything to do with it, in my case."

I think if I had to choose my least favorite common contagious disease, it would have to be stomach flu.  Fortunately, I don't get it often, but the time I had it the worst -- a never-to-be-forgotten twelve hour period of presumed food poisoning in Belize -- I would have happily jumped off a cliff to end my misery, had I had the strength to do anything other than kneel on the floor with my face in the toilet.  But even so, I have to admit I laughed when I read about this.  It's all very well to rail against government regulation, and I actually agree that governments often go way overboard in trying to license and regulate and restrict damn near everything.  (Take, for example, a law still on the books in Philadelphia that requires bloggers to purchase a $300 business privilege license, a practice that puts 99% of bloggers in the red.)

On the other hand, there are some regulations that are there for a reason, and the restrictions on selling unsafe foods are among them.  And as far as the sick West Virginia delegates, I hope they're all feeling better by now.

But I still think it's kind of funny.

Pharmacies, the FDA, and homeopathy

It seems like mostly what I cover in this blog is bad news.

People believing crazy stuff, bizarre actions people take (or refuse to take) because of their superstitious beliefs, mind-bending cases of illogic.  But today, I want to deliver some good news to anyone who thinks that rationalism and evidence should carry the day:

The FDA is finally moving toward taking a stand on homeopathy.

[image courtesy of the Wikimedia Commons]

Next Monday and Tuesday, April 20 and 21, 2015, from 9 AM to 4 PM Eastern Daylight Time, the FDA has actively solicited input from stakeholders regarding the preparation and sales of the preparations that homeopaths refer to as "remedies" but the rest of us call "water" and "sugar pills."  These stakeholders include, but are not limited to, "consumers, patients, caregivers, health care professionals, patient groups, and industry."  The hearing is to be held at the FDA White Oak Campus in Silver Spring, Maryland, and required preregistration (which unfortunately closed two days ago; I didn't find out about this until yesterday).  However, you can watch a live webcast of the proceedings if you're so inclined (information about how to do this can be found here).

Even if the opportunity to present publicly has passed, you can still voice your opinions to the FDA review board in writing until June 22.  Here are the questions they are trying to resolve:

• What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
• What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
• Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
• Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
• Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
• A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
• Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
• Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

If you are a medical researcher or health care provider, it's crucial to get information to the FDA that would give them leverage to remove these worthless "remedies" from pharmacy shelves.  It's critical, however, that any submissions not be simple rants.  Make them evidence-based, and specific to the questions for which the FDA is seeking information.  Sharon Hill, over at Doubtful News, directs you to frame your responses thusly:

If you are in the medical profession, I HIGHLY RECOMMEND YOU SPEND SOME TIME TO SUBMIT COMMENTS.  If you have pertinent info as an educator, parent, or consumer, your voice is needed also...  You can submit either electronic or written comments to http://www.regulations.gov or Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Organize your comments to identify the specific questions or topic to which they refer and be sure to reference the docket number.

Let me reiterate what I've said before: there is no scientific evidence that homeopathy works, and no logical mechanism by which it could work, given that the dilutions involved result in there being not a single molecule of the original active ingredient left by the time the preparation is sold.  There is no reason these quack cures should be sold in pharmacies, even with any number of disclaimers on the label, given the potential for uninformed or misled consumers to take them rather than seeking out legitimate medical help.

And high time for the FDA to take a stand on this.  Let's make sure that they get the information necessary for it to be the right stand.